Vioxx: A Drug That Killed 60,000 Americans

A little-known drug called Vioxx was prescribed to over 20 million Americans, leading to one of the largest pharmaceutical recalls in history. The painkiller, developed by Merck, was withdrawn from the market in 2004 after evidence showed it doubled the risk of heart attacks and strokes.

The story is told through a personal account of a former Navy buddy who recalled a conversation with his friends about Vioxx. They had never heard of the drug, despite being well-read and successful individuals.

Vioxx was approved by the FDA in May 1999 after a six-month 'priority review', which prioritized its perceived therapeutic advantage in reducing gastrointestinal side effects compared to older NSAIDs like naproxen.

The pre-approval clinical trials involved around 5,000 patients across eight to nine studies, but they were not designed to rigorously evaluate heart-related outcomes. The FDA's priority pathway expedited review was based on GI benefits, despite the limitations of the trials.