No Review Needed of 2004 Suicide, University of Minnesota Says

Despite calls from a group of faculty members for a full investigation, the University of Minnesota has declined to reexamine the death of a young man who committed suicide in 2004 when he was enrolled in a psychiatric drug trial at the school. In December, eight bioethicists wrote a letter to the university's Board of Regents, alleging ethical violations and requesting an external investigation into the death of Daniel Markingson. The U.S. Food and Drug Administration (FDA) had previously conducted an inquiry and cleared the school and the physicians leading the trial.

On Monday, Clyde Allen Jr., chair of the Board of Regents, wrote to the bioethicists that "there was no improper or inappropriate care provided to Mr. Markingson, nor is there evidence of misconduct or violation of applicable laws or regulations." The bioethicists had alleged, among other things, that the study was compromised by financial conflicts of interest and financial incentives to recruit and retain study participants. They also wrote that Markingson, because of his illness, was unable to provide informed consent. In a long note released on Monday, the university's general counsel, Mark Rotenberg, disagreed that Markingson was unable to provide consent and wrote that the consulting fees the lead physicians received from the drug company funding the trial were "properly reported."

These responses are "a risk management exercise," says bioethicist Carl Elliott, who led the faculty protest. He worries that nothing has changed in how Minnesota runs clinical trials and that the oversight system across the country "is almost completely reliant on a kind of self-monitoring" by universities. Investigations by FDA and others, Elliott and his bioethicist colleagues argued, did not tackle many fundamental problems with how the schizophrenia study was run.

Rotenberg did not address this concern directly in his letter, although he did posit that FDA's investigation was "extensive." His stance appears to have hardened in recent weeks. In an interview in December, Rotenberg acknowledged that even if FDA and criminal inquiries "didn't find any malfeasance, ... it may be that we need to review our ethical standards here and either articulate them in a different way or revise them." That does not appear to be happening now, says Elliott, who doesn't know what he'll do next to advocate for the case.