UNIVERSITY OF MINNESOTA Trin Cee Campus Center for Bioethics 1504 Boynton 410 Church Sect SE Minneapolis, MIN 55455-0346 e12-s4 960 November 29, 2010 aarti E-mail: bioetx@unn.cdu ‘we bioethicesamn eds Board of Regents University of Minnesota 600 McNamara Alumni Center 200 Oak Street SE Minneapolis, MN’ 55455-2020 Dear Board of Regents Members: ‘On May 8, 2004, a young man named Dan Markingson committed suicide in a psychiatric research study at the University of Minnesota. The study was sponsored by the pharmaceutical ‘company, AstraZeneca, Over the past (wo years, articles in the St, Paul Pioneer Press and Mother Jones magazine have suggested an alaiming series of ethical violations and lapses with that study which, if true, suggest serious problems in the way that clinical research is conducted and overseen at the University. Those ethical violations include: recruiting a mentally ill, possibly incompetent subject into a research study while he was under an involuntary ‘commitment order; large financial conflicts of interest on the patt of the University researchers conducting the study; a payment structure for the study which included financial incentives to recruit and retain subjects rather than provide them with standard therapy; an allegedly biased. study design aimed at generating positive results for AstraZeneca rather than investigating a ‘genuine scientific question; the failure of University researchers to address the legitimate concems of Mr. Markingson’s mother, Mary Weiss, who warned that her son was suicidal and ‘who attempted for months to have him removed from the study as bis mental condition deteriorated; the apparent development of a specialized unit in Fairview Hospital designed to identify severely mentally ill subjects for recruitment into research studies; and finally, a failure of the institutional oversight system for protecting human subjects of research, Although the University of Minnesota and AstraZeneca were cleared of blame by an FDA investigator in 2005, we believe that the problems outlined in the Pioneer Press and Mother Jones articles are serious enough to warrant further investigation. These reports raise troubling questions that to date have not been addressed in the University's response to the death of Mr. Markingson. Patients participating in research studies at the University of Minnesota need to be confident that the University is doing everything it can to protect them from harm. For this reason, we respectfully request that the Board of Regents appoint an impartial panel of experts in research ethics and University governance of medical research to investigate the Markingson case, particularly any larger structural or financial conditions that might have played a role in his death and which may still be putting patients at risk. Given the ongoing controversy over conflicts of interest in the Academic Health Center, we believe that it is important that pane] members come from outside the University of Minnesota and have no financial or professional relationships to the researchers responsible for the study inwhich Mr. Markingson died. While it is understandable that some of our colleagues will have little interest in revisiting this case and the ethical issues it raises, we are persuaded that there is,a disturbing and unjustifiable gap between how the University has responded to this death and the careful, critical investigation it warrants. We therefore seek your intervention in this matter. Yours sincerely, Qse Carl Elliott MD, PhD Professor, Center for Bioethics; and Departments of Pediatries and Philosophy, University of Minnesota 7 / ry WH Bath? Dianne Bartels, RN, MA, PhD Assistant ah Center for Bioethics; and Department of Medicine, University of Minnesota GaxI* eacthenles Joan Liaschenko, RN, PhD, FAN Professor, Center for Bioethics; and School of Nursing, University of Minnesota Marpaté Wolf Mary Faith Marshall, PhD Professor, Center for Bioethics; and Department of Family Medicine and Community Health, University ee ‘Minnesota John Song, % MPH, MAT Associate Professor, Center for Bioethics; and Department of Medicine, University of Minnesota Leigh Turner, PhD Associate Professor, Center for Bioethics; and School of Public Health and College of Pharmacy, ‘Susan Craddock, PhD Chair, Department of Gender, Women, and Sexuality Studies; and Affiliate Faculty Member. Center for Bioethics, University of Minnesota Le Che Joan Tronto, PhD Professor, Department of Political Science; and Affiliate Faculty Member, Center for Bioethics, University of Minnesota