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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?

To: Bluegreen who wrote (9268)	3/18/1999 5:36:00 PM
From: Bluegreen	Respond to of 17367

George, you know one does not have to be that critical about efficacy especially if adding to conventional therapies or areas where no treatment is available BUT safety is always critical. The FDA has become in my opinion so whimsical and obsessed with efficacy that their safety standards are a joke as recent events have evidenced. I think they feel their efficacy turf is being invaded and took their eye off safety. Think about it George, you are a Type II diabetic with plenty of oral meds out there to choose from but you are given Rezulin and your liver blows up! But hey, Gee whiz, the stuff sure has efficacy! Even if none of the other oral meds worked, couldn't you still take insulin for control of Type II without the worry of your liver dissolving on you? Think goodness changes are before Congress!

To: Bluegreen who wrote (9268)	3/30/1999 8:43:00