Sid Wolfe, health research group director at Public Citizen, a Washington-based consumer advocacy group, said he stumbled upon the Celebrex study while looking on the PhRMA website for something else. On Monday, Public Citizen renewed its call for the FDA to immediately ban Celebrex and Pfizer's other controversial painkiller, Bextra.
While the FDA said it will "review the petition carefully," the nation's largest health maintenance organization -- guided by outside studies -- has acted more decisively. Beginning today, 6.2 million Kaiser Permanente members in California no longer will receive new Bextra prescriptions.
Kaiser is urging doctors to avoid prescribing high doses of Celebrex "until information is available to reassure our physicians that the drug is safe," said Dr. David Campen, head of Kaiser's pharmacy operations.
The quiet release of the 1999 Celebrex study comes amid high-profile disclosure of heart problems with such popular painkillers as naproxen, Bextra, Celebrex, and Vioxx. The worries halted clinical trials, led to Vioxx being withdrawn from the market, and raised concerns among arthritis sufferers.
Amid the flurry of activity, European and American regulators are preparing for meetings this month to weigh the risks and benefits of the entire class of so-called cox-2 inhibiting painkillers, including Bextra, Celebrex, and Vioxx.
According to Pfizer's fourth-quarter earnings report, worldwide sales of Celebrex exceeded $3.3 billion in 2004, with $1 billion in revenue in the fourth quarter. Celebrex revenue rose by 24 percent that quarter, after Vioxx was taken off the market and Pfizer heavily advertised Celebrex. Bextra sales reached nearly $1.3 billion last year, with a 57 percent jump in fourth-quarter revenue.
Pfizer faces scores of lawsuits from angry investors and patients alleging harm from Bextra and Celebrex as well as consumer fraud allegations that claim Pfizer's advertising minimized health risks. In December, Pfizer agreed with the FDA's request to stop advertising both products. In addition, the Department of Justice has sought documents from the company and a coalition of attorneys general are scrutinizing Pfizer's marketing of Bextra and Celebrex.