For the Record: Leigh Turner letter to Governor Dayton #markingson

December 20, 2013

Governor Mark Dayton
Office of the Governor
130 State Capitol
75 Rev. Dr. Martin Luther King Jr. Blvd.
St. Paul, MN 55155

Re: An Open Letter Concerning Mary Weiss and Mike Howard’s Petition Requesting an Independent Investigation of Possible Psychiatric Research Misconduct at the University of Minnesota 

Dear Governor Dayton:

On December 5, you were presented with a petition asking you to initiate an investigation of the death of Dan Markingson and additional reports of possible psychiatric research misconduct at the University of Minnesota. Dan Markingson’s mother, Mary Weiss, and Mike Howard launched the petition earlier this year. I am an Associate Professor at the University of Minnesota’s Center for Bioethics and School of Public Health. I am one of the 3495 individuals that signed the petition. With the other signatories, I hope that you will play a leadership role in ordering an independent, external investigation of allegations of psychiatric research misconduct at the University.

 Repeated efforts to persuade senior university administrators of the urgent need for an independent investigation of possible psychiatric research misconduct have all failed. While the University of Minnesota’s Faculty Senate recently passed a resolution calling for an inquiry into the Markingson case, President Kaler has already indicated that whatever panel is established will not investigate Dan Markingson’s death. Furthermore, it appears that President Kaler envisions himself playing an active role in selecting panel members. Individuals appointed to an independent, external inquiry must not be chosen by individuals whose conduct will have to be examined by the investigation.

As Governor, you have the authority to establish an independent investigation. Unlike President Kaler, you have no conflicts-of-interest that might prompt questions about the independence and integrity of such an investigative panel. Should you establish a body responsible for investigating reports of psychiatric research misconduct at the University, I urge you to mandate that this panel address Dan Markingson’s death and additional reports of alleged research misconduct.

Last May, I wrote to President Kaler and urged him to support Mary Weiss and Mike Howard’s petition. He refused. I was subsequently contacted by several individuals who reported that their loved ones suffered serious harm while enrolled in psychiatric clinical trials conducted by faculty members in the University’s Department of Psychiatry. They indicated that what happened to Dan Markingson was very similar to what their relatives endured. Professor Carl Elliott, a colleague of mine at the Center for Bioethics, has been contacted by an even larger number of individuals describing incidents that raise serious questions about the adequacy of protections for psychiatric research subjects at the University. These citizens need to be given an opportunity to bring their reports of mistreatment and abuse to an independent body authorized and empowered to investigate their claims.

Given university administrators’ repeated refusals to investigate reports of psychiatric research misconduct, the conduct of senior university officials must be scrutinized as part of any legitimate inquiry. President Kaler, Vice President and Dean Aaron Friedman, General Counsel William Donohue, former General Counsel Mark Rotenberg, other senior administrators at the University of Minnesota, and Regents have repeatedly failed to make reasonable inquiries in response to reports of possible violations of rights of research subjects.

As both a faculty member at the University and a resident of the state of Minnesota, in the strongest possible terms I urge you to initiate a thorough, independent, external investigation into reports that psychiatric research misconduct has occurred at the University of Minnesota. I have no confidence that senior officials at the University of Minnesota are fulfilling their moral and legal duties and addressing these reports with the urgency and attentiveness that they require.

 

Yours sincerely,

 

 Leigh Turner, PhD 

Associate Professor 

University of Minnesota Center for Bioethics 

N520 Boynton, 410 Church Street SE 

Minneapolis, Minnesota, 55455 

A Question of Accountability

Accountability: The obligation of an individual or institution to account for its activities, accept responsibility for them, and to disclose the results in a transparent manner

A Question of Accountability

Each year the administration presents to the Regents the University Plan, Performance, and Accountability Report. Here are some excerpts from the September 2013 Report:

1. Compensation

Sibson also found that employee compensation in these four areas [human resources, budget & finance, information technology, and purchasing services] is at market rates for higher education and slightly lower than in the private sector.

See p. 73 of the 2013 Accountability Report.

The Sibson Consulting report on "spans and layers" does not even use the word "compensation" much less make any finding about market rates for higher education. See the August 2013 Sibson report.

Nor does the Huron Consulting report on administrative services benchmarking make any such finding. Huron refers to compensation simply to note that the U of M Office of Human Resources is preparing a compensation study. See p. 101 of the June 2013 Huron report.

For a report that does have information on the compensation of U of M senior administrators see On The Cost of Administration Part IV.

2. Facilities Management

Focusing on service [for Facilities Management] represents a shift away from taking care of the University's buildings and toward caring for the needs of the people and programs in them. This includes focusing on a culture that enhances productivity, demands accountability, and places a premium on clear communication.

See p. 86 of the 2013 Accountability Report.

On November 26, 2013 the U of M vice president for university services appeared at the meeting of the faculty Senate Committee on Finance & Planning. The minutes of the meeting record the following:

He [Professor Luepker] noted that he had been informed that most of the construction work done on campus is by private contractors; Vice President Wheelock affirmed that almost all of it is done through competitive bids and that University staff only do small projects.

See p. 5 of the November 26, 2013 SCFP report (emphasis added).


On that same day KMSP reported:

University investigators dismissed a complaint that Louden appeared to organize the bidding process to minimize the competition for Skyline, but according to e-mails, it appears that she and her staff did just that. 

Instead of considering the inspection of several buildings as one project, which would have to be put out for bidding, she told them to break up the inspections building by building. That kept prices low enough that Skyline would be given the work without bidding for it. 

A pile of purchase orders show Skyline pulled in hundreds of thousands of dollars over the past 5 years.

KMSP report of November 26, 2013 quoted in A Cover Up Culture.

3. Costs of Administration

[The administration] reduced administrative costs by $32.6 million, eliminating and consolidating administrative offices and processes.

