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everything is fine now?…

Posted on Tuesday 2 June 2015

It seems to me that President Kaler at the University of Minnesota thinks if he words things just right, people will believe what he says. So he says the same things over and over in a slightly different way and then seems surprised that we all don’t say, "Oh, I see, everything is fine now" and leave him alone.
Counterpoint from Eric Kaler: U is moving forward on research ethics
And it is, with an action plan on ethics in research that has the potential to be a national model.
Minnesota StarTribune
by Eric W. Kaler
May 30, 2015

Difficult ethical issues are inherent in medical research, especially clinical trials involving human subjects. Research holds the promise of finding lifesaving treatments, but it sometimes depends on the participation of vulnerable patients suffering from serious illnesses. We at the University of Minnesota take seriously our responsibility to patients participating in clinical studies, and our critics are wrong when they assert that we have turned a blind eye to our ethical obligations [“Medical research: Honor code still needs strengthening,” a May 27 commentary by U Prof. Carl Elliott].

Let me be clear about Dan Markingson’s 2004 death by suicide, which is at the center of much of this conversation. The events have been the subject of many proceedings, including two reviews by the U.S. Food and Drug Administration [2005 and 2015], a lawsuit in Hennepin County District Court [2008], complaints to the Minnesota Board of Medical Practice against two doctors [2009 and 2010], and a review by the legislative auditor [2015].

As the legislative auditor concluded, we can never know if Markingson’s tragic death was the result of a clinical study conducted at 26 sites, including the University of Minnesota. However, it is clear we could have done better in our response to the concerns raised about these events. I have apologized to Dan Markingson’s mother, to a legislative committee and at public forums…
In this attempt to deny responsibility, the question is teleported to the clinical study. While the clinical study itself was nothing to write home about, what’s on the table isn’t the clinical study. The Protocol is clear, patients who didn’t respond were to be withdrawn. So a grossly psychotic patient with lethal delusions and disorganized thinking was in full view, not responding to the study medication, and nobody noticed, in spite of being confronted about that by Dan’s mother repeatedly [see making sense…]. Dan wasn’t studied clinically.
To their credit, our university faculty wanted further assurance that our current program was at the highest levels of ethics and science, and in December 2013 the Faculty Senate requested an independent external evaluation of our human subjects protection program…
At the  time, the limiting of the investigation to the current program and not the Markingson case per se was Kaler’s idea, not the Senate’s [see the following brief posts with links on Carl Elliot’s Fear and Loathing in Bioethics blog from December 2013]:

Meanwhile, back to President Kaler’s counterpoint. As with many of his statements, Kaler says essentially that everything is fine now and that Carl Elliot et al should be satisfied and move on:
Critics are important voices, but there comes a point at which criticism of past actions stops being a catalyst for reform and, instead, becomes a barrier to necessary change in the future. We can’t change the past, but with vigilance, dedication and integrity, we will move forward. I promise all Minnesotans, our faculty and students, and our future patients and their families that the University of Minnesota’s human subjects research program will soon be a model for other universities.
Other U·of·M Administrative types are accusing Carl of sticking on this issue as résumé padding and book selling COI, this criticism documented by a U·of·M colleague blogging on The Periodic Table [see For the Record: U·of·M faculty member of Academic Freedom and Tenure Committee Steps Over Line?  and  For the Record: More foolishness from a member of #umn Academic Freedom and Tenure Committee]. Neither passion nor perseverance are conflicts of interest in my book – they’re expressions of interest of the best kind.

Dan Markingson was in the hospital for around six months in 2003/2004. Mary Weiss, his mother, was told that everything is fine now – and it wasn’t. Mary Weiss, Mike Howard, Carl Elliot, Leigh Turner, and all investigators have been repeatedly told that everything is fine now in the decade since – and it wasn’t. So why should they listen to President Kaler’s tired message that everything is fine now? Let’s hope they don’t…
  1.  
    wiley
    June 2, 2015 | 5:27 PM
     

    I shocked to learn from Carl Elliot’s article in Mother Jones that social workers were hired to evaluate the test subjects’ responses. It just floored me.

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