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In his work appearing in the latest issue of Mother Jones magazine, as well as cited on MinnPost and discussed recently on Minnesota Public Radio, University of Minnesota faculty member Dr. Carl Elliott raises serious concerns and levies a number of allegations toward the University of Minnesota, select members of our faculty, and our institutional review board.

We were aware of the Mother Jones article before its publication, and have followed Dr. Elliott’s media outreach on the subject.  Prior to the release of the Mother Jones article, University officials did approach the publication about the opportunity to provide a counter-viewpoint piece, but we were denied that opportunity.

Consistent with our University’s tradition of encouraging a wide diversity of viewpoints and perspectives, we support Dr. Elliott in raising some important issues. The protection of the rights of individuals who participate in clinical research is fundamental to the clinical research enterprise. Indeed, our system of clinical research is predicated on public trust that policies and practices are in place to assure that such protections will be carried out appropriately. The University of Minnesota takes these responsibilities very seriously, and is recognized as a national leader in its commitment to stringent oversight of research on human subjects. For these reasons we take seriously the concerns raised by Prof. Elliott, and value an academic environment in which he and others of our colleagues can raise issues critically, and, we hope, constructively.

In this spirit we would like to share a few facts that are not clear through Dr. Elliott’s recent media efforts.

As Elliot himself acknowledges in the Mother Jones article – but overlooked on Minnesota Public Radio – the issues raised in the article in question have been reviewed by Federal, State, and academic bodies over the last five years, including the FDA, the Hennepin County District Court, the Board of Medical Practice and Minnesota Attorney General’s office, and the University and its IRB. None found fault with the University, none found fault with the involved faculty, and none found any causal link between the Café trial and the unfortunate death of Dan Markingson.

We recognize, of course, that none of these investigations and reviews can provide complete comfort or closure to Dan’s mother and family, and the University community offers its sincere condolences to them on their painful loss.

Readers should understand that, contrary to Dr. Elliot's assertions, the University did not sue Mary Weiss. Ms. Weiss brought suit against the University and others. Following the conclusion of any civil case in Minnesota courts, the prevailing party is entitled to recover certain out-of-pocket costs (not including attorney’s fees) as determined by the court. In this case, the University prevailed and its costs were submitted to the court for review in accordance with routine civil court procedure. Subsequently , when the parties determined that there would be no further court proceedings, the University voluntarily withdrew its claim to recover its costs before any award was made by the court.

Faculty in our department of psychiatry have made great progress in pursuit of effective treatments for mental health disease. The department’s work – much through clinical trial efforts – has made a significant impact through its community clinical outreach and treatment programs. However, these conditions remain today among the most difficult to manage and treat. It is that challenge which our psychiatry faculty is seeking to address with its clinical research.

Lastly, as was widely reported, the University of Minnesota adopted a conflict of interest policy earlier this month (August). Dr. Elliott’s assertion that the medical school was “dropped” from this policy is completely inaccurate. On the contrary, this policy was expanded to the whole Academic Health Center. Click here to read a copy of the policy.
 

---Mark B. Rotenberg, General Counsel