Advisory panel recommendations for expanded marketing approval are usually followed by the FDA.  Philadelphia Inquirer journalist, Miriam Hill, reports that until yesterday, the chair of PDAC was listed as Dr. Jorge Armenteros, a psychiatrist hired by AstraZeneca "to talk to other doctors about prescribing Seroquel, the company's antipsychotic."  But suddenly, his name was removed and the other panel members who were also paid by AstraZeneca, 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."

Worse still: "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."

FDA--CDER procedures raise serious doubts about the legitimacy of its initial approval process by which AstraZeneca gained FDA marketing approval for Seroquel.

"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."

FDA's drug approval process--both initial approvals and expanded label approvals--needs to be thoroughly overhauled, and the CDER leadership removed.

See Seroquel (quetiapine) safety profile: http://news.prnewswire.com/ViewContent.aspx?ACCT=109&STORY=/www/story/04-03-2009/0005000638&EDATE=

Posted by Vera Hassner Sharav

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

PhiladelphiaInquirer

Conflicts for FDA committee set to weigh risks of Seroquel

By Miriam Hill

AstraZeneca P.L.C. 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.

AstraZeneca said yesterday it had no say regarding which committee members vote, and referred questions to the FDA.

Company spokesman Tony Jewell said, "AstraZeneca believes the Advisory Board and the FDA will make the appropriate scientific and medical determination concerning the benefit-risk profile of the company's supplemental new drug applications for Seroquel XR in major depressive disorder and generalized anxiety disorder."

FDA spokeswoman Sandy Walsh said that temporary members sometimes replace standing committee members but that the agency does not say why such substitutions occur. Armenteros remains the chair of the standing committee until his term expires in June, she said.

Many researchers receive pay from the pharmaceutical industry, which funds most research. Government officials have increasingly encouraged disclosure of such relationships.

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.

London-based AstraZeneca did not approve the research, the documents show.

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."

If the FDA committee approves the expansion, it would give AstraZeneca access to millions more patients because so many people suffer from depression and anxiety.

Currently, the FDA has approved Seroquel to treat schizophrenia and bipolar disorder, relatively rare diseases.

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