NIH Officials Disregarded Concerns Over Welfare of AIDS Drug Study Participants, Agency Employees Say in TestimonyNIH 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).
In her testimony, Smith said the environment at NIH "can be fairly uncomfortable," adding, "There are a number of things that you really don't talk about. You don't hold up any projects even if you feel there are safety issues for certain projects." She also testified that Fishbein was a "strong advocate" for improving the safety of study participants and his dismissal is "a warning to other individuals." According to Luzar, her managers often "sided" with the "front-line researchers" financed by the agency rather than with NIH safety and regulatory officials, the AP/USA Today reports. "I think we (safety officials) got in the way and that we were an impediment to the science," Luzar said, adding 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," the AP/USA Today reports. "I think the culture was certainly strong for a period of time that the ends could justify the means," she said. Testimony from Smith and Luzar and documents obtained by the Senate Finance Committee, which is investigating Fishbein's claims, show that safety concerns over AIDS studies "frequently" were "overruled or delayed" by managers, according to the AP/USA Today. Luzar testified that NIH for two years did not comply with federal regulations and her request to update safety protocol and instruct researchers in a $36 million AIDS drug trial to consider newly recorded side effects of the drug, including "suicidal tendencies," the AP/USA Today reports. Smith also testified that a NIH supervisor delayed reporting the death of a study participant for days and was "behaving as if she were a pharmaceutical company and did not clearly understand regulatory requirements for such a study."
NIH managers in interviews have acknowledged "problems" with their AIDS research program, but they could not address specific allegations because of various ongoing investigations, the AP/USA Today reports. The Senate Finance Committee and the HHS inspector general currently are investigating Fishbein's allegations, while NIH is conducting an internal investigation into claims on sexual harassment. However, NIH managers said they are "taking steps" to end any sexual harassment in the agency and improve communication between employees when safety concerns are introduced, according to the AP/USA Today. "We must be sure our staff works productively and in a timely fashion with our investigators to resolve any issues related to the conduct of our studies, with the highest priority paid to patient safety," NIAID Acting Deputy Director Clifford Lane said. In response to Luzar's testimony concerning the delay in federal safety regulations, NIH said that trial participants were "never in jeopardy" because doctors were informed of the potential side effects "as they became known," according to the AP/USA Today. "It is clear we can do a better job in our communications within the division and our communications with our investigators," Lane said, adding, "We want to see all our processes take place in the quickest possible way, and two years is a long time for any process" (AP/USA Today, 4/11).