STUDY BY VIOXX CRITIC LINKS DRUG TO EXTRA CORONARY CASES

Merck & Co.'s arthritis drug Vioxx may have caused as many as 140,000 excess cases of serious coronary heart disease in the U.S. by the time it was withdrawn from the market in September, an FDA official and several fellow scientists conclude in a study published in a medical journal. Many of these cases of heart disease may have been fatal, David Graham, associate director for science in the U.S. Food and Drug Administration's Office of Drug Safety, writes in the Lancet. His findings will likely raise the volume on the drug-safety debate that has swept Washington in recent months. Dr. Graham and other critics of the FDA accuse the agency of being too slow to ban or tighten regulations on medicines that cause serious side effects. Dr. Graham's study compares the incidence of coronary heart disease in patients taking Vioxx and other anti-inflammatory drugs. The study analyzed data from 1.4 million patients taking such drugs in California from 1999 to 2004. People taking Vioxx had a 34% higher chance of coronary heart disease when compared with people who used other anti-inflammatory drugs, the study concludes.
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Jeanne Whalen, The Wall Street Journal, 01/25/2005
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