A University of Minnesota ethics professor is asking for an investigation into drug study recruiting at the school and raising questions about whether mentally ill patients have been rubber-stamped into research.
The professor, Carl Elliott, says he has obtained consent documents for two separate schizophrenic patients that appear to be exact copies — not just in the subjects’ apparent replies, but in the positions of the lettering on the pages.
Elliott said it is improbable that separate patients would provide identical responses to the questionnaire, which includes open-ended questions about the risks and requirements of clinical research. And that, he said, raises questions about whether the university was really examining patients to determine their ability to consent to research.
In comments following the publication of this story, the university’s general counsel, Mark Rotenberg, challenged the authenticity of the documents and disagreed that study recruiters failed to obtain proper and independent consent from mentally ill patients.
“I am challenging these allegations directly,” he said. “We have no reason to believe the consent forms were prepared inappropriately.”
Elliott’s allegation revives concerns about patient recruiting tactics that surfaced after the May 2004 suicide of Dan Markingson, who was participating in a drug trial known as CAFE, which compared the effectiveness of antipsychotic drugs.
The university was dismissed from a lawsuit by Markingson’s family and cleared of blame in the suicide by an arm of the U.S. Food and Drug Administration. But Elliott, a professor of bioethics, and others have maintained that the university’s recruitment of Markingson was coercive and a breach of research ethics.
“Judging from this admittedly circumstantial evidence,” Elliott wrote on his blog, “it appears as if someone in the Department of Psychiatry may have been using a generic, photocopied form with predetermined answers as documentation that mentally ill research subjects were competent to consent to research studies.”
One of the evaluation forms Elliott posted was from Markingson’s lawsuit case file. The other came from another family. Elliott said he has heard from more families since his blog post about identical letters in their medical files.
The Star Tribune contacted families who told Elliott they had duplicate letters in their possession, but they declined to comment due to pending investigations of their claims.
Markingson died by suicide in May 2004, while he was participating in the CAFE study despite multiple protests by his mother to the university. She insisted that her son was unstable and needed to withdraw from the study and receive different mental health care and medication.
Since details about the Markingson case were publicized in 2008, Elliott has become a vocal critic of the way the university recruited Markingson into research and responded after his death. After posting his most recent blog, Elliott filed a complaint with the U of M’s research integrity officer, claiming that the duplicate letters show evidence of research misconduct.
He received a reply Tuesday indicating that the university won’t investigate because the alleged misconduct did not occur within the school’s seven-year statute of limitations for such complaints. Elliott said he plans to file a complaint with the FDA Office of Scientific Investigations as well.
While the university officially denied Elliott’s request for an inquiry, Rotenberg said Wednesday night that university officials will retrieve consent records from a storage warehouse in Rosemount and look into the claim. While Rotenberg said the allegation is extremely serious, he doesn’t have any reason to believe that identical, pre-filled forms were used to obtain consent from multiple patients.
The recruiter in the CAFÉ study, Jean Kenney, informed university officials that she didn’t use a single form like that in recruiting. He questioned whether the supposedly duplicate forms were simply all copies of documents from the Markingson legal files, which have been scanned and published online by critics of the university and its handling of the Markingson case.
Shortly after Markingson’s death, his consent to participate in research was reviewed by Dr. Stephen Olson, the psychiatrist in charge of Minnesota’s arm of the national CAFE study. In a May 17, 2004 letter to university oversight officials, Olson said that Markingson “answered the evaluation questions satisfactorily” and was “considered competent to sign the consent.”
At the time Markingson participated in the study, Olson was his primary doctor but also a legal adviser on whether Markingson should be committed, and was the lead researcher for the CAFE study.
As a result of the Markingson case, the Minnesota Legislature has since made it illegal for a psychiatrist to recruit his own patients into his own clinical trials.
Since Markingon’s suicide, the only person publicly sanctioned in the case was Jean Kenney, the former U of M social worker who worked under Olson and recruited patients into his clinical trials. While not disciplined, Kenney agreed last November with the Minnesota Board of Social Work to complete additional training due to recordkeeping errors she made in Markingson’s care. The board also accused her of making clinical judgments about Markingson’s response to medication that were beyond her training as a social worker and of failing to adequately respond to the concerns of Markingson’s family.