… in the Minneapolis Star Tribune notes that the most charitable description of what’s been going on at the clubby University of Minnesota medical school would be “bizarre.”
Wednesday, April 29, 2015
from the Star-Tribune:
Recently, research in our department has been the focus of in-depth examinations from an external review requested by the University of Minnesota Faculty Senate and the state legislative auditor. Both reports commented on broader university practices that need to be improved and requested changes specific to the Department of Psychiatry with regard to how we recruit and seek informed consent from potential participants in research studies. We are appreciative of the effort invested by the authors of both reports and welcome the opportunity to continue to improve as a result.
The University of Minnesota Department of Psychiatry faculty and staff are dedicated to excellence in patient care, scholarship and educating future generations of physicians. We take this mission seriously and aspire to apply standards and practices to our work that will make the state of Minnesota proud. Our community is faced with the immense pain and suffering associated with mental illness. This pain affects individuals, their families, communities and treating providers. Our mandate and passion is to relieve the symptoms of mental illness, including those that lead to suicidal thoughts and actions. Unfortunately, knowledge of the causes and means of relieving the symptoms associated with mental illness is still quite limited relative to other fields of medicine, and even with the best treatment currently available, we will lose some of those for whom we care.
We deeply believe that conducting sound scientific research is the way to increase knowledge about mental illness so that the associated pain and suffering can be decreased. We have incredible respect for our study participants and we are grateful for their generous decision to participate in research; without them, advances in patient care would not be possible. We are aware that research participation is never without risk and we are committed to doing everything we can to minimize those risks. We as researchers and clinicians recognize that the balance between the risks and benefits of research participation has significantly changed over the past decades and will continue to evolve in the future. Thus, we believe that the long-term protection of human subjects will involve ongoing conversations between researchers, clinicians, patients and the broader community. We are committed to being active participants in these conversations.
Toward that end, we are listening to and grateful for the guidance expressed in the reports and are moving swiftly toward implementing the recommended changes. As a faculty, we are determined to be open to examine issues such as consent and conflict of interest and to expand our perspective through open conversations with the broader community. In addition, we are aware of the stigma and marginalization associated with mental illness and welcome input from patients and families to ensure that we improve our practices in ways that promote acceptance and inclusion. By working toward these goals, we remain committed to our mission to embody excellence in patient care, scholarship and education, and will always endeavor to hold ourselves to the highest standard in its implementation.
The faculty of the University of Minnesota Department of Psychiatry
How about saying this? "We're sorry. We're sorry that a patient died as a result of our research study. We're sorry we have been so brazen in our attempts to deflect responsibility. We're sorry for acting arrogantly for the past 10 years." What. The. Heck. Can somebody at the U just say they're sorry??
O.K. The U Psychiatry Department has metaphorically speaking put themselves on the couch and on the clock - let us see what the result is.
Where were all these concerned faculty while the Markingson case was being bashed about by the University's PR mouthpiece or legal counsel? Where were these concerned faculty after a psychiatric nurse came forward and spoke about a culture of fear within the psychiatry departments research ? I remember reading a 2006 Audit of the Psychiatry Department that exposed many faculty or staff were afraid of being retaliated against if they spoke up about concerns with patient safety and how certain psychiatrist were conducting studies. Are these the same faculty that never did a thing to change the atmosphere within that department? Now after two outside investigations all of sudden they want the world to know how concerned they are? This is not the behavior we should be expecting from the faculty of the department of psychiatry at the University of Minnesota. I agree with others here...where are the names of these righteous authors, or are they afraid of still being retaliated against...,
Have to agree with all the other comments. If this was meant to rebullid public trust in Psychiatry at the U, it's an epic fail. We need a real, heartfelt apology for past misdeeds if they are ever to be trusted again. I've been hearing about their arrogance for 30 years. It's time they looked in a mirror and faces up to their shortcomings and the effects of those shortcomings on others. Spare us the sanctimony of "we're just trying to help the mentally ill".
