University of Minnesota research case needs scrutiny

  • Article by: CARL ELLIOTT
  • Updated: May 13, 2013 - 9:26 AM
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An open letter to Gov. Mark Dayton:

Last week marks nine years since a young man from St. Paul named Dan Markingson committed a violent suicide while enrolled in a psychiatric research study at the University of Minnesota. It also marked five years of heated controversy about the questionable ethics of the study, which were first reported by Jeremy Olson and Paul Tosto in the St. Paul Pioneer Press in May 2008. Despite dozens of formal complaints to university officials, professional organizations and federal oversight bodies, Dan’s mother has been unable to get a fair hearing. You have the opportunity to correct that.

In late 2003, a psychiatric research team at the University of Minnesota used the threat of involuntary commitment to coerce Dan Markingson into an ­industry-funded clinical trial of ­antipsychotic drugs, despite the objections of his mother, Mary Weiss. Dan was experiencing an acute psychotic episode and had been repeatedly judged unable to make his own medical decisions. For several months after he was enrolled in the study, Mary tried desperately to get him out, warning that his condition was spiraling downward and that he was in danger of committing suicide. She was ignored.

Five months into the study, Markingson stabbed himself to death with a box-cutter with such force and violence that he nearly decapitated himself.

The study was riddled with ethical problems: a dubious scientific rationale, conflicts of interests for the researchers and financial incentives to keep subjects in the study as long as possible. Yet according to the deposition of Richard Bianco, the university official responsible for research oversight, the university never even investigated Markingson’s death. When his mother filed a lawsuit, the university successfully claimed that as a public body it was immune from such a suit. Stunningly, the university then filed a legal notice against Dan’s mother, demanding $57,000 to pay for part of its legal fees.

Recent findings suggest that Markingson may not have been the only psychiatric research subject who was mistreated. Last November, the Minnesota Board of Social Work ruled that the study coordinator for the trial in which Dan died had routinely signed the initials of physicians on study records, had been given responsibilities far beyond her training, had ignored warnings that Dan was in danger of killing himself, and had failed to warn subjects of new risks of the study, such as diabetes and hyperglycemia.

Serious questions also have been raised about the capacity of some subjects to give informed consent and about whether they actually authorized the release of their private health information to a pharmaceutical company. The sponsor of the study, AstraZeneca, paid $520 million to settle federal fraud charges, and unsealed documents in that litigation have implicated the University of Minnesota. Yet the university has repeatedly refused to open an inquiry, referring all questions to the general counsel for legal rebuttal.

Gov. Dayton, six weeks ago Mary Weiss and her friend Mike Howard started a petition asking you to appoint an external panel to investigate Dan’s death. It has been signed by nearly 2,500 people, including three former editors of the New England Journal of Medicine; the editor of the Lancet; a former editor of the British Medical Journal, and the former health and disability commissioner of New Zealand. More than 200 experts in medical ethics and related disciplines also have signed, including six members of the Institute of Medicine and the medical historian who uncovered the Guatemala syphilis studies, which resulted in an apology by President Obama in 2010.

Many alumni and friends of the university have expressed their deep shame over the university’s actions. As former philosophy professor Helen Longino has written: “Do you really want the great University of Minnesota to become an academic pariah?”

Please do the right thing and appoint a panel to investigate these alarming events. As a faculty member who has been teaching and writing about research ethics for 20 years, I do not currently believe that anyone considering signing up for a research study at the U has reason to trust that their welfare and health will be properly safeguarded.

Only by a thorough, impartial investigation can trust in the University of Minnesota be restored.

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Carl Elliott is a professor in the Center for Bioethics at the University of Minnesota.

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