2004: The Vioxx Scandal

In late 2004, after three years of denying that its arthritis drug Vioxx could induce heart attacks and strokes, Merck finally bowed to reality and withdrew it from the market. Commenting on this event, the New England Journal of Medicine described it as “the largest prescription-drug withdrawal in history.”

A few weeks later, in testimony presented to the United States Senate Committee on Finance, Dr. David J. Graham (Associate Director for Science and Medicine in the FDA’s Office of Drug Safety) estimated that between 88,000 to 139,000 excess cases of heart attack had been caused by Vioxx in the U.S. alone, and that, of these, around 30-40% of the patients had probably died.

However, these figures are made even worse by the fact that Merck had already been aware of Vioxx’s potential dangers long before it was eventually withdrawn.

For example, nearly a year before Merck had received results from the clinical trial that supposedly prompted it to withdraw the drug, it had already received preliminary results from a earlier, separate, study of patient records that similarly indicated that Vioxx posed cardiovascular risks.

Moreover, although Merck had long insisted that it had never pursued a clinical trial to directly study the heart risks of Vioxx, arguing that other tests it was conducting would supply those answers just as quickly, it had actually been poised to begin a major cardiovascular study of the drug in 2002 but had abruptly cancelled the project just before it was set to start.

Worse still, official company documents show that Merck had actually considered whether to develop a study to test the possibility that Vioxx might pose a heart risk as early as 2000. Instead, however, it rejected pursuing this study and its marketers had apparently feared that carrying it out could send the wrong signal about the company's confidence in the drug

Not surprisingly, therefore, criticism of Merck’s scandalous deceptions reached right up to the U.S. Congress. At a congressional hearing on Merck’s sales tactics, for example, Congressman Henry Waxman openly stated that it had misled doctors for years about the safety of the drug. "Health risks were viewed as 'obstacles' the sales force was instructed to surmount," he said.

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