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Minnesota Ethicist, Steve Miles, Criticizes COI Draft

My colleague, Gary Schwitzer, writes an excellent blog and is one of the country's premier health care journalism experts. He has a post up on Schwitzer Health News blog:

The draft conflict of interest policy being considered by the University of Minnesota is insufficient according to Dr. Steve Miles, a UMN med school professor of medicine and bioethics. He wrote to me:

The document identified as Administrative Policy: Individual Conflicts of Interest (DRAFT 11/09/09) (text downloaded from http://blog.lib.umn.edu/bgleason/pt/Coi_draft.pdf) is an incomplete and flawed document that will do little to regulate the kinds of misconduct and concerns that have brought this University and many other United States universities before Congressional inquiries or harsh media scrutiny. I agree with those who are also frustrated with the lack of transparency of the drafting of this fourth generation document.

University collaboration with industry groups is necessary and can be ethically done. However, these relationships must be managed to prevent biasing of education, presentations to the media, testimony to public policy groups, or scientific publications. These relationships must also be done in a way that prevents research from being corrupted or that abridges protections for human subjects.

My comments arise from my perspective in the health sciences and may not apply to this policy insofar as it may affect Conflicts of Interest in other University Endeavors. My comments are not comprehensive given that it is not clear that the process is open to debate in its scope or fundamentals.

SECTION I. Reporting. By reporting rough dollar amount of income for "each compensated relationship with a business" rather than income from each business entity, it is possible for any business to slice its compensation to faculty into small pieces (i.e., discrete relationships) that understate the extent of the Conflict of Interest. For example, if BIO INC gives a faculty member $99,000 in honorariums and a 24,000 travel budget, the faculty would not trigger the Conflict of Interest review and the categorical disclosures would add up to 60,000 to 125,000. This problem with reporting has implications for the clarity of the disclosures that are addressed in SECTIONS IV and V.

SECTION III. Managing Conflicts.
On the important question of the relationship between a conflict of interest review committee and the Institutional Review Board, it is left unspecified if the conflict committee is supervisory to the IRB or advisory to it. Furthermore, it is entirely unclear how a conflict of interest committee is routinely informed of human subjects research since it receives its information through the REPA system and there is no specified obligation on the part of the IRB to check back to the conflict of interest or REPA program. Finally, the most problematic studies involve the use of devices or off label uses that are not part of prospective study protocols, e.g. the much discussed INFUSE study. The Draft policy does not address non-IRB clinical innovations by researchers with conflicts of interests.

SECTION VIII, X, XI. Speaking Engagements, Commercially Produced Education Materials, Gifts etc.
The policy does not address conflicts of interest as they pertain to continuing medical education. It would be easy for the University to adopt wholesale the standards and interpretive guidelines of the Accreditation Council for Continuing Medical Education (http://www.accme.org).

SECTION XII: Nationally, there is increasing recognition that "free drug samples" are a marketing tool that promotes the more rapid introduction of costly drugs at variance with responsible practice guidelines. This is why schools like Johns Hopkins and the University of Iowa have abandoned the practice and The American Society of Health System pharmacists opposes it. The trend is clear. This draft gives no reason for electing not to lead or for narrowly restricting the kinds of free samples might be distributed (i.e., highly costly, non reimbursed drugs that have immediate life saving effect on persons with very rare conditions).

The Conflict Review Committee (CRC) is defined on page 12. Apparently there are many of these since the document throughout used references to an "appropriate" or "a" "conflict review committee." It is not clear whether the repeated use of the generic non-capitalized "conflict review committee[s]" meet the same membership standards and accountability of standards as the CRC.

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