The federal government has designated children among the vulnerable populations—which also include pregnant women, cognitively impaired people, and prisoners—who deserve special protections as the subjects of research. In Dr. Crusher’s scenario, these children will face genuine risks of medical complications at no benefit to themselves, and they are generally too young to assent meaningfully to such risks. Under these circumstances, the federal government allows institutional review boards (IRBs) to approve such studies only under narrow circumstances, including when risk is low and whether the study is of vital importance “for the understanding or amelioration of the subject’s disorder or condition.” (If the research does not meet these requirements, the US Department of Health and Human Services may, under certain circumstances, commission a panel of experts to authorize the study.) In practice, Dr. Crusher will have to convince an IRB that the increased risks of brain biopsies are minor to these patients and that the data she gathers will prove crucial in cancer research. IRBs can be notoriously unsympathetic audiences, however, so she may have her work cut out for her.
50
Lithium in the Water
Several strong epidemiological studies have demonstrated that regions of the world where the element lithium occurs naturally in the drinking water have lower suicide rates. (The current proposed theory is that lithium is a protective factor in brain development, so it may take decades for the benefits of such lithium exposure to pay off in suicide prevention.) No known negative side effects have been associated with trace lithium exposure, but few long-term studies have been conducted to detect such risks.
The epidemiological studies on lithium have drawn the attention of Otis, the mayor of a small English city that has one of the highest suicide rates in the Western world. Otis proposes adding trace amounts of lithium to the drinking water in his community to see if this intervention will help. He believes this might, in the long run, prevent up to fifty unnecessary deaths each year. “If you don’t want to be exposed to lithium,” says Otis, “you can always buy bottled water.”
Is Otis’s proposal ethical?
Reflection: Preventing Suicide
The data supporting a link between lithium in the drinking water and lower rates of suicide is surprisingly robust. Studies in Texas, Japan, Austria, and Greece have all demonstrated similar findings; the Texas study showed a decrease in violent crimes such as homicide and rape as well. (One must emphasize that these are not the levels of lithium used to treat mental illness but trace amounts measured in micrograms per liter.) An analogy might be drawn to the trace amounts of fluoride added to drinking water to prevent tooth decay, which the Centers for Disease Control describes as one of the ten greatest public health achievements of the twentieth century, but which continues to be opposed by alternative medicine advocates, libertarians, Christian Scientists, and others on the political right and left. Assuming that lithium prevents suicide, this does not necessarily mean it should be added to the water supply. Rather, such a decision must be weighed against the costs of doing so, including economic expense, the rights of those opposed to lithium exposure, and concern for theoretical long-term side effects of such exposure. For all we know—and there is no data for this, but it is always possible—people in the lithium-exposed communities that have lower suicide rates are also less creative or courageous.
One risk of opposing the addition of lithium is falling for what is often called an “appeal to nature”—the belief that something is better or healthier because it is naturally occurring. (This concept ought not to be confused with the “naturalistic fallacy,” an unrelated concept proposed by British philosopher G. E. Moore.) Many substances that occur naturally, such as arsenic, are quite toxic; others that are synthetic, such as aspirin, can be highly therapeutic. Lithium occurs naturally in the drinking water in some regions and not in others, but that tells us little about whether it is ethical to add it to the drinking water where it is not present. Presumably there is not a significant difference, morally speaking, between diverting lithium-rich water to a lithium-poor watershed and merely adding the lithium to the water in the latter area. Both achieve identical outcomes, albeit one in an arguably less natural manner.
When evaluating any uses of publicly shared resources like the water supply, one should not ask whether the use is natural, but rather whether it is health-promoting or serves the public. Forming consensus on such a subject is not easy, however, as the conflict over fluoridation demonstrates. Until the public can better understand the illogic of appeals to nature, proposals like Otis’s are unlikely to gain much political traction.
51
“Why Didn’t You Warn Me I Was at Risk?’
Several forms of colon cancer are inherited and affect patients at an early age. The offspring of these patients are advised to undergo frequent colonoscopies to detect precancerous growths that can either be excised individually or that require removal of the entire colon. This has been known to oncologists since the 1950s.
In 1995, Moe was diagnosed with early-onset colon cancer. Patients with Moe’s specific variant of inherited cancer generally develop the disease between ages forty and seventy; Moe was forty-two. Moe instructed his oncologist, Dr. Jekyll, that under no condition did he want his family to learn that he had cancer. “It’s my business,” he says. “Why make them worry when this might not affect them until they’re seventy years old?” Moe’s children grow up believing that their father died of an untreated intestinal blockage.
Twenty years after Moe’s death, his eldest daughter, Maureen, develops colon cancer at the age of forty-one. Her oncologist informs her of the genetic nature of her condition, which leads her to investigate more closely her father’s medical history. In a box of his papers, she discovers the medical records from his treatment by Dr. Jekyll. These include the diagnosis of early-onset colon cancer. Maureen immediately hires a lawyer and sues Dr. Jekyll, who is still in practice, for negligence. In her state, the statute of limitations did not start to run until she discovered her injury, so it is still possible for her to make a claim.
