Financial Ties of the Members of the Tysbari Advisory Panel

The Boston Globe reported that a new law designed to "limit industry influence" on the US Food and Drug Administration (FDA) have not had much effect. The law requires disclosure of financial ties to relevant organizations by participants on the FDA's advisory panels, but allows the FDA to seek waivers to let those with such ties serve on these panels.

The news article focused on ties affecting an advisory panel that recommended that Tysbari, a drug for multiple sclerosis, made by Biogen Idec and Elan, be allowed back on the market. Five of 12 had relevant financial relationships. It quoted Dr Karl Kieburtz, the chairman, who is a consultant to Biogen Idec, "All behavior is guided by conscious and unconscious motives. Consciously, I'm not aware of of any swaying of my decision-making based on the fact I did consulting for Biogen Idec within the last year." Kieburtz noted that he received no more than $12,000 for consulting, which was not related to Tysbari or multiple sclerosis, and he gave the payments to his institution, the University of Rochester, or charity. Another member of the panel, Dr Steven DeKosky, "said he didn't know he had a conflict until he filled out the FDA's disclosure forms in which he had to list all the work he'd done recently for industry." DeKosky "disclosed he'd received less than $10,001 as an industry sponsored speaker and was paid less than $10,001 by Pfizer Inc. as a visiting professor. Until the FDA issued his waver, DeKoskey said he did not know that a rival MS drug is made by a company that has a financial agreement with Pfizer." The article also reported that "other Tysbari advisers reached by the Boston Globe who received FDA waivers said drug industry funding did not influence their votes."

The FDA's stance was that trying to get the most expert to serve on the panels requires recruiting "scientists with drug industry sponsorship. Barring those researchers would result in smaller panels with less expertise."

However, Merrill Goozner, director of th Integrity in Science Project for the Center for Science in the Public Interest, (and author of the blog, GoozNews), thinks that the FDA should issue no waivers, "Period. End of story. Get rid of scientists with conflicts from serving on the FDA advisory panels."

A while back we posted on an article in JAMA (Brennan TA et al. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA 2006; 295: 429-433.) that argued that practicing physicians should be barred from receiving even gifts of trivial value (the proverbial pen or coffee mug with the company logo on it) because

social science research demonstrates than the impulse to reciprocate for even small gifts is a powerful influence on people's behavior. Individuals receiving gifts are often unable to remain objective.

If there is concern that getting a coffee mug with a company logo might affect a practicing physician's decision making, there surely ought to be a concern that getting $10,000 for consulting, giving a talk, or being a visiting professor, even if that money ultimately goes to one's employer, may affect the decision-making of a member of an influential national committee. As both a recent NY Times op-ed, and the JAMA article argued, the effects of gifts or other payments may not be conscious, so the recipients may not honestly be conscious of their effects. (Dr Kieburtz seemed to acknowledge that possibility above.) Thus, that their recipients deny that the gifts had conscious effects is of little comfort.

Thus, if the goal is unbiased decision making, Merrill Goozner's "just say no" approach to panel members with conflicts of interest seems justified.

(Full disclosure: I own more than $10,000 worth of stock in Elan.)