OFFICE OF THE LEGISLATIVE AUDITOR STATE OF MINNESOTA
A Clinical Drug Study at the University of Minnesota, Department of Psychiatry
The Dan Markingson Case
March 19, 2015
Members of the Legislative Audit Commission:
The Office of the Legislative Auditor conducted a review of the Dan Markingson case at the request of the chairs of the House and Senate Higher Education Committees.
Dan Markingson was a young man who committed suicide in 2004 while participating in a University of Minnesota Department of Psychiatry drug study. The case was the subject of a civil lawsuit and several regulatory reviews, but it still remains controversial.
While we think it is impossible to make a causal connection between Markingson’s death and his participation in the drug study, we concluded that the case involves serious ethical issues and numerous conflicts of interest.
We are especially troubled by the response of University leaders to the case; they have made misleading statements about previous reviews and been consistently unwilling to discuss or even acknowledge that serious ethical issues and conflicts are involved.
We make two recommendations for legislative action to better ensure that human subjects are protected when they participate in drug studies conducted by the University of Minnesota Department of Psychiatry.
This review was conducted by Elizabeth Stawicki, Joel Alter, and Jim Nobles. Sincerely, James Nobles
We do not think it is possible to know whether Dan Markingson’s suicide was connected to his participation in the University clinical drug study; the suicide of a person with serious mental illness may involve many contributing factors. However, the Markingson case raises serious ethical issues and numerous conflicts of interest, which University leaders have been consistently unwilling to acknowledge. They have repeatedly claimed that clinical research at the University meets the highest ethical standards and dismissed the need for further consideration of the Markingson case by making misleading statements about past reviews. This insular and inaccurate response has seriously harmed the University of Minnesota’s credibility and reputation.
A primary problem uncovered by our review is past and current University leadership that is defensive, insular, and unwilling to accept criticism about the Markingson case either from within or outside the University. However, we do not have a recommendation that would change attitudes at the University about openness, accountability, and transparency. We can only suggest that the Legislature make the issue—and need for change—a more important consideration in selecting people to serve on the University Board of Regents.
To strengthen the protection of human subjects in University research, we make the following recommendations:
- The Legislature should enact legislation that requires the University of Minnesota to fully implement the external review panel’s recommendations before the University’s Institutional Review Board approves additional Department of Psychiatry drug studies.
- The Legislature should enact legislation that authorizes the state’s Office of the Ombudsman for Mental Health and Developmental Disabilities to monitor the participation of people in the University’s Department of Psychiatry drug studies. The Legislature should provide the office with adequate resources to effectively monitor psychiatric drug studies at the University
Download Special Review ReportTHE DAN MARKINGSON CASE (23 downloads)
University of Minnesota made “serious” ethical errors in trial of antipsychotics, finds report
The University of Minnesota’s handling of a case in which a psychiatric patient participating in a drug trial killed himself raised “serious ethical issues and numerous conflicts of interest, which university leaders have been consistently unwilling to acknowledge,” a scathing report by the state’s legislative auditor has found.1
The patient, Dan Markingson, then aged 27, killed himself in 2004, slashing open his neck and abdomen with a knife, while enrolled in a clinical trial that was comparing three antipsychotic drugs for the treatment of patients experiencing a first episode of psychosis. The drugs being evaluated were quetiapine (marketed as Seroquel), olanzapine (Zyprexa), and risperidone (Risperdal). The trial, called Comparison of Atypicals in First Episode of Psychosis CAFÉ), was funded by AstraZeneca, the manufacturer of olanzapine. BMJ 2015;350:h1628
Dan Markingson Investigation
- FDA Guidance
- Current Good Manufacturing Practice Requirements for Combination Products
- FDA 1572 Statement of Investigator
- FAQs for FDA 1572
- INSTRUCTIONS FOR FILLING OUT FORM FDA 1572
Last Updated: 2015-08-12
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