Thursday, February 7, 2013

The deepening mystery over Seroquel Study 41 and Charles Schulz

The mystery over AstraZeneca’s notorious Study 41 has deepened.

Study 41, if you recall, was one of the contested studies of Seroquel that emerged in litigation against AstraZeneca.  Internal emails and documents suggested that the study was buried and the results spun, and that Charles Schulz appeared to be involved.  Here is what I wrote about the study last month for the Mad in America blog:

“Later, in a trial known as Study 41, AstraZeneca compared Seroquel XR – the extended release version of Seroquel – to placebo in patients experiencing acute schizophrenia. The University of Minnesota was one of the study sites, and Charles Schulz was the site investigator. Remarkably, Study 41 showed Seroquel XR performing no better than placebo for schizophrenia.  In emails, AstraZeneca officials refer to Study 41 as a “failed study,” or “code red.” Advisors (such as Schulz) and employees were instructed not to discuss the study. So what did AstraZeneca do? They buried it and tried it again, this time in India, Bulgaria, Romania, the Philippines, Russia, Greece and South Africa. That trial was called Study 132, and it turned out positively. So in 2007 AstraZeneca published that study in the Journal of Clinical Psychiatry. The second author of that study was Charles Schulz, who presented the data at the annual meeting of the American Psychiatric Association and served as the academic point man in company press releases.”

Mike Howard filed a complaint with the university about Schulz’s involvement in Study 41, pointing not only to the hiding of research results but to the fact that the study randomized some acutely psychotic patients to placebos, effectively depriving them of treatment for the duration of the study.  The response  to Howard came from Mark Rotenberg, the General Counsel, who wrote, “Dr. Schulz did not participate in Study 41, because no subjects were enrolled at the University.”

Rotenberg’s statement that Schulz was not involved appears to be at odds with the published study itself, which appeared in Psychopharmacology Bulletin in 2008.  In that journal article, Schulz is listed as a Study 41 investigator.  In fact, the published article has another surprise: Steven Olson is also listed as an investigator for Study 41.  Olson, of course, was the University of Minnesota principal investigator for the CAFÉ study in which Dan Markingson died.

This news raises a number of intriguing questions.  Did Study 41 actually take place at the University of Minnesota?  Was the protocol approved by the IRB?  Did Schulz and Olson each sign a Form 1572 for the FDA?  And why would Rotenberg claim that Schulz did not participate in the study when the published literature indicates that he did?

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