This research ethics series uses the story of Dan Markingson’s participation in a clinical trial of anti-psychotic drugs at the University of Minnesota, his suicide 2004 while participating on the study, and subsequent events as a case study in which to explore various aspects of clinical trial conduct. In previous posts, I’ve looked at issues of “good clinical practices” and ethics: consent, investigator responsibilities and conflicts of interest. Then I examined the university’s response and then turned to the importance of careful documentation of consent. Next, I explained how I was transformed by Dan’s story from looking at it simply as an objective case lesson in clinical trial ethics, to an advocate for an independent investigation of the University of Minnesota. In a more recent post, I shared reactions to the announcement that Mark Rotenberg, the UMN’s General Counsel, was leaving Minnesota to assume a similar post, now as Counsel and Vice-President at Johns Hopkins University. Most recently, I have asked Dr. Jeffrey Lieberman, who was Principal Investigator on the CAFE and CATIE trials, to address concerns that have been raised about the ethics and conduct of that trial.
Remember when University of Minnesota General Counsel Mark Rotenberg proclaimed the University’s innocence, stating that Dr. Carl Elliott’s concerns “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?” Rotenberg insisted, “None found fault with the University. None found fault with any of our faculty.”
Then we learned that the Board of Social Work, which issued the corrective action against Ms. Kenney, was represented by Assistant Attorney General Benjamin R. Garbe. (page eight) They cited her undertaking tasks beyond the scope of practice of a social worker—but this was clearly done with Dr. Olson’s knowledge and support. Still, the Principal Investigators, who are legally responsible for the conduct of the studies they supervise, have not been held accountable.
But there was this letter from Deputy Attorney General Michael Vanselow to Mary Weiss on May 17, 2005 that raised questions as to the credibility of Mr. Rotenberg’s claim, stating, “We are also willing to work with you and Jim Gottstein in regard to drafting some proposed legislation to address some of the systemic problems that contributed to your son’s death.” Such legislation was passed in 2009 and is known as “Dan’s Law.” This law prohibits recruiting most patients who are under a commitment agreement into clinical trials.
And remember when “Rotenberg asked the university’s Academic Freedom and Tenure Committee to take up the question of “[w]hat is the faculty[’s] collective role in addressing factually incorrect attacks on particular university faculty research activities?” – a question that appeared both to accuse Elliott of “factually incorrect attacks” and to call for some unspecified action to “address” them.”
The Board of the Regents, in a letter exonerating itself to concerned faculty, noted that the FDA, the Minnesota Attorney General and the Minnesota Board of Medical Practice had previously conducted investigations and reached the same conclusion. The Board deferred to Rotenberg, who again alluded to the AG’s office in his defense.
There’s one small problem with Rotenberg’s assertion that the Attorney General’s office had investigated the Markingson case and found no fault with the University—we now have definitive proof that never happened. In a just released letter to Dan’s mother, Mary Weiss, the Office of the Attorney General confirms that it “has not made any independent investigation or determination regarding the care rendered to your son.”
In light of confirmation that Mark Rotenberg’s statements have been misleading, at best, perhaps it is time for President Kaler to rethink his defense of his General Counsel’s work and support an independent investigation.
Many ethicists, university faculty and concerned citizens—more that 2700—are calling on Governor Mark Dayton to appoint an independent investigation of psychiatry studies at the University of Minnesota. I explained my support for this here. You can add your support here.
“Molecules to Medicine” banner © Michele Banks
photo of Dan and Mary courtesy Mary Weiss