University of Minnesota defends drug studyMINNEAPOLIS (AP) — University of Minnesota officials say there's no foundation for concerns that its psychiatrists might have "rubber-stamped" vulnerable schizophrenic patients into a drug study.
MINNEAPOLIS (AP) — University of Minnesota officials say there's no foundation for concerns that its psychiatrists might have "rubber-stamped" vulnerable schizophrenic patients into a drug study.
Professor Carl Elliott raised the questions on a blog last month, and posted patient evaluation forms from the files of two mentally ill research subjects that contained responses that appeared to be identical. That raised the specter that the forms had been filled out in advance and that patients weren't actually evaluated for their ability to properly consent to participate.
University General Counsel Mark Rotenberg told the Star Tribune for a story published Thursday (http://bit.ly/WN3Ltf ) that university officials investigated Elliott's claim by reviewing patient records from one of the studies he mentioned, a project called CAFE that compared the effectiveness and side effects of three antipsychotic drugs.
Each patient's folder contained an evaluation form with unique responses and markings, Rotenberg said.
"There is no evidence that any of them contained predetermined, photocopied answers," he said.
It's the latest dispute regarding Dan Markingson, who committed suicide at age 26 in 2004 while participating in the CAFE study. Markingson's mother, Mary Weiss, tried to keep her son out of the trial and questioned whether he was coerced into participating.
The U.S. Food and Drug Administration investigated his death and said it found no evidence of wrongdoing by the university. The school also was dismissed from a lawsuit filed by Markingson's family.
Elliott posted two copies of evaluation records from Markingson's legal file and compared them with an identical record provided by the family of another research subject.
Rotenberg said publicity surrounding the Markingson lawsuit resulted in many records from the case being distributed online, and perhaps that's how the duplicate came to exist.
"The form, in our opinion, is simply another copy of the Markingson 'evaluation to sign consent' form," he said.
Elliott hasn't backed down, and said the university has not allowed him to see the school's evaluation-to-consent records from the CAFE study.
Elliott published an editorial Wednesday on Pharmalot, a blog that analyzes the drug industry, in which he encouraged people to sign a petition asking Gov. Mark Dayton to order an independent investigation of the Markingson case.
The petition, by the Markingson family, has gained more than 1,000 signatures, including those of university faculty, two former editors of the New England Journal of Medicine and more than 100 experts in medicine and bioethics.