Thursday, November 15, 2012

The University of Minnesota was not involved? Some further thoughts on the “corrective action” against Jean Kenney in the Markingson case

The “corrective action” against Jean Kenney, the study coordinator in the clinical trial in which Dan Markingson committed suicide, has sparked new attention to the case.  I posted my initial reaction to the action on Monday; here are some further thoughts.

First, in statements to the press, the General Counsel for the University, Mark Rotenberg, appears to claim that the University of Minnesota was not involved in the deliberations about Kenney.  In a statement to Pharmalot, Rotenberg says that Kenney “hasn’t been employed by U of M for years and we were not a party to the proceeding.”  To City Pages, Rotenberg said, “The University was not a party in the Corrective Action.”  The idea that the university was not involved in this case seems highly implausible.  Kenney was defended by the same law firm that defended the University of Minnesota in the lawsuit brought by Mary Weiss, and her spokesperson in the affair has been David Alsop, the attorney who defended the university.  Asked by Pharmalot whether the university paid Kenney’s legal fees, Rotenberg said that the university “may have made a fee arrangement with her.”  (“May have”?  Does this mean Rotenberg doesn’t actually know if the university paid Kenney’s legal fees?)

Second, while the “corrective action” lists a number of alarming problems with Kenney’s work, it does not mention most of the most egregious ethical wrongdoing in the case of Dan Markingson – the fact that he was coerced into the trial over the objections of his mother while under a commitment order, his questionable capacity to give informed consent, the conflicts of interest of the investigators, the financial incentives to enroll Markingson in the study, the dubious scientific value of the CAFE study, to name just a few.  These omissions can’t be because Kenney was not involved in these matters.  For example, Kenney was the person charged with assessing Markingson’s competence to consent.

Third, Mike Howard and Mary Weiss also filed a complaint about Stephen Olson, Kenney’s supervisor in the CAFÉ study, to the Minnesota Board of Medical Practice.  Yet unlike the Board of Social Work, the Board of Medical Practice took no action.  Why not?  The wording of the “corrective action” by the Board of Social Work suggests that Kenney was simply following the orders of her superiors.

Fourth, Rotenberg says the findings by the Board of Social Work will not change the university’s stance toward the CAFÉ study.  According to Pharmalot, Rotenberg says “the university does not feel obligated to reopen its investigation into the handling of the CAFE trial.”  If this is so, it would be a serious mistake.  According to the deposition of Stephen Olson, Markingson was only one of seventeen subjects enrolled by the University of Minnesota in the CAFÉ study.  If Kenney made this many mistakes with Markingson, it stands to reason that her mistakes would very likely extend to the other subjects in the study.  In addition, Kenney was also the study coordinator for the AstraZeneca CLEAR study, and more importantly, the National Institutes of Mental Health CATIE study.  If University of Minnesota administrators were genuinely interested in getting to the bottom of these problems, would they not want to look further?

Carl Elliott

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