Drug study recruiting at U of M questioned
Star Tribune: Minneapolis, MN
by JEREMY OLSON
February 28, 2013A 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.
The university was dismissed from a lawsuit by Markingson’s family and cleared of blame in the suicide by an arm of the U.S. Food and Drug Administration. But Elliott, a professor of bioethics, and others have maintained that the university’s recruitment of Markingson was coercive and a breach of research ethics. “Judging from this admittedly circumstantial evidence,” Elliott wrote on his blog, “it appears as if someone in the Department of Psychiatry may have been using a generic, photocopied form with predetermined answers as documentation that mentally ill research subjects were competent to consent to research studies.” One of the evaluation forms Elliott posted was from Markingson’s lawsuit case file. The other came from another family. Elliott said he has heard from more families since his blog post about identical letters in their medical files…
Mickey,
I can appreciate your sentiments on this.
The drug companies misled doctors.
No question about that.
But is it not the responsibility of *prescribers* to weed through what was obviously hype and propaganda?
Why did so many doctors fall for the lines of recent college grads (many of whom have little or no medical training or knowledge) – with their drug samples, glossy marketing brochures and free lunches… often with pretty smiles, high heels and short skirts? (stereotyping, but true)
And why did they fall hook-line-and-sinker for so *long*?
Long enough to create a statute of limitations?
Fool me once…
The buck stops the only place it can stop.
On the medical profession.
On the prescribers.
Duane
Re: Pretty smiles, high heels and short skirts
Before I get accused of being “sexist”…
Anyone who’s been in a waiting room more than once knows exactly what I’m talking about.
Let’s not kid ourselves.
Duane