Vioxx Problems Known Years Before Recall
MONDAY, Nov. 23 (HealthDay News) -- Problems with the popular arthritis drug Vioxx, including increased risk for heart attack, stroke and death, were known for years before the drug's voluntary withdrawal from the market in 2004, a new report says.
Contrary to claims by the manufacturer, Merck & Co., dangerous side effects were evident in 2000, a year after the drug was put on sale, but independent investigators lacked access to all the clinical trial data, so no one voiced concerns until four years later, say the authors of the latest look at the controversy.
In a statement released Tuesday, Merck officials said this: "Merck believes the article published in The Archives of Internal Medicine in today's issue related to Vioxx used unreliable methods and reached incorrect conclusions."
"The first time Merck observed a difference in a placebo-controlled study was when it learned the results of the APPROVe study in September 2004. We voluntarily withdrew Vioxx from the market within a week of those results," the statement continued.
"Merck acted responsibly -- from researching Vioxx prior to approval in studies with approximately 10,000 patients to monitoring the medicine while it was on the market -- to voluntarily withdrawing the medicine when it did," the statement said. "Our decisions were based on the data from well-controlled clinical trials."
But the authors of the new study believe the Vioxx saga points to a larger problem, one that involves the drug approval process in the United States.
"One of the challenges in health care is to recognize these safety risks early," said lead researcher Dr. Joseph S. Ross, an assistant professor of geriatrics and palliative medicine at Mount Sinai School of Medicine in New York City.
The trials that drug companies conduct to get U.S. Food 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.
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