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.
"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.
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."
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Turner goes into further detail on his blog and in a letter sent to the AAHRPP on the same day, where Turner points out even more conflicts of interest, including that the AAHRPP can't be considered unbiased in its review, as it receives money every year to accredit the very program it investigates.
We reached out to both the U of M and the AAHRPP for answers to how they chose the reviewers, but both gave us relatively vague statements. From a U of M spokesperson:
"From the start, our goal has been to ensure a vigorous process that fulfills the Faculty Senate's resolution to conduct a thorough, professional, independent and transparent review of our human subjects research practices. AAHRPP submitted the strongest proposal to administratively manage this process; it is not conducting any portion of the review. The review will be undertaken by a group of independent, internationally-recognized experts in the field of human subjects research protection. As part of this process, potential conflicts of interest will be managed appropriately."
And from Elyse Summers, the President and CEO of AAHRPP:
AAHRPP is proud to be a leader within the human research protections community. Consistent with that role, AAHRPP is well-positioned to have identified and assembled an independent panel of world renowned experts in the fields of bioethics, medicine, psychiatry, law and human research regulations, who, individually and collectively, have the experience, intellect, and integrity to conduct the evaluation requested by the University of Minnesota. AAHRPP will logistically manage the work but will play no role in the substantive analysis, decision-making, conclusions or recommendations of the expert team. As an organization committed to identifying and promoting the highest level of human research protections, we at AAHRPP are as eager as anyone to learn from the findings of the independent expert panel.
Turner isn't the first to voice concerns with the review process. Other critics include the consumer advocacy group Public Citizen and U of M bioethics professor Carl Elliott, who wrote two complaints to the organization earlier this year about the lack of oversight at U of M.