AIDS Drug Safety Report Changed

If a drug company had done this, heads would roll:

WASHINGTON – The government’s chief AIDS researcher removed some negative safety conclusions from a subordinate’s report on a U.S.-funded drug experiment, then ordered the research to resume over objections from his staff, memos show.

As justification, Dr. Edmund Tramont, chief of the National Institutes of Health ‘s AIDS Division, cited his four decades of medical experience and argued that Africans with an AIDS crisis deserved some leniency in meeting U.S. safety standards, according to interviews and documents obtained by The Associated Press.

Tramont’s staff, including his top deputy, had urged more scrutiny of the Uganda research site to ensure it overcame record-keeping problems, violations of federal patient safety safeguards and other issues. These problems had forced a 15-month halt to the research into using a single dose of nevirapine to prevent African babies from getting AIDS from their mothers.

AP reported Monday that NIH knew about the problems in early 2002 but did not tell the White House before President Bush launched a plan that summer to spread nevirapine throughout Africa.

Now, officials have new concerns the lone dose of nevirapine may cause long-term resistance to AIDS drugs in the hundreds of thousands of African patients who received it, foreclosing future treatment options.

NIH officials say that Tramont’s actions were based on his greater experience and an “honest difference of opinion” with his safety experts, and pointed out that Tramont has no financial interest in promoting nevirapine.

O-kay.

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