Thursday, December 16, 2004

Politics and the NIH Nevirapine Study in Africa

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.

4 comments:

Kevin C. Fleming said...

Yipe. Not unexpectedly, an unelected and unaccountable international NGO has acted in a political fashion that puts its stated goals at risk. In such organizations, innovation and efficiency are far less important than avoiding blame and amassing power.

Egan said...

Here is an excellent example of non-monitary (i.e. political/power) motives as opposed to "evil corporate" ones that I tend to emphasize. With both types of motivating factors, which many argue arise out of characteristics of human nature (power and greed), a potent solution is transparency.

That is whay we need the press!!!! (And blogs like this that allow free and expositional conversation!)

Egan

Roy M. Poses MD said...

To set the record straight, the NIH may be many things, but it's not a non-governmental organization (NGO). Of course, these comments also describe behavior in some government agencies.

Kevin C. Fleming said...

Re: NIH. Of course, Roy is correct (Ed. ~what were you thinking?). The incentives in government and for NGOs are similar, however, and I agree with Egan that transparency is essential.

My concern in cases like this is that having this problem aired is far less helpful than having the correct incentives in the first place.