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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: BigKNY3 who wrote (6404)	12/2/1998 1:37:00 PM
From: Anthony Wong	Respond to of 9523

U.S. FDA Officers Say 27 Drugs Shouldn't Be on Market, Watchdog Group Says Bloomberg News December 2, 1998, 11:03 a.m. ET FDA Officers Say 27 Drugs Shouldn't Be on Market, Report Finds Washington, Dec. 2 (Bloomberg) - U.S. Food and Drug Administration medical officers in a survey identified 27 drugs they thought should not have won agency approval in the last three years -- according to the watchdog group Public Citizen. Nineteen of 53 officers who replied to the Public Citizen survey identified the 27 drugs and said they had in at least some instances raised concerns about their safety, according to the consumer group's report. The report comes as FDA critics charge the agency's accelerated review of drugs has led to an increase in recalls for safety reasons. Public Citizen did not name any of the 27 drugs and was not specific about the concerns the medical officers raised. Many of the officers, who are the FDA scientists responsible for closely reviewing an application and making approval recommendations, said the agency is clearing more drugs in less time and said that they felt more pressure to recommend approvals than three years ago. ''Our findings are shocking by any yardstick,'' said Sidney Wolfe, director of Public Citizen's Health Research Group and a co-author of the study. ''Subtle and not so subtle pressure is being brought to bear on FDA physicians who dare to question a drug's safety.'' Public Citizen's Health Research Group, in recent years a frequent critic of the FDA for moving too fast to approve drugs, queried a total of 172 agency medical officers for its study. Of that group, 53 replied to the survey, a roughly 31 percent response rate. The survey promised total anonymity to officers who chose to respond. Eight of the replying officers who filled out surveys said in a total of 14 instances over the past three years, they had been instructed not to present their own opinion or data during an advisory panel hearing called to review particular application, the report said. Most Recalls in History The Public Citizen report follows the most drug recalls in FDA history. The withdrawal of American Home Products Corp.'s Duract pain reliever in June marked the sixth withdrawal of a drug due to safety concerns in 12 months, after only 10 such recalls between 1980 and 1996. During that 12-month period, American Home also pulled its fenfluramine diet drug and Redux, a diet drug it sold for Interneuron Pharmaceuticals Inc. Meanwhile, Roche Holding AG pulled its Posicor blood pressure drug and Hoechst AG replaced its Seldane allergy drug with its next generation Allegra version -- following worries about dangerous interactions between Seldane and other drugs. And in August 1997, Novartis AG pulled its Ex- Lax off the shelves after the U.S. government proposed banning its key ingredient on safety concerns. Pressure on FDA The spate of recalls put pressure on the FDA as critics said the agency was moving too fast to approve drugs and not screening them carefully enough. In recent years, the agency has nearly doubled the number of drugs it approved each year. Between 1996 and 1997 the agency approved the largest number of drugs -- 92 -- ever in a two-year period. Still, Congress has told the FDA that if anything, it should speed up its approval rate. And FDA officials and supporters say the agency's standards haven't suffered as a result of faster approvals, which have come mainly as the agency has hired more reviewers with funds garnered by fees from companies. Many side effects are so rare that they don't emerge in clinical trials, no matter how thorough they are, FDA supporters say. In addition, the growing number of new drugs available means that unforeseen drug interactions are more likely, they say. Public Citizen in the past has often criticized the FDA and drugmakers. In August, the group petitioned the FDA to convene an expert advisory panel to review the safety of Viagra after the drug was used by patients who later died. While the FDA has updated warnings on the drug's label, the agency hasn't found any direct link between the impotence pill and the deaths. It also hasn't moved to convene an advisory panel to review the drug. Also in August, an FDA medical officer took the unusual step of publicly criticizing the way the FDA and drug companies handle the design of studies of new diabetes drugs, prompting a letter of support from Public Citizen. The reviewer, Robert Misbin, pointed at the time to Warner-Lambert's Rezulin study as one example. --Kristin Jensen and Kristin Reed in the Washington newsroom

To: BigKNY3 who wrote (6404)	12/2/1998 1:55:00 PM
From: Anthony Wong	Respond to of 9523

