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Seroquel study exposed, drug risks kept secret.

On Behalf of | Mar 18, 2009 | Firm News

Created: 18 March 2009

In an story that appears on its front page, the Washington Post (3/18, A1, Vedantam) reports, “The study would come to be called ‘cursed,’ but it started out just as Study 15” which “was a long-term trial of the antipsychotic drug Seroquel.” Recently exposed “documents show” that “Study 15 suffered the same fate as many industry-sponsored trials that yield data drugmakers don’t like: It got buried” and “it took eight years before a taxpayer-funded study rediscovered what Study 15 had found — and raised serious concerns about an entire new class of expensive drugs.” The study’s findings “were never published” or distributed to physicians, and marketing campaigns were developed based on “less rigorous studies” that yielded “positive results.” The FDA received the results of the study but “the agency has strenuously maintained that it does not have the authority to place such studies in the public domain.” Only through lawsuits have the “details of Study 15…emerged.”