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Documents on Seroquel Show Drugmaker Knew of Risks

Mon, 03/02/2009 - 4:55am
By LINDA A. JOHNSON AP Business Writer TRENTON, N.J. (AP) — Internal AstraZeneca reports and e-mails written by company officials show they knew a decade ago that their psychiatric drug Seroquel caused diabetes and major weight gain, plaintiffs' lawyers said Friday after releasing dozens of the previously sealed documents. "They not only failed to warn about the risk of diabetes, but they marketed it as not having that risk," said Houston attorney Ed Blizzard, one of the lead attorneys representing roughly 15,000 plaintiffs suing the British drugmaker. 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. AstraZeneca spokesman Tony Jewell said plaintiffs' lawyers are "mischaracterizing that we knew that it caused diabetes." He said it remains unresolved whether Seroquel causes diabetes, and that AstraZeneca PLC has shared all relevant and required data with the Food and Drug Administration, both before and after the FDA approved Seroquel as safe and effective in 1997. "AstraZeneca believes that the Seroquel (detailed package insert) has always provided adequate and appropriate information and warnings based on available data," Jewell said. Blizzard claims that the company knew as early as 1997 that Seroquel caused significant weight gain — a problem linked to the surge in new cases of Type 2 diabetes — and knew by 2000 that it caused diabetes in some patients. "Our position was that the public has the right to know" what the documents contain, Blizzard told reporters during a Friday afternoon teleconference. Among the hundreds of pages released Friday was a report labeled "Safety Position Paper" by AstraZeneca's recently hired global drug safety physician, Dr. Wayne K. Geller, 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 said that document was only a draft and that after reviewing all evidence about Seroquel, company officials concluded it "did not establish that Seroquel causes diabetes." Meanwhile, a 1997 e-mail written by Lisa Arvanitis, then the AstraZeneca project physician for Seroquel, stated, "I was really struck by how consistent the data was" from multiple patient studies showing weight gain "is more rapid initially," but continues for at least a year. "It doesn't stop," she wrote. "The other issue of what we tell the sales force is more problematic." Meanwhile, a memo a few months earlier from an AstraZeneca "commercial strategist," Richard Lawrence, discusses one patient study, called Study 15, presented at a meeting of doctors and states, "Lisa has done a great 'smoke-and-mirrors' job!" The company "could put a positive spin (in terms of safety) on this cursed study," Lawrence adds. A 1999 e-mail from John Tumas, chair of the Seroquel publications team, discusses "cherry picking" of data and states the company by then had "buried" Study 15, two others and was considering doing so with a fourth. A 2001 product brochure states most side effects with Seroquel are "mild or moderate," and that "minimal weight gain may reduce the likelihood that treatment with Seroquel will lead to diabetes." And a 2005 guide for sales representatives written by Christine Ney, whose title was "Scientific Alignment Manager" for Seroquel, 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." Yet the document cites reports of patients taking Seroquel and similar drugs suffering high blood sugar, "in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death." Plaintiffs' lawyers say that until very recently, the company's warnings were buried far down in the lengthy package insert, rather than being put prominently at the top of it. Thousands of Seroquel lawsuits filed in federal courts have been consolidated under one judge in Orlando, Fla. Others are filed in state courts in New York, New Jersey and Delaware, where AstraZeneca has its U.S. headquarters. Blizzard and his colleagues, after obtaining the documents in the course of the litigation, have been seeking since August 2007 to get them released, but AstraZeneca officials had argued they were confidential. On Thursday, just before a hearing at which the company's lawyers were to have to prove to a federal judge why 111 different documents should not be released, AstraZeneca agreed to release 102 of them, Blizzard said. Some of the unsealed documents indicate a further problem for AstraZeneca's sales representatives: Study after study showed Seroquel was not as effective as competing drugs in the same class, including Eli Lilly & Co.'s Zyprexa. Meanwhile, AstraZeneca said Friday that the FDA has asked for additional information about the safety and effectiveness of a newer version of the drug, Seroquel XR extended release tablets. That version is proved for schizophrenia and bipolar disorder, but the company is seeking approval to market it for anxiety and major depression.
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