Thursday, January 2, 2014

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 

Wednesday, January 1, 2014

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