March 19, 2009

Seroquel Research Scandal At Univ. Of Minnesota

The St. Paul Pioneer Press has a fine article out today detailing how one University of Minnesota psychiatry professor, Charles Schulz, claimed that Seroquel's performance was superior to older drugs like Haldol when in fact the research data he was working with showed Haldol to be more efficacious. Schulz made this claim in 2000. From 2002 to 2007, he receieved $112,000 in fees from AstraZeneca, the drug's maker, plus about $450,000 from Eli Lilly, the paper reports.

The details of this are stunning, so read the article and remember that the anonymous blog referred to in the paper's account of Schulz, who defends his work, is none other than Clinical Psychology and Psychiatry: A Closer Look, authored by none other than CL Psych, which broke the news around Schulz on March 2. And that news came out of the Seroquel documents, which CL Psych got from this website.

Check out how the paper attributed to Cl Psych:

"An Internet psychiatry blog first raised questions March 2 about the research Schulz presented at the APA conference and why it lacked any of the company's findings.

"'It raises troubling questions when an independent academic author presents results that are in direct opposition to the underlying data,' wrote the blogger, an anonymous academic."

I've never before seen a paper attribute to an anonymous blog, except for some of those satirical blogs such as the one allegedly detailing Steve Jobs' life.

Meanwhile, AZ spokesman Tony Jewell issued this statement, which says in part:

"AstraZeneca believes the totality of the science around Seroquel – including company-sponsored studies, research sponsored by the federal government, and physician experience – confirms it is an effective and appropriate treatment choice for patients with serious mental illness."

Would AZ like to include unpublished studies and buried studies in the "totality of the science around Seroquel?" Or is the company planning to make Study 15 available to the public?

Posted by Philip Dawdy at March 19, 2009 01:09 PM
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Comments

What the heck is there to say at the Seroquel Hearing beyond NO, Advisory Committee, recommend NO for extended use of Seroquel XR? Do we say: Take this AND Zyprexa off the market because the evidence is OUT that negative clinical trials were suppressed? Recommending black boxes has no effect: Look at all the elderly dying like flies despite the black box? And the zillions of kids on this class of drugs? And if the FDA gets copies of the hidden negative trials but is not ALLOWED to share them? Or not allowed to copy other countries like Japan and slap black boxes all over them immediately, thus saving lives? What - recommend that Congress do something? Last time we tried that, with PDUFA re-authorization, the drug safety effort was shredded like wheaties. Put the recommendations out anyway and make sure DRS. Hamburg and Sharfstein at least hear the agony?

My pessimism knows no bounds at this point.

Posted by: anonymous at March 19, 2009 07:07 PM

well congrats and way to go to CP! Clinical psych blog, quoted...that's a step forward for mental health blogs!

Posted by: Stephany at March 19, 2009 09:00 PM

I agree with anonymous. It's ridiculous that they are even having a hearing with all the recent publicity surrounding the failure of the science behind the original approval -- I mean, sexual favors, hidden studies, total corruption of results -- the drug shouldn't even be on the market let alone being approved for something as widespread as "depression and anxiety." It's making a mockery of the whole system that's supposed to be preserving our public health.

Posted by: Sara at March 19, 2009 09:33 PM

I totally agree, Sara!

Posted by: Stephany at March 20, 2009 02:21 AM

$662.000 in five years.
I don't know how much the others receive.
When will it be possible to create a charter of who receives how much from the Pharmas?

Politician -
Researcher -
Rep. -
Ghost-writer -
Kol -
Physician M.D. -
Physician PH.D -
Psychologist -

FDA (a list with the occupation and fees)

The list is long.

Posted by: Ana at March 20, 2009 01:02 PM

Totality. that's a good one. Totality.

Posted by: MedsVsTherapy at March 21, 2009 07:53 AM
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