Vioxx recall strategy aggressively defended by Merck

It is obvious that the public relations and strategy experts for Merck are asking the company leadership to mount an aggressive campaign to defend its strategy. Apart from statements made to the media, Merck has also inserted full-page ads in several leading newspapers discussing and defending its strategy related to Vioxx recall.

In a prepared testimony by Raymond V. Gilmartin, President, Chairman and Chief Executive Officer of Merck and Co., Inc. before the United States Senate Committee on Finance last week, nothing new was said. Here are the key points made:

• The Food and Drug Administration approved Vioxx only after Merck had extensively studied the medicine.
• Merck continued to extensively study Vioxx after it was approved for marketing to gain more clinical information about the medicine.
• Merck has promptly disclosed the results of numerous Merck-sponsored studies to the FDA, physicians, the scientific community and the media and participated in a balanced, scientific discussion of its risks and benefits.
• Until data from the APPROVe clinical trial became available in September, the combined data from randomized controlled clinical trials showed no difference in confirmed cardiovascular event rates between Vioxx and placebo and Vioxx and NSAIDs other than naproxen.
• While epidemiological studies have an important role to play, given their inherent limitations, when both epidemiological studies and randomized controlled clinical studies are available, the randomized controlled clinical trials are the most persuasive evidence.
• As soon as the data from the APPROVe study became available, Merck acted quickly to withdraw the medicine from the market.

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