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Seroquel Studies Cherry Picked, Company Docs Show

Posted by Jane Akre
Friday, February 27, 2009 10:37 AM EST
Category: Major Medical, Protecting Your Family
Tags: AstraZeneca, Antipsychotics, Depression, Bipolar Disorder, Alzheimer's Disease, ADHD, ADD, Seroquel

Litigation is yielding internal company documents on Seroquel, the antipsychotic.

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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. #  


3 Comments

Anonymous User
Posted by f@u
Saturday, February 28, 2009 4:45 AM EST

what is this even about? really?

Anonymous User
Posted by Jill Stout
Saturday, February 28, 2009 7:00 PM EST

I am a person with bipolar disorder, and finding medications that help this terrible disease is truly wonderful. My doctor explained the risk of weight gain and diabetes to me, and I chose to take Seroquel anyway, because bipolar is more terrible than diabetes to me. I have had some weight gain but that my bipolar has been controlled by this medication is the critical
factor here. Thousands of other people live more productive and balanced lives with this medication. That must be taken into account. Most doctors, I believe, are honest in informing their patients about the pros and cons of the medications they prescribe, and if not, the pharmacist provides a written report which details all side effects of the medication along with directions about how to take it. There are too many people suffering with this brain disease who need this medication.

Anonymous User
Posted by Don
Sunday, March 08, 2009 7:26 AM EST

I have bipolar disorder, and my doctor had me on this Seroquel. I really like my doctor and would never wish to cause him a problem. However, I had a significant reaction to this drug. I did not gain weight or develop diabetes. But, the medication did the opposite of what it was supposed to do (stabilize mood). I forget the medical term my doctor used, but I became even more manic, highly agitated, and felt that my unauthorized actions were authorized. In that state of mind, I made decisions at work that could have jeopardized my position. My wife and I have a child going to medical and can't afford that. It still worries me even though no harm was done

Comments for this article are closed.

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