Saturday, March 2, 2013

Did the University of Minnesota destroy disputed Seroquel study records? The mystery of Study 41 continues.

This week I received a puzzling and alarming series of emails from yet another University of Minnesota official.

On February 7, 2013, I posted a blog entry about AstraZeneca’s notorious Study 41, the failed trial of extended-release Seroquel that AstraZeneca had buried and spun with the help of Charles Schulz. The mystery was whether Charles Schulz was a Study 41 investigator, as this internal AstraZeneca email suggests, or whether he was merely the PR front man for a later study. Mark Rotenberg, the General Counsel for the university, claimed that Schulz “did not participate in Study 41, because no subjects were enrolled at the University.” Yet Schulz is listed as a Study 41 investigator on the published study in Psychopharmacology Bulletin. So was his colleague, Stephen Olson.  This discrepancy raised a series of questions. Did the university IRB approve Study 41, and if so, were Schulz and Olson listed as Study 41 investigators? Were any subjects enrolled at the University of Minnesota? If so, were any subjects harmed in the trial?

On February 9, I filed a Data Practices Act request with the university. I asked for two things. First, I asked for the FDA Forms 1572 for Charles Schulz and Stephen Olson. (The Form 1572 documents an investigator’s commitment to supervise a study and provides assurance that he or she will comply with FDA regulations.) University of Minnesota IRB guidelines require all investigators to submit a copy of the Form 1572 to the IRB (see section 3.16 of the guidelines). Second, I asked for any Serious Adverse Event reports submitted to the IRB. Those reports would document any deaths or serious injuries that occurred in the trial.

The response to my request came from Susan McKinney, the Director of Records and Information Management at the university. At first McKinney told me that investigators are not required to file Forms 1572 with the IRB. When I pointed out that current IRB guidelines suggested otherwise, she sent me an even more alarming reply. She said, “In accordance with the University of Minnesota retention schedule, this file was destroyed in 2010. I have enclosed a copy of the destruction certificate.”

I am not sure what to make of this response. It is impossible to tell from the “destruction certificate” whether any records were in fact destroyed. But if they were, their destruction strikes me as very suspicious.

First, like the CAFÉ study, Study 41 was sponsored by AstraZeneca. But the IRB submission for the CAFÉ study guaranteed the retention of study records for a minimum of 15 years (see page 79.)  And that IRB submission is dated February 11, 2002 – during roughly the same period as Study 41. Yet the records for Study 41 were allegedly destroyed after only seven years. Why would two AstraZeneca studies of Seroquel conducted during the same general time period have such dramatically different retention schedules?

Second, if the records for Study 41 were destroyed on January 6, 2010, as the destruction certificate appears to suggest, it is hard to know how Mark Rotenberg and Frances Lawrenz could have adequately investigated Mike Howard’s complaints about Schulz and Study 41. Howard’s complaint to the Board of Regents is dated December 28, 2009, and Mark Rotenberg’s response claiming that no subjects were enrolled in Study 41 at the university is dated February 11, 2011. If the Study 41 records were destroyed only nine days after Howard’s original complaint, what evidence is Rotenberg drawing on for his claim that no subjects were enrolled at the university? Of course, it is possible that Rotenberg had sources for his information apart from those filed at the university. But he cites no sources for his claim.

Third, if the “destruction certificate” is correct, the University of Minnesota destroyed the records for Study 41 while AstraZeneca was still battling federal charges that it had fraudulently marketed Seroquel. In early 2009, internal AstraZeneca documents had revealed that Charles Schulz was involved in spinning a different Seroquel study – so-called “Study 15” -- to make Seroquel appear better than the study indicated. The Star Tribune reported that scandal on March 19, 2009. But it was not until April 27, 2010 that the Department of Justice announced that AstraZeneca had settled federal charges for $520 million. Why would the University of Minnesota destroy Study 41 documents while those documents might still be relevant to ongoing federal charges?

5 comments:

  1. The statement in the article suggesting that Dr. Schulz did not participate in the study because he didn't enroll anyone is actually immaterial in my opinion. If he was listed as a investigator along with Dr. Olson in the published paper, named by the study sponsor AstraZeneca as a investigator, where does Mark Rotenberg get off by saying he wasn't involved? That's insane. So where is the retraction from whatever journal naming Schulz and Olson as investigators? If the published paper on the study can't even get the correct names of the investigators and what study sites contributed to the data, what good is this published article about study 41? Why should anyone believe a thing the article says? From reading Mr. Howard's complaint against Schulz and his citing of study 41 and Schulz's endorsement of Seroquel from study 132 there is no doubt in my mind that Schulz was nothing more than a paid barker from AstraZeneca, and if this is the accepted standard of teaching and behavior that the University condones there needs to be a much larger investigation than just the one surrounding Dan Markingson and others that have been harmed by the psychiatry research quacks.

    Christine Harmon

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  2. Omerta is a code of silence demanded by the Cosa Nostra or Mafia, and it apparently has found it way into the University of Minnesota. The University has treated the Markingson case with nothing more than "if we don't talk about it, it'll go away, or if we don't say anything, therefore it doesn't exist, and we if can perpetuate the lies and the denials long enough most people will give up, Study 41 didn't happen because Mark Rotenberg tells us so, Chuck Schulz and Stephen Olson were never really investigators for the study, that was just all made up, the payments they received and the University received during that time was just fabricated or to quote Rotenberg maybe someone at the Board of Pharmacy just copied those payments dollars off the internet somewhere and just filled in Schulz and Olson's names. I'm sure that's what happened. I think I'll suggest to Cody Wiberg at the Board of Pharmacy that he needs to go to a undisclosed storage unit in Rosemount and look for the original payments to physicians report from AstraZeneca, just to verify the dollars that were paid to the doctors and U because the legal counsel said there was no study.

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  3. A disabled female psych patient at UMass Medical Centet was essentially forced into an unethical research study on psychotic depression run by Eli Lilly and the NIMH in 1996. She ended up killing herself after she was broken out of the study; her chart had been doctored to hide her trauma history and her past high risk attempts. No one was criminally charged and her case was not openly reviewed by the public.

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    1. Thanks, this sounds horrible and intriguing. Could you provide more information?

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  4. I think you are one of the bravest and most tenacious people I've read. Keep up the work you are doing. It is important.

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