Untangling the Vioxx-Celebrex Controversy: A Story about Responsibility

Abstract

While the withdrawal of prescription drugs is not a new concept, the Vioxx and Celebrex controversy has put a new spin on the issue of withdrawal. Vioxx and Celebrex belong to the same class of drugs and both were linked to increased heart risks. While Merck chose to withdraw Vioxx from the market, Pfizer decided to keep Celebrex put, choosing instead to suspend all direct-to-consumer advertising and make small labeling changes. This paper attempts to construct a story about why these two companies took such contrasting reactions, which was right, and what should be done in the future. But before delving into that analysis, it is important to understand the background of the controversy, including the history and development of Vioxx and Celebrex, why they were approved in the first place, and the basis for such approvals. Next, it is crucial to comprehend the different medical studies that have been conducted, which are the basis on which action has been demanded from the companies. From there, it may then be possible to analyze the different actions taken by Merck and Pfizer and what resulted from such actions, which will allow for better basis in which to evaluate who was right. Finally, in every step of the controversy, the FDA’s actions will be examined, including its formal and informal guidance, regulatory powers, and an analysis of when and why it chooses to take or not take action.