NurseWeek/HealthWeek | Advocacy group call HIV study 'unethical'

Advocacy group calls HIV study in developing countries ‘unethical’

posted 5-9-97

A consumer group is calling for the United States government to halt funding of what it calls unethical studies involving HIV-infected pregnant women in developing countries.

At least 1,000 babies will die because researchers are issuing placebos and withholding zidovudine, or AZT, from some mothers in nine overseas studies, according to Public Citizen, a nonprofit organization founded by Ralph Nader. Previous studies have shown AZT reduces the transmission rate of HIV from mother to newborn by up to two-thirds.

U.S. officials have defended the studies, underwritten by the National Institutes of Health and the national Centers for Disease Control and Prevention (CDC), pointing to a different “standard of care” in the United States and the African, Asian, and Caribbean countries where the studies are taking place.

Similar perinatal studies in the United States provide AZT to all participants, and AZT is a standard course of treatment in the United States. However, the regimen costs at least $800 per person, which is 80 times the annual healthcare budget of residents of many developing countries.

According to researchers, the studies may reveal less expensive alternatives for treatment, including shorter courses of AZT, that may be feasible for women in poorer countries.

The placebo approach is “the most rigorous and the most scientifically valid way” to find new, affordable treatments that are relevant to poor countries and that protect against perinatal transmission of HIV, according to Helene Gayle, MD, director for the National Center for HIV, STD, and TB Prevention at the CDC. “The main goal of our research is to provide answers that are feasible in the countries in which we are doing studies so that we’ll be able to provide a true benefit.”

However, Public Citizen argues that the foreign studies violate a federal law that forbids U.S. physicians from conducting experiments in other countries that would not be tolerated in the United States. In a letter to the Health and Human Services secretary, Public Citizen accused the administration of “perpetrating a new African-Asian-Caribbean Tuskegee in which many more people will die.” The Tuskegee Syphilis Study in Alabama went on for 50 years and involved poor blacks whose syphilis treatment was deliberately withheld by the government.