Dr. Steven Nissen, cardiologist at the noted Cleveland Clinic, will lead an unprecedented international study of the safety of the COX-2-inhibiting pain drug Celebrex, the only COX-2 inhibitor remaining on the market after the withdrawal of Vioxx and Bextra. Leading an unusual mix of academic researchers, government watchdogs and pharmaceutical industry insiders, the study will be funded by Pfizer, Inc., manufacturer of Celebrex, at an estimated cost of $100 million.

Both Vioxx and Bextra were withdrawn after studies showed a link between the COX-2 inhibitors and heart attacks, strokes and other adverse cardiovascular events. Vioxx, manufactured by Merck and Co., is currently under review in courtrooms across the country as thousands of personal injury victims bring lawsuits against the manufacturer for failure to warn patients and doctors of the cardiovascular risks of the drug.

The Cleveland Clinic study will test Celebrex against two types of NSAIDs, ibuprofen (sold over the counter as Advil, Motrin and many other brands) and naproxen (sold as Aleve and Naprosyn), and may provide answers to millions of arthritis patients concerned about the risks associated with COX-2 inhibitors. Dr. Nissen has served on FDA drug advisory panels in the past and chaired one on the COX-2 drugs. Nissen and another Cleveland Clinic cardiologist, Dr. Eric Topol, were among the first doctors in the U.S. to publish warnings about the safety of Vioxx.

Sales of Celebrex worldwide have declined 45% in 2005 over 2004, but the drug still produced over $1.25 billion in revenue for Pfizer during the first nine months of the year. Pfizer is betting that the study, called PRECISION for Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen or Naproxen, will raise consumer confidence in their drug. There are also considerable consumer concerns about the over-the-counter drugs as well. Nissen estimates the study will take approximately four years to produce results. The study will test about 20,000 people throughout the U.S., Canada, Eastern Europe, Australia and South America.

Source: Marilynn Marchione, “Study to Test Safety of Celebrex,” Associated Press, December 13, 2005; Stephanie Saul, “Pfizer to Finance $100 Million Safety Study of Celebrex,” New York Times, December 14, 2005.