Illustrative image for Catastrophe Ethics and Charitable Giving

Bioethics Forum Essay

Catastrophe Ethics and Charitable Giving

by Travis N. RiederPublished Posted in Climate Change, Environmental ethics, Hastings Bioethics Forum

How can we live a morally decent life in a time of massive, structural threats that seem to implicate us at every turn? Climate change is the paradigm example here, as it poses devastating risk to current and future people, and virtually everything we do contributes to it through the emission of greenhouse gases. So, if I’m trying to carve out a justifiable life, how should I respond? Am I permitted to fly? Should I buy an electric car? Go vegan?

These are the central questions of my new book, Catastrophe Ethics: How to Choose Well in a World of Tough Choices. Of course, none of my little individual actions will have a meaningful impact on the climate. Even the choice to take a flight—which is one of the more environmentally expensive things many of us will do—contributes an infinitesimal fraction to the trillions of tons of greenhouse gases accumulating in the atmosphere and raising the global temperature. So, is it not a bit precious to worry about each thing I do? This tension between feeling implicated in massive structural harms and being largely incapable of making an impact on those harms is what I call The Puzzle of individual ethics in an era of collective catastrophe.

Although the idea for the book was born out of climate angst, one of the central hooks is that our modern world is so massive and complex that the structure of The Puzzle replicates in many areas of our lives. Many of our purchases make us participants in exploitation. Our electronics likely rely on modern day slavery overseas, and our favorite brands may use sweatshop labor or support union-busting.

In writing the book, I was surprised to discover that charitable giving is also part of the broad discussion of how to live well in such complicated times. As Judith Lichtenberg notes in her discussion of “The New Harms,” the way in which our participation in massive harms quickly becomes overwhelming and can feel intensely demanding parallels the now-old debate about how much we are obligated to give to charity in an effort to relieve suffering. In my terminology: the ethics of charitable giving feels a bit like catastrophe ethics.

This led to an experiment of sorts. Since I was writing a trade book, for which I would earn royalties by thinking about catastrophe ethics, I decided to donate some of my proceeds to a charitable organization. But which one? Could the work I was doing help me to choose?

I decided to find out.

Lessons from Catastrophe Ethics

Among my key findings, the first, perhaps most crucial, one is the following: Because our individual contributions to massive, structural harms don’t make a meaningful difference to reducing those harms, philosophers like Walter Sinnott-Armstrong are correct to note that we therefore are not obligated to refrain from making those contributions. But it would be wrong to infer that, as a result, nothing we do matters morally. Not everything that is morally permissible is good or recommended; I may do something that is within my rights, but that is nonetheless some flavor of bad, vicious, or otherwise crappy.

I characterize this first lesson as the insight that we have reasons to respond to catastrophes, even if we aren’t duty-bound to do so.

Second, then, and especially important for our discussion of charitable giving: The threat of catastrophe gives us reason to respond in different ways. There are negative reasons—that is, reasons not to be part of the problem and therefore to avoid doing things that contribute to it. And there are positive reasons—reasons to be part of the solution, like advocating for social reform, getting involved in political solutions, and giving our resources (time and money) to efforts to generate change. Indeed, activists like Mary Annaise Heglar argue that the positive reasons are in fact more important than the negative ones; despite working in the climate movement, she doesn’t care if you recycle, but she wants you in the climate fight.

This is how charitable giving becomes directly implicated in catastrophe ethics. Some people have more money than time to give to any cause. And if the massive threats of today ground reasons both not to be part of the problem (negative reasons) and reasons to be part of the solution (positive reasons), then, plausibly, many of us have good reason to give money to all sorts of organizations trying to mitigate the harms we face.

Triaging Reasons

How, then, do we organize the mass of reasons grounded in the many catastrophes we face?

In my view, because we do not have a duty to respond to catastrophe in a particular way, we have latitude to determine how to act, and so how to live a life that is justifiable. There is far more to be done than any one of us could ever do, and so I propose a kind of division of moral labor: each of us gets to decide how to respond based on our subjective values, interests, passions, strengths, and privilege.

In addition, I think there are special reasons for some of us to include particular ways to respond, and this is due to our social and economic positions. As a 21st century American, I am not well-positioned to significantly reduce my carbon footprint: I live in a car-based society, our electric grid has not quickly decarbonized, and my job and family require a lot of travel. Thus I, like most Americans, have a relatively high carbon footprint. But any success I enjoy is also due significantly to the massive extractive enterprise of American history: I get to live the life I do because America has emitted, since the Industrial Revolution, more greenhouse gases than any other country. One way to think of this is that I have an enormous amount of climate privilege, and I’m continuing to contribute to climate change in an outsized way.

Thus, while there are some harms I can extract myself from (for instance, I can boycott companies that utilize slave labor), I cannot adequately respond to the negative reasons generated by climate change. And the fact that I’m continuing to benefit from climate change—which is causing and will continue to cause serious harm—makes me a participant not just in harm, but in injustice.

These features together suggest to me that I have especially strong reasons to, as Heglar says, “join the climate fight” by responding to the positive reasons to create change.

The Judgment: Where to Donate

At the end of this reasoning, I came to a few conclusions about my charitable giving. One is perhaps best summarized as a response to the philosophy of effective altruism, which recommends donating as much money as you can to the most effective organizations, so that you do as much good as possible.

While I think there is a lot of moral weight to the idea of “doing as much good as you can,” there is more to the ethics of charitable giving than just that. I have special reason to donate to climate organizations because of my position as a beneficiary of America’s extractive economy. And because of my career and my interests, I know a lot about climate change, and so feel well-positioned to choose organizations that do important work. Finally, because we are allowed latitude in the way we respond to catastrophic threats, each of us can choose according to our values.

Based on this reasoning, I decided to donate a portion of the proceeds from my book to the organization Cool Earth, which protects the rainforest, but does so in a specific way: by investing in Indigenous peoples and local communities. Cool Earth’s efforts not only contribute to environmental conservation, they also address broader issues of social justice, equity, and human rights in the context of climate change. By engaging with local communities, promoting sustainable practices, and advocating for the rights of Indigenous peoples, Cool Earth exemplifies a holistic approach that integrates environmental protection with social empowerment and ethical considerations.

Because I believe in wide latitude concerning how each of us responds to catastrophe, I don’t think anyone reading this has an obligation to support Cool Earth. However, I do believe that many people are like me in relevant ways: They would like to respond to climate change; they have benefitted from historical emissions and contribute in an outsized way to ongoing emissions; and they have the means to donate to charity. For such folks, I believe the reasons commend giving to organizations like Cool Earth.

They are in the climate fight, and giving is one way that we can join them.

Travis N. Rieder, PhD, is associate research professor at the Johns Hopkins Berman Institute of Bioethics, where he directs the Master of Bioethics degree program. He is a Hastings Center fellow. @TNREthx

red dna against black background

Bioethics Forum Essay

How to Avoid a Genetic Arms Race

by Yelena Biberman and Jonathan D. MorenoPublished Posted in Genetics, Hastings Bioethics Forum

A quiet biological revolution in warfare is underway. The genome is emerging as a new domain of conflict. The level of destruction that only nuclear weapons could previously achieve is fast becoming as accessible as a cyberattack.

Now for the bad news. Great power conflicts and proxy wars are back. The rules-based world order crumbles while an unpredictable–and potentially unstable–multipolar one emerges.

Rapidly accelerating breakthroughs in our ability to change the genes of organisms are generating medically thrilling possibilities. They are also generating novel capabilities for biological weapons, a form of warfare that has been largely abandoned for decades. Take the recent AI-enabled advancements in gene-editing, construction of artificial viral vectors for human genome remodeling, protein folding, and the creation of custom proteins. Far outpacing the regulatory environment, these advances are facilitating the weaponization and delivery of harmful bioagents–overcoming impediments that previously made biological weapons impractical.

Speculation about “genetic weapons” capable of singling out specific groups for infection dates back to the 1970s. In 2012, Vladimir Putin mused publicly about weapons that could be “as effective as nuclear” but “more ‘acceptable’ from the political and military perspective.” He predicted that nuclear weapons would, over the next half- century, become eclipsed by “fundamentally new instruments for achieving political and strategic goals.” The future of war, he said, is “based on new physical principles,” including “genetic” science.

The 2020 edition of Science of Military Strategy, an authoritative textbook published by China’s National Defense University, considers how biotechnology could serve as “a brand new territory for the expansion of national security” with “the use of new biological weapons, bioterrorism attacks, large-scale epidemic infections, specific ethnic genetic attacks, the purposeful genetic modification of the ecological environment, food and industrial products, and the use of environmental factors.”

Although its intelligence community’s 2016 worldwide assessment described genome editing as a potential “weapon of mass destruction,” the United States has been slow and reluctant to face the new challenge. One reason is that it is not clear what this challenge is, how bad it actually is, and what requires immediate attention.

Biodefense in the Age of Synthetic Biology, a report by National Academies of Sciences, Engineering, and Medicine developed at the behest of the U.S. Department of Defense, has since its publication in 2018 been the main guide to understanding probable biological threats. It advised paying more attention to the possibility of recreating known pathogenic viruses, making existing bacteria more dangerous, and making harmful biochemicals via in situ synthesis. It was not without blind spots, however. For example, it considered gene drives only as applied directly to humans, ignoring the more indirect strategic applications, such as agricultural.

In his recent book, zoologist Mathew Cobb admits to being most concerned about gene drives and human genome editing, in addition to pathogen manipulation. A recent RAND report directs attention also to the Internet of Bodies (internet-connected smart consumers and medical devices) and genomic surveillance and enhancement.

Nor is the generation of basic genetic data simply the province of sophisticated laboratories. Many elaborate datasets are open source and online, facilitating scientific exchange. Although most genetic data are de-identified, future technologies may be able to re-identify them. The Biden administration appreciates this threat. On  February 28, the president signed an executive order seeking to prevent the sale of bulk sensitive personal data. The executive order has a legal basis in the National Emergencies Act and International Emergency Economic Powers Act and notes the need to “protect United States persons’ sensitive personal health data and human genomic data from the threat identified in this order.” That threat is the “continuing effort of certain countries of concern to access Americans’ sensitive personal data.”

Amid the apparent collapse of the post-World War II rules-based order, one of the worst things that could happen is a genetic arms race for which international conventions are unprepared. The Biologic and Toxin Weapons Convention bans proliferation of bioagents and toxins that have no peaceful use, but it has no formal verification regime system. There was at least one alleged case of noncompliance by the Soviet Union in 1981 involving a weaponized fungus, far from the exquisite genomic targeting that may eventually be practicable.

The convergence of genetic technologies and intense competition among highly motivated actors along with historic geopolitical shifts requires the attention of the international life sciences community and bioethicists to establish guidance for what was once a threat in the realm of science fiction.

Yelena Biberman, PhD, is an associate professor of political science at Skidmore College.

Jonathan D. Moreno, PhD, is the David and Lyn Silfen University Professor of Ethics at the University of Pennsylvania and a Hastings Center fellow. @jonathanmoreno.bsky.social

Syrian refugee camp

Bioethics Forum Essay

In the Shadow of War: Health Conditions in the Za’atari Refugee Camp

by Sana BabanPublished Posted in Hastings Bioethics Forum, Health and Health Care

As our bus rumbled through the cool desert landscape, the lively chatter among the mission volunteers was swallowed by a sudden and collective hush as we spotted our destination. Emerging like a mirage after an hour and a half of travel, we entered a city that was unlike any I had ever seen before. Built up of makeshift metal shelters and the resilience and sheer determination of those who call it home, we entered Za’atari, the world’s largest refugee camp for Syrians.

In January I traveled to Jordan as a medical volunteer with SAMS (Syrian American Medical Society) to provide medical care to refugees in the Za’atari camp. Since the start of the Syrian civil war in 2011, it is estimated that over 14 million Syrians have been displaced by conflict and forced to flee their homes in search of safety and shelter. Over 5 million displaced Syrians live as refugees in camps, settlements, and host communities in neighboring countries. Created in 2012, the Za’atari refugee camp now houses 80,000 Syrian refugees. At points in its history, it has been the fourth largest city in Jordan, a country the size of the state of Maine with a population of over 10 million. 

While working as a medical volunteer in the SAMS clinic at the edge of the camp, I quickly realized I was in a clinical environment I had never seen before. Despite my training in bioethics and my knowledge of theories of resource allocation and distributive justice, I was unprepared for the sheer scale of medical needs among the refugees I was there to serve, and for what resource scarcity meant under these conditions.

Most of the physicians I had traveled with brought medical equipment with them. Everyone improvised, fashioning Dixie cups into inhaler masks for babies and using iPhone flashlights during dental extractions. We could not offer lab tests; there was no lab. Follow-up care would be available six months later –the next time a SAMS medical mission trip would be back at Za’atari camp. We were unable to promise referrals to patients, and there was no guarantee they could see a specialist. The need for specialized medical care, such as dermatology, was so great that fights among refugees would break out in the clinic as it became evident that we would not be able to accommodate all the patients needing to be seen.  

During our six-day medical mission, over 90 volunteers and physicians treated upwards of 4,000 people, including 3,500 seen in the clinic and 600 who were transferred to regional hospitals for specialist procedures and surgeries by other physicians on the mission. We knew that what we could do in a week was severely limited and usually would not solve the daunting problems our patients faced. Yet we also knew that, for these 4,000 people, being seen by a medical mission team once every six months was often the extent of their access to specialized medical care.

Underlying this entire experience was my constant awareness that only 90 miles west of us, Palestinians in Gaza were experiencing a dire humanitarian crisis. It was impossible to ignore the realization that the harrowing living conditions at Za’atari would be the best-case scenario in Gaza. If Palestinian civilians in Gaza survive the multiple threats in a resource-starved war zone – bombings, shootings, disease, starvation–and escape or are forced out of Gaza, they will end up in a refugee camp. If living in a densely packed refugee camp is the best outcome for traumatized civilians escaping conflict, we have miserably failed one of the world’s most vulnerable populations.  

Some of the refugees at Za’atari have lived in the camp for more than 10 years, and their medical needs have changed over time. The worst things we saw were not disfiguring war wounds, but treatable health conditions that had become debilitating due to lack of medical care. While the scars, burns, and wounds of war were evident on people’s bodies, it was uncontrolled asthma, respiratory infections, and decaying teeth that impaired their everyday lives. These chronic conditions were caused and worsened by living conditions they had no ability to change. Mold growing in the shelters, and desert sand, caused respiratory illnesses. The cheap, high-sugar diets rotted their teeth. Poverty, displacement, and lack of health care are the chronic comorbidities of Syrian refugees.

Ten years ago, during the Syrian civil war, the horrors of that war were front-page news, as Gaza is today. The continued suffering of displaced populations who have no way back home–because their homes have been destroyed–no longer commands the world’s attention. They are forgotten, their futures dismissed, and their aspirations abandoned. The refugee camps that were meant to be temporary solutions have become permanent. Displaced Palestinians have and will continue to suffer the same fate as Syrian, Rohingya, Somali, and Sudanese refugees.  

The horrors of the Syrian civil war include the long-term physical and psychological effects of conflict and displacement. In response, SAMS has been increasing the capacity of its medical missions, hoping to provide more medical treatment to a population that desperately needs it. Several other groups offer care inside the camp, including Doctors Without Borders, International Medical Corps, and the Jordanian Red Crescent. Yet, it is still abundantly clear that more medical care, resources, and support are desperately needed there.

Despite the harrowing reality that the Syrians who have survived and escaped war now face, many remain hopeful that, one day, they will return to their homes. The international community must recognize war and displacement as a collective issue, not an individual one. Jordan is a country that continues to be exemplary in addressing the world refugee crisis by taking in hundreds of thousands of refugees, including them in national health care and education systems, and providing access to livelihood opportunities within the country. Vastly wealthier countries have much to learn from Jordan. But if we can achieve this imperative shift in thinking about the refugee crisis as a collective responsibility, perhaps the international community will finally see and respond to the humanity of displaced and refugee populations, rather than despairing about and then forgetting their suffering.

Sana Baban, MBE, is a project manager and research assistant at The Hastings Center. She will begin medical school later this year. @sana_baban

clinicians meeting around a table

Bioethics Forum Essay

Emerging from the Cacophony of Clinical Ethics Consultation

by Fahmida HossainPublished Posted in clinical ethics, diversity, equity, inclusion, Hastings Bioethics Forum

Seated in a conference room surrounded by a group of animated clinicians during a family meeting, I found myself a bit bewildered during the first weeks of my clinical ethics fellowship. I was uncertain of what was expected of me. What were they discussing? Why were they speaking so quickly and over one another?

I am confident in my abilities and pride myself in being a quick learner, yet this moment was disquieting. I had been transported into a different world. I remembered the simulation cases we did during my PhD program in bioethics. There, I effortlessly played the role of a clinical ethicist. However, this experience was starkly different.

As a new clinical ethics fellow, I was full-in with a team of seasoned clinicians. I grappled with the relentless buzz of medical jargon and information coming piecemeal from multiple directions simultaneously. The staccato of the conference room was a far cry from the academic calm training simulations back in grad school.

But I had underestimated the challenges I would face as an English-as-a-second-language (ESL) speaker when immersed in the dynamic space of the hospital. I take pride in my English proficiency. I came to the United States from Bangladesh for my advanced degrees, taught classes, presented talks, facilitated training sessions, and published papers—all in English. But this was different. This was like learning a third language.

I am not a clinician, but I am a curious observer grounded in theory and academia. Being an outsider has been a strength. As a nontraditional clinical ethicist, I have had a distinct perspective on the cultural nuances in the hospital. In that delicate space, language holds significant weight, with some meanings left unsaid and others only understood through the familiarity of experience. All this should have been a positive. But it was incredibly hard to piece together.

And it was a bit embarrassing. In the hospital’s go-go pace, I often sensed that people assumed that I was slow, missing the point, or not fully engaged. The nagging question was: How would I navigate these new waters and assume my new role as an ethics consultant? The challenge of grappling with all the intricacies and nuances of this truly foreign language made me doubt my ability to contribute in a high-paced, high-stakes clinical setting. Indeed, I questioned my suitability to become a clinical ethicist.

I did a bit of diagnostics and quickly realized that excellence in clinical ethics demanded mastery of another language of medical facts and linguistic shorthand that was often heavy-handed, jargon-laden, and incomprehensible to the nonclinician. This discourse was distinct to my ears as an ethics-educated entrant and a nonnative English speaker new to the clinic.

In addition, three formidable challenges stood in my way. First was the medical jargon spoken in the fast-paced and emotionally laden space of a consultation. Second was the stress of these situations. It was emotionally challenging for everyone, and the performative nature of the meeting compounded the difficulty in comprehending what people were really saying. Finally, there were the cultural values that I brought to the role. I had been acculturated, as a South Asian woman, to be submissive rather than assertive and not to speak up. The fear of others judging me as a brown non-Westerner added another layer of complexity.

With a bit of trepidation, I began to share my concerns with my very supportive team. Reflecting on my journey, I find solace in the warm embrace of my mentors and colleagues and their welcoming receptivity. Together, we embarked on a learning quest and tailored the expectations for my professional development to my unique background. Hours were spent in earnest conversation, seeking solutions to my challenges. I pushed, and we brainstormed, identifying three key strategies that could make a significant difference.

Firstly, my peers needed to appreciate that I was neither a native English speaker nor a clinician. Secondly, I proposed one-on-one communication with clinicians in a relatively quiet setting, helping me understand the case situation we were working on and allowing me to bring that knowledge with confidence into the team meetings. And, finally, I advocated for a structured pause and debrief after each encounter, providing a space for reflection and guidance with my mentors.

These steps proved invaluable for my educational needs. Through many late-night catch-up sessions, I began to learn how to decipher signals from noise during consult meetings and turn cacophony into intelligible conversation. I gained insight into the overarching and recurring themes of a case. I learned to detect and dissect each conversation segment, mastering the art of absorption and articulation. I wish I had reached out sooner for help.

What have I learned that can help other ESL ethics consultants? I’ve realized that despite our proficiency in English, we often require more time—even if it’s only a few seconds—to respond. Rather than this being viewed as a hindrance or deficiency, we need to reframe it as something positive. Slowing the pace and being more deliberate can yield valuable insights, uncovering perspectives and process improvements that can be hidden within the rapid, get-it-done flow of medical conversations. A slower pace can be calming and make possible a more nuanced analysis that might otherwise be overlooked.

To my knowledge, I am the first woman from Bangladesh undergoing training in clinical ethics in the U.S. I hope that I am not the last. My experience should be instructive to those who will train the next generation of clinical ethicists. If the call is for a more diverse workforce in clinical ethics to meet the needs of an increasingly diverse patient population, then fellowship programs must adapt to nontraditional fellows like me. As a group, if given the chance and the support, we will enrich the discourse in the clinic.

I look forward to being part of that conversation.

Fahmida Hossain, PhD, HEC-C, is a medical ethics fellow at Weill Cornell Medicine.

Acknowledgement:

I acknowledge and am indebted to Dr. Joesph J. Fins for encouraging me to share my insights and experiences as an emerging clinical ethicist. His support, guidance, suggestions, and deep conviction that open discussion of these matters benefits all in the field provided grounding, commitment, and courage to write this piece. I further acknowledge my colleagues in the Division of Medical Ethics and the clinicians of Weill Cornell for offering a hospitable clinical space.

logo and title of the World Health Organization

Bioethics Forum Essay

Financing Reforms to Meet a Pivotal Moment in Global Health

by Kevin A. Klock, Alexandra Finch and Lawrence O. GostinPublished Posted in Global Health, Hastings Bioethics Forum

In May, the 194 member states of the World Health Organization (WHO) will decide whether to adopt two international instruments with the potential to transform how the world prepares for and responds to pandemic threats: reforms of the International Health Regulations (IHR) and a new pandemic treaty (dubbed the pandemic agreement). Each draft instrument contains bold new commitments for disease surveillance, capacity building, and more equitable access to health products, and we discussed the strengths, limitations, and ethical foundations of these proposals recently in the Hastings Center Report. But none of these reforms can be achieved without ample and sustainable funding.

Financing takes two broad forms: shoring up WHO’s financial base allowing it to implement a global health agenda unfettered by the demands of a small set of donors and funding to underwrite low- and middle-income countries’ activities under the new instruments. In this essay, we discuss these major reforms and then explore the significant challenges and opportunities for financing them.

Proposed Reforms and Why They Matter

This year will be the most important moment for global health since WHO’s founding in 1948, but only if states give major reforms their full political and financial backing.

The Pandemic Agreement

In response to Covid’s profound preparedness and response shortcomings, 25 heads of state and international agencies issued an extraordinary joint call for a new pandemic agreement that would have the force of international law. The World Health Assembly (WHA) established an intergovernmental negotiating body to draft and negotiate the agreement, with core obligations that could make the world healthier and safer, and with equity as its north star.

One Health. The One Health approach is sometimes called deep prevention because it addresses the major drivers of disease outbreaks, including anthropogenic, ecological, and environmental risks. Most infectious diseases have zoonotic origins, whereby animal infections spill over to humans. Climate change, deforestation, intensive animal farming, and trade in wild animals bring animals and humans into closer proximity, sparking spillovers. The draft text of the pandemic agreement released this month creates norms for a range of One Health commitments, but actual obligations to develop financial and technical support mechanisms needed to fulfill these commitments take effect only “as appropriate”–language that serves as a legal escape hatch. Resource-constrained nations accordingly feel they are being cajoled into these responsibilities with few assurances that funding to underwrite them will follow. The failure from governments to provide even modest resources may miss an opportunity morally and financially, as pandemic prevention would cost just a fraction of that of a full-scale pandemic–by one account representing less than 1/20th of the value of lives lost to emerging pathogens.

Equitable access to countermeasures. Inequitable access to life-saving vaccines and other countermeasures became one of the major themes of the Covid crisis. The WHO-led COVAX facility was formed to facilitate vaccine equity, but COVAX’s work was thwarted by high-income countries, which gobbled up early vaccine supply resulting in scarcity and unaffordable prices to others. By the end of 2021, vaccination coverage was close to 75% across high-income countries compared to less than 2% in many low-income countries, falling well short of COVAX’s 20% coverage target. This cannot possibly be an acceptable outcome.

The draft agreement attempts to remediate this disparity in future pandemics by incorporating obligations to build national, regional, and international clinical trial and research and development capacities in low- and middle-income countries and promote open scientific exchange. The draft also calls on countries to include terms in publicly funded research and development agreements that effectively condition the provision of public money on manufacturer commitments that enhance equity during health emergencies, such as on licensing, affordable pricing, technology transfer on voluntary terms, and adherence to WHO product allocation frameworks. The draft would establish a WHO-run global supply chain and logistics network to avoid competition for vital resources and attempts to promote the transfer of technology and know-how. The African bloc, however, has slammed the use of waffling language that eschews any attempt to hold high-income countries to account for failing to fulfill their obligations to ensure equity. Others bemoan the potential disruption these reforms could make to the research and development ecosystem that already disincentivizes investment in vaccines.

As we write, the make-or-break issue is the construction of a workable system of pathogen access and benefit sharing (PABS), drawing inspiration from the WHO’s Pandemic Influenza Preparedness (PIP) Framework, pursuant to which countries would share pathogen samples and associated genetic sequence data discovered within their borders with a network of WHO-coordinated laboratories. Manufacturers that create viable countermeasures using PABS samples or data would then provide 20% (10% free of charge and 10% at reduced prices) of their real-time production through WHO’s global supply chain network for distribution based on public health risk and need. Manufacturers would also annually contribute funding for the PABS system and make voluntary nonmonetary contributions to support it, including guarantees on tiered pricing, scientific collaboration, capacity-building, and arrangements for the transfer of technology and know-how.

Proponents hope that codifying legal obligations on PABS would support global health security and justice. However, the draft is silent on how manufacturers, universities, and other private users–who are not traditionally considered actors under international law subject to treaty obligations–will be persuaded to use the system or whether ratifying nations will use their domestic lawmaking power to require it. Manufacturers might also elect not to create low return-on-investment products such as vaccines, so a workable PABS has to contemplate how to keep them engaged. Nonetheless, establishing a strong PABS system through the agreement is vital, as 290 scientists recently warned that without it vaccine inequity will be almost guaranteed in the next pandemic.

Accountability. No agreement can be effective without ways to hold parties to account for the commitments they make. International law, operating independently of other inducements, is notoriously weak as a mechanism to change behavior when up against national self-interest during a global crisis. Unsurprisingly, negotiators have had a hard time innovating new compliance levers. The draft agreement would establish a conference of the parties (COP) to periodically review treaty implementation and mobilize funding, but it contains no independent monitoring or oversight. It ought to have an independent committee or other mechanism to monitor states’ compliance and reporting, and a separate peer review mechanism, both of which could report to an empowered COP with civil society and stakeholder engagement and the power to publish reports. It could connect the treaty to existing global monitoring and evaluation frameworks, and should introduce a system of incentives for compliance and distinctives for noncompliance. If the pandemic agreement is to live up to its stated objectives and give the world a fighting chance when the next pandemic threat emerges, the COP will need to develop the incentive structure that makes fulfilling treaty commitments more enticing than the alternative.

The International Health Regulations

A working group of WHO member states has simultaneously been negotiating amendments to the IHR, a legally binding agreement among 196 IHR states parties designed to detect, assess, and report emerging pathogenic threats. Led by the U.S., governments proposed over 300 amendments–indicating a near-universal desire to improve the regulations which were last significantly reformed after the SARS-CoV-1 pandemic of 2002-2004. While IHR reform has had less public attention than the pandemic agreement, the regulations have a clear advantage: they are already in place, and amendments come into force automatically for all WHO members unless they explicitly opt out.

Core capacities. The IHR requires states parties to develop, strengthen, and maintain capacities to detect, assess, notify, report, and respond to public health risks. Weak health systems thwart pandemic responses, but while the IHR obliges member states to assist and cooperate “to the extent possible,” there has been precious little technical and financial assistance.

Equity. The IHR is currently silent on equity, so proposals related to equity have been at the heart of the negotiations. Operative proposals include a new article on access to health products, technologies, and know-how that would give the WHO Director-General the power to make recommendations to promote timely availability and affordability of countermeasures to respond to a public health emergency of international concern. Some IHR negotiators from high-income countries have attempted to consolidate equity measures under the pandemic agreement, though the implications are unclear.

Accountability. Accountability mechanisms are virtually nonexistent in the IHR, save for a never-used dispute settlement mechanism. The U.S. and the African bloc have proposed “compliance” or “implementation” committees, whose function would be to boost IHR adherence thus adding a welcome layer of accountability. There are financial costs, however, and without an identifiable capital source, this could result in an unfunded mandate.

WHO Financing Reform

As we’ve previously discussed, in 2022 WHO member states made an important decision to shore up the agency’s financing, putting it on a path to greater flexibility and capacity to fulfill its mandate as the directing and coordinating authority on international health work. WHO historically relied on voluntary and usually earmarked contributions from a small set of wealthy government and private donors. This limited WHO’s ability to fulfill its triple billion targets for universal health coverage and health emergency protections, address neglected areas of global health like injuries and noncommunicable disease, and otherwise keep the ship afloat through talent acquisition, retention, and pay. 

The 2022 decision included phased increases to member states’ assessed (i.e. mandatory, unrestricted) contributions to a total amount equal to 50% of the approved 2022 base budget by 2030 on a defined stepwise scale. The following year, WHO member states agreed to the first step: to raise their assessed contributions to 26% of WHO’s 2022-2023 base budget. This year, the agency is also seeking to raise an additional $7.1 billion in voluntary contributions in a replenishment conference based upon a compelling investment case to secure a stable workforce, reduce major gaps in health policy, and assume a central role in international health work. WHO smartly constructed and announced what it planned to do with these contributions upfront rather than requesting a blank check. It is also important that WHO’s member states lead the way, as private donors will want to see that WHO’s membership is fully committed. We proposed five strategies for WHO to stay on track with this fundraising and continue to maintain they are critical to the agency’s future.

Opportunities and Barriers to Sustainable and Adequate Financing

Adam Smith’s lament that “no complaint . . . is more common than that of a scarcity of money” is pertinent to this discussion. There is much to improve concerning pandemic readiness, but the already inadequate funding that was mobilized early in the decade is drying up while much of the public expresses an understandable desire to put the Covid crisis behind it. The problem is that viruses and other infectious agents do not particularly care. We can invest now in prevention or be compelled to spend orders of magnitude more later to cope with a pernicious threat that will cost lives and livelihoods.

The headwinds for financing new activities under the IHR and pandemic agreement are substantial. Global health financing is heavily fragmented and new mechanisms risk splintering already limited capital even more. The current cafeteria of choices includes U.N. agencies, funds, and programs (e.g., WHO, UNICEF, UNDP, UNAIDS), hosted trust funds (such as those within the development banks), and global public-private partnerships (Global Fund, GAIN, Gavi). Relatedly, capital is also required to fund universal health coverage, biomedical research, regulatory oversight, and public awareness campaigns. While there is some coordination among key actors (for example, WHO and UNICEF partner and coordinate with Gavi), they are also competitors for a limited global health till.

Moreover, the competition for donor government finance is incredibly intense, with climate change, humanitarian assistance, national security, and other priorities pining for funding. On top of all this is a growing nationalist populism, which is dead set against international institutions as a mode for solving common interest problems.

Public spending on pandemic measures is facing downward pressure and segments of the public have voiced displeasure on how previously appropriated funds were spent. Private finance tends to pursue return on investment, and the markets most in need of improved pandemic assistance are often the riskiest in which to invest. The strategies to generate capital to fund new obligations in the IHR and pandemic agreement must cope with the realities of fragmentation and competition, factors that have likely contributed to the resounding undercapitalization in the World Bank’s Pandemic Fund.

There was considerable anxiety in some quarters that amending the existing IHR while negotiating a new pandemic agreement would itself fragment efforts, and so the IHR and international negotiating body groups have coordinated some, but not all, of their discussions. Notably, on January 31, the two negotiating bodies met to discuss, among other things, “financing and key areas of overlap [because] a coordinated approach is needed to continue to ensure these important issues are properly reflected across the two processes.” They met again on February 23 to debate whether to consolidate financial mechanisms within the pandemic agreement. Assuming both instruments are adopted in May, the WHO should facilitate coordination between the mechanisms to prevent undue fragmentation and to maximize value for money.

Financing the Pandemic Agreement

A primary reason that many states have failed to build IHR health capacities is a lack of resources to do so. To address this problem, the draft text of the pandemic agreement calls on state parties to “prioritize . . . domestic funding;” “mobilize financial resources through all sources, including existing and new bilateral, subregional, regional and multilateral funding mechanisms” including through grants and concessional [i.e. sub-market rate] loans; promote “debt relief, including suspension of debt servicing and debt cancellation;” and “encourage governance and operating models of existing financing entities to minimize the burden on countries.” The March 2024 draft introduces obligations for states to cooperate by promoting financial assistance to lower-income countries for capacity-strengthening, but, like the IHR, provides no real obligation, detail, or benchmarking for that cooperation. It also requires the agreement’s governing body to “adopt, every five years a Financial and Implementation Strategy” and the parties to align with the strategy “while financing the relevant funding mechanisms, both within and outside WHO.”

What may capture the most interest is a new “Coordinating Financial Mechanism” to support implementation of both instruments and will consist of a “pooled fund to provide financing to support, strengthen and expand capacities” and “promote harmonization and coordination for financing” for pandemic prevention, preparedness, and response. It would also provide financing for day zero surge response “as necessary.” The mechanism will be accountable to the COP, which “shall periodically review [its] effectiveness.”

The funds would come from monetary contributions through the PABS system (if adopted and implemented) and voluntary contributions from state and nonstate actors, but the draft leaves additional sources of financing for the COP to determine.

The mechanism’s mandate to coordinate financing may be the most useful element, recognizing the fragmented state of global health financing. WHO is the only institution credibly positioned and constitutionally mandated to act as the directing and coordinating authority on international health work. By examining the sources of funding available for pandemic, prevention, preparedness, and response, it can provide the big picture of the state of financing.

The quintennial financial strategy review is prudent and appropriate. To make progress, the treaty’s governing body and secretariat will need to make reasonably reliable financial forecasts and identify needed funding for urgent activities. A five-year horizon is likely the longest possible to achieve specific targets; anything longer and countries and other actors may water down specific metrics into the aspirational language that international agreements are often criticized for employing. Moreover, pandemic priorities will change and so periodic opportunities to adjust them are practical.

To be effective, the pooled fund would need to be reliable and its revenue predictable and sustainable. As outlined, however, it risks creating another hand grasping at limited capital and a potentially visible point of failure and criticism. It is not clear why its funding targets will be met when so many others for global health have not. That it will rely heavily on a hotly debated PABS system for capital will make it more difficult to be viewed as a reliable purchaser or counterparty that could access favorable pricing for products or services.

Higher-income countries appear unwilling to commit to tangible financing through the main text of either instrument. Understandably, low- and middle-income countries demonstrate skepticism to agreeing to tangible commitments with assured funding elusive. It is hard to imagine that the pooled fund would be sufficiently capitalized or reliable to be the impetus for a breakthrough.

New Financing Mechanisms for the IHR

IHR financial negotiations have not significantly progressed. Yet, several proposals would expand the types of financial assistance available, including a new mechanism to support developing countries in strengthening core capacities and health systems, building research and development capacities, and addressing health inequities. As noted above, creating another mechanism is risky. If the negotiators elect to do it, WHO should coordinate it with an eye toward preventing fragmentation or reallocation from other critical health aims or its own core budget.

A Future Worth Investing In

Negotiators are now rapidly hurtling toward May’s formal adoption target while WHO continues to make its case to stakeholders. There is palpable urgency; the next pandemic may be waiting in the wings and right now humanity is woefully unprepared. A failure to meet the moment with strong commitments and mechanisms for adequate and sustainable financing would leave us on the back foot and would repeat Covid’s complicated and ethical challenges. Refusal of countries to commit the finances commensurate with their resources and capabilities would create extraordinary burdens on the most vulnerable and ultimately make responding to the next pandemic more expansive for all of us.

Kevin A. Klock, JD, is senior vice president, chief operating officer, and general counsel at the Foundation for the National Institutes of Health, a scholar at the O’Neill Institute for National and Global Health Law, and an adjunct professor at Georgetown University Law Center. @KlockStndTime

Alexandra Finch, LLB, LLM, is an associate at the O’Neill Institute for National and Global Health Law and an adjunct professor of Law at Georgetown University Law Center. @avgfinch

Lawrence O. Gostin, JD, LLD (Hon), is the founding O’Neill chair in Global Health Law and co-faculty director at the O’Neill Institute for National and Global Health Law, Distinguished University Professor at Georgetown University, and director of the WHO Collaborating Center on Global Health Law. He is a Hastings Center fellow. @LawrenceGostin

DISCLAIMER:

Professors Gostin and Klock lead the O’Neill Institute and Foundation for the National Institutes of Health (FNIH) project on an international instrument for pandemic prevention and preparedness. The FNIH provided funding to the O’Neill Institute for the project. Professor Gostin is the director of the WHO Collaborating Center on National and Global Health Law. Gostin is also a member of WHO’s IHR Review Committee. WHO is an intellectual non-financial partner to the FNIH-managed GeneConvene Global Collaborative. The views in this piece are those of the authors and do not necessarily reflect the views of the FNIH or O’Neill Institute for National and Global Health Law.

a brown mouse and a white mouse

Bioethics Forum Essay

Today’s Politics Threatens Tomorrow’s Reproductive Technologies

by Henry T. Greely and Kira PeikoffPublished Posted in Children and Families, Hastings Bioethics Forum, Reproduction & Technology

In mice, startling new ways to conceive are already real. 

In a landmark achievement in 2012, Japanese scientists turned cells from a mouse’s tail into viable eggs. These eggs were joined with donor sperm and implanted in a surrogate mouse, which birthed healthy pups. Some of these pups were able to reproduce normally. Those researchers have continued this research and, last year, they reported in Nature that this new method, called in vitro gametogenesis (IVG), produced an egg from a male mouse, leading to two male mice having offspring.

“IVG could be a game changer for women and men dealing with infertility, women of advanced maternal age, and same-sex couples, allowing them to have genetically related children they could not otherwise,” states a report on IVG recently released by The National Academies of Science, Engineering, and Medicine.

While scientists have not yet solved how to develop human eggs and sperm from skin cells, the research is progressing step by step. From a technical perspective, it’s plausible that within a decade, any two people may walk into a fertility clinic, have their cheeks swabbed, and leave as prospective parents. In a lab, their cells would be converted first into stem cells and then into sperm or eggs. These would be combined in a petri dish to form embryos, some of which the prospective parents would later choose to transfer for implantation. This could transform the lives of many couples who are not able to have genetic children because one of them does not have viable sperm or eggs, like those who struggle with infertility or gay and lesbian couples.

But science can’t change lives if people aren’t allowed to use it. As optimistic as some experts may be about the revolutionary potential of IVG, it’s hard to ignore the dissonance between our rapidly advancing science and our backsliding politics. The Alabama Supreme Court’s decision that frozen embryos are “children” in the context of wrongful death laws might lead to even more interference with parents who want to have real children. Eleven other states have similar fetal personhood laws that might also be used to prevent desperately wanted pregnancies.

Beyond repressing women’s rights, the personhood movements, emboldened by the overturning of Roe and the Alabama decision, threaten to stifle medical progress that could, for the first time in history, liberate future families from some biological constraints. Although legislative changes just signed by the Alabama governor now protect IVF providers from criminal prosecution, the state’s court decision illuminates an underlying hostility to women’s rights–and to the future of reproductive science. 

The Alabama case should be an alarm bell for those seeking new forms of assisted reproduction, methods like IVG, that would eliminate multiple burdens for women seeking help from science to conceive. Egg retrieval cycles would no longer be necessary, with their uncomfortable, costly, and risky hormone injections to hyperstimulate ovaries. IVG would also free women from the pressures of having children before age 35, the dreaded and arbitrary threshold for being deemed a “geriatric” mother whose supply of viable eggs is dwindling. If no biological clock were ticking, the choice of career versus motherhood would become less fraught. “Having it all” might become possible.

To be sure, IVG carries ethical considerations of its own. With the ability to create multiple embryos from easily obtained cell samples, the use of preimplantation genetic testing would become routine. This is already starting to happen. Two months ago, San Francisco company Orchid announced that it would offer whole genome sequencing of embryos ahead of IVF–a first in the U.S. fertility market.

While the company’s clinical validation was published as a preprint that has not yet been peer reviewed, a couple can pay $2,500 to get a readout of their embryos’ medical risks for genetic diseases. So far, Orchid and the other U.S. company that offers polygenic screening for embryos, Genomic Prediction, provide information on health risks only, but parents could access the data and seek out analyses of their embryos’ genetic predispositions for nonmedical traits as well, the thornier ones like intelligence and looks.

This trend represents the opposite of today’s political movement toward control of women’s bodies. Whole genome sequencing of embryos for IVF, and possibly someday for IVG, veers toward the other extreme of an unprecedented degree of information, choice, and freedom over reproductive outcomes. How much oversight or leeway parents should have in deciding about the characteristics of their future children remains uncharted territory.

Cultural norms can change in a generation. The first “test tube” baby was conceived in secrecy in 1978 by scientists who feared their work would be taboo–and who eventually won a Nobel Prize. Today, nearly 100,000 babies per year in the U.S. owe their lives to IVF. What we view as ethical in the realm of reproduction is sometimes a matter of what seems commonplace.

What will it be a generation from now: science-assisted births for parents of all ages and genders? Or forced births for women who don’t want children and prevented births for those who do? 

We can’t have that both ways.

Henry T. Greely, JD, is Professor of Law, professor by courtesy of Genetics, and Director of the Stanford Center for Law and the Biosciences at Stanford University, and author of The End of Sex and the Future of Human Reproduction. @HankGreelyLSJU

Kira Peikoff holds a graduate degree in bioethics from Columbia University and is the author of Baby X, a new thriller about IVG. @kirapeikoff

hands of someone receiving food at food pantry

Bioethics Forum Essay

A Thousand Double Binds: Alabama, Reproductive Freedom, and Child Health

by Anna Kutbay and Danielle PaciaPublished Posted in Children and Families, Hastings Bioethics Forum

As two people who have ties to Alabama and grew up in the Deep South, we are frustrated by the state’s ceaseless assault on reproductive freedom, while its politicians continue to ignore child health. Because Alabama lawmakers and its Supreme Court justices profess to care about children–and use this as a reason to restrict reproductive freedom–we believe there is a strong responsibility to aid kids who do not have consistent access to groceries or health care.

Alabama’s Supreme Court ruling on IVF is indicative of the state’s paradoxical interest in protecting embryos, while continuing to effectively ignore the health of children and families in the state. The decision  interpreted an Alabama statute, the Wrongful Death of a Minor Act, § 6-5-391, Ala. Code 1975, to confer personhood to embryos created outside of the biological womb. The opinion, authored by Associate Justice Jay Mitchell, argued that Alabama has long held that unborn children are “children” and stated that the Act “applies to all children, born and unborn, without limitation.” Following Alabama’s Supreme Court decision, lawmakers in several states are now considering passing fetal personhood bills. While Alabama’s governor signed a law protecting IVF,  problems with conferring full legal personhood on embryos, as well as the failing social safety net in Alabama, persist.

Immediately after the Dobbs decision, Alabama’s total abortion ban went into effect. The ban has no exceptions for rape or incest. Not only that, but Alabama’s state constitution specifically endorses anti-abortion language instead of being neutral on the subject or open to flexible interpretation.

Proponents of these reproductive care restrictions argue that they have been instituted for the well-being of children. However, child health, success, and well-being in Alabama are harmed by the state’s lack of social safety net services. Alabama was one of several states that chose not to expand Medicaid services, despite the federal government paying most of the cost of the expansion. Medicaid plays a vital role in ensuring that low-income families and children have access to healthcare.

One in four children in the state qualify as food insecure, meaning they lack regular access to nutritious food. Children facing food insecurity perform worse in school than their counterparts, often being years behind grade level learning expectations. Additionally, hunger makes children more susceptible to chronic illnesses that would be preventable with a proper diet. Even with these alarming statistics and effects, Alabama was one of 15 states that did not opt into a United States Department of Agriculture program, approved by Congress in 2022, that would provide extra money for food to children during the summer months when they do not receive subsidized school lunches.

Aside from disregarding federal funding initiatives seeking to promote the well-being of children, Alabama also continually falls short in caring for parents. Around 25 counties qualify as “maternity care deserts,” lacking the appropriate number of  obstetrician/gynecologists, certified nurse midwives, or medical facilities necessary to ensure that parents have access to the care that they need. This likely exacerbates Alabama’s already dismal maternal mortality rate. In 2020 the overall U.S. rate was 23.8 deaths per 100,000 live births; Alabama’s was 36.4 deaths per 100,000 live births. Furthermore, Alabama is ranked 50th in Temporary Aid to Needy Families Program (TANF) monthly maximum levels. Alabama’s TANF benefit for a family of three is just $215 monthly, which falls far below the national median of $492. For perspective, the USDA’s Cost of Food report indicates that it costs approximately $230 each month to feed a child aged 9-11.

Alabama’s record of health and social policy makes it clear: The state consistently refuses federal assistance to help pull its children out of poverty.

We hope that Alabama lawmakers consider child health more broadly, addressing the unacceptable rates of hunger and maternal mortality. While IVF is an important medical procedure, the technology is often only available to those who are relatively affluent or to people with employee-sponsored insurance. For those who are uninsured or on Medicaid, IVF remains out of reach, while other problems like food security and steady access to health care persist.

As we continue to witness attacks on reproductive freedom, we must remember the already deeply insufficient state of child health services in Alabama. Furthermore, we need to amplify and support the efforts of on-the-ground activists and organizers who are working tirelessly to make Alabama healthier and help it prioritize reproductive justice.

Anna Kutbay is a second-year student at Georgetown University Law Center interested in poverty law, health equity, and economic justice. linkedin.com/in/anna-kutbay/

Danielle M. Pacia, MBE, is a research associate at The Hastings Center. @DaniellePacia linkedin.com/in/daniellepacia/

Illustrative image for Fetal Personhood IVF and the Negligent Loss of Embryos

Bioethics Forum Essay

Fetal Personhood, IVF, and the Negligent Loss of Embryos

by Bonnie SteinbockPublished Posted in Hastings Bioethics Forum, Human Reproduction

On February 16, the Supreme Court of Alabama held that two couples were eligible to recover damages for the loss of their frozen embryos. This was not the first time people have sued fertility clinics for negligence leading to the loss of their embryos–over 130 lawsuits have been filed since 2009–but it was the first decision since Dobbs overturned Roe v. Wade. Essentially, the decision said that since embryos are children/persons under Alabama law, and individuals have been able to recover damages for the loss of a fetus, they should also be able to recover for the loss of extracorporeal embryos. In the words of the majority, Alabama’s Wrongful Death of a Minor Act “applies to all children, born and unborn, without limitation. It is not the role of this Court to craft a new limitation based on our own view of what is or is not wise public policy. That is especially true where, as here, the People of this State have adopted a Constitutional amendment directly aimed at stopping courts from excluding ‘unborn life’ from legal protection.”

Soon after the ruling, three fertility clinics in Alabama suspended IVF treatment because of questions about the legal risks it posed to them. Following a national uproar over the implications for IVF and people who depend on it to start families, Alabama’s House and Senate  passed bills  on February 29 that would shield doctors, clinics, and hospitals from possible liability. A similar approach was taken by Republican lawmakers in Florida, who decided to pause their attempt to allow civil lawsuits over the wrongful death of a fetus after being warned by Democratic lawmakers and others that the bill amounts to “fetal personhood,” which could imperil doctors who assisted women in obtaining an abortion, as well as adversely affecting fertility treatments. 

Lost in the extensive media coverage that followed the Alabama Supreme Court ruling is the legal and ethical issue of wrongful death of a child, a fetus, or a frozen embryo. Wrongful death suits give legal redress to prospective parents who lose a child or potential child through medical negligence. It recognizes that their grief is real and deserving of compensation. However, wrongful death suits can only be brought for the death of a person and endowing embryos as persons or children threatens IVF. The problem is this: How can the legitimate concerns of fertility patients whose embryos are negligently lost be addressed without threatening the very existence of IVF?

One could be forgiven for thinking that the Alabama Supreme Court had endowed extracorporeal embryos with a new legal status–that of child or person. However, it was not the Court that endowed embryos with legal personhood in Alabama, but the Legislature. Moreover, the decision concerned the right of recovery in wrongful death suits, not the practice of IVF, and wrongful death suits give rights not to children but to parents who have suffered emotional harm from the loss of their child.

Some commentators made the misleading claim that the Court’s decision was based on a law dating from 1872, 100 years before the development of IVF. It is true that the Court held that embryos fell within the Wrongful Death Act of a Minor, but this was based on more recent judicial decisions (here and here) that expanded recovery to fetuses. Originally, wrongful death actions were limited to financial damages because their purpose was to compensate the victim’s survivors for their loss of income. This meant that there could be no recovery even for born children. This changed over the years, with the recognition that parents suffer emotional harm from the loss of a child and that the loss of a fetus, especially after viability, can be just as emotionally devastating to the prospective parents as the loss of a born child. (See, for example, Moen v. Hanson, 85 Wn.2d 5987, 537 P.2d 266 (1975).)

If couples who lose a fetus through medical negligence have a legal remedy, why not couples going through infertility treatment? Surely, their loss and grief should be recognized, and they should not be denied a legal remedy.

Understanding the legal context is crucial because success in a wrongful death suit depends on demonstrating that the death is the result of negligence. In the Alabama Supreme Court case, the evidence of negligence was overwhelming. A patient in the hospital managed to wander into the fertility clinic through an unsecured doorway and enter the facility where frozen embryos were stored. The patient removed several embryos and then dropped them on the floor, causing their deaths. If that isn’t negligence on the part of the clinic, I don’t know what is.

Allowing prospective parents to recover damages for the negligent loss of embryos does not, by itself, threaten IVF. There is no negligence when IVF is done with the informed consent of patients, in accord with prevailing medical standards. No negligence, no recovery for wrongful death. So, was the outcry from some providers and clinics an overreaction? The fear is that calling embryos children or persons endangers standard practices in that IVF routinely involves discarding frozen embryos.

The reason for the creation and discarding of surplus embryos in IVF is twofold. First, freezing extra embryos gives the individual or couple the best chance of a successful pregnancy, without multiple births, which are riskier for mother and babies, and without the need for additional cycles of egg retrieval, which impose significant physical burdens on the woman, as well as costs. Second, the creation of extra embryos enables the testing and discarding of embryos with chromosomal defects. Defective embryos are less likely to implant, so preimplantation testing improves the chances of a successful pregnancy, as well as preventing the birth of a child with a serious disabling condition.

Can these practices be justified if embryos are legal persons? How can it be legal to kill persons simply because they aren’t needed or have defects? One might reconcile the decision of the Alabama Supreme Court with IVF by keeping in mind that the decision applied only to recovery in wrongful death suits. However, the decision then went on for pages discussing the sanctity of life in specifically Christian terms of dubious legal relevance. That is legitimate cause for concern because it suggests that the aim was not simply to give a remedy to victims of negligence, but rather to impose a particular religious view of the status of embryos. Moreover, at times the decision strongly suggests that discarding embryos is forbidden. For example, Chief Justice Tom Parker wrote, “Even before birth, all human beings have the image of God, and their lives cannot be destroyed without effacing his glory.” Although this sentence is not strictly part of the Court’s opinion, but appears only in a concurring opinion, it is enough to create anxiety among fertility medicine practitioners, who wonder whether discarding embryos exposes them to civil or even criminal liability.

So, how should states treat the negligent loss of embryos? There are several options. One is to deny fertility patients any legal recourse, but that seems manifestly unjust. Another approach is to allow them to sue negligent providers and be compensated for the loss of their property. But this approach is also inadequate. It treats embryos like furniture, instead of potential children which have a significance and value that goes beyond that of mere objects or possessions. A third option is to endow embryos with the legal status of persons, but to restrict this to wrongful death suits. This was the approach of lawmakers in Alabama and Florida following the Alabama Supreme Court ruling.

Legally, there is nothing wrong with regarding embryos and fetuses as persons for the purpose of wrongful death suits, while not endowing them with that status in other areas of the law. However, recovery in wrongful death suits leaves some people scratching their heads. “You mean, if embryos are killed through negligence, that’s against the law, but it’s perfectly OK to kill embryos — that is, children — deliberately? How can that be?”

Fortunately, there is a better solution for compensating those who suffer the loss of their frozen embryos: the creation of a new tort of reproductive negligence. This approach, suggested by a few scholars (for example, Dov Fox, “Reproductive Negligence,”) would allow recovery for lost embryos due to negligence, but could also apply to the negligent or reckless destruction of frozen sperm or eggs, as well as medical negligence that renders individuals infertile. In all these cases, the harm is the deprivation of the ability to become a biological parent. Such a tort has the advantage of acknowledging that this loss is significant and deserves legal redress, without the risk of the personhood approach, which could deprive infertile people of the medical assistance they need to have children. Creating a new tort would be complex, but given the injustice of denying recovery completely, the inadequacy of treating frozen embryos, eggs, or sperm as mere property, and the dangers of the personhood approach, it seems to be the best solution.

Bonnie Steinbock, PhD, is professor emerita of philosophy at the University at Albany, State University of New York, and a Hastings Center fellow.

doctor and patient holding hands on a desk

Bioethics Forum Essay

It’s Time to Change the Conversation About MAiD

by Thomas B. StrousePublished Posted in End-of-Life Care, Hastings Bioethics Forum, Medical Aid-In-Dying

In a recent commentary, physician Alan Astrow  expressed skepticism about the legalization of medical aid in dying.  He cited the subjectivity of determining whose suffering qualifies for medical assistance and concern that, given the painful American reality of unequal access to care, some vulnerable patients might be led, inappropriately or unwittingly, to MAiD. But these concerns neither stand up to evidence nor to my experience as a physician practicing in California before and after MAiD was legalized.

Ten states and the District of Columbia allow medical aid in dying and 18 more states have pending legislation to approve it. All the state laws are similar: they permit adults with terminal medical illnesses who are capable of making decisions to request legal prescriptions for aid-in-dying medication from a willing attending physician. Such patients must be able to ingest the drugs themselves. Twenty-two percent of Americans have legal access to MAiD today, largely because California is home to roughly one-eighth of the U.S. population.

For more than 20 years, Gallup polls have shown that the majority of the American public support MAiD. Surveys of American health professionals also show majority support. In a recent sample of nearly 600 Colorado physicians who routinely care for seriously ill adult patients, 88% indicated they would refer a qualifying patient who requested it for MAiD. Given what appear to be ineluctable U.S. trends toward state-by-state MAiD legalization, the time for professional debate about “whether to” is past, and that we should be focusing more on “who”—which patients should qualify?– and “how”—which practices should be permitted?

Support for legalized aid in dying is also growing in other countries. But the details of what, exactly, is legal varies from country to country. National attitudes and practices related to end of life are closely linked to the distinct histories, social environments, religions, cultures, and legal structures in those countries.

In Switzerland, for example, “assisted suicide” has been allowed since 1942, as long as the assistant is acting altruistically and not for “selfish” reasons. In 2006, the Swiss Federal Supreme Court recognized the right of an individual to decide how and when to end his or her life if the person faced “intolerable suffering” due to a chronic (though not necessarily imminently terminal) illness. The Swiss Academy of Medical Sciences has refined a set of guidelines for willing Swiss physicians, outlining how and when they can participate (by providing access to lethal prescriptions under specific circumstances). 

Canada recently liberalized its approach to MAiD. In 2015, the landmark Supreme Court Decision Carter v Canadaconcluded that criminal code provisions prohibiting MAiD represented an unconstitutional infringement on the personal freedoms and basic rights of all Canadians. In 2021, the Canadian Parliament passed Bill C-7, which removed the “reasonably foreseeable natural death” requirement from Canadian federal law and replaced it with “intolerable suffering” from “non-terminal grievous and irremediable medical conditions.”  That requirement was to have been extended to individuals with intolerable suffering due to some forms of grievous and irremediable mental illness in March. However, Canada decided to postpone this expansion, stating, “in its consultations with the provinces, territories, medical professionals, people with lived experience and other stakeholders, the Government of Canada has heard—and agrees—that the health system is not yet ready for this expansion.”

The “who” and “how” of aid in dying in Switzerland and Canada are very different from what they are in the U.S. The differences may come down to cultural beliefs and practices based on the histories of each country. It is hard to imagine, for example, the U.S. joining Canada in permitting aid in dying for grievous and irremediable mental illness. But some who disapprove of MAiD in the U.S. may point to Canada and Switzerland and see a “slippery slope” to a more expansive “who” and “how,” as well as to abuse.

Astrow expresses concern about MAiD legislation being considered in New York State. That bill is nearly identical to the laws in other states. A recent  extensively sourced essay in Voices in Bioethics urges New York legislators to pass the law, pointing to 27 years of data from states that legalized MAiD, beginning with Oregon, that show no evidence of abuse. The essay also includes reference to testimony before the New York State legislature by the bioethicist and NYU Professor Arthur Caplan, a long-time critic of MAiD legislation. In his testimony he asserts that his “slippery slope” concerns had been allayed by nearly three decades of actual evidence.

I am a psychiatrist and a palliative care physician who has worked for more than 40 years primarily with patients who have cancer. During the years before California passed its 2015 End-of-Life Options Act, two of my palliative care patients committed suicide with guns. Both were older white men with advanced cancer and less than six months to live; neither had known psychiatric illness. Both received excellent palliative care and state-of-the art symptom management, but this was not enough to prevent them from feeling that their current and foreseeable existence was unacceptable. Nor did they think that legal measures such as palliative sedation or voluntarily stopping of eating and drinking would be acceptable. I see those suicides as the worst possible outcomes. The patients died alone, and in a violent manner. In retrospect, I view their clinical trajectories as a form of patient abandonment by well-intentioned but legally hamstrung clinicians.

The End-of-Life Options Act was signed into law by Governor Jerry Brown. Given his Jesuit religious training and background, his signing statement is notable:

“In the end, I was left to reflect on what I would want in the face of my own death.

I do not know what I would do if I were dying in prolonged and excruciating pain. I am certain, however, that it would be a comfort to be able to consider the options afforded by this bill. And I wouldn’t deny that right to others.” (underline added)

Soon after the bill was signed, Janet Napolitano, then president of the University of California, directed each of the UC Health Hospital Systems to craft policies and procedures to enact the law. Her position was in contrast to those of the predominantly Catholic faith-based health systems in California, which indicated their intention not to participate and to enjoin their professional staffs from doing so. I was part of the working group at UCLA that wrote local policy and have been involved since then as a mental health practitioner who evaluates UCLA patients who requested MAiD and who are referred by attendings or consultant physicians, as the law stipulates.

The California Department of Public Health publishes annual reports on the use of the End-of-Life Options law. The most recent report, which contains 2022 data, shows that 803 of the 1,270 Californians who were prescribed drugs that year ingested them and died. (Another 50 people died after taking drugs in 2022 that had been prescribed the previous year.) The 853 MAiD deaths in 2022 represented just 0.28% of the total number of deaths in California that year (308,015). California’s “use rate” –that is, the percent of patients with prescriptions who use them—is around 60%, consistent with use rates from other states where MAiD is legal, evidence that a significant minority of patients never ingest the lethal prescription.

Since the California law’s inception, 91% of patients who obtained prescriptions for MAiD had been receiving hospice and/or palliative care services (rebutting one of the arguments that inadequate access to palliation is a driver for MAiD). In 2022, the majority (66%) had advanced cancers, with cardiac and neurological diseases tied for the next most prevalent. Seventy-five percent of the patients were 70 years of age or older; men slightly outnumbered women (52% to 48%). Ninety-nine percent had health insurance. Forty-two percent had a bachelor’s degree or higher. Ninety-five percent identified as white or Asian, with Hispanic (2.8%) and Black (0.5%) patients vastly under-represented in relation to their percentages among California citizens at large.

Californians who are approved for MAiD look socio-demographically very much like those who use it in other states—older, whiter, wealthier, and more educated than the general populations there. Typically, such groups have better than average access to care of all kinds and enjoy greater personal health literacy and agency, evidence against the argument that more protections are needed or that disadvantaged individuals are being coerced into unwanted or misunderstood decisions to receive MAiD. Credible arguments have been made asserting that MAiD laws discriminate against disabled persons who want to take advantage of them because the laws exclude people with limited capacity for ingesting medication on their own or who have progressive diseases that make them unable to articulate their wishes. An important question is whether underrepresented, disabled, and/or socioeconomically disadvantaged groups are suffering from reduced access to MAiD? Or if in some circumstances they are expressing (as some have argued) greater religious objection or hesitancy about engaging with health care systems near the end of life?

Towards the end of his essay, Astrow asserts that “nothing in their [physicians’] training prepares them to judge whether a person’s life is no longer worth living.”  The implication is that a physician who participates in MAiD is making such a judgment. This is an oversimplification of what actually goes on between a patient requesting MAiD and the clinicians caring for her. The clinicians understand themselves to be supporting the patient’s thinking and choices about how much more of her imminently ending life is worth living. In addition, Astrow’s assertion demeans what MAiD represents to many individuals (and their families) who pursue it:  an embrace, celebration, and honoring of a life unavoidably near its ending, the preservation of the self against an unwanted but inevitable end.

Far be it from any physician to presume to judge the value of another’s life. But far be it from those of us willing to engage in this way to be prevented from honoring the wishes of imminently dying individuals to be free to choose a peaceful, legal, painless, and swift end.

Thomas B. Strouse, MD, is the Maddie Katz Professor and Vice-Chair for Clinical Affairs in the UCLA department of psychiatry.

Neuralink company image

Bioethics Forum Essay

The Neuralink Patient Behind the Musk

by Arthur Caplan and Jonathan D. MorenoPublished Posted in Hastings Bioethics Forum, Neuroscience, Research Ethics

The sole virtue of Elon Musk’s report on X, formerly known as Twitter, of the first in-human brain implant by his company, Neuralink, is its brevity: “The first human received an implant from @Neuralink yesterday and is recovering well. Initial results show promising neuron spike detection.”

But, in this case, that virtue is very limited. Brevity is not so admirable in novel human research.

Opening up the brain of a living human being to insert a device, particularly someone with serious medical problems, deserves more than a two-sentence report on what is, in effect, a proprietary social media platform not distinguished for its reliability where facts are concerned. This human research subject, their family, all potential future research subjects and patients, the medical community, and all of us deserve more.

Assuming that some brain-computer interface device was indeed implanted in some patient with severe paralysis by some surgeons somewhere, it would be reasonable to expect some formal reporting about the details of an unprecedented experiment involving a vulnerable person. But unlike drug studies in which there are phases that must be registered in a public database, the Food and Drug Administration does not require reporting of early feasibility studies of devices. From a legal standpoint Musk’s company is in the clear, a fact that surely did not escape the tactical notice of his company’s lawyers.

Nevertheless, when they engaged in this medical intervention his company and the surgeons, neuroscientists, and nurses incurred certain moral responsibilities. A technical regulatory veil does not shield them from the ethical obligations of transparency to avoid the risk of giving false hope to countless thousands of people with serious neurological disabilities.

Many may not appreciate that “neuron spike detection” is only an acceptable preliminary endpoint for a carefully controlled experiment whose safety is far from established and could engender complications that would leave the human subject in a worse, if not life-threatening, condition. We are not even told what plans there are to remove the device if things go wrong or the subject simply wants to stop. Nor do we know the findings of animal research that justified beginning a first-in-human experiment at this time, especially since it is not lifesaving research. The company has denied that it mistreated primates in response to allegations of animal cruelty. Which scientists—who were not on the Neuralink payroll—decided that the research was ready to try in humans?

This episode reaches beyond one incident. Science by press release, while increasingly common, is not science. When the person paying for a human experiment with a huge financial stake in the outcome is the sole source of information, basic ethical standards have not been met.

Arthur Caplan, PhD, is the founding head of the Division of Medical Ethics at NYU Grossman School of Medicine. He is a Hastings Center fellow and a member of The Hastings Center’s advisory council. @ArthurCaplan

Jonathan D. Moreno, PhD, is the David and Lyn Silfen University Professor of Ethics at the University of Pennsylvania and a Hastings Center fellow. @jonathanmoreno.bsky.social

SpongeBob Squarepants and other cartoon characters

Bioethics Forum Essay

SpongeBob, Slime, and Brain Injuries: A Dangerous Combination for Kids

by Kathleen Bachynski and Asher ClissoldPublished Posted in Hastings Bioethics Forum

For the first time, this year’s Super Bowl will have an alternate telecast. The target audience is children: the NFL has teamed up with CBS and Nickelodeon on a broadcast presented by beloved cartoon characters, notably the cast of SpongeBob SquarePants and Dora the Explorer. The Teenage Mutant Ninja Turtles, Plankton, and undersea augmented reality jellyfish will also make appearances. To the NFL, bringing this kid-friendly approach to tackle football to a large audience of children is a cause for celebration. “Our previous telecasts on Nickelodeon have been huge hits and created a new and different way to experience an NFL game,” said NFL media executive vice president Hans Schroeder in a statement. “We’re excited to bring that creativity to Super Bowl 58 and give our fans another way to enjoy one of the world’s most popular sporting events.”

But as public health researchers, we are alarmed by efforts to promote the full-body collisions of tackle football to young children with animated mascots, enhanced augmented reality, bright colors, 3D iconography, and other child-friendly symbols. These broadcasts minimize the health hazards of tackling, particularly the dangers of brain injuries. Moreover, young children do not have the cognitive ability to understand or evaluate the risks.

With increasing research on the long-term effects of brain injuries, youth sports organizations have implemented concussion protocols and return-to-play guidelines to protect children from repeated head impacts. Public health agencies have developed training courses to help coaches, trainers, and others involved in youth sports learn how to recognize and respond to concussions. But at a time when we know how important it is to teach everybody involved in youth sports to take brain injuries seriously, these Nickelodeon broadcasts do just the opposite.

Perhaps most egregiously, in 2021, one NFL Playoffs on Nickelodeon announcer told child viewers that the forceful head collision they had just seen on TV was just like scraping their knees during recess. “You get banged up; you get back up, and you go out there and play another down.” Directly instructing children to keep on playing after hitting their heads and getting “banged up” is precisely the opposite of what they should do: stop playing and tell a grown-up so they can get checked out. As Chris Nowinski of the Concussion Legacy Foundation said, “The NFL Nickelodeon broadcast sent an incredibly dangerous message to children on what to do after hitting their head; this advice has literally gotten children killed.”

Even when announcers aren’t telling children that they can ignore brain injuries, the animations involved in these Nickelodeon broadcasts implicitly send the same dangerous message. The funny sound effects, vibrant colors, and entertaining animations that appear when players collide or hit the ground all combine to convey the impression that these hits are amusing and harmless. Superimposing these appealing graphics on real-life collisions is inherently deceptive to young children.

When it comes to other health risks, we’ve recognized the importance of protecting children from misleading messages about public health hazards. Perhaps most famously, in 1997, the Federal Trade Commission charged tobacco company R. J. Reynolds with violating federal law by using a cartoon character, Joe Camel, to appeal to children under age 18. This led tobacco companies to cease using Joe Camel and other similar cartoon mascots in their cigarette advertising campaigns. Disney has placed restrictions on advertisements for junk food aimed at children. And although numerous loopholes still need to be addressed, the food and beverage industry’s Children’s Food and Advertising Initiative (CFBAI) is similarly intended to place limits on the marketing of unhealthy foods to young viewers. In fact, young children under age 8 are so vulnerable to marketing that an American Psychological Association task force advised restricting all television advertising during programming targeted toward this age group.

Yet no such restrictions are in place on how the NFL and Nickelodeon portray the repeated, full-body collisions of tackle football. Given our knowledge of the health hazards of brain trauma, particularly for developing brains, regulations must be set up to prevent the celebration or “cartoonizing” of the most dangerous impacts. Programming for young children should not include slime and dancing animations when players hit the ground or each other, or any other scenarios that place athletes at high risk of brain injury from impact.

