As the White House prepared an initiative to combat AIDS in Africa, the Associated Press reported that top NIH officials glossed-over severe problems with an ongoing study of nevaripine to prevent maternal-fetal transmission of the HIV virus. An NIH consultant found major problems with a site in Uganda in 2002. Westat Inc., hired to audit the site, found failure to get patients' consents for the study, under-reporting adverse drug events, and administration of wrong drug dosages.
But Dr. Edward Tramont, the Director of the AIDS Division of the NIAID, over-ruled objections to continuing the project, "I want this restriction lifted ASAP because this site is now the best in Africa run by black Africans and everyone has worked so hard to get it right..." Further, he wrote it was important to encourage Africans' fight against AIDS "especially when the President is about to visit them." The Deputy Director of the Division, Dr. Jonathan Kagan objected, "we should not be motivated by political gains and it's dangerous for you, of all people, to be diminishing the value of our monitors." Nonetheless, Tramont erased concerns about the Ugandan site from an official report that wound up at the FDA. The NIH never warned the White House.
Further documents about this case are available here.
Here it appears that politics once again trumped good research methods, and possibly patients' safety.
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