Return of Vioxx to Market Is Possible, Merck Says

A senior Merck official on Thursday at an FDA advisory committee meeting said that the company might return the COX-2 inhibitor Vioxx to the market in the event the agency determines that the benefits of all COX-2 inhibitors outweigh the safety risks, the Wall Street Journal reports. The committee, which began three days of meetings on Wednesday to examine the safety of COX-2 inhibitors, includes members of the FDA arthritis and drug safety and risk management advisory committees. Merck withdrew Vioxx from the market in September 2004 over potential safety risks, and the possible return of the medication would represent "a shocking turn of events after one of the biggest drug withdrawals in U.S. history," the Journal reports. According to the Journal, Merck might return Vioxx to the market as part of a "strategic" move that would help the company in Vioxx-related lawsuits, serve as "a boon to the company's finances" and help the company "make a case" for FDA approval of the COX-2 inhibitor Arcoxia. However, Vioxx likely would face "tough new label warnings and possibly other restrictions," the Journal reports (Wilde Mathews/Hensley, Wall Street Journal, 2/18). According to the New York Times, the announcement by Merck "was a remarkable disclosure in an already landmark hearing," in which some committee members have indicated that "they believe that all the COX-2 drugs ... carry heart risks" (Harris, New York Times, 2/18). FDA at the meetings "has signaled that it would be willing to consider a re-entry to the market" for Vioxx, the Journal reports (Wall Street Journal, 2/18). Panel Chair Alastair Wood said that a reintroduction of Vioxx to the market "would be an amazing outcome" (Mondics, Philadelphia Inquirer, 2/18).

Merck Head of Research Testimony
Merck head of research Peter Kim testified that "if the advisory committee and the FDA conclude that the benefits of this class outweigh the risks in some patient populations, then we would have to consider the implications of these new data given the unique benefits Vioxx offers." Kim said that Merck withdrew Vioxx from the market "based on the information that was available to us at that time, knowing there were alternative therapies." However, he added that "we're no longer dealing with a situation where Vioxx is unique in its cardiovascular risk." According to the Journal, the testimony "appeared to be part of an orchestrated rollout," after the company "se[t] the stage for the idea in a presentation to the panel Wednesday" (Wall Street Journal, 2/18). Merck Research Laboratories Senior Director Ned Braunstein on Wednesday testified that all COX-2 inhibitors likely increase risk for cardiovascular events. Braunstein said that despite the claims of other pharmaceutical companies, "The data strongly suggest it is a class effect" (Kaiser Daily Health Policy Report, 2/17). Kim on Thursday said that in the event the committee determines Vioxx has similar risks as Celebrex and Bextra -- COX-2 inhibitors that remain on the market -- "then that would be important to us to take that into consideration with regard to Vioxx" (New York Times, 2/18). Kim added, "There are unique benefits to Vioxx. The science has progressed, and we need to take that science into consideration" (Schmid, AP/Las Vegas Sun, 2/17).

Merck Statement
Merck officials on Thursday said that the company "has not altered its position on the voluntary withdrawal of Vioxx" and that "anything further would be speculation" (Wall Street Journal, 2/18). However, Merck said in a statement, "If the advisory committee and the FDA conclude that the benefits of this class outweigh the risks in some patient populations, then we would have to consider the implications of these new data given the unique benefits Vioxx offers" (New York Times, 2/18).