Hype Trumps Science in AIDS Vaccine Research

By: AIDS Healthcare Foundation

Los Angeles, CA - October 26, 2009

Data from the largest HIV vaccine trial ever undertaken was presented last week at the AIDS Vaccine Conference in Paris. Unfortunately, news of the possible misrepresentation of the results of the $105 million study—funded by the U.S. National Institutes of Health (NIH) and the U.S. Military—has already harmed the credibility of AIDS vaccine research. And, without an independent body evaluating the decisions of the NIH, the erosion of public opinion is sure to continue.

News of the first possible breakthrough in 25 years of AIDS vaccine research came fast and furiously last month—generated by press releases. Both the NIH and U.S. Military statements touted the results of the 16,000-person study as 31% effective in preventing HIV infection. However, a secondary analysis—one that was not released—later surfaced, showing that the study results were not statistically significant and that the vaccine was ineffective. Dispiriting, but not entirely unexpected news for a study that combined one failed vaccine with another widely believed to be without promise.

The premature and partial reporting of select—and favorable—vaccine trial data here underscores an inherent and glaring conflict of interest: Researchers working on government-funded vaccine trials may be incentivized to show successful outcomes regardless of what the data may actually prove in order to maintain or increase funding for continuing research. What is needed is rigorous review and evaluation of such vaccine trial data by an independent body. For NIH-funded scientists or US government researchers to also evaluate the significance of their own research is akin to allowing students to grade their own papers.

In a letter published in the journal of Science in 2004, twenty-two prominent AIDS vaccine scientists warned the National Institute of Allergy and Infectious Diseases about the lack of efficacy for the Thai AIDS vaccine trial. Despite this—and the recently- revealed disappointing results of the trial—Dr Anthony Fauci, director of the NIH, still declares that "it is indeed possible to generate an immune response against HIV.” How many more millions of dollars need to be spent before Dr. Fauci is convinced?

From 2000 and 2006, U.S. public-sector funding for AIDS vaccine research more than doubled, from $327 million to $854 million. At an expenditure of nearly $900 million a year, the time has come to push the re-start button on AIDS vaccine research and consider re-directing this funding away from expensive, large-scale clinical trials and into treating the 33 million people living with the disease worldwide.

After the failure of two large-scale vaccine trials, AHF went on record last year opposing wasteful AIDS vaccine funding, believing that if such funding were applied to proven strategies such as effective prevention, testing and access to AIDS drugs, much could be achieved. Numerous scientific studies have shown the potential for treatment to not only save the life of the person receiving it, but to render him or her significantly less infectious. Thus, treatment is prevention and increasing worldwide access to it must be the global health community’s highest priority. Currently, only a small fraction of those infected have access to the medical breakthrough that was established nearly 15 years ago: lifesaving antiretroviral medications.

If additional government funding is to be spent on vaccine research, then an independent review committee must be put into place to evaluate the potential of research avenues. Such oversight will ensure that the millions of dollars in research monies are being spent wisely and effectively, instead of squandered on large-scale clinical trials widely believed to be without promise. Without such oversight, the AIDS community runs the risk of a repeat of this latest debacle and the further undermining of support for such research.

We do recognize that there are some promising avenues of AIDS vaccine research, such as the recent discovery by scientists at The Scripps Research Institute of two rare and potent broadly neutralizing antibodies isolated from a clade A HIV-infected African patient. Such works are highly commendable and indeed should be encouraged by the NIH. It is just that we do not believe in drilling in dry holes where no oil has been found—or in perpetuating areas of research because large-scale commitments have been made. That is simply wasteful. And waste is not acceptable in the life-and-death race to end the AIDS scourge, which has already taken 25 million lives.

As a medical provider caring for more than 110,000 people living with HIV/AIDS in 21 countries, AIDS Healthcare Foundation is not anti-hope. Our organization practices the art of the possible every day. But we strongly believe that hope for an AIDS vaccine should never take the place of rigorous scientific review – especially not in the high-stakes pursuit of a solution to one of the most important humanitarian issues of out time—and with millions of lives hanging in the balance.

Michael Weinstein is President of AIDS Healthcare Foundation. Homayoon Khanlou is Chief of Medicine/USA for the AIDS Healthcare Foundation.