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Faculty Senate votes for inquiry into U’s clinical-trial practices

The vote was in response to a letter sent to the university’s Faculty Senate and president from scholars in bioethics, health law and biomedical research.

University of Minnesota Faculty Senate voted 67-to-23 on Thursday to create an independent panel of experts.
MinnPost photo by Susan Perry

The University of Minnesota Faculty Senate voted overwhelmingly on Thursday to create an independent panel of experts to conduct an inquiry into how the university runs its clinical trials involving human subjects.

The 67-to-23 vote was in direct response to a letter sent to the Faculty Senate and U of M President Eric Kaler in October from more than 170 leading academic scholars in bioethics, health law and biomedical research.

The letter had asked the Faculty Senate “to take the moral responsibility of a public institution seriously, and to explicitly endorse and request the establishment of a fully independent, transparent, and detailed inquiry” into the death of Dan Markingson, a mentally ill young man from St. Paul who committed suicide in 2004 while enrolled in a drug-company-sponsored U of M clinical trial of a psychiatric drug.

Many questions about Markingson’s case, particularly how he was recruited into the study and whether he was mentally competent to give consent, have remained unresolved.

University is ‘under a cloud’

Most faculty members who rose to speak in support of the independent inquiry at Thursday’s meeting commented on how those unresolved questions  — and the university’s handling of them — has jeopardized the reputation of the university.

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One of those speakers was Naomi Scheman, professor of philosophy and gender, women and sexuality studies. “A significant number of highly credible, fair-minded, prominent people in the field of research ethics have raised doubts about the way some research is conducted at the University of Minnesota,” she told her colleagues.

“We are all of us under this cloud,” she added, “and this cloud needs to be removed. Only a credible investigation into what happened in [the Markingson] case and as well as into continuing policies and procedures will remove that.”

Among the faculty members who rose to speak against the resolution was Dr. Susan Berry, a professor of pediatrics and chair of the executive panel of the U of M’s institutional review board (IRB), which is responsible for reviewing research projects that involve human subjects.

“We should not have anything to fear about any kind of investigation,” she said.

But the U of M’s IRB, she added, already participates in rigorous and ongoing evaluation of its actions and procedures.

‘I did not coerce Dan’

Dr. Stephen Olson, the U of M psychiatrist who oversaw the clinical trial in which Markingson was enrolled (and who eventually settled a malpractice suit brought by Markingson’s mother for $75,000), also spoke at the meeting. He made a rare public defense of his actions in the case.

“I want to say that this whole thing has been an ordeal for me personally,” he said. “I feel badly about the death of Dan Markingson. It was a tragedy. But cancer patients die in cancer studies all the time, and it’s not a surprise that people with mental illness will die in a trial of mental illness.”

Olson then claimed that the 170-plus academic signators of the letter to the Faculty Senate have been misled by “distortions and mistruths.”

“I did not coerce Dan into the study,” said Olson. “I did not threaten him with being sent to the state hospital. I did not ignore his mother’s complaints that he was getting worse. There were many other clinicians involved in his care.”

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“The reason that we haven’t been able to defended ourselves,” he added, “is that the university lawyers have said that we, as a university, and I, personally, can be sued for violating Mr. Markingson’s privacy by disclosing the details of his care.”

‘A tremendous first step’

Mary Weiss, Markingson’s mother, was unable to attend Thursday’s Faculty Senate meeting because she is recuperating from a recent stroke. But Mike Howard, a close family friend, said after the meeting that Weiss has always agreed to the full release of her son’s medical records.

“That’s absolutely not a problem,” he said.

Howard said he was “overwhelmed” Thursday by the faculty’s strong support for the resolution. “It was a tremendous first step,” he said.  “It restores some faith that there is some integrity here.”

Earlier on Thursday, Howard delivered a petition with almost 3,500 signatures, including more than 200 academic experts in bioethics, medical research, psychiatry and health law, to Gov. Mark Dayton’s office. The petition asks the governor to appoint an independent panel of experts in research ethics to investigate the death of Dan Markingson and other possible research misconduct in the U of M’s department of psychiatry.