Serious ethical lapses in this dept. Cut out the bad prior to asking for forgiveness
I am not quite sure what the point of this editorial is. The majority of the issues surrounding the U's psychiatry department center on a select few of its researchers and certainly the outgoing department chair. Since there was no mention of the harm that has been done, the unethical practices that went on for over a decade, the denials and false statements regurgitated at every opportunity by the U's General Counsel or PR department, until there is an acknowledgement of wrongdoing within the psychiatry research venue, this is just more meaningless words. The university's motto Driven to Discover is a joke and an insult when related to its psychiatry department. Plain and simple, for all of the patients and their families or loved ones that have been harmed by the psychiatry department, clean up your act.
It would be enlightening to know who actually wrote this. It rates about a C- for content. Although it does get a B for Pandering. I suspect one or two psychiatrists had input and it was written by high priced legal counsel.
If this wasn't penned by a PR firm, nothing was.
Maybe they didn't sign names because they rank really high in paranoia on the MMPI?
Perhaps you can lead the way by reducing reliance on over-medication, holistic approaches, (as in, Dr Oz) etc. etc. also, prevention? Try trauma-informed narrative therapy practices, integrated medicine approaches, meditation etc. traditional methods are not working--quite obviously and pander to the drug companies….but i am sure your faculty enjoy the conferences.
I am kind of wondering why there are not actual names signed to this, rather than a group signature?
The problem with the University of Minnesota Department of Psychiatry is its ongoing arrogance, evident in this post. As a family member of a mentally ill person, we have dealt with this arrogance, which discounted our involvement, harmed our loved one, and lead to a worse trajectory for this individual. This arrogance is super evident in the negligence and cover up in the case of Dan Maringson. It is also something which many other individuals and families have experienced at the hand of the U of M Department of Psychiatry. There are certainly some good individual providers in this group, as well as some who need to move on with their careers.
Please, do us the courtesy of signing your individual names-or not. Please improve your practice, your care standards, your ethics, and your capacity to work with families. We are waiting for this to happen. Till then, please save the editorials. Thank you.
Probably because one of the "individuals" is named Big Pharma.
Exactly. Psychiatry, in general, causes more mental health problems than it helps.
at 10:34 AM
Tuesday, April 28, 2015
For the Record: Minnesota Legislature must hold hearings on psychiatric research misconduct #Markingson
By Trudo Lemmens, Raymond DeVries, Lois Shepherd and Susan M. Reverby
The university’s leaders have failed to take meaningful action and failed to restore trust.
The following commentary has also been signed by 159 scholars of health law, bioethics, medicine and pharmacy from U.S., Canadian, European, Australian and New Zealand institutions. Their names and affiliations are listed in the attached document below.
As scholars of health law, bioethics and medicine, we are calling on the Minnesota Legislature to conduct public hearings on psychiatric research misconduct at the University of Minnesota.
Two reports issued in the last five weeks have exposed serious flaws in the University of Minnesota’s system for protecting human subjects of research. When systems fail, the appropriate response is to admit to the problem and to work hard to fix it. The report by Minnesota's Legislative Auditor [PDF], focusing on the tragic suicide of Dan Markingson in an industry-sponsored psychiatric drug trial, describes how university leaders have denied and covered up these flaws for the past 10 years.
Two years ago we wrote a letter to theUniversity Senate, co-signed by more than 170 U.S. and international scholars, demanding an independent investigation of Markingson’s suicide. We did so to support U of M faculty members who had been repeatedly stonewalled when raising concerns about exactly the issues exposed in the two reports. Like these faculty members, we received standard responses from senior administrators claiming that several “investigations” and courts failed to find any problems. We also challenged these misleading claims, providing details as to why those independent assessments were nonexistent, cursory or compromised by conflicts of interest, but we never received an adequate response.
