University of Minnesota rules out a new probe in 2004 research suicide case involving West St. Paul man

University of Minnesota officials said Monday they will not initiate a new investigation into the 2004 suicide of a West St. Paul man who was enrolled in a controversial medication study at the U.

Last year, a dozen faculty members and a student group at the U called for an investigation into the death of Dan Markingson after reports that the research study in question might have featured a series of ethical violations.

The concerns about the research were first raised in a 2008 series of articles in the Pioneer Press and amplified by an article last year in Mother Jones magazine by Dr. Carl Elliott, a bioethicist at the U.

But in a Monday letter to Elliott and colleagues, the chairman of the U's board of regents wrote "we do not believe further university resources should be expended re-reviewing a matter such as this, which has already received such exhaustive analysis by independent authoritative bodies."

"Our general counsel has provided us with the extensive reviews of this case that were performed over the years by a number of independent experts and governmental units," chairman Clyde Allen Jr. said in the letter. "Each and every one of these reviews resulted in the same conclusion: there was no improper or inappropriate care provided to Mr. Markingson, nor is there evidence of misconduct or violation of applicable laws or regulations."

Markingson was enrolled in a comparative drug trial at the U that was financed by drug maker AstraZeneca. The

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research effort sought to compare the effectiveness of three commonly used antipsychotic drugs.

The Pioneer Press articles detailed how Markingson's mother, Mary Weiss, couldn't get her son removed from the study even as she came to believe his schizophrenia was worsening. Weiss filed a lawsuit accusing Markingson's psychiatrist and the study's director, Dr. Stephen Olson, of forcing him to sign up.

The lawsuit claimed the university kept Markingson enrolled to preserve its research and to keep payments coming from his participation. The U received about $15,000 for Markingson's participation, and the study offered the university a total of $327,000 and a chance to raise the profile of its schizophrenia program.

The U was dismissed from Weiss' lawsuit in February 2008, and Olson settled in April of that year.

The death prompted reviews by the state mental health ombudsman and the U.S. Food and Drug Administration into the conduct of the university and Olson, who was Markingson's only psychiatrist at the time he recruited him into the study. But no oversight agency has blamed either Olson or the U for the death or cited for research violations.

In his Mother Jones magazine article, Elliott added to the debate by suggesting that the study in which Markingson was enrolled was designed primarily to help a drug company market its product — not to answer a genuine scientific question.

But there is no factual basis for that allegation, argued Mark Rotenberg, the U's general counsel, in a separate letter to Elliott and colleagues released Monday. The psychiatry department chairman at Columbia University designed the study, Rotenberg wrote, which was approved by independent review boards at research centers across the country.

Elliott and colleagues questioned the payment structure for the research study because it provided incentives for the U to recruit and retain subjects rather than provide standard therapy. Rotenberg countered that it is common for study budgets to increase or decrease depending on the number of participants.

The faculty members also questioned why the U did not address the concerns of Weiss. Rotenberg argued that caregivers believed Markingson's condition was improving at the time of his suicide.

"His death was a tragic shock," Rotenberg wrote. "Notwithstanding Ms. Weiss' belief, there simply is no evidence that Mr. Markingson's death was causally connected to his participation in the (medication) study."

Elliott said Monday he was disappointed — but not surprised — by the university's response. It's unclear what the next steps might be.

"There is nothing in the response that we did not already know," he said. "The university is just repeating the same things it has said all along."

Christopher Snowbeck can be reached at 651-228-5479.

via twincities.com

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