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Minnesota Legislature must hold hearings on psychiatric research misconduct

The university’s leaders have failed to take meaningful action and failed to restore trust.

The following commentary has also been signed by 159 scholars of health law, bioethics, medicine and pharmacy from U.S., Canadian, European, Australian and New Zealand institutions. Their names and affiliations are listed in the attached document below.

As scholars of health law, bioethics and medicine, we are calling on the Minnesota Legislature to conduct public hearings on psychiatric research misconduct at the University of Minnesota.

Two reports issued in the last five weeks have exposed serious flaws in the University of Minnesota’s system for protecting human subjects of research. When systems fail, the appropriate response is to admit to the problem and to work hard to fix it. The report by Minnesota's Legislative Auditor [PDF], focusing on the tragic suicide of Dan Markingson in an industry-sponsored psychiatric drug trial, describes how university leaders have denied and covered up these flaws for the past 10 years.

Two years ago we wrote a letter to the University Senate, co-signed by more than 170 U.S. and international scholars, demanding an independent investigation of Markingson’s suicide. We did so to support U of M faculty members who had been repeatedly stonewalled when raising concerns about exactly the issues exposed in the two reports. Like these faculty members, we received standard responses from senior administrators claiming that several “investigations” and courts failed to find any problems. We also challenged these misleading claims, providing details as to why those independent assessments were nonexistent, cursory or compromised by conflicts of interest, but we never received an adequate response.

University of Minnesota leaders now finally acknowledge that some of the university’s practices “have not been above reproach.” But these half-hearted admissions of guilt came only after Minnesota’s Legislative Auditor blasted them for being “defensive, insular, and unwilling to accept criticism” and for making “misleading statements.” Most troubling is that the university has now appointed several of the same administrative leaders who in the past failed to act and to respond by making appropriate changes to the university’s research system. It also appointed others with conflicts of interest. Internal critics, who should be praised for pushing for better protection of research subjects, remain largely marginalized and isolated. In the meantime, another psychiatric research scandal – featured in the New York Times on April 17 – suggests that U of M leaders may be sitting on information about other potential wrongdoing. How many new scandals must emerge before more substantive action is taken?

The university’s leaders have failed to take meaningful action and failed to restore trust. We therefore believe, like former Gov. Arne Carlson, that it is essential for the Minnesota Legislature to conduct public hearings as soon as possible. Legislative hearings will signal to university administrators in Minnesota and elsewhere that the protection of research subjects is of public concern and that academic institutions will be held publicly accountable.

Minnesotans deserve to know how problems of such proportions were covered up for so long. They deserve to know why university officials stonewall requests for information. And most of all, they deserve to know whether and how many more research subjects have been mistreated, injured or died in psychiatric studies at University of Minnesota hospitals.

Trudo Lemmens (LLM bioethics, DCL) is William M. Scholl Chair in Health Law and Policy and Professor at the Faculty of Law and the Faculty of Medicine of the University of Toronto. 

Raymond DeVries (Ph.D.) is a professor at the Center for Bioethics and Social Sciences in Medicine at the University of Michigan Medical School. 

Lois Shepherd (J.D.) is Peter A. Wallenborn, Jr. and Dolly F. Wallenborn Professor of Biomedical Ethics Professor of Public Health Sciences and Professor of Law at the University of Virginia. 

Susan M. Reverby (Ph.D.) is Marion Butler McLean Professor in the History of Ideas and Professor of Women's and Gender Studies at Wellesley College.

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Comments (2)

An endemic problem?

Somehow the University of Minnesota administration expects us to believe that the very people who got us into the current mess will be able to clean it up. The same people who told us that there was no problem for many years.

This kind of behavior reminds me of the case of Leo Furcht which was covered by the Star-Tribune some time back.

See:

U Doctor on Ethics Panel Disciplined
link http://bit.ly/1bqLOun

Here a U of M faculty member who had been involved in an egregious case of conflict of interest was later put on a panel that was to set new conflict of interest rules for the U of M.

The Dean of the Medical school at that time commented that she chose Furcht for the task force because he had extensive experience with national professional organizations on devising conflict-of- interest rules. "That seemed to me to be a compelling reason to appoint him to that role," she said. Dean Powell also admitted that she did not inform the rest of the task force members about the sanctions against Furcht. "I did not think it was relevant," she said.

This after the panel that investigated Furcht concluded that Furcht "knew or should have known" that he was required to disclose the financial arrangement with Baxter, because he had "a significant financial interest" in MCL and the stem-cell technology.

[In November 2003, Furcht sold MCL for $9.5 million in stock, sharing 5 percent of the proceeds with the university.]

The panel also recommended that Furcht be disciplined and questioned whether he should retain his position as department chair. It also raised concerns that he may have misused his position "to personally benefit him and his commercial interests," and recommended further investigation.
In her letter concluding the matter, Powell wrote: "Despite this, I value your managerial abilities as a department head and wish to retain you in this role."

[After leaving her position as dean, Dr. Powell, left to join Dr. Furcht's department, Laboratory Medicine and Pathology.]

The panel also stated:

"the panel recommends that the Dean consider undertaking an investigation to examine whether Dr. Furcht committed misconduct under Setcion 10 of the Faculty Tenure Code. This section includes the following ground as a bais for suspension, termination, or other disciplinary action against a faculty member."

"Egregious or repeated misuse of the powers of a professional position
to solicit personal benefits or favors." Faculty Tenure Code, Section 10.21(c)

Several of Dr. Furcht's actions raise questions about possible misuse of his professional position. In particular, further review may be needed to determine whether Dr. Frucht misused his faculty and/or department head position in ways such as the following:

a) To arrange for research to be conducted at the University to personally benefit him and his commercial interests:

b) To delay or avoid addressing REDACTED concerns about payment of research fees for the Baxter research performed in REDACTED laboratory;

c)To direct the use of University funds to cover research performed in REDACTED laboratory that served the commercial interests of Dr. Furcht and MCL; and

d) To manipulate and mislead REDACTED into performing research at the University that personally benefited Dr. Furcht and his commercial interests.

===================

In her letter concluding the matter, Powell wrote: "Despite this, I value your managerial abilities as a department head and wish to retain you in this role." Dr. Furcth is still department head.

The reason that I go into such detail in this matter is to show why so many of us believe that Dr. Kaler's attempt to have the Markingson problem dealt by the same people who are responsible for the problem will not be credible both within and without the University of Minnesota.

William B. Gleason, PhD
retired faculty
University of Minnesota
Department of Laboratory Medicine and Pathology

U of M alum - Phd Chemistry (1973)

Again

I will reiterate my lengthy responses to the Carlson article and agree with Dr. Gleason.

Kaler needs to act but he is not the culprit. The former Dean Powell, Leo Furcht and UMP leadership are the ones who need to take responsibility. Powell has retired, Furcht should be fired and so should Powell, and UMP should be called before the legislature to explain their lack of action and endangerment of patients. They employ the doctors so they have a major responsibility here.

Arne should quit calling notice to the incompetents he put in place that led to this fiasco and it should be put to bed. Since the Medical school and UMP cannot or will not police themselves, have the legislature appoint a temporary overseer for the community, much like they did with Win Wallin. Maybe Bill McGuire ( give him a sales tax deal for doing it!) or someone with business and medical experience- Dick Migliori would be another excellent choice. The whole medical school needs an ethical enema. And someone who knows the difference from right and wrong should be making some tough calls.