For the past two years, the United States has been conducting experiments on pregnant women infected with HIV in Africa, Thailand and the Dominican Republic, in which some women are given drugs that can prevent transmission of the deadly AIDS virus to their babies and some receive only dummy pills.
The studies are so controversial that even some of the government’s own scientists have questioned whether they are ethical. Now, one of the nation’s most prestigious medical journals has thrown a harsh spotlight on the research, with an editorial that likens it to the notorious Tuskegee experiment, in which poor black men suffering from syphilis were left untreated.
The AIDS studies, which involve 12,211 women in seven countries and are paid for by the National Institutes of Health and the Centers for Disease Control and Prevention, aim to help the developing world find a cheap, effective method of preventing transmission of HIV to babies. The research is based on one of the most dramatic discoveries of the AIDS epidemic: that women who take the drug AZT during pregnancy can cut the risk of transmission by two-thirds.
But the drug regimen, as used in the United States, costs about $1,000 per mother, so public health officials want to know if there are less expensive ways to use AZT to achieve the same benefit. Half the foreign women in the experiments receive AZT, at varying levels that differ from the amounts used in the United States. The other half get the dummy, or placebo, pills.
As a result, critics say, more than 1,000 infants will contract the AIDS virus, infections that the studies’ detractors say could be prevented.
“We have turned our backs on these mothers and their babies,” complained Dr. Peter Lurie of Public Citizen, an advocacy group that has condemned the research.
Federal officials counter that the use of dummy pills is the only way to get a quick, reliable result, and that it is not depriving women of therapy they would have otherwise received, since AZT is not affordable in the Third World. But some critics suggest that this argument is reminiscent of defenses offered for the Tuskegee experiment, in which researchers watched the ravages of syphilis while saying that the subjects of their study, poor black men from rural Alabama, would not have been treated in any case.
“Some of the same arguments that were made in favor of the Tuskegee study many years ago are emerging in a new form in the AZT studies in the Third World,” Dr. Marcia Angell, the executive editor of The New England Journal of Medicine, said in an interview this week. In today’s issue of the journal, Dr. Angell writes that the current AIDS research represents a “retreat from ethical principles.”
The use of dummy medication has always been controversial in medical research, but never more so than with studies involving AIDS. In the United States, advocates for AIDS patients have all but eliminated placebo-controlled clinical trials by demanding that every patient have access to some kind of drug therapy.
But the same is not true in the developing world, where many can barely afford aspirin, let alone expensive medicines like AZT.
Nonetheless, the journal editorial has touched off an intense debate about whether the mother-to-infant transmission studies should continue. Several experts in medical ethics said they had urged officials at the health institutes and the disease-control centers to abandon the studies, or at least reconsider. The National Bioethics Advisory Commission may address the matter when it meets in Washington this week.
“If you tried to do this study in the U.S., you would have to do it through a throng of demonstrators and a sea of reporters,” said Dr. Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. “I wouldn’t do this study without a design that would let me run it without a placebo. I think you owe that to your subjects, even if they are not educated enough, savvy enough to demand it from you.”
Still, Caplan says, the Tuskegee analogy is inappropriate because the Alabama men were falsely told that they were getting treatment. Others agree, and say that that there is nothing wrong with U.S. researchers’ tailoring their studies to the health care systems of other nations, without regard to standards here.
“The facts are different in different places,” said Dr. Norman Fost, director of the medical ethics program at the University of Wisconsin.