Vioxx Reactions – Statements from the Medical Community

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VIOXX ® Worldwide sales in 2003 were $2.5 billion.  

Shares of Merck & Co. plunged nearly 27 percent. Investors erased a stunning $26.8 billion from Merck's market capitalization and sent its shares down $12.07 to close at $33. The Whitehouse Station , N.J. , company was immediately hit with litigation which claimed the claimed the drug is defective and Merck failed to warn of health risks associated with VIOXX ® .

"Some of us in the medical profession have seen this coming and have been discussing this with patients," said Dr. Calvin Brown, an associate professor of rheumatology at Rush University Medical Center in Chicago . "Doctors phones across the city are ringing off the hook. I don't think Merck hid anything, but they saw the glass as half full. But many of us in the medical profession saw it as half empty."

"Today's announcement by Merck is the latest evidence that this family of drugs, the Cox-2 inhibitors, once referred to as super aspirins are turning out to be super disasters," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "In trying to be a good citizen, Merck ignores its checkered history with VIOXX ® ."

"While the cause of these results is uncertain at this time, they suggest an increased risk of confirmed cardiovascular events," Peter S. Kim, president of Merck Research Laboratories, said in a prepared statement. He added that "while we recognize that VIOXX ® benefited many patients, we believe this action is appropriate."

In the first 18 months of their study, Merck said there was no difference in the risk of heart attack or stroke in patients taking either VIOXX ® or a placebo.

"Beginning after 18 months, however, the risk of cardiovascular event did increase among those on VIOXX ® ," said Merck chairman and chief executive officer Raymond Gilmartin. "Accordingly, we are withdrawing VIOXX ® effective today. We are taking this action because we believe it best serves the interest of patients."

"Patients who are currently taking VIOXX ® should contact their health care providers to discuss discontinuing use of VIOXX ® and possible alternative treatments," Merck said.

"In this study, there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking VIOXX ® compared to those taking placebo," Merck said in a press release.

"Given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal (of VIOXX ® ) is the responsible course to take," Merck chief Gilmartin said.

"This is a very significant negative for Merck. Not only is this a nearly $3 billion drug, but it calls into question the future of one the key drugs in its pipeline, Arcoxia," said Scott Henry, an analyst at Oppenheimer & Co.

"Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market," Acting FDA Commissioner Dr. Lester M. Crawford said in a statement.

"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."

In a statement Thursday announcing the withdrawal, Merck Chairman and CEO Ray V. Gilmartin said: "We're taking this action because we believe it best serves the interests of patients. 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."

Individual patients with a long history of taking VIOXX ® should not necessarily be alarmed by these findings, said Dr. Michael Fleming, president of the American Academy of Family Physicians.

"It's very difficult to translate findings from a population-based study into individual patients," he said. "If someone is taking VIOXX ® presently, they need to call their physician right away" to consult with their doctor as to the potential need for specific tests, Fleming advised.

"I am sure we are going to ask for more data but I can't tell you exactly what that data is,'' Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said on a conference call.

Acting FDA Commissioner Dr. Lester M. Crawford said that Merck was right in pulling the drug voluntarily.

"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," Crawford said in a statement Thursday.

In the three-year clinical trial, 3.5 percent of the VIOXX ® patients suffered a heart attack or stroke, while only 1.9 percent of the patients in the placebo group suffered a cardiovascular event, the FDA said.

"We agree with Merck's actions and believe they did the right thing," an FDA official said during a conference call this morning.

"Sure, this is a legal risk," said Jon Fisher, a fund manager at Fifth Third Bank, which owns Merck shares. "It's the society we live in. There are lawyers sharpening their pencils right now."

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