The US government's chief of AIDS research rewrote a safety report on a US-funded drug study to change its conclusions and delete negative information. Later, he ordered the research resumed over the objections of his staff, documents show.
Dr. Edmund Tramont, chief of the National Institutes of Health's (NIH) 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 US safety standards, according to interviews and documents obtained by AP.
Tramont's staff, including his top deputy, had urged more scrutiny of the Uganda research site to ensure it overcame record-keeping problems, violations of federal patient-safety safeguards and other issues that forced a 15-month halt to the research into using nevirapine to prevent African babies from getting AIDS from their mothers.
AP reported on Monday that NIH knew about the problems in early 2002 but did not tell the White House before US President George W. Bush launched a plan that summer to spread nevirapine throughout Africa. Now, officials have new concerns the drug may cause long-term resistance in the hundreds of thousands of African patients who received it, foreclosing future treatment options.
"I am not convinced that the site is indeed prepared to become active," Dr. Jonathan Fishbein, an expert NIH hired to improve the agency's research practices, wrote Tramont in July last year.
Fishbein contended he should be given time to review Uganda's capabilities and safety monitoring before letting the site reopen, or NIH would risk being "toothless" in its new efforts to clean up sloppy research practices. He added that professional safety monitors hired by NIH had reservations about the site.
Tramont dismissed the safety monitors' concerns, saying he didn't believe they fully understood AIDS.
"I am convinced that this site is ready to resume given the limitations of doing research in any resource-poor, underdeveloped country," Tramont wrote on July 8 last year, in response to Fishbein.
"I want this restriction lifted ASAP because this site is now the best in Africa run by black Africans and everyone has worked so hard to get it right as evidence [sic] by the fact that their lab is now certified," he wrote.
NIH officials acknowledge Tramont rewrote the report and overruled his staff on the reopening, 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.
Those who raised objections "were part of a large team of which Dr. Tramont was the head, and it is important that the people involved in that team should express their opinion and there should be discussion," said Dr. H. Clifford Lane, the NIH's No.2 infectious disease specialist and one of Tramont's bosses. NIH designated Lane to speak to AP on Tramont's behalf.
Lane said an internal NIH review concluded Tramont had not engaged in scientific misconduct. Separately, the National Academy of Sciences is investigating whether the Uganda research is valid.