Dilemmas

1. Is it ethical to help a patient against his will or when he doesn't know or understand his situation?
   
2. Human subjects research: when is use of a placebo ethical?
   
3. When is extraordinary lifesaving care appropriate?
   
4. Is it ethical to continue life support in brain-dead patients so others may live?

Sidebar:
At Yale, a growing focus on bioethics

What do you think?
The responses provided here by Yale faculty members address four problems that troubled readers of Yale Medicine because a proper course of action was not easily decided. What would you have done, faced with the same dilemmas? Send your thoughts to Letters, Yale Medicine, P.O. Box 7612, New Haven, CT 06519-0612, or via e-mail to ymm@yale.edu.

Two alternatives, each a little wrong

With that definition of a dilemma in mind, Yale’s cadre of bioethicists wade into our mailbag and weigh in on readers’ questions from the front lines of medicine.

By Marc Wortman
Illustrations by Serge Bloch

In the 1980s, neurosurgeon Dennis D. Spencer, M.D., HS ’77, was a leader in an investigational effort at Yale to transplant fetal cell tissue in the brains of Parkinson’s disease patients. Animal studies had shown that implanting the cells might reverse the tremors and other neurological problems caused by the disease. His research team applied for a grant from the National Institutes of Health (NIH) to carry out some of the first studies in humans. Unlike other teams applying for the grants, Spencer’s group refused to include placebo surgery as part of their study. The sham surgery would have required him to carry out all the steps of the transplant surgery—drilling a hole through a patient’s skull and inserting a needle into the hole—but without delivering any fetal cells. “My reading of the literature,” he now says, “showed that any placebo effect from surgery would have been short-lived. We believed that over time you could clearly judge the efficacy of the procedure without subjecting patients to an unnecessary risk. We felt to do so would be unethical.” NIH insisted on the placebo surgery. “We didn’t get funded.”

For Spencer, who is now interim dean of the School of Medicine, that experience marked the beginning of his need to study bioethics in a more focused way. “I started reading the literature on the ethics of using surgery as placebo. I read what happened in the past and that helped crystallize the issue for me.” He and his colleagues began a series of debates on the subject at NIH and neurosurgical society meetings. “For scientists, study controls and placebos are important, but you need to consider the ethical issues.” While no formal policy on placebo surgery resulted, “We got people to think about it.”

The need to think about, explore and, when possible, resolve such complex issues has increased at Yale and elsewhere as medicine has become more complex. Spencer is one of many Yale physicians who regularly encounter ethical challenges in their work. They have a number of resources available to advise them when necessary. The Yale-New Haven Hospital Bioethics Committee—a panel of physicians, nurses, lawyers, social workers, clergy, ethicists and community members—reviews dilemmas, sets guidelines for care and also looks into issues about the quality of hospital services and physician conduct. “As professionals,” says Thomas P. Duffy, M.D., professor of medicine and a founding member of the Bioethics Committee, “we have an obligation to monitor how all of us are performing as physicians. The actions of one reflect on all of us.”

When urgent bioethical dilemmas requiring swift, high-level decision making arise, physicians can turn to the hospital’s chief of staff, Peter N. Herbert, M.D. ’67, HS ’69, and attorneys for final arbitration. Any Yale investigator seeking to carry out experiments involving human subjects must file an application with one of four university institutional review boards that oversee the studies, based on federal guidelines. A variety of other departmental committees and individual experts are also available to help resolve disputes when they occur. “Ethics,” says Robert J. Levine, M.D., HS ’63, professor of medicine and a co-founder of the hospital ethics committee, “is civilized society’s alternative to violence in dispute resolution.”

Levine is co-chair of Yale’s Interdisciplinary Bioethics Project and director of the Donaghue Initiative in Biomedical and Behavioral Research Ethics at Yale. He points to the Greek origins of medical ethics as what he terms “a field for developing standards for behavior that is praiseworthy or blameworthy.” However, he also defines an ethical dilemma as one in which there are “two alternative courses of action, each of which is a little wrong.”

Disputes arise because opposing responses are possible. Nonetheless, dilemmas require resolution if the needs of individuals and society are to be met. Last autumn, Yale Medicine invited its readers to submit biomedical dilemmas they have encountered in the course of their work, and many of you responded with issues where a proper course of action was not necessarily obvious. Issues ranged from a family that insisted for religious reasons that a loved one who was suffering not receive pain medication to concerns about the professionalism of colleagues.

