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Seroquel Studies Cherry Picked, Company Docs Show

By Jane Akre

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Injuryboard - Help Center - Seroquel Injuryboard News - Expanded use of Seroquel, December 2008 Injuryboard News - Antipsychotics and the sudden risk of death, January 2009 Injuryboard Blog - Cherry Hill New Jersey - Seroquel litigation, February 2009

 

IMAGE SOURCE: Wikimedia Commons/ Seroquel pills/ author: Lucas Bombach

 

Often litigation yields secrets a company would rather keep quiet.

That is what's happened in litigation over the antipsychotic drug, Seroquel, made by AstraZeneca Plc. 

Bloomberg News filed a motion to unseal records in the case and AstraZeneca has agreed to release more than 100 files. 

Lawyers representing former Seroquel users also got the company to unseal thousands of documents before a hearing in Orlando, Florida where federal lawsuits over the drug have been consolidated. 

They show not only did the drugmaker keep quiet about at least three clinical trial results, but Bloomberg reports that the company cherry picked the favorable data from one study for a presentation. 

AstraZeneca is facing about 15,000 lawsuits charging that it failed to warn consumers that Seroquel can cause diabetes while the company promoted the drug for unapproved uses such as schizophrenia and bipolar disorder.

Among the information released was an e-mail referring to a study in which Seroquel was outperformed by Johnson & Johnson's rival drug, Risperdal.  Noting study results that began to show Seroquel's link to diabetes, the drug makers global safety officer said in an e-mail that that was not a conclusion, just a discussion. 

Seroquel is an antipsychotic approved in 1997 by the FDA to treat schizophrenia, hallucinations, delusions and hostility.  It is the company's second biggest seller, generating sales of $4.45 billion in 2008.  In 2003, the FDA eventually required Seroquel carry a stronger warning concerning diabetes.

Nexium is the second largest seller for London-based AstraZeneca.

The FDA has requested additional information about Seroquel after AstraZeneca requested it expand use for generalized anxiety disorder, and adult depression.   

In October, Seroquel received FDA approval for its extended-release version to be used to treat bipolar disorder, making Seroquel XR ("XR" indicates extended release), the first medication cleared for depressive and manic episodes associated with bipolar disorder. The XR designation means the patent is protected until 2017.

"AstraZeneca has studied Seroquel extensively and shared all relevant and required data with the FDA -- both before and after the agency approved it as safe and effective," Tony Jewell, AstraZeneca's spokesman, said in an e-mailed statement to Bloomberg.

Two lawsuits against AstraZeneca over Seroquel have already been dismissed for failure to prove the plaintiff's diabetes was linked to their use of the drug.

AstraZeneca is vowing to fight the litigation rather than settle.  The company is fighting the unsealing of other files that show what sales reps told doctors during meeting and what the company presented to foreign regulators about Seroquel. 

Antipsychotics are increasingly used to treat bipolar disorder, schizophrenia, ADHD in kids, and even aggressive behavior in Alzheimer's patients. #  

Originally posted at InjuryBoard by Jane Akre

Full post as published by InjuryBoard on February 27, 2009 (boomark / email).