The stunning decision was based on data from a three-year clinical trial on colon cancer that showed an increased risk of heart attack, strokes and other cardiovascular complications from cancer patients who were taking Vioxx.
Study abruptly halted
The clinical trial, originally intended to show that taking Vioxx in a 25-milligram dose prevented the recurrence of polyps in the colon and rectum, was abruptly halted after Merck found the higher heart risk compared to patients who were taking placebos.
Vioxx is one of Merck's biggest-selling drugs, bringing in $2.5 billion in sales last year, according to industry data consultant NDC Health in Atlanta, second in the category to Pfizer's Celebrex. Merck supported Vioxx with $78 million in measured media spending last year, according to TNS Media Intelligence/CMR, behind only its allergy medication Singulair ($114 million) and cholesterol medication Zocor ($82 million).
Omnicom Group's DDB Worldwide in New York handles the direct-to-consumer account for Vioxx, while Interpublic Group of Cos.' Foote Cone & Belding, New York, has the professional business. Merck spent $45 million on Vioxx in the first six months of this year.
"We're taking this action because we believe it best serves the interest of patients," Merck's chairman and president-CEO, Raymond V. Gilmartin, said in a statement. "Although we believe it would have been possible to continue to market Vioxx with labeling that would incorporate these new data, given the availability of alternative therapies and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take."
The Food and Drug Administration, which approved Vioxx in 1999, accepted the voluntary withdrawal and issued a public health advisory for patients currently on the drug.
"Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market," FDA Acting Commissioner Dr. Lester M. Crawford said. "Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo."
Merck announced the news before the stock market opened. In pre-market activity on the New York Stock Exchange, Merck shares dropped more than 14%, or $6.35, to $38.72.