See p. 4 of the 2013 Accountability Report.


The administration did reduce certain costs in mission support and facilities and in leadership, but there were increases in other expenditures in those two categories that were even greater. There was a net increase of $41.7 million in expenditures for mission support & facilities. There was a net increase of $7.9 million in expenditures for leadership. The 2013 Accountability Report fails to mention these net increases. See A Complete Accounting.



4. Medical School.

Tackling another priority to return the Medical School to national prominence, the University, University of Minnesota Physicians, and Fairview agreed on a new "integrated structure" to better serve patients, increase funding for the Medical School, and enhance the University health sciences training and research.

See p. 8 of the 2013 Accountability Report.

The "integrated structure" is just the beginning of the long term efforts necessary to restore the Medical School. In its June 2013 report the Strategic Planning Committee described numerous "key initiatives" that must be implemented to enable the Medical School "to regain its position of excellence" by 2025. The Medical School Faculty Advisory Council released its own report describing major obstacles to achieving the "key initiatives." See An Institution Adrift Part II. The 175 page 2013 Accountability Report fails to even mention these reports much less review their analyses of the problems facing the Medical School.



5. Clinical Research Trials.

Key steps taken in 2012 [to translate scientific breakthroughs into improved health] include:

Initiated new resources and consultative services for research teams, including the Clinical Research Ethics Consultation Service . . .  

Added expert staff members to guide, serve, and collaborate with research teams, including an Institutional Review Board specialist . . . .

See p. 60 of the 2013 Accountability Report.

The Institutional Review Board reviews research projects to ensure that human subjects are not placed at undue risk and that they give uncoerced, informed consent to their participation. See the IRB description.

In May 2004 Dan Markingson committed suicide while he was a participant in a U of M clinical trial. His psychiatrist recruited him for the trial as an alternative to a civil commitment as a mentally ill person likely to do harm to himself or others. An FDA investigation in 2005 concluded that there was no misconduct.

The U of M administration uses this 2005 FDA conclusion as a primary reason to reject calls for another investigation. But in 2012 the Minnesota Board of Social Work took corrective action against the social worker who was the study coordinator. Perhaps the most damning findings were these:

2(g)(1) Despite the large amount of data gathered as part of the CAFE study, the records are devoid of any evidence that the data was critically analyzed or used in the treatment planning process. . . 

2 (g)(4) There were critical omissions in Licensee's [U of M study coordinator] documentation that were relevant to suicide prevention and chemical dependency treatment. . . 

2(h) On March 17, 2004 Licensee received an e-mail message from the CAFE study sponsor warning of a new risk of hyperglycemia and diabetes for patients taking medications used in the CAFE study. This new information effectively invalidated client #1's [Dan Markingson's] original informed consent.

See pp. 3--4 of the report of the Minnesota Board of Social Work (emphasis added).

Yet the U of M president still refuses to conduct a new and independent investigation of the Markingson case. Is this being true to the principle of accountability? See Time To Do The Right Thing.



Michael W. McNabb
University of Minnesota B.A. 1971; J.D. 1974
University of Minnesota Alumni Association life member

For the Record: More #umn alums blast admin for #markingson denial

From the Star-Tribune:

Will the U review or whitewash a research subject's death?

The Dan Markingson case, involving a drug trial, has been a self-perpetuated cloud over the school for a decade.

As scholars of medical ethics and proud alumni of the University of Minnesota, we have been pained by the cloud that has hung over our alma mater in the decade since Dan Markingson killed himself while enrolled in a university-sponsored drug trial.

Many prominent voices have called for an independent investigation into Markingson’s death, including editors of the world’s most prestigious medical journals and more than 250 other ethicists, physicians and scholars.
Unfortunately, rather than working to be accountable and transparent, the university administration has taken a relentlessly defensive posture — hiding behind its lawyers, targeting its critics and distorting the facts.

Most notably, the administration has dismissed the need for an independent investigation by claiming that the university’s treatment of Markingson “has been exhaustively reviewed by federal, state and academic bodies since 2004,” in the words of the university’s general counsel. However, some of these claimed reviews simply did not occur, while others did not examine the most troubling aspects of the Markingson case. For example, the administration has repeatedly claimed that the Hennepin County District Court exonerated the university in a lawsuit brought by Markingson’s mother. In fact, the university convinced the court that it had legal immunity from the suit and could not be held liable no matter how badly it may have treated Markingson.

The administration’s refusal to commission an independent investigation of the Markingson case has tainted the university for far too long. That began to change recently when the Faculty Senate responded to a letter signed by more than 175 scholars asking for an external, independent investigation into the Markingson case. By an overwhelming margin, the Faculty Senate voted to approve a “Resolution on the Matter of the Markingson case” and endorse an inquiry into clinical research practices at the university.

Yet University of Minnesota President Eric Kaler appears intent on continuing the university’s efforts to avoid scrutiny. In a recent interview with the Minnesota Daily, Kaler said that the inquiry will not look at Markingson’s death at all, but rather will focus solely on “what we are doing now and what we’re going to do moving forward.”

Such a limited inquiry would defeat the purposes of the Senate’s action. Although the resolution does call for an inquiry into the university’s current practices, the Senate left no doubt that the aims of that investigation included resolving “questions [that] continue to be raised about the policies and procedures followed in the Markingson case” and addressing the harm to the university’s reputation “in consequence of this tragic case and its aftermath.”

Any inquiry that merely considers the university’s forms and policies without examining the experiences of actual research subjects would only further erode confidence in the institution and compound the harm to its reputation.
In addition to seeking to limit the scope of the investigation, Kaler seems intent on handpicking the investigators. Any involvement by the administration in selecting the members of the investigative panel would destroy the body’s credibility. The offices of the president, the general counsel and the Academic Health Center are all important players in the Markingson controversy whose roles must be examined by the investigative panel. It would be a clear conflict of interest for the targets of this inquiry to select their own investigators.