University of Minnesota leaders now finally acknowledge that some of the university’s practices “have not been above reproach.” But these half-hearted admissions of guilt came only after Minnesota’s Legislative Auditor blasted them for being “defensive, insular, and unwilling to accept criticism” and for making “misleading statements.” Most troubling is that the university has now appointed several of the same administrative leaders who in the past failed to act and to respond by making appropriate changes to the university’s research system. It also appointed others with conflicts of interest. Internal critics, who should be praised for pushing for better protection of research subjects, remain largely marginalized and isolated. In the meantime, another psychiatric research scandal –featured in the New York Times on April 17 – suggests that U of M leaders may be sitting on information about other potential wrongdoing. How many new scandals must emerge before more substantive action is taken?
The university’s leaders have failed to take meaningful action and failed to restore trust. We therefore believe, like former Gov. Arne Carlson, that it is essential for the Minnesota Legislature to conduct public hearings as soon as possible. Legislative hearings will signal to university administrators in Minnesota and elsewhere that the protection of research subjects is of public concern and that academic institutions will be held publicly accountable.
Minnesotans deserve to know how problems of such proportions were covered up for so long. They deserve to know why university officials stonewall requests for information. And most of all, they deserve to know whether and how many more research subjects have been mistreated, injured or died in psychiatric studies at University of Minnesota hospitals.
Trudo Lemmens (LLM bioethics, DCL) is William M. Scholl Chair in Health Law and Policy and Professor at the Faculty of Law and the Faculty of Medicine of the University of Toronto.
Raymond DeVries (Ph.D.) is a professor at the Center for Bioethics and Social Sciences in Medicine at the University of Michigan Medical School.
Lois Shepherd (J.D.) is Peter A. Wallenborn, Jr. and Dolly F. Wallenborn Professor of Biomedical Ethics Professor of Public Health Sciences and Professor of Law at the University of Virginia.
Susan M. Reverby (Ph.D.) is Marion Butler McLean Professor in the History of Ideas and Professor of Women's and Gender Studies at Wellesley College.
at 8:10 AM
Sunday, April 26, 2015
Tuesday, April 21, 2015
• Carlson's Star Tribune commentary: University can't regain trust under current leadership
A state legislative audit in March rebuked the university — and its psychiatry department in particular — for the way it treated Markingson, who had been participating in a university study of an anti-psychotic drug made by the pharmaceutical company AstraZeneca, which financed the research.
• April 10: University of Minnesota bioethicist Leigh Turner, a critic of Kaler's, discusses Schulz's move
Kaler responds to Carlson, critics
Kaler should step down
The university covered up its own mishandling
There should be legislative hearings
The university administration has been misleading in its public responses to the case
The university's research suffers from rampant conflict of interest
The mistakes of the past must be accounted for in the present
The people who created the problem are now being asked to fix it
Kaler's statement on the Markingson case
at 1:35 PM
Monday, April 20, 2015
For the Record: "Submerge the truth at all costs. Deceive the public. Deceive the faculty. Deceive the legislature. Deceive the media." Governor Carlson on President Kaler (Markingson)
In an op-ed for the Star Tribune and on several recentradio and television programs, former Gov. Arne Carlson has been calling on the University of Minnesota to fire its president, Eric Kaler, for his continual “cover-up” of problems regarding research ethics in the university’s psychiatry department.
Last month, the Minnesota Office of the Legislative Auditor released a scathing report that rebuked Kaler and the U for misleading the public about serious ethical breaches in the tragic case of Dan Markingson, a young man from St. Paul who committed suicide in 2004 while enrolled in an industry-sponsored clinical trial at the U involving the anti-psychotic drug Seroquel. In the wake of the report, the U immediately suspended enrollment in any clinical drug trials being overseen by its psychiatry department until a team of independent reviewers could determine that all patients in those trials are protected.
Kaler, however, disagrees that there was any kind of cover-up going on at the U. "When I arrived in 2011, I was made aware of the [Markingson] case," he said in an MPR interview on Friday. "It was then six years, seven years old. I reviewed the documents. I reviewed a report from the FDA, I reviewed legal findings, I reviewed a report from the Board of Medical Practice of Minnesota. And I relied on those highly credible organizations in their findings. ... It's clear, in hindsight, that those reports were not as reliable or thorough as they were represented to be. But I would argue that, presented with [that] kind of evidence from those kinds of sources, it was hard for me to believe that there was ever misconduct."
