The Wall Street Journal: "Several panel members expressed conflicted feelings. Panel member David Oakes, a biostatistics professor at the University of Rochester, said his vote to keep Avandia on the market wasn't a 'vote of confidence,' but reflected concerns about the quality of the data in several Avandia studies linking it to heart attack risk. ... Former FDA Commissioner David Kessler said the Avandia controversy 'will chart the future direction of the agency on drug safety,' and result in more time and money spent by companies getting drugs approved, and 'more safety for the consumer.' Dr. Kessler noted the recall of the painkiller Vioxx in 2004, which was, like Avandia, linked to serious heart problems after it was on the market. 'Vioxx and Avandia together have shown the agency and industry that they need to address serious, but common adverse events' before approval" (Mundy and Corbett Dooren, 7/14). The Associate Press: "The agency convened the two-day panel meeting to help untangle over 1,000 pages of conflicting evidence about Avandia's risks. The drug has a long, knotty history at the FDA. Since diabetics are already predisposed to heart risks it is extremely difficult to tell which heart attacks are drug-related and which are simply caused by the disease. The task of evaluating Avandia's possible side effects across dozens of studies has dragged on for years without definitive answers" (Perrone, 7/15).
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