Officials say mentally ill research subjects were screened carefully.
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.
“Never in my life,” Elliott said, “have I felt the kind of shame that I feel at the way my university has treated Mary Weiss.”
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. That family has asked to remain anonymous.
Rotenberg said publicity surrounding the Markingson lawsuit resulted in many records from the case being distributed online, and perhaps that is how the duplicate came to exist with another family.
“The form, in our opinion, is simply another copy of the Markingson ‘evaluation to sign consent’ form,” he said Wednesday.
Rotenberg said that families who believe they have questionable documents from the CAFE research should come forward with them.
“We absolutely want to see them and investigate,” he said.
Petition seeks inquiry
The university’s response has not caused Elliott to back off his criticism; he said he has asked to see the university’s evaluation-to-consent records from the CAFE study for himself but so far has not been allowed to do so.
On Wednesday, an editorial from Elliott was published 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.