University of Minnesota officials have investigated a concern raised by a bioethics professor — that U psychiatrists might have "rubber-stamped" vulnerable schizophrenic patients into drug studies — and concluded it is "completely false."
In a blog last month, professor Carl Elliott 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 wherewithal to consent to the risks and responsibilities of clinical research.
On Wednesday, university officials said they investigated Elliott's claim by reviewing all the "evaluation to sign consent" records from one of the studies he mentioned — a project called CAFE, which compared the effectiveness and side effects of three antipsychotic drugs.
Each patient's folder contained an evaluation form with unique responses and markings, said Mark Rotenberg, the university's general counsel.
"There is no evidence that any of them contained predetermined, photocopied answers," Rotenberg said.
The dispute over consent evaluation records is the latest regarding Dan Markingson, who died by 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.
An investigation by the U.S. Food and Drug Administration after Markingson's death found no evidence of wrongdoing by the university, which also was dismissed from a lawsuit filed by Markingson's family. The recruiting of Markingson did draw concerns from Minnesota's mental health ombudsman, though, and resulted in legislation that prevents doctors from recruiting their own patients into their psychiatric drug studies.
The case also drew the attention of Elliott, who has since become an outspoken critic of his own university.
