ANOTHER CAUTION ON VIOXX, CELEBREX
November 18, 2005 08:58

Merck's Vioxx, Pfizer's Celebrex and similar painkillers increase the risk of death among patients who have already survived a previous heart attack, especially when taken in high doses, according to data released at the American Heart Association conference. Patients who have heart disease should not use these types of drugs, called COX-2 inhibitors, according to Dr. Gunnar Gislason, a research fellow at Bispebjerg University Hospital in Copenhagen and the lead independent researcher in the study, which was funded by the Danish Heart Foundation and the Danish Pharmaceutical Association. "These results are a cause for concern but not panic," said Gislason. "If you can avoid them, it makes sense to switch to another type of medication if you have cardiovascular disease." "We have not yet seen the study," said Merck spokesman Chris Loder, who noted that drug safety is typically established through randomized controlled clinical trials, which is different from the type of study conducted by Gislason. "Randomized controlled clinical trials are the gold standard." Pfizer executives were not immediately available to comment. Aaron Smith, CNN/Money, 11/13/2005

When Merck & Co. won the New Jersey Vioxx trial last week, it faced a plaintiff who had taken the painkiller for only two months. Now, a state-court judge is upping the ante. Carol Higbee, the New Jersey judge overseeing 3,500 Vioxx cases in Merck's home state, told lawyers in a private conference on that she wants the next 10 or so trials in her courtroom to involve plaintiffs who took the drug for 18 months or longer. That's going to make Merck's job defending itself much harder. The company acknowledged last year that Vioxx increased heart-attack risks when people used it daily for 18 months or more, and it pulled the drug from the market based on that conclusion. That means one of Merck's main defenses in the previous two cases is gone, says Scott D. Lassetter, who heads the Products Liability and Mass Tort Group at Weil, Gotshal & Manges, a top defense firm not involved in the Vioxx cases. In the recent case in New Jersey, Merck argued that because the plaintiff took Vioxx for only two months, his heart attack probably wasn't caused by Vioxx. Jurors interviewed afterward agreed. After acknowledging that 18 months of usage can be a problem, Merck's only other defense is that a plaintiff's other risk factors, like obesity or smoking, caused the heart attack and not Vioxx, said Mr. Lassetter. Barbara Martinez, The Wall Street Journal, 11/11/2005.