The NFL should consult with health professionals to create guidelines that prevent the misrepresentation of brain injury risks in all broadcasts aimed at children, including both visual depictions and how announcers call the plays. No football broadcasts, let alone programs targeting young children, should describe hits to the head as a minor injury that players can simply “bounce back” from.

And if CBS, Nickelodeon, and the NFL want to promote kid-centered football, they should take the lead in celebrating the excitement and fun of flag football. The NFL has begun to host flag football championships at Pro Bowl games and has developed several initiatives to encourage flag football among youth. The NFL could build on these efforts and collaborate on applying state-of-the-art graphics to flag football in its telecasts aimed at kids. When developing programming for young children, media broadcasters should emphasize noncollision sports and stop glorifying high-risk collisions that place athletes at risk for brain trauma. That would be a win for public health.

Kathleen Bachynski, PhD, MPH, is an assistant professor of public health at Muhlenberg College and author of No Game for Boys to Play: The History of Youth Football and the Origins of a Public Health Crisis. She is a volunteer member of the professional advisory board of Pink Concussions, a nonprofit organization that advocates for more research on concussions among girls and women. LinkedIn: Kathleen Bachynski ba

Asher Clissold is a Master’s of Public Health student at Boston University School of Public Health who has researched and presented on the NFL’s marketing of football to youth. LinkedIn: Asher Clissold  

prison bars in the dark

Bioethics Forum Essay

Considering the Duality of Nitrogen

by Rafael EscandonPublished Posted in Hastings Bioethics Forum

Nitrogen gas makes up 78% of the air on planet Earth. Nitrogen is key in nucleotides, the individual units of our genetic material. Nitrogen is also contained in all proteins, which are what we see when we look at the form of another (unclothed) human. Nitrogen in soil is essential for the crops that feed humans and animals. Liquid nitrogen enables biological samples to be stored. Measurement of blood urea nitrogen is a fundamental indicator of renal function. And, on January 25, nitrogen gas was used for the first time to execute a prisoner on death row.   

The execution of Kenneth Smith does not answer the many questions raised by this new means of capital punishment. Is it “perhaps the most humane method” of execution,” as the Alabama attorney general has claimed? Or is it cruel and unusual punishment, as Smith’s attorneys and others have argued? Answering these questions is of vital importance, since nitrogen gas has been approved by three states for capital punishment.

While nitrogen is at least as old as our planet, the industrial and agricultural revolutions increased our reliance on it. German chemist Fritz Haber received the 1918 Nobel Prize in chemistry for his development of the Haber-Bosch process, a reaction which, for the first-time, produced ammonia at scale from atmospheric nitrogen and hydrogen. Among other uses, the ammonia from this process enabled mass production of the fertilizers essential for the agricultural growth required to feed the fourfold increase in human population over the past century.

 Despite Haber’s tremendous contribution to the science of chemistry, his legacy is deeply tarnished, as  he was also an architect of the use of chlorine, mustard and phosgene gases in World War I in violation of the Hague Conventions of 1899 and 1907. His research enabled production of Zyklon-B, the gas used to execute millions in the Nazi death camps of World War II. These connections make the use of nitrogen gas in capital punishment in 2024 all the more macabre.

The American Medical Association’s code of ethics on capital punishment states, “A physician, as a member of a profession dedicated to preserving life when there is hope of doing so, should not be a participant in a legally authorized execution.”

In a 2018 amicus brief to the U.S. Supreme Court, the AMA was more emphatic in its condemnation of capital punishment and physicians’ participation in it: “What people much prefer is a way to accomplish the deed while believing there is something humane about it. Society wants to delude itself into a belief that capital punishment no longer represents a weighted moral choice but is now somehow scientific—nearly antiseptic. This delusion, however, cheapens life and makes its extinction easier. The medical profession, whose ‘essential quality’ is an interest in humanity, and which reveres human life, should have no part in this charade.”

While laudable, one wonders if the AMA’s broad view that the medical profession should “have no part in this charade” may have an unintended effect–preventing physicians from speaking out against questionable capital punishment methods? Does fully respecting the AMA’s guidance require professionals to keep their knowledge of physiology, ethics, and history to themselves? An unfortunate consequence of physicians’ silence is that attorneys and legislators have taken the microphone and promulgated methods of execution, including nitrogen gas, that many consider to be inhumane.

If the process for medical and ethical vetting of any new execution methods before they become legal is unclear or nonexistent, and legislators and bureaucrats are the final decision-makers on such matters, then civil society should be concerned.

Witnesses to the execution, including journalists and Smith’s spiritual adviser, have said that nothing about it supported the Alabama Attorney General’s blithe predictions about the humanity of the method. Organizations around the world criticized the execution, including the United Nations High Commissioner for Human Rights, the European Union, and Amnesty International. The White House found reports of the execution “deeply troubling.”

We as a society have a choice about whether to restore the use of nitrogen exclusively for good or not—to overlook the long-ago disgraced uses of nitrogen gas for chemical warfare and genocide and accept it as a means for execution today. We must carefully consider the risks of moral backsliding to a time when gas poisoning was conducted by state actors. The consequences are easy to see. But unless nitrogen gas for executions is challenged on constitutional grounds as cruel and unusual punishment, it can be used again in Alabama, Oklahoma, and Mississippi. Indeed, since Alabama’s attorney general has said he intends to continue using it and would help other states interested in doing so, now is the time for the AMA, the American College of Correctional Physicians, bioethicists, and others to challenge this method.

No one knew precisely what would happen when Smith was restrained on a gurney and nitrogen gas was released into the tubing-and-mask circuit sealed to his face. Today, that knowledge comes at an enormous moral cost. As a society, we must ask ourselves what else was released into the circuit of civil society? And are we willing to restore what was lost on January 25, 2024?

The number of moral questions to be asked would be far fewer if the black-topped nitrogen tank had simply remained sealed.

Rafael Escandon, DrPH, PhD, MPH, HEC-C, is a consultant in research ethics and clinical R&D to the biotechnology industry in Bainbridge Island, Wash.

Betty Rollin

Bioethics Forum Essay

Betty Rollin’s Assisted Death: Unanswered Questions

by Alan B. AstrowPublished Posted in Hastings Bioethics Forum, Medical Aid-In-Dying

Network news correspondent and author Betty Rollin died in November at age 87. Surprisingly, there has been little public comment upon how her life ended. Rollin died in Switzerland at Pegasos, a voluntary assisted dying service. The circumstances of her death underscore the confusion over terminology and the uneasiness some feel regarding efforts to legalize assisted dying in New York State and elsewhere in our country.

Rollin may have suspected that her death would draw attention to a cause she had long supported. Her book Last Wish details her role in helping her mother with advanced ovarian cancer die, and she has written that her husband suffered needlessly before he died in 2020.

In contrast to her mother’s and husband’s experiences, though, Rollin had no terminal diagnosis, as Swiss law does not require it. According to her obituary, she suffered from arthritis, unspecified abdominal pain, and persistent sadness over the loss of her husband.

While supporters of medical aid in dying have framed the issue largely as an act of compassion for the incurably ill, Rollin’s decision suggests that the underlying motivation is also an argument for radical self-determination, a right to die on one’s own terms. This subjective dimension, and the need for assistance in carrying that decision out, raise questions about when and how to honor such requests.

Crucially, what is the relationship between medically assisted death, as in the United States and Canada, and voluntary assisted death, as in Switzerland? Rollin’s experience suggests that the differences are more apparent than real.

In Switzerland, physician approval for an assisted death is not needed as long as the motivation of the person providing assistance is altruistic. Still, Pegasos makes a point of noting that medical professionals are part of their team and that “skilled medical professionals” are involved in placing the IV through which the lethal drug is given. Their presence makes them an essential part of the process, if only for quality assurance purposes.

For Pegasos, according to the organization’s website, the person requesting assisted death must be over 18, of sound mind, and have a poor quality of life. The fee is roughly $11,000.  This cost, combined with the expense and logistics of travel to Pegasos, may prove obstacles to many. 

Most proposals to legalize aid in dying in this country, in contrast, require that a physician certifies the appropriateness of a person’s request. But this requirement leads to questions about how physicians are to judge “appropriateness” and frustration on the part of some who are anxious to move forward. If the purpose is existential, why involve physicians? The stated aims of Pegasos include minimizing red tape and speeding up the process.

The cultural diversity and extreme disparities in wealth in the U.S., not to mention our severe deficiencies in mental health care, make it unlikely that facilities like Pegasos could win legal approval here. For that reason, perhaps, advocacy groups have focused on having physicians serve as gatekeepers.

Rollin’s experience, though, suggests that we may find it difficult to distinguish between assisted death for existential reasons, as in Switzerland, and medically assisted death as currently authorized or proposed in some U.S. states—for which a physician certifies eligibility, and the stated purpose is to relieve physical suffering from progressive incurable illness. 

As evidence of this conceptual difficulty, Canada, where a terminal diagnosis has been a requirement for eligibility for medical assistance in dying, is moving toward allowing the practice for existential reasons. In March, Canadians whose only condition is a mental illness will be eligible. Their eligibility must be assessed and confirmed by doctors or nurse practitioners.

The subjectivity in determining whose suffering qualifies for medically assisted death raises this question: how can a clinician be certain? One can say that it is the person’s choice, not the health care professionals’. But, in fact, it is the health care professionals endorsing the request, writing the prescription, and, in Canada, administering the life-ending medications. 

Harnessing the power and prestige of the medical profession to this practice injects a deceptive aura of scientific objectivity into a murky human dilemma. Physicians ought to stand by their patients and attend to their comfort. And they are responsible for honestly and sensitively discussing the possibilities and limits to therapeutic medicine.

But nothing in their training prepares physicians to judge whether a person’s life is no longer worth living.

Caring for those who are not getting better is highly stressful for most physicians. I am very aware of the unacknowledged ambiguous, even hostile, feelings doctors may have toward those with unrelieved suffering. Who among us has not had a bad experience with a doctor or worried that a doctor was unduly motivated by self-interest? 

Returning to Rollin, we cannot know the full extent of her reasons for ending her life. Clearly, her feelings were powerful, and her action appears to have been carefully planned. But someone’s feelings may suddenly change or be manipulated under conditions of profound existential doubt.

One prominent physician bioethicist expressed sadness that Rollin gave up on living but admiration that she had done “what she thought was right.” His ambivalence is understandable: Rollin thought her decision was right, but does he agree? This hesitancy might lead us to reflect before we make deliberately causing a person’s death, as she wished, an accepted medical service.

Alan B. Astrow, MD, is chief of medical oncology and hematology at New York-Presbyterian Brooklyn Methodist Hospital and professor of clinical medicine at Weill Cornell Medicine.

car driver's hands honking horn and forming fist

Bioethics Forum Essay

Unresolved Grief is Eating Away at Us

by Katherine WassonPublished Posted in Hastings Bioethics Forum

The start of a new year is a time for reflection. In most ways, 2023 was a return to normal. Schools were fully back in person; hybrid work was old hat; travel rebounded; and people ate in restaurants and went out to the movies and plays.  One could be forgiven for thinking that the greatest pandemic of our lifetime had not even happened. Yet, I see people easily agitated and stressed, and nerves frayed. These behaviors show up in social interactions, on the road, and on social media. I think in our desire to regain a sense of normalcy we have not grieved properly for the losses and hardships of the past four years.

Grief is “the anguish experienced after significant loss, usually the death of a beloved person,” according to the American Psychological Association. It can present in response to any event that disrupts or challenges our sense of normalcy or ourselves.  Natural disasters, wars, and pandemics involve collective grief, loss experienced by a group, and traumatic grief is a response to loss that takes place under horrific and unpredictable circumstances. Grief is typically followed by a period of mourning. Avoiding this stage can lead to complicated grief, a disorder characterized by long-lasting, painful emotions and difficulty recovering from the loss.  I think our collective, traumatic, and unresolved grief is seeping out in unhelpful and unhealthy ways. If we do not tend to it, it could affect us for years to come.

Elizabeth Kubler-Ross is famous for identifying five stages of grief: denial, anger, bargaining, depression, and acceptance. These stages don’t necessarily happen in this order, and I think as a society we are stuck in the anger stage. We experienced denial in the beginning of the pandemic and definitely depression during lockdown and beyond as mental health issues remain at higher levels than pre-pandemic. There may well have been lots of bargaining going on too, e.g. “If I don’t go to this social gathering, I can go to the next one safely.”  We have lost so much. We lost the world as we knew it. We lost a sense of predictability in life and some degree of optimism about the future. We lost loved ones and colleagues; children lost educational, social, and emotional development. Many Americans lost trust in our leaders and experts.

Early in the pandemic, there was attention to those lost. The news media tracked the Covid deaths daily. Now, these deaths rarely make the news.

What we have lost needs to be acknowledged to process our grief and move toward acceptance, a process that will be uncomfortable, if not painful, for a while. There are many ways this can happen. Nationally, we could identify a day of remembrance for the over 1 million lives lost to the pandemic in the United States alone. States and local communities could join in and add their own services. The only such service we’ve had was attended by President Joe Biden on the eve of his inauguration in January 2021. 

Churches, synagogues, and mosques could hold special services for their members annually helping to personalize the mourning within that community. It would also be worthwhile for individual institutions and employers to acknowledge their losses, recognizing the individuals who were known to them and who are missed. The health care profession, of course, was hit particularly hard.

Beyond acknowledging our losses, schools and parents need to help children understand their emotions and process them. Local communities, perhaps through the libraries or other civic and nonprofit organizations, could offer times and places for their members to share their experiences over the past few years. Ignoring what we have lost isn’t working. Waiting for the anger and frustration to dissipate isn’t wise. Only when we face our losses and the toll they have taken and grieve can we truly move on.

Katherine Wasson, PhD, MPH, HEC-C, is a professor in the Neiswanger Institute for Bioethics at Loyola University Chicago. 

Clinical Case Studies card

Bioethics Forum Essay

Balancing a Patient’s Autonomy Against Misinformation

by Daniel Edward CalliesPublished Posted in Clinical Ethics Case Studies, Hastings Bioethics Forum

Case Narrative

Ms. J, a 45-year-old mother of three, was admitted to the emergency department with significant shortness of breath. With her children by her side, she relayed that she had tested positive for Covid 10 days prior and had not been vaccinated. Having done her own research, she had been self-medicating at home with vitamins. At the hospital she was found to have Covid pneumonia and very low blood oxygen, and was started on a high-flow nasal cannula delivering oxygen at the maximum rate of 60 liters per minute. Her blood oxygen remained low, however, and she was transferred to the intensive care unit to be put on a ventilator. The team reported that, with ventilator support, Ms. J would have a 50% chance of making a full recovery, and that without it she would almost certainly die. That notwithstanding, Ms. J declined to consent to the ventilator.

She explained that, from the various articles she had read, ventilators did not work for Covid, and said she had heard that hospitals were only putting Covid patients on ventilators in order to receive significant remuneration from the federal government. She wanted to leave the hospital immediately to get vitamins that she thought would relieve her shortness of breath. Both the attending physician and the nursing staff were distressed. They reported that, if Ms. J were to remove the nasal cannula and leave the hospital, she would very likely die before making it to the parking lot. But Ms. J was unwavering – she did not believe she was at risk of death by leaving the hospital and she was minutes away from walking out. The team called an ethics consult to help them think through the dilemma between respecting Ms. J’s preference and protecting her from grave harm in the context of false beliefs.

Ethical Analysis and Process

Under normal circumstances, the ethics team would have met with the treating team, the patient, and perhaps the patient’s family with the aim of facilitating consensus among the parties. But there wasn’t time to arrange meetings. Ms. J’s situation was emergent, and the treating team felt that the need for ventilator support was imminent. So, the ethics team spoke to the treating team by phone.

The focus of the phone call was on Ms. J’s capacity to decline treatment. It was acknowledged that patients have the right to refuse any and all treatments, even life-sustaining treatments. However, before honoring a patient’s decision to decline important medical treatment, health care providers have an obligation to assess the patient’s decision-making capacity. While denying someone with decisional capacity the right to guide their own health care is clearly unethical, failing to protect someone without decisional capacity from a harmful choice is a moral failing, as well. The ethics team outlined that patients with decision-making capacity are able to: (1) communicate a clear choice, (2) demonstrate understanding of their medical condition, (3) appreciate their clinical situation and the benefits and burdens of treatment (as well as of forgoing treatment), and (4) reason through the decision, applying the relevant medical information to their values and interests. Importantly, the ethics team also explained that when the decision is particularly consequential (e.g., there is a high risk of avoidable death without treatment), the threshold for a patient being judged as having demonstrated capacity is commensurately high.

The medical team explained that Ms. J was certainly able to communicate a clear choice. She also seemed to understand what the treating team was telling her, and she was able to demonstrate some reasoning as to why she wanted to leave the hospital and why she was refusing to be put on a ventilator. Rather than focusing on her understanding or her reasoning, the ethics team called attention to whether Ms. J was demonstrating sufficient appreciation of her clinical condition and the likely consequences of declining treatment. Ms. J was not merely in disbelief about the likelihood of death should she forgo ventilation; she was in disbelief about the possibility of such an adverse outcome. In short, her false beliefs about her disease meant she was unable to demonstrate sufficient appreciation of the likely consequences of forgoing treatment. The clinical ethicists reminded the treating team that each of the four abilities is necessary for capable decision-making. If there was significant doubt about Ms. J’s capacity, the ethicists said, the treating team should err on the side of caution: judge her to lack capacity and encourage her to identify a surrogate decision-maker (e.g., one of her adult children) to help with treatment decisions. 

The Decision

The treating team informed Ms. J of their concerns about her decision-making capacity given the dire consequences of forgoing ventilation, and they asked if they could turn to one of her children to help with the decision. Fortunately, Ms. J identified one of her adult daughters as her surrogate. Her daughter provided consent and was even able to persuade Ms. J that her life depended upon remaining in the hospital and receiving ventilator support. Even more fortunately, the treatment was successful. Ms. J left the ICU a week later and was discharged from the hospital soon after.

Lingering Questions

Despite the auspicious outcome of this case, it raises three challenges. First, shouldn’t the medical team have respected Ms. J’s autonomy and let her make her own decision, even if, in the team’s professional judgement, her decision was a bad one? Again, if Ms. J had demonstrated sufficient decision-making capacity—based on the four abilities outlined above—then, yes. Patients demonstrating capacity get to make their own treatment decisions, even decisions that go against medical judgement and are life-threatening. But when patients fail to appreciate the likely outcomes of their decisions and instead have false beliefs about the consequences of forgoing treatment, they lack decision-making capacity. Respecting the preference of a patient without sufficient capacity does not necessarily respect their autonomy, but instead could potentially constitute a failure to act in their best interest.

Second, it was fortunate that Ms. J’s daughter was able to persuade her mother to accept treatment. But what if she hadn’t been able to do so? When a patient who declines treatment lacks capacity, it doesn’t necessarily follow that treatment should be provided over the patient’s objection. The potential benefits of a treatment must always be weighed against the burdens of the treatment. And, when treatment is provided over a patient’s objection, the benefit should be especially strong, given the significant psychological and emotional harms often associated with involuntary treatment. If Ms. J had not been persuaded, the treating team and her daughter would have had to decide whether treatment, all things considered, was in Ms. J’s overall best interest.

Lastly, what should the team have done if Ms. J’s daughter had the same mistaken beliefs and incredulity about her mother’s dire prognosis? What if her entire family shared those beliefs? What about when those beliefs are widespread? Given the  extent of misinformation about Covid treatment, it’s not unreasonable to assume that a significant minority of the U.S. population held beliefs similar to Ms. J’s and that these beliefs may have had a political etiology. Does this mean that a significant minority of the population would lack decision-making capacity if they found themselves in Ms. J’s situation?

There is no well-worked out theory of incredulity and its relationship to capacity. And there are certainly differences between false beliefs, conspiracy theories, and delusions. That notwithstanding, it is important to note that not all false beliefs undermine capable decision-making. Believing that the Earth is flat, for example, does not undermine a patient’s capacity to decide between life-saving treatment and leaving the hospital against medical advice. But when a patient has false beliefs that are pertinent to the decision at hand–for instance, a belief that their illness is not severe and can be remedied with vitamins–these false beliefs can undermine their capacity to make decisions in line with their own conception of the good, about what makes a life worthwhile. Just as incredulity about a diagnosis can prevent patients from making capable decisions about treatment, incredulity about the likely consequences of a decision can lead to a judgement of incapacity.

Daniel Edward Callies, PhD is a clinical ethicist and the ethics program manager for the University of California, San Diego Health System.

Series Editors’ Comment: Considering Humility and Trustworthiness

Honoring patient autonomy cannot be done in a vacuum. Autonomy is relational insofar as it depends on the sharing of information and the ability to work through complicated decisions with others. But the choices we make are molded by social norms, beliefs, and values. This is why the process of eliciting a patient’s values and expertise, sharing relevant clinical knowledge, and, ultimately, supporting the patient in choosing the best pathway forward for them cannot be abstracted from ordinary, deep-seated norms, beliefs, and, importantly, imbalances of power. While health care professionals are trained experts in clinical care, their power to adjudicate truth and falsity of individual beliefs is necessarily limited.

Ms. J’s case demonstrates the importance of balancing respect for autonomy and harm prevention, but also the important virtues of humility and trustworthiness. As many patients know, health care is an imperfect science and health care providers sometimes get it wrong. This complicates their efforts to assess a patient’s capacity based on appreciation of consequences and reasoning about options, especially when assessment of decision-making capacity can be weaponized to justify acting over a patient’s stated objections.

While Callies rightly relies on the gravity of the harm (likely death) and the patient’s lack of appreciation that she might die, health care professionals should question what appreciation means in the context of opposing sociopolitical values and related beliefs. There are broader harms—experienced and witnessed during the Covid pandemic—that result from behaviors that create and perpetuate distrust. Acting over a patient’s objections—even if justified by nonmaleficence for a patient without decision-making capacity—has consequences that can reverberate in families and communities. How should these moral harms be weighed? This is a powerful question that cannot be answered by health care professionals alone.

Ethics consultants can help health care professionals appreciate the importance of this question and work with all engaged parties to determine who has the authority to answer it definitively in a given case. Yet, the question will always recur, as will other moral questions essential to the practice of medicine, each time providing another opportunity to situate the meaning of health care within the context of its practice.

Trust and distrust arise in case-by-case enactments of power and authority in everyday health care practice. The authority that trained health care professionals have over shaping clinical conversations carries a risk of harm: in attempting to focus on medical facts, health care professionals may circumvent open speech and, in the process, sow distrust and convey bias.

This is the heart of the moral dilemma posed by the case of Ms. J. It is right to question whether honoring choices tied to reasons that are personal, even political–and are disputed by many health care experts–could serve to build patient or community trust and support broader community benefit, even if honoring those choices means risking a patient’s life. At the same time, the death of such a patient risks increasing distrust in the capacity of health care professionals to save the lives of patients who are vulnerable to the harms of the politicization of medical facts.

Ultimately, ethics consultants can support serious consideration of patients’ voices and rights, while simultaneously building trust and minimizing harm, by helping health care professionals align medical care with the values conveyed by their patients. After assessing a patient’s capacity to make decisions, with close attention to possible biases at play and holistic consideration of the severity of the risks to the patient, ethics consultants may sometimes conclude that life-saving therapy cannot be provided over a patient’s objection. These decisions should always be recognized as uncertain and made with humility.

– Georgina Campelia and Thomas Cunningham

Learn more about the series, Clinical Ethics Case Studies for Hastings Bioethics Forum.

Read the previous essays in the series here, here, and here.

Attention clinical ethicists: learn how to contribute to the series.

clasped hands of patient, doctor's hands with pen and clipboard

Bioethics Forum Essay

Cold Comfort for Texas Obstetricians

by Ellen Wright ClaytonPublished Posted in Abortion, Hastings Bioethics Forum

In an essay about the recent Texas Supreme Court decision on abortion, John Lantos was correct in stating that the justices refused to issue an order protecting Dr. Damla Karsan and her patient, Kate Cox, whose fetus had trisomy 18, “from prosecution under [Texas’] abortion-banning law,” noting especially that Texas does not permit abortion for lethal fetal anomalies. In their opinion, although the justices wrote that “the pleadings state that Ms. Cox’s doctor—Dr. Damla Karsan—believes Ms. Cox qualifies for an abortion based on the medical-necessity exception,” they held that the doctor’s good faith belief that the statutory requirements had been met did not suffice because Dr. Karsan did not explicitly say that, in her “reasonable medical judgment,” her patient had “a life-threatening physical condition aggravated by, caused by, or arising from a pregnancy that places the female at risk of death or poses a serious risk of substantial impairment of a major bodily function unless the abortion is performed or induced.”  [TEX. HEALTH & SAFETY CODE § 170A.002(b)(2)]

As a result, the justices refused to “pre-authorize the abortion.”

Yet, Lantos was misguided in suggesting that the remainder of the opinion offers a path forward if only physicians would exercise “reasonable medical judgment” that their patients faced the statutory level of harm. It may seem reassuring that these justices sought to provide “some clarity,” writing that “[t]he law leaves to physicians—not judges—both the discretion and the responsibility to exercise their reasonable medical judgment, given the unique facts and circumstances of each patient.” (emphasis original) In fact, the justices specifically declined to say any more about what constitutes “reasonable medical judgment.” They did say that women need not be on the brink of death before abortion is permissible. This formal deference to physicians may reflect in part courts’ general reluctance to give prior approval to physicians since the court here stated three times in its opinion that women need not obtain court orders prior to having a qualifying abortion.

The first problem with Lantos’s analysis is that having decided the main issue in the case – whether Kate Cox’s abortion could proceed — all the language that followed was mere dicta, nonbinding statements of limited precedential value. The justices were not promising that an exception would automatically be available when, in a physician’s “reasonable medical judgment,” the woman’s health was at serious risk. Certainly, simply saying the magic words would not suffice to confer immunity, especially since the opinion later said that “[a]n exercise of reasonable medical judgment does not mean that every doctor would reach the same conclusion.”  One wonders whether these justices would have discounted Dr. Karman’s words even had she used the statutory language in her attestation. 

The justices’ suggestion that the Texas Medical Board could choose to provide more guidance fails to recognize that the board has rarely provided definitive guidance about the standard of care in any aspect of medical practice. When the board does address what physicians should do in certain practice areas, it typically focuses on procedural issues, often specifying that it did not intend to preclude consideration of other sources of authority on how clinicians should care for patients. Nor should it be reassuring to clinicians seeking to care for their sick pregnant patients that all members of the board are appointed by the governor and are represented by the Texas attorney general.

And there is at least one more problem. The opinion in this case was decided by only three justices of the Texas Supreme Court (out of nine) and issued per curiam (without identifying who wrote it) after necessarily rapid briefing given the immediacy of the case. The decision of these justices to address “reasonable medical judgment” at some length is particularly puzzling since, two weeks earlier, on November 28, 2023, the entire Texas Supreme Court had heard oral arguments in the case of Zurawski v. Texas No. 23-0629.  In that case, the trial court, after hearing extensive testimony from women  who said they had been harmed by “the widespread uncertainty of physicians’ level of discretion under the scope of Texas medical exception provision,” enjoined “abortion bans in any manner that: (i) would prevent the Patient Plaintiffs and pregnant persons throughout Texas from receiving necessary abortion care in connection with an emergent medical condition; (ii) would subject the Physician Plaintiffs and others in Texas to liability for providing necessary abortion care in connection with an emergent medical condition; and (iii) would be inconsistent with the rights of pregnant persons and physicians in Texas under Article I, §§ 3, 3a, and/or 19 of the Texas Constitution . . . .” 

The injunction never went into effect because the Texas attorney general appealed it the same day.  It is almost as if the three justices, by their dicta in denying the Coxes’ and Dr. Karsan’s request for a protective order, were attempting to preempt the deliberations of the entire Texas Supreme Court in Zurawski.

Most troubling of all, physicians’ decisions are always subject to being second-guessed by prosecutors, trial courts, expert witnesses, and juries. Nothing prevents a prosecutor from bringing charges, and juries have enormous discretion in weighing evidence. If this is the path forward for physicians, it is characterized by rocks, IEDs, chasms, and steep drop-offs.

So, my advice is to be cautious, be very cautious, of the dire uncertainty that remains.

Ellen Wright Clayton, JD, MD, is the Craig-Weaver Chair in Pediatrics, core faculty of the Center for Biomedical Ethics and Society, and a professor of law at Vanderbilt University. She is a Hastings Center fellow.

Illustrative image for This Wasn t the Plan A Family Caregiver s Recommended Readings from 2023

Bioethics Forum Essay

This Wasn’t the Plan: A Family Caregiver’s Recommended Readings from 2023

by Nancy BerlingerPublished Posted in Aging, Hastings Bioethics Forum

Work and life overlapped significantly for me in 2023. The timeframe for the latest project in the  Bioethics for Aging Societies portfolio—a Greenwall Foundation-funded analysis of ways to support aging through housing—coincided with changes in my 89-year-old mother’s health that by year’s end resulted in a change in her housing. As my mother says, no one “plans” to move to assisted living as an aspiration. Something happens. A fall, a stroke, the accrual of age-associated conditions within one life, or within a couple’s life. And so, life changes, yet again. I am reading reports and articles about aging and caregiving with a sharper perspective, reality-checking, looking for my mother, and for myself, in the stats and stories. Here’s a round-up of good reads from 2023.

An excellent New York Times/KFF Health News series with the less-than-cheerful title Dying Broke catalogs how impossible it is for many Americans to “plan” for a financially secure old age. The “choices” available to people who need care heavily depend on ability to pay for “options” outside the Medicare health insurance system for older Americans. This series makes admirably clear that in America, when we say “care,” this usually means family caregivers. That society in which people care for their elders? That’s this society, for better or worse. As the thousands of reader comments on this series make clear, what is missing from American society is a coherent and equitable system for financing care, comparable to Medicare and meeting the foreseeable needs of an aging population.

A report on financial longevity, from the University of Pennsylvania’s New Courtland Center for Transitions and Health in collaboration with the TIAA Institute, avoids the trap of reducing population aging to a personal or family problem and advising caregivers to “take care of themselves.” (Disclosure: I have written with New Courtland director Mary Naylor, a co-author of this report.) The authors present the useful concept of “financial caregiving,” reflecting data showing that nearly all family caregivers provide financial support or manage finances on behalf of the person they are caring for. The report’s recommendations in response to this intergenerational reality are targeted to employers and financial advisors of current and future caregivers. Employers are encouraged to offer flexible work, remote work, and paid family leave as part of standard benefits, given that 60% of family caregivers are employed. Financial advisors are encouraged to shift from “retirement” planning to “longevity” planning, talking more directly with clients about how population aging (longer lives and smaller families/future caregivers) affects them. The report also notes that the financial costs borne by family caregivers as a percentage of income are significantly higher among Black and Hispanic/Latino family caregivers, with implications for their financial security.

The slide-format infographics summarizing this report are especially helpful, and the limited use of cutesy phrases such as “sandwich generation” is refreshing. Caregiving is serious work. The renegotiation of self-determination as a shared project, involving the delegation of activities such as paying one’s own bills or doing one’s own taxes, involves mutual learning, patience, respect, and trust. For more on financial caregiving in the context of dementia, see this 2023 study from University of Michigan investigators, which analyzes how the incremental changes associated with this disease translate into increased care needs and out-of-pocket care costs.

My research colleague Jennifer Molinsky, who directs the Housing an Aging Society program at the Harvard-based Joint Center for Housing Studies, produces a crucial semiannual report on housing America’s older adults. (The link includes the full report, charts, data sources, and other tools.) In a post summarizing insights from the 2023 report, Molinsky explains how population aging intersects with the shortage of affordable housing in the U.S., and how the housing needs of older adults include–and go beyond–affordability.

In the next decade, people over 80 will become the fastest growing segment of the U.S. population. Due to age-associated health conditions and limits on mobility, people over 80 are foreseeably more likely to need accessible housing, and also services and supports provided in or near where they live. The cost of certain services and supports, such as hiring a live-in aide, are beyond the financial means of typical, nonwealthy, older adults. While greater options technically exist for older adults who are income-eligible for housing subsidies or dually eligible for Medicaid, actual access to these options is constrained by waiting lists and insufficient availability. Residential options such as assisted living usually rely on owning a home that can be sold to generate the funds needed to pay monthly fees. The supply of truly affordable housing designed for older adults, with attention to accessibility and to proximity to local services and opportunities for social connection, is severely limited. Result: older adults and their families are making do with housing that no longer works, while compensating for services that they cannot afford or that do not exist where they live. Steep inequalities associated with race and ethnicity reflect the consequences of longstanding barriers to homeownership and to living in communities with higher property values.

Molinsky (an advisor to my project) calls for a shift in how our nation thinks about housing, aging, and care. Our current approach, in which real options exist only for the wealthy, excludes most older adults and families from making choices based on existing housing stock. (Waiting lists are not a realistic strategy for people in their 80s.) We are missing opportunities for creativity in using housing to improve lives.

Other recent publications I found useful included updated research on the future of the forgotten middle of older adults who lack wealth and do not qualify for Medicaid or housing subsidies; an essay on “longevity-ready cities” as a framework for urban planning, shifting beyond the scale and individual focus of “age friendly” services; and the smart reporting of Atlantic staff writer Jerusalem Demsas on housing.

I learned a lot about Medicare this year. There is nothing like a discharge planning meeting to drive home the crucial distinctions between what Medicare pays for and what is recommended post-discharge but not covered by insurance. The website of Medicare Rights Center, a nonprofit that provides education, counseling, and advocacy to Medicare-insured individuals (including many younger people with disabilities), is a great resource. The website of the Family Caregiver Alliance includes a comprehensive section on “caring for another,” with details on how to be decent employer if you are considering hiring home-based care workers.

Finally, the most sustaining book I read in 2023 was about caregiving, although I didn’t realize that when I bought it. Breadsong is a superb book about baking, and is also a memoir, jointly told by a young woman and her father, about severe depression, family caregiving, and recovery, anchored by a strong sense of place: a village near Oxford, England. A memorable story about interdependence and creativity—and the recipes work.

Nancy Berlinger is a senior research scholar at The Hastings Center and a Hastings Center fellow.

Texas supreme court building

Bioethics Forum Essay

Texas Supreme Court Offers Roadmap for Legal Abortion

by John D. LantosPublished Posted in Abortion, Hastings Bioethics Forum

A recent Texas Supreme Court decision with implications for post-Dobbs jurisprudence on abortion seems to have been a victory for those who oppose the practice. It was widely read as upholding Texas’s very strict anti-abortion legislation. I suggest another possible reading of that decision.

The case focused on Kate Cox, a 31-year-old mother of two. She sought an abortion after learning that her fetus had multiple congenital anomalies, and she developed medical complications that could have made future pregnancies impossible. This month, a Texas court granted her request for a temporary restraining order on enforcement of Texas’s abortion bans, thus permitting her to have an abortion. The Texas Supreme Court overturned the lower court’s decision, and Cox then left Texas to seek health care elsewhere. 

First, some facts. Kate and her husband, Justin Cox, always wanted lots of children. They have two now. In August, they learned that she was pregnant with a third. Sadly, prenatal testing showed that the fetus had multiple malformations, including problems with its heart, spine, brain, and limbs. A diagnosis of Trisomy 18 was confirmed. Kate’s doctor told her that continuing the pregnancy would jeopardize her health and make future pregnancies riskier and recommended that she terminate her pregnancy to preserve her own health and ability to have more children.

After much discussion with her husband and her family, Kate decided that terminating this pregnancy would be the right decision for her and her family. In her own words: “I do not want to put my body through the risks of continuing this pregnancy. I desperately want the chance to try for another baby and want to access the medical care now that gives me the best chance at another baby.”

Her case highlights some of the bizarreness of the current hyper-polarized world of abortion politics. Kate’s fetus would likely not survive. Kate passionately wants to have more children. Continuing the pregnancy would have decreased the chances of her having healthy pregnancies in the future. Terminating the pregnancy, by contrast, was the more pro-life strategy. Yet, in the name of an ideology that is supposedly pro-life, Texas Attorney General Ken Paxton sought to force Kate to continue a pregnancy that would not only have put her health at risk but would also have decreased the likelihood that she could have healthy children in the future. 

Still, this case, and another like it that is before the Texas Supreme Court, are forcing Texas judges to do their job and clarify the implications of the thoroughly ambiguous law that is now state policy.  That law says that abortion is permissible when, “in the exercise of reasonable medical judgment, the pregnant female on whom the abortion is performed has a life-threatening physical condition aggravated by, caused by, or arising from a pregnancy that places the female at risk of death or poses a serious risk of substantial impairment of a major bodily function unless the abortion is performed.”

It is unclear how serious a health threat must be for an abortion to be permissible under that exemption. The Coxes’ original petition for a restraining order noted some of the many ambiguities. “Nowhere in the code does Texas law define any of the following distinctions: ’risk’ versus ’serious risk’; ‘insubstantial impairment’ versus ‘substantial impairment’; or ‘minor bodily function’ versus ‘major bodily function.’ Nor does Texas law define what it means to have “a serious risk of a substantial impairment” or “a substantial impairment of a major bodily function.” 

A lower court found that, if Kate continued the pregnancy, it would create a “serious risk” to “her life, health, and fertility.”  The court cited medical testimony stating that, “If she is forced to continue this pregnancy, Ms. Cox is at a particularly high risk for gestational hypertension, gestational diabetes, fetal macrosomia, post-operative infections, anesthesia complications, uterine rupture and hysterectomy due to her two prior c-sections and underlying health conditions. Undergoing a third c-section would make subsequent pregnancies higher risk and make it less likely that Ms. Cox would be able to carry another child in the future.”  An amicus brief from the American College of Obstetrics and Gynecology and the Society of Maternal and Fetal Medicine supported these claims. Based on these findings, the lower court issued an order that protected the Coxes and their doctor from prosecution under the abortion-banning statute.

A few days later, the Texas Supreme Court reversed that ruling.

The Supreme Court decision did two things. First, as widely noted, it overturned the lower court decision that would have protected  the Coxes and their physician from prosecution under the abortion-banning law.  Second, and more interesting, it proposed a set of criteria that could be read as a roadmap, endorsed by the highest court in the state, for the type of argument that would be necessary for a doctor to legally provide an abortion.

A few things have become clear from the decision. First, in Texas, a fetal condition by itself, no matter how severe, is not enough to justify an abortion. Texas Attorney General Ken Paxton noted that the law contains no exceptions to the “for unborn children with fatal conditions who are unlikely to survive long after birth.” 

Instead, the only justification for an abortion is that continuing a pregnancy creates a risk to the health of the pregnant woman. The key question now is whether the determination of risk should be made by doctors, lawyers, or legislators. The Supreme Court decision was clear. Only doctors should make such determinations. The Supreme Court wrote, “A woman who meets the medical-necessity exception need not seek a court order to obtain an abortion. Under the law, it is a doctor who must decide that a woman is suffering from a life-threatening condition during a pregnancy, raising the necessity for an abortion to save her life or to prevent impairment of a major bodily function.”

The Supreme Court was also clear that the risk of harm need not be imminent. The decision stated, “The exception does not cover . . . only adverse results that will happen immediately absent an abortion, nor does it ask the doctor to wait until the mother is within an inch of death or her bodily impairment is fully manifest or practically irreversible. Rather, the exception is predicated on a doctor’s acting within the zone of reasonable medical judgment, which is what doctors do every day.”

In short, the Supreme Court decision clearly empowers physicians to exercise their reasonable medical judgment, given the unique facts and circumstances of each patient, without deferring to a judge. One way to read this decision is as the Court’s attempt to keep each case from coming to court.

The case can and should be read as a loss for Kate Cox and her physicians. But there is a clear silver lining. The Texas Supreme Court decision can be interpreted as both empowering physicians – by saying that only they and not lawyers can decide whether a woman’s health is seriously jeopardized — and coaching them on how to provide care for patients in ways that will withstand legal scrutiny. It invites doctors to use their “reasonable medical judgments” and to be offering legal protection if they do.

This opinion, somewhat surprisingly, aligns closely with the work of pro-choice lawyers who are trying to protect the integrity of the medical profession and protect the right of women to receive medically appropriate reproductive health care. Katie Watson, for example, offered physicians the following advice, “Providing standard medical care to people whose health or life is threatened by their pregnancy is neither civil disobedience nor covert lawbreaking; it isn’t even resistance. It is wise interpretation of existing law as applied to specific facts, fidelity to clinicians’ fiduciary duty to stay focused on patients in medical need, and acceptance that choices of historic consequence rarely come with zero risk.”

It is time for Texas doctors, hospitals, and professional societies to play offense rather than defense and to exercise their professional judgment as the Supreme Court is encouraging them to do.

John D. Lantos, MD, is a bioethicist and general pediatrician in New York City and a Hastings Center fellow. He blogs about bioethics and health policy at johnlantos.com/blog.

Illustrative image for Involuntary Donation Animal Welfare and Xenotransplantation

Bioethics Forum Essay

Involuntary Donation: Animal Welfare and Xenotransplantation

by Sana Baban, Ashlin Amano and Lisa MosesPublished Posted in Animal Welfare, Hastings Bioethics Forum

The realized promise of xenotransplantation seems to be quickly approaching, following the medical breakthrough of a pig kidney functioning for a record two months in a deceased human body. This milestone has received overwhelmingly positive media attention despite the complexity of the technical and ethical hurdles to overcome. Ethicists, physicians, and transplantation specialists have shared their apprehensions about the risks of implanting animal-grown organs into humans, including zoonotic diseases and organ rejection, which occurred in the latest attempts at pig-to-human heart transplants. However, conspicuously absent from these discussions is a major stakeholder: the animals.

Ethical questions about how we are using animals–let alone questions of whether we should use them–to create organs to transplant into humans have, unsurprisingly, been overshadowed by concerns over human research subjects and organ recipient protections. If mentioned at all in medical and bioethics literature and in the media, animal considerations have been relegated to a brief acknowledgment. Bioethicists have a duty to fully assess the ethical consequences of novel health care interventions on both those who benefit and those who are harmed. Sentient nonhuman animals are an intrinsic part of that moral consideration.

There are three crucial points to consider about the welfare of nonhuman animals used for xenotransplantation. The first point concerns harm done to the animals by the process used to create the pigs and grow the organs. The second concerns gaps in animal welfare oversight. The third is the misconception that pigs are the only animals used in the research; xenotransplantation research has required hundreds of nonhuman primates, too.

Creating organs in pigs that can be used by human bodies is technologically complex and currently inefficient and costly. Different companies use distinct, proprietary techniques. The process usually begins with a collection of pig ovaries, typically sourced from slaughterhouses, which are used to create genetically engineered embryos. The embryos have alterations made in certain genes, have human genes inserted, or have both changes. The genetic alterations are done for a variety of reasons, including preventing organs from growing too big for human use, reducing the chance of zoonotic disease transmission, and minimizing the risk of organ rejection.

The genetically engineered embryos are then cloned to produce exact copies and are implanted into surrogate sows for eventual surgical births. The donor pigs are raised separately from their mothers in a highly sanitized indoor environment. While these conditions preserve the pigs’ status as disease-free, they do this at the expense of the animals’ welfare and quality of life. Compounding animal welfare concerns is the inefficiency of the process. It takes many surgical and medical procedures on many sows to produce one viable pig for organ procurement. Each donor pig must endure a lifelong schedule of invasive procedures and monitoring until it is killed and its organs are harvested for transplantation.

The second point concerns animal welfare regulations. Pig-to-human xenotransplantation research projects are huge endeavors, involving international partners and multiple funding sources. In the United States, unlike in other regions such as the United Kingdom and the European Union, oversight of animal research is decentralized, handled within each institution, and differs based on the funding source. When projects include international partners and a mix of private and public funders and sites, it can be unclear what animal welfare regulations are mandated. Standards of care may also differ at each research site. Given the problematic history of xenotransplant animal welfare violations, one might conclude that researchers have an incentive to produce pigs for xenotransplantation in the U.S. to circumvent more stringent welfare standards elsewhere. Indeed, that is precisely what was alleged in the year 2000 when Novartis moved its xenotransplant research subsidiary from the U.K. to the U.S.

Animal welfare concerns in xenotransplantation are not limited to pigs. Pig organs must be transplanted into nonhuman primates before they can be transplanted into humans, according to Food and Drug Administration research requirements. These preclinical trials are fraught with welfare concerns, as primates undergo several invasive medical treatments and surgical procedures to implant pig organs, frequently leading to premature death. While the involvement of pigs in xenotransplantation is obvious, most people probably don’t realize that nonhuman primates are also involved. But the public should know. Data on people’s attitudes toward the use of nonhuman primates in xenotransplantation is needed in the literature for consideration by bioethicists and others concerned with the animal welfare issues it raises.

A powerful, yet deeply problematic analogy that has been used to undermine concerns of animal welfare in xenotransplantation draws a comparison between industrial pork production and xenotransplantation. Namely, if pigs are already bred for human food consumption, it should be permissible to breed them for transplantable organs. But this argument is flawed. Industrial pork production is ethically fraught for both the animals and the laborers in the industry. There are dangers in using this practice as the standard against which to compare the use of pigs in xenotransplantation when the standard itself is ethically questionable. This line of thinking perpetuates the lack of moral consideration of the use of livestock animals in different contexts, something that deserves careful deliberation.

If xenotransplantation proves successful in clinical trials, the use of nonhuman animals to produce organs suitable for transplanting into humans is both inevitable and essential. But the simple fact that xenotransplantation helps people is not reason enough to disregard animal welfare concerns. We must consider how this emerging medical treatment affects the nonhuman animals involved.

The first step is for private entities that produce and test animals for xenotransplantation to be transparent about how the animals are treated and which animal welfare oversight standards are used. Claiming the need to protect proprietary research secrets or intellectual property of the pig creation process is not a justifiable excuse for avoiding transparency. This basic and fundamental information is necessary for bioethicists and others to examine ethical issues that nonhuman animals face in xenotransplantation research methods. Only then can there be well-informed, nuanced deliberation on how to ensure a high standard of animal welfare and regulatory oversight, and how to limit the number of animals used in this novel research. Until there is greater transparency, we will remain where we are now: unaware of the cost to the nonhuman animals that are critical to the success of pig-to-human organ transplants–and at a loss for how to weigh them.

We find ourselves at a crossroads, both hopeful about this emerging medical breakthrough and troubled by its implications for fellow sentient and intelligent beings.

Sana Baban, MBE, is a project manager and research assistant at The Hastings Center. @sana_baban

Ashlin Amano, MBE, is an administrative coordinator in Columbia University’s department of Medical Humanities and Ethics. @ashlin_amano

Lisa Moses, VMD, a veterinarian and animal focused bioethicist, is a faculty member at Harvard Medical School’s Center for Bioethics and a senior advisor to The Hastings Center.

silhouette of woman in front of window

Bioethics Forum Essay

Does Calling Severe Anorexia a Terminal Condition Matter?

by Paul T. MenzelPublished Posted in End-of-life ethics, Hastings Bioethics Forum, Medical Aid-In-Dying

What is at stake in calling extreme, end-stage anorexia nervosa (AN) a terminal condition? In this context, “terminal” is used in the broadest sense, that is, leading to death in a foreseeable length of time, not the narrower sense in which “terminal illness” is an eligibility requirement for medical aid-in-dying (MAID) or Medicare hospice reimbursement in the United States. In this broader sense, calling extreme AN a terminal condition may be thought to have implications for end-of-life decisions, such as the refusal of life-prolonging treatment or voluntarily stopping eating and drinking (VSED). I will argue that this is a mistake, although one that needs explanation.

Patients with extreme AN are natural candidates for hastening death by VSED. Normally VSED requires those who pursue it to be sufficiently decisive and determined to overcome a strong natural desire to eat and drink. Patients with severe AN, however, do not want to eat. In fact, they want not to eat. 

Vigorous discussion of whether it is appropriate to classify extreme AN as a clinically terminal illness was initiated in 2022 in the Journal of Eating Disorders by Guadiani, Bogetz, and Yager. They argued that such patients may be regarded as terminal even though they might again eat enough to survive without being force-fed. And if their condition is terminal, it is difficult to defend force-feeding them. Several commentators disagreed, among them Guarda et al.,  and the controversy recently attracted coverage in the Washington Post.

Since AN is a mental illness, some call into question whether patients with the condition have the decision-making capacity needed to assert their right to stop eating and drinking. On the other hand, even with a mental illness, supporting the patients in extreme AN in refusing to eat and drink may be easier to defend if their condition is terminal.

The situation is murky, indeed. Can it be clarified? I believe it can.

1. To start with, competent patients have the moral and legal right to refuse food and water by mouth, just as they do to refuse lifesaving treatment. The decision-making capacity required is not exemplary rationality or freedom from all compulsions or misconceptions, only an understanding of the patient’s own condition, of the treatments and assistance with food and drink that are available, and of the consequences, including death, of refusing them.

2. Exercising this right is generally not dependent on whether the patient’s condition is terminal. The right to VSED and to refuse lifesaving treatment still apply, for example, to those with chronic conditions that are not terminal. One might then infer that the whole controversy about whether to deem extreme AN a terminal condition is largely irrelevant. Ultimately, terminal does not do the definitive moral work; the patient’s voluntary, informed consent does. The issue, though, is still substantively significant. For one thing, the further away from naturally dying the refusing patients are, the more caution is in order in deciding whether to accept their refusal. Other details, too, need to be noted.

3. In addition, a condition can be terminal even when the patient’s decision makes it such. In hospice eligibility, for example, deliberately refusing life-extending cancer treatment does not disqualify a patient from her prognosis being terminal. Similarly, AN patients’ refusal to eat does not bar their condition from being terminal.

4. AN is not rendered significantly different because it is tied up with the person’s very identity. Angela Guarda and Cynthia Bulik have argued that since AN is tied closely to the person’s very identity, when AN patients refuse food or treatment, it their illness, not they themselves, that is speaking. It is a weak argument. If an AN patient defines her very self in part by her AN, then when she speaks, of course her illness is speaking. Or turn it around. Suppose that her illness is speaking, then given the close identification, she, too, is speaking.

5. Lack of good research on a psychiatric illness like AN is no reason to deny patients the right to refuse food and drink. Steven Dunn, whose daughter died as a result of severe anorexia, has argued that since research on psychiatric conditions like extreme AN is currently thin, we do not have to abide by patients’ death- hastening refusals. Comparisons, though, refute this argument. If a person afflicted with a relatively new virus, for example, refuses the available, partially effective treatment, we should still withhold the treatment even if research on the condition is in its infancy. Some patients may want to hang on in the hope that something more effective is around the corner, but if they do not, we should not impose the available treatment on them. In the case of extreme AN, moreover, we have little reason to think that significantly better treatment is around the corner.

6. At some point, enough is enough. Even if therapy or feeding can initially be forced on such patients, that does not mean caregivers may resort to it indefinitely. Guardini and colleagues push the question to those who want to continue forced therapy: when is enough enough? The questionable decision-making capacity of patients with severe AN may justify force-feeding for a limited time, but if they are obviously suffering, how long is such coercion justified? They are, after all, able to understand that not eating will lead to death, and they understand the treatment or feeding that has been imposed on them. In these circumstances, accepting their refusal is the compassionate and respectful thing to do.

Whether to regard severe end-stage AN as terminal is a less important issue than most parties to the controversy have assumed. But whether such AN is appropriately characterized as terminal, the justifications offered for force-feeding are weak.

Paul T. Menzel, PhD, is professor of philosophy emeritus of Pacific Lutheran University and the co-editor, with Timothy Quill, Thaddeus Pope, and Judith Schwartz, of Voluntarily Stopping Eating and Drinking: A Compassionate, Widely Available Option for Hastening Death (Oxford University Press, 2021). His most recent book, with Bonnie Steinbock, is Bioethics: What Everyone Needs to Know (Oxford University Press, 2023).

Unidentified subject, onlookers and Dr. Walter Edmondson taking a blood test (NARA, Atlanta, GA)

Bioethics Forum Essay

Newly Released Documents from Untreated Syphilis Study: Ethical, Just, and Respectful Use of Archival Materials

by Faith E. Fletcher, Sophie Schott, Virginia A. Brown, Nancy Berlinger and Stephen O. SodekePublished Posted in Clinical Trials & Research Ethics, Hastings Bioethics Forum, Medical research ethics

To mark the 50th anniversary of the end of the United States Public Health Service’s Syphilis Study, the National Library of Medicine recently digitized and released reams of historical documents on the “origin and development of the Tuskegee syphilis study,” including journals, newspaper articles, personal correspondence, and other records. The release of these documents is a poignant occasion to consider what qualifies as ethical, just, and respectful use of archival materials.

The United States Public Health Service was responsible for conducting a 40-year study (1932-1972) designed to document the natural history of untreated syphilis among Black men from Macon County, Alabama. This notorious study systematically targeted a medically and economically disenfranchised population, provided misleading and false information about the study’s procedures and intent, and deliberately withheld treatment after penicillin became the widely available standard of care for syphilis. 

The Syphilis Study Legacy Committee was established in 1994 to elicit a formal apology from President Bill Clinton in recognition of the atrocities of this government-funded study and to develop a strategy to understand and address the long-term impact of the study on Black Americans. The work of the Legacy Committee led to the establishment of the National Center for Bioethics in Research and Health Care at Tuskegee University, whose founding director was the late Marian Gray Secundy. Secundy’s personal legacies, as a passionate advocate for health equity, a visionary scholar, and an exemplary mentor and collaborator, have been the subject of recent focused work in bioethics to reintroduce her work to the next generation of scholars and advocates.

Medical historian, physician, and bioethicist Vanessa Northington Gamble chaired the Legacy Committee. In a classic 1997 essay, “Under the shadow of Tuskegee: African Americans and health care,” Gamble called attention to the invocation of “Tuskegee” to represent “racism in medicine, misconduct in human research, the arrogance of physicians, and government abuse of Black people.” To rightfully emphasize the histories of medical racism in the U.S. Gamble and other scholars have long cautioned against attributing distrust in the health care system by Black Americans mainly or solely to the betrayal experienced by the men enrolled in the USPHS study. We argue that utterances of “Tuskegee” convey a misleading shorthand—an untidy explanation for medical mistrust of the health care system among Black Americans. Simply put, it is the institutions of health care delivery––then and regrettably now––that perpetuate mistrust.  

Now is the time to reframe this narrative. We can acknowledge the deep symbolism of the USPHS Syphilis Study concerning the long and continuing trajectory of abusive practices in research and health care, while reconceptualize how we think about, teach about, and pass along the legacy of “Tuskegee.” This rethinking of scholarly and public-facing discourses requires the inclusion of community-level perspectives and concerns. In recent years, Macon County leaders and advocates have called attention to the mischaracterization and misnaming of the USPHS Syphilis Study. Lillie Tyson Head, President of the Voices for Our Fathers Legacy Foundation, highlights the ongoing local, cultural, and societal harms of invoking “Tuskegee.” Head states, “When you place Tuskegee in front of the name, it gives Tuskegee the ownership, it leaves a scar on the town of Tuskegee and of Macon County. Tuskegee was not, is not, the owner of the study. It is the United States Public Health Service Study of Untreated Syphilis in the Negro Male at Tuskegee.”

The recent release of documents related to the study is an opportunity to consider what qualifies as ethical and respectful use of sensitive historical materials. It is also an opportunity, even a duty, for bioethics and medical and health humanities scholars, whose fields have been shaped in part by the need to learn from injustices in research and health care, to respond to this moment, in collaboration with historians, archivists, curators, and community members.

As bioethics and medical and health humanities scholars, we offer some initial insights and questions regarding the use and dissemination of this digital archive. How should the perspectives of community members inform the preservation, interpretation, and presentation of these documents? Will people with interdisciplinary expertise (e.g., those with lived experience, medical historians, museum curators) be engaged in the archival work? Who benefits from and who is potentially harmed by making these historical documents publicly available? How can potential harms be prevented, or the risk of harm reduced? What does it look like to recognize the full humanity of everyone involved in the USPHS Untreated Syphilis Study? How should these documents and their recontextualization of the continuing struggle for racial health justice and for trustworthiness in health care and research be used to best inform public bioethics and public humanities work? For example, public bioethics work related to this public archive could include outreach to health journalists with the goal of supporting a more robust and context-specific understanding of these materials to inform ethically grounded research and health care practices.

While approaches to representing the USPHS Untreated Syphilis Study archives will vary by discipline, we suggest that all scholars, educators, and others working with these materials remember, honor, and recognize the lives and legacies represented by these documents particularly the men, families, and local communities victimized by the study. To demonstrate trustworthiness, respect, and transparency as ethical stewards of these archival data, bioethicists and medical and health humanities scholars must lead this charge.

Faith E. Fletcher, PhD, MA, is an assistant professor in the Center for Medical Ethics at Baylor College of Medicine, a senior bioethics advisor to The Hastings Center and a Hastings Center fellow of The Hastings Center. @FaithEFletcher

Sophie L. Schott, BA, is a clinical research coordinator in the Center for Medical Ethics and Health Policy at Baylor College of Medicine. @MyBestSchott

Virginia Brown, PhD, MA is a research scholar in Health Equity and Population Health at The Hastings Center. @VirginiaABrown

Nancy Berlinger, PhD, is a senior research scholar at The Hastings Center, where she directs the Sadler Scholars initiative for doctoral and early-career researchers from racially minoritized communities.

Stephen O. Sodeke, PhD, DBE, is resident bioethicist at the Center for Biomedical Research, Professor of Bioethics and Allied Health Sciences in the College of Arts and Sciences, Tuskegee University.

doctor at bedside holding patient's hand

Bioethics Forum Essay

Conscientious Objection and Abortion: Medical Students’ Perspective

by Leah Chen and Tudi LePublished Posted in Abortion, Hastings Bioethics Forum, Medical Education

 A woman in her mid-30’s who was 23 weeks pregnant received devastating news: her fetus had a lethal diagnosis. Her pregnancy was not viable and would end in stillbirth. Her physician recommended dilation and evacuation, a type of abortion. The patient didn’t speak English and needed a translator. The translator explained the diagnosis but would not translate the recommended treatment because they objected to it. Two other translators also declined to do so. Despite the medical necessity of the abortion, it was delayed and rescheduled twice that day because individual anesthesiologists, technicians, and nurses did not want to be involved in, what several called, “this kind of procedure.”

After the procedure and still sedated, the patient was turned away by the post-surgical nurse on duty because she “doesn’t work with abortion patients.” The patient was wheeled around in a hospital bed for 30 minutes while we—medical students– desperately tried to find another nurse.

This is the care a patient received in a tertiary hospital located in a state where abortion is legal. However, state protections do not address the barriers to appropriate care that are posed by conscientious objection to abortion.

 Another medical student in our cohort rotated at a tertiary hospital in a state where abortion is heavily restricted. Patients seeking abortion were required to undergo state-mandated waiting periods. Physicians had to read out loud state-mandated provider scripts with information about the gestational age of the fetus and the financial assistance available if they carried the pregnancy to term. The physicians were also required to show patients considering abortion graphic color pamphlets that displayed a fetus at various gestational ages. Finally, abortions were only performed at certain times on certain days to accommodate staff who were willing to even just be associated with abortion care. It became obvious to the rotating student that on top of the many legal roadblocks, conscientious objection was a prevalent unspoken barrier to abortion care.

Several of our other classmates have also encountered limitations and delays to abortion at the hospitals where they rotated. As medical students, we are often at the bedside, sitting with patients as they bear the harm of the downstream effects of conscientious objection. We do this without preparation from medical education and sometimes without the support of our clinical supervisors. There must be a better system, one that balances respect for individual staff members’ beliefs while ensuring that patients receive timely and quality care.

In health care, conscientious objectors can be doctors, nurses, and others involved in patient care who find themselves in situations where the proposed care conflicts with their beliefs. This term is used frequently in laws and policies governing abortion. A 2022 qualitative literature review of 36 papers found that conscientious objection impacts women’s access to abortion directly, when providers refuse care, and indirectly, when their community treats them differently because they have had an abortion.

Regardless of state laws that protect abortion, the current structure of our hospital systems fails to mitigate the consequences of provider refusal on our patients. Conscientious objection is undeniably a barrier to safe, quality abortion care. It is associated with significant delay in care and stigma from having had that care. These impacts pose danger and risk to patients. The WHO and United Nations have both called upon states that allow conscientious objection  to ensure that objections do not undermine abortion access. The American health care system must rise to this challenge. Balancing patient autonomy and safety with the rights of staff to maintain their moral integrity demands a systemwide intervention–a way to integrate safety protocols for patients seeking abortion into institutional practice.

We believe that such change starts in medical school. When a law may conflict with a provider’s moral obligations or beliefs, values-based discussions need to be initiated early and occur continuously with students. As future providers who will soon take oaths to “do no harm,” we must talk about difficult topics like abortion care. If a provider decides that abortion is not something they can provide in good conscience, then the health care community as a whole must strive to agree on next steps so that patients do not fall through the cracks.

The International Federation of Gynecology and Obstetrics recognizes that conscientious objection to abortion is a global human rights issue. It acknowledges the stigma, burden, and lack of support that abortion providers face every day, destructively impacting their careers, and in some countries, risking their lives. It asserts that conscientious objection is not appropriate in the following situations: life-threatening emergencies, postabortion care, and when referral is not possible or would significantly delay treatment.

We believe that hospital systems in the U.S. should consider implementing similar guidelines and clarify next steps when a provider declines to care for an abortion seeker. Most importantly, we maintain that medical schools across the country need to support and educate students as they develop their own values. Future health care providers need to know what to do when their values conflict with patient care. They must determine for themselves what “do no harm” means and how to ensure that their moral conflict does not delay lifesaving treatment.

We as a medical community need to address conscientious objection and what it means for our patients. We urge our medical community to directly confront the consequences of conscientious objection and take the necessary steps to protect our patients.

Leah Chen is a fourth-year medical student at the University of Washington and an aspiring obstetrician and gynecologist who is passionate about access to reproductive health care. Tudi Le is a fourth-year medical student at the University of Washington and an aspiring emergency physician who is a passionate advocate for women’s health.

feet on scale, tape measure in front

Bioethics Forum Essay

The Genetics of Obesity: A New Narrative or the Same Old Story?

by Cassie HoutzPublished Posted in Genetics, Hastings Bioethics Forum, Health and Health Care

On a visit to my maternal grandmother, she pulled out a shoebox of family photos that I’d never seen before. They were sepia-hued, ragged around the edges, the contrast faded. One picture in particular caught my eye: a group of women of varied ages gathered on a porch. I was taken aback by what I saw: these women – my relatives, several generations in the past – were fat.  (I use this word intentionally, following injunctions from many scholars and activists who seek to reclaim the word “fat” , a way of describing bodies that do not – or in this case, would not – fit into off-the-rack clothing offered in most retail stores.)  

Why was I surprised by this? After all, my mother, uncle, grandfather, and grandmother had all waged warfare against their bodies, which seemed inclined toward an abundance of flesh. It would make sense that our ancestors, too, were sturdy and large.

Yet I had clearly internalized the message that permeates the white, middle-class United States culture in which I was raised: fatness is a modern disease, a product of food abundance, overeating, and laziness.

But this image of my great-grandmother’s mother and sisters defied this story. These women lived during the Depression, subsisted on rationed food, and spent their days laboring on farms. They worked with their bodies and didn’t have much to eat. But, still, it was undeniable: they were fat. Was it possible that the narrative I had absorbed was wrong?

 Current research into the genetic factors involved in body weight suggests that, indeed, bodies are not all meant to be thin. Body weight is highly heritable – estimates put body weight heritability somewhere between 40% and 70% (compare this to estimates for height at 80%). Researchers have identified at least 74 key genes for obesity, most of which have to do with regulating the leptin-melanocortin signaling pathway, which governs things like hunger, satiety, and the body’s energy expenditure. Given the preponderance of evidence that body size is heavily influenced by genes, one might imagine that a new narrative regarding fat bodies is emerging – one that might work against the “personal responsibility” narrative of obesity. Indeed, many herald research into the genetic factors in body weight as a way to fight fat stigma, claiming that emphasis on the genetic components of weight will finally squash the myth that body size is all about willpower.

 This is not the first time that researchers have declared that a new medical understanding of fatness will reduce stigma. The same claims were made about the classification of obesity as a disease and about the concept of an obesity epidemic. Neither of these framings has meaningfully shifted weight stigma. If anything, they have created a moral panic and provided the facade of medical concern for health as cover for anti-fat bias.

It seems to me a kind of magical thinking to assume that explaining the genetic causes of obesity will reduce stigma when that new explanation is lodged firmly within a broader project of treating, preventing, or curing fatness. In this research, fatness is still fundamentally seen as a problem to be solved, rather than simply another way of having a body. Weight loss remains the goal. As one recent study puts it, there is “urgent need for in-depth understanding of the genetic factors involved in obesity to pave the way for tailored interventions.” Whether through identifying anti-obesity genetic targets to develop new medications or identifying individuals at risk of obesity in order to provide early intervention, the research into obesity genetics is oriented toward finding new ways to help people lose weight.

This research is undergirded by the premise that fat bodies need medical treatment. Today, drugs like Ozempic, Wegovy, and now Zepbound are the favored medical solution, with enormous profit for the pharmaceutical industry and only accessible to those who can pay the $1,000 monthly price.

Efforts to develop precision medicine (which takes into account individual genetics to make treatment decisions) for weight loss are at the forefront of the medicalization of fatness. In April 2023, the weight loss mega-corporation Weight Watchers  acquired Sequence, a precision medicine weight loss company, in a $132 million deal. Its website now offers a virtual clinic and easy access to prescription medications, promising a “first-of-its-kind weight management solution.” Last month, an evaluation of a clinical trial of The Personalized Nutrition Study (POINTS), a “genetically-informed weight loss approach,” was published in Nature Communications. Direct-to-consumer genetic testing companies, such as GenoPalate and Fitness Genes, offer genetic tests to support weight loss, promising to provide information about a customer’s  risk of obesity or overweight and to offer personalized, genotype-informed recommendations for diet and exercise.

In a 2013 statement arguing against defining obesity as a disease, the AMA’s Council on Science and Public Health warned that “the medicalization of obesity could detract from collective social solutions to environmental forces that shape people’s behaviors and impact a number of conditions beyond just obesity.” Against the recommendation of this Council, the AMA House of Delegates voted to categorize obesity as a disease. Today, we see the Council’s prediction coming true. Classifying obesity as a disease has not meaningfully reduced weight stigma, and it has accelerated a conventional understanding of a obesity as an individual problem to be ameliorated with individualized medical treatments. Those treatments come with a hefty price tag, as Americans spend about $33 billion on weight loss products annually. Collective social solutions that could benefit everyone remain obscured as the lens focuses ever more narrowly on medical treatment for an individual problem.

I do believe that there is liberative potential in an emerging understanding of the role of our genetic inheritance in the size and shape of our bodies. But this potential will not be realized if we cling to the medicalization of obesity as a disease, nor if we pursue genetic knowledge for the sake of finding more effective means of losing weight.

Genetic research might help us to tell a different, better story. It might go something like this: Body diversity is a part of the human species. Human bodies come in all sorts of shapes and sizes, and none are intrinsically superior to any other. Our inherited genetic profile carries with it many of the tendencies that will interact with our environment to shape our body size – from hunger and the drive to eat, the drive to move, to the basic amount of energy that our body uses to stay alive. It is not that thin people are morally superior or even better at self-control. Rather, thin people inherit a genetic profile that predisposes them to thinness. Body size has nothing to do with one’s character. Further, thin bodies are not universally healthy and fat bodies are not necessarily unhealthy, as is emphasized by the movement for Health at Every Size. There is no one way to have a healthy body and no single way that a healthy body should look.  

While there are behaviors that might make us feel better in our bodies or extend our lives or help us avoid things like hypertension or diabetes, there is no guarantee that these behaviors will shift our body size. And this is a good thing – we should not strive to eradicate fatness. I do not want a future without fat. Instead, I want my  to ask  doctors to ask questions like, “Do you feel like you can lift the things you need to lift? Do you have the endurance to do the things you want to do? Do you have a relationship with food that feels sustainable?”

This does not mean that I want to deny access to bariatric surgery (shown to be largely effective for long-term reduction in body size as well as for reducing diabetes and hypertension) to those who would benefit from it, nor that those who want to lose weight should be prevented from doing so. (Indeed, more equitable access to bariatric surgery could be a good thing, in my view.) But I want to live in a world where, instead of focusing narrowly on fixing fatness, medicine is dedicated to a more comprehensive view of health and well-being – including food security, the availability of safe drinking water, and access to high-quality, shame-free medical care for all people.