Finally, the investigative body must be given the legal authority it needs to conduct a thorough investigation. It must be empowered to look at financial records, to obtain internal e-mails and communications, to give legal protection to whistleblowers, and to interview former patients and research subjects and protect them from retaliation. For example, the panel should have the authority to waive confidentiality agreements that former patients and their family members may have signed as part of legal settlements with the university.

The Faculty Senate’s resolution presents an excellent opportunity to bring closure to a tragic case that has sullied our university for far too long. But this can only happen if the investigation is thorough, broad and independent, rather than carefully managed by the administration.

Matt Lamkin is an assistant professor at the University of Tulsa College of Law.

This article was also submitted on behalf of 

Emily Smith Beitiks, deputy director of the Longmore Institute on Disability at San Francisco State University; 

Joseph E. Davis, director of research at the Institute for Advanced Studies in Culture, University of Virginia; 

Alicia Hall, assistant professor of philosophy, University of Alaska, Fairbanks; 

Susan Hawthorne, assistant professor of philosophy, St. Catherine University; 

James Harold, associate professor of philosophy at Mount Holyoke College; 

Ramona Illea, associate professor and chair, Department of Philosophy, Pacific University; 

Monica Greenwell Janzen, faculty member, Hennepin Technical College; 

Greg Kaebnick, editor, The Hastings Center Report; 

Barton Moffatt, assistant professor of philosophy, Mississippi State University; 

Susan Parry, philosophy instructor, Hennepin Technical College; 

Elita Poplavska, assistant professor, Riga Stradins University, 

and Maran Wolston, Philosophy Department faculty member, Minneapolis Community and Technical College.

From comments posted on this piece:

I'm certain President Kaler would like to continue to bury the details of this case. Hopefully more ethical officials at the university will prevail.

Excellent article. If Kaler actually thinks the Markingson case was simply a one-of-kind tragedy at the U-MN he's beyond help. Wake-up Mr. Kaler, your psychiatry department has ruined many lives.

This egregious and disgusting behavior by the University's president has to come to a halt. This man and his ideas and morals are certainly part of the problem not part of the solution. We have lost all respect for the University over this scandal and the others that have been kept in the dark. Shame on Mr. Kaler and either do the right and ethical thing and step aside, or resign. It's apparent you are not able to lead this university with integrity and truthfulness.

At the very least, everyone involved at the U of M in the epic and continuous fumbling of the PR on this episode should be fired.

It seems that the University must be afraid that many more Markingson's will appear if such an investigation takes place. There is no other logical explanation for all the repeated statements of no-wrongdoing from the administration. Had this been case, the University would simply have produced all the documents that prove their claims and this case would have ended. That has never happened and agree with the fact that the PR representatives at the U that have been allowed to speak or answer inquires are some of the worst in their field.

I can appreciate the fact that many years have past since this young mans death, what I don't understand though is why the UMN has repeatedly offered up the same excuses time after time trying to defend themselves. And they are just that, excuses, not credible documentation that they looked into this death and how and why it happened, and any steps they've taken to prevent something as tragic as this from happening again. It isn't so much the act of suicide here from an obviously unbalanced young man, but the enabling to cover it's tracks afterwards by the University's top officials and legal team of any violations of human rights or human subject's protection. A totally independent investigation is long overdue, and if/when other such cases surface, the University has to be transparent in their handling of such tragedy's. Until that happens, I have lost all respect for research at the UMN.

It would be fitting of President Kaler to demonstrate the same amount of enthusiasm for seeking the truth about not only the Markingson case, but for the others the University is aware of or have taken great pains to avoid, as he displays on the football sidelines during gophers games. To have ignored this scandal for so long is such an embarrassment for the University as well as the state.

We are witnessing an abdication of responsibility on the part of University President Kaler. He has positioned himself as an executive unaccountable to anyone but himself. He must have been made fully aware of the Markingson scandal and agreed beforehand to staying on the University’s road of denial as a condition of his employment. It’s not rocket science folks, the University simply cannot allow a totally independent investigation conducted by qualified unattached investigators, knowing full-well what that investigation will reveal. How many more abused human subjects are there that the University knows about and have also tried to stifle? Hint: There are numerous. I’m old enough to recall Nixon raising his two fingers above his head and claiming that he’s not a crook following Watergate…The University by their denials are simply mimicking that disgusting behavior.

As a U-alum I am ashamed of this total disregard of responsibility from President Kaler. This scandal has hung like a cloud over the university for years and finally Kaler was given an opportunity to save face and claim he was just acting on the vote from the Faculty Senate and appoint an independent investigation of not only the Markingson case, but of the others that exist. President Kaler has a responsibility to answer to everyone and not just his immediate conspirators in cover-up mode. I was once proud of the reputation of the University of Minnesota's Medical School, and all of it's accomplishments. That pride has really taken a hit over this episode.

Agree with almost all of the posts. For Dr. Kaler to not recognize the fact that there are more human subjects and their families that have had research violation issues with the department of psychiatry is just ludicrous. The recent Fox News report showed another individual, and it's 100% guaranteed that there are many more such patients that were taken advantaged of, or had their rights abused by researchers at the University's psychiatry clinic's and hospital wards. I know personally of three such individuals.

It's quite amusing to think that the state's Attorney General's Office prosecuted Accretive for violating 100's if not thousands of patients protective health records at Fairview, and yet Kaler and University want everyone to accept and believe that nothing like that occurred with mentally ill patients within the two University controlled wards at Fairview? Having had a family member that worked on those and other mental health wards at Fairview, she was disgusted and alarmed on a regular basis over the violations occurring by research psychiatrists or their staff. For Kaler to insinuate that those incidents didn't take place on a regular basis is just ridiculous. To claim that all is 'today' without recognizing and admitting the the wrongs from the past just invites more of the same in the future.

