A panel of medical experts has defended a controversial U.S. AIDS study in Uganda that has been attacked for improprieties. The research shows that an AIDS drug can safely reduce an infected mother's ability to transmit the deadly virus to her newborn during childbirth. Allegations had surfaced that the study was flawed.
A late 1990s study by U.S. and Ugandan researchers of more than 600 pregnant women showed that a single dose of the drug nevirapine given during labor cut mother-to-child HIV transmission by half.
The findings have led to widespread nevirapine use in Africa because it is inexpensive and easy to administer once a woman's labor begins. It is also given to the newborn in the first week after birth.
But critics charged that the study was flawed and failed to report serious side effects of the drug. An Associated Press news report in December said 14 infant deaths and thousands of bad reactions were not disclosed during the Ugandan testing.
Because of the controversy, the U.S. agency that funded the study, the National Institutes of Health, asked the Institute of Medicine, an independent advisory body to the U.S. government, to review the study and its procedures. After inspecting all documents related to the research, nine doctors, public health experts, and medical ethicists appointed by the Institute of Medicine conclude the Ugandan study is valid.
Panel member Mark Kline, a Baylor College of Medicine pediatrician, explains.
"Nevirapine really is the cornerstone of efforts to reduce mother-to-child transmission of HIV in poor countries around the world, particularly in Africa, so the concerns that have been raised about the study really have had a chilling effect on the use of this drug," he said. "So we're happy to report that the drug is efficacious and is safe because we would obviously like to do anything we possibly can do to help to provide tools for the prevention of mother-to-child transmission of HIV in poor settings around the world."
The experts upheld the appropriateness of the study procedures and found no evidence that the researchers failed to report infant deaths. The panel did find that the scientists failed to report some adverse health events in some infants during the trial, but it found no evidence that the underreporting differed between those children who got nevirapine and those who got a drug with which it was being compared, AZT.
The National Institutes of Health (NIH) says that only 10 percent of the adverse reactions were due to the drugs.
The Institute of Medicine (IOM) evaluation comes as a relief to Marc Isaac of the Elizabeth Glaser Pediatric AIDS Foundation, a U.S. organization that supports nevirapine use in 20 countries.
"The IOM is unassailable as a respected body," she said. "This is the definitive clean bill of health that we were all looking for. It should be a true turning point. This should be a moment where we can turn away from controversy and turn toward providing services to people in the world who need them and saving lives."
The U.S. National Institutes of Health says criticism of the Ugandan study was misinformation that could have caused the deaths of thousands of newborns from HIV had doctors stopped using nevirapine.