AstraZeneca PLC knew a decade ago that their psychiatric drug Seroquel caused diabetes and major weight gain but failed to warn physicians and patients about the associated risks said plaintiffs' lawyers.

The lawyers said as per documents that were unsealed in a U.S. federal court with reports and e-mails written by company officials it was apparent that AstraZeneca knew of the risks associated with the drug as far back as 2000.

Ed Blizzard, an attorney at Blizzard, McCarthy & Nabers in Houston was representing roughly 15,000 plaintiffs suing the British drug maker who say they developed diabetes from taking Seroquel, part of the family of drugs known as atypical antipsychotics.  He said, "They not only failed to warn about the risk of diabetes, but they marketed it as not having that risk."

As per the plaintiffs claim Seroquel, approved for treating schizophrenia and bipolar disorder, caused diabetes, weight gain and related health problems, from kidney failure and heart attacks to amputations and damage to the pancreas, which makes insulin. Seroquel is AstraZeneca's second-biggest selling drug with $4.5 billion in sales in 2008.

Tony Jewell, a spokesman for AstraZeneca said the plaintiffs' lawyers are "mischaracterizing that we knew that it caused diabetes. AstraZeneca believes that the Seroquel (detailed package insert) has always provided adequate and appropriate information and warnings based on available data.
 
He added "AstraZeneca has studied Seroquel extensively and shared all relevant and required data with the FDA." The drugmaker "believes that the Seroquel label has always provided adequate and appropriate information and warnings based on available data," he added. Jewell said the first two cases alleging harm from Seroquel have been thrown out of court for insufficient evidence.

Blizzard said internal e-mails and other documents showed AstraZeneca officials had evidence of Seroquels' link to weight gain which is a risk factor for the development of diabetes. He added that the company knew as early as 1997 that Seroquel caused significant weight gain and knew by 2000 that it caused diabetes in some patients and still used promotions suggesting Seroquel had no effect on weight or could lead to weight loss.

Among the documents opened on Friday was a report by AstraZeneca's recently hired global drug safety physician, Dr. Wayne K. Geller, labeled "Safety Position Paper", that detailed 27 reports from 1994 through 2000 about diabetes in Seroquel patients, 19 of them new cases and eight exacerbations of existing diabetes.

"There is reasonable evidence to suggest that Seroquel therapy can cause impaired glucose regulation including diabetes mellitus in certain individuals," Geller concluded. Jewell called the document a draft and said that after reviewing all evidence about Seroquel, company officials concluded it "did not establish that Seroquel causes diabetes."

The list of papers that was opened included a 1997 e-mail written by Lisa Arvanitis, then the AstraZeneca project physician for Seroquel referring to multiple patient studies showing weight gain, as well as a memo a few months earlier from an AstraZeneca "commercial strategist," Richard Lawrence, discussing one patient study, called Study 15 and a 1999 e-mail from John Tumas, chair of the Seroquel publications team where he states the company by then had "buried" Study 15. 

The papers also include a 2005 guide for sales representatives written by Christine Ney, whose title was "Scientific Alignment Manager" for Seroquel, where she instructs them to "neutralize customer (doctor) objections to Seroquel's weight and diabetes profile," partly by stressing that "to date the available data has not established a causal link between diabetes and Seroquel."
About 9,000 Seroquel lawsuits involving 15,000 patients have been filed, and many have been consolidated in Florida. Others are filed in state courts in New York, New Jersey and Delaware.