Monday, November 19, 2012

Fact-checking the General Counsel at the University of Minnesota

Ever since critics began asking questions about the death of Dan Markinson in a clinical trial at the University of Minnesota, the General Counsel for the university, Mark Rotenberg, has responded with a uniform message: the case has already been investigated many times, and no wrongdoing has ever been found. That's how Rotenberg responded to my article about the case in Mother Jones, and that's how he responded last week to the news that the Board of Social Work had issued a “corrective action” to the study coordinator for the clinical trial in which Markingson died. Rotenberg told City Pages:

“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 any of our faculty. Most importantly, none found any causal link between the CAFE trial and the death of Mr. Markingson."

This is a deeply problematic statement, but it has been repeated so many times that reporters appear to believe it.

First, to say that the university's Institutional Review Board reviewed the case and found no fault is highly misleading. The IRB is the university body charged with protecting subjects in university research studies. It reviews all studies that are done at the university. Its mistakes in overseeing the CAFE study are part of what is at issue in this case.

Second, I have never been able to verify Rotenberg's claim that the Minnesota Attorney General's office reviewed the Markingson case and found no fault. No report from the Attorney General's office appeared in the documents associated with the lawsuit by Mary Weiss, nor to my knowledge has it appeared in any other publicly available material. If there was such a review, and if it indeed found no fault with university faculty members, it needs to be squared with the “agreement for corrective action” for Jean Kenney, which apparently did involve the Attorney General's Office, and which came to a very different conclusion.  According to that document (see page 8) the Board of Social Work panel was represented by Assistant Attorney General Benjamin R. Garbe.

Third, it is wrong to claim that the Hennepin County District Court reviewed the case and found no fault with university faculty members. In the lawsuit brought by Mary Weiss in Hennepin County District Court, a judge ruled in a partial summary judgment that the university IRB was “statutorily immune from liability.” As Matt Lamkin at Stanford Law School told me, to suggest that the University of Minnesota was exonerated in this lawsuit is like a diplomat who got drunk and ran over a kid claiming he was "exonerated" by diplomatic immunity.

As for the decisions of the Minnesota Board of Medical Practice: we'll never know what the Board decided, because its files are closed. (It is probably worth noting, however, that the Board consistently disciplines fewer doctors per capita than nearly any other state in the country.) The only review that is publicly available is a report by the FDA – a deeply flawed investigation that I have written critically about in the Hastings Center Bioethics Forum.

No comments:

Post a Comment