State audit finds ethical issues in drug trial suicide

Report prompts University to immediately suspend enrollment in active and pending psychiatric drug trials.

by Christopher Aadland

The University of Minnesota has halted enrollment in all psychiatric drug studies after a state legislative audit criticized its research ethics.

The report released by the Office of the Legislative Auditor Thursday, looked into the 2004 suicide of Dan Markingson, who was enrolled in an antipsychotic drug study at the University when he died. The report also found “serious ethical issues and numerous conflicts of interest,” which the report said University leaders and officials refused to acknowledge.  

While the report said the University failed to appropriately protect Markingson, it wasn’t possible say whether Markingson’s suicide was related to his involvement in the school’s drug trial.  

The report also criticized the University for using misleading statements about past investigations and faulted administrators and the Board of Regents for ignoring calls for further reviews.

“This insular and inaccurate response has seriously harmed the University of Minnesota’s credibility and reputation,” the report said.

More than a decade of scrutiny over the University’s clinical research has followed since Markingson’s suicide. Last month, a separate external report managed by the Association for the Accreditation of Human Research Protection Programs, Inc., found “significant problems” with the University’s human subjects research program.

The legislative auditor’s review, along with the external report, was presented in front of the Senate Higher Education and Workforce Development Committee Thursday, where school leaders and officials fielded questions from state lawmakers.

“We’re here 11 years later because we didn’t have a good investigation up front,” Sen. Eric Pratt, R-Prior Lake, said Thursday. “You can’t have an ethical program unless you have ethical people.”

The legislative auditor’s report also made some recommendations, including legislation to require the University to fully implement the external review panel’s recommendations before psychiatric drug trials could continue at the school, and to provide the state Office of the Ombudsman for Mental Health and Developmental Disabilities with funds to monitor the University’s psychiatric drug studies.

“We will, before the session ends, reconvene this group,” Sen. Terri Bonoff, DFL-Minnetonka, said Thursday. “I’m sure you’ll see some legislative proposal come forward as a result.”

After the release of Thursday’s report, the University announced the suspension of enrollment in its psychiatric trials. Other steps include forming a community oversight board made up of experts in research ethics and developing a “plan of action” by May 15 to implement recommendations from the AAHRPP review.

“I want to express our deepest sympathy to Dan Markingson’s mother, Mary Weiss, and apologize to her for his death while he was under our care,” said University President Eric Kaler in a statement. “While we strive to be the very best, it is clear that we can do better.”