Merck Defends Handling of Vioxx Recall

Executives of Merck(MRK Quote - Cramer on MRK - Stock Picks) on Wednesday emphatically defended their handling of the arthritis drug Vioxx, saying they acted promptly to withdraw the drug when clear scientific evidence showed that long-term use increased the risk of heart attack and stroke.

Any claim that the company dawdled in pulling the drug "is contradicted by the facts," said Peter S. Kim, president of Merck Research Laboratories, in a Wednesday news conference.

Merck announced the Vioxx recall on Sept. 30, a move that knocked 27% off the company's share price that day. The stock has continued to decline since then, falling as low as $29.75. Recently, shares are off 49 cents, or 1.6%, to $30.36. Shares of Pfizer (PFE Quote - Cramer on PFE - Stock Picks), whose rival drug Celebrex comes from the same family of drugs, have also been under pressure from time to time since the Vioxx recall.

Kim reaffirmed that Merck will continue to test Arcoxia, which belongs to the same class of drugs as does Vioxx. Arcoxia is sold in 47 countries, but it is still under review by the Food and Drug Administration.

Kim reiterated what Merck officials said when they announced the Vioxx recall: The company quickly acted after results of a carefully-controlled study showed that patients taking Vioxx for more than 18 months had a higher risk of heart attack and stroke than patients receiving a placebo.

If the clinical trial had been discontinued at 18 months, there would have been no statistically significant difference in these dangerous side effects between the patients taking Vioxx and patients taking a placebo, Kim said. For the first 18 months, this clinical trial involving 2,600 patients produced results that were "completely consistent" with the results of earlier tests that led to Vioxx's approval by the Food and Drug Administration, Kim said.

This latest clinical trial, nicknamed APPROVE, was testing whether Vioxx had any beneficial impact on colon polyps. The test was halted immediately after the safety issues were discovered.

Kim also pointed out, as he did on Sept. 30, that Merck acted only after it had been informed by an independent safety monitoring committee that was supervising the APPROVE trial. Merck never saw the results of this study until it was informed about the side effects in late September, Kim said. This independent committee had met twice a year for the four-and-a-half years that this study had been conducted. Merck will present results of the APPROVE trial at a medical conference in San Antonio, Texas on Oct. 18.

Merck estimates that 105 million U.S. prescriptions were written for Vioxx between May 1999, when the product was launched, through August 2004. The company says approximately 20 million people in the U.S. have used the drug. The company said it cannot at this time estimate the number of people outside the U.S. who have used the drug.

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