Latest #markingson post on Star-Tribune Community Voices

Wackos roll off the line in a seemingly never ending stream

Source: Flickr

Latest #markingson post on Star-Tribune site: 

Those pesky wackos are back again ... 

Finally time to do the right thing?

Time to do the right thing at the University of Minnesota? #Markingson

 Da Mayor: "Doctor, always do the right thing."

Link to Youtube movie trailer

The time is always right to do the right thing.   Martin Luther King 

Do the right thing, even when it is hard.  Joel Osteeen

Do the right thing because it is right. W. Clement Stone 

Sometimes it is better to lose, and do the right thing... Tony Blair 

Leaders are people who do the right thing. Warren Bennis 

In plain Texas talk: It's do the right thing. Ross Perot 

You do the right thing, even if it makes you feel bad. The purpose of life is not to be happy but to be worthy of happiness. Tracy Kidder

Or, as Mark Yudof said in his inaugural address as president of the University of Minnesota:

"Minnesotans expect us to be fair in providing access to the University for their sons and daughters. If we do not provide reasonable access--including access for those who are underprepared and historically underrepresented in higher education and in the upper levels of our socioeconomic life, the taxpayers and state government of Minnesota will turn their backs on our graduate, research, and outreach functions. Simply stated, it is imperative that we continue to embrace our land-grant roots if we are to thrive."

"The need for integrity permeates every aspect of the University. The education mission of the University must be taken seriously--not just the way to get state funding."

"Administrators should tell the truth, keep their word, implement what they promise, and not dissemble. My point is plain enough: Without integrity, the phrase higher education is an oxymoron."

"When making decisions, I view shared governance and consultation with constituent groups as only fair because of the enormous stake they have in the University. Without fairness there is no legitimacy and no buy in to the institutional vision." 

"At the crossroads of expectation and reality, human fallibility and aspiration, individual will and institutional inertia, I hope that you will forgive my inevitable lapses, take joint responsibility for the nurturing of values and goals, and find comfort in the progress we make together."

"God bless all of you and God bless the University of Minnesota."

 Mark Yudof handled a horrible scandal in the athletic department with grace and dignity,  with no excuses and no dissembling. I have been very disappointed with the University of Minnesota administration since his presidency. Yudof fired people (the athletic director as well as coaches and support staff) and had Tonya Moten Brown essentially take over the athletic department. And his humility was not false.

The time for stonewalling has passed. Trying to dodge the issues inherent in the Markingson case is a fool's game. A university without integrity is not really a university. Bread and circuses do not a great university make, nor idle chatter about the infamous third greatest public research university in the world.

Time to walk the talk, President Kaler.  Otherwise,  disappointed  University of Minnesota alums will have to take a hike from their alma mater.  In the Twin Cities alone there are plenty of places for higher education philanthropy besides the University of Minnesota - Augsburg and Macalester colleges being two examples. Note that at these two schools the student debt at graduation is lower than that at the public University of Minnesota, to our everlasting disgrace.  I hope not.

One might whine that Mac is a school for the rich, a terrible and untrue argument, but such a charge is obviously not credible for Augsburg College with its much more modest endowment. When Auggie, as it is familiarly known,  got donor money of questionable provenance, they gave it back. This is what doing the right thing means.  And the education available at Auggie is hardly for chumps. An Auggie, Peter Agre, recently won a Nobel Prize in chemistry. Nice ROI on that, I'd say. Kudos, Auggie, a Minnesota school that makes me proud. Macalester is also in this category as well as many other fine Minnesota  small liberal arts colleges, or SLACs to use au courant higher ed jargon.

Our recent University of Minnestoa debt-saddled alums and their parents are none too happy with the performance of our university. Nor are our state legislators who are heartsick and bewildered by the fact that we are one of the leaders in the country - for student debt. Perhaps the plan is to salvage our position with sports dollars? I understand that Louie Nanne has been charged with raising two hundred million dollars for our athletics program. Under the present circumstances of crushing debt for our students, this is pathetic.

And of course if one desires to contribute money for medical research, there is always the Mayo. What's been going on at Fairview-University hospital lately does not exactly inspire warm and fuzzy feelings in the hearts of the populace. People will vote on the University's performance with their feet and their checkbooks. This goes also for the people in the state legislature.

If the University wants to see private philanthropic support, perhaps they should give us something to be proud of? Manufactured hash tags like #umnproud will not suffice.

Is it finally time to do the right thing in the Markingson matter? More evasion will only serve to further erode our reputation in the real world. Out there where recent University of Minnesota administrations apparently would prefer not to go.

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Latest Carl Elliot post about #markingson

Yesterday I put up a "for the record" post on an interview with President Kaler that appeared in the Minnesota Daily.

When I use this phrase, I try to put up the original material without highlights, emphasis change, or comments so that the readers may decide for themselves what they think about the document or statement.

Usually I intend to follow up with a reaction to the "for the record" post. But in this case, Dr. Carl Elliot has already done the job and I re-post his comments (with permission):



Kaler on Faculty Senate resolution: "It’s not a review of the Markingson case"

I think we're getting a pretty good idea of where the University of Minnesota administration plans to take the "independent review" endorsed by the Faculty Senate last week.  This interview with President Kaler appears in today's Minnesota Daily:

The Faculty Senate just passed its resolution to create an independent, external panel to investigate how the institution conducts clinical research on human subjects. What do you think of the most recent developments in the Dan Markingson case?

I’m a big believer in shared governance, and so I’m willing to take the advice of the Senate and the panel. ... I think they will find that our review processes are robust and that we do, in fact, protect patients in clinical trials, but there’s been concern raised in how we do that, and so our goal is to air out clearly and very publicly what we do and have a panel of external experts validate that and be sure we are doing this absolutely as well as can be done.

