Data undermining Thai HIV vaccine trial not reported, AHF disappointed

AIDS Healthcare Foundation (AHF), the largest non-profit HIV/AIDS healthcare provider in the US which now provides treatment and services for more than 110,000 individuals in 21 countries worldwide in the US, Africa, Latin America/Caribbean and Asia, expressed frustration and disappointment at the news that data that seriously undermines a widely reported Thai HIV vaccine trial were not released publicly when other, more favorable data from the vaccine trial were publicly reported late last month. The release of only partial—and favorable—data, which showed initial efficacy in approximately one third of the Thai vaccine trial participants, led to worldwide favorable publicity for the thought-to-be-promising vaccine effort, which was conducted by researchers from the US Army and Thailand.

According to the Wall Street Journal (Oct. 10-11, 2009), a second heretofore suppressed or previously unreleased analysis of data from the same Thai vaccine trial suggested that the “modest protection highlighted by researchers might be a statistical fluke.” The Journal reported that the additional data were available to the US and Thai researchers on September 24^th when they announced the trial results to worldwide acclaim, but they chose not to release them. WSJ also noted,

“The incomplete disclosure raises the question of whether the Army, the Thai government and the U.S. National Institutes of Health—which helped fund the study—rushed to give a positive spin to what may turn out to be another inconclusive AIDS-vaccine effort.”

“Following the repeated failures in AIDS vaccine research over the years, the premature and partial reporting of select—and favorable—vaccine trial data here underscores an inherent and glaring conflict of interest: Researchers working on NIH-funded vaccine trials may be tempted to try to show successful outcomes regardless of what the data may actually show in order to maintain or increase NIH funding for continuing research,” said Michael Weinstein, President of AIDS Healthcare Foundation. “What is needed is rigorous review and evaluation of such vaccine trial data by an independent outside body. For NIH-funded scientists or US government researchers to also evaluate and discuss the significance of their own research is akin to allowing students to grade their own papers. Data can be cherry-picked; more so, if there is an incentive for future or increased government research funding based on today’s thought-to-be ‘promising’ outcomes.”