Study 15, silence was not golden: Seroquel: you got fat for a reason

From the Washington Post: March 2009

WaPost article:

"Study 15 was silenced in 1997, the same year Seroquel was approved by the Food and Drug Administration to treat schizophrenia. The drug went on to be prescribed to hundreds of thousands of patients around the world and has earned billions for London-based AstraZeneca International -- including nearly $12 billion in the past three years.

AND

"The results of Study 15 were never published or shared with doctors, even as less rigorous studies that came up with positive results for Seroquel were published and used in marketing campaigns aimed at physicians and in television ads aimed at consumers. The results of Study 15 were provided only to the Food and Drug Administration -- and the agency has strenuously maintained that it does not have the authority to place such studies in the public domain."

AND

"The study would come to be called "cursed," but it started out just as Study 15.

It was a long-term trial of the antipsychotic drug Seroquel. The common wisdom in psychiatric circles was that newer drugs were far better than older drugs, but Study 15's results suggested otherwise.

As a result, newly unearthed documents show, Study 15 suffered the same fate as many industry-sponsored trials that yield data drugmakers don't like: It got buried. 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.


Far from dismissing Study 15, internal documents show that company officials were worried because 45 percent of the Seroquel patients had experienced what AstraZeneca physician Lisa Arvanitis termed "clinically significant" weight gain.


Jeffrey Lieberman, a Columbia University psychiatrist who led the federal study, said doctors missed clues in evaluating antipsychotics such as Seroquel. If a doctor had known about Study 15, he added, "it would raise your eyebrows."
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October 2009

Jim Edwards, BNET blog, "AstraZeneca's Fuzzy Seroquel Math: When 45% Gain Weight, It's "Weight-Neutral":

"Even though AstraZeneca executives wrote emails in 1997 saying they believed Seroquel caused weight gain, AZ instructed product managers to promote the drug as having only a “a neutral effect on weight,” according to documents unveiled in litigation in a Florida federal court."

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It appears that gaining 50 lbs. on Seroquel might just be in your imagination, not because of the antipsychotic or your good cooking.