Easing of FDA rules may have led to deaths
Media hasn't put 2 and 2 together, says Steve Drake
Last April 1, an Associated Press article that was not a joke began, "A pharmaceutical company abruptly halted its study of a blood substitute in U.S. emergency room patients after discovering they were dying at a higher rate than expected."
"This news was of interest to me because of another story, from November 5, 1996," says Steve Drake of Not Dead Yet. On that day, the New York Times's Gina Kolata had reported on the U.S. Food and Drug Administration's easing of requirements that informed consent be obtained for enrollment in trials of experimental medical procedures.
"For the first time in a half century, new federal regulations allow investigators to enroll patients in some medical research studies without their consent," wrote Kolata. "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."
"TV coverage of this FDA change at the time indicated that experimental use of artificial blood would be one of the first applications of this rollback of the Nuremberg Code," said Drake. In her article, Kolata explains that this Code "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," wrote Kolata.
"The voluntary consent of the human subject is essential," says the Nuremburg Code.
"The leader of the group of bioethicists who quietly lobbied and won the FDA changes," says Drake, "was Norman Fost, the first recipient of the funded chair at Princeton that Peter Singer will now hold." (See "Peter Singer appointment draws warning," D.R. Nation, September/ October). At the time of the FDA change, Fost was Director of the Center for Clinical Ethics at the University of Wisconsin.
"We are seeing a worldwide trend in the use of 'nonconsenting subjects,'"says Drake. "A few years ago, most of the European community signed onto a new set of research guidelines that allows incapacitated people (people with mental retardation, in 'persistent vegetative states' or in comas) to be 'enlisted' in research not of direct benefit to the subjects."
"No press coverage seems to have put the earlier story together with the April 1 news," says Drake, "but it seems highly likely that the people in the artificial blood experiment gone bad were 'enrolled' in this research project without their consent--and that a number of people may have died as a result of getting the artificial blood."
"Given that the subjects are now dead (and evidently do not have next of kin), it is unlikely there's worry of lawsuits regarding wrongful deaths in this scenario," says Drake. "Convenient, isnšt it?
"Is there going to be a re-evaluation of the wisdom of this exception to the requirement of informed consent?" asks Drake. "Or is it still ethical, due to the fact that the press hasn't caught on and there will probably be little danger of litigation resulting from the deaths of unwitting participants?"
"One would think that the early termination of studies involving nonconsenting subjects would have been newsworthy--yet it received scant attention from the press," Drake continues. "No coverage of the discontinued study tied it to the FDA informed consent exemption."
"According to investigative reports from a couple of years ago, the FDA's own data indicate that about half the medical researchers they have monitored (after the fact) had significant problems in terms of documenting informed consent or giving enough information so that consent could be truly informed," Drake adds. "It seems we are giving further powers to a group that has a shitty track record of obeying already existing rules."
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