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

To: Biomaven who wrote (7115)	9/29/2002 1:14:43 PM
From: RCMac	Respond to of 52153

NYTimes article on Dr. McClellan today: "FIVE QUESTIONS FOR DR. RAYMOND L. WOOSLEY Terror Adds to Safety Issues Awaiting New F.D.A. Chief By JULIE FLAHERTY AFTER 20 months without a leader, the Food and Drug Administration may be getting one. Last Wednesday, President Bush nominated Dr. Mark B. McClellan, a White House adviser who is an expert in health care economics, to the position. Dr. McClellan, whose confirmation by the Senate is widely expected, would be in charge of one of the biggest and most wide-ranging agencies in Washington, with jurisdiction over products representing 20 percent of every consumer dollar spent. The appointment of a new commissioner has been eagerly awaited by food and medical safety experts. Dr. Raymond L. Woosley, a pharmacologist and vice president for health sciences at the University of Arizona, is known for his research into the safe use of medicine. He spoke on Thursday about the challenges facing Dr. McClellan. JULIE FLAHERTY Q. What do you see as the most important priority for Dr. McClellan at the F.D.A.? A. There is a whole new range of priorities after 9/11, so No. 1 has to be an expedited review and approval of drugs for the protection from terrorism. The whole related question of food safety is a critical part of this. Even before 9/11, food safety was a serious problem, and continues to be, with mad cow disease and E. coli and other concerns. Another major priority, I hope, will be addressing the problems of regulating the dietary supplements that really aren't dietary supplements. The F.D.A. is going to have to start reviewing and regulating them as drugs to protect the public. Q. Dr. McClellan's background is primarily in Medicare and other health care financing issues that are not part of the F.D.A.'s jurisdiction, and he has little experience in drug safety and food contamination issues. Does that present a problem? A. Not really. The scope of the responsibilities for this position is so immense. Something like 75 to 80 percent of everything we contact in our day is under the purview and review of the F.D.A. There is no way anyone in that position is going to have the full coverage of expertise needed for that job. So he has to think about what team he needs to assemble to help him fill in the strengths he needs. The most important thing for this position is the medical background. It will come down to him to say, "Is this drug ready to go to the public?"; to know the medical use of those devices, those drugs, firsthand; the risk-benefit ratio that you learn about in medical school; knowing that medicines can be life-saving but they can also be harmful. Those really have to weigh heavily on the person making those decisions. Q. How will Dr. McClellan's strength in economics and health policy help him? A. The agency in the past has operated very much in isolation, but Secretary Thompson [Tommy G. Thompson, secretary of health and human services] has expressed interest in having the agency be more a member of the team that addresses the needs of the health of the public. The prescription drug benefit discussions — the commissioner will probably not play a role in those decisions, but by being a spokesperson for the agency, it will help inform the economic decisions that have to take place. And vice versa. If the agency is going to review a drug that will be covered by Medicare, it's going to be exposed to elderly patients in large numbers very quickly, and that has to be part of the safety plan. Q. A growing number of drugs have been taken off the market, suggesting that the F.D.A. might have been too hasty in approving them. What should the new commissioner be doing about that? A. I don't think it means they were too hasty. Drugs will always need to be taken off the market. Every drug that goes on the market is an experiment, because you will never know all you need to know about a medication until it is in broad public use. Even if you could study 30,000 patients before a drug goes on the market, you will still have the possibility that there is one in 50,000 that are going to be harmed and the drug will have to come off the market. I've often said we know more about a drug before it goes on the market than we ever have before. Our failing has been what we do once it's on the market. The agency has not been given the resources to adequately monitor and evaluate post-marketing safety of drugs and devices, and that's been the problem. If we had a better safety system we would have drugs approved more quickly. Q. This appointment comes at a time when the F.D.A. is under growing drug industry pressure to broaden the rules on how drug makers can market their products. How should the new commissioner respond? A. Marketing affects risk, because marketing affects the people who are exposed to a medication. Drugs are approved with a certain type and pattern of population exposure, so when a drug goes on the market it is approved for use in that population as it was in the studies. But marketing can sometimes drive the drug into new uses, new populations where we don't have any evidence that it will be safe and effective. Good marketing should follow good drug development and not get out in front of it." nytimes.com Raymond Woosley, MD, PhD, was head of pharmacology at Georgetown medical school, and has been an advisor to Sepracor. This is from the University of Arizone PR announcing his appointment as head of UA's College of Medicine: "Dr. Woosley's initial research focused on the clinical pharmacology of anti-arrhythmic drugs. He helped provide the scientific underpinning of the Cardiac Arrhythmia Suppression Trial (CAST), which began in 1987 with 27 sites nationwide to test the use of antiarrhythmic drug therapy to decrease mortality. He served as co-director of this trial, which demonstrated for the first time that antiarrhythmic drugs can suppress cardiac arrhythmias but still increase the risk of sudden death. Dr. Woosley also conducted groundbreaking research on the medication Seldane, a popular antihistamine introduced in 1985 that was withdrawn from the market after reports that taking it in conjunction with certain drugs could cause potentially fatal abnormalities in heart rhythm. His work led to the discovery of fexofenadine, a safer version of Seldane that now is marketed under the brand name Allegra. More recently, Dr. Woosley's research has explored why women appear to be more susceptible than men to potentially fatal arrhythmias caused by a number of prescription drugs." ahsc.arizona.edu I'm not sure whether his SEPR association continues: it is unmentioned in the UA PR, and he appears to have sold his SEPR shares: biz.yahoo.com --RCM