Regulatory Paternalism in the Market for Drugs: Lessons from Vioxx and Celebrex

Abstract

The trials and tribulations of the pharmaceutical industry made front-page news in the Fall of 2004. On September 30, 2004, Merck & Co. announced that it would voluntarily pull its Cox-2 inhibitor, Vioxx, from the market. To say the least, the decision to take the drug off the market caused no little stir. Vioxx, which had entered the market with great fanfare in 1999, had become an instant blockbuster drug with over one hundred million prescriptions, twenty million users, and about $2.5 billion in annual sales. The success of the drug paralleled that of two Pfizer Cox-2 inhibitors, Celebrex and Bextra. The success of all three drugs is (or at least, was) attributable to their apparent ability to satisfy the best of both possible worlds by relieving pain without provoking the risk of stomach or intestinal bleeding inherent to ibuprofen and similar drugs. The number "2" appended to the term Cox, with respect to drugs such as Vioxx, signified a welcome measure of specificity. Drugs in this family could work effectively where needed without causing disruption where they were not wanted. Indeed, Merck had such confidence in the ability of Vioxx to specifically target its effects that the company was seeking to expand the portfolio of permissible uses by raising the dosage to determine the effectiveness of Vioxx in treating polyps-intestinal growths that could become cancerous. However, during these trials, Merck discovered in its own clinical data an apparent increase in the number of negative cardiovascular occurrences, which, if extrapolated, "may" suggest that as many as 27,000 persons had died from the use of the product.