U rejects profs’ call for trial review

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The University of Minnesota’s Board of Regents and General Counsel on Monday dismissed eight professors’ request for an outside investigation into the suicide of a former clinical patient.

In a letter to the regents sent in late November, eight professors from the Center for Bioethics asked for further review of what they considered “an alarming series of ethical violations and lapses” that contributed to Dan Markingson’s death.

In the board’s response to that letter sent Monday, regents Chairman Clyde Allen cited the results from investigations into the incident by the University’s Institutional Review Board and the U.S. Food and Drug Administration as well as the Minnesota Board of Medical Practice. The investigations found “no evidence of misconduct or violation.”

Dan Markingson was committed to a psychiatric ward at the University of Minnesota Medical Center, Fairview in 2003 and entered into a research trial funded by the drug company AstraZeneca for its new anti-psychotic drug. He committed suicide six months later.

Markingson’s death sparked an intense ethical debate on whether the doctors caring for him had a financial conflict of interest between patient health and the drug company sponsoring the trial Markingson was enrolled in.

The University’s IRB and the FDA subsequently cleared the University in the case. Markingson’s mother, Mary Weiss, filed a suit against the University in the Hennepin County District Court that was eventually dismissed.

In the regents’ response, Allen wrote “at this time … we do not believe further

University resources should be expended re-reviewing a matter such as this, which has already received such exhaustive analysis by independent authoritative bodies.”

General Counsel Mark Rotenberg dismissed all seven allegations the bioethicists made in their letter to the board.

“It is not clear from your letter that you are completely familiar with the details of these previous reviews,” Rotenberg wrote.

The response was disappointing but not unexpected, said Carl Elliot, one of the eight bioethics professors who signed the initial letter.

“The letters simply repeat what the general counsel’s office has said in the past,” he said.

Leigh Turner, another bioethics professor who signed the letter, said the response simply says “people have looked at this, so there’s nothing left to look at.”

“The point of writing the letter was to suggest that, in fact, there hadn’t been adequate attention paid to what had taken place,” Turner said.