1 Boring Old Man

U faculty calls for review of controversial drug study

Star Tribune

by JEREMY OLSON

December 5, 2013

Nearly a decade after Dan Markingson died by suicide while participating in a U of M drug trial for schizophrenics, the U’s Faculty Senate raised his death as a reason to re-examine their institution’s handling of vulnerable research subjects. At a meeting Thursday, the senate voted 67-23 to ask the university for a review of how the university recruits and protects people in clinical trials. Questions have emerged in recent years about whether U psychiatry researchers coerced the young, delusional Markingson into a drug study that he didn’t fully understand and his mother didn’t want for him. Most recently, a petition by more than 180 leading researchers and ethicists asked the university to review its conduct.

“These are not random cranks out there,” said Karen-Sue Taussig, a Faculty Senate member and liberal arts professor. “These are people who are really quite eminent in their field.” Faculty members at Thursday’s meeting expressed different views on the issue — some questioning whether the U put research goals ahead of Markingson, who died at age 26, and others believing the institution did everything it could to protect him. The psychiatrist who treated and recruited Markingson to the so-called CAFE study, which was funded by drugmaker AstraZeneca to compare three antipsychotic drugs, even made a rare public defense of his research.

But most faculty members agreed that the university’s credibility in the research world has been damaged by a decade of unresolved questions over Markingson’s death, and that an independent, external review could help rebuild its reputation. “We are all of us under this cloud and this cloud needs to be removed,” said Naomi Scheman, a philosophy professor and Faculty Senate member.

Whether the vote called for a broad look only at the university’s research practices, or a specific examination of the Markingson case, was a matter of dispute after the vote. U bioethicist Carl Elliott, who has been a leading critic of the university’s conduct in the study, said it will have to address Markingson’s death in some meaningful way. “If anyone wants this investigation to clear the name of the university — as a lot of people said they do — then it will have to deal with Dan,” he said. After Markingson’s death at a halfway house in May 2004, a review by the U.S. Food and Drug Administration found no wrongdoing by the university.

However, the state mental health ombudsman did raise concerns that Markingson was recruited by a psychiatrist, Dr. Stephen Olson, who also could advise a judge on whether his patient should be committed to a state mental health hospital. And state legislation has since outlawed doctors from recruiting their own patients into psychiatric drug studies because of that risk of coercion. Olson told the Faculty Senate that he felt badly for the loss of Markingson but that he did not coerce him into the study and that the call for an investigation was prompted by mistruths. “Cancer patients die in cancer studies all the time,” he said, “and it’s not a surprise that people with mental illness will die in a trial of mental illness.”