Lantos claimed that OHRP and Public Citizen were “deeply misinformed” about the design of the SUPPORT study. We acknowledge that as of April 10 when we first wrote to HHS Secretary Kathleen Sebelius about this study, Public Citizen only had access to limited excerpts from the study protocol and one institutional review board-approved consent form that were presented in OHRP’s March 7, 2013, letter to the University of Alabama at Birmingham (UAB).    

We subsequently obtained the complete SUPPORT study protocol and consent forms that were approved by 22 IRBs and used at approximately two dozen neonatal intensive care units . Our analysis of these documents not only affirms the appropriateness of OHRP’s determination that the UAB consent form failed to mention the reasonably foreseeable serious risks of the oxygen experiment, but it demonstrates that the consent form deficiencies were far more significant than those discussed in OHRP’s letter. Indeed, the important, material factual omissions from the consent forms, combined with mischaracterizations of the study, misled the parents of babies enrolled in the study about the true purpose, nature, and risks of the research. 

Study Overview

The study involved two simultaneous complex experiments. In one experiment, the babies were randomly divided into two groups, each receiving a different treatment to assist breathing. Babies in one group were treated with a face mask, called a continuous positive airway pressure (CPAP) mask. Babies in the other group were intubated and given the drug surfactant, which helps lungs stay open, and placed on mechanical ventilation.

For the other experiment, babies in both the CPAP and mechanical-ventilation groups were further randomly divided into a low-oxygen group and a high-oxygen group (the oxygen experiment). For the low-oxygen group, the investigators tried to maintain oxygen saturation levels in a low target range (85% to 89%), and for the high-oxygen group in a high target range (91% to 95%), rather than adjust each baby’s oxygen levels within the broader range of 85% to 95% — identified as the “normal” range by the investigators — to meet the baby’s individual needs, as would have been the case if the baby had not been in the study.

Consent Form Deficiencies

The serious deficiencies in the SUPPORT study consent forms become readily apparent when information in the protocol, as well as statements made by the investigators, is compared with information in the consent forms.

The oxygen experiment’s purpose was to test the hypothesis that “relative to infants managed with a higher Sp02 range . . . the use of a lower Po02 range (85% to 89%) will result in an increased survival without the occurrence of threshold ROP [retinopathy of prematurity, which can  cause blindness] and/or the need for surgical intervention.” Consistent with this hypothesis, the primary endpoint was a composite of death and ROP. Knowing that death was a key endpoint was critical for understanding the true purpose of the experiment.

In contrast to the protocol, while most of the consent forms noted that the purpose of the oxygen experiment was to assess the effects of the two oxygen targets on the incidence of ROP, none disclosed that another key purpose was to determine whether babies were more likely to die in the low- or high-oxygen group. The incomplete descriptions of the purpose of the oxygen experiment in the consent forms were therefore misleading.

The protocol summarized the oxygen experiment’s design as follows: “A prospective comparison of a lower SpO2 range (85% to 89%) with a higher more conventional SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.”

Thus, the investigators themselves considered the high oxygen saturation target range to be “more conventional” treatment for premature babies receiving routine standard of care, which implicitly meant that the low oxygen saturation target range was more unconventional.

This clear protocol characterization of the relative difference between the low- and high-oxygen targets contrasts sharply with the statements in most of the consent forms implying that both ranges were equally conventional, such as the following from the UAB consent form: “[Both target] saturations are considered normal ranges for premature infants.”

Condensed, incomplete descriptions of oxygen treatment, such as the one above, were misleading because they lacked an appropriately detailed explanation of the usual standard of care in critically ill premature infants and the segment of the broader 85% to 95% “normal” target oxygen saturation range that was most commonly targeted as part of routine NICU care at the medical centers conducting the study. Of note, one consent form suggested that an oxygen saturation range of 88% to 92% was most commonly targeted in many NICUs, whereas another stated that the saturation was usually targeted at 88% to 94%. Disclosures of the oxygen saturation ranges most commonly targeted for premature infants at a particular institution should have been included in all consent forms to allow parents to have better understood how the experimental interventions would have altered the care of their babies.

A more disturbing component of the oxygen experiment was the procedure under which the medical team caring for each study baby was according to the protocol, intentionally given inaccurate information about the baby’s oxygen saturation levels by using pulse oximeters miscalibrated across the wide range of oxygen saturations between 85% and 95%. Medical teams apparently were instructed to try to maintain the oxygen saturation for study babies between displayed readings of 88% and 92%. However, for any displayed oxygen saturation level between 88% and 92%, the actual oxygen saturation was 85% to 89% in the low oxygen group and 91% to 95% in the high-oxygen group. The 5% to 6% difference in the actual saturation levels between groups represented clinically important differences in the babies’ actual blood oxygen content, which certainly could have adversely impacted clinical decisions made by the medical teams caring for these babies.

Half of the 22 IRB-approved consent forms did not disclose that the medical teams caring for babies in this experiment would be intentionally given inaccurate information about the babies’ oxygen levels. Moreover, none of the consent forms described how this experimental procedure could have impacted important clinical decisions related to the babies’ care.

The combined experimental procedures of randomly assigning infants to interventions using narrow low or high oxygen saturation targets plus the use of miscalibrated pulse oximeters represented a clear departure from the standard of care that these critically ill infants would have received had they not been enrolled in the study. Yet, the majority of the consent forms included statements assuring subjects’ parents that all research procedures used in the study were “standard of care.”

Study risks

Surprisingly, the “Risks and Benefits” section of the study protocol listed no risks of the oxygen experiment. Nevertheless, other parts of the protocol, as well as recent statements made by the study investigators, reveal that the oxygen experiment posed significant risks to the premature infants who were enrolled.

For example, the “Background” section of the protocol indicated the following: “[O]xygen toxicity can result in increased risk for [chronic lung disease], retinopathy of prematurity (ROP) and other disorders. Alternatively, oxygen restriction may impair neurodevelopment.”

Some study investigators also recently stated: “Death was included in the primary outcome because it competes with retinopathy . . .

Thus, the investigators were aware when designing the study that manipulating oxygen therapy to target narrow low and high oxygen saturation ranges in premature infants could have had different effects on these acknowledged competing risks. Targeting the high-oxygen range could have increased the risk of ROP, whereas targeting the low-oxygen range could have increased the risk of brain injury and death. Furthermore, the study’s statistical analysis plan revealed that the death rate was an important variable to be measured for the oxygen experiment.

A small minority of the IRBs that reviewed the study actually appear to have recognized some of the risks posed by the oxygen experiment because two consent forms identified ROP as a risk of the high-oxygen group. However, all of the consent forms failed to disclose that death was a risk of the research, even though an increased risk of death was reasonably foreseeable based on the information presented in the protocol.

Finally, perhaps the most troubling aspect of the consent forms was the universal failure to disclose the additional reasonably foreseeable substantial risks of harm to the infants resulting from providing the medical teams with inaccurate information about the babies’ blood oxygen saturation levels. The blood oxygen saturation level is a critically important clinical parameter monitored in such patients. This experimental procedure had the potential to adversely impact important clinical decisions, such as whether to intubate a baby and start mechanical ventilation or whether to extubate an intubated baby and discontinue mechanical ventilation. Inappropriate decisions regarding intubation and extubation certainly could have exposed babies to foreseeable risks of harm. (For specific examples of how babies could have been harmed see: Carome M, Wolfe S, Macklin R. Report prepared for Secretary of Health and Human Services Kathleen Sebelius: http://www.citizen.org/documents/2124.pdf.)

The following protocol statement indicates that the investigators recognized the potential for inappropriate intubations and extubations in study infants: “CPAP infants who require intubation three times, for any criteria, will have all subsequent treatment including subsequent extubations and any further re-intubations performed using unit Standard of Care. This addition is to prevent such infants from being exposed to further protocol driven intubations and extubations.”

Even more disturbing, the majority of the consent forms included extraordinarily misleading statements like the following: “Because all of the treatments proposed in this study are standard of care, there is no expected increase in risk for your infant.”

Our conclusions

Lantos states that the “most important ethical issues for the future of clinical research . . . are the issues of honesty, transparency, and safety.” Public Citizen agrees. Disturbingly, the consent forms used in the SUPPORT study failed to present an honest and transparent disclosure of the purpose, nature, and risks of the oxygen experiment, thereby leading parents to believe the experiment was safer than it was.

It is neither OHRP’s determination nor Public Citizen’s critique regarding the study that poses a threat to biomedical research and the advancement of medical knowledge and innovation. Rather, the real threat to such scientific endeavors is unethical research, which undermines the public’s trust in the motives and conduct of researchers. Conformance with the fundamental ethical principles for conducting human subjects research must never be sacrificed in the quest to advance medical knowledge.

Lantos’s accusation that “criticism [of the study] . . . discredits bioethics” is completely without merit. The findings of consent-form deficiencies by OHRP and Public Citizen were well-founded and carefully explained. Indeed, as more information about the study has become available, the apparent degree of seriousness of the consent failures has only escalated. Attacking messengers who raise serious, well-reasoned concerns about the ethics of a study does not discredit bioethics. Instead, it discredits the attackers.

For a more detailed discussion of the problems with the SUPPORT study, see http://www.citizen.org/documents/2124.pdf.

Michael Carome, M.D., and Sidney Wolfe, M.D. are, respectively, Deputy Director and Director of Public Citizen’s Health Research Group.

The central point of disagreement between defenders and critics of the study appears to be whether participants in the study were receiving medical care that was different from the care they would have received outside the study and whether participation in research therefore carried any medical risks that required risk/benefit scrutiny by IRBs or disclosure to parents of the infants enrolled.  This would appear to be a factual matter about which one could obtain some clarity, but discussions of this issue have been somewhat opaque. 

Part of the reason for this may be different, but unacknowledged, understandings of the concept of “standard of care,” a term used – both in the informed consent forms and the commentary about them – but rarely defined in this debate. 

Defenders of the study, as well as the investigators themselves, insist that because the lower (85 percent to 89 percent) and higher (91 percent to 95 percent) ranges of oxygen saturation provided to the infants were within the standard of care, understood as a range of 85 percent to 95 percent, there were no known risks to participants in the study.  David Magnus and Art Caplan write, “Given that there was variation in clinical practice [within the guideline-specified range of 85 percent to 95 percent] at the time the study was mounted, it is not clear how randomization among treatment options could have created novel risk over random physician preference.”  John Lantos writes, “Every baby in the study received treatment that could have and perhaps would have been given to babies who were not enrolled in the trial.”  The understanding of “standard of care” used by these commentators seems to lean toward the legal concept of that name.  In an ordinary malpractice case, physicians will be liable only if they fail to provide minimally competent care, care outside the range of what reasonable physicians would provide.  Appropriately, the legal standard of care is broad and often allows for many different approaches. 

Critics of the study – namely OHRP and Public Citizen – use a different understanding of standard of care. They are focused on either what physicians, or in this case, institutions, typically do or what a particular physician or institution typically does, not the range of what physicians can or might do without risking legal liability or criticism from their peers. OHRP’s determination letter relating to the study indicates that, at the time the study was initiated, participating institutions allowed oxygen saturation levels to range between 85 percent and 95 percent, rather than confining levels to either the lower or upper portion of that range. This led OHRP to conclude that the level of oxygen received by infants in the study “was different from what they would have received had they not participated in the study.”  Some received more oxygen than they otherwise would have, thus facing a greater, and foreseeable, risk of blindness, while others received less oxygen than they otherwise would have, thus facing a greater, and foreseeable, risk of brain injury and death.  A recent analysis by Public Citizen also focuses on what the usual practice was and, based on newly released documents, reports that the SUPPORT protocol itself stated that the higher oxygen-saturation range was “more conventional.”  In addition, two of the informed consent forms (the only ones that include this information) suggest that usual practices tended toward a target range of 88 percent to 92 or 94 percent.   

This is the crux of the problem.  Which of these two understandings is most appropriate for evaluating and disclosing risk of harm in a research context?  Whether the care provided will be within the bounds of acceptable practice or whether it will be the same as what the patient would receive outside of research?  

Defenders of the study have expressed outrage over OHRP’s action. Lantos criticizes OHRP (and Public Citizen) of endorsing “an anti-intellectual, unscientific approach to medical innovation” and concludes that “the real risk to babies come from reckless and ill-informed opinion about highly ethical scientific studies.”  In a more recent essay, he accuses OHRP of wanting doctors to stop doing research and to rely instead on “mystical certainties.”  Magnus and Caplan are more restrained. They charge that OHRP’s action “poses substantial risk” to the conduct of valuable research.   

 But it is not out of bounds for a research oversight system responsible for protecting subjects to ask – similar to the informed consent standards for medical treatment – “What do reasonable people who are considering enrollment in a study want to know?”  If this is the question asked, most likely the answer would be that they would want to know what reasonably prudent physicians typically, or usually, or conventionally do in situations similar to that of their child’s.  Given such information, they would better understand that enrolling in research means allowing physicians to do something different from the medical care they would normally receive, with potential attendant risks and benefits. 

Defenders of the study suggest that because physicians didn’t know the optimal level of oxygen saturation, any particular infant’s physician, or NICU, could have reasonably chosen to hover within the lower or upper range. But did they?  And if they didn’t, why not? These are questions to which the parents in the SUPPORT study had a right to answers.  Because they were told that their children would receive standard of care, they couldn’t know to ask them. 

Lois Shepherd, J.D., is the Peter A. Wallenborn, Jr. and Dolly F. Wallenborn Professor of Biomedical Ethics, Professor of Public Health Sciences, and Professor of Law at the University of Virginia.

Their central claim is that the “consent form failed to mention the serious, reasonably foreseeable risks related to the part of the study comparing two experimental strategies for managing oxygen in extremely premature infants. Those risks, correctly identified by OHRP, included increased risks of brain injury; an eye disease called retinopathy of prematurity, which can lead to blindness in severe cases; and death, depending on the randomized group assignment of each baby.”

The problem here is that those risks were not “correctly identified.” Neither Public Citizen nor OHRP understand the differences between, on the one hand, the risks of enrolling in the research project and, on the other, the risks associated with being an extremely premature baby. All of the risks that they talk about are risks associated with neonatal intensive care for premature babies. Not one of these risks was increased by being in the study.