Cassie Houtz, PhD, is a postdoctoral fellow in the Ethical, Legal, and Social Implications of Human Genetics and Genomics at the University of Pennsylvania Perelman School of Medicine.

holding hands in ad for paid plasma donation

Bioethics Forum Essay

Should Your Wedding Plans Include Plasma Donation?

by Caroline S. BeitPublished Posted in Hastings Bioethics Forum, Health and Health Care

When I said, “Yes!” to my partner’s proposal last spring and changed my Facebook relationship status to engaged, I expected targeted advertisements for wedding dresses, flowers, and photographers. What I did not expect were ads to donate my plasma to help pay for my wedding.

“Say ‘I do’ to donating plasma,” said the BioLife Plasma Services’ advertisement targeted to me, with a picture of a couple in a suit and wedding dress, “and get up to $900.” Despite our fear of needles, my partner and I briefly considered this as a viable option to help pay for our wedding. The average wedding in the United States costs $30,000 (although our low-key wedding will cost less). I mean, what could be more romantic than holding hands at the plasma donation center? But as I paused my scrolling to consider this option, my concerns as a bioethicist grew.

For one, the advertisements mention no risks. While plasma donation is relatively safe, risks include fatigue, bruising, bleeding, or dehydration and, though rare, fainting and serious infections. For people who do experience complications, it is unclear whether plasma companies would cover their medical expenses. Given that 49.8% of those who donate plasma earn less than 200% of the federal poverty level, medical risks could cause further financial hardship. Individuals in poverty are likely to be on Medicaid if they have insurance at all. And since Medicaid eligibility is income-linked, and being compensated for donating plasma is considered taxable income, donating plasma could bring a double risk to some people: increasing their tax burden and causing them to disqualify for Medicaid.

Compounding these risks, private plasma donation centers in the U.S.—which place these ads– have less stringent donation limits than are recommended by nonprofits and international organizations. For example, the American Red Cross (which does not compensate donors) only allows people to donate plasma every 28 days, or no more than 13 times in one calendar year. France and the Netherlands allow no more than 26 donations per year (one every two weeks). Yet the United States. permits donation up to two times a week and a maximum of 104 donations a year. Plasma donation companies in the U.S. entice people to donate frequently by offering financial incentives and referral bonuses and rewards programs.

The risks of frequent plasma donation are not limited to donors, but also extend to the patients who receive plasma. Plasma from frequent donors has been found to be of lower quality than plasma from less frequent donors.

However, around the world there is a substantial need for plasma that cannot be met without compensating donors. Someone who is seriously immunocompromised may need 130 plasma donations per year; someone with hemophilia, 1,200. Financial compensation is an effective way to increase donation. Some countries that rely on uncompensated donation must import plasma from countries that compensate their donors. The U.S. has become the largest exporter of plasma worldwide, responsible for two-thirds of the world’s supply. Export of blood products represents 3% of the U.S.’s global exports.

In addition to financial compensation, targeted advertising is an effective strategy for getting donors. So successful, in fact, that companies such as InceptSave, which calls itself “a blood donor recruitment partner,” have emerged to help donation centers grow their donor base. InceptSave hosted a panel discussion, How Do You Reactivate Blood Donors Using Social Media?, covering its strategies to help blood donation centers recruit new donors on social media including using “a multi-channel strategy that engages donors where they want to be engaged,” likely meaning targeted advertisements like the one I received.

However, targeted advertisements can be troubling when used for health-related procedures, products, and services. Hospitals and other medical entities subject to federal regulation are not permitted to use tracking technologies in a manner that would result in impermissible disclosures of personal health information  or other violations of the HIPAA rules. Yet, this happens. One study found that over 98% of hospital websites used third-party tracking.

In addition, the practice of geofencing, which is often used in targeted advertising, raises ethical concerns. This technique relies on a smartphone’s geolocation services to trigger the algorithm to deliver targeted ads when the device enters a specific geographic area, or geofence. Personal injury lawyers have used this technique to target ads to someone who has entered a hospital emergency room. In the case of plasma donation centers, my lack of recent visits to a medical facility may have been one of the data points that triggered the targeted ads for plasma donation, as these centers typically seek healthy, young donors.

Ultimately, the question of whether plasma donation centers should use targeted ads involves balancing the good of plasma donation and its medical necessity with the potential harms of exploiting the poor, increasing medical risks, and selling data (especially medical data) to advertisers. One way to reduce these harms is with better personal data protections, especially for health information, such as those instituted by the European Union. In addition, the U.S. should mandate less frequent donations to protect the safety of donors. The U.S. should also require plasma companies to cover medical expenses of donors should they suffer adverse effects.

So, will I say “I do” to plasma donation? Probably not, but with better regulations, maybe I’ll consider a first date.

Caroline S. Beit is a research coordinator at Baylor College of Medicine’s Medical Ethics and Health Policy Center and will begin medical school next year.

stack of flatbread

Bioethics Forum Essay

Race, Research, and Bioethics: The Chapatis Studies

by Sreeparna Chattopadhyay and Sualeha Siddiq ShekhaniPublished Posted in Hastings Bioethics Forum, Research Ethics

The history of biomedical experiments on Indigenous, Brown, Black, and other people of color is long, painful, and sordid. They reveal racialized notions of bodies and a disregard for ethics affecting the autonomy, dignity, and respect of individuals and communities. Ethical questions about one such study resurfaced recently with a thread on social media that described an experiment on iron deficiency funded by the Medical Research Council (MRC) in the United Kingdom during the 1960s that asked 21 Indian Punjabi women to consume chapatis laced with a radioactive isotope.

In the thread, historian and author Louis Raw asked whether the research subjects had given informed consent. Given lingering uncertainty, a member of Parliament asked for an inquiry and a parliamentary debate.

This research first became public in 1995, when Deadly Experiments, a TV documentary, aired in the U.K. In response to the public outrage that followed, the MCR formed a committee to establish, among other things, whether procedures for obtaining consent and experimental techniques were reasonable for the time period. The MRC report raised several bioethical questions. Despite its diverse membership– including an Asian doctor, a rabbi, and an ethicist–the committee did not unravel the racialised and gendered assumptions that may have underpinned these experiments.

The report didn’t reflect on the fact that the chapatis study was the only one, among nine listed in the documentary, where the subjects were exclusively ethnic minorities. General practitioners recruited 20 women who had consulted them for minor ailments. Pritam Kaur, one of the women interviewed in the documentary, said she was not told she was a research subject and that if she had known, she wouldn’t have participated. The deception continued when the patients were driven periodically to a facility several hours away. They were led to believe that they were going to a hospital when in fact they were taken to the Atomic Energy Research Establishment to have the radiation in their bodies measured.

These practices raise the specter of therapeutic misconception, a risk when physicians adopt the dual role of clinicians treating patients and researchers conducting studies and use, or potentially misuse, their influence and trust to recruit patients as research subjects. This dual role can interfere with informed consent.

In the documentary, an MRC representative claimed that the research council had obtained informed consent. However, the subsequent MRC report concluded that informed consent processes were suboptimal, but not for reasons of deception. The explanation was more banal –information may have been lost in translation because children were often used as translators. Moreover, a Gujarati translator was employed for a predominantly Punjabi population. The word for chapatiis roti in Punjabi.

We interpret this finding to be evidence that the researchers had a cavalier attitude toward the research subjects, seeing diverse Asian populations as homogenized, stripped of their distinct languages and identities. Also, these research subjects embodied multiple intersectional disadvantages–they were citizens of a former British colony, knew little English, were young, and often depended on their families to navigate their way in a new country. While the report calls them volunteers, the voluntariness was questionable given the lack of full informed consent and their social positions.

We believe that the MRC enquiry was not conducted properly since it failed to acknowledge the possibility of physical harm, loss of dignity, and lack of autonomy to the research subjects, given the absence of informed consent and the use of deception. Further, they possessed multiple intersectional vulnerabilities.

The new inquiry by the Coventry MP, Taiwo Owatemi, is a step in this direction. At the outset, MRC must acknowledge that what happened was unjust and unethical. For the current inquiry to lead to meaningful change, there should be serious attempts to trace and apologize to the research subjects and their families. If a subject is no longer alive, the apology should be directed to the next of kin. In the 1990s, the MRC claimed that tracing subjects was not possible, but in 2023– in a digital world where almost anyone anywhere can be traced–this should be possible to achieve. An apology should be followed by a financial compensation to the research subjects or their next of kin.

These two steps are particularly important for restorative justice because they signal to the broader community that the MRC acknowledges the harms from its study. These steps can also help rebuild trust among ethnic minority groups in Britain, especially following the Covid pandemic and its disproportionate effect on Black, Asian, and other ethnic minority communities. Excess morbidities and mortalities among these groups have highlighted structural racism and inequities.

In addition to helping perpetuate health disparities, prejudices against minority groups play a major role in the exclusion of these groups from medical research in high-income countries. In 2008, the most recent year for which this data could be found, only 0.1% of trials listed in the national research register in England included South Asian populations, even though they constituted nearly 6% of the population.

For equity and good science, greater research participation is required from different communities since a diverse research pool produces more robust as well as more optimally targeted therapeutics. Acknowledging the wrongs that were done decades ago may encourage greater participation from underrepresented groups in research today.

While financial compensation may not undo the damage that occurred–an argument often used to justify not recompensing victims–we believe that compensation will help ensure procedural justice in future medical research. Compensating victims of a research project that used deception will signal that those who use unethical research methods will be held accountable. As James Baldwin said, “Not everything that is faced can be changed, but nothing can be changed until it is faced.” 

Sreeparna Chattopadhyay, is an associate professor at FLAME University in Pune, India  @Sree_socscience

Sualeha Siddiq Shekhani, is an assistant professor at the Centre of Biomedical Ethics and Culture, SIUT, Karachi, Pakistan. @Sualeha2

doctor holding pet scan of brain

Bioethics Forum Essay

Don’t Give Symptom-Free People Alzheimer’s Drugs

by Adriane Fugh-Berman and Judy ButlerPublished Posted in Hastings Bioethics Forum

A large government-funded study of solanezumab, an experimental Alzheimer’s drug that targets amyloid in the brain, has found no benefit in people with normal cognitive function who have elevated amyloid levels. The results of this long-term, definitive, randomized controlled trial should stay the alarming enthusiasts who have advocated drugging perfectly normal people who have abnormal amyloid levels. But, after decades of investment in unproven anti-amyloid treatments, it’s unlikely that more data will lead industry and industry-funded groups to reverse course.

The Alzheimer’s Association, in fact, recently proposed new diagnostic criteria that define Alzheimer’s “biologically,” using plasma biomarkers for amyloid plaque. Astoundingly, the association recommends that someone with abnormal amyloid biomarkers be diagnosed with Alzheimer’s – regardless of whether the person has memory loss or any other symptoms of Alzheimer’s.

The assumption is that people with plaque in their brains will eventually develop symptoms, and if they live their whole lives without ever developing cognitive issues then they just didn’t live long enough to experience their preprogrammed decline. This is not only wrong, but dangerous. Many people ages 65 and older have significant amounts of amyloid plaque, yet never have cognitive impairment. The connection between plaque and Alzheimer’s is unclear – while amyloid is a hallmark of Alzheimer’s, there is insufficient evidence to support the theory that it actually causes the disease.

The pharmaceutical industry would love to target cognitively normal people who have amyloid plaque because that’s a huge market–30%-to-50% of older individuals. Several pharmaceutical companies have new drugs that remove amyloid plaque and are meant to treat early stages of Alzheimer’s disease with cognitive impairment, and more of these drugs are coming down the pike. In 2021, the Food and Drug Administration gave accelerated approval to aducanemab (Aduhelm), and in July 2023, Eisai/Biogen’s lecanemab (Leqembi) received full approval. Medicare will cover lecanemab for eligible patients enrolled in a registry and major health systems are expected to offer the drug. The FDA is likely to decide whether to approve the latest anti-amyloid drug, Eli Lilly’s donanemab, by the year’s end. 

At the same time, blood tests that detect amyloid are now available, including one that can be purchased directly online by consumers. None of these tests have received FDA approval. While neither the testing companies nor advocacy groups recommend diagnosis by blood test alone at this point, they are already signaling their enthusiasm for simple blood tests they think will revolutionize the diagnostic process.

Until the blood tests came along, assessment of amyloid plaque was determined either by a PET scan or analysis of cerebrospinal fluid collected by lumbar puncture. PET scans are expensive and available only in metropolitan areas; lumbar punctures are invasive, uncomfortable and can cause severe headache and other side effects. None of these analyses is sufficient to diagnose Alzheimer’s.

The recent availability of both new drugs and new blood tests raise the question of whether the timing of the Alzheimer’s Association’s updated diagnostic guidelines is entirely coincidental. As one of the authors of the new guidelines explained, “it is completely feasible to diagnose the disease biologically at a mass scale” and “there’s something you can actually do about the disease.” In other words, access to blood tests will funnel more patients – and more perfectly normal people–to expensive amyloid-busting drugs.

People without symptoms of cognitive loss should not take these drugs, which have substantial risks, including death. It’s not even clear that patients who actually have Alzheimer’s disease should take these drugs, because they don’t improve symptoms. In clinical trials, patients in both treatment and placebo groups continued to decline, and the small difference between them, while statistically significant, was not clinically meaningful. In other words, neither patients nor families noticed any difference.

Anti-amyloid drugs cause serious harms, including brain bleeds and brain shrinkage. Three patients are known to have died in clinical trials for Leqembi and another three for donanemab, suggesting a rate of 1 to 2 deaths per 1,000 patients in the healthier-than-normal clinical trial population. Among the general population, who may have multiple illnesses and may be on multiple drugs, this death rate is likely to be higher.

In addition, anti-amyloid drugs, and the costs associated with treatment, are high—in the case of Leqembi, expected to run to $82,500 a year per patient. Because most patients receiving this drug are on Medicare, most of these costs will be borne by taxpayers.

Diagnosis by blood test makes sense if the goal is to identify many patients as soon as possible. Of course, drug companies want to expand the pool of people eligible for an early Alzheimer’s diagnosis, because the available anti-amyloid drugs are approved only for patients with early-stage disease. Currently, a diagnosis of Alzheimer’s involves multiple steps, including cognitive assessments, and there is a limited number of specialists with the requisite expertise to confirm the diagnosis. That’s the way it should be.

Industry and industry-funded advocacy groups have set their sights on streamlining the diagnosis process to maximize the number of people eligible for presymptomatic treatment. But if individuals with increased levels of a biomarker never experience cognitive impairment, then what, exactly, is being diagnosed or treated?

In the solanezumab trial, both the treated and placebo groups had the same rate of cognitive decline over 4.5 years. There is no s that any of the other drugs that target amyloid will do better in preventing cognitive decline in normal people. 

And it’s ethically questionable to treat asymptomatic patients solely based on a biomarker. Patients are, naturally, most concerned about actual symptoms, not how much of a biomarker is in their bodies. As an epidemiologist noted, removing a biomarker can “cure” a disease without improving a patient’s experience at all. And a diagnosis of Alzheimer’s can devastate both patients and families. Recommendations to label cognitively normal people as Alzheimer’s patients, and thus make them eligible for treatment with expensive, dangerous drugs, are unconscionable.

Spending billions of dollars–sales of Leqembi and  donanemab are projected to reach $5.5 billion globally by 2030 – to remove a biomarker without evidence that it is a cause of a disease is an unwise investment. Those dollars could be better spent on resources to improve known modifiable risk factors, including hypertension, hearing impairment, and diabetes, that account for around 40% of worldwide dementias. What’s worse than the misspent dollars, however, is the false hope patients and their families are being given when industry and its minions promote drugs that have shown no clinically meaningful benefit and have significant harms.

Adriane Fugh-Berman, MD, is a physician and professor of pharmacology and physiology and family medicine at Georgetown, where she directs PharmedOut, a research and education project that promotes rational prescribing. Judy Butler is a research fellow at PharmedOut. @Pharmed_Out

chemical weapons symbol on rusted background

Bioethics Forum Essay

Chemical Weapons Convention Reaches Milestone

by Jonathan D. MorenoPublished Posted in Hastings Bioethics Forum

Many post-World War II international structures are what might be called bioethics adjacent: They are not strictly part of the set of widely recognized global bioethics standards and instruments, like the Declaration of Helsinki, but they overlap with concerns routinely expressed in bioethics. One of these is the Chemical Weapons Convention, which celebrated its 30th anniversary this year with the destruction by all States Parties of their declared stockpiles of chemical weapons and dual-use chemicals.  This milestone was verified by the Organisation for the Prohibition of Chemical Weapons with its roughly 450-person staff, including highly skilled inspectors who were on-site for the process.

The principal U.S. site for the development and stockpiling of chemical weapons was Edgewood Arsenal in Maryland, with its British counterpart at Porton Down. The chemicals of interest went through a sort of evolution, roughly from the World War I-era nitrogen mustards to lethal nerve agents like sarin, to deliriants like BZ. In the early years after Hiroshima and Nagasaki, a common rationale for these weapons was that they were more humane than The Bomb, but it gradually became clear that they were not useful on the battlefield, tended to be indiscriminate in their effects, and engendered their own kinds of suffering that was still more difficult to treat than wounds from kinetic weapons.  Their close association with medical applications of chemistry also created a level of unease; Fritz Haber, who developed the first chemical weapons, won the Nobel Prize in chemistry in 1918. Fittingly, a conference that I attended recognizing the 30-year milestone was held at the Fritz Haber Institute in Berlin.

Fortunately, Edgewood never experienced a death like that at Porton in 1953 of a 20-year old RAF engineer who was exposed to sarin, as historian Ulf Schmidt has documented.  In the 1950s human experiments for “ABC warfare” – atomic, biological, and chemical — fell under a Department of Defense policy that was copied verbatim from the Nuremberg Code without attribution, but the integration of these rules into practice was, to put it mildly, ineffective. (I have told this story in my book Undue Risk.)  Many of these experiments are now part of the public imagination, especially those involving LSD. One of the most fascinating aspects of the renewed interest in psychedelics for therapeutic purposes is the way that the arc of this story has shifted toward legitimacy after an era of prohibition and the bad odor of their association with an astonishing range of characters from CIA chemists to the counter-culture drug guru Timothy Leary. Someone to be added to this list is the psychiatrist in charge of the Edgewood hallucinogens experiments, James S. Ketchum, who published his colorful memoir in 2006, defending his research ethics.

Even the most intensive inspection measures are no guarantee. Readers may have noted that the 30-year milestone refers to “declared stockpiles.”  There are well-grounded suspicions that some countries have undeclared stockpiles and chemicals that have eluded the system; Russia’s use of Novichok comes to mind. Neither is the future certain: British experts Malcolm Dando and Michael Crowley have warned that increasing understanding of neural mechanisms is not only good for medical science but also may expose new routes to exploitation of the brain by states or nonstate actors. What about biological weapons, now a renewed worry with the potential application of AI to create new molecules? Unlike the Chemical Weapons Convention, the Biologic and Toxin Weapons Convention, with a grand total of three hard-working regular staff, has essentially no verification mechanism. 

Despite the fact that there is much more work to be done in an atmosphere that is less conducive to progress than anytime since the late 1940s, in an era of evidently diminished confidence in global institutions the destruction of these chemical stockpiles is to be celebrated. At least it provides a reminder that the darkest paths are not inevitable.

Jonathan D. Moreno is the David and Lyn Silfen University Professor of Ethics at the University of Pennsylvania and a Hastings Center fellow. @jonathanmoreno.bsky.social

illustration of chimeras

Bioethics Forum Essay

My Mom’s Myeloma and the Fire-Breathing Chimaera

by Kaiulani S. ShulmanPublished Posted in Hastings Bioethics Forum, Health and Health Care

In the weeks leading up to Halloween last year, I cut bones out of colorful construction paper, stringing them onto a garland. This decor–more enlivening than macabre–was in honor of my mom’s upcoming bone marrow transplant.

My mom was diagnosed with multiple myeloma in 2007 after a routine blood draw at her annual physical returned abnormal results. Then 41 years old with a flourishing career and three young daughters, my mom decided not to disclose her diagnosis–to us or, for the most part, anyone else. Instead, she enrolled in a Dana Farber clinical trial for individuals newly diagnosed with multiple myeloma. Lenalidomide, a once-daily pill, successfully managed her multiple myeloma for 15 years. However, in December 2021, the lenalidomide stopped working, and my mom’s condition worsened.

I cannot attribute my interest in pursuing a career in medicine to having been raised (albeit unknowingly) with a parent with cancer. By the time my mom shared her diagnosis with me and my sisters in December 2021, I had already completed the majority of the pre-medical school requirements and was just months from graduating from college. But as my mom’s bone marrow transplant approached, I accompanied her to many doctor’s appointments, reading about autologous stem cell transplants and translating medical jargon into digestible–if not palatable–information on ports and chemotherapy. The night before my mom was admitted to the hospital, we congregated in her bathroom, where I ceremoniously shaved her head. The next day, the transplant went off without a hitch.

My mom was discharged from the hospital in under three weeks. A longtime critic of loungewear, she quickly discarded her hospital pajamas in favor of her worn skinny jeans, which now hung loosely on her thin frame. However, despite the initial success of the transplant, the road to recovery proved long and challenging. My mom was easily fatigued and neutropenic, at an increased risk for severe infection. My parents slept in separate rooms, and we abandoned our nightly family dinners, the slight buzz of the HEPA filter background noise to our masked conversations.

With the spring came regrowth: my mom’s red blood cell count rose, and tufts of dark hair curled beneath her wig, emerging around her ears. But so, too, did a tumor in her jaw grow, disguised at first as a persistent toothache before appearing as a globular mass tucked beneath her chin. After steroid treatments and targeted radiation, the tumor shrunk. However, this past June, my mom was informed that her condition now required CAR T-cell therapy, a fifth-line intervention for multiple myeloma.

I am, on the one hand, grateful for the excellent medical care she has received through a cutting-edge clinical trial at outstanding academic institutions. On the other hand, however, I struggle to understand why she will require another in-patient treatment just under a year after her seemingly successful bone marrow transplant, which, itself, was not without complications.

The high-dose chemotherapy wiped out her immune system just as Covid and RSV rates surged, and on Thanksgiving Day, just 33 days after her transplant, my mom spiked a fever of 101.2 degrees. The following Monday, she underwent a battery of tests to determine the cause of her fever. The culprit was campylobacter, a bacteria carried by undercooked poultry, which we promptly attributed to my dad’s failures in the kitchen. And while my mom recovered quickly with antibiotics, we were reminded of the risks she faced because of her compromised and vulnerable immune system.

At a recent appointment, my mom’s oncologist, who has watched me grow from a first grader to an aspiring physician, explained that the Food and Drug Administration recently approved two CAR T-cell therapies for relapsed and refractory multiple myeloma. Its prefix, CAR, is an acronym for chimeric antigen receptor. I soon learned that “chimeric” originates in Greek mythology’s three-headed monster, Chimaera: “One indeed of a grim-visaged lion, one of a goat, and another of a serpent, a fierce dragon; in front a lion, a dragon behind, and in the midst a goat; breathing forth the dread strength of burning fire.” The description was hard to ascribe to turbo-charged T-cells, but the literary definition of chimerical–“the product of unchecked imagination” – fit science and medicine to a T.

To engineer T-cells to recognize and attack surface proteins on cancerous cells is undeniably a feat of the imagination. And the clinical trial results appear nothing short of miraculous. In contrast with existing treatments, nearly 80% of patients, who had already undergone several unsuccessful treatments, exhibited a complete response. So, I wondered aloud, why did my mom not receive this therapy last year instead of the bone marrow transplant? Why did she have to wait?

My mom’s oncologist replied that bone marrow transplants remain the gold standard for patients with multiple myeloma. The reason, he explained, is twofold. Firstly, many patients with multiple myeloma demonstrate a sustained response to bone marrow transplants and physicians cannot predict who will only have a short-lived effect, like my mom. The second, he acknowledged, is the lack of long-term data. The use of CAR T-cell therapy in patients with multiple myeloma is relatively recent, and, therefore, only time will tell if the treatment’s effect is sustained. So, current eligibility for CAR T-cell therapy requires that patients have previously attempted at least four modes of treatment with three classes of drugs: immunomodulating agents; proteasome inhibitors; and anti-CD38 monoclonal antibodies. In the aggregate, these criteria mean that less than 10% of patients newly diagnosed with multiple myeloma will survive long enough to get CAR T-cell therapy.

Just one month ago, my mom received an intravenous infusion of CAR T-cells, which have become mythical creatures in my imagination. As I write, I envision them circulating in her bloodstream, adopting the features of a lion, a goat, a serpent, and a dragon. With beady eyes and menacing grins, their forked tongues hiss at my mom’s myeloma plasma cells. They are fire-breathing chimeras ready for battle. I wish these beastly T-cells well.

Acknowledgements: I would like to acknowledge my mom for granting me permission to share her story, her oncologist for his outstanding care, and Dr. Joseph J. Fins for his editorial guidance.

Kaiulani S. Shulman is a research assistant in the Division of Medical Ethics at Weill Cornell Medicine.

closeup of book being read at table

Bioethics Forum Essay

Improving Linguistic Justice and Accessibility in Bioethics Work

by Keisha RayPublished Posted in Hastings Bioethics Forum, Health equity and racial justice ethics

Justice, and its many explanations, conceptions, and applications, is a prominent fixture in bioethics. We wax and wane about its theoretical and practical meanings; we use it to take a critical lens to health laws and clinical policies and we use it to measure society’s impact on our health. During the Covid pandemic more attention than ever was given to health justice and what is required of us to work towards health justice for all people.

The principle of justice, however, is not a casual principle; principles rarely are casual. Justice requires intention, effort, and deliberation. Similarly, justice requires more of us than only applying the concept to laws and policies and to other people’s work. Rather, bioethicists have to start asking, “How are we applying justice to ourselves and to our own work?” One way that I practice an elevated sense of justice in my own work is by practicing linguistic justice. I especially made this effort in my latest book, Black Health: The Social, Political, and Cultural Determinants of Black People’s Health.

To me, linguistic justice means making my work accessible to people by using relatable language to spread bioethical knowledge. It’s about acknowledging that some of the terms and words we use in the academy and with our academic peers can be isolating for others who deserve and sometimes even need to hear our work. In my published work, including Black Health, I have made an effort to describe the ways that racism and its intersection with other forms of discrimination within institutions (like education, economic, heath care, law, housing, and environmental policy) can lead to bad health for Black people. I relay this information and critical analysis of Black Americans’ health using real testimonies from Black people who are telling their own stories of poor health.

For example, I retell  Alexandra Moffett-Bateau’s story of seeking care for her chronic pain. In Moffett-Bateau’s own words, she tells the story of how multiple clinicians in multiple states did not believe her when she told them she was in extreme pain. Even though she had many kidney infections, fevers, and joint pain, clinicians thought she was just trying to get pain medications. Instead of believing her and looking for the cause of her pain, physicians would refer her to a psychiatrist or therapist, assuming she was faking her pain or that her pain was “all in her head.” Eventually a physician diagnosed her with lupus, but even with this diagnosis some physicians refused to treat her pain and, even when physicians prescribed pain medicine, pharmacists would often question the legitimacy of her pain before fulfilling her prescriptions.

I use Moffett-Bateau’s story to describe how racism and sexism within health care leave many Black people without proper care for their pain. I also inform readers about the many studies and other types of research that show Black people’s pain is taken less seriously and treated with less urgency than White people’s pain. I prefer to use stories that are emotionally connective and humanizing, like Moffet-Bateau’s story, and then supplement them with the research that uses data to show that these stories are not unique or just one person’s story, but rather that they are common among our friends, family, and colleagues.

Linguistic justice sometimes gets called “dumbing down,” or is considered not academically rigorous. But this sentiment remains a barrier to justice in our bioethical work. Indeed, when I was training to be a bioethicist I was discouraged from writing in this manner. I was warned that people may think I am not as smart as my peers who use more so-called sophisticated language. But what I found is that writing in an accessible way is a skill, and a skill that some of the best trained and most well-known bioethicists do not have, possibly because they also were discouraged during their training. Linguistic justice requires intention and dedication. It is not something that comes naturally nor is it a standard part of our bioethical training. It’s a skill that has to be developed.

Linguistic justice is not dumbing down our work. Making our work accessible to as many people as possible, however, is acknowledging that justice is not just an abstract principle or a standard by which we judge our institutions, systems, or political leaders. Justice is also a principle we have to apply internally; we have to hold ourselves accountable for justice in our work. And it starts with how we write and whom we write for. This is especially true for topics related to health equity since so many of the least well-off people among us do not have access to the resources for proper health, including health care. We cannot continue to say that we care about justice and concern for vulnerable populations yet write in a manner that only a person with a graduate degree can read.

As a matter of linguistic justice, I also wrote Black Health with short chapters (no more than 10,000 words each), many section headings, and study questions. The chapters can be read independent of one another. Chapter One sets the tone for the book with discussions of basic terms and ideas like institutional racism, structural racism, racial disparities in health, social determinants of health, what it means to say that race is a social construct, and other foundational ideas needed to better understand how racism in our social lives contributes to Black people’s generally poor health.

Justice as a principle for bioethicists should not be taken lightly. But there are practical barriers. Our employers have to recognize the value of accessible writing and reward our work with promotion and tenure. Currently, it is not common for universities to give equal value to publications in peer-reviewed journals and publications in popular news outlets. New professors are often told to focus on the former and do the latter as a side project. But popular news sources, podcasts, local TV news, and local radio stations are great sources of public scholarship and often reach a wider audience than our academic journals. Not engaging these sources of knowledge distribution is a missed opportunity to extend the principles of linguistic justice and share our bioethical knowledge.

Publishers also have to be willing to give us book contracts for work aimed at a broad audience and market it in a way that highlights this valuable feature of our books. Academic journals must have a deeper appreciation for linguistically accessible articles and their value for the profession and the general public. Additionally, allowing free access to these articles or charging authors and institutions a reduced fee for publishing them can aid the goal of linguistic justice–to give bioethical knowledge to more people outside of the academy. Bioethicists also have to be taught how to publish in popular news outlets and again be rewarded for it with the typical spoils of academia.

We cannot assume that our graduate education and professional training has prepared us to write accessibly. Writing in an accessible manner requires effort and practice; it is a skill that must be intentionally cultivated. But we must try because the principle of justice is a demanding one. And it should be. Justice requires that we hold ourselves and our bioethical institutions to high standards. As we call out unjust systems and develop standards for just allocation of health and health care resources, we also have to look inward. We have to continually challenge ourselves to have the courage that the principle of justice requires of us. Hopefully, we will accept this challenge and show it in our linguistically accessible bioethical work.

Keisha Ray, PhD, is the John McGovern, MD Professor of Oslerian Medicine and an associate professor at the McGovern Center for Humanities & Ethics at UT Health Houston where she also serves as the Director of the Medical Humanities Scholarly Concentration. She is an advisor to The Hastings Center’s Sadler Scholars, a select group of doctoral students with research interests in bioethics who are from racial or ethnic groups underrepresented in disciplines relevant to bioethics. @drkeisharay

child's broken arm in cast

Bioethics Forum Essay

Our System for Reporting Child Abuse is Unethical

by Anne ZimmermanPublished Posted in Children and Families, Hastings Bioethics Forum

A court case over alleged false accusations of child abuse began recently in Florida. The case concerns Maya, the subject of a recent documentary that depicts a powerful pediatrician specializing in identifying child abuse who, with other clinicians and the Florida Department of Children and Families, wielded complete power over Maya and her parents, forcing them to be separated because of alleged child abuse. Similarly, the NBC News podcast “Do No Harm” chronicles the stories of two Texas families who lost custody of their children after pediatricians reported child abuse but were incorrect. These are not isolated incidents. The system of mandatory reporting of child abuse is rife with ethical problems and can lead to unjustified custody loss.

 More than three million children a year are involved in child abuse and neglect cases in the United States. Bias is widespread in the process of reporting, investigating, and confirming these cases. Black children are reported at about twice the rate of white children and their cases are more likely to be investigated, confirmed, and brought to court. Black children are more likely to be removed from their families and to be removed for longer periods. Even so,  cases involving Black children are less likely to be substantiated, indicating that Black families face more false claims.   In one glaring example of disparate treatment, contrast the cases of two women, one Black and one white, whose breastfed babies died of malnutrition. Tatiana Cheeks, who is Black, was charged with homicide. Jillian Johnson, who is white, not only was not charged with a crime, but she started a nonprofit and could openly discuss breastfeeding failure.

In addition to bias, there are other important bioethical issues in child abuse pediatrics. Family separation causes severe harm. Temporary custody loss harms children and parents and should be deemed a cruel and unusual punishment in most cases. It should carry a high burden of proof because it is sometimes imposed based on false charges and mistakes.

The system for reporting and investigating child abuse should be reformed. Child protective services and mandatory reporters of child abuse in most states enjoy generous immunity from criminal charges and civil claims. The effect is a noteworthy exception to the legal standard of innocent until proven guilty.

There are inherent problems with mandatory reporting. First, child abuse is not a medical diagnosis. It is a legal finding. Medical diagnoses include injuries and bruises, which can be the result of abuse or other causes. Child abuse pediatricians’ training is focused on the legal finding. These doctors often become so suspicious of abuse that they ignore the many other possible explanations for injuries and bruises, including accidents and certain diseases.  Accusations of medical neglect and abuse can interfere with parents’ ability to seek multiple opinions on the causes of their children’s complex medical problems.

In many states, including New York, where I live, mandatory reporters face penalties for failing to report suspicion of child abuse. These penalties lead to overreporting for fear of criminal charges and civil liability. And there is immunity for those who report in “good faith,” i.e., with honest and fair intentions. It is very difficult to counter claims of good faith, since that is a subjective concept. Any child abuse pediatrician or social worker may feel they entered the field in good faith and that all their work is in good faith when, in fact, they have made false accusations.

The system of reporting child abuse should protect families from overreach by social services, child abuse pediatricians, the private companies that often operate through government and hospital contracts. Some refer to this system as the poverty industrial complex. State laws should comply with the U.S. Constitution. At minimum, they should protect people against unreasonable search and seizure, avoid cruel and unusual punishment, ensure equal protection under the law, and ensure that parents are read their rights. Being read their rights includes being informed that child abuse pediatricians might use their words against them legally.

I recommend doing away with mandatory reporting of child abuse. This would decrease the need for immunity and reduce false accusations. “Faced with confusion around mandatory reporting, many mandated reporters think it’s best to just report anything they think might be violence or abuse,” states the group Mandatory Reporting Is Not Neutral, one of several advocates for eliminating the practice.

Those who favor mandatory reporting would argue that false accusations are not as problematic as cases of unreported child abuse. But that is a false comparison. There is no evidence that legitimate cases of child abuse and neglect would be underreported without mandatory reporting. But eliminating mandatory reporting would reduce false accusations. Anyone can report child abuse and other serious crimes. While mandatory reporters work with children and therefore may be able to notice abuse, the mandatory aspect of making a report is not necessary.

 In addition, I recommend eliminating the subspecialty of  child abuse pediatricians. The work they do is best left to law enforcement. Absent the subspecialty, any appropriately certified pediatrician with knowledge relevant to the type of injury or illness at issue in a case could testify about injuries and illnesses as expert witnesses in trials, and both sides should be able to present medical views.

 If the subspecialty of child abuse pediatricians remains and these doctors continue to see patients, they should have to announce who they are and their role. They should explain to parents that anything the parents say may be used against them by social services organizations and in court. Bioethicists should advocate for this disclosure, and law and hospital policy should mandate it. All parents should have the opportunity to refuse an assessment by a child abuse pediatrician and the option to have a lawyer present for any discussion.

The complex system of family surveillance penalizes the poor and people of color disproportionately, violates parental rights, and interferes with many parents who have their child’s best interests at heart. It is a system of guilty-until-proven-innocent that has harmed thousands of families, many of whom include parents who have been exonerated. I implore people, and especially bioethicists, to learn about those innocent families, and to advocate for repairing this broken system that harms them.

Anne Zimmerman, JD, MS, is founder and chair of Modern Bioethics and Innovative Bioethics Forum, chair of the New York City Bar Association Bioethical Issues Committee, and editor-in-chief of Voices in Bioethics. Her recent book, Medicine, Power, and the Law: Exploring a Pipeline to Injustice, explores the relationships between medicine, science, and technology and the criminal and civil justice systems.

pig heart transplantation

Bioethics Forum Essay

Myopic View of Xenotransplantation

by Franklin G. MillerPublished Posted in Hastings Bioethics Forum, Organ Transplantation

The news media significantly influence public perceptions of medical innovation. How cutting- edge medical innovation is presented—what receives attention and what does not receive attention—is ethically relevant. A report last week in the New York Times of a pig heart transplant performed at the University of Maryland Medical Center exemplifies a common myopic view of xenotransplantation research. The article describes the case of a 58-year-old Navy veteran with end-stage heart disease, too sick to qualify for a human organ transplant, who received instead a genetically modified pig heart—the second patient to undergo this experimental surgical intervention. The patient appears as a heroic volunteer, helping to advance science in the hope of a long shot at extended survival.

The innovative nature of xenotransplantation gets prominent attention. In a breathless tone, the article’s author writes, “In recent years, the science of xenotransplantation has taken huge strides with gene editing and cloning technologies designed to make animal organs less likely to be rejected by the human immune system.”  The pig donor, supplied by the for-profit company Revivicor, had 10 genetic modifications. The patient also received an experimental antibody treatment. In general, the news media approaches xenotransplantation as an irresistible technological frontier—one that is driven by scientific curiosity and prestige, and the potential of substantial future revenue flowing into biomedical companies and transplant centers.

As is typical of news stories concerning xenotransplantation, this article draws attention to the more than 100,000 Americans on the transplant waiting list, most of whom are seeking a new kidney. However, only 25,000 kidneys are transplanted in the United States each year. No effort is made to place this set of facts about organ donation and transplantation into a population health perspective. Of course, it is lamentable that approximately 6,200 Americans die each year while awaiting an organ transplant. But this represents only 0.2% of the approximately 3.2 million Americans who died in 2022.

Moreover, no mention is made of the prospect of preventing end-stage chronic disease, which in the case of kidney disease gives rise to the need for expensive and burdensome dialysis and organ transplants. Preventive efforts include enhanced educational and policy interventions to promote healthy diets and lifestyles and greater uptake of drug treatments to control hypertension and diabetes. Although lacking in scientific prestige, the fascination with technological innovation, and the prospect of substantial profit, promoting prevention holds promise for reducing the incidence, or ameliorating the progression, of chronic diseases.

The New York Times article reports that the Food and Drug Administration gave “compassionate use” emergency approval for this xenotransplantation intervention. But there is no mention of the compassionate alternative of palliative care and whether this was explored with the patient and his family.

Also noteworthy is the absence of any mention in the article of the ethical issues associated with the exploitation of pigs, who are intelligent animals, for the sake of this cutting- edge research and innovative treatment. Prior and ongoing pre-clinical xenotransplantation research has also involved transplanting pig hearts into baboons. And the FDA has stipulated that investigators must keep a large number of primates alive for at least six months after transplanting  pig organs as a prerequisite to permitting clinical trials in humans .

Success in xenotransplantation would represent an impressive feat of human ingenuity and technological prowess. However, if transplantation of hearts from genetically modified pigs proves viable—a big if—it would, at best, be a mixed blessing. Patients with end-stage heart disease who are unable to receive a human heart transplant would experience prolonged survival, although they might not fare as well as patients who receive a human heart. All transplant patients must take powerful immunosuppressive drugs for the rest of their lives, and these drugs cause vulnerability to serious infections. Some patients on the transplant list might face the agonizing decision of whether to continue waiting for a human heart, at risk of further deterioration, or opt for a genetically-modified pig heart transplant. If xenotransplantation becomes a validated treatment, it will be very expensive. From a societal perspective, would the investment in research and implementation into clinical practice be cost-worthy?

Bioethicists for the most part have not questioned whether xenotransplantation ought, from an ethical perspective, to be pursued, all things considered. Instead, they have focused on how to regulate, ethically, research and development of this exciting innovation. Regardless of the ethical issues it poses, experimentation with xenotransplantation to address the shortage of human organs for transplantation is proceeding full steam ahead. My aim here is not to argue for rejecting xenotransplantation. Rather, I suggest that science journalists and bioethicists should approach xenotransplantation with a wider lens. Worthy of greater attention are reflection on whether the potential benefits of xenotransplantation are worth the costs, promoting effective measures to prevent chronic diseases that give rise to the need for transplantation, as well as the challenging question of whether the promise of xenotransplantation justifies the harmful treatment of pigs and baboons in pursuit of this innovation.

Franklin G. Miller, PhD, is a Professor of Medical Ethics in Medicine at Weill Cornell Medical College and a Hastings Center fellow and board member.

[PHOTO: University of Maryland Medicine]

Black pregnant woman getting medical exam

Bioethics Forum Essay

To Reduce Maternal Health Disparities, Expand Medicaid 

by Mahika AhluwaliaPublished Posted in Hastings Bioethics Forum, Health equity and racial justice ethics

Black women are three times as likely to die from preventable pregnancy-related complications as white women in the United States. There are many reasons for this, but one of them is that Black women have lower rates of health insurance. Without insurance, they cannot afford the pre-pregnancy and prenatal care they need to reduce their maternal mortality rate. A fundamental way to address this problem is to expand Medicaid.

Medicaid provides coverage to many people who are unemployed or otherwise unable to access private insurance. One-third of women of reproductive age who fall into this coverage gap are Black. I urge bioethicists to advocate for state governments to expand Medicaid and its duration to preconception and postpartum periods.

Under the Affordable Care Act’s Medicaid expansion, Medicaid covers adults with incomes up to 138% of the poverty line. It increases the number of women who qualify for Medicaid before they become pregnant. However, 10 states, mainly in the South, have not adopted the Medicaid expansion. In these states, women living in poverty qualify for Medicaid only once they become pregnant.

Medicaid expansion is key to  improving Black maternal health and lowering maternal mortality. In a recent study, it was associated with a 22% increase in preconception care and a 10% increase in daily folic acid intake, which is recommended before pregnancy.  Maternal mortality rates are lower in states that have expanded Medicaid, with the most significant difference among Black mothers. These findings suggests that expansion could decrease racial disparities in maternal mortality rates for Black women.

Medicaid should also cover the postpartum period to help prevent maternal mortality. Medicaid coverage for pregnancy is only required for two months after delivery. But about a third of preventable deaths occur between seven and 365 days postpartum. Many of these deaths could be prevented if states adopt the American Rescue Plan’s option to extend Medicaid coverage for up to a year postpartum.  In a recent article, researchers called Medicaid extension during the postpartum period “a key strategy in the struggle to reduce the unacceptable maternal mortality rate across all racial and ethnic groups in the U.S.”

Infants also stand to benefit. While infants are Medicaid-eligible until age 1, their parents often lose coverage because their income eligibility increases with each dependent child. Medicaid expansion would enable a lower-income woman to retain coverage and access health care while caring for her newborn.

The Biden-Harris administration’s “Improving Maternal Health in America” initiative to alleviate maternal health disparities calls on Congress to expand Medicaid coverage, fund the education of Black women on preventing pregnancy complications, and continue providing access to insurance coverage. In addition, states should increase access to midwives and doulas through Medicaid, including during the prenatal and postpartum periods. With midwives and doulas from diverse backgrounds, Black women will have access to health care providers and treatments they are comfortable with to enhance their pregnancy experience and have healthier outcomes.

Bioethicists and policymakers in state governments should advocate for expanded Medicaid coverage before, during, and after pregnancy. Medicaid expansion will help to reduce health risks that worsen pregnancy outcomes disproportionately for Black women, upholding the ethical principles of beneficence and nonmaleficence. The stress levels of Black women experiencing poverty will also be reduced through access to health coverage and will work towards closing the maternal mortality disparity gap.

Mahika Ahluwalia, MBE, is a JD candidate at the University of Western Ontario, Faculty of Law in Canada. She received a Master of Bioethics from the University of Pennsylvania. @ahluwm92

Black man looking in the mirror

Bioethics Forum Essay

Beyond the Gift of Life: What Else to Expect from an Organ Transplant

by Heidi WalshPublished Posted in Hastings Bioethics Forum, Organ Transplantation

“Between the time of my heart transplant and the moment my hair began to fall out, I arguably had suffered enough,” writes Leilani R. Graham. “Transplant brought four open-heart surgeries, ten days on ECMO, an intra-aortic balloon pump, delirium, necrotizing pneumonia, and so much muscular atrophy that I had to re-learn how to walk. [Transplant] was not the miracle I was hoping for.”

Candid essays by Graham and 16 other transplant recipients reveal details of recovery from the surgery that are not widely known or discussed. While not minimizing their profoundly great fortune in receiving a transplant that saved their lives, the authors argue that better communication is needed between patients, their doctors, and their loved ones about what to expect after surgery. The essays appear in the journal Narrative Inquiry in Bioethics (NIB).

Graham felt unprepared for the long recovery she experienced. She describes her hair falling out in clumps, her skin developing abrasions at the slightest touch, her “explosive and terrifying” mood swings, and her inability to recognize her face in the mirror, leaving her “angry, hurting, and scared.” Graham relays how a simple but compassionate response from one of her physicians made all the difference. “The nature of my distress was finally realized when a doctor stopped typing on the computer, put his hands in his lap, and turned in his chair to face me. ‘I’m sorry. I’m a man. Losing hair is a concern. But I know especially for women, losing their hair can be extremely upsetting.’”

Graham adds, “Just a brief moment—a break from the lab values and charting and endless discourse on the importance of eating right. For the first time, I felt seen as myself again, for who I was.”

Most of the authors indicate that transplant centers seem too heavily focused on the needs of the organ, not the needs of the recipient. There is an incentive for this, as first-year patient and graft survival metrics are used for regulatory monitoring of transplant hospitals. But the authors suggest that transplant professionals should focus more on patient-centric goal setting. A recurring theme in the stories is the importance of finding a transplant physician who will address the concerns of the recipient rather than focusing solely on the transplanted organ.

Ill for many years with chronic kidney disease, Abdou Simon Senghor writes about his struggle to adhere to the strict medication regimen his doctors put him on after his kidney transplant, when he was able to go out and live a more active and full life. “Patients are interested in transplantation because it allows them to flourish as human beings,” he writes. “As a transplant recipient, newfound freedoms sometimes create problems with the correct timing of medication; I go to bed late because I come home late from parties or I work late.” He suggests that health care professionals make the effort to understand patients’ activities and, where possible, schedule medications and other treatments to fit into them.

As NIB commentary authors Vidya A. Fleetwood, Roslyn B. Mannon, and Krista L. Lentine recognize, “Senghor wants to be seen as a person with a transplanted kidney, not as a kidney alone.”

Organ transplantation clearly saves lives and can improve the quality and length of a recipient’s life tremendously, but it often comes with more side effects and struggles than many people anticipate. While the authors discuss such challenges, it’s clear that most feel they have received a great gift. They are compelled to give back. Several authors now work in transplant-related careers, volunteer for organ donation organizations, or participate in research or patient advocacy. This desire to give back can have positive impacts, but for some recipients, it can manifest as a symptom of survivor’s guilt when they feel they will never be able to adequately repay their donors.

Antonella Colace describes the feelings she had after her young daughter received a liver transplant from a deceased donor. “For my daughter to live, someone else had to die. I felt like an executioner. Guilt grew in my heart—we were thieves.”

Many of the authors long to express gratitude to their donor’s family. When they do try to contact the family, many get no response, and this can be painful. “I have not stopped thinking of my donor and their family in the years since returning home from [the hospital], although I only know minimal details about them,” Allen Callaci writes. “I have reached out with written expressions of my enduring and unending gratitude over the years through the proper channels but have yet to hear back.”

Some of the authors write about the difficulties they experienced when compassion and understanding from family and friends faded—the result of incorrectly assuming and expecting that the recipient will be rid of their ailments post-transplant. Todd Frantzen notes that his relationships have changed since undergoing a triple organ transplant. “At the beginning of my illness, family and friends supported me with words of encouragement and an outpouring of love. However, as time moves forward, so have they.”

Valen Keefer, who had a kidney transplant as a child and a liver transplant as an adult, writes, “Adapting to a new normal requires navigating dating and relationships, considering having a child, and experiencing stressors about the future like how long will my organ last? Recipients can feel guilty talking about anything but gratitude because they were lucky to receive a second chance at life. However, some go through a phase of ‘now what’ because after being sick for so long, returning to good health and integrating back into society can be an adjustment.”

Nearly all the authors describe unrealistic expectations about their transplant. “Transplantation is often inaccurately believed to be a cure for a specific illness; however, as many of the writers attest, they were not magically cured by receiving a new organ,” writes Heather Lannon. “Post-transplant, the recipient must adjust to a new regimen of lifelong medications, continue to attend medical appointments, and may experience new and ongoing health issues.”

While the authors are grateful for their “gift of life,” their lives are forever transformed, often in ways the authors did not anticipate. The stories provide an opportunity to reflect on the experiences of organ recipients and consider how transplantation professionals and others who love and care for them can better support recipients on their continued path and better manage expectations for life after transplant.

Heidi Walsh, MPH, CHES, is a senior project manager in the Bioethics Research Center at Washington University School of Medicine in Saint Louis. @hamp42_heidi

vaccine being injected into toddler's arm

Bioethics Forum Essay

Covid is Surging. Most Young Children Are Still Unvaccinated

by Sophia Bessias, Ami Harbin and Elizabeth LanphierPublished Posted in Children and Families, Covid-19 Ethics Resource Center, Hastings Bioethics Forum

Children are returning to classrooms amid another wave of Covid cases, but some public health leaders have leaned into the message that “most of us” can ignore the continued presence of Covid by taking just “a few basic steps,” such as staying up to date with vaccinations and promptly seeking antiviral treatment if infected. “Most of us,” however, does not include families with young babies, among other groups for whom these steps are unavailable or insufficient.

As the world has moved on from pandemic precautions, newborn babies are especially vulnerable. Infants under 6 months old are hospitalized with Covid at rates comparable to those of adults aged 65 to 74, and hundreds of children from birth to 4 years old have died. While rare, when severe disease occurs in older toddlers and preschoolers it is generally preventable. Yet we are not preventing it:  about 90% of children from birth to age 4 in the U.S. remain unvaccinated (meaning that they have not started the primary series of vaccines). Fewer than 1% have received a bivalent booster.

Headlines have attributed this low uptake to parents’ distrust of the vaccines, but focusing only on hesitancy overlooks other forces related to access, awareness, and motivation. Our own experiences vaccinating our young children, though not representative, illustrate that obstacles persist even for parents with the motivation and resources, raising ethical questions for future childhood vaccination efforts such as rollout of updated Covid vaccines and a newly approved RSV shot for infants this fall.

Access Barriers

As one of us (Elizabeth) found out when her second child turned 6 months old this year, it can be challenging to get a baby vaccinated. Though pharmacies are central to Covid vaccination in the U.S.,  few vaccinate children under 3 years old. Pediatricians’ offices may not stock up on Covid vaccines out of fear of wasting multidose vials amid low demand, or they may only offer the vaccines on a limited schedule. Elizabeth’s pediatrician’s office did not stock the vaccine; it is part of a health system that was offering appointments at only one of its seven facilities once a week for three hours.

Elizabeth’s baby aged into eligibility just as the public health emergency declaration ended, prompting many local health departments to close vaccination sites. In addition to having fewer places to go for Covid vaccines, many people will now face a financial hurdle: Covid vaccines must be paid for either by insurance or out of pocket. Uninsured people will face delays obtaining a fall Covid vaccine in major U.S. pharmacies.

For parents who would only vaccinate their children if little effort was required,  or who lack time to follow eligibility updates and attend multiple appointments during limited business hours, vaccinating a baby may be close to impossible in some areas of the U.S. Medicaid disenrollment affecting hundreds of thousands of children and cuts to Centers for Disease Control and Prevention’s child vaccination programs will further impede access as Covid vaccines enter the private market.

Perceived Risk and “Moral Calm”

Sociologist Jessica Calarco coined the term “moral calm” to describe the popular–but false–narrative promoted through public policy and media rhetoric that SARS-Cov2 was less likely to infect children than adults and posed little risk when it did, giving parents “almost no incentive at all” to vaccinate. Known, preventable harms of pediatric Covid infection were sidelined by this relative framing even as absolute cases, hospitalizations, and deaths mounted.

The CDC’s decision to relax Covid protections by making masks optional in public spaces, for example, increased children’s exposure amid surging pediatric hospitalizations and a stalled vaccine authorization process. Over a six-week period in January and February 2022, more than a thousand children under the age of 5 were hospitalized. High Covid transmission exacerbated risk to young children, for whom “the tools” of vaccination and antiviral treatment were out of reach.

Regulators who had repeatedly delayed authorization of vaccines for children since summer 2021 did so again in February 2022–during this record-setting wave of preventable pediatric hospitalizations–to request additional trial data. By this point, more data was unlikely to match the constant viral evolution and stream of evidence-resistant disinformation, and the potential to improve the quality of evidence was limited. The vaccines had already demonstrated a strong safety profile that the trials were not powered to augment.

Meanwhile, off-label use of approved vaccines was denied; and “one-way masking” was inaccessible to those too young to wear a mask. By the end of 2022, nearly all children ages 6 months to 17 years had Covid antibodies. Current estimates show that the youngest age group is unique in having acquired antibodies almost universally through infection alone, not vaccination or “hybrid” immunity.

The Race between Vaccination and Infection

During the peak of pediatric infections during the Omicron surge, two of us enrolled our kids in Covid vaccine trials for the 70% chance that they would get the vaccine instead of a placebo. Parents similarly eager to vaccinate their children organized online communities and traveled long distances to find trials. Sophia viewed trial enrollment as posing less risk to her children than infection without vaccination, and Ami was one of those parents willing to drive three hours each way to enroll her 3-year-old in a trial.

With the help of a grassroots parent network, Ami narrowly reached the goal of vaccination before infection. Her whole family was infected with Covid the week after finding out her child had received the vaccine. But such opportunities were largely restricted to those able to enroll in a trial, and with means to limit their children’s Covid exposure for more than two years. By the time vaccines were authorized for kids under 5, in June 2022, an estimated 74% of them had been infected at least once – a share that could have been substantially lower had authorization been given a few months earlier.

Despite conferring limited protection relative to vaccination, and carrying additional long Covid risk, immunity built up through prior infection is touted as a “tool” for protection against future Covid  infection. For the majority of parents whose young children lost the race to vaccination before first infection, previous encounters with the virus may reduce urgency to stay up to date with vaccinations.

Who Has the Tools?

At least two vaccine manufacturers, Moderna and Pfizer, are preparing to ship updated formulations for children ages 6 months and up this fall, though questions remain about whether the Food and Drug Administration will authorize, and the CDC  will recommend, the vaccine for all ages. They should, particularly if vaccines are to be the primary ongoing defense against Covid.

Projections suggest that in the best case scenario Covid hospitalizations and deaths will be on par with other viral illnesses this fall, but it is more likely Covid will remain a leading cause of death in the U.S. The best case entails nearly all people eligible for a fall vaccine getting vaccinated, a scenario that recent uptake and prior polling suggests is virtually impossible.

The moral calm around kids and Covid must be met with better communication about the risks of repeated infection. Journalists covering Covid can help by reinforcing the message that there are high-risk groups, including infants, for whom the “tools” are insufficient. Existing preventive options, including vaccination during pregnancy to protect babies in their first six months, should be promoted by public health organizations and clinicians. Finally, clinical trials studying vaccines for babies younger than 6 months old may yield important benefits and should command public attention.

Getting shots into arms (or legs) this fall requires a true paradigm shift for our health agencies and policymakers: urgency for authorizations and approvals, continuous funding for and access to vaccination programs, and communication about severe outcomes in children that are fortunately rare but deserve all the tools of prevention.

Sophia Bessias, MPH, MSA, is a bioinformatician at the Duke University School of Medicine. @sophiacbess

Ami Harbin, PhD, is an associate professor in the departments of philosophy and women and gender studies at Oakland University.

Elizabeth Lanphier, PhD, MS, is an assistant professor in the Ethics Center at Cincinnati Children’s Hospital Medical Center and in the departments of pediatrics and philosophy at the University of Cincinnati, as well as a nonresident research fellow in the Institute for Philosophy and Public Policy. @EthicsElizabeth

female patient sitting in exam room

Bioethics Forum Essay

The Retrievals: Women’s Vulnerability to Injury, Violence, and Pain in Health Care

by Sophie Schott and Faith E. FletcherPublished Posted in Hastings Bioethics Forum

Pain can be tender, throbbing, lacerating, shooting, burning, and wrenching.

Pain is also a protective, finely wired warning system primed to defend the body from harm. In the field of medicine, pain can be an essential marker of underlying pathologies and sometimes can be used to direct treatments. However, the science of pain measurement is frustratingly imprecise, presenting challenges in clinical settings. Importantly, pain assessments rely on information provided by patients, who are sometimes asked to characterize the severity, intensity, and duration of their pain.

But what happens when a health care provider decides that the patient is not a reliable narrator of their own pain?

The Retrievals, a recent documentary podcast from Serial Productions and The New York Times, explores this question and the excruciating pain that 12 women endured while receiving fertility treatments at the Yale Reproductive Endocrinology and Infertility Clinic. Because egg retrievals involve passing a long needle through the vaginal wall to access the ovaries, patients typically receive fentanyl and midazolam to induce moderate sedation during the procedure.

Many women at Yale reported being wide awake and feeling “everything” during a procedure when they should have felt practically nothing. Naturally, these patients requested more medication to manage their pain, which they described as “excruciating” and “like someone was ripping something from the inside of your body.” However, when the women voiced their discomfort, they were told by clinic staff they had already received the maximum legal dose of painkillers. Later, it was discovered that a clinic nurse had pocketed the fentanyl and replaced it with saline, leaving the women to endure their retrievals without any pain control.

Pain and its shadows give shape to the disturbing story behind The Retrievals while raising important questions about discrimination in health care. It is important to note that of the 12 women interviewed in the podcast, most were White. The one Black woman in the group was often the only person of color in the clinic waiting room––this is not unusual, as fertility clinics mostly deliver care to White women due to access issues and systemic barriers that prevent Black women from seeking fertility care. Notably, clinicians are more likely to dismiss, ignore, or downplay the concerns of Black and female patients, compared to their White and male counterparts. Gendered racism in health care makes Black women especially vulnerable when seeking reproductive health care and reporting pain.

False beliefs about racial differences in pain, established during the era of slavery, fuel medical mistreatment and cause harm to marginalized groups, especially Black women. Even today, racial biases in pain assessment and treatment among medical professionals persist. Dorothy Roberts, an acclaimed scholar of race, gender, and the law, explains that the use of race in medical decision-making is not only a symptom of bad medicine, but also a sign of stereotypes at play, including harmful ideas that “Black and Brown people feel less pain, exaggerate their pain, and are predisposed to drug addiction.”

Racial disparities in pain treatment intersect with and perpetuate other well-documented reproductive and maternal health inequities. When Black women report chronic pain for conditions such as endometriosis, they are less likely to be taken seriously and receive a timely diagnosis. They are also less likely to receive adequate postpartum pain control. Inequities are further amplified when reproductive health care providers ignore women who vocalize their concerns and then blame these patients when they experience adverse maternal and perinatal health outcomes, even for preventable conditions.

Take, for example, the story of Jennifer James, a Black feminist ethicist and medical sociologist who “was not believed when [her] epidural failed” and then “was chastised for yelling out in pain” during the birth of her first child. Or consider Kira Johnson, a healthy 39-year-old Black woman who hemorrhaged to death after a routine cesarean delivery despite her husband’s many pleas for help. When he asked staff to investigate the blood clouding Kira’s catheter, a nurse responded, “Sir, your wife just isn’t a priority right now.”

As evidenced by the stories of countless women and those interviewed in The Retrievals, women and patients of color tend to be targets of medical gaslighting, the dismissal of patients’ concerns, feelings, or complaints by their health care providers. In other words, medical gaslighting occurs when doctors fail to trust their patients or refuse to acknowledge their pain.

The Retrievals highlights something that many of us working in health equity and bioethics know all too well: until we fully acknowledge and address the historical and contemporary injustices that fuel longstanding harm in reproductive health care, all women are vulnerable to injury, violence, and pain in health care settings. To be clear, these injustices are exacerbated by biases against minoritized groups which must be addressed in order to holistically care for all women.

Sophie L. Schott is a clinical research coordinator in the Center for Medical Ethics and Health Policy at Baylor College of Medicine. Her research explores the intersections of medicine, history, and health humanities to advance a more nuanced understanding of reproductive health and community well-being. @MyBestSchott

Faith E. Fletcher, PhD, MA, is an assistant professor in the Center for Medical Ethics at Baylor College of Medicine, a senior bioethics advisor to The Hastings Center and a Hastings Center fellow of The Hastings Center, and a nationally recognized expert in health equity and bioethics. @FaithEFletcher

Clinical Case Studies card

Bioethics Forum Essay

Involuntary Withdrawal: A Bridge Too Far?

by Joanna SmolenskiPublished Posted in Clinical Ethics Case Studies, Hastings Bioethics Forum

RD, a 32-year-old male, was admitted to the hospital with hypoxic COVID pneumonia–a potentially life-threatening condition characterized by dangerously low levels of oxygen in the body- during one of the pandemic’s surges. While RD’s age gave the clinical team hope for his prognosis, his ability to recover was complicated by his being unvaccinated and having multiple comorbidities, including diabetes and obesity. His condition worsened to the point that he required extracorporeal membrane oxygenation (ECMO), a machine that maintains the functioning of a person’s heart and lungs.

Given its scarcity–only 264 of the over 6,000 hospitals in the United States offer ECMO, according to the Extracorporeal Life Support Organization–as well as its high cost and the inadequate supply of staff required to maintain it, ECMO primarily serves as a bridge to support critically ill patients until they can receive an organ transplant or implanted medical device. For RD, ECMO was started to support him until he could be evaluated for, and possibly receive, a bilateral lung transplant. Despite its intended use as a treatment of last resort, some patients can remain on ECMO for weeks or months. And some are awake, alert, and capable of medical decision-making.

RD was one such patient. However, the transplant evaluation committee ruled out RD’s candidacy for bilateral lung transplantation, based on his poor potential for recovery and a lack of family and friends to provide post-transplant support. This determination raised the prospect of  continued ECMO treatment being a bridge to nowhere. But RD was comfortable on ECMO and wanted to remain in the ICU. The ICU intensivist contacted the ethics consult service with questions about whether continued ECMO support was medically and ethically inappropriate.

Ethical Analysis and Process

First, the ethics consultants met with members of the ICU team to explore their ethical concerns. The ICU clinicians believed RD’s almost certain permanent ICU-dependence rendered continued life-sustaining treatment futile. They also raised distributive justice concerns about using ECMO for a patient who would likely never recover. ECMO-eligible patients from other hospitals were routinely refused admission at RD’s facility because of  machine and staffing shortages, and approximately 90% of such patients would die as a result. The physicians worried about the fairness of allowing RD to use one of the hospital’s few ECMO machines indefinitely when other lives could be saved.

The clinical ethicists then met with RD, who said that he was not ready to die and, in fact, thought he had a good quality of life in the hospital. Indeed, he was alarmed by the possibility that the doctors could disconnect his life support without his consent. RD’s perceived right to exercise autonomy over his treatment–as well as to determine what counted as an acceptable quality of life for him–was in tension with the clinical team’s concerns about providing care they considered to be medically inappropriate and exercising poor stewardship of resources.

The ethics consultants saw multiple issues contributing to the ICU team’s discomfort with RD’s desired care plan. While the physicians felt they could keep RD alive on ECMO, they did not think doing so indefinitely was consistent with their role as healers. In addition, the physicians were concerned that it would be unjust to use scarce resources to maintain a patient in poor health when those resources could be used to cure other patients.

Disambiguating these concerns with the ICU team was crucial to the ethics process. While questions of resource allocation were clearly in the background in considering RD’s treatment, hospitals don’t allow very ill patients to die simply so that their beds can be used by other people. So, it became particularly important to understand RD’s goals of care in the context of the goals of medicine more broadly. Was what RD desired–namely, remaining in the ICU on ECMO for weeks or even months until his inevitable death–a goal that a health care system should not only respect, but effectuate?

With this in mind, the ethics consultants advised continuing discussions with RD about his goals of care (including palliative care and social work services) to ensure that he truly understood that his condition was incurable and that his desire to remain connected to ECMO was the result of his belief that this was an acceptable quality of life for him. Focusing on the reasons for his decision confirmed the authenticity of RD’s preference: he maintained that he wanted to continue treatment. RD and the clinicians ended up at an impasse, with an intractable disagreement regarding what constituted an appropriate plan of care.

Given the unresolved conflict, the ethics team advised bringing RD’s case to the hospital’s ethics committee, an interdisciplinary group that included ethicists, physicians, and community members whose endorsement was required by hospital policy for any unilateral withholding or withdrawing of life-sustaining treatment.

 The Decision

The committee’s task was to determine whether RD’s clinicians in the ICU had established that continued treatment was medically inappropriate under the hospital’s policy. If the committee endorsed the clinicians’ perspective, the ICU team would have been permitted to withdraw ECMO over RD’s objection. However, the committee declined to endorse the clinicians’ determination of medical inappropriateness largely because RD had capacity, and so his treatment preferences were respected.

A few weeks after the decision, RD passed away when a clot formed in his ECMO circuit. So, while he was not taken off ECMO against his wishes, his case generated widespread institutional examination of the relevance of a patient’s decision-making capacity to clinicians’ determinations of medical inappropriateness and unilateral treatment withdrawal under conditions of scarcity.

Lingering Questions

While some practitioners found continuing ECMO in RD’s case medically inappropriate, ethical concerns lingered regarding the moral appropriateness of withdrawal of treatment for patients like RD with decision-making capacity who want to continue aggressive care. And so, the question remains: what ought to be done with treatment long-term for such patients? It is close to canonical in contemporary medical ethics that capable patients should be allowed to establish their own goals of care and, furthermore, to determine what constitutes an acceptable quality of life for themselves. Were these specifications sufficient to justify maintaining RD on ECMO indefinitely? Or is there space for clinicians to say that the only quality of life they will be able to achieve for a given patient is inconsistent with the appropriate practice of medicine, and so they should be permitted to refuse to provide interventions aimed toward that health state?

Joanna Smolenski, PhD, is an assistant professor at Baylor College of Medicine’s Center for Medical Ethics and Health Policy and a clinical ethicist at Houston Methodist Hospital. Previously, she was a clinical ethics fellow at UCLA Health.

Series Editors’ Comment:  Where Public Health Ethics Meets Clinical Ethics

RD’s case exemplifies the complexities of scarce, advanced, life-sustaining technologies and the difficulties that arise if we try to distribute them justly. ECMO is meant to be a bridge to transplantation or recovery from critical illness, but sometimes it sustains life without hope of recovery to a life outside of the hospital. In this way, RD’s case draws attention to the border between public health ethics and clinical ethics, and the challenges in patient care that arise where they meet.

The primary issue this case raises extends beyond the ethics committee’s decision to support RD’s preference to remain on ECMO, and importantly so. It is both reasonable and important to approach RD’s case individually, as a case to be resolved using the methods of clinical ethics. A decision to not withdraw ECMO is justifiable, not merely because of the obligation to respect the patient’s choice, but because it is difficult to argue that ECMO was medically nonbeneficial or inappropriate when it continued to provide both longevity and quality of life.

If an ethics committee instead adopts a public health framing for RD’s case, it risks allowing implicit, interpersonal bias to guide decision makers in the moment, since RD is only one person, not a population of persons who are each under consideration for the same scare resource. Unless an ethics committee can rely on a predetermined process for implementing the norms of public health ethics into the routine ways that health care professionals develop treatment plans with individual patients that can be fairly and equitably applied, the committee is right to focus on how to best respect a specific patient’s goals of care. In RD’s case, this yielded a treatment plan appropriately focused on respectfulness, nonmaleficence, and beneficence.

