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.
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
Firms tied to some MDs who set policy
Treatment advice focuses on drugs, researchers find
By Carey Goldberg
April 2, 2009
Virtually all the psychiatrists who wrote the latest clinical guidelines for how to treat depression, bipolar disorder, and schizophrenia had financial ties to drug companies, according to preliminary findings by Boston-based researchers.
The guidelines focus heavily on medications and give relatively little attention to nondrug treatments and how and when to phase out drugs prescribed for mentally ill patients, the authors wrote. They said three common diagnoses generate some $25 billion in drug sales per year.
"Most patients assume that when they're prescribed a drug, the decision is made on the basis of an objective review of the scientific evidence," said the paper's lead author, Lisa Cosgrove of the University of Massachusetts at Boston. "However, our study raises the question: Is that decision based in science, or is there a financial incentive behind it? This is an important question because the lack of biological tests for mental disorders renders psychiatry especially vulnerable to industry influence." ...
The study, scheduled to be published online this month in the journal Psychotherapy and Psychosomatics, found that among 20 authors of the guidelines, 18 had at least one financial tie to drug companies. It did not name names or specify sums, but found that 12 guideline authors had ties in at least three categories, such as consulting, research grants, speaking fees, or stock ownership.
To find financial ties, Cosgrove and her colleagues, who included Sheldon Krimsky of Tufts University and Dr. Harold Bursztajn of Harvard Medical School, searched publicly accessible databases such as Medline and the records of the federal patent office.