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Another Minnesota Bioethicist Speaks Out Against COI Draft

What's it going to take? Dr. Cerra? Dr. Bruininks?

As a graduate of the University of Minnesota and a faculty member in the Medical School, all I can say is that I am appalled by the behavior of Dr. Cerra and his predecessor in this matter. Blame is shared by the central administration - especially President Bruininks - for this almost comical, but certainly tragic, situation.

From Gary Schwitzer's health news blog:

Carl Elliott, MD, PhD of the University of Minnesota (Professor, Center for Bioethics; Professor, Department of Pediatrics, University of Minnesota Medical School; Professor, Department of Philosophy, College of Liberal Arts), wrote to me this afternoon as follows:

"The biggest problem with this document is that it will do little if anything to fix the conflict of interest problems which have embarrassed the university. In addition to the problems highlighted by Steve Miles, consider these:

1) The policy places no caps on the amount of money faculty members can receive from the pharmaceutical industry as consultants. It simply lowers the reporting threshold.

2) The primary mechanisms for dealing with conflicts of interest in the draft document are disclosure and "management" by a Conflict of Interest Committee. But there is no published evidence that disclosure reduces the bias created by financial conflicts, and besides, the Academic Health Center already has a Conflict of Interest Committee. It has not exactly been a great success. Is there any reason to think that the new policy will change this?

3) For the most part, this policy still requires faculty to report potential conflicts only after they arise, rather than asking a committee to review potentially troublesome arrangements in advance. This means that troubling industry arrangement may become evident only after they are concluded.

4) The policy initially seems to limit faculty members from giving marketing talks for the pharmaceutical industry, but in fact, the conditions it outlines are unlikely to limit those talks in any meaningful way. Specifically: the policy says that such talks must reflect the speaker's views, be evidence-based, and disclose the funding for the talk. But most marketing talks for the drug industry already meet those criteria. (The problem is not that the talks are not evidence-based; the problem is the particular spin that sponsors and speakers put on the evidence.) The only new condition here is that speakers are required to disclose the specific amount of money they are being paid. This may deter some speakers, but in general, the empirical data shows that industry-funded speakers and authors rarely disclose their funding sources even when they are required to.

5) The policy will permit the pharmaceutical industry to provide educational materials to students, residents and faculty, as long as the funding is disclosed and the marketing purpose is not outwardly obvious. But the problem with industry-produced educational material is precisely that its marketing purpose is not at all obvious, even when it has been produced by the marketing department of the company.

6) The policy proposes to manage the potential conflicts of interest for medical researchers by having researchers ask research subjects if they would like to have the researcher's financial relationships disclosed to them. There is no evidence in the medical literature to suggest that this is an adequate solution. The problem with financial incentives is not secrecy; the problem is that financial incentives may lead researchers to expose subjects to interventions that are not in their best interests.

7) The first draft of these guidelines recommended that the university office of Continuing Medical Education institute a plan to be free of pharmaceutical industry funding within five years. That recommendation has disappeared."

If we have no integrity at the University of Minnesota Medical School, what do we have?

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