Policy & Politics
NIH Officials Disregarded Concerns Over Welfare of AIDS Drug Study Participants, Agency Employees Say in Testimony
April 11, 2005
NIH officials "repeated[ly]" disregarded agency employees' concerns over the safety of participants in AIDS drug trials, according to the testimony of two senior officers and documents gathered by investigators, the AP/USA Today reports. 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," as well as sexual harassment and "intimidation," 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 (Solomon, AP/USA Today, 4/10). Fishbein in January told a panel of the Institute of Medicine in Washington, D.C., that the Uganda study was "so poorly conducted" that it "potentially put the lives of hundreds" of participants and infants at risk. NIH -- which maintains that nevirapine is safe for single-dose use in HIV-positive pregnant women to reduce the risk of vertical HIV transmission -- asked IOM to conduct a review of the study. NIH hired Fishbein to improve its research practices, but the agency earlier this year decided to fire him for poor performance during a probationary period. However, Fishbein said he believes he was fired in retaliation for his refusal to overlook research shortcomings (Kaiser Daily HIV/AIDS Report, 2/4). An IOM panel last week released a report saying that there is no evidence that the Ugandan trial had any serious flaws (Kaiser Daily HIV/AIDS Report, 4/8).
Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/hiv. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2004 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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