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Science & Medicine

HIV/AIDS Vaccine Researchers at NIH Meeting Call for Increase in Basic Research, New Strategies

[Mar 26, 2008]

HIV/AIDS researchers called for an increase in basic research on the virus and new strategies for research into a vaccine on Tuesday during an NIH AIDS Vaccine Summit, the New York Times reports. The summit was held to discuss the future of HIV vaccine research following the recent failure of a Merck vaccine candidate (Altman, New York Times, 3/26). Merck in September 2007 announced it had halted a large-scale clinical trial of its experimental HIV vaccine after the drug failed to prevent HIV infection in participants or prove effective in delaying the progression of the virus to AIDS. The vaccine candidate also might have put some trial participants at an increased risk of HIV (Kaiser Daily HIV/AIDS Report, 3/25).

Experts at the meeting said that NIH's National Institute of Allergy and Infectious Diseases should support basic research into HIV prevention, testing and treatment strategies. In addition, researchers said NIAID should support efforts to develop animal models of HIV, and they also called for cooperation between scientists developing such models and those developing vaccine candidates (New York Times, 3/26). NIAID Director Anthony Fauci at the meeting said scientists should begin to focus research on discoveries about the immune system, animal models and innovative vaccine concepts (Chase, Wall Street Journal, 3/26). According to Fauci, more fundamental knowledge about HIV, as well as the way the body and experimental vaccines respond to the virus, is needed before a safe and effective vaccine can be developed (New York Times, 3/26). "We need to turn the knob toward [basic scientific] discovery -- nobody should be unclear about that," he said. Carl Dieffenbach, head of NIH's Division of AIDS, said that the "summit does mark a change in our approach."

Several researchers at the meeting -- which drew about 300 scientists from around the world -- said NIAID should fund new, innovative research proposals and support younger scientists who might abandon HIV vaccine research for less challenging fields (Brown, Washington Post, 3/26). Fauci said an initial step would be to trim existing projects to provide $10 million to $15 million in immediate funds for about 30 grants for researchers who propose novel ideas. He added that some of the grants would go to young scientists (New York Times, 3/26).

According to the Post, NIH is spending about $497 million on HIV vaccine research this year, with about $476 million going to researchers not affiliated with the agency. About 47% of the funds go toward basic research, while 38% go toward human testing of vaccine candidates (Washington Post, 3/26). Fauci said that he will try to increase funding for vaccine research (Emery, Baltimore Sun, 3/26).

Reaction

Fauci said that there is not an "immediate solution to the problem," adding that researchers will need to "justify what [they] are doing" and determine the next steps during smaller meetings (New York Times, 3/26). Michael Weinstein, president of the AIDS Healthcare Foundation, called on researchers to "pull the plug on vaccine research," adding, "Do we have any other enterprise that has been studied for 25 years and for which we've spent billions of dollars where we have no results?" He added that there is "no evidence we'll ever have an AIDS vaccine."

Mitchell Warren of the AIDS Vaccine Advocacy Coalition in response to Weinstein said that the failure of the Merck trial "is not the end of the line for AIDS vaccine research," adding that it is a "critical moment in the field" (Washington Post, 3/26). Glenda Gray of the University of Witwatersrand in South Africa added that "any call to halt vaccine funding is like abandoning Africa." Fauci responded that "under no circumstances" would researchers "discontinue AIDS vaccine research" (Wall Street Journal, 3/26). "We will not discontinue research, period," Fauci said, adding, "Not only will we not decrease it, we will in fact try to increase it" (Baltimore Sun, 3/26).

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Drug Access

Indian Generic Drug Maker Strides Acrolab Receives Tentative FDA Approval for Combination Antiretroviral

[Mar 26, 2008]

FDA on Tuesday announced that it has given tentative approval to Indian generic pharmaceutical company Strides Acrolab for its fixed-dose antiretroviral drug that contains lamivudine, nevirapine and stavudine, Reuters/Yahoo! Malaysia News reports (Reuters/Yahoo! Malaysia News, 3/26). Tentative FDA approval means that although existing patents or other issues prevent marketing of the drug in the U.S., the drug is qualified for consideration in the President's Emergency Plan for AIDS Relief (FDA release, 3/24). The FDA approval is for multiple strengths of the combination therapy, according to Dow Jones (Dow Jones, 3/24). The two versions are 30 milligrams, 150 mg and 200 mg of stavudine, lamivudine and nevirapine, respectively, and 40 mg, 150 mg and 200 mg of stavudine, lamivudine and nevirapine, respectively (FDA release, 3/24).

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