February 9, 2014 Attorney General Lori Swanson Minnesota Attorney Generals Office 1400 Bremer Tower 445 Minnesota

Street St. Paul, MN 55101 Re: Open Letter Requesting An Investigation of Possible Psychiatric Research Misconduct at the University of Minnesota Medical Center, Fairview Dear Attorney General Swanson: I am contacting you because I believe there is an immediate need for the Attorney Generals Office to investigate possible psychiatric research misconduct at the University of Minnesota Medical Center, Fairview. If various allegations concerning psychiatric research misconduct are true, it is possible that numerous state and federal laws have been violated. I wish to file a formal complaint with your Office and ask you to investigate whether psychiatric clinical trials at the University of Minnesota Medical Center were conducted in compliance with all applicable state and federal laws. Before deciding to contact you I made numerous efforts to alert President Eric Kaler and the University of Minnesotas Board of Regents to the necessity of investigating possible psychiatric research misconduct. Accompanying this letter you will find my letters to President Kaler, General Counsel William Donohue, and Richard Beeson, Chair of the Board of Regents. Professor Carl Elliott, a colleague of mine at the Center for Bioethics, has sent many additional letters to various university officials and made repeated efforts to convince senior administrators of the need to investigate reports of psychiatric research misconduct. Our attempts to work within the University of Minnesotas reporting structures have failed. President Kaler has indicated that he plans to establish an inquiry into current policies and practices governing human subjects research. However, he has stated that this inquiry will not address specific reports of psychiatric research misconduct. Given the gravity of allegations concerning possible psychiatric research misconduct, the persistent unwillingness of senior administrators to make reasonable inquiries in response to these reports, and the possibility that state and federal laws have been violated for many years, I am asking you to investigate. Since I am sure you are already familiar with the death of Dan Markingson while he was a research subject at Fairview, and are also aware of the various ethical and legal issues identified by his mother, Mary Weiss, and her friend, Mike Howard, I will not provide a detailed account of the

2 numerous unanswered questions concerning the care Markingson received while he was a participant in an AstraZeneca-sponsored clinical trial. Rather, I wish to emphasize that in addition to the Markingson case there appear to be many other instances of possible psychiatric research misconduct at the University of Minnesota Medical Center, Fairview. Multiple sources of evidence reveal the need for an investigation of possible psychiatric research misconduct at Fairview. In 2013, Mary Weiss and Mike Howard established an online petition calling upon Governor Dayton to investigate psychiatric research misconduct at the University of Minnesota. Detailed comments left at that website reveal that many individuals have disturbing accounts of the care they or their relatives received while enrolled in clinical studies conducted at Fairview. Additional allegations of research misconduct can be found on the webpage for the Community Alliance for Ethics in Minnesota Psychiatry. Remarks made by an anonymous subject interviewed by a Fox9 investigative reporter examining the Markingson case also prompt questions about coercive recruiting tactics and unethical conduct in human subjects research at Fairview. In addition, I have had personal communications with individuals stating that they or their relatives were victims of psychiatric research misconduct at the University of Minnesota Medical Center, Fairview. These accounts do not prove the existence of research misconduct at Fairview. Rather, they indicate the need to investigate whether reports of psychiatric research misconduct are true. An additional reason why current allegations of psychiatric research misconduct deserve serious consideration is that the University of Minnesotas Department of Psychiatry has a history of misconduct in human subjects research. In 1997, the FDA disqualified Dr. Barry Garfinkel, the former Director of Child and Adolescent Psychiatry, from conducting human subjects research. Garfinkel was also sentenced to federal prison for research fraud. In 1998, the Minnesota Board of Medical Practice disciplined Dr. Faruk Abuzzahab, a clinical faculty member in the Department of Psychiatry, for the deaths and injuries of forty-six patients under his care, including seventeen subjects enrolled in clinical studies. (Some of these studies were conducted at Fairview.) In 2000, the FDA disqualified Dr. James Halikas, former Director of the Department of Psychiatry Chemical Dependency Program, from conducting clinical research because he was found to have mistreated research subjects. Senior administrators at the University of Minnesota argue that these examples of research misconduct do not reflect current practices. However, internal communications at the University of Minnesota reveal that senior university officials are aware of recent problems involving human subjects research conducted by faculty members in the Department of Psychiatry. In 2009, Dr. Sue Berry, Chair of the University of Minnesotas IRB Executive Committee, wrote to then-Vice President for Research R. Timothy Mulcahy, the institutional official responsible for human subjects protection, and urged him to conduct a thorough review of the Department of Psychiatrys program of human subjects research. Noting that trials conducted by faculty members in the Department of Psychiatry involve extremely vulnerable research subjects, Berry stated, The IRB has had numerous complaints and concerns about the management of some studies in this group. Describing eleven reviews conducted by the Office of Regulatory Affairs over a two-year period, Berry wrote, Those reviews have indicated problems with requesting approval for changes in studies, notifying the IRB of unanticipated problems, consent processes, documentation of consent, HIPAA compliance, confidentiality of data, record keeping on multi site studies, payments

