Letter to lawmakers criticizes regents’ oversight

Last May, I posted about a letter that former Gov. Arne Carlson sent to University of Minnesota regents expressing his concern over the university's handling of the case of Dan Markingson, a drug-trial patient.

Markingson committed suicide about a decade ago while in the study, and critics believe he was exploited by university researchers.

Today, University of Minnesota bioethicist Carl Elliott -- one of the harshest critics of the university's handling of the case -- forwarded to me a letter he says was written by Carlson, and which he and fellow U of M bioethicist Leigh Turner signed. It was to be distributed today to legislators, Elliott said.

A staff member for Sen. Chris Eaton (DFL - Brooklyn Center) said he was familiar with the letter, and that Carlson spoke with Eaton about it.

The letter criticizes the role played by the administration and the Board of Regents, saying they have not been the watchdog they should be in problematic drug-trial cases that may involve suicides, injuries and conflicts of interest, among other things:

"Most disturbing is the deliberate refusal of the Board of Regents to publicly review or hold hearings on what they knew was clearly a troubled area."

The letter asks the Legislature to review annually the board's performance in meeting goals and challenges, and asks for a "special citizens commission" to review research of psychiatric drugs, as well as the oversight process and the performance of the board and other management.

The letter says the commission could help legislators in "setting up a more professional process for the selection of Regents. Defined and proven leadership talents must replace the current system which is little more than a political beauty contest."

I have a call or email in requesting comment from both Carlson and Board of Regents Chairman Richard Beeson.

Below is the letter. Following that is a reply forwarded by a university spokesman.

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The university and its critics have clashed repeatedly over whether the U has adequately investigated the Markingson case.

The university's response:

The University of Minnesota has a responsibility and an obligation to look for answers to some of the most difficult health questions, including issues related to mental health. As the Dan Markingson case so tragically illustrates, mental illness can be devastating, and we need to find better treatments to try to prevent similar tragedies in the future.

However, while the case of Dan Markingson was definitely a tragedy, it was not a scandal. Over the last ten years, this case has been thoroughly investigated by multiple independent entities including:

• The Food and Drug Administration (FDA)

• The Hennepin County Fourth District Court

• The Office of the Ombudsman for Mental Health and Mental Retardation

• The State of Minnesota Board of Social Work

• The Minnesota Board of Medical Practice

Contrary to what the letter states, all of these reports are available to the public. None of these investigations found evidence of misconduct by the University of Minnesota.

The University of Minnesota is committed to upholding the highest standards when conducting research involving human subjects. We are constantly evaluating our processes and procedures to be sure we are a leader in this area. In fact, at the recommendation of our Faculty Senate, we are currently undergoing an independent review of all of our human subject research practices to be sure we are meeting the highest standards. That review is expected to be issued in early March.

The University is uniquely positioned to do the groundbreaking research that is needed to find these new treatments. Clinical research involving human subjects plays a critical role in our mission to improve the lives of millions in Minnesota and beyond.

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