from Minnesota: Dan Markingson revealed…

Posted on Thursday 19 March 2015

This report was released at 2:00 PM today from the Minnesota OFFICE OF THE LEGISLATIVE AUDITOR:*

This is the one released last week by group of six experts appointed by the Association for the Accreditation of Human Research Protection Programs:

  • Finding 1. Dan Markingson was extraordinarily vulnerable when Dr. Olson recruited him into a drug study; Markingson was mentally ill and faced commitment to a state psychiatric hospital if he did not cooperate with the Fairview University Medical Center treatment plan and his treatment team’s aftercare recommendations following discharge. In 2009, the Legislature pass ed a law restricting the enrollment into drug trials of persons under a stay of commitment.
  • Finding 2. AstraZeneca, the financial sponsor of the CAFÉ drug study, prorated its payments to the University based on the number of subjects Dr. Olson enrolled in the study and the number of follow -up meetings the subjects completed. Dr. Olson’s goal was to enroll 30 people, and he had difficulty meeting that goal. This created an incentive to enroll and keep Dan Markingson in the CAFÉ drug study in November 2003.
  • Finding 3. Markingson’s mother, Mary Weiss, expressed strong concerns about her son ’s participation in the drug study and continually warned that he was not improving. There is little evidence that the study team adequately followed up with her about her concern.
  • Finding 4. Dr. Olson told the University’s Institutional Review Board (IRB) that drug study participants would each have an advocate, but Markingson did not have an advocate with him at the time he signed the informed consent to participate in the CAFÉ drug study.
  • Finding 5. The University of Minnesota’s Institutional Review Board (IRB) conducted a superficial review of Dan Markingson’s suicide. The IRB did not review medical records, did not seek information from anyone other than Dr. Olson, and did not review information about Markingson’s suicide.
  • Finding 6. The Minnesota Board of Social Work investigated CAFÉ study coordinator Jean Kenney, a licensed independent clinical social worker . 61 The Board found that she performed tasks beyond her competency and made significant errors. As a result, the Board entered into an Agreement for Corrective Action with Kenney. Although the Board only had jurisdiction over Kenney, we believe its findings suggest that Dr. Olson inappropriately delegated tasks to Kenney and failed to provide her with adequate supervision.
  • Finding 7. The Minnesota Board of Medical Practice’s review of Dr. Stephen Olson was compromised because the expert consultant the Board hired to analyze the case had numerous conflicts of interests.
  • Finding 8. University leaders — both administrators and regents — have responded to the Markingson case by dismissing the need for further review and ignoring serious ethical issues.
  • Finding 9. An external panel of experts that recently reviewed the University’s current human subjects protection program found significant and troubling problems.
    March 19, 2015 | 6:30 PM

    The fact that they had a social worker doing the interviews always struck me as an odd negation of their specialty; but they cost less, don’t they? I have to wonder if that made any difference in the pay that others received— especially for the CRO.

    March 20, 2015 | 1:50 AM

    @ Wiley — Quite possibly, but I also wonder if they needed someone who was either extremely compliant or extremely clueless, someone who would overlook extremely serious symptoms and pathology in order to recruit or maintain participants in the study.

    The power differential between Kenney and Olson may have been a contributing factor. I wonder how she was recruited for the gig. I wonder whether she was just an overworked hack, a clueless ingenue, a nurse Ratchet type, or whether she sincerely believed she was helping the mental health care system take the next leap forward.

    It sounds like she was not even suspended. Where I work, you pretty much get automatically suspended for far less dangerous violations that don’t even have anything to do with clients– say, blowing over .08 at a DUI checkpoint– and the corrective action usually involves thousands of dollars in reimbursement to the board and a lot more than 18 hours of CEUs.

    The report is still a bit baffling. “we think it is impossible to make a causal connection between Markingson’s death and his participation in the drug study,”

    Impossible? Kind of a weasel word, like, “Maybe the study was responsible, but we couldn’t determine that, because to do so would have been impossible– just too hard, can’t be done, outside the moral and legal capabilities of our species.”

    March 20, 2015 | 7:14 PM

    This could cheer you up, Catalyzt. Though it’s said that there can’t be a judgment made on whether or not the drug contributed to his death, considering how little is known about the actual effects of these drugs and the fact that he was homicidal to begin with, I think that makes sense.

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