Merck Vioxx News and Press Releases

A controversial study of Vioxx, the arthritis painkiller drug removed from the market in September, has finally been published in the British medical journal The Lancet. The US Food and Drug Administration study, by lead researcher Dr. David Graham, of the FDA's office of drug safety suggests as many as 140,000 patients in the US may have suffered serious heart damage from taking Vioxx.

Graham says many of the cases may have been fatal.

The study was originally slated to be published in November, however, Graham, says the FDA threatened to dismiss him if the study appeared in a medical journal. Vioxx was voluntarily removed from the market by Merck & Co. when clinical trials linked the Cox-2 inhibitor to an increased heart attack and stroke risk.

Graham's study compared the incidence of coronary heart disease in patients taking Vioxx and other non-steroidal anti-inflammatory drugs (NSAIDs). Graham and colleagues looked at 1.4 million patients in California who had been prescribed Vioxx and other NSAIDs from 1999 to 2004. The team reported finding more than 8000 cases of coronary heart disease and just over 1,500 sudden cardiac deaths.

Patients taking Vioxx had a 34 percent greater chance of coronary heart disease, compared with those taking other NSAIDs, according to Graham's findings.

Merck Getting By With Or Without VIOXX

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Even with the elimination of VIOXX, Merck managed growth in revenue for the fourth quarter.

2005-01-25 - Merck announced that earnings per share for 2004 were $2.61, reflecting a $0.25 unfavorable effect on third-quarter results associated with the company's Sept. 30 voluntary worldwide withdrawal of VIOXX, compared to earnings per share from continuing operations* of $2.92 in 2003. In addition, 2004 results include an additional $604 million reserve recorded in the fourth quarter solely for future legal defense costs for VIOXX litigation. The company has not established any reserves for any potential liability relating to the VIOXX litigation.

"We have stated previously that we intend to defend these lawsuits vigorously," said Merck Senior Vice President and General Counsel, Kenneth C. Frazier. "This reserve is consistent with our commitment to defend the company."

Merck will continue to monitor its legal defense costs and review the adequacy of the associated reserves. The company has not established any reserves for any potential liability relating to the VIOXX litigation.

"As a company, we are moving beyond the VIOXX withdrawal. We are focused on renewing growth and accelerating the process of change to position Merck to best meet the demands of the market and the challenges of the environment," said Merck Chairman, President and Chief Executive Officer Raymond V. Gilmartin. "We continue to streamline our business processes, allocate resources to the areas of highest potential growth and accelerate the speed at which we develop products. We are also driving growth through new and established products, new indications and formulations, and clinical trials that bolster our products' safety and efficacy profiles. In addition, our financial strength supports our ability to grow both internally and through licensing agreements and targeted acquisitions."

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