U of M professor bashes review of university's drug research program

Categories: U of M

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Dan Markingson and his mother, Mary Weiss, in 2004

A University of Minnesota bioethics professor is criticizing the university's review into its drug research program, detailing many conflicts of interest and questioning the backgrounds of the appointed investigators, including one involved in an alarming medical malpractice case.

In a July 16 blog post on his website, U of M associate professor Leigh Turner criticized the Association for the Accreditation of Human Research (AAHRPP), an organization that the university hired last month to review its clinical trials on human subjects. In the post, Turner points to a number of questionable aspects of the organization's review, most notably that the group will only look into current research practices, despite the university's troubled past.

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"What appears to be underway is a carefully managed 'review' that is designed to ignore the elephant-in-the-room," Turner writes. "...Once again, senior university officials have eliminated the possibility of a meaningful independent inquiry."

That "elephant-in-the-room" that Turner's referring to is the case of Dan Markingson, a schizophrenic man who committed suicide while part of an anti-psychotic drug study at the university in 2004. Markingson's family sued the university, saying that while they repeatedly tried to pull Markingson out of the study, the researchers refused to listen.

While the study has since been investigated, there are questions about those reviews, with fellow U of M bioethics professor Carl Elliott calling one of the investigations, "misleading, remarkably uncritical, and often simply baffling."

Turner says the Markingson study is important to the new review in two ways. First, because this new inquiry will only look at current research practices, it will avoid having to review the Markingson case and other ethically controversial cases. In addition, Turner says, one of the reviewers that the AAHRPP appointed for the case, Melissa Frumin, was a defendant in a lawsuit that was alarmingly similar to the Markingson case.

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U of M professor Leigh Turner

In that case, Frumin served as the chair of an Institutional Review Board overseeing a Massachusetts study on gene transfer in which a patient, Robert Zeman, allegedly received a "double dose" of the medication on one side of his body. However, Zeman alleges, he only saw a consent form letting him know of that of dosage after he had received the treatment. From there, Zeman saw his condition deteriorate, prompting him to sue his doctor and the Institutional Review Board overseeing the study, saying that the board didn't properly review the study or its consent forms.

Frumin was ultimately removed as a defendant in the case, but Turner says that doesn't matter -- for the university reviewers to choose someone involved with a lawsuit so close to the Markingson case is just irresponsible.

"Out of all the people you could go out and find, there are thousands of [Institutional Review Board] chairs," Turner tells us. "Why would you pick her? That just seems bizarre to me."

(Continue to page 2 for more details.)



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