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1 18 Q UINNIPIAC L AW

2 Medicine & ethics An uneasy partnership Scientific breakthroughs beget moral dilemmas & legal debates B Y KAREN BAAR At the University of Pennsylvania Center for Resuscitation Science, researchers study how to treat the dead. Sounds like science fiction, but the center was featured in a Newsweek story in the May 7 issue. This newest frontier in our brave new world may offer hope for heart attack victims who have been clinically dead for as much as an hour as it strives to extend the current window for successful resuscitation. Medical science continues to provide us with nearly miraculous ways to save and prolong life. But how does our pluralistic society of individuals holding divergent religious, moral and ethical beliefs resolve the controversies that inevitably arise from new scientific research and technology? And how do we allocate the precious, but not unlimited, resources of our health care system? Quinnipiac faculty and alumni are deeply involved in studying the issues behind these questions. One of them abortion exemplifies the clash between technological development and the influence of moral, ethical or religious values on policymaking. Unfortunately, Roe v. Wade [the 1973 Supreme Court decision legalizing abortion] politicized the debate and brings out well-organized, well-funded angry people on both sides, says Quinnipiac Law Professor Stephen Latham. Many other hot-button topics, such as human embryonic stem cell research and end-of-life issues, are connected through threads of argument to that debate, which often has been framed in terms of whether the fetus is a full moral person in its own right. For example, the Terri Schiavo controversy had to do with whether she was a full moral person after being in a persistent vegetative state, he says. The Supreme Court framed its Roe decision in terms of viability, or the ability of the fetus to survive outside the womb. Today, medical technology permits us to do things that are more and more I hate to say it, but godlike, allowing the fetus to survive at an earlier stage. So the viability framework becomes problematic if it s a moving target, says Brad Saxton, dean of the School of Law. Q UINNIPIAC L AW 19

3 The decision to legalize abortion was not just about women s rights; it was also motivated by safety concerns because many were suffering complications or dying from illegal procedures. New techniques have made late-term abortions safer, too, adding fuel to an already raging fire. In the past, doctors induced labor prematurely for abortions performed after the first trimester. Because the fetus wasn t viable, it didn t live. Today, there are two methods for later-stage abortions dilation and extraction (called partial-birth abortion by pro-life advocates) or another technique, called dilation and evacuation. In these procedures, the fetus is partially dismembered. These procedures are faster and less expensive, and are considered emotionally less stressful to the patient, and safer for some women than undergoing labor. However, they entail a violent death for the fetus, rather than simply a fatally premature birth. The Supreme Court recently handed down a decision (Gonzales v. Carhart) upholding the Partial-Birth Abortion Ban Act of 2003, which prohibits the lesscommonly used dilation and extraction method in which the fetus is killed after most of its body is outside the mother. This reflects a shift in focus on the abortion issue, says law Professor Stephen Gilles. The original battle was Must states allow abortion at all? Now, it has become Even if abortion must be permitted, doesn t it make a difference which methods we allow? Should we be treating this developing life more respectfully? In the opinion of the court, the method does make a difference. What s more, that decision reaffirmed that states can intervene by enacting enhanced informed consent or mandatory counseling laws. In theory, these laws would fully inform women of the physical and emotional risks of abortion, and of the consequences to the fetus lest they regret their choice later. However, critics argue that these new laws requiring women to view an ultrasound or be counseled about fetal pain before their abortion are little more than a guilt trip. Already, a law passed in South Dakota requires that when seeking an abortion, a woman be told that the procedure will terminate a whole, separate, unique, living human being. That law is being challenged in federal court; however, as many as 10 other states are considering ways to enhance informed consent. Gilles says: In addition to using informed consent laws to persuade women not to have abortions, the new decision implies that the government can use them to influence a woman to have a late abortion by inducing labor, rather than by one of the newer methods. One big unanswered question is whether the government can ban the more common of those methods (dilation and evacuation) if its law included a health exception for women who can t safely undergo induced labor. 20 Q UINNIPIAC L AW