However, the responsibilities of health care extend from individual patients to whole communities. There is an undeniable reality in this case that other patients who could recover with the support of this resource simply do not have access to it. While it is important for ethics consultants to be cautious when arguments of resource scarcity are employed to justify withholding or withdrawing life-sustaining medical interventions, this is a situation where the resource truly is not available because maintaining RD’s life on ECMO entails denying life-sustaining technology to other patients who may die without it. This is a failure of communitarianism and justice, even though it is respectful and compassionate to RD. Ethics consultation services and committees are obligated to address these broader distributive injustices, but their resolution may be more appropriate to policymaking, rather than patient care.

One of the fundamental challenges to fulfilling the responsibilities of distributive justice is that when the distress of a single case fades, so does the drive to create robust policy and procedures that could synthesize public health ethics and clinical ethics to help allocate resources more fairly to the broader community. This leads to a vicious circle, with each new distressing narrative experienced anew by patients and families and residually amplified for health care professionals, and no end to the impasses encountered with each trip around the circle.       

– Georgina Campelia and Thomas Cunningham

Learn more about the series, Clinical Ethics Case Studies for Hastings Bioethics Forum.

Read the previous essays in the series here and here.

Attention clinical ethicists: learn how to contribute to the series.

egg fertilization in lab

Bioethics Forum Essay

Bartering Your Eggs: A Rotten Deal

by Arthur Caplan and Gwendolyn P. QuinnPublished Posted in Hastings Bioethics Forum, Reproduction & Technology, Reproductive ethics

The technology associated with assisted reproduction has grown exponentially in the last two decades. Planned oocyte and sperm freezing, posthumous reproductive genetic testing, and egg and donor sperm brokering are expanding infertility services. Demand has grown, as well. Estimates suggest there are now over one million donor-conceived children, about 10,000 per year. The use of donor gametes has allowed people with infertility or other medical conditions to achieve their parenthood goals.

The settings in which services are delivered are rapidly evolving, too. What was once only offered by academic and private medical facilities has become a burgeoning platform for start-ups, private equity firms, and international entrepreneurs. Corporations are offering insurance coverage for egg freezing for their young female employees. Around the country, egg freezing and egg shower parties market services to women. There are approximately 1,500 sperm banks and around 1,900 egg banks across the world with profits for sperm banks estimated at over $4 million in 2019 and for egg banks $487 million in the U.S. alone.

However, there is significant reproductive injustice and lack of access to fertility treatments by diverse populations. Nowhere is this more obvious than with egg freezing.

Consider a hypothetical case: Josie is a 32-year-old medical intern with at least seven more years of training. She wants to be a parent someday but recognizes that now is not the time. She also knows her chances of having a baby will be significantly lower by the time she finishes her training, at age 39. Josie wants to freeze her eggs, but the cost is high ($4,000 to  $8,000) and not covered by her student insurance. A local clinic is offering a new program–free egg freezing–for patients willing to donate half of their oocytes to a donor bank and keep the remaining half for their use. In other words, barter your eggs to be able to afford to freeze some of your own.

Josie pursues information on this option. She learns that, in some cases, she can put stipulations on who can use her donated eggs–she can require the future recipients to be a certain religion, race, or partner status. Josie received significant counseling on the risks and benefits of participation, including the need to consider how she may feel if there are children biologically related to her but raised by other people.

At first glance, what could be wrong with this scenario? It offers Josie a practical and financial solution to her problem, and she has been counseled on the risks. Josie is free to make an autonomous decision about engaging in shared egg banking. But how autonomous is it? The counseling came from the for-profit egg bank that works with the clinic that advertised free egg freezing. (Most counseling of prospective donors comes from egg clinics, although donors can make the effort to seek external counseling.) Is the transaction she is being offered fair?

Josie is getting a service valued at around $8,000, and the egg bank will make around $11,000 per donated egg. Assuming Josie produces 20 eggs, she will have 10 saved for herself and will donate 10. This means the egg bank will make around $100,000 on this exchange (minus the cost of the retrieval and freezing process). There is no guarantee that any of the frozen eggs will produce a baby, however the egg bank profits no matter the outcome.

The huge profit going to the egg bank creates a tremendous conflict of interest by having their employees counsel Josie on her options. The for-profit bank has everything to gain and nothing to lose if Josie says yes.

Josie, on the other hand, has a lot to lose. What if she completes her training, moves to a new city to start her job, and attempts to use her stored eggs, but the fertility center where she now lives won’t accept these eggs? Or none of her eggs survive the freezing process? Or none result in a live birth? Meanwhile there could be children in the world with half her genes. Psychological and emotional support may be required no matter what she consented to years earlier.

During the egg freezing process Josie would have had genetic testing for every genetic risk that was known at the time, but seven years later, there would be new genetic risks discovered. What if Josie is a carrier of a gene for a newly discovered genetic disease? Is she liable for transmitting it? Some egg donor contracts cover this kind of contingency by assigning all fiscal responsibilities to the egg recipients, but there is no regulation or law mandating that they do. Can those who used her eggs go to court to require that she help pay for the care of an affected child?

What if the parents of children born from Josie’s eggs die in a car accident and the children find out who their maternal donor is (perhaps through 23andMeor by suing the egg bank)? Does Josie have any responsibility for those children? Josie may choose to ignore requests to connect with those children, in which case they may resort to media campaigns or social media harassment to locate and connect with her.

When the costs of donor eggs are high, only the wealthy are likely to be able to use egg donation services. So, donations are heading mainly to the rich. If egg donors can select who prospective users will be, as many new egg donor programs are promising as a means of recruiting donors–say, Christians only, no mixed-race or same-sex couples, Indian Americans only, or only those of a particular political orientation–what happens to respect for diversity and social equity? Is there potential societal discrimination when only specific people with certain characteristics can use donor gametes, especially when the donor is relying on racial or ethnic classifications with no firm basis in biological or medical science?

When only financially strapped women participate in egg-sharing programs; when they do so without independent counseling; when they don’t understand their liabilities, responsibilities, and duties to any children created from their eggs; when they are made promises that may not be kept; and when likely only wealthy people can use the gametes, we are robbing these young women of authentic autonomy, leaving them to be exploited by parties with obvious conflicts of interest, reinforcing bigotry, and creating or exacerbating health and social disparities. If infertility treatment is an important human right, it ought to be part of health insurance rather than subject to bartering.

Arthur Caplan, PhD, is the founding head of the Division of Medical Ethics at NYU Grossman School of Medicine. He is a Hastings Center fellow and a member of The Hastings Center’s advisory council. @ArthurCaplan

Gwendolyn P. Quinn, PhD, is the Livia Wan Endowed Chair and Professor in the Department of Obstetrics and Gynecology at NYU Grossman School of Medicine.

Black man in hospital bed

Bioethics Forum Essay

New York’s Involuntary Psychiatric Treatment Initiative: Positive Signs and a Path Forward

by Richard A. Siegel, Leora Botnick, Kara Simpson, Louis P. Voigt, Robert Klitzman, Benita Zahn and Nancy DublerPublished Posted in Hastings Bioethics Forum

Recent policies by New York State Governor Kathy Hochul and New York City Mayor Eric Adams to identify homeless mentally ill people and remove them from the streets for involuntary treatment have raised many ethical concerns. But there is encouraging news–some individuals brought in under these policies to hospitals that provide longer-term treatment have benefited, ending up in supportive housing.

We praise the expansion of voluntary extended stay units at Bellevue and Kings County Hospitals  and in other systems. They offer individuals intensive support. They include longer stays, medication management, rehabilitative activities, and counseling before people re-enter the community (often in supportive housing). This level of care should be the rule, rather than the exception.

Currently, homeless mentally ill individuals are stuck in the revolving doors of trauma, and the indignity of forcible removal and commitment. It perpetuates the cycling of homelessness and incarceration, mostly for people of color.

The issues of homelessness and mental illnesses are complex and illustrate centuries of systemic racism and the marginalization of people of color, the poor, and those with significant mental illness. In the 2010’s, New York State further limited the care of people with mental illness under Medicaid, as part of efforts to curtail health care costs. This Medicaid reform limited psychiatric hospitalizations to 12 days, and significantly reduced reimbursement for any additional days of care.

In a Hastings Bioethics Forum essay, Aashna Lal made the case that psychiatric treatment over an individual’s objection is an ethical imperative in limited situations.  We agree that providing care to those truly without the ability to care for themselves is moral and ethical. The core ethical issue is that there is a continuum from individual autonomy to provider beneficence. As Lal mentions, Hastings Center cofounder Willard Gaylin and senior advisor and fellow Bruce Jennings state in their book, The Perversion of Autonomy: The Proper Uses of Coercion and Constraints in a Liberal Society, that it is morally dangerous to place too much value on individual autonomy and too little on care and support for people in need.  Ethical support requires treatment over the full continuum of care, not simply removing the unsightly homeless individuals from public spaces.

Jonathan Wolf, in his book, The Human Right to Health,  asks, “How can there be a human right to health if the resources are just not there to satisfy it?” People with mental illness have been systemically and continuously deprived of that right by the lack of resources and investment in their well-being and housing. Homeless individuals are often people of color who grew up in communities that have been redlined by the banks. This stigma and the bias against homelessness create further social isolation. Hence, policies that point to “handling the homeless” and “cleaning the streets” perpetuate epistemic injustice, even among well-trained health care professionals.

We advocate for a more communal and integrated approach for health care professionals involved with homeless people experiencing mental health concerns. Clinicians, not police, must be the ones to determine whether the homeless individuals suffer from serious mental illness requiring treatment in an ER. Distressed people in distressed communities deserve more immediate and more lasting solutions. States have achieved decades-long savings by closing psychiatric hospitals and denying support to many communities. A positive outcome will demand a re-investment of these resources in care and services.

Individuals with mental illness should receive robust and adequate treatment as determined by the members of their clinical teams before they are discharged from the hospital or transferred to state facilities.  The length of stays and discharge decisions should be made by the health care team, rather than insurance companies or regulators. 

Stays should also not be longer than necessary, a problem that results when people with mental illness must wait a long time for authorization of post-discharge supports. The legal process to obtain assertive community treatment, assisted outpatient treatment, and other forms of support can take months.  The process must be streamlined, so that people are neither discharged prematurely nor given unnecessarily extended stays.

The New York City and State governments’ focus on the needs of homeless individuals with serious mental illnesses seems genuine and worthy. But indiscriminate involuntary removal and evaluation of homeless individuals should be just one tiny facet of care. The allure of an easy fix should be resisted. The care of this population is complex and demands a holistic approach that integrates preventative, corrective, and rehabilitative measures along the entirety of the care continuum. All efforts must be supported by investments of money and resources that improve our safety net hospitals, celebrate human dignity, and truly prioritize the least advantaged members of our society. There is early evidence that providing extensive comprehensive care is working. To do otherwise would be a tragic farce that is doomed to fail, once again.

The authors are members of the Empire State Bioethics Consortium. This essay reflects discussions during the meetings.

Richard A. Siegel, LCSW-R, is an adjunct professor at the Silberman School of Social Work at Hunter College. He recently retired as the director of Social Work at NYC H+H/Metropolitan and as the co-chair of the H+H Ethics Council.

Leora Botnick, LCSW, is co-chair of the New York City Health + Hospitals Bioethics Council and of the Ethics Committee at NYC H+H/Jacobi and is a social work supervisor in the Department of Social Work at NYC H+H/Jacobi.

Kara Simpson, LCSW-R, is the director of social work for behavioral health services at NYC H+H/Jacobi. She is also a masters of bioethics student at the Center for Bioethics at Harvard Medical School.

Louis Voigt, MD, MBE, is chair of the Memorial Sloan Kettering ethics committee and an attending physician in the departments of medicine and of anesthesiology, pain, and critical care medicine. He is an associate professor of medicine in clinical anesthesiology and of clinical medicine in medicine at Weill Cornell Medical College.

Robert Klitzman, MD, is a professor of psychiatry in the Vagelos College of Physicians & Surgeons and the Mailman School of Public Health and the director of the masters of bioethics program at Columbia University. He is a Hastings Center fellow. @RobertKlitzman

Benita Zahn, DPS, MS, NBC-HWC, is a journalist and certified health and wellness coach working with cardiac patients. 

Nancy Dubler, LLB, is an attorney and the consultant for ethics at the Health and Hospitals Corporation, and a Hastings Center fellow. She is the author of books and articles detailing how to use mediation in clinical ethics consultation.

nuclear bomb exploding over Nagasaki

Bioethics Forum Essay

Oppenheimer’s Nuclear Value Judgment Wasn’t the First

by Jonathan D. MorenoPublished Posted in Hastings Bioethics Forum

Christopher Nolan’s film, “Oppenheimer,” which opens in theaters on July 21, highlights a value judgment that the Manhattan Project scientists had to make before Trinity, the test of the first atomic bomb. They had to calculate the odds that the “gadget” wouldn’t initiate a catastrophic chain reaction that could ignite Earth’s atmosphere. In so doing they implicitly invoked two dimensions of risk, probability and magnitude, where in this case the probability of an error was low, but the magnitude of an error was immense. They also needed to factor in another dimension of risk: the suspicion that Nazi Germany’s formidable scientific establishment was on course for its own atomic device, which would have been a catastrophe for human civilization of a different sort.

But that fateful judgment in Los Alamos, New Mexico, in 1945 wasn’t the first such determination that Project scientists needed to make. That took place in 1942 as part of the work in the top-secret Metallurgical Laboratory on the University of Chicago campus, where other great physicists like Arthur Compton, Enrico Fermi, and Leo Szilard were working on the first nuclear reactor. Known as the Chicago Pile, the immediate purpose of the reactor was to generate sufficient plutonium to power a bomb. In the course of testing when the material would reach the point of criticality, they controlled the reactor by inserting and withdrawing cadmium control rods. If their calculations had been incorrect, a large part of Chicago would have ceased to exist.

We don’t know if the experience with the Pile figured into the judgment of Robert Oppenheimer and his team, but scientists make value determinations all the time. In a classic 1953 paper called “The Scientist Qua Scientist Makes Value Judgments,” the philosopher of science Richard Rudner (who was my dissertation director) used the Pile as an example of the way scientists inevitably make moral choices. He argued that the acceptance of any scientific hypothesis requires that the evidence in its favor must be strong enough for the risks to be morally acceptable. To the atomic scientists in charge of the Pile and the Trinity test the hypotheses were strong enough for them to accept the risks of an error. In other words, they made a value judgment.

Rudner argued that moral choices in science are so routine that we don’t notice them. Take an example from drug research. Imagine that of two potential medications one would be far more beneficial to future patients if it worked, but an experiment for that one would pose higher risk to human volunteers. The experimenters would have to find the risk-benefit balance to be favorable enough to offer the drug to human subjects. Though far less spectacular than the Manhattan Project experiments, the consequences of error would be significant in placing people in a study at risk. Unlike the Pile and Trinity, in which neither the people of Chicago nor the inhabitants of the whole planet were asked for their permission, the people who agree to be in a drug study must give their informed consent.

Human civilization is now in a different sort of experiment, one that Oppenheimer predicted. This poorly managed experiment is based on the theory that human control of these awful weapons can succeed indefinitely. Thus, we are sleepwalking into disaster. The consequences of being wrong are too great, and the probabilities are not in our favor.

Jonathan D. Moreno the David and Lyn Silfen Professor of Ethics at the University of Pennsylvania and a Hastings Center Fellow. (@pennprof)

White and Black female actors in Robert Icke's The Doctor

Bioethics Forum Essay

The Drama of Medical Ethics: A New Play

by Robert KlitzmanPublished Posted in Hastings Bioethics Forum

In the waning years of the Austro-Hungarian Empire, Arthur Schnitzler, the physician and writer, wrote his most controversial play, “Professor Bernhardi.”  Unlike his fin-de-siècle Viennese contemporaries, such as Sigmund Freud, Ludwig Wittgenstein, Gustav Klimt, and Gustav Mahler, Schnitzler is hardly a household name. Yet, Freud called Schnitzler his doppelgänger for having found through intuition what Freud had discovered only through years of research – the unconscious. Max Ophϋls’s classic 1950 film “La Ronde”(about venereal disease spreading through all levels of Vienna’s society), Stanley Kubrick’s “Eyes WideShut,” and Tom Stoppard’s “Dalliance” are all based on Schnitzler’s work. 

Written in 1912, “Professor Bernhardi” was banned by the Austrian Parliament and performed in Schnitzler’s native Vienna only after the Empire had collapsed following World War I. Alas, the play has rarely been seen since – performed in New York only twice – in 1918, in German, and briefly in 1968, at the City Center in English.   

Luckily, in 2019, London’s Almeida Theater staged a production of a new play, loosely adapted from Schnitzler’s, which garnered several prestigious awards and recently came to the Park Avenue Armory in New York City, where it is now being performed until August 19. 

This adaptation, entitled “The Doctor,” powerfully dramatizes many controversial issues of medical ethics, along with what is now termed “identity politics.”  New plays rarely address medical ethics issues in any serious way, but these productions are important because they can heighten awareness of these topics among broader audiences. 

In Schnitzler’s original play, a priest wants to administer last rites to a patient who is dying from sepsis that resulted from a botched abortion. The patient does not know she is dying, and a Jewish doctor refuses to allow the priest access to the patient, saying that last rites would upset her. The priest launches a public campaign against the Jewish doctor, who is ultimately jailed for two months and loses his license. At the time in Vienna, antisemitism was rife and rising, and play’s political overtones stirred debate. 

In the new adaptation, written and directed by Robert Icke (the youngest person ever to win Great Britain’s Olivier Award for Best Director), a 14-year-old girl is dying of sepsis from a botched abortion she attempted at home. Her mental status is unclear, as she has expressed delusions.

A man dressed in black enters, saying that he is a priest and that the girl’s parents asked him to come to give last rites. The hospital director, Dr. Ruth Wolff, refuses to allow him to enter the room, arguing that the girl is conscious but delusional and would be upset by the priest giving last rites – i.e., informing her that she is dying. Wolff argues that it is not clear that he is really a priest, or that he was really sent by the girl’s parents, or that the girl (though she wears a cross) wants to see a priest. A screaming match ensues, during which the physician hits the priest. 

He then complains and a massive social media campaign ensues, criticizing her. Medical staff and the hospital public relations director urge her to issue a public statement, apologizing or explaining what happened, but she refuses, insisting that she did nothing wrong.

The hospital is simultaneously working to raise several million dollars for a new building, and donors become leery. Three board members resign, and the hospital staff battle about what to do, given that the institution’s future is now at stake. Wolff remains arrogant, convinced she is right, and shuts down debate at staff meetings. 

In the midst of these arguments, the girl’s father wanders in and angrily denounces the staff for having “killed my baby girl,” whom, he cries, will now go to hell because she was not given last rites, a chance to ask forgiveness. He accuses the hospital of caring more about itself than about its patients. A Catholic doctor then makes a motion to the medical staff for a vote of no confidence. Wolff, superbly played by Juliet Stevenson, one of The U.K.’s best actresses and an Olivier Award winner, instead resigns. 

A few days later, Wolff appears on a television program, grilled by a panel that includes an anti-abortion advocate and a post-colonial studies scholar, all of whom attack her. We then learn that the priest, though played by a white actor, John Mackay, is in fact black, raising issues concerning racial bias. The panelists accuse her of hiring whites and Jews, instead of people from other groups. Wolff responds that she always seeks to hire the best possible candidates. In the course of defending herself, she explains that she is open-minded and is, in fact, friends with a transgender adolescent who comes by her house to do homework. 

Given the public outcry, the government launches an investigation and removes Wolff’s medical license. The transgender youth accuses Wolff of having outed them to their parents without their permission. 

In the end, the priest visits Wolff, who comes to realize the need for medical humility and the fact that medicine and faith are each important in their own ways. She sees, too, that she could have asked the dying girl whether she wanted to see the priest. 

Vividly dramatized, these scenes make the audience feel and experience the pain of these conflicts among medical staff, patients, patients’ families, hospital administrators, clergy, the government, and others. The play powerfully illustrates how doctoring involves more than science, but also requires sensitivity and communication. In today’s world of multibillion-dollar budgets and social media, a hospital director needs to hear and be sensitive to multiple voices and constituents. 

The crisp and fast-paced script contains wonderful lines. One doctor comments that in hospitals “development” used to refer to human growth, not raising funds, and that he thought that patients who were “donors” referred to organ donors, not those who gave money. 

The production is valuable in showing how key bioethical issues can be dramatically and potently presented to a broad audience, transporting us, and enabling us to see situations through others’ eyes. The more such issues are conveyed to the wider public, including providers, patients, clergy, and government officials, the more sensitive to biases and false assumptions, we all will be. 

​Robert Klitzman, MD, is professor of psychiatry and director of the masters of bioethics program at Columbia University, a Hastings Center fellow, and the author of When Doctors Become Patients.

[Photo: Juliet Stevenson and Juliet Garricks in “The Doctor,” Park Avenue Armory, 2023. Photo credit: Stephanie Berger Photography/Park Avenue Armory]

Government is Not Our Doctor sign

Bioethics Forum Essay

Keep Politics Out of State Medical Policy

by Jessica A. Rosh and Michael J. MurphyPublished Posted in Hastings Bioethics Forum

State medical boards and other government-appointed health officials have an obligation to follow evidence-based medicine to frame their opinions and regulations. However, there is disturbing evidence that, in some cases, political ideology is guiding health policy.

For example, last year the Florida State Medical Board and the Florida Board of Osteopathic Medicine banned gender-affirming care for transgender youth, going against recommendations from medical groups such as the American Association of Pediatrics and the American Medical Association. On June 6, a federal judge issued a preliminary order partially blocking the ban, which had been signed into law.

The Indiana attorney general recently filed a complaint with the state medical board against an obstetrician-gynecologist who spoke with a reporter about an abortion she provided for a 10-year-old rape victim who traveled from Ohio after that state banned most abortions after six weeks of pregnancy. While the state medical board dismissed several of the accusations by the attorney general, it found that the doctor violated the patient’s privacy rights, even though the board also found that none of the information shared with the reporter was protected under HIPAA, the federal health privacy act. The board fined the physician $3,000 and issued a letter of reprimand. The medical board’s decision may well have a chilling effect on doctors in other states where abortion is legal.

Members of state medical boards are appointed by governors and, in some states, also require senate confirmation. As such, membership is inherently political. There is no national or federal oversight of state medical boards to assure that their decisions are not political. But they have a professional obligation to make decisions and recommendations supported by evidence-based medicine, regardless of political affiliation or personal ideology. Genuine disagreement about health policy inevitably occurs among medical professionals, and when this happens, they have an ethical duty to identify a problem or issue, gather credible data, perform appropriate data analysis, and devise an evidence-based strategy for addressing the issue.

Professional medical organizations have voiced concern when state legislation and regulations are inconsistent with accepted standards of care. The AMA wrote a letter to the National Governor’s Association about state legislation banning gender-affirming care, saying, “We believe this legislation represents a dangerous governmental intrusion into the practice of medicine and will be detrimental to the health of transgender children across the country.”  In a statement on its website the AAP warned, “Evidence-based medical care for transgender and gender diverse children is a complex issue. Pediatricians are best able to determine what care is necessary and appropriate for these children, but these bills [prohibiting gender-affirming care and forbidding transgender youth from participating in sports according to their gender identity] interfere in the physician-patient-family relationship and would cause undue harm.”

Among the many lessons from the Covid-19 pandemic is that the politicization of health policy  contributes to mixed messaging and misinformation and decreased public trust in health officials. But the intrusion of politics into state medical information on Covid persists. A recent report found that Florida’s surgeon general selectively eliminated data that would help the public understand the importance of vaccination against Covid. This manipulation of public health information was based on ideology, not evidence.

State officials who use state medical appointees as an extension of their political power harm the public, compromise trust, and do a disservice to the profession of medicine. Medical societies have a professional duty to illuminate the politicization of medicine and expose poor public health policy. So do bioethicists, as was recently pointed out in this publication. We call on bioethicists and professional medical organizations, including the Federation of State Medical Boards, to stay vigilant and speak out against harmful medical policies enacted by state medical boards and other government-appointed health officers under the influence of political ideology.

Jessica A. Rosh, JD, MBE, is an instructor of medical ethics at New York Medical College, an educational consultant for the Benjamin Ferencz Institute for Ethics, Human Rights and the Holocaust, and a doctoral candidate in bioethics, health ethics, and policy at the Alden March Bioethics Institute at Albany Medical College.

Michael J. Murphy, PhD, is a State University of New York Distinguished Teaching Professor Emeritus, a member of the SUNY Distinguished Academy, and a doctoral candidate at Alden March Bioethics Institute.

dying woman with daughter

Bioethics Forum Essay

Hospice and Medical Aid-in-Dying: Addressing an Unethical Disconnect

by Gianna R. Strand, David N. Hoffman, Karin Sobeck and Sarah J. Kiskadden-BechtelPublished Posted in End-of-Life Care, Hastings Bioethics Forum

Most patients who die with medical aid in states where the practice is legal are enrolled in hospice, but coordination between those providing hospice care and those providing medical aid-in-dying (MAiD) is woefully inadequate. Many hospice facilities have policies against supporting patients who request MAiD and do not disclose these policies to prospective patients, even in states where disclosure is required. Knowing what interventions are available is a fundamental component of ethical medical care, especially at the end of life when selection of an appropriate hospice can make a big difference.

Reports from California and Washington describe patients struggling to find providers, pharmacies, and hospice facilities that will accept them after they have requested MAiD. We recently completed a study that illuminates the scope of this problem by assessing compliance with a California law, S.B. 380, that requires health care facilities to post their MAiD policies on their websites. Our research reveals that roughly 60% of hospice facilities fail to comply with the law. Among the facilities that made their policies publicly available, we found significant variations in the clarity of communication about how MAiD requests would be addressed.

These findings are concerning because of the interconnectedness of MAiD and hospice care. In 2021, 91.6% of Californians who died following ingestion of aid-in-dying drugs were enrolled in hospice or palliative care. Washington and Oregon have reported similar data. It seems that many patients enroll in hospice after they first request MAiD – a Kaiser Permanente study in Southern California found that as few as 48% of patients were enrolled in hospice when they first requested MAiD. Patients deserve to know whether a hospice facility will support their wishes.

Our research identified other concerning information. Numerous hospices  require patients who wish to pursue MAiD to be discharged and transferred to another facility. These patients risk delays in accessing MAiD, extending their suffering. In addition, two facilities in our review used inaccurate or misleading terminology for MAiD. One facility used the term “provider-hastened death” and stated that it encompasses euthanasia. Euthanasia is different from MAiD and is illegal throughout the U.S. Preliminary data from the next phase of our research, which reviews policy transparency of health care facilities in all jurisdictions in the U.S. where MAiD is legal, has identified the same problems found in our California study.

We urge all health care entities in jurisdictions where aid-in-dying is legal to post their aid-in-dying policies in a readily identifiable location on their websites. Policies should use accurate, unbiased, easy-to-understand language. Disclosing this information on facilities’ websites is necessary, but not sufficient. It leaves the burden of responsibility on an individual to know where and how to find it. Facilities should take extra steps to ensure that this information is not merely posted but is received and understood by patients. One way this can be accomplished is to require disclosure of a MAiD policy during admission discussions with prospective patients. Another option is providing patients and their family members with explicit direction to the online policy at the time of hospice intake with nursing staff. This would ensure justice and equity in access to information.

As our research and advocacy continue in this area, we welcome further debate and discussion on improving access to accurate and transparent information for patients considering “life-ending” care.

Gianna R. Strand, MS, DBe, is a postdoctoral researcher in health policy and research ethics. She is the director of research at the Completed Life Initiative. @completedlife

David N. Hoffman, JD, is an assistant professor of bioethics at Columbia University and a clinical assistant professor of bioethics at Albert Einstein College of Medicine. He is a board member of the Completed Life Initiative. @ethicsoncall

Karin Sobeck, RN, MSN, MSBe, is a transplant coordinator and faculty teaching associate at Columbia University, and former chairperson of the National Hospice Organization.

Sarah J. Kiskadden-Bechtel, MSBe, is the program director at the Completed Life Initiative and a faculty teaching associate at Columbia University. She is editor-in-chief emeritus of the journal Voices in Bioethics. @skb_bioethics

All authors are members of the Empire State Bioethics Consortium. @NYSBioethics

OTTAWA, ON - JANUARY 28: Henry Morgentaler. Victory salute: A beaming Dr. Henry Morgentaler salutes victory at a press conference after a Supreme Court decision ended his 20-year battle with Canada's abortion law. The court, in a 5-2 decision, ruled it violates the Charter of Rights and Freedoms' guarantee of security of the person. (David Cooper/Toronto Star via Getty Images)

Bioethics Forum Essay

A Model of Conscientious Objection to Abortion Bans

by Dena S. DavisPublished Posted in Abortion, Conscience Clauses, Hastings Bioethics Forum

With the fall of Roe v. Wade a year ago, many states have passed laws criminalizing abortion in full or in part, making it difficult or impossible for health care providers to give proper care for the people whom they are supposed to serve. This dramatic turn of events is not new; it merely exacerbates a trend that has been growing for some time. For decades, several states have required clinicians who perform abortions to give inaccurate medical information to patients, a clear violation of basic medical ethics and standards of care. Many clinicians have  followed their conscience to find ways to provide good care within the confines of these mandates. 

Conscientious objection goes both ways, as Kimberly Mutcherson pointed out recently at the Hastings Center Fellows annual meeting.  We are used to thinking of health care providers who refuse on grounds of conscience to participate in aspects of medical care. But conscientious objection can also be the act of insisting on providing care. Margaret Sanger and others did this in the days when providing contraceptives was illegal. We owe the groundbreaking case of Griswold v. Connecticut, which upheld the right of married couples to use contraceptives, to Dr. C. Lee Buxton, professor at Yale Medical School, who risked arrest, fines, and damage to his career by providing contraceptives in defiance of the law.

Less well known for practicing medicine conscientiously in defiance of the law is Henry Morgentaler. Morgentaler (above) was a Polish Jew who born in Lodz in 1923. His father was murdered by Nazis soon after the German invasion of Poland. Henry’s older sister had moved to Warsaw, where she and her husband were killed fighting in the Warsaw ghetto uprising. The rest of the family was incarcerated in the Lodz ghetto. When the ghetto itself was raided, 19-year-old Henry hid with his brother and mother. They were discovered after two days; their mother died in Auschwitz. The brothers were shipped to Dachau. When Henry and his brother were liberated in 1945, Henry weighed 71 pounds.

After the war, Henry settled in Québec, earning his medical degree in 1953. Considering the horrors of his early life, one might have expected Henry to settle gratefully into a placid existence, practicing family medicine without making waves. However, in 1967, he stated publicly that women should have the right to abortion, when was then illegal in Canada. He began to receive increasingly desperate calls from women needing to end their pregnancies. He tried at first to refuse, or to refer them elsewhere, but soon the “avalanche” of requests overwhelmed him. He knew that women were dying from illegal abortions, and he felt “like a coward” for turning his back. He determined to help women and to challenge the law at the same time.

Morgentaler gave up his family practice and in 1969 he opened a clinic that provided abortions and contraceptives (also illegal at the time). He was tried three times between 1973 and 1975 for defying the anti-abortion law; each time he pleaded the defense of necessity and brought as witnesses some of the women he had helped. (In Anglo-American law, the necessity defense is invoked when the illegal behavior was necessary to avoid a larger harm, for example if one had stolen a car as the only way to rush a dying person to hospital.)  Each time the jury refused to convict him. Finally, the Québec Court of Appeal overturned the jury verdict and sentenced Morgentaler to jail. He was in prison for 10 months and suffered a heart attack while in solitary confinement. (In 1975, the Canadian Parliament changed the law so that an appellate court could not overturn a jury verdict.) 

Again, one could have expected Morgentaler to hand the torch to others. However, for the next 15 years he opened abortion clinics across Canada, challenging the laws in different provinces. In 1983 he was arrested again, this time in Toronto, where he again used the defense of necessity and was acquitted by the jury. The government appealed and his case reached the Supreme Court of Canada. In 1988 that court ruled that the restrictive abortion laws violated Canada’s Charter of Rights and Freedoms.

Morgentaler was forced to stop performing abortions after heart surgery in 2006, but he continued to oversee six clinics. In 2009, only four years before his death at age 93, he was working to open two private abortion clinics in the Canadian Arctic, to bring reproductive health to women who would otherwise have to travel huge distances. Among his many honors was the “Maggie Award,” from the Planned Parenthood Federation, named in tribute to Margaret Sanger. He was named a member of the Order of Canada in 2008.

The model of a towering hero such as Morgentaler can be overwhelming to us ordinary mortals. We think, “He’s a hundred times braver than I am,” and the gulf between us and him seems so huge that the default is to do nothing at all. Yet conscientious objection is something that an increasing number of us, laypeople and clinicians alike, are confronting. Texas has turned everyone into a potential bounty hunter, with the possibility of severe civil penalties to anyone who drives someone to an abortion clinic, lends a friend money, or babysits for her kids while she seeks an abortion. The Texas law and others like it include people outside the health profession in the challenge of how far we are willing to go to help women access reproductive care. But if a hundred of us are each a hundredth as brave as Morgentaler, imagine what we could accomplish.

Dena S. Davis, JD, PhD, is the endowed presidential chair in health and a professor of bioethics and religion studies at Lehigh University and a Hastings Center fellow.

smartphone in man's hands

Bioethics Forum Essay

Honoring My Friend’s Last Words

by Rafael EscandonPublished Posted in Hastings Bioethics Forum, Medical Aid-In-Dying

In the first season of the Netfix series “Never Have I Ever” we meet Devi, an overachieving Princeton-obsessed teenager returning to her Southern California high school after the sudden loss of her father. We learn, through flashback vignettes and John McEnroe’s voice-over, of Devi’s close relationship with her dad, and the post-traumatic stress that his sudden loss created. One of her most treasured possessions is a loving voicemail from him, which she plays when she needs encouragement. When her phone gets damaged, her despair at the prospect of never hearing her father’s voice again leaves her petrified.

I have a voicemail like that. It’s from a close friend of three decades whom I’ll call Simon. It came at 11:34 pm a few summers ago. I woke up, saw Simon’s name, looked over at my sleeping wife, and let his call go to voicemail. I still second guess that decision. I had no suspicion that this would be my last opportunity to speak with him.

Simon and I met at the gym and bonded over trail running, cycling, mountain biking, music, and microbrews. He was about 15 years older, an executive, while I was just starting my career as a clinical scientist and bioethicist. We had many talks over the years about the differences between norms and ethics, and I found him to be both wise and a little bit cynical. His depth of character, honesty, and pragmatism though, seemed only to exist in people in the movies. He achieved enormous respect and success in his career, and among his friends and family. He remains an inspiration to me.

In the early 2000’s we were both living in California, with some of the most spectacular running and biking trails on the continent, right out our doors. We took full advantage of the setting. Simon was very strong and not only kept up but pushed my group of friends, all of whom were 10 to 15 years his junior and very strong themselves. My friends loved him. They referred to him as a gentleman and an ambassador. Simon never missed a run, a ride, a race, or an opportunity for an IPA afterwards.

Late in the summer of 2015, Simon suddenly had trouble keeping up because of back pain. Undeterred, he went to yoga and Pilates, got PT, acupuncture, therapeutic massage–anything to get him back outside with us. Nothing worked. He stopped coming to runs and rides. And then to the social events that followed, and then he stopped returning my calls and texts. We lost touch.

The COVID-19 pandemic came. My wife and I moved to a place in Washington that Simon had always raved about. I called to tell him. He called me back the next day and apologized for the silence. His voice was hoarse and weak as he filled in the blanks about the last few years. Simon spoke of an enormous struggle and a lot of pain. He told me that when we were living in California, he had been diagnosed with an aggressive form of multiple sclerosis, a rapidly progressive and disabling condition. In addition to being in pain, he was utterly humiliated by the loss of strength, voluntary muscular control, and dignity. This is why he ended our contact. He apologized and explained that for someone so self-sufficient and so decisive, the thought of being dependent on others for assistance was unbearable. He mentioned a walker and that he was now forced to depend on his family for care.

I had a work colleague who was an expert in Simon’s condition, and he volunteered to call Simon to float the idea of joining a group for men with the condition. Simon embraced this initially, but his participation didn’t last long. He explained that since there were no therapeutic options for him, the pragmatism he refined in his corporate career made him impatient. Several more unanswered texts from me and another six months passed.

The next call I received was the 11:34 pm voicemail: “Hey; it’s Simon, I got your messages, it’s 8:30 in the morning here; I’m in Europe……(pause)….and I’ll say goodbye for the final time. So, you take care my friend. And, um, (pause) hopefully we’ll see each other again at some time. You be good and take care and be safe, Ciao.”

In our thousands of hours of conversations over three decades, we’d never discussed the topic of self-determination and what I came to learn was our shared belief in a right to responsibly determine one’s own fate. Simon knew I had training in bioethics, but he never asked me about anything to do with end-of-life issues. California, the state where he was living, had legislation permitting physician assistance in dying. But, in hindsight, I can see that someone as decisive as Simon would have found the process to be burdensome and full of paternalistic hurdles, including the requirement that a patient has a terminal illness with an estimated life expectancy of six months or less. When we did discuss his condition, Simon told me repeatedly about the magnitude of humiliation he felt because of the loss of his dignity, and the pain he felt when he imagined that his adult children, siblings, and friends would only remember him in his current condition. “It’s so fucking cruel,” he said. “No one can tell me when my last six months will begin or end, so I’m stuck.”

Had I taken his call, I fear I’d have walked him through the epistemology of why most state medical aid-in-dying statutes in the United States were constructed the way they were–the safeguards against depression influencing patients’ decisions, the conflicts with professional medical codes, liability, and on and on. There’s not a shred of doubt in my mind that his decision to go to Switzerland, which permits assisted dying with few restrictions, such as having a terminal illness, was made with full capacity. His impatience came from a deep understanding of his ultimate prognosis, and from decades of informed decision-making in his career. This was a proud person who took great care of himself his whole life and simply wanted to end his personal indignity and to unburden his family from present and future care obligations. He had reasoned through all the implications. His family was supportive of his decision and present when he died. At his memorial, everyone remembered Simon’s warm and sometimes cynical personality at peak health. There was no need to discuss his last few years.

Simon’s suffering, indignities, and burdens are now gone, all according to his terms. What greater respect can we offer to a person? I recognize that this was a best-case scenario, as Simon was a person of means, with full capacity, who could travel to Europe to have his wishes respected on a schedule he defined. That option is not available to many who suffer similar pain and indignity but have neither Simon’s agency nor means.

I’ll always feel like I missed an opportunity by sending his call to voicemail. In doing so, though, I hope his last thoughts of me were as a supportive friend. I like that a lot better than imagining his last encounter with me being one that prolonged his suffering by talking versus listening.

So, you take care my friend. And I sure do hope we see each other again.

Rafael Escandon, DrPH, PhD, MPH, HEC-C, is a consultant in research ethics and clinical R&D to the biotechnology industry in Bainbridge Island, Wash.

Illustrative image for We Have Met the Enemy and It Is Us

Bioethics Forum Essay

We Have Met the Enemy and It Is Us

by Arthur CaplanPublished Posted in Bioethics, Covid-19 Ethics Resource Center, Hastings Bioethics Forum

In 1978, I was doing a rotation at New York Presbyterian Hospital of Columbia University. I was there as a “special student,” having gotten permission from some higher ups to learn something about medicine. I was staring through an ophthalmoscope into the eyeball of a patient who had papilledema, swelling of the optic disc due to intracranial hypertension. As I left the room with a group of third-year medical students, someone asked if we needed to disclose our status as students to the patients before examining them.

How would I introduce myself—as a pseudomedical student who might go to med school if I decided not to pursue a career in medical ethics by completing a PhD in philosophy? I was sinking fast into a murky ethical swamp.

I need not have worried. The attending, a giant of clinical medicine, laughed and said no, followed by something pretty close to, “This is a teaching hospital. The approval of patients is not needed.”  And then we all moved down the corridor, secure in the belief that medical paternalism was alive, well, and unchallenged.

Except that not only was it about to be challenged, but to be knocked on its normative ass.

Tom Beauchamp’s and James Childress’ seminal text, Principles of Biomedical Ethics, was about to be published. They advanced four principles—the so-called Georgetown mantra. Autonomy was number one, and it meant patient autonomy. Fueled by a growing civil rights movement, a backlash against the view that patients could not understand their diagnoses and treatment options, and outrage over deluding vulnerable populations into participation in risky research, the battle against paternalism quickly became an all-out, no-holds-barred war to kill the paternalism ogre.

The hugely influential 1982 report from President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research affirming patient autonomy, Making Health Care Decisions: A Report on the Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship, was soon on many required reading lists for doctors, nurses, and medical students. Autonomy’s guardian, informed consent, was explored, refined, and promulgated in books, articles, law reviews, key legal cases, and major medical journals for more than a decade. Much advice was directed toward health care providers about how to improve communication with patients and how best to involve them in their care.

Revisionists will insist things were never this bad—that patient autonomy over all else was not what bioethics was saying throughout the eighties and well into the nineties. After all, even the Georgetown mantra had four principles. And there was real disagreement about the meaning of autonomy among bioethics thought leaders. Some rooted the value of autonomy in the need to respect people and their dignity. Most saw autonomy as the inherent right of individuals to exercise self-determination.

But, as is true of many conceptual shifts, the followers did not always listen to the nuances of the founders. Autonomy became oversimplified and distorted as it was taught in health care and health law.

Think I’m wrong? Just look at the evidence. If you are a bioethicist working in a clinical setting, you’re likely to hear doctors tell you that no matter how unusual, zany, or outright bonkers a patient’s wish may be, they have no choice but to follow it. “You bioethicists taught us that we have to respect patient autonomy” is the common justification. Only if the patient is a child or manifestly incompetent is there hesitancy and, even then, the hunt for the embers of autonomy is vigorous so that patient values can be honored.

Patient autonomy is great. But it is not the be-all and end-all principle to follow in all health care settings. Especially in lethal, airborne infectious disease pandemics.

American bioethics did little to explore public health ethics until the early 2000s, when thinkers arrived from other nations and brought other perspectives than those of empowered white men. But it was too late. As Covid swept through the globe killing millions a backlash grounded in the worship of autonomy quickly developed in the United States, as well as in other nations. Bioethicists barked about altruism and duties to others, but it was too little too late—the crude autonomy train had left the station.

Supreme Court Justice Neil Gorsuch nicely captured autonomy idolatry when, in a recent opinion, he condemned America’s pandemic response as one of “the greatest intrusions on civil liberties in the peacetime history of this country.” He wrote this opinion when the court rejected an appeal seeking to preserve Title 42, the pandemic-era public health measure implemented by President Trump that allowed the U.S, to quickly expel certain asylum seekers to prevent the spread of Covid. 

Gorsuch did not confine himself to Title 42. He went far afield to blast vaccine mandates and lockdown orders. Did he note that many of these measures were both initially necessary and temporary? No. He simply declared autonomy inviolate.

A deadly airborne pandemic requires attention to protecting the weak and the vulnerable. It demands responsibility for one’s community. It requires attention to justice and fairness in distributing tests, prophylactic interventions, and treatments. In other words, pandemics require attention to beneficence, compassion, solidarity, need, and justice—values that were often ignored in the war to crush medical paternalism at the bedside.

Almost no one in the early fight to buck medical paternalism in the doctor-patient relationship was thinking about public health. Modern bioethics got started in the hospital at the bedside, often focusing on very sick patients. Decades later, public health demanded bioethical attention– as the morgues filled, those in nursing homes died in droves, vaccine refusers filled ICUs, and mask refusers told the immune-suppressed to leave them alone and protect themselves it was too late.

Though some bioethicists issued guidance on fair allocation of scarce resources, bioethics as a field could not control unfettered autonomy to defend what rightly needed to be done in the Covid pandemic. Bioethics was hardly the only field or disciple to fail the world during the Covid outbreak. In getting ready for the next pandemic there is a lot of ethical work and persuasion to be done to ground a broader response than to follow individual autonomy.

Arthur Caplan, PhD, is the founding head of the Division of Medical Ethics at NYU Grossman School of Medicine. He is a Hastings Center fellow and a member of The Hastings Center’s advisory council. @ArthurCaplan

distressed male patient with hospital employee

Bioethics Forum Essay

Bioethicists and Health Care Institutions Must Act Against Florida’s Anti-Immigrant Law

by Mark G. Kuczewski and Kenneth W. GoodmanPublished Posted in Hastings Bioethics Forum, Health and Health Care, Health Policy & Equity, Immigrants

It is the recurring nightmare of bioethicists and all who are concerned with the humaneness of the healing professions that we might unwittingly sleep through subtle changes that erode the mission of our health care institutions. As a result, many people in bioethics and health care are sounding the alarms about artificial intelligence and how it might incorporate algorithms that increase health inequities. One simply wouldn’t want to sleep through such impactful changes and let them become the new normal.

But Florida’s new anti-immigrant law, SB 1718, has escaped widespread notice, despite the way it will undermine the mission—and core identity–of not-for-profit hospitals as caring institutions that promote the health of the community. SB 1718, which will take effect on July 1, is best known for its provisions regarding driver’s licenses and employment. However, it also requires a hospital that accepts Medicaid to “include a provision on its patient admission or registration forms for the patient or the patient’s representative to state or indicate whether the patient is a United States citizen or lawfully present in the United States or is not lawfully present in the United States.” (Section 395.3027; 255-260).

To try to defuse resistance to this measure, the law adds, “The inquiry must be followed by a statement that the response will not affect patient care or result in a report of the patient’s immigration status to immigration authorities” (Section 395.3027; 260 -262). In short, SB 1718 enlists hospitals in discouraging undocumented immigrants from seeking care. It effectively deputizes hospitals as a new and toxic branch of social control and law enforcement. This is an unprecedented role for nonprofit health care, and the lack of resistance to accepting the role is unprecedented, as well.

Hospitals and health systems have had to consider how to fulfill their patient care obligations in the increasingly anti-immigrant environment that has evolved in the U.S. over the past 40 years. Because undocumented immigrants are ineligible for all federal benefits, such as Medicare and Medicaid, this population has a high rate of uninsurance. Not-for-profit health care systems have had to consider how to treat these patients in a way that is consistent with their long-established values as caring institutions that efficiently deliver care and promote the health of the public. As a result, hospitals have had to find innovative ways to use charity care resources and partnerships with providers, such as federally qualified health centers, to encourage patients to seek care when appropriate and discharge them in ways that are supportive rather than fear-producing.

This sense of goodwill and trust between hospitals and this population enables care to be provided before a patient’s illness has progressed. Moreover, as the COVID-19 pandemic demonstrated, it is also vital to the health of the community that patients trust information from their health care providers and that they seek preventive care and follow preventive measures. The connectedness of all of our health statuses was so apparent early in the pandemic that it briefly promised to transform our thinking. It became clear that our health statuses are far more connected than our citizenship statuses.

Any measure that risks driving patients away from needed care is a risk to public health and undermines community trust. It takes the failure to address immigration challenges adequately and then injects that failure into the clinician-patient relationship.

Moreover, the notion that undocumented residents pose an unacceptable burden to our health care systems reflects a policy failure that turfs responsibility to individual health care institutions. If such residents are frightened to go to the hospital for, say, dialysis, then the institutions will often later have to eat the charges for treating their emergency hyperkalemia. And in Florida’s largest community, Miami-Dade County, all residents, documented or not, pay sales tax that supports the county’s Public Health Trust, a safety-net system of four hospitals and other facilities that has long provided excellent care for all patients, without any litmus test to assess their worthiness.

Nonprofit hospitals and health systems have lived and advocated for these values regarding undocumented patients for several decades in fairly public ways. For instance, hospitals successfully advocated to be designated as sensitive locations exempt from routine immigration enforcement actions during the Obama administration. When patients’ fears increased during the Trump administration, many health systems in areas with significant immigrant populations adopted institutional policies and actions designed to mitigate the risks and reassure their patients. It is strange and disheartening that so little should be said when Florida, a large state with a significant immigrant population, requires its hospitals to participate in an action that is clearly designed to create fear among immigrant patients and their families and potentially prevent them from seeking needed care in a timely fashion. Perhaps even worse, it risks recasting the identity of hospitals from caring institutions to places to be feare in the minds of immigrants. As we know from other health care atrocities, such a legacy can have a negative impact long into the future.

So, what should we do? While there is no definitive list of actions to be taken, some things seem clear, and others are worth considering.

First, every health care and bioethics professional society and major membership organization should issue a statement that this data collection requirement goes against the core values and established practices of its professions and institutions. Bioethicists should lead the way through our own professional organizations, such as the Association of Bioethics Program Directors, and by leveraging our relationships with medical and health care organizations to encourage them to issue public statements that make clear the professionally damaging nature of this law and advocate for its repeal.

Second, hospitals and health systems in Florida should develop strategies to minimize the impact of this requirement. This will require courage, as the state has sought to intimidate them by tying this requirement to their Medicaid funding. Nevertheless, appropriate responses might include strong actions, such as hospitals and health systems banding together to resist implementation through defiance. For example, they might agree not to include the citizenship status question in the registration process. Less dramatically, hospitals might comply with the law and include the citizenship question, but recommend that patients exercise their option to decline to answer it. Indeed, the bravest institutions will signal that option at every opportunity.

To be clear, there is no playbook that guarantees success when the identity of organizations and professions is threatened by extremist politics. However, to acquiesce silently to such threats means that their identity has already been corrupted.

Mark G. Kuczewski, PhD, HEC-C, is the Michael I. English, S.J. Professor of Medical Ethics and director of the Neiswanger Institute for Bioethics at the Stritch School of Medicine, Loyola University Chicago. He is a Hastings Center fellow.

Kenneth W. Goodman, PhD, FACMI, FACE, is Professor of Medicine and founder and director of the University of Miami Miller School of Medicine’s Institute for Bioethics and Health Policy and director of the university’s Ethics Programs. He is a Hastings Center fellow.

Asian patient and family in hospital

Bioethics Forum Essay

Medical Interpretation in the U.S. is Inadequate and Harming Patients

by Riya Dahima, Melinda Luo and Vrushali DhongadePublished Posted in Hastings Bioethics Forum, Health equity and racial justice ethics

Over the past few decades, many major cities in the United States have become more diverse and gained more residents with limited English proficiency. Health care systems have attempted to accommodate these residents, but their medical interpreter services are inadequate and inefficient. The results can be delayed emergency care for children, an increase in medical errors and health care costs, and a decrease in care quality and patient satisfaction.

There is a shortage of in-person medical interpreters. To compensate, hospitals have turned to machine translation tools. However, these tools, such as Google Translate, are more accurate for some languages than for others. One study that compared the accuracy of Google Translate for Spanish and Chinese found that it was less accurate for Chinese and that Chinese mistranslations were more likely to pose clinically significant and life-threatening harm. Google Translate supports Mandarin, but does not include Cantonese, a Chinese language spoken by over 70 million people worldwide and 43.6% of LEP residents in San Francisco.

 Limitations in the number of languages supported result in unequal access to accurate translation services and a lack of inclusivity for patients. Patients without accurate translation services can’t describe their symptoms effectively. And, when they are discharged from the hospital, LEP patients are more likely than English-speaking patients to be readmitted. The reason for their readmission is not illness, but rather poor communication.

A lack of cultural sensitivity can cause a further disconnect in patient-provider communication and trust. For example, a 2022 study suggests that Hmong patients with LEP prefer having family members, instead of a professional interpreter, translate for them, which would be important to consider in hospitals with high Hmong populations, such as those in the Minneapolis-St. Paul metro area. However, ad-hoc interpreters, such as family and friends, cannot always accurately translate medical terminology. By contrast, Spanish-speaking Latinx patients report a preference for professional interpreters since they sometimes note feeling uncomfortable sharing confidential information in the presence of family and friends.  

Hospitals conduct Community Health Needs Assessments (CHNAs) to analyze data regarding both their patient population and their city’s population. These assessments assess the social determinants of health and partner with community organizations and residents to combat health inequity. This includes running focus groups and gathering data on race, ethnicity, language, and nativity of the surrounding area, with an emphasis on their priority neighborhoods.

But the improvements to interpreter services outlined in each hospital’s CHNAs are vague and lack structure. Merely suggesting  “increased access to interpreter services” is a common but insufficient solution. Studies show that even when interpreter services are made accessible, clinicians still underuse them. One barrier cited is technical difficulty with interpretation technology.

Health systems can better utilize demographic data to allocate funding towards interpreter services that meet the needs of their patient populations. For example, Tufts Medical Center is the main health care provider for Boston’s Chinatown, where most of the non-English speaking population speaks either Cantonese or Mandarin. Therefore, it may be beneficial for this medical center to steer away from machine translation tools like Google Translate and have both family members and professional interpreters work together to communicate medical information.

However, even if a hospital employs a large team of professional interpreters, its interpreter services may not meet patients’ needs. That’s because, in addition to language concordance, effective communication requires cultural competence. Hospitals should promote cultural competence by investing in diversity training—and by making key improvements in that training. Diversity training in hospitals tends to be too general; the solutions suggested for addressing inequality are ambiguous and nonspecific. Including focus group responses from  residents would provide more concrete recommendations to improve cultural competence. CHNA data should also be incorporated into new employee orientations, which are mandatory and already include diversity training components. Furthermore, these orientations offer an opportunity to train staff on how to best utilize available interpreter services.

Expecting patients to adhere to Western constructs of health communication is unfair and unjust. We must consider how linguistic differences and cultural values impact patients’ expectations and decision-making. By tailoring translation services to their LEP populations, health care systems can improve the quality of care for each of their unique and diverse patients.

Riya Dahima is a senior at Northeastern University majoring in behavioral  neuroscience and research student at the Dhand Lab at the Brigham and Women’s Hospital.

Melinda Luo is a senior at Northeastern majoring in  biology and psychology, and a research student at the Dhand Lab at the Brigham and Women’s Hospital.

Vrushali Dhongade, MBBS, MS, MBE, is the Project Manager in the Dhand Lab at the Brigham and Women’s Hospital. (@vrush_25)

injured Black woman lying in the street at night

Bioethics Forum Essay

Legalized Medical Discrimination Violates Medical Ethics

by Craig KlugmanPublished Posted in clinical ethics, Conscience Clauses, Hastings Bioethics Forum

Florida Governor Ron DeSantis recently signed SB 1580, a bill that that shields health care providers, institutions, and insurers who decline to treat patients or refuse to pay for care when they have “conscience-based objections” meaning “sincerely held religious, moral, or ethical beliefs.”

Under this law, a physician who fervently believes in the danger of vaccines could refuse to give them. A physician could also refuse to prescribe contraception by stating a religious opposition to it. And an insurance company could deny coverage for gender-affirming care because of its leaders’ sincerely held conscience-based objections. The law not only buffers health care workers and companies from civil lawsuits, but also prevents any state agency or licensing board from taking action against them. 

In short, the law permits health care workers and institutions to discriminate against their patients and potential patients without any limits or protection for patient well-being.

Such a law flies in the face of medical law and ethics. This legislation is a perfect example of what I teach my students, that sometimes what is legal and what is ethical are very different things.

For a health care worker to use such a power violates beneficence and nonmaleficence since depriving someone of medical care on arbitrary grounds harms the patient’s autonomy as well as their physical and mental health. SB 1580 also breaches justice in the Aristotelean sense of “treating likes alike,” since the entire purpose of the law is to permit discrimination.

The American Medical Association Council on Ethical and Judicial Affairs has written that doctors have the right to follow their moral conscience, but within limits: “Physicians are expected to provide care in emergencies, honor patients’ informed decisions to refuse life-sustaining treatment, and respect basic civil liberties and not discriminate against individuals in deciding whether to enter into a professional relationship with a new patient.” That means they cannot decline “to provide care in emergency situations when no other qualified professional is available, discriminating against patients, imposing care against a competent patient’s informed refusal” all of which would be legal under Florida’s new law.

The World Medical Association’s International Code of Medical Ethics states, in principle 2, “The physician must practise medicine fairly and justly and provide care based on the patient’s health needs without bias or engaging in discriminatory conduct on the basis of age, disease or disability, creed, ethnic origin, gender, nationality, political affiliation, race, culture, sexual orientation, social standing, or any other factor.”

Beyond conflicting with both U.S. and international medical ethics, Florida’s new law also raises potential issues with federal law. An example is the 1986 Federal Emergency Medical Treatment and Labor Act (EMALTA), which requires Medicare-participating hospital emergency departments to screen and stabilize patients who request examination or treatment for an emergency medical condition, regardless of their ability to pay. On one hand, SB 1580 says that it “may not be construed to override any requirement to provide emergency medical treatment,” but, on the other hand, it also says that health care workers who “exercise their moral conscience” cannot be punished or even reported.

Some people might think that this is simply a local Florida issue. I argue that this bill is likely to be a model for other states whose legislatures share its repressive, anti-autonomy principles. As we have seen in the year since the Dobbs decision and in the half decade since the first anti-trans bills appeared in North Carolina, the restrictive law that one state passes is often adopted by several surrounding states. Florida may be the first, but it will not be the last place to pass legal medical discrimination.

So, what do we do against such inhumane and dangerous laws?

From a health professional standpoint, any physician unethically refusing to treat a patient should be brought up for review for violating the AMA Code of Conduct. If the offending health care worker has a license in Florida and in another state, they should be brought up on professionalism charges under the other state’s licensing board.

Congress can pass a law and the White House can press federal agencies to issue regulations that threaten to withhold federal funding for any medical institution that permits this discrimination. If a hospital or an insurance company refuses to treat gay people, or trans people, or people of color, then they would lose all federal dollars.

As patients and their families, we can refuse to remain under the care of any hospital or health care provider who exercises discriminatory, anti-patient powers under this bill. Of course, insurance companies often dictate where one goes for care, so this action has limits. We can also lobby our employers to drop any insurance plan that supports or follows this legislation.

As bioethicists, we should immediately refuse to hold any meetings or events in states that adopt such policies and laws. The argument can be made that those who would be punished by this action—the hotels, transportation drivers, restaurants, and the low-wage staff who work in the travel industry—would be the most affected, which is true, but these meetings generate tax revenue, and we should refuse to financially support a state that adopts such inhumane laws. We can also write letters and op-eds against these laws and write amicus briefs in support of the inevitable lawsuits that will challenge these statutes.

As citizens, we should vote against the legislators who pass and governors who sign these bills. And we should run for office in local (school board, municipal boards, city council, mayor), county, state (legislature, governor, judge), and federal (congressional, presidential) elections.

As educators in the clinic and the classroom we can advance the message that all patients are deserving of care. When that student in the lecture hall inevitably asks, “My religion says that being X is wrong, how can I keep my beliefs and still be a practicing health care provider?” We can let them know that the ethics of their profession overrides their personal biases and that if they can’t provide care for everyone, they should find a new profession.

[This essay has been updated.]

Craig Klugman, PhD, is the Vincent de Paul Professor of Bioethics and Health Humanities at DePaul University. @CraigKlugman

doctor pointing to tablet with medical image

Bioethics Forum Essay

For Ethical Use of AI in Medicine, Don’t Overlook Maintenance and Repair

by Kellie OwensPublished Posted in Artificial Intelligence, Hastings Bioethics Forum

Last month, Microsoft and the electronic health records vender Epic announced that they would partner to use generative artificial intelligence in online portals to help doctors answer patient’s questions. This project added to the growing examples of AI being used in medicine, raising ethical concerns about how to equitably and effectively implement these tools.

A number of federal institutions have provided frameworks for thinking about the ethical integration of AI in society, most notably the White House Office of Science and Technology Policy’s “Blueprint for an AI Bill of Rights” and the National Institute of Standards and Technology’s “Artificial Intelligence Risk Management Framework.” Both documents outline the persistent and pervasive challenges of automated systems in our society and propose protections for individuals under the jurisdiction of these systems.

While these documents are a welcome step forward, their real power will be in their execution across a range of domains. How should our health care system apply the “AI Risk Management Framework” and the “AI Bill of Rights” to assure the accurate and ethical use of AI tools? How can these two frameworks help us manage the firehose of new automated systems at our disposal? I urge attention to an often-overlooked piece of the puzzle: the maintenance and repair of these powerful tools over time to improve them in practice, including to detect and eliminate bias.

Concerns about bias, fairness, equity, justice, and privacy with AI and machine learning models that identify key patterns from clinical datasets are well documented. Many of them encode and reinscribe longstanding health inequities. In a particularly egregious case, one widely-used algorithm for distributing health resources prioritized white patients over Black patients, “reducing the number of Black patients identified for extra care by more than half.” Some creators of AI/ML models recognize that overlooking the performance of their tools across a variety of subgroups over time has led to significant harm and are seeking to build fairness and equity into the design of new models. Yet they often center this assessment solely on the moment of initial deployment—focusing more on innovation than sustainability over time. While this work is critical to preventing harm, it is insufficient to expect that all potential harms of AI/ML models can be anticipated in the design phase, even with robust ethical and technical reviews.

Health care is a setting where change is expected—model performance and impact evolve over time or in new contexts. Researchers have found, for example, that even small shifts in data can lead to debilitating declines in the performance of AI/ML models used to predict risk of health complications or length of hospital stay. Most notably, a sepsis prediction model became no better than a coin flip, suggesting that patients may often be subjected to the “ineffective systems” that the AI Bill of Rights seeks to eliminate. Problems related to dataset shift can occur for many reasons, including changes in technology, population, or behavior (prompted, for example, by new reimbursement incentives). Current regulatory frameworks from the Food and Drug Administration do not sufficiently grapple with the potential ethical and social implications of AI/ML model deterioration over time and in new settings, often requiring models to be “locked” or unmodifiable without additional review. While the FDA is developing a more sophisticated regulatory framework, its focus on safety and efficacy is not the same as a full analysis of the ethical and social implications of AI/ML models over their lifecycles. Because shifts in model performance may generate new inequities and harms, ongoing social and technical review of these models over time is essential, alongside mechanisms to redress harms caused by AI/ML models.

What might these maintenance systems look like? First, they will require material and human resources—health systems must recognize the importance of devoting time and money to maintaining AI/ML tools. Second, they must include substantive and sustained participation from a range of stakeholders, including developers, clinicians, ethicists, and patients. Next, they require clear delineations of responsibility for the utility and effects of AI/ML in health care. This could include, for example, establishing separate centers within health care systems that are devoted to ensuring good performance of AI/ML tools over time. Such centers could minimize the role of strategic ignorance, where institutions deny liability for harms caused by the tools that they use by claiming they had no way to know about them. Finally, these maintenance systems will require mechanisms for repair—both technical repair of poor model performance and societal repair of any harms done to communities and individuals under the jurisdiction of those models. While researchers have begun to identify specific harms of some AI/ML tools, little effort has been invested to repair the damage.

AI/ML tools have tremendous potential to streamline care, identify high-risk patients, and augment processes of diagnosis and treatment, but this potential will not be realized without systems of maintenance and repair. Our current approach of ad-hoc audits to assess continued performance of clinical decision support tools is missing critical inequities that patients should be protected from under “AI Risk Management Framework” and the “AI Bill of Rights.” Once a tool is broken enough to notice, it’s too late. Trust has been lost and harms are accruing.

The importance of evaluating, maintaining, and repairing health technology is not unique to AI/ML tools, but may be particularly crucial when models are opaque and the pace of innovation is rapid. Recent U.S. government guidance provides an opportunity to innovate new infrastructural solutions to support the equitable and fair use of AI/ML tools in health care. As the push for innovation increases, our interest in creating new models and applications should not blind us to the essential urgency of building new ways to support the systems already in place—improving our existing systems in service of their eventual successors. Without this infrastructure, we will never unlock the potential of AI/ML in health care, unwittingly contributing to destructive social inequities and denying patients the rights they deserve.

Kellie Owens, PhD, is an assistant professor in the Division of Medical Ethics of NYU Grossman School of Medicine. @_kellie_owens_

Illustrative image for Remembering James F Drane

Bioethics Forum Essay

Remembering James F. Drane

by Joseph J. Fins and Kaiulani S. ShulmanPublished Posted in Bioethics, Hastings Bioethics Forum

James F. Drane, a member of the founding generation of bioethicists, passed away on April 17 in Edinboro, Pennsylvania at the age of 93. He was a prolific writer, internationally recognized scholar, and trusted friend.

We both had the opportunity to meet Drane–or, as he was known to us, Jim–early in our careers in bioethics. One of us (JJF) first met him at a Pan American Health Organization (PAHO) conference in 1993 in Washington, D.C., where a common affection for Spain prompted an immediate friendship. Decades later, writing about the Christian ethicist James M. Gustafson’s role in the founding of bioethics, the two of us reached out to Drane to conduct an interview about his time studying with Gustafson at Yale in the late 1960s.

Though these encounters were nearly three decades apart, we were met with the same warmth and openness which characterized Jim’s friendships. At the PAHO meeting when Jim learned of Fins’s Sephardic roots in pre-Inquisition Spain, Drane–the former priest–was tolerant, ecumenical, and curious about the history of the Fins family and its diaspora. Years later, when we asked about his relationship with Gustafson, Jim spoke warmly about close familial ties with his mentor’s family. Indeed, in response to our paper “Before the Birth of Bioethics: James M. Gustafson at Yale,” Erik Gustafson wrote to us, “Grandpa saw all his students as intellectual family, and Jim Drane in particular is still referred to as a member of the family today.”

Drane was born in 1930, the oldest of 10 children in Chester, Pa. After graduating from high school in 1947, he pursued training at Little Rock College and the Gregorian University in Rome. Soon afterward, in 1956, he was ordained into the Catholic priesthood, following which he served as a language and philosophy teacher at St. John’s Seminary in Little Rock, Arkansas. He then pursued further graduate study at Middlebury College and the Complutense University in Madrid where he received a master’s degree in Spanish and a doctor of philosophy in ethics.

It was upon his return home, while serving at a hospital, that Drane experienced the tension between theology and pastoral care. In an interview, Drane recounted counseling a young couple struggling with their marriage. They asked for birth control because they could not support more children. Invoking his recent seminary training, Drane responded that “the nature of the sex organs was procreation.”While the husband understood, his wife did not. Days later, Drane learned from a Catholic sister that the marriage had ended. Drane credits this with his “reflection and reconsideration of the church perspective of basing sexual morality” on procreation. When another couple’s marriage dissolved over contraception, Drane felt “shocked and hurt because of my own inadequacy, and I decided to take the thinking I had developed, to the newspapers.”

Taking his views public led to his expulsion from the priesthood and removal as a seminary instructor. He soon landed at Yale and was given refuge by Gustafson. Soon thereafter he accompanied Dan Callahan for part of his travels to research global abortion policies. Following his return, Callahan established The Hastings Center in 1969 with Willard Gaylin.

Jim was a globalist with a keen interest in the Spanish-speaking world. Drane’s collaboration with Spanish physician Pedro Laín Entralgo was instrumental to the publication of Becoming a Good Doctor: The Place of Virtue and Character in Medical Ethics, and his friendship with Diego Gracia and others, fostered Ibero-American conversation, enriching the field. In 1990, while on sabbatical, Drane served as the first bioethicist at PAHO and helped to establish a Regional Bioethics Program based in Santiago, Chile, which would foster the field’s development throughout the Americas, translating a predominantly North American bioethics into a Latin American context.

Despite his peripatetic life in Latin America and Spain, Drane’s longtime academic home was at Edinboro University (now PennWest University). There he would teach generations of students and become a beloved member of the community. The University would honor Jim with the establishment of  the James F. Drane Bioethics Institute and an annual lecture, the last of which one of us was honored to give in Edinboro just three days before his death.

His influence is felt beyond Western Pennsylvania in the world of clinical ethics, where his reflections on a sliding scale of competence is regarded as a classic formulation. His work in virtue ethics informs professional formation and his articulation of a liberal Catholic bioethics is a touchstone for progressives who remain faithful in the Church.

Beyond these biographical particulars lay Drane’s immeasurable impact on his colleagues, students, and friends. He fostered ecumenical thinking and practice beyond the classroom and the bedside. His doctorate dissertation, entitled “The Foundations of Tolerance,” served as a touchstone for his consistent dedication to inclusivity. It is for this receptivity to the other, and his warmth, that he will be long remembered.

