The University of Minnesota has halted patient enrollment in all psychiatric drug studies after a state report criticized the school’s handling of a suicide during a clinical trial in 2004. The report, released last Thursday by Minnesota’s Office of the Legislative Auditor, says the university’s reaction to both the death of 27-year-old Dan Markingson and subsequent calls for investigation have “seriously harmed” its credibility and reputation. The report also argues that the Markingson case “raises serious ethical issues and numerous conflicts of interest, which University leaders have been consistently unwilling to acknowledge.” Markingson had been enrolled in a trial for antipsychotic drugs while committed involuntarily to a university hospital. One of the trial leaders was his treating psychiatrist.
The university’s president, Eric Kaler, announced that his school would suspend enrollment in current and upcoming drug studies in the Department of Psychiatry until they could be reviewed by an outside institutional review board (IRB). The school’s IRB came under fire last month after a separate review suggested the panel was not examining trials as closely as it should be.
Although the two reports are very different, their authors express at least one overlapping worry: that the school has not responded well to criticism. In the words of the 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. However, we do not have a recommendation that would change attitudes. … We can only suggest that the Legislature make the issue—and need for change—a more important consideration in selecting people to serve on the University Board of Regents.” The report recommends that the state legislature enact new laws that would allow the legislature to more closely monitor participation in psychiatric drug studies at the university.
The Board of Regents will meet this Friday to discuss the report.