Friday, May 17, 2013

For the Record

A dollop of bluster on the usual boilerplate...

University of Minnesota research case is not a scandal

In a May 13 commentary (“U research case needs a close look”), University of Minnesota faculty member Carl Elliott called for yet another investigation into the tragic death of Dan Markingson, a patient who was battling schizophrenia. Markingson took his own life in 2003 while taking part in a clinical trial aimed at treating his condition.

The story may be familiar to some readers. For years, Elliott has focused his energy on this single issue. Yet as Elliot clamors for more examination, he seems to feel no responsibility to accurately report what has already been done.

Elliott claims that despite “dozens of formal complaints to university officials,” the issue has never been formally investigated. He knows this is inaccurate.

Examinations of the Markingson case have been conducted by the U.S. Food and Drug Administration (FDA), the Hennepin County District Court, the Minnesota Board of Medical Practice (assisted by the Minnesota attorney general’s office) and the University Office of General Counsel, at the direction of the Board of Regents. The latter was prompted by Elliott himself.

None of these investigations found that the university in any way contributed to Markingson’s death. Most notably, the FDA, the federal agency charged with responsibility for such matters, conducted an extensive review of this matter. In its final report, the FDA “did not find any evidence of misconduct, significant violation of the protocol or regulations governing clinical investigators or IRBs in this inspection, data audit, or interviews.” Because he did not agree with this conclusion, Elliott ignores the review and asks for further investigation.

Elliott has filed numerous requests for information over the years and has published countless accounts of the Markingson case. These requests have required the university to expend untold resources addressing his allegations over and over again as we attempt to respond to his selective and distorted narrative.

We at the University of Minnesota are proud to have researchers willing to take on extremely challenging problems, and to search for answers to tough questions. Sadly, not all of these patients get cured, but hopefully every case gets us closer to that goal.
Mr. Markingson’s suicide was a tragedy, but it is not a scandal. Nine years later, it is time to stop blaming our university and our researchers.

We hope Star Tribune readers won’t allow Elliott’s campaign to cloud reality. Judge the university not on unfounded accusations, but on careful examination of the facts surrounding this case, and on the scale of the groundbreaking advancements taking place across our campuses every day.

Dr. Aaron Friedman is vice president for health sciences and dean of the Medical School at the University of Minnesota.

From the Comments:

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.    

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-truths trying to support a lie.

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

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.

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

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.
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 else.
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, except 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

Dean Friedman’s recent dismissal of the concerns raised by Dr. Carl Elliott and others in the Dan Markingson affair would be astounding if it did not fit into the already established narrative of delay, deny, and dismiss. While several agencies have “examined” aspects of the study and Markingson’s suicide, no thorough and independent investigation has been done which draws all the aspects together to see how the pieces fit together to form a picture which is more shocking than the parts. If Dr. Friedman and the UMN wants the discussion of scandal to go away, there is an easy way to do that: get behind the drive for an independent investigation to answer all the questions. If you have nothing to hide, nothing will be found and the lapses and problems of the study will be explained. Without knowledge of what went wrong (surely even Dr. Friedman will admit that things went wrong?) there is no way to go forward to ensure that not only it never happens again but also that future research done at UMN is given proper weight and credibility. Unfortunately given the past responses of UMN to questions the only way we can ensure that a real investigation occurs is to provide a comprehensive outside review. Alternately, the school could release the documents and information necessary for a public inquiry without an appointed investigative panel. But both seem unlikely from the believers of delay, deny, and dismiss.

"Judge the university not on unfounded accusations, but on careful examination of the facts surrounding this case." Great idea! The university has already been investigated and exonerated? Let's see the evidence. Elliott has posted loads of documentation on this case on scribd. All we're getting from the U is the same boilerplate denials from the PR folks.