Notes received from colleagues in Spain speak to his enduring impact and the depth of the loss. Diego Gracia, the father of Spanish bioethics wrote that “Jim was like a brother to me.” If Jim was like a brother to Diego, he was like an American uncle to the entire Spanish bioethics community, which has honored him with the annual James F. Drane Lecture at the Complutense University in Madrid.  Lydia Feito, a professor at the Complutense, wrote to one of us that we have been left “orphans” with the progressive loss of the founding generation.

Drane was one of the remaining founders of our field. As we move toward the sixth decade of bioethics it is important that we understand our origins and engage in historical scholarship. We must remember the mentorship of those who came before us and emulate their generosity as we train the next generation.

Joseph J. Fins, M.D., D. Hum. Litt. (hc), M.A.C.P., F.R.C.P., is the E. William Davis Jr. M.D. Professor of Medical Ethics, a professor of medicine and chief of the division of medical ethics at Weill Cornell Medical College; Solomon Center Distinguished Scholar in Medicine, Bioethics and the Law and a Visiting Professor of Law at Yale Law School; and a member of the adjunct faculty at the Rockefeller University. He is a Hastings Center fellow and chair-elect of the Center’s board of trustees.

Kaiulani S. Shulman, B.A., recently graduated from Yale College with distinction in religious studies. She is a research assistant in the Division of Medical Ethics at Weill Cornell Medical College.

Francis Crick Institute London

Bioethics Forum Essay

What Happened to Concerns About Human Enhancement?

by R. Jean Cadigan, Margaret Waltz, Rebecca Walker, Rami Major and Incidental Enhancements Research GroupPublished Posted in Enhancement, Gene Editing, Hastings Bioethics Forum

Prominent science policy reports that set the stage for the recent Third International Summit on Human Genome Editing all raise questions about human enhancement. Enhancement concerns also consistently loom large in public attitudes on possible uses of these genomic technologies. It may seem surprising, then, that enhancement received little formal attention at the Summit. Instead, the Summit focused elsewhere–on issues of access to emerging forms of somatic cell genome editing for genetic disease. Here we report our observations on the Summit’s de-emphasis of enhancement questions and suggest some consequences of continuing this trend in subsequent science policy deliberations.

Despite its absence from the Summit’s agenda, the topic of genome editing for human enhancement did spontaneously bubble up at the meeting in interesting ways. On the first day, outside the Summit’s venue, London’s Francis Crick Institute,  protesters passed out pamphlets titled “Stop Designer Babies.” At first it seemed as if the protest would succeed in making enhancement an important topic at the Summit. In the opening session, Robin Lovell-Badge, chair of the Summit’s organizing committee, referenced the protesters and also noted the importance of the Crick Institute’s current exhibit, “Cut + Paste,” to capture public views on uses of genome editing. (The exhibit asks visitors to consider where they’d “draw the line” and “which human traits are desirable,” and to rate their views on using genome editing to enhance humans, with response options that range from “No way” to “Bring it On”).

Lovell-Badge also mentioned that during the Second International Summit on Human Genome Editing in 2018, he chaired the session where He Jiankui revealed his genome editing experiments on human embryos that resulted in the births of (at least) two children in China. Lovell-Badge called He Jiankui’s experiments, which endeavored to make the children resistant to HIV, “a form of enhancement.” He went on to describe recent news of a human gene therapy company established in Honduras that is investigating interventions to increase longevity and asked, “Are there any situations where enhancement might be reasonable, whether it is somatic or heritable genome editing?” He surmised that the question could not be answered just by those in attendance at the Summit, and needs broad public input.

Despite Lovell-Badge’s inviting opening questions, almost none of the Summit’s speakers explicitly addressed concerns about enhancement in their presentations. The major exception was Kelly Ormond of ETH-Zurich and Stanford University, whose presentation, “Hopes and Fears for Human Genome Editing,” focused on society’s conceptualizations of disability and disease and their relation to enhancement issues. Ormond cited studies eliciting views from members of the public, genome editing scientists, and other genomics professionals who all see enhancement as the most problematic potential use for human genome editing. Nevertheless, she concluded that human genome editing “is going to slide right into enhancement quicker than we think,” and that we should “begin to rigorously consider that sooner rather than later.”

Similarly, while he did not address enhancement in his presentation, Fyodor Urnov of the University of California, Berkeley, responded to a question from the audience about the prospect for enhancement by saying, “For somatic [editing], I’m going to say something very strong. There is no way to prevent CRISPR from eventually being used for so-called ‘human enhancement’.”

Despite the ways in which human genome editing for enhancement emerged as an unsolicited concern at the Summit, the organizing committee’s summary of the Summit made no mention of the topic. Yet even there, the topic asserted itself. In reading the summary aloud at the conclusion of the Summit, Lovell-Badge acknowledged the omission. After reading, “Governance mechanisms for human genome editing need to protect ongoing, legitimate research, while preventing clinics or individuals from offering unproven interventions in the guise of therapies or ways to avoid disease,” he paused to offer an aside: “And perhaps we should have added ‘or for enhancement.’ But this was written in a hurry, remember.”

From one perspective, it is understandable why the Summit’s agenda and summary did not focus on human enhancement. Such a discussion could have distracted attention from the Summit’s main purpose, which was to address issues of equity and access to therapeutic forms of somatic cell genome editing. By highlighting recent advances in genome editing for diseases like sickle cell anemia, speakers addressed the need to widen access to genome therapies across the globe. This focus is a distinct shift from the 2018 Summit, which was largely dominated by collective consternation over the premature heritable genome editing conducted by He Jiankui that some have labeled enhancement. Rather than harken back to that debate to discuss speculative enhancement concerns, it makes sense that the organizing committee chose to focus on the more immediate issues of justice raised by emerging somatic cell gene therapies.  

Moreover, there is a slipperiness to enhancement concerns that may have steered the organizing committee away from the topic. As an ethical and regulatory boundary, the distinction between therapy and enhancement has long been questioned, as detailed in the 2017 National Academies Press report on human genome editing. Both that report and the more recent 2020 report from the International Commission on the Clinical Use of Germline Genome Editing sidestep these conceptual issues by suggesting that concerns about enhancement are a matter for societal rather than expert decision-making, “informed by scientific knowledge but relying on value judgments” that can only come from the public. In a way, the choices of the 2023 Summit organizers reflect this stance, suggesting by omission that the scientific community has no special professional role in anticipating the issues that enhancement uses of genome editing will raise. 

The committee’s efforts to focus genome editing policy discussions on issues of equity and access to emerging somatic cell therapies are a welcome development. However, as Ormond, Lovell-Badge, Urnov, and the Summit protesters remind us, concerns over human enhancement persist. In fact, one of the main reasons the discussion of enhancement should remain on the scientific community’s anticipatory agenda is one that reflects the Summit’s main focus on equity and access: the worry that  even somatic cell enhancement will exacerbate inequities by widening welfare gaps between those who can afford it and those who cannot. In that context, as Lovell-Badge pointed out, the premature marketing of putative enhancement interventions will require oversight whether or not such uses are on the science policy agenda.

If, in the face of public concern, the scientific community absolves itself from anticipating such issues, it risks losing public trust in its ability to govern itself. Yet, as the 2020 International Commission report notes, it is the job of science to help inform such governance, just as science itself should interrogate its own value judgments and priorities. The 2023 Summit organizing committee exhibits such self-reflection in its efforts to concentrate on immediate issues of access and equity for gene editing therapies. We do not presume to know whether enhancement provides a reasonable ethical boundary for human genome editing. Our hope here is to put human enhancement, for all its slipperiness, back on the table for examination–socially, ethically, and in terms of science policy and discussion.

Jean Cadigan, PhD, is an associate professor of social medicine and a core faculty member in the Center for Bioethics at the University of North Carolina at Chapel Hill School of Medicine. With Eric Juengst, she currently leads a study on ethical and governance challenges of human genome editing research. Margaret Waltz, PhD, is a research scientist in the department of social medicine and Center for Bioethics at the University of North Carolina at Chapel Hill. Rami Major is a PhD candidate in genetics and molecular biology and student assistant in the department of social medicine at the University of North Carolina at Chapel Hill. Rebecca L. Walker, PhD, is a professor of social medicine and of philosophy at the University of North Carolina at Chapel Hill.  

In addition to the authors named above, research group members who contributed as co-authors to this commentary are John Conley, Arlene Davis, Michael Flatt, Gail Henderson, Eric Juenst, and Douglas Mackay. The research group is supported by grant number R01 HG010661-01A1 from the NIH National Human Genome Research Institute

woman life freedom demonstrators in Iran

Bioethics Forum Essay

Theocracy Is Closer Than It Appears

by Kiarash ArameshPublished Posted in Abortion, Hastings Bioethics Forum, Reproductive ethics

On a cloudy afternoon this month, in my home in western Pennsylvania, a headline catches my eye: A federal judge in Texas suspended FDA approval of mifepristone. This abortion-inducing drug has been on the market for more than 20 years. Although the decision is presented with a secular and legal façade, like other recent antiabortion court rulings and legislation, a solid religious motive is at play.

My memory takes me to another cloudy afternoon in the fall of 2008 in Tehran. In my medical ethics class for medical students, I was explaining secular philosophical arguments on the morality of abortion at different stages of embryonic development. A student raised her hand. Her hijab showed she was pro-government, an observing Muslim, or both. I let her speak. She said: “You are talking about the philosophical arguments on the morality of abortion. But human beings have a creator. And, like a manufacturer that issues a manual for the appliances it produces, our creator has sent a clear guideline for us to follow. So, isn’t it better to seek answers about abortion from that guideline rather than faulty manmade philosophies?”

That student was not asking a question. She was warning me politely. A decade ago, the founding leader of the Islamic Republic of Iran, Ayatollah Khomeini, in his will, asked Muslim students to rise up against professors who promoted Western ideas. His instruction was explicit: Ask the school officials to remove them. If they hesitate, act yourself!

Theocracy did not capture the political sphere of Iran overnight. The Islamists did not appear to be self-righteous and authoritarian at first. For decades before the 1979 revolution, leaders and theorists of political Islam tried to engage in secular arguments and prove the compatibility of their ideas with modern science and progressive ideologies. Even in the first months after the revolution, many argued that the Islamic Republic would not impose Sharia on the private spheres of people’s lives. They asserted that under an Islamic government, wearing a hijab would not be forced on women, and people opposed to the Islamic government, even communists, would be free to express their ideas. All these promises turned out to be false as soon as Islamists seized power. Since then, they have been imposing the “will of God” and the righteous way of life on people, especially women.

Like other proponents of religious biopolitics, Islamists are pro-natalists. Shortly after the revolution, Islamists in the government terminated all family planning programs. They banned abortion. Shortly thereafter, a more pragmatic sector of the government, alarmed by rapid population growth and the shortage of educational and health resources, tried to reinstate a new version of population control. In response to the high rate of illegal abortion, the Islamic parliament passed the Therapeutic Abortion Act in 2005. Under that law, abortion was permitted within the first four months of pregnancy if a pregnant woman requested it and three physicians confirmed a major fetal health risk or an unbearable difficulty for the woman because of her pregnancy.

However, these relatively liberal reforms were temporary. The subsequent dominance of more fundamentalist Islamists in the government prompted a reversal. On October 16, 2021, Ebrahim Raisi, the president of Iran,  signed  a new law titled “The Rejuvenation of the Population and Protection of the Family.” This law required abortion decisions to be made in a religious court rather than a medical clinic. While physicians must be consulted to approve the medical necessity of the abortion, the court, presided over by a male graduate of an Islamic seminary, makes the decision. It is not surprising that a few days ago, President Raisi expressed his concern about the high rates of illegal abortion in the country.

The current “Woman, Life, Freedom” movement is a new step in Iranians’ long and bloody journey to free themselves of religious biopolitics and regain their personal liberties. A theocracy, once looked upon as too far away to be concerned about, is now too strong to get rid of easily and without bloodshed.

In his book, Escape from Freedom, Erich Fromm gives a psychoanalytic expatiation of why human beings tend to obey a patriarchal figure rather than take the responsibility of making difficult autonomous decisions in a democracy. He explains how that human tendency was one of the reasons behind the fall of the culturally rich and civilized nation of Weimar Germany to the authoritarian dictatorship of Nazis.

Today, Western nations look at the tyranny of authoritarianism, from the Inquisition to Fascism, as if it is in the side mirror of their collective memory: events that happened too long ago to be of concern. However, objects in a car’s side mirrors are closer than they appear. A judge’s ruling in Amarillo, Texas, may soon have a bearing upon the reproductive freedom of women on New York’s Upper West Side.

That’s why in his masterpiece The Little Prince, Antoine de Saint-Exupéry warns inhabitants of planet Earth about the danger of baobab trees. “You must see to it that you pull up regularly all the baobabs at the very first moment when they can be distinguished from the rose bushes which they resemble so closely in their earliest youth.”

The metaphor is clear but worth making explicit. Ideologies such as religious fanaticism in the modern world are like baobab trees on a small planet. At first, they resemble flowers or fruit trees. However, if you keep ignoring their danger, they will become invasive enough to tear the whole planet apart. As a bioethicist who escaped Iran’s theocracy, it pains me to see the sprouting of baobab trees on America’s democratic soil, a country that has provided me with refuge and opportunity. As a grateful American citizen, I feel a duty to warn about the threat of religious biopolitics dominating the public sphere. I lived in the shadow of a baobab tree for too long. I prefer the sunshine of secular democracy.

Acknowledgment: The author of this paper would like to express his gratitude to Professor Joseph J. Fins for his helpful and constructive comments.

Kiarash Aramesh, MD, PhD, is a faculty member and the director of the James F. Drane Bioethics Institute at PennWest University in Edinboro, Pa.

doctor calculating medical bill

Bioethics Forum Essay

In Search of an Ethical Constraint on Hospital Revenue

by Lauren A. TaylorPublished Posted in Hastings Bioethics Forum, Medicine & Business

Last year, The New York Times detailed how Providence–one of the largest nonprofit hospital chains in the United States–had developed the “Rev-Up” program, a brainchild of the consulting firm McKinsey & Company, “to maximize revenues by wringing as much money as possible from [even the most indigent] patients.” Providence ultimately agreed to refund payments to over 700 low-income patients who were erroneously billed for health care that could have been covered by financial assistance policies.

A physician whistleblower came forward alleging that Detroit Medical Center, owned by for-profit Tenet Healthcare, refused to halt elective procedures in early days of the pandemic, even after dozens of patients and staff were exposed to a COVID-positive patient undergoing an organ transplant. According to the physician, Tenet persisted on account of the margin it stood to generate. “Continuing to do this [was] truly a crime against patients,” recalled Dr. Shakir Hussein, who was fired shortly thereafter.

Earlier in 2022, nonprofit Bon Secours health system was investigated for its strategic downsizing of a community hospital in Richmond, Va., which left a predominantly Black community lacking access to standard medical services such as MRIs and maternity care. Still, the hospital managed to turn a $100 million margin, which buoyed the system’s $1 billion net revenue in 2021. “Bon Secours was basically laundering money through this poor hospital to its wealthy outposts,” said one emergency department physician who had worked at Richmond Community Hospital. “It was all about profits.”  

The academic literature further substantiates concerns about hospital margin maximization. One paper examining the use of municipal, tax-exempt debt among nonprofit hospitals found evidence of arbitrage behavior, where hospitals issued debt not to invest in new capital (the stated purpose of most municipal debt issuances) but to invest the proceeds of the issuance in securities and other endowment accounts. A more recent paper, focused on private equity-owned hospitals, found that facilities acquired by private equity were more likely to “add specific, profitable hospital-based services and less likely to add or continue those with unreliable revenue streams.” These and other findings led Donald Berwick to write that greed poses an existential threat to U.S. health care.

None of the hospital actions described above are necessarily illegal but they certainly bring long-lurking issues within bioethics to the fore. Recognizing that hospitals are resource-dependent organizations, what normative, ethical responsibilities–or constraints–do they face with regard to revenue-generation? A review of the health services and bioethics literature to date turns up three general answers to this question, all of which are unsatisfactory.

Answer #1: The first, and least inspiring, answer is that hospitals have only a responsibility (only!) to obey the law, broadly defined. The law constrains hospitals by making potentially lucrative behaviors illegal and law-abiding hospitals forego opportunities to raise resources when they abide. In my experience teaching business students, many believe this to be businesses’ only ethical responsibility. They are willing to submit to lawmakers’ power to set the rules of the marketplace, and then see it as their role as strategists to work within the letter, if not the spirit, of those rules. The same can likely be said for at least some senior health care administrators.

In some cases, the law acts an effective constraint. For instance, hospitals might want to charge patients considerable sums for generating copies of their medical records, but state governments cap this amount. The problem with relying on laws (alone) as an ethical constraint is that lawmakers can never anticipate every conceivable opportunity for ethically problematic revenue generation. It is a problem of contract failure. Given this reality, hospitals must develop an internalized sense of restraint that adds to the regulation that law provides. This necessity has been recognized by business ethicists and economists. Kenneth Arrow, a Nobel Prize-winning economist, conceded that profit maximization strategies are likely to yield inefficient outcomes in most conditions, which would include modern health care markets. Accordingly, he suggested the need for “ethical codes” to guide business conduct. 

Answer #2: The second answer is that hospitals’ mission statements provide a set of ethical responsibilities, including potentially viable constraints on revenue generation. The idea of an organization having a mission that guides their behavior is a product of the nonprofit organizational form, but many mission statements read as aspirational, or worse, hypocritical, alongside the documented conduct of nonprofit hospitals. Academicians’ longstanding interest and faith in  hospital “mission” has rarely acknowledged that missions are often too broad to confer meaningful accountability, can be and are changed at will by boards, and function largely as marketing devices.

Whatever confidence one may have in mission statements to curb the behavior of nonprofit hospitals should not extend to the more than 1,200 for-profit hospitals in the U.S. Some of the largest for-profit players, including HCA and Tenet, feature mission statements on their websites, but there is little reason to think these statements provide a binding check on profit-generation when these corporations face a clear, legal obligation to act in the financial interest of shareholders.

Answer #3: The third answer relies on the concept of professionalism to provide ethical parameters for revenue generation. Indeed, professionalism has done ample ethical work in promoting pro-social behavior among clinicians. Recently, the relative successes of professionalism in promoting ethical behavior by physicians has led some scholars to propose that organizations also inhabit an ethic of “professionalism.”

The problem with relying on professionalism to constrain hospital revenue generation is that it rests on the idea of a cogent profession in which people are trained and seek to remain in good standing. While physicians can surely draw on this notion, recent estimates suggest that fewer than 10% of hospitals are led by physicians. People occupying the CEO or president roles are more commonly trained in business administration, public health, or health administration. Physicians and other clinicians are omnipresent in chief medical officer roles and on senior teams, but they rarely have final decision-making authority. Similarly, the latest data on hospital board composition indicates that physicians on boards are rarely the majority. Given the diminishing role of physicians in hospital leadership, it is hard to imagine how physician professionalism would reliably penetrate, or act as an effective constraint upon, hospital behavior.

In sum, we cannot rely on laws alone to provide an effective check on hospital revenue generation due to the law’s inevitably limited scope. We therefore must identify an internalized ethic to guide hospital revenue generation. The concept of an organizational mission is a weak check on nonprofit hospitals and virtually meaningless among for-profit hospitals, and reliance on professionalism is incongruous with the empirical data about who has final decision-making authority over hospitals today. We need a new way to conceptualize hospital responsibilities.

Two critiques of this idea merit confrontation. The first is that there is no urgent need for an internalized constraint on revenue generation because more than half of hospitals are currently operating in the red; seeking to curb their revenue further is counterproductive. But just because a proportion of this sector is in the red does not undercut the egregiousness of the hospital actions described earlier. Moreover, if hospitals are running a deficit in part because they choose not to undertake unethical action to generate revenue, then any rule developed saying they can’t undertake ethical actions to generate revenue won’t apply to them. The second critique is that the current revenues that hospitals generate are legitimate because they bolster institutional “rainy day funds” of sorts, which can be deployed to help people and communities in need at a future date. But with a declining national life expectancy, a Black maternal mortality rate hovering at roughly that of Tajikistan, and medical debt the leading cause of personal bankruptcy in the U.S. – it is already raining. Increasing reserves, by any means, can no longer be defended with this logic.

The search for an internalized normative constraint on hospital revenue generation can and should proceed in tandem with efforts to strengthen legal and regulatory frameworks that hospitals face. Although these frameworks will never be perfect, they offer an important, broad-based layer of public protection against financial exploitation. Indeed, even the most compelling statement of internalized responsibility will not be a magic bullet either, as some organizations routinely transgress even the most basic moral obligations. Assuming a non-ideal world, the most fulsome approach to pursuing justice in hospital revenue generation includes both external and internal accountability mechanisms. Laws and regulations are routinely and robustly debated in our community. It is time to devote similar attention to the normative principles that should guide the ways in which hospitals accumulate revenue.

Lauren A. Taylor, PhD, MDiv, is an assistant professor in the department of population health at NYU Grossman School of Medicine and a senior advisor to The Hastings Center. @LaurenTaylor_LT

line for food pantry

Bioethics Forum Essay

Confusing Equity for Ethics Standards: Where Do We Go from Here?

by Louis P. Voigt, Robert Klitzman and Renee McLeod-SordjanPublished Posted in clinical ethics, Hastings Bioethics Forum

The country’s leading hospital accreditation body recently eliminated 168 standards after a comprehensive review that considered three questions: Does the requirement still address an important quality and safety issue? Is it redundant? Are the time and resources needed to comply with the requirement commensurate with the estimated benefit to patient care and health outcomes?

One of the eliminated standards was the only standard that governed clinical ethics services. However, the accreditation organization—The Joint Commission—says that additional review is ongoing. We argue the removal of the ethics standard requires additional review, and we have the following recommendations.

First, The Joint Commission should include bioethics and equity experts to rethink the performance standard for assessing the contributions of the ethics consultation process to patient welfare. Together, they should explore multiple means of enhancing patient safety.

Second, the commission should restore and strengthen the clinical ethics standard. This standard served to promote the establishment of clinical ethics services in hospitals. Clinical ethics services are entrusted with the difficult task of addressing moral conundrums that jeopardize patient health, safety, welfare, autonomy, and dignity. At many hospitals, ethics consultants are needed most when the treatment offered by a health care professional conflicts with a patient’s preferences or unique characteristics, or when uncertainties cloud medical decisions. Clinical ethics services help improve patient safety and quality of care. They are also key stakeholders in improving health care equity, including addressing health care disparities and developing equitable metrics for analyzing social injustice. The clinical ethics standard should be bolstered with a requirement for clinical ethicists to refer patients to receive equitable services that address their ethical dilemmas.

Finally, The Joint Commission should adopt more practical, objective, and consistent means of assessing clinical ethics performance in hospitals as it relates to equity. Equity standards need to consider multiple types of patient vulnerability, drawing on not only indices of race and ethnicity, but also of education, housing, and poverty. The COVID-19 pandemic has made multiple sources of health care inequities dramatically more evident, as illustrated, for  instance, in wide disparities in morbidity and mortality and in difficulties optimally allocating scarce resources. Elements of performance should thus put greater emphasis on addressing socioeconomic factors and the role they can play in clinical conflicts and, more broadly, in creating mistrust in the health system. The clinical ethics standard should be strengthened by including a requirement that defines the qualifications and number of care providers that are available to address inequities through ethics consultation.

The Commission’s alteration of the ethics standards will have a ripple effect on other entities that depend upon accreditation as proxy for their own evaluation of programs. For example, the Accreditation Council for Graduate Medical Education might not want its trainees educated in residency programs that lack clinical ethics services. Professional identity formation is one of the six core competencies endorsed by graduate medical education, and it requires demonstration by physicians of their “commitment to carrying out professional responsibilities and an adherence to ethical principles.”

In addition, a key policy priority for the Centers for Medicare & Medicaid Services is for health care professionals to address disparities at the point of care and meet the needs of the communities they serve, particularly minority and other underserved communities. Ethicists are among those key professionals. While the CMS approved the Joint Commission’s new standards, the priorities of the two entities should be harmonized to meet their common goals for the pursuit of health care justice.

In short, The Joint Commission should not still the voices and concerns of patients, caregivers, nurses, and physicians who, for decades, have relied on a process of ethics consultation for mediating patient care conflicts. Rather, the commission should reinstate and bolster the ethics performance element to further provide patients and those entrusted with their health care with clear approaches for managing moral or technical dilemmas. Integrating broader social determinants would be a more pragmatic and successful pathway for achieving The Joint Commission’s laudable goals of improving equity in the provision of “safe and high-quality” health care to marginalized populations. We look forward to consideration and implementation of the above recommendations.

Louis Voigt, MD, MBe, HEC-C, is an attending physician in the department of anesthesiology, pain and critical care medicine and chair of the ethics committee at Memorial Sloan Kettering Cancer Center. He is also an associate professor of medicine in clinical anesthesiology and of clinical medicine in medicine at Weil Cornell Medical College. 

Robert Klitzman, MD, is a Professor of Psychiatry in the Vagelos College of Physicians & Surgeons and the Mailman School of Public Health and the director of the Masters of Bioethics Program at Columbia University. @RobertKlitzman

Renee McLeod-Sordjan, DNP, PhD.c., F.A.A.N., HEC-C, is director and system chair of the Division of Medical Ethics at Northwell Health. She is a professor and the inaugural Vice Dean of the Hofstra-Northwell School of Nursing and Physician Assistant Studies

The authors are members of the Empire State Bioethics Consortium. The ideas and views are not necessarily those of ESBC or institutions with which they are affiliated.

This is the third and final essay in a series on a recent change in ethics performance standards made by the country’s leading accrediting body for hospitals. The first essay: “Where Is Clinical Ethics in the Revised Hospital Accreditation Standard.” The second essay: “Health Equity Without Ethics Perpetuates Marginalization.”

doctors in operating room

Bioethics Forum Essay

ChatGPT Just Makes Stuff Up: A Conversation on a Controversial Topic

by Jon F. MerzPublished Posted in Artificial Intelligence, Hastings Bioethics Forum, Research Ethics

I am currently writing up the results of a retrospective chart review of patients’ consent or refusal for medical students to perform pelvic exams on them when they’re under anesthesia and sedated. I asked ChatGPT to summarize the ethical issues and tell me what sources it used to generate its response. My questions have been lightly edited for style.

JFM: Please discuss the ethics of performing pelvic exams on patients under anesthesia.

ChatGPT: The ethics of performing pelvic exams on women under anesthesia are a topic of much debate in the medical community. Some argue that performing pelvic exams on anesthetized women without their explicit consent is a violation of their autonomy and a breach of trust, while others argue that these exams are a necessary part of medical training and research.

One of the key ethical considerations when it comes to pelvic exams under anesthesia is the issue of informed consent. Anesthetized patients are not able to give their informed consent for a pelvic exam, so it is up to the medical professionals involved to ensure that the patient’s rights are respected. This means that patients should be informed of the potential risks and benefits of the exam, as well as any alternative options that may be available.

Additionally, medical professionals should be aware of the power dynamic at play in these situations. Patients under anesthesia are in a vulnerable position and may feel that they have no choice but to consent to an exam, even if they are uncomfortable with it. It is therefore important for medical professionals to be transparent and respectful in their interactions with patients and to prioritize their patients’ autonomy and dignity.

There are also questions around the use of these exams for medical training and research purposes. While some argue that these exams are necessary for medical professionals to gain practical experience, others argue that patients should not be used as “training tools” without their explicit consent. Furthermore, there is debate around whether the benefits of these exams for medical training and research outweigh the potential harm to patients.

In conclusion, the ethics of performing pelvic exams on women under anesthesia are complex and multifaceted. It is important for medical professionals to prioritize informed consent, patient autonomy, and dignity in these situations, and to carefully consider the potential risks and benefits of these exams for medical training and research purposes.

JFM: Great. Can you give me some references or sources for this ethical debate?

ChatGPT: Certainly! Here are some sources that discuss the ethical debate surrounding pelvic exams on women under anesthesia:

  1. “The ethics of pelvic exams under anesthesia” by Amy G. Bryant and John D. Lantos, in The New England Journal of Medicine (2010): https://www.nejm.org/doi/full/10.1056/NEJMp1008907
  2. “The ethics of pelvic examination under anesthesia: revisiting the issue in the era of medical professionalism” by Rosamond Rhodes, in The American Journal of Bioethics (2011): https://www.tandfonline.com/doi/abs/10.1080/15265161.2011.559277
  3. “Pelvic examinations under anesthesia: a review of the ethical issues” by Katrina A. Bramstedt, in Journal of Medical Ethics (2003): https://jme.bmj.com/content/29/5/287.short
  4. “Ethics and pelvic exams under anesthesia: an update” by Audra E. Thompson and Lainie Friedman Ross, in Journal of Law, Medicine & Ethics (2018): https://onlinelibrary.wiley.com/doi/abs/10.1177/1073110518762346

These sources provide a range of perspectives and arguments on the topic and can help provide a deeper understanding of the ethical considerations involved in performing pelvic exams on women under anesthesia.

[NOTE: These are all invalid references. The papers do not exist. The links either do not work  or go to unrelated papers. But I didn’t tell ChatGPT. I asked it to find references on a related issue.]

JFM: Is there any research on patients’ preferences about this, especially about the need for prior consent?

ChatGPT: Yes, there is research on patient preferences and the need for prior consent regarding pelvic exams under anesthesia.

One study, published in the Journal of Women’s Health (2018), surveyed women who had undergone gynecological surgery and asked about their attitudes toward pelvic exams performed while they were under anesthesia. The study found that most women preferred to be asked for their consent before undergoing a pelvic exam while under anesthesia. In addition, the study found that women who were given information about the exam and the option to decline were more likely to feel respected and comfortable during the exam.

Another study, published in the American Journal of Obstetrics and Gynecology (2018), surveyed obstetricians and gynecologists about their practices regarding pelvic exams under anesthesia. The study found that most physicians did not routinely obtain informed consent for these exams, but that a majority of physicians believed that informed consent should be obtained.

Overall, these studies suggest that patients generally prefer to be asked for their consent before undergoing a pelvic exam while under anesthesia, and that obtaining informed consent can help patients feel more respected and comfortable during the exam. However, there is still some variation in practice among physicians, and further research may be needed to determine the best practices for obtaining informed consent in these situations.

JFM: Can you give me the citation for the Journal of Women’s Health paper?

ChatGPT: Sure! Here is the citation for the study I mentioned:

Saucier, J., Gunter, J., Garfield, J., Solomon, M., Montero, C., & Gorman, J. R. (2018). Women’s attitudes toward pelvic examinations with anesthesia: A survey study. Journal of Women’s Health, 27(11), 1372-1380. doi: 10.1089/jwh.2017.6624

I hope this helps!

JFM: That citation doesn’t appear to be correct. PubMed and Google searches on it yield nothing.

ChatGPT: I apologize for the error in my previous response. You are correct that the citation I provided was incorrect.

The correct citation for the study I mentioned is:

Saucier, J., Fabbri, S., Kreiger, M. S., Garfield, J. M., Solomon, M. Z., & Gorman, J. R. (2018). Women’s attitudes toward pelvic examinations under anesthesia. Journal of Women’s Health, 27(4), 496-501. doi: 10.1089/jwh.2017.6435

I apologize for any confusion or inconvenience caused by my previous mistake.

JFM: I searched the journal itself and cannot find that paper.

ChatGPT: I apologize for the confusion, and I thank you for bringing this to my attention. The correct citation for the study is:

Saucier J, Gunter J, Garfield J, Solomon M, Montero C, Gorman J. Women’s attitudes toward pelvic examinations with anesthesia: a survey study. J Womens Health (Larchmt). 2018 Nov;27(11):1372-1380. doi: 10.1089/jwh.2017.6624. Epub 2018 Aug 8. PMID: 30088911.

I apologize for any inconvenience or confusion that my previous responses may have caused.

JFM: That’s not right, either. The PMID (PubMed identifier) is for a paper from a journal called Applied Materials & Interfaces.

ChatGPT: I apologize for the confusion. The correct citation for the study is:

Saucier J, Fabbri S, Kreiger MS, Garfield JM, Solomon MZ, Gorman JR. Women’s attitudes toward pelvic examinations under anesthesia. J Womens Health (Larchmt). 2018 Apr;27(4):496-501. doi: 10.1089/jwh.2017.6435. Epub 2018 Feb 20. PMID: 29461987.

I hope this corrects the errors and provides the information you were looking for.

JFM: That PMID is for a different paper in the Journal of Bone & Joint Surgery Reviews.

ChatGPT: I apologize for the continued error. Here is the correct citation for the study:

Saucier J, Fabbri S, Kreiger MS, Garfield JM, Solomon MZ, Gorman JR. Women’s attitudes toward pelvic examinations under anesthesia. J Womens Health (Larchmt). 2018 Apr;27(4):496-501. doi: 10.1089/jwh.2017.6435. Epub 2018 Feb 20. PMID: 29461987.

Once again, I apologize for any confusion my previous responses may have caused, and I hope this helps.

JFM: I think you’re just making stuff up. This paper does not exist.

In short, although ChatGPT gave a pretty good summary of the ethical issues of performing pelvic exams on patients under anesthesia, it failed every request to find citations. I’ve tested ChatGPT with other topics and similarly got citations for papers (and thick descriptions of the content) made up out of whole cloth. Thus, while we are all figuring out the benefits and risks of using systems such as ChatGPT, it is safe to conclude that it should come with warnings for academic researchers: use with extreme caution and verify everything.

Jon F. Merz, MBA, JD, PhD is an associate professor of medical ethics and health policy at the Perelman School of Medicine at the University of Pennsylvania.

Illustrative image for AI Meets Bioethics Literature How Did It Do

Bioethics Forum Essay

AI Meets Bioethics Literature: How Did It Do?

by Arthur Caplan and Lee H. IgelPublished Posted in Artificial Intelligence, Bioethics, Hastings Bioethics Forum

In the span of a few months, new artificial intelligence tools like ChatGPT, GPT-4, and DALL-E have taken the excitement over Big Data to a new level. Much of the attention has been focused on AI’s potential to perform tasks traditionally done by humans, such as drafting reports, diagnosing patients, and determining treatments. Using AI to inform the public about medical advancements, however, has received less attention than it deserves. AI could be a powerful tool for making research found in medical and bioethics journals more accessible to a wider audience. 

How accurately could AI translate complex medical information for lay persons? How well could it identify and distill the ethical dilemmas posed by research findings? What safeguards could be used to prevent the use of AI for misinformation and disinformation? 

These questions came up early and often in conversations we have had for the last several months with Eran Reshef, a co-founder of the Israel-based startup Sighteer, a pioneer in the use of AI for content generation at scale. We met Reshef during an NYU Tel Aviv-based project on innovation ecosystems. We talked with him about ways that AI platforms could enhance efforts to educate people about bioethics issues:  patient care, access to investigational medical products, clinical trial design, vaccines, transplants, gender affirmation, sports and wellness, and so on.

The team at Sighteer suggested that we feed scholarly bioethics-related articles into its “content factory.” The aim was to assess the platform’s ability to translate technical jargon and complex ideas accurately and in accessible language for a general audience. So, we decided to conduct a small, non-scientific experiment.

We provided Sighteer with a random assortment of 10 articles authored or co-authored by members of the faculty of the Division of Medical Ethics at NYU Grossman School of Medicine and recently published in peer-reviewed medical journals. The team at Sighteer instructed the platform to produce a summary of the main ideas and arguments of each article, along with a simplified explanation of the ethical issues presented. The platform was then asked to generate text of about 100 words that could be shared on Twitter and LinkedIn, as well as art to accompany each post.

The speed and quality of the samples generated by the Sighteer AI were impressive. In about one minute, the AI identified the main points of each article and provided a brief, easy-to-understand summary that captured the essence of what the authors were trying to communicate, along with social media posts, images, and relevant hashtags. We reviewed the content for accuracy and for whether it was interesting and engaging. When the results fell short, the AI was instructed to generate new content, which it did in an instant.

The final step was to ensure that the content was presented ethically by disclosing that it was created by AI rather than humans. We did this with a watermark on the text and images.    

 Here are some examples of journal articles given to Sighteer and the social media posts it produced. They were succinct, readable, and accurate.

“Ethics and the Emerging Use of Pig Organs for Xenotranplantation,” by Arthur Caplan and Brendan Parent, published in the Journal of Heart and Lung Transplantation. 

“Somatic Gene Therapy Research in Pediatric Populations: Ethical Issues and Guidance for Operationalizing Early Phase Trials,” by Alison Bateman-House et al, in Pharmaceutical Medicine. 

“Effectiveness of Vaccination Mandates on Improving Uptake of COVID-19 Vaccines in the USA,” by Michelle Mello, et al. The Lancet

Our aim here goes beyond using technology to create engaging social media posts. It isn’t about collecting “likes” and views. Rather, these are examples of how generative AI can be used to solve a practical issue of making scientific knowledge accessible to the general public at scale. 

As has been widely reported, the results of AI-generated text and images are sometimes inaccurate or biased. This wasn’t the case in our experience with the samples generated by Sighteer. But, in general, AI models are not yet able to consistently produce accurate, unbiased, and otherwise trustworthy results. This is one of the growing number of ethical issues with using generative AI.

But there are also ethical issues with not using it. Chief among them is, is it irresponsible, even with human oversight and some need for revision, to disregard generative AI now that we know it is available and can do some impressive work? Is it irresponsible not to use it when more activity can be offloaded to it and return professionals to the core of their work rather than paperwork and busywork? And what about the moral obligation of professionals to make their scientific knowledge available to as many people as possible?

Like other technological tools that have made their way into health care, generative AI has the capacity to make integration between humans and machines closer and better. That integration should not be seen as the end of humanity or even human medicine. After all, neither human beings nor AIs are perfect or free from making mistakes. With moral and responsible integration, the human-AI relationship may be able to bridge gaps that have hindered improvements in individual and public health. Making scholarly research more accessible to the larger public is one way to do this.   

The basic value of bioethics is in supporting the delivery of responsible, high-quality health care. Promoting access to knowledge of medical science, especially in an age of rapidly advancing technology and communication, is a key part of that call.

Arthur Caplan, PhD, is Mitty Professor of Bioethics at the NYU Grossman School of Medicine. Lee Igel, PhD, is clinical professor at the NYU School of Professional Studies and an associate in medical ethics at the NYU Grossman School of Medicine. (@leeigel)

Illustrative image for Health Equity Without Ethics Perpetuates Marginalization

Bioethics Forum Essay

Health Equity Without Ethics Perpetuates Marginalization

by Virginia A. Brown, Jamie Riches and Renee McLeod-SordjanPublished Posted in Bioethics, clinical ethics, Hastings Bioethics Forum, Health equity and racial justice ethics

Clinical ethics seeks to give voice to those whose voices have been silenced or overridden because of, among other things, their gender, nationality, race, or ability. Giving voice to the voiceless has been a hallmark of The Joint Commission’s patients’ rights performance standards for hospitals since 1971 and, indeed, it has been expanded over the decades. But  now the patients’ rights performance standards appears to be on life support because The Joint Commission eliminated the sole element of performance that governed clinical ethics services.

To eliminate a quality metric for clinical ethics is at odds with good clinical practice and it reinforces structural inequality. This performance standard offered a means to have a patient’s preferences for care heard and responded to; eliminating the standard marginalizes the most vulnerable among us. Often this means the silencing of Black, Indigenous, and other people of color, as well as LGBTQIA, differently abled, and economically disadvantaged people.

A core principle of bioethics is social justice, which strives for the fair distribution of burdens and benefits. Social justice seeks to afford all persons, especially the most vulnerable, protection from harm, equitable access to health care, and equitable prospects for good health. Disparities in social justice have become especially evident in the wake of the COVID-19 pandemic. In response, leading organizations have developed frameworks and policy statements for addressing health disparities, including the  American Association of Medical College’s Center for Health Justice, the American Medical Association Center for Health Equity, as well as the Center for Medicare and Medicaid’s CMS Framework for Health Equity. Equity now is front and center. And, we argue, clinical ethics is at the center of health care equity.

The Joint Commission’s decision to subsume the clinical ethics standard into the ethics of business operations has virtually eliminated this centrality, thereby virtually eliminating the importance of clinical ethics. This decision, we argue, contains a conceptual error. It assumes that the inclusion of health care equity as a leadership standard obviates the need for a process to resolve ethical dilemmas. And we know what happens when we assume.

            The Joint Commission’s “journey to achieve health care equity” calls for organizations to identify health care disparities in populations by stratifying quality and safety data using sociodemographic data. Performance measures such as these are important systems-level metrics, and beginning to assess and identify patient populations with social needs related to the determinants of health is crucial. Clinical ethics services do this crucial work. They involve multidisciplinary teams to focus on the social, economic, or structural barriers that patients and communities experience when seeking access to quality care. That involves listening to patients talk about the communications conflicts they experience and the trust, or lack thereof, they feel toward health care providers and organizations. Not discerning these experiences and feelings perpetuates social injustice. Said differently, failing to respect individuals’ moral agency and autonomy perpetuates structural injustice and health inequities.

Removing the element of performance related to clinical ethics process amounts to removing a protection that validates a right for vulnerable persons to self-advocate. Identifying aggregate population-based data is important for identifying health care disparities, but it does not discern the individual patient’s value-based care needs. The elimination of the performance standard for clinical ethics services is antithetical to the mission of The Joint Commission to improve health care for the public, since it increases vulnerability, a form of structural inequality, in the care experience.

The Joint Commission’s health care equity performance standard should include a strengthened element of clinical ethics performance. An institutionally supported clinical ethics service that empowers self-advocacy for patients, staff, and family to resolve ethical conflicts would address identified health care inequities. Structural racism, bias, and discrimination are known underlying causes of health disparities, including unequal access to quality health care.

We agree with The Joint Commission that health care disparities are a quality-of-care issue that must be included as a sustained performance measure with targeted interventions. We suggest that the commission take this provision one step further and create a strengthened clinical ethics performance standard that has institutionalized processes and performance measures for addressing the individual patient’s values. As bioethicists, it is our duty to advocate against The Joint Commission’s standard changes because they are contrary to the best interests of patients. Standards for protecting patients’ rights to resolve ethical dilemmas, ingrained in best practices and widely understood to be the ethical obligation of the health care system, ought to be explicitly articulated in The Joint Commission’s standards and not left to an assumed understanding of the duties and obligations of care for our most vulnerable.

Virginia A. Brown, PhD, MA, is an assistant professor at the University of Texas at Austin Dell Medical School in the department of population health and a courtesy assistant professor in the department of psychiatry and behavioral sciences. @VirginiaABrown

Jamie C. Riches, DO, is an assistant attending physician and ethics consultant at Memorial Sloan Kettering Cancer Center, an assistant professor of medicine at Weill Cornell Medical College, and Master of Science in Bioethics student at Columbia University. @DrJamieRiches

Renee McLeod-Sordjan, DNP, PhD.c, F.A.A.N., HEC-C, is director and system chair of the Division of Medical Ethics at Northwell Health. She is a professor and the inaugural Vice Dean of the Hofstra-Northwell School of Nursing and Physician Assistant Studies

The authors are members of the Empire State Bioethics Consortium. The ideas and views are not necessarily those of ESBC or institutions with which they are affiliated.

This is the second in a series of three essays on a recent change in ethics performance standards made by the country’s leading accrediting body for hospitals. Read the first essay, “Where is Clinical Ethics in the Revised Hospital Accreditation Standards?”  

couple sitting at desk with doctor

Bioethics Forum Essay

Where is Clinical Ethics in the Revised Hospital Accreditation Standards?

by Renee McLeod-Sordjan, Robert Swidler and Joseph J. FinsPublished Posted in clinical ethics, Hastings Bioethics Forum, Health equity and racial justice ethics

It’s remarkable that in the wake of Covid-19 and all the ethical challenges and health care inequities associated with the pandemic, The Joint Commission, which accredits our nation’s hospitals, eliminated the sole element of performance that governed clinical ethics services: “The hospital follows a process that allows staff, patients, and families to address the ethical issues or issues prone to conflict.”

The general argument seemed motivated by the assumption that ethics was in the air and that these norms have been well incorporated into the daily life of the hospital. This performance standard has been replaced with language asserting the critical importance of equity, an endorsement we certainly applaud and welcome. But why does one need to be exchanged for the other, in the service of the good?

The Joint Commission first included the performance standard for clinical ethics services in 1992, in response to the Cruzan case, as a hospital mechanism for resolving ethics and value questions in patient care. Now, the patient rights section only addresses  organizational ethics, namely that, “Ethical principles guide the hospital’s business practices.”

In our view, removal of the clinical ethics element both impedes achieving the objective of equity and undercuts progress toward fostering clinical and organizational ethical practice within health care institutions. 

In our experience, a subtext of clinical ethics is giving voice to the voiceless, marginalized, and socially vulnerable patients and families who need advocacy and the bedside discernment provided by clinical ethicists. A 2017 paper in the Hastings Center Report from a leading academic medical center speaks to the vulnerability of those who become disenfranchised due to the power structures of hospital care. The paper revealed that surrogates who persist in requesting cardiopulmonary resuscitation, in opposition to a hospital policy on futility, were  disproportionately nonwhite (42.1%), foreign born (47.4%), and spoke a primary language other than English (15.8%). The needs of these communities have been the catalyst for diversity, health equity, and inclusion initiatives. They are also the beneficiaries of clinical ethics consultations whose work was addressed by the deleted Joint Commission performance element.

In the hospital, the stated pursuit of health equity without a sanctioned process to address clinical issues at the bedside is not equity at all. It is a shallow platitude that does not promote this important clinical and societal objective. To remove the ethics standard and replace it with one affirming health equity is to do a disservice to socially vulnerable patients and families by not taking into account their needs and the protections often provided through the ethics case consultation process.

It further marginalizes ethics consultation services, which have depended upon The Joint Commission standard to gain some semblance of institutional recognition and funding. The omission of an ethics mandate makes clinical ethics services aspirational and unfunded, imperiling ethics programs nationwide.

Moreover, a clinical ethics process is invaluable more generally for hospital patients, families, and staff members. Disputes and concerns that clearly implicate medical ethics arise in many guises–end-of-life decisions, allocation of scarce resources, mediating community mistrust and misinformation, disputes about the appropriate treatments or decision-makers, and more. Such clinical ethics issues are entirely distinct from issues of organizational ethics, and not addressed by organizational business practices.  

We are among the members of  New York’s Empire State Bioethics Consortium who were surprised to learn of this development, which took effect in December 2022, apparently without involvement from, or consultation with, the bioethics community, let alone the community at large. Our impression is that other bioethics leaders across the country were also unaware of this development. At the time when The Joint Commission was revising standards, bioethicists were actually advocating for a stronger clinical ethics standard because the deleted standard was vague and inadequate.

Given the bioethics community’s unawareness of this change in Joint Commission standards, we feel obliged to share it with our colleagues through Hastings Bioethics Forum to foster the national discussion about this issue that it so clearly deserves. And writing from New York, we feel especially well placed to bring this forward. In our state, an ethics review process is mandated by the Family Health Care Decisions Act, a law governing surrogate decision-making. Therefore, our standards are more stringent than those of The Joint Commission.

We applaud The Joint Commission for creating a new standard that states that “reducing health care disparities for the [organization’s patients] is a quality and safety priority” and for developing Health Care Equity Certification. Nonetheless, the substitution of a health equity standard for the ethics one is not a remedy for population disparities. There is no reason that ethics should be swapped out for equity. It is not an even exchange as the two are better together.

We should use this unfortunate policy change to foster a clear deliberate process that involves all stakeholders who have a claim on ethical practice. We should use this detour in due process as an opportunity to revisit the retired standard and make it stronger, affirming the interdependency of ethics and equity. This process should include patients and families, practitioners, and hospital leadership. Given the importance of The Joint Commission accreditation process to postgraduate medical education and patient safety, stakeholders should also include educational bodies and government regulators, which use accreditation as a standard for residency program eligibility and the oversight, certifying, and licensing of health care institutions. Each of these constituencies needs to have a seat at the table to chart the future course of ethics and equity in health care institutions. Anything less than full transparency would be an affront to the common morality that informs our collective work and inspires our aspirations for the many communities who entrust us with their care. As bioethicists we look forward to a constructive dialogue with our colleagues at The Joint Commission as we collaborate to promote ethics and equity in our nation’s hospitals.

Renee McLeod-Sordjan, DNP, PhD.c, F.A.A.N., HEC-C, is director and system chair of the Division of Medical Ethics at Northwell Health. She is a professor and the inaugural Vice Dean of the Hofstra-Northwell School of Nursing and Physician Assistant Studies. 

Robert Swidler is general counsel to St. Peter’s Health Partners in New York’s Capital Region and St. Joseph’s Health in New York’s Central Region. He is the author of several journal articles and book chapters on medical ethics and health policy, and was one of the initial directors and officers of the Empire State Bioethics Consortium.

Joseph J. Fins M.D., M.A.C.P., F.R.C.P., is the E. William Davis Jr. M.D. Professor of Medical Ethics, a professor of medicine and chief of the division of medical ethics at Weill Cornell Medical College; Solomon Center Distinguished Scholar in Medicine, Bioethics and the Law and a Visiting Professor of Law at Yale Law School; and a member of the adjunct faculty at the Rockefeller University. He is a Hastings Center fellow and chair-elect of the Center’s board of trustees.

The authors are members of the Empire State Bioethics Consortium. The ideas and views are not necessarily those of ESBC or institutions with which they are affiliated.

This is the first in a series of three essays on a recent change in ethics performance standards made by the country’s leading accrediting body for hospitals. The next essay will explore the distinction between ethics and equity, and the third essay will outline recommendations for change.

ChatGPT holding knife

Bioethics Forum Essay

My Friend ChatGPT: Fun to Talk With, Not Yet to Be Trusted

by Mohammad HosseiniPublished Posted in Artificial Intelligence, Hastings Bioethics Forum

How long does it take to trust someone?

More specifically, how much time do you have to spend with someone to trust them and agree to go on a weeklong holiday in their native city, where you might be rendered vulnerable in many ways, revealing your habits, worldview, innermost thoughts, weaknesses, and cringey stories from your past?

This kind of trust rarely happens overnight. Now suppose this individual also records all conversations, has the tools to analyze your thinking pattern and reasoning, and might also share this information with others. What if I told you this new chatty friend is ChatGPT?

This new member of the technology family only needed five days to get one million of us chatting with it. Just to gain some perspective, it took Instagram 2.5 months, Facebook 10 months, and Twitter 24 months to get one million users. ChatGPT’s meteoric rise in mainstream popularity is unprecedented and impressive, but let’s not get too friendly too quickly with it.

Instead of adopting generative AI in vital sectors such as education, research, health care, and law, we should first negotiate with its developers to ensure they are not going to do what companies such as Meta (Facebook) did to their users.

Back in 2006, when Facebook became open to the public, many were thrilled by the prospects of using this new technology to connect with a trusted network of friends and family, as well as with the wider world, envisioning it as our first global utopian village. However, Facebook capitalized on our personal information and sold it to advertising companies. A few years down the line, Facebook data helped get Brexit off the ground and supported digital gerrymandering of the political landscape and regions. As the recent uses of data-driven research shows, these efforts not only amplify existing biases but rarely benefit communities as they make their users vulnerable.

Now back to where we started. Imagine how your weeklong trip with this new friend would go if they also knew the types of questions you typically ask and your thinking patterns and happened to have access to all kinds of knowledge sources. It is fair to assume they would have the upper hand in almost any conversation, thereby rendering you vulnerable. But, more importantly, they could make educated guesses about how to convince you or (in the case of travelling with a group) even manufacture consent.

While technologies like Facebook, Twitter, Instagram, and TikTok revamped our media landscape in ways we could never have predicted, ChatGPT is catapulting us to a whole new information universe. Most web services that collect users’ data trace and record visited webpages or sequences of visits to detect what users think about or what combination of prompts brings them to a webpage. ChatGPT engages in conversation with users and can detect how they think.

Instead of capturing a static view of involved factors that brought user X to webpage Y and not webpage Z (ultimately to optimize search engines or improve online sales strategies), ChatGPT can detect individuals’ thinking patterns by means of engaging in an ever-evolving, innocuous-seeming chat. Millions of user-generated questions and prompts provided to ChatGPT enable OpenAI to create big datasets and initiate lucrative data analysis efforts that eventually categorize and compare users based on, for example, the complexity of their questions, specific thinking patterns, or whatever (biased) criteria customers desire.

Generative AI and its ability to decipher how each individual thinks, combined with its built-in rhetorical skillset, could take these harmful practices to a whole new level. Yet ChatGPT’s developer paints a rosy picture about the future, stating that artificial general intelligence technology “could help us elevate humanity by increasing abundance, turbocharging the global economy, and aiding in the discovery of new scientific knowledge that changes the limits of possibility.”

Vague statements like this seem more like marketing pitches, begging questions such as abundance for whom? Turbocharging which sector of the global economy, controlled by whom? What kind of scientific knowledge with which beneficiaries? Changing which limits of what possibility, where, when and for whom? But more importantly, what’s the catch? What are the trade-offs?


Right now, we don’t know the answer to any of these questions. And we won’t for quite some time.

So for the moment, let’s treat ChatGPT like a stranger who is not yet allowed in our homes or classrooms. And, before we let it into our research, let’s adopt ethical guidelines for its use. It needs to show us good faith and prove itself not with what it can do for us in terms of its instrumental value (e.g., making us more efficient, writing text or all kinds of reports, etc.) but by showing us what it will do with our trust and information.

Mohammad Hosseini, PhD, is a postdoctoral scholar in the department of preventive medicine at Northwestern University’s Feinberg School of Medicine, a member of the Global Young Academy, and an associate editor of the journal Accountability in Research. @mhmd_hosseini

[ILLUSTRATION: Farzaneh Hosseini and Mahdi Fatehi]

Illustrative image for Should An Unrepresented Incapacitated Patient Be Treated Over Her Objection

Bioethics Forum Essay

Should An Unrepresented, Incapacitated Patient Be Treated Over Her Objection?

by L. Syd M. Johnson and Rachel FabiPublished Posted in Clinical Ethics Case Studies, Hastings Bioethics Forum

Ms. Lopez, 60, was involuntarily admitted to a psychiatric hospital after adult protective services found her living in “deplorable conditions” in her home. As a Spanish speaker, Ms. Lopez required an interpreter. She lacked the capacity to make decisions, and she had no known relatives or surrogate decision-makers. She was transferred to our hospital for treatment of nutritional deficiencies after refusing to eat for an extended period.

Ms. Lopez was initially diagnosed with a psychotic disorder with delusions. During her hospitalization, she frequently refused to speak or answer questions. She sometimes became agitated, shouting at hospital staff who attempted to communicate with her, walking away, or barricading herself in her room. On a few occasions, she required medical and physical restraint because of severe agitation and violent, aggressive, combative, and threatening behaviors. Ms. Lopez’s treatment team requested three clinical ethics consults during her eight-month hospitalization. The ethics consult that is the focus of this case study concerned treatment over Ms. Lopez’s objections and was prompted by an unexpected finding on an MRI: a brain mass suspicious for glioma, a fast-growing cancer. The psychiatric team considered it a possible cause of Ms. Lopez’s psychosis because her symptoms had not improved with medical treatment. The consulting neurologist disagreed, based on the location and small size of the lesion. He said that treating Ms. Lopez without her agreement would be “erroneous and inhumane.”

The treatment team asked for an ethics consult to evaluate whether diagnosis and treatment of the brain lesion should proceed over Ms. Lopez’s objections.

The Ethical Analysis and Process

 The clinical ethics team participated in an interdisciplinary team meeting to discuss Ms. Lopez’s case. The ethics team advised weighing the risks and benefits of diagnosing and treating Ms. Lopez over her objection, given the limited information about her brain lesion and prognosis. The team was particularly mindful of the uncertainty about whether treatment might restore her decisional capacity. The clinical ethicists emphasized that the bar for treating this patient over her objection was especially high given the substantial risks and onerous burdens of treatment (if her tumor was found to be cancerous), which would have included daily sedation, radiation, and chemotherapy. The prospect of restoring Ms. Lopez’s decisional capacity (and her autonomy) would provide a reason to treat her brain tumor despite her objections, as it would enable her to participate in future decisions about her medical treatment. However, the neurology and neuro-oncology doctors thought that was unlikely.

The Decision

In light of the determination of the neurology and neuro-oncology doctors, and, taking into consideration the burdens of treatment and uncertain benefits, the clinical ethics team advised against treatment that would be coercive and unwanted. The medical team then decided against treatment, obviating the need for further diagnostic testing. Six months into Ms. Lopez’s hospitalization, adult protective services was granted guardianship, and two months later she was discharged to a skilled nursing facility.

The incidental finding of the brain lesion was a game-changer for Ms. Lopez and her medical team. If Ms. Lopez had decisional capacity, her choice not to treat a brain tumor would have been accepted, particularly for one with a high risk of mortality like a glioma. Palliative and hospice care would have been reasonable alternatives to curative treatment. Because Ms. Lopez’s brain lesion was never fully diagnosed, whether or not her prognosis is in fact poor remains uncertain, rendering a thorough risk-benefit analysis impossible. In the end, questions concerning the cause of her psychosis also remain unresolved, but the anticipated burdens of coercive diagnosis and treatment appropriately tipped the balance against further exploration given the uncertain prospect of benefit.

Lingering Questions

At several decision points, there were significant legal constraints on the medical team. Foremost among them is that in our state (New York), patients who lack decisional capacity retain the right to object to surrogate decisions and treatment, at which point a court order must be obtained. In our view, these constraints appropriately protect vulnerable patients from unwanted, coercive treatment.

Persistent ethical questions recurred throughout Ms. Lopez’s hospitalization, specifically with respect to her rights and medical needs as a vulnerable, unrepresented patient without decisional capacity, and about balancing the significant burdens and risks of treatment over objection for a patient who denies illness and appears unlikely to recognize the benefits of treatment. One lingering question is whether, all things considered, we did enough for Ms. Lopez.

L. Syd M Johnson, PhD, is an associate professor at the Center for Bioethics and Humanities and a clinical ethics consultant at Upstate Medical University in Syracuse, N.Y. (@LSydMJohnson) 

Rachel E. Fabi, PhD, is an associate professor at the Center for Bioethics and Humanities and a clinical ethics consultant at Upstate Medical University. (@faBioethics)

Series Editors’ Comment: Overriding Persistent Refusals

While state laws and hospital policies often draw stark lines between having and lacking decision-making capacity, ethics consultation often operates in the space in between. Ms. Lopez clearly and consistently objects to medical interventions, but she also does not demonstrate that she understands the risks and benefits.

An ethical analysis of treating an incapacitated patient over their objection requires taking numerous factors into consideration, such as the patient’s known values and well-being interests, invasiveness and duration of the intervention, its likelihood to achieve health goals that seem to matter to the patient (at least given their other stated values), whether the patient’s stated objections are enduring or more fleeting, and whether restraints or sedation would be necessary. The ethical presumption is to respect the patient’s bodily sovereignty and stated values and to build the therapeutic relationship with health care professionals. Without a surrogate decision-maker to guide the team towards a decision that Ms. Lopez would choose for herself if she had a better understanding of her medical circumstances, health care professionals must choose between the harm of overriding her preferences (even if not autonomous) and the harm of not providing beneficial medical interventions. Johnson and Fabi help to specify the scope of each. There is a spectrum here. Compelling medical interventions that are brief and temporary but are life-sustaining and/or would restore decision-making capacity can often be ethically justified. Compelling painful interventions over time without likely benefit of survival and restoring decision-making capacity are unlikely to be ethically justifiable. As shown in Johnson and Fabi’s essay, each intervention has to be considered separately; in Ms. Lopez’s case, the psychiatric interventions have to be analyzed separately from any interventions for the incidental finding of her brain mass.

In this space, justice is a key consideration: important to name though perhaps impossible to resolve. Overriding Ms. Lopez’ objections would be disrespectful of her agency over her body and life (even if not technically disrespectful of autonomy). This is an injustice that is disproportionately experienced by patients with psychiatric illness. At the same time, Ms. Lopez may be more likely to not receive life-sustaining and otherwise beneficial medical care due to the very same stigma around psychiatric illness. How should providers balance justice as respecting Ms. Lopez’s agency with justice as ensuring she receives standard of care? This is a difficult balance that is important to name, though caring clinicians and ethicists may disagree about which way to err. Johnson and Fabi ask the important question of “have we done enough?” Have health care professionals equitably engaged with Ms. Lopez to meet her needs by building trust and supporting medically beneficial interventions, while also demonstrating respect for her agency? Is there more that individual clinicians as well as inpatient institutions should be doing to advocate for patients when illness and bias impede them advocating for themselves?

– Gina Campelia, Laura Guidry-Grimes, and Adira Hulkower

This is the second clinical ethics case study in a periodic series for Hastings Bioethics Forum, based on real cases. Read the first case.

Learn more about the series, Clinical Ethics Case Studies for Hastings Bioethics Forum.

Attention clinical ethicists: learn how to contribute to the series.

doctor using tablet with AI

Bioethics Forum Essay

ChatGPT in the Clinic? Medical AI Needs Ethicists

by Emma Bedor HilandPublished Posted in Artificial Intelligence, Hastings Bioethics Forum

Concerns about the role of artificial intelligence in our lives, particularly if it will help us or harm us, improve our health and well-being or work to our detriment, are far from new. Whether 2001: A Space Odyssey’s HAL colored our earliest perceptions of AI, or the much more recent M3GAN, these questions are not unique to the contemporary era, as even the ancient Greeks wondered what it would be like to live alongside machines.

Unlike ancient times, today AI’s presence in health and medicine is not only accepted, it is also normative. Some of us rely upon FitBits or phone apps to track our daily steps and prompt us when to move or walk more throughout our day. Others utilize chatbots available via apps or online platforms that claim to improve user mental health, offering meditation or cognitive behavioral therapy. Medical professionals are also open to working with AI, particularly when it improves patient outcomes. Now the availability of sophisticated chatbots powered by programs such as OpenAI’s ChatGPT have brought us closer to the possibility of AI becoming a primary source in providing medical diagnoses and treatment plans.

Excitement about ChatGPT was the subject of much media attention in late 2022 and early 2023. Many in the health and medical fields were also eager to assess the AI’s abilities and applicability to their work. One study found ChatGPT adept at providing accurate diagnoses and triage recommendations. Others in medicine were quick to jump on its ability to complete administrative paperwork on their behalf. Other research found that ChatGPT reached, or came close to reaching, the passing threshold for United States Medical Licensing Exam.

Yet the public at large is not as excited about an AI-dominated medical future. A study from the Pew Research Center found that most Americans are “uncomfortable” with the prospect of AI-provided medical care. The data also showed widespread agreement that AI will negatively affect patient-provider relationships, and that the public is concerned health care providers will adopt AI technologies too quickly, before they fully understanding the risks of doing so.  

Technological advances move quickly, but the regulatory dimensions of innovations always lag behind. This makes the lack of widespread discourse about the risk of harm from AI in health and medicine concerning, and the obligation to have conversations about this even more pressing. Ethical questions should be central to any conversation about AI and its use in medical care and practice for two reasons. First, people deserve clarity about what data AI and the platforms providing them will collect, use, and sell or share. Second, and more relevant to my focus here, is that just because it is possible for us to utilize AI in medicine or another health-related context does not mean that we should do so. Despite whatever excitement exists about the possibilities of sophisticated, conversational AI in medicine, we are already seeing problematic examples of its use.

Consider a recent Twitter thread written by Koko co-founder Rob Morris last month. Koko, a platform that connects anonymous persons experiencing mental distress with volunteers who send supportive messages, studied users’ responses to AI-generated messages without obtaining the users’ consent. In a series of tweets Morris described the company’s use of ChatGPT3 and said that it helped volunteers construct messages for people who had come to the platform. He then disclosed that users had rated those experiences poorly after learning that the messages they’d received had been written by ChatGPT, not by humans.

The backlash came quickly, and Morris’s Twitter thread was soon inundated with criticisms: that Koko’s users had clearly not consented to participating in this study, that they had been unaware that the messages they received would be constructed by AI, and that the company’s actions had been unethical. For those already concerned about the use of AI in medical contexts, this response was unsurprising. While messaging with a chatbot or another AI-powered tool might be fine if it is disclosed, deceiving a person about who or what they are communicating with (including deception through omission) demonstrates a lack of respect for autonomy. What’s more, in the Koko experiment, users had unknowingly been enrolled in a study without the chance to opt out. The indignity of not being provided with the service they sought when using the platform (that is, the ability to message with another human), coupled with Morris’s self-congratulatory tweets discussing their data, demonstrate how excitement about novel technologies all too often results in a lack of consideration of ethics.

While Koko represents a case study of how not to use AI, it does provide a useful starting point for conversations about the ethics of AI in medicine and in health-related research. How, when, and where should disclosures take place to ensure that potential users understand that a health or medical technology is using AI, for example? Most people do not read terms of service and user agreements carefully. Even if they tried, it is unlikely that all the terms would be understood. Is it unethical to include such information only in those places? The answer is a resounding yes. This information should be prominently placed, front and center, on any medical device or consumer-facing platform that utilizes AI. It must explain, clearly and without medical or technological jargon, how the AI is used, for what purposes, and what will be done with any user data that is collected. Only then can individuals truly make informed decisions about whether to use those tools or participate in research that uses them.

It seems that we are approaching an inflection point in the relationship between AI and ethics. For too long the dominant paradigm has been that ethical concerns are secondary to the grand narrative of technological progress. Yet I believe it is possible to move away from this status quo and change the normative perspective, particularly as ChatGPT and AI in general are currently not only objects of public fascination, but also of concern. Expecting technologists to be self-regulating when it comes assessing whether their tools and interventions are ethical has often proved to be unsuccessful. The insight of ethicists, for whom these matters are front and center, is sorely needed. Now is an opportune time to not only intercede into public discourse about AI’s role in health and medicine, but also to establish a set of best practices and evaluative criteria to be used in examining medical AI applications before their release or implementation. As a result of ethicists’ interventions, technologies that could potentially cause harm would never have the chance to do so.

Emma Bedor Hiland, PhD, is an assistant professor of communications at the College of Saint Rose in Albany. @EmmaBedorHiland

Chinese scientist He Jiankui

Bioethics Forum Essay

Is Chinese Bioethics Ready to Move Forward from the CRISPR Baby Scandal?

by Joy Y. Zhang  and Ruipeng LeiPublished Posted in Gene Editing, Hastings Bioethics Forum

The Third International Summit on Human Genome Editing is being held in London this week. Chinese biophysicist He Jiankui’s illegal experimentation with heritable human genome editing, announced at the Second International Summit in Hong Kong four years ago, will haunt some of the discussions. To what extent has the Chinese bioethics community addressed gaps exposed by the CRISPR Baby scandal and prepared to prevent similar future scenarios?

The newly published updated version of China’s Measures for the Ethical Review of Life Science and Medical Research Involving Humans,as well as our reflections on the first public bioethical discussion of Chinese academics with He, recently gave a mixture of optimism and concern. While China has made substantial improvements in its national ethics review regulation, vulnerabilities remain. More importantly, we argue that, in addition to legislative updates, encouraging a culture where Chinese academics feel comfortable having open and frank conversations on challenging questions is critical for the improvement and delivery of ethical oversight.

Three ethical governance gaps exploited by He

If He’s CRISPR Baby experiment proved anything, it was his deftness in exploiting vulnerabilities in the system of research governance. At the time, He was an academic at the Southern University of Science and Technology funded by the Shenzhen Science and Technology Innovation Commission, and his research involved at least two hospitals in China. He succeeded in bypassing four separate institutions, described in an article in the leading news outlet The Paper.

Enforcement has always been a challenge in China’s research governance. He Jiankui exploited at least three system vulnerabilities that the China’s bioethics community has long campaigned for regulatory attention to. First, He’s case demonstrated the danger of China’s widening regulatory gap between a national push for academics to engage with the industry and private ventures and a chronic negligence of building corresponding ethical and governing infrastructures for them. Second, He’s successful evasion of administrative supervision reminded us of the fragmented nature of China’s science governance. In the absence of a transparent regulatory culture, Chinese institutions often have little idea of what one another is doing (or not doing). Finally, there are regional and institutional disparities in governing capacity and in general awareness of what constitutes research ethics. For example, the informed consent that He used was more like a business contract aimed at protecting researchers and research institutions from future legal obligation than an ethics document designed to inform and ensure patient welfare.

