updated 4/7/2005 6:13:23 PM ET 2005-04-07T22:13:23

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, an expert scientific panel has concluded.

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“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 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 was 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 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. “Our sense is we now can focus on the real issue, saving lives.”

AP 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 the United States 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.

NIH acknowledges its study suffered from flawed document keeping and violated some federal regulations, but says it believed its scientific conclusions about nevirapine’s usefulness and safety remained valid. It requested the Institute of Medicine 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 longer than intended in instances where their mothers 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” and no patients in the experiment were ever put in serious jeopardy.

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 disregarded by managers and front-line researchers.

AP reported last month that six of the nine experts who served on the panel currently get money from NIH, the agency which supervised the research they were reviewing. Some members of Congress have questioned whether the financial ties would weaken the report’s credibility.

And the IOM panel did not address emerging data showing nevirapine can create resistance that lasts for months in women or children who took even a single dose, rendering some treatments for their AIDS less effective.

That concern has caused South Africa to call for the end of nevirapine’s use to prevent mother-to-baby transmission of AIDS. More expensive cocktail combinations of drugs are likely to be used.

Isaac said the resistance issue was a concern and that nevirapine should be used to protect babies only when other, better cocktail treatments aren’t available. “This report makes clear nevirapine is part of our arsenal, but it is only part of the arsenal,” he said.

The study also steered clear of the controversy of whether the NIH study complied with Good Clinical Practices (GCP), a sweeping set of record-keeping and patient protections that NIH says it is requiring its researchers to follow.

The IOM panel said GCP was voluntary and that it remained confident the researchers for the study were in “substantial compliance” with the federal guidelines they were obligated to follow — some of which were tougher than the GCP conditions.

Meanwhile, federal and congressional investigations into disputes between NIH’s researchers and the agency officers charged with safety and compliance have elicited new information showing that some concerns reached high into the agency.

For instance, the No. 2 official in the AIDS division, Dr. Jonathan Kagan, wrote an e-mail rebuking his boss, AIDS division director Dr. Edmund Tramont, for trying to give an award to the frontline researchers in the Uganda study within months of the problems surfacing.

“We cannot lose sight of the fact that they screwed up big time,” Kagan wrote Tramont in the 2003 e-mail provided to AP. “And you bailed their asses out. I’m all for forgiveness, etc. I’m not for punishing them. But it would be ’over the top’ to me to be proclaiming them as heroes.”

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