Should Dr. Jekyll be liable for damages?
Reflection: Inherited Diseases and Privacy
The legal and ethical duties of physicians to individuals who are not their patients have expanded significantly over the past half century. Whereas once claims of doctor-patient confidentiality absolved providers of most obligations toward third parties, courts have now trimmed those protections substantially. Many state laws, modeled on California’s “Tarasoff rule,” require psychiatrists to warn and/or protect the potential victims of dangerous patients. Some states expect physicians treating patients suffering from contagious diseases to notify family members of their risk. In the Tennessee case of Bradshaw v. Daniel (1993), a court for the first time expanded that duty to warn relatives of noncontagious patients as well. In that case, the wife of a man treated for Rocky Mountain spotted fever was not informed that she might have been exposed to the illness through the same source as had her husband. She later also died of the disease, and her family won a lawsuit on the grounds that she had not been advised to seek medical care. In addition, several jurisdictions have enacted mandatory partner-notification statutes, requiring physicians to report patients testing positive for the AIDS-causing HIV virus to the health authorities, who will then inform the patients’ at-risk contacts of their exposure. The widespread rise of genetic diagnoses and testing has raised the question of what duties physicians may owe to patients’ family members at future risk of hereditary disease.
The first two courts to address the question of whether the risk of genetic illness should be shared with a patient’s relatives decided the matter differently. In Pate v. Threlkel (1995), the Florida Supreme Court, noting the importance of physician-patient confidentiality, ruled that a physician had fulfilled his duties when he told the patient herself of her family’s risk; it was therefore the moral obligation of the patient, not the doctor, to pass this information
along to vulnerable relatives. A year later, in Safer v. Estate of Pack, the New Jersey courts arrived at precisely the opposite conclusion, finding negligence where a physician failed to warn the patient’s child directly of her genetic risk of colon cancer. While telling patients of the danger to their relatives is now widely understood to be a part of sound medical practice, how to act when patients wish to keep the information secret remains controversial.
Both the American Society of Human Genetics (ASHG) and the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research issued specific guidelines on disclosing hereditary risks to family members. According to ASGH policy, such disclosure must meet the following four criteria: (1) efforts to get the patient to tell his family directly have failed; (2) the risk of serious harm is high; (3) a specific at-risk relative can be identified; and (4) methods of prevention or treatment exist, or early monitoring reduces risk. These guidelines conflict with those of the American Medical Association, whose principles favor maintaining confidentiality.
Unlike Dr. Jekyll, who cannot undo the damage to Maureen, future physicians may choose to inform patients in advance that they will breach genetic confidentiality, as a matter of policy, to protect relatives at risk. Such “fair warning” might, of course, drive some patients away from effective medical care. Most, however, will likely accept this as a necessary corollary of treatment. That approach would eliminate the need for litigation like Maureen’s in the future, although it will offer little guidance to the judge in Dr. Jekyll’s case.
52
The Boundaries between Mice and Men
A neurology researcher has a novel idea for studying the mechanisms of diseases that affect brain cells, such as Parkinson’s disease and Alzheimer’s disease. She intends to inject human brain cells into mice embryos to trace their development. She estimates that the brains of these embryos would be 50 percent human and 50 percent mouse. The hybrid mice would be killed painlessly long before birth. The researcher would then study their hybrid brains for rudimentary elements of human cognition. Her long-term goal is to create mouse models for the development of drugs that can treat serious human diseases.
Should the researcher be allowed to go ahead with this experiment?
Reflection: Human-Animal Hybrids
Until the 1970s, animal chimeras—cross-species hybrids—were largely the stuff of mythology. Yet starting with the success of biologists Paul Berg and Richard Mulligan at Stanford University in transplanting rabbit hemoglobin genes into primate kidneys, scientists managed to generate a slew of rapid advances in the field: A hematologist at the University of Nevada, Reno, claimed to have produced sheep with livers that were partially “humanized”; a lab at the Mayo Clinic produced “pigs with human blood.” In China, researchers fused human skin cells with rabbit eggs. Yet the most significant and controversial step in the field occurred when Irving Weissman, a professor in the departments of pathology and developmental biology at Stanford, asked for—and received—permission from the university to create mice embryos with brains derived from human neurons. Weissman had previously produced mice embryos whose neural tissue was 1 percent human, but he hoped that using only human neurons, coupled with mouse glial cells, would generate a model for studying human neural tissue in the laboratory.
Opponents of human-animal chimera research are particularly concerned about the use of neural tissue in these experiments. Critics fear that mice with human brain cells could develop some human cognitive qualities and could even experience humanlike suffering. These bioethicists often see the hybrids as an affront to human dignity. They also express concerns related to species integrity and human uniqueness—or what columnist Wesley J. Smith refers to as “human exceptionalism.” Making mice more human, according to some commentators, also makes humans more like mice. Senator Sam Brownback of Kansas has introduced legislation multiple times to prohibit human-animal hybrids in research, but the bills have failed to gain traction.
