MBA 520 Ethics and Leadership
in a Global Environment
15 November 2009
Merck, the FDA, and the VIOXX Recall
In 1999, Merck started a clinical trial called VIGOR, checking the effectiveness of VIOXX in patients with gastrointestinal problems, and in this trial they noted for the first time that patients taking VIOXX suffered roughly twice as many heart attacks and strokes as those taking the control, Naproxen. Early in 2000, Merck began another clinical trial intended to test for the effectiveness of VIOXX as a possible cure for colon cancer. By 2003, the panel monitoring this trial noted that the incidence of heart attacks and strokes was 20 percent higher among patients on VIOXX than on the placebo and by 2004 this difference was 80 percent; in September of that year Merck withdrew Vioxx from the market (Waymor).
If I was the CEO of Merck I would have disclosed these risks to the FDA as soon as they were discovered so that the patients currently taking VIOXX would have been able to make their own informed decisions whether to continue taking it or not. Merck profits would have dropped, but patients would have lived and Merck’s legal liabilities would have been far less. By the time Merck withdrew VIOXX, they had known of evidence that it lead to increased cardiovascular risks for at least three years and possibly more and had publicly denied that there was any risk associated with VIOXX (Waymor).
On September 30, 2004, Merck ran an ad in many national newspapers which announced their withdrawal of VIOXX from the market. The advertisement consisted of a letter from Raymond B. Gilmartin, Chairman, President and CEO of Merck, and included the company motto: 'where patients come first." The ad typically appeared in the business section of the newspaper, but placing it in the daily newspaper around the country suggests that it was meant to be viewed by the public at large....