4 Stem cell battle What was unusual about Roe v. Wade was that the Supreme Court established a national framework for abortions. Policy decisions on other controversial medical issues have been left to the states. One current example is human embryonic stem cell research, which has been banned from receiving federal funding. President George Bush has said he opposes the funding for moral and religious reasons. However, there is a distinction between the two, says David Katz, MD, associate adjunct professor of epidemiology and public health, Yale University School of Medicine. Katz recently moderated a televised public forum, hosted by Quinnipiac, that focused on key issues surrounding stem cell research. Morality is not religion. Of course, scientific research must pass through an ethical prism. We have to safeguard the morals of our society but also honor public health science. We need to get religion out of public policy, Katz says. The stem cell battle has shifted to the states, which can proceed with human embryonic stem cell research as long as the money comes from state coffers. Some states are banning it, and some are funding it, and on both sides you have protests, says Latham. Because Connecticut has decided to go forward and fund this research, debates about the moral status of the human embryo are not part of the process. Yet, there are still moral and ethical questions, explains Latham, who recently was appointed by Connecticut s governor to serve on the state s Stem Cell Research Advisory Committee. Besides evaluating grant proposals to support stem-cell research, Latham works with university oversight bodies (at Yale, UConn and Wesleyan) to discuss solutions to ethics problems that arise in the course of the research. Latham cites this hypothetical: Suppose that Connecticut has decided it s inappropriate to pay egg donors for anything beyond lost time [rather than for the required hormone treatments and surgery] and also that it s OK to use leftover frozen embryos for research if the embryo donors have given a certain kind of informed consent. Now, let s say that California or Singapore permits greater payments to egg donors, and also permits use of frozen embryos after a much more abbreviated informed-consent discussion. Should Connecticut s researchers be able to purchase celllines originally derived in California or Singapore, where their ethical standards for cell-line creation are different? Informed consent issues It s clear that ethics and law sometimes struggle to keep up with the complex issues born of medical advances. The field of medical ethics, so prominent today, is actually quite young. A sea change began with our ability to do CPR, says Ronald Rozett, MD, medical director of the physician assistant program in the School of Health Sciences. When I was in medical school in the early 1960s, the question was, Do you tell the patient the truth? Today, we have practical concerns about brain death, and when to remove a patient from a ventilator. Rozett says patients, when they are well, should be encouraged to execute advanced directives about end-oflife decision making, and families and physicians should respect those written wishes. End-of-life issues arise not only with the elderly, but with those at the other end of the spectrum: premature Regulating Pharmaceuticals The pharmaceutical industry is a glaring example of the interplay of ethics, technological development and financial interest, says Professor W. John Thomas, director of the health law concentration. He has studied the issue in the context of the FDA s approval of Vioxx. This widely used medication, approved in 1999, was taken off the market in 2004 because of concerns about the increased risk of heart attack and stroke associated with long-term, high-dosage use. It s a curious and troubling circumstance. The FDA acted as an agent of the pharmaceutical industry, he says. Thomas has studied s between the scientific researchers and the policymakers at the FDA in which the policymakers urged the researchers to approve the drug. The folks who made policy at the FDA had come from the pharmaceutical industry, so the regulators were previously the regulated, and they came with a particular perspective. His conclusion: Ethicists and lawmakers, rather than people with a direct interest in the process, should be setting the ground rules for how the FDA regulates pharmaceuticals. Q UINNIPIAC L AW 21

