Wednesday, April 29, 2015

For the Record: An open letter from the faculty of the U Psychiatry Department #Markingson

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.

Tuesday, April 28, 2015

For the Record: Minnesota Legislature must hold hearings on psychiatric research misconduct #Markingson

from MinnPost:

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.

Sunday, April 26, 2015

For the Record: U's handling of drug study suicide earns an 'F' among peers

Dan Markingson and his mother, Mary Weiss. Weiss was concerned that her son wasn't getting better during his six months in the U of M study. 

As University of Minnesota leaders try to control the damage caused by their handling of a decade-old drug-trial suicide, some academics around the world are ensuring the case will live on in the classroom.

The story of Dan Markingson has become a case study in some college courses, and appears to bolster faculty and alumni concerns that the scandal has stained the university's reputation.

"I don't share my experience at the University of Minnesota with the kind of pride that I'd like to be able to," said Matt Lamkin, a U of M alumnus and University of Tulsa law professor who teaches the case in his classes.

The university has received scorching criticism in recent weeks after two recent reports blasted it for the way it has treated vulnerable human research subjects, including Markingson.

Markingson killed himself while participating in a corporate-sponsored clinical drug trial at the university in 2004. Last month, a legislative audit said the conditions under which Markingson participated were potentially coercive.

The legislative auditor found multiple conflicts of interest in the case, and said university leaders had blown off the concerns of Markingson's mother that he might hurt himself.

• April 17: U's Kaler responds to critics over Markingson case
• March 19: Legislative auditor blasts U over ethics, conflicts in drug trial patient's suicide

The audit also criticized the university for thwarting attempts to look into the case further. It said university leaders misled the public about the thoroughness of past inquiries, dismissed calls for a full investigation, and otherwise "ignored serious ethical issues."

Especially concerning to the investigators was that some of the very problems that plagued the Markingson case still haunt the university today, as shown in an external review released in February. "A primary problem ... is past and current university leadership that is defensive, insular, and unwilling to accept criticism," Legislative Auditor James Nobles wrote.

That's not exactly news to at least 175 scholars around the world who've had the Markingson case on their radar since at least since 2013. That's when University of Toronto health law professor Trudo Lemmens sent a letter to President Eric Kaler expressing concern over the U's handling of the situation.

Those 175 scholars who signed it — many of whom specialize in medicine, bioethics and law — come from U.S. colleges and universities such as Harvard, Stanford, Northwestern, and the universities of California, Pennsylvania, Virginia and Michigan. The letter also contained signatures from academics in 18 foreign countries, including 10 in Europe.

Some of those academics have either discussed the case or assigned it as reading material in at least 18 universities in the United States and other parts of the world, according to interviews, emails and copies of course syllabi.

"There's a lot of uproar, and there's certainly a lot of attention in the academic community about what's happening at the University of Minnesota," Lemmens said.

Scholars who spoke to MPR News said the case stands out for a few reasons.
First is its comprehensiveness.

Kenneth DeVille, chief institutional integrity officer in East Carolina University's division of health sciences, says the case contains many ethical concerns — such as patient coercion, safety of the study's design, and the U's response to concerns over Markingson's safety — that his students could easily understand.

The issues "really run the gamut," he said.

The case is also quite uncommon. Professors said only a handful of publicized contemporary cases rose to the level of Markingson's.

Chief among them are the 1999 death of 18-year-old Jesse Gelsinger during a University of Pennsylvania gene therapy experiment, and the 2001 death of 24-year-old Ellen Roche during a Johns Hopkins University asthma drug study. In both cases, federal investigators discovered multiple problems in the ways the universities handled the experiments.

Scholars say the Markingson case is also one of the few to have a wealth of information behind it, including original documentation online, and in scholarly journals, and major national publications.

The publicity has only increased with the university's refusal to come clean in the case, they said.

