AIDS drug sent to Africa sparks concern

WASHINGTON – Weeks before President Bush announced a plan to protect African babies from AIDS, top U.S. health officials were warned research on the key drug was flawed and may have underreported reactions including deaths, documents show.

The 2002 warnings about the drug, nevirapine, were serious enough to suspend testing for more than a year, let Uganda’s government know of the dangers, and prompt the drug’s maker to pull its request for permission to use the medicine to protect newborns in the United States.

But the National Institutes of Health chose not to inform the White House as it scrambled to keep its experts’ concerns from scuttling nevirapine in Africa as a cheap solution, documents obtained by the Associated Press report.

“Everyone recognized the enormity that this decision could have on the worldwide use of nevirapine to interrupt mother-baby transmission,” NIH’s AIDS research chief, Dr. Edmund C. Tramont, reported March 14, 2002, to his boss, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

The documents show Tramont and other NIH officials dismissed the problems with nevirapine research in Uganda and were slow to report concerns to the Food and Drug Administration.

Nevirapine research in Uganda was so riddled with sloppy records that NIH couldn’t be sure from patient records which mothers got the drug. Instead, they had to use blood samples to confirm doses, the documents show.