Response to University of Minnesota President's Letter
- Blog Post by: Bill Gleason
- June 5, 2013 - 3:45 PM
Elliot told me in an interview last week. "There were so many things that went wrong -- the consent process, the commitment order under which [Markingson] was recruited into the trial, the financial incentives of the university, the financial incentives of the investigators, the sheer worthlessness of the trial. Anyone who looked into this and knew anything about clinical research would say this is terrible."
See the article by Paul Tosto and Jeremy Olson in the Pioneer Press:
"A schizophrenic, Markingson killed himself in 2004, while enrolled in a study at the U comparing anti-psychotic drugs. Documents surfacing the past year in a lawsuit over his death have raised questions about whether the U psychiatrist running the study followed university ethical guidelines. They also raise questions about why the Institutional Review Board, the internal group charged with protecting people in university studies didn't intervene."
It should be noted that the work of Olson and Tosto was awarded the Premack Prize for investigative journalism by the University of Minnesota School of Journalism. Judges said of their work: "Through the eyes of one patient, this story shed considerable light on the complicated and competing interests between the development and path to market of new drugs, funding needs of the University and the integrity of medical research."
My colleague Professor Leigh Turner of the University of Minnesota Center for Bioethics has sent two communications to President Kaler asking him to sign a petition - currently at 2700 signatures - for an independent review of the death of Dan Markingson, a participant in a clinical trial at the University of Minnesota that ended for him in suicide.
I am perplexed as to how the president could make the claim that the actions of the University did not "in any way" contribute to the death of Mr. Markingson.
Even a small sampling of the events that occurred makes this claim very difficult to back up. The fact that the General Counsel at the University of Minnesota did an investigation means exactly nothing. He is the University's mouthpiece and the results of his supposed investigation were never made public.
The Hennepin County District Court only concluded that the University was immune from prosecution, not that the University did not do anything wrong in the matter. The claim that the Minnesota Board of Medical Practice investigated the matter is simply meaningless since the records of the Board are closed. So to claim that the U has somehow been exonerated by the Board is unprovable.
The FDA investigation has also been debunked. See: "How the FDA got the Markingson case wrong."
So why is the University of Minnesota so afraid of an unbiased, outside, investigation? If it is true that the U has done nothing wrong, why not do it? The fact that a large number of people both inside and outside the University have asked that this be done is of no consequence? Many of these people are alums, faculty, and citizens of the state of Minnesota.
And these people - like me - will remember, when the subject of the University of Minnesota comes up, the less than honorable way in which the U has behaved in this matter. People thinking about enrolling in clinical trials should be aware of what happened at Minnesota to Dan Markingson, and that the University apparently thinks the way he was treated is perfectly OK. They should also be aware that if any negligence should occur, the U is immune from a lawsuit. I hope that this information is given to prospective enrollees as part of the informed consent process.
The University of Minnesota needs to fix its demagnetized moral compass. Just because something is not illegal does not mean that it is ethical.
Hoping to be a proud Gopher again, when this situation is finally addressed by the University of Minnesota.
U of M alum and faculty member
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