3 to subjects, and data management. Issues have been noted at virtually all phases of engagement of human subjects. . The most recent example under review by the IRB involves the lapse of an approved protocol due to failure to report at the continuing review interview. Almost 50 subjects were enrolled in the study during the lapse. Berrys letter suggests a pattern of research misconduct involving faculty members in the Department of Psychiatry. Her letter ends, We have learned that when one area of research such as human protections is of concern, there are often systemic issues affecting all areas of research compliance. It is the pattern and frequency of problems and vulnerability of the population that prompts this request. Despite Berrys request, the University of Minnesota commissioned a superficial review instead of establishing a thorough independent investigation of possible psychiatric research misconduct. Based upon various sources of information, it appears that allegations of psychiatric research misconduct are all related to the conduct of a group of psychiatrist clinician-investigators employed at the University of Minnesota Medical Center, Fairview. It seems that most or all of these individuals also have appointments as faculty members at the University of Minnesota. Reports of research misconduct appear to be linked to industry-funded trials. Should you decide to investigate whether psychiatric clinical studies at the University of Minnesota have violated state and federal laws, I recommend that you pay particular attention to ten key legal and ethical concerns. First, I urge you to investigate whether individuals suffering from serious mental illnesses were consented into psychiatric studies even though they lacked capacity to make informed decisions about whether to participate in clinical research. Second, I urge you to investigate whether threats of involuntary commitment were used to coerce vulnerable psychiatric patients into providing their consent to participate in clinical studies. Third, I urge you to investigate whether violations of the Health Insurance Portability and Accountability Act occurred, possibly as a result of clinical trial personnel providing confidential medical information to study sponsors or contract research organizations without first receiving permission from patients. Fourth, I urge you to investigate whether there were cases where researchers conducting psychiatric clinical studies failed to disclose to research subjects all study-related risks. Fifth, I urge you to investigate whether there were instances in which clinician-investigators financial conflicts-of-interest were not fully disclosed to research subjects. In addition, I recommend that you examine whether financial conflicts-of-interest played a role in the development of aggressive recruitment strategies.

4 Sixth, I urge you to investigate whether financial conflicts-of-interest extended to the Institutional Review Board, the Department of Psychiatry, and the University of Minnesota, possibly undermining integrity of the very research governance structures that are supposed to protect participants in clinical studies. Seventh, I urge you to investigate whether there were unjustifiable uses of Evaluation to consent forms that were supposed to be used to assess and document whether individuals possessed capacity to make informed and autonomous choices concerning participation in clinical research. Eighth, I urge you to investigate whether family members who did not want their loved ones in psychiatric clinical studies and believed that their relatives lacked capacity to make informed choices about participating in clinical research were ignored, dismissed by researchers, or provided inadequate responses, thereby deflecting questions concerning whether decisions to participate in research should be made by study subjects or their surrogates. Ninth, I urge you to investigate how many study subjects participated in particular studies, why in the case of at least one clinical trial there exists conflicting accounts of the number of study participants, and what basis there might be for differing claims concerning something as elementary as the number of subjects enrolled in a trial. Tenth, I urge you to investigate why senior university administrators at the University of Minnesota have refused to investigate reports of psychiatric research misconduct despite repeated calls and overwhelming evidence concerning the need for such an investigation. It is my belief that there are sufficient moral and legal grounds for the immediate initiation of a thorough investigation of whether violations of state and federal laws have occurred during the course of psychiatric research conducted at the University of Minnesota Medical Center, Fairview. I hope that you agree and investigate what I can only describe as profoundly alarming allegations of research misconduct. Yours sincerely,

Leigh Turner, PhD Associate Professor University of Minnesota Center for Bioethics cc: Eric Kaler, President, University of Minnesota Carolyn Wilson, President, University of Minnesota Medical Center, Fairview Rulon F. Stacey, President and Chief Executive Officer, Fairview Health Services