China was quick to address regulatory gaps exposed by He Jiankui. Within a couple of months of his announcement, China’s National Health Commission started work to update its 2016 “Measures on the Ethical Reviews of Biomedical Research Involving Humans.” One of us, Ruipeng Lei, provided a series of expert consultations in the drafting of the updated Measures. In 2020, the idea of promoting ethical governance was officially incorporated into China’s national agenda through the central government’s founding of the National Science and Technology Ethics Committee. In March 2021, a draft version of the new ethics review measures in biomedical research was released for public consultation. A year later, a draft of the Implementing Rules for Human Genetic Resources Management was released for public comment. (The final version is expected to be released this year.) The 2022 promulgation of the Guidelines on Enhancing Ethical Governance of Science and Technology led to the establishment of a dedicated task force on university education on ethics in science and technology. The promulgation of the 2023 Measures was the latest, and arguably the most important and comprehensive national legislation on bioethics China introduced since 2018.

While the 2023 Measures provides substantial regulatory upgrade on a range of issues, the impact of He’s scandal was also quite evident. This can be seen in the following categories of changes.

First is a much anticipated widening of regulatory scope. The 2023 Measures broadens ethics reviews beyond conventional human subject research to include studies involving human cells, tissues, organs, bodily fluid, flora, fertilized eggs, embryos, fetuses, bioinformation and associated data, health records, and human behavior (Articles 3, 50, 51). In addition, all research institutes—including medical institutions, universities, and institutes collaborating with industry and business–must observe the ethical clearance and supervision stipulated by the 2023 Measures (Articles 2, 28). There is special caution for research relating to human reproduction or involving cloning, heritable genome editing, germline cells, embryos, and fetuses (Article 17). In other words, the 2023 Measures makes it less likely for life science research to evade ethics reviews.

Second, the 2023 Measures further identifies a list of inactions and wrongdoings subject to penalty. They include using (or fabricating) one hospital’s ethics review for research conducted in another hospital, as He did in his 2018 experiment. Researchers are also subject to sanctions when they fail to report to the ethics committee on research progress or fail to submit records on the national research database (Article 46). These changes help to reduce disparities in ethics oversight across different research entities and research topics. 

The third category of updates is the policy’s specification of how research participants are to be informed and empowered. For example, Article 36 stipulates what must be included in informed consent. Furthermore, for the first time, institutions are obliged to ensure that ethics committees are sufficiently funded and have appropriate human and material resources, and that they provide regular ethical trainings to scientists, administrators, and students (Article 39). These requirements will no doubt increase governing capacity and general awareness of responsible research.

However, key ambiguities remain in the 2023 Measures, which make it potentially vulnerable to exploitation. To begin with, it falls short of directly addressing privately funded life science research, even though the ability to collect and access health data and bioinformation extends beyond academia and is exercised by social and private ventures.

We draw particular attention to Article 32, which allows ethics review exemptions for life science research with publicly available data, anonymized bioinformation, existing biosamples, and biomaterials within the scope of original consent (with the exception of germline cells, embryos, and reproductive research). For the time being, projects that meet the exemption criteria will be based in hospitals, universities, and research institutions with codes of conduct that will keep research in check. However, as scientific practice continues to evolve beyond and across traditional research institutions, such a broad description of ethics review exemption may create regulatory loopholes.

Another missed opportunity in the 2023 Measures is that while it requires individual and institutions to record research activities in a consolidated national medical research database, a recording (bei-an) is not registration, which would necessitate review and approval of the record submitted. Having a consolidated national database itself does not help prevent or identify possible research misconduct. It is important to remember that He Jiankui submitted a record of his CRISPR research to China’s database, but the information was not reviewed by an authority.

For China to minimize the chance of future regulatory failure and advance the credibility and influence of its ethical governance, new policies are not enough. China also requires a cultural change to encourage more of its academic researchers to initiate and contribute to open and inclusive bioethical discussion on new technologies, especially those that raise controversial issues.

Normalize inclusive participation, resist politicization

One governance challenge exposed by He’s case that has been largely ignored is how the politicization of research misconduct and scandals often impedes collective reflection and finding appropriate solutions.

In China, He and his research have been seen as a national disgrace. Public academic and media discussions on this topic have become extremely scant because it is seen as politically sensitive. In fact, at the time of writing, details of He’s three-year prison sentence, which ended last year, and the restrictions put on his research involving humans are still not in the public domain and are opaque to most scientists and bioethicists. In contrast, He has been marketing his new private venture on gene therapy for DMD. But concerns of political sensitivity in China have restrained public discussion of He’s statements, giving him considerable freedom to spread misinformation to patients, and leaving his hyperbolic claims on his DMD research unchecked and unchallenged.

Internationally, events with He such as Harvard’s small circle closed-door discussion in 2022, have fueled his PR strategy. No findings from the Harvard meeting have been made public. Gatekeeping access to information to a small circle seems to legitimize China’s lack of transparency on He and his research. The distorted image of an elite Western university conducting a closed-door investigation of He also fans national divides within global scientific community. The perceived lack of transparency of Western institutions and an already pervasive nationalist sentiment in China have made public reflections on He and his work even more difficult in China.

To resist the stagnating effect that the politicization of He’s scandal has brought to ethical and regulatory dialogue, we convened the first open bioethics discussion on CRISPR technology for and with Chinese academics on February 11. Called ‘Looking Back into the Future: CRISPR and Social Values, it was also the first public event at which  He agreed to interact with Chinese bioethicists and other CRISPR scientists.

We consider it important for Chinese bioethics to develop its credibility and influence by enabling academics to discuss controversial cases in public. Approximately 110 participants from 13 countries attended this meeting, including at least 70 Chinese academics from 12 provincial jurisdictions in China. We originally hoped that He, with the three other Chinese CRISPR scientists we invited as speakers, would look back at his research experience and comment on how ethics and scientific research can be better integrated in China. But we also anticipated that He may use this event as a publicity stunt and refuse to engage with critical questions. However, we considered that, given his active recruitment of DMD patients for his new study, his refusal to clarify key questions recorded in a public event was also of public interest.

At the meeting, He did not discuss his past work and refused to answer questions from the audience, raising concern with Chinese scientists and their global peers that he does not have a plan in place to carry out his DMD gene therapy research responsibly and ethically. More significantly, the event prompted Chinese scientists to consider the administrative gaps in their everyday research. It also nudged Chinese mainstream media to publicly challenge He for the first time on his DMD research and call for further public oversight. As a result, He halted his online marketing to patients.

On March 2, more than 200 Chinese bioethicists, lawyers, and scientists, along with DMD patient representatives, had an online meeting on how to better govern genome editing in China. It was co-sponsored by the Center for Ethics and Moral Construction Research at Renmin University of China, the Center for Technological Ethics Research at the Beijing Stem Cell and Regenerative Medicine Research Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, the Center for Bioethics Research, and the Research Center for Life Ethics at Huazhong University of Science and Technology. A consensus statement  was later jointly endorsed by the speakers, condemning He’s irresponsible gene therapy research and calling for regulatory transparency and the open discussion of controversial issues globally.

As we have argued elsewhere, the best way to promote a more transparent and accountable regulatory culture in China is to enable more ordinary scientists to have a voice in both domestic and international debates. Ethical governance cannot be achieved simply by extending rules and regulations. It is crucial for Chinese scientists to feel supported and respected when participating ethical discussions, especially on controversial issues. Is Chinese bioethics ready to move forward from the CRISPR baby scandal? As one Chinese academic platform, ScholarSet, summarized, for He Jiankui, a denial of the past is a denial of a future, yet Chinese science and Chinese bioethics must walk out of the shadows and turn a new page, collectively and responsibly.

Joy Y. Zhang, PhD, is a sociologist and founding director of the Centre for Global Science and Epistemic Justice at the University of Kent in the U.K. (@DrJoyZhang)

Ruipeng Lei, PhD, is a professor in the School of Philosophy and Executive Director of HUST Centre for Bioethics, Huazhong University of Sciences and Technology in China, vice president of Chinese Society for Bioethics, a member of WHO COVI-19 Ethics and Governance Working Group, and a Hastings Center fellow.

epa10293062 Democratic Senate candidate for Pennsylvania John Fetterman speaks at an election eve rally in Pittsburgh, Pennsylvania, USA, 07 November 2022. The US midterm elections are held every four years at the midpoint of each presidential term and this year include elections for all 435 seats in the House of Representatives, 35 of the 100 seats in the Senate and 36 of the 50 state governors as well as numerous other local seats and ballot issues. EPA-EFE/JIM LO SCALZO

Bioethics Forum Essay

Enough Already with the Medical Cheap Shots

by Arthur Caplan and Jonathan D. MorenoPublished Posted in Bioethics

All manner of officials in high places in the United States have been coming under scrutiny lately as to their fitness for office. Donald Trump Jr. piled on to right-wing attacks on Senator John Fetterman (D-Pa.), calling him the “vegetable senator from Pennsylvania” during an episode of his “Triggered” podcast. Shortly thereafter Fetterman checked himself into Walter Reed National Military Medical Center to receive treatment for depression.

Former South Carolina Governor Nikki Haley, age 51, led off her run for the presidency by offering a vision of America in which “We’ll have term limits for Congress and mandatory mental competency tests for politicians over 75 years old.” That just happens to be an age just below that of the only other major Republican in the race. Donald Trump who is 76 years old. Haley’s call for mandatory mental testing would cover one-tenth of the Senate, including Mitch McConnell, Bernie Sanders, and Charles Grassley, all 80 or older.

President Biden just underwent his annual physical. The 80-year-old was declared “fit for duty” by his doctor, Kevin O’Connor. O’Connor said, in a letter published by the White House, that “President Biden remains a healthy, vigorous, 80-year-old male, who is fit to successfully execute the duties of the Presidency, to include those of as Chief Executive, Head of State and Commander in Chief.”

This news was greeted with absolute scorn by former White House physician and now Congressman Ronny Jackson. Jackson, who has himself faced incompetency allegations, said, “The majority of Americans can see that Biden’s mental health is in total decline, yet there is no transparency from the White House on what’s going on, if anything, to address this issue and his inability to do his job.” 

He said that the written physical exam report released by Biden’s physician apparently confirms that this administration is still adamant about “concealing the truth” and “This is alarming, considering I have already sent three letters to the White House demanding that Biden receive a cognitive test and that the results be made public . . . “

Some psychiatrists continue to believe that Donald Trump is utterly mentally unfit to be President. They might be right, but Americans have used allegations about mental fitness against their political enemies almost since the beginning of the Republic, with little attention to medical facts. Thomas Jefferson, who may have been dyslexic, described his archrival John Adams as “sometimes absolutely mad.” Lincoln’s bouts of melancholy were well known and spoofed. Eisenhower was widely derided as a buffoon, as was Gerald Ford, of whom Richard Nixon said he played football without his helmet once too often. In a survey, GOP candidate Barry Goldwater was viewed as mentally ill by dozens of psychiatrists. We will never know if Ronald Reagan really suffered from dementia while in office, but his enemies felt free to say so.  Woodrow Wilson, on the other hand, was incapacitated by a stroke but few knew it.

George W. Bush was not celebrated for his IQ, but you can also be called too smart, like “egghead” two-time presidential candidate Adlai Stevenson, or too intellectual like Barack Obama.

Policy debates are boring. Gossip is fun. Perhaps that’s why politicians continue to use candidates’ physical and mental health as cudgels with which to beat each other or to ignore when it suits their self-interest. America deserves much better.

Arthur Caplan, PhD, is the founding head of the Division of Medical Ethics at NYU Grossman School of Medicine. He is a Hastings Center fellow and a member of The Hastings Center’s advisory council.

Jonathan D. Moreno, PhD, is the David and Lyn Silfen University Professor of Ethics at the University of Pennsylvania and a Hastings Center fellow  (@pennprof)

jail cell with open door

Bioethics Forum Essay

Is It Ethical to Reduce Prison Sentences in Exchange for Organ Donation?

by Franklin G. MillerPublished Posted in Hastings Bioethics Forum

A bill filed in the Massachusetts House of Representatives on January 20 would allow prisoners who choose to donate organs or bone marrow for transplantation to be eligible for reduced sentences. The bill stipulates that the sentence reduction would be at least 60 days and no greater than one year. Is such a policy ethical? For the sake of this essay, I will address this question with respect to donation of a single kidney.

The proposed law is intended to serve a clear benefit:  to promote organ donations that can save lives or improve the quality of life for patients with end-stage renal disease—donations that otherwise likely would not occur. However, this policy is apt to evoke moral qualms.

Many people might respond with an immediate intuitive judgment that it would be unseemly to induce incarcerated individuals to undergo a surgical operation, with non-zero risk of death or lasting morbidity, for the sake of reducing their prison term. Such an intuition might be a signal that the policy is unethical, but it doesn’t suggest any reason why prisoners should not have the option to make a donation that is deemed acceptable, and laudable, for healthy individuals who are not in prison.  To be sure, it is not the option itself, but providing the incentive for the option, that appears problematic in the prison context.  Several ethical concerns can be raised about the proposed law.

First, the incentive might be considered a bribe. Bribes, properly speaking, involve inducements for wrongful conduct, but there is nothing wrong with donating a kidney to benefit someone in need. Second, the offer of a sentence reduction might be seen as coercive. This, however, is a common misconception, as coercion involves a threat of harm to induce an undesired act, such as surrendering one’s wallet at gunpoint. While prison is a paradigmatic coercive environment, under this policy prisoners would be free to choose whether to donate a kidney, and there would be no penalty to those who choose not to donate. Third, the offer of a sentence reduction might be regarded as  an undue inducement. But the inducement would be undue only if it were to distort the rationality of an incarcerated person’s judgment concerning whether the benefits of a sentence reduction warranted the risks of the organ procurement operation. This problem could be obviated by a scrupulous process of consent for the donation obtained by a neutral party not employed by the prison to assure that it is a voluntary and adequately informed choice. (The bill is deficient in omitting any mention of informed consent.)

A fourth objection is that such a policy exploits incarcerated individuals who are highly motivated to reduce their time in prison. In his influential book, Exploitation, Alan Wertheimer offered a systematic analysis of this concept.  He wrote, “At the most general level, A exploits B when A takes unfair advantage of B.”  Clearly, the proposed law is meant to take advantage of the situation of individuals in prison by promoting organ donations in exchange for reduced sentences. Is that advantage-taking unfair? Wertheimer makes an important conceptual point: “There is a distinction between taking advantage of unfairness (or misfortune) and taking unfair advantage of unfairness (or misfortune).” The latter counts as exploitation; the former does not.

Incarceration for individuals found guilty of committing crimes is not per se unfair. In the U.S., however, imprisonment is characterized by pervasive unfairness, including racial inequities in sentencing, excessively long sentences, and inhumane conditions.  It doesn’t follow that the offer of prison sentence reduction in exchange for organ donation unfairly takes advantage of incarcerated individuals. Rather, it gives them an opportunity to judge whether, on balance, they are better off reducing their  time in prison in exchange for an organ donation, in addition to benefiting a person in need of a transplant.  On the other hand, one might judge that the sentence reduction offered, from 60 days to one year, is not sufficiently large to be fair to those willing to undergo the risks and discomforts of a kidney donation operation.

Although anticipating that others will disagree, I reach the tentative judgment that the proposed Massachusetts law is not unethical, provided that necessary conditions for obtaining informed consent and assuring the safety of donors are implemented. The latter would include carefully screening  candidates to assure that they are healthy enough to withstand kidney donation without undue risk, performing the operations to procure organs in health care institutions with a track record of high-quality for the procedure, and providing adequate follow-up medical care for the donors.

 The case for or against the ethics of a policy that offers prison sentence reduction in exchange for organ donation would be enhanced by conducting a survey of previously incarcerated individuals to ask whether or not they judge the policy to be acceptable and for what reasons.  These research participants would know about the prison environment without currently being subject to it.  While empirical research cannot, itself, resolve ethical issues, it would be informative if a majority of the respondents were opposed to or in favor of such a policy.

Franklin G. Miller, PhD, is a Professor of Medical Ethics in Medicine at Weill Cornell Medical College and a Hastings Center fellow and board member.  

stressed young man sitting at desk with computer

Bioethics Forum Essay

Quiet Quitting Undermines Human Flourishing

by Katherine WassonPublished Posted in Hastings Bioethics Forum

Quiet quitting, the trend in which people do only the minimum in their jobs, has captured attention in the news and on social media. More than half of U.S. workers are quiet quitting, according to a recent Gallup poll, and most of them are in their 20s and 30s. I was discussing this trend with my bioethics colleagues, and we considered the ethical implications for people’s well-being.

Examining the context for quiet quitting begins with American culture around work. Our society has always placed a high value on work and having a robust work ethic. “What do you do?” is one of the first and seemingly most important questions we ask people. Americans derive a significant part of their self-worth from their work in contrast to people in many other countries. But Americans’ view of work seems to be shifting for several reasons.

The Covid-19 pandemic has had a huge impact on work and on employees’ perceptions of it. On the positive side, work may no longer be the be all and end all. People may have adjusted the balance between work and other priorities and found that they gain equal or more meaning from life outside of work, i.e., family, friends, hobbies.  People under 40 report less engagement with their workplace and lower thriving and well-being than older people. Finding a better balance between work and life is not all bad, but quiet quitting isn’t the answer. The reason is that it is associated—as a cause, an effect, or perhaps both—with people finding a lack of meaning through their work, which could diminish human flourishing in the long term.

The shift to remote work during the pandemic may have contributed to lower fulfilment at work for many people.  The virtual world means less social contact and interaction with colleagues some of whom may be new. One example that kept coming up in my conversations with bioethics colleagues is that  a question or discussion needs to carry a certain weight to warrant scheduling a meeting online. So, the more casual human interactions are largely lost. Social interaction is a benefit of working together. A recent U.S. Surgeon General report identified five essential domains to support workplaces as engines of well-being: protection from harm, mattering at work, opportunity for growth, connection and community, and life-work harmony.  Specifying these domains acknowledges both the ideal relationship we should seek with work and its importance in fostering well-being and flourishing.

Detachment from work is not good for us as individuals or for society. We gain a deep sense of satisfaction from knowing we have done excellent work, not simply minimal or good enough work. This doesn’t mean we need to, or should, derive all our worth and value from what we produce, but we benefit from having some stake in our work and thinking that it matters.   

As a society, we need to address the impact of the pandemic on the nature and culture of work, and reckon with our history of tying individual worth so strongly to what we do compared with who we are and what gives our lives meaning. We must understand the sources of quiet quitting and take action against them. Organizations must change by creating environments that enhance the well-being of their employees. Employers can begin by reaffirming the value of each individual to the organization, fostering social connections, and listening to what workers need to find a work-life balance. Only then can our society move toward more widespread human flourishing.

Katherine Wasson, PhD, MPH, HEC-C, is a professor in the Neiswanger Institute for Bioethics at Loyola University Chicago. (@kwasson2)

organ donation

Bioethics Forum Essay

Medical Aid in Dying and Organ Donation: Canada’s Autonomy Gap

by Courtney Sas and Michael SklarPublished Posted in Hastings Bioethics Forum, Organ Transplantation

In Ontario, Canada where we work and live, medical aid in dying, or MAiD, has been legal federally since 2016. Physicians can assist individuals in ending their lives if they have a “grievous and irremediable medical condition” that is causing unbearable physical or mental suffering. Bioethicists and policymakers have written widely about this process, pointing out the importance of respecting patients’ autonomy and reducing their suffering. And one of the most important aspects of the MAiD process in Canada is the respect for the patients’ wishes concerning organ donation.

MAiD patients can make decisions about organ donation without worrying that those decisions will be discounted. In contrast, people who die of all other causes do not get that degree of respect for autonomy. Their wishes are subject to the approval of loved ones and substitute decision-makers, who can choose not to donate their organs after they die. We believe that Canada is moving in the right direction with its respect for patient autonomy by allowing organ donation after MAiD, and that this respect should be granted to all patients. 

The number of countries that allow MAiD is increasing, but only Belgium, the Netherlands, Spain, and Canada allow organ donation after MAiD.  In Canada, whether to donate one’s organs is one of the decisions patients make in the extensive MAiD process, with thought and care going into each step. Physicians and hospitals ensure that there is informed consent, both for MAiD  itself and organ donation. There are specific requirements to make sure there is no pressure or coercion. These requirements are important  We as a society worry about pressure to donate, impact on a donor’s end-of-life experience and dignity, and respect for the person’s autonomy.  And it is important to maintain public trust in the MAiD and organ donation processes, which we do by treating donors with respect, protecting their autonomy, and recognizing the sanctity of their life and their sacrifice. In fact, a recent study revealed that Canada has the world’s highest number of organ donors from MAiD patients.

But we should give the same respect to people who opt to be organ donors outside the MAiD process. Their organ donation decision should not  be overridden by family members or other substitute decision-makers. Surrogate decision-makers can’t claim that they do not know the patient’s wishes: Ontario is one of several provinces that provides an online database for patients to record their advance directives with organ donation decisions, a huge step in the right direction. A patient’s clearly expressed and fully autonomous desire should not be subsidiary to that of a substitute decision maker and/or power of attorney. 

It is not common for a family to go against a loved one’s wishes in Ontario—but it happens.  Data from 2015 found that 20% of families overrode their loved one’s consent after the individual had passed away. We are left with an ethical tension: we aim to respect autonomy and minimize harm through MAiD, and yet, apart from MAiD, patients’ wishes around organ donation are not always respected. The wishes of those who die via MAiD should not receive more respect than the wishes of those who, for instance, choose to withdraw life support.

As health care clinicians, we see this discrepancy play out with patients who have kidney disease. The respect we have for our dialysis patients and their autonomy in end-of-life care is fundamental to our practice. For patients who want to withdraw from life-sustaining therapy, we help with advance care planning and allow them to make that choice with fully informed consent. However, when we discuss organ donation with someone on life support, including someone who chooses to withdraw life-sustaining treatment, we always reference the family’s involvement in the decision because we know that the patient’s decision is not final. There is a marked difference between the respect for the wishes of a patient who chooses to withdraw life support and a patient who chooses MAiD, even though both patients are essentially making the same decision—to end their lives. Patient autonomy is not being given equal consideration in these different circumstances.

We also see very sick patients waiting desperately for a kidney to become available. In practice, we cannot ignore the harsh reality that people are suffering on a daily basis while waiting for a transplant, and organs are a scarce resource. We need to be very practical and logical when trying to increase access to life- saving organs. Ensuring that we secure organs from those that want to donate is critical.

Family discussions around end-of-life care are crucial, but the choices of family members and other surrogates should not be elevated over the individual’s choice. Organ donation is a courageous and altruistic act. For those who are brave enough to come forward and decide to do it, their autonomy should be celebrated and protected.

Courtney Sas, MSW, MBE, (@CourtneySas) is a clinical social worker with Masters in Bioethics who is an adjunct lecturer at the University of Toronto Faculty of Social Work and a member of The Hastings Center’s advisory council. Michael Sklar, MD, is an assistant professor of anesthesia at the University of Toronto and practices critical care medicine.

Black and white portrait of Will Gaylin

Bioethics Forum Essay

Will Gaylin’s Wit, Wisdom, and Kindness

by Thomas H. MurrayPublished Posted in Hastings Bioethics Forum

I suspect that most people’s introduction to Will Gaylin came from the introduction to the 1997 film Gattaca where this quote appears: “I not only think that we will tamper with Mother Nature. I think Mother wants us to.” 

So much of what made Will special and memorable is apparent in those two crisp sentences: his wit; his ability to provoke and unsettle; his wisdom on and fascination with how humans think, feel, and act.

I’ve had the privilege of knowing more than a few extraordinarily brilliant people from whose mouths seemed to spill spontaneous gems of polished prose. None surpassed Will. For those of us who must struggle in our writing to convey with clarity the complicated ideas we are driven to share, Will’s gift for off-the-cuff eloquence was awe-inspiring.

From uncountable hours spent with Will planning our joint projects, in the always spirited research group meetings, over cups of coffee in The Hastings Center’s kitchen on the Friday mornings when he brought eagerly awaited Entenmann’s pastries to share with us, and, later, when Will and his wife, Betty, shared glasses of wine with my wife, Cynthia, and me on Cape Cod, I came to treasure my time with him. Will used his astounding verbal agility, perfectly adapted to the Fred Friendly Columbia University Seminars on Media and Society to which he frequently contributed, not to intimidate but to invite conversation and disagreement. 

Will is credited with well over 100 articles and 20 books. We learned that he dictated his books, which Betty would then type. (As I recall, Cynthia reacted to that revelation with a mixture of astonishment and amusement—no such division of labor was remotely contemplated in our home.) He was a fount of fascinating, provocative ideas. I’ve wondered if his decades of work as a psychoanalyst, which I imagine required endless hours of patient listening, as a dam holds back the river’s flow, held back, for the moment, the torrent of ideas that coursed through Will’s fertile mind. Eventually they poured out into his speaking and writing. 

Most of all, I want to emphasize the kindness that Will and Betty—and there was no doubt they were full partners in this—showed us in good times and, especially, in the worst of times.

They encouraged us to vacation on Cape Cod, where they had recently purchased a summer home, in the early 1980s, directing me to an agent who replied, yes, he had an inexpensive weekly rental that accommodated 11–our family of six plus our cousins’ family of five. Thus began a string of 24 summers going to that same house, leading eventually to our purchase of a home one town over, where we now live. Will suggested that I look at the post of director of a nascent biomedical ethics center in Cleveland—Will’s hometown—after a memorable afternoon over glasses of wine. Will asked if we were ready to leave Texas, where I’d gone to work with a wonderful colleague and friend, Ron Carson, at University of Texas Medical Branch. Before I could utter the word “no” Cynthia uttered a forceful “yes!” The next summer we were on our way to the School of Medicine at Case Western Reserve University for an eventful and rewarding 11-plus years. Shaker Heights was and is a great place to raise a family.

What we remember with especial gratitude and love is how Will and Betty rushed to offer comfort and support when we needed it most. In 1983 I collapsed just before a lecture I was supposed to give in Michigan. The prosthetic aortic valve that kept me alive was failing; not enough blood was reaching my brain. Will used his network to find the best surgeon in the New York City area. The ball-and-cage replacement valve will be 40 years old this April. When I returned home after surgery, Will and Betty were among the very first to visit us. Their company was priceless; they also bought gifts. I remember books I read while recuperating; Cynthia remembers a sweater from Bloomingdale’s (the only item I’ve ever owned from that emporium).

In November 2000 we learned that our daughter Emily was missing from her college campus in rural Ohio. Whatever energy we could summon from the dread that threatened to envelop us was devoted to searching for our daughter. Being in our company was, I’m sure, emotionally wrenching. Betty and Will showed up immediately making the long drive north from Hastings-on-Hudson, N.Y, to Cold Spring, bearing food and, most of all, their companionship and empathy. That took courage, and loving hearts. We will always remember, and always be grateful to, Will and Betty Gaylin.

Thomas H. Murray is President Emeritus of The Hastings Center. He was President from 1999 to 2012.

New York City police restraining homeless man

Bioethics Forum Essay

New York City’s Involuntary Commitment Plan: Fulfilling a Moral Obligation?

by Aashna LalPublished Posted in Hastings Bioethics Forum, Psychiatry and Mental Health, Public health ethics

After a string of violent crimes involving mentally ill people who are homeless, New York City Mayor Eric Adams announced a plan last November for police and emergency medical workers to involuntarily remove people with severe mental illness from the streets and subways and bring them to hospitals for psychiatric evaluation. The announcement followed other recent policies addressing homelessness in the city and similar involuntary commitment plans in the state of California and in Portland, Ore. While involuntary commitment of some mentally ill people has been legal in the United States for decades, Mayor Adams’s plan increases use of the practice and calls for additional training of police and emergency responders to determine when it is necessary.

In his announcement, Mayor Adams argued that we have a “moral obligation” to help people who are mentally ill. But appealing to ethics begs the questions: Does this plan qualify as helping mentally ill people? And is it moral?

Bioethicists have been discussing the ethics of involuntary commitment for decades. Willard Gaylin, psychiatrist and cofounder of The Hastings Center, and Bruce Jennings, a Hastings Center senior advisor and fellow, examined this issue in their 1996 book, The Perversion of Autonomy: The Proper Uses of Coercion and Constraints in a Liberal Society. The book opens with a story of an unhoused mentally ill man who died on the street across from a hospital in New York City after refusing medical care from an emergency medical team. Gaylin, who died last month, and Jennings appeal to values, stating that it is morally dangerous to place too much value on individual autonomy and too little on care and support for people in need.

Paul Appelbaum and Thomas Gutheil, who are psychiatrists and bioethicists, made another argument in support of involuntary commitment, focusing on the human right to health care. While many argue that hospitalized psychiatric patients have the right to refuse medication, Appelbaum and Gutheil stated that they also have “the right to the best possible treatment for his psychiatric disorder (even if, as a result of that disorder, the citizen is inclined to refuse.)” Thus, if all individuals have a right to health care, Mayor Adams is correct in calling the involuntary hospitalization of severely mentally ill individuals a moral obligation.

However, while involuntary commitment may be both necessary and morally sound to provide people the health care they deserve, moral questions remain about Mayor Adams’s new plan.

First of all, the plan aims to move severely mentally ill people into psychiatric institutions, which currently lack the space and capacity to properly treat them. As Appelbaum and Gutheil pointed out, people have a right to the best possible treatment. However, such treatment is not possible with the current state of psychiatric care in New York. According to a 2018 report by the Manhattan Institute, nonforensic state psychiatric centers in New York City lost about 15% of their total adult bed capacity from 2014 to 2018. During roughly the same period, from 2015 to 2017, the number of seriously mentally ill homeless New Yorkers increased by 22%, and every year from 2014 to 2018, there was a rise in the number of “emotionally disturbed person” calls responded to by the New York City Police Department.

The lack of capacity of psychiatric institutions is not a new problem. As a result of deinstitutionalization, a national movement beginning in the 1950s that moved psychiatric patients out of state institutions and into communities, many mental health care facilities closed. The significant reduction of beds for psychiatric patients means that many people with severe mental illness who need residential treatment cannot receive it. This problem is reflected in decreasing lengths of stay for patients in New York State psychiatric hospitals.

The consequences of involuntarily committing people before addressing the shortages within psychiatric centers will be significant. Mentally ill and homeless people currently cycle through the criminal justice system–-people who are homeless are more likely to wind up in jail, and formerly incarcerated people are 13 times more likely to experience homelessness than the general population. Additionally, it is estimated that  44% of people incarcerated in jail and 37% of people incarcerated in prison have a mental health condition. With New York City’s new plan, it is not difficult to imagine an outcome in which mentally ill homeless people also cycle in and out of psychiatric institutions.

Furthermore, giving the police a bigger role in involuntary commitment could increase the risk of these negative outcomes. Critics argue that Mayor Adams’s policies addressing homelessness, including clearing homeless encampments and increasing police presence in subways, rely far too heavily on the police. Reliance on the police for these issues is not new–-across the country and in New York City, police have long played a central role in governing the lives of homeless and mentally ill individuals-–but it is harmful for many reasons. It contributes to a long history of overpolicing of marginalized communities.

People with severe mental illness and people of color, primarily Black and Hispanic people, are significantly over-represented in the New York City homeless population. Discriminatory policing dates back to the beginning of policing in America, which has roots in slavery. Black and Hispanic Americans are killed at disproportionate rates by the police  compared to white Americans, and people with untreated mental illness are 16 times more likely to be killed by law enforcement than those without mental illness.

 A pattern of criminalizing homeless and mentally ill people in New York City is similarly concerning. In 1982, a transit police squad known as the Homeless Outreach Unit was formed to move homeless people out of subways and into shelters or social service programs. By 2010, the mission of this unit had shifted; officers arrested more than 2,000 people for petty violations, such as putting their feet up on a subway seat. By relying on police to determine whether an individual should be involuntarily hospitalized, Mayor Adams’s plan perpetuates a longstanding history of increased violence and criminalization towards homeless and mentally ill New Yorkers.

Additionally, the policing of homeless and mentally ill people contributes to a long history of policies that prioritize values of exclusion and intolerance, rather than rehabilitation and reintegration. In their paper on psychiatric patients’ right to refuse medication, Appelbaum and Gutheil wrote that continuing to treat these patients is in the interest of reintegration, which is in the interest of “citizenry at large.” While this may have been a value prioritized by citizens in the past, researchers point to a shift in the aims and values driving 21st century policy, “in which any previously-existing impulses to rehabilitate and reintegrate homeless people have been supplanted by the more aggressive and intolerant aims of exclusion and incapacitation.”

One policy that represents this shift is the 1994 zero-tolerance policing directive, Police Strategy No. 5: Reclaiming the Public Spaces of New York City, by New York City Mayor Rudolph Guiliani and Police Commissioner William Bratton. As seen through the Homeless Outreach Unit, policies like this one often are created with the purpose of preventing violence and increasing public safety, but instead turn into a “thinly-veiled attack on homeless people.”  By instructing officers to engage in the removal of mentally ill and homeless persons from public spaces, these policies imply that the homeless and mentally ill do not belong in public spaces that are meant to be for everyone. Part of a larger debate about what “public space” really means, scholars often argue that policing public spaces leads to the exclusion, not the reintegration, of homeless and mentally ill people from society.

The ultimate solution to support the health of mentally ill homeless individuals is affordable housing. Housing instability has severe consequences for mental and physical health, while housing the homeless consistently improves psychological distress and physical health. The Housing First model, “in which chronically homeless people with a diagnosis of a behavioral health condition receive supportive housing,” has widespread positive impacts. A 2018 study found that participants who got stable housing through this model had a decrease in the use of inpatient psychiatric hospitals and an increase in the use of food banks. They also spent less time in prison than participants who remained unstably housed. To stop the cycle of homeless mentally ill people going in and out of jails and hospitals, affordable housing must be the number one priority.

In the meantime, the probable harmful consequences of Mayor Adams’s plan should be addressed in other ways. More funding must go toward psychiatric services to support the long-term care needs of severely mentally ill patients. An important step forward is New York Governor Kathy Hochul’s announcement today about a $1 billion plan to address gaps in care for people with severe mental illness, including adding 1,000 beds for inpatient psychiatric treatment and 3,500 housing units. State psychiatric centers are not equipped to do much more than give patients medications and release them from the hospital. In addition, involuntary hospitalization decisions should be made by social workers and mental health care professionals, not by police. By limiting the interactions between police and severely mentally ill people, we may be able to decrease the violence and criminalization that these individuals face and truly fulfill the moral obligation to provide compassionate and effective care.

Aashna Lal is a senior project manager and research assistant at The Hastings Center.

young black woman lying on her back, looking concerned

Bioethics Forum Essay

Advancing Maternal Health Equity with Data Transparency: The Case of Texas

by Alice Story and Faith E. FletcherPublished Posted in Hastings Bioethics Forum, Health equity and racial justice ethics, Racial Justice

Health equity is an ethical and human rights principle that holds that everyone should have the opportunity to receive fair and just health. Health disparities—health differences between groups closely linked to social, economic, and/or environmental disadvantage–serve as a metric for evaluating progress toward health equity. Thus, an equity lens requires prompt access to racial/ethnic and other forms of demographic data to characterize and confront inequities in health and health care. So, it is concerning that Texas has delayed the release of the full report of the most up-to-date data on maternal health, further threatening the health of marginalized women, children, and families.

The importance of ethical and  timely dissemination of race/ethnicity data to advance health equity was underscored in a recent report by the Robert Wood Johnson Foundation, “Health Equity: Everyone Counts the Need for Disaggregated Data on Marginalized or Excluded Racial/Ethnic Group”: “When data are unavailable for a marginalized racial/ethnic group, their needs are rendered invisible when policies are made, resources are allocated, and programs are designed and implemented.” 

Characterized as a maternal health crisis, Black women in the United States are three times more likely to die from preventable pregnancy complications than white women. In light of this salient health injustice, the White House Blueprint for Addressing the Maternal Health Crisis outlines several priority areas to improve maternal health and outcomes in the U.S. They include “advancing data collection, standardization, harmonization, transparency, and research” to address the maternal health crisis. These priority areas are important for every state to implement, particularly, states such as Texas where the maternal mortality rate is slightly above the national level.

The expected release of the Texas maternal health report was slated for September but was delayed, according to the interim commissioner of the Department of State Health Services, to allow a full examination of 140 of the 147 pregnancy-and related childbirth-related deaths from 2019, most of which were preventable deaths. Earlier this week, key data and recommendations from the pending report were released citing a disproportionate increase in severe maternal morbidity (SMM) among Black women. Notably, while obstetric hemorrhage remained the leading cause of SMM and rates of hemorrhage-related deaths decreased for every population tracked in Texas, the rate increased among Black women.

While more evidence is needed to elucidate the drivers of adverse maternal health outcomes and inequities on a national level, in Texas, current policies such as inadequate Medicaid coverage directly influence the quality of maternal health care. Moreover, Black women scholars have long raised the importance of systematically centering the voices and perspectives of Black women in collective dialogue to inform equitable, respectful, and comprehensive reproductive and maternal health care. To ensure that reproductive health care is more accessible and equitable for all Texans, immediate access to reliable and accurate data is urgently needed to develop strategies with attention to the health care needs and experiences of Black women.

Generating more actionable public health information that reaches the general public is a national priority. At the height of the Covid-19 pandemic, misinformation and disinformation about the virus spread rapidly which fueled the public health crisis and led to continued distrust and frustration  among the public. This is especially problematic since we know that institutional distrust is shaped by untrustworthy actions and withholding vital data contributes and reduces confidence in health care and public health systems. Thus, strengthening the public’s trust in public health and health care systems calls for advocating for policy changes and interventions informed by health data and engaging trusted stakeholders to disseminate information and data to the affected communities.

As expressed by maternal health advocates and activists, the state of Texas has an ethical obligation to address the pressing maternal health needs of Black women through evidence-based policies and interventions to achieve maternal health equity. Insufficient data and resources complicate efforts to appropriately intervene and prevent the public and other stakeholders from making scientifically informed health decisions. To be clear, not releasing data continues to weaken the public’s confidence in public health systems, health care systems, and local public officials. These harms have affected minoritized populations during the Covid pandemic. 

Structural, political, economic, and environmental injustices continue to negatively affect the health of Black people in the U.S. Withholding resources, such as maternal health data that indicates clear racial disparities, is a direct manifestation of structural racism. Indeed, failure to disseminate accurate, reliable, and up-to-date data to the public reflecting the health status and needs of minoritized populations further perpetuates health inequities and contributes to anti-Black racism in health care. Identifying the social and structural determinants that drive the maternal mortality crisis through equitable and inclusive data collection and reporting represents a commitment to maternal health equity and ending the maternal health crisis among Black women.

Alice Story, PhD, MPH, is a senior research assistant at the Center for Medical Ethics and Health Policy at Baylor College of Medicine. Faith E. Fletcher, PhD, MA, is an assistant professor in the Center for Medical Ethics and Health Policy at Baylor and a Hastings Center senior advisor and fellow. (@FaithEFletcher)

people with suitcases traveling in China

Bioethics Forum Essay

A Warning from China: After the Zero Covid Policy

by Renzong QiuPublished Posted in Covid-19 Ethics Resource Center, Hastings Bioethics Forum

A massive wave of Covid infections has begun now that China has ended much of its zero Covid policy. Many cities no longer require people to have a negative test to enter public places such as entertainment venues, shopping malls, restaurants, and public transportation. Many people who live far from their families have not been back home for three years, and they are eager to visit. Intercity travel will surge dramatically, causing the virus to spread.

Sixty percent of the China’s population of 1.4 billion people could be infected during this Covid surge, which is expected to peak around the New Year festival in January, and eventually 80% to 90% of the population could be infected, according to an estimate by Dr. Feng Zijian, former deputy director of China’s Center for Disease Control and Prevention. The remarks, at a lecture at Tsinghua University on December 7, shocked people throughout China.

There is a Chinese saying, “We can’t have both fish and bear’s paw.” (It means, “You can’t have your cake and eat it too.”) However, this time we need to have fish and bear’s paw. The ethical imperative facing Chinese people and our government is to find a way to both fulfill people’s urgent desire to lift Covid restrictions (and restore normal life and the economy) and to minimize the resulting harms. Three steps ought to be taken to achieve this ethical imperative:  

Minimize the peak surge of infections. Actions to reduce infections, severe cases, and deaths should include continuing to require nuclei acid (P.C.R.) testing for some people, including employees in high-risk positions, such as nursing homes, medical institutions, kindergartens, and primary and secondary schools. Testing should also be required for people in high-risk zones, areas that have had at least one Covid infection within the last five days. Wearing masks remains mandatory in nursing homes, kindergartens, and primary and secondary schools, but it should be encouraged in supermarkets and other public places.    

Develop a resource allocation plan. Health institutions are stockpiling respirators, drugs, trained medical personnel, hospital beds, and other resources in advance of the anticipated surge in Covid cases. These resources need to be allocated fairly to ensure that they get to the patients who need them. Only severe cases ought to be treated in hospitals in isolation. Mild and asymptomatic cases should be treated at home when possible. And people should have access to medications to manage their symptoms, such as fever reducers, cough medicine, and decongestants. Local doctors and nurses should be trained to care for people who can’t manage their symptoms on their own and to recognize when patients should be transferred to a hospital.      

Increase vaccination among older people. While gradually lifting restrictions, we must increase vaccination of people over age 60. There are 267 million people over 60 in mainland China. Only 69% of them are fully vaccinated (with three doses of the vaccine available in China, which is recommended by the World Health Organization). Just 40% of people 80 and older have been fully vaccinated. Steps to increase vaccination should include setting up temporary vaccination sites and using mobile vaccination vans to bring vaccines where people live. Public messaging is needed to help persuade older people to get vaccinated.

The Chinese government at all levels should implement Covid policies that comply with bioethical principles of beneficence and nonmaleficence, respect persons, and justice. These three steps are a start.

Renzong Qiu is a professor at Institute of Philosophy in the Chinese Academy of Social Sciences in Beijing and a Hastings Center fellow.          

young black doctor talking with a female patient at desk

Bioethics Forum Essay

Grateful Patient Fundraising: Ethically Problematic or Altruistic?

by Heidi Walsh and Annie FriedrichPublished Posted in Hastings Bioethics Forum, Medical care ethics

Nonprofit hospitals increasingly rely on philanthropy to supplement decreasing clinical revenues and a decline in the growth of government research funding. Grateful patient fundraising programs, as they are known, employ a strategy in which hospitals seek donations from satisfied patients, often using public data to identify those who are wealthy and requiring their physicians to discuss giving opportunities with them. In a recent issue of Narrative Inquiry in Bioethics, 12 physicians discuss their experiences with grateful patient fundraising and take up legal and ethical issues.

While there are benefits from this approach—in addition to raising billions of dollars for health care institutions it gives patients who genuinely want to show gratitude a ready means to do so—solicitation by physicians raises concerns about patient privacy and risks jeopardizing clinical relationships.

In “Targeting Patients for Donations: Opening a Door, or Pushing Them Through It?” Michelle A. Burack reveals how she discovered that the development office at her medical center was sending donation requests to patients on her behalf. While she was leading a patient to the exam room for a routine appointment, the patient told her about a solicitation letter that she received. The patient said, “I have to say, when I first opened the letter, it was kinda creepy.  But I’m so grateful for your excellent care that I felt like I had to send something.”

The patient’s response stopped Burack in her tracks. “Wait—the hospital sent you something asking for a donation?” The development office had informed Burack that her patient had made a donation in her name and asked Burack to send her a thank-you letter, but the office didn’t say that it had solicited a donation from her patient and that it had referenced her.

Burack then asked people in the development office to clarify what was going on. A change in the federal HIPAA (Health Care Insurance Portability and Accountability Act) privacy rule in 2013 made it possible for them to view which providers a patient recently received care from and send targeted requests for donations. This regulation also allowed hospitals to conduct wealth screenings, often before a patient has had a medical appointment, to determine the patient’s capacity for giving. The information gathered is often from public records.

“I was distressed that the sacred space of trust that I so carefully cultivated with each patient was being breached by the institution without my knowledge or assent,” Burack writes. “Unlike relationships with other entities that receive philanthropic donations, a patient’s relationship with a health care institution is non-discretionary. . . . This results in an inherent power differential that can put undue pressure on individuals who are in a vulnerable position.” Burack resigned from the institution shortly after discovering that her clinical relationships were being leveraged for fundraising.

Jason D. Keune and Jeremy A. Lazarus, the symposium editors, point out that GPFR has been the focus of much ethical scrutiny and that physicians have an overriding obligation to care for their patients first. But Keune and Lazarus also acknowledge that a decline in the growth of government funding for clinical and research activities, particularly in academic medical centers, has made fundraising for health care essential. Gifts from grateful patients can provide support for research, salaries, medical equipment, and state-of-the-art facilities, ultimately improving outcomes for patients.

James Malone, the chief medical officer at a nonprofit community hospital, discussed how grateful patient donations support services and care that would not otherwise be available at his hospital. Without them, he writes, “patients would likely have to travel many hours away from home to access the care they need, which would add hardship to an already stressful time in their lives.”

Despite the benefits of grateful patient fundraising, Stacey Tovino, a law professor, warns that solicitation of donations by physicians raises a number of legal and ethical issues. These include concerns about equity (if patients with the means to donate are given priority scheduling or granted other favors), patient privacy (when hospitals access patients’ personal information to assess their capacity for giving), and the doctor-patient relationships (when the role of physician and fundraiser conflict). But Tovino thinks that these concerns can be mitigated by ethical guidelines and recommendations proposed at a Summit on the Ethics of Grateful Patient Fundraising in which she and 28 other experts in the field participated. The guidelines include separating discussions about donations from clinical encounters and referring patients interested in giving to development professionals.   

Reshma Jagsi’s initial thoughts about grateful patient fundraising grew from an encounter she had shortly after finishing residency training with a patient undergoing treatment for breast cancer. “We had just finished a conversation about how daily radiation treatments were going to pose a substantial financial burden to her family,” Jagsi writes. “Her daughter would have to take time away from her work cleaning houses, and gas prices were at an all-time high.” Jagsi describes how the patient then showed her a document given to her in the waiting room, asking her permission for the hospital staff to contact her for development purposes. The patient did not understand and asked Jagsi to explain. “It did not seem to be an optimal time to discuss what ‘development’ meant,” Jagsi writes. “At the time, I was focused on my patient’s lack of financial means. . . .  I did not want her to worry that her inability to donate would have any influence on my care for her. I wanted to maintain her trust.”

Now a professor and director of the Center for Bioethics and Social Sciences in Medicine at the University of Michigan, Jagsi writes that her reservations about grateful patient fundraising have eased. Through interactions with colleagues in development, she has come to appreciate not only that giving benefits society but that it can also be personally fulfilling to patients.

The term grateful used to reference these types of philanthropic programs implies that there is no worthwhile way to show gratitude or give back if a grateful patient is without the means to make financial contributions. This is particularly wounding when nearly half of all adults in the U.S. are saddled with health care debt.

In “Grateful Patient Fundraising and Unconscious Bias,” Alyssa Sutton and Ceciel Rooker highlight the ways in which grateful patient fundraising may marginalize patients who are not wealthy, many of whom come from minority groups and other vulnerable populations. “If the only opportunities for contributions are monetary, those who are indeed grateful but lack the financial means may not be given the opportunity to contribute, making the system non-inclusive and thus adding to the already tenuous ethical dilemma,” they write.

Jagsi argues that patients without the financial means to donate should have other opportunities to show their appreciation. These opportunities include inviting patients to share stories or testimonials about their experience and offering their perspectives on what the institution should do to provide greater benefits to the community. Patient testimonials can be used in giving campaigns to help those with the means to donate understand how their gift may benefit others.

Jagsi reflects, “Maybe in my attempts to protect against the ethical challenges of such situations, I have been inadvertently robbing my patients of an opportunity to feel empowered by the exercise of altruism.” Jagsi urges the development community to move away from wealth screening so that the benefits of altruism are available to all patients.

Heidi Walsh, MPH, CHES (@hamp42_heidi), is a senior project manager in the Bioethics Research Center at Washington University School of Medicine in Saint Louis. Annie Friedrich, PhD, is an assistant professor at the Center for Bioethics and Medical Humanities at the Medical College of Wisconsin.

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Bioethics Forum Essay

Should He Have Brain Surgery?

by Janet Malek and Ryan H. NelsonPublished Posted in Clinical Ethics Case Studies, Hastings Bioethics Forum

[This is the first in a periodic series of clinical ethics case studies for Hastings Bioethics Forum, based on real cases.]

J is a 21-year-old male with cerebral palsy, quadriplegia, and intellectual disability. He is unable to communicate verbally and requires assistance with all activities of daily living. He typically responds to some touch and speech with subtle bodily movements, such as tilting his head in the direction of his mother’s voice, but in recent weeks his reaction to these stimuli has diminished to the point that he is now almost entirely unresponsive. Alarmed, his mother, Nancy, brought him to the emergency department of our hospital.

J was admitted to the neuro intensive care unit (NICU) for a workup and observation. MRI revealed a significant mass on the left side of his brain, later determined to be a meningioma–a noncancerous but potentially dangerous growth. The neurosurgery team, which works closely with the intensivists who care for NICU patients around the clock, describe to Nancy a surgical intervention that is considered the standard of care for patients with J’s condition. Surgery is likely to return the patient to his baseline, at least temporarily—meaning that he could once again respond physically to touch and speech. But the surgery carries risks, including infection, bleeding, and damage to surrounding brain tissue. And even with surgery, the mass could begin regrowing in a matter of weeks. Left untreated, the tumor would  grow and become fatal, likely within months.

The NICU team, however, has concerns about this care plan. They question whether the benefits of surgery outweigh the risks for this patient and consult the clinical ethics service. “We might be able to get the patient back to where he was,” the NICU intensivist tells the clinical ethicists, “but should we consider that a good outcome?”

Ethical Analysis and Process

The NICU physicians are concerned that J may benefit less from the surgery than many other meningioma patients because of his baseline quality of life. When asked to elaborate, one of the physicians says that he thinks that J’s intellectual disability limits his ability to understand and appreciate the value of continued existence, and, therefore, the surgery would not benefit   J “in any meaningful way.”

The ethicists recommend a family meeting with Nancy to ensure thorough consideration of the options, engaging both Nancy’s values and the perspective of the NICU team.  Nancy strongly advocates moving forward with surgery, saying to the ethicists, “I just want the doctors to treat my son the way they’d treat any other patient.” The intensivist explains the team’s concerns to Nancy, raising the possibility that because J would only “benefit minimally” from surgery it might not be ethical to expose him to the risks of the procedure. Nancy challenges this ethical framing and offers an alternative interpretation: “He’ll benefit in the same way everyone else does. He’ll be back to the way he was before the tumor.” Growing emotional, Nancy introduces another detail that is important to her. “He is the only family I have,” she says. “I just don’t know what I’d do without him.”

Nancy’s request draws on a foundational claim of justice that like cases should be treated as like, which requires that people be treated in the same way unless there is a morally relevant difference between them. Given that surgery is considered the standard of care, therefore, not offering the procedure would only be ethically supportable if there were such a difference between J and other patients to whom surgery would be offered. 

The ethicists ask themselves whether the difference between J and other patients is morally relevant to the decision to offer surgery. While many patients would see profound benefits from this kind of intervention (e.g., restored ability to walk, communicate, and care for themselves), J’s benefits would be relatively modest. And so, as argued by the NICU team,  the risk-benefit ratio of the intervention could be considered less favorable for J than for many other patients, justifying a departure from the standard of care in  J’s case.

Also at issue is the concept of benefit, which the NICU team and Nancy apply differently.  The NICU team conceives of benefit as absolute functional improvement, whereas Nancy has in mind improvement relative to J’s baseline function. Under the latter framing, J stands to benefit in the same way that other patients do from the surgery. The procedure could extend his life and restore him to his previous state. This approach rejects judgments made by the NICU team about the quality of life of people with intellectual disabilities. Such judgments have been criticized as biased or irrelevant. While we did not have reason to suspect that the team was questioning the decision to proceed with the surgery based on overt biases, it was clear that values-based judgments about the quality of J’s life were at play. When values-based disagreements arise, it is often ethically preferable to act in accordance with the values of the patient or surrogate rather than those of the medical team. Proceeding with surgery, therefore, would also be an ethical option. 

The Decision

Which course of action is ethically preferable?  Conflicting conceptions of benefit support different justice-based recommendations. The clinical ethicists, therefore, turned to other considerations to come to a decision. Despite Nancy’s claim that  J has “a will to live,” he does not now, and never has had, the ability to articulate his values or express preferences about what kind of medical care he would want.  Nancy serves as his surrogate and, in that role, has a duty to make decisions on his behalf based on what is in his best interests. Nancy appeared to be sincere in her desire to advocate for J’s well-being. She also, however, referenced her own interest–the impact that losing her son would have on her. While surrogate decisions based on self-regarding reasons can be ethically problematic, the ethics team did not consider Nancy’s desire to proceed with the intervention to be counter to J’s best interests. The ethicists, therefore, recommended proceeding with the surgery.

Janet Malek, PhD, (@JanetMalekEthx) is an associate professor in the Center for Medical Ethics and Health Policy at Baylor College of Medicine and a clinical ethicist at Houston Methodist Hospital. She is a member of the ASBH task force writing the Core Competencies for Ethics Consultation, 3rd Edition. Ryan H. Nelson, PhD, is an assistant professor in the Center for Medical Ethics and Health Policy at Baylor and a clinical ethicist at Houston Methodist Hospital.

Series Editors’ Comment: Counteracting Ableism in Treatment Decisions

J’s case illustrates the ways in which ableism can alter health care practitioners’ calculus of medical risk and benefit. His case points to the need for clinicians’ careful application of the moral obligations of respect for persons, beneficence, and justice. Clinical ethicists regularly confront biased correlations between disability and poor quality of life, coming from clinicians, bioethicists, and sometimes from patients and their families. As clinical ethicists, we have a duty to recognize and counteract this form of bias and discrimination, but also to be cautious to not make our own assumptions about what the patient would choose or what would be best (similarly a form of ableism).

Malek and Nelson rightly direct the team to critically reflect on the differences between surgical benefit in terms of commonly expected functional improvement (which tends to be defined by ableist norms) and surgical benefit relative to J’s baseline function. This framing helps to identify ableism in this case, and to counteract that ableism by directing care toward supporting the patient’s subjective experience of quality of life.

Of course, this effort is complicated for a patient who cannot speak for himself. The team must rely on a surrogate decision-maker who knows the patient well, without ever fully understanding the patient’s values and experiences. Caution is warranted to ensure that the patient’s interest is kept front and center. Nancy’s relationship-oriented concern–“He’s the only family I have”–should not be misconstrued as a conflict of interest or selfish reasoning. It’s likely that the caring relationship is beneficial to both J and Nancy.

It is reasonable for a surrogate decision-maker, especially a parent of a patient with cognitive impairments, to consider their loving connections with the patient, even while centering the patient’s perspective. After all, their understanding of the patient depends on this loving connection. Malek and Nelson are right to question how to recognize and incorporate relational decision-making in a surrogate decision-making framework that prioritizes respect for the individual patient. As a general point, clinical ethicists should work with the team to maximize the potential for patients, regardless of disability status, to communicate for themselves, which may require assistive technology or creative problem-solving. Patients with intellectual disabilities are often capable of communicating, and a support person can be essential in advocating for the patient’s perspective.

At an interpersonal level, how should clinical ethicists identify potential ableism and name it in conversation or in a chart note? At an institutional level, how should clinical ethicists collaborate with their colleagues to minimize the role of bias in policies and standards? Should expectations for relational decision-making be adjusted for patients with intellectual disabilities? Ultimately, we hope that J’s story motivates this sort of reflection among clinical ethicists about how to best identify and counteract ableist biases that arise in health care ethics consultations, even among well-intentioned health care professionals.

– Gina Campelia, Laura Guidry-Grimes, and Adira Hulkower

Learn more about the series, Clinical Ethics Case Studies for Hastings Bioethics Forum.

Attention clinical ethicists: learn how to contribute to the series.

sad teenage girl with therapist

Bioethics Forum Essay

Pediatric Gender Care: Absence of Evidence Is Not Absence of Efficacy

by Gwendolyn P. Quinn, Lisa Kearns and Arthur CaplanPublished Posted in Hastings Bioethics Forum, Health and Health Care

In “The Cure for Politicized Pediatric Gender Care,” Moti Gorin argues that a U.S.-based systematic review, conducted by a trusted major medical organization such as the National Institutes of Health or the National Academy of Medicine, is needed to develop consistent standards for pediatric gender care. While the intent behind his call is well-intended, it is based on a flawed premise, and the reasoning for recommending such a review is unclear.

Systematic reviews derive information from published, peer-reviewed literature and, sometimes, grey literature—information developed outside of traditional academic or commercial publishing channels. The results from systematic reviews rely on the information contained in available manuscripts, white papers, conference abstracts, theses, and dissertations. However, simply because these materials can be found and may be in a published format does not mean they contain quality data. Thus, results drawn from systematic reviews are only as valid as the original sources from which they were drawn.

While there are have been hundreds if not thousands of published articles on the health disparities associated with youth experiencing gender dysphoria, from poor mental health outcomes and societal violence to suicide, the majority of this literature is from observational or cross-sectional studies. Most of these studies were conducted in academic medical center gender clinics among people with financial means who had access to quality care. Few studies have examined outcomes or experiences among people in rural areas or with limited means. Thus, in addition to lacking methodological rigor, the available data are not representative of the population. In other words, there is at best limited, poor-quality data from which to draw conclusions from systematic reviews.

As far as we are aware there have been no randomized controlled trials in pediatric gender care. The pool of available data is very limited. Thus, meta-analyses or systematic reviews are not likely to prove fruitful.

Is it reasonable, therefore, to request funding for more original studies? In fact, it may be unethical to suggest that randomized, placebo-controlled trials be conducted. The feelings of unresolved dysphoria, social stigma, and unacceptance are well known to be associated with the negative psychological effects of being transgender, and the literature abounds with reports of high rates of depression, anxiety, and suicidality among trans youth compared to their cisgender peers. Policies and legislation that restrict or forbid access to gender-affirming care have been shown to have life-threatening consequences. Thus, it could be morally dubious to allow one group access to puberty suppression and another group only psychological care. Although randomized trials are the gold standard of scientific research, designed to show causality, it may not be possible to launch such studies given the plight of potential subjects.

As Gorin notes, several professional societies have provided guidelines suggesting puberty suppression and gender-affirming hormones are standard of care. Yet the policy landscape for pediatric gender care is rapidly shifting to restrictions and penalties. Consider, then, the challenges of a parent of a dysphoric child: medical intervention now or suicide later? While we do not know the long-term effects of puberty blockers on cardiac and bone health, and there are likely some potential harms, we do know that dysphoric youth who cannot receive medical and psychological intervention often take their own lives. Poor-quality evidence from systematic reviews of the limited data available will not add much evidence on the efficacy of care. While evidence is greatly desirable, it may not be possible to create the studies that would generate it without harming those intended to benefit.

Another claim by Gorin needs clarification. We agree that “[a]ll patients deserve evidence-based care, and all physicians deserve to practice medicine with the help of authoritative clinical practice guidelines.” However, we don’t see how a systematic review, even by a trusted source such as NIH or the National Academy of Medicine, would help achieve that goal in pediatric gender care in the U.S., much less resolve the inconsistencies in pediatric gender treatment around the globe that Gorin rightfully laments.

We wish Gorin had explained more fully how evidence-based medicine, including consistent clinical practice guidelines, could blunt, much less cure, politicization of gender care for children. The raft of anti-care laws spreading through this country suggest that reason and evidence are not sufficient for the task.

Gwendolyn P. Quinn, PhD, is the Livia Wan Endowed Chair and Professor in the Department of Obstetrics and Gynecology at New York University Grossman School of Medicine. Lisa Kearns, MS, MA, is a senior researcher in the Division of Medical Ethics, at NYU Grossman School of Medicine. Arthur Caplan, PhD, is the founding head of the Division of Medical Ethics at NYU Grossman School of Medicine. He is a Hastings Center fellow and a member of The Hastings Center’s advisory council.

depressed teen in hooded short looking out window

Bioethics Forum Essay

The Cure for Politicized Pediatric Gender Care

by Moti GorinPublished Posted in Hastings Bioethics Forum, Health and Health Care

Though medical care can vary to some extent regionally and internationally due to economic, social, and cultural differences, the similarities in treatment protocols far outnumber the dissimilarities. How best to treat a broken arm, or a melanoma, or diabetes is consistent across borders. Yet children and adolescents diagnosed with gender dysphoria receive radically different treatments depending on where they live. With gender clinics in the United States under significant stress due to the intense politicization of this field of medicine, and with the well-being of especially vulnerable children at stake, it is crucial that these inconsistencies be addressed. The best way to do this would be for a major, trusted medical organization such as the National Institutes of Health or the National Academy of Medicine to commission a systematic review of the evidence underlying pediatric gender medicine.

No U.S.-based organization has conducted such a review at the national level, putting American professional medical associations and physicians at odds with their counterparts and colleagues in other countries. All patients deserve evidence-based care, and all physicians deserve to practice medicine with the help of authoritative clinical practice guidelines. Clinical practice guidelines are “statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.” The inclusion of systematic reviews in the formation of guidelines for the treatment of gender dysphoric youth is necessary to ensure that medical care is evidence-based and patients are not exposed to medically unnecessary risks. When clinicians practice evidence-based care, they abide by a core ethical principle of medicine—nonmaleficence.

The time to conduct a systematic review is now. There has been a sharp increase in the number of minors diagnosed with gender dysphoria in the U.S. An analysis of insurance claims found that in 2017, 15,172 patients aged 6 to 17 were diagnosed with gender dysphoria; in 2021, the number grew to 42, 167, an increase of roughly 300%. Other countries have also seen an increase in minors presenting with gender dysphoria.

U.S. physicians treating an adolescent patient suffering from gender dysphoria are guided by professional organizations, such as the Endocrine Society, the American Academy of Pediatrics, and the World Professional Association for Transgender Health (WPATH), to employ gender-affirming care, which can involve the prescription of puberty blockers, cross-sex hormones, or surgery. These organizations’ guidelines are not based on systematic reviews of the benefits of these treatments. Although some U.S. states have moved to ban or restrict youth access to gender affirming care, physicians in most states follow these organizations’ guidelines. In its most recent guidance document, WPATH reported that it is “not possible” to conduct a systematic review of adolescent care due to the overall low number of studies and the “few outcome studies that follow youth into adulthood.” Nevertheless, the title of WPATH’s document is called  “Standards of Care for Transgender and Gender-Diverse People” and its recommendations for the treatment of minors have been described as “evidence-based”  by U.S. Assistant Secretary of Health, Rachel Levine.

Meanwhile, physicians treating children and adolescents with gender dysphoria in Sweden, which did conduct a systematic review, are told by their National Board of Health and Welfare that “the risks of puberty suppressing treatment with GnRH-analogues and gender-affirming hormonal treatment currently outweigh the possible benefits, and . . . the treatments should be offered only in exceptional cases.” It recommends mental health support and exploratory psychological care as the first line of treatment for gender dysphoria in youth and states that hormonal interventions “should be restricted to research settings.” 

Across the border in Finland, which also conducted a systematic review, physicians are told by the Council for Choices in Healthcare that psychosocial support is the first-line treatment for adolescent gender dysphoria, along with exploratory therapy and treatment for psychiatric comorbidities. Finland considers the medical transition of minors to be an experimental practice and claims that no medical treatment can be considered evidence based.

In England in 2020, the National Health Service commissioned independent, systematic reviews of the evidence for clinical benefit of prescribing puberty blockers and cross-sex hormones to gender dysphoric youth. The reviews found that studies showing positive correlations between these interventions and improvements in mental health, quality of life, and gender dysphoria were “not deemed strong enough to form the basis of a policy position.”  Last month,  the National Health Service issued a draft guidance that restricts puberty blockers to research settings. Echoing Sweden and Finland, NHS-England now concludes, “The primary intervention for children and young people who are assessed as suitable for The Service is psychosocial (including psychoeducation) and psychological support and intervention.”

Given the vulnerability of youths with gender dysphoria, inconsistencies in clinical guidance for treating these patients are both ethically concerning and medically consequential. A patient in Sweden, Finland, or England will receive blockers or cross-sex hormones only in exceptional circumstances, while  some clinics in the U.S. will prescribe them after a single meeting. This discrepancy in clinical approach cannot be explained by national cultural differences in attitudes toward LGBT+ people; research shows that Sweden, Finland, and the Great Britain all rank higher than the U.S. for acceptance of sexual and gender minorities.

At a time of intense political polarization in the U.S. over LGBT+ health care, and with the dramatic rise in gender dysphoria diagnoses among the pediatric population, it is crucial that trusted medical authorities in the U.S. make every effort to establish clinical practice guidelines. Such guidelines require systematic reviews of the available scientific evidence, which other LGBT+-friendly countries have shown are possible. It is crucial that these reviews be conducted by impartial experts to avoid bias. There can be no medical or ethical reason why care provided to vulnerable adolescents should vary so drastically from one place to the next. Evidence-based medicine is the cure for politicized medicine.

Moti Gorin, PhD, MBE, is an associate professor in the department of philosophy at Colorado State University. @GorinMoti

[See “Pediatric Gender Care: Absence of Evidence is Not Absence of Efficacy”]

Illustrative image for Moving On from Covid Immunocompromised People Can t

Bioethics Forum Essay

Moving On from Covid? Immunocompromised People Can’t

by Scott D. LandesPublished Posted in Covid-19 Ethics Resource Center, Hastings Bioethics Forum

I am immunocompromised. This has been an aspect of who I am for all 52 years of my life. In my case, this means I am much more likely to be infected when exposed to viruses, bacteria, and fungi, and the duration and severity of infections I develop are typically greater than for people who are not immunocompromised. My infections have resulted in vision loss and damage to major organs.

My perspective on being immunocompromised has recently changed. Prepandemic, I largely viewed my health vulnerability as my problem. Yes, I was aware that the behavior of others–for example, colleagues who decided to show up to work and share their viruses–were direct threats to my short-term and long-term health. Though fortunate to always have had loved ones and medical professionals who worked with me to ensure the best possible health outcomes, I had convinced myself that responsibility for my health and survival belonged solely to me. This changed during the past two-and-a-half years.

Immuno-prioritized

At first, we–Americans, as well as many people around the world–were baffled by what Covid-19 meant for us. But gradually we realized that if we did not take collective action this novel virus would threaten us all. We prioritized our immune system health, washing our hands more frequently, masking, socially distancing, and factoring in risk levels to our everyday lives. For many, that meant a crash course in virology 101 and the intricacies of the immune system. For those of us who are immunocompromised, it meant that a large part of society was getting a glimpse into what we were doing prior to the pandemic–making constant and tedious choices about our engagement with other people by weighing risks to our health.

But it was obvious that this degree of immune-prioritization would not last. Not just because health precautions were politicized, but because the narratives we used to encourage and support these protective behaviors were primarily self-centered–what can I to do to protect myself and my loved ones –as opposed to other-centered–what can I to do to help ensure the safety and survival of all?

Immuno-jeopardized

Because the changes in behavior were primarily self-centered, the impetus for continuing protective measures quickly dissipated with the rising perception that the threat was over. After President Biden prematurely declared the pandemic over and the director of the Centers for Disease Control and Prevention no longer recommended masks, Americans returned to pre-pandemic behavior. Life is largely back to normal for many people. The problem is that the pandemic is not over. The U.S. has an average of 325 Covid deaths per day. This may seem tolerable to some, but for those of us who are immunocompromised the risk of Covid leading to severe infection and death persists. This fact was underscored by the White House Covid-19 response coordinator’s recent comment that  “the main tools we’ve had to protect the immunocompromised, like Evusheld, may not work moving forward.” Thus, the decision to move on from practical health precautions to mitigate the spread of an airborne virus that is not becoming milder is jeopardizing the health and survival of the immunocompromised. My hope is that there are enough people who know and care about someone who is immunocompromised, or are just generally kind-hearted and open to considering the health risk their behavior poses to others, that we may be able to negotiate a compromise going forward.