"Had the U not behaved the way it behaved, we might not be talking about this at all," said Misha Angrist, a Duke University professor who has taught the case to students of public policy. "You can't ignore the institutional response to what happened, and a large part of what makes this case so outrageous was the U's stonewalling."

Lecturers say their students react to the case with disbelief.

"The impact is profound," University of Sydney (Australia) bioethics professor Ian Kerridge wrote in an email. "They are stunned."

Law professor Lamkin said some of his students are outraged, and don't understand how such a case could happen.

"I've had multiple people ask why there have been no criminal charges," he said.
Students aren't the only ones who shake their heads.

Harvard psychiatry professor Alexander Tsai said when he talks to colleagues about the Markingson case, remarks about the university's handling of it are often "derisive in tone."

Tsai noted Kaler's recent statement that the U's declarations about previous investigations weren't false but "imprecise."

"You can't help but snicker when you hear something like that," Tsai said.

Yet Tsai and other scholars said that barring further revelations, the overall stain on the university's reputation will probably be short-lived. Most doubted the case would have much of an effect on the U of M's ability to recruit faculty and students or win grants.

U of M philosophy professor Naomi Scheman, who warned two years ago that the U had a cloud over its reputation, said she suspects there might be some problems in the Markingson case that aren't unique to the University of Minnesota.

"I would hope that ... [the case] is being used to point out problems that are endemic to most pharmaceutical company funded research at universities," she said. "I would be somewhat dismayed if it was being used in a way that allowed other institutions to pat themselves on the back and say, 'Look how horrible things are at the University of Minnesota. Aren't we by comparison wonderful?"

Tuesday, April 21, 2015

For the Record: U's Kaler responds to critics over Markingson case (from MPR)

link to original MPR post

University of Minnesota President Eric Kaler responded Friday to an expanding group of critics calling for his resignation.

Kaler has found himself under fire as the university navigates the fallout from the 2004 suicide of a drug-trial patient — and allegations that it mishandled the case before and after the patient's death.

legislative audit found the university ignored "serious ethical issues" in its treatment of Dan Markingson, a mentally ill man who committed suicide while participating in a clinical drug trial run by the university.

Former Gov. Arne Carlson called for the university to fire Kaler in an op-ed piece for the Minneapolis Star Tribune last week. Carlson talked to MPR News' Tom Weber on Monday.

• Carlson's Star Tribune commentary: University can't regain trust under current leadership

The trial and suicide occurred before Kaler took office, but Carlson said the president didn't handle the case appropriately, based on the information he received about it.The university declined to comment this week until Kaler joined Weber Friday to discuss the case and the criticism.


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.

An external review in February also criticized the university for not doing enough now to protect vulnerable patients like Markingson.

• Legislative auditor's report | MPR News story

The audit was prompted in December 2013 by lingering faculty concerns over Markingson's death.

Critics say university researchers coerced Markingson into participating in their clinical drug trial, dismissed the concerns of his mother that he was getting worse and ignored her pleas to remove him from the study. University President Kaler has long defended the university's record, saying a previous federal investigation found no wrongdoing.

Legislative Auditor James Nobles wrote in his report that it's impossible to know whether Markingson's suicide was linked to the U's drug study. But he found that researchers ignored repeated warnings that Markingson's condition was not improving.

Nobles' audit also found that the university's research oversight panel conducted a "superficial review" that suffered from conflicts of interest. And he said university leaders have repeatedly made misleading statements about the thoroughness of past reviews as they rejected calls to look into it further.

"The insular and inaccurate response has seriously harmed the University of Minnesota's credibility and reputation," Nobles wrote.

The auditor recommended lawmakers prohibit the U from approving more psychiatry department drug studies until the university fully implements suggestions from an outside review panel.


Psychiatry head steps down | Dr. Charles Schulz, who led the university's psychiatry department for 16 years, announced in early April that he is stepping down. He will remain on the faculty and keep his position as executive medical director, according to a university announcement this morning. In a statement, university officials said the move "will allow him to focus his time more exclusively on patient care."

