The Fix Is In

Less than three weeks after the release of the Legislative Auditor’s scathing report on the “serious ethical issues and numerous conflicts of interest” connected to the Markingson case, President Kaler has established an “implementation team” tasked with reforming the University of Minnesota’s human subjects research protection program. According to the press release, “President Kaler has asked the team to advance the program to become a national model, meeting the highest standards of ethics and science.” In reality, with an FDA investigation in progress and the University’s dysfunctional research oversight “system” exposed by both the Legislative Auditor and a team of AAHRPP-appointed reviewers, I suspect that the University of Minnesota is about to become a “national model” of a very different kind.

Fumbling yet another opportunity to do the right thing, President Kaler has appointed to this “team” a predictable mixture of sidekicks, cronies, stooges, and physicians with glaring financial conflicts-of-interest.

Chairing the committee is Dr. William Tremaine, a gastroenterologist at the Mayo Clinic and director of that institution’s IRB. According to Dr. Tremaine’s curriculum vitae, he has received funding from such industry sources as AstraZeneca, Pfizer, GlaxoSmithKline, Janssen, Millenium Pharmaceuticals, UCB Pharma, Norwich Eaton Pharmaceuticals, Proctor & Gamble Pharmaceuticals, Tillots Pharma AG, Centocor, Astra Merck, Schering-Plough, Solvay, Axys Pharmaceuticals, Merck & Co, InKine Pharmaceutical Company, Reid Rowell Pharmaceuticals, Sandoz Pharmaceuticals, ELAN Pharmaceuticals, Astra Pharmaceuticals, Glaxo Wellcome, VSL Pharmaceuticals, Centocor, Amgen, and Novartis. The Pioneer Press database of pharmaceutical company funding of Minnesota physicians documents additional industry payments to Tremaine.

The announcement of Tremaine’s appointment as committee chair failed to disclose these financial conflicts-of-interest. Nor has President Kaler explained why someone with such extensive ties to the pharmaceutical industry is the optimal person for reviewing “best practices on managing conflicts of interest.” It is also unclear why a gastroenterologist is the ideal individual to lead a committee assembled as a result of a psychiatric clinical research scandal.

Dr. Timothy Schacker and Dr. Daniel Weisdorf also have ties to industry. According to his CV, William Durfee, a Professor in the Department of Mechanical Engineering, has consulted for Medtronic and other companies. Again, the University’s announcement of the implementation team makes no attempt to disclose these financial conflicts-of-interest and explain why individuals with such conflicts were appointed to the committee.

Dr. Steven Miles, a faculty member at the Center for Bioethics is a truly head-smacking choice. Back in November 2010, Miles was not among the bioethics faculty members who wrote to the Board of Regents and urged them to initiate an independent investigation of the Markingson case. Given the damning findings in the Legislative Auditor’s report, his lack of involvement can hardly be characterized as a badge of honour. In 2012, as co-director of the Research Ethics Consultation Service, Miles refused a direct request to investigate the Markingson case and examine apparent failures of research oversight. It appears that President Kaler has finally found a bioethicist with whom he is sympatico.

Paul Goering, a psychiatrist and Vice President at Allina Mental Health, is another jarring choice. According to Losen v. Allina Health System, Goering was a defendant in a medical-negligence and wrongful-death action brought against three Allina physicians. Much like the judge’s decision in Mary Weiss’ lawsuit against the University, on the grounds of statutory immunity the Court of Appeals dismissed the claims against Dr. Goering and the other defendants. I can only assume that President Kaler made no attempt to consult with Mary Weiss and Mike Howard or consider the “optics” of this choice before appointing Dr. Goering to the committee.

Several committee members ought to be dragged before the state legislature and asked to explain themselves instead of being appointed to this committee. Prior to the release of the Legislative Auditor’s report, Brian Herman and Brooks Jackson did nothing in response to repeated calls for an investigation of the Markingson case and related allegations of psychiatric research misconduct. They are now co-vice chairs of the committee. Carolyn Wilson, another senior administrator whose conduct needs to be examined by state legislators, is a committee member. Debra Dykhuis, Executive Director of the human research protection program, is also on the committee even though one of the key questions the task force ought to ask is whether she and other leaders of the research protection program need to be replaced.

According to the final page of 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.” The first page of the report 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.” The Board of Regents passed no resolutions that addressed these repeated failures of leadership.

Rather than appointing individuals willing to examine the role that senior administrators played in making false statements and issuing repeated denials in response to calls for an investigation of psychiatric research misconduct, President Kaler has rounded up the usual suspects. This pathetic and all-too-predictable performance is what passes for “decisive action” at the University of Minnesota.

These committee members are not going to ask searching questions about failures at the highest levels of institutional governance. Rather, they will make sure that institutional “reforms” do not extend to demanding resignations and replacing themselves and President Kaler with more capable and credible leaders.

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