November 19, 2013 Richard B.

Beeson Chair of the Board University of Minnesota Board of Regents 600 McNamara Alumni Center 200 Oak Street S.E. Minneapolis, MN 55455 Re: The Office of the General Counsel Must Not Investigate Allegations of Research Misconduct Dear Mr. Beeson: On November 11, 2013, I alerted you and other regents to possible new instances of psychiatric research misconduct at the University of Minnesota. In just the last week, two more individuals have reported they were mistreated while they were psychiatry patients under the care of University researchers. One of these individuals was featured in last weekends Fox9 KMSP investigative report into the death of Dan Markingson. Here is comment left by a former psychiatry patient who viewed Jeff Baillons report: I was just horrified after viewing the news program last evening airing on the Fox channel in the Twin Cities, MN. I could have been Dan Markingson or the other person that preferred to be anonymous, as I had a very similar experience with Dr. Olson and Riverside hospital. I too was recruited for a drug study and the pressure to consent was enormous, and being extremely vulnerable at the time just added to the anxiety. Fortunately, I was able to arrange my discharge with help from my family and sought and received treatment elsewhere. I was visited everyday in my hospital room by a study staff coordinator, sometimes twice a day, and at least once everyday was pressured by Dr. Olson to enroll. I was not the only patient being harassed in this manner. This abuse has to be investigated. Such statements prompt many questions concerning how patients are being recruited into psychiatric clinical trials at the University of Minnesota. Rather than respond to my letter or assign this task to someone capable of conducting a legitimate inquiry I instead received a reply from the Universitys general counsel. But the general counsel has a fundamental conflict-of-interest. The Office of the General Counsel exists to ensure the best possible litigation outcomes and minimize legal problems for the University. Its mission is to represent the University in adversarial forums zealously and to protect the Universitys legal

2 interests in all transactions. When you refer to the general counsel complaints concerning possible research misconduct you direct them to someone employed to advocate for the university rather than to a body responsible for promoting justice, fairness, and truth regardless of whether the universitys interests are maximized. When cases go to trial the Office of the General Counsel litigates with the objective of having juries side with the University. To avoid going to trial, the Office of the General Counsel, or the outside legal counsel it retains, sometimes settles with plaintiffs. The goal when settling lawsuits is to do everything possible to reduce the cost to the University. Lawyers in the Office of the General Counsel take pride in the savings they generate for the University. This mindset is understandable given the adversarial role the Office of the General Counsel plays in representing the Universitys interests. However, what is best for the University often is not what is best for Minnesotans claiming that they are victims of wrongdoing. What is striking about the University of Minnesota is the routine manner in which allegations of research misconduct are routed straight to the general counsel. When Mike Howard wrote to the Board of Regents and filed complaints against Stephen Olson and Charles Schulz, his complaints were investigated and dismissed by the Universitys former general counsel, Mark Rotenberg. When Professor Elliott and I along with six other faculty members urged members of the Board of Regents to investigate the death of Dan Markingson, Mark Rotenberg briefed the Board and then wrote a dismissive reply to our request. When Professor Elliott filed a complaint with the Universitys Research Integrity Officer and requested that she not contact lawyers in the Office of General Counsel, she ignored his plea and forwarded his complaint to a lawyer in the Office of General Counsel. Mark Rotenberg then dismissed Elliotts request. When I contacted President Kaler and urged him to support an independent investigation of Markingsons death, President Kaler refused to support such an investigation and then forwarded my request to Mark Rotenbergs replacement, William Donohue. Likewise, when Professor Lemmens and over 170 academics wrote to the Faculty Senate and called for an independent inquiry into Markingsons suicide the respondent was the general counsel. When I wrote to you and reported possible instances of psychiatric research misconduct I received a response from the general counsel. Given the manner in which all requests to investigate the death of Dan Markingson and allegations of research misconduct are funneled to the general counsel, it is obvious that this University is refusing to conduct fair and legitimate investigations of possible instances of research misconduct. Instead, it is forwarding such complaints to a highly partisan employee. Members of the Board of Regents, President Kaler, and additional senior administrators then claim that the general counsels investigations are somehow definitive even though they consist of little more than superficial appeals to authority. For example, on numerous occasions the general counsel has claimed that the University was properly evaluated by the Food and Drug Administration. He never acknowledges or addresses significant flaws in the Establishment Inspection Report prepared by the FDA investigator. The General Counsel has also claimed that the University was investigated by the Minnesota Board of Medical Practice. This board does not investigate institutions and their research governance structures. Likewise, the Universitys previous general counsel claimed that Minnesotas Attorney General investigated the University. The Attorney Generals Office conducted no such

