November 5, 1996 11/ 5: U.S. Ban on Medical Experiments Without Patient Consent Is Eased By GINA KOLATA For the first time in a half century, new federal regulations allow investigators to enroll patients in some medical research studies without their consent. The Food and Drug Administration regulations, which took effect on Friday, apply only in carefully circumscribed situations. The patients must have a life-threatening condition, like a severe head injury, and must be unable to say whether they want to be part of a study. They would be selected only if it was not feasible to obtain consent from a relative. Furthermore, the community in which the research is done must be notified about the study, and the research design must have been reviewed and approved by the Food and Drug Administration. Even the most ardent supporters of the new regulations say they understand the seriousness of what they have done. They have repealed a principle that dates back to the Nuremberg trials of Nazi doctors after World War II, when American judges were agonizing over rules that might prevent doctors from ever again using human subjects in horrendous experiments. The judges wrote a code of ethics, the Nuremberg Code, whose first principle was that no one should ever be forced to take part in a medical experiment. "The voluntary consent of the human subject is essential," they wrote. "It's a tremendous philosophical change," said Dr. Norman Fost, director of the Center for Clinical Ethics at the University of Wisconsin, who lobbied for the change. Bonnie Lee, a senior policy analyst at the drug agency who wrote the new regulations, said, "This is not something we did lightly or easily." But supporters of the regulations say patients will benefit. The requirement for informed consent, they say, was hobbling research that could save lives. Fost said the regulations would liberate researchers to study treatments that were desperately needed. Until now, he said, "research was not moving forward." The harm would be greater if patients were kept out of such studies, he argued, than if they were entered without their explicit consent. Others, however, are gravely concerned. "It's a fateful step," Jay Katz, an ethicist and lawyer at Yale University, said in a telephone interview from Germany, where he was at a conference marking the 50th anniversary of the Nuremberg doctors' trials. "The first sentence of the first principle of the Nuremberg Code," he said, stated that nothing should be done to human beings without their consent. And now, he said, "here we are making exceptions." The new rules arose out of the frustration of some ethicists and medical researchers. The problem, said Fost, was that the previous rules were making it virtually impossible to study treatments that must be provided to patients who are gravely ill or injured, with heart attacks, strokes or head injuries, for example, for whom time is of the essence, and whose relatives cannot be found in time to give permission for experimental treatments. At the same time, scientists were testing seemingly nontoxic drugs in animals that promised to save the lives of many of these patients. "All of this technology was bubbling up three or four years ago," Fost said. And, he added, most patients would have wanted to be part of studies of experimental treatments for their injuries or illness if they could have spoken for themselves. Fost said that if the choice for a patient with a severe head injury was to receive standard treatment, which is of little help, or to be part of a study testing a drug that seems to have virtually no side effects and that has saved the brains of animals, "it seems to me that a reasonable person would very much want to be in the study," Fost said. "Consent," Fost said, "is a means to an end." The goal, he added, "is to do what the patient would want." And so Dr. Michelle H. Biros, an emergency medicine expert at the Hennepin County Medical Center in Minneapolis, Fost and others met privately in Washington two years ago and developed a consensus statement on waiving informed consent in emergencies. Their statement was published in The Journal of the American Medical Association in April 1995 and the campaign to get the Federal regulations changed was begun. Now the group has succeeded. "We didn't accept all of their recommendations, but they certainly were very useful," Ms. Lee said. Some medical researchers, like Dr. Raj Narayan, chairman of the department of neurosurgery at Temple University School of Medicine in Philadelphia, are delighted. Narayan, who studies patients with severe head injuries, agreed with Fost that patients would want to receive promising experimental drugs. "We do not really have any good drug that has been proven to be beneficial for patients with head injuries," Narayan said. And the mortality rates are high -- 30 percent to 40 percent in the best medical centers, and as high as 50 percent for some types of injury. "If it were my child or my family member or myself that was the patient with a severe head injury, I would definitely want to be included in a study," Narayan said. Of course, most experimental drugs, no matter how promising in animal studies, never get to market. They fail to help patients when they are tested in clinical trials. But, Narayan said, he thinks most people would be willing to take a chance, given the alternatives. Others are not so sure. George Annas, an ethicist and health lawyer at Boston University, said, "Most people would not want a doctor to flip a coin when they come into an emergency room." Instead, he said, "they would want their doctor to do what is best for them." And, he added, "that is what you lose in this -- you lose the right to have your doctor treat you however he thinks best." Annas dismissed the argument that the research provided an opportunity for patients. "For most people, research is not an opportunity," he said. "The average person wants treatment, not an opportunity to be researched on." And, he added, "the idea that people might be denied new treatments is silly." An experimental drug is experimental because no one can say if it is useful or if its risks exceed its benefits. "If we knew it would work, it would be a treatment," Annas said. His concern, he said, is that investigators are "just trying to make research more efficient at the expense of human rights." The potential downside, he said, "is that doctors won't try to get consent of the family anymore -- now there's zero reason to look for them." Katz is particularly concerned because the regulations allow doctors to enroll unconscious patients in studies in which some subjects are given dummy medication. "The new regulations send a dangerous message to the research community," he said. That message, he explained, is that it is more important for research to proceed than it is for patients to have an opportunity to agree to be research subjects. Dr. Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, takes a middle ground. Although he understands the arguments of people like Narayan, he said, concerned doctors are not the only ones who want the research to go forward. Drug companies and the makers of medical devices have a financial stake in seeing that the research is done. And, Caplan added, perhaps most important, the Food and Drug Administration has taken away a shining symbol of researchers' concern for the protection of research subjects. So, he asked, is the benefit worth the risk of engendering distrust, of alienating people who might see doctors and drug companies as the worst sort of opportunists, experimenting on comatose people without their explicit consent? "Without much fanfare, we've veered away from a five-decade tradition," Caplan said. Fost said he understood such concerns. It is frightening to many to think about casting off a symbol like informed consent. But, Fost said, "I'd say, 'Give me enough time to sit down and talk to people and things that seem outrageous on the surface may not be so after a while.' " It is not as though the investigators have not included safeguards, he said. In fact, he added, "there are so many safeguards that some people think we've safeguarded it to death."
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