Information About Nevirapine Should Prompt ‘Overhaul’ of NIH’s Treatment of Patients, Warnings, Editorial Says
A recent series of Associated Press articles concerning clinical trials of the antiretroviral drug nevirapine "demand[s] an overhaul of how NIH treats patients and warnings" because Americans should be able to "trust that government medical research is honest and respectful of the patient," a Billings Gazette editorial says (Billings Gazette, 12/22). The articles concerned NIH's research on the use of nevirapine in single doses among HIV-positive pregnant women in Uganda to determine the drug's ability to reduce the risk of vertical HIV transmission. The initial results from the research, which began in 1997, showed that the drug prevented HIV transmission to newborns in as many as half of the births. However, by early 2002, medical safety specialists, an auditor with NIH and 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 and underreporting of fatal and life-threatening reactions to the drug. Because of the reported problems, NIH suspended the research for 15 months from spring 2002 to summer 2003 to review the trial and take corrective steps. Earlier this month, Dr. Edmund Tramont, director of the National Institute of Allergy and Infectious Diseases Division of AIDS, admitted that he altered a safety report on the use of nevirapine in pregnant women to change its conclusions and remove negative information about the drug (Kaiser Daily HIV/AIDS Report, 12/21). NIAID in a statement said the "procedural problems" of the trial "had no bearing on the safety and efficacy of single-dose nevirapine used to prevent mother-to-infant transmission" (NIAID statement, 12/17). Although most medications include risks, determining the level of risk is a decision that should be made by doctors and researchers, as well as patients through an informed consent process, the editorial says. The recent "shocking report" shows that "patients, researchers and government policy makers were deprived of information needed to weigh risks and benefits of a medicine," the editorial says. As a result, the "White House and the Congress must hold NIH accountable," the editorial concludes (Billings Gazette, 12/22).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.