page response, defended itself against Topol's assertions. "Dr. Topol neglects to mention the fact that Merck undertook three separate clinical studies designed, collectively, to assess the cardiovascular safety of Vioxx versus placebo," the Merck statement said. The company said it was the results from one of those studies that led to its "decision to voluntarily withdraw Vioxx from the market worldwide." That trial was designed to see if Vioxx could prevent recurrence of colon polyps, which can become cancerous. Dr. Garret FitzGerald of the University of Pennsylvania said it was possible all COX-2 inhibitors could affect heart risk by acting on the epithelium that lines blood vessels. "We now have clear evidence of an increase in cardiovascular risk that revealed itself in a manner consistent with a mechanistic explanation that extends to all the coxibs," he wrote in a separate editorial in the Journal. "It seems to be time for the FDA urgently to adjust its guidance to patients and doctors to reflect this new reality. Only the FDA can provide unbiased and informed guidance; it has a role to play beyond watchful waiting." --More 2339 Local Time 2039 GMT
