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Strict NIH ethics rules provoke mixed response from scientists
A report due out this month aims to settle serious questions about a clinical trial of an AIDS drug in Uganda. But patient advocates say that the furor over the trial has already caused severe damage—by eclipsing the poor treatment of clinical researchers in developing countries and by undermining the fight against AIDS. The trial, which is called HIVNET 012 and was funded by the US National Institutes of Health (NIH), tested whether short courses of the drug nevirapine could prevent pregnant women in Uganda from passing the disease to their babies. But in December last year, a series of articles by the Associated Press alleged that there were serious flaws with record-keeping in the trial after it started in 1997. The NIH, backed by many scientists and AIDS activists, says the flaws were not serious enough to undermine the study’s finding that the drug regimen works. To clarify the situation, the agency asked the US Institute of Medicine to conduct an independent study of the issue. Their report is expected to be published in late March. But advocates say that the report is unlikely to resolve the most important lesson from the Ugandan trial: that poor countries cannot be expected to perform research to US standards without comparable funding. Arthur Ammann, a doctor and president of the nonprofit group Global Strategies for HIV Prevention in San Rafael, California, says the Ugandan investigators who conducted HIVNET 012 were told by the NIH that they could not receive money to offset overhead costs. This type of funding, which is routinely given to US institutions that receive NIH grants, goes towards such items as buildings, instruments, computers and record-keeping systems. “To ask people overseas to do trials to our standards without giving them comparable resources is a slap in the face,” Ammann says. As a result of lobbying by Ammann and other advocates, the NIH changed its policies after the HIVNET 012 trial ended. The agency now allows overseas grantees to receive overhead costs of up to eight percent on top of grants—still much less than the 30% or more awarded to US institutions. The NIH has also begun funding more training for clinical investigators in developing countries. But critics say these are only the first steps, and that they would like to see complete parity with US clinical trial researchers. Without this, they say that problems are likely in other investigations, particularly in light of the growing amount of clinical research on HIV vaccines, malaria and tuberculosis in developing countries. “We’ve got to do everything we can to support research infrastructure there,” Ammann says. Meanwhile, other advocates are fighting to convince pregnant women in developing countries that it is still safe to take nevirapine—a drug they say has prevented thousands of women from passing HIV on to their babies. They say the Associated Press articles have reignited confusion and fear among AIDS patients. “There are people going on the radio and telling people to stop taking nevirapine,” says Nathan Geffen, national manager for the Treatment Action Campaign, an advocacy group based in South Africa. “This is having consequences for public health.” Erika Check, Washington DC Child protection: Furor over nevirapine may have undermined HIV prevention efforts.