Drug Study Recruiting at University of Minnesota Questioned
3/6/2013 8:05:10 AM
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.