Audit: Serious ethical issues in drug trial suicide


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ST. PAUL, Minn. (AP) — University of Minnesota leaders have consistently ignored conflicts of interest and other ethical issues surrounding the suicide of a schizophrenic man enrolled in a drug trial through the school, according to a legislative audit Thursday that spurred immediate action from the university.

The school had a financial incentive to recruit Dan Markingson into the study and its research review board evaluation of Markingson's violent 2004 suicide was superficial, the audit found. In a legislative hearing that followed the audit release, University of Minnesota President Eric Kaler told lawmakers the school has already suspended enrollment in drug trials through its psychiatry department. He pledged other changes.

Markingson enrolled in a study at the university comparing the effectiveness of antipyschotic drugs over protests from his mother, who repeatedly asked researchers to remove him once it began. The study's lead researcher was also Markingson's psychiatrist, an arrangement later banned by lawmakers.

Markingson killed himself in May 2004, six months after enrolling in the study. That triggered years of accusations he was coerced into the study and that the school ignored questions about his death.

Dr. Stephen Olson, Markingson's psychiatrist, still works at the university as an associate professor of psychiatry. He told lawmakers Thursday that Markingson said several times he was aware he had other treatment options.

"He wanted to be in the study," Olson told the Senate Higher Education and Workforce Development Committee. "He thought he was getting good care."

It's impossible to know whether the suicide of Markingson was a result of his participation in the study, the Office of the Legislative Auditor said in its report. But school administrators and members of its governing board have repeatedly misrepresented past reviews of the case and dismissed the need for further investigation, according to the report.

"This insular and inaccurate response has seriously harmed the University of Minnesota's credibility and reputation," the report said.

An external review released last month found the school's human research program was strong in some areas but weak in others, including a lack of expertise on the medical research board that evaluates projects.

Kaler said the school is creating a team to carry out the recommendations in that previous review, which include adding members to that board and spending more money on training. The university will also appoint a community oversight board to make sure the school's human subject practices meet best standards, the president told lawmakers.

"We take these findings seriously, and we are prepared to address them and move forward as an improved research university," he said of the two reviews.

The audit suggests the Legislature suspend all psychiatric drug trials at the school until it enacts the recommendations. It also says the state mental health ombudsman should be given funding and authority to monitor such studies at the university.

Markingson's mother, Mary Weiss, has suffered strokes and is seriously disabled partly due to the stress of advocating for her late son, family friend Mike Howard wrote in a letter to the auditor's office.

"Nothing is going to change anything for Dan Markingson," Howard said at the Senate hearing. "But hopefully what Mr. Nobles' report will do will ... change things for people in the future."

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