For the Record, Walking the Talk

"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."

 Dean Aaron Friedman in the Star-Tribune

Defining Privilege

Dean Friedman delivered the following speech at the 2013 Medical School commencement ceremony.

You have worked very hard to get here, and you all deserve this moment to pause, to reflect on the experience, and to take pride in what you have learned and what you have accomplished.

Graduating from medical school makes you members of a special group. You have pledged your talents to an important cause and you have shown you have the skill to be entrusted with a vital role in our society.

Today you become members of a privileged group.

But what does it mean to be "privileged?"

It's an important question.

I believe your interpretation of this word will go a long way in determining your success as a physician, and defining the satisfaction you derive from your career.

Does being privileged mean you are special? Does it mean you are elite? Does it entitle you to a certain level of status and respect?

That is one way to look at it. When you are practicing medicine you will bring a skill set to the job that few can match. You will save lives. What could possibly be more important? You may feel your patients are lucky to have you as their doctor.

There are physicians you will encounter in your career that subscribe to this definition.

I remember a time when I was working in the ICU helping a very sick child with multi-organ failure. She could not be moved but needed a procedure to get more vascular access.

A chief resident came to see the child in the room and informed us that the procedure had to be done in the operating room because that is where he works best and he is the best at this type of procedure. When we told him the child was too ill to move, he said loud enough for all to hear, "If you want the best you will need to move the child to the operating room. Otherwise get someone else."

I remember being taken aback by this doctor's perspective. And the rest of us – the family, the nurses, and the other physicians in the room – we were all supposed to feel privileged to have access to this doctor's skill. This was not about a sick child. This was about whether that child was going to be granted an audience with this doctor. Would she be that lucky?

This kind of perspective is more common than you might expect. As you set the course of your career, I want to encourage a different perspective on the idea of "privilege."

Early in my career as a physician I had a patient that I first started to see when he was one day old. I got to know his family well. This little boy developed kidney failure and at the age of 5 he needed a biopsy of his transplanted kidney.

It was a tough procedure, but we usually allowed a family member in the biopsy room because it helped the patients. In this case it was the boy's mother who stayed with her son, holding his hand. We successfully completed the biopsy and the mother thanked the radiology technician who assisted with the procedure. The technician told the mom she should thank me because I did most of the hard work. The mom said, "I know, we thank him every day."

I remember thinking how amazing it is that a mother would say, “thank you.” And how privileged I was to be able to take care of that child and be part of that family.

As physicians we are allowed into people's lives during their highs and their lows. We get a rare chance to help them through challenges, to share in their joy, to give them hope, and to help them through when things don't go well. Each of these paths allows us an opportunity to make a difference.

From my perspective, it's not about getting recognition, but if you remember what a privilege it is to play this role in other people’s lives, you will in fact be very privileged.

For the Record

A dollop of bluster on the usual boilerplate...

From the Star-Tribune:

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?

Weeping Angel 

Part of mausoleum of canon Guilain Lucas (1628)

Photo credit: Wikimedia Commons

 In Memory of Dan Markingson

Tomorrow, May 8, 2013, will mark the ninth anniversary of the death of Dan Markingson in the CAFE study at the University of Minnesota. 

In his honor and in the hope that the same thing does not happen to another mother's son, please consider signing a petition to Mark Dayton, Governor of Minnesota, asking him to see that an independent investigation of this death is carried out. 

This is a matter of honor to University of Minnesota students, faculty, staff, administrators, alumni, and friends. It is also an obligation to citizens of the State of Minnesota who ultimately bear some responsibility for what goes on at their university.  

With my sincere apologies to Mary Weiss, Dan's mother, for what she has been put through by my university.

Bill Gleason, U of M alum and faculty member

The Minnesota House of Representatives

sends the University of Minnesota 

 a not so subtle message

Before voting, the House amended the bill on Thursday to shift $543,000 from the university’s appropriation to the state grant program. That’s the amount the university is spending this year on two independent studies of its administrative costs and efficiency, said Rep. Steve Drazkowski (R-Mazeppa), who proposed the change.

From the Minnesota House House of Representatives Session Daily:


House passes higher education budget that would freeze tuition

In a vote that some lawmakers hailed as a first step toward curbing the rising costs of college, the House on Thursday passed an omnibus bill that would freeze tuition for two years at both of Minnesota’s public higher education systems.


