Tuesday, April 12, 2005

NIH Officials say agency pressured by Pharma

"NIH medical officer Betsy Smith and Mary Anne Luzar, chief regulatory compliance officer at NIH's National Institute of Allergy and Infectious Diseases Division of AIDS, in taped video testimony said that the 'disregard for federal safety regulations,' is 'so widespread' at NIH that employees are 'afraid' to delay studies even if 'they see a safety problem,' according to the AP/USA Today.

"Luzar and Smith's testimonies were offered in a lawsuit brought against NIH by Dr. Jonathan Fishbein, a former agency employee who claimed misconduct in the reporting of an NIH-funded study on the use of the antiretroviral drug nevirapine among pregnant HIV-positive women in Uganda.

"In her testimony, Smith said that Fishbein was a 'strong advocate' for improving the safety of study participants and his dismissal is 'a warning to other individuals.' She added that division managers were 'totally unsupportive' of safety concerns and gave into 'tremendous pressure' from pharmaceutical companies and researchers in the 'name of trying to cure AIDS.


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