The state of knowledge regarding oxygen therapy at the time this study was designed and initiated can found in many papers that were written at the time.  Ten years ago, Cole and colleagues summarized what was known about oxygen therapy for premature babies.  They wrote, “We do not understand optimal oxygenation management in extremely low gestational age neonates (<28 weeks’ gestation).  No randomized control trial has clarified the relation between retinopathy of prematurity (ROP) and blood oxygen (PaO₂), transcutaneous oxygen (tcO₂), or oxygen saturation (SpO₂) levels.”[i]

Given that, here is a partial list of the information that the new letter insists should have been included in the consent form, but which is in fact incorrect:

1. That enrolling babies in the study would expose them to an increased risk of brain injury compared to babies who were not in the study. In fact, there was no evidence prior to the study that oxygen therapy in the ranges being used in the study would lead to an increased risk of brain injury. And no evidence of such increased risk was found in the study.

2. That enrolling babies in the study would expose the babies to an increased risk of retinopathy of prematurity and/or blindness. In fact, there was no evidence prior to the study that enrolling babies in the study would lead to an increased risk of retinopathy or blindness. And it did not.

3. That enrolling babies in the study would expose babies to an increased risk of death. In fact, there was no evidence that enrolling in the study would lead to an increased risk of death. And it did not. 

4. That doctors, using clinical judgment, would have made clinical decisions that would have resulted in better outcomes than doctors following the study protocol. There was, in fact, no evidence that this was true. And, as it turned out, it was not. 

5. That the technique of adjusting oxygen saturation monitors so that they masked doctors from seeing the actual oxygen saturations within a narrow range led to more risky treatments. In fact, there was no reason to believe that this would happen if the doctors followed the protocol. And it did not happen. There was no difference in intubations between the two groups.

It would be hard to know from Public Citizen’s cascade of misinformation that babies in the SUPPORT study (or, for that matter, in similar studies carried out in many other countries)  had better outcomes than babies who were not in the study. The babies in the studies had lower rates of death, lower rates of disability, lower rates of retinopathy, and were less likely to undergo invasive procedures such as intubation than were babies who were not in the studies. The data showing this comes from comparisons of the outcomes of babies who were in the studies with any and every possible comparison group – babies who were eligible for the studies but not enrolled, babies who were treated at the same time (or a few years before or a few years after) in the same countries, and babies in other countries who had the same conditions as babies in the studies. 

Take mortality rates. For babies in the study, mortality rates were 15.3 percent to16.6 percent in Canada, 16.6 percent to 19.2 percent in Australia, New Zealand, and the UK, and 16 percent to 20 percent in the US.  For babies in the U.S. who were not in the studies, mortality rates for babies born in 2003-2007 who were not in the study were 24 percent.[ii]  In Victoria, Australia, mortality rates for such babies born in 2005 were 25 percent. For all of Australia, in 2010, mortality rates were 20 percent. For all of Canada in 2010, mortality rates were 23 percent for babies at these gestational ages. That is, mortality rates for babies in the study were 20 percent to 40 percent lower than for babies who were not in the study.  Babies in the studies also had lower rates of retinopathy, blindness, and cerebral palsy compared to babies born at the same gestational ages in those same countries.

Public Citizen dismisses the relevance of these data by saying, “It is not clear why the investigators think these data are important or relevant.”

So let me explain. An informed consent form is supposed to inform parents of the risks of a study. It should do so by explaining to them what is known or believed to be true. So the first criteria for judging such forms is to look at what was known at the time they were written. By those criteria, the informed consent forms used in the SUPPORT study were adequate and accurate. It is possible that, in retrospect, we come to understand new things about the risks or benefits of an innovative treatment. That can be assessed by looking at data from studies and is an additional way of evaluating whether consent forms were adequate. 

Before the SUPPORT study was done, a large meta-analysis concluded that there would be no difference in death or neurocognitive impairment using restricted oxygen versus liberal oxygen. There was a suggestion that restrictive oxygen would lead to lower rates of retinopathy.   That, then, is what the consent form stated. The fact that a post-hoc analysis showed that, compared to babies who weren’t in the study, those in both arms of the study had better outcomes is interesting and important. It suggests directions for future research. It suggests that there may be benefits to being in a study, benefits that an informed consent form ought to mention.

Clearly, the studies were well-designed, they answered important clinical questions, and they did so without causing harm.  

So a mystery remains. Why would a so-called “citizen advocacy group” insist that consent documents for such safe and well-designed studies ought to misinform parents of the true risks of enrolling their babies in studies? And why they would now want to shut down other studies that are also well-designed and ethically appropriate? 

The explanation for that mystery was, I believe, given decades ago by Dr. William Silverman. Silverman was a pioneer of neonatology. He was one of the first doctors to warn about the toxicity of high-dose oxygen. He was a passionate believer in clinical studies to improve the safety and efficacy of neonatology. He was familiar with the types of arguments that are now being made by Public Citizen. He identified them as a belief in “mystical certainty” rather than an acceptance of “scientific uncertainty.” He noted, “Doctors are viewed suspiciously when they ask questions – a switch from their accustomed role as providers of answers.”

Neonatologists today want to investigate the safety and efficacy of commonly used but inadequately studied therapies. They develop an unprecedented international collaboration to do so. The protocols are carefully reviewed by IRBs. The consent forms are reviewed for accuracy and understandability. Parents are accurately informed of the risks and benefits of the research. The studies are done in a careful and prospective manner. Babies in the studies are protected from the risks of therapies that have not been validated and have better outcomes than babies who are not in the studies. The results of the studies could help many other babies. 

But then federal agencies whose task is to insure the conduct of responsible research criticize the studies. They suggest that parents should have been warned against the studies by being given false and misleading information. They suggest that babies would be better off if doctors would ignore their scientific uncertainty, stop doing such research, and go back to the era of mystical certainties. Who would have thought we’d see the day when the Office of Human Research Protection and Public Citizen would be insisting upon misinformed consent?  With advocates like these, who needs enemies?

John B. Lantos, M.D., a Hastings Center Fellow, is director of pediatric at Children’s Mercy Hospital and the University of Missouri-Kansas City School of Medicine. He was not involved with the SUPPORT study. Children’s Mercy Hospital is now in the NICDH Neonatal Research Network but was not at the time of the SUPPORT study.

In many ways, my first year of medical school has felt like another immersion program in which learning to speak a new language allows me to navigate a new world. My notes from any given day of school have dozens of new terms. Multiplied over the course of the school year, we have learned literally thousands of new words. There are body parts, symptoms, conditions, bacteria, drugs, and molecules to be learned: flexor carpi ulnaris, dysphagia, glomerulonephritis, pseudomonas aeruginosa, methotrexate, phospholamban.  These new words allow my classmates and me entry into the previously cordoned off world of doctors.

While my medical immersion program has been similar to my Spanish immersion program in many ways, it's also different in a key aspect. While learning Spanish made it easier to communicate with people I went to Spain to meet – my host family, the little girl at the music school where I played piano, fellow travelers in a youth hostel – I'm not entirely sure that this new medical language will help me communicate with the people I came to medical school to learn to care for – patients. Surely it helps us communicate effectively with other medical students and doctors, but that is not the end goal of medicine. Our medical language is not a language that promotes human connection, or even common understanding with our patients.

While some medical terms defy simple explanations, we often learn words derived from Latin and Greek for things that could be understood with commonly used English words: emesis for vomiting, tachypnea for increased frequency of breaths, hematopoiesis for production of blood cells. As I learn this new language, I try to remind myself that in order to connect with patients, I'll need to translate these technical words back into the language I spoke before I decided to become a doctor.

Yet just like my time in Spain, this medical immersion program is not just linguistic but also cultural. In the midst of learning thousands of new medical terms, we are also learning particular ways of talking about other people's lives, bodies, and experiences. Thus, this new language shapes not only how our future patients will understand us, but how we will come to understand them.

In their 1994 article on the so-called hidden curriculum in medical education, Frederic Hafferty and Ronald Franks wrote that "medical education does not take place in a cultural vacuum, within a value-neutral environment or in a place in which medical morality simply replicates lay values. Medical training is not just learning about becoming a physician, it involves learning how to ‘cease’ to be a layperson."

This ceasing to be a layperson has been most evident to me through these changes in language. A subtle example is how we use the word “patient.” When I began medical school, I identified much more strongly with patients than doctors. Thus I found it jarring when learning about a certain body part or disease our professors would talk about it "in patients." Don't we all have lungs? Couldn't any one of us develop hypertension? Yet we often speak of “patients’ lungs” or “patients with hypertension” as if we, by becoming doctors, are somehow different from them.

At the same time, while I can identify with the experience of being a patient, I have never identified as a patient. I never thought of myself as a pneumonia patient or a repetitive stress injury patient, even though I have been both. The same is often true of people with more serious illnesses. In the 1980s, some AIDS activists living with the disease began actively identifying themselves as “people living with AIDS” and rejected the term “AIDS patients.” While "people living with AIDS" implied an identity separate from disease and continued perseverance to live, "AIDS patients" implied helplessness and inevitable death.

It may seem completely medically appropriate to speak of “diabetic patients” or “heart failure patients.” And in the midst of learning so many new medical terms, these ways of talking about the people we will someday care for may go unnoticed. But when I think about what I know about how people experience illness, and the importance of doctors seeing patients as whole people, I see no meaningful drawback to saying "people with diabetes" or "individuals with heart failure" instead.

This is just one example of the new words and phrases we learn in this language immersion program. There are many others for which the social stakes are similarly high, like normal and abnormal, sex and gender, compliance and adherence. Just as we require precision when describing anatomical structures, we – especially those of us learning to be doctors – ought to think very carefully about the words we use to describe patients.

During one of our recent lectures, a professor was discussing a medical therapy that did not cure his patient. "The patient failed the therapy," he explained. Then he stopped himself and said, "No, the therapy failed the patient." Just this simple change in word order conveyed a completely different understanding of how doctors ought to orient themselves toward their patients. And it reminded me that as I struggle in the coming years to diagnose and treat, I should strive to ensure my language doesn't fail my patients, too.

Colleen Farrell, a former research assistant at The Hastings Center, is a student at Harvard Medical School.

In the United States each year, 2.5 million people die. Because cause of death is often a condition typically associated with age, Medicare billing-code data offers a reliable way to understand where older people were, day by day, as they approached the end of their lives. A recent article by Joan M. Teno, health services researcher at Brown University, and her team, published in JAMA in February 2013 and subsequently picked up by the media, compared samples of Medicare patients who died in 2000, 2005, and 2009. Each sample included nearly 300,000 patients, all of whom had a medical diagnosis of cancer, chronic obstructive pulmonary disease, or dementia for the final six months prior to death. This data suggests that these patients were hospice-eligible and their deaths were not unexpected.

Digging into the data, the researchers found that over the course of this nine-year period the percentage of patients who died in hospice increased. However, these hospice referrals tended to come only after dying patients had spent time in the intensive care unit. That is, the intensity of treatment near the very end of life first spiked sharply upward. As Teno and her co-authors explain, “Site of death, as noted on a death certificate, only provides information on where a person was at the moment of death,” while understanding the end of life as an “experience” involves looking at all places of care, the transitions between these places, and when and why these transitions occurred. They conclude that, even with more frequent referrals to hospice and the expansion of palliative care programs in hospitals over the period they studied, “the notion that there is a trend toward less aggressive care” may be unfounded.

Reading Joan Teno’s careful research and analysis in this article and others, I am reminded of the technique of Jan van Eyck, the 15th century northern European painter who was the first master of the new medium of oil painting. Analysis of van Eyck’s works reveal that he applied layer upon layer of translucent paint to create the impression of light that shapes space and reveals surface and texture. (The Getty Museum has created this public website of images from its recent documentation of van Eyck’s “Ghent Altarpiece.”) It was not a quick or simple way to work, but it built up the light. So, too, does the science that describes, day by day, layer by layer, the complexity of the end of life in our society, and that suggests the complexity of the work needed to change this experience. If the picture that emerges from this study — of the ICU as the route to hospice — troubles us, are we willing to think and act differently? And how much earlier in the journey?

Nancy Berlinger, a research scholar at The Hastings Center, is the lead author of The Hastings Center Guidelines for Decisions on Life-Sustaining Treatment and Care near the End of Life, just published by Oxford University Press. This post first appeared on the Oxford University Press Blog. 

In July, we got the news – Dad’s colon cancer was back. He had a six-month prognosis, so we began the planning: a big 95^th birthday party, caregiving schedule, trips to the doctor. Since I am the only sibling living out of town, I planned more frequent, then monthly, and finally every-two-week trips from Atlanta to Seattle. My dad had always been involved in research, part of a decades-long longitudinal study to gauge the effects of aging, so it was no surprise that he signed up for an Alzheimer’s study that involved a rapid autopsy and brain harvest.

 My brother-in law joked that he would ruin the curve, since he continued to be on boards and committees throughout his 90s. For me, a bioethicist who helps draft post-mortem harvest guidelines, now it was my dad, my family. My father was dying and all those worries and questions loomed –  would I get there at the right time, would we say goodbye as I hoped we would, what would we share in those last few months, how would the end be, what would I feel like when the body was whisked away?  It was a tearful, stressful, six months.

We were fortunate that his death came quickly at the end – he was bedridden for only three days. And I was able to arrive in time to be by his side the night before he died.

There were choices along the way. Should we try to treat the cancer? Fortunately, his oncologist carefully explained how the risks outweighed the benefits given his health history, so he did not make that choice. When to enter hospice? Once again the oncologist was very helpful. At her urging, he entered hospice in October, since studies showed that the longer you were in hospice the longer you lived, and the better your quality of life.

 The hospice team was very aggressive in managing his comfort, ordering palliative radiation for a painful tumor in his neck a few months before he died. A little surprisingly, the hospice nurse did suggest we admit him for rehydration during those last three days. Wisely, my father declined, a decision supported by the rest of the family, and we were not sucked into an institutional setting, or the temptation to “just try this one thing.”

His death coming so quickly did take us by surprise. He started morphine for air hunger late in the evening of the second day being bed-ridden and died the next morning the cause of death was believed to be a heart attack. My brother and sister-in-law were with him and sent out the text to the whole extended clan: “Dad passed away at 7:29.”  I was staying at my sister’s. She immediately left for his place, with me following a few minutes behind.  My oldest sister would need a few hours to catch a ferry and get there.

