AIDS Research Chief Rewrote Safety Report

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Dr. Edmund Tramont, chief of the National Institutes of Health (news - web sites)'s AIDS Division, took responsibility for both decisions. He cited his four decades of medical experience and argued that Africans in the midst of 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 that forced a 15-month halt to the research into using 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 (news - web sites) launched a plan that summer to spread nevirapine throughout Africa. Now, officials have new concerns the drug may cause long-term resistance in patients who received it, foreclosing future treatment options.


"I am not convinced that the site is indeed prepared to become active," Dr. Jonathan Fishbein, an expert NIH hired to improve the agency's research practices, wrote Tramont in July 2003.

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more: http://story.news.yahoo.com/news?tmpl=story&cid=541&ncid=716&e=4&u=/ap/20041214/ap_on_he_me/aids_drug

....Behind the scenes, Tramont asked to see Smith's report before it was submitted to medical authorities, including the Food and Drug Administration (news - web sites). "I need to see the primary data — too much riding on this report," Tramont wrote Jan. 23, 2003.

A few weeks later, the safety report was published and sent to FDA (news - web sites) without Smith's concerns and with a new conclusion.

The study "has demonstrated the safety of single dose nevirapine for the prevention of maternal to child transmission," Tramont's version concluded. "Although discrepancies were found in the database and some unreported AEs (adverse reactions) were discovered ... these were not clinically important in determining the safety profile."

In disbelief, Tramont's staff began inquiring how Smith's report got changed. An answer came back from the top.

proof: http://www.newsmeat.com/fec/bystate_detail.php?st=MD&last=Tramont&first=Edmund