Seroquel User Wants Judge to Unseal Papers for FDA
Wed, 03/11/2009 - 12:39pm
By LINDA A. JOHNSON AP Business Writer TRENTON, N.J. (AP) — A patient who claims the psychiatric drug Seroquel gave him diabetes has asked a judge to unseal maker AstraZeneca's confidential documents about its side effects before U.S. regulators decide whether to approve a version of the drug for millions of new patients. The British drugmaker has applied to the Food and Drug Administration for approval to market Seroquel XR, the extended release version, for depression and anxiety. That would make it a possible treatment for more than 20 million Americans alone. Seroquel XR is now approved for treating schizophrenia and bipolar disorder, which affect far fewer people. A panel of FDA advisers is to consider safety data on Seroquel XR at an April 8 meeting, then make a recommendation to the agency as to whether it should approve the two new uses. Seroquel XR now carries warnings that it can cause high blood pressure, diabetes and death. Lawyers for roughly 15,000 former Seroquel users suing AstraZeneca over alleged harm from the drug claim company officials kept its dangers secret for years. In one of those lawsuits, a Vietnam veteran who took Seroquel for five years is asking a New Jersey judge to unseal some confidential documents his lawyers have obtained during the discovery process in his case. Lawyers for Ted Baker, 60, of Bastrop, La., have asked New Jersey Superior Court Judge Jamie Happas to unseal 19 specific documents — out of roughly 2.85 million generated so far in the litigation — so that they can present them to the FDA advisory panel members at the hearing. The documents in question include internal company analyses of safety data on Seroquel that the lawyers believe FDA staff and advisers have never seen. "We think it's important that they have the benefit of what we have learned," Ellen Relkin, one of Baker's lawyers, told The Associated Press in an exclusive interview Wednesday. "What we believe the FDA does not have are internal memos where they analyze the studies (and state) their real opinions or concerns about the data." Tony Jewell, a spokesman for AstraZeneca, said Wednesday the company believes that all the appropriate scientific data on Seroquel has been provided to the FDA. "We believe the advisory committee process should be based in science and allow for a fair vetting of the issues related to potential new indications for Seroquel XR," he said. "While it is unfortunate that plaintiffs' lawyers are attempting to insert themselves into what should be a scientific discussion, we are reviewing their requests." Baker, who suffered from post-traumatic stress disorder and depression, took Seroquel from 2001 through 2006. He was diagnosed with Type 2 diabetes in March 2004, "due to his Seroquel use," his lawyers claim. The FDA does allow third parties and members of the public to make comments or brief presentations at its advisory committee meetings, and to submit handouts and other materials. An agency spokeswoman could not immediately say whether an advisory panel had previously been presented with evidence that was just unsealed amid litigation over a drug for which advisers were considering additional uses. "I'm not aware of that happening" before, Relkin said. "It's an unusual situation." She said the judge has set deadlines of March 20 for AstraZeneca's lawyers to respond to Baker's motion and supporting brief, and March 25 for Baker's lawyers to then respond. Relkin said it's standard during discovery for both sides to designate all documents as confidential initially to get the process moving quickly, then ask to have that designation lifted. Her brief states that many of the documents should not be sealed. Seroquel has been taken by millions of patients since it came on the market in 1997. Seroquel XR was approved in May 2007 for treating schizophrenia in adults and approved in October 2008 for use in patients with bipolar disorder. Relkin said plaintiffs lawyers believe the drug causes Type 2 diabetes through two mechanisms: stimulating appetite and significant weight gain, and by raising levels of blood sugar and cholesterol.