It’s certainly resulted as a consequence of a lot of repetitive publicity about the Markingson case, but it’s not a review of the Markingson case; it’s a review of what we are doing now and what we’re going to do moving forward.

This is something that began before you were president. What do you see as your role?

My role is to look forward, and as I said, that will be the charge of the panel.

And just to reinforce the point, the Daily editorial staff writes:

Though some, including University bioethicists and professors, may want more answers involving Markingson’s death, we should focus on avoiding potential tragedies and unethical behavior in the future.

The resolution passed by the Faculty Senate responded to an international call for an investigation into the death of Dan Markingson.  How would an investigation that avoids the Markingson case do anything to restore confidence in the university?

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For the Record: Kaler talks external review - not a review of #Markingson case

Kaler talks Markingson case

From the Minnesota Daily:


The Faculty Senate just passed its resolution to create an independent, external panel to investigate how the institution conducts clinical research on human subjects. What do you think of the most recent developments in the Dan Markingson case?

I’m a big believer in shared governance, and so I’m willing to take the advice of the Senate and the panel. ... I think they will find that our review processes are robust and that we do, in fact, protect patients in clinical trials, but there’s been concern raised in how we do that, and so our goal is to air out clearly and very publicly what we do and have a panel of external experts validate that and be sure we are doing this absolutely as well as can be done.

It’s certainly resulted as a consequence of a lot of repetitive publicity about the Markingson case, but it’s not a review of the Markingson case; it’s a review of what we are doing now and what we’re going to do moving forward.

This is something that began before you were president. What do you see as your role?

My role is to look forward, and as I said, that will be the charge of the panel.

The Daily weighs in on the #Markingson "investigation"

My question: Will the University of Minnesota Face Up To Ethical Responsibilities or Continue In Denial and Evasion?

Faculty push for independent research review

The Faculty Senate wants an outside panel to examine clinical trials.
By Kia Farhang Marion Renault December 09, 2013

The University of Minnesota Faculty Senate is calling for an independent, external panel to examine how the University does clinical research on human subjects.

The measure passed in a 67-23 vote Thursday after renewed calls from scholars and bioethicists to re-examine the 2004 suicide of Dan Markingson, a 26-year-old who participated in a clinical drug trial 10 years ago at the University of Minnesota Medical Center, Fairview.

Since Markingson’s suicide, many within and outside the University have raised questions about the CAFE study, the psychiatric drug trial he participated in and the University’s standards for ethical research.

An international group of bioethicists wrote to University President Eric Kaler and the Faculty Senate in October asking for an independent investigation of issues arising from the CAFE study.

The measure calls for a look at current human research practices at the University, not an investigation of the Markingson case.

The resolution that passed Thursday isn’t binding, said Eva von Dassow, Faculty Senate vice chair and associate classical and near Eastern studies professor.

But Kaler, who chairs the Faculty Senate, told reporters after the meeting that he’s moving forward with the recommendation.

University officials will begin scouting nationwide early next year for experts to conduct the review, Kaler said, but no timeline is set for when the evaluation would be completed.

Kaler said he thinks the investigation will show that the University’s current research policies are “in very good shape.”

The Faculty Senate made three amendments to the original proposal, including one that requires the results of the inquiry to be reported back to the Senate for discussion.

The other two amendments added more details about Markingson to the resolution and struck the word “investigative” from the panel’s definition.

Markingson case lingers

While Thursday’s resolution doesn’t call for an investigation into the Markingson case, several faculty members said lingering questions from the incident have clouded the University’s reputation as a premier research institution.

Multiple reviews of the Markingson case at the University, state and national levels found no wrongdoing in the CAFE study. The only official finding of wrongdoing was a corrective action agreement for a study coordinator from a Minnesota Board of Social Work investigation last fall.

But several prominent scholars don’t believe past inquiries into the case were credible, said philosophy professor Naomi Scheman.

“We do have a good reputation, and we’ve worked hard to earn that reputation,” she said, “but it’s crumbling before our eyes.”

Others, like public health professor Dr. Russell Luepker, said at the meeting that the investigations into the Markingson case have been sufficient. He said documents questioning those past investigations contain a “number of half-truths and distortions.”

But Luepker said he supports a review of the University’s ethics procedures and practices despite his qualms about the proposal’s origins.

“The issue here, I think, is not a 10-year-old case of a tragedy that occurred, which has been investigated thoroughly, and nothing has been found,” he said, “but we should never stop from asking questions and review such a critical area.”

Cultural studies and comparative literature professor Cesare Casarino said the full truth of the Markingson case still needs to come out.

When it comes to determining whether there was any wrongdoing in the case, the burden of proof is on the University, Casarino said.

Dr. Stephen Olson, the CAFE study’s lead psychiatrist, told reporters after the meeting that he welcomes any investigation into the Markingson case.

“I’ve got nothing to hide,” he said. “We didn’t do anything wrong.”

He said at the meeting that Markingson’s suicide was tragic but unsurprising.

“Cancer patients die in cancer studies all the time,” he said, “and it’s not a surprise that people with mental illness will die in a trial of mental illness.”

Olson said he and his colleagues involved with the study haven’t been able to fully defend themselves because they don’t have the legal right to release Markingson’s medical records.

For Mike Howard, a representative for Markingson’s mother, Mary Weiss, the Faculty Senate’s action Thursday was “a huge vindication.”

‘This cloud hangs over us’

The University already has channels set in place, like the Institutional Review Board, that hold it to “rigorous standards of ethics,” pediatrics professor Dr. Sue Berry said at the meeting.

But William Durfee, a mechanical engineering professor and Faculty Consultative Committee chair, said while the University passes those voluntary accreditation processes with “flying colors,” it might not be enough.

