- Associated Press - Monday, March 23, 2015

MINNEAPOLIS (AP) - The University of Minnesota has halted the recruiting of patients for all its psychiatric drug studies until concerns about research oversight are resolved.

The decision follows a critical external review and legislative audit that raised ethics issues in the recruitment and treatment of a patient in a schizophrenia drug study who committed suicide a decade ago.

The length of the suspension and its impact on research is unclear, the Star Tribune (https://strib.mn/1DR70oU ) reported. Fourteen of the studies already are underway, and three are in the pipeline.

Recruitment has been suspended for studies examining drug therapies for autism, depression, substance abuse and schizophrenia, regardless of whether researchers had any connection to the trial in which the patient died.

Examples include Dr. Kathryn Cullen’s study of whether a dietary supplement reduces self-harm behaviors in teens, and the university’s arm of a national, industry-funded trial of an experimental drug for obsessive-compulsive disorder.

Cullen said a colleague was about to enroll four families into a study of therapy and medication approaches to adolescent depression, but now he’ll probably lose them.

“It’s hard enough to get our projects done without hindrances like this. It’s difficult to recruit families,” she told the newspaper. Still, she said she supports the suspension as a step to improving her department’s credibility.

Dr. Brian Herman, the university’s vice president for research, says nothing will change for patients already enrolled in trials. But others will have to wait to participate until an independent review board examines oversight of the studies and determines that they minimize the risk of patient harm.

“We just need to make sure … that the danger to the patient has been minimized and the approach by which the patient consented and was asked to participate in a trial was correct,” Herman said.

On Thursday, a legislative audit found that 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.

The school had a financial incentive to recruit Dan Markingson into the study and its research review board evaluation of Markingson’s 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 had suspended enrollment in drug trials through the psychiatry department and pledged other changes.

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.

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.

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Information from: Star Tribune, https://www.startribune.com


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