A state board has issued “corrective action” against the University of Minnesota study coordinator in a 2003 research trial that led to the suicide of participant Dan Markingson.
The report is the first official action to allege any wrongdoing since the suicide, which bioethicists have said may have been a result of ethical lapses. They still say the corrective actions are not enough.
The Minnesota Board of Social Work said Jean Kenney made repeated errors in documentation, performed tasks beyond her expertise and didn’t adequately address family concerns over the treatment of Markingson, who committed suicide during the study.
Critics say Markingson was coerced into the study and that he didn’t give completely informed consent.
Markingson was involuntarily committed to the University of Minnesota Medical Center, Fairview psychiatric ward in 2003. He was then entered into a University of Minnesota anti-psychotic drug research trial funded by AstraZeneca.
Six months after joining the study, he stabbed himself to death. He was 26.
Mike Howard, a close friend to Markingson’s mother, Mary Weiss, filed the initial complaint against Kenney in early 2009 with the Minnesota Board of Social Work.
The board hired an independent investigator to look into the complaints, Howard said.
“It’s a hard document to make sense of,” said University bioethics professor Carl Elliott. “On one hand it outlines a fair amount of wrongdoing, but on the other hand there’s no punishment of any significance for Kenney. The really serious wrongdoing in the Markingson case isn’t really addressed in [the report].”
Howard added that the report may be the end of Kenney’s involvement with the case but that he anticipates further action regarding others involved.
“I think [Kenney] was a pawn,” Howard said. “She did what she was told.”
Kenney’s job was to recruit patients for the study, called “Comparison of Atypicals for First-Episode of Psychosis,” as well as to collect data from those enrolled.
The board found that Kenney routinely performed tasks beyond her level of expertise and competence. She made numerous errors in notes, like writing “hyperthyroidism” instead of “hypothyroidism” and listing the wrong dosage of Markingson’s medication.
Once Kenney made an error, it would be repeated throughout the study.
The board also says Kenney went back to the records after Markingson’s suicide to fix some of her errors.
David Alsop, who represented Kenney, said “some of her documentation was not the best” but denied that those errors affected Markingson’s care or caused his suicide.
Alsop said Kenney doesn’t want to comment directly to the media.
As demanded by the board, Kenney will complete 18 hours of continuing education and three hours of consultation and write up a report on what she learned for the board.
If Kenney completes the assigned tasks, the board will close the investigation.
“There’s no more action,” Alsop said. “This is the end of it.”
The board also found problems with the CAFÉ study as a whole.
“Despite the large amount of data gathered” in the study, there did not seem to be an analysis of the data, including in the treatment planning process, according to the document.
The record also links the problems to Markingson’s suicide.
“There were critical omissions in [Kenney’s] documentation that were relevant to suicide prevention” the board investigation found.
The corrective action comes after years of calls for further investigation into the ethics behind the study. But multiple internal and external investigations found no wrongdoing by the University, and it has defended those involved in the study since the start.
In late 2010, eight University professors sent a letter to the Board of Regents seeking external review of what they said was “an alarming series of ethical violations and lapses” leading to Markingson’s death.
Regents denied the request, citing investigations by the University’s Institutional Review Board, the Food and Drug Administration and the Minnesota Board of Medical Practice that all found no evidence of misconduct.
Elliott was one of the professors in the letter.
“The University of Minnesota Department of Psychiatry was complicit in manipulating research results for AstraZeneca, and it looks very likely that the CAFÉ study was part of that manipulation,” Elliott said.
Vice President for Health Sciences Aaron Friedman, defended the University’s involvement with research funded by industry, saying in a letter to Academic Health Center employees, “it’s our job to ensure that knowledge becomes widely available,” according to a 2011 email.
In a statement responding to the board’s corrective action, University General Counsel Mark Rotenberg said Kenney is no longer an employee at the University. He referenced the investigations that found no wrongdoing on behalf of the University.
“Most importantly, none found any causal link between the CAFÉ trial and the death of Mr. Markingson,” he said.
Howard said the University is in denial.
“That’s how the U does things,” he said. “It’s deny, deny, deny.”
The report is “the first part of recovering” for those who were close to Markingson, Howard said.
In the weeks leading up to Markingson’s suicide, his mother wrote letters to Charles Schulz, head of the University’s Department of Psychiatry. She expressed concern with her son’s involvement in the CAFÉ studies and the care he received from psychiatrist Stephen Olson, who also was a co-investigator in the study. She asked if Schulz would feel comfortable if his own son were in Markingson’s position.
In his response, Schulz wrote, “I would be very interested in my son receiving treatment in a well organized treatment trial that has been run by such effective staff as Dr. Olson and Jeannie Kenney.”