The Vioxx debacle

Abstract

This paper discusses the issue on the market withdrawal of a popular pain relief drug - Vioxx. The popularity of this drug stems from its manufacturer's (Merck) claim that the drug has no gastrointestinal side effects making it superior to other pain relievers available in the market. However, a number of external clinical trials showed that Vioxx increased cardiovascular risk. Investigations showed that even before the drug was introduced in 1999, there was an awareness at Merck that Vioxx might carry significant cardiovascular risk but Merck's advertising did not include any mention of the risk of the heart problems that further studies revealed. The US Food and Drug Administration (FDA) then required Merck to send letters to physicians to correct "false or misleading impressions and information". In the end the withdrawal of this money-making drug from the market ensued. This caused Merck's stock price to fall by 40% and a loss of US$40 billion in market capitalization. The scandal has also put the FDA in the hot seat as calls for an independent drug safety board to monitor the safety of drugs that have been approved and are on the market. This episode shows that what Merck did was unethical. Drug companies must keep in mind that drugs and medical devices have risks but it is important that the risks be proportional to the benefits.