Wednesday, April 1, 2015

"The cynic that I am, when such praise is so lavish, I ask myself if there is something more that I am missing."

From Chuck Turchick to the Board of Regents, in the Minnesota Daily.

Dear Regents,

I attended your meeting on Friday and I noticed that in the discussion regarding the human subjects research resolution, several of you were effusive in your praise of President Eric Kaler and his administration’s transparency and accountability, not to mention your self-congratulations as well. The cynic that I am, when such praise is so lavish, I ask myself if there is something more that I am missing.

It seems to me there are two sets of issues arising from the reports of the external review panel and the legislative auditor. First, there are the micro-level issues regarding how specifically to decrease the likelihood of a recurrence of the problems those reports enumerated.

In the words of one regent, addressing those issues will include making changes to ensure that appropriate structures go into place to better scrutinize the trials, evaluate potential conflicts, ensure safeguards and hold the University to the highest ethical standards but also the legal and regulatory standards. These issues deal with the specifics of how to correct what was done wrong in the Dan Markingson case and in human subjects research more generally at the University of Minnesota.

A second set of issues, however, deals with a more macro-level approach.

These are the broader questions and include the following: Is there a prevailing culture at the University that has led to the problems outlined in these two reports? Is there a culture of fear that prevents people from speaking out? Has the University been insular and defensive, as the legislative auditor noted, when shortcomings have been pointed out? Why can’t the University administration even meet with the courageous faculty whistleblowers, without whom your resolution would never have been considered, let alone use the expertise of these medical ethicists on the various task forces and committees it is creating?

Why did it take 11 years for the University and the Board of Regents to come to realize these problems existed?

Has the University been more concerned with its public image than with getting at the truth?

Is there an academic arrogance that has led to the current situation?

Is there an excessive corporatization of the University, and has that contributed to these problems?

These and no doubt others are the issues not dealt with in your resolution. Maybe this was intentional, and your lavish and self-congratulatory praise was meant to mask that omission. But if there are such underlying problems, merely dealing with the micro-level issues will not begin to bring the University’s human research protection program to “a level that is above reproach,” as called for in your resolution.

Tuesday, March 31, 2015

"President Eric W. Kaler cordially invites you to the 2015 State of the University Address"

From the administration:

President Eric W. Kaler cordially invites you to the 2015 State of the University Address.

3:30 to 4:30 p.m.
Coffman Memorial Union Theater
300 Washington Ave S.E., Minneapolis

The presentation will conclude with a moderated question-and-answer period, followed by a light reception in the theater lobby.

For information on how to submit a question or watch online, follow this link. 

Saturday, March 28, 2015

"Minnesotans have been ill-served by their flagship university in this tragic affair"

"Leadership and transparency were lacking in research subject’s suicide," says the Star Tribune editorial board.  Now there's an understatement.  Read the full editorial.

"Mr. Kaler needs to take a bow and graciously exit"

Comments on Kaler from the Star Tribune


Okay, so we lied about there having ever been an Attorney General's Office investigation surrounding the Markingson case, Okay, so we lied about there having been a Medical Board investigation of the University, Okay, so we lied about the Hennepin County Court exonerating the University when in fact we hid behind Immunity from being sued, Okay, so we lied about there having been numerous internal IRB investigations that found nothing wrong, Okay, the General Counsels office has spread false information for years surrounding this sad case, .............but today as your University President...I'm standing here telling the truth...oops..I guess that was a misstatement.  Shameful behavior from this university.  When are firings going to be announced ? General Counsels Office must have a few, the department of psychiatry at a minimum must get rid of the chair of the department and obviously Mr. Markingson's study investigator and the study staff if any of them are still around, and then I think Mr. Kaler needs to take a bow and graciously exit.



How many more regents meetings is it going to take to handle the numerous other fiasco''s surrounding the U's psychiatry department.  Watching the live stream yesterday I was very disappointed that they never addressed all of the issues from the state Auditors Report nor the disgusting findings from the Senate Faculty ordered investigation citing the work climate as hostile or fearful for staff working under Schulz or Olson.



Why is it when a politician, government work lies it's called a misstatement and when the rest of us don't tell the truth it's called a lie??



Watched a clip of King Kaler on the news last night. He needs to practice on his sincerity.



Thank you Carl Elliott. All of your perseverance and sacrifice made a difference. Your are a Minnesota hero. Perhaps the University can also apologize to you for marginalizing your work and your voice.



