Monday, November 12, 2012

"I was just following orders": a Seroquel suicide, a study coordinator, and a "corrective action"

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. The Minnesota Board of Social Work has just issued an “agreement for corrective action” for Jean Kenney, the study coordinator for the CAFÉ study in which Markingson died. 

It is an odd document. On the one hand, it contains a number of remarkably damning findings. For example, despite the fact that Kenney had no formal medical training, she apparently administered prescription drugs to research subjects and made formal judgments of the side-effects. She frequently assessed the severity of potentially dangerous adverse events such as akathisia, and sometimes she even assigned the job to a social work intern she was supervising. According to the Board, her record-keeping was “devoid of any clearly articulated, consistent set of treatment goals” and she omitted crucial information relevant to suicide prevention. When Markingson’s mother, Mary Weiss, left “alarming voicemail messages” about her son’s condition, Kenney did not respond adequately.  Kenney also made significant mistakes about medication dosage and a medical diagnosis, and these mistakes remained in the chart until well after Markingson’s suicide, when Kenney went back and changed them. To top it all off, Kenney often signed the chart with the initials of a physician.

It also appears as if Markingson was enrolled in the CAFÉ study without his consent. On March 17, 2004, the study sponsor warned investigators of a new risk of Seroquel – specifically, the hyperglycemia and weight gain now known to be common side-effects of many atypical antipsychotics. Kenney was supposed to notify all study subjects of this new danger and ask for their agreement to remain in the study by signing a revised consent form. But Kenney failed to do this. As the Board points out, this failure to communicate this new information “effectively invalidated” Markingson’s informed consent.   

Yet on the other hand, the punishment handed out by the Board is hardly adequate to the offense.  Kenney will be required to complete 18 hours of continuing education over a period of nine months.  In fact, the document makes it very clear that no formal disciplinary action is being taken against Kenney. The document merely represents an “agreement for corrective action.” According to the document, Kenney claims that the study was “supervised by a national sponsor and approved by the University of Minnesota through its institutional review board,” and that she was “acting under that supervision and in accordance with the protocols that had been approved.” In other words, she was just following orders. 

Up to this point, University of Minnesota administrators have uniformly defended the CAFÉ study and its investigators, Stephen Olson and Charles Schulz. The Board of Regents refused a request for an external inquiry. Mark Rotenberg, the General Counsel, has weighed in vigorously on several occasions. The Vice-President for Research, Tim Mulcahy, has also made his opinion known. In 2011, Aaron Friedman, the Dean of the Medical School and Vice-President for Health Sciences, sent an email to the faculty making it clear where he stood on the matter.  “As a result of this case, our department of psychiatry has experienced significant scrutiny and withering criticism over the past five years, and through it all, the faculty of the department have performed remarkably well in fulfilling its mission,” Friedman wrote, singling out Olson and Schulz for praise. “I see the Regents’ statement as the end of the University’s review of this specific patient’s case.”

Yet as the Board of Social Work has shown, it may not be so easy to put an end to this case. These findings concern only one study and one subject, but Kenney was apparently the study coordinator for a number of clinical trials at the University of Minnesota. For example, in a deposition given for a lawsuit about the death of Dan Markingson, Kenney stated that she was the study coordinator for the CATIE study -- a large, NIMH sponsored trial that has been enormously influential. If Kenney was unqualified to perform her tasks as study coordinator for the CAFÉ study, it stands to reason that she was probably unqualified for the CATIE study as well. And that raises questions of concern not just to the NIMH, but to the FDA and the Office of Human Research Protection. 

Carl Elliott

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