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News & Analysis | REG•WATCH Blog | Press Room
Wednesday, December 15, 2004
NIH Chief Rewrote Safety Report on AIDS Research
US officials reportedly knew of problems with AIDS drug nevirapine and hid their findings from the White House, allowing them to go ahead with a $500 million distribution plan of nevirapine in Africa. Another Associated Press report revealed that NIH chief of AIDS research, Edmund Tramont, rewrote the safety report on the US-funded drug study in Uganda, changing its conclusion and deleting negative information. Excerpts provided by the AP show the astounding difference between the originals and the revisions. For instance, the original report stated, "Acceptable or required timeframes for reporting SAEs (severe adverse events) and deaths were not followed.'' The statement was revised to say, " There was some concern expressed by one of the American physician monitors about the adequacy of standards of clinical care in Uganda.'' The documents obtained by AP include both the original and revised report as well as written correspondence from Tramont in which he expresses he dismisses attempts from his staff to address the problems with the Uganda study.
UPDATE: Another AP article shows that NIH doctors continued a clinical trial of nevirapine on a pregnant woman after they knew the drug was causing acute liver-failure, which eventually led to the woman's death. NIH then hid their knowledge of cause of death from the woman's family.
Read AP article.
Read AP documents.
Posted by Genevieve Smith
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