Auditor: 'Serious ethical issues' at U of M over trial patient's suicide - Bring Me The News

Auditor: 'Serious ethical issues' at U of M over trial patient's suicide

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The University of Minnesota has suspended enrollment in its psychiatric trials after being criticized in a report by the state's legislative auditor into the suicide of Dan Markingson in 2004.

Auditor Jim Nobles said the death of Markingson while he was enrolled in an anti-psychotic drug trial at the U identified "serious ethical issues and numerous conflicts of interest."

In a special report released Thursday, Nobles also accused the U of making "misleading and inaccurate statements" about past reviews of the case, and criticized previous comments dismissing the need for further investigation.

"This insular and inaccurate response has seriously harmed the University of Minnesota’s credibility and reputation," he concluded.

In a letter of response, president Eric Kaler said the university would be "suspending enrollment in all Department of Psychiatry interventional drug studies currently active or awaiting approval," until they have been reviewed by an independent review board.

It will also be reviewing its practices and formulating a plan of action to improve its human subjects research procedures.

"Before all else, 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. The loss of Dan Markingson’s life was a terrible tragedy," Kaler said in a news release Thursday afternoon.

The Markingson case

Markingson, a 27-year-old who suffered from schizophrenia, took his own life in May 2004 while participating in a university clinical drug study funded by pharmaceuticals giant AstraZeneca.

His mother, Mary Weiss, lost in a lawsuit against the university in 2007, but did receive a $75,000 settlement from his treating physician, Dr. Stephen Olson, after she filed a medical malpractice claim for failing to provide her son with "proper care and treatment."

Nobles said it is not possible to know whether Markingson's suicide could be connected to his participation in the trial, but was heavily critical of the U's response to the case, and its unwillingness to acknowledge the ethical issues and conflicts it raised.

In response, the university said it had not been alerted to ethical breaches, but admitted that "some of our practices have not been beyond reproach."

"We are sorry that, in particular related to the case of Mr. Markingson, our response has come across as defensive," Kaler added in his letter. "We want to assure you that our only intent has been to be factual in our responses."

The Star Tribune said Nobles' findings are the "strongest corroboration by a government agency of criticisms raised by Markingson's family."

The newspaper notes it comes two weeks after an independent review by the university's Faculty Senate found "lapses in the protection of clinical subjects" and identified "weak patient protections" within the psychiatry department.

Findings in the report

The Pioneer Press reports Markingson was under an involuntary court order for treatment, and that he was a patient of U psychiatrist Dr. Olson when he was enrolled in the trial. This led to Minnesota lawmakers, in 2009, barring researchers from recruiting their own patients into clinical trials.

The report described Markingson as being "extraordinarily vulnerable" when he was recruited into the study, and faced being committed to a state psychiatric hospital if he failed to cooperate with a treatment plan set out by Fairview University Medical Center.

It also notes that there is "little evidence" the U's study team followed up on Weiss' warnings her son was not improving during the trial.

It states that Dr. Olson had "inappropriately delegated" tasks to study coordinator Jean Kenney, who was later found to have performed tasks "beyond her competency and made significant errors."

Nobles also found an independent consultant brought in to investigate a complaint by Weiss to the Minnesota Board of Medical Practice had several conflicts of interests, including being a member of the University's independent Institutional Review Board when it approved Dr. Olson's drug trial in which Markingson participated.

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