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Disputed AIDS Research Gets OK

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 the disease, 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 obtained by The Associated Press.

The report, which is slated to be made public Friday, will have implications in both 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 will be 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.

AP reported in December that U.S. Office of Human Research Protections had concluded the NIH experiment in Uganda that dated to the mid-1990s had violated numerous federal patient safety rules.

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

NIH acknowledges its study suffered from flawed document keeping and violated some federal regulations, but that it believed its scientific conclusions about nevirapine's usefulness and safety remained valid. It requested the IOM study.

The IOM report states that it, too, found "procedural lapses," record-keeping problems, some unreported adverse events and instances in which researchers failed to get consent to keep African children in the experiment for longer than intended in instances where their mother may have died.

The panel said the underreporting of some bad reactions, known as adverse events in the scientific world, "may limit the generalizability" of some of the study's conclusions.

But it added, "while there were some procedural deficiencies reported by auditors, none appeared to have affected the outcome of the study."

The document is unlikely to end congressional and federal investigations into whether the NIH safety and legal compliance officials' repeated concerns about this and other research projects were repeatedly disregarded by managers and front-line researchers.

By John Solomon