Tuskegee Redux?

Tuskegee Redux?

"The Shame of Medical Research" by David J. Rothman, in The New York Review of Books (Nov. 30, 2000), 1755 Broadway, Fifth Floor, New York, N.Y. 10019–3780.

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"The Shame of Medical Research" by David J. Rothman, in The New York Review of Books (Nov. 30, 2000), 1755 Broadway, Fifth Floor, New York, N.Y. 10019–3780.

As American medical researchers have pressed the fight against AIDS, some have been conducting more of their clinical trials in Africa and Asia. So have investigators from American drug firms who want to test new treatments for various ailments without the regulatory and financial burdens of research at home. But the researchers seldom give their overseas test subjects the same high level of medical care that Americans receive. Rothman, a professor of social medicine at the Columbia College of Physicians and Surgeons, says this is wrong.

The question of whether Western standards should be applied in Africa and Asia first arose, Rothman says, after clinical trials in the United States determined in 1994 that the drug azidothymidine (AZT), though highly toxic, significantly reduced the transmission of HIV from infected pregnant mothers to their children. This treatment immediately became standard in American hospitals, but it was too expensive ($800 for a six-month course of AZT) for developing countries, where the average citizen spends less than $25 a year on health care. Researchers then sought to determine whether administering a small amount of AZT late in the pregnancy, at a cost of only $50, would be almost as effective. They conducted clinical trials involving some 17,000 pregnant women, mostly in southern Africa and Thailand. The women generally were given either the small amount of AZT or a placebo. Had the trials been conducted in the United States, Rothman notes, the women in the control group would have been given not a placebo but the alreadyproven six-month AZT treatment.

Critics such as Marcia Angell of the New England Journal of Medicine charged that in giving the women placebos, the researchers showed "a callous disregard of their welfare," in violation of the World Medical Association’s code of ethics for human experimentation. But Harold Varmus and David Satcher, the then-heads, respectively, of the National Institutes of Health and the Centers for Disease Control and Prevention, which funded some of the research, defended the use of placebos. The six-month AZT treatment, they said, not only was very expensive but required frequent medical monitoring beyond the capacity of developing countries. Use of the placebos also allowed researchers to find out more quickly that the small-dose treatment was effective, thus sparing more infants. Africans and Asians on local review boards had approved the clinical trials, and the United States, proponents said, should not be dictating research ethics for developing countries.

That was far from the end of the controversy, however. "AIDS investigations in developing countries often withhold effective treatments from research subjects," says Rothman. This is not only because the treatments are costly and hard to administer, but because they can fatally undermine the research. For example, researchers from the University of Washington and the University of Nairobi who were studying not the efficacy of AZT but how HIV is transmitted from pregnant women to their children, could not have carried out their study if they had given the women AZT.

Some advocates, Rothman notes, contend "that the tidal wave of AIDS sweeping the world, particularly in southern Africa, is so dreadful that researchers must be given a relatively free hand." But he disagrees. "When we take account of the misery and stunted hopes of people in Uganda, it is not enough for investigators to say that their research left them no worse off.... Do unto others as we do unto ourselves—a principle for researchers everywhere."

 

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