House members voted 86-44 to approve a plan that would spend $2.72 billion on higher education over the next two years, an increase of about $150 million over current spending. Most of the new money would fund a tuition freeze for resident undergraduates at both the University of Minnesota and the Minnesota State Colleges and Universities system. Research and new initiatives would get a much smaller slice.


“It is time to send a strong message to the institutions,” said Rep. Ryan Winkler (DFL-Golden Valley). If the public puts more money into higher education, “The students are the ones that should benefit.”


Thursday’s floor debate on the omnibus higher education finance bill followed more than a dozen committee hearings at which House members picked apart the budgets of MnSCU and the university. Some legislators have criticized both systems for what they see as unnecessarily steep tuition hikes and excessive administrative spending.


Winkler was quick to add that lawmakers, through votes cast over many years, share responsibility for the costs borne by today’s students. “It has been the Minnesota Legislature that has dramatically defunded higher education,” he said.


Before voting, the House amended the bill on Thursday to shift $543,000 from the university’s appropriation to the state grant program. That’s the amount the university is spending this year on two independent studies of its administrative costs and efficiency, said Rep. Steve Drazkowski (R-Mazeppa), who proposed the change.


The bill includes language intended to increase legislative oversight of higher education, requiring more detailed spending reports from both systems. Its House sponsor, Rep. Gene Pelowski Jr. (DFL-Winona), said that the House Higher Education Finance and Policy Committee – which he chairs – will consider more accountability measures in the next year.


Several Republicans praised the bill, with Rep. Glenn Gruenhagen (R-Glencoe) calling it an attempt at “real reform in government spending.”


Rep. Bob Barrett (R-Lindstrom) opposed the bill, arguing that the university should fund lower resident tuition by increasing the rate charged to out-of-state students. “The people of Minnesota are subsidizing nonresident tuition,” he said.

No More Dan Markingsons

With the permission of PZ Myers - my esteemed colleague at the University of Minnesota, Morris:

link to original

(emphasis mine)

A few weeks ago I gave a talk in Seattle in which I pointed out that science is not sufficient to define moral behavior. A substantial part of that talk was a catalog of atrocities, such as the Tuskegee syphilis experiment. I said that in purely scientific terms, that was a good experiment; if the subjects had been mice, for instance, setting aside an untreated control group to study the progression of the disease would have been considered an essential part of smart experimental design. One could still argue that the needs of the many outweigh the needs of the few…if one were willing to distance oneself from the humanity of the subjects.

Yes, one can always retreat to the excuse that these were cases of bad science, where the scientists violated the rules of their own profession. But where do the ethical guidelines come from? Not science.
I missed a trick, though. I talked mainly about old cases, when there’s a clear case of the conflict between ethics and science playing out right now, right at my home university: the case of Dan Markingson, the young man who was enrolled in an experimental pharmaceutical study and kept there, even as his mental illness worsened, and who eventually committed suicide.

There’s a new article by a bioethicist on this case.

The research abuse in this case is so stunning that when I first learned about it I could scarcely imagine it happening anywhere, much less at the university where I work. In late 2003, psychiatric researchers at the University of Minnesota recruited a mentally ill young man named Dan Markingson into a profitable, industry-funded research study of antipsychotic drugs. The researchers signed him up over the objections of his mother, Mary Weiss, who did not want him in the study, and despite the fact that he could not give proper informed consent. Dan was acutely psychotic, plagued by delusions about demons, and he had repeatedly been judged incapable of making his own medical decisions. Even worse, he had been placed under an involuntary commitment order that legally compelled him to obey the recommendations of the psychiatrist who recruited him into the study.

For months, Mary tried desperately to get Dan out of the study, warning that he was getting worse and that he was in danger of committing suicide. But her warnings were ignored. On April 23, 2004, she left a voice message with the study coordinator, asking, “Do we have to wait for him to kill himself or someone else before anyone does anything?” Three weeks later, Dan committed suicide in the most violent way imaginable. His body was discovered in the shower of a halfway house, his throat slit so severely that he was nearly decapitated, along with a note that said, “I went through this experience smiling.”

