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 They have repealed a principle that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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