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AUGUST 14, 2006
Statins Could Cause Legal Headaches Pfizer insists that Lipitor's safety record "is very well established" Gerald M. Ward never worried much about his high cholesterol. But when the former Air Force pilot applied for a job at American Airlines Inc. (AMR ) four years ago, he was told he wouldn't be hired until he got the problem under control. So Ward's doctor put him on Pfizer Inc.'s (PFE ) cholesterol-lowering statin Lipitor, the world's best-selling drug, worth $12 billion in 2005. Soon after, Ward claims he suffered a baffling set of symptoms: amnesia, depression, and a condition called peripheral neuropathy that causes pain in his hands and feet. Now he's suing the pharmaceutical giant over Lipitor. "It's not safe," according to Ward, 48: "Pfizer has not warned the public about this." Ward is one of 19 patients who filed lawsuits against Pfizer in June and July in New York's Supreme Court. The lawsuits allege that Pfizer failed to inform physicians and patients adequately of the risk that Lipitor can cause serious neurological side effects. "Pfizer intends to vigorously challenge in court all the baseless claims made in these lawsuits," the company said in a written statement. Lipitor's safety record "is very well established," the statement said. Concerns about statin side effects have been lurking under the surface for years, but a confluence of events could turn them into a major headache for Pfizer and other statin makers. In addition to the Lipitor lawsuits, scientists at the University of California at San Diego have spent the past six years tracking 1,000 patients in a trial. Some of the participants have been taking Merck & Co.'s (MRK ) Zocor and Bristol-Myers Squibb Co.'s (BMY ) Pravachol, while the rest receive a placebo. "It's very clear there's a lack of familiarity by patients and physicians about neurological side effects," says Dr. Beatrice A. Golomb, assistant professor of medicine at UCSD and the lead investigator. "That sometimes hurts patients." The labels on statin medicines do, in fact, include warnings to the effect that some patients have developed memory loss, muscle pain, and other adverse side effects. But critics say the risks are underplayed. Ward's lawsuit, for example, quotes the Lipitor Web site as saying "Lipitor has a proven safety profile," and "Lipitor has been proven to be as safe as taking a sugar pill." Despite such promotional language, the patients suing Pfizer have a tough task ahead of them. They must demonstrate that Lipitor actually caused the symptoms that plague them. "And they have to prove the company knew more than they warned," says Paul Rheingold, a New York attorney who is not representing any of the plaintiffs. "That will be extremely difficult." Ward, who lives in Ashburn, Va., says he is willing to do whatever is required. He recently left the airline industry because he feared his lingering neurological problems made him a danger to himself and to his passengers. "All my life I wanted to fly," says Ward, who now works part-time at a desk job with the Air Force Reserve. "The thing I love the most, I can't do anymore." 
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