You know, I’ve been impressed with my university on many occasions: their commitment to academic freedom has been exemplary, my interactions with the university’s lawyers (I’ve had a few of them…) has always left me satisfied that they are fair and pragmatic. But this is a failure not just of the scientists involved, but the administration of the university. It’s an embarrassment.

Yet for three years the University of Minnesota has managed to bluster and stonewall its way through all the criticism, insisting that it has already been exonerated. Even when the state Legislature passed “Dan’s Law” in 2009, banning psychiatrists from recruiting mentally ill patients under an involuntary commitment order into drug studies, the university continued to insist it had done nothing wrong.

I suspect that the stonewalling is out of fear of opening the door to legal action against a university that is already struggling with constantly dwindling support from the legislature. But it’s necessary that they confront this issue and deal with it honestly — it’s the only way to restore confidence with UM’s ethical culture, and it’s the only way to make sure there are no future Dan Markingsons.
And it’s that last bit that is the important concern.

My Thanks to PZ for a lucid statement of the problem. This is about the reputation of the University of Minnesota. If we cannot face up to - and fix - the problems involved in this tragedy then why do we deserve the trust and support of the state of Minnesota?

Should a reader be unaware of the petition to Minnesota Governor Mark Dayton for an independent investigation of the Markingson tragedy, please consider signing it at the following link:

Governor Mark Dayton of Minnesota: Investigate psychiatric research misconduct at the University of Minnesota

What Minnesota Representative Pewlowski Had

To Say About University Educational Finances

From MPR On CAMPUS:

Yesterday was practically Gene Pelowski Day.

First the House higher-education committee chairman appeared on MPR’s Daily Circuit.

Forty minutes later, he held a press conference unveiling the latest version of the House higher-education bill.

Then he held his committee’s hearing.



On why he focused on a tuition freeze instead of adding more to the State Grant program:

“(Lower) tuition helps everyone. Everyone in this state is helped by lower tuition. The best type of grant program is in tuition. If we’re going to raise tuition and then selectively spend more to help a few in the grant program, we’re feeding an animal that is insatiable. And that animal has literally brought higher education to its knees in this state. … The grant program helps a few. (Lower) tuition helps everyone. I think it’s time to help everyone.”

On his proposal to beef up administrative reporting requirements for the University of Minnesota and MnSCU — as opposed to the Senate’s proposal to withhold a percentage of funding until both systems meet performance goals:

“Depending on what our target (budget) number is, maybe the approach should be to use both. … We may have the best of all worlds here.”

On how lawmakers could force the U to change its practices, considering it’s technically autonomous from the state (except for its intake of state funding):

“We’re working to find out what kind of mechanism to use with the University of Minnesota. I would hope that the regents would finally use their ability to finally have oversight of the university. But because of the U’s extra-constitutionality, it’s much more difficult. And even working with the legislative auditor, it’s difficult to craft what would be mandatory language for the university.”

On telling the difference between a purely administrative position and an one that includes an academic role, so that cutting administration doesn’t harm the classroom in the process:

“That’s going to be the ongoing problem — and I’m sure we’ll be able to solve it.”

On the “restoration” of legislative oversight of the U and MnSCU, which he says has been gone for the past 8-10 years:

“It’s time we looked at tuition increases the same way we looked at tax increases, and we had the same level of legislative oversight in tuition increases that we have with the tax increase. Both have technically the same impact, and both have a tendency never to go away.”

On the use of a consulting firm to analyze the U’s administrative structure and look for ways to make it more efficient:

“They’re spending a half million dollars to find out something they should already know.”

On the U’s handling of tuition increases:

“I think the U, by its own admission in our committee, raised tuition because it could. I think it raised it way beyond (what) it needed to for the cuts that were being instituted over the last 8-10 years, and I think now there has to be a reversal.”

Everyone has won, and all must have prizes...

The Dodo Bird Verdict by the American College of Psychiatrists  

My colleague, Dr. Carl Elliot, has written another excellent piece on the Markingson situation at the University of Minnesota.  

