The Associated Press reports (below) that lawyers for Ted Baker, 60, of Bastrop, La., have asked New Jersey Superior Court Judge Jamie Happas to unseal 19 specific AstraZeneca documents–out of roughly 2.85 million generated so far in the Seroquel litigation– so that they can present them to the FDA advisory panel members at the hearing.
As was reported on February 27, AstraZeneca documents that had been collected during Seroquel litigation in Florida, documents that were unsealed by the judge, reveal that the company “buried” unfavorable studies that showed the drug posed a serious risk for diabetes.
A plaintiff in the NJ case, Ted Baker, a Vietnam veteran, suffers from a drug-induced, debilitating disease–diabetes–which he claims is a consequence of taking Seroquel. His lawyers argue: "What we believe the FDA does not have are internal memos where [AstraZeneca scientists] analyze the studies (and state) their real opinions or concerns about the data."
Evidence uncovered during litigation shows that the company concealed vital drug safety data–thereby putting patients prescribed their drug at risk of debilitating, life-shortening disease. Beyond the disturbing evidence of corporate crime, is the disinterest shown by FDA officials whose responsibility is to make drug safety determinations based on an examination of all the scientific evidence.
Instead of requesting from the court documents pertaining to drug safety information–as a matter of public health policy–FDA officials limit their drug safety analysis to selective information presented to the FDA by the drug manufacturer.
Indeed, FDA's disinterest in the concealed information uncovered by the Seroquel litigation is demonstrated by its onvening an advisory panel hearing for April 8–while the drug's safety is a matter of mass litigation–to consider EXPANDING the approved use of this dangerous, diabetes inducing drug for depression and anxiety.
AP reports: "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."
On April 8, the committee will discuss safety and efficacy issues of supplemental new drug applications from AstraZeneca Plc for Seroquel XR for the treatment of major depressive disorder and generalized anxiety disorder. Particular safety issues for discussion on April 8, regarding the Seroquel XR applications are concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinesia.
For those wishing to testify at the FDA hearing:
Those who wish to testify must submit request by MARCH 18
Written testimony has to be submitted by March 27
CONTACT: Yvette Waples. Her email is yvette.waples@fda.hhs.gov. Her fax is 301-827-6778. Phone is 301-827-7001.
You have to contact her if you want to speak at the meeting, which is to be held at the Hilton Wash. DC/Silver Spring Hotel, the Ballrooms, 8727 Colesville Rd. Silver Spring MD . When asking to speak (1-2 each day) tell name or names of presenters, brief statement of topic, and time needed….. Of course, time needed is not what you get–that depends on the time alotted for public comment, and the number of speakers. Speakers should consider giving 20 to 30 written copies of your testimony with attachments, if any, to the psychopharmacological committee and extra copies for press handouts.
ASSOCIATED PRESS
Seroquel user wants judge to unseal papers for FDA
March 11, 2009 – 4:37pm
By LINDA A. JOHNSON
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.
(Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.)