Wednesday, April 15, 2015

For the Record: Former Governor Arne Carlson: Markingson case: University of Minnesota can't regain trust under current leadership

Arne Carlson’s portrait ultimately finds a great deal of acclaim. As far as the best, Heywood says, “the honor has to go to Arne Carlson, who loved Minnesota (and the U of M in particular) that he made his portrait twice the size of anybody else’s, and lavished attention on every last detail. The picture gives over a full quarter of the frame to the old stone of the U, with Uncle Arne leaning casually, sporting his favorite U of M jacket. 
Butterflies frolic symbolically on the stone, while a yellow bird hovers behind amongst the ornamental trees. The flat paint and 'artless' composition is instantly recognizable as derivative of the (derivative themselves) Brotherhood of Ruralists, known to a generation of British schoolchildren as the illustrators of the front covers of the Arden Shakespeare.” 
Swiszcz, too, is touched by the scale and attention to detail: “I am glad I went to see this in person, or I would never have known this painting is roughly three times as large as all the others. 
Oh – guess what? Arne really loves the U! You can almost feel the little tufted surface on the “M” of his letter jacket. In case there is any doubt, the painting's frame has little maroon "M"s in each corner.    MinnPost

Arne Carlson - Governor's Portrait

“The University constructed a defense to deny liability by claiming immunity. I think that defense evolved or you might say devolved into a strategy to simply avoid any accountability or responsibility and to deny that there were any serious ethical issues. And we found that serious ethical issues and conflicts of interest just permeated this case.”
James Nobles, legislative auditor, March 20, 2015
link to original in Star-Tribune

The University of Minnesota, like many other universities, has a sizable clinical research program that tests experimental drugs for safety and efficacy. The understanding between the companies that develop these drugs and the consuming public is that such drugs are carefully tested on humans and that these clinical trials must comply with strict ethical, scientific and regulatory standards. These research protections were developed after a series of research scandals that involved abusive treatment of vulnerable populations such as economically disadvantaged communities, prisoners, children, and individuals suffering from mental illness.
Ever since the violent suicide of Dan Markingson in 2004, the administration of the University of Minnesota has received repeated calls for the release of more details about the care and protection afforded the victim. These calls have come from faculty members at the university, from local community members and from researchers from around the world. But instead of being transparent and forthright, the administration created a standard response similar to that expressed by the university’s former general counsel, Mark Rotenberg: “As we’ve stated previously, the Markingson case has been exhaustively reviewed by Federal, State and academic bodies since 2004. The FDA, the Hennepin County District Court, the Minnesota Board of Medical Practice, the Minnesota Attorney General’s office and the University’s Institutional Review Board have all reviewed the case. None found fault with any of our faculty.”
If correct, that would be a most understandable and appropriate response. However, it falls far short of the truth. Consider this:
• State attorney general’s office: Never conducted any such investigation.
• Hennepin County District Court: In a lawsuit brought by Mary Weiss, the mother of Dan Markingson, the judge ruled that the university’s Institutional Review Board (IRB) was “statutorily immune from liability.” But immunity is a far cry from exoneration. As Matt Lamkin, an alumnus of the University of Minnesota’s graduate program in bioethics and a current member of the faculty at the University of Tulsa Law School, has noted: “to suggest that the University of Minnesota was exonerated in this lawsuit is like a diplomat who got drunk and ran over a child claiming he was ‘exonerated’ by diplomatic immunity.”
• The University of Minnesota Institutional Review Board: Richard Bianco, the university official responsible for overseeing research subject protection, stated under oath in his deposition that the university had not done any investigation into Markingson’s death.
• The Minnesota Board of Medical Practice: The legislative auditor’s report released last month describes the board’s review of Markingson’s death as “compromised” because the “independent investigator” the board hired had “numerous conflicts of interest.” (Dr. David Adson, a colleague of the psychiatrist under investigation, also received more than $585,000 from the drug industry and more than $145,000 from AstraZeneca, whose drug was being tested in the study in which Markingson committed suicide.)
• The U.S. Food and Drug AdministrationThe FDA did review the case, and its report is public. Critics have taken exception to the narrowness of scope in that the report failed to examine the conflicts of interest, enrollee mistreatment, the unresponsiveness of Markingson’s doctors to his mother’s concerns and the civil-commitment order used to pressure Markingson into enrolling in the study.
Despite the obvious falseness of the claim of numerous and exhaustive investigations, the university president, Board of Regents and various administration officials all have used this cover as a hammer against those who dissented and called for an independent investigation.
Unfortunately, this weapon worked all too well. Time and again, news stories covering the Markingson case contained a paragraph citing these numerous and thorough investigations and a finding of no fault. What was missing was an effort to fact-check that claim.
No one wants to believe any administration of higher education would engage in conduct not representative of the highest standards of truthfulness. As a society, we view politicians with a certain skepticism, but tend to have the opposite view when it comes to religious leaders, judges and educators.
But the reality is that any management system can deny wrongdoing and block calls for an independent investigation. When Eric Kaler took the reins as president of the university in 2011, he had already been sent material by Dr. Carl Elliott, a critic of the university’s handling of the Markingson case and faculty member at the Center for Bioethics. In his 2010 article for Mother Jones magazine, Elliott wrote about the issues of poor standards, conflicts of interest involving an all-too-cozy relationship with drug companies, the lack of independent oversight and the way the threat of involuntary commitment was used to coerce Markingson into the drug study.
During his first year at the university, Kaler had to make a major decision. Prudent management would have involved meeting with Elliott, learning about the specific ethical issues related to Markingson and broader concerns about psychiatric clinical research, and dealing with the growing scandal. But Kaler chose instead to perpetuate the prevailing coverup. He opposed any independent review, never responded to the charges made in the media, ignored or dismissed critics, and stood firm in his belief that it would all blow over.
In so doing, President Kaler tarnished his office and abandoned the principles of truthfulness, openness and integrity. He also frittered away the moral authority that is so essential to governance. His failure to provide ethical leadership permitted the scandal to grow. The result was more stonewalling of requests for information from faculty and media and increased attempts by administration officials to demonize critics, including referring to some scientists as “wackos.”
Perhaps most troubling is the culture of intimidation associated with the Department of Psychiatry. The university’s own external review refers to this culture as a “climate of fear.” Extending from that department to the university’s senior management team, the apparent goal was to make certain no one questioned authority.
On June 16, 2014, I met with Kaler and Board of Regents Chairman Richard Beeson, and went over all the materials covering conflicts of interest, the falseness of their claims of endless investigations, as well as the damage being done by news articles highly critical of the university’s handling of the Markingson scandal. Kaler was quiet and rarely asked a question. As a result, I focused more attention on the lack of oversight and leadership provided by the Board of Regents and its failure to examine the circumstances of Markingson’s death. Given the deeply troubled history of research in the Department of Psychiatry over the past 25 years, a history that includes six suicide deaths, untold injuries, the conviction and imprisonment of one professor, the barring of two researchers by the FDA, and a barrage of poor publicity, I was stunned by Beeson’s response that this matter “has not risen to the level of our concern.”
Last week, the university announced that Charles Schulz has decided to resign as chairman of the Department of Psychiatry. He will retain his position as executive medical director, and his faculty appointment. The news release announcing his departure made no mention of the department’s troubled record, or the research controversies in which Schulz has been personally involved. Rather than removing him as department chairman and taking additional disciplinary action, the university has provided Schulz with a soft landing.
The very administrators and regents responsible for the current debacle now promote themselves as trustworthy agents of change. We will not see meaningful reform of research on human subjects, nor the restoration of prestige at the university, so long as Kaler, Beeson and other leaders responsible for years of denials and stonewalling remain in charge.

