… 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.”
Friday, May 17, 2013
For the Record
A dollop of bluster on the usual boilerplate...
University of Minnesota research case is not a scandal
In a May 13 commentary (“U research case needs a close look”), University of Minnesota faculty member Carl Elliott called for yet another investigation into the tragic death of Dan Markingson, a patient who was battling schizophrenia. Markingson took his own life in 2003 while taking part in a clinical trial aimed at treating his condition.
The story may be familiar to some readers. For years, Elliott has focused his energy on this single issue. Yet as Elliot clamors for more examination, he seems to feel no responsibility to accurately report what has already been done.
Elliott claims that despite “dozens of formal complaints to university officials,” the issue has never been formally investigated. He knows this is inaccurate.
Examinations of the Markingson case have been conducted by the U.S. Food and Drug Administration (FDA), the Hennepin County District Court, the Minnesota Board of Medical Practice (assisted by the Minnesota attorney general’s office) and the University Office of General Counsel, at the direction of the Board of Regents. The latter was prompted by Elliott himself.
None of these investigations found that the university in any way contributed to Markingson’s death. Most notably, the FDA, the federal agency charged with responsibility for such matters, conducted an extensive review of this matter. In its final report, the FDA “did not find any evidence of misconduct, significant violation of the protocol or regulations governing clinical investigators or IRBs in this inspection, data audit, or interviews.” Because he did not agree with this conclusion, Elliott ignores the review and asks for further investigation.
Elliott has filed numerous requests for information over the years and has published countless accounts of the Markingson case. These requests have required the university to expend untold resources addressing his allegations over and over again as we attempt to respond to his selective and distorted narrative.
We at the University of Minnesota are proud to have researchers willing to take on extremely challenging problems, and to search for answers to tough questions. Sadly, not all of these patients get cured, but hopefully every case gets us closer to that goal.
Mr. Markingson’s suicide was a tragedy, but it is not a scandal. Nine years later, it is time to stop blaming our university and our researchers.
We hope Star Tribune readers won’t allow Elliott’s campaign to cloud reality. Judge the university not on unfounded accusations, but on careful examination of the facts surrounding this case, and on the scale of the groundbreaking advancements taking place across our campuses every day.
Dr. Aaron Friedman is vice president for health sciences and dean of the Medical School at the University of Minnesota.
From the Comments:
For some reason, nobody at the University of Minnesota is willing to discuss the actual facts of Dan Markingson's suicide -- the involuntary commitment order, the coercion, the conflicts of interest, the rigged trial, the unsealed documents from the AstraZeneca litigation, the unresponsiveness of university psychiatrists to the desperate warnings of Dan's mother that Dan was in danger of killing himself. Instead, they always refer to the 'investigations" already conducted -- some of which did not even occur. Let me quote a passage from the deposition of Richard Bianco the official responsible for research protection at the U. Q: Has the IRB done any investigation into the death of Dan Markingson? A: Not a formal investigation, no. Q: Has the university done any investigation into the death of Dan Markingson? A: No. And later: Q: To the best of your knowledge, did anyone at the IRB, at the University of Minnesota, or anyone under your office investigate this case, actually look at the records and see the court documents that I’m describing, and if so, could you give me the name of that person? A: Not to my knowledge. Q: Nobody did that. A: No.
at 10:23 AM