Drug Companies Unlikely To Develop HIV Vaccine; Government Must Invest More in Development, NIH Official Says

Pharmaceutical companies likely will wait for the government to develop an effective HIV vaccine because of a lack of financial incentive to develop a vaccine in the private sector, Edmund Tramont, director of the Division of AIDS at NIH's National Institute of Allergy and Infectious Disease, said in July 2005 during a deposition regarding an employment lawsuit, the AP/Yahoo! News reports. Tramont's deposition in the case of former NIH employee Jonathan Fishbein was obtained recently by the Associated Press. "[W]e're going to have an HIV vaccine," Tramont said in the deposition, adding, "It's not going to be made by a company. They're dropping out like flies because there's no real incentive for them to do it." Therefore, he added, government agencies must spend more "time and energy" toward developing new treatments for market. If the government develops an effective vaccine, pharmaceutical companies will then "make it and sell it and make a profit" without having "to make that big investment," Tramont said. However, Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said U.S. drug companies are "firmly committed to HIV/AIDS vaccine research and development, with 15 potential vaccines in development today." He added, "Vaccine research is crucial to controlling the AIDS pandemic, and our companies are well aware of the need to succeed in this vital area of science." Tramont in an e-mail response said the lack of incentive for an HIV vaccine parallels the history of other vaccine development, which is why there "was/is a shortage of flu vaccines." The International AIDS Vaccine Initiative estimates that about $682 million is spent annually on HIV/AIDS vaccine research and development, with about $100 million coming from the private sector (Solomon, AP/Yahoo! News, 12/26/05).

Fishbein Reinstated
Fishbein, who was officially fired by NIH in July 2005 for poor performance during a probationary period, was reinstated as special assistant to the deputy director of NIAID on Dec. 12, 2005, his attorney Stephen Kohn said late last month, the AP/Boston Globe reports (Solomon, AP/Boston Globe, 12/24/05). Fishbein -- who was hired to improve NIH's research practices -- has said he believes he was fired in retaliation for his refusal to overlook research shortcomings, and many members of Congress objected to his dismissal. In January 2005, Fishbein told a panel of the Institute of Medicine in Washington, D.C., that an NIH-funded study on the use of the antiretroviral drug nevirapine among pregnant HIV-positive women in Uganda was "so poorly conducted" that it "potentially put the lives of hundreds" of participants and infants at risk. An IOM panel in April released a report saying that there is no evidence that the Ugandan trial had any serious flaws. An internal, nonpublic NIH report written in August 2004 raised concerns that firing Fishbein would give the "appearance of reprisal," but it also criticized him for not taking enough time to adapt to the "culture" of NIAID (Kaiser Daily HIV/AIDS Report, 7/5/05). According to government officials, Fishbein likely will look for another assignment in the federal government (AP/Boston Globe, 12/24/05). Senate Finance Committee Chair Charles Grassley (R-Iowa) last week welcomed the reinstatement of Fishbein, saying, "His allegations led to an acknowledgement by NIH of deep-seaded, systematic problems that are finally being addressed by high-level managers" (Solomon, AP/Washington Post, 12/28/05).