Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
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Associated Press (12.15.04) - Wednesday, December 15, 2004
John Solomon
Tramont's top deputy and other staff had urged closer scrutiny of a Uganda research site in response to issues - including record-keeping problems and violations of federal patient safeguards - that had led to a 15-month halt in an experiment examining whether a single dose of the drug could prevent mother-to-baby HIV infection.
On Monday, AP reported that NIH knew about the problems in early 2002 but did not inform the White House prior to President Bush's launch of a program to distribute nevirapine across Africa.
In July 2003, Dr. Jonathan Fishbein - an expert hired by NIH to improve research practices - wrote to Tramont that NIH risked being perceived as "toothless" if the suspended experiment were resumed before Uganda's capabilities and safety monitoring were reviewed. Tramont dismissed the concerns of safety monitors, saying he did not believe they fully understood AIDS, and called for the restriction to be lifted "ASAP." In an e-mail, Tramont wrote that it was important to encourage Africans' fight against the epidemic "especially when the president is about to visit them." A few days after Tramont ordered the clinics reopened, Bush visited Africa.
Officials at NIH acknowledged that Tramont rewrote the report and overruled his staff on restarting the experiment; he did so, they said, due to an "honest difference of opinion" with safety experts. Tramont had no financial interest in nevirapine, and the flawed study began well before 2001, when he joined the agency.
Dr. H. Clifford Lane, one of Tramont's supervisors at NIH, said an internal review found Tramont had not engaged in scientific misconduct. The National Academy of Sciences continues to investigate whether the Uganda research was valid. Lane said NIH believes it helped save hundreds of thousands of African babies by administering nevirapine. However, he acknowledged problems with the research and said NIH now believes nevirapine should not be the first choice to prevent HIV in infants - if other options are available - because of the recent discovery that a single dose may cause long-term resistance to AIDS drugs.
On Tuesday, the Elizabeth Glaser Pediatric AIDS Foundation expressed concern that the controversy over the 2002 research could deter African nations from using nevirapine; it called on medical experts to deliver new, better solutions to the developing world.
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