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Whistleblower Warns of More Vioxx Risks
Thursday, February 17, 2005
Use of the painkiller Vioxx poses the risk of hundreds to thousands of additional heart attacks in older men, a Food and Drug Administration whistleblower told a panel reviewing the safety of painkillers.
Dr. David Graham, an FDA advisor, spoke at an FDA meeting of advisers about the safety of cox-2 inhibitor drugs Vioxx, Celebrex, and Bextra. When speaking on the Merck manufactured drug Vioxx, which was recalled from the market in September 2004, he said studies indicate a range of increased heart attack risk, from as few as 400 or as many as 10,800 additional heart attacks in men aged 65 to 74. Dr. Graham also cautioned that patients in clinical trials are generally healthier than patients in the real world, so the figures could be on the low end. The typical user of this type of painkiller is someone in their 60s, not only men, with other health problems. That person already had a one-in-50 risk of heart attack, he said.
Dr. Graham said he believes there is also a risk in taking Celebrex at high doses, but does not have enough information on Bextra. "I'm attracted to the Cox-2 hypothesis," Graham said, referring to suggestions that the heart problems cover the entire cox-2 class of drugs, which include Vioxx, Celebrex, and Bextra.
An official of Merck said at Wednesday's hearing that the problem appears to affect the whole class of drugs, while Pfizer Inc., the maker of maker of Celebrex and Bextra argued those products are safe.
When Merck withdrew Vioxx on Sept. 30 the company acted because it feared some problem with the drug itself was leading to the strokes and heart trouble. But Dr. Ned S. Braunstein, senior director of Merck Research Laboratories, told the panels that since then studies suggesting similar problems with Celebrex and Bextra have changed his mind. "The data strongly suggest it is a class effect" for all drugs of that type, Braunstein said.
Cox-2 inhibitors are designed to help people in chronic pain from conditions such as arthritis. At least two other cox-2 drugs are awaiting approval from the FDA, Arcoxia from Merck and Lumiracoxib from Novartis Pharmaceuticals.
Cox-2 inhibitors have become blockbuster sellers over the past 15 years, offering relief from chronic pain without causing the stomach and intestinal troubles that plague many other painkillers. The advisory committees are holding a three-day session to gather data on the safety of Cox-2 inhibitors and to make recommendations regarding their future use. These recommendations could range from limiting these drugs to people not known to be at risk of heart problems, reducing the dose or duration of use, requiring tougher warning labels and even taking the drugs off the market.
An FDA health official told the panels there were preliminary indications of heart problems with Vioxx before it was withdrawn, but it was difficult to sort through conflicting data. Dr. Lourdes Villalba, medical officer responsible for Vioxx at the FDA's Center for Drug Evaluation and Research, said a study done in 2000 comparing Vioxx with the painkiller naproxen showed a higher rate of heart problems with Vioxx, but other studies had conflicting results.
Dr. Kenneth M. Verberg, Pfizer vice president for inflammation and immunology, defended Celebrex as safe, though he said there is little data on use of the drug for more than one year. Further long-term testing of Celebrex is needed, he said.
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