WASHINGTON, D.C.--Fifteen AIDS-therapy trials planned or under way in developing countries violate international and national ethics guidelines, charged Ralph Nader's Public Citizen organization in a press conference here today. But officials from the National Institutes of Health and the Centers for Disease Control and Prevention, which have helped fund the trials, defended them as ethical.
The watchdog group claims that the trials, which test against a placebo several therapies to prevent transmission of HIV from infected mothers to their babies, do not offer the best known treatment--AZT--to all participants. The trials, ongoing or about to begin in Africa, Asia, and the Caribbean, would never pass ethical muster in the United States, says epidemiologist Peter Lurie of Public Citizen. "It's a very clear double standard," he says. The group wants Secretary of Health and Human Services Donna Shalala to order that all participants receive AZT and to launch an investigation.
But Phillip Nieburg of the Centers for Disease Control and Prevention in Atlanta says the studies are ethical and are vital to addressing the double standard that exists in AIDS worldwide. Nieburg, an epidemiologist who was previously involved in one of the questioned trials in the Ivory Coast, points out that an expert panel concluded in 1994 that because lengthy AZT therapy is not feasible or affordable for pregnant women in developing countries, placebo-controlled trials are the best way to rapidly assess alternative treatments. It's unclear, however, whether the government plans to make any changes in the ongoing trials to address Public Citizen's concerns: As ScienceNOW went to press, federal officials were still formulating an official response to the charges.
Lurie concedes that "hundreds of people knew about" these studies. Indeed, Science wrote about them 20 months ago (4 August 1995, p. 624). But, he says, "no one has complained" until now, adding: "We're taking a stand."