NIH Official Altered Drug Study

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Dr. Edmund Tramont, director of the National Institute of Allergy and Infectious Disease Division of AIDS, altered the conclusions from a safety report on pregnant women taking the drug nevirapine in order to cover up its negative side effects.

Since the mid-1990s, nevirapine, an antiretroviral drug, has been used despite government warnings that it could cause deadly liver problems or rashes when multiple doses were administered over time.

A study in 2002 was conducted to evaluate whether or not nevirapine could possibly decrease the risk of mother-to-child HIV transmission.

Multiple Problems With Drug Research

Medical safety experts, an NIH auditor and the manufacturer of the drug agreed that there were various faults discovered within the study. Some of these faults included giving improper doses to study participants and neglecting to report specific fatal and detrimental reactions to the drug.

A report compiled by a medical officer under Tramont, Dr. Betsy Smith, revealed that the research lacked in safety reporting. Smith also reported that the records kept of the patients failed to meet the standard level of clinical research.

Tramont Puts Positive Spin on Drug Reports

Tramont requested to review the report before it was passed on to the FDA. Interestingly enough, after his review the report showed very different recommendations, none of which included any of Smith's prior recommendations. Tramont's revised recommendations reported that any negative reactions regarding the drug use were not of importance in assessing the safety of the drug.

Tramont also claimed he wrote the report after the inquiry into the changes in Smith's report.

The family of Joyce Ann Hafford paid the ultimate price for the negligence of the drug nevaprine -- her life. Despite the signs of liver failure, Hafford's doctors continued to give her the experimental drug nevaprine throughout her pregnancy as an attempt to save her unborn son from contracting AIDS.

It was only after the family received copies of NIH's internal case documents from the Associated Press that they realized the experimental drug regimen was the likely cause of Hafford's death.

Medical News Today December 16, 2004

Houston Chronicle December 15, 2004

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