While I was packing up to hurry over, my younger sister called for the information on the orange card. The hospice nurse needed the information. The call was made – we had five hours. Five hours? So short – the brain would have to be harvested by 12:29.  My oldest sister had to get there. How about pick up at 11:30 am?  Will that work? Yes, the transport team will be there.

 Now what – three short hours to say good-bye.  Yet those three hours stretched into timelessness. My older sister arrived at 10. We each had time alone with the body. We each said goodbye. It was now shortly after 10 so we called the transport team to come earlier, at 11. We gathered around the body, joined hands to surround him with our love one last time, and said my dad’s favorite grace: “Well sir, we are all together again. We have our health and the rest is up to you.”  My mind smiled at the incongruity of the words, but it was exactly what my dad would have wanted us to do. We were done.  And it wasn’t 11 yet.

The transport team arrived, somber, respectful, in black suits. The paperwork was filled out and the body was transferred to the gurney and maneuvered out the door. The condominium manager asked us to transfer the body out of the building via the side door instead of the front door. The hospice nurse insisted that she accompany the body to make sure it was treated respectfully.  My brother’s words summed up how we felt as our dad’s body went from warm to cold: “It was time for him to go.”

My mother had been part of the same program, but because she died in the hospital, the rapid autopsy logistics were handled without us. Unfortunately, in my dad’s grief, some of the paperwork was filled out incorrectly and we lost her remains for two weeks. After we told the hospice nurse this story, she cited all the steps in the process and requested that study personnel call us as each step was finished. They each complied and this time we always knew where the remains were, though, you had to laugh, since my dad’s name is Aubrey, sometimes a feminine name, the callers would inform us about the whereabouts of “our mother’s remains.” It still was added comfort to know where his remains were in the process from autopsy room, to memorial group, to cremation, to pick-up.

As an ethicist specializing in part in post-mortem research, I always wondered about several details of the process. Was the timeframe for “rapid autopsy” too short for families? It may be for some, but for my clan it was perfect.  Nor is warm autopsy the right term. As others have suggested, it was not, since the lack of warmth was just what made it seem so right for the body to leave.  Would this process be as respectful as all our guidelines insist it be? It was for us. It was just right that the “transport guy and gal” dressed like funeral directors and that each movement of the body was done somberly and respectfully.  The polite phone calls, prefaced by condolences, assured us his remains were being tracked. The presence of the hospice nurse was a key factor in making the process work so well for us. She handled the initial phone calls, shepherded the body and listened to our concerns that Dad’s remains might get lost as had our mom’s.

 Finally, just as I had argued previously from my academically removed position, the peace that comes from honoring my dad’s autonomous wishes was deep and satisfying.  Equally satisfying was the sense that he was helping advance medical science and future people.  He wanted this. We could do it. What an opportunity for my dad and family to continue to make a contribution. My hope is that other families will make this choice. It was certainly right for us.

Acknowledgement: I want to thank my sisters, brother, brothers-in-law, husband and children, for their edits and agreement to tell this intimate family story.

Rebecca D. Pentz is a professor of research ethics at Emory University School of Medicine.

The petition also has a noticeable gap. Very few signers come from the University of Minnesota. In fact, only two people from the Center for Bioethics have signed: Leigh Turner and me. This is not because any faculty member outside the Department of Psychiatry actually defends the ethics of the study, at least as far as I can tell. What seems to bother people here is speaking out about it. Very few faculty members are willing to register their objections publicly.

Why not?  Well, there are the obvious possibilities – fear, apathy, self-interest, and so on.  At least one person has told me she is unwilling to sign because she doesn’t think the petition will succeed.  But there may be a more interesting explanation that I’d like to explore.  For those who are unfamiliar with the scandal, however, let me backtrack briefly and explain the events in question.  (You can read the longer version in Mother Jones magazine and additional background in a Bioethics Forum post.)

In late 2003, Dr. Stephen Olson, the head of the schizophrenia program at the University of Minnesota, recruited an acutely psychotic young man named Dan Markingson into an AstraZeneca-funded research study of antipsychotic drugs.  Olson enrolled Dan despite the fact that he had been repeatedly judged incapable of giving informed consent, despite the fact that his mother objected to his participation, and despite the fact that Dan had been placed under an involuntary commitment order that legally compelled him to obey Olson’s recommendations. For months, Mary Weiss, Dan’s mother, tried desperately to get her son out of the study, warning that his condition was worsening and that he was in danger of committing suicide. Her warnings were ignored. In May 2004 Dan stabbed himself to death with a box cutter so violently that he nearly decapitated himself.

The research study itself was plagued by ethical problems:  financial incentives to keep subjects in the study as long as possible, conflicts of interest for the investigators, an inexplicable gap in the exclusion criteria, and a questionable scientific rationale.  AstraZeneca was eventually forced to pay $520 million in fraud penalties, and some of its misconduct was traced back to the University of Minnesota.

You might think that events this alarming would prompt a university investigation. That is not what happened.  Instead, the university blocked Mary’s efforts to get Dan’s medical records, and when her lawsuit against the university was dismissed on grounds of sovereign immunity, it filed a legal action against her, demanding $57,000 in legal costs.  Even as evidence has accumulated suggesting a much larger problem involving more psychiatric studies and more mistreated subjects, the university has stonewalled every effort to get to the truth.

Why would faculty members remain silent about such an alarming sequence of events?  One possible reason is simply because they do not feel as if the wrongdoing has anything to do with them.  The University of Minnesota is a vast institution; the scandal took place in a single department; if anyone is to be blamed, it is the psychiatrists and the university administrators, not them. Simply being a faculty member at the university does not implicate them in the wrongdoing or give them any special obligation to fix it.  In a phrase: no guilt, hence no responsibility.

My view is somewhat different.  These events have made me deeply ashamed to be a part of the University of Minnesota, in the same way that I feel ashamed to be a Southerner when I see video clips of Strom Thurmond’s race-baiting speeches or photos of Alabama police dogs snapping at black civil rights marchers. I think that what our psychiatrists did to Dan Markingson was wrong in the deepest sense. It was exploitative, cruel, and corrupt.  Almost as disgraceful are the actions university officials have taken to cover it up and protect the reputation of the university.  The shame I feel comes from the fact that I have worked at the University of Minnesota for 15 years. I have even been a member of the IRB.  For better or worse, my identity is bound up with the institution.

These two different reactions – shame versus guilt – differ in important ways.  Shame is linked with honor; it is about losing the respect of others, and by virtue of that, losing your self-respect. And honor often involves collective identity. While we don’t usually feel guilty about the actions of other people, we often do feel ashamed if those actions reflect on our own identities.  So, for example, you can feel ashamed at the actions of your parents, your fellow Lutherans,  or your physician colleagues – even if you feel as if it would be unfair for anyone to blame you personally for their actions.

Shame, unlike guilt, involves the imagined gaze of other people. As Ruth Benedict writes: "Shame is a reaction to other people’s criticism. A man is shamed either by being openly ridiculed or by fantasying to himself that he has been made ridiculous. In either case it is a potent sanction. But it requires an audience or at least a man’s fantasy of an audience.  Guilt does not.”

 In scandals, this imagined audience can produce very different, even opposite, reactions.  On the one hand, it is what leads many people to try so hard to keep scandals secret. This impulse to cover up wrongdoing can be toxic, as the Catholic Church has discovered.  But it is also what leads insiders to speak out publicly against a scandal. By speaking out, you show that you are separating yourself from the wrongdoing in order to maintain your honor and self-respect. You are saying to the world, “Do not think that I am a part of this.”

Shame and honor may seem like old-fashioned ideas, but if you read the comments left on the petition by University of Minnesota alumni, you cannot help but be struck by their language.  “How shameful for UMN, my alma mater.” “I am a graduate of the University of Minnesota and want to be proud of my school, but following this case has made me deeply ashamed.”  “I am a University of Minnesota alumn, and I am ashamed of my alma mater right now.” “To call this merely shameful would be wholly inadequate.”  “Attended U of MN Medical School and then U of MN Psychiatry residency – ashamed of the Psychiatry Department.”  “I am a graduate (CLA, 1981) and ashamed of the way the University continues to handle this tragic case.”  “The University's legal team should also be ashamed of their behavior in further victimizing this family.”

Obviously, this shame is something I understand, or else I would not be working so hard to raise awareness of the petition and convince others to sign on.  (You can sign the petition here.)  I also believe that the truth will eventually come out, and when that happens, there will be more than enough shame to go around.  The refusal to investigate will only make things worse.  As Jesse Ballenger writes on the petition, “As a faculty member at a university (Penn State) now notorious for failing to investigate abuses, I find the refusal of the University of Minnesota to confront this scandal sadly familiar.”

Carl Elliott, a Hastings Center Fellow, is a professor at the Center for Bioethics at the University of Minnesota. His most recent book is White Coat, Black Hat: Adventures on the Dark Side of Medicine.

On April 10, 2013, the advocacy group Public Citizen reacted to OHRP’s findings with a letter to Kathleen Sibelius, director of Health and Human Services. Public citizen criticized HHS for being too mild in its critique and too lenient in its proposed remedy. It claimed that the study was “highly unethical” because it “exposed 1,316 extremely premature infants to increased risks of either death or retinal damage.” It also claimed that egregious omissions in the informed consent process “caused parents to enroll their premature infants in this experiment under the false pretense that it was much safer for their infants than was known to be the case.” Public Citizen’s critiques go beyond informed consent. They suggest that the study should never have been done in the first place because enough was already known about oxygen therapy that “any study comparing the two experimental target levels of oxygen saturation would be both unethical and not compliant with requirements of HHS regulations.” Public Citizen demanded that the directors of both HHS and NIH personally apologize to all of the parents who enrolled their babies in the study.

OHRP and Public Citizen are deeply misinformed about the design of SUPPORT, about the well-being of the infants enrolled in it, and about oxygen therapy for neonates generally. Their criticisms of the study are not only off-target, but dangerous.

In the study, infants were randomized to doses of oxygen that would maintain their oxygen saturation levels at either 85-89% or 91-95%. At the time, standard care was to keep infants somewhere in the range between 85% and 95%, without any greater specificity. According to OHRP, the consent form accurately described this as the normal range for oxygen saturations and accurately stated that all infants who were in the study, as well as those who were not, would receive oxygen at concentrations that would keep oxygen saturations between 85%-95%.

At the time the study was designed and conducted, there was wide variation in standard practices of oxygen administration throughout the world. As one scholarly review of such therapy noted, “NICUs in the US today have a wide range of SpO2 [oxygen saturation] guidelines… A randomized, controlled trial is needed to establish a safe upper limit of SpO2 in the premature infant at risk for developing ROP [retinopathy of prematurity].”(1) Most clinicians and investigators at the time believed that lower oxygen levels were safer than higher ones in that they protected infants from retinopathy without increasing mortality. Very few people would have guessed that lower oxygen levels would lead to increased mortality, although many hoped that it would lead to lower levels of retinopathy. The SUPPORT study was designed to determine whether these beliefs and hopes were true. The consent form thus focused on ROP and stated, “the benefit of higher versus lower levels of oxygenation in infants, especially for premature infants, is not known.”

As it turned out, the study showed that the mortality rate was higher in the lower oxygen group than in the higher oxygen group. This surprising finding has now led OHRP to conclude retrospectively that the consent form was inadequate and for Public Citizen to conclude that the study was unethical and that the parents of babies who were enrolled deserve an apology. I believe that both OHRP and Public Citizen are learning the wrong lessons and drawing the wrong conclusions. To see why, I focus on three questions that bear on the ethics of this study and of neonatal research more generally: 1) Was the study design ethical and appropriate at the outset? 2) Were babies in the study harmed? and 3) Was the consent form adequate?

Was the SUPPORT study design ethical and appropriate at its outset?

Public Citizen says no. OHRP and the investigators (and their IRBs) say yes. OHRP and the investigators are right. At the time of the study design, there was significant uncertainty within the professional community about the optimum level of oxygen to provide to premature babies. In 2002, Tin reviewed the available data and concluded, “Oxygen must have been given to more infants than any other medicinal product in the last 60 years. Despite that, we still know very little about how much infants actually need, or how much it is wise to give. The depth of our ignorance is really quite embarrassing.”(2) Silverman echoed these sentiments, noting that “the optimum range of oxygenation… remains to this day, unknown.”(3) The recognition of the need for better data was not limited to the United States. An international consortium of researchers in neonatology recognized the need for – and conducted – similar trials. In fact, this is the only time in the history of neonatology when researchers around the world acknowledged the urgent need for a prospective randomized trial. There was clearly a state of “community equipoise” about oxygen dosing. Studies of the effects of oxygen on survival, retinopathy, and long-term neurological outcome were essential and ethically appropriate.

Were babies in the study at higher risk than babies who were not in the study?

Public Citizen and OHRP say yes. The investigators and IRBs say no. The investigators and IRBs are right. Every baby in the study received treatment that could have and perhaps would have been given to babies who were not enrolled in the trial. At the outste, nobody knew which treatment was safer. Babies who were randomized to one treatment or the other were thought to be at no higher risk of a bad outcome (or likely to have a good outcome) than babies whose treatment was decided based on clinical judgment. This was true at the beginning of the study and, we now know, it remains true now that the data have been analyzed.

How do we know? The fact that this study was conducted within the NICHD Neonatal Research Network actually allows the risk of the study to be quantified. That is because the network collects data on all babies born at these gestational ages, whether they are in a study or not. The data for babies in the study, and for all babies treated at these same hospitals, can be found in two papers, one in the New England Journal of Medicine and one in Pediatrics. The first, published May 10, 2010, reported survival rates and rates of severe eye disease for all babies in the SUPPORT study.(4) The other, published August 23, 2010, reported the same outcomes for all babies in the neonatal research network (some of whom were in the SUPPORT trial, most of whom were not).(5) Here is what they show. The babies in the “low oxygen” arm of the clinical trial had a mortality rate of 19.9%. The babies in the “high oxygen” arm of the study had a mortality rate of 16.2%. Babies in the network overall had a mortality rate of 24%. For severe retinopathy, the numbers are 8.6% (low oxygen group), 17.9% (high oxygen group) and 24.1% (overall group). In other words, babies in both arms of the study had higher survival rates and lower rates of retinopathy than babies who were not in the study. The fact that some babies in the study were in the overall group minimizes these differences. The true differences were probably larger. Babies enrolled in the study were protected, not endangered, by being in the study.

