Unpublished Study Links Seroquel To Weight Gain, Diabetes

Main Category: Litigation / Medical Malpractice
Also Included In: Schizophrenia;  Diabetes;  Obesity / Weight Loss / Fitness
Article Date: 19 Mar 2009 - 6:00 PDT

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The details of an unpublished year-long study linking AstraZeneca's schizophrenia drug Seroquel to weight gain and diabetes has recently emerged in lawsuits throughout the U.S., making the incident a "case study in how drug companies can control the publicly available research about their products," the Washington Post reports.

The study, known as Study 15, and AstraZeneca internal documents have been released by the law firm Blizzard, McCarthy & Nabers, which is one of several firms that have filed about 9,210 lawsuits alleging that Seroquel caused weight gain, diabetes and hyperglycemia in thousands of U.S. patients. Study 15 compared Seroquel to an older drug called Haldol and found that patients taking Seroquel gained an average of 11 pounds per year, that the drug was not more effective than Haldol in preventing psychotic relapses, and that 82% of the patients on Seroquel dropped out of the study before its completion. AstraZeneca ended the study in 1997, the same year the drug was approved by FDA, and the results were never published or shared with physicians.

FDA had access to Study 15; however, the agency lacked the authority to publicize the results. In its approval of the drug, FDA officials noted that 23% of patients taking the drug in all available studies experienced significant weight increases, compared with 6% of the control-group patients taking sugar pills. Since its approval, Seroquel's label has noted that diabetes and weight gain were seen in some study patients, but the company suggests that such effects are not definitive and might be related to patients' underlying conditions. In 2006, FDA warned AstraZeneca against diminishing such problems in sales pitches.

Internal documents show that in 1999 John Tumas, the head of the AstraZeneca team tasked with getting articles published, defended "cherry picking" data. That year at an American Psychiatric Association conference AstraZeneca presented data indicating that Seroquel helped psychotic patients lose weight based on a company-sponsored review of 65 patients. While the company promoted the data to physicians, internal documents show that AstraZeneca officials did not have much confidence in the psychiatrist who conducted the study and were concerned he violated protocols and did not get informed consent from patients.

Eight years after Study 15, a costly federally funded study found similar results, which "caused consternation among doctors," according to the Post. Jeffrey Lieberman, a Columbia University psychiatrist who led the federal study, said that if a physician had known about Study 15, "it would raise your eyebrows" (Vedantam, Washington Post, 3/18).

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