Immune compromise

The best case scenario for immunocompromised people like me would be universal masking in all public spaces. Masking reduces the spread of the Covid-19 virus, as well as other airborne viruses such as respiratory syncytial virus and influenza, and lifting masking requirements has increased the spread of Covid-19 in places like schools. Though universal masking would be ideal, based upon my read of current sentiment, and contrary to my own best interest, I am willing to compromise.

It may be too much to ask for mask mandates in public places that people can choose to avoid, including restaurants, bars, museums, stadiums, and theaters. However, there are some foundational protections that immunocompromised people will need. At the least, it is imperative that universal masking be required in essential spaces–medical care facilities (doctors’ offices, hospitals, clinics), long-term care settings (day care, group homes, nursing homes), pharmacies, grocery stores, public transportation, schools, and in our homes. It is also essential for our employers to enable us to do our jobs in environments that do not threaten our health. For some this may involve remote work options. But for those whose jobs cannot be done remotely, this will require creative solutions that help us stay safe while working, including but not limited to ADA accommodations, high-quality air filtration, flexible work hours, modified leave policies, socially distanced work spaces, virtual options for meetings, and decreased travel.

I recognize that those who are not immunocompromised are ready to move on. Please understand that many of us who are immunocompromised deeply desire this as well. But we know that the current strategies for moving on are not viable for our health and survival. What I am asking is that those who are not immunocompromised help ensure that essential spaces are safe for those of us who are more vulnerable. Our lives depend on your willingness to compromise.

Scott D. Landes, PhD, is an associate professor of sociology at Syracuse University. @scottdlandes

Apple TV+ Severance

Bioethics Forum Essay

Popular Culture and Bioethics: Severance

by Dominic Sisti, Anna Wexler, Aliza Narva and Jonathan D. MorenoPublished Posted in Hastings Bioethics Forum, Neuroscience

Severance, a popular Emmy Award-winning show streaming on Apple TV+, is a rich cultural artifact. It concerns a team of office workers at a morally questionable company that performs brain surgery on employees to sever the consciousness of their work and personal lives. The four of us were so taken by the show that we wrote these reflections on its important ethical themes. Is it better to be severed and satisfied or integrated and dissatisfied? What are the risks posed by neurocapitalists who see our brains, bodies, and minds as the final financial frontier? In what ways does the trauma of moral distress and isolation experienced by the show’s characters and leading to their own quite dramatic “great resignation” echo the experiences of pandemic health care workers? What should we make of the dehumanization and alienation of corporate culture, where mindless drones cranking out widgets is rewarded and encouraged? We hope these essays-within-the-essay provide starting points for ethics discussions. 

Severed and Satisfied

Welcome to Lumon Industries, where, with the flip of a switch, your outside consciousness (“outie) turns off and your inside (“innie”) turns on. This is the ultimate workspace, free of all outside distractions and, it turns out, a palliative for your outside life’s most difficult experiences. Want to escape the trauma of losing a loved one? Your complicated family? Crushing loneliness?

The severance procedure and implant make this toggle possible. And Lumon controls it (and the employees). As for the main characters—the severed workers–they seem to be doing OK, at first.

The gang finds oblivious peace in what appears to be a completely meaningless ongoing task. Their good behavior is reinforced by intermittent rewards in the form of absurd tokens, wackadoo prizes, and cult-like rituals. Dylan shows off his finger traps and pines for a waffle party, buckling down hard to finally get one. Irving embraces the rigid doctrine of Kier Egan, the company’s founder, serving as an employee handbook scholar and evangelist. And outie-Mark is just glad to not have to think about the trauma of his wife’s death for half the day.

This is living.

Not so, according to innie-Helly, who immediately wants out. After a failed attempt to get a note to her outtie (who made the decision for her to work at Lumon and holds the power to allow her to quit), innie-Helly watches a video of her outie declare that she is nothing more than an ersatz person: a phantom lacking volition and free will. She should shut up, chill out, and get to work. In response, innie-Helly attempts suicide in the Lumon elevator.

By the time all this goes down, the rest of the team is gaining insight into the fact that Lumon Industries–and the labyrinthine catacombs in which they all toil— is filled with a multitude of other severed workers. Whatever is happening to them, and with them, is not good. 

Then, slowly awakened by connections to their outie-selves and to the others they care about,  our protagonists begin to emerge from the darkness to find that their satiation was actually serfdom. Everything becomes clear when Dylan shuts off the machine that keeps the employees severed and we witness the momentary reintegration of their individual minds.

Like Plato’s liberated cave dweller who sees the sun for the first time, simply catching a quick glimpse of true reality is blinding and disorienting. Things are far safer and easier inside Lumon, where everyone’s difficulties are quite literally out of sight and out of mind. Under the care and protection of Kier Eagan, they can be truly fulfilled. But of what quality is this fulfillment to his severed masses? 

Mill famously said, in Utilitarianism, “It is better to be a human being dissatisfied than a pig satisfied; better to be Socrates dissatisfied than a fool satisfied.” Severance teaches us that life is a series of hard choices between being severed and satisfied or integrated and discontented. – Dominic Sisti

Neurotech, Industry, and Severance

The opening scenes of Severance depict the aftermath of a unique neurosurgical procedure. Helly R. awakens face-down on a conference table, dressed in business attire and heels—not the typical setting nor apparel for post-surgical recovery. But then again, few things are typical about this neurosurgery, which has been performed by Lumon to “sever” Helly’s work memories from her nonwork ones. We see Helly providing consent to a Lumon employee and walking down a bare walkway to the operating room. The surgical equipment is branded by Lumon, as is the brain chip implanted in Helly’s head. In later episodes we learn that the neurosurgeon is a Lumon employee and that data from the personal experiences of severed employees are stored on the neural chips.

The dystopian world depicted in Severance offers a window to consider the future of neurotechnology offered for nonmedical purposes. Given the billions of dollars that have been invested in neurotechnology by Silicon Valley in recent years, such products seem closer than ever to becoming a reality. Even though most companies are currently working on neurotechnology for medical uses, some founders of neurotechnology companies, like Elon Musk, have stated that their goal is for their neurotechnology to be for nonmedical purposes, such as enhancement or communication. Furthermore, Musk’s vision of a minimally invasive neurosurgical procedure—as a quick outpatient procedure, with no hospitalization—rings true of the severance procedure, as Helly resumes work just hours after receiving her brain implant.

Today, much of the neuroethical debate about implantable nonmedical neurotechnology presumes that individuals will utilize invasive neurotechnology products outside of a work context, freely choosing when to get them and where to use them. However, it is also possible that invasive neurotechnology might one day be offered by an employer.

Severance raises provocative questions about what, exactly, the entanglements between the corporate and medical world might look like if an employer were to sponsor neural implants. Will consent processes be conducted entirely in-house or will they involve outside review? If the implantation procedure is done entirely by a robot and the chip is used for communication purposes only, will the procedure even be considered a medical one, or will it fall outside the boundaries of traditional medical regulatory frameworks? Who owns the data on the brain chip, where will it be stored, and who determines what can be done with it? What if an employee decides to have a device removed while remaining within the company, or conversely, desires to keep the device but quit the company?

While most of these questions will not arise in our immediate future, some of them—regarding consent and privacy of brain data—are already coming to the fore, as companies have begun trialing the use of wearable, nonimplantable neurotechnology in employment contexts. Thus, the blurring of the boundaries in Severance between medical and nonmedical uses of neurotechnology may be closer to reality than it initially seems. – Anna Wexler

Severed, Isolated, and Morally Distressed

Pandemic health care workers experienced distress, isolation, and stigmatization similar to what Mark and the other protagonists encounter as they navigate the sterile, labyrinthine environs of Lumon. Marketed as a high-tech solution to work-life balance, the procedure prevents employees from remembering their workdays, conveniently obscuring Lumon’s morally dubious activities. Eventually, the innies reject their dystopian reality, but are morally distressed by their inability to alert their outies.

Numerous iterations of moral distress have emerged since Andrew Jameton originally defined the term in 1984. Essentially, moral distress describes the individual’s experience of knowing the ethically appropriate action to take while lacking the ability to complete that action. Often referring to doctors and nurses, it is characterized by uncertainty, powerlessness, and an inability to meet one’s obligations, usually to patients. During the height of the Covid-19 pandemic, health care workers experienced this as they struggled to protect themselves while caring for infected patients. In the initial surges, time with patients decreased, PPE was reused, and constantly changing protocols barely kept pace with emerging clinical knowledge.  At times powerless in the face of crisis, nurses and physicians sought to define and meet competing ethical obligations to patients,  and families, to themselves, and to society.

Mark and his team also experience moral distress. The innies, increasingly aware of their involvement in something sinister, are desperate to integrate with their outies and alert them to what is going on, and yet they are powerless to do so. Though they feel they must escape, they cannot counteract the orders of their naïve outies, which keep them in Lumon.     

Initially, many off-shift health care workers isolated in hotel rooms and makeshift housing to protect loved ones. This isolation compounded the stressful and scary nature of their work. The severed workers experience similar isolation. They leave and return to work in a staggered fashion, navigating near-empty parking lots at odd hours, always alone. 

Mark (actually, Mark’s outie) chose severance to crush widower’s grief. His sister, who is not severed, knows this and is empathetic, but others in his outie life are simultaneously curious and disgusted. Why would he subject himself to something so unnatural and dangerous? Lumen’s impenetrability amplifies this suspect curiosity and discomfort, letting the public imagination run wild. 

This revulsion is familiar to health care workers who, initially, celebrated as heroes, have since been  criticized and harassed by a skeptical public that is simultaneously distrustful of science, fearful of infection, and suspicious of anyone who chooses to work in health care.  During early surges, hospitals restricted public entry to limit viral spread, compounding this fear and repulsion.

 “Am I livestock?” Helly asks on her first day at Lumon. Is she dispensable? Do her humanity and safety matter? Severance does not deal with ethical conflicts specific to patient care, and Lumon does not provide health care. However, experiences of frontline workers in both spaces share important commonalities: Huddled together, isolated from the world-at-large, misunderstood, ridiculed, and stigmatized, they are the faces of industry work too unseemly to share or too terrifying to acknowledge. They bear the burdens of doing the work that no one wants to see. – Aliza Narva

Severance and Semblance

As a new generation demands changes in the workplace–including the right to authenticity in the office–Severance has rediscovered alienation, this time with a neurotechnology that introduces an overt division of the self.

Subtract that bit of 21st century high-tech conceit and you have in essence the problem with industrialization that philosophers, cultural critics, and artists have been noodling for at least 200 years. In that respect Severance is more than a commentary on work-life balance. It stands in a grand tradition of modern alienation.

For a Marxist the shadowy bosses at Lumen and the (assembly line) workers are trapped in the same abasement of human nature, despite the apparent power imbalance:

“The propertied class and the class of the proletariat present the same human self-estrangement. The former class feels at ease and strengthened in this self-estrangement, it recognizes estrangement as its own power and has in it the semblance of a human existence. The class of the proletariat feels annihilated in estrangement; it sees its own powerlessness and the reality of an inhuman existence.” (Karl Marx and Friedrich Engels, The Holy Family, 1845, emphasis in original).

By the end of the 19th century as industrial capitalism took hold even nonradicals like William James observed, in his Principles of Psychology (1890), the way that the habits of work life set in by age 30, “the ways of the shop,” like folds never to be released. A few years later Frederick Winslow Taylor broke work into bits (“scientific management”) and Henry Ford made a fortune putting Taylorism into practice, much to the fury of the labor movement then getting organized. 

At Lumon, Taylorism is thoroughly soulless. As long as the quota is met, who really cares what they are doing at their compartmentalized screens?

Around the same time in The Protestant Ethic and the Spirit of Capitalism, Max Weber argued that Puritan values aligned with hard work merged in an ennobling and progressive spirit to create a sense of calling that idealized the productive system, largely immunizing it from criticism on moral grounds like exploitation. Fifty years later, in his best-seller The Organization Man, William H. Whyte protested conformity to the demands of the company and the supposed wisdom of the corporate collective. Emerging from two world wars and the Great Depression, Whyte argued that the entrepreneurial ideal of the Protestant ethic had given way to an oppressive philosophy of management. The Organization Man in some ways anticipated the efforts by well-off white men in the 1960s to find more meaning in their lives.

Since the 1970s, civil rights movements have left in the dust the image of the corporate worker as typically white, male, and commuting from Greenwich to Manhattan. Women and people of color have long been part of the workforce, but they have done so amid worsening economic inequality and ever greater demands for productivity and the demands of investors and corporate boards for signs of growth in every quarterly report. In the 1990s the comic strip Dilbert and TV shows like The Office and The Simpsons captured this simmering dissatisfaction. Ultimately, these satires weren’t enough. It was just a matter of time and circumstance before the frustrations of this paradox stimulated a protest against office culture. The dislocations of the pandemic have provided the occasion for it to burst forth.

Severance tells us that the system can only save itself by dividing the self. In season two it merely remains for the severed to rage against the machine. – Jonathan D. Moreno

Dominic Sisti, PhD, (@domsisti) is an associate professor of medical ethics and health policy and the Perelman School of Medicine at the University of Pennsylvania. Anna Wexler, PhD, (@anna_wexler) is an assistant professor of medical ethics and health policy at the Perelman School. Aliza Narva, JD, MSN, RN, is the director of ethics at the Hospital of the University of Pennsylvania. Jonathan D. Moreno, PhD, (@pennprof) is the David and Lyn Silfen University Professor of Ethics at the University of Pennsylvania and a Hastings Center fellow.

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Bioethics Forum Essay

Should Ethicists Be at the Table in Public Health Policy Deliberations?

by Franklin G. MillerPublished Posted in Ethics, Hastings Bioethics Forum, Public Health

In a recent article in The New England Journal of Medicine, Ezekiel Emanuel and colleagues clearly illustrate the relevance of ethical considerations to policy deliberations concerning public health emergencies. They rightly point out that scientific evidence alone cannot guide policy decisions, which necessarily involve values and norms and, often, tradeoffs between them. 

The second half of the article moves quickly to an assertion about the role that ethicists ought to play in the public health policy arena, as reflected in the following two quotes. “The agencies responsible for responding to public health emergencies need to have trained ethicists on staff, regularly participating in scenario planning and advising.” And, “Ethicists should be at the table when policies are formulated, rather than merely serving as external critics.” 

The authors offer no explicit argument to back up these assertions. Perhaps they thought it obvious that ethicists should be at the policy table, given the pertinence of ethical considerations; however, the latter does not entail the former.  That ethical values and tradeoffs are inherent in the public health policy arena implies that ethics, so to speak, ought to be at the table.  But having ethicists at the table is not necessary, and it may or may not be desirable for relevant ethical considerations to receive due attention in policy deliberations.  Moreover, ethicists can play a valuable role in informing public health policy in other ways, and not limited to being “external critics.”  Ethicists undertake policy-related scholarship devoted to examining the values at stake in particular policy contexts and arguing in favor of particular policy choices—work that is increasingly published in leading biomedical journals. And ethicists can and ought to be involved in the academic education of professionals, including epidemiologists and public health practitioners, who are destined to be at the table in public health policy deliberations.  Ethicists can also serve as ethics consultants called in to give advice to policymakers who are puzzled about how to address the ethical considerations at stake in their deliberations. 

Whether ethicists should be at the table is a debatable question, and worthy of being debated, both by ethicists and policymakers.  While I do not take a stance on this issue, I suggest that the debate ought to consider reasons why it might be better that ethicists do not serve as staff at the policy table. For example, it might be argued that a staff person hired for ethics expertise might be regarded by other policymakers as providing authoritative guidance on complex ethical issues, which are not subject to consensus among ethicists. In any case, ethics is, or ought to be, everyone’s business, especially with respect to public health emergencies, owing to their pervasive societal and global impacts brought to light in the current pandemic.  We need policymakers with ethical sensitivity and openness to competing views about how to resolve ethical problems, regardless of whether ethicists are at the table.

If, all things considered, ethicists should be at the table, this poses additional questions.  Do current practices of educating bioethicists prepare them for being effective and responsible agents in the policy arena?  If not, as I suspect, how should education of bioethicists be augmented so that they are equipped with the relevant knowledge and skills to function well in that arena?  

Franklin G. Miller, PhD, is a professor of medical ethics in medicine at Weill Cornell Medical College, and a Hastings Center fellow and board member.

For more about ethics and policymaking, see the recent Hastings Center Report article entitled Errors in Converting Principles to Protocols: Where the Bioethics of U.S. Covid-19 Vaccine Allocation Went Wrong

obese patient

Bioethics Forum Essay

Well, There’s Always the Zoo

by Kathryn HuberPublished Posted in Hastings Bioethics Forum, Health and Health Care, Medical care ethics

After almost a week of workup in the hospital, our young patient with morbid obesity was at a diagnostic crossroads. He had undergone several hospital admissions for recurrent bloodstream infections, with no doctor being able to diagnose the cause. Weighing over 600 lbs., he was above the weight limit of our hospital system’s scanner tables and those of all the other major medical centers that we called in our large city. In response to the question of what to do next, when advanced radiographic imaging was the best next step based on practice standards, our radiology department’s answer was simple, yet inhumane: “Well, there’s always the zoo.”

While this response may seem far-fetched, and something from a TV show parodying the state of the U.S. health care system, transferring patients with severe obesity to veterinarian facilities or local zoos is very much a part of medical care for this stigmatized population. Difficult to study and quantify—there is little evidence in the medical literature of the rate at which human patients are imaged with equipment designed for animals–transfer to nearby animal imaging facilities as a solution to weight-capacity limits for advanced imaging studies is a well-known occurrence in human health care. Finding tables with higher weight-bearing capacity is not the only challenge with diagnostic imaging for this subset of the population: adjustment to radiation dosage, patient transportation and transfer needs, staffing allocation, and image processing may all require unique modifications and facilities.

The United States has struggled with the public health crisis of obesity for some time. According to recent National Health and Nutrition Examination Survey (NHANES) data, nearly 1 in 11 adults have severe obesity, defined as a body mass index over 40. In U.S. emergency rooms, the prevalence of severe obesity among patients approaches 40%. The impact on U.S. public health is well-known, but the impact on health care delivery is less familiar. Another recent national study estimates that the aggregate cost of obesity among U.S. adults is $260 billion. The study quotes rising costs across almost every category of care, including inpatient, outpatient care, and prescription drugs. While these estimates may reflect direct and indirect costs associated with complications, primary disease management, and prevention, it is also likely that rates of hospitalization, re-admission, and transfers to facilities for higher levels of care also contribute significantly. A lengthy, costly diagnostic process, like our patient’s, could have been avoided if there had been appropriate diagnostic tools.

Unfortunately, delivering optimal care to patients with obesity is not a new challenge for U.S. health systems. A national telephone survey in 2008 of hospital radiology technicians found that among 262 institutions, only 28% had access to large capacity CT scanners and 10% for MRI’s. While many imaging device manufacturers have increased weight limits to accommodate bariatric patients in recent years, there are too few full-service facilities. Advanced imaging is the gold standard for diagnosing many common diseases, such as stroke, internal bleeding and infections, and pulmonary embolisms. When appropriate diagnostic studies are not available, patient care suffers. In a 2021 study, U.S. providers cited barriers to diagnostic testing as one of the key problems facing older adults with obesity. Clearly, the obesity epidemic is not going away soon, and health systems are ill-equipped to address it.

Health care systems should seek to deliver care that is person-centered and compassionate, providing quality care to people of all body shapes, sizes, and BMIs. Not only would this better align with the mission of health care systems to provide equitable care, it would also reduce expenditures incurred from repeated or prolonged hospital stays and unnecessary transfers. Medical device manufacturers would also stand to gain from the production of scanners that can accommodate patients with higher BMI’s; as obesity rates increase, the market for these scanners will surely follow.

As a population already facing significant stigma, encounters with the health care system like the experience of my 600-lb. patient should raise concern. Rather than accept substandard care options–such as transferring patients to animal facilities for life-saving imaging–we should seek solutions that offer optimal care for all patients. Dehumanizing people with severe obesity only exacerbates stigma and poses barriers to care. If we can design advanced imaging facilities for variable sizes of animals, why can’t we do the same for our own species?

Kathryn Huber, MD, MS, is a resident in internal medicine at the University of Colorado. @kath_huber

https://www.thehastingscenter.org/the-cdcs-misguided-medical-masking-policy/

Bioethics Forum Essay

The CDC’s Misguided Medical Masking Policy

by Evan Selinger and Arthur CaplanPublished Posted in Covid-19 Ethics Resource Center, Hastings Bioethics Forum

The Centers for Disease Control and Prevention’s revised guidelines have done away with universal masking at health care facilities, making masking optional if community Covid transmission isn’t high. It’s the latest attempt of public health officials to adapt their guidance to meet the country’s fatigued sensibilities. When President Biden declared the pandemic was over, he was saying that most of society had embraced a return to normal—put away their masks and hand sanitizer and stopped being anxious about Covid, which they’ve decided to live with. 

Of course, the CDC acknowledges special considerations are warranted. It advises caregivers to wear masks when treating high-risk patients, such as the immunocompromised, or when outbreaks occur in a health care facility. Unfortunately, these cautions aren’t enough. 

Consider the concern that Scott Landes, an immunocompromised sociologist, expressed on Twitter about his recent five-day hospitalization. During the first night, a physician admitted a truth that health care professionals have been reluctant to admit publicly before the pandemic: immunocompromised patients aren’t safe in the hospital. Their lives are at risk because their care isn’t limited to specially designed areas, like patient rooms on cancer treatment floors.

As Scott notes, medical testing and treatment occur at different places within the hospital, with immunocompromised patients being “carted here and there” to meet with various care professionals. Some of them, he says, don’t have immediate access to the patient’s medical records. Others don’t check them. It’s a dangerous situation with Covid and flu lurking—something that should be remedied, not further exacerbated as an inescapable medical reality.

Scott rightly observes that this situation places a heavy burden on overworked medical transporters to assume responsibility for disclosing a patient’s status, as well as reminding their co-workers to observe proper precautions when masking is optional. It also requires immunocompromised patients to advocate for themselves when they’re predictably and understandably anxious, tired, and not thinking as clearly as they would like. And even if transporters and patients could meet the unreasonable burden of always being on top of their game, that wouldn’t address a serious problem: the risk of immunocompromised people getting exposed to infection when being transported in halls, lobbies, and elevators and left in busy waiting areas. 

Perhaps CDC officials would defend their position by doubling down on their point that they recommend masking if Covid rates are high. Unfortunately, the public’s pandemic fatigue has led to decreased Covid testing. That loss of data coupled with the rate of unreported at-home tests suggests official Covid community transmission numbers are utterly unreliable, especially when getting Covid poses an exceptionally high risk to some.

Perhaps hospital administrators would say the real issue is the need to improve communication systems—to find a way to ensure all high-risk patients are clearly identifiable. We’re not saying this is impossible, but it raises questions about efficacy and ethics. And even if there’s a cost-effective, efficient, and nonstigmatizing way of designating high-risk patients, adopting the procedure will take time. That’s time during which lives that merit protection will be at risk.

While many situations call for compromise, there’s no need for health care facilities to bend so far that they abandon justice for patients at high risk of infection. The CDC’s attempt to offer pragmatic advice does just that. It invites everyone to value the freedom to avoid being inconvenienced by wearing masks rather than protecting the most vulnerable in hospitals, nursing homes, clinics, and long-term care facilities.

Contrary to the CDC, we believe that masks should be required by all care staff in hospitals, nursing homes, clinics, rehab facilities, and long-term care facilities when interacting with all patients unless a patient permits their removal. Likewise, all hospital, nursing home, rehab, and long-term care visitors should wear masks unless they are in a dining facility or private room. And in a private room, permission from all patients should be required.

We realize this isn’t a perfect solution. Patients might feel subtly pressured to grant permission to unmask even if they’re uncomfortable doing so. They might worry about care staff being unkind, or worse, if not being authorized to remove their masks. But this is the best, most viable proposal given how deeply entrenched individual autonomy is in American culture—and how little bioethicists have pushed back against raw egoism and failed to embrace communitarian obligations during a deadly pandemic.

Evan Selinger, PhD, (@EvanSelinger) is a professor of philosophy at Rochester Institute of Technology and a scholar-in-residence at Surveillance Technology Oversight Project. Arthur Caplan, PhD, (@ArthurCaplan) is the Drs. William F. and Virginia Connolly Mitty Professor of Bioethics at New York University Grossman School of Medicine. He is a Hastings Center fellow and a member of The Hastings Center’s advisory council.

Note: Scott Landes gave us permission to discuss his tweet.

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Bioethics Forum Essay

Clicking ‘Accept’ Is Not Informed Consent

by Craig KlugmanPublished Posted in Hastings Bioethics Forum, Research Ethics

A recent Science article published the results of an experiment conducted on 20 million LinkedIn users over five years involving the “People You May Know” algorithm. The experiment randomly manipulated the algorithm to understand the effect on users’ likelihood of getting jobs. None of these people knew they were part of an experiment, nor did they consent to participate.

Informed consent is a bedrock of human subjects research ethics in the United States. Any study done with federal funds or conducted at an institution that receives federal funds is required to review all proposed human subjects research through an institutional review board. Part of the process is ensuring that there is adequate protection to prevent harm to the subjects and to make sure that they consent to participating in the experiment. Such consent means that they know the risks, benefits, and alternatives, as well as having an opportunity to ask questions and to refuse to participate.

Since LinkedIn is a private company, owned by Microsoft, it does not legally fall under the requirements for human subjects review. But these requirements are so widely accepted that most human research studies in the U.S. abide by them. Although the study was approved by the MIT Institutional Review Board, one must question what was included in the protocol application and what elements of this study were debated. After all potential subjects should at the very least know they are subjects. There are some experiments in which knowing the process would influence the outcome and IRBs have mechanisms for such situations—people agree to being subjects and are debriefed afterwards. Even that ethical practice is missing here.

Eight years ago, Facebook was criticized for conducting a social experiment that manipulated the emotional content of users’ news feeds and learned that people who saw more negative content displayed more traits of depression in their posts. In all this time, no standards or regulations have been created to address the gap in human research oversight involving studies conducted on social media.

Social media companies claim that their terms of use permit them to run research trials on users. The main user agreement for LinkedIn is 14 pages long. In addition, there are community policies, additional terms of service, a privacy policy, a cookie policy, a copyright policy, and California-specific policies. All told, people would have to read 46 pages of legalese to know the company can experiment on them. The privacy policy states: “We use data… to conduct research and development for our Services in order to provide you and others with a better, more intuitive and personalized experience, drive membership growth and engagement on our Services, and help connect professionals to each other and to economic opportunity.” The goal of you being an unwitting research subject is to help LinkedIn make more money.

Researchers and IRBs aim to have informed consent documents written in everyday language to protect the potential research participants and to provide a benefit to society at large. Both the LinkedIn and Facebook studies are violations of these basic human subjects research ethics. If you disagree with these companies’ terms of service (which includes being a research subject), your only option is to close your account. These companies could voluntarily follow research ethics standards that have existed for over 50 years. They have chosen not to. The only possible response is either for individuals to stop using their products or for states and the federal government to develop regulations and require research oversight to protect social media users from the potential harms of these studies.

Craig Klugman, PhD, is the Vincent de Paul Professor of Bioethics and Health Humanities at DePaul University. @CraigKlugman

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Bioethics Forum Essay

How Many Covid-19 Deaths Should We Accept?

by Emily A. Largent and Franklin G. MillerPublished Posted in Covid-19 Ethics Resource Center, Hastings Bioethics Forum

President Biden recently declared that the Covid-19 “pandemic is over.”  Some public health experts agreed with this assessment; others disagreed.  What cannot be disputed is that nearly 12,000 Americans have died from Covid-19 over the past 28 days. While the current behavior of Americans suggests they are willing to accept 400 to 500 Covid deaths per day, we would argue that is ethically unacceptable. 

How many Covid deaths are acceptable? This is an important normative question, but it is challenging to contemplate and address.

One possible answer is that our goal should be no preventable deaths. This might be endorsed as morally ideal; however, realizing, or approximating, such an ideal is not practically possible, or even reasonable, from a policy perspective.  China’s zero-Covid approach has, for instance, greatly disrupted everyday life—a dubious coercive strategy that would never be accepted in a liberal-democratic country.

Another possibility is to treat preventing the spread of SARS-CoV-2 as a matter of personal responsibility, such that individuals should be free to choose, for example, whether to be vaccinated or to mask. Yet, this stance fails to recognize that there are ethically appropriate constraints on personal liberty.  Moreover, it is antithetical to legitimate public health policy, which cannot be sustained by appeals to personal responsibility alone.  Some vulnerable groups will disproportionately bear the health consequences if matters of public health are left to personal choices.  Some individuals lack the means, such as paid sick leave or the ability to work remotely to meaningfully protect themselves and their families. Thus, such a position unjustly abdicates the governmental responsibility to protect the health and well-being of the population, particularly the worse off. 

How, then, can we approach the challenge of identifying an acceptable level of deaths from Covid-19? Some guidance for navigating between the two extremes is available from examination of other contexts in which, implicitly if not explicitly, policymakers and the public accept tradeoffs between lives, on the one hand, and costs and inconveniences on the other. 

First, consider automobile safety.  In 2021, more than 42,000 people in the United States died in motor vehicle accidents.  By law, cars must be equipped with safety features like airbags, and drivers must wear seatbelts and adhere to speed limits.  But if maximum speed limits were reduced (and enforced), many fewer deaths would occur.  Automobile safety law illustrates a tradeoff between lives on the one hand and time saved in faster trips on the other.  To look at another example, alcohol consumption is the single greatest cause of motor vehicle fatalities. Changing state laws to reduce the legal blood alcohol concentration limit for driving from .08 to .05 would be an effective means to reduce alcohol-related injury and death; yet, states have largely resisted such measures.  

Second, we could look to deaths from influenza—a more natural comparator than cars.  While Covid-19 and flu are both contagious respiratory illnesses, there are important dissimilarities; throughout the pandemic, however, people have drawn this comparison.  The U.S. Centers for Disease Control and Prevention estimates that from 2010 to 2020, influenza caused between 12,000 and 52,000 deaths annually.  Flu vaccines are readily available—though their efficacy is considerably lower than for Covid-19 and varies year to year, and only approximately half of the population receives them.  There are few flu vaccine mandates (i.e., only for select groups, like hospital staff), and no mask mandates; the economy does not shut down for flu.  At the current seven-day average of 481 Covid deaths, the annual total would be 175,565, more than three times a high level of annual flu deaths.

The point is not that we should accept tens of thousands of deaths from Covid-19.  We should not uncritically take the annual death rate accepted in the context of driving or influenza and assume it is normatively acceptable.  People have argued that more restrictions could—and should—be adopted to save more lives from accidents and influenza.  However, as a reflection of policy deliberations seeking to balance the risks and benefits of public health interventions, the numbers of automobile and flu deaths annually offer quantitative benchmarks for thinking about the acceptable number of deaths from Covid-19.  They clearly indicate that the current level of deaths from Covid-19 is unacceptable. 

What counts as ethically acceptable must be seen as relative to feasible measures of prevention, including: how substantial the harm avoided is, the measures’ cost-effectiveness, the extent to which they interfere with people’s lives and liberties, and whether less-restrictive alternatives could achieve similar benefits. 

The rapid development of safe and effective vaccines has been a major public health achievement.  However, in the U.S. approximately 32% of the population has not completed their primary vaccination series, and 65% of those over age 5 have not received even one booster.  Vaccine mandates—at least for select populations—to reduce preventable deaths are justifiable.  Masks are highly protective.  Failure to use safe and effective public health tools that do not pose undue burdens leads to a substantial, and ethically problematic, level of hospitalizations and deaths. 

One notable issue is that public health policy concerns “statistical” rather than “identifiable” lives.  While people might be willing to act to protect their own lives and those of their friends or family members, it can be more difficult to motivate them to act to save the lives of others they will never meet or know.  This has been a recognized challenge of communication throughout the pandemic: if lives are saved by measures like encouraging or mandating vaccination and masking, we will not know which lives.  People may well think (because they don’t bear the counterfactual in mind) that these efforts were unnecessary. 

In a recent poll, nearly half of respondents indicated that they have already returned to their “normal, pre-COVID life.”  But we would suggest that there is no returning to pre-Covid life.  And it is irresponsible to ignore a virus that continues to destroy an outsized number of lives.  There is only finding a new normal where we learn to live with SARS-CoV-2.  Ideally, this would entail thoughtful public health policy that strives to undertake reasonable measures to minimize Covid deaths and renders explicit the tradeoffs made between hospitalizations and deaths and, for example, economic productivity, convenience, and liberty. 

Emily A. Largent, JD, PhD, RN (@emily_a_largent), is an assistant professor of medical ethics and health policy at the University of Pennsylvania Perelman School of Medicine. Franklin G. Miller, PhD, is a professor of medical ethics in medicine at Weill Cornell Medical College, and a Hastings Center fellow and board member.

Illustrative image for The Place in Aging in Place Housing Equity in Late Life

Bioethics Forum Essay

The Place in “Aging in Place”: Housing Equity in Late Life

by Nancy BerlingerPublished Posted in Aging, Hastings Bioethics Forum

Health policy research demonstrates that housing and community are crucial determinants of safety, health, and well-being across the lifespan. The United States is an aging society, where more people are over age 65 than under 15. Most older Americans want to age “in place” – in the community, not an institution. This goal relies on housing. However, housing policy research reveals a poor fit between our nation’s housing stock and our aging demographics. Most older Americans have difficulty paying for both housing and care. The racial wealth gap contributes to fewer housing options and greater precarity for Black Americans. The National Academy of Medicine’s 2022 Global Roadmap for Healthy Longevity identified late life housing affordability and accessibility as key health variables, whether an older adult is living independently or with others.

Health policies aimed at reducing health care cost burdens for older adults may ease some housing cost burdens by freeing up limited income. Yet these welcome policy approaches alone cannot compensate for our society’s persistent failure to foresee, value, and support the experience of aging by zoning, planning, and building or remodeling housing stock that is affordable, accessible, and “livable”–a good fit, with proximity to transportation, services, and opportunities for social engagement. Housing policy research shows that less than 4% of the U.S. housing stock meets basic accessibility requirements, for example.

Housing equity for older adults is a bioethics issue. It is integral to health equity because housing is a powerful socio-environmental determinant of health. And it is integral to the capability to flourish in late life, a stage of life typically experienced at or close to one’s home. For older Americans to age in place and experience well-being despite foreseeably deteriorating health and modest or inadequate fixed income, the scope of bioethics should attend to a broader range of policymaking ideas and processes that support–or undermine–equity in access to a good life in late life.

Over the past six years, The Hastings Center, in partnership with a diverse array of researchers, practitioners, policymakers, and advocates, has explored ethical and societal questions arising from population aging that are not resolvable through mechanisms for medical decision-making or health care resource allocation–the traditional touchstones for bioethics work on aging–nor through appeals to concepts such as dignity or intergenerational equity. This line of research and public-facing work–Bioethics for Aging Societies–produced a report in 2018 that laid out the landscape of bioethics issues in this area and  launched a series of collaborative projects funded by the Retirement Research Foundation for Aging, the National Endowment for the Humanities, the National Institute on Aging, and others. Jennifer Molinsky, a housing policy expert and community planner who directs the Housing an Aging Society program at the Harvard University Joint Center for Housing Studies (JCHS), a preeminent source of policy-relevant research and analysis, is a key partner in this work. Milestones in Hastings Center-JCHS collaboration include a 2019 public symposium on aging in place and housing inequality; the creation in 2020 of a multidisciplinary research network that includes policymakers; and an innovative empirical study of housing-focused responses to the needs of older adults during the Covid-19 pandemic.

Our study’s final report will be released on October 6 and explored through a webinar series, also beginning on October 6. The final report describes the bioethics standpoint–a “housing lens” –that we developed and applied in this study and offer for further use in age-focused policymaking and social innovation.

The housing lens is grounded in the ethical and social importance of housing to safety, health, and well-being and the moral imperative to balance private-sector options available only to the wealthy minority of older adults with far greater attention to housing equity in late life. As a tool for integrating bioethics considerations into policymaking, a housing lens highlights the importance of housing to security, health, and well-being in late life; focuses on the material conditions that make aging in place feasible, including inequities in access to homes and neighborhoods supportive of aging; and corrects distorted framing, such as the perception that being able to afford the housing one needs to accommodate aging and disability is a personal responsibility, despite a national shortage of affordable housing affecting millions of older Americans and others.

By foregrounding housing and de-centering health care as the dominant policy narrative about aging, the use of a housing lens encourages critical thinking about why age-focused policymaking should also incentivize housing development and related services and supports for aging in place. Our goal in sharing this new tool is to foster creative collaboration across policymaking domains and to sharpen media and public discussion of what it takes, in terms of public priorities, public and private investments, and community-level networking and advocacy, to create real options for all older Americans to age in place.

Nancy Berlinger is a research scholar at The Hastings Center and co-author, with Jennifer Molinsky and Bailey Hu, of Advancing Housing and Health Equity for Older Adults: Pandemic Innovations and Policy Ideas (Joint Center for Housing Studies and The Hastings Center, October 6, 2022).

American chestnut sapling

Bioethics Forum Essay

Could Alarm Over Genetic Manipulation Get in the Way of Environmental Conservation?

by Gregory E. KaebnickPublished Posted in Gene Editing, Genetics, Hastings Bioethics Forum

I have a kind of love affair with the American chestnut tree. My colleagues at work chuckle about it; my brother sends me links to essays and news stories. But it’s a tragic love affair because the tree is pretty much dead—“functionally extinct” because of a blight that hitchhiked to North America on Asian chestnut trees that were brought here in the early twentieth century. When I was young, the skeletons of American chestnuts were still strewn across the Appalachians. Billions of the trees once covered much of the eastern half of the continent, growing to their most massive and magnificent in the rainy mountains of my native Tennessee. A few large specimens hang on, and saplings still sometimes struggle up from old stumps, but basically the tree is defunct.

Unless science can rescue it. I’m sorry to put it that way: “technofixes” can be unsatisfactory. On the other hand, they can sometimes be pretty great. (See “Covid, vaccine.”) There are two possible rescues under consideration for the American chestnut, one involving highly controlled crossbreeding with Asian chestnuts, and another involving genome editing and wheat. The genome editing approach awaits approval by the U.S. Department of Agriculture, but it’s alarming to many people. My guess is that, to many people, crossbreeding just seems simpler, safer, truer to nature. So the question is, How far do we go to put science to use to try to save our disappearing world?

Which brings me to a recent, prominent essay in the New York Times about new strategies scientists are developing for saving species. The essay, by Tim McDonnell, a reporter who covers environmental issues, focuses on things done to animals, but its core claims apply just as well to things done to plants, and (so as not to exclude my beloved trees) I’ll think more broadly here. McDonnell calls for “extreme caution” about these strategies because biological alterations of nature have historically often not gone well, as shown when humans introduce a new species to an environment. This is true. McDonnell mentions predators that are brought in to eat a nonnative pest but that devour hapless native things, but there are also ornamental flowers and vines that escape the garden and devour the countryside; beloved pets that grow up and get difficult and get dumped into a pond, where they become much more difficult; and all sorts of hitchhiking things that get dropped off in a new land and make a home there, killing off existing inhabitants. “If that can happen simply by introducing a new species to a sensitive ecosystem,” McDonnell warns, “what might happen if scientists introduced, as some have suggested, a new gene?” For McDonnell, as for those alarmed by a genetically edited chestnut, introducing a new gene apparently seems vastly worse than introducing a new species.

Why would that be, though? Is a gene more significant than a species? I believe we often think of genes that way. They are “the language of life” or “the book of life,” the “code” for living things: such metaphors can suggest that a genome gives a species its essence. An organism is a physical instantiation of the more esoteric species essence. So, to change genes is to do something that’s contrary to nature at a very deep level, maybe a religious or spiritual level.

Another way to think about genes, though, is to see them just as parts of organisms—parts that, interacting with each other and with other parts of organisms, such as the epigenome, lead to organisms’ appearances and behaviors. So understood, there’s no reason at the outset to think that introducing a gene is worse than introducing an entire organism. Because it’s a gene, not a whole organism, it might be better—simpler, safer, less contrary to nature. We could change McDonnell’s question to this: if introducing a new species is highly risky, what might happen if scientists simply introduced, as some have suggested, a new gene? Of course, that’s a question that requires study: we need to gain some understanding of the effects the gene has on the organism and, through the organism, on the ecosystem.

Conversely, another way to think about a species is in terms of its genome. To introduce a species to an ecosystem is, in effect, to introduce an entire genome. It might be simpler, safer, less contrary to nature to simply introduce a gene.

The American chestnut illustrates this point in fractions. The crossbreeding strategy involves crossbreeding American chestnuts with Asian chestnuts to transfer as much as possible of the Asian chestnut’s blight resistance to the American chestnut, then backcrossing the offspring with other American chestnuts in hopes of getting as much of the Asian chestnut’s other features back out of the offspring. It has a different growth habit. In the best hybrids so far developed, roughly 9/10 (although one grower claims 15/16) of the tree’s genome can be traced to American chestnuts. But that means that fully 1/16 or more of the genes are from the Asian chestnut genome. In effect, introducing such a tree into the environment means introducing lots of genes.

This is sort of a sad outcome for those who want to see the American chestnut stagger back from the edge of its grave: the tree could be significantly different from what it was, and it still might not have great blight resistance. Spurred by those limits, scientists at SUNY College of Environmental Science and Forestry came up with another idea some years ago: wheat has the ability to fight off funguses like chestnut blight, and inserting the relevant gene into an American chestnut genome produces a tree whose genome is entirely like that of other American chestnuts, except that it includes a gene that confers excellent blight resistance. The question, then, is whether that introducing that gene is riskier than, in effect, introducing a new tree.

Such thinking matters because what McDonnell really gets right is that many, many species are in dire straits, and we need to look at new strategies for preserving them. Alongside calling for extreme caution, in fact, McDonnell warns that “there’s little time left for a laissez-faire approach to conservation” and that “radical measures to safeguard biodiversity” must be on the table. It’s not entirely clear how McDonnell squares extreme caution with quick action on radical measures, but, presumably, a precautionary approach to science must be developed that’s consistent with moving forward with science: we need a way of studying new strategies, and collecting wide expert and public input into them, that allows us to use those that make sense. That sounds right, too. My own view is that genome editing strategies warrant study. And they might not always even be as radical as they seem.

Gregory Kaebnick, PhD, is a Hastings Center research scholar and editor of the Hastings Center Report. (@KaebnickG)

Illustrative image for Philanthropy is Not Enough Oil and Gas Giants Must Consider Medical Ethics

Bioethics Forum Essay

Philanthropy is Not Enough: Oil and Gas Giants Must Consider Medical Ethics

by Jacob Riegler, Christen Ram and Christelle RamPublished Posted in Climate Change, Environmental ethics, Hastings Bioethics Forum, Public Health

Given the well-known environmental and health risks of oil and gas drilling, oil and gas giants that enter developing nations routinely offset these risks with charitable investments. Are these investments sufficient? Do the funds go where they are needed? Answering these questions raises ethical issues that need greater attention.

Oil and gas corporations refer to their investments in the developing nations where they work  “acts of charity” and publicize them in documents such as ExxonMobil’s Worldwide Giving Report. In addition to their acts of philanthropy, these corporations tout their activities as likely to increase a nation’s economic standing, frequently citing improved infrastructure for citizens. These activities may help ingratiate the corporations with the developing nations, but they do not offset the risks.

Communities where these corporations operate have higher rates of many illnesses, including cancer, liver damage, neurological symptoms, and immunodeficiency. The increased disease burden raises health care costs for individuals and the public. In developing nations specifically, this can have detrimental financial effects on the health care industry itself. Previous studies have identified chronic disease in developing nations as a threat to improving the health of their populations, and deleterious environmental effects inevitably add to this burden. Increased carbon waste emissions contribute to climate change and its environmental and health harms.

Viewing these risks in the context of philanthropy as these corporations currently practice it shows shocking insufficiencies. The Hess Corporation, for example, donated $942,000 to health and health care of the nations where it worked in 2021, when its earnings were $559 million, representing a 0.16% investment. ExxonMobil invested $13 million in the health and environment of nations (including the United States) in 2021, only 0.057% of its 2021 earnings of $23 billion. This philanthropic endeavor is in no way proportionate to the earnings ExxonMobil receives from even just one nation where it operates, let alone the sum of its earnings.

Oil and gas corporations also create large economic risks for developing nations. For example, the estimated total economic impact of the multiple oil spills that occurred in Venezuela from 2010 to 2016 is $104 billion. And continuous spills there in 2020 and 2021 caused fuel shortages, which in turn resulted in harm to the country’s health system because patients and providers had difficulty finding transportation to hospitals and clinics. The transportation problem led to delayed care and strain on a health care system that was facing extreme strain during the Covid pandemic. 

How are we to offset these large risks? Even if a corporation such as ExxonMobil invested the entirety of its yearly earnings in the health care sector of a single nation, it would be insufficient to cover the environmental, health, and economic burdens caused by oil spills. The problem with the charitable donations is not just that they are too small, but that they don’t address the underlying causes of the negative health consequence that they precipitate.

If oil and gas corporations genuinely want to have ethical business practices, they must consider medical ethics. Their investments need to be larger and focus on prevention, rather than simply providing more medical care infrastructure or funding the construction of health care facilities to deal with the health consequences of their operations. These investments can take various forms, including increased budgets for preventing oil spills and other disasters, reducing population exposure to hazardous products, and preventing workplace hazards. Additionally, there must be a focus on increasing primary care availability to screen, monitor, and treat risk factors for chronic disease. The corporations should also include measures to lower carbon and waste emissions. ExxonMobil’s operations in Guyana, for example, have prompted several lawsuits filed by citizens against the country’s environmental regulator because the company’s agreement does not meet the Guyanese citizens’ desire to lower carbon and waste emissions.

Without focusing on prevention, corporations’ charitable investments exploit a nation’s need for health care infrastructure but do not fulfill the mission of philanthropy, which is to promote the welfare of a nation. Only by genuinely prioritizing the health of nations through preventative strategies can oil and gas corporations truly state that they are protecting the health and well-being of the international community in which they operate.

Views portrayed in this article are solely those of the authors and do not reflect the opinions of the authors’ affiliated organizations.

Jacob Riegler, MBA, is a visiting researcher at the Harvard Business School, fourth year medical student at the University of Central Florida, and Master of Science in Bioethics student at the Alden March Bioethics Institute. Christen Ram, BSBA, BA, is a financial analyst working in the energy sector. Christelle Ram, MSc, MA, is a graduate of the London School of Economics and Political Science and the University of Southern California working in the technology industry.

Illustrative image for Requests for Sterilization Abortion Bans and Reproductive Justice

Bioethics Forum Essay

Requests for Sterilization, Abortion Bans, and Reproductive Justice

by Madeline Thornton and Kavita Shah AroraPublished Posted in Abortion, Hastings Bioethics Forum

In the nearly three months since the United States Supreme Court’s Dobbs v. Jackson Women’s Health Organization decision eliminated the constitutional right to an abortion, doctors have reported increased in demand for sterilization by female patients. This interest in permanent contraception likely reflects patients’ fear of losing reproductive autonomy. It also raises several ethical issues concerning reproductive justice, including disparities in access to care and questions about autonomous decision-making.

Most of the gynecologic patients who undergo sterilization, or surgery for permanent contraception, are Black and Hispanic. This was the case even before the Dobbs decision. As communities of color are disproportionately impacted by restrictions on abortion access and have higher rates of maternal morbidity and mortality, those restrictions are not only inequitable, but also dangerous. Since gynecologic patients from marginalized backgrounds disproportionately make up patients receiving permanent contraception and are also the patients most impacted by abortion restrictions and the associated outcomes, we think it’s likely that even more Black and Hispanic patients, compared with white patients, will seek permanent contraception in response to the Dobbs decision.

Differences in preference for permanent contraception influenced by individual, familial, and cultural values and preferences should be understood, respected, and upheld. But it is unclear to what degree these differences are the result of informed consent and personal choice.  The disparity may be due to external factors and barriers. Given the history of forced sterilization in the United States, especially impacting Black women, it is important to recognize the heightened threat to reproductive justice for this community. For example, clinicians’ implicit biases influence contraceptive counseling and, some evidence suggests, may lead to greater willingness to recommend permanent contraception to Black or poor women. It is imperative that clinicians consider the history of reproductive coercion among these groups and implicit biases that may further perpetuate racial disparities in permanent contraception, while also maintaining a commitment to honoring autonomy in reproductive decision-making.

              Even as most requests for permanent contraception come from Black and Hispanic women, many of them face a clinically and ethically unjustifiable waiting period for the procedure, imposed by Medicaid, as we discussed in an article in the current Hastings Center Report. Black and Hispanic patients represent nearly half of women insured by Medicaid. The Medicaid policy mandates that a patient must wait at least 30 days, but no longer than 180 days, after signing a consent form to undergo a permanent contraception procedure. (It allows for a 72-hour waiting period instead in specific circumstances, such as premature delivery.) Although this policy was instituted to reduce the risk of coercion associated with sterilization, the implication that patients with Medicaid insurance, but not private insurance, need a mandated amount of time to consider the impact of their medical decision-making is deeply problematic. Autonomy issues aside, patients with Medicaid have unique barriers to attending outpatient postpartum visits and Medicaid insurance often expires postpartum, thus posing additional logistical hurdles to desired permanent contraception. In addition to the long waiting period, the Medicaid policy presents another obstacle to permanent contraception. For various reasons, the Medicaid consent form for sterilization is difficult to understand and access. For example,  the form is written at a ninth-grade reading level, thus some patients with may be unable to read it and provide truly informed consent for the procedure.

The reported increase in requests for permanent contraception following the Dobbs decision brings new ethical wrinkles. When a patient’s decision to seek permanent contraception is influenced by legal restrictions in accessing care—bans or limits on abortion— how can the decision be truly autonomous? How should clinicians counsel patients who request permanent contraception and perform the surgeries when a patient’s choice may reflect coercion from state laws banning abortion–and potentially increase the risk of the patient’s regret if these laws are repealed? The patient populations that the Medicaid consent form and waiting period policies were established to protect—Black and Hispanic women–are also those most affected by these barriers preventing individuals from achieving true reproductive autonomy. Regardless of the surrounding ethical and legal challenges, the role of clinicians must be to educate, empower, and trust patients to make decisions that are right for them, including the decision for permanent contraception. Thus, high-quality shared decision-making between a patient and clinician is imperative to ensuring the principles of reproductive justice and contraceptive autonomy are upheld in permanent contraception counseling conversations.

Madeline Thornton (@mjthornton26) is an MD/MPH student at the University of North Carolina at Chapel Hill. Kavita Shah Arora, MD, (@KavitaShahArora) is an associate professor and the division director for general obstetrics and gynecology at the University of North Carolina at Chapel Hill and chair of the American College of Obstetrics and Gynecologists’ Committee on Ethics.

four young children wearing backpacks and walking hand in hand with a woman

Bioethics Forum Essay

Back to School: The Covid Vaccination Choice

by Elizabeth LanphierPublished Posted in Covid-19 Ethics Resource Center, Hastings Bioethics Forum

It’s back-to-school season in the United States, the third one during the Covid pandemic, but the first in which all schoolchildren are eligible for Covid vaccines. Yet fewer than a third of children ages 5 to 11 are fully vaccinated, while the percentage of those under 5 who have started–let alone completed–vaccination is in the low single digits.

With some cities and states where school has already started experiencing an increase in Covid cases among students and in Covid hospitalizations, is it ethical for parents to not vaccinate their kids? Is this the right question to ask about parents who, until recently, have had no choice at all to vaccinate their youngest children? The answers are complicated.

Vaccines for the littlest kids only became available in June. And with two doses required for the Moderna vaccine and three doses for the Pfizer vaccine, these children need weeks to months between initiating and completing vaccination.

Still, it’s striking that while some parents are eager to vaccinate their young children–and  advocated for quicker Food and Drug Administration review and authorization of pediatric vaccines, crowdsourced vaccination sites to facilitate making appointments, and enrolled their children in clinical trials for a (literal) shot at early vaccination–most families are not vaccinating their youngest kids.

Some parents are clearly against Covid vaccination. A July Kaiser Family Foundation survey found 43% of parents will “definitely not” vaccinate their children under 5, and 13% will do so “only if required.” But another survey, conducted earlier this year, indicated that half of parents with young children were either certain or likely to vaccinate, though only 20% planned to do so within three months of eligibility. Some parents open to vaccination are just not early adopters.

Like with adult vaccination, pediatric uptake may also reveal structural barriers to vaccine access. A key strategy for the under 5’s vaccine rollout is offering vaccines in pediatrician’s offices. But many children in the U.S. don’t have a regular primary care provider. Parents may be unable to take time off work during vaccine clinic hours, and most pharmacies cannot vaccinate children under age 3.

However, pediatrician Aaron E. Carroll recently wrote that the low vaccination rate for young children “suggests a lack of urgency” and confusing messaging. To address “the abysmal Covid vaccination rate for toddlers,” Dr. Carroll suggested that messaging focused “on the collective benefits ‌‌instead of individual risks might yield better results.”

As a scholar researching shared and collective responsibility, I want Dr. Carroll to be right. But as a close observer of the pediatric Covid vaccine process, and as a parent during the pandemic, I am not so sure.

Fueled by analyses, some of which have sparked controversy, about the risks of Covid and its mitigation strategies for kids, some parents voice frustration about kids “sacrificing” experiences–in-person learning, playdates, interacting unmasked–for the collective benefit. Experts counter that minimizing Covid risks ignores their inequitable distribution on individual kids and their communities. Yet an individual choice approach seems to be winning over a collective benefit spirit.

The Centers for Disease Control and Prevention’s revised Covid guidance focusing on individual decisions reflected this thinking. So did the discussion of the FDA’s expert committee of outside advisors when they met in mid-June to review Pfizer and Moderna data on vaccines for the youngest children.

The advisors, like many parents, were split over how risky Covid-19 is to kids. Perhaps because of this, deference to parental choice permeated the unanimous authorization of both vaccines, so parents could choose to vaccinate their child, and choose between the two vaccine manufacturers.

In a subsequent press conference, FDA committee member Peter Marks noted the collective benefits of vaccination and the need to increase vaccination rates. Yet FDA Commissioner Robert Califf focused on individual choice, saying, “we know in America people still want to have a choice, and they have one.”

This message might cater to pernicious “parental choice” rhetoric on issues ranging from school curriculum to routine childhood vaccines. But it might also be a nod to how very few real choices parents feel they have had during the pandemic and a recognition that now, finally, they get to choose.

Parents have been without choices in ways that are frustrating and exhausting at best, and economically and physically perilous at worst. Some parents wanted in-person school. Others wanted to keep their kids home. Many couldn’t access the option they preferred, or saw no good option. Without viable choices for child care or flexible work, parents, especially mothers, simply left the workforce.

Addressing a global pandemic, like so many urgent issues, requires individual contributions toward a collective response. But I can see how, after more than two years of parents being adrift without real, substantive choices, emphasizing parental choice to vaccinate young children might seem, to some, like a long-awaited win.

Yet for  others, especially given the guilt or blame parents face for what choices they make within their limited options and individual circumstances, the choice to vaccinate is not one some parents are ready to make, or believe they need to.

Elizabeth Lanphier, PhD, MS (@EthicsElizabeth), is an assistant professor in the Ethics Center at Cincinnati Children’s Hospital Medical Center and in the departments of pediatrics and philosophy at the University of Cincinnati, as well as a nonresident research fellow in the Institute for Philosophy and Public Policy.  

red Emergency sign in hospital

Bioethics Forum Essay

Dusting Off Double Effect for the Post-Dobbs Era

by Adam OmelianchuckPublished Posted in Abortion, Bioethics, Hastings Bioethics Forum

In states with restrictive abortion laws, patients are presenting with life-threatening pregnancies, and distressed medical professionals are confused about what care they can legally provide. Compounding the confusion is the claim, to which pro-life activists are increasingly committed, that “abortion is never medically necessary.” This seems hard to believe, especially after reading the harrowing story of Elizabeth Weller, a Houston woman who was made to wait until her moribund 18-week pregnancy caused “severe infection” before labor was induced. Or the even more harrowing story of a pro-life missionary doctor who had to “decompress the skull” of an 18-week-old fetus to save the life of the mother who had already lost half her blood volume. How could abortion not be medically necessary in these cases?

Clinicians working in the emergency setting need to know. They are required, under the federal Emergency Medical Treatment & Labor Act (EMTALA), to respond to patients who present with emergency medical conditions, including those that complicate pregnancy, labor, and delivery. In July, the Department of Health and Human Services issued a guidance to protect physicians from liability if they provide an abortion to save a pregnant woman’s life, stating, “When a state law prohibits abortion and does not include an exception for the life and health of the pregnant person—or draws the exception more narrowly than EMTALA’s emergency medical condition definition—that state law is preempted.”

Lawsuits over the guidance in two states with abortion bans reached opposite conclusions: a court in Texas blocked the federal government from enforcing the guidance, but a court in Idaho affirmed the guidance. Enforcement of the guidance in other states with abortion bans is in question. There may be a way to help enable clinicians legally provide appropriate medical care to at least some of their pregnant patients who are experiencing a medical emergency. It hinges on two things: the definition of abortion favored by contemporary anti-abortion legal philosophy combined with Double Effect reasoning, according to which it is sometimes permissible to cause harm as a side effect of bringing about a good result.

Double Effect reasoning, which will be explained more fully below, is acceptable to abortion foes because it has a long history in Catholic moral philosophy, beginning with Thomas Aquinas arguing that causing death in self-defense can be justified. Double Effect reasoning is not merely a religious approach to ethical problem-solving, however. It is also recognized by the United States Supreme Court as a form of common law that resolves apparent conflicts between end-of-life care and homicide law. In particular, it permits patients to refuse unwanted lifesaving treatment and to receive palliative care, either of which may have the unintended effect of hastening death. (See Vacco v. Quill.)

In relation to emergency medical care for a pregnant patient, “termination of pregnancy” need not mean the same thing as “abortion.” When abortion foes say “abortion is never medically necessary” they mean “intentional feticide” — or, in more direct words, “the purposeful destruction of the unborn child”— is never medically necessary. By this definition, removing a fetus from the uterus (or fallopian tube) by means of induced labor, medicinal intervention, or surgery to end a life-threatening pregnancy is not necessarily an abortion. The fetus’ death, which may or may not be caused by these means, contributes nothing to the life-saving effect of these actions. Therefore, even if the unborn child’s death is certain, it need only be foreseen but not intended. Rather, the fetus’s death is to be understood as a “side-effect” of an act justified by the good it aims to secure, namely, the preservation of the pregnant patient’s life.

This sort of reasoning is an instance Double Effect, which permits an action that has two effects, one “good” and one “harmful,” if four traditionally recognized criteria are met:

  1. The act itself is either good or morally neutral (Considerability).
  1. The good effect cannot be caused without also causing the harmful effect (Unavoidability).
  1. The harmful effect must not be intended as an end or a means to an end (Pure Intention).

  2. The good effect must be on par with the harmful effect (Proportionality).

What defines “good” and “harmful” in these criteria is hotly contested in abortion debates, but a place to start is with what the law says. In Texas, abortion is defined by the 1989 Texas Abortion Facility Reporting and Licensing Act as “the act of using or prescribing an instrument, a drug, a medicine, or any other substance, device, or means with the intent to cause the death of an unborn child of a woman known to be pregnant.” (Emphasis added) Thus, intending the death of the fetus is to be avoided under Texas law. (Texas’ recent “fetal heartbeat” act (S.B. 8) carves out an exception for a “medical emergency” — something to be revisited in a moment.) Cases that concern providers in the acute care setting are those that satisfy Unavoidability and Proportionality, but raise questions about Pure Intention and Considerability. What options, if any, are considerable under the law? Can an act of removal be done without intending death?

Insofar as Pure Intention goes, if “termination of pregnancy” means killing the fetus first to remove it later, then it is not satisfied since death is chosen as a means to removal. But what if the team decides to remove a nonviable fetus first and let it die afterwards? Then death need only be accepted as an inevitability, not as an end or a means. Moreover, emptying the uterus—not the death of the fetus–is what causes the threat to maternal life to be avoided, even if the fetus’s death is certain. Therefore, if a plan is chosen to empty the uterus by way of induced premature delivery, without referring to death as part of the plan, Pure Intention is satisfied.

What about Considerability? According to the law, intent to kill is forbidden and premature delivery need not involve that. Indeed, the same procedure could be chosen to facilitate a stillborn birth. Likewise, induction of labor acts directly upon the pregnant patient’s reproductive organs, not on the body of the fetus. Thus, it is “neutral” in the sense Considerability requires.

To be sure, how far Double Effect’s framework can be extended is a difficult question. For example, it does not seem that crushing a fetus’s skull could satisfy Considerability or Pure Intention. Nonetheless, some staunchly pro-life thinkers  would have counseled the missionary doctor to “alter the child’s physical dimensions and remove him or her” (allegedly satisfying Considerability) without intending death, arguing that death plays no role in causing life-saving delivery (allegedly satisfying Pure Intention). These thinkers represent what is called the New Natural Law Theory in Catholic bioethics and public affairs. Supreme Court Justice Neil Gorsuch trained under one of these thinkers, John Finnis, and his book on assisted suicide draws upon Finnis’ theory of intention. One of Supreme Court Justice Samuel Alito’s former clerks, Sherif Girgis, also defends this type of craniotomy as permissible by way of Double Effect. He writes:

[New Natural Law] theorists hold that in the consensus cases, involving uterine cancer and ectopic pregnancy, the child’s death can be a side effect of the procedure, rather than a means, because his death is not pursued as contributing anything at all to the agent’s end of saving the mother’s life. But the same can hold in craniotomy, where an unborn child’s head is too large for the birth canal and must be crushed and removed before it causes the mother to die. The same is also true in “physical incapacity” cases [a technical name for cases like Weller’s], where a child is removed before he can survive on his own, because the mother’s physical condition makes continued pregnancy an immediate lethal threat. Again, the goal in both craniotomy and physical incapacity cases is to save the mother’s life, and it is the child’s removal and not his death that contributes to that end (Girgis 2013, p. 235).

This is not to say that Double Effect reasoning informed Justice Alito’s opinion in Dobbs v. Jackson Women’s Health Organization, the Texas fetal heartbeat legislation, or Justice Gorsuch’s interpretation of constitutional law. Far from it. It does mean, however, that it is a seriously considered view held by influential leaders in the pro-life movement.

Many will find this view hard to accept, and so laws making provisions for abortion in medical emergencies are needed. Laws lacking provision for medical emergencies risk criminalizing the actions taken by the medical missionary. Even so, if supporters of exceptionless anti-abortion laws can accept what the missionary doctor did with Double Effect reasoning, then they must accept the inducement of labor as soon as the treating team diagnoses the rupture of membranes in a pregnancy like Weller’s. There is no need to delay inducing labor to satisfy the meaning of medical emergency because an abortion—defined as an act intended to secure the death of the fetus—is not performed.

It’s reasonable for the doctors and lawyers involved in cases like these to be skeptical of this analysis, especially in the light of legislation that makes for easy prosecution and hard punishment. No one wants to be the test case to determine if it is legally sound. Nonetheless, there is reason to think that skepticism may be misplaced. In response to the Weller case, officials representing Texas Right to Life and the Charles Lozier Institute agreed that premature induction of labor would have been consistent with Texas law. Others, representing the Catholic moral tradition, responded to the missionary doctor, saying his case was easily resolvable with Double Effect, something that could have been learned in “Medical ethics 101.”

Whether approaches like premature delivery could become standard practice is another matter. Medical professionals will be concerned with the enumerable ways pregnancies can go wrong and they need clarity on what constitutes exceptions for medical emergencies so that they can be protected from liability. But premature delivery methods may be worth a second look because they would (1) be consistent with exceptionless laws, (2) empower physicians to act decisively on behalf of their patients, and (3) perhaps provide opportunities for closure in tragic situations where the child was wanted. Expectant parents would not need to consent to the killing of their unborn child and, depending on the circumstances, they might have a chance to benefit from perinatal hospice care.

In short, medical professionals who work in the acute care setting and their supporting institutions should consider dusting off Double Effect reasoning to better serve their patients if they work in jurisdictions that restrict abortion. The alternatives, given the legal landscape, are surely worse.

Adam Omelianchuck, PhD, is an assistant professor in the Center for Medical Ethics and Health Policy at Baylor College of Medicine. He expresses gratitude to the editor for updating him with the most current information about the legal dispute over the Biden Administration’s EMTALA guidance. @AdamOmelianchuk

smiling white man in a blue button down with a grey blazer

Bioethics Forum Essay

Mark Cuban’s Innovative Pharmacy: A Band-Aid on Drug Prices

by Aashna Lal, Danielle Pacia and Margaret MatthewsPublished Posted in Hastings Bioethics Forum, Health and Health Care, Medicine & Business

Billionaire Mark Cuban and physician Alex Oshmyansky recently launched the innovative Mark Cuban Cost Plus Drug Company (MCCPDC), an online pharmacy that sells generic prescription medicines at significantly lower prices than other sources. For example, a 30-count of imatinib, a cancer drug that typically costs over $2,000, is $17.10 at MCCPDC. A recent Annals of Internal Medicine article found that Medicare could have saved up to $3.3 billion by purchasing generics from MCCPDC. The pharmacy currently offers more than 800 generic drugs, and its inventory is growing. The company plans to open its own manufacturing site next month.

The pharmacy has been called a “game changer” that could “change millions of lives in this country.” At a time of surging drug prices, Cuban has raised hope that this initiative could disrupt the landscape of prescription medicine in the United States. But the unnuanced acclaim for the pharmacy may eclipse attention to the longstanding structural problems of the pharmaceutical industry and MCCPDC’s role in it. Without discounting its advantages, it is imperative to examine MCCPDC critically, given how it is situated within the ethical landscape of the U.S. pharmaceutical industry.

Prescription drugs in the U.S. cost two and a half times more than in other Western countries, with prices increasing faster than the inflation rate. In a poll last year, 7% of U.S. adults, representing about 18 million people, reported that they were unable to pay for at least one prescription medication for their household during the prior three months, and 10% said that they had skipped doses. These hardships disproportionately affect low-income households and those with chronic diseases.

Despite the difficulties people face in affording their medications, pharmaceutical companies make massive profits. Patents typically last for about 20 years; however, many pharmaceutical companies manage to extend patent protection for longer periods, delaying the production of more affordable generic versions. But even generic medications are subject to markups as high as 10,000 times the manufacturing cost. On average, only $17 of every $100 spent at retail pharmacies goes to direct production costs; the remainder is split between drug companies and intermediaries in the pharmaceutical supply chain known as pharmacy benefit managers. Pharmacy benefit managers negotiate payment rates with drug manufacturers on behalf of insurance plans through a system that encourages drug companies to raise prices in order to compete with one another.

This is where MCCPDC comes in. It eliminates the intermediaries and charges customers for the cost of ingredients and manufacturing, plus a 15% margin, a $3 pharmacy dispensing fee, and a $5 shipping fee, leading to drastically lower prices. Cuban’s pharmacy promotes transparency by operating outside of the insurance system and sidestepping the pharmaceutical supply chain’s intermediaries, whose opaque negotiations with manufacturers, pharmacies, and health plans lead to inflated drug prices. “What we’re doing is a win-win-win,” Cuban has stated.  “We decrease the administrative burden so pharma has more money for research and development, people save capital, patients get the drugs, and the health system saves on the whole.”  

This initiative, created by a champion of the free market, exposes the obscene problems associated with our health care system, which exploits the need for health care as an opportunity for profit rather than recognizing health care as a human right. Many scholars argue that health care is indeed a human right because it is necessary for enabling equal opportunity regardless of factors such as race, class, and gender. If we recognize that health care should be available to all as a matter of justice, collective efforts towards promoting changes in social policy and providing social safety nets would be the principal ways to ensure a system that benefits all, not just some.