How can this be? There are a few possible explanations. It may have been a selection bias, as Rich and colleagues suggested.(6) Since consent for the study was sought prenatally, pregnant women who were receiving prenatal care were more likely to enroll their babies in the study than women who did not receive prenatal care. Another possible explanation is that damage from oxygen toxicity is not related to the absolute level but instead is associated with fluctuations in oxygen level, so that the babies in the trial, who received more stable levels of oxygen than babies not in the trial, may have been better off as a result. Or it may reflect the well-known but poorly understood phenomenon of “inclusion benefit,” by which subjects in either arm of a randomized trial have better outcomes than patients who were eligible for the study but not enrolled.(7) The fact is, we don’t know why babies in the trial did better. But we know that they did. Thus, to claim that babies were harmed by being in the study and that those harms could have been avoided by receiving conventional therapy is not just wrong, but dangerously wrong, as it will discourage research, discourage parents from enrolling their children in important research studies, and, by ignoring the actual data, suggest that even completed research ought to be ignored.

In spite of this data, OHRP suggested that the consent form should have stated that “the level of oxygen being provided to some infants, compared to the level they would have received had they not participated, could increase the risk of brain injury or death” (OHRP letter, page 10). Given the data, it is hard to know how to interpret OHRP’s reasoning. Their position is apparently that informed consent forms need to inform parents not only of known risks and of possible risks, but also of risks that the investigators did not think were possible – even after those risks have been shown not to exist. Essentially, there is no risk that does not fall into this category. By these criteria, consent forms should state something like, “ANY risk that you can imagine, and ALL risks that you cannot even imagine, and EVEN RISKS THAT HAVE BEEN SHOWN NOT TO EXIST, are possible as a result of participation in this study.”

Should the consent form have more accurately disclosed the goals of the study?

The goals of a study are different from the risks of the study. The SUPPORT study, according to its protocol as cited by OHRP, was designed to determine whether “a lower target range of oxygen saturation (85% to 89%), as compared with a higher target range (91% to 95%), would reduce the incidence of the composite outcome of severe retinopathy of prematurity or death among infants who were born between 24 weeks of gestation and 27 weeks 6 days of gestation.” The consent documents did not mention the goals of the study. They should have, and they should have explained that nobody knew if either arm of the study would do better or worse or whether babies in the study would do better or worse than those receiving “conventional” therapy outside the study. A model for such disclosure can be found in the consent form for a similar trial conducted in New Zealand, in which the consent form described the risks and benefits as follows:

“Too high oxygen in the blood for long periods may 1) contribute to abnormal development of the retina (a condition called retinopathy of prematurity – ROP) and affect vision – it is even possible for some babies with ROP to become blind; 2) contribute to changes in the lungs that mean the baby needs ongoing help with breathing for weeks or months (a condition called bronchopulmonary dysplasia – BPD); 3) be one cause of damage to brain cells and lead to developmental problems.

Too low oxygen in the blood for long periods may 1) increase the risk the baby will not survive or contribute to poor growth; 2) raise blood pressure in the lungs and contribute to bronchopulmonary dysplasia; 3) damage the brain cells and lead to developmental problems.” (BOOST-NZ consent, July 2005, personal communication from Brian Darlow, principal investigator of BOOST-NZ)

The risks of reckless opinions

The most important ethical issues for the future of clinical research, both in neonatology and in other areas of medicine, are the issues of honesty, transparency, and safety. Trials should not be done if the risks are too high or if the study subjects aren’t informed of those risks. Interim analyses of data should allow studies to be stopped if one arm is clearly riskier or more beneficial than the other.

It is difficult to convey the need for randomized trials to any patient, but perhaps particularly to parents of critically ill children. Perhaps for this reason, there have been very few prospective randomized trials in neonatology. As a result, many therapies in neonatology have not been validated and may be dangerous. Neither parents nor babies are well served by a system that is exquisitely attentive to the risks of randomized trials but oblivious to the risks of unvalidated therapies. But that is exactly what OHRP and Public Citizen recommend. If their recommendations are followed, avoidable harm to babies will occur.

Their criticism of this important trial also discredits bioethics. Bioethics, at its best, advocates for the most vulnerable patients and criticizes doctors and researchers who put those patients at risk. In this instance, OHRP and Public Citizen have, in the name of bioethics and advocacy, criticized clinical investigators who were trying to prevent the use of harmful and unvalidated treatments and, instead, endorsed an anti-intellectual, unscientific approach to medical innovation for the most vulnerable patients.

The SUPPORT trial should be praised for its design. It was a crucially needed, rigorous evaluation of risks and benefits of supplemental oxygen for premature babies. Moreover, the study demonstrably protected babies. Study subjects were benefitted, not harmed, by being in the trial. The risks to babies in the trial were lower, not higher, than the risks to which babies not in the study were exposed. No apology is needed for that.

It is shocking that OHRP and Public Citizen did not see fit to understand the study or, apparently, to analyze the results before claiming that it was risky to babies. The real risk to babies comes from reckless and ill-informed opinion about highly ethical scientific studies. To minimize this risk, OHRP and Public Citizen should apologize to the investigators and to the parents of the babies in these studies for their sensationalistic misinterpretations of the support study. If they do not, and if fewer babies are enrolled in such studies, then more rather than fewer babies will die, more rather than fewer babies will go blind, and OHRP and Public Citizen will have been responsible for those harms to innocent babies.

1. C.G. Anderson, W.E. Benitz, A. Madan, “Retinopathy of Prematurity and Pulse Oximetry: A National Survey of Recent Practices,” Journal of Perinatology 24 (2004): 164-68.

2. W. Tin, “Oxygen Therapy: 50 Years of Uncertainty,” Pediatrics 110 (2002): 615-16.

3. W.A. Silverman, “A Cautionary Tale about Supplemental Oxygen: The Albatross of Neonatal Medicine,” Pediatrics 113 (2004): 394-96.

4. SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network, “Target Ranges of Oxygen Saturation in Extremely Preterm Infants,” New England Journal of Medicine 362 (2010): 1959-69.

5. B.J. Stoll et al., “Neonatal Outcomes of Extremely Preterm Infants from the NICHD Neonatal Research Network,” Pediatrics 126 (2010): 443-56.

6. W. Rich et al.,“Enrollment of Extremely Low Birth Weight Infants in a Clinical Research Study May Not Be Representative,” Pediatrics 129 (2012): 480-84.

7. J.D. Lantos, “The ‘Inclusion Benefit’ in Clinical Trials,” Journal of Pediatrics 134 (1999): 130-31; W.A. Silverman, “Disclosing the ‘Inclusion Benefit,” Journal of Perinatology 22 (2002): 261-62; G.E. Vist et al., “Outcomes of Patients Who Participate in Randomized Controlled Trials Compared to Similar Patients Receiving Similar Interventions Who Do Not Participate,” Cochrane Database Systematic Review July 16, no. 3 (2008):MR000009.

The solutions, however, are far from clear, as Charles Ornstein, a veteran health care journalist, discusses very movingly in an article in ProPublica about his mother.

Shortly after Harriet Ornstein was admitted to the hospital, her heart stopped. It was revived with CPR, and then she was put on a ventilator. Doctors said that the prognosis was grim and suggested that the family consider removing her from the breathing machine.

The family knew Harriet’s end-of-life wishes. She didn’t want to be artificially kept alive if she had no chance of a meaningful recovery. That seemed to be the situation she was in. And yet Ornstein, his father, and his sister still didn’t know if taking her off the ventilator was the right thing to do. What if the medical assessment was wrong?

The family had reason to wonder. Last summer, doctors were wrong in determining that Charles’s father would not pull through after his heart stopped beating and revived after 10 minutes of CPR. “They asked about his end-of-life choices,” Ornstein wrote. He and his mother began discussing his funeral. But, despite the odds, he made a full recovery within weeks. Ornstein wondered how the doctors could have been so confident that he would die.

The family resolved to get a second opinion on Harriet’s condition. They consulted with a neurologist who suggested two additional tests. Two days later, the results confirmed the earlier prognosis. At this point, they decided to honor their mother’s wishes. “She died peacefully, on her own terms, late that night – my dad, my sister and I by her side.”

A week later, Ornstein began to wonder if his family’s decision was consistent with what he had learned as a health care reporter about the problems with futile end-of-life care. “Did we waste resources while trying to decide what to do for those two extra days?” he asked.

He posed this question to Elliott S. Fisher, a professor of medicine at Dartmouth and a leader of the Dartmouth Atlas of Health Care, which tracks disparities in health care spending. Fisher said no. “You never need to rush the decision-making,” he said. “It should always be about making the right decision for the patient and the family.”

But what if the Ornsteins had taken two weeks or two months to make their decision? How much time is too much? At what point would they have been wasting money on futile care?

Daniel Callahan, co-founder of The Hastings Center, who has devoted much of his career to considering health care at the end of life and its cost implications, said that the unwillingness to give up hope, however improbable the odds, is part of the problem. “That way of thinking could lead families to keep searching for still another second opinion and a third, etc.,” he said.

Of the Ornsteins’ case, he said: “The combination of a patient advance directive not to treat if that would be of no benefit and a basically hopeless diagnosis by the first round of doctors should have been enough. Termination of treatment would have been the right thing to do.”

But, as Charles Ornstein discovered, it’s easier to identify the right thing to do when considering the health care system as a whole or the cases of strangers than when making the definitive decision for your mother – even when you know your mother’s wishes. “In all my reporting, I'd never realized how little the costs to the broader health-care system matter to the family of a patient,” he wrote. “When that patient was my mother, what mattered was that we had to live with whatever decision we made. And we wouldn't get a chance to make it twice.”

In the weeks following his mother’s death, he was left hoping that what he learned will make him a better, more compassionate journalist. “Most of all,” he wrote, “I will always remember that behind the debate about costs and end-of-life care, there are real families struggling with real decisions.”

Susan Gilbert is The Hastings Center’s public affairs and communications manager.

This incident generated national headlines, and it continues to be widely debated. Many were shocked that an assisted living facility would evict an elderly couple who wanted to die in their own apartment. The Rudolphs’ son, Neil, stated the administrators at the assisted living facility were “inhumane” and along with Compassion and Choices used the death of his parents to advocate for VSED (voluntarily stopping eating and drinking for the sole purpose of causing death).

Barbara Coombs-Lee, president of Compassion and Choices, has consistently maintained VSED is “universally available, legal, safe, painless, and suitable for the gentle parting in one’s own home with loved ones present.” Compassion and Choices created a national campaign “Peace at Life’s End. Anywhere” to advocate for VSED. In my estimation this effort has clouded the ethical conundrums at the end of life and blurs the lines between how we perceive assisted suicide, palliative care, and terminal sedation.

Dying by VSED has sparked an intense and polarizing debate. On one side you have Compassion and Choices maintaining that VSED is a panacea for those who want to end their lives in the absence of assisted suicide legislation. On the other hand you have groups such as Not Dead Yet and the Anti-Euthanasia Coalition arguing that VSED is inherently flawed and poses a serious risk to vulnerable populations such as the elderly and disabled. What is absent in discussions of VSED, assisted suicide, and euthanasia in general is a disability rights perspective.

 This omission is unfortunate in part because the fear of disability, cognitive and physical, at the end of life is palatable. Indeed, fear of disability, dementia, and the loss of independence and personal autonomy are often cited as the reasons many people Oregon choose assisted suicide. Ira Byock has written: “Americans are scared to death of dying. And with good reason. While rarely easy under any circumstances, we make dying a lot harder than it has to be.”

 The vast majority of Americans continue to die in hospitals. Far too many people needlessly suffer at the end of life, and deaths perceived to be bad leave a lasting and negative impression of the American health care system. Death, like disability, is a complex amalgamation of issues: existential angst, physical pain, loss of independence and control of one’s bodily functions, and situational depression are but a few of the variables people must cope with. Moral and ethical questions abound and I would argue that people with disabilities are uniquely suited to have a prominent role in discussions about end-of-life care.

We Americans are fiercely committed to equality, and yet most will admit that some populations are devalued: people with a disability, the elderly, and terminally ill.  According to Carol Gill, when a person who is not in one of these groups expresses a desire to die via VSED, “it is characterized as ‘suicidal,’ and the individual is treated accordingly.”

But, she adds: “For persons with severe disabilities, however – particularly persons who use a respirator, feeding assistance, or other life aides – the desire to die has acquired labels such as ‘refusal of treatment,’ a wish to avoid prolonged suffering or dying, a desire to let terminal disease take its natural course (used in cases of long-term disability lacking any evidence of terminal illness!), and ‘not committing suicide.’ The implication is that there is something natural, reasonable, or proper about a disabled person’s dying as opposed to a nondisabled person’s dying.”

Theoretically, the belief of Compassion and Choices that any person can opt to end his or her life by VSED is correct – anyone does indeed have this option “when physical decline and suffering become pointless and unbearable.” What advocates for VSED conveniently ignore is the cultural response when an individual actually expresses such a desire.

It does not take much effort to find examples of people with a disability who are applauded because of their brave desire to die. In The New York Times, Jane Gross writing about her mother’s death and Dudley Clendinen writing about his desire to die before ALS locked him in spring to mind. These are well known end-of -life stories.

 Contrast them with Larry MacAfee, David Rivlin, and Christina Symanski, quadriplegics who all expressed a desire to die. Few people outside of the disability rights community will know these names. Symanski who did in fact die via VSED reinforced an ugly truth about how people perceive disability – that one is better off dead than disabled. Of course few people will openly admit this. Jackie Leach Scully identifies this nonverbalized bias “disablism.” “People who are nonconsciously or unconsciously disablist do not recognize themselves as in any way discriminatory,” she wrote; “their disablism is often unintentional, and persists through unexamined, lingering cultural stereotypes about disabled lives.”

