Merck Vioxx News and Press Releases

Panel may consider class-action status

By MIKE HOYEM
MHOYEM@NEWS-PRESS.COM

January 25, 2005 - Seven federal judges will descend on Fort Myers Thursday to make some key decisions in the tidal wave of lawsuits filed against the company that manufactured Vioxx. The U.S. Judicial Panel on Multidistrict Litigation will hear arguments from attorneys on how and where to handle scores of lawsuits against Merck & Co. Inc., which marketed the arthritis and pain medication.

Vioxx was withdrawn from the market Sept. 30 after a study showed the drug may cause heart trouble. Some of those who are suing the company accuse it of selling the drug despite earlier indications it could be harmful, even fatal. According to documents filed in U.S. District Court in Fort Myers, lawsuits against the company are pending in at least 24 federal districts nationwide involving 378 plaintiffs and thousands of others who are seeking to join a class action suit against Merck & Co.

Merck & Co. attorney Sharon L. Kegerreis of Miami said so many lawsuits have been filed that it's necessary for the panel to centralize the cases. In a motion filed Dec. 27, Kegerreis wrote there are numerous "overlapping factual issues and similar legal theories" in the cases, and a failure to centralize them would cause a "waste of judicial resources."

In Fort Myers, the law firm of Viles & Beckman represents hundreds of Vioxx plaintiffs. "The law firm has close to 1,000 Vioxx clients from around the country," said Mike Fallon, the firm's marketing director. "We also have some international clients."

Viles & Beckman is asking the court to order Merck & Co. to provide free, ongoing health monitoring and medical care for those who have taken Vioxx. The firm is also seeking punitive damages and compensation for the plaintiffs' medical bills, pain and suffering. Kegerreis wrote that the publicity surrounding the withdrawal of Vioxx from the market "has spurred the filing of additional lawsuits."

Kegerreis couldn't be reached Monday for comment.

The current findings support this possibility, showing an elevated cardiovascular risk for the oldest COX-2 inhibitor, Celebrex, as well as for two newer agents, Bextra and Dynastat (parecoxib). The results stem from three studies that will appear in the March 17th edition of The New England Journal of Medicine, but were released early due to possible public health implications. Their release coincides with a highly anticipated US Food and Drug Administration meeting taking place later this week.

Using data from the Adenoma Prevention with Celecoxib study, Dr. Scott D. Solomon, from Brigham and Women's Hospital in Boston, and colleagues assessed the occurrence of cardiovascular events in 2035 patients treated with Celebrex, at a dose of 200 milligrams or 400 milligrams twice daily, or with inactive "placebo". The primary outcome the researchers looked for was a combination of death from heart-related causes, heart attack, stroke, or heart failure. The patients were followed for about 3 years. The rates of the primary outcome in low- and high-dose Celebrex users were 2.3 and 3.4 percent, respectively, both significantly higher than the rate among placebo users -- 1.0 percent.

In the second study, Dr. Nancy A. Nussmeier, from St. Luke's Episcopal Hospital in Houston, and colleagues assessed the cardiovascular effects of Dynastat and Bextra when used for pain control after coronary artery bypass surgery. The study involved 1671 patients who were treated with intravenous Dynastat then oral valdecoxib, intravenous placebo then oral Bextra, or just placebo for the first 10 days after surgery. The rate of harmful effects in both COX-2 inhibitor groups was 7.4 percent, while the rate in the placebo only group was 4.0 percent. Of particular concern, patients treated with Dynastat and Bextra were nearly four times more likely to experience a heart attack or stroke than those given placebo.

Results from the third study, known as the Adenomatous Polyp Prevention on Vioxx Trial, provide further evidence that Vioxx use is associated with an elevated risk of heart attack and stroke. In the study of 2586 patients, Dr. Robert S. Bresalier, from M. D. Anderson Cancer Center in Houston, and colleagues found that Vioxx users (25 milligrams daily) were nearly twice as likely as placebo users to experience a heart attack or stroke. This elevated risk was first apparent after 18 months of use. "It sure looks like (the elevated cardiovascular risk) is a class effect," Dr. Bruce M. Psaty, co-author of an accompanying editorial, told Reuters Health. "This is the best evidence we have so far of the cardiovascular risks associated with the COX-2 inhibitors."

As to why the risks seen with COX-2 inhibitors were not identified and reported earlier, Psaty, from the University of Washington in Seattle, cites problems with initial trial designs and with the FDA. "As early as 1996, it was recognized that COX-2 inhibitors had actions that could increase the risk" of heart attacks and stroke, Psaty noted. However, the initial studies looking at these drugs were designed to assess pain relief, not to look for these problems, he added.

Another issue is the relative "powerlessness" of the FDA once a drug is on the market, Psaty said. "It's very difficult for the FDA to protect the health of the public. They need to be given more authority so that they can force drugmakers to make necessary changes in a timely fashion. In the case of Vioxx, Merck and the FDA were in negotiations for 2 years to revise the label."

An FDA panel will be discussing the cardiovascular risks of COX-2 inhibitors later this week. Today, a veteran scientist with the FDA who was scheduled to present unpublished data at the meeting said he would not be presenting these data, citing intimidation by senior officials.

SOURCE: New England Journal of Medicine, March 17 edition, released February 15, 2005

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