University of Minnesota research case is not a scandal

  • Article by: Aaron Friedman
  • Updated: May 16, 2013 - 6:32 PM

Dan Markingson’s case was a tragedy, but it is not a scandal.

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bcelliottMay. 16, 13 6:55 PM

For some reason, nobody at the University of Minnesota is willing to discuss the actual facts of Dan Markingson's suicide -- the involuntary commitment order, the coercion, the conflicts of interest, the rigged trial, the unsealed documents from the AstraZeneca litigation, the unresponsiveness of university psychiatrists to the desperate warnings of Dan's mother that Dan was in danger of killing himself. Instead, they always refer to the 'investigations" already conducted -- some of which did not even occur. Let me quote a passage from the deposition of Richard Bianco the official responsible for research protection at the U. Q: Has the IRB done any investigation into the death of Dan Markingson? A: Not a formal investigation, no. Q: Has the university done any investigation into the death of Dan Markingson? A: No. And later: Q: To the best of your knowledge, did anyone at the IRB, at the University of Minnesota, or anyone under your office investigate this case, actually look at the records and see the court documents that I’m describing, and if so, could you give me the name of that person? A: Not to my knowledge. Q: Nobody did that. A: No.

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meegwichMay. 16, 13 6:57 PM

The very first question that comes to mind is where is the documented proof of all these so-called investigations. The University of Minnesota has not once produce a single document. The Hennepin County District Court investigated the Markingson death and CAFE' study..on what jurisdiction? The court never investigated the death of Dan Markingson. Where exactly is Mr. Friedman getting his information? The Board of Medical Practice never investigated the University and the CAFE' study, again, under what jurisdiction? The board investigated the behavior of the treating psychiatrist and his boss, not the University. The same treating psychiatrist settled a malpractice suit. You only do that when you're wrong or guilty. Yet the U claims all is well in research land. Why then was Dan's Law's passed unanimously at the state capitol? Prohibiting the disgusting behavior of the research psychiatrist at the UMN. The Minnesota Board of Social Work found all kinds of problems with the study coordinator at the University and her behavior and the University paid for her legal counsel. Mr. Friedman's article is exactly what's wrong with research at the UMN, no accountability and a bunch of half-truth's trying to support a lie.

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humph010May. 16, 13 8:47 PM

Dr. Elliott, I sincerely hope that you serve the University of Minnesota in your faculty role with the same zeal and tenacity in your academic, research, and service responsibilities.

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wbgleasonMay. 16, 13 9:50 PM

One might think from reading Dean Friedman's piece that Dr. Elliot is some sort of lunatic who, alone, has been agitating for a totally unnecessary investigation of the death of Dan Markingson. Ask yourself: Why has the petition asking the Governor to have an outside investigation of this matter been signed by 2500 people around the world, including citizens of our state, U of M grads, and U of M faculty? There is plenty of documentation on the petition site (Google: Markingson petition) that shows this situation qualifies for the word "scandal" which is defined as: An action or event regarded as morally or legally wrong and causing general public outrage: "a bribery scandal." Synonyms for scandal are: disgrace and shame. With all due respect, Dean Friedman, this situation is eminently qualified to be described as a scandal. William B. Gleason, U of M alum and Medical School faculty member.

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imissuptownMay. 17, 1312:28 AM

I'm not privy to the details of this situation, but there is an interesting shift in language in this op-ed. Elliott calls for a formal investigation into the circumstances behind Dan M.'s death. Dr. Friedman says that this has been done, but his proof is that various agencies have "examined" the situation. But the problem is that the sum of the various "examinations" do not equal or approximate a formal investigation of the entire circumstances that led to that death. Presumably, the FDA looked in to whether any protocols were violated during the study. The Minnesota Board of Medical Practice would likely simply assess whether this behavior deviated from standard practices. The Hennepin County District Court simply ruled on who could sue. The University Office of General Counsel would simply review the case for the university’s legal liability. None of these would constitute an independent formal investigation in the eyes of most folks.