“There’s a sense … as faculty that we almost want to hold the University to a higher standard than that,” he said.

Sociology professor David Pellow said he’s been through the IRB process at five different research universities and found the University of Minnesota’s to be the most “rigorous,” “comprehensive” and “impressive.”

But Pellow said his confidence has faltered and he feels the University should respond to “a growing and global call” for an external review.

Not conducting the review, he said, could be dangerous for the University as a whole.

“As scholars around the nation, and indeed the world, look askance and wearily at our perceived troublesome practices … [they will] likely discourage their students and colleagues from studying here, working here and collaborating with faculty here,” Pellow said.

Anthropology professor Karen-Sue Taussig said the University needs to show its commitment to research ethics, especially to the 175 international bioethicists and scholars who signed the October letter to the Faculty Senate, many of whom are renowned in their fields.

“The fact that this cloud hangs over us in the way that it does shows that we are not being successful in demonstrating that to the public and our colleagues elsewhere,” she said.

=============End of Daily Article

To try to evade looking into what happened in the Markingson case is a very bad strategy for the university, painful as it may be after many years of denial that anything was wrong.

I've written about this on the Star-Tribune Community Blogs website:

Markingson Case: Has the Gordian Knot puzzle been solved at the University of Minnesota?

A short excerpt:

The Gordian Knot of the Markingson matter can be solved, crudely speaking, in two ways. One is the "Alexandrine solution." [cutting the knot in half with a sword]

 But simply "give them an investigation of things as they are now" may solve the problem at one level, but will it will simply intensify questioning and even outrage at another. The time for stonewalling is over.

 The alternative is to take the knot apart. Follow the unravelled rope from one end - the Markingson case - to the other end: clincal practices in the present.  What was wrong - if anything - in the Markingson case?  What has changed as a result of it - for example Dan's Law? And where do we stand now, has anything actually changed? Is there a difference between what is ethical and what is legal?  Are we now following clinical practices in accord with  the highest ethical standards not just the law? 

 "Profiles in courage" should not only be an exemplar for politicians. It is time for the University of Minnesota administration to step up to the plate and demonstrate some courage.

I'll write again as things develop. We all love our university. Some day I'd like to be #umnproud again. 

For the Record: #Markingson resolution as amended and passed at University of Minnesota Faculty Senate

Source

Approved by the:

Faculty Senate - December 5, 2013 Administration - PENDING Board of Regents - no action required

Issues Arising from the CAFE Study

 and the Suicide of Dan Markingson 

PREAMBLE:

In May 2004, Dan Markingson, while enrolled in a clinical trial of an antipsychotic drug (the CAFE study) at the University of Minnesota, committed suicide. Since then individuals and groups within and outside the University have raised questions about the study, how Markingson was recruited into it, his treatment during the study, and the circumstances of his suicide.

On October 21, 2013, a letter co-authored by six bioethicists from outside the University, with 175 co-signatories, was addressed to President Eric Kaler and Professor Eva von Dassow, as chair and vice-chair (respectively) of the Faculty Senate, and to members of the University of Minnesota Senate. The letter asked the Senate to endorse and request an independent investigation of the issues arising from the Markingson case and the CAFE study. That letter is available at:

http://www1.umn.edu/usenate/fsenate/docs/131205toronto_letter.pdf.

The list of additional co-signatories is available at:

 http://www1.umn.edu/usenate/fsenate/docs/131205toronoto_signatures.pdf.

On November 20, 2013, fourteen faculty senators co-signed a request to the Faculty Consultative Committee to place this matter on the agenda of the December 5 Faculty Senate meeting for discussion, and further requesting that a resolution calling for an independent investigation be presented for discussion and action. That letter is available at:

http://www1.umn.edu/usenate/fsenate/docs/131205letter_to_fcc.pdf.


The FCC discussed the letter and the issues it raises at its meetings on Oct. 24, Nov. 14, and Nov. 21. While these discussions have not reached a conclusion, and members of the FCC have varying views, a consensus emerged that it is appropriate to bring the matter before the Faculty Senate at this time. The FCC wishes to emphasize the following points.

First, it is important that those participating in decisions about this matter familiarize themselves, with the history of the case and investigations conducted to date.

Second, as the FCC studied this issue, two things became clear: that the Markingson tragedy specifically had been investigated several times from different perspectives, and that those investigations did not address the broader question of whether the University's current policies, procedures and practices, some of them changed since the Markingson case, reflect both best practices in clinical research on human subjects and the faculty's high ambitions for ethical behavior. Members of the FCC also recognize that external evaluations can have the advantage of fresh perspectives not biased by familiarity with current practice, and are a way for the public to have the utmost confidence in the integrity of the research conducted at the University of Minnesota.

For this reason, the FCC feels that the way forward is to recommend that an independent and transparent examination be undertaken to evaluate the University's procedures, practices, and policies governing clinical research on human subjects, and in particular clinical research involving adult participants with diminished functional abilities. While the specific charge for such an examination requires further work, FCC believes issues to address may include investigator conflict of interest, institutional conflict of interest, consent policies and procedures, case management of enrolled participants, mechanisms for overseeing such research and mechanisms for addressing adverse events.

