Summary

Original source:
http://www.reuters.com/newsArticle.jhtml?type=businessNews&storyID=6888727

Details

• Bayer AG may have known its withdrawn cholesterol-lowering drug Baycol caused a high rate of a serious muscle condition more than a year before it added a warning to its label, according to a prominent medical journal.
• An editorial in the Journal of the American Medical Association is one of several articles to appear in next week's edition focusing on drug safety and the ability of the U.S. Food and Drug Administration to monitor it effectively.
• The articles were released early amid a rising furor over the recent withdrawal of Merck & Co.'s arthritis drug Vioxx and subsequent questioning by critics of the U.S. Food and Drug Administration's rigor in assessing Vioxx's safety.
• The editorial suggests there is a critical inadequacy in the system of monitoring drug safety as it falls to the drug companies themselves to collect, evaluate and report data from postmarketing studies of their own products.
• A review of published information and data obtained from internal company documents, which the authors saw while serving as experts for defendants in Baycol law suits, showed the company knew of the drug's risks earlier than stated.
• Bayer said in response that it closely watched the safety of Baycol after its approval and amended the drug's label as evidence of adverse reactions became apparent.
• "It is unreasonable to expect that the same agency that was responsible for approval of drug licensing and labeling would also be committed to actively seek evidence to prove itself wrong," the authors said.
• However, Brian Strom, who has been a member of the FDA drug safety and risk management advisory committee, in a separate article argued that the system worked in the case of Baycol despite the obvious conflict of interest.

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