Even ethicists who favor such research in principle have urged considerable caution on the part of researchers. Legal scholar Henry Greely and his colleagues, in an article in the prestigious American Journal of Bioethics, noted that these experiments would be problematic, even if not inherently unethical, if they so unsettled the public that they “undermined support for … other useful biomedical research.” However, any initial popular concern over Weissman’s request has largely evaporated, and human-mouse hybrids are increasingly part of scientific endeavors. The most striking feature of the scenario at the start of this chapter may be that at many universities today, the prospect of mice with half-human brains is neither surprising nor particularly controversial among researchers—although the idea of such chimeras still remains highly objectionable to a large segment of the US public.
53
Doctoring a Dictator
Fozzie is the brutal dictator of a wealthy nation that enjoys a long-standing military alliance with the United States. He develops a rare leukemia, a blood cancer, which is resistant to conventional chemotherapies. However, there is a drug trial about to begin at a major US hospital for a promising but experimental new therapeutic agent that may treat this variant of the disease. Fozzie secures an emergency visa and arranges with the hospital to participate in the study, which holds out the only realistic chance of saving his life.
Dr. Steven Strange, the chief of oncology at the hospital, had initially agreed to allow Fozzie to receive the experimental treatment. Yet on the same day Fozzie arrives, before the treatment begins, Dr. Strange’s friend gives him a book on human rights abuses in Fozzie’s nation. Dr. Strange reads enough of the book to learn that Fozzie’s government is responsible for the deaths of thousands of innocent civilians and has been implicated in sexual violence, torture, and even cannibalism. He is troubled by the prospect offering a treatment that will allow Fozzie to continue to rule when Fozzie’s people have no access to basic medical care or the most fundamental human rights. “Lots of people die of leukemia in his country,” says Dr. Strange’s friend. “None of them are allowed to come to the United States for experimental treatments.”
Is it ethical for Dr. Strange to refuse to provide the experimental treatment to Fozzie?
Reflection: Human Rights and Treatment
The leaders of developing nations, both dictators and those democratically elected, have a long history of traveling to wealthy Western countries for medical care. The result is that the world’s leading democracies often play medical host to the planet’s most brutal rulers. In 2012, Ethiopian strongman Meles Zenawi died while undergoing treatment in Belgium. That same year, Saudi Crown Prince Nayef received cancer treatments in Cleveland and later died in Geneva, Switzerland. Spain played host to dying Gabonese dictator Omar Bongo in 2009 and Angolan strongman José Eduardo dos Santos in 2017, while Germany has welcomed Kazakh despot Nursultan Nazarbayev for regular medical checkups. Professor Ian Taylor, an expert on African politics, has noted that of the ten African heads of state to die of natural causes between 2000 and 2015, all received foreign medical care and eight died abroad. Many of these nations have deplorable human rights records, and their populations have highly limited access to healthcare of any meaningful quality. Yet possibly the most famous case occurred when President Jimmy Carter allowed the former shah of Iran to undergo surgery at New York Hospital in Manhattan in 1979. Carter’s decision, widely criticized at home and internationally, led to a major foreign policy crisis.
Surprisingly, the bioethics community has remained relatively silent on this subject. As a general principle, medical ethics favors that healthcare be delivered apolitically. When Bahrain placed medical professionals, such as nurse Rula al-Saffar, on trial for providing emergency first aid to antigovernment protesters in 2011, numerous international medical associations condemned the government’s actions. Similarly, physicians’ groups have criticized the targeting of doctors by all sides in the Syrian Civil War. However, such effo
rts to keep medicine apolitical make it difficult for these same organizations to raise their voices when dictators seek treatment abroad. Although a few commentators have suggested rules requiring world leaders to receive healthcare in their own nations, these efforts remain quixotic.
Just because the US government has given Fozzie a visa, however, does not mean that Dr. Strange has an ethical obligation to treat him. In fact, physicians generally have no obligation to treat anyone with whom they do not already have an established relationship. (One might argue that such a relationship was created when Dr. Strange initially agreed to enroll Fozzie into the protocol, but as treatment has not yet started, this is debatable.) Patients are turned away from potentially life-saving experimental therapies all the time—often as a result of circumstances beyond their control, such as that a study reaches its enrollment limit. Unlike Fozzie, these individuals often die without ever even learning that such studies are ongoing.
Dr. Strange may wish to take into account the broader impact of rejecting Fozzie as a patient. The result may be the further politicization of medicine and could make it more difficult for groups such as the World Health Organization and the International Council of Nurses to protest the treatment of physicians abroad. Or the refusal may serve as a statement that draws public attention to the plight of the victims of human rights abuses under Fozzie’s dictatorship. Yet physicians are often constrained in any efforts to publicize their refusals: dictators generally want their medical treatment kept secret, and confidentiality laws prevent doctors from publicizing such requests without permission. The truth is that the public has very little idea of how many problematic leaders seek medical care in their countries. Doctors may be refusing to provide care to such autocrats all of the time. There is no way of knowing. Yet just because the public is unlikely to learn of Dr. Strange’s decision does not absolve him of the choice of whether to treat her controversial patient.
Who Says You're Dead? Page 14