Gary Williams MD, PhD, chairman of the department of medicine at Scripps Clinic Medical Group, in La Jolla, California, and co-chair of the symposium Clarifying the Risk/Benefit of COX-2 Selective Inhibitor Use at the 6th EULAR Annual European Congress of Rheumatology in Vienna, spoke with CIAOMed on Wednesday regarding the current controversy over the fate of the COX-2 inhibitors.

Gary Williams, MD, PhD speaking at
EULAR 2005 in Vienna, Austria.

---

CIAOMed: In light of the February 16-18 FDA Advisory Board hearings in Washington, DC, and the overwhelming coverage, particularly in the lay press, what is your current thinking about COX-2 inhibitors and cardiovascular risk?

GW: "I think the news cycle stopped around the time of the [FDA] advisory committee, with the tremendous coverage on CNN, in The New York Times, and The Wall Street Journal about the fact that the COX-2 inhibitors have risk. I think the data have subsequently demonstrated, to some people's great surprise, that the issue of cardiovascular risk is not limited to the coxibs, is present in all the NSAIDs, and that, in fact, the worst players may in fact be nonselective NSAIDs, something that I think was not considered in February [at the FDA hearing on coxibs]. The criticism of very large observational trials is something we're all aware of. Randomized controlled trials need to be done, as difficult as they are and as large a population that they would require. But I think that the totality of the epidemiologic data in thousands and now tens of thousands of events, suggests that there is a sorting out of risk; that some of the COX-2 inhibitors don't look like others."

CIAOMed: What, in your view, then, is the fate of this class of medications?

GW: "Rofecoxib is not on the market currently, and it remains to be seen whether it will come back. It also remains to be seen whether the FDA will be interested in that. But celecoxib, rather than being painted with the same broad strokes, can be seen in a little different light, given the data. And also the FDA final decision is not widely publicized, though it is available on the Internet. But it has not appeared in the medical literature, and has been avoided by the lay press. I think there are many reasons for that. But one thing they would have to say is, 'perhaps we were a little ahead of the data,' or 'perhaps we might have to back up a little bit from some of the statements that were made,' because I think we're all reassessing, and more data is needed."