This action is far too little and comes far too late. As someone who has worked in academic research, the problem is NOT the federal regulations for obtaining consent and protecting those enrolled in the studies. The problem is a sense of superiority and entitlement in the power structure, which says the "rules" don't apply to ME and MY important work. MY GOOD INTENTIONS and compassionate FEELINGS trump the outcomes of my actions. This is NOT just a problem at the University of Minnesota...though it is a disproportionate location for it. This is a problem of the arrogance and corruption of power, which runs through all levels of Minnesota society in both government and the private sector. We see the same basic problem ruining the Minnesota Department of Human Services with its inability to come clean about the role its leadership has played in causing massive numbers of patient and staff injuries/deaths while endangering the public by forging blindly ahead with fundamentally flawed policies for the mentally ill. Minnesota's governance organizations refuse to challenge the existing power structure or to hold administrators accountable. Sorry folks...nothing to see here in Lake Wobegon where all the children are above average. The solution, unfortunately, requires more than just the work of the Auditor Nobles. Minnesotans need to seek federal intervention to protect the public from Minnesota's corrupt institutions and their arrogant leadership. Unlike other states I have lived in, Minnesota clearly cannot govern itself.



They broke the public trust. Coercion happens not only on clinical trials, but in the psychiatric settings where children and adults are given psych meds inappropriately without proper oversight.
Where are the national accreditation and quality review measures that track more than compliance and cursory side effect documentation?  Are these professors going to age out of the University? Get their pensions? And be replaced by their protégés?

Apology accepted. Where is the remuneration? Restoration? Change and vigilance?



Eliminate the program. The U has too many existing problems to deal with. There are plenty of other colleges to pick up the slack.



Hooray, the U of M has finally been forced to admit what they have denied for a decade, that they lied to and deceived almost everyone that followed this terrible episode.  Ten years later and two independent reviews later the residents of this state (that have been paying their salaries) are finally told some of the truth.  This is actually disgusting.  We need to be able to trust what we are told by the University, and so far regarding this issue and obviously others involving the Department of Psychiatry it's been Schulz-Gate, or Olson-Gate.



Alright, this is a positive first step after 50 negative ones by the University regarding the Markingson case and others.  Step two, fire the chair of the psychiatry department along with the principal investigator that was responsible for this whole scandal.  Clean house once and for all.



Too little, too late. Need bigger, more meaningful reforms, and indictments.



Indictments? Indictments happen when laws are broken. Can you point to a specific law that was broken in this case?



@trapheler Forging HIPAA documents. Failing to get proper consent after protocol change. Photocopying one competency assessment 20 times and changing the names. The PI should have been nailed for all of this. Just fraud in general I guess. Unfortunately, the fda people aren't trained to look for fraud. Just witness consents and drink your coffee.



Wait. Let me understand: this is for an incident that occurred in 2004? If the regents haven't bothered to notice, it's currently 2015. Beyond the issues going on in Psychiatric Studies, I'd say the U has another scandal here - the utter lack of timeliness in its responsiveness. Eleven years? Yeah, there's a problem all right .... 


President Kaler: Our lies were not intended to mislead

"Kaler acknowledges U misstatements on drug study"

  -- Minneapolis Star Tribune, March 28 2015

"Kaler, meeting with reporters, acknowledged that the public may have been misled by the university’s repeated claims that it had been investigated, and cleared, by the state attorney general."

"'That was not a full-fledged attorney general’s investigation,' Kaler said. He said the attorney general’s office had merely helped the state Board of Medical Practice review a complaint against two U psychiatrists."

“'Was there an attorney general’s office investigation? The answer is no,' Kaler said. But he said the university’s assertions, which began before he became president, 'would have led somebody to believe' that it was. 'In that sense, it was misleading or inaccurate.' He later called it 'imprecise,' adding, 'I don’t think it was meant to mislead.'”

Read the rest of the story in the Strib.

Kaler's inadequate response to the Markingson case

University of Minnesota President Eric Kaler’s response to the Legislative Auditor’s review skirts the heart of the findings and, in doing so, risks losing the university’s opportunity to regain public trust.
The auditor reviewed the experiences of Dan Markingson and other human subjects in drug trials in the department of psychiatry. The report found that drug trials had run amok. Conflicts of interest permeated the management of the trials. Vulnerable individuals were urged, perhaps manipulated, into participating in the trials. And some individuals suffered terribly as a result. Kaler’s March 18 response promises specific, immediate actions to correct the flaws in the department’s research protocols.
By putting the camera up close so that only the substantive research issues fall within the frame, the university sidesteps a blunt criticism. The auditor’s report found that the Markingson case raised serious issues — which university leaders have been consistently unwilling to acknowledge.
In the 10 years since Markingson’s death, the university has had two presidents, several medical school deans and several senior vice presidents of the Academic Health Center. When so many different leaders touch a problem, yet there is no change in the management of the problem, we likely have a systemic cultural pattern rather than an individual proclivity that needs correction.
Report authors throw up their hands in the face of this challenge. The report acknowledges it does not have “a recommendation that would change attitudes at the university about openness, accountability, and transparency”; it is up to the university. Consider bringing this concern into the frame, examining closely the dynamics that led to these missteps, telling us what you learn from your self-reflection and what you plan to do. Reassure us that the auditor’s critique has been received, not sidelined, and will be addressed.
Carolyn Chalmers, Minneapolis
The writer is a former director of the Office for Conflict Resolution at the University of Minnesota.