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Philadelphia Inquirer
Conflicts for FDA committee set to weigh risks of Seroquel
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Philadelphia Inquirer
Conflicts for FDA committee set to weigh risks of Seroquel

By Miriam Hill
Apr. 4, 2009

AstraZeneca paid Florida child psychiatrist Jorge Armenteros to talk to other doctors about prescribing
Seroquel, the company's powerful antipsychotic.

And until yesterday, Armenteros also was listed as the chair and a voting member of a Food and Drug
Administration advisory committee with a lot of power over Seroquel, which generated $4.45 billion in sales
last year for AstraZeneca, whose U.S. headquarters are in Wilmington.

On Wednesday, the advisory committee is expected to decide whether to expand dramatically the use of
Seroquel XR, an extended-release version of the drug, which is used to treat depression and anxiety. But
five members - including Armenteros, who did not return a call to his Coral Gables, Fla., office seeking
comment - will not be voting.

Why not?

Paul Pennock and Steve Sheller, lawyers who are suing AstraZeneca and other makers of antipsychotics on
behalf of patients who say the drugs triggered their diabetes, say it's because they uncovered company
documents revealing potential conflicts of interest ...

In documents Pennock obtained as part of the lawsuits, the most serious of the possible conflicts detailed
involves Armenteros. In addition to being a paid speaker for AstraZeneca, he proposed research comparing
Seroquel to Risperidone, a competing psychotic used to treat aggression in children ...

Armenteros often studied antipsychotics in children, according to a database funded by the National
Institutes of Health.

"How can someone sit as chair of an FDA advisory committee crucial to AstraZeneca and Seroquel for five
years even though he was an extensively trained speaker for AstraZeneca on Seroquel?" asked Pennock, a
lawyer for the New York firm Weitz & Luxenberg.

The revelations come amid intense scrutiny of the FDA and of relationships between researchers and drug
companies.

"The industry is infected with greed," said Sheller, who runs the Philadelphia law firm that bears his name.
"You can't trust the approvals, you can't trust the studies, and now you can't trust the FDA."

Continued here: http://www.philly.com/inquirer/business/20090404_Conflicts_for_FDA_committee_set_to_weigh_risks_of_Seroquel.html


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