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Public Database and New Method Proposed to Enhance Drug Safety for Consumers

In a recent study published Monday in the Archives of Internal Medicine several authors propose a new way of monitoring drugs that could increase the margin of safety for consumers. Utilizing internal documents from the Vioxx litigation, Dr. Joseph S. Ross of the Mt. Sinai School of Medicine in New York and others set out a method of analyzing clinical studies and post-marketing surveillance data that showed had Merck utilized their method, the cardiovascular risk of Vioxx would have been known two years before Merck withdrew the drug from the US market.

How could we be doing post-market surveillance in a better way? said Dr. Ross, an assistant professor of geriatrics and palliative medicine at Mount Sinai School of Medicine in Manhattan. For drugs that we are concerned about, that are high risk, this could be a blueprint going forward. The method used is called meta-analysis, which simply means analyzing a number of studies together in order to obtain a larger view of drug safety. DR. Ross and his co-authors looked at 30 placebo controlled studies in which Vioxx was administered for at least 4 week or longer in doses of 12.5 mg or greater. Placebo controlled means a group of matched subject were given a sugar pill and compared to subject given Vioxx in order to validate the study results. Utilizing this process, Dr. Ross and colleagues determined that the risk associated with Vioxx was evident 2 years before withdrawal.

Merck has questioned the research method and contends that its own meta-analysis did not reveal any risk until the time of withdrawal. Other critics note that there are so many drugs on the market that it would probably be impossible, if not prohibitively expensive, to cumulatively track all of them, said Dr. Elliott M. Antman, a professor of medicine at the Harvard Medical School. Still, Dr. Antman said it would make sense for the agency to give conditional approval to certain new drugs, requiring drug makers to file cumulative analyses of safety and efficacy data several years later in order to obtain permanent approval.

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