The government's chief of AIDS research rewrote a safety report on a U.S.-funded study of the anti-HIV drug nevirapine, sold in the United States as Viramune, to change its conclusions and delete negative information. Later he ordered research on the drug resumed over the objections of his staff, documents show. Edmund Tramont, chief of the National Institutes of Health's AIDS Division, took responsibility for both decisions. He cited his four decades of medical experience and argued that Africans in the midst of an AIDS crisis deserved some leniency in meeting U.S. safety standards, according to interviews and documents obtained by the Associated Press.
The AP reported Monday that the NIH knew about problems related to a Uganda study of using nevirapine to prevent HIV transmissions from HIV-positive pregnant women to their infants, including record-keeping problems, violations of federal patient safety safeguards, and other issues that forced a 15-month halt to the research. NIH officials acknowledge Tramont rewrote a key safety report on nevirapine and overruled his staff, but said he did so because he was more experienced and had an "honest difference of opinion" with his safety experts. They noted he had no financial interest in nevirapine and that the troubled study began well before he joined NIH in 2001. Lane said an internal NIH review concluded Tramont had not engaged in scientific misconduct.
Tramont admits to changing a report written by one of his medical officers that summarized safety concerns during a review of the Uganda studies. The report, finished in January 2003, said the Uganda trial suffered from "incomplete or inadequate safety reporting" and that records on patients were "of poor quality and below expected standards of clinical research." The lead researcher strongly urged NIH not to make sweeping conclusions about nevirapine based on the Uganda research. "Safety conclusions from this trial should be very conservative," she wrote. But Tramont says he changed the report and altered its conclusion to say that the study "has demonstrated the safety of single dose nevirapine for the prevention of maternal to child transmission," Tramont's version concluded. "Although discrepancies were found in the database and some unreported AEs [adverse reactions] were discovered...these were not clinically important in determining the safety profile." (AP)