Posted Mar 18, 2009 06:19 pm CDT
A law firm that represents patients who took the antipsychotic drug Seroquel has revealed documents about a hush-hush study showing patients who took the medicine had a risk of weight gain and diabetes.
The so-called Study 15 was disclosed to the Food and Drug Administration but not to doctors or the public, the Washington Post reports. “The saga of Study 15 has become a case study in how drug companies can control the publicly available research about their products,” the story says.
About 9,210 lawsuits have been filed against the drug maker AstraZeneca International. One law firm representing plaintiffs is Houston-based Blizzard, McCarthy & Nabers. Name partner Ed Blizzard told reporters about the documents in a conference call late last month after a federal court unsealed them, Reuters reports.
The company “not only failed to warn physicians and patients about the risk of diabetes but they also marketed them in a way that represented that there was no risk,” Blizzard said, according to the Reuters story. Company officials even presented a company-sponsored study at two conferences from a Chicago psychiatrist who concluded the medicine helped patients lose weight, the Post story says.
AstraZeneca agreed to release the documents after Bloomberg filed a motion in a Florida federal court seeking their release.
AstraZeneca spokesman Tony Jewell told Reuters that the first two cases alleging harm caused by Seroquel were dismissed for insufficient evidence. He told the Post that the FDA had access to Study 15 before it approved Seroquel as safe and effective, and the study was suspect because so many patients dropped out.