Last week I sat on the final panel of the Fourth National FDA Regulatory Symposium. The topic for discussion was “Striking the Right Balance: How to Manage Conflicts of Interest in the Wake of the IOM Report and Congressional Reform Proposals.
Moderated by Wayne Pines (APCO), my fellow panelists were Eric Campbell (Associate Professor Harvard University) and Marc Wilenzick (Assistant General Counsel, Pfizer – and a former Assistant Chief Counsel at the FDA).
Some commentary:
- We should all pay attention to our nomenclature. It’s not about “conflict of interest” – it’s about (as Secretary Sebelius correctly says) “interest.” And having an “interest” is not necessarily a bad thing – as long as you’re transparent about it.
- Dr. Campbell, who sat on the IOM’s COI committee, said that the Institute’s report was “bipartisan.” I corrected him – pointing out that it’s “non-partisan.” Or at least it’s supposed to be. He graciously accepted the point.
- Dr. Campbell acknowledged the importance of physicians (both practicing and those in the realms of both clinical and academic research) working with industry. That’s nice. But when I pointed out to him that physicians who do so (and particularly in the great Commonwealth of Massachusetts) are increasingly viewed as tainted – if not as outright criminals – he had no answer.
- My point to Dr. Campbell (and to all members of the COI Polloi) is that actions (often ones with political intent) often have unintended consequences (often on the public health).
In my concluding remarks I made the point that, when it comes to “transparency,” we need to weigh “interest versus benefit." That, as with drugs and devices, we must consider the “safe use” of transparency.
