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NIH Official Caught Altering Drug Safety Report

In another blatant act of rewriting drug safety, according to Associated Press reports, Dr. Edmund Tramont, director of the National Institute of Allergy and Infectious Diseases Division of AIDS, rewrote a safety report on the use of the antiretroviral drug nevirapine in pregnant women in order to change its conclusions and remove negative information about the drug.

Nevirapine is an antiretroviral AIDS drug used since the mid-1990s, and the government has warned since at least 2000 that it could cause lethal liver problems or rashes when taken in multiple doses over time.

More than two years ago, the National Institutes of Health (NIH) received data from a Ugandan study testing whether nevirapine can reduce the risk of mother-to-child HIV transmission that prompted the agency to suspend the trial for more than a year and warn Uganda's government of the risks associated with the drug when used in pregnant women.

According to documents obtained by the Associated Press, poor record keeping might have caused an underreporting of severe reactions to the drug, including deaths. The documents also show that Tramont and other NIH officials regarded the problems with the trial as exaggerated and did not immediately report safety concerns about the drug to the FDA.

Those admissions are little consolation to the family of Joyce Ann Hafford, a pregnant HIV-positive woman from Memphis, Tenn., who died from liver failure, a toxic side effect of nevirapine, administered during a U.S. drug trial. In fact, Hafford's family says they were never told NIH had concluded that the experimental drug regimen likely caused her death until the Associated Press gave them copies of NIH's internal case documents this month.

Even worse, Hafford seemed unaware of the liver risks, according to her family. They even kept the bottle of nevirapine showing it had no safety warnings.

Blind greed, gross misconduct or a skewed view of the world, take your pick... The world of conventional medicine isn't a very safe place.

Medical News Today December 16, 2004

Houston Chronicle December 15, 2004

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