Schulz, coincidentally, faced more scrutiny on Friday after the New York Times raised questions about the recruitment of subjects for a 2010 drug trial.

• April 10: University of Minnesota bioethicist Leigh Turner, a critic of Kaler's, discusses Schulz's move

University says it will reform | Kaler told faculty members in early March that the University of Minnesota will change the way it treats human test subjects.

Kaler said when the review began that he expected the report would validate the school's practices. He told the university's Faculty Senate he had thought the school was doing better than it was.

"It is worrisome that we have such a distance to go to reach the very highest standards," he said.

In early April, the university announced it had gathered a team to lay out a plan for carrying out dozens of reforms recommended in the February review. Kaler says he expects the plan by May 15.

Concern in the Legislature | At the March hearing about the legislative audit, state Sen. Eric Pratt, R-Prior Lake, told Kaler, "You can't have an ethical program unless you have ethical people ... people willing to look at themselves critically and admit their mistakes." Kaler responded that he was open to personnel changes if they were necessary.

Alumni call for Kaler resignation | A group of alumni — who identify themselves as "teachers and scholars of medical ethics" — signed a letter to the Legislature demanding Kaler's resignation. Carlson and university bioethicists Carl Elliot and Leigh Turner sent a similar letter in February.

Kaler responds to Carlson, critics

Kaler said he's focusing his efforts on acknowledging the mistakes of the past and learning from them. Knowing what he knows now, would he have done things differently?
"It's been a very harmful injustice. It's brought tremendous reputational harm to the University of Minnesota," Carlson said.

"I certainly would have," he said. "Hindsight is a wonderful thing that's 20/20, and when I arrived, I should have taken a deeper look at our human subjects around patients with diminished capacity. I should have called a group together to do that before we did it in 2013."

Carlson and other critics of the university's approach to the Markingson case have made a number of statements about how the case was handled and how it ought to be remedied. In his conversation with MPR News, Kaler offered a response.

Kaler should step down

Kaler, Carlson said, should no longer be at the helm.

"When President Kaler came on board, he was sent materials on the seriousness of the Markingson case, the fact that there was a cover-up in existence, and all he had to do was meet with members of his own department of bioethics at the university to discover what the truth was. He refused to do that. And instead he participated in the cover-up," Carlson said.

Kaler said he has no plans to leave his position.

"I don't have any plans to resign," he said. "I think I have strong support in the faculty leadership; I know I have board support. I have made, literally, thousands of decisions in the four years I've been here, and some have been criticized, rightly and wrongly. But I think any decision like that should be based on the body of my work, not on one particular issue."

The university covered up its own mishandling

The former governor said the university administration's response to the Markingson case constitutes a cover-up.

"When I use the word cover-up, what I'm saying is, every time anybody ... asks for information from the university, they are told: 'This has been investigated' time and time and time again," he said. "It turns out that, of the five investigations, four never really existed. So, you decide for yourself what this constitutes. Is that the kind of behavior you want from the head of an institution whose reputation rests on its ability to reflect integrity?"

Kaler said he disagrees.

"I don't think this in any way ... is a cover up. When I arrived in 2011, I was made aware of the case. 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," he said.

"Significantly, the legislative auditor pointed out that the FDA findings unequivocally state that there was no evidence of misconduct or significant violation of research protocol," he added. "The Board of Medical Practice [report] was presented as a thorough investigation, according to the auditor. 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."

There should be legislative hearings

Schulz's resignation as head of the university's psychiatry department isn't enough, Carlson said. He called the move, in which Schulz will remain on faculty and keep his position as executive medical director for the school, inadequate.

"First of all, there has not been one single hearing on the cover-up," Carlson said. "There has not been one single hearing where President Kaler, his team, his lawyers, and members of the Board of Regents were subject to questions. ... How come?"

Kaler said the audit itself is accountability enough.

