Minnesota’s legislative auditor will review psychiatric research practices at the University of Minnesota following controversy over the death of a schizophrenic patient in a drug trial 10 years ago.
While he has declined to investigate the death in the past, Legislative Auditor James Nobles said Wednesday that he is launching a “preliminary review” of the U’s conduct in psychiatric research overall and in the so-called CAFE drug trial in which Dan Markingson was enrolled when he died by suicide in May 2004.
Calls for independent investigations of the Markingson case have come in recent months from Minnesota lawmakers, former Gov. Arne Carlson, the Public Citizen advocacy group, and in a petition signed by some of the nation’s foremost medical researchers and ethicists.
“The issue with them is that [university officials] haven’t been as open as people expect them to be,” Nobles said Wednesday.
Nobles sent a request to university President Eric Kaler Tuesday asking for copies of all reports of “adverse events” that have occurred in psychiatric research studies since January 2004.
Markingson’s recruitment into the CAFE study, which was funded by drugmaker AstraZeneca to compare the effectiveness of three antipsychotic drugs, has fueled concerns even a decade after he died at age 26. Critics have accused Dr. Stephen Olson, the U psychiatrist who led the study, of having coercive power because he was recruiting Markingson into the drug trial at the same time that he was recommending to a court whether or not Markingson should be committed to a psychiatric hospital.
Olson has denied wrongdoing, and a 2005 review by the U.S. Food and Drug Administration did not fault him or the university. But Minnesota lawmakers have since enacted a law that prevents a psychiatrist from recruiting his own patients into a research study when they are subject to commitment orders.
Olson’s dual role had also been questioned by the state’s mental health ombudsman in a report, but Markingson’s death didn’t become a public controversy until a 2008 newspaper report and subsequent articles and advocacy efforts by Carl Elliott, a U bioethics professor.
Earlier this year, the university’s Faculty Senate voted to fund an independent review of psychiatric research practices at the U — arguing that the university’s academic reputation has suffered from lingering questions about the Markingson case.
Kaler has endorsed that review, which will be general in nature and won’t focus on the Markingson case.
University officials have defended the psychiatry department in the Markingson case, noting that prior government reviews did not fault the institution or its doctors. The university also was dismissed from a lawsuit filed by Markingson’s family.
Nobles said he plans to examine the adverse event reports from psychiatric research over the past decade and any information from the contractor that has been hired to conduct the Faculty Senate review before deciding whether to proceed with his own full inquiry.
“I certainly hope I can be helpful in resolving” the controversy, he said.
The only official penalty stemming from the Markingson case and the CAFE trial came last December, when the Minnesota Board of Social Work sanctioned a social worker for exceeding the scope of her training by assessing patients in the CAFE trial for the severity of side effects and by dispensing prescription drugs. The sanction also mentioned her failure to respond to family concerns in a timely manner — a reference to the letters Markingson’s mother sent, pleading for her son to be removed from the study because his condition wasn’t improving.
“Do we have to wait for him to kill himself or someone else before anyone does anything?” his mother wrote.
Last month, friends and relatives remembered Markingson on the 10 year anniversary of his death, and held a demonstration on campus calling for the U to be more accountable about the handling of his case.
Mike Howard, a longtime friend of Markingson’s mother, Mary Weiss, said the passage of time hasn’t lessened the family’s desire for answers.
“Ten years?” he said. “I guess if was 20 years, you still keep fighting.”