… in the Minneapolis Star Tribune notes that the most charitable description of what’s been going on at the clubby University of Minnesota medical school would be “bizarre.”
Thursday, June 6, 2013
For the Record
Response of Professor Leigh Turner to
University of Minnesota President Kaler
on the Markingson Clinical Trial Death
June 5, 2013
Eric Kaler, PhD
President, University of Minnesota
202 Morrill Hall
100 Church Street S.E.
University of Minnesota
Dear President Kaler:
Thank you for your letter of May 29, 2013. While I appreciate receiving your response to my letter, the substance of your message is inaccurate and unconvincing. When asked to initiate an investigation into the death of Dan Markingson and the clinical study in which he was enrolled, the standard response from senior officials at the University of Minnesota is to claim that no additional review is required because Markingson’s death has already been thoroughly investigated by the Office of General Counsel, University of Minnesota IRB, FDA, Hennepin County District Court, Minnesota Board of Medical Practice, and the Office of the Minnesota Attorney General. Your response echoes several of these familiar talking points even though they have all been discredited. My previous letter to you provides a brief summary of why there needs to be an independent, impartial investigation of Dan Markingson’s death, the CAFÉ study, and possible psychiatric research misconduct at the University of Minnesota. Here, I limit myself to rebutting the claims you make in your letter.
You mention that the death of Dan Markingson has “been the subject of proceedings” before the University of Minnesota’s Office of General Counsel. The Office of General Counsel is not an impartial investigative body. To the contrary, the mandate of the Office of General Counsel is to “zealously represent” the University of Minnesota. In the lawsuit brought against the university by Dan Markingson’s mother, Mary Weiss, the Office of the General Counsel defended the University of Minnesota. The University of Minnesota’s Office of General Counsel advocates for, defends, and advances the interests of the University of Minnesota. It is not a suitable internal body for impartially investigating complaints that faculty members have engaged in research misconduct. Mark Rotenberg, the university’s former General Counsel, should never have been allowed to serve as the University’s legal counsel, in-house “investigator”, and de facto public spokesperson deployed to rebuff calls for an independent inquiry into Dan Markingson’s death. The University of Minnesota must stop misusing the Office of General Counsel in this manner.
It is true that Dan Markingson’s case was the subject of legal proceedings before the Hennepin Country District Court. What your letter fails to acknowledge is that in this wrongful death lawsuit the University of Minnesota won summary judgment on the basis that it is statutorily immune from liability. As you must know, to be deemed statutorily immune from liability is not a vindication of conduct. On the contrary, it simply means that the University of Minnesota did not have to defend itself against the lawsuit brought by Ms. Weiss. Such an outcome should never be portrayed as an exoneration of the University of Minnesota.
The Minnesota Board of Medical Practice responded to complaints about Dr. Stephen Olson and Dr. Charles Schulz. Unfortunately, your letter omits several key points. The medical licensing board does not investigate universities and institutional review boards. There is therefore no meaningful basis for suggesting that the Minnesota Board of Medical Practice investigated the University of Minnesota. The Minnesota Board of Medical Practice issued form letters stating that “the facts of the case did not provide a sufficient basis for the Board to take disciplinary or corrective action” in response to the filed complaints. However, there is no public record of the Board’s deliberations, the scope of its investigation and the issues it addressed, the evidence it gathered, and the reasoning that informed its conclusions. What is a matter of public record is that the Minnesota Board of Medical Practice does not investigate universities, institutional review boards, and institutional research governance structures.
With regard to the FDA, the Establishment Inspection Report issued by the FDA failed to acknowledge the numerous reports documenting that Dan Markingson was psychotic and lacked the capacity to make his own medical decisions. As my May 13 letter to you notes, on at least three occasions shortly before Markingson was enrolled in the CAFÉ study he was judged to lack decision-making capacity. In addition, the person who enrolled him in the study was unqualified to assess decision-making capacity of prospective research participants, under considerable pressure to recruit study participants, and, as the clinical trial coordinator for the trial, had a serious conflict-of-interest. An independent investigation of Dan Markingson’s death and the study in which he was enrolled must examine how and why Markingson was “consented” into a clinical study when he was diagnosed as psychotic, lacked insight into his disease and mental state, and was deemed unable to make informed decisions about administration of antipsychotic drugs. The FDA Inspection Report fails to address the paper trail documenting the various occasions Markingson was deemed mentally incompetent to make his own medical decisions. The FDA Inspection Report also fails to note that Markingson was enrolled in the CAFÉ study despite his mother’s repeated objections. It is possible that this significant flaw in the FDA’s inspection report is connected to the FDA investigator’s failure to interview Dan Markingson’s mother, Mary Weiss, and ensure that her voice was taken into consideration.
I must draw to your attention two important omissions in your letter.
First, in 2009, the Minnesota State Legislature passed a law that restricts individuals under civil commitment orders from being enrolled in psychiatric drug studies. This statute, as I’m sure you know, is commonly referred to as “Dan’s Law.” I encourage you to reflect upon why it was necessary for the Minnesota State Legislature to pass this law.
Second, your letter fails to mention the Corrective Action that the Minnesota Board of Social Work issued to the study coordinator for the CAFÉ trial. According to this document, Jeanne Kenney, the trial coordinator, “regularly completed forms, gathered information, and performed tasks that were beyond Licensee’s competence and scope of practice as a clinical social worker.” Kenney also made numerous documentation errors, dispensed prescription drugs without authorization and in violation of University of Minnesota policy, initialed documents with a doctor’s initials, failed to respond to family concerns in a timely and effective manner, failed to document key information related to medical interventions and treatment plans, prepared documentation that “consistently fell below the minimum standards of practice for a clinical social worker,” failed to develop a “clearly articulated, consistent set of treatment goals,” failed to document in a timely manner “alarming voicemail messages from family members,” and “effectively invalidated” Dan Markingson’s original informed consent by failing to disclose to him new information concerning risk of hyperglycemia and diabetes. Of particular significance, the Board of Social Work found that “there were critical omissions in Licensee’s documentation that were relevant to suicide prevention and chemical dependency treatment.” Given the findings of the Minnesota Board of Social Work, it is noteworthy that you and other senior administrators at the University of Minnesota fail to mention this document when you list prior investigations of Dan Markingson’s death. The Corrective Action issued to Jeanne Kenney reveals the need for an investigation that examines all layers of oversight and includes analysis of the faculty members responsible for supervising the clinical trial coordinator and conducting the study.
There is an urgent need for an independent and impartial investigation of Dan Markingson’s death, the study in which he was enrolled, and possible psychiatric research misconduct at the University of Minnesota. Carl Elliott, my colleague here at the Center for Bioethics, makes an exhaustive case for such an investigation. Senior officials at the University of Minnesota claim that Markingson’s death was fully reviewed. However, an independent, thorough investigation has not occurred. I therefore ask you to reconsider your decision, sign the petition initiated by Mary Weiss and Mike Howard, and write to Governor Dayton and request an independent investigation of possible psychiatric research misconduct at the University of Minnesota. Whatever you decide, I want my correspondence with you to document that in the strongest possible terms I urged you to support such an investigation.
Leigh Turner, PhD
University of Minnesota Center for Bioethics
N520 Boynton, 410 Church Street SE
Minneapolis, Minnesota, 55455
at 10:28 AM