But the issue is not quieting down. Last week, a group of 15 U alumni who are now teachers or scholars of medical ethics joined Carlson in calling for Kaler’s firing. And on Friday, the New York Times ran an articlethat detailed yet another questionably run clinical trial involving the U’s psychiatry department (and Seroquel). In this 2010 study, controls were so lax that one of the enrollees — a sex offender — crushed up the drug and surreptitiously fed it to other men at his residential treatment facility.
On Friday — before Kaler spoke on MPR and before the Times published its article — MinnPost talked with Carlson about the university’s handling of the controversies surrounding its psychiatric department and why he thinks it’s time for Kaler to step down. An edited version of that interview follows. MinnPost has requested a followup interview with Kaler, but was told he is not immediately available.
MinnPost: Why do you believe that President Kaler should be fired?
Arne Carlson: When [Kaler became president of the University of Minnesota in September 2011] he had already been sent materials by Dr. Carl Elliott, who’s a professor of bioethics, relative to all the dilemmas and problems and legal faults that were occurring at the university. So he was informed when he came that this problem existed. This problem had also received considerable attention from both the national media and the local media, including, by the way, the Minnesota Daily. So when he came in, he had to make a decision, and that decision was, “Do I call up Professor Elliott and sit down and find out what this is all about? Do I do some independent research and find out what this is about? Or do I simply let the past continue to roll?” He chose the latter. He made that decision.
When he made that decision he chose to consciously not obey the rules of the University of Minnesota. He deliberately made the move that he would no longer pursue the mission of the University of Minnesota, which is a search for truth. [He] became part of subverting the truth and stonewalling ... and ultimately deceiving by claiming [there had been] investigations that never occurred and claiming that these were exhaustive investigations. How can you have an exhaustive investigation that was never held?
MP: In President Kaler’s response to the legislative auditor’s report he wrote that if the earlier external reviews of the Markingson case had been flawed, then he and other officials at the U had not been aware of it.
AC: Bear in mind that this is the highest paid administrator in public service in Minnesota. He makes significantly more than the president of the United States, so the public has a perfect right to expect a high level of performance. So [Kaler] now says, “Gee, I did not know.” That means he paid no attention whatsoever to the materials that were sent by Professor Elliot. It means he paid no attention whatsoever to all the media reports, and he paid no attention whatsoever to the history of the program, which by that time had included six suicide deaths, the incarceration and imprisonment of a professor and the barring of research by the [U.S. Food and Drug Administration] of several of his own personnel.
So either it’s a case of profound ignorance or he’s simply being untruthful.
MP: Why would he choose to ignore that information?
AC: I think that’s a question he has to answer. … I think President Kaler owes it to the public to set in motion a whole independent review of his role, as well as [the role] of his vice president, the [university’s] legal department and the Board of Regents. They’re all complicit in the cover-up, and it requires an independent review. But he is absolutely adamantly opposed to any such review.
MP: In the wake of the legislative auditor’s report, the university has created two new committees to develop and implement reforms to its human research programs. Leigh Turner [a bioethics professor at the U] and othershave criticized the university for appointing to those committees people who either ignored or dismissed earlier calls to investigate the Markingson case. Do you share those concerns?
AC: What’s interesting here is for 10 years you’ve had people waving the red flag and saying, “Gee, this is wrong, this is wrong, this is wrong.” Not one of those people has been put on any committee. Not one. But all the people who were either part or acquiesced in the cover-up, they’re all on the committee. … Then they bring in a doctor [to head one of the committees], and he’s packed with financial conflicts of interest. … We have 80,000 doctors in America, and we can’t find one without a conflict of interest? [The U has appointed Dr. William Tremaine, a gastroenterologist who is director of the Mayo Foundation Office of Human Research Protection, to head one of the new committees. Tremaine has received funding from many pharmaceutical companies, including AstraZeneca, the company that funded the U study that Dan Markingson was in when he committed suicide.