Therefore, the FCC suggests to the Faculty Senate the following resolution:

Resolution on the matter of the Markingson case

WHEREAS the faculty of the University of Minnesota are committed to upholding high ethical standards in the conduct of research;

WHEREAS questions continue to be raised about the policies and procedures followed in the case of Dan Markingson, a 26-year-old participant in a clinical trial who committed suicide in 2004;

WHEREAS the University has suffered reputational harm in consequence of this tragic case and its aftermath;

WHEREAS the faculty seek to ensure through independent evaluation that the University's ethical standards for clinical research on human subjects meet or surpass the norm,


BE IT RESOLVED that a panel external to and independent from the University of Minnesota be constituted for the purpose of conducting an inquiry examining current policies, practices, and oversight of clinical research on human subjects at the University, in particular clinical research involving adult participants with diminished functional abilities. The administration, in collaboration with appropriate faculty governance committees, shall initiate the constitution of such an independent panel and shall support its inquiry. The panel shall have authority to obtain any records it deems necessary for a thorough inquiry, to the extent consistent with applicable law. At the conclusion of the inquiry, the panel shall issue a report that will be made publicly available, within the limitations of regulations governing the protection and privacy of individuals, including research participants, and the results will be reported back to the Faculty Senate so that senators have an opportunity to ask questions and discuss the report.

Farewell to University of Minnesota Medical School Dean Friedman

But first, this may be painful and require  anesthesia, 
so please click the play button above for some 
soothing music while you read.
Primum non nocere and all that...

When our beloved General Counsel, Mark Rotenberg, moved on to greener pastures at Hopkins, I thought he deserved a suitable send-off given his contributions to the University.  See my post:

Farewell to Mark Rotenberg, University of Minnesota General Counsel

Although Dean Friedman in only three years has had nowhere near the time in which to do similar damage, I believe that he also richly deserves a tribute. 

In my time as a faculty member at the U, I have  seen the following Medical School Deans in action and inaction:

Dr. David Brown - he of the scandal that cost the U of M $32 million for abuses in the medical school. 

Dr. Frank Cerra - he of the foot-dragging performance in reforming conflict of interest rules at the University of Minnesota. Pay special attention to the unofficial medical school anthem at this link. 

We had two insiders during this time.  Dr. Al Michaels and Dr. Shelly Chu held the fort while numerous outside searches failed. Both were reputed to be good people. I have no evidence to the contrary.

And then there was... Dr. Deborah Powell.  I don't even know where to go with this, but here is a start: "The Ethically Challenged U of M Medical School Administration"  Among other highly questionable moves, Dr. Powell put Dr. Leo Furcht into a position of leading a group to redo conflict of interest policies at the University without informing committee members that he had been involved in quite a conflict of interest himself.   Nice, huh?

Eventually, Dr. Powell was unhorsed in mid-stream by Dr. Frank Cerra in his administrative position as Vice President for the Academic Health Center and replaced as dean by...

Dr. Frank Cerra!

The mind reels.

And when Dr Cerra stepped down as VP/Dean, he was replaced by today's celebrant, Dr. Friedman.

So what to say about Dr. Friedman?  I'll keep it simple and just post about a  few of the preposterous things he has written, no doubt aided and abetted by people in the U of M's PR department, people like Justin Paquette whose modus operandi  is obvious from this post. 

So here are just a few links in tribute to our latest about to be emeritus dean. May he live long and prosper.

1. University of Minnesota Medical School Dean and Academic Health Center Vice President Dr. Aaron Friedman to Step Down  Good overall summary - if I do say so.

Note especially the pathetic defense of homeopathy written, nominally, by two medical school deans, Friedman and Cerra. Don't all doctors take chemistry as undergrads? I guess a few of them don't remember much chemistry - at least the concepts of dilution to infinity and Avogadro's number.

2. http://ptable.blogspot.com/2013/05/for-record-dollop-of-bluster-on-usual.html

Dr. Friedman's pitiful attempt to defame Dr. Carl Elliot: "We hope Star Tribune readers won’t allow Elliott’s campaign to cloud reality." Dr. Friedman's Star-Tribune commentary was shredded in the comments that are included in the link.


3. Latest from the University of Minnesota Medical School: All the News That's Fit to Manage?

"To complain internally to the university community about the unfairness of the press after having dissembled as outlined above is not worthy of a University of Minnesota medical school dean."

4. University of Minnesota Medical School Dean Aaron Friedman: Driven to Dissemble?

There is, unfortunately, more. But the point is made.

Needless to say, I will not be attending the big shindig scheduled to celebrate Dr. Friedman's stepping down, nor did I attend Mr. Rotenberg's bon voyage party.


To give a certain symmetry to this post, I'll end with a final celebratory interlude. Those of you who have done your link homework will recognize it as the unofficial anthem of the University of Minnesota Medical School.  Let's hope that changes in the future.

$$$

$$

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#Markingson Case: Has the Gordian Knot puzzle been solved at the University of Minnesota

I've put up a new post on the Star-Tribune Community Voices site.

KMSP-9 Video: U faculty call for outside review #markingson

KMSP-9 has graciously allowed embedding of their video report on this matter. It should be noted that their recent work  has contributed greatly to progress in the Markingson case. Kudos.

KMSP-TV

KMSP-9 Reports on #markingson resolution vote at U of M Faculty Senate

INVESTIGATORS: U of M Senate resolves to review human research

MINNEAPOLIS (KMSP) -

For nearly 10 years, family and friends of Dan Markingson have pushed for an outside investigation of his death after he violently took his own life while enrolled in a drug study at the University of Minnesota.

On Thursday, the University of Minnesota's Faculty Senate took a bold step, passing a resolution that calls for outside experts to review how the school conducts research on human subjects.

"We are all of us under this cloud, and it has to be removed," Professor Naomi Scheman contended.

Markingson was mentally ill when he was recruited to sign up for the study. His psychiatrist, Steven Olson, was the principal investigator, and part of his salary was being paid by the drug maker.

Mary Weiss, Markingson's mother, repeatedly complained to the U that her son's condition was worsening, and she feared he would kill himself.

"He didn't pass away, he was killed," Weiss said. "They let him die."

Weiss, who is recovering from a stroke, was unable to attend the faculty Senate meeting, but a close family friend called the results of the vote "overwhelming."