Arne H. Carlson was governor of Minnesota from 1991-1999.

Some comments from the Star-Tribune web site
It's and shame more people aren't commenting. James and Arne are both straight shooters. Anyone doubting Arnes devotion and love of the U only need look at his picture in the Capitol. Arne bleeds maroon and gold. I'm sure like a lot of Minnesotans you hope and expect excellence, and it's difficult to criticize. But it's time for a Regime change. It starts with the Board of Regents. The Board needs a reset with members who want to roll up their sleeves and define their proper role, appoint a new President who they will hold accountable. Anything less will not do. From 1200 miles away I can see its bloated and accountable to no one.

Gov. Carson comments are on point. I applaud his efforts to hold the U accountable.
I have a U professional degree and worked there in many capacities, including as adjunct prof.
There is little or no U accountability, the Regent promulgated Code of Conduct is essentially meaningless and not at all enforced. (Yet the U and Kaler 'go after' students if they violate their 'Code.')
Regent Vice Chair Dean Johnson should be aware that the U's Office of General Counsel (OGC) and the Office of Institutional Compliance (OIC) blatantly disregard or ignore statute provisions passed during his long legislative tenure.
Regents provide inadequate oversight and the OCG ad OIC hold inordinate sway and essentially have insufficient professional ethics to hold their important U positions.
It is truly a shameful situation at U and unfortunately there is insufficient leadership at U to address situation.
I have little faith in Dayton, or MN House/Senate to adequately address U problems,

 It's not the crime, it's the cover up. No one forced Kaler to repeatedly lie in public about this and no one else needs to smear him. He's done a bang up job of that himself.

We all understand that nobody wants to own this.  In particular we've seen a complete abdication of responsibility by the Board of Regents.  The University of Minnesota has constitutionally guaranteed autonomy, the degree of which is unique among the educational institutions of this state. Our constitution thus levies a high burden of responsibility on the Regents, especially in cases like this which strike at the heart of the integrity of the University.  Unfortunately the Board of Regents appears to have become a safe haven for politically connected nonentities who haven't the slightest interest in exercising the level of authority granted to them.  It's a shame and an embarrassment to Minnesota that this case has dragged on for over a decade while the Regents have been content to allow it to fester and grow in toxicity.  That this had to be taken up by the State Auditor (with a great deal of prodding by outsiders like former Governor Carlson, and many others) represents a management disaster of the first order.  I don't believe the Regents are easy to remove.  However, they all should resign immediately to make way for competent oversight of the management of our University.  At last they could finally make an important contribution to the University's future.

The entire PR and legal counsel offices should be immediately dissolved. I know more about how to handle a situation like this from watching the TV show, Scandal, than they do. You'd think that over the past several years someone would have taken Kaler aside and said, "This looks really, really bad for the University." Instead, they kept insisting that the U was beyond reproach. This all points to an incredible level of political naivete and hubris exceeding even that shown during the Najarian debacle. Clean house and scrub the floors till there's not smell left.

I would think that at some point the University, and especially President Kaler, would get tired of seeing themselves as the lead story on Fox 9 news every night.  Nothing against Fox news, they've done an admiral job of covering this debacle at the U, but it just seems that either the U is that ignorant to think that this scandal is not going away anytime soon, or it's just that they are so arrogant that they think they can't or won't be held accountable.  My money is on Arne and his army.

Unfortunately, University of Minnesota administrations have listened more closely to the U's attorneys than to its ethicists.

Thank you, Governor Carlson, for this very important op-ed. Kaler and his very highly-paid administrators and staff need to be held accountable. The time for spin and PR gimmicks is over.

A sad spectacle of abuse of power, willful neglect, and intentional abdication of responsibilities

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