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Associated Press, Published March 21 2013

University of Minnesota defends drug study

MINNEAPOLIS – 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 said 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.


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