Despite flaws in study, HIV drug is called safe

Although U.S. standards were violated, studies on a drug used to shield babies against HIV infection from their mothers were sound enough to prove the drug's efficacy, an expert panel said.

WASHINGTON - Controversial U.S. 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 from HIV infection, 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 first obtained by The Associated Press.

The report, released Thursday, will have implications in Africa, where medical officials are debating whether to withdraw the drug, and in the United States, where investigators are examining whether U.S. 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 and which has been engulfed in months of controversy but has insisted that 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.

Researchers last year warned that a single dose of the drug given to a pregnant woman to protect her baby could make the mother resistant to later treatment with the drug.

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 taken or will take the drug in the single-dose regimen can be sure it is safe.

The Associated Press reported in December that the U.S. Office For Human Research Protections had concluded that the NIH experiment in Uganda that dated to the mid-1990s had violated federal patient safety regulations.

However, the NIH did not inform the White House of the problems before the United States began sending hundreds of millions of dollars worth of nevirapine to Africa in 2002 to try to stop the spread of AIDS from infected pregnant women to their babies.

The NIH has acknowledged that its study suffered from flawed document keeping and violated some federal rules but said it believes its scientific conclusions about nevirapine's usefulness and safety remained valid