UNIVERSITY OF MINNESOTA

Office oft/ic General Counsel 360 McNamara Alumni Center 200 Oak Street S.E. Minneapolis, MN 55455

Of 612-624-4100 Fax: 612-626-9624

November 13, 2013 Leigh Turner Associate Professor Center for Bioethics N504 Boynton 410 Church St SE Minneapolis, MN 55455-0346

RE: Response to letter dated 11.8.13

Dear Associate Professor Turner: I am responding to your letter to President Kaler of November 8, 2013 and your very similar letter of November 11 sent to Richard Beeson, Chair of the Board of Regents. In your letter to Regent Beeson, you note that in November 2010, you were one of a number of signers of a letter to the Board of Regents in regard to the Dan Markingson matter. You suggest in your letter that "the Board declined to investigate", implying that there was no response to the letter. As you know, the University reviewed each of the 10th and responded in the attached letters to you issues raised in the letter of November from Board of Regents Chair Clyde Allen and General Counsel Mark Rotenberg dated February 7, 2011. These letters specifically address your claims and the reasons for the Universitys position. While you and your colleague have written many times in the past about "allegations of misconduct", in both your current letters you claim that there are "new instances of psychiatric research misconduct" at the University and that you and your colleague have been contacted by individuals or family members who allege this misconduct, but you provide no specific information that would enable an investigation. If you have information about misconduct or harm to patients or research subjects, please provide that information as soon as possible and we will investigate it and take whatever remedial action is appropriate. It is inaccurate for you to suggest that the University has somehow failed to "investigate" matters when you have not provided any actionable information of these supposed misdeeds. I also note that you suggest in your letter that Dan Markingson was not competent to consent to his medical treatment and entry into a clinical trial. In this state, and elsewhere, determinations of competence are made by courts. In this instance, Mr. Markingson was evaluated by court-appointed examiners prior to the hearing on his stay of commitment in November 2003 in the Dakota County District Court. Those

Driven to Discover -

701090

Professor Turner November 13, 2013 Page 2 examiners concluded that he was able to consent to treatment, and therefore he had the jgt to express his consent, or not, in regard to his medical treatment. The Dakota County District Court issued its order on that basis on November 20, 2003 setting further conditions for his continuing treatment and assigning a court-appointed caseworker to oversee his treatment. It would seem that you would understand that medical patients have the right to control their treatment to the maximum extent possible. One does not permanently lose that right just because they had an acute episode of mental illness. In this case, Mr. Markingson did have a serious acute episode of mental illness and was hospitalized. However, after Markingson received treatment, including medication, the courtappointed examiners concluded that he was , able to make determinations as to his treatment, and he chose to enter into the CAFE study, with the concurrence of his court appointed caseworker. As time went on, Mr. Markingson chose to continue in the study, which you can confirm by reading the deposition of David Pettit, the Dakota County caseworker, who closely monitored Mr. Markingsons progress. In the litigation that followed Mr. Markingsons death, his right and ability to consent to treatment was again addressed as a major issue in the case. The Hennepin County District Court concluded that he was competent to consent to enter the study, and that he did consent Thus two Minnesota district courts reviewed the issue of Mr. Markingsons competency. While it may be that you do not agree with these assessments, these courts, not the University, had the responsibility to determine, and did determine Mr. Markingsons rights in regard to his treatment. As you know, we believe that the claims with respect to this matter were properly evaluated by the Food and Drug Administration, the Hennepin County District Court and the Minnesota Board of Medical Practice. The Food and Drug Administration investigated this matter spending 8 days on campus interviewing witnesses and reviewing documents On July 22, 2005, the FDA issued its Inspection Report finding "No evidence of misconduct or significant violation Of protocol or regulations were found in this inspection" As you know, a lawsuit was initiated against the University and its IRB as well as against the principle investigators of the study. The Hennepin County District Court dismissed the case against the University and one for the principle investigators while the other principal investigator entered into a nominal settlement of the matter. Finally, the same individuals who brought suit filed extensive complaints against the two principle investigators with the Minnesota Board of Medical Practice. The doctors responded to these complaints. After its review the Board dismissed both complaints.

Professor Turner November 13, 2013 Page 3

But regardless of the conclusions of the FDA, the courts, and the Board of Medical Examiners as to the Markingson matter, if you have actual evidence of what you term "new" research misconduct please provide it to us so that it can be properly investigated and reviewed.

Very truly yours,

William P. Donohue General Counsel WPD/ml Enclosures