In December, a U.S.-backed Ugandan drug trial sparked scandalous headines: The Associated Press revealed that the National Institutes of Health (NIH) dismissed safety issues related to a study of single-dose nevirapine (Viramune)—the centerpiece of Bush’s 2002 African AIDS campaign—in preventing mother-to-child transmission (MTCT). NIH AIDS division head Edmund Tramont, MD, acknowledged having heavily “edited” a report to the FDA, over his staff’s objections. Months later, the reason remains unknown.
Tramont, an AIDS doc for 20 years, defended his actions as ethical, even as critics called for his head. The study’s science was “first-rate,” he said: In the five-year study’s first phase, nevirapine cut MTCT by half. Still, the NIH suspended the study in 2002 due to poor record keeping. Fifteen months later, Tramont made his revisions—the NIH acknowledges he has the authority to do so—and ordered the test clinic reopened, just in time for a Bush photo-op. Dismissing the timing as coincidental, Tramont presents himself as cutting through red tape to save lives.
But when the AP story broke, some activists began pushing for a nevirapine moratorium, others for Tramont to resign. The Rev. Jesse Jackson of the Rainbow/PUSH coalition told the media: “Research standards and drug quality that are unacceptable in the U.S. must never be pushed onto Africa.” Meanwhile, the South African government accused the NIH of treating Africans like “guinea pigs.”
While not the first choice for MTCT—even one dose can cause resistance in Mom—at $4, it’s affordable. “In a perfect world, every HIV positive mother would have combination therapy,” says Tramont. “You do what you can afford.” Many African AIDS activists agreed, arguing that nevirapine is better than nothing. At press time, the National Academy of Sciences is reviewing the study.