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Biotech / Medical : Monsanto Co. -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (683)	12/2/1998 1:10:00 AM
From: Anthony Wong	Respond to of 2539

(AP) FDA Panel Approves Arthritis Drug Tuesday December 1 10:15 PM ET By LAURAN NEERGAARD AP Medical Writer SILVER SPRING, Md. (AP) - Millions of Americans may soon get to take the first in a new class of painkillers that promise to relieve aches and inflammation with fewer stomach-damaging side effects. Advisers to the Food and Drug Administration recommended unanimously Tuesday that Searle's Celebrex be allowed to sell, by prescription, for arthritis relief. Celebrex is thus expected to be the first in a new class of painkillers called ''cox-2 inhibitors'' to hit the U.S. market. Wall Street views Celebrex as the next potential blockbuster drug, because of hope that it will cause fewer ulcers, stomach bleeding and other gastrointestinal side effects commonly caused by today's most popular painkillers. Analysts predict that tens of millions of people will take cox-2 inhibitors to relieve a variety of kinds of pain. But the FDA's advisors dampened some of those expectations: While the panel said Celebrex may help arthritis sufferers, it stopped short of recommending the drug's use for other kinds of pain. And the advisers had cautions for consumers: While there are suggestions that Celebrex may be more stomach-friendly, few people have taken it long enough to know its long-term safety. Searle is a subsidiary of Monsanto Co. (NYSE:MTC - news), whose stock fell by $1.8125 a share to $43.50 a share in heavy trading Tuesday. ''I frankly think these drugs are safer,'' said panel chairman Dr. Steven Abramson of New York's Hospital for Joint Diseases. But, he asked, is there enough proof to let Searle tout the drug as significantly safer? ''It's a close call.'' It doesn't need the same ulcer warning that other painkillers get, the panel said. But, ''Certainly this drug is not ulcer-free,'' said Dr. Daniel Lovell, a Cincinnati, Ohio, pediatric rheumatologist. The FDA is not bound by the panel's advice, but typically follows it. Millions of people now depend on aspirin, ibuprofen, naproxen and a host of other pills called ''non-steroidal anti-inflammatory drugs,'' or NSAIDs. They're used for arthritis, everyday aches, recovering from surgery and myriad other pains. Many are available without a prescription; others come in higher-dose prescription-only strengths. But NSAIDs can cause ulcers, stomach bleeding and other gastrointestinal side effects, especially in long-term users. NSAIDs are blamed for hospitalizing 107,000 Americans every year, and killing 16,500. In 1990, scientists announced the reason. NSAIDs target an enzyme called cyclooxegenase that is responsible for much inflammation behind pain. But it turned out there are two types of this enzyme. Cox-2 was behind the inflammation, while cox-1 actually protects the stomach lining. Unfortunately, NSAIDs hit both. The theory was that if scientists could develop a more specific drug that targeted just cox-2, it would alleviate pain and inflammation while not bothering the stomach. Half a dozen companies began racing to develop a better NSAID. Searle's Celebrex, known chemically as celecoxib, is the first under FDA scrutiny. In studies of about 13,000 patients, it appeared to work almost as well as prescription-strength naproxen in patients with osteoarthritis. In rheumatoid arthritis sufferers, it appeared to work almost as well as another popular NSAID, diclofenac. But even if Celebrex isn't better than other painkillers, experts theorized it still would sell if proved safer. So Searle gave 4,700 endoscopies - snaking a tube into patients' stomachs to see if ulcers were forming even before they experienced symptoms. Some 25 percent to 40 percent of patients taking ibuprofen or naproxen showed these mini-ulcers, vs. 5 percent to 10 percent of Celebrex patients. Mini-ulcers can heal on their own, so doctors questioned the relevance of those endoscopy studies. Too few patients in Searle's studies have gone on to experience serious health problems such as gastric bleeding to know for sure if the new drug would lower hospitalizations and deaths, some FDA panelists warned. The new drugs are causing consternation among aspirin and other NSAID makers, who attended Tuesday's meeting en masse to insist their drugs are still good for millions of people. Merck & Co. is close behind Searle, last week filing an application for the FDA to consider its own cox-2 inhibitor.