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Skepticism and questions about AIDS vaccine trial

Yesterday I attended a fundraiser in Palo Alto for the Rotary's Child AIDS Project, where some national leaders in the AIDS fight expressed skepticism about the promising results of a new AIDS vaccine study reported last month. Paul Volberding, a professor at UC San Francisco and one of the early pioneers in the epidemic, and Stephen Lewis, former UN Envoy for AIDS in Africa, both shared their misgivings about the latest double-barreled vaccine.

Their concerns emerged just as press reports suggested that the vaccine study may have been flawed. The Wall Street Journal was among the first outlets to report that the findings may have been weaker than originally reported and that the results, in fact, were statistically insignificant.

In the initial announcement Sept. 24 on the trial, researchers said they had found 31 percent fewer HIV infections among patients treated with the vaccine, compared with those who received placebos. The trial involved 16,000 volunteers in Thailand. The treatment involved two vaccines that when tested separately had failed earlier trials. It was the first time an AIDS vaccine was shown to have promise, so there was widespread interest in the findings.

Questions now are being raised as to whether the results were released prematurely, before they had undergone thorough peer review. Anthony Fauci, MD, director of the National Institutes of Allergy and Infectious Diseases, initially declined to speak to the Wall Street Journal but was quoted later in a New York Times story as saying that releasing the results before an AIDS meeting in Paris
this month was a mistake.

Volberding, a professor at UC San Francisco and one of the early leaders in AIDS in this country, told 150 people at the Rotary event that he had doubts about the results from the outset. He said the numbers involved were "too small to be significant." The fact that the two vaccines alone had failed earlier trials made it a "stretch" to think they could work in combination, he said.

Lewis also noted that patients in the trial who received the vaccine combo did not have lower viral loads, or a reduced amount of virus circulating in their systems - a fact that had baffled scientists. That meant the vaccine couldn't be effective over the long term, Lewis noted.

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