In its opposition to VSED Not Dead Yet has noted: “The disability community can readily empathize with chronic pain and the struggles to get the medical profession to address it with competence and commitment. We can empathize with what it feels like to lose mobility and need help with daily tasks. But we also know from experience that independence is not really about whether we need mobility devices or personal assistance, it’s about whether we have control over the way those needs are met.”

 This is not an abstract issue. This affects real people. People like Thomas Young, a disabled veteran shot and paralyzed in Iraq in 2004 who has expressed his intentions to die via VSED next month. Young, a so-called Wounded Warrior, and subject of the critically acclaimed film Body of War, might die not because he has a severe disability but we as a society have failed him and countless others.

William J. Peace is an independent scholar. His research interests include disability rights, bioethics, body art and modification, and the history of anthropology. His blog is Bad Cripple.

One problem with the article that has been overlooked by critics concerns the goal that Callahan takes for granted: reducing overall national obesity. Callahan makes passing reference to two kinds of reasons for reducing national obesity rates, but neither seems compelling.

The first might be considered intervening for the purpose of preventing the overweight and obese from further harming themselves. Callahan hints at this reason for interventions when he mentions the “health impacts of obesity” and the fact that it “shortens lives.” Rising obesity rates mean that more people are committing self-harm and justifies more severe interventions.  Is this a good reason for mounting a large-scale intervention?

Many people will balk at this paternalist reasoning. Even if it is better to be of a normal weight, coercing someone solely for his or her own benefit is objectionable. 

But even if we were sympathetic to paternalist lines of reasoning, it is not clear that decreasing someone’s overall weight is definitely for his or her good. While extreme forms of obesity are highly correlated with increased mortality, recent highly publicized evidence has indicated that both overweight and grade 1 obese persons enjoy decreased all causes of mortality relative to those of a normal or average weight.

The second kind of reason Callahan references might be considered intervention for the purpose of preventing harm to others. Callahan mentions here the “cost” of obesity. But while obesity can undeniably lead to expensive medical charges, studies have shown that obesity is actually cheaper in the long run than is healthiness, as Callahan himself admits. The study Callahan cites shows that lifetime medical costs in the study group of Dutch patients were highest for those who were of an average weight and did not smoke; lower for those who were obese but did not smoke; and lowest of all for those who smoke.

While this result will seem counter-intuitive to many people, its explanation is not particularly complicated. Good health does not prevent illness or death, it merely delays them. Those who are obese and/or smoke will, sadly, contract illness and die at a younger age. Consequently, the obese use fewer lifetime medical resources. 

If we look at wider social costs, the same holds true or is even exacerbated. People who lead healthy lifestyles spend their productive years paying taxes or insurance fees, and then spend a relatively longer period of retirement reclaiming their prior contribution to these systems. Those leading unhealthy lifestyles often make it through the bulk of their productive life (i.e. prior to retirement), but spend a relatively shorter period of time receiving Medicare, social security, or other social benefits.        

Where does this leave us?  While we may join Callahan in regretting that the nation is becoming progressively fatter, it isn’t clear that this necessitates anything like the massive coordinated response suggested by Callahan. Directly referring to the good of the overweight and/or obese when designing interventions is morally problematic. But even if it weren’t, data showing that some overweight or obese persons may live longer calls into question whether it is even plausible to defend the proposed interventions by referring to the good of those they target. Referring to the costs to others, while acceptable in principle, would be similarly problematic if it turns out that the most severely obese persons have the lowest lifetime medical costs and impose the fewest costs on society.

Stigmatization is a drastic means for treating any social problem. But before considering such a drastic means, we’d do well to contemplate carefully whether there is a problem that definitely needs to be fixed.

D. Robert MacDougall is a postdoctoral fellow at Dalhousie University in Halifax.

Responding to the obesity epidemic presents a conundrum for policymakers because many of the strategies designed to address obesity conflict with deeply held moral values and legal protections, as Daniel Callahan argued in his article in the Hastings Center Report. For example, banning certain types of foods, such as artificial trans-fatty acids, restricts the freedom to decide what one eats and can undermine cultural traditions associated with food. Many people object to paternalistic government control over the human diet, such as New York City’s rule prohibiting restaurants, movie theaters, and other businesses from selling sugared drinks in portions larger than 16 ounces.

Taxes on foods tend to be regressive because economically disadvantaged people spend a higher percentage of their income on food than economically well-to-do people. Food taxes can be regarded as unfair because they have a disproportionate impact on individuals who are already economically disadvantaged.  Regulating food advertisements that are not inherently deceptive may conflict with legal protections for freedom of speech. 

Many of the government strategies for dealing with the obesity epidemic that focus on controlling diet are not well-supported by the evidence. Although studies have shown that restrictions on portion sizes can impact caloric intake, it is not known how consumers and businesses will respond to New York City’s rules concerning the size of sugared soft drinks.  Consumers might take in the same amount of sugared drinks or total calories, and businesses might circumvent the ban by offering free refills or other discounts. The impact of taxes on soft drinks is also uncertain. Economic models indicate that taxes on soft drinks may have only a marginal impact on obesity, because soft drinks represent a small percentage of caloric intake (7% or less) and taxes that are not so high as to be regressive will have only a minimal impact on consumer behavior.

The specter of a slippery slope toward increased government control over the human diet looms large in any attempt to ban, regulate, or tax specific foods or portion sizes. If the government can ban trans-fatty acids, for example, the door is open for banning other types of foods, such as processed meats, sugared drinks, potato chips, and donuts.  Strategies that deal with role of the built environment in the obesity epidemic are well-supported by the evidence and do not raise troubling concerns about paternalistic interference with the human diet or regressive taxation. The built environment includes structures humans have created for housing, business, industry, recreation, education, and transportation, such as roads, sidewalks, bike lanes, open areas, single-family homes, apartments, office buildings, schools, and shopping malls. Governments can impact the built environment through zoning ordinances, urban planning, annexation rules, housing codes, and construction of roads and parks.

 A systematic review, published last year in the American Journal of Public Health, of 169 studies examining the relationship between the built environment and physical activity or obesity found that 89.2% of those studies demonstrated statistical associations between the built environment and physical activity or obesity. Aspects of the built environment associated with increased physical activity or reduced obesity included parks, sidewalks, trails, recreational facilities, school playgrounds, and traffic safety.  All of the studies included in these reviews were observational and did not involve controlled experiments to determine the effectiveness of interventions in the built environment. To enhance our understanding of the role of the built environment in physical activity and obesity, it is important to conduct experimental studies, such as controlled clinical trials of environmental interventions. 

Some may object to government efforts to shape the built environment that restrict property rights of landowners, builders and developers, but these restrictions can be justified as necessary to promote important government aims, such as the promotion of public health and safety. Building codes can be justified to protect people from harms resulting from poorly constructed or designed buildings. Requiring that a home have a sidewalk in front of it is no different, in principle, from requiring that it have railing on entrance steps higher than 30 inches, since both measures are designed to protect or promote human health. A zoning law that promotes the development of schools and businesses within walking distance of homes is no different, in principle, from a law that prohibits factories from being built near schools. 

While it is still important for policymakers to consider strategies for addressing the obesity epidemic that focus on caloric intake, strategies that focus on making the built environment more conducive to physical activity should be given a high priority because they do not restrict freedom in objectionable ways or constitute regressive taxation. Instead of limiting or controlling choices, they enhance one’s ability to make healthier choices: a person can choose to walk to work, enjoy a park, or take the stairs instead of the elevator, even when they are not required to do so.    

David B. Resnik, JD, PhD, is a bioethicist at the National Institute for Environmental Health Sciences. This article is the work product of an employee or group of employees of the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH).  However, the statements, opinions or conclusions contained therein do not necessarily represent the statements, opinions or conclusions of NIEHS, NIH, or the United States government. 

The modern hospice movement started in the 1970s as a holistic philosophy of care that stressed pain and symptom control as well as emotional and spiritual support. When hospice became a Medicare benefit in 1982, partly predicated on being a cheaper as well as more humane form of care, it became a set of federal rules.  Now it is a business model complete with cost-cutting and revenue-enhancing strategies. Can hospice serve all these masters? And to what degree do patient and family preferences and values enter into these equations?

Two recent studies demonstrate the tension between efforts to bring the benefits of hospice to patients and their families earlier in the course of a final illness and the requirement that hospice patients die on regulators’ schedules and without expensive drugs or procedures that affect the bottom line.

Joan M. Teno and colleagues reported on changes in end-of-life care for Medicare fee-for-service beneficiaries in 2000, 2005, and 2009.  At first glance the news looks good. In 2009 more people were dying at home (32.6 percent), where they almost universally say they want to be, than in 2000 (24.6 percent)  More people (42.3 percent) were using hospice at the time of death in 2009 compared to 2000 (21.6 percent).  But there is more to the story. A third of the people who died in hospice care were treated in an ICU in the last 30 days of life.  Over 40 percent of these patients had a transition from one care setting to another in the last 30 days. Transitions at any stage of illness are traumatic but they are particularly burdensome when a person is acutely ill. 

On the “too late” side of the equation, although hospice use increased, 28.4 percent of these patients used hospice for three days or less. A day or two of hospice care may be better than dying in a hospital but it barely provides the opportunity for patients and families to adjust to the new staff, services, and routines. Even though hospice provides bereavement services for a year after a death, many families may not take advantage of this service because they have not developed a trusting relationship with hospice. Whether they use this service or not, their last memories are likely to be of the confusion and chaos surrounding the transitions. This seems the worst of all possible end-of-life care scenarios -- aggressive intensive care, unlikely to change the outcome, followed by a difficult transition, and ending with a few days of hospice care.

An editorial by Grace Jenq and Mary E. Tinetti calls the changes reported by Teno et al. “more, not better care.”  In place of what they call the “default” decision of transfer to an ICU as patients accumulate acute medical problems at the end of life, they suggest developing explicit criteria for ICU admission -- “a threshold of likely benefit and expectancy.”  While such a standard might be defensible, it would be difficult to craft and implement, and would likely encounter resistance from physicians who are committed to “trying everything” and from families who insist on “doing everything.”  When there is conflict within a family, one person with a strong view can block consensus. Finally it is much easier for providers (and families) to opt for ICUs, when insurance, which covers hospital care much more completely than care in any other setting, is picking up the tab.

On the “too early” side of the hospice pendulum, Melissa D. Aldridge Carlson and colleagues reported on a survey of 591 hospices   and found that 78 percent had “at least one enrollment policy that may restrict access to care for patients with potentially high-cost medical care needs.”  For example, patients who have intrathecal catheters to administer medications, or are receiving palliative chemotherapy or radiation may be denied access.  Twelve percent restricted access if the patients did not have a caregiver at home. 

Barriers were found most often in small hospices, for-profit hospices, and hospices in certain regions of the country. Hospices in the Mountain and Pacific census regions tended to have the most restrictive policies, while those in the South Atlantic region had the least restrictive policies. Nonprofit hospices were almost twice as like to have open-access policies as for-profit hospices, which are the fastest growing segment of the hospice industry.  Hospices interpret the regulations differently and make different decisions about whom to accept.  Doctors, patients, and families are left without the information they need to make the best choice possible under the circumstances.  In some areas there is only one hospice, making the option essentially unavailable.   

The Teno study looked at three diagnoses – cancer, chronic obstructive pulmonary disease (COPD), and dementia. Hospice was designed for cancer patients, but increasingly patients with other, less predictable diseases are potential hospice beneficiaries. It was also designed to be flexible in terms of length of stay, recognizing that there would be patients with very short stays and some with very long stays. Predicting when a patient has six months or less to live is not a hard science. Some patients do very well on hospice because of the good care they receive, which keeps them out of the hospital. They outlive the first six months even though their overall health is declining. (My mother was one such hospice patient.) It seems counterintuitive to penalize hospices for providing good care, even if it means a longer episode of care. 

There is a process for recertifying these patients for continued hospice services, but with auditors looking over their shoulders, hospices are wary of too many recertifications. It is too soon to tell whether San Diego Hospice’s decision to file for bankruptcy will be a trend or an isolated event. If white knights in the form of hospitals rescue hospices and take them over, will that improve access to care or will it simply make the hospice decision even more dependent on the perspective and economics of acute care settings?

What to do?  In their editorial, Jenq and Tinetti point out that site of death is an inadequate measure of the quality of end-of-life care, “given the many transitions endured, and intensive care services received.” A more appropriate metric, they suggest, might be whether patients’ goals were elicited and care intended to achieve those goals provided early enough to make a difference. Teno and colleagues suggest increasing the hospice per diem rate for patients who require complex palliative treatments.  They also propose removing the Medicare hospice benefit limit on receiving concurrent care. 

But there is a more basic problem. Many patients and families don’t know what hospice is and what it is not. They know even less about palliative care. But they do want more information. I direct the United Hospital Fund’s Next Step in Care campaign; of the more than 20 family caregiver guides on our Web site, the most frequently downloaded by far is the guide to hospice and palliative care.  Hospice is not the right choice for everyone. And hospices vary in terms of quality. But hospice should be accepted or rejected on the basis of reality, not myth, and with the expectation that patients and families are the central figures.

Hospice and palliative care are part of a continuum of care. While outpatient palliative care is becoming more common, palliative care is still mostly available in hospitals. Making palliative care at home a Medicare benefit would make it easier for patients and families to approach advanced illness as well as end-of-life care in a more coordinated and compassionate manner, rather than the abrupt transition it now is for many patients and families.

Just like the three bears in the children’s story, hospice patients come in all sizes. Goldilocks was an intruder who did a lot of damage in her search for “just right” accommodations before being discovered and fleeing into the forest. Goldilocks as hospice auditor should avoid doing harm by penalizing patients who do not fit the “just right” standard.

Carol Levine is director of the Families and Care Project of the United Hospital Fund and a Hastings Center Fellow.

Under Belgian law euthanasia is permitted if a person is able to make his or her intensions clear to others and a physician determines that the person is experiencing “unbearable pain.” The Verbessem case has generated controversy worldwide. Multiple news reports characterized the deaths as a mercy killing. The message was clear: death is a logical and reasonable option if a person will become deaf-blind. By logical extension there are some disabilities that are a fate worse than death. One does not need to be terminally ill to be euthanized.

