FDA Panel Member Removed from Review of COX-2 Inhibitors

Curt Furberg, a professor at Wake Forest University, has been removed from an FDA advisory panel set to review the safety of COX-2 inhibitors next year, after he publicly questioned the safety of Pfizer's Bextra, the Wall Street Journal reports (Mathews/Hensley, Wall Street Journal, 11/12). Preliminary results of a University of Pennsylvania study presented on Tuesday at the American Heart Association annual conference in New Orleans indicated that Bextra doubles patient risk for heart attack and stroke (California Healthline, 11/11).

Furberg said FDA informed him that he would no longer participate in a committee meeting next year to review the safety of COX-2 inhibitors, including Bextra, Pfizer's Celebrex and Merck's Vioxx, after he was quoted in the New York Times as saying Bextra appeared to have similar risks to Vioxx -- which was withdrawn from the market in September for safety reasons -- and Pfizer tried to conceal that information (Wall Street Journal, 11/12). The FDA meeting on COX-2 inhibitors is scheduled for mid-February (California Healthline, 11/11).

"They'd said because I had taken a public position, I was disinvited," Furberg said, adding that his statements were "evidence-based." Furberg said, "I collected the information to get evidence to contribute to the debate, I drew a conclusion and I'm off." Sandra Kweder, acting director of FDA's office of new drugs, said, "If he's already expressed a particular point of view, and especially written a paper on it, it would be difficult to expect him to come to such a meeting and be objective about the subject." An unnamed Pfizer spokesperson said, "Pfizer would never intervene in any way with the FDA's regulatory process" (Wall Street Journal, 11/12).

FDA's arthritis advisory board committee, which will meet in February to discuss the safety of the COX-2 inhibitor class of arthritis pain relievers, plans to review "all available data" about COX-2 inhibitors, including "confidential unpublished trials" and ongoing "long-term safety studies," the AP/Detroit News reports. The committee is scheduled to meet Feb. 16-17 to consider whether the heart safety risks that led Merck to voluntarily withdraw Vioxx from the market exist in other COX-2 inhibitors. According to the AP/News, a "crucial issue" for the panel is whether the painkillers cause blood clots or "simply fail to prevent [them] in people otherwise at risk for heart woes."

Kweder said last week that the committee will consider data from all available studies, including a 3,600-patient, placebo-controlled trial of Celebrex and a preliminary study of Bextra that found similar risks in the drug as were found in studies of Vioxx. However, the AP/News reports that the panel -- which also will discuss the ethics of placebo-controlled trials -- still might not have access to enough information to reach a conclusion about all COX-2 inhibitors. Gary Hoffman, chair of rheumatic and immunologic diseases at the Cleveland Clinic Foundation and a member of the FDA panel, said, "I don't know whether there is enough data available to say there is a class effect that would be appropriate to generalize to all COX-2 inhibitors about coronary artery disease. But that is what we are all concerned about." Hoffman added, "It's possible that the committee will decide there isn't adequate data and additional studies or ongoing studies need to be continued" (Henderson, AP/Detroit News, 11/12). CBS' "60 Minutes" on Sunday is scheduled to include a segment examining when Merck had evidence about the safety risks of Vioxx (Bradley, "60 Minutes," CBS, 11/14).