Grassley Says FDA Is Suppressing Graham Study on COX-2 Inhibitors in Advance of Advisory Panel Meeting
Sen. Chuck Grassley (R-Iowa) on Friday in a letter to FDA Acting Commissioner Lester Crawford asked that agency officials respond by Monday to allegations that regulators instructed drug safety officer David Graham not to discuss a recent, unpublished study he co-wrote on COX-2 inhibitors in his presentation at an advisory committee hearing scheduled for Thursday, the New York Times reports (Harris, New York Times, 2/12). Members of the FDA arthritis and drug safety and risk management advisory committees on Wednesday will begin a three-day meeting to determine whether to remove COX-2 inhibitors from the market over safety concerns.
Questions have arisen about the safety of COX-2 inhibitors in recent months after Merck in late September 2004 withdrew the COX-2 inhibitor Vioxx from the market because of safety concerns. FDA recently announced that Bextra -- a COX-2 inhibitor manufactured by Pfizer -- could increase patient risk for heart attack and stroke, and recent studies have found that the safety concerns associated with Vioxx could apply to all COX-2 inhibitors. The members of the advisory committees will review hundreds of documents from FDA scientists and the manufacturers of COX-2 inhibitors and hear testimony from scientists, physicians and patients (American Health Line, 2/11).
An FDA spokesperson said that Graham was advised to "rely on published literature in his talk" and that it remains his decision whether to include data from his recent study. Graham maintains that agency officials have instructed him not to present the findings because they say the study has not been adequately vetted, the Times reports. Graham said, "This study bears directly on the whole reason why this advisory meeting is being held in the first place."
Study co-author Gurkirpal Singh of Stanford University School of Medicine said, "We have significant new information that will alter the thinking about these drugs. I don't understand why they won't let us present this information" (New York Times, 2/12).
Jonca Bull, director of the FDA office that reviews new arthritis medications -- in a memo to members of the advisory committee released on Friday -- wrote, "Is there a patient population for whom the risk is warranted, given the known potential for benefit?" She also asked if "COX-2 drugs continue to be marketed, how much and what kind of information is necessary to justify" approval of such treatments? (American Health Line, 2/11).
Gail Cawkwell, Pfizer's COX-2 medical director, said, "What we hope will come out of this is a sense of scientific resolution on what is the right approach. What we don't think will come out of it is an immediate change to the marketing of our products."
Lehman Brothers analyst Anthony Butler said the review is "not likely to result in the complete withdrawal" of Celebrex and Bextra. Webster Consulting Group President David Webster said the panel is likely to consider limiting the way COX-2 inhibitors are advertised and suggest that they be prescribed only to those at risk of stomach bleeding.
A committee of the European Medicines Agency this week also is holding meetings to address potential cardiovascular risks of COX-2 inhibitors (Schwab, Newark Star-Ledger, 2/13). FDA has advised physicians and patients to exercise caution with painkillers while the advisory committee investigates the issue (Schmid, AP/Las Vegas Sun, 2/13).
In addition to evaluating the safety of COX-2 inhibitors, the panel also might evaluate "how well the FDA is doing its job," according to the Times (New York Times, 2/12). Ken Reid, editor of Washington Information Source -- which publishes five newsletters that track FDA -- said that the agency is "very close to losing their oversight over drugs" and must "take decisive action" (Newark Star-Ledger, 2/13).