The setting is Africa and Asia. The research subjects are pregnant women infected with the AIDS virus. The purpose of the studies, sponsored by the U.S. government, is to see if a short regimen with the anti-AIDS drug AZT can reduce the chances that an in fected mother will transmit the lethal virus to her baby. Half the women will get the course of AZT; the other half will get no drug treatment.
Remember Tuskegee! cries a Washington watchdog organization, referring to the shameful government experiment begun in the 1930s in which poor rural African American men with syphilis were not given available treatments for their disease. Once again, the c ritics charge, research subjects in government studies are being denied effective treatment. How can one group of women not be given any drug treatment -- when there is a proven treatment to protect the fetuses of pregnant women infected with HIV, the vir us that causes AIDS? Once again, the critics charge, the research subjects are poor; once again, they are people of color.
"In essence, the U.S.-funded researchers are conducting experiments abroad that would never pass ethical muster in the U.S.," write Peter Lurie and Sidney M. Wolfe of Public Citizen Health Research Group and several other physicians in a letter to Donna E . Shalala, the secretary of the Department of Health and Human Services.
But is this really Tuskegee Redux?
The concern over AIDS studies in Africa and Asia is less an ethical dilemma than an economic one. The proven regimen with AZT used in the United States to reduce the chances of the virus passing from mother to child is not available in the developing worl d. It is too complicated to provide on a large-scale basis and too costly. It requires that a woman take AZT tablets for one-third of her pregnancy and receive intravenous AZT during delivery; in addition, the infant is given the drug for six weeks after delivery. .
Scientists conducting the AIDS studies point out that the women are not being denied care, because the AZT regimen is not available in these countries. The whole point of the research is to find a simpler drug therapy that has some chance of being used in developing countries, where the problem of pediatric AIDS is most severe.
"There's no denial [of care]," says physician Phillip Nieburg of the U.S. Centers of Disease Control and Prevention (CDC). "If the women were denied a drug that's available to the general population, that would clearly be unethical."
In human research, scientists usually compare a new treatment against standard therapies. "You take the standard of care -- whatever it is -- and compare it with a new intervention. Unfortunately, in the developing world there is nothing in the standard o f care," says Nieburg.
The principles of medical research are the same regardless of global boundaries. These principles have to do with respect and protection of people who enroll in medical studies, their informed consent and knowledge of the purpose of the study, the likelih ood of benefit, and a just and uniform standard in the way the study is carried out.
Research in developing countries with vulnerable populations and relatively high rates of disease call for even more stringent precautions to guard against exploitation. A key principle, according to international ethical guidelines drawn up under the aus pices of the World Health Organization in 1993, is that the research address the health needs and priorities of the community participating in the study.
Certainly pediatric AIDS is a health problem of crisis proportions in developing countries. Infant death rates, which had been declining in Africa, are on the rise. By the year 2010, for example, infant mortality rates in Zambia are expected to be 60 perc ent higher as a result of AIDS; in Malawi, 40 percent higher. Finding a cost-effective strategy to block mother-to-infant transmission of the virus is a priority in these countries.
In two studies sponsored by the CDC, for example, one in the Ivory Coast, the other in Thailand, half the women will be given a short course of AZT and half will receive no drug treatment. It's not clear that a reduced regimen of AZT will be effective. Sc ientists are also concerned about side effects from the drug, particularly anemia, which is already a chronic problem for many women in developing countries.
Comparing the new regimen to no treatment is the most efficient way to determine the therapy's benefit, Nieburg says. For developing countries to invest in an anti-AIDS therapy, they have to be sure the benefit is worth the cost. Instead of a therapy that costs about $1,000 to administer to each woman, they are looking for a strategy that costs maybe $50. As Nieburg says: "These very poor countries have to make very tough choices about scarce health resources."
As the superpower in medical research, the U.S. government has to be like Caesar's wife and stand above even the perception that ethical standards have been bent. But in developing countries where an estimated 1,000 HIV-infected babies are born each day, the overriding goal is to find a cost-effective therapy. For now, it seems that the studies underway in Africa and Asia are the quickest way to achieve that goal.
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