Friday, August 30, 2013

University of Minnesota: Home of the Whopper

Spoiler alert: Mark Rotenberg told another whopper, but the University of Minnesota is standing behind it.

A couple of days ago I posted about my continuing efforts to get copies of the "reviews" of Dan Markingson's death -- reviews which, according to Rotenberg, found no fault with the university or its researchers.  As I mentioned, I did not believe that these "reviews" -- supposedly conducted by the IRB and "the University" -- actually exist. One reason I doubted their existence was a deposition by Richard Bianco, the head of research protection at the university when Dan died. Bianco testified that neither the IRB nor anyone else at the university had investigated that death.  For that reason, it seemed pretty suspicious when Rotenberg claimed not only that the reviews had been conducted, but that they had cleared the university of blame.

Yesterday, I finally got a response from Susan McKinney, the records manager for the University of Minnesota.  McKinney never quite gets around to admitting that the reviews don't actually exist, but her explanation is intriguing.

The most interesting thing about the letter is the simple fact that McKinney actually wrote and sent it. Her letter is not simply a response to my request. It is a vigorous defense of Mark Rotenberg's press release. Is public relations really part of a records manager's job description?

But the letter is also filled with misleading statements and weasel words. While McKinney admits that "there is no written IRB report" on Dan Markingson's death, she says that the death was "reviewed" at IRB meetings.  As anyone who has been on an IRB knows, this means nothing. In fact, it could mean as little as a 15-second statement by the panel chair telling IRB members that an adverse event report was received and that the investigator concluded there was no relationship between the adverse event and the study drug.  Rotenberg's 2010 press release said that the IRB was among the many review bodies that found no fault with the university or any faculty members. If that's the case, where is the evidence?

It gets worse. McKinney writes that when the IRB was notified of Dan's death "the matter was immediately reported to the FDA," and she goes on to point out that I have a copy of the FDA investigation. But according to Mike Howard, he and Mary Weiss were the ones who notified the FDA and asked for an investigation. If the University of Minnesota IRB also notified the FDA and asked to be investigated, I would very much like to see that communication.  (I have filed another Data Practices Act request.)

What about Rotenberg's claim that "the University" reviewed Dan's death?  McKinney appears to suggest that this review consisted of 1) the university's legal defense against the lawsuit by Mary Weiss, and 2) Rotenberg's responses to the complaints that Mike Howard and Mary Weiss filed with the Board of Regents.

Well, there are a couple of serious problems with that explanation.  First of all, a defense by a university's lawyers does not constitute a review by the university.  Rotenberg gave the impression that an impartial university body had looked at the evidence with the aim of finding the truth.

Secondly, the responses by Rotenberg that McKinney refers to were not sent until February and March of 2011 -- over six months after Rotenberg issued his press release. It is hard to credit the idea that he was referring to these responses in September 2010 (unless, of course, he had already decided what those responses were going to be.)

My conclusion?  That University of Minnesota officials understand quite well how misleading and deceptive Rotenberg's statement was, but they are so intent on defending him that even the records manager has been instructed how to spin it.



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