Somebody tell me that that is what we teach our students at the University of Minnesota school of business. Everything that’s being taught there is practiced in the opposite fashion at Morrill Hall. It’s stunning. Where is the transparency? Where is the accountability? Where is the oversight? …
Fundamentally, colleges and universities are in the business of integrity. They are in the mission of searching for the truth. And in the process of searching for the truth, you have tremendous respect for dissent. That’s what you expect on a college campus. Here we have the practice of the exact opposite. Submerge the truth at all costs. Deceive the public. Deceive the faculty. Deceive the legislature. Deceive the media. But the operative word isdeceive. That doesn’t represent a very healthy search for the truth.
The second thing is the governance at the University of Minnesota. The president basically runs everything. I met with a member of the Board of Regents, and she told me in no uncertain terms that it was her feeling that the board feels that they are subservient to the president, and everything I’ve seen verifies that. I think the board feels they work for the president. The faculty Senate has very, very little power. Everything is concentrated in the office of the president, so he is completely and totally responsible for this whole scandal. His defense is ignorance. That’s a stunning defense. Somebody tell me the virtue of ignorance.
MP: What is your reaction to the announcement that Dr. Charles Schultz is stepping down as head of the university’s Department of Psychiatry? [Schultz was co-investigator, along with U psychiatrist Dr. Stephen Olson, of the drug trial in which Markingson died.]
AC: First of all, when you lose your moral authority, which President Kaler has, and when you’re complicit in the cover-up, as President Kaler is — and as the Board of Regents is — then how can you punish anybody? You can’t because you’re not willing to punish yourself. So they arrange the softest of soft landings they possibly could. He still retains his position as medical director, and he retains his tenure in his professorship and his pension and everything else.
What you basically have at the University of Minnesota now is two different sets of laws. You have the people on top, the Board of Regents, the president and his top officers — they made the rules and the regulations, but they don’t have to obey them. They’re exempt from that. It’s only the faculty and the students and the employees who have to obey the rules and regulations. I don’t know how you can have a bifurcated system of justice and have it operating.
MP: The CAFE drug study that Dan Markingson was enrolled in when he killed himself was not a study designed to come up with a new breakthrough drug to help people experiencing psychotic episodes. It was designed to compare three competing drugs that were already on the market. Should the U or any other university be involved in drug-company studies like that — ones that are primarily about building market share?
AC: You’re raising a very valid question. … When a company contracts with a university for a drug test, that test is more likely to be favorable than if it were conducted neutrally. So there’s a built-in bias. … There’s also a financial incentive [for the university]: For if you flavor, if you will, the results towards one company, they’re going to come back and give you more contracts. That means that if you’re a hard nose, you’re going to have a tough time getting those contracts.
The very integrity of the FDA process is really at issue here. … I think that all these contracts should go through the National Institutes of Health, and they should disperse them out. There should be a neutral governing body that decides who gets what. Right now what you have is an endless array of conflicts of interest. You [the university researchers] get paid whatever it is — $15,000 — for every person you enroll. [For the CAFE study, AstraZeneca paid the U’s Department of Psychiatry $15,648 per enrollee.] You know as well as I do that there will be a temptation to go kind of easy on the [enrollment] restrictions.
MP: Particularly if you’re having trouble enrolling people.
AC: Of course. And your pool tends to be mentally impaired, so it’s a dreadful situation — it truly is — for universities. Nevertheless, [if you’re going to do the research] you want to make it as loaded with integrity and protection for the enrollee as is humanly possible.
MP: Has the U’s reputation been tarnished by this?
AC: Very much so, and it continues to be tarnished.
MP: Have you heard from people outside the university on that?