When I first read about the Verbessem brothers’ euthanasia I was struck that not a single news story contained a comment by a person who is deaf-blind. Deaf-blind people were outraged, as was the wider disability rights community. The media has utterly and completely rejected a disability rights perspective in favor of simplifying a story that is in fact quite complex.

For one thing, the Verbessem euthanasia highlights an unpleasant truth too many ignore: social supports for people with a disability in general and for the deaf-blind in particular are woefully inadequate.  Depression, social isolation and unemployment among the deaf-blind is rampant. Technology is available that would empower the deaf-blind to lead independent lives. This technology is expensive and governments worldwide do not want to spend limited resources on people whose lives are not valued. This is the harsh reality virtually every person with a disability faces as global second-class citizens.

Proponents of assisted suicide and euthanasia are pointing to the Verbessem brothers’ deaths as justification for ending the lives of people who are “suffering.”  For instance, in Belgium, the Socialist Party has presented parliament with dramatic changes that would legalize euthanasia for specific conditions. The proposed legislation would allow minors and Alzheimer’s disease patients the right to die. Death for children would only be extended to minors if they are capable of “discernment or affected by an incurable illness or suffering we cannot alleviate.”

Stephen Drake, research analyst for Not Dead Yet, has characterized the use of the word suffering rather than pain as a bait-and-switch tactic utilized by proponents of assisted suicide legislation. Pain is not the primary reason people seek out assisted suicide. Statistics in Oregon, where assisted suicide has been legal since 1998, demonstrate that people who utilized the Death with Dignity Act did not end their lives because they were in pain. People ended their lives because they lost their autonomy, the ability to participate in activities that made life enjoyable, and because they felt a loss of dignity. Between 1998 and 2010 only 22  percent of people cited pain as the primary reason for seeking assisted suicide.

I am not suggesting that people at the end of their lives and those with  terminal conditions do not suffer or experience pain. However physical pain can be alleviated in most cases. Suffering is far more subjective -- what exactly qualifies as suffering? It is not uncommon for people to associate disability with pain, suffering and end-of-life issues. I contend that fear and a deeply ingrained bias against disability are primary variables in assisted suicide.

Do not be misled by those who use the Universal Declaration on Human Rights to argue assisted suicide is about free choice and self-determination (the right to life, liberty, and security of person). This line of reasoning conveniently ignores the gross lack of social supports that disability activists have fought for here and abroad. No one wants to discuss the practical options the Verbessem brothers had. I saw no discussion about how many independent skill centers are devoted to the deaf-blind. In fact, I can think of only two such centers in North America.

Disability in the most general sense of the term is hopelessly misunderstood. Helen Keller is lauded for her supposed heroic ability to “overcome” her disability. This legacy of individual triumph over personal adversity is a historical travesty. Keller was an ardent socialist and a routinely generated controversy with statements such as the following: “I had once believed that we are all masters of our fate – that we could mold our lives into any form we pleased. . . .  But as I went more and more about the country I learned that I had spoken with assurance on a subject I knew little about. I forgot that I owed my success partly to the advantages of my birth and environment. Now, however, I learned that the power to rise in the world is not within the reach of everyone.”

Keller was spot on about the importance of power. The Verbessem brothers were disempowered. When the lack of power is coupled with a country that embraces assisted suicide and seeks to legislate euthanasia the consequences can be deadly. I am concerned that the Verbesssem brothers’ euthanasia is a harbinger of the future. However, I take comfort in the fact there are deaf-blind people who will not be silent. For instance Coco Roschaert, a blind-deaf writer, wrote that what “the Deafblind community of the world can do is rise up, unite, EDUCATE the world of our abilities, FIGHT for our right to a better quality of life, CHANGE laws, society rules and our mindset about how we should live. The world needs to stop pitying us, spoon feeding us, patting us on the head and whispering behind our backs that our live is destined to be a big nothing because of dear, we can’t hear or see.”

William J. Peace is an independent scholar. His research interests include disability rights, bioethics, body art and modification, and the history of anthropology. His blog is Bad Cripple.

We should all be concerned about obesity and its consequences for individual and public health.  No one opposes better education about nutrition or the availability of affordable and healthy food choices for all. There is a legitimate role for government and business in combatting this problem, and childhood is as good a place to start as any. But using social pressure to shame the obese is, well, shameful.

It is wrong to assume that all obese people are the same and that they are obese for the same reasons. It may well be that some are obese as a result of poor lifestyle choices, although even among those, one needs to be careful to assess how much choice actually exists. Poverty may make the choice of cheap carbohydrates a necessity if one is to avoid actual hunger. Beyond those whose obesity is the result of willful couch-potato behavior and sugary sodas (though one should ask whether it is really willful or is rather the result of some pathology), I am not sure what science knows about why people become and remain obese.

Perhaps I should be clearer. From personal experience, unless my health care providers are uneducated and in possession of fraudulent medical and related professional degrees, I can say that science knows very little. I have lived most of my life as a thin person, but after cancer treatment and menopause (more or less simultaneously), I found myself gaining weight. My body mass index hovers in the “overweight” range, but only a millimeter or two this side of “obese.” In the past 10 years, I have sought solutions to my weight gain from a family doctor, an internist, and three highly qualified nutritionists. I eat well and exercise. Apart from genetics, no one has a reason for my weight gain; no one has been successful in finding a diet or exercise program that has produced results. I know that there are others like me out there.

Shame will not help me, and it should not be used on me. Shaming presumes that all obese people are engaging in shameful behavior. It is impossible to judge from looking at a person why she is the size she is, or whether behavior that may cause weight gain is entirely within a person’s control.

Callahan falls back on his own experience as a former smoker, claiming that the “force of being shamed and beat upon socially” was instrumental in his breaking the habit, even more influential than threats to his health. And he was not alone. He credits the success of the antismoking campaign to its “turning what had been considered simply a bad habit into reprehensible behavior.” He acknowledges that blaming the victim has not been effective in other public health initiatives and that the antismoking campaign might have been an outlier in this regard.  But he then goes on to suggest kinds of social pressure that might be brought to bear on the obese – not outright discrimination, but what he calls “a kind of stigmatization lite.”

He is a little vague as to what forms that social pressure ought to take, but he believes that leaving individuals to address their problems on their own is insufficient. This is where the “edgier strategy” of social pressure comes in. Somewhat ambiguously, he writes that most people who are already overweight and obese “are already lost,” yet later he states that there may be some hope. Obese people who don’t realize that they are obese need a “shock of recognition” that comes from “a carefully calibrated effort of public social pressure.”

I suspect that Callahan might be correct in his assessment that stigmatization was an effective strategy to get some people to quit smoking. Putting aside for the moment the very real issue of addiction to tobacco and its curtailment of real choice, smoking is a behavior. As such, it can be identified and made the object of shame. Lung cancer and emphysema may be the result of smoking, but is there any among us who think shaming is appropriate for those who suffer from these, or any, diseases? In Callahan’s view, if shame is to be heaped, it might be reserved for the actual behavior of buying and drinking extra-large sodas or eating daily at fast food establishments, or engaging in perennial couch-sitting. Obesity, like lung cancer, is not a behavior, but rather, could be the result of certain behaviors. To simply point and shame a large person is to shame the result, not the behavior itself.

 But this may be a quibble that misses the larger point. Even if we wanted to stigmatize behavior, we the public are seldom in a position to judge someone else’s food habits as reprehensible; we simply do not know enough about an individual’s story: does he always get fries with that? Is this my first and only donut this year, or do I eat them by the dozen? Or, in my case, does my overweight condition persist not because of, but in spite of, my healthy behaviors?

“Stigmatization lite,” really? Full of ignorance and judgment, short on compassion, and probably on results.

Susan B. Apel is a professor at Vermont Law School and director of its General Practice Program. She is also an adjunct professor at the Geisel School of Medicine at Dartmouth.

The article’s focus on social pressure is extremely controversial, as responses from the media, readers, other bioethicists, other Hastings scholars, and the general public is making abundantly clear. (These blog posts at The Atlantic and The Huffington Post are representative.) Respondents have raised a number of objections to this part of Callahan’s argument: that it gets the facts about stigmatization wrong, that the analogy to smoking mischaracterizes what was effective about smoking prevention efforts, and that it is demeaning to people who are overweight (and already agonizing about it). In addition, some who have seen reports about the article are concerned that Callahan’s position may increase school bullying.

The article is actually one of several very controversial pieces that have appeared in the Report in recent years. Others include articles on the Western media coverage of female genital cutting and on physician involvement in executions and torture. And scores of articles, essays, and other commentary in the Report have staked out positions that, though less controversial than the positions above, are still deeply objectionable to at least some readers.

The editorial decision whether to publish these pieces is often difficult, even agonizing. Accepting an article for publication may look like accepting the article’s position, but in fact, the question we try to answer is not whether we agree with the piece. The Report and the Center exist to foster free debate on important and very difficult questions, and they therefore try to avoid taking positions themselves. Those of us who edit the Report sometimes agree with what eventually appears in the Report, and sometimes disagree. (And others at The Hastings Center may agree or disagree with the Report’s decisions about publication.)

Publishing an article certainly reflects a decision that the article makes a useful contribution of some sort to the societal discussions it addresses. What counts as a “useful contribution” is complicated, though. One great way of contributing usefully to a debate is to point out the right answer to it, but even a position that is roundly rejected may be said to move a debate forward—by effectively articulating a widely held position, for example, clarifying a distinction, or showing the implications of an analogy. A widely rejected piece can also be useful by stimulating insights from readers who might then become authors themselves.

Neither do we want to go to the other extreme, of course, and stir up controversy for controversy’s sake. It is ongoing productive exchange that we seek, not just authors with whom we agree and not just authors who will goad us or our readers.

In that spirit, we invite responses to Callahan’s article, both on Bioethics Forum and in the Hastings Center Report. The responses should be thoughtful, but they may certainly disagree with the positions Callahan tries to develop, and they may disagree very strongly. We cannot promise to publish everything sent us, but we are interested in seeing your views.  We aim to use this occasion to generate wide-ranging ideas about how best to address the obesity epidemic. Those interested in writing commentaries are encouraged to contact us at editorial@thehastingscenter.org.

Gregory E. Kaebnick is the editor of the Hastings Center Report and editorial director of The Hastings Center.

I would guess that most Americans, even Jewish-Americans, had never heard of metzitzah b’peh (oral suction) until the recent controversy between ultra-Orthodox Jews and the New York City Department of Health and Mental Hygiene.  It refers to a custom performed after a circumcision in which a mohel (ritual circumciser) orally sucks the blood away from the baby boy’s penis. To insure the requirement that blood be shed and then hygienically removed (sucking was deemed the best means of achieving this hygiene anciently), metzitzah b’peh became part of circumcisions in the 2nd century, according to scholars. Most Jews, even observant Modern Orthodox Jews, have abandoned the practice.  But a small minority adheres to and defends it, based on the First Amendment – somewhat surprisingly now on free speech grounds in addition to its religious liberty provisions.

An attorney representing adherents argued recently that requiring parental consent violates the mohels’ freedom of speech. By verbalizing the potential dangers involved with the procedure, the argument goes, mohels are being forced to say something they don’t believe.  To their mind, the procedure is safe. Such novel First Amendment arguments aside, to my mind, safety is not the only issue, and a new regulation mandating consent forms is an inadequate solution to the problem.  First Amendment rights (for religion or speech) do not provide carte blanche.  The state can legally intervene in the face of clear and present danger, especially to protect children, regardless of parental consent, and metzitzah b’peh merits such intervention.  Not only does it pose health risks but it defies broader community standards. There are some things that parents should not get to consent to on behalf of their children. 

The best response to this controversy would involve not parental but rabbinical consent –religious leaders themselves taking the lead in modifying this tradition. There are other, safer, and more sterile ways to see that blood has been drawn and to clean the circumcision wound. If like other religious minorities Orthodox Jewish Americans have rights, they also have responsibilities as citizens and members of a larger national community – obligations Jews recognize in Hebrew Scripture.  Reforming a tradition will be most successful if it comes from within the community. One physician from Borough Park, Brooklyn, who spoke to the Jewish Daily Forward last March on the condition of anonymity, makes such a suggestion, saying, “The best thing would be to focus on an intra-community education effort. I know there are Haredi [ultra-Orthodox] physicians trying to re-educate the public to make them more aware of the risk . . . . You need a critical mass of rabbis who will set off a chain reaction.”

Today the very thought of metzitzah b’peh conjures fears about the transmission of communicable disease, and indeed the procedure has been contested for quite some time in this country and in Europe too.  In 1873 four babies in New York City contracted what appeared to be syphilis, and three of them died. The same mohel had circumcised all four and had performed metzitzah b’peh.  Then, as now, the Board of Health got involved and requested an investigation, which was conducted by Dr. R.W. Taylor, surgeon to the New York Dispensary in the Department of Venereal and Skin Diseases. The question of whether the babies died from syphilis at all, much less syphilis caught from the mohel, could not be determined definitively. 

Taylor nonetheless connected these and potentially other tragic deaths with circumcision and oral suction. Just below the surface was a disparaging assessment of Jewish immigrants. He coupled oral suction and syphilis with the “lower classes of Jews.”

Many Jewish people, myself included, would like to see ultra-Orthodox religious leaders abandon the practice of oral suction. At the same time, we wish to protect the rights and freedoms of religious minorities, Jews and non-Jews alike, and we are concerned about how such communities are treated in public discussions. A report last month on NPR’s “All Things Considered” that examined the metzitzah b’peh controversy, for example, fell into a portrayal of religious Jews as ignorant and backward, evidenced by the transcription of the radio broadcast’s unfortunate attempt to render the mohel’s voice in a pidgin English.

A. Romi Cohn, a mohel from Borough Park, is quoted regarding the health department’s proposed requirement of parental consent for this risky procedure: “But we have a mayor; he's the mayor of the universe. We gonna follow his instructions.” And concerning the health and safety of the many babies he has circumcised, Cohn is quoted as saying, “If there's any slight possibility – I'm not saying 50 percent, even 1 percent – that that baby gonna get hurt, we not allowed to perform that circumcision.”  

