Weeks before President Bush announced a plan to protect African babies from AIDS, top U.S. health officials were warned that research on the key drug was flawed and may have underreported thousands of severe reactions, including deaths, government 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.
_____Recent AIDS News_____
In China, an About-Face on AIDS Prevention (The Washington Post, Dec 8, 2004)
HIV Infection Rate Holds Steady in U.S. (Associated Press, Dec 2, 2004)
World AIDS Day Marked Amid Warnings (Associated Press, Dec 1, 2004)
HIV Increasing Faster Among Women Than Men, Report Finds (The Washington Post, Nov 24, 2004)
Maker Removes Generic AIDS Drugs From Approved List (The Washington Post, Nov 10, 2004)
More on AIDS
But the National Institutes of Health, the government's premier health research agency, chose not to inform the White House as it scrambled to keep its experts' concerns from scuttling the use of nevirapine in Africa as a cheap solution, according to documents obtained by the Associated Press.
"Everyone recognized the enormity that this decision could have on the worldwide use of nevirapine to interrupt mother-baby transmission," NIH's chief of AIDS research, Edmund C. Tramont, reported March 14, 2002, to his boss, Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases.
The documents show that Tramont and other NIH officials dismissed problems with the nevirapine research in Uganda as overblown and were slow to report concerns to the Food and Drug Administration.
NIH's nevirapine research in Uganda was so riddled with sloppy record-keeping that NIH investigators could not be sure from patient records which mothers got the drug. Instead, they had to use blood samples to confirm doses, the documents show.
Less than a month after Bush announced a $500 million plan to push nevirapine across Africa to slow the AIDS epidemic, the Department of Health and Human Services sent a nine-page letter to Ugandan officials identifying violations of federal patient-protection rules by NIH's research.
Nevertheless, NIH officials said they remain confident after re-reviewing the Uganda study and other research that nevirapine can be used safely in single doses by African mothers and children to prevent HIV transmissions during birth. But they acknowledged their Uganda research failed to meet required U.S. standards.
As a result, NIH recently asked the National Academy of Sciences to investigate its science in the case and has spent millions in the past two years improving its safety monitoring and record-keeping.
One lesson derived from a closer review of the Uganda research is that even single doses of nevirapine can create instant resistance, meaning patients may not be able to use the drug or others in its class again when their AIDS worsens, Lane said.
Lane said NIH officials were aware in spring 2002 about the impending White House announcement on nevirapine but did not tell presidential aides of the problems because they were confident, even before reviewing the Uganda research, that the underlying science was solid.
The White House -- though unaware of the NIH concerns -- also remains confident in Bush's $500 million plan in 2002 to send nevirapine to Africa. Bush approved $2.9 billion for global AIDS fighting next year.
Senate Finance Committee Chairman Charles E. Grassley (R-Iowa) has asked the Justice Department to investigate NIH's conduct. In a letter released yesterday, Grassley said he was compelled to do so by "the serious nature of these allegations and the grave implications if the allegations have merit."