Office oft/ic General Counsel 360 McNamara Alumni Center 200 Oak Street S.E. Minneapolis, MN 55455
November 13, 2013 Leigh Turner Associate Professor Center for Bioethics N504 Boynton 410 Church St SE Minneapolis, MN 55455-0346
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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.
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.