Working with Levine, Contributing Editor Marc Wortman and the editors of Yale Medicine selected four provocative and difficult-to-resolve dilemmas. Individual faculty members with relevant expertise were invited to reflect on one of the dilemmas and to present their views of the logic of a resolution. The dilemmas are presented anonymously but are based on real situations described by readers from around the country. YM

Marc Wortman is a contributing editor of Yale Medicine.

Dilemma 1

Is it ethical to help a patient against his will or when he doesn't know or understand his situation?

A young man with schizophrenia and a history of non-compliance with treatment was admitted to my outpatient practice in a severely psychotic condition. He was completely lacking insight into his condition, and all approaches to gain compliance—most importantly, taking medications that could reduce his psychotic state—failed. His mother convinced me to prescribe medication, which she secretly placed in the patient’s food for nearly two years. I saw the patient for medication checks regularly, but he was unaware of his “compliance” throughout this time. This strategy resulted in slow, steady and quite remarkable improvement in all areas of functioning. The only untoward event, if you will, was the patient’s return to a pattern of partial compliance and eventual return of some symptoms several weeks after I chose to tell him the entire story. I had simply grown too uncomfortable with the situation, realized that this could not go on forever, and hoped that his clinical improvement just might allow him to embrace a proven, efficacious treatment (which was the ultimate plan discussed with his mother prior to embarking on treatment). Despite some decline in his condition and only partial compliance, the patient continues today improved from admission and much more amenable to inducements to adhere to his regimen. I believe I have given this individual a fighting chance where there was none—yet I have been acutely aware of the ethical dilemmas in his treatment along the way. Was I right to pursue this course?

“A person with schizophrenia, such as this patient during psychotic exacerbations, may not be capable of making a variety of decisions and may require guardians to look after their interests. Guardians, however, may not force medications on outpatients in Connecticut,” says Howard V. Zonana, M.D., professor of psychiatry and head of that department’s forensic psychiatry residency program. “Patients frequently don’t like to take medications. They have some unpleasant side effects. As part of their illness, some patients don’t believe they’re sick.” Zonana chaired the YNHH Bioethics Committee from its inception in 1985 until 1999.

He notes that psychiatrists are not alone among health care providers in receiving requests from one family member that they deceive another about care being given. For instance, physicians in family practice may encounter patients with sexually transmitted diseases who request that the doctor treat their spouses surreptitiously because they are afraid of threatening their marital situation. To hide information from one patient for the sake of another, he says, “is putting the needs and beliefs of the person who wants to keep the secret first and is conspiring in a deception. The doctor who does so is making complicated value judgments and is being co-opted. Sometimes, as in a case like this, it may work out, but there are many more times when it won’t, and the price for a betrayal of trust is very high, threatening both the present and future physician-patient relationships.”

Zonana, medical director for the American Academy of Psychiatry and the Law, helped to write the state of Connecticut’s civil commitment statutes. Psychiatrists, he points out, operate under extensive legal regulation because they have powers akin to those of the police to detain a mentally ill person involuntarily. He says, “There are many chronic schizophrenics on the street, and we don’t go around surreptitiously injecting them with syringes of medications. There’s always a balance between individual autonomy and social needs and health. If somebody becomes gravely disabled or dangerous, the person loses some autonomy. There is always a dilemma about what values the individual and a community hold more primary. In this case, I don’t see the clinical situation compelling enough to justify this deception.” He contends that there are other ways to help someone gain insight into his or her condition. “The doctor’s intent was clearly humane, but I think in the long run honesty trumps health outcomes. I would not have been willing to do this.”

Dilemma 2

Human subjects research: when is use of a placebo ethical?

There are several standard drug therapies that can help prevent vertebral fractures in some women with osteoporosis, a potentially serious problem associated with a condition common among aging women. A pharmaceutical company asked me to design and direct a study of a new medication that shows promise of preventing fractures in many more women. I designed the study to compare the new drug with placebo, in which neither the clinician nor the patient would know whether she was receiving the drug or a pill having no effect. Based on statistical analysis, the proposed trial could not show the new drug’s effectiveness until the number of new fractures in the placebo group exceeded by 150 the number in the group receiving the new drug.

