logo and title of the World Health Organization

Bioethics Forum Essay

Financing Reforms to Meet a Pivotal Moment in Global Health

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

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

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

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

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

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 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

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

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

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

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

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 seriesClinical Ethics Case Studies for Hastings Bioethics Forum.

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

Attention clinical ethicistslearn 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

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.