UMN’s Research Protections Program Potemkin Village

April 14, 2015

Eric Kaler, PhD

President, University of Minnesota

202 Morrill Hall

100 Church Street S.E.

University of Minnesota

Minneapolis, MN, 55455

 

An Open Letter Concerning Your Research Protection Program Potemkin Village

Dear President Kaler:

I am writing to inform you of serious problems with the two committees established to reform the university’s dysfunctional human research subjects protection program. I am referring to the Implementation Team and the Research Compliance Advisory Committee. While there are significant shortcomings with the recommendations these committees are supposed to implement, here I will not dwell on the limitations of the AAHRPP-reviewers’ report. Rather, I want to draw your attention to the particular individuals appointed to these committees.

Let me begin with some background. As you know, the Legislative Auditor’s report on the Dan Markingson case offered scathing criticism of you and other senior administrators. The first page of that document states, “We are especially troubled by the response of University leaders to the case; they have made misleading statements about previous reviews and been consistently unwilling to discuss or even acknowledge that serious ethical issues and conflicts are involved.”

You maintained that longstanding pattern of dishonesty in your response to Mr. Nobles. Referring to various reviews of the Markingson case (some real, some fabricated by university officials), you wrote, “If these external reviews were flawed, we were not aware of those shortcomings.” As one of numerous individuals who made repeated efforts to bring such flaws to your attention, I was disappointed to see you defend yourself with this blatant lie.

You have now appointed to these two committees tasked with improving human research protections many of the senior university officials and hospital administrators who joined you in ignoring or dismissing pleas to investigate the Markingson case. As several of my colleagues warned in a recent editorial, you have put the foxes in charge of the henhouse.

Brian Herman, Brooks Jackson, Debra Dykhuis, Carolyn Wilson, Frances Lawrenz, and Steven Miles all refused to take action on the Markingson case. All of these individuals were in a position to either directly investigate allegations of research misconduct in the Markingson’s case or use their positions and influence to press for such an investigation. In the face of what the Nobles report describes as a case that “involves serious ethical issues and numerous conflicts of interest,” the most charitable statement that can be made of some of these individuals is that they were bystanders who chose to do nothing. Others joined you in opposing efforts to initiate an investigation of the Markingson case.

None of these individuals should be appointed to committees tasked with reforming research protections at the university. On the contrary, if state legislators hold hearings and investigate failures in the conduct and oversight of psychiatric clinical trials at the university, these administrators and faculty members ought to join you in being compelled to defend their inaction.

I must also challenge the systematic manner in which critics of the conduct and oversight of psychiatric clinical research at the university were excluded from these committees. Carl Elliott, Naomi Scheman, Teri Caraway, Karen-Sue Taussig, David Pellow, William Messing, and numerous other colleagues have expressed serious concerns about the adequacy of institutional protections for human research subjects. None of these faculty members were invited to serve on these committees.

According to the Legislative Auditor’s report, “A primary problem uncovered by our review is past and current University leadership that is defensive, insular, and unwilling to accept criticism about the Markingson case either from within or outside the University.” Excluding from these committees individuals who have publicly questioned the conduct of senior university officials will perpetuate this defensive and insular pattern of decision-making and behavior.

If senior administrators at this university ever decide to make a genuine effort to better protect research subjects, they will need to include individuals who dissented from the university’s longstanding official dogma that there was no need to investigate the Markingson case and additional allegations of psychiatric research misconduct.

I must also condemn the inclusion of individuals with financial conflicts-of-interest and the subsequent failure to disclose those committee members’ conflicts-of-interest. Neither the website listing committee members nor the press release announcing their appointments reveals these individuals’ financial conflicts-of-interest. Furthermore, according to the minutes from the April 8, 2015 meeting of the Implementation Team, “Each member was asked to declare any potential conflicts of interest and there were no relevant conflicts.” In fact, there are relevant conflicts of interest and they have not been disclosed.

For example, Dr. William Tremaine, Chair of the Implementation Team has substantial undisclosed financial conflicts-of-interest. According to Dr. Tremaine’s curriculum vitae, he has received funding from over twenty-five pharmaceutical companies. These companies include AstraZeneca, Pfizer, GlaxoSmithKline, Janssen, Millenium Pharmaceuticals, UCB Pharma, Norwich Eaton Pharmaceuticals, Proctor & Gamble Pharmaceuticals, Tillots Pharma AG, Astra Merck, Schering-Plough, Solvay Pharmaceuticals, Axys Pharmaceuticals, Merck & Co, InKine Pharmaceutical Company, Reid Rowell Pharmaceuticals, Sandoz Pharmaceuticals, ELAN Pharmaceuticals, Astra Pharmaceuticals, Glaxo Wellcome, VSL Pharmaceuticals, Centocor, Amgen, Shire, Abbot Laboratories, Astra USA, and Novartis. The Pioneer Press database of pharmaceutical industry funding of Minnesota doctors documents additional industry payments to Dr. Tremaine.