3 investigation. In making such appeals to authorityappeals that are profoundly misleading because they refer to investigations that either did not occur or failed to examine institutional governance of human subjects researchthe general counsel functions as an apologist for the University. Mr. Donohues function as lead apologist for the University is nowhere more evident than in his account of Dan Markingsons capacity to provide informed consent to participate in the CAF study. Mr. Donohue insists that Dan Markingson was competent to consent to participation in the CAF study. But the evidence strongly suggests that this is untrue. For example, on November 14, 2003, an Examiners Statement in Support of Petition for Commitment prepared by Dr. Stephen Olson, Dan Markingsons treating psychiatrist, documented that Markingson lacked insight, did not believe he had a mental illness, and lacks the capacity to make decisions regarding such treatment. Olsons statement also noted that Markingson was delusional, had threatened to kill his mother, and believed he was supposed to attend a Satanic cult gathering at which he would be asked to kill others for the greater good. Also that same day, the Director of Behavioral Services at Fairview-University Medical Center petitioned to have Markingson committed to a treatment facility. On November 17, 2003 a Pre-Petition Screening Program Report stated that Markingson is believed not to have the capacity to make decisions regarding Neuroleptic medications. It noted that Markingson did not acknowledge a mental illness as the cause of his bizarre beliefs. The report also stated, He has had delusional thinking and beliefs. He allegedly made threats to slit his mothers throat and he stated he may be asked to kill people as part of a satanic ritual and he stated that he was prepared to do so. He lacks insight to attribute these delusions to a mental illness and receive treatment. Two days later, on November 19, 2003, James L. Jacobson, PhD, completed an Examiners Report. He reported that Markingson suffered from a substantial Disorder of Thought, Mood, Perception, Orientation, Memory. In response to the question, Is there a Gross Impairment of Judgment, Behavior, Capacity to Recognize Reality, Capacity to Reason or Understand?, Jacobson wrote, Yes. On November 20, 2003, the Dakota County District Court determined that Dan Markingson was mentally ill and in need of treatment. The court had him committed to the Anoka Metro Regional Treatment Center. While the commitment was stayed under a series of conditions, there is no indication that the Dakota County District Court understood that the following day Markingson would be asked to consent to participate in a research study instead of being entered into the treatment plan mentioned in the order for stayed commitment. Given repeated findings that Markingson lacked capacity to make informed decisions about his illness and the medications best-suited for his psychiatric condition, combined with the failure of Markingsons treating physician to inform the court that he sought to enroll him as a consenting subject in a clinical study, there is good reason to argue that an independent investigation of Dan Markingsons death must include careful scrutiny of his capacity to make health-related decisions both before and while he was a research subject in the CAF study.

4 Mr. Donohue fails to address unanswered questions concerning the Evaluation to Sign Consent Form. This form was used to assess Markingsons mental capacity give proper informed consent for the CAF study. Several family members of patients with mental illnesses allege that their relatives have in their medical files a form with the same answers as the Evaluation to Sign Consent Forms from Dan Markingsons file. Their claims prompt questions concerning how numerous patients could reportedly have evaluation forms with identical answers. Following Dan Markingsons death, the Minnesota House of Representatives passed legislation that is popularly known as Dans Law. The law ensures that psychiatrists cannot recommend a stay of commitment, have the court compel patients to comply with their doctors treatment recommendation, and then have the doctors treatment plan consist of enrolling the patient into a clinical drug trial that he or she is conducting. Yet despite passage of a law that is a direct response to how Dan Markingson was recruited into the CAF study, the University has never admitted wrongdoing or acknowledged the need to examine its human research protections. In his response to my letter, the general counsels apologetics are on full display in his failure to mention the Board of Social Works Corrective Action agreement with the study coordinator for the CAF trial. That document reveals that the clinical study coordinator failed to inform Dan Markingson and other study participants of newly identified risk of hyperglycemia and diabetes. As the agreement notes, original informed consent is effectively invalidated when researchers fail to disclose new risks. Regents should be aware of other findings made by Minnesotas Board of Social Work. According to the Agreement for Corrective Action, the CAF study coordinator performed tasks that were beyond her competence and scope of practice, dispensed prescription drugs without authorization, initialed clinical documents with a physicians signature, failed to record critical information and committed documentation errors, made critical omissions that were relevant to suicide prevention, and failed to enter relevant and prompt chart notes after Markingsons mother left alarming messages concerning his deteriorating health. The Agreement for Corrective Action notes that Kenneys primary defense was that the CAF study was supervised by a national sponsor and approved by the University of Minnesota through its institutional review board, and Licensee alleges that she was acting under that supervision and in accordance with the protocols that had been approved. These statements provide insight into why the general counsel fails to mention the Agreement for Corrective Action when summarizing various investigations into the death of Dan Markingson. They point to the need for an investigation of the faculty members supervising the clinical study coordinator, the role of the Universitys IRB in approving and overseeing the CAF study, and the Universitys protocols for protecting research participants in the CAF trial. Since all allegations of research misconduct are funneled to the general counsel, I am concerned that the individuals who contacted me with reports of possible instances of psychiatric research misconduct will not receive a fair hearing at the University. I am disturbed and alarmed that I cannot assure individuals reporting allegations of research misconduct that the University can be trusted to conduct a fair and legitimate investigation of their concerns. While I will nonetheless encourage them to contact the Board of Regents, I am dismayed by the general counsels statement

5 that he will investigate their concerns. These individuals should instead be told that if they come forward with their complaints whatever information they provide will not be investigated by anyone in the Office of the General Counsel. As I noted in my previous letter to you, the Board of Regents is choosing a course that risks causing tremendous economic and reputational damage to the University of Minnesota. Let me therefore remind you once more of your fiduciary responsibility for the long-term welfare of the University. Yours sincerely,

Leigh Turner, PhD Associate Professor University of Minnesota Center for Bioethics N520 Boynton, 410 Church Street SE Minneapolis, Minnesota, 55455