Eight professors from the University of MinnesotaâÄôs Center of Bioethics sent a letter to the Board of Regents on Monday requesting an investigation into the suicide of a former clinical trial patient by an outside âÄúimpartial panel of experts.âÄù
The patient, Dan Markingson, was committed to the psychiatric wing of University of Minnesota Medical Center, Fairview in 2003 and entered into a clinical trial for an anti-psychotic drug. He committed suicide a year later. The incident was largely exposed by the St. Paul Pioneer Press and, some believe, implicates University researchers in ethical lapses.
The incident was investigated and cleared by an internal review board and the FDA. The Hennepin County District Court dismissed a lawsuit against the University by MarkingsonâÄôs mother over her sonâÄôs death.
However, bioethics professor Carl Elliot, who wrote an article on the case for Mother Jones magazine in September, said he believes the UniversityâÄôs response was insufficient and the incident warrants further investigation.
âÄúIt looks as if some very serious ethical problems occurred in this [clinical] trial and weâÄôd like the University to look into that,âÄù Elliott said.
He signed the letter to the regents along with more than half of the Bioethics CenterâÄôs listed âÄúcore faculty.âÄù The letter lists âÄúlarge financial conflicts of interest on the part of the University researchers conducting the studyâÄù and states that the University failed to respond to MarkingsonâÄôs motherâÄôs attempts to remove her son from the study, and to warnings that he was suicidal.
Elliott said Markingson was admitted to Fairview under âÄúa stay of commitment,âÄù which meant the court could enforce involuntary commitment if Markingson refused to participate in a treatment plan. Markingson signed up for an experimental plan suggested by his doctor after being initially diagnosed as âÄúpsychotic, delusional and incompetent to consent to medical procedures,âÄù Elliott said.
Six months later Markingson stabbed himself to death.
The faculty letter questions the objectivity of the clinical trial, and calls for outside review due to âÄúthe ongoing controversy over conflicts of interest in the Academic Health Center.âÄù
The AHC would not comment on the letter, but spokesman Justin Paquette said the case has been reviewed multiple times and âÄúnone found fault with the University, none found fault with the involved faculty.âÄù
Professor Mary Faith Marshall also signed the letter. Marshall was a chairwoman of the now defunct National Human Research Protections Advisory Committee. She said the issue needs to be examined on a federal level.
âÄúI feel that the system let Dan Markingson down,âÄù she said. âÄúHe was not as protected as he should have been âÄî as any research subject should have been.âÄù
Marshall said the Office for Human Research Protections was asked to look at the Markingson case but didnâÄôt feel it had purview in the case, because it was not a federally funded research project.
âÄúI would hope that we can ensure that we have a system that would prevent something like this from happening again,âÄù she said.
Elliott said the letter is meant to only focus on the particular case, and any other follow-up would depend on the panelâÄôs findings. He could not speculate on the regentsâÄô reaction to the letter.
âÄúItâÄôs not actually clear that the Board [of Regents] is aware of this case,âÄù he said.
Matt McGeachy, a student representative to the Board of Regents, said the case would have been handled by the boardâÄôs Litigation Review Committee, and at least some of the regents would be familiar with it.
McGeachy mentioned the case, along with the Troubled Waters film controversy, in a draft of his student representative report, which he was going to present to the board. But the Regents office asked him to edit out the entire section on conflicts of interest due to âÄústylistic concernsâÄù which were not fully explained.
He was told his report didnâÄôt reflect the âÄústudent voice.âÄù
McGeachy thinks MarkingsonâÄôs story is significant.
âÄúItâÄôs not just the legal conduct of the University, but itâÄôs the ethical conduct of the University that matters very deeply to students and the faculty alike,âÄù he said.
General Counsel Mark Rotenberg said he will be discussing the case and the letter with the board and Bruininks tomorrow.
âÄúWe are going to carefully review the letter and respond to it, respectfully, in the near future,âÄù he said.