1 Boring Old Man

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.