terça-feira, 3 de julho de 2007

WSJ: risco cardiovascular do Vioxx é mais precoce ainda

The Wall Street Journal informa com exclusividade que os riscos cardiovasculares decorrentes do Vioxx são mais precoces do que descritos nos estudos anteriores. Problemas para a Merck. New Vioxx Study May Cast Doubt On Merck Claims By HEATHER WON TESORIERO July 3, 2007 In a new blow to Merck & Co.'s defense in the Vioxx litigation, results from a yet-to-be-published study suggest that increased heart risks associated with the painkiller began immediately after patients started taking the drug. Since Merck withdrew Vioxx from the market in September 2004, it has argued that patients weren't at any heightened risk of a serious cardiovascular event unless they had taken the medicine for at least 18 months. The new study, known as Victor, was conducted by researchers at Oxford University in England. A Merck defense attorney sent a copy of the study to New Jersey Superior Court Judge Carol E. Higbee along with a letter saying that it was "our understanding that this manuscript has been accepted" for publication by the New England Journal of Medicine. A prepublication version of the study was reviewed by The Wall Street Journal. The study, which was designed to see whether the drug would curb progression of colon cancer, compared Vioxx, known generically as rofecoxib, with placebo in a total of 2,434 patients who were followed for two years. The study was halted when Merck pulled Vioxx from the market after another study, known as Approve, linked the drug to an increased risk of heart attacks and strokes. The new report includes only information about cardiovascular findings. According to the manuscript, 16 of the 23 cardiovascular events occurred in the Vioxx patients, and half of those occurred in patients within 12 months of taking the drug. "It would appear...that patients do not need to take rofecoxib for 18 months to be at increased risk of a cardiovascular thrombotic event," the authors wrote. The study also suggests that by 14 days after patients stopped taking the drug, the risk of heart and stroke went away. In the wake of the withdrawal, Merck faces about 28,000 lawsuits. Of those that have gone to trial, the company has won 10 and lost five. A spokeswoman for the New England Journal of Medicine, citing publication policy, declined to discuss the status of the manuscript. In a statement, Merck's outside counsel Ted Mayer said, "The reported findings with respect to confirmed thrombotic events in short-term use are not supported by the data found in the other available large placebo studies with Vioxx, including Alzheimer's studies, ViP and Approve."

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