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Merck & Co. sought patent protection for a way to reduce cardiovascular problems in Cox-2 inhibitors, the class of drugs that includes Vioxx, as early as 1998 — a year before the popular pain killer was introduced, newly disclosed documents show. The application suggests that Merck was attempting to reformulate the drugs targeted for arthritis sufferers two years earlier than had been previously disclosed. But while the patent was granted in September 1999 by the World Intellectual Property Organization, Merck officials say no product with those properties was ever introduced. Instead, Merck began marketing Vioxx in the United States soon after it was approved by the Food and Drug Administration in May 1999. Merck stopped selling Vioxx last September after a study showed it doubled the risk of heart attack and strokes for patients taking it for at least 18 months. That triggered a stampede to courthouses, with more than 4,000 lawsuits already filed against the drug maker. Mark Lanier, the Texas lawyer who last week won a $253.4 million verdict against Merck at the first Vioxx suit to be tried, said the 1998 patent application provides further evidence that the company knew about the drug’s dangers even before it was introduced — and marketed it anyway. But Merck lawyer Ted Mayer said the company knew that Cox-2 inhibitors didn’t have the cardioprotective properties of other pain relievers such as aspirin and was trying to enhance the class of drugs, not hide any defects. Cox-2 inhibitors were designed to be gentler on the stomach than aspirin and Mayer said Merck sought to create a drug that would avoid the side effects of gastrointestinal bleeding while still offering cardioprotective benefits. “We were not trying to fix a problem,” Mayer said. According to the application, the invention would provide a method for treating, preventing or reducing the risk of conditions such as heart attacks, blood clots and strokes in patients taking Cox-2 inhibitors. Lanier said he didn’t introduce evidence about the patent application at the Texas trial because he didn’t know it existed. Mayer countered that it had been handed over to plaintiffs lawyers in discovery and was entered into evidence, even though it was not mentioned at the trial that ended last week. The Associated Press, which earlier reported about attempts in 2000 to reformulate Vioxx to reduce its cardiovascular risks after its introduction, learned about the 1998 patent application from a doctor working with Lanier. In 2000, Merck researchers privately sought to reformulate the drug even as the company was publicly playing down a study that highlighted the pain relief medication’s potential heart attack risk, according to an internal company document. The widely publicized study in March 2000 found that patients taking Vioxx were five times more likely to have heart attacks than individuals using the generic medicine naproxen. Merck insisted at the time that this was a result of naproxen’s cardioprotective properties and not any defect in Vioxx. But behind the scenes, company scientists were considering combining Vioxx with another agent to reduce the risk of heart attacks and strokes, according to the document obtained by the AP. That document, a communication between Merck researchers and the company’s patent department, stated that the way Vioxx works to reduce pain might also increase cardiovascular problems. They suggested a patent be sought for a combination drug mixing Vioxx with another agent to lessen the risk. Merck applied for a patent in 2001 but nothing came of that invention, either. In 2003, Merck entered into an agreement with Bedford, Mass.-based NitroMed Inc. to develop nitric oxide medicines that could be used to treat cardiovascular and inflammatory diseases. Preventing blood clots is one of nitric oxide’s properties, according to Nitromed. Blood clots can lead to heart attacks. By 2004, the companies were testing a nitric oxide-enhanced Cox-2 inhibitor using a derivative of rofecoxib, which is the primary ingredient in Vioxx. The study of that drug was halted after Vioxx was removed from the market. Copyright 2005 Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.

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