Summary: ISCTM 2010 National Mental Health Research-to-Policy Forum: Industry/Academic Relationships: Continuing Collaboration in an Era of Evolving Standards

Principled Research in the Face of Conflicts of Interest

Chairmen:  R Keefe, Duke University Medical Center;  N Schooler, State University of New York

Speaker:  R. McKinney, MD, Duke University

Summary

Main themes that were emphasized during Dr. McKinney’s presentation included the following:

• Conflicts of interest (COIs) are ubiquitous – e.g. car mechanics, dentists, neurosurgeons.
• Because of this, we have a natural sense of COIs which can be used to assess the appropriateness of COIs in academic/industry settings.
• Questions to ask ourselves include:  Do they impact primary professional obligations?
• It is easiest to measure financial COIs, and we tend to focus on those.
• We can recognize COIs, but can’t know how much it affects behavior.  Research shows that even small gifts may have effects.

Q&A included the following:

1. What about conflict for the institution as well as the investigator?  “Institutional COI” – Duke has a committee to review.  Reference was made to the Nancy Oliveri case at the University of Toronto.  She received a Hematological drug and experienced side effects, spoke up about it, but UT (who was being paid by manufacturer) did not support her.
2. Have you asked lay public; done market research?  For example, lay public sees cutoffs of $10k/25k as substantial amounts.  Yes; community said $25k is “too much”
3. Lower/minimal limits make functioning impossible.  Can we answer questions from a pharmaceutical employee at a poster session?  Grassley has suggested zero.
4. How much COI should you have?  Ex:  FDA advisory committee – there may be little knowledge among members with no COI.  Preference is to minimize COI, esp. when there are dichotomous decisions (e.g., approve a drug or not, as with FDA advisory committees).
5. How do we manage the perception of COI, and have a positive impact?  Stress the importance/value of interaction between academia and industry – start with the assumption that there is value.  Advocate for more academic/industry interaction, but well-policed.
6. ISCTM receives a substantial proportion of its funding from industry sources.  Do you have any advice for us on how to manage that perception in the current environment?  1) transparency – we believe in it, this  is the mission.  2) advocate for patients first.
7. Academia/Industry dichotomy may be false.  COIs exist for both.  “if you don’t have conflict, there shouldn’t be any interest”