Rendering speech in such jarring dialect – as African American critics have long noted – is often a tool of ridicule or derision. If listeners heard Cohn speak on the air, they could appreciate his accent but focus attention on his conviction that human life is a top priority; reading non-grammatical parlance, on the other hand, insinuates the prejudicial notion that Orthodox Jews are untrained, alien, and un-American, just as Dr. Taylor’s report for the New York Board of Health did 150 years ago.

Ultra-Orthodox Jews should live true to their word about protecting human lives and amend the practice, as other observant Jews have already done before them. They should respond to the risks of herpes and other communicable diseases, which the rite of metzitzah b’peh poses. And while adhering to the essence of their beliefs, they should adjust to the larger world they live in, respecting and supporting the society that supports their freedoms and way of life.

Elizabeth Reis, professor of women’s and gender studies at the University of Oregon, is the author of Bodies in Doubt: An American History of Intersex. She is a visiting scholar in the History of Science Department at Harvard University.

Yet one might ask whether in fact the charge that we are always too late is true? Sometimes no, and sometimes yes. Many problems of the “new biology,” as it was often called in the 1960s and 1970s, were foreseen well in advance of their technical achievements. The possibility of genetic engineering and prenatal genetic testing, for instance, was much discussed, long before they became clinical reality. The charge was often leveled, in fact, that alarmist speculation about some imaginable downside of the new biology–and anxious talk about a coming Brave New World– would endanger valuable research and should stop. My colleague Willard Gaylin was chastised by his dean at the Columbia University College of Physicians and Surgeons for an article he wrote for The New York Times Magazine about the possibility of reproductive cloning. Such talk would hurt the school’s ability to raise grant money, he was told.

Then there was the case of recombinant DNA research in the mid-1970’s. Some bioethicists and scientists saw potential dangers, broadcast their possibility, and helped establish a short (and voluntary) moratorium on the research. No hazards ever emerged and some scientists, later led by James D. Watson, argued that it was a fatal mistake for scientists to make their worries public. What they will get is an uninformed, irrational public.

Yet there are other examples of public worries about biological developments that led scientists to carry out their research in secret to avoid public and legislative scrutiny. The death last year of Lesley Brown, mother of the first IVF child, born on July 25, 1978, was a reminder of that tactic. The researchers, Patrick Steptoe and Robert Edwards, had begun their research in the 1960s and immediately came under attack on scientific and ethical grounds. They decided simply to avoid that fuss by going underground, neither talking about nor publishing on their work. The world learned nothing about the failures they may have encountered along the way, nor did it care about them in the wake of the success of the procedure, now commonplace.

In that vein, I am reminded of a comment by Robert Oppenheimer in the aftermath of the development of the atom bomb: “When you see something that is technically sweet, you go ahead and do it, and you argue about it only after you had your technical success. That is the way it was with the atom bomb.” Of course there have been ethical arguments ever after about whether the development of the bomb was ethical and now, interestingly, there have recently been some relatively low-key contentions that second thoughts may be in order on IVF, with clear harms to some mothers and their children from the procedure. But just as arguments against nuclear weapons have not much changed the course of human history, it is equally unlikely that faith in the value of IVF will soon be diminished.

Ethical catch up, it turns out, does not do much good when some research meets with public approval, ethical warts and all. And anxious ethical foresight is not necessarily any more effective when it leads savvy researchers to keep to themselves, even when worried, their own failures and misgivings, hoping to be saved in the end by the kind of home-run success of the nuclear scientists working on the Manhattan project and Edwards and Steptoe making IVF possible.

If correct, that perception may not be altogether helpful for us in ethics. We can do some clean- up work, but we are at the mercy of the consciences of the researchers. We can only hope that, if real dangers turn up–for instance, with synthetic biology research–the scientists will be the first to tell us, and maybe invoke just the kinds of public worries their colleagues will not want. That will take some courage as well as some willingness to entertain the possibility–despite the “sweetness” of the research—that all might not turn out well. As with most other spheres of life, it is positive, upbeat thinking that is welcomed and gets the grants. The Grinch who steals science is no more favored than the one that tried to steal Christmas.

Daniel Callahan, cofounder and President Emeritus of The Hastings Center, is the author most recently of a memoir, In Search of the Good: A Life in Bioethics, and The Roots of Bioethics: Health, Progress, Technology, Death.

“I would be happy to meet with you in person to talk about him,” I somehow managed to stumble out.  “But I don’t feel comfortable saying anything over the phone.” I figured that delaying her in this way would buy me time to speak to her son and senior doctors about what to do.

In some ways, it is hard now, when all of us routinely sign privacy forms when visiting the doctor, to imagine that time.  It seems another era.

On occasion, fellow physicians also used to mention celebrity patients they or others had treated.  I confess I found myself interested to hear about movie stars who had psychiatric problems.  I heard how one famous TV star would hide under his hospital bed. I was shocked.  But these divulgences also made me a bit uncomfortable, like I was looking at someone’s dirty laundry. I was.

Luckily, things have changed in many ways.

But the tragic death earlier this month of Jacintha Saldanha, the British nurse who believed that two journalists calling about Kate Middleton, the Duchess of Cambridge, were Queen Elizabeth and Prince Charles, and who then committed suicide, reminded me of these issues.  

Reportedly, she had taken the call, and passed it onto another nurse, who provided information.

We in the U.S. might dismiss the incident as something that happened in another country, and thus doesn’t concern us. We are fortunate here to have HIPAA.

But I think some problems remain.

The call for medical confidentiality dates back to at least Hippocrates, who wrote,“What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account one must spread abroad, I will keep to myself.”

Yet medical staff have continued to speak about patients when they shouldn’t. In one 1995 study, researchers found that on 259 one-way hospital-elevator rides, they overheard 39 inappropriate comments on 36 rides (13.9 percent). Of the comments – by doctors as well as nurses – half were violations of patients’ confidentiality. The other half included staff complaining about their jobs, other employees, and patients. In an emergency room, a 1997 study in Academic Emergency Medicine reported that breaches of confidentiality occurred for more than 53 percent of patients.  “Mr. ‘Y’ is a pain in the ass,” one health care provider was overheard saying.

Hopefully, HIPAA has reduced these violations.

But in 2008, UCLA found that dozens of hospital staff had peeked into the medical records of celebrity patients, including Maria Shriver, Farah Fawcett, and Britney Spears, when these employees were not involved in these patients’ care. Such violations have occurred at other institutions as well.

The rise of electronic medical records, and transmission of information through email and the Internet makes it easier in some ways to access information about patients.  

Several major institutions have thus wisely set up “firewalls” when VIPs are admitted – choosing “code names” for them that only staff immediately involved in the patient’s care are told. Staff who type a VIP’s real name into the hospital’s computer system, seeking information, when they are not involved in the patient’s treatment, have been reprimanded or suspended.

These breaches are part of a larger problem -- VIP syndrome -- a major ailment in hospitals. Celebrities often get worse care because staff bend over backwards to provide extra attention, and lose objectivity, and the media seek and publicize information.

The spread of genetic information further raises these concerns. Increasingly, patients’ full DNA is being sequenced, revealing mutations for a wide variety of diseases. Subtle health discrimination persists. At times, people have told me that they have revealed genetic and other health information -- to “work friends”, co-workers, bosses, and others -- and that they were later “passed over” for promotion (not fired, but not advanced).  Companies selling life, disability, and long term care insurance can also legally seek this information and use it to determine eligibility for coverage.

Facebook users – especially young ones – routinely post potentially compromising photos and information about themselves that employers and others at times seek. I have at times Googled people I have thought of hiring. These users often haven’t thought about the future harms that might ensue.

Ms. Saldanha’s death makes me think about things I have seen and done.

With the rise of electronic medical records, threats to privacy may be mounting. I have seen how health information, once divulged, cannot be
undisclosed, and takes on a life of its own. Tabloid journalists seek it, and health care employees may share it when they shouldn’t.

Patients and health care providers may send health information via email, which can be hacked. (Cyber vandals have, after all, entered even corporate and government Web sites.)

Most importantly, as health care providers, patients and family members, I think of what we can each do – how tempting it is to hear about and spread information, and how much we need to resist that.

We are not all royalty, but we do deserve medical privacy. I have seen both sides, and continue to realize how much more careful we need to be.

Robert Klitzman, M.D., is a professor of clinical psychiatry and director of the Masters of Bioethics Program at Columbia University. He is the author of Am I My Genes? Confronting Fate & Family Secrets in the Age of Genetic Testing.

I ran my gloved hands along his skin and realized, to my own surprise, that I wasn’t going to faint, or throw up, or cry. Instead, my classmates and I used a brown Crayola marker to draw an incision line down his spine. With this elementary line as our guide, we cut through the skin of his back and separated it from the underlying muscles. The more I could see of the muscles, arteries, and bones, the more fascinated I became.

On that first day, the questions that had occupied my mind all summer – Is it possible to harm someone who has died? What relationship does a lifeless body have to the person who inhabited it? – were distant thoughts. What I hadn’t anticipated was that, for better or worse, changing into scrubs, holding a scalpel for the first time, and using an entirely new vocabulary for the body parts I’ve known my whole life would simultaneously distance me from the human significance of anatomical dissection and pull me closer into the culture of medicine.

But those earlier questions were really just below the surface. During our second day in the anatomy lab, we were to study the arms.To ease our task, we needed to rotate the man’s arm. There was no way to do this but by clasping his hand and turning it. Because I happened to be standing alongside his hand, this task became mine. Clasping his hand felt eerily similar to holding the hand of a loved one. But it was unmistakably lifeless.

Though my mind was supposed to be focused on identifying the biceps brachii and cephalic vein, I could not stop thinking about his hand. I imagined a loved one holding it as he lay in the hospital before his death. I imagined him throwing a small grandchild up in the air and catching her in heaps of laughter. I wondered if he had played golf or the piano, or if he liked to cook.

While these may seem like pleasant thoughts, the juxtaposition of the image of a man full of life with the reality that I was dissecting his dead body brought me to a halt. I could hardly reach the end of our session without falling apart. Some of my classmates have told me this is why they don't let themselves have these thoughts at all. 

That night I dreamt that I was having dinner with a good friend. After we ate, we walked around the streets of our neighborhood, which happened to be filled with strung lights, live music, and laughing children. As I was recounting the dream to myself I realized that there was one odd detail: my friend had been missing her hand. My mind immediately flashed to the image of the cadaver’s hand.  Just as I had wondered what he had done with his hands in his life, while in my sleep I had seen my friend without her hand and wondered how she would lift her daughter, touch her husband, or simply peel an orange.

As I was getting ready for school the next morning, I felt haunted by what we were doing, seeing, touching. I didn't know how I could possibly go back to the lab, how I could cut into the man's body again. But somehow, I did.  Somehow, in the days that followed, when I held the man’s heart in my hands, the sense of awe and excitement I felt on that first day returned.

Anatomical dissection is not intended to promote empathy. We are not required to talk about how we feel afterward. This is our first experience when we must focus strictly on the task in front of us while with a “patient.” We have a schedule to stay on and structures to find. Expose the brachial plexus. Saw through the clavicle.

Before beginning medical school, I thought that the proximity to death in the anatomy lab would paralyze me. I was scared, and continue to be scared, of the suffering and tragedy that we will see in the hospital. But the anatomy lab has given me something else to be wary of: how quickly something that was once emotionally wrenching and deeply disturbing can become so normal.

During our first days of school, our faculty told us that we would need to learn appropriate detachment. If we get too wrapped up in our patients’ lives, we won't be as good doctors, nor will we be able to function personally. We wouldn't be able to learn what we need to learn in the anatomy lab if we were constantly considering the moral and human questions anatomical dissection raises. However, as we detach ourselves from those questions we risk neglecting them altogether.

A few weeks after I had been so affected by holding the cadaver’s hand, a classmate told me that he found the anatomy course to be dehumanizing at times. This casual comment struck me because, though I had had that same feeling previously, in just a few weeks time that thought had become distant. I realized how easy it was for me to become more detached than I wanted to be.

Though I will probably never dissect a human cadaver again, the lessons I take from the experience will likely come to bear in the clinic time and again. Just as with anatomical dissection, the sickness and suffering that inhabit any hospital may at first give me nightmares, but then someday seem normal. And yet in completely detaching ourselves from our patients we risk treating them as mere bodies rather than whole people and losing the parts of ourselves that made us want to be doctors in the first place. Therefore, we must search for ways to reinforce our human and moral engagement with our work. While we knew just where to look to find the brachial plexus, this search will likely be more meandering and more surprising, but certainly no less important.

Colleen Farrell is a first-year medical student at Harvard and a former research assistant at The Hastings Center.

Illness, one’s own or that of a loved one, may leave individuals vulnerable, not only physically and emotionally but decisionally, as well, particularly when it comes to fundraising efforts and solicitations specifically aimed at those affected by an illness. Taking part in or pledging money for a breast cancer walk, with proceeds going to the American Cancer Society, may be thought of as an eminently benevolent manifestation of such an inclination, the desire to contribute time, effort, and money to support research and clinical care for a disease that has hit too close to home.

Contrast the altruism of that sunny October morning with news stories, published only weeks earlier, of deception in fundraising for medical charities, most notably the in-depth, investigative reporting posted on Bloomberg in September. The exceptionally well-researched exposé by David Evans reveals a troubling scene as prominent medical charities contract with telemarketing firms for fundraising (this article focused on telemarketer InfoCision), with the latter keeping most and in some cases – astonishingly – all of the money collected.  

While it is important to note that the Bloomberg piece did not address fundraising walks, it did report the following:

“The American Cancer Society, the largest health charity in the U.S., enlisted InfoCision from 1999 to 2011 to raise money. In fiscal 2010, InfoCision gathered $5.3 million for the society. Hundreds of thousands of volunteers took part, but none of that money – not one penny – went to fund cancer research or help patients, according to the society’s filing with the U.S. Internal Revenue Service and the state of Maine. . . .  Every bit of it went to InfoCision, the filings say. The society actually lost money on the program that year, according to its filings. InfoCision got to keep 100 percent of the funds it raised, plus $113,006 in fees from the society, government filings show.”  