"I never thought it would come to this, speaking on behalf of Mary Weiss," Mike Howard said. "Thank you."

Now, it's up to University of Minnesota President Eric Kaler to decide what happens next.

"I'll consult with experts on campus to identify external people who have the expertise necessary to make an evaluation," Kaler said. "We'll invite them to come review what we do and we'll report the result."

Kaler does have the option to do nothing. The university has long maintained that the death of Markingson was a tragedy, but not the fault of researchers.

An investigation by the FDA found no evidence of misconduct, but critics say that review was incomplete and they have been pushing for a far more in-depth investigation.

"I welcome any investigation," Olson said. "I've got nothing to hide. We didn't do anything wrong."

More than 3,000 people, many of them medical professionals, have also signed a petition calling on the governor to get involved in the Markingson case. That petition was delivered to Gov. Mark Dayton's office on Thursday morning. His staff says he will have a response soon.

Star-Tribune on #Markingson by Jeremy Olson

Faculty Senate Meeting on #Markingson

Resolution for Investigation Approved

Some Uncertainty About What This Means

Jeremy Olson is quite a good reporter who has been in on the Markingson situation for quite some time. At his previous job with the St. Paul Pioneer Press, he and Paul Tosto received the Primack Award from the U of M for their investigative journalism on this and related cases. I'll tidy up this paragraph with links later.

But for now, from the Strib:

Nearly a decade after Dan Markingson died by suicide while participating in a U of M drug trial for schizophrenics, the U’s Faculty Senate raised his death as a reason to re-examine their institution’s handling of vulnerable research subjects.

At a meeting Thursday, the senate voted 67-23 to ask the university for a review of how the university recruits and protects people in clinical trials.

Questions have emerged in recent years about whether U psychiatry researchers coerced the young, delusional Markingson into a drug study that he didn’t fully understand and his mother didn’t want for him. Most recently, a petition by more than 180 leading researchers and ethicists asked the university to review its conduct.

“These are not random cranks out there,” said Karen-Sue Taussig, a Faculty Senate member and liberal arts professor. “These are people who are really quite eminent in their field.”

Faculty members at Thursday’s meeting expressed different views on the issue — some questioning whether the U put research goals ahead of Markingson, who died at age 26, and others believing the institution did everything it could to protect him. The psychiatrist who treated and recruited Markingson to the so-called CAFE study, which was funded by drugmaker AstraZeneca to compare three antipsychotic drugs, even made a rare public defense of his research.

But most faculty members agreed that the university’s credibility in the research world has been damaged by a decade of unresolved questions over Markingson’s death, and that an independent, external review could help rebuild its reputation.

“We are all of us under this cloud and this cloud needs to be removed,” said Naomi Scheman, a philosophy professor and Faculty Senate member.

Whether the vote called for a broad look only at the university’s research practices, or a specific examination of the Markingson case, was a matter of dispute after the vote.

U bioethicist Carl Elliott, who has been a leading critic of the university’s conduct in the study, said it will have to address Markingson’s death in some meaningful way. “If anyone wants this investigation to clear the name of the university — as a lot of people said they do — then it will have to deal with Dan,” he said.

After Markingson’s death at a halfway house in May 2004, a review by the U.S. Food and Drug Administration found no wrongdoing by the university.

However, the state mental health ombudsman did raise concerns that Markingson was recruited by a psychiatrist, Dr. Stephen Olson, who also could advise a judge on whether his patient should be committed to a state mental health hospital. And state legislation has since outlawed doctors from recruiting their own patients into psychiatric drug studies because of that risk of coercion.

Olson told the Faculty Senate that he felt badly for the loss of Markingson but that he did not coerce him into the study and that the call for an investigation was prompted by mistruths.

“Cancer patients die in cancer studies all the time,” he said, “and it’s not a surprise that people with mental illness will die in a trial of mental illness.”

U of Minnesota President agrees to outside review #markingson

UMN president agrees to outside review 

of clinical research practices

Report from On Campus:

University of Minnesota President Eric Kaler says he will form an outside panel to review how the U treats human subjects in clinical trials.

 His announcement followed a faculty resolution today requesting a review of the U’s practices. 

The panel is a response to the 2004 death of patient Dan Markingson, who killed himself while enrolled in a clinical drug study at the U. 

Faculty leader Naomi Scheman says lingering questions over his death have put the U’s reputation under a cloud.

“It’s not going away because — despite the university’s insistence that it has been adequately investigated — very credible, serious, thoughtful, fair-minded people do not find those investigations genuinely to be credible.” 

Kaler says he welcomes the review, saying it would put to rest any doubts over how the U handles people in clinical research.

“Let’s look at what we’re doing now, currently. I have a great deal of confidence in what we’re doing, and I think an external validation of that — which is what I expect it to be — will close the chapters.”

Kaler said he will form the panel early next year.

Carl Elliott, who has been one of the main scholars raising questions — and who has called for an outside investigation into Markingson’s death — says he’s trying to stay optimistic:

“It all depends on who picks the panel, what they’re allowed to look at, and what kind of access and power they have to get at records, to get at court documents, to get at finances, to interview people who have been involved in clinical care as patients and research subjects that were in the department of psychiatry. All that stuff is going to be important .. for whoever sets up this panel to make sure they’re given the tools and expertise to do their job.” 

This morning, a friend of the Markingson family, Mike Howard, delivered a petition with almost 3,500 signatures to Gov. Mark Dayton’s office asking for “an external panel of experts to investigate ethical wrongdoing in psychiatric research at the University of Minnesota, including the circumstances surrounding Dan’s death.”

He later [called] Kaler’s announcement of the panel “a tremendous first step.”

He added:

“The records will speak for themselves. … It does restore some faith that there is some honesty and integrity at the University. Because for a long time, it has been held in a closet. And today is the first day it came out.”