Our hospital’s institutional review board, or IRB, rejected the study, claiming it would be unethical to treat patients with a placebo when there are standard therapies that are known to be at least partially effective. The review board suggested that, instead of placebo, we give the control group one of the standard therapies. I disagreed because most women who have osteoporosis do not receive such treatment, particularly when they have no symptoms. (The women to be recruited for this study will have no symptoms of osteoporosis.) Furthermore, most vertebral fractures complicating osteoporosis have no symptoms, and the women who have such fractures often don’t even know it; it’s not as if they have serious pain or disability. Moreover, it will still be necessary to continue the trial until the number of new fractures in the control group exceeds by 150 the number in the group receiving the new drug. The same number of women will experience this injury; it will just take a lot longer to reach that number. In other words, there would be a substantial loss in efficiency of the trial with no compensating benefit. Was the review board’s action right in this case?

As chair of the Human Investigation Committee at the School of Medicine for 30 years until 2000, Professor of Medicine Robert J. Levine, M.D., HS ’63, was called upon to review hundreds of applications for testing new therapies. He is the author of the widely used book Ethics and Regulation of Clinical Research and founding editor of the journal IRB: A Review of Human Subjects Research. He agrees with the review board’s decision. “When a therapy known to be effective already exists, even if only partially beneficial, and withholding the effective standard may result in serious complications, it is unethical to use placebo.”

Levine suggests that the physician consider an alternative study using what he terms an “add-on” design for the trial. This is possible when a new drug acts by a different mechanism than the standard drugs currently used in medical practice. In osteoporosis, one of the standard therapies, a combination of vitamin D and calcium, is partially effective in the prevention of new fractures, according to Levine. Since vitamin D/calcium works differently in the body than the new drug, he believes it would be appropriate to give this combination to all patients and also give half of the patients the new drug and the other half the placebo. “In this way,” he says, “the trial has the advantages of being a placebo-controlled study without depriving the women of a known, partially effective therapy.” Although it will still be necessary to continue the trial until the number of new fractures in the control group exceeds by 150 the number in the group receiving the new drug, Levine believes the loss of efficiency will be compensated by the therapeutic benefits to the participants getting the placebo. “If I were on that IRB, I would approve such a study.”

Dilemma 3

When is extraordinary lifesaving care appropriate?

A baby boy was born at full term but via an emergency Cesarean section, with a mysterious, intense skin reddening. Immediately following birth, he was put into the pediatric intensive care unit in the hospital where I work. Over the next three days, he had multiple organ failures—of the myocardium, lung and liver. On his fourth day of life he had a major seizure. Studies showed intracranial bleeding, described by the pediatric neurologist called in to see him as “the worst I’ve ever seen.”

The baby was transferred to a medical center where he received extensive evaluation and supportive care. The family decided on a “No Resuscitation, No Extraordinary Measures” order and made that clear to the doctors. No cause for the bleeding or other aspects of his condition was ever found. The outlook presented to the family by pediatricians was very grim, and he was not expected to leave the hospital.

Still in the first week of life, the boy was not swallowing well and was regurgitating so often that a Nissan operation was considered. This procedure cinches up the esophageal-gastric junction to prevent gastric reflux. The family approved the surgery, but unknown to the family, the surgeon also inserted a gastric feeding tube brought out through the upper abdomen. Given nourishment via the feeding tube, the child began to hold his own and gradually improve over a period of several weeks.

Today the child is a couple of years old and weighs around 30 pounds. He is still fed through the tube, never swallows, has no excretory control, has never rolled over, cannot sit up, receives anti-seizure medication, makes no purposeful movements other than occasional random arm waves, does not crawl, does not speak or respond to commands and basically has an IQ of zero. His medical bills have totaled nearly $1 million so far, with the local county government bearing most of that cost. The family is responsible for the insurance copayments, incidental care and other costs amounting to more than a third of the family’s income.

A young family is blessed with a son, but burdened with that son being a clearly nonfunctioning human being. “Miracles” do occasionally happen in medicine, but there is no miracle for this unfortunate family. The question is, what should have been done and what should not have been done?

“There is no legal or theological basis, in Catholicism, Judaism or the majority of Protestant faiths, for keeping alive by artificial means someone for whom there is no possibility of recovering,” says Sherwin B. Nuland, M.D. ’55, HS ’61, clinical professor of surgery and author of How We Die: Reflections on Life’s Final Chapter. He points out that in the landmark 1976 Supreme Court case of Karen Ann Quinlan, who was in a persistent vegetative state and whose parents had sought for her to be removed from life support, her priest and the local bishop believed that she should be allowed to die. (Removed from life support, she lived on in that state until her death in 1985.)

