Lives of Ugandan Babies in Danger

NIH Researcher says U.S. Government Botched Ugandan AIDS Study

A U.S.-funded study testing an AIDS drug in Uganda endangered the lives of hundreds due to negligent research practices, a researcher with the National Institute of Health said recently.

Last Tuesday Dr. Jonathan Fishbein made public statements condemning research methods and practices of a study testing the effectiveness of the AIDS drug nevirapine, used to help protect babies in Africa from being infected with HIV during and shortly after birth.

At a hearing before a panel of experts from the Institute of Medicine, Fishbein asserted that the study was "so poorly conducted that its data must be rendered invalid as a matter of law, policy, and human health."

"African life it would appear is not to be regarded as highly as American life," Fishbein told investigators.

The panel has been asked to validate Fishbein’s claims that the study was so flawed that data generated should be rendered unacceptable, requiring an entire re-evaluation of the procedure of treating HIV-infected, pregnant women a single dose of nevirapine to prevent the spread of the infection to the baby.

The NIH, who conducted the study, acknowledged that the research done in Uganda did not meet required U.S. standards but defends itself by citing the hundreds of thousands of babies have been saved through the use of nevirapine.

As reported in the Washington Post, Dr. Clifford Lane, a deputy director at the National Institute of Allergy and Infectious Diseases admitted that in 2002, when the study was reviewed, some flaws were found but "in reviewing everything and double-checking . . . we found nothing to question the safety and efficacy of nevirapine."

This is not the first instance in which the overall effectiveness of nevirapine has been questioned.  Last year Africa’s Medicines Control Council (MCC) decided to reject the NIH study due to the allegations of flawed research.

The African National Congress (ANC) accused United States health officials with using Africans as guinea pigs in order to promote the sales of the drug by lying about negative side effects.

Used since the 1990’s, Nevirapine is considered a valuable drug by U.S. health officials and AIDS activists but it is also known for its potentially deadly side effects.  The NIH website specifies potential fatal side effects of the drug including liver failure and skin reactions in addition to several less severe ones.

Nevirapine, marketed in the United States as viramune, can be administered to pregnant women in order to prevent the infection of HIV to their fetuses.  The drug passes easily through the mother’s bloodstream into the baby’s, helping to protect it both during development and after birth.