"I don't think such hearings are necessary. I think all of the documents are in the public domain," he said. "And what's really important is that we've made very important steps forward to improve our human subject studies: We commissioned in 2013 with leadership from the faculty senate an external review that was incredibly thorough, and we are working hard to implement the findings from that group."

He added: "In fact, the principal findings from the legislative auditor was to implement those plans. I called that group in and asked them to define what we needed to do to be above reproach, and they generated 63 recommendations. Frankly, when I read that report, the distance between where we are now, which is at the level of the rules and law, to get from there to beyond reproach is a pretty good distance. We have much work to do, but we're going to do it."

Jim Nobles, Minnesota's legislative auditor and author of the Markingson report, recommended that changes be codified into law in order to provide additional accountability. But Kaler said there is enough momentum on the part of the university's administration to put the recommended changes into place.

"I don't think a law is necessary to have that happen. We're going to be incredibly transparent," he said. "One of the reasons I'm doing this conversation with you [MPR News' Tom Weber] now is to help the people of Minnesota understand that we're being open and that we're moving forward to implement the plans. People will be able to see that. And if you don't see that and you don't believe that's being done, then you ought to call for my resignation. "

The university administration has been misleading in its public responses to the case

The legislative auditor's report said university leaders have repeatedly made misleading statements about the thoroughness of past reviews as they rejected calls to look into it further. Carlson contends that university administrators participated in a cover-up to hide the school's shortcomings in the Markingson case, a claim Kaler rejects. But the university has stumbled in its recent public response, and has had to correct itself on a number of occasions.

"As the legislative auditor reported and as I reported," Carlson said, "that cover-up was essentially a series of false statements, clearly designed to mislead the public, the legislature and the faculty."

Carlson said the university had been purposely evasive, in order to perpetuate a cover-up. Kaler admitted the school had made mistakes, but said none of them had been intentional.

"To the degree that there were misleading statements made, I've apologized for those," he said. "The one that I know of was the statement in one of our communications that, in fact, the attorney general had conducted an investigation. And that is not precisely correct. What happened is that the attorney general took some depositions in assistance to the Board of Medical Practice. That's not an attorney general investigation, and that was an incorrect statement."

He went on: "At some point also, we talked... — I believe back in the 2000s — about an [Institutional Review Board] investigation. In fact, it was an IRB look at this, but it didn't qualify as an IRB investigation. Again, I relied on things from the FDA and the [Minnesota Board of Medical Practice]. These are the national and statewide organizations that are meant to guarantee the outcome in these kinds of siutations."

The university's research suffers from rampant conflict of interest

Nobles' audit found that the university's research oversight panel conducted a "superficial review" of the case, which he said suffered from conflicts of interest.

Markingson's mother, Mary Weiss, said Dr. Stephen Olson held a clear conflict of interest — he was her son's treating physician but also the director of the clinical trial, where there were financial and other pressures to keep Markingson enrolled in the study over her objections.

In addition, Nobles' legislative audit found that a Minnesota Board of Medical Practice review of Olson was "compromised" because the consultant analyzing the case had "numerous" conflicts of interest.

Kaler said the university is working on it.

"I think that the appearance of conflict of interest is certainly there," he said. "We have a conflict of interest management plan. As part of the recommendations from the external panel, we will look at our conflict of interest statments and be sure that we have the right language, that we do trust but we also verify to a greater degree than we probably do now.

"As part of our going forward," he added, "we're going to engage in these conversations, and we're going to decide openly where conflicts of interest exist; where they exist and can be managed; and where they exist and cannot be managed and must be avoided."

The mistakes of the past must be accounted for in the present

"Let me put it this way: If this episode had occurred in the Obama administration, we would have hearings 24 hours a day, nonstop," Carlson said. "If this were in the Dayton administration, I suspect we would have the same.

"We ought not to treat management systems differently. We should hold the management system at the University of Minnesota just as accountable as we would a governor's management system, a president's management system or a business managment system. And we're not doing it here."