A founding member of the Yale-New Haven Hospital Bioethics Committee, Nuland notes that fear of legal ramifications often drives doctors to pursue extraordinary means to keep their patients alive, sometimes even in violation of expressed patient and family wishes. The courts have consistently supported patients, their families and physicians who choose not to have “heroic” measures taken to keep a loved one alive. “I think fears of legal repercussions are unfounded,” he says. “The medical team needs to make clear the various scenarios if they do or do not intervene. Then it all gets down to the wishes of the patient or the closest kin. This was a violation of the family’s hope, and of their intentions for their child.”

He believes that the physicians erred at many levels. “There is no way for people of any knowledge to disagree about what this child’s outcome would be. There is no possibility that the physicians did not know this.” Nuland believes that, by pursuing surgical procedures, the pediatric surgeon violated several moral and ethical principles. “The only criterion for a treatment decision should be the patient’s welfare.” He suspects that the surgeon may have operated on the patient because the “case was a rare opportunity to improve his or her technical skills in operating on a tiny baby. He was prolonging this poor child’s life by carrying out procedures that make no sense whatsoever. The physicians knew this. This seems morally and ethically reprehensible.”

He believes that a physician must look at the goals of any therapy he or she undertakes. “They seem to have decided the goal was to discharge the patient from the hospital. To me the goal is what makes most sense for this family and this child.”

Dilemma 4

Is it ethical to continue life support in brain-dead patients so others may live?

I was working in a trauma room. A patient was brought in who had been shot through the head. Although he had vital signs, he was hemorrhaging rapidly through the wound. There was wide destruction of his brain tissue; much of it had spilled out on the stretcher. My immediate reaction was, “This poor person has died.” Any intervention at that point seemed futile. Then another doctor who was present ordered blood. I was shocked and asked, “Why?” The doctor replied, “Perhaps he will be an organ donor.”

We aggressively resuscitated a person who was demonstrably beyond saving with large volumes of blood, ventilator support and other means on the chance that we would find a family member in time to ask if he would be a donor. Was it right to treat the patient in front of us—who was functionally dead and moments from being without vital signs—as a potential source for an organ harvest?

If the two physicians agreed that the patient could clearly not be saved, it would be ethically acceptable to stop treatment, according to Mark R. Mercurio, M.D., HS ’85, co-chair of the Yale-New Haven Hospital Bioethics Committee and associate clinical professor of pediatrics, who also co-directs a bioethics seminar series for pediatrics residents. “However,” he adds, “that does not mean that continuing aggressive treatment with the goal of enabling possible organ donation was unethical.”

According to Mercurio, there are several ways of looking at the question. The patient-centered approach is perhaps the one most widely favored by medical ethicists. It holds that in the absence of any knowledge of the patient’s wishes, decisions should be guided by his or her best interest. To determine this, physicians must weigh the relative benefits and burdens imposed on the patient by a particular course of action. “Pain should always be considered as a potential burden,” he says. “Also, perhaps his family will be left with a much larger financial burden, which might be viewed indirectly as a burden to him.”

It may also be valid to consider the interests of others, including family members or society at large. While it may seem wrong to treat the patient just to serve someone else’s interests, keeping the patient alive for a period of time while important information is gathered might be appropriate. “Some ethicists feel that we do not need to restrict the analysis to the patient,” Mercurio states, “but can consider the interests of others affected by those decisions as well. Perhaps his family will draw some measure of comfort from organ donation, and just as their cost may be perceived as his cost, their consolation may be seen as a benefit to him.” Such an analysis could, he suggests, be expanded still further to incorporate potential organ recipients or even a much wider set of people. “It seems the questioner sought adherence to a patient-centered ethic, but perhaps the other physician thought it reasonable to consider the interests of others. Ultimately it is a matter of opinion, not medical fact, which approach is more appropriate.”

Mercurio concludes that while the physicians may not have been ethically required to continue the treatment, “I do think it was ethically permissible for them to do so, at least until the patient’s status as a possible organ donor could be clarified. If they learn that he had not chosen to be an organ donor, and the family did not choose that for him, at that point I would then recommend ceasing further efforts to maintain vital signs.”

One final point: “When the correct course between two options is not clear, it seems to me the wiser choice is the one that is potentially reversible when more information becomes available,” says Mercurio. “This would also favor attempts to maintain vital signs until the patient’s and family’s wishes regarding organ donation could be clarified.”

