… in the Minneapolis Star Tribune notes that the most charitable description of what’s been going on at the clubby University of Minnesota medical school would be “bizarre.”
Tuesday, June 2, 2015
Setting the Record Straight: Dr. Mickey Nardo does a number on #umn President Kaler
From Dr. Nardo's web-site: 1 Boring Old Man
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.
Minnesota StarTribuneby Eric W. KalerMay 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 , complaints to the Minnesota Board of Medical Practice against two doctors [2009 and 2010], and a review by the legislative auditor .
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…
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]:
University of Minnesota bioethics alumni say Kaler should not be allowed to whitewash the Markingson case
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…
at 3:10 PM