Tag: CAFE study

Last year, eleven years after the suicide of Dan Markingson in a University of Minnesota drug study, external investigations found evidence of coerced study recruitment, troubling conflicts of interest, shoddy scientific review, deep mistrust of U leaders, and a climate of fear and intimidation in the Psychiatry Department. U leaders solemnly promised the people of Minnesota that they were finally going to clean up the mess. Last week, yet another investigation found that nothing has changed.

In addition to hosting the Panorama programs and The Famous Grouse history of Study 329, Study329.org has a comprehensive timeline on the origins of concerns about the SSRIs and the risk of suicide, initially with Prozac and subsequently with Paxil/Seroxat. The hope is to provide a comprehensive repository for anyone who wants to study SSRIs, RCTs, and Study 329 in particular.

The wait has been exhausting, but it is possible that a flicker of light may finally shine on the dark recent history of psychiatric research at the University of Minnesota. Given these upcoming investigations of psychiatric research at the University of Minnesota, the time is right to look back at some of the disturbing, unanswered questions that have emerged over the past several years.

Responding to a letter signed by 175 scholars asking for an inquiry into the death of Dan Markingson at the University of Minnesota, the Faculty Senate voted to investigate clinical research at the university. But the university president says the Markingson case will not be part of the investigation. What is he trying to hide?

For a scathing, 11-minute overview of the death of Dan Markingson at the University of Minnesota, and new allegations of coercion into psychiatric clinical trials, you can't do much better than this excellent investigative report by Jeff Baillon.

In the business of clinical trials, the most valuable commodities are the research subjects. Filling clinical trials is hard, and filling them quickly is even harder. That’s why in 2000 a clinical investigator told the HHS Office of the Inspector General that research sponsors were looking for three things from research sites: “No. 1—rapid enrollment. No. 2 — rapid enrollment. No. 3 — rapid enrollment.”

The recent research scandals out of the University of Minnesota’s Department of Psychiatry may be alarming, but they are not new. Back in the 1990s, when the university was working its way towards a crippling probation by the National Institutes of Health (for yet another episode of misconduct (this time in the Department of Surgery), the Department of Psychiatry hosted two spectacular cases of research wrongdoing, both of which resulted in faculty members being disqualified from conducting research by the FDA.

The suicide of Dan Markingson at the University of Minnesota has brought notoriety to the CAFÉ study and its site investigators, Stephen Olson and Charles Schulz. But the “corrective action” recently issued by the Minnesota Board of Social Work against the CAFÉ study coordinator, Jean Kenney, has raised another disturbing question.

Ever since critics began asking questions about the death of Dan Markinson in a clinical trial at the University of Minnesota, the General Counsel for the university, Mark Rotenberg, has responded with a uniform message: the case has already been investigated many times, and no wrongdoing has ever been found. That's how Rotenberg responded to my article about the case in Mother Jones, and that's how he responded last week to the news that the Board of Social Work had issued a “corrective action” to the study coordinator for the clinical trial in which Markingson died.

The suicide of Dan Markingson at the University of Minnesota has brought notoriety to the CAFÉ study and its site investigators, Stephen Olson and Charles Schulz. But the “corrective action” recently issued by the Minnesota Board of Social Work against the CAFÉ study coordinator, Jean Kenney, has raised another disturbing question.

In the "agreement for corrective action" against CAFE study coordinator Jean Kenney last week, the Board of Social Work cited Kenney's failure to respond to "alarming voicemail messages" from family members of Dan Markingson. Presumably, the Board is referring to a message left by his mother, Mary Weiss, which warned, "Do we have to wait until he kills himself or someone else before anyone else does anything?" The failure of Kenney and Stephen Olson to take the warnings of Mary Weiss seriously has been one of the most disturbing aspects of this case. In a deposition for the lawsuit filed by Weiss, Kenney was questioned about her response. Here is an excerpt. (The initial questions come from Gale Pearson, an attorney for Mary Weiss.)

Out here in Minnesota, where the snow is gently falling, many of us are hunched over our computers, puzzling over a document just posted by the state Board of Social Work. It concerns the death of Dan Markingson (or as the document calls him, “Client #1”). Markingson, of course, was a young man under a commitment order who was coerced into a profitable Seroquel marketing study at the University of Minnesota over the objections of his mother, and whose condition spiraled downward until he committed suicide.