This statement is as self-serving as it is duplicitous. The "investigations" mentioned are precisely the stonewalling and evasion that a true inquiry is needed to penetrate. The local county "investigation" was to do nothing. The University's "investigation" was a statement by its own counsel exonerating the University and himself - when he himself is the center of part of the scandal, responsible for suing the mother of the deceased victim then demanding that she drop her complaints as a condition of foregoing judgment against her for complaining about her own son's mistreatment. He also issued a thinly-veiled threat against faculty who raise questions of propriety against the university - again, this is the man who "investigated" his own conduct and that of the university that employed him, and found no wrong-doing. The FDA's "investigation" merely stated that they would not proceed because the investigators had approval from the University IRB, while the IRB itself stated that its role was not to protect research subjects but they rather left that up to the investigators. Meanwhile, the actual facts of the case are clear: the victim was under court order to comply with the researcher's treatment orders under threat of incarceration; the researched used that authority to enroll the patient in an experimental study after previously testifying that the patient could not legally consent to his own treatment (or, thus, to participate in research); the patient visibly decompensated, including threatening suicide, during the experiment, which fact was brought to the attention of numerous parties including the principal investigator, who refused to take action; the investigator and the university had a financial conflict of interest in the form of payments of over $15,000 per subject in the study and would thus have lost money by releasing this victim from the protocol; the study also exhibited numerous irregularities including improper and illegal practice of medicine by the unqualified project administrator, forgery of medical orders by that administrator, and apparent forgery of consent documents affecting this victim and others. None of this has been investigated in a thorough and authoritative way, and no one responsible has been held accountable even for the obvious and admitted violations of law and procedure, to say nothing of the death of a desperate patient known to them to be suicidal and unable to consent to the treatment he was subjected to against his will. This issue - unlike the victims of this sad and abusive project - will not die. The sooner light is shown where it is needed, the sooner a proper resolution can be achieved. The shrill and hostile efforts of those in authority to obscure and evade their responsibility for these events - a tragedy, an abuse, and a scandal - only underscore how necessary this is.

Aaron Friedman seems to be claiming that the ethical failures of medical professionals in the psychiatry department should not be considered scandalous---in effect, he seems to be claiming that egregious ethical failures which calls into question the ethical integrity of the research conducted by faculty in the Department of Psychiatry at the University of Minnesota is no big deal. According to Aaron Friedman, Dean of Medicine, he believes that any blame should be assigned to the whistleblower, bioethicist, Carl Elliott. What I don't understand is how can failing to properly investigate a fatal "tragedy," worse, to minimize the value of Dan Markingson's life, (and his mother's loss) serve the interests of the University of Minnesota? The University's failure to properly investigate the ethical lapses which led to Dan's death, is the real tragedy. This lack of concern implies that the ethical integrity of faculty members and researchers is unimportant. It also gives the impression that the health and well-being of individuals who are enrolled in clinical trials at the UMN is not valued; that Human Rights will not be protected or defended. I fail to see how not holding unethical medical professionals accountable serves the University? It seems a gross error in judgement to defend faculty members who carelessly violate ethical guidelines for research with human subjects, violate the ethical guidelines of the medical profession and utterly failed to perform the ethical medical duties owed a delusional patient. Can it be that the Dean of Medicine, believes there is nothing wrong with entering delusional people adjudicated in Court to be incapable of providing Informed Consent into drug trials? Dr. Friedman is basically asserting that the fatality of Dan Markingson, who was not able to defend or advocate for himself, is not worthy of an investigation. The failure to investigate the circumstances of Dan's death undermines the integrity of the Department of Psychiatry, it calls into question the ethical integrity of all the clinical trial research conducted at the University of Minnesota. It is certainly a strange professional opinion for a Dean of Medicine to share with the public...

yobluemama2@ thank you, my sentiments exactly. This opinion from the Dean of Medical School is way out of bounds. What message is he sending to prospective medical students, never mind how your research ends up, or how many patients may have been harmed, just how many have you enrolled and what are they worth in dollars? If I had any lingering doubts about the University's culpability in this young man's death this piece today took all those doubts away. Shame.
It is very apparent from the majority of the comments that Dean Friedman’s obsession with denials at the expense of truth is taking a very heavy toll. But at the same time, the University’s endless ranting about being exonerated is getting very sickening. In school we were taught the definition of a “profession” most importantly includes the responsibility for self-regulation. By blaming a bioethicist at the University who appears to be the only one concerned with the truth is an impotent exercise. Not exactly the standard of leadership one would expect from the medical school dean. At the end of the day, the responsibility for the issue rests with the University to do the honorable thing and welcome an independent investigation, and not have the dean basically stating “if the glove doesn't fit, you must acquit.”
Dean Friedman's opinion piece is more accurately described as a psychological defense mechanism in which a person is faced with a fact that is too uncomfortable to accept and rejects it instead, insisting that it is not true despite what may be overwhelming evidence.
You know, I seem to have missed the part where the University's medical school dean mentions anything whatsoever about the value the U puts on patient safety. It's in there somewhere, right?

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