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Policy & Politics

NIH-Funded Study of Nevirapine Use in Pregnant Women Endangered Lives of Participants, Infants, Agency Auditor Says

January 5, 2005

An NIH-funded study on the use of the antiretroviral drug nevirapine among pregnant women in Uganda was "so poorly conducted" that it "potentially put the lives of hundreds" of participants and infants at risk, NIH auditor Dr. Jonathan Fishbein said on Tuesday before a panel of the Institute of Medicine in Washington, D.C., the AP/Yahoo! News reports. NIH -- which maintains that the drug 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 recently decided to fire him for poor performance during a probationary period (Kerr, AP/Yahoo! News, 1/4). However, Fishbein said he believes he is being fired in retaliation for his refusal to overlook research shortcomings. A federal administrative law judge in November denied Fishbein whistleblower status because he was hired as a "special consultant" and therefore lacks standard civil service protections (Kaiser Daily HIV/AIDS Report, 1/3). Fishbein's appearance at the hearing marks his first public testimony since he released documents allegedly showing problems with the nevirapine trial and since a series of Associated Press articles were published detailing concerns with the study (AP/Yahoo! News, 1/4).

Case Background
NIH in 1997 began studying the use of nevirapine in single doses among HIV-positive pregnant women in Uganda to determine the drug's ability to prevent vertical HIV transmission. The initial results showed that the drug prevented HIV transmission to newborns in as many as half of births. However, by early 2002, medical safety specialists and auditors with NIH as well as the drug's manufacturer Boehringer Ingelheim all cited "widespread" problems with the research in Uganda -- including a failure to receive participants' consent about changes in the study, administration of incorrect doses, and delays in reporting and underreporting of fatal and life-threatening reactions to the drug. Because of the reported problems, NIH suspended the research from spring 2002 to summer 2003 in order to review the trial and take corrective steps. Last month, National Institute of Allergy and Infectious Diseases Division of AIDS Director Dr. Edmund Tramont also admitted to rewriting a safety report on the use of nevirapine in pregnant women in order to change its conclusions and remove negative information about the drug. However, NIAID in a "Q & A" document regarding the trial said that nevirapine is a "safe and effective" treatment to reduce the risk of vertical HIV transmission and that reviews of the study data "have found only a very small number of serious adverse reactions that potentially might be due to nevirapine" (Kaiser Daily HIV/AIDS Report, 1/3).

During his testimony, Fishbein "accused NIH of a double standard" and said that the Ugandan study "would not have passed muster" with U.S. health officials, according to the AP/Yahoo! News. "The actions of the NIH reveal a callous indifference to the fate of Africans. African life, it would appear, is not to be valued as highly as American life," Fishbein said. Although Fishbein did not make any conclusions about the safety or efficacy of nevirapine, he did "cit[e] shoddy data collection, careless record-keeping and quality-control issues," the AP/Yahoo! News reports. NIH "rushed to defend the study without really looking closely at what the problems were, the egregious problems in the study," he said, adding, "And they kept defending it and digging themselves deeper and deeper into a hole they couldn't get out of" (AP/Yahoo! News, 1/4). Because of the problems with the study, Fishbein told the panel that he "did not trust any of [its] findings," according to Reuters/Yahoo! News. The Ugandan study was "so poorly conducted that its data must be rendered invalid as a matter of law, policy and human health," Fishbein said, adding that even laboratory data from HIV tests conducted on infants in the study should be discounted. Data were generated, "often by individuals that didn't have the training," he said (Fox, Reuters/Yahoo! News, 1/5).

Dr. Clifford Lane, NIAID acting deputy director, in an interview with the Associated Press said that although there were record-keeping problems with the study, nevirapine is saving infants' lives in Africa, according to the AP/Yahoo! News. "The overall conclusions remain valid that single doses of nevirapine given to the mother during labor and given to the child shortly after birth were safe and could reduce the spread of HIV disease from mother to baby," he said (AP/Yahoo! News, 1/4). AIDS advocates who often disagree with NIAID also have said that despite the Ugandan study's procedural flaws, the data were correctly interpreted. "The data discrepancies don't alter the fundamental findings," Gregg Gonsalves of Gay Men's Health Crisis said. Both Zackie Achmat, head of the South African treatment advocacy group Treatment Action Campaign, and Dr. Mark Dybul, deputy chief of the President's Emergency Plan for AIDS Relief, also have said that nevirapine is an important drug that saves the lives of infants (Kaiser Daily HIV/AIDS Report, 1/3).

Media Must "Carry Out Due Diligence in Reporting," Letter to Editor Says
A recent Billings Gazette editorial concerning the Ugandan trial "failed to mention" that single doses of nevirapine have "prevented thousands of infections and deaths among children in poor countries," Lane and Gregory Folkers of NIAID write in a Gazette letter to the editor (Lane/Folkers, Billings Gazette, 1/5). The editorial said that the recent "shocking report" on the trial shows that "patients, researchers and government policy makers were deprived of information needed to weigh risks and benefits of a medicine" and that the "White House and the Congress must hold NIH accountable" (Kaiser Daily HIV/AIDS Report, 12/23/04). According to Lane and Folkers, "distortions of facts concerning nevirapine may lead to the decreased use in developing countries of a proven, lifesaving regimen to prevent mother-to-child HIV transmission." Therefore, the media must "carry out due diligence in their reporting and editorializing, particularly when drawing conclusions on issues that have a direct impact on public health," Lane and Folkers conclude (Billings Gazette, 1/5).

Back to other news for January 5, 2005

Reprinted with permission from You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at The Kaiser Daily HIV/AIDS Report is published for, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2005 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.
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