At Yale, a growing focus on bioethics

A biting wind blows through the darkened Yale campus on a cold December night. The irony of the end-of-the-year gloom is not lost on the 25 members of the End-of-Life Issues working research group meeting in a seminar room at the Institution for Social and Policy Studies (ISPS). This night, four staff members from the Connecticut Hospice in Branford speak about the stresses faced by caregivers for the dying. The audience is composed of students; faculty from the medical, divinity and nursing schools, as well as faculty from other academic institutions; and local community members.

During the discussion that follows, Fred A. Flatow, M.D., a former oncologist who is now a hospice physician, notes the challenge that doctors newly arrived from traditional hospital settings frequently encounter switching from one mode of care to another. “They are always looking to treat a disease,” he said. “We tell them they have to treat the patient, not the disease.” The group then launched into a debate over the differing and sometimes conflicting emotional qualities and approaches to patients that caregivers need to succeed in each medical setting.

That sort of investigation into the nature and impact of medical care and research goes on somewhere on campus almost every day. The group meeting this evening is just one of 15 different working research groups, in bioethics that hold monthly meetings on topics ranging from technology and ethics to allocation of health care. The various groups as well as publications, seminar and speaker series and visiting professors, are part of the burgeoning Interdisciplinary Bioethics Project at Yale.

Launched in the summer of 1997 by the ISPS to bring together the swelling numbers of people interested in the field, the bioethics project has drawn more than 500 participants to its programs from departments across the university, the local community and the larger world of academia and health care. “The project is fluid and that accounts for its popularity,” says Carol A. Pollard, associate director of the bioethics project at the ISPS, who coordinates the project’s many activities. “People come to ask why we don’t do something in an area with an underlying ethical question. They can then work with us to make it happen.”

Those efforts received a major boost last year when the Patrick and Catherine Weldon Donaghue Medical Research Foundation awarded the Bioethics Project a five-year, $2.1 million grant. According to Robert J. Levine, M.D., HS ’63, professor of medicine, and Divinity School Professor Margaret A. Farley, Ph.D., co-chairs of the Bioethics Project, part of those funds will go toward community outreach, including a statewide network of institutional review boards, the hospital and medical center ethics watchdog committees that oversee biomedical and behavioral research. The grant also helps to bring a prominent bioethicist-in-residence to Yale each school year. This year’s visiting faculty member is David H. Smith, Ph.D., a professor of religious studies at Indiana University, where he is immediate past director of the Poynter Center for the Study of Ethics and American Institutions. He is currently at work on a book on religion and the morality of care for the dying. At Yale, he is teaching popular courses to undergraduate and graduate students on bioethics and also directs the End-of-Life Issues working research group for the year.

Many of the working groups focus on policy issues and have become voices in wider public debates. “It is in the nature of biomedical ethics,” says Levine, “that almost anything is potentially related to public policy.”

Several of the Bioethics Project’s groups have taken on a life of their own, developing their own visiting-speaker series and seeking outside support for their efforts. One of the larger groups, the Stem Cell Interest Group, was founded in May 2002 by medical student Rajesh Rao with stem cell scientist Diane S. Krause, M.D., Ph.D., associate professor of laboratory medicine and pathology, as an advisor. The group has grown from 15 to 150 members from a wide range of disciplines. It has brought speakers to Yale including leading stem cell investigators and Christopher Reeve, an advocate for more research in the field. The group now hopes to establish a multidisciplinary program, with medical and ethical research and education as components.

Most of those involved in the working groups are not formally trained as bioethicists. Interim Dean Dennis D. Spencer, M.D., HS ’77, who attends meetings of various study groups, has spoken on bioethics as part of an annual guest lecture series on the field held at the Joseph Slifka Center for Jewish Life at Yale. “I am not a bioethicist per se,” he says, “but as a neurosurgeon, I’m engaged in it in the trenches. Most of us consider ethics to be common sense. All you need to do is ask a resident a tough ethical question and you see that it is not just common sense. We all bring baggage and a set of beliefs that you have to get rid of in approaching these issues. You have to acquire a basis to argue your views rationally.”

A member of the End-of-Life Issues group, Stanley H. Rosenbaum, M.D., professor of anesthesiology, medicine and surgery, agrees. “I spend so much energy dealing with acute medical problems. This helps me step back and consider the justice and ethical aspects of what we do.”

—Marc Wortman