NIH Reveals Problems with Nevirapine anti-AIDS drug tests in Uganda

The New York Times: U.S. Officials Knew of AIDS Drug Risks:

"The government's research on using an AIDS drug to protect African babies was so flawed that health officials had to use blood tests after the fact to confirm patients got the medicine. Ultimately, they had to acknowledge the study broke federal patient protection rules........

"Ultimately, NIH did stop the Uganda research for 15 months -- from the spring of 2002 to the summer of 2003 -- to review the science and take corrective actions..........

"they acknowledged their Uganda research failed to meet required U.S. standards and have asked the National Academy of Sciences to investigate..........

"Though the White House was never told of the problems, they were serious enough that the U.S. Health and Human Services Department sent a nine-page letter to Ugandan officials identifying violations of federal patient protection rules by NIH's research.......

"In 1997, NIH began studying in Uganda whether it could be given safely in single doses to stop mother-to-baby HIV transmission. That research showed it could reduce transmission in as many as half the births.

"But by early 2002, an NIH auditor, the agency's medical safety experts and the drug's maker all disclosed widespread problems about the U.S.-funded research in Uganda.......

"Boehringer and NIH auditors cited concerns such as failing to get patients' consent about changes in the experiment, administering wrong doses and delays and underreporting of ``fatal and life threatening'' problems.

"'It appeared likely, in fact, that many adverse events and perhaps a significant number of serious adverse events for both mother and infant may not have been collected or reported in a timely manner,'' Westat Corp. found in March 2002. Westat is a medical auditing firm hired by NIH to visit and audit the Uganda site.

"Westat reported there were 14 deaths not reported in the study database as of early 2002 and that the top two researchers in Uganda acknowledged thousands of bad reactions that weren't disclosed."