Kaler said he sees this as an issue of addressing the mistakes of the past — and learning from them. Throughout his tenure, he has repeatedly stated that one of his top-level goals is to make the University of Minnesota one of the nation's best public research universities.

MPR News' Tom Weber asked Kaler if reaching that goal is still possible, given the blow to the university's reputation that came with the audit.

"We've got to move forward. We're talking about trials that took place in 2004, 2005, 2008," Kaler said. "Your question highlights the need for us, with great intensity, to move forward with the recommendations of the external panel and to develop a research ethics environment that is above reproach.

"Those efforts will not happen instantaneously. They will take time. But it is absolutely a personal priority of mine to restore confidence in the ethics of our human subject resarch, particularly for people with diminished capacity. I take this personally. I love the University of Minnesota, and I'm enormously unhappy that this situation happened in the 2000s, and we're going to fix it."

The people who created the problem are now being asked to fix it

Given all the causes a former governor might choose to champion after his term is up, why this one? Carlson said it's because he saw in this case a group of people without a voice. "One of the things I remember the most is that sometimes the best causes are the ones that are lost causes," he said. When a group of people associated with the case approached him, he couldn't ignore it.

"These were people who, for 10 years, including the mother of Dan Markingson, were simply looking for justice. They were looking for some answers. Doors had been slammed in their face. They had been told one whopper after another. They had been mistreated. They had been sued. One of the professors has been placed on probation.

"So, a lot of people have been hurt. ... Not one single person has been held accountable. Nobody. And now we're asking the same people who created this scandal to give us the remedy."

Kaler, though, disagrees. A lot has changed since 2004, he said.

"We have a new general counsel, a new vice president for research, a new dean of the school of medicine, a new vice president for health sciences, and a new president in place since those trials occurred," he said.

"Now, could we be faulted, each and every one of us individually as we came into office and looked at this, [for not all reaching] the same conclusion? Is that a fault? Perhaps it's a human failing, but I don't think it limits our ability to move the conversation forward."

Kaler's statement on the Markingson case

MPR News' Tom Weber, Cathy Wurzer, Alex Friedrich, Britta Greene and Paul Tosto contributed to this report.

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)

From MinnPost:

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.


A return to the Medieval

I'll start with a disclaimer. I've never been a university president, so it's entirely possible that I'm led astray here because of my own lack of relevant experience. Nonetheless…
I’d argue that the first and most important point here is that Universities all over the country, including the U, have adopted a corporate model. The reasons for that are various, but primarily center around money, in the form of financial support from either/both the public and private sector. Surely Mr. Carlson understands this. That the University President is paid more than the Governor of the state supports that corporate-model contention. Boards of Regents and legislatures usually have very positive feelings for the corporate model, since most (not all, but typically sizable numbers) Regents and legislators are, or have been, corporate executives, or have worked in that environment.
In the corporate model, the CEO is essentially just as Mr. Carlson has described Mr. Kaler’s role. While the university president may not rule by “divine right,” it’s not at all unusual for him (or, in rare cases, her) to rule absolutely. Corporations are the antithesis of democracy. In terms of their internal political operation, they generally follow the Medieval pattern. Power is absolute, and is concentrated at the top,. The CEO’s opinions are the only ones that count, at least in terms of how the corporation operates, spends its money, deals with the public’s perception of its mission, etc. Lesser officials (e.g., Deans at the university level) fill the roles of vassals. Regents typically have full-time jobs elsewhere, and have neither the time nor inclination to be nit-pickers, whether financial, ethical or instructional. Faculty are minor role-players, and students…? Well, they’re students. What do they know?
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.

Time to clean house.

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).

Thanks for this compelling interview

Thank you for this very compelling interview. Assuming Arne Carlson is right in what he's saying, previous reports on this scandal that I've read have been in the nature of coverups.
The public utterances that I've heard from Mr. Kaler paint him, in my eyes, as a shallow promoter/fundraiser with nothing substantial to say. Unimpressive, at best.
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

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.

Thanks for a very good new

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.