Minnesota Bioethicists Critique Their University

Eight bioethicists at the University of Minnesota are charging that their own institution has committed an "alarming series of ethical violations" in a clinical trial where a young man committed suicide in 2004. The eight, who include roughly half of the university's bioethics core faculty members, yesterday released a letter to the university's Board of Regents, asking the board to set up an external investigation into the death of Daniel Markingson. He committed suicide violently while enrolled in a trial of antipsychotic medications through the university's psychiatry department. The letter alleges that his death wasn't adequately investigated earlier.

"Bioethicists should not ignore disaster in their own backyard," says Mary Faith Marshall, one of the signers. Marshall came to the University of Minnesota in 2005 after serving in the federal bioethics policy arena. Among other things, she chaired a committee investigating the 1999 death of 19-year-old Jesse Gelsinger in a gene therapy experiment at the University of Pennsylvania.

The bioethicists' letter was spearheaded by Carl Elliott, a tenured faculty member in the department who studies conflicts of interest in the pharmaceutical industry. Elliott wrote a scathing article about the case in Mother Jones magazine this fall. As he documented there, Markingson was enrolled in a clinical trial while severely mentally ill and against his mother's wishes; he also alleges that the university's psychiatry department stood to gain financially by enrolling and retaining him in the trial. In an investigation after Markingson's death, the U.S. Food and Drug Administration cleared the university of any misconduct and said there was no evidence that Markingson could not voluntarily consent to the study.

That hasn't assuaged Elliott. "For me the main motivation is personal shame. I just feel embarrassed to work at a university that would treat human subjects and their families this way," he says.

After Elliott began speaking out about the case in the fall, the university's general counsel, Mark Rotenberg, released a statement arguing the university's side of the story. Markingson's death was reviewed to varying degrees by outside investigators, he noted. "None found fault with the involved faculty, and none found any causal link" between the study and Markingson's suicide.

But the eight bioethicists wrote in their letter to the university that the Mother Jones piece and a 2008 series in a local newspaper, the Pioneer Press, "raise troubling questions that to date have not been addressed in the University's response to the death of Mr. Markingson."

Asked whether the university had a response to the letter, spokesperson Daniel Wolter wrote in an email: "There isn't any additional statement at this point as there isn't really anything new beyond Professor Elliott repackaging his position in new and different formats." The university's general counsel was not available to discuss the case before ScienceInsider's deadline.

After hearing Wolter's comment, Marshall said: "I still say, when a research subject dies in one of your studies, the public and the private message should be, 'We are really sorry about this and we are going to do whatever we can do to make sure this never happens again.' "