U rejects profs’ call for trial review

Professors say there was a conflict of interest in the drug study that led to a suicide.

by Kyle Potter

The University of MinnesotaâÄôs Board of Regents and General Counsel on Monday dismissed eight professorsâÄô 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 âÄúan alarming series of ethical violations and lapsesâÄù that contributed to Dan MarkingsonâÄôs death.
In the boardâÄôs response to that letter sent Monday, regents Chairman Clyde Allen cited the results from investigations into the incident by the UniversityâÄôs Institutional Review Board and the U.S. Food and Drug Administration as well as the Minnesota Board of Medical Practice. The investigations found âÄúno evidence of misconduct or violation.âÄù
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.
MarkingsonâÄôs 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 UniversityâÄôs IRB and the FDA subsequently cleared the University in the case. MarkingsonâÄôs mother, Mary Weiss, filed a suit against the University in the Hennepin County District Court that was eventually dismissed.
In the regentsâÄô response, Allen wrote âÄúat this time âĦ 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.âÄù
General Counsel Mark Rotenberg dismissed all seven allegations the bioethicists made in their letter to the board.
âÄúIt is not clear from your letter that you are completely familiar with the details of these previous reviews,âÄù Rotenberg wrote.
The response was disappointing but not unexpected, said Carl Elliot, one of the eight bioethics professors who signed the initial letter.
âÄúThe letters simply repeat what the general counselâÄôs office has said in the past,âÄù he said.
Leigh Turner, another bioethics professor who signed the letter, said the response simply says âÄúpeople have looked at this, so thereâÄôs nothing left to look at.âÄù
âÄúThe point of writing the letter was to suggest that, in fact, there hadnâÄôt been adequate attention paid to what had taken place,âÄù Turner said.