As television screens across the tri-state area beamed an uplifting story of collective altruism, the glow may have been dimmed, for some viewers, by nagging concerns about financial stewardship. The reporting by David Evans highlighted a number of unsettling issues. First, the vulnerability on the part of patients and families to give, coupled with telemarketing industry practices crafted to prey on that inclination. Second, the lack of transparency and disclosure endemic to these practices, including but not limited to telephone scripts that claim falsely inflated shares of the money collected will go to the charity when contracts actually specify, and filings later prove, otherwise. Then there is the scope, the extent to which an array of prominent medical charities, including an organization as renowned and respected as the American Cancer Society, would become ensnared by these practices.  Finally, returning to the perspective of patients and families, there are the feelings of injustice and betrayal, the usurping of voluntariness, and the erosion of trust when the deception is, at long last, unveiled. 

Given its place on the periphery, this topic, understandably, has garnered relatively scant attention within the bioethics community.  Perhaps our interest is further constrained by our perceived inability to change the situation, with interim answers seemingly confined to tired calls for awareness and education. Someday, perhaps, strict limits will be placed on these practices, through regulatory or statutory law or through the courts.  (Notably, a seminal 1999 Federal Court of Appeals case, United Cancer Council v. Commissioner of Internal Revenue Service 165 F.3d 1173 (7^th Cir. 1999), considered, without resolving, the question of whether a contract between a charity and a for-profit fundraiser may be so disproportionately advantageous to the latter that it jeopardizes the charity's tax exempt status. The appellate court remanded the case to the tax court for further proceedings, but the case settled, leaving open the question of upper limits and formulas to govern these fundraising arrangements.)

 Until such time as limits are set, we may be left with little more than a nominal giver beware.  Yet for those of us engaged in the nonprofit community, serving on boards, or as administrators, or even as volunteers, there may be an opportunity to do more, to be a voice against deceptive practices, no matter the rationale, and steadfastly for disclosure, transparency and patient protection in all forms. 

While this issue may, at first glance, seem to be a matter for those in nonprofit management or tax law, protection of patients and caregivers runs to the heart of bioethics.  As these deceptive practices infiltrate health charities, as commercial telemarketers prey on the vulnerabilities of patients and families to donate for a disease, with small-to-negligible fractions of the funds collected actually being spent on research or clinical care, we are confronted with the subversion of well-intentioned altruism, the manipulation of decisional vulnerabilities, and the insidious compromise of respect for persons and justice.

Ready or not, this is our issue too.

Meredith Stark, Ph.D., .M.S., is a faculty member in the Division of Medical Ethics at Weill Cornell Medical College in New York.  Joseph J. Fins, M.D., M.A.C.P., is Chief of the Division of Medical Ethics at Weill Cornell, the E. William Davis Jr. Professor of Medical Ethics, a Hastings Center Board Member and Fellow, and chairman of the Fellows Council. The views expressed here are solely those of the authors and not of any affiliated institution.

Evidence: Making environmentally friendly changes can save hospitals a lot of money – and save the U.S. health care system billions of dollars.

That is the finding of a study published by the Commonwealth Fund last month, “Can Sustainable Hospitals Help Bend the Health Care Cost Curve.” A Commonwealth Fund webinar held yesterday drew on the study’s findings.

Health care facilities generate a large share of the country’s waste and pollution. They create 6,600 tons of waste per day and an estimated 8 percent of all U.S. greenhouse gas emissions and 7 percent of total carbon dioxide emissions. If all U.S. hospitals adopted measures such as improving fuel efficiency from heating and cooling systems and recycling or reusing some supplies in operating rooms, the study estimated that the total savings could exceed $5.4 billion over five years and $15 billion over 10 years.

The estimates were based on data from hospitals that have reduced their environmental footprint over the past five years by reducing their energy use, reducing waste, and making more efficient use of operating room supplies (reprocessing and reusing single-use medical devices and not throwing away unused items from prepackaged supplies formulated for specific surgical procedures). The researchers then extrapolated their findings to all U.S. hospitals based on existing institutional data to estimate the potential for hospital cost savings nationwide.

“Many of the interventions studied did not involve any additional identifiable costs and realized immediate savings,” write the authors. “Given the small costs and the positive return on investment within a short time frame for the sustainability activities studied – as well as their broader environmental and public health benefits – we recommend these innovations for all hospitals.”

The authors also suggest that public funds be allocated to help safety-net hospitals that cannot afford to the costs. “For cash-strapped safety-net hospitals, where even small capital investments are a stress, these interventions can be within reach with the use of federal and state funds to support the cost-saving changes,” they write. 

The authors include Susan Kaplan, research assistant professor of the School of Public Health of the University of Illinois Chicago, and Blair Sadler, a senior fellow at the Institute for Healthcare Improvement and a fellow and board member of The Hastings Center.

Accompanying the study are two posts for The Commonwealth Fund Blog written by CEOs of health care systems that had reduced their environmental footprint and costs. George C. Halvorson, chairman and CEO of Kaiser Permanente, which owns and operates 37 hospitals and more than 600 medical centers, writes that Kaiser has saved “tens of millions of dollars over the past few years in the three areas highlighted in the report: energy efficiency, waste minimization, and reprocessing.” Kaiser also aims to divert 40 percent of its waste from landfills by 2015.

Jeffrey Thompson, CEO of Gundersen Health System, based in La Crosse, Wis., discusses the results of a sustainability program launched in 2008. “At the time, our energy costs were rising at an alarming $300,000 a year,” he writes. “Those costs were being passed along to patients in the form of higher health care costs. That wasn’t OK with our board or, most importantly, with our patients.” An energy audit revealed “dozens of energy-saving opportunities.” They involved a $2 million investment, but have yielded more than $1.2 million in savings each year from lower energy costs.  Additional savings come from sterilizing and reusing or recycling 95 percent of single-use surgical items in the OR (rather than throwing them away) and from recycling other materials.

The benefits of reducing energy and waste extend beyond saving money. The authors of the Commonwealth study state that these measures may also save lives by reducing the incidence of cancer, liver and kidney disease, and reproductive problems linked to environmental pollutants.

The Commonwealth study was small, and therefore not definitive. The authors call for more research to delineate the savings and other benefits. But with luck it will start a very positive conversation. At a time of bitter disagreement over the sacrifices that will need to be made to avoid the “fiscal cliff,” who can argue with the prospect of cutting health care costs and keeping people healthier by going greener?

Susan Gilbert is the public affairs and communications manager of The Hastings Center and editor of Bioethics Forum.

But what does this mean for the field of bioethics?  The BP oil spill raises issues that fall squarely within the field’s domain, including public health and the ethical use of technology. 

The explosion was a result of BP’s insufficient controls on high-tech equipment that dropped five miles before piercing the earth to gulp petroleum from beneath the sea-floor. Without doubt, the Gulf of Mexico’s ecology will be permanently impacted by the 35,000 to 65,000 barrels of oil per day that leaked from a sea-floor oil gusher for 56 days, triggered by the explosion. 

Along with the environmental damage, the BP oil spill created a multiplicity of public health concerns.  Crude oil contains a mixture of carcinogens such as volatile hydrocarbon compounds. Before allowing volunteers to venture near the oil spill, BP required participants to sign a waiver of liability, which stated that exposure may lead to numerous, and potentially fatal, health risks.  According to Marylee Orr, Executive Director for Louisiana Environmental Action Network (LEAN), those exposed to the oil experienced dizziness, headaches, nausea, and rapid heart beat. Other effects to exposed individuals, who include but are not limited to fishermen and clean-up volunteers, continue to be explored.  For example, PAHs have been proven to cause tumors in laboratory animals that have inhaled the fumes from these substances.  However, at the time of the spill, local public health officials determined that respirators were not required for oil clean-up crews. 

The ethical questions surrounding the public health implications of the BP spill are numerous.  What was the ethical obligation to ensure the health and safety of those who were exposed to the oil?  Was there a unique obligation to offer them access to any kind of specialized medical care?  If so, on whom does the responsibility fall – the government, insurance companies, BP, or some combination thereof?  Furthermore, similar to informed consent questions encountered in other settings, one might consider whether the waiver of liability that BP provided adequately informed individuals of the health risks, alternatives, and consequences of participation.  Were the circumstances under which people signed the forms free of coercion or conflicts of interest?

The use of advanced technology that serves to alter the natural world also raises significant concerns.  The BP spill is not the only disaster caused by the use of advanced technology, and it will probably not be the last one.  As history has progressed, so have human technologies to alter the natural order in ways that were previously unimaginable.  And thus, traditional ethical questions arise – how should humanity utilize technology in a way that protects human values, but does not hinder scientific advancement?  This debate is as relevant to embryonic stem cell research as it is to the creation of drills with the ability to stretch for miles in search of petroleum and other natural resources. 

Many companies rely on developing technology for large oil companies in order to secure a financial profit, and many companies specialize in manufacturing technologies that impact the environment, and as a result, public health. What are the ethical considerations that must be addressed when, or before, creating this kind of nature-altering technology?  The interdisciplinary expertise that already lies within the bioethics community can greatly help to inform the framework for ethical concerns raised by the BP spill.  For example, the spill raises broad philosophical questions, such as: What sort of moral values guide the human relationship with nature?  Are there obligations to protect nature?  If so, what are they?  International and cross-cultural observations regarding approaches to the environment may lead to a better understanding of the ethical considerations across countries and cultures.

As the global demand to harness the environment’s energy to power modern life is increasing, the ethical debates that surround the BP experience are vast.  

Samer B. Korkor is a lawyer in Washington, D.C. 

Reports from Presidential bioethics commissions, like most government reports, usually have a short shelf life.  But perhaps because it was the subject of extensive media commentary, “Ethically Impossible” had a chance of surviving the usual fate of instant obscurity.  It prolonged discussion and debate over an infamous example of research malfeasance by a government agency that was hidden from view for almost 65 years. The report itself spanned 200 pages, with more than 700 citations to the records of Dr. Cutler and thousands of other documents. Like similar reports, the published version was only the tip of the investigative iceberg. Both the report text and its notes represented untold hours of digging through archives and published materials by Commission staff members and similarly extensive deliberations by the Commission Members themselves.  The report contained appendices that summarized much of this effort, but for obvious practical reasons, making all of it accessible in a printed document was impossible.  

But in this age of digital document storage, another option appeared, and three other online electronic sources now exist to extend the reach of “Ethically Impossible.” All are available at bioethics.gov.  First, the report itself is online in PDF form, both in English and Spanish.  Second, the Commission has just released and posted  A Study Guide to “Ethically Impossible.” It is free and available for immediate use in classrooms and elsewhere. The Study Guide is designed to be accessible to university students, professionals of all types, and members of the public who are interested in developing a more thorough understanding of the historical and ethical issues that arose in investigating the PHS studies. The guide raises questions that refer to particular events described within “Ethically Impossible” or the documents it references.  Each section in the guide is followed by a bibliography directing the reader to sources for further study.

In addition, each publically available document (from government archives, publications and reports) is connected to the online report via hyperlink.  If a contemporaneous letter from Dr. Cutler to a colleague discussing concerns related to the ongoing STD studies was cited, a virtual copy of that letter is linked to the source note. If Cutler mentioned a specific procedure or study location in his laboratory record, the actual pages containing his comments are linked to the notes. By clicking on the link, any reader can review the same documentation that the Commission used in compiling an historical summary of events in Guatemala and in performing an ethical analysis of their significance.

A Subject Data Spreadsheet is the third online resource connected to the Commission report.  Commission staff developed it to collect information on each person who became a research subject in Guatemala, and track the specific studies in which they participated.  It includes a detailed compilation of all the research subject information in the Cutler files and identifies the subject populations and the procedures researchers performed on them. The online spreadsheet (absent research subject names) presents data from 7,000 subject note cards and a variety of research notebooks and reports that describe the STD research in minute detail. 

The PHS/ Guatemala case is already being mentioned alongside Tuskegee, Willowbrook and the Chronic Diseases Hospital Case as an incident in the history of U.S. bioethics worth exploring more fully in courses on research ethics. In 2013 I will be teaching a seminar on the Guatemala STD research to a class that will consist of law students and public health graduate students. The Commission report will be the focal point of the course, since it provides a roadmap to many of the materials that describe the context in which the studies began.  Those materials will be available to students online at no cost, and should provide an instant frame of reference for class discussions and a rich source of topics for student papers. 

Students who use “Ethically Impossible” and the related online resources will have the opportunity to view, within a more complete context, how the Guatemala research was planned and how it took place.  They will be able to assess internal agency debates about its scientific validity and its political sensitivity for themselves. They will also be able to experience the difficult questions that arise when it is necessary to make moral assessments about events in the distant past. 

This depth of background has not been easily available for students who examine most other incidents in the history of bioethics.    These new tools for studying the PHS/Guatemala studies fit the digital age we work in.  These efforts demonstrate the Presidential Commission’s commitment to transparency. It keeps the sources used in this historical investigation durable and more accessible to students, educators, and the public.

Paul A. Lombardo, Ph.D., J.D. is the Bobby Lee Cook Professor of Law at Georgia State University in Atlanta and a Senior Advisor to the Presidential Commission for the Study of Bioethical Issues. This post originally appeared on the Presidential Commission’s blog.

Costs and responsibilities shift from the health sector to institutions neither designed nor equipped to treat patients with behavioral health and addiction illnesses, according to a recent post in the blog for the Vera Institute of Justice.

“Police, indigent defense systems, the judiciary, correction facilities, and parole officers have become de facto mental health service providers,” writes David Cloud, program associate for Vera’s Substance Use and Mental health Program. “When people with chronic behavioral health needs lack access to care in the community, they are more likely to end up in hospital emergency rooms, police cars, jails, or prison. This reality is behind the gloomy fact that Rikers Island in New York City and the Los Angeles County Jail house more people with mental illness than any hospitals.”

All this is another way of saying that the quality of care for people with mental illness and substance abuse problems deteriorates.  

The Affordable Care Act offers some hope. Through Medicaid expansion and other means, it can enable state and local governments to strengthen community health services for a substantial portion of the population – uninsured childless adults – who now only receive care in emergency rooms or jails. “The bottom line is that cuts for community mental health budgets mean rising costs elsewhere,” Cloud writes. “Governments should remain aware of the clear difference between cutting and shifting costs, especially when the latter can be more expensive in both dollars and quality of life.” Read the full post here.

Susan Gilbert is The Hastings Center’s public affairs and communications manager.