Monday, December 6, 2010

University of Minnesota Faculty

Letter to Regents:

Call for Outside Investigation of

Markingson Suicide

Board of Regents
University of Minnesota
600 McNamara Alumni Center 

200 Oak Street SE

University of Minnesota

Minnesota 55455-2020

November 23, 2010

Dear Members of the Board:

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 two years, articles in the St. Paul Pioneer Press and Mother Jones magazine have suggested an alarming 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 part 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 concerns 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 his 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 our 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 panel 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 our university has responded to this death and the careful, critical investigation it warrants. We therefore seek your intervention in this matter.

Yours sincerely,

Carl Elliott MD PhD
Professor, Center for Bioethics and Departments of Pediatrics and Philosophy

Dianne Bartels, RN, MA, PhD 

Assistant Professor, Center for Bioethics and Department of Medicine

Joan Liaschenko, RN, PhD
Professor, Center for Bioethics and School of Nursing

Mary Faith Marshall, PhD 

Professor, Center for Bioethics and Department of Family Medicine and Community Health

John Song, MD, MPH, MAT
Associate Professor, Center for Bioethics and Department of Medicine

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

Joan Tronto PhD
Professor, Department of Political Science and Affiliate Faculty Member, Center for Bioethics


I am proud of my colleagues for not letting this matter rest.


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