Let me be clear: the Chair of a committee asked to “review best practices on managing conflicts of interest” failed to disclose his conflicts-of-interest. Is this failure an indication of the leadership he will provide when developing policies intended to “manage” such conflicts?

Dr. Tremaine appears to have had these significant conflicts-of-interest while Chairing the Mayo Clinic’s Institutional Review Board and serving as Director of the Mayo Clinic’s Office of Human Research Protection. Dr. Tremaine’s ties to the pharmaceutical industry raise serious questions about the Mayo Clinic’s IRB and need airing publicly. Dr. Tremaine’s conflicts-of-interest resemble the many financial conflicts-of-interest Dr. David Adson had while he was an IRB Chair here at the University of Minnesota.

According to databases documenting industry payments to physicians, committee members Dr. Timothy Schacker and Dr. Daniel Weisdorf also have financial conflicts of interest. While not a physician and therefore not identifiable in “Dollars for Docs” databases, Professor William Durfee has consulted for Medtronic and other companies. There likely are additional conflicts-of-interest. Since committee members have not been compelled disclose them I am left to wonder what a full account of financial conflicts of interest would document.

At no point have you or other senior university administrators attempted to explain why individuals with such financial conflicts-of-interest were appointed to the committee. Nor have you explained why these conflicts-of-interest were allowed to go undeclared while preaching the imminent arrival of an era of transparency and openness in which the university’s research protection program will be “world-class” and “Beyond Reproach.”

Rather than inviting scrutiny from an investigative body that would examine failures in the conduct of psychiatric clinical trials, failures in research oversight, and failures in your leadership and the role played by your senior management team, you and other administrators have instead assembled individuals willing to help build your research protections program Potemkin Village.

According to the Legislative Auditor’s report, by making misleading claims and refusing to investigate credible allegations of research misconduct, university leaders “seriously harmed the University of Minnesota’s credibility and reputation.” These leaders are now the very individuals tasked with “reforming” the university’s research protection program. Groupthink is being promoted by excluding dissenters from these committees. The inclusion of individuals with financial conflicts-of-interest and the subsequent failure to disclose those conflicts-of-interest further compromises the integrity of this process.

President Kaler, this university has suffered tremendous reputational damage under your leadership. Must you continue compounding the harm?

Yours sincerely,

Leigh Turner, PhD

Associate Professor

University of Minnesota Center for Bioethics

cc: William Tremaine, Professor of Medicine, Mayo Clinic

Jerry Menikoff, Director, Office for Human Research Protections, DHHS

Kristina Borror, Director of the Division of Compliance Oversight, OHRP

Sean Kassim, Director, Office of Scientific Investigations, FDA

Catherine Parker, Office of Scientific Investigations, FDA

Arne H. Carlson, Former Governor of Minnesota

Terri Bonoff, Minnesota Senator, Chair, Higher Education & Workforce Development Committee

Dan Schoen, Representative, Minnesota House of Representative

Carl Elliott, Professor, Center for Bioethics, University of Minnesota

David Pellow, Professor, Department of Sociology, University of Minnesota

Naomi Scheman, Professor, Department of Sociology, University of Minnesota

Teri Caraway, Associate Professor, Department of Political Science, University of Minnesota

Karen-Sue Taussig, Associate Professor, Department of Anthropology, University of Minnesota

William Messing, Professor, Department of Mathematics, University of Minnesota

Steven Miles, Professor, Center for Bioethics, University of Minnesota

Timothy Schacker, Professor, Department of Medicine, University of Minnesota

Daniel Weisdorf, Professor, Department of Medicine, University of Minnesota

Carolyn Wilson, Executive Vice President and Chief Operating Officer, Fairview

William Durfee, Professor, Department of Mechanical Engineering

Trudo Lemmens, Professor, Faculty of Law, University of Toronto

Michael Carome, Director, Public Citizen Health Research Group

James Nobles, Legislative Auditor for the State of Minnesota

Brian Herman, Vice President, University of Minnesota

Brooks Jackson, Vice President, Health Sciences & Medical School Dean, University of Minnesota

Frances Lawrenz, Associate Vice President for Research, University of Minnesota

William Donohue, General Counsel, University of Minnesota

Keith Dunder, Legal Counsel, University of Minnesota Academic Health Center

Susan Berry, Chair, University of Minnesota IRB Executive Committee

Debra Dykhuis, Executive Director, University of Minnesota Research Protection Program

Richard Beeson, Chair of the Board of Regents, University of Minnesota

Dean Johnson, Vice Chair of the Board of Regents, University of Minnesota

Patricia Simmons, Regent, University of Minnesota

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