Calling it a Ã¢â‚¬Å“potential public health disaster,Ã¢â‚¬Â advisors to the U.S. Food and Drug Administration (FDA) soundly refused to recommend the approval of MerckÃ¢â‚¬â„¢s new painkiller Arcoxia, which the company developed to succeed <"http://www.yourlawyer.com/topics/overview/vioxx">Vioxx, a dangerous drug that was pulled from the market in 2004. (Both Vioxx and Arcoxia are in the same class of drugs, a type of non-steroidal anti-inflammatory drug (NSAID) known as COX-2 inhibitors.) At a meeting today of the FDAÃ¢â‚¬â„¢s Arthritis Advisory Committee, the panel voted 20-1 against FDA approval of the drug, although that vote is non-binding and the FDA doesnÃ¢â‚¬â„¢t necessarily have to follow the panelÃ¢â‚¬â„¢s recommendation.
The fight against Arcoxia (etoricoxib), intended to be used to treat osteoarthritis, was led by Dr. Daniel Graham, an FDA scientist in the Office of Surveillance and Epidemiology, a part of the FDAÃ¢â‚¬â„¢s Center for Drug Evaluation and Research (CDER). Ã¢â‚¬Å“What youÃ¢â‚¬â„¢re talking about is a potential public health disaster,Ã¢â‚¬Â Graham said. Ã¢â‚¬Å“We could have a replay of what we had with rofecoxib,Ã¢â‚¬Â another name for Vioxx.
Graham and other advisors noted that Arcoxia may carry with it the same increased risk of heart attacks and strokes that plagued Vioxx; they also claim that Arcoxia is no more effective in treating arthritis pain than other safer alternatives. Ã¢â‚¬Å“There is nothing special about this drug that would warrant giving it to patients and putting them at risk of a cardiovascular death, period,Ã¢â‚¬Â noted another committee member, Dr. David Felson of Boston University.
Sidney Wolfe, director of the Health Research Group at watchdog Public Citizen, was asked to testify at todayÃ¢â‚¬â„¢s committee meeting. Wolfe not only urged that MerckÃ¢â‚¬â„¢s application be rejected by the FDA, but he also suggested that the drug should be pulled from the market in the 60 countries where it is currently sold. Ã¢â‚¬Å“How can the approval of etoricoxib and the large numbers of preventable, life-threatening cardiovascular adverse reactions be justified?Ã¢â‚¬Â Wolfe asked the committee. Ã¢â‚¬Å“Why should the similarly dangerous offspring of Vioxx be approved? The answer is that it should not.Ã¢â‚¬Â
Ã¢â‚¬Å“It is time to shut the door on further additions to this dangerous class of COX-2 inhibitor drugs,Ã¢â‚¬Â Wolfe added. Ã¢â‚¬Å“The idea that there may be certain patients, however unidentifiable they are, who might benefit from this drug is just not good enough as a basis for its approval. In addition, further trials on these COX-2 drugs are unethical and should be stopped.Ã¢â‚¬Â