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Vioxx Problems Known Years Before Recall
Date:11/23/2009

od and Drug Administration approval are too short and are usually not designed to uncover safety problems, Ross said.

"There is no mandate to publish the trials, so if you don't have access to the FDA records, you don't know what the drug risk is," he said. "Once it's approved, maybe or maybe not, the trial continues to be studied, and even then, there is no mandate to publish the findings."

The report, published in the Nov. 23 issue of the Archives of Internal Medicine, should be used to better understand drug safety, Ross said.

Ross's group set out to test the truth of a statement by Merck's chief executive officer before a U.S. Senate committee in November 2004 that earlier clinical trials showed no difference in the risk of heart events between patients taking Vioxx (rofecoxib) and those taking a placebo.

The researchers found 30 trials with a total of 20,152 patients, comparing the anti-inflammatory medication with placebo.

Twenty-one of those trials had been completed by the end of December 2000, and a risk of heart attack, stroke and death among patients taking Vioxx was clear and should have led to a safety warning, Ross said.

The risk for those cardiovascular events was 35 percent higher among patients taking Vioxx compared with those taking placebo. The association grew as more trials were completed, increasing to 39 percent in April 2002, when newer data was analyzed, and to 43 percent in September 2004, according to the study.

"Physicians and the public deserve to be in a position to make informed choices about risks and benefits, and the disclosure and dissemination of information about potential risk immediately after its recognition is absolutely essential. Our study provides insight into what should have been known about the risks of rofecoxib," the authors wrote. "If we are to detect harms early and protect the public's health, while ensuring the availability of new, clinic
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