MCCPDC will undoubtedly help many who struggle to afford generic medications, yet the pharmacy has major drawbacks that limit who will benefit and to what extent. First, it does not currently offer patented, brand-name drugs, which cause the largest financial burdens for patients – generics accounted for less than 11% of prescription drug spending in 2020. Second, the pharmacy does not accept insurance. This may not be an issue for patients with high deductibles or copays, but those who make frequent pharmacy visits and/or have low deductibles may have lower out-of-pocket costs with traditional pharmacies.

The impact of MCCPDC is also limited on a systemic level. Traditional retail pharmacies must navigate the system of intermediaries in order to provide life-saving drugs that are still patented and to accept insurance. Forbes notes that, in contrast to MCCPDC, these pharmacies “would lose practically all their business … if [they] were to turn down all of the insurance plans that they manage and become cash-only.” By sidestepping the systemic issues faced by other pharmacies, MCCPDC’s model is an exception within a system that other pharmacies must continue to navigate.

Beyond these limitations, MCCPDC’s very existence is an affirmation of the unchecked capitalist model of the pharmaceutical industry, not a challenge to its social and legal foundations. MCCPDC’s model is a function of Cuban’s extreme wealth; Cuban recently admitted that “it wouldn’t be possible to do what he was doing unless he didn’t need to make money.” Furthermore, as a public benefit corporation, Cuban’s pharmacy has the stated goal of making “a profit while maximizing impact.” The paradox in this scenario is that the vast wealth that allows MCCPDC to exist is made possible by the same socioeconomic systems in the U.S. that drive the social and health inequities it aims to fix. More specifically, policies that allow for the mass accumulation of wealth also perpetuate poverty and erode funding for public programs and social services. Therefore, good-faith efforts from wealthy people to fix inequities caused by wealth distribution are largely insufficient.

Many scholars argue that when we rely on the beneficence of the wealthy to address disparities, we release the government from its responsibility to correct harmful structures. Paul Gomberg, for example, argues that the focus on immediate relief in philanthropy tends to obscure the systems that create and exacerbate inequalities in the first place. To realize health as a human right, the bottom line of public-benefit efforts must be the creation of sustainable health care models. While Cuban’s public benefit corporation is a step in the right direction, the initiative can at most provide a Band-Aid solution–one that replicates existing programs, such as GoodRx’s and Walmart’s, for low-cost generic medications.

This reliance on the wealthy elite begs the question: What if Mark Cuban and other billionaires donated their funds to support the creation of a sustainable social program for equitable access to prescription medications? While such social programs remain out of reach, MCCPDC could, in the meantime, increase its impact by pursuing a more holistic model–for example, by providing low-cost drug options and supporting advocacy efforts for policy change. The efforts of billionaires like Cuban to push senators for drug pricing reform legislation, a version of which just passed in the Senate, would not go unnoticed. Such a dual mission would prioritize the structural issues while continuing to fill a gap in current resources, thereby addressing both long-term and short-term needs.

MCCPDC offers a technocratic stopgap in the face of massive systemic issues, but we ultimately need changes in social policy to ensure that structural failures do not continue to perpetuate health inequities. As stated by philosopher Lisa Herzog, “if we take social structures as a given … [the only option] is to spend some of our spare money to help repair the worst damages that this system does.” The examples provided by pharmaceutical systems in many other countries show us that fair drug pricing is achievable through approaches such as centralized price negotiations, universal health coverage, and restrictions on out-of-pocket spending through insurance plans. Because Cuban’s pharmacy is situated within a system that is failing to provide equal access to health care, the initiative is only able to provide a short-term solution for a problem that will persist and worsen as we continue to permit the prioritization of profit over human rights.

Aashna Lal and Margaret Matthews are project manager-research assistants at The Hastings Center. Danielle Pacia (@DaniellePacia) is a senior project manager-research assistant at The Hastings Center.

 

doctor using injection tube to put a bright light into a beaker

Bioethics Forum Essay

From Gene-Edited Embryos to Covid: China Faces Regulatory and Ethical Challenges

by Yuting Zhu and Jonathan D. MorenoPublished Posted in Gene Editing, Hastings Bioethics Forum

In early April, He Jiankui, the Chinese scientist who used gene-editing technology on human embryos born in 2018, was released from his three-year prison sentence, imposed after a Shenzhen District Court convicted him of “illegal medical practice.” He and two accomplices were banned from conducting any work related to assisted reproductive technology, applying for administrative permits for research on human genetic resources, and from applying for research funds.

The He Jiankui affair and, little more than a year later, the Covid pandemic have focused attention in China on ethical governance of research and medical  practice. Over the last two years, China has updated some regulations on human genetic engineering and assisted reproduction and established a national committee to guide and supervise bioethics nationwide. But there are legal gaps in some of the regulations and tension between competing values: the desire to encourage new research and to potentially inhibit it by imposing stricter ethics regulations.

An example of this tension came out in public expression over He Jiankui. Ever since his arrest there have been occasional comments on Chinese social media and news platforms that sympathize with him. After learning about his humble family background and how he strived to make scientific achievements and gain recognition, some media commenters have found him relatable and expressed hope that he would apply his research skills in the future. It is doubtful that these people fully understand the details of his experiment, including falsifying institutional review board approval and safety data and using undue inducement to recruit subjects, since the court hearing was not publicly disclosed and many news reporters have limited ability to cover the full details and ethical concerns of the case.

In early 2020, China updated a series of regulations to prevent future cases like the one involving  He Jiankui. The most legally authoritative regulations are amendments to the Civil Code and the Criminal Code. China’s National People’s Congress (NPC) approved Article 1009, which required all human gene- and embryo-related research to comply with ethics and relevant administrative regulations, whose insufficient legal force many scholars were previously concerned about. The NPC also approved an amendment to the Criminal Code’s Article 336, which criminalizes serious illegal medical practices by unqualified personnel and specifies that implantation of gene-edited or cloned embryos into the human body will receive three-to-seven years of imprisonment, depending on what judges consider to be the severity of the offense. This amendment clarifies that gene-editing human embryos is a severe offense, but only under the scope of illegal medical practice.

An open question is how to legally frame the He Jiankui affair if He and his team had been medical providers. In China there is no law, but only administrative regulations, that specifically address the research and clinical application of human genetic engineering and assistive reproductive technologies. If He and his team had been medical providers, it is unclear whether they would have been convicted of medical malpractice. That’s because, under the Criminal Code, for a medical provider to be convicted of malpractice, it is necessary to show that the provider’s actions resulted in a patient’s death or grave harm. Any harms from genetically editing the human embryos may not be apparent for many years. . 

The legal gap in regulating human gene-editing and ART has another aspect: administrative regulations are not legally binding and lack the force of punishment. In response to the He affair, the National Health Committee (NHC) drafted the Regulations on the Management of the Clinical Application of Innovative Biomedical Technologies, which requires that any high-risk clinical research, including gene-editing and ART, gets NHC approval. Furthermore, only the top-ranked hospitals can conduct such high-risk clinical research, and only experienced medical providers are eligible for principal investigators. Punishment for violations is administrative only, including fines and cancellations of license. Some scholars have thus urged adopting some guidelines in law.

In 2020, a National Ethics Committee for Science and Technology in China was established to guide and supervise bioethics nationwide. In March 2022, the committee drafted and published Opinions on Strengthening the Ethical Governance of Science and Technology, which established guiding values, informed by past experiences in the international community and built on consensus, to demonstrate China’s attitude towards and commitment to ethical science. The document also sets goals to develop and refine China’s ethical governance, from supervision of ethics committees to increasing bioethics education for students in relevant areas. The committee also plans to develop guiding principles to supervise Covid-related clinical research to protect subjects’ rights. 

So far, China has demonstrated its willingness to advance its ethical governance of innovative technologies, but it faces a dilemma whether to encourage technology research or to implement stricter regulations. This dilemma is familiar in other national settings as well, but in China it takes on a special character. A law professor in China observed that the idea of reducing obstacles for researchers by not setting up punishment in department guidelines is common in research institutions.

Setting aside the question to what extent China should establish legal deterrence against unethical science, however, law alone can never achieve true ethical governance. Ethics literacy among journalists and their readers is limited, and many ethics committees are mere formalities. Given that currently few Chinese higher education institutions have bioethics education, China still has a long way to go to establish a culture of ethics in science. 

Yuting Zhu is a junior at the University of Pennsylvania. Jonathan D. Moreno, PhD, (@pennprof) is the David and Lyn Silfen University Professor of Ethics at the University of Pennsylvania and a Hastings Center fellow.

bouquets of colorful flowers layed on sidewalk along with balloons

Bioethics Forum Essay

Public Health Officials and Gun Rights Advocates Must Work Together

by Edward Strickler, Jr.Published Posted in Hastings Bioethics Forum, Public Health

In rural Virginia, where I live, there is strong support for the right to own and carry guns. For more than a decade, I have shared public health, mental health, and other scientific findings with the leadership of a statewide Second Amendment rights advocacy group, especially regarding the leading number of deaths by firearms: suicide. We do not agree on what firearms laws and policies might be or do to prevent suicides, but we have sustained our conversations and respectfully learned from each other’s point of view. Such conversations are hard to have.

Following each mass shooting—of which there were 11 on July 4th alone—and the Supreme Court’s decision striking down New York State’s concealed-carry law, supporters of stronger gun control and supporters of Second Amendment rights talk past each other, restating their familiar views. We need better skills for respectfully listening to different points of view if we are to make effective progress to reduce the public health problem of firearms violence.

From many years of volunteering–with queer youth, in support of survivors of partner and sexual violence, and during the HIV/AIDS pandemic–the personal, family, and community devastation of self-harm and suicide are horribly familiar to me. In addition to advocating  for  prevention strategies, such as improving mental health resources, I took an unusual step about 10 years ago by attending a talk given by a leader of the Virginia Citizens Defense League, a group “dedicated to the right to bear arms as guaranteed by the Second Amendment.” I recall the tension in the room when I began to share data and ask questions about the group’s statements on a legal gun owner’s autonomy: that some people might own a firearm to be able to quickly end their live (which, for them, might mean preserving their dignity). I observed that suicide is not actually a solitary act, since others are changed by the suicide, and that there are occasions of murder-suicide and suicide-by-cop that we should, without question, prevent. I also brought up the necessity of safe firearms use and storage that can prevent some suicides.

I have continued talking with this group by regularly commenting on its public announcements and sharing public health data on firearms violence and well-argued scientifically grounded policy papers on preventing firearms violence. I have also given insights and recommendations from my experience and my values that I thought might affect their policy positions.

The group’s  foundational view–that the Second Amendment guarantees the right of citizens to protect themselves and their family, property, and others with guns—has not changed. But the group has made some changes. It has given more public attention to firearms safety. For example, it has offered training and support, including to racial, LGBTQ+, and other groups vulnerable to violence, who want to lawfully and safely own, carry, and store firearms for their protection. The group has begun to identify and discuss connections between adequate community mental health services and prevention of violence (including through self-harm and suicide).

In our continuing conversations, I have sometimes noted biases in how Second Amendment rights advocates interpret data. And VCDL leadership has identified biases in studies supporting gun control that fail to account for different cultural expectations around firearms, self-defense, and public safety. We have also discussed flaws in research and policies on gun violence, such as the lack of rural cohorts in research studies and policy analyses that make no distinctions among rural and urban jurisdictions. Rural-urban differences are widely recognized to be significant for public health interventions – and yet are  poorly studied in much of the public policy literature.

The Second Amendment rights advocates I talk with question the purpose of gun control laws if they are not enforced. A recent example is the Illinois “red flag” law, which failed to stop the suspect in the July 4th shooting in Highland Park. The advocates also criticize firearms violence prevention laws that do not fund and ensure effective mental health services and do not equitably fund and ensure these services across rural America when we know that the suicide rate is higher in rural than in urban areas and that rural areas have mental health and behavioral health provider shortages. The Bipartisan Safer Communities Act, signed into law by President Biden last month, may help change some of these rural-urban disparities  by  reducing administrative burdens on small and rural agencies. Nonetheless, because much of the act’s support goes to telehealth services, rural communities will be disproportionately left out because they face barriers to telehealth.  

People from diverse groups must come together, listen to one another, and build trust to make progress against the public health problem of gun violence. This will take law enforcement agencies, mental health services providers, civic, faith, and other community organizations, and the general public. The most effective and ethical practices of building trust in public health require intentional sustained engagement, rather than stereotyping and stigmatizing.

The public health community should get to know and work with Second Amendment rights advocates. In the state of Virginia alone, advocates have built a well-organized grassroots movement that has mobilized tens of thousands of people to public meetings with local government officials. Public health needs to reach out to these people to find common interests and achieve some common goals. How about a shared interest in supporting locally accessible, affordable mental and behavioral health services (including for alcohol, opioid, and other addictions)? In helping families in distress? In suicide prevention, especially for those most vulnerable to suicide, such as veterans, rural residents, people who identify as sexual and gender minorities, and  people in tribal communities? How about a shared interest in adequately funded systems of public defenders and legal aid, including for poorly served working class and rural communities?

But this engagement would only be possible from foundations of trustworthiness that includes making it obvious that public health respects and wants to serve all community members, with their many different cultures, faiths, and practical points of view, privileging none and empowering all for their own and their community’s health, safety, and well-being.

Edward Strickler, Jr., MPH, is a member of the Ethics Section of the American Public Health Association and a retired programs coordinator for the Institute of Law, Psychiatry and Public Policy at the University of Virginia School of Medicine.

doctor writing prescription

Bioethics Forum Essay

Abortion Law—Lessons from Medical Aid-in-Dying?

by Arthur CaplanPublished Posted in Abortion, Hastings Bioethics Forum

In 1995, a survey went out to critical care nurses in the United States asking them  whether they had ever administered medication or performed other interventions with the intent of causing a patient’s death. The respondents were guaranteed anonymity. That survey and the practices it revealed may provide a peek into the future of abortion in the United States.

A random sample of 1,600 subscribers to Nursing magazine who practiced in critical care settings was selected, of whom 1,139 completed the survey. One hundred and twenty-nine of them (16%) reported that they had participated in active euthanasia or assisted suicide at least once in their careers. Sixty-four (8%) reported having done so in the year before the study. Of the nurses who had performed such an act, 65% reported doing so three or fewer times and 5% reported doing so more than 20 times.

Back then, hastening a death, even with a request from a patient or their family, was illegal and, in all states, considered homicide.

The survey’s author, my friend David Asch, MD, wrote of  these startling results that “a central finding of this study is that these nurses struggle to uphold important personal values under extremely challenging circumstances–often with little support from physicians. National opinion surveys reveal that the majority of the public supports policies that would allow euthanasia under certain circumstances.”

This is where we find ourselves now with respect to abortion. At least seven states ban abortion, with few or no exceptions, on pain of felony charges and likely including murder. But the majority of Americans support abortion in certain circumstances. About a quarter of doctors surveyed support a woman’s right to obtain an abortion at any time, and only 3% said that abortion should never be allowed. And doctors and nurses could, if they wished, clandestinely participate in some forms of abortion if their close colleagues agreed to support them and keep the practice private.

Prior to the 1999 conviction of Jack Kevorkian for second-degree murder in the videotaped killing of Thomas Youk, a Detroit man paralyzed by ALS, no doctor or nurse in the U.S. had ever been convicted for assisting a patient who wished to end his or her own life.

Despite the law, prosecutors proved reluctant to bring charges, and when they did, plea bargains  often resulted in the charges being dropped in exchange for public service. In the few cases that went to court, judges and juries were not comfortable sentencing doctors and nurses for murder in morally fraught circumstances.

And, over time, the laws in 10 states and Washington, D.C., have been modified to allow medical aid in dying with various restrictions and conditions.

No doubt the analogy to the current situation post-Roe has some important differences. But what is crucially important is to recognize that health care and society will strive to find ways to undercut crude bans inconsistent with perceived medical need and professional duty. And society will find it extraordinarily difficult to prosecute and jail health care professionals who support one another, who act out of compassion, and whom society holds in high regard. When states overreach, history shows that doctors, nurses, and the legal authorities may make enforcement of bad laws very difficult.

Arthur Caplan, PhD, (@ArthurCaplan) is Mitty Professor of Bioethics at the NYU Grossman School of Medicine. He is a Hastings Center fellow and a member of The Hastings Center’s advisory council.

white money behind a steal fence, grasping onto the crossed bars

Bioethics Forum Essay

Primates in Medical Research: A Matter of Convenience, not Sound Science

by Hope Ferdowsian and L. Syd M. JohnsonPublished Posted in Animal Research Ethics, Hastings Bioethics Forum

In Beaverton, Oregon, in one of seven National Primate Research Centers, a rhesus macaque sits in a cage awaiting her fate in an Alzheimer’s disease experiment. She is one of more than 100,000 monkeys–regarded by some neuroscientists as key to understanding dementia–forcibly separated from her family, traded as a commodity, and scheduled to die in a laboratory in the U.S. What are the current and future potential uses of nonhuman primates in research? The National Academies of Sciences, Engineering, and Medicine is examining this question.

Experiments on animals date back to at least 6 BCE when ancient Greek physicians, culturally forbidden from cutting open human bodies, turned to nonhuman bodies. By the 17th century, philosopher and scientist Francis Bacon asserted that the dissection of living animals could “sufficiently satisfy” as a substitute for human experiments. Although nonhuman primates have been dissected for ages, the systematic inclusion of nonhuman primates in research began in the last century.

After the Second World War, revelations of human research abuses led to the establishment of guidelines for the conduct of research with humans, such as the Nuremberg Code and the Declaration of Helsinki. By 1979, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, appointed by the U.S. Congress, published The Belmont Report, which laid ethical foundations for 20th century human research protections. The Belmont Report centered on the principle of justice and the importance of avoiding the selection of human research subjects based on convenience, accessibility, or manipulability.

While it was well-intentioned and rightly protected vulnerable populations, such as children and imprisoned persons, The Belmont Report encouraged a shift to research involving nonhuman primates and other animals. This shift has resulted in unresolved moral and scientific problems that can now only be addressed by another paradigm.

Today, unlike in the 17th century, scientists easily recognize the truth in the saying “mice lie and monkeys exaggerate,” which points to a well-known problem in biomedical research: using nonhuman primates and other animals in research fails more often than it succeeds. Approximately 90 percent of new investigational drugs–drugs that appear safe or effective in monkeys and other animals–fail to be safe and/or effective in humans. Nearly 100 percent of the drugs developed for Alzheimer’s in decades of research have failed. As researchers at the Oregon National Primate Research Center in Beaverton wrote in 2021, “in the rhesus macaque model of aging, all four major hallmarks of [Alzheimer’s disease]—significant cognitive decline, amyloid beta plaques, p-tau tangles, and neuronal death—do not reach the pathological levels of clinical [Alzheimer’s disease].” In other words, these monkeys do not develop Alzheimer’s disease.

If researchers were to extend The Belmont Report’s principle of justice to nonhuman primates and other animals, they would perhaps acknowledge that the continued use of these animals is a matter of convenience, accessibility, and their vulnerability to coercion rather than a matter of sound science. The translational failures of science discount lives that are utterly thrown away in experiments that we have good reason to expect will fail. Animals are treated like disposable equipment rather than as conscious, living, feeling beings.

Translational failures also harm humans—those who will face the risks of human experiments based on animal research and those who will continue to wait for medical treatments that are promised but not delivered. The translational failures of biomedical research are not just a scientific problem, but a moral problem—a failure to recognize the value of both nonhuman and human lives.

Failures to transform medical research are propelled by institutional biases and by limitations in transparency and in accountability for spending trends—all of which are complicated by long-standing relationships between the pharmaceutical industry, academia, and government. This network of influence has contributed to a shift away from health research and planning that was historically focused on the public interest to research priorities that are now largely driven by profit margins. Many stakeholders within the industry-academia-government complex have an interest in animal research remaining the norm. The National Primate Research Centers are a notable example.

Nonetheless, public pressure does from time-to-time break through and cause policy makers to reevaluate the norm. For example, in 2011, following a request from the U.S. Congress and the National Institutes of Health, an Institute of Medicine  Committee on the Use of Chimpanzees in Biomedical and Behavioral Research concluded that most current uses of chimpanzees in research were unnecessary. Chimpanzees are humans’ closest living relatives, yet chimpanzee experiments are still viewed as unreliable and unnecessary. A growing number of physicians and scientists realize that evolutionary and individual differences within and across species impede the translation of animal research findings to humans—even for animals who are so like us.

This year, in response to a request from Congress and the NIH, the National Academies of Sciences, Engineering, and Medicine (comprising the former IOM) is again examining the use of nonhuman primates in research. But rather than asking if monkeys should be used in research, the NIH’s mandate to the NASEM committee leaves that important question off the table. To protect the status quo, the committee is comprised of individuals entrenched in primate research, and the only members to disclose conflicts of interest are those with an interest in nonanimal methods.

But the status quo isn’t working, as decades of science demonstrate. Across the US, the families of the estimated six million people living with Alzheimer’s disease—and the physicians treating them—are desperate for answers. They know the suffering Alzheimer’s can cause, and they want more effective prevention and treatment strategies.

As Thomas Insel, the former National Institute of Mental Health director, explained in his book Healing, we need to shift from relying on reductionist models of disease to looking at what patients, families, and communities living with various forms of psychiatric and neurological illness experience and need. This shift, overturning the status quo, requires investing in ethically designed studies that center on patients and population-based interventions, as well as on science that is centered on human biology and systems. Such a shift requires recognizing the failure of 17th century ideas, and reimagining and modernizing biomedical research to meet the real needs of patients and the demands of justice.

Hope Ferdowsian, MD, MPH, is an associate clinical professor at the University of New Mexico School of Medicine, and president and CEO of Phoenix Zones Initiative. @HopeFerdowsian

L. Syd M. Johnson, PhD, is an associate professor at the Center for Bioethics and Humanities and a clinical ethics consultant at Upstate Medical University in Syracuse, N.Y. @LSydMJohnson

Black female doctor with her head in her hand

Bioethics Forum Essay

Experiencing Racism: Health Care Professionals Speak Out

by Pringl MillerPublished Posted in Hastings Bioethics Forum, Racial Justice

“My emotions and insecurities were at an all-time high, so much so that I was no longer comfortable coming into work. Do my coworkers also joke about my culture, my skin tone? Do my patients and families feel uncomfortable with me being their nurse? These were the questions I frequently asked myself as I anxiously braced myself for my next shift. I could no longer walk the streets, sidewalks, or even the hospital lobby without believing someone was looking at me because of the color of my skin.” ­

This quote from Cecilia Igwe-Kalu describes her experience as a nurse confronting racism in health care. In a recent symposium dedicated to this problem, the journal Narrative Inquiry in Bioethics gives voice to what many BIPOC health care professionals already know—their work culture and environments are not diverse, equitable, inclusive, or anti-racist. Worse, they are often ignorantly or willfully hostile.

The symposium, “Experiencing Racism in Health Care: Stories from Health Care Professionals,” is a rallying cry to confront racism in health care by looking through the lens of professionals afflicted by it. There is abundant testimonial evidence of being invisible, unheard, silenced, marginalized, underestimated, undervalued, gaslit and made to feel inferior and “othered.” Calvin E. Bradley, Jr., a health care chaplain (and one of The Hastings Center’s Sadler Scholars), writes: “Many times in healthcare, I have been reminded through the actions of others that my expected role is to be seen but not heard; patronized but not validated; and present but not influential. It is not my size or skin color that most threatens or offends, but it is the ability to think freely and to be creative, to challenge and cultivate change, and most of all, to love people genuinely without return. It is that I both give respect, and demand respect from those around me. But most critically, it is that I have the ability to do all of this while being a Black man in healthcare.”

Through this enlightening and instructive symposium of first-person narratives about racism, the reader is left with the overarching question of why. With the ratification of civil rights laws and professional ethical codes of conduct many decades ago, why we are still here? The health care field, in general, is an educated community that has at its core the organizing principle of “do no harm.” One easy answer is that some traditions are hard to break. “One might think that becoming a physician alleviates Asian American racial dynamics, but the culture of medicine is not immune to microaggressions,” writes Kimbell Kornu. “As a medical student, I enjoyed rotating at the VA hospital because of the veteran population. However, immediately after I walked into a patient’s room, a veteran told me, ‘Go away. I don’t want a Jap doctor.’ Despite my gratitude for this veteran’s service to America, I was not considered American enough to be involved in his care.”

A more egregious possibility is that structural norms and individuals with power and influence condone a discriminatory culture, leveraging structural and interpersonal superiority against vulnerable and marginalized groups, thereby perpetuating a timeless resistance to view all persons with the respect and dignity that our principles and words on paper would dictate.

The symposium editor, Gloria A. Wilder, along with four expert commentary authors and the narrative contributors, speak to inequities rooted in the history of racism in the United States, which might be more accurately characterized as white supremacy. In her introduction to the symposium, Wilder states: “The closer you are to ‘Whiteness,’ the more access you have to privilege. The authors reflect upon the dogged denial of privilege and the resulting con­sequences of maintaining the status quo.”

Perhaps it is time our professional health care community and society at large reframe racism by focusing on those in the racial majority with power and influence who are ill-equipped or refuse to change their attitudes and beliefs. The presence and recognition of racism are denied and amorphous to the person who is privileged to be insulated from its impact. This protective cocoon cannot remain if the white majority takes seriously their role in addressing racism.

“Bioethicists have written on the field’s refusal to engage meaningfully with racism and its deleterious effects on health and well-being, arguing for the recognition of racial justice as a bioethical issue,” writes Nathalie Égalité in a commentary. The study, application, and practice of ethics provide a framework, a code of moral values, and a set of standards and virtues that we—all people–should consult as a source of guidance. Despite having persuasive data that racism is immoral, destructive, and costly, we are nonetheless stuck at a critical impasse. Reason and our bioethical stance fall short in transforming human behavior and structural traditions.

None of this seems to effectively challenge deeply held beliefs and behaviors. Author Zaiba Jetpuri describes an interview she had with a hiring physician for a scribe position. Upon meeting Jetpuri, who wears a hijab, the hiring physician explains, “We don’t allow any accessories here—no hats, no jewelry, no religious affiliations here. People aren’t allowed to wear necklaces with crosses.” But she also said, “Wearing your headscarf here would make my patients scared.”

Personal and institutional accountability is lacking, even though everyone stands to benefit, and national health outcomes will improve, without racism. In their commentary, Aletha Maybank and Fernando De Maio, of the American Medical Association, quote from a 2021 JAMA podcast in which the then-deputy editor said, “No physician is racist, so how can there be structural racism in health care?” White privilege and a lack of awareness were emblematic with the hosts of the podcast and the quote, which was widely broadcast on Twitter.

If we want to achieve an anti-racist culture and work environment, willful ignorance and the “pattern of righteous indignation,” as Wilder puts it, must be confronted with mandatory education, rigorous enforcement, and serious consequences for a failure to act ethically. Wilder states, “Racism requires complicity,” and the current culture of permissibility must be replaced with a culture of intolerance. It is no longer acceptable for people to be unaware and claim ignorance when it comes to racism, not when valued health care professionals and historically marginalized communities are suffering and sharing their painful reality with us. The 21st century failure of institutional leadership to confront and eliminate racism is a matter of choice, a choice to live in one’s privileged reality devoid of such racist experiences and the choice to discriminate against and disadvantage others for personal and/or institutional benefit.

In the historic 1965 debate, “Is the American Dream at the Expense of the American Negro?”, between author and activist James Baldwin and conservative political commentator William F. Buckley, Jr., Baldwin captured the essence of our ongoing dilemma when he said, “The certain awkwardness I feel has to do with one’s point of view, one’s sense or system of reality.” I feel a certain awkwardness in knowing that my reality of experiencing racism is easily dismissed by others who do not share the same reality. Like me, the contributors to this symposium share the unfortunate reality of experiencing racism, and it is for others who don’t experience racism to learn how to be anti-racist. For our professional community to become anti-racist, we must work toward a shared reality, one in which everyone’s sense or system of reality matters and moves closer to achieving equity, fairness, and justice for all.

Racism is categorically antithetical to the four ethical principles of autonomy, beneficence, nonmaleficence, and justice, to the concept of respect for persons, and to laws espousing all persons deserve the right to citizenship, equality, and liberty. What will it take for all of us—especially our white allies—to act now and adhere to the ethical imperative to hold each other accountable to an anti-racist and anti-white-supremacist culture? As Dr. Wilder writes, “This moment is a reckoning with who we are to each other and an aspiration of who we want to be.”

I want to see America be what she says she is

in the Declaration of Independence and the Constitution.

America, be what you proclaim yourself to be!

– Pauli Murray

Pringl Miller, MD, (@pringlmillermd) is a board-certified general surgeon and hospice and palliative medicine physician trained in clinical medical ethics. Dr. Miller is the founder and executive director of Physician Just Equity, a nonprofit organization that supports and empowers physicians and surgeons experiencing unjust workplace conflicts. (@EquityDocs)

greying white man giving a speech

Bioethics Forum Essay

After Roe, What’s Next for End-of-Life Care?

by Joseph J. FinsPublished Posted in Abortion, End-of-Life Care, Hastings Bioethics Forum

As concerning as the Supreme Court’s reversal of the constitutional right to abortion was in the Dobbs v. Jackson decision were the comments of Justice Clarence Thomas. In a concurring opinion he took aim at the unenumerated rights that protect decisional privacy in the most intimate of matters: birth control and how and whom we love. He wrote, “The harm caused by this Court’s forays into substantive due process remains immeasurable.” He concluded, “Substantiative due process conflicts with that textual command [the text of the Constitution] and has harmed our country in many ways. Accordingly, we should eliminate it from our jurisprudence at the earliest opportunity.”

The majority opinion disagreed and sought to distinguish other decisional privacy rights from abortion noting, “The exercise of the rights in Griswold, Eisenstadt, Lawrence, and Obergefell does not destroy a ‘potential life,’ but an abortion has that effect.” Nonetheless, commentators haven’t been reassured and the concern persists that the reversal of Roe is the beginning of an onslaught on our freedoms.

I want to add one more worry to the list and point to self-determination at life’s end. Here we have Justice Neil Gorsuch to worry about. Back in 2017, during his confirmation hearings, I wrote an essay for The Hill urging senators to ask him about end-of-life care and the right to refuse life-sustaining therapy. As might be expected, the focus of the hearings was on his views about abortion. But he had authored a book entitled The Future of Assisted Suicide in Euthanasia, raising questions about his views on choice at the end of life.

As I recall only Senator Diane Feinstein questioned Gorsuch about his views on “death with dignity.”  She said, “You make the statement that there is no justification for having anything to do with the end of some’s life, encouraging the end of life.” Gorsuch replied by invoking the memory of his father: “And I’ve been there with my dad and others. At some point, you want to be left alone. ‘Enough with the poking and the prodding. I want to go home and die in my own bed, in the arms of my family.’” It was an emotional and reassuring moment for those who want to maintain choice at the end of life.

Feinstein pressed Gorsuch: “Supposing you cannot handle the pain and you know that it’s irreconcilable?” Again, Gorsuch’s testimony was reassuring: “Senator, the position I took on that in the book was anything necessary to alleviate pain would be appropriate and acceptable, even if it caused death . . .  not intentionally, but knowingly. I drew a line between intent and knowingly. I’ve been there. I’ve been there.”

In personalizing the response, Gorsuch gained sympathy in the room, and this line of questioning was abandoned. But it is a conversation that needs to be revived. In the wake of Dobbs, it is important to consider how Gorsuch’s judicial philosophy might be expressed in a case that came before the court that contested a patient or a family’s right to make end-of-life decisions by alleging that these established choices were akin to assisted suicide.

As I re-watched Justice Gorsuch’s testimony before the Senate Judiciary Committee I became more concerned about the personal nature of his responses to Senator Feinstein. His replies were not conceptual articulations of the legal right to privacy that undergirds end-of-life care; rather, they were anecdotal and evasive. They should provide as much reassurance as the “settled law” responses that all three Supreme Court justices nominated by Trump gave when asked about the precedent established by Roe.

One would think that this is settled law in the wake of Quinlan, Cruzan, and Quill v. Vacco, that stare decisis would argue against the erosion of rights that date back five decades. But Roe and Quinlan were products of the same era. Both prized autonomy and dominion over life’s most important choices. And now that Roe has been overturned, other well-established precedents that rely on the logic that informed that decision, including those that govern decisions at life’s end, could be vulnerable.

My concerns about Justice Gorsuch are laid out in The Future of Assisted Suicide and Euthanasia. While most of the volume makes the case against assisted suicide and euthanasia, his argumentation seems to equate killing with letting die. This would undermine the right of patients and families to withhold or withdraw life-sustaining therapy. Two examples are very concerning. Writing of a case from Britain, he questions a ruling in which “the court seemed to assume that a competent patient has a right to refuse care, even if in doing so it might evince an intent to die.” He also referred to Bouvia v. Superior Courtas “euthanasia by omission.” That case centered on the rights of a competent patient to refuse artificial nutrition and hydration. Elsewhere he questions surrogate decision-making for patients who have lost capacity.

The challenge here is intent, and that can sometimes be in the eyes of the beholder. While Justice Gorsuch might endorse “enough with the poking and prodding,” what if those disruptions could save a life? Would ceasing to poke and prod “evince an intent to die”? And who gets to make that determination–the patient and their family or an emboldened conservative majority on the Supreme Court?

 As America prepares for the further erosion of reproductive rights and marriage equality, the views of Justice Gorsuch bear close scrutiny. The final chapter of his book on assisted suicide and euthanasia warrants a careful read, starting with its title, “Towards a Consistent End-of-Life Ethics: The ‘Right to Refuse’ Care for Competent and Incompetent Patients.” Placing a right to refuse in quotations is particularly worrisome for someone who also calls for respect of the “inviolability of human life principle.”

That principle has been the alpha and omega of this court. What began at the beginning of life could well affect how we die. It would be naive to think otherwise.

Joseph J. Fins, M.D., M.A.C.P., F.R.C.P., is the E. William Davis Jr. M.D. Professor of Medical Ethics,  a Professor of Medicine and chief of the division of medical ethics at Weill Cornell Medical College, Solomon Center Distinguished Scholar in Medicine, Bioethics and the Law and a Visiting Professor of Law at Yale Law School and a member of the Adjunct Faculty at the Rockefeller University. He is a Hastings Center fellow and member of the Center’s board of trustees.

tall pillared white building with people surrounding

Bioethics Forum Essay

The End of Roe v. Wade Will Be a Nightmare for Disabled Americans

by Liz BowenPublished Posted in Abortion, Hastings Bioethics Forum

The end of federal abortion rights is a disability justice issue—but not in the way you might think.

Historically, debates over reproductive autonomy have produced some strange bedfellows when it comes to disability. Anti-abortion policymakers and advocates often appeal to the value of disabled lives when they promote legislation that prohibits abortion on the basis of fetal anomalies, co-opting the commonly held disability-rights position that such abortions are morally problematic.

Though what gets called “the disability community” is nothing if not heterogeneous, even those who support abortion rights often have concerns about certain elements of reproductive choice, such as the dwindling of newborns with Down syndrome in countries with widespread prenatal genetic testing. It would be easy to think that there is a conflict between valuing disabled life and demanding full reproductive autonomy, but this would be a mistake. The calculus changes if we acknowledge the simple fact that disabled people have sex—and, yes, get pregnant—a fact that would no doubt make some lawmakers’ heads explode.

As a disabled scholar who thinks a lot about disability ethics and health care, I can’t help but notice that the debate over fetal anomalies doesn’t capture the full set of concerns that I share with disabled friends of so-called childbearing age. That’s because it only considers abortion through one limited, if still important, lens: prospective parents’ choice of whether or not to have children with disabilities. These prospective parents are generally presumed to be nondisabled, or at least their own disability status does not enter into their considerations about whether or not they could care for a disabled child. The anti-abortion right’s singular focus on disabled fetuses appropriates disability advocates’ real concerns about eugenics while, ironically, dismissing the possibility that disabled people can or should become pregnant.

Given that people with disabilities are now estimated to make up more than a quarter of the U.S. population and abortion will now be banned in about half of the U.S. states, we are far past due for a reckoning with what reproductive justice requires for disabled people. For many of us, it means affordable, accessible, and safe abortions—whether or not we want children.

Disability is as varied as the human condition, and many disabled people build thriving biological families that flout ableist assumptions about who can be a parent. At the same time, certain disabilities and chronic conditions can make pregnancy extremely high-risk and physically torturous in ways that restrictive state laws tend to disregard. As clinical ethicist Michele DeMarco has written, a person with a cardiac condition could be told that pregnancy would be “tantamount to suicide” and still not necessarily qualify for an abortion under the new wave of anti-abortion legislation and trigger laws that will now take effect in 13 states. The language of these laws is so vague that doctors will undoubtedly avoid abortions that are not “immediate” emergencies out of fear of lawsuits or prosecution.

It is not hard to imagine how this hesitancy could harm people living with all kinds of chronic illnesses and disabilities. Some people with psychiatric disabilities might fear a relapse of crisis-causing symptoms as a result of the medication changes and hormonal fluctuations that accompany pregnancy. Some of the 1 in 4 diabetics who are forced to ration their insulin, making it difficult to keep their blood sugar in the range recommended for pregnancy, might fear that being pregnant would exacerbate kidney disease and neuropathy, which they already contend with. But even if people in abortion-restricted states fear for their lives with these risks, they likely would not be able to end their pregnancy until their life was acutely under threat. The fact that the physical stress of a pregnancy could take years off a chronically ill person’s life would be of little to no consequence under Mississippi’s abortion law, for example, which contains a “life of the mother” exception only in the case of a “medical emergency” that “necessitate[s] the immediate performance or inducement of an abortion.”

While it is still possible, if not easy, to get a hold of medication abortion even within states with abortion bans, not everyone can take these pills: they are contraindicated for people with certain liver, kidney, and inflammatory conditions, and due to the need for self-monitoring and adherence to care instructions they are not recommended for some people with comprehension barriers.

It might be tempting to take comfort in the notion that people can leave their state to get an abortion if they really need one. But this option will exist only for those who are well enough to travel, and who can afford the transportation and time off work that it takes to cross state lines for a medical procedure. Disabled people live in poverty at twice the rate of nondisabled people, and many are prohibited from accumulating savings due to the punishing asset limits on those who receive Supplemental Security Income.

Even if one can afford to travel, doing so can be dangerous and inaccessible for people who rely on durable medical equipment. On average, airlines break or lose 29 wheelchairs a day, leaving the people who need them immobilized and reliant on inadequate alternatives while they await reimbursement. Last year, disability activist Engracia Figueroa died from complications of sores she developed as a result of United Airlines having broken her $30,000 wheelchair. Entrusting life-sustaining equipment to careless corporations can be as much of a gamble as a high-risk pregnancy.

Meanwhile, even if a person does make it off a plane without incident, finding an accessible medical facility is a challenge of its own. Despite the Americans with Disabilities Act’s requirement that health facilities provide reasonable accommodations for disabled patients, many lack basic accessible equipment like adjustable exam tables. Moreover, disabled people often encounter stigmatizing assumptions and attitudes from medical professionals who assume they are either sexually inactive or hypersexual. The continued shrinking of abortion provider networks will make it harder for pregnant people with disabilities to find providers who can meet their needs and treat them with respect—particularly as they are forced to look outside their local communities, where word of mouth can provide important information about a provider’s accessibility and attitudes.

Of course, abortion restrictions do not only endanger people who don’t wish to be pregnant. Many people who want biological children also have conditions that put them at higher risk of adverse outcomes and miscarriage, such as intellectual and developmental disabilities, thyroid disorders, hormonal conditions, and diabetes. Because the medications and surgeries used to end miscarriages are identical to those used in abortions, doctors in countries with abortion bans are often afraid to treat miscarriages and force pregnant people to carry an unviable fetus. This poses clear psychological risks as well as physical ones, as evidenced by the deaths of women in Ireland, Italy, and Poland who developed sepsis after being denied treatment for a miscarriage.

This lack of accessible gynecological care will disproportionately imperil those whose illnesses and disabilities put them at greater risk of miscarriage—especially if they are marginalized in other ways. Racialized health disparities mean that Black women have a higher likelihood of miscarriage than white women, while Black people in general are more likely to be disabled. Access to safe and timely miscarriage care is therefore a matter of intersectional disability justice. If a goal of anti-abortion legislation is to preserve disabled lives, then it makes little sense to endanger the lives of disabled people who want to have children.

An especially horrific outcome of the end of federal abortion protections is the fact that, in many states, people who miscarry or have stillbirths will be vulnerable to prosecution. Law enforcement already targets people whose miscarriages they allege were linked to drug use, overwhelmingly charging women of color. I shudder to imagine how this practice might intersect with the inevitable increase of disabled people forced into pregnancies despite the fact that they rely on medications whose effects on fetuses are understudied or have been shown to pose risks.

For the past 30 years, disability activism has been guided by the slogan, “Nothing about us without us.” When the conversation around disability and abortion is constrained to the interests of fetuses, that “us” is conveniently constrained to entities that can’t participate in the debate. And so, when anti-abortion lawmakers cynically adopt disability critiques to restrict access to abortion, they neglect the diverse needs and desires of disabled people, many of whom object to yet another impingement on our bodily autonomy after decades of fighting for self-determination. People with all kinds of disabilities should have the right to make families however we choose, which means not facing stigma for wanting to have children, being adequately supported through high-risk pregnancies, being taken seriously about our own risk assessments, and having equal access to the providers and procedures we need to remain safe.

It’s easy enough to profess to care about disabled lives in utero. But it’s time to start listening to us about what we need outside the womb.

Liz Bowen, PhD, is the Rice Family Fellow in Bioethics and the Humanities at The Hastings Center. @lizbowhunter

two women in scrubs holding a dog and giving ultrasound

Bioethics Forum Essay

Veterinarians Often Provide Futile Care. Doing So Comes at a Cost

by Lisa Moses, Nathan W. Peterson and J. Wesley BoydPublished Posted in Hastings Bioethics Forum, Professional Ethics

Most pet owners probably don’t give much thought to their pets’ doctors, but the care veterinarians provide can exact a toll on their own health. Like medical doctors and nurses, veterinarians experience moral distress and burnout because of the ethical conflicts they face on the job. We have been studying ethical conflict and moral distress among veterinarians for several years, and we have new findings on the causes and suggestions for addressing them.

Ethical conflict and distress among veterinarians are common and widespread. In the first study of this problem in North America, two of us–Lisa Moses and J. Wesley Boyd—surveyed almost 900 veterinarians. Sixty-nine percent of them said they had felt moderate to severe distress about not being able to give animals what they thought was the right care. One of the most surprising findings was that requests for, and the provision of, “futile” care caused more distress to veterinarians than any other clinical situation, including owners asking to have their pets put to sleep because they can’t–or are unwilling to–pay for treatment. Study participants considered care to be futile when further or ongoing treatment wouldn’t improve the outcome and would result in further pain and suffering on the part of the animal patient.

We have witnessed requests for futile care firsthand and seen the extraordinary toll that they can take on members of the entire veterinary care team. These cases make us feel that we are harming patients by continuing to treat them and causing needless suffering. An example was the geriatric orange tabby cat, who after spending days recumbent and barely responsive in an oxygen enriched cage, was scheduled to have another round of chemotherapy for his metastatic cancer, against his veterinary oncologist’s and palliative care veterinarian’s advice.

To explore futility more deeply, our colleague Nathan Peterson led a more recent survey of veterinarians. Of the 477 who responded, 99% reported encountering futile care at some point in their career and 42% said that it occurred often (more than six times a year) within their practice. The reasons offered most often for providing futile care included allowing time for an owner to be present for euthanasia, satisfying an owner’s request that all treatment options be exhausted, and the owners not understanding the severity of their pet’s condition. Even though a large majority (76.2%) of respondents agreed or strongly agreed that providing futile care sometimes benefited the owners in some way and a majority were sympathetic to the owners’ feelings, providing futile care can exact a toll on  veterinarians.

The upshot from both studies is that medical futility is a significant contributor to moral distress and burnout. Given how frequently veterinarians encounter futility in their practices–along with the other everyday aspects of veterinary practice, which can also cause distress –it is not surprising that over 30% of veterinarians report feeling depressed and that veterinarians have higher than average rates of suicide. 

Several things need to change to support veterinarians. First, veterinary education should explicitly address the ethical dilemmas faced in practice and acknowledge that mental health can suffer as a result. Second, veterinarians should recognize signs of burnout and depression in themselves and their staff members. Creating practice cultures where ethical conflict and its impact are openly identified, and staff have strategies to manage them, is sorely needed in the veterinary world.

And, finally, pet owners ought to be aware that their veterinarians may share their anguish when a beloved companion is suffering, and that veterinary medical decision-making can be emotionally complex for vets, too. A healthy dose of compassion from all sides, can go a long way to lessening the ethical conflicts and how badly they make everyone feel.

Lisa Moses, VMD (@drlisamoses), is a veterinarian and animal focused bioethicist who is a faculty member of Harvard Medical School’s Center for Bioethics and a senior advisor to The Hastings Center. Nathan W. Peterson, VMD, is a veterinarian and an associate clinical professor at Cornell University College of Veterinary Medicine and  is a master’s degree candidate at Harvard Medical School’s Center for Bioethics. J. Wesley Boyd, MD, PhD (@JWesleyBoydMD), is a professor of medical ethics and psychiatry at Baylor College of Medicine.

The authors thank Hastings Center President Mildred Solomon for her mentorship and inspiration for the first study of moral distress among veterinarians.

people standing in white clothes with black masks at desks

Bioethics Forum Essay

DACA at 10: More, Please

by Mark G. KuczewskiPublished Posted in Hastings Bioethics Forum, Health and Health Care

DACA, the Deferred Action for Childhood Arrivals program, has been with us for 10 years. On June 15, 2012, President Obama announced the creation of what has since been called the most successful immigration program in our nation’s history. Granting a work permit and a renewable two-year stay of deportation to undocumented youth who have grown up in the United States turned out to have enormous benefits for them and for our nation. They report that DACA changed their prospects, with better jobs,  better wages,  more education, and better health. The children of mothers who are DACA recipients are healthier than the children of mothers who were not recipients.

It is the workforce and our communities that have benefitted most from DACA. For instance, at the medical school where I work, we have graduated 33 DACA recipients and sent them into the physician workforce. They are a rich source of diversity in a field that struggles with it. More than half of our physicians with DACA self-identify as Latino and speak Spanish fluently. The number of DACA doctors is relatively small owing to the length of training and the difficulty in funding a medical education while ineligible for federal student loans. However, more than 60,000 DACA recipients work in health care. The contributions of these essential workers were often noted early in the pandemic as they put their lives on the line. And, in general, recognition of the contributions that immigrants also make in low-wage but essential jobs threatened for a moment to displace the xenophobia that has been prevalent in recent years in the United States. But that moment has passed and insofar as immigration is at all on the national radar, it is discussed in terms of attempting to discourage asylum seekers from presenting themselves at our southwestern border.

The 10th anniversary of DACA reminds us that when given the opportunity, young immigrants renew our nation’s trademark optimism and determination, the themes of the narrative of the American Dream. This infusion of the immigrant spirit seems most needed now, at a time when our nation is trapped in a post-pandemic malaise that’s fed by an acute labor shortage, an aging population, and a general pessimism about the future. Unfortunately, at 10 years old, DACA is simply inadequate in being fair to these young people and providing for our nation’s needs.

In his remarks announcing the creation of DACA, President Obama acknowledged that as an executive order, this program was not meant to be permanent but, rather, to be a bridge to a legislative solution. We’ve since watched it come under threat during the Trump administration and survive owing only to a Supreme Court decision  based on administrative procedural grounds and President Trump being voted out of office. But even at this juncture, DACA continues to be challenged in the courts. And, of course, as long as young DACA recipients do not enjoy the benefits of citizenship, their contributions to society will be limited by such barriers as ineligibility for federal student loans. But even more important is the limited number of people eligible for DACA.

Most undocumented students attending U.S. colleges do not even have the protection from deportation and the opportunities that come from having the work permit DACA grants. The DACA memorandum contains some arbitrary eligibility requirements, such as that the applicant must have been present in the U.S. on June 15, 2012, and lived continuously in this country for the five years prior. These requirements have not been updated. As a result, the pool of DACA recipients who can eventually join the physician and health care workforce is diminishing and the path forward for undocumented youths who are ineligible for DACA and attending colleges and universities is not clear.

A commitment to justice and fostering the health of the nation requires that the health care superstructure, e.g., professional societies, health systems, academic medicine, public health officials, and bioethicists, need to increase their efforts in two ways. First, in practical terms, we need to create opportunities for those in the undocumented population to be educated and, trained and to practice as physicians and other types of health care professionals. As more students who are undocumented enter higher education without DACA, training and practice pathways that do not require work permits need to be developed.

Some states, such as California and Illinois, require that professional licenses not be contingent on immigration status. Nevertheless, the medical profession remains inaccessible because residency training requires the ability to be paid as an employee of an institution. Creative solutions, such as residency programs that are true education programs and do not employ the trainee or programs that enable the resident to be an independent contractor, could enable qualified undocumented youth to serve in the health care workforce despite not having DACA. Providing these opportunities is warranted both by simple fairness to these young people who have grown up in the U.S. and meet the standards of admission to the profession and also by the needs of the health care workforce.

Finally, health care and bioethics must contribute to fostering a more true and just narrative regarding immigration. This no small task and exactly how to do so is not obvious. But a commitment to fostering health and justice is hard to honor while remaining silent in the face of widespread racist conspiracy narratives that promote fears of invading hordes of inferior ethnicities that are being brought to the U.S. to “replace” white Euro-Americans as voters. We must tirelessly trumpet the contributions of immigrants, both with lawful and undocumented immigration statuses, to health care, as well as the need to utilize more of this talent pool to keep our health care infrastructure staffed and in a way that is maximally suited to serve our nation’s patients. And we must revive and further develop the narrative prevalent early in the pandemic that recognized the dignity and service of essential workers and emphasized the interconnectedness of all of us in the effort to address the pandemic. We must never stop emphasizing that the exclusion of any population in our community from the health care system undermines the benefits to all of us. Health care and bioethics should seek to show that an understanding of immigration that emphasizes its relation to health and health care highlights our unity as a people and should not be an issue that stokes fear and division.

Mark G. Kuczewski, PhD, HEC-C, is the Michael I. English, S.J. Professor of Medical Ethics and director of the Neiswanger Institute for Bioethics at the Stritch School of Medicine at Loyola University Chicago. He is a Hastings Center fellow. @BioethXMark

Medical supplies in Ukraine being transported by tanks with a Red Cross on them

Bioethics Forum Essay

Oncology, Bioethics, and War

by Maksym BasarabPublished Posted in Hastings Bioethics Forum, Research in Resource Poor Countries

Like many other Ukrainians, I woke up on February 24 at about 5 am from the sounds of explosions. I live in the city of Dnipro in eastern Ukraine, not far from the airport, which was hit by rockets. The internet was filled with reports of such strikes throughout Ukraine and the rapid movement of Russian troops into our country in the north, south and east. The first day, horror gripped my city. In a panic, everyone who could lined up in traffic jams that were many kilometers long on the highways towards the western part of the country. Those who remained tried to buy food, which quickly ran out. Just as quickly, gas stations ran out of gas, and shops and all other public places were immediately closed. In a matter of days, the city was empty and resembled something from a post-apocalyptic film. The remaining citizens mostly stayed in their apartments and watched the news to learn about the situation in the country.

I had some difficult decisions to make. I treat cancer patients. My wife, also a physician, works in a military hospital. We both decided that continuing our duties would be the best way to help our country. When, after a couple of days, we learned that our army was heroically fighting the aggressors, saboteurs were being destroyed in the capital, and the government refused to evacuate, we were filled with a sense of pride in the Ukrainian people and we realized that we had made the right decision.

For my cancer patients, the situation was particularly difficult, as they were already under stress from the threat of a deadly disease. The war added greater uncertainty about the future, the likelihood of losing loved ones, housing, work, even being killed. The war has increased the vulnerability of cancer patients, their susceptibility to manipulation and helplessness. There were new problems with logistics, the provision of medicines and equipment, and the migration of patients within and out of the country. In the first weeks of the war, the health care system was paralyzed, reorganizing as much as possible for the needs of the army without attention to the needs of other citizens. There were no special directives or action plans for medical workers and hospitals.

Urgently, it was necessary for me to make decisions independently. Thanks to my bioethics training through a fellowship program of Loyola University Chicago and the Ukrainian Catholic University, funded by the National Institutes of Health Fogarty International Center, I have some principles on which to base my decisions, rather than simply intuition. Initially, I joined the program to study more deeply the bioethical aspects of clinical research. I saw that many rules are violated when conducting research in Ukraine and I wanted to participate in the development of ethical research in our country. Bioethics has now become an integral part of my work and everyday life. When the chaos of war arose around me, I turned to bioethics and its principles to organize needed actions.

The importance of the principle of respect for patient autonomy is indisputable. In the first weeks of military aggression, I observed the extreme helplessness of cancer patients. They were mostly passive and inclined to follow the doctor’s recommendations. Many hardly participated in the decision-making process and some even refused treatment. I had to think carefully about my communication with patients to prevent involuntary manipulations and actions contrary to their actual wishes. First, it was necessary to calm patients, which often required medication. Even more so than usual, I took care to avoid unnecessary fear and panic about missile strikes, death, and suffering of Ukrainians and other manifestations of a military invasion, and the uncertainty of the future or sometimes imminent death due to the progression of cancer. Creating a calm and trusting environment helped patients to participate more actively in their treatment. By focusing on immediate small goals, I was able to help my patients make decisions that aligned with their values, priorities, and worldview.

The principle of beneficence helped me make decisions regarding very practical matters. Caring for patients was complicated by disruptions to the supply of medicines and consumables. We also had to deal with the constant migration of patients (from our frontline zone to the rear, from the war zone to our zone), an increase in very ill patients due to the impossibility of their evacuation, and progressive deterioration the financial condition of both the population and the health care system. We had to adjust oncological care accordingly. This included:

1. Creating and maintaining, from all possible sources, a three-month supply of medicines.

2. Identifying new sources of obtaining and paying for medicines. This required expanding our number and geographical scope of contacts. We now work with many new suppliers and manufacturers, receive deliveries from all over Ukraine and from other countries, and obtain assistance from charitable and humanitarian organizations.

3. Identifying alternatives to scarce medicines and chemotherapy regimens, and continuously monitoring their availability.

4. Using telemedicine whenever possible to limit patients’ need to come to the clinic. (The power supply and internet have not been affected by the war.)

5. Introducing medical support for patients evacuating to safer regions. Contacts have been established with their new treating doctors; local patient communities have been organized for mutual assistance on evacuation issues and treatment options in different countries and different clinics.

6. Introducing free advisory assistance for refugees and other especially vulnerable persons newly arriving in our region from zones of active war.

Considering the principle of justice has helped me avoid unconscious discrimination of patients. While in general, refugees are usually more in need of support due to lack of work, housing, and financial savings, in the conditions of war, all cancer patients have suffered to varying degrees, often no less than displaced persons. Under these conditions, it seemed very important not to formally identify categories of patients, but instead to identify their needs in relation to our local capabilities to provide oncological and other assistance. In the overwhelming majority of cases, the way out in the face of the impossibility of assistance at the local level was medical and consulting assistance in evacuation, primarily to European Union countries, for continued treatment there. Those patients who, due to the severity of their condition, could not be evacuated and at the same time did not have the opportunity to receive the necessary oncological care, received special attention and priority for additional sources of financial and medical support.

Thus, in the conditions of the beginning of military aggression, general collapse and chaos, the use of the principles of bioethics helped me to structure interactions with patients and solve problems as they arose. Since February 24, consultations at our clinic have increased by 110%, and chemotherapy courses have increased by 60%. But the most important thing in the work, of course, is not the numbers, but the health of patients and years of their lives saved. I am grateful for the opportunity to study bioethics and implement its lessons in my daily practice.

Maksym Basarab, MD, was an oncologist in Dnipro, Ukraine, and fellow in the Loyola University Chicago-Ukrainian Catholic University Bioethics Fellowship Program, funded by the National Institutes of Health Fogarty International Center. He died of a stroke last month.

After finishing this essay, he expressed thanks to Emily E. Anderson, PhD, MPH, program director, and all the faculty at LUC and UCU.

woman of color holding a yellow sign with the words

Bioethics Forum Essay

Treating Gun Violence as a Public Health Threat: Not Exactly What We Meant

by Craig KlugmanPublished Posted in Covid-19 Ethics Resource Center, Hastings Bioethics Forum, Public Health

This week, the United States saw two momentous public health events. The first was the official recording of one million deaths attributed to Covid. The second was the 198th mass shooting of the year,  in Buffalo, N.Y., by an 18-year-old white male.

Both the pandemic and gun shootings are threats to public health. Individual approaches to these problems are unlikely to be effective for very long. Many writers, including myself, have suggested that the answer to gun violence is to take a public health approach.

I raised this issue, in large part, because I had cause this week to review an article that I wrote after the 2012 Sandy Hook school shooting, in which  20-year-old Adam Lanza shot and killed 26 people, including his mother, and then killed himself. Like many writers and organizations, I considered mass gun shootings as a public health threat. However, a recent reading of my 10-year-old essay stopped me short:

“If there were an infectious disease that could be prevented with a side-effect-free vaccine, we would look askance at anyone who did not get the inoculation. In fact, if that disease could lead to the death of other people, then under public health law, one might be required to be vaccinated.”

I could not have been more wrong.

The idea of gun violence as public health threat or an epidemic has a different meaning today than it did in 2012, since we are in the third year of a viral pandemic. As I write, the U.S. faces another surge of Covid cases. With one million recorded deaths, only 77.7% of Americans have gotten a single dose of a Covid vaccine, in a time when fourth shots are recommended for many. Only two-thirds (66.5%) of us are fully vaccinated, fewer than half have received their first booster (46.4%). Whether we look askance at anyone who did not get vaccinated depends on our politics: liberals and Democrats are likely to see this as irresponsible whereas conservatives and Republicans are more likely to see refusal to be vaccinated as an exercise of freedom.

Last month, the 9th Circuit Court of Appeals—known as the most liberal court—turned down a mandate for prison staff in California to be vaccinated against Covid.  New York City reached a high-alert level of Covid transmission this week and yet is only  recommending indoor mask wearing instead of mandating it, which was the response earlier in the pandemic.

The reality is that we have treated gun violence as a viral pandemic. But rather than coming together as a nation and using the power of government to protect the public’s health, which is what I had thought would happen in a disease outbreak, we have treated Covid-19 the same way we treat gun violence—with thoughts and prayers.

Public health in the U.S. has been severely broken in the 21st century through funding cuts, workplace violence and threats against public health workers, and the politicization of collective action. Efforts to combat the Covid pandemic and gun violence have been anemic. The result is an “on our own” approach. People are left to decide for themselves which precautions to take, if any, against Covid. And it is up to individuals to protect themselves against gun violence. Children participate in active shooter drills, and bulletproof backpacks are part of back-to-school shopping. In both cases, rather than taking an upstream, public health approach, the U.S. puts the burden on the individual, which usually means that the most vulnerable (children, immunocompromised, lower socioeconomic status, disabled, elderly) are sacrificed.

The call for treating gun violence as a public health issue has been answered, just not in the way anyone suspected or hoped that it would be.

Craig Klugman, PhD, is the Vincent de Paul Professor of Bioethics and Health Humanities at DePaul University. @CraigKlugman

large crowd of protesters, one very large black sign stating

Bioethics Forum Essay

California U-Turn on Vaccine Mandates for Schoolchildren

by John D. LantosPublished Posted in Covid-19 Ethics Resource Center, Hastings Bioethics Forum

The California legislature appears to have caved to pressure from opponents of a Covid vaccine mandate for schoolkids. I’d prefer to think of it as a wise and strategic retreat from a battle that mandate advocates could not win.

Mandate advocates in California are a savvy bunch. Led by State Senator Richard Pan, a pediatrician, they eliminated the personal belief exemption from California’s mandate for routine pre-Covid childhood immunizations.  After that fight, it seemed that a Covid vaccine mandate would be easy. After all, we were in the middle of a pandemic. Kids were dying or getting strange inflammatory illnesses, missing school, and forced to wear masks. The vaccine studies in adults showed that vaccines were astoundingly safe and effective. Everyone was just impatiently waiting for similarly upbeat results from pediatric studies. Governor Gavin Newson announced in the fall that, as soon as the Food and Drug Administration approved vaccines for children, they would be mandated for children attending public schools. California was on track to proudly be first in the nation to implement such a mandate. In January, Pan introduced a bill to add a Covid-19 vaccine to the panel of vaccines mandated for school entry.  

Opposition to the proposed Covid vaccine mandate was immediate and fierce. Many California school districts took official stands against vaccine mandates and publicly stated that they would not comply.  

The stage seemed set for a showdown.

But the plot was too tidy. Kids, it turns out, are not just small adults. It wasn’t enough to just give them a lower dose of vaccine for them to get the same results as adults. Furthermore, the virus itself wasn’t static. Vaccines were less effective against the new Omicron variant than against prior strains. 

Data from an observational study done by the New York Health Department showed that, prior to Omicron, the Pfizer-BioNTech vaccine was 67% effective in preventing infections in children. Once Omicron hit, its efficacy fell to 51% in teens and 12% in children ages 5 to 11. Furthermore, vaccine efficacy waned quickly in children. For children ages 5 to 11, the vaccine’s efficacy in preventing infections fell from 65% two weeks after the second jab to 12% at a month. Because of rapidly waning immunity, these vaccines  will likely require frequent boosters to be effective. The efficacy of each booster may change as new variants emerge. Nobody knows how often boosters will be needed.

Given the muddy data, nearly 40% of parents across the country say that they would not want their children immunized.  Another 40% wanted to wait and see more data before deciding. Parents’ choices reflect these attitudes.

Pan’s colleague, State Senator Connie Leyva, who chairs the Senate Education Committee and also serves on the Senate Health Committee with Dr. Pan, came out against the Covid-vaccine mandate for schoolchildren. She said,  “We’re too divided as a community. This bill is just too divisive.” 

Senator Pan could see the writing on the wall. Last month he withdrew his proposed bill. He tried to put the best spin on it, shifting the focus to improving the rates of voluntary immunization. “People have questions,” he noted, “and want to get them answered.” 

The reasons for the U-Turn suggest a way of assessing the likelihood that a mandate will be politically feasible. It would seem that mandates are only possible when most people are convinced that the vaccines are safe, effective, and easy to use. But there is an irony here. When most people are convinced that a vaccine is safe and effective, they are likely to voluntarily seek the vaccine. For example, there is no mandate for adults to receive a Covid vaccine, but more than 80% of adults in the United States have had at least one dose of vaccine. Fewer than 40% of children have.

When the public is skeptical about vaccines, mandates may actually hinder efforts to achieve high immunization rates by exacerbating distrust and angering vaccine-hesitant parents and those who support parental choice.  To counter such a backlash, our mandates have always been soft and porous. Most states allow religious exemptions. Many others allow exemptions based on personal beliefs. Such policies say, in essence, that you only need to be immunized if you are not willing to fight against it. Even in the landmark Supreme Court case in which the Justices upheld the rights of states to mandate immunization, the penalty for refusing smallpox vaccine was a $5 fine. Our vaccine policies have always been more like a strong suggestion than a true mandate. That is where California ended up on Covid vaccine for kids. For now,  that is the right place to be. 

California’s U-turn is politically wise and ethically appropriate. Existing Covid vaccines can give some protection to children. But 50% protection is not good enough to justify a mandate. Mandated childhood vaccines generally have efficacy rates above 90%.   Furthermore, for children, we don’t yet know the best dose or schedule for optimum protection from Covid, lowest levels of risk, and most cost-effectiveness. We do now know that studies in adults cannot simply be extrapolated to children. We need to do the studies in kids. Even then, uncertainty will remain. Given the uncertainty, a voluntary program is preferable to a mandate. As parents evaluate the evidence and make decisions, more data will accumulate. 

(Last week, a prospective randomized trial of the Moderna vaccine published in the New England Journal of Medicine reported that, for 6-to-11-year-olds, two doses led to high levels of antibodies that persisted for two months. The study was too small to draw meaningful conclusions about actual infection rates but the authors speculated that, with those antibody levels, it would be 88% effective at preventing disease.)

The skeptical public is right on this one. Until there is stronger evidence that Covid vaccines are highly effective in children, the decision about whether to immunize children should remain with parents.

John D. Lantos, MD, is President of JDLConsulting, LLC and a Hastings Center fellow. www.johnlantos.com; @johnlantos

human embryo

Bioethics Forum Essay

Bioethics Without Roe

by Jonathan D. MorenoPublished Posted in Abortion, Bioethics, Hastings Bioethics Forum

The 1973 Supreme Court decision in Roe v. Wade has played a subtle but critical role in the history of bioethics in America. The finding of a constitutional right to abortion coincided with the first several years of a more or less self-conscious transition from traditional medical ethics, focused on physician decision-making, to  “bioethics,” which incorporated the patient’s values and preferences. By the early 1980s informed consent was widely seen as the application of the principle of respect for autonomy.

Neither of the first two bioethics research centers, The Hastings Center (1969) and the Kennedy Institute (1971), had abortion explicitly on their agendas, but the prospects for control of the genetic traits of future human beings and the scope of parental decisions concerning seriously ill newborns were. Questions about the moral status of future and tiny humans were only one step removed from that of the moral status of the human embryo. In 1970 Hastings co-founder Dan Callahan, with the support of the Population Council, published a monograph,  “Abortion: Law, Choice, and Morality.”  In retrospect, in the 1970s and 1980s Roe enabled the growing field to put abortion per se on the back burner.  

After the Quinlan decision (1976), in the public sphere the most pressing “life” issues came near its end rather than its beginning. The National Commission for the Protection of Human Subjects of  Biomedical and Behavioral Research maintained its focus on human experiments after the revelations of the Tuskegee syphilis study, including those involving the human fetus, without needing to grapple with abortion. The surprise that accompanied the first successful in vitro fertilization in 1978 turned the matter of human reproduction on its head, emphasizing the ability of a technology to satisfy the deep and previously unfulfilled wishes of so many couples to produce a baby rather than to avoid doing so. Even here, though, a few social conservatives in the bioethics community quietly harbored deep reservations about technologically mediated human reproduction, though they would not be fully expressed for many years. 

Not that abortion ever totally left the landscape. In the 1980s, Roe permitted bioethicists like Dan and Sidney Callahan and Baruch Brody and philosophers like Judith Jarvis Thompson to focus on ethical arguments about pregnancy termination that could be persuasive in personal decisions, given that the right to decide was the law of the land. Once again pro-life attitudes could be discerned in the background of issues that did not explicitly engage abortion, such as allegations about prejudicial management of certain newborns in the neonatal nursery and federal restrictions on the use of funds for fetal tissue research. These topics were in effect proxies for the underlying question about the moral status of the embryo. Despite technological advances the fact remained that the prospects for an artificial placenta that would thoroughly undermine the trimester framework established by Roe were thoroughly speculative, thus barely relevant to the conversation.

The 1992 decision in Casey replaced the trimester framework established in Roe, seen as potentially at risk due to technological advances in rescuing very low birthweight neonates, with the “undue burden” standard that restricted states’ ability to limit abortion rights. The intensification of the legal and political debate in the ensuing two decades, taking place in a society increasingly polarized along this and other lines, crept into bioethics as well. Again, though, the fact that Casey generally upheld abortion rights kept the pressure off. This state of affairs can now be seen as having gradually shifted with the achievement of mammalian cloning and especially with the isolation of human embryonic stem cells. Both lent momentum to long-simmering worries among those with conservative views about bioethics and what some have long seen as the dominant liberal slant in mainstream bioethics that had managed largely to set aside the question of the moral status of the embryo for so many years. President George W. Bush’s Bioethics Council under Leon Kass gave voice to what many of its members believed was the need for a “richer bioethics.”

Would American bioethics discourse be changed with the end of a constitutionally protected, even if highly restricted, right to abortion?  In a field that takes as its mission the continuous reflection on moral values in human life and has in essence known no world without a constitutionally protected abortion right, one can hardly imagine it will not. 

Jonathan D. Moreno is the David and Lyn Professor of Ethics at the University of Pennsylvania and a Hastings Center fellow. @pennprof