Psychiatric Research Misconduct at the University of Minnesota: How Forced Participation in Drug Trial Resulted in Death

by Vera Sharav
ALLIANCE FOR HUMAN RESEARCH PROTECTION

I have just signed a petition urging Mark Dayton, Governor of Minnesota to appoint an independent, external panel of experts to conduct an investigation into gross medical research and clinical care misconduct by psychiatrists at the University of Minnesota who put their financial interests above the life of a patient in their care.

Background: In November 2003, a court ordered independent assessment confirmed that Dan was psychotic, “lacked capacity to make decisions regarding neuroleptic medication. ” Instead of acute standard care at the hospital, Dan was enrolled into a commercial, market promotion drug trial by psychiatrists at the University of Minnesota who coerced Dan with the threat of involuntary commitment—i.e, incarceration—to get him to agree to be a subject in AstraZeneca’s Seroquel trial.

The psychiatrists and the University had significant financial interests in signing up patients as subjects.

Dan was enrolled over the objections of his mother, Mary Weiss, and his mental condition quickly worsened into acute paranoid psychosis. For months Mary tried desperately to get her only son out of the dangerous experiment, warning the psychiatrists that Dan’s condition was deteriorating and that he was in danger of killing himself.

The psychiatrists, Dr. Stephen Olson and Dr. Charles Schulz, refused to listen to Mary Weiss’ pleas to withdraw her only son from the trial that clearly endangered his life.
On May 8, 2004, Dan committed suicide by mutilating himself with a box cutter, so violently he nearly decapitated himself. http://markingson.blogspot.com/

More recently, evidence of misconduct and serious privacy violations in psychiatric studies at the university have emerged, suggesting that other research subjects may have died or suffered serious injuries, or that they have been mistreated in other ways. Eight bioethicists at the University of Minnesota itself have called for an external investigation, yet the university still refuses.
http://www.scribd.com/doc/49659724/U-of-M-Board-of-Regents-Markingson-Letter

Dan Markingson’s case has garnered outrage from a growing list of prominent physicians, bioethicists, health law specialists, medical humanities faculty, and concerned citizens who have joined the call for an investigation by signing the petition headed by Jerome Kassirer, former editor of the New England Journal of Medicine, and Peter Gotzsche of the Nordic Cochrane Center. See partial list of petition signers

Please add your name and sign the petition urging the Governor of Minnesota to appoint an independent, external panel of experts to conduct an investigation into gross medical research and clinical care misconduct at the University of Minnesota.

Petition by Mike Howard:

In November 2003, psychiatrists at the University of Minnesota used the threat of involuntary commitment to force a mentally ill young man named Dan Markingson into a very profitable, industry-funded study of antipsychotic drugs. Dan was enrolled in the study over the objections of his mother, Mary Weiss. For months Mary tried desperately to get him out of the study, warning the psychiatrists that Dan’s condition was deteriorating and that he was in danger of killing himself. The psychiatrists refused to listen to her. On May 8, 2004, Dan committed suicide, and Mary lost her only child.

I feel privileged and humbled to have called Dan my friend. Because of a very unique situation I had a front row seat watching Dan’s resilience as he attempted to overcome not only his original mental and emotional crisis, but also the trauma that occurred when he was betrayed by those who were charged and licensed to provide care, healing and protection. For the past nine years Mary and I have tried unsuccessfully to have the University of Minnesota and its psychiatrists held accountable for Dan’s death. But Mary’s lawsuit against the university was dismissed on a technicality in 2009, and the university used legal threats to force her to give up her right of appeal.

Even so, Mary has refused to back down. In 2009, the Minnesota state legislature passed “Dan’s Law,” which prohibits researchers from recruiting a patient under an involuntary commitment order into a psychiatric drug study. Media outlets such as Mother Jones, the St. Paul Pioneer Press, City Pages and Scientific American have published accounts of Dan’s story. His story was also featured in the documentary film, Off Label. In 2010, AstraZeneca, the sponsor of the study in which Dan died, settled federal fraud charges for $520 million, and a University of Minnesota psychiatrist was implicated. Last year, the Minnesota Board of Social Work found serious wrongdoing by the study coordinator for the research study in which Dan died.

More recently, evidence of fraud and serious privacy violations in psychiatric studies at the university have emerged. It is possible that other research subjects have died or suffered serious injuries, or that they have been mistreated in other ways. Bioethicists at the University of Minnesota itself have called for an external investigation, yet the university still refuses.

I cannot tell anyone else what way of speaking out is most aligned with his or her own personal principles. However, I believe those of us who are personally affected by these issues must break the silence about the human rights violations inherent in coerced participation in psychiatric research. While University of Minnesota researchers used many unethical methods to force Dan to participate in this research study, the most egregious of them was fear. Dan was afraid that there was no alternative to taking part in the study, and that he would face a complete loss of liberty if he did not participate.

Given the repeated failure of university officials to act in good faith, I believe that the Governor of Minnesota, Mark Dayton, should appoint an external panel of experts to investigate ethical wrongdoing in psychiatric research at the University of Minnesota, including the circumstances surrounding Dan’s death. The panel should be given latitude to investigate the University of Minnesota human subject protection program, the Department of Psychiatry, the Office of the General Counsel, and any other university officials involved in the oversight of human research.

Let me finish by allowing Mary Weiss, Dan’s mother, to speak for herself.

Dan and I were very close. I have experienced more anguish than I thought humanly possible since Dan’s death. He had dreams, like everyone. He had a talent for creative writing, and he had hoped one day to write for The New Yorker magazine. Unfortunately, his unfinished life robbed him of this dream. In fact, his short time on earth took many dreams from him, and also from me. The things he wished for, I wanted him to realize. Please demand an investigation into the circumstances surrounding Dan’s death, and help ensure no other family ever suffers such a loss from unregulated and improperly supervised clinical trials. Please sign the petition below. Help us find justice, not vengeance.

Mike Howard

Sign the petition here.