The ongoing controversy about the US Army's AIDS vaccine trial took a new turn last week, when a senior statistician involved in the program resigned. Bill McCarthy, director of Biostatistics at the Army-sponsored Jackson Foundation, alleged that the Army had "covered-up" information relating to the release of early data on MicroGeneSys' gp160-based VaxSyn candidate.
Much of the controversy centers around Bob Redfield, who first presented the results of an efficacy study of VaxSyn at the AIDS conference in Amsterdam last year. It was on the strength of this data that the Army selected the MicroGeneSys vaccine for inclusion in its study. Dr McCarthy has been at odds with Dr Redfield for some time, and has alleged that the data presented at Amsterdam did not reflect the actual results of the Phase I gp160 trial (Marketletter November 22, 1992). As a result of an investigation by the National Institutes of Health, funding was transferred to the NIH and a new protocol involving several different vaccine candidates was proposed. Earlier this year, however, the responsibility and funding for the trial reverted to the Department of Defense.
After his resignation, Dr McCarthy said that the enquiry set up by the Army to investigate the matter, which exonerated Dr Redfield of scientific misconduct, was a "whitewash" which failed to address the issue appropriately. The Jackson Foundation management has turned a blind eye to the situation because of its reliance on Army funding, he adds.
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