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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