AC: I’ve gotten a lot of emails. … I’ve got a good friend who’s on the review board at Massachusetts General [Hospital]. He’s stunned by this because just from an institutional perspective you want to do everything you possibly can to protect the integrity of your brand. That’s what’s so stunning. All these news articles come out, and it doesn’t move President Kaler. When I showed him all these headlines [last June], he didn’t have any reaction whatsoever. And then, when I got into a debate with [Richard Beeson, chair of the Board of Regents,] about the brand — because Beeson sits on a bank board — I repeatedly asked him, “Do you mean to tell me if all these negative stories appeared about your bank, your bank board would have absolutely no concern?” His answer was, “You’re comparing apples and oranges.” I said, “No, I’m not. I have sat on corporate boards, and I know something about brand protection. Are you telling me that your bank board would ignore all this bad publicity and do nothing about it?”
MP: What would you like to see done?
AC: The Legislature has been amazingly passive. That’s been a huge disappointment. There isn’t a single legislator who has stepped forth and said, “You know what? This scandal is serious. It imperils the virtues of a very fine university, and we’re the ones who appoint the Board of Regents. We have to assume responsibility. Let’s drill down and find out exactly what happened.”
There should be an investigation into the cover-up. It should be public. President Kaler, his vice president, his legal staff, [and] the Board of Regents should all be called in to testify and to be held accountable for the very rules and regulations that they themselves promulgate. That has not happened — and apparently is not going to happen. … I think that’s appalling. I’m stunned, absolutely stunned. …
The issue here is not only the reputation of the University of Minnesota, but also the reputation of Minnesota as a state. I think this state celebrates people who have integrity, who are willing to be open, who are willing to care, who are willing to acknowledge when they make mistakes — and who are willing to be held accountable. But I don’t believe the Board of Regents, President Kaler or his management staff reflect any of those virtues.
SUBMITTED BY RAY SCHOCH ON APRIL 20, 2015 - 10:48AM.I’ve never met Mr. Kaler, and don’t know him at all, but his public utterances certainly fit the stereotype of the corporate CEO. When he says he “reviewed” previous reports, for example, does that mean he read them in detail, asked probing questions about their conclusions, talked to the people involved? Or does it mean he glanced at the reports, or, at most, read the “executive summary?” His point is not without merit when he asserts that he had no reason to doubt the integrity of the reports submitted to him, but with someone’s death involved, his attention to the matter ought to be more than superficial. If the claim is made, as it often is in the context of executive salaries, that higher pay is merited because of the higher level of responsibility, then that level of responsibility implies a level of oversight and integrity that seems to be lacking in this case. It’s a public university, is it not? As a public institution, its officers, regardless of specific titles, ought to be answerable to the public.
SUBMITTED BY DAVID MARKLE ON APRIL 20, 2015 - 11:44AM.Arne is right, I think, and this matter points to the overgrown nature of the University bureaucracy, a very big, top heavy corporate structure accountable only to the legislature. And if legislators don't diligently exercise oversight, it's a bad deal--and expensive--for the public (including students).
SUBMITTED BY ALAN MULLER ON APRIL 20, 2015 - 11:59AM.Truth is that US academia, if the word still applies, is in a state of moral crisis as well as various other sorts of crisis. Minnesota would be better off with a smaller U, but one less self-serving and characterized by more independence and integrity.
Re: Thanks... new
SUBMITTED BY PETER MIKKALSON ON APRIL 20, 2015 - 1:46PM.It's not often I find myself in admiration of former Gov. Carlson, but he got this snafu exactly right. It's high time Minnesota leaders stopped patting themselves on the back (and the resultant pay raise) and long overdue for an honest assesment of morally deficient failure(s). Plural.
SUBMITTED BY DIMITRI DREKONJA ON APRIL 20, 2015 - 2:50PM.Thanks for a very good interview. Having followed this case closely over the past several years, it's my opinion that Gov. Carlson is absolutely correct when he points out that even a cursory review of the material in the popular press raised enough issues to cast doubt on the prior reports that "cleared" the University. Even if one took the view of being skeptical of the popular press, and thought that they were over-sensationalizing things, Dr. Elliott had been clearly laying out the issues for years. Scores of academics (many internationally known) signed onto petitions asking for greater investigation of how this study was run, and thus clearly saw that all was not well. If they could tell this from afar, it's odd that it took the recent reports to get this sort of attention in house.
at 3:25 PM