Eight professors from the University of Minnesota’s 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 “impartial panel of experts.”
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 Markingson’s mother over her son’s death.
However, bioethics professor Carl Elliot, who wrote an article on the case for Mother Jones magazine in September, said he believes the University’s response was insufficient and the incident warrants further investigation.
“It looks as if some very serious ethical problems occurred in this [clinical] trial and we’d like the University to look into that,” Elliott said.
He signed the letter to the regents along with more than half of the Bioethics Center’s listed “core faculty.” The letter lists “large financial conflicts of interest on the part of the University researchers conducting the study” and states that the University failed to respond to Markingson’s mother’s attempts to remove her son from the study, and to warnings that he was suicidal.
Elliott said Markingson was admitted to Fairview under “a stay of commitment,” 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 “psychotic, delusional and incompetent to consent to medical procedures,” 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 “the ongoing controversy over conflicts of interest in the Academic Health Center.”
The AHC would not comment on the letter, but spokesman Justin Paquette said the case has been reviewed multiple times and “none found fault with the University, none found fault with the involved faculty.”
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.
“I feel that the system let Dan Markingson down,” she said. “He was not as protected as he should have been — as any research subject should have been.”
Marshall said the Office for Human Research Protections was asked to look at the Markingson case but didn’t feel it had purview in the case, because it was not a federally funded research project.
“I would hope that we can ensure that we have a system that would prevent something like this from happening again,” she said.
Elliott said the letter is meant to only focus on the particular case, and any other follow-up would depend on the panel’s findings. He could not speculate on the regents’ reaction to the letter.
“It’s not actually clear that the Board [of Regents] is aware of this case,” he said.
Matt McGeachy, a student representative to the Board of Regents, said the case would have been handled by the board’s 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 “stylistic concerns” which were not fully explained.
He was told his report didn’t reflect the “student voice.”
McGeachy thinks Markingson’s story is significant.
“It’s not just the legal conduct of the University, but it’s the ethical conduct of the University that matters very deeply to students and the faculty alike,” he said.
General Counsel Mark Rotenberg said he will be discussing the case and the letter with the board and Bruininks tomorrow.
“We are going to carefully review the letter and respond to it, respectfully, in the near future,” he said.