5 babies. There are lots of neonatologists who ve begun to question the whole purpose of what they do at times. Do we try to sustain the life of a baby born at 22 weeks for a very short period of time at extreme cost? The argument is always you can never tell, and there are many terrific examples of preemies who go on to live spectacular lives. However, there are also those who are chronically disabled, in pain, or who lead limited lives, says Rozett. Yet, some disability advocates argue that implicit in such a view is the judgment that it s better off to be dead than to be disabled, which arguably devalues the disabled life, Saxton notes. The United States generally has left difficult, end-of-life decision-making to families and physicians, sometimes with the help of medical ethicists. However, in other areas of medicine, the law plays a role. The law is key in issues of informed consent. Since 1974, any institution conducting research that is federally funded or overseen must have an institutional review board for the protection of human subjects. We look at the research subjects, first and foremost, to ensure that they receive full disclosure and provide informed consent. It s essential that every study have some benefit, whether it s directly to the participants or to society in terms of scientific knowledge gained, explains Cathleen Montano 03, manager, Yale School of Medicine Human Investigation Committee. One of the functions of an institutional review board is to scrutinize the ways in which rapid scientific progress may affect individuals. Research on the genetics of certain diseases is a prime example. Should subjects be informed if a study finds that they might have a tendency toward a certain disease? Can that issue be anticipated before they are enrolled, so they are aware of the possibility? Sometimes, these questions arise in the context of ongoing studies. Many studies come back to us for review on an annual basis. We might have researchers who have been working on a study for 20 years. What are the risks and benefits of reporting this information to those subjects, assuming we can even find them? We have some lively discussions, says Montano. Federal institutional review board regulations don t always keep up with what is going on in the research community. The regulations mandate additional protections for prisoners, pregnant women and children, who are deemed to be vulnerable populations. What they don t cover are people who are decisionally impaired. Says Montano: What if there is someone in the emergency room with head trauma or a drug overdose, people in the intensive care unit, or those with end-stage neurodegenerative diseases, like Alzheimer s and Parkinson s, and we have a treatment that is not yet approved but holds out hope? In these cases, federal regulations require the consent of a legally authorized representative, as 22 Q UINNIPIAC L AW

6 Hot Issues in the Pipeline THE INTERSECTION OF RELIGION AND CHILD PSYCHIATRY: Certain religious groups, including the Church of Scientology, have been lobbying states for barriers to prescribing psychiatric medications for children. Some school districts have prohibited staff from even suggesting mental health care to parents. DISPUTES OVER STATE ABORTION-RELATED LEGISLATION: This may include fetal pain statutes and laws requiring women to view videos or ultrasounds to discourage abortions. defined by state statutes, to permit their participation in research. So what do you do when your statutes don t identify such a representative in the research context? Because Connecticut, unlike some other states, does not have comprehensive regulations addressing human subjects in research, and because federal regulation of this area is evolving, review boards tend to adapt the way informed consent is handled for children to cover the decisionally impaired. Montano thinks writing such legislation would be a great project for students in the health law concentration. Saxton says, You have concerns about ethics, morality and religion, amniocentesis and other tools that allow early detection of serious defects in a fetus; abortion; human embryonic stem cell research; cloning; confidentiality; and privacy. With pharmaceuticals, there are issues about patents and intellectual property rights, and how they are marketed and priced. And with informed consent, there are concerns about individual freedom and autonomy. The law becomes the place where these different roads run together. And sometimes it becomes a battleground. Saxton says Quinnipiac students develop the skills and the wisdom to play a role in helping society work out these issues. Our faculty and alumni are not just teaching in this area but are actively involved in thinking and writing about it, and they re getting attention from policymakers. MEDICAL FUTILITY CONFLICTS: In Texas, under legislation signed by then-gov. Bush, when a medical team agrees that further treatment is futile, either on medical or qualitative grounds, the hospital is allowed to discontinue treatment. If the family wants to continue, it must try to transfer the patient to another hospital; if that isn t possible, it must pay for the treatment. NEUROLAW : New technologies that illuminate the workings of the brain are being used as evidence in some cases to argue that a defendant was incapable of judgment, of controlling himself, or of making a reasoned decision. CONTINUING DEBATE OVER ASSISTED SUICIDE: Already allowed in Oregon, other states are considering laws allowing doctors to help terminally ill patients die. DEBATES OVER CHILDREN ON DEMAND : Most Americans support the right to abort a fetus if there is a prenatal diagnosis of a serious genetic defect. As prenatal screening and other reproductive technologies become more sophisticated, what happens when parents want to terminate a pregnancy because of gender, intelligence or other traits? Q UINNIPIAC L AW 23

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