A Scientific Panel Backs AIDS Study Done in Africa
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WASHINGTON – The American research in Africa that violated federal patient protection rules was nevertheless conducted well enough to support its conclusions that the AIDS drug nevirapine could be used safely to protect babies, an expert scientific panel has concluded.
“The committee finds that there is no reason based in ethical concerns about the design or implementation of the study that would justify excluding its findings from use in scientific and policy deliberations,” the Institute of Medicine panel said in a report.
The report, released yesterday, will have implications in both Africa, where medical officials are debating whether to withdraw the drug, and in America, where investigators are examining whether American research is complying with federal law. The report was welcomed as good news at the National Institutes of Health, the federal agency that funded the nevirapine study in Uganda. The NIH has been engulfed in months of controversy, but has insisted the drug is safe.
“NIH expects that the findings by the IOM will restore confidence in the validity of the conclusions of this study, allow the controversy surrounding the issue to subside, and facilitate policy decisions that seek to promote the health of newborns at risk of HIV infection,” the agency said in a statement.
The Elizabeth Glaser Pediatric AIDS Foundation, one of the largest providers of AIDS assistance in the Third World, also hailed the report’s finding, saying those who have and are taking the drug in single doses can be sure it is safe.
“I think this will now allow us to put to rest the questions about the safety and efficacy of nevirapine,” said Mark Isaac, the foundation’s vice president. It was reported in December that the U.S. Office of Human Research Protections had concluded the NIH experiment in Uganda that dated to the mid-1990s had violated federal patient safety rules.
However, NIH did not inform the Bush White House of the problems before America began sending hundreds of millions of dollars in nevirapine to Africa in 2002 to try to stop the spread of AIDS from infected mothers to their babies.
