Merck Faces Increased Credibility Problems Over Arthritis Drug, Vioxx®
WHITEHORSE STATION, NJ -- February 11, 2005 -- A clinical trial gave early warning that those who took the arthritis drug, Vioxx® (rofecoxib), were at increased risk for heart attacks and strokes after just four months, according to an article published this week in the Wall Street Journal. Merck, the drug's manufacturer, halted the study, and withdrew Vioxx® from the market in September, 2004. At that time, the company suggested that patients could be at increased risk for heart problems only if they used Vioxx® for at least a year and a half.
Known as APPROVE, the clinical trial was to determine whether Vioxx® was beneficial for patients with colon polyps. A safety committee monitoring the study expressed their concerns about Vioxx®'s effects on the heart at their first meeting in January, 2002, according to the Journal. Later on, a chart tracking the rate of heart attacks, strokes, and congestive heart failure showed a greater rate of these events among Vioxx® users than among patients taking fake pills or placebos. In some cases, these Vioxx® side effects occurred after only four months.
The Journal reported study trends from the chart and committee records: a 20% higher chance of heart attack or stroke in Vioxx® patients than in those taking placebos in May, 2003; an increased risk of 40% in November, 2003; an increased risk of 80% in February, 2004; and finally, an increased risk of 120% in the month when sale of the drug was halted.
Merck Canceled Vioxx® Study (Valor Clinical Trial) in 2002
Merck also may be questioned about another study known as the Valor trial, which would have focused on Vioxx® patients who had experienced chest pain. The company abruptly dropped this clinical trial in March, 2002, before it began (New York Times, February 8, 2005). According to the Times, Merck had already contacted researchers, selected international study sites, contacted another drug manufacturer, and prepared a 70-page document about how the test should be conducted.
Merck stopped the Valor trial at about the same time as the company and government officials were in negotiations on the labeling of Vioxx®. Some critics of Merck feel that if the study had proceeded, researchers would have established the link between Vioxx® and heart problems much sooner.