Seroquel is not approved for children.  It has a black box suicide warning for kids and the elderly.
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    St. Petersburg Times
    Facing numerous Seroquel lawsuits, drugmaker AstraZeneca releases documents
    By Kris Hundley  
    In Print: Saturday, February 28, 2009

    The public got a glimpse into the inner workings of a global pharmaceutical
    company Friday when AstraZeneca released more than 100 sealed documents
    in a tsunami of lawsuits claiming its powerful antipsychotic Seroquel caused
    diabetes, weight gain and other health problems.

    Among the documents:
    A Chicago psychiatrist who claimed patients lost weight on Seroquel had his
    research touted in AstraZeneca's marketing materials — then trashed in
    interoffice memos. Seroquel marketing managers discussed "burying" the
    results of three unfavorable clinical trials and "cherry-picking" useful data from
    a fourth. Even before the drug received FDA approval in September 1997, an
    AstraZeneca employee was praising a co-worker's great "smoke-and-mirrors"
    job on a key study.

When physicians asked about the link between Seroquel, diabetes and weight gain — a link the
company's safety manager warned about as early as 2000 — Christine Ney, AstraZeneca's "scientific
alignment manager," had this advice in a voice mail to sales reps in August 2005: "neutralize customer objections" and "refocus" on the positive by
referring to a handy "Weight and Diabetes Sell Sheet."

"Thanks everyone and good selling!" Ney said.

Seroquel, approved for schizophrenia and bipolar disorder but prescribed for everything from insomnia and depression to ADHD in kids, is one of the
world's bestselling drugs, with $4.45 billion in sales last year.

But like another leading antipsychotic, Eli Lilly & Co.'s Zyprexa, Seroquel has been blamed for causing diabetes, weight gain and other health
problems. Lilly has agreed to pay $1.2 billion to settle patients' lawsuits and $1.4 billion to settle criminal charges of illegal marketing.

AstraZeneca, a U.K.-based company, says the FDA has repeatedly upheld the safety of Seroquel, and the company plans to vigorously defend itself
against thousands of patient lawsuits.

Regarding Friday's disclosures, company spokesman Tony Jewell said: "Selected documents produced in connection with the Seroquel product liability
litigation do not provide a fair and accurate picture. The evidence will show that AstraZeneca acted reasonably and responsibly with regard to the
development and marketing of Seroquel."

About 6,000 personal injury complaints have been consolidated in U.S. District Court in Orlando for pretrial proceedings. In a victory for the drugmaker,
the judge dismissed the first two cases set for trial. Another 3,000 cases are pending in state courts.
In addition to the personal injury cases, AstraZeneca is being sued by four states for off-label marketing of Seroquel. The company said the U.S.
Attorney's Office in Philadelphia is investigating its marketing practices.

AstraZeneca had resisted efforts to unseal hundreds of company documents produced in the Orlando proceedings. "This (disclosure) could jeopardize
public safety by causing confusion and alarm in patients, who may then discontinue their medication without seeking the guidance of a medical
professional," the company's lawyers said in a court filing.

But just hours before a hearing Thursday, AstraZeneca and plaintiffs' attorneys hammered out a compromise: All but a handful of documents would be

Steve McConnell, AstraZeneca's attorney, argued that the remaining papers must remain confidential because they contain trade secrets and other
proprietary information. Among the sealed documents are results of two clinical studies, sales' reps call notes since January 2004 and correspondence
with foreign regulatory authorities.

McConnell also insisted that communication between AstraZeneca and the FDA regarding expanded use of Seroquel should remain under wraps
because the "negotiating process" is ongoing.

But U.S. Magistrate Judge David Baker was skeptical. "What about the public interest in reviewing the integrity of the FDA's administrative process?" he
asked from the bench.

"The public might want to know if the FDA is running a slipshod operation."

The judge ordered the agreed-upon material to be made public by Wednesday. The first batch hit the court's electronic files Friday.

Among the documents was harsh criticism from an AstraZeneca executive of Dr. Michael J. Reinstein, a Chicago psychiatrist who was one of the
company's paid consultants for Seroquel. In a note in October 2001, Georgia Tugend, U.S. brand manager for Seroquel, slammed the quality of
research performed by the doctor's group.

"Our clinical colleagues have significant and numerous issues in the past with the quality of research that this group has produced,'' she said in the
internal memo. "There is little confidence that Good Clinical Practices can be adhered to."

This is surprising because the documents also included a Seroquel marketing piece featuring Reinstein's research showing that the drug had led to
weight loss in a patient.

Reinstein said Friday that AstraZeneca paid him about $40,000 a year for 10 years to promote Seroquel
among doctors. Reinstein, who said AstraZeneca ended his contract at the end of 2007, described the
company's negative comments as "sour grapes."
Full story here:

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St. Petersburg Times
Facing numerous Seroquel lawsuits,
Drugmaker AstraZeneca releases documents
Page created 2/28/09, modified 4/1/09
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