Saturday, January 11, 2014

How many psychiatric studies were done at the U and who did them?

Last week I posted lists of psychiatric studies conducted at the University of Minnesota by Charles Schulz and Stephen Olson from 2001 through 2013. (You can also see those lists on Scribd: Olson's studies are here, and Schulz's studies are here.)  I can't be sure that this list is complete, but it is what I was given by the university in response to a Data Practices Act request. There are a couple of oddities here, and I could use some help trying to figure them out.

The first is an inconsistency (to put it politely) between the number of studies listed for Charles Schulz, and the number Schulz claimed to have conducted when he was questioned by an attorney for Mary Weiss.  The list I was provided indicates Schulz was principal investigator for eleven studies between 2001 and 2006.  But in his deposition, which was conducted in 2007, Schulz says, "I have not been the principal investigator of a study for quite some time, maybe one or two studies."  (See page 20 of the deposition, which corresponds to page 18 on Scribd.)

This is puzzling. What reason would Schulz have to tell an attorney that he had only conducted one or two studies when he had actually done eleven?  Later, when Schulz is asked many studies he has been the principal investigator for in the last five years, he replies, "I'm thinking of two or four."  (See page 159 of the deposition, and page 143 on Scribd.)  The correct number, according to the list I was given, appears to be ten.

The other puzzle concerns AstraZeneca's mysterious Study 41. Study 41, of course, 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.  The published study lists Schulz as an investigator.  But Mark Rotenberg, the General Counsel for the university until last year, has claimed that Schulz was not an investigator for the study and that no subjects were enrolled in the study at the University of Minnesota. (See my previous posts on Study 41 here and here.)

The newly released list of studies does little to clarify the puzzle. Study 41 is not listed among the trials conducted by Charles Schulz.  Instead, Stephen Olson is listed as the Study 41 principal investigator.  (See number 50 on the chart.)

To be honest, I'm not sure what to make of this information.  Why would Schulz claim to have done such a small number of studies?  If Schulz "did not participate in Study 41," as Rotenberg claims, why would his name appear as a Study 41 investigator in the published study?  Is it true that no subjects were enrolled in Study 41 at the U?  According to the chart, the study ran for over 18 months under Olson's direction.  That's a long time for a study to run without accruing any subjects at all.

If anyone has any thoughts, please email me, leave a comment on this post, or leave a comment on the Community Alliance for Ethics in Minnesota Psychiatry Facebook page.

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