Wednesday, June 5, 2013

Response to University of Minnesota President's Letter 

Concerning the Markingson Case

Originally posted at Star-Tribune's Community Voices Blog:

Brief Background:

See the article by Susan Perry in Minnpost:

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:

Patient's Suicide Raises Questions

"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 invesigative 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 occured 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.

Bill Gleason

U of M alum and faculty member

Some comments on the Strib site:

What amazes me most about this situation is the absolute blinders the administration wears. The history of the U of M over the past 2 1/2 decades is so filled with high-level unethical behavior it's amazing. If Dr. Kaler wants to move forward the only way to do so is to put this behind us. He should consider appointing an independent panel of bioethicists and clinicians to investigate this claim free from the contamination of the U of M on both sides--on the "yes you did" and the "no we didn't" sides. Accept the outcome, apologize and pay up if necessary. Then, clean up the house at the U of M. Throw out that weak conflict of interest piece that was instituted and adopt the one that was conveniently ignored. Last, no more BS like the Polly incident, the Najarian incident, the Schulz-Seroquel marriage, the Polla scandal, the Sainfort-Jacko scandal, the Furcht scandal, and so on.

For those unfamiliar with the aforementioned scandals, an introduction to each may be found at:

More on Polly, Grassley, and the U...

U doctor on ethics panel was disciplined

Professor Gleason, I could not agree more with your assessment of the response letter from Dr. Kaler. Having followed this episode in the media and internet and realizing that what happened to this young man could happen to anyone, and this is the response from the president of the University? There is not even a hint that Dr. Kaler is interested in the unbiased truth once and for all, just the regurgitation of the same denials that have never once been proven. I just recently read where the University sent lobbyist over to the capitol back a few years ago to try and persuade legislators to not vote for Dan's Law. The strategy backfired and the law was passed unanimously. Where is the mention of the fact that a law was passed in this state because of the unethical and coercive behavior of university research psychiatrist? Dr. Kaler doesn't mention it, he simply spews the same rhetoric the University has done for years to bolster their denials and lies. I'm ashamed of the behavior of Dr. Kaler in his response, he's suppose to be a leader, not a follower.

Good question. If Dan's Law was necessary, how can the U administration claim that nothing wrong was done in this matter? And why did they lobby against Dan's Law?

As Dan Markingson's mother put it in response to University of Minnesota VP Mulcahy:

Mulcahy states also in his article, “The University is steadfast in its commitment to the protection of all research subjects.”

If this had been the case, “Dan’s Law” — which was passed unanimously in both the Minnesota House and Senate in 2009 — would have been entirely unnecessary.

This law now prevents anyone on a stay of civil commitment from entering a psychiatric clinical drug study and also prohibits any doctor from putting his or her own patients into his or her own clinical drug study.

Further comments on the Strib site:

I find this response from the President of the University of Minnesota absolutely disgusting. He's responding to a professor at his own university who seems to be genuinely concerned about whether in fact the university did or has done everything possible to give closure to this mans family, and the best he can offer is we've been exonerated by ourselves, but don't ask me for any proof. He would have been better off not saying anything and continued the university's pattern of stonewalling the truth. Mr. Kaler, you have certainly not distinguished yourself in any manner, and I hope residents of our state remember this every-time you show up at the capitol with your hands out and trying to defend the top-heavy administration that you created and condone.

There are 2700 signatures for the petition when the U has a student population of over 51,000 and faculty and staff population of over 3,000? That's not too terribly impressive. "The FDA investigation has also been debunked." The author of the article "debunking" the FDA investigation is none other than Carl Elliott. That's hardly an unbiased source.

To which I responded: 

Did you read Professor Elliot's article debunking the FDA report? I use the word "debunking" as my professional opinion. Here is a link to the article. If you disagree with Dr. Elliot's analysis, please explain why. Whether 2700 signatures on a petition is worth blowing off is a matter of debate. Given the credentials of those signing and the fact that many are alums, faculty, students and citizens, I wouldn't attempt to minimize these efforts. One powerful example is: "Attended U of MN Medical School. then U of MN Psychiatry Residency - ashamed of the Psychiatry Department - have been in private practice since 1977 - Have seen first hand the hijacking of Psychiatry by BigPharma." Plenty more where that came from.

The one glaring question that the University and now Dr. Kaler has forever avoided or refused to acknowledge is...if there was no wrongdoing of any kind...why did the University seek immunity under state law from being sued? Why not have just welcomed the suit and let the facts speak for themselves? It's now very apparent from Mr. Kaler's response that the University has no desire for the truth, and in fact is afraid of it.

The U of M administration uses the FDA investigation in 2005 as a primary reason to reject another investigation. But in 2012 the Minnesota Board of Social Work took corrective action against the social worker who was the study coordinator. Perhaps the most damning finding was that "there were critical omissions in [the social worker's] documentation that were relevant to suicide prevention." The response from the U of M general counsel was that the social worker is no longer an employee of the University. This is the response of an institution that places a higher priority on the protection of its reputation than on the protection of its patients.

For further information on the matter of the study coordinator, please see:

Would you be interested in having your son participate in a clinical trial run by these folks?


Sanctions imposed in 2004 U drug trial death

This research would never be approved by an Institutional Review Board today. Indeed, an independent review of the case would go a long way to address any institutional irregularities and provide guidance to future remedies. It is a terrible miscalculation by Dr. Kaler.



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