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leighturnerMay. 17, 13 2:22 AM

Aaron Friedman claims that the University of Minnesota has expended “untold resources” in response to Carl Elliott’s call for an investigation into the death of Dan Markingson and the clinical trial in which Markingson was enrolled. Whatever resources the university has expended responding to Carl Elliott’s concerns appear to have been spent stonewalling at every turn Elliott’s carefully reasoned and evidence-based requests for an investigation. For example, the University of Minnesota’s Research Integrity Officer, Research Subject Advocate, Director of the Clinical Research Ethics Consultation Service, and Board of Regents have all refused to investigate Dan Markingson’s death. Elliott’s requests for documents have likewise been greeted with stonewalling. To date, in response to data requests filed by Elliott, he has been informed that documents are missing, destroyed, or will not be provided to him. These responses raise questions about whether the university is violating state open records laws. Faced with such a consistently obstructionist response from within the University of Minnesota it is understandable that Elliott is now calling for an independent investigation. I join Elliott in this call and encourage readers to consider signing the petition calling upon Governor Dayton to initiate an investigation of possible psychiatric research misconduct at the University of Minnesota. For someone who claims to be concerned with “the facts”, Aaron Friedman provides few of them. He apparently wants to claim that Dan Markingson’s death is old news and there is nothing to investigate. His account of prior “examinations” is misleading and fails to address any of the many ethical and legal issues identified by Carl Elliott and other individuals who have examined Markingson’s death. For example, Friedman does not confront elementary questions about whether the threat of involuntary commitment coercively forced Dan Markingson into a clinical trial, how and why Markingson was deemed competent to provide informed consent despite his condition, why all financial conflicts of interest were not disclosed to study participants, and why Dan Markingson remained in the study despite his mother’s pleas. Questions continue to swirl around Dan Markingson’s death. These questions are going to persist until the evasive responses cease, efforts to belittle and intimidate Carl Elliott end, and an independent investigation occurs. Leigh Turner, faculty member, University of Minnesota Center for Bioethics

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meegwichMay. 17, 13 4:54 AM

This op-ed from Dr. Friedman isn't the first time he's tried to manipulate the facts to serve his own purpose. Just a few years ago he challenged a Strib reporter claiming that he had made six or so accusations in a story that made implications or judgments that were simply wrong and led to unfair conclusions. The reporter and the Strib stood behind the accuracy and fairness of that story with documents and took exception with his misrepresentations of their work. Anyone else see a pattern here? and exactly where would someone find the earth shattering, cutting edge research results produced by the University's psychiatry department? The latest ranking of psychiatry departments within medical schools has the UMN near the bottom. Those are facts.

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luxaeternaMay. 17, 13 6:12 AM

The case is a decade old. It was investigated by several government agencies. It's time to move on.

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psychapooMay. 17, 13 7:28 AM

Friedman says the U has spent "untold resources addressing (Elliott's) allegations over and over again." Well, from what I can tell,the responses have been, for the most part: 1)We don't have that information 2) We've destroyed that information and 3) It's already been investigated. Yes, I'm sure that's way too much work to do when a patient has died under your department's care. How do you guys get any work done when you're so busy writing letters refusing to do anything?

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drjudystoneMay. 17, 13 8:41 AM

Once again, the UMN is trying to divert attention from serious problems in their midst and play kill the whistleblower, Professor Elliott. It is Dr. Friedman and the University who are trying to distort the issues by incorrectly suggesting that the UMN has performed adequate investigations and has been cleared of all wrongdoing. Specifically, I have examined the FDA’s “investigation” and found it superficial and woefully lacking. Even if giving them the benefit of the doubt, considerable disturbing information has come to light that they apparently were unaware of at the time, warranting a new and more complete investigation. The Minnesota Board of Social Work found significant fault with the study coordinator’s actions. (document on Scribd). Clinical Research 101 states that the Physician Investigator bears responsibility for work done under his supervision, and he settled a malpractice suit, yet the UMN says there was no misconduct? This might be described as delusional behavior. If Dr. Friedman’s allegations against Dr. Elliott were true, and the University had clearly been absolved of wrongdoing (which hasn’t happened, excepted in their own minds), then how does he explain that: “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,” as well as “More than 200 experts in medical ethics and related disciplines [who] 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?” Note: All of Professor Elliott’s assertions are openly available for anyone to review on his web site and on Scribd, where he provides the source documents, and on my Scientific American, “Molecules to Medicine” columns about the UMN’s scandalous behavior. I await the UMN showing such transparency, rather than their customary stonewalling. Despite Friedman’s misleading diversionary tactics and Mr. Rotenberg’s chilling attempts to intimidate faculty dissent, critics of Dr. Elliott should recognize that he does not stand alone, given the array of people supporting this request for an independent investigation. When you get this caliber of signatories, you should know this issue is substantive and is not going away. Judy Stone, MD, Author of text "Conducting Clinical Research" and Scientific American blog network column on clinical trials

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