St. Louis Post-Dispatch: Monsanto arthritis drug gets approval of FDA panel Wednesday, December 2, 1998 By Yuki Noguchi Post-Dispatch Washington Bureau SILVER SPRING, Md. -- A federal advisory panel unanimously recommended approval Tuesday for Celebrex, the drug Monsanto Co. has developed for treatment of osteoarthritis and rheumatoid arthritis. For 40 million arthritis sufferers, one in six Americans, the advent of Celebrex and similar drugs may mean an option to the anti-inflammatory drugs now commonly used for arthritis that often bring side effects like ulcers and stomach bleeding. Analysts predict the drug, from Monsanto subsidiary G.D. Searle & Co., will be on the market early next year, and may generate annual sales of $1 billion. The advisory panel to the Food and Drug Administration gave Searle virtually everything it sought for the drug, to be sold by prescription only: * The panel accepted Searle's claim that Celebrex, taken once a day, is effective for the treatment of osteoarthritis. * The panel recommended that the FDA allow Searle to modify the warning label the agency now requires for nonsteroidal anti-inflammatory drugs. Searle's clinical studies show fewer gastrointestinal side effects from Celebrex than from such anti-inflammatory drugs now on the market, such as naproxen. * The panel hasn't approved Searle's request to market Celebrex for "general management of acute pain." That would have vastly increased its sales. The advisory committee's decisions are not binding, but the FDA usually follows its actions, especially when its conclusion is unanimous. The FDA will make a final determination by the end of the year. "We're pretty satisfied with the outcome of the day," said Phil Needleman, Searle's co-president. He said the panel's support marks "the beginning of an era of smart drugs." Sergio Traversa, an analyst for Mehta Partners, an investment research firm in New York, said Monsanto "got almost everything they were asking for." Searle's announcement that Celebrex is effective as a once-a-day drug makes it comparable with a rival medication, Vioxx, which Merck & Co is developing. Merck applied for FDA review last week, but Vioxx will not reach the market at least until next fall, Traversa said. Then it will have to combat Celebrex, which will be marketed jointly by Searle and Pfizer Inc., he said. "The key point" is what kind of labeling Celebrex will finally get, and whether it will be able to market itself as a general painkiller, Traversa said. Critics on the panel said such a label would, in effect, approve the drug for use against headaches, menstrual cramps and other symptoms for which Searle has not conducted clinical tests for effectiveness. Sidney Wolfe, head of Public Citizen's Health Research Group, said there isn't yet enough evidence to allow Celebrex on the market without the standard warning label. "Purported new classes of drugs such as Celebrex offer not only new mechanisms of action, but also new mechanisms of potential toxicity and the possibility of a new spectrum of adverse events," he said. But members of the panel agreed that the studies on Celebrex showed a low incidence of severe gastrointestinal side effects compared with other nonsteroidal anti-inflammatory drugs. Panel members called for a "conservative," modified warning label that details Searle's clinical findings. Searle's clinical tests of over 13,000 patients showed that the incidence of ulcers and stomach bleeding was about 0.2 percent, compared with almost 4 percent for most NSAIDs. "It would be great" to get approval for the general labeling, said Monsanto spokeswoman Scarlett Foster. "But it will do nothing to slow this drug down." The FDA and Searle officials will discuss other matters, such as Celebrex's effects on the kidneys, and the direction of other clinical tests. The panel said further tests would be needed to determine the long-term effects of the use of Celebrex. Monsanto had announced earlier that the results of clinical studies showing that Celebrex does not interfere with methoxtrate and warfarin, two drugs often prescribed to arthritis patients. Copyright (c) 1998, St. Louis Post-Dispatch stlnet.com

To: BigKNY3 who wrote (6404)	12/2/1998 2:15:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 9523

Goldman Sachs Summary (from mot Mouth of Yahoo MTC thread) messages.yahoo.com@m2.yahoo.com Mission accomplished. Bad news: Acute pain indications decision deferred. Good news: (1)Panel unanimously recommended osteo & rheumatoid arthritis approval (much bigger market). (2)Panel agreed Celebrex's important benefits vs conventional NSAIDS need to be reflected in labeling. (i)conventional NSAIDS label deemed not appropriate for Celebrex. Rewording. (ii)Endoscopy data deemed relevant & permissible in labeling (very favorable). (iii)Agreed that, unlike NSAIDS, Celebrex is okay with aspirin, methotrexate, warfarin.(3)Approved 1-a-day OA data."