Nevirapine cuts mother-to-child HIV transmission. Credit: AFP Photo/Anna Zieminski

An AIDS drug used to block transmission between mothers and babies in Africa may be more dangerous than health officials knew. According to documents obtained by the Associated Press, the chief of the US National Institutes of Health (NIH) AIDS Division, Edmund Tramont, changed a report on the antiretroviral drug nevirapine to minimize safety concerns.

The drug has been shown to decrease mother-to-baby HIV transmission by 50%, but can also promote drug-resistant forms of the virus, which can limit treatment options for the mothers at later times. It has also been linked to potentially fatal liver toxicity, as well as less serious side effects.

In 2002, five years after the NIH began studying the drug in Uganda, several reviews of the trial pointed to flawed research practices and underreporting of side effects. The research was halted while the NIH and outside auditors reviewed the project. Tramont reinitiated the study 15 months later, after reportedly rewriting a report that said safety data collected from the trial may be inaccurate.

The NIH supports the research, citing the many babies saved by the drug, but has also stopped recommending nevirapine as the first-choice treatment for prevention of mother-to-child transmission of the HIV if other options are available. An NIH review board has cleared Tramont of all scientific misconduct allegations. The US National Academy of Sciences is reviewing the issue and expects to release a report in March.