Background:

“They Need to be Held Accountable”

And That’s the News from the Department of Psychiatry

The Road to Perdition

“I Was Just Following Orders”: a Seroquel Suicide, a Study Coordinator, and a “Corrective Action”

The University of Minnesota was not Involved? Some Further Thoughts on the “Corrective Action” Against Jean Kenney in the Markingson Case

Carl's piece from Mad in America:

To Honor or Investigate

April 15, 2013

A number of years ago, I had occasion to meet a local psychiatrist named Dr. Faruk Abuzzahab, a former faculty member in the Department of Psychiatry here at the University of Minnesota. The occasion was a class in medical ethics I was teaching, and which Abuzzahab had been ordered to take. As I later wrote in The New Yorker, the Minnesota Board of Medical Practice had judged Abuzzahab a danger to the public and had suspended his license in response to the deaths or injuries of forty-six patients under his supervision, seventeen of whom had been research subjects. Abuzzahab had recruited severely ill patients into profitable, industry-funded drug trials, often in violation of eligibility criteria, and kept them in the studies even after their conditions worsened dramatically. When the board suspended his license, it cited his “reckless, if not willful, disregard of the patients’ welfare.”

You might think being sanctioned for the deaths and injuries of 46 patients would damage a psychiatrist’s career. Unfortunately, you would be wrong. Shortly after the suspension was lifted Abuzzahab was back at it, giving marketing talks for industry and conducting trials. In 2003, only a few years after his suspension, the American Psychiatric Association awarded him a Distinguished Life Fellowship.

That episode came to mind again this morning when I read a press release from the university about Dr. Charles Schulz, the current Chair of the Department of Psychiatry. Apparently Schulz will be receiving the 2014 Stanley Dean Award for Research in Schizophrenia from the American College of Psychiatrists. Of course, readers of Mad in America will probably know Schulz better as a thought leader for AstraZeneca implicated in the events leading up to the $520 million fraud settlement, and his role in the CAFÉ study – the clinical trial at the University of Minnesota into which Dan Markingson was recruited under threat of involuntary commitment, resulting in his suicide. (For the rare reader of Mad in America unfamiliar with the Markingson case, see this article.) 

The timing of this announcement is intriguing. For the past month, a petition to investigate psychiatric research misconduct at the university has been quietly gathering momentum. The number of signatures has just passed 2100. It is not often that you will find an issue on which the editors of The Lancet and Guinea Pig Zero agree, but the need to investigate the University of Minnesota is one of them. MindFreedom International has endorsed the petition; so have 200 academic experts in health law, clinical research and medical ethics, including former editors of The New England Journal of Medicine. Many alumni of the university have left distraught comments on the petition. One example: “I went to the U of MN and am appalled by what I’ve read about this case.” 

At this point, it still not clear who will prevail: those who want to honor the Department of Psychiatry, or those who want to have it investigated. Of course, I am in the latter group, along with the family and friends of Dan Markingson. But the other side is wealthier and better armed. If you have been following this case but have not signed the petition yet, please consider signing on. Even better: sign it, tweet it, email it to your friends, and post it on your Facebook page. You can find the petition at this address: 

http://chn.ge/13TtenX

Will no one rid me of this meddlesome priest?

Why the Administration of the University of Minnesota loves Carl Elliot...

As does the departing General Counsel


From the Minnesota Daily

(emphasis mine)

How we have betrayed research subjects

By
Carl Elliott — professor, University Center for BioethicsApril 15, 2013

It has been five years since the Pioneer Press reported the disturbing sequence of events leading to the suicide of Dan Markingson in a psychiatric research study at the University of Minnesota. During that period, it is hard to say which development has been more remarkable: the indifference of the University community or the torrent of international condemnation.

“I have been following this story, open-mouthed, as it has unfolded,” writes Iain Brassington, a medical ethicist at the University of Manchester. According to Richard Smith, the former editor of the British Medical Journal, “There is clear evidence that things went badly wrong.” Susan Reverby, the Wellesley historian who uncovered the Guatemala syphilis studies, has called for an external investigation, as well as the former editor of the New England Journal of Medicine, the editor of The Lancet and the former editor of the Health and Disability Commissioner of New Zealand.

An editorial in the Medical Journal of Australia has compared the scandal to the Tuskegee syphilis study.

Helen Longino, a faculty member in the University Department of Philosophy for years before moving to Stanford University, has written, “Do you really want the great University of Minnesota to become an academic pariah?”

The answer, apparently, is yes. On campus, there have been no protests, no outraged letters and no calls for accountability. And now that General Counsel Mark Rotenberg is heading for the exit door, we are not even hearing the customary denials of responsibility.
The case itself has become notorious.

In late 2003, Dr. Stephen Olson and his study coordinator, Jean Kenney, recruited a mentally ill young man named Dan Markingson into a highly profitable, industry-funded clinical trial of antipsychotic drugs despite the objections of his mother, Mary Weiss. Not only had Markingson been repeatedly judged mentally incapable of making his own medical decisions, he had been placed under a civil commitment order that legally compelled him to obey Olson’s recommendations.

As Markingson’s condition spiraled downward, his mother tried desperately to get him out of the study, at one point warning the study coordinator. Her pleas were ignored. In May 2004, Markingson violently killed himself. His body was found in the shower of his halfway house with a note that said, “I left this experience smiling.”

This research study had red flags all over it: conflicts of interest for the investigators, financial incentives to keep subjects in the study as long as possible, a dubious scientific rationale and an industry sponsor that was eventually forced to pay $520 million in fraud penalties. Perhaps most astonishing of all, when a lawsuit by Mary Weiss against the University was dismissed on grounds of sovereign immunity, the University filed an action against her, demanding that she pay the University $57,000 in legal costs.

The University never investigated Markingson’s suicide, according to the deposition of Richard Bianco, the former head of research protection, and during the five years since the death became public, the official stance of the University has been: Stonewall, evade, deny. Last fall, the Minnesota Board of Social Work found that Jean Kenney, the study coordinator, had failed to warn Markingson about new dangers of the study drugs, performed duties that have exceeded her training and falsified the initials of doctors on study records. It is likely that Kenney’s misconduct affected other research subjects, yet the University is still pretending that there is nothing to investigate.

Last month, Weiss and her friend Mike Howard started a petition on change.org to Gov. Mark Dayton asking for an external investigation. The petition has attracted more than 2,000 signatures, 175 of them from scholars in medical ethics, clinical research and health law.

The administration has portrayed Markingson’s suicide as an isolated episode from the past. In fact, we don’t know whether other subjects have died, been injured or been mistreated — and unless there is an investigation, we will never know. The Department of Psychiatry has had major research scandals in the past, and the public only learned of them after years of cover-ups and deception by University officials.

If anyone has a duty to make this shameful episode right, it is the faculty and students of the University. Please join Weiss and Howard in their petition to Dayton.

The petition may be found here.

 Show us the money!

On looking at the Editorial pages of the Strib today there were no more articles about the University of Minnesota and its financial situation for what seems to be the first time in a long while. So far, Governor Carlson has weighed in, Regent Cohen has responded, and both Representative Winkler and The Periodic Table have responded to Regent Cohen.

Will this brouhaha make a difference?

It had better or the U will continue to be viewed by many of the citizens of the state in a bad light. The first move is to make keeping tuition reasonable and to really mean it. 


From this Sunday's Letters to the Editor of the Star-Tribune:


U EXCESS

A former governor’s criticisms draw support

Former Gov. Arne Carlson’s critique of the University of Minnesota’s “bloat” is correct (“A skewed U,” April 7). I obtained a degree from the U in 1973, when paying for education by working was easy. These days, the salaries those in this bloated administrative fiefdom pay themselves seem criminal — a direct theft from Minnesota students who fall into horrible debt to pay tuition. In addition to obscene salaries, lavish pensions are awarded to administrators — “richer than the average” university employee. It’s high time to vote out the politicians who allowed this travesty to happen.

RICHARD BOROTZ, Chanhassen

• • •



The U ranks 68th on U.S. News & World Report’s list of best national universities. It ranks seventh in its relevant peer group — the original Big Ten — and the president’s salary is third-highest in this group. Given the Byzantine nature of administrative compensation, and the fact that no one seriously considers a correlation between pay and the quality of work for this class of employees, the data suggest a starting place for discussion. Let’s ask some students or debt-laden graduates for their thoughts.

JOHN AMMERMAN, St. Louis Park

• • •

I’m a graduate of the U who cannot thank Carlson enough for being so objective and honest. He is, without a doubt, on the mark.

BILL PLANTE, Edina

* * *