By Judy Stone | January 8, 2013
Scientific American
Demystifying drug development, clinical research, medicine, and the role ethics plays
In earlier posts, we’ve looked at issues of consent, investigator responsibilities, and conflicts of interest on the case of Dan Markingson’s suicide while participating in a clinical trial of anti-psychotics at the University of Minnesota. This time, we turn to the University’s response.
Not surprisingly, the University has claimed it has no responsibility for any wrongdoing—that in fact, no wrongdoing even occurred. But there are some inconsistencies in the story and unanswered questions. There is also concern over how the University has responded to criticism. We’ll examine these issues in this post.
Background regarding the University’s response
In response to the Minnesota Board of Social Work’s “corrective action” vs. Jeanne Kenney, the social worker/study coordinator who did most of the study assessments on Markingson, the UMN’s General Counsel Mark Rotenberg stated, “As we’ve stated previously, the Markingson case has been exhaustively reviewed by federal, state and academic bodies since 2004. The FDA, the Hennepin County District Court, the Minnesota Board of Medical Practice, the Minnesota Attorney General’s Office and the University’s Institutional Review Board have all reviewed the case. None found fault with the University. None found fault with any of our faculty. Most importantly, none found any causal link between the CAFE trial and the death of Mr. Markingson.”
Yet a number of UMN faculty have remaining concerns and have requested an independent investigation. Two years ago, eight faculty members in the Bioethics Department wrote Rotenberg, citing the University’s conflicts of interest in the matter. The UMN declines to reexamine the case, saying that they have been exonerated. In October 2012, Dr. Carl Elliott, Professor in the UMN Center for Bioethics, wrote Dr. Debra DeBruin, director of the Clinical Research Ethics Consultation Service for the UMN Clinical and Translational Science Institute, again requesting a review. This time Dr. Elliott expressed concern regarding human subjects protections in other trials conducted by the psychiatry department as well. As always, Dr. Elliott’s concerns were thoroughly documented. Once again, the University has turned away.
The entire story is here.
Thanks to Tom Fink for this story.
