Conflict-of-Interest.net

Check out this commentary over at the Research Ethics Blog — Seroquel, Sex, and Conflict of Interest — about sexual relations being the basis for a COI in drug promotion. As Chris MacDonald notes, its

refreshing to see a conflict of interest story that doesn’t have money at its core. It’s worth reminding ourselves that while money may be reputed to be the “root of all evil,” in real life human judgment is in fact subject to a whole range of biasing influences.

Bryn Williams-Jones

Here’s another story about attempts to set financial thresholds (at $100 annually!) in order to manage COI in physician-consulting with industry: “Sunshine” bill sets $100 trigger for disclosing drug industry pay to doctors.

Bryn Williams-Jones

Another example of why the FDA needs to clean up its act, if its going to rebuild is shakey public confidence…“Mistakes” made: FDA acknowledges Lilly phoned to question Sanjay Kaul’s inclusion on prasugrel panel

Prior to the February 3, 2009 Food and Drug Administration advisory panel hearing on prasugrel (Lilly/Daiichi Sankyo), the drug’s sponsor called the agency to question the inclusion of Dr Sanjay Kaul (Cedars-Sinai Medical Center, Los Angeles, CA) on the Cardiovascular and Renal Drugs Advisory Committee, heartwire has learned.

The agency received a phone call from Lilly on January 30, 2009, just four days before the advisory panel was scheduled to meet to discuss the risks and benefits of the new antiplatelet agent. The call was made by Lilly to staff members in the cardiovascular and renal division at the Center for Drug Evaluation and Research.

In an area as much under the ethical microscope as drug regulation, and one in which the risks of COI (for research subjects, patients, governments) are significant, it should be obvious that critical distance is necessary to avoid even apparent COI.

Bryn Williams-Jones

Well, that’s the question posed in this very thoughtful and enlightening story — Is Sunlight Always the Best Disinfectant? Are Financial Conflicts of Interest in Research Inherently Unhealthy? — by Michael Werner and Ari Stern at Science Progress.

As they note, one of the key problems with attempts to regulate or build effective policy regarding financial COI, is that it remains unclear what amount of money constitutes a conflict. In the US,

However, nearly all policies identify a specific dollar amount as the threshold for a potential financial conflict of interest, which must therefore be reported. The AAMC found that 95 percent of institutions’ policies based their reportable compensation requirements on federal guidelines, which require disclosure of ties of $10,000 or more.

Federal law does not prohibit—or even define—a conflict of interest. Rather, FDA regulations address issues surrounding financial disclosure by investigators.

But even if there are appropriate disclosure mechanisms in place (and one can settle on a dollar figure – which is problematic), these may be insufficient, or worse yet, misleading.

In fact, some published analyses of university financial disclosure policies cast doubt on whether a disclosure-based approach will effectively protect research participants and research integrity. These studies raise questions about whether such policies would truly help potential research participants make better-informed decisions as to whether to participate in a research project, or effectively deter researchers from accepting problematic financial conflicts.

And in terms of protecting research subjects by helping people be more informed about researcher interests:

Subsequent studies further indicate that the disclosure of a researcher’s financial interests in a clinical trial may not affect a patient’s willingness to participate in the study, unless the researcher could earn money contingent upon the trial results.

So what then, would be an appropriate way forward? Werner and Stern argue that regulatory mechanisms are still important, but they have to be enforced. More challenging, however, is determining actionable and consistent definitions of COI , and building consensus on what actually constitutes a financial COI. And this will, they argue convincingly, only be resolved with in-depth empirical research into the full range of interests at stake in medicine and science and the diversity of potential conflicts that can arise. Only then will it be possible to development and test practical tools to mitigate conflicts in bioscience and university research more generally.

Bryn Williams-Jones

The story about the University of Minnesota’s Medical School, and its development of a COI policy, continues to turn up interesting elements (commented on previously here). The following story (Public perceptions of conflicts of interest) by a journalist who participated in the review process highlights the importance of transparency in dealing with COI, both in its occurrence, and in the development of policies to manage COI.

How does the public perceive industry funding of continuing medical education? Would the public, if told, wonder why a recommendation to end industry funding of CME was removed from the final report? I was the only true “outsider” on this task force, and I don’t know why it was removed. On several occasions, I urged the task force to bring outside parties into the process. What has the Medical School done to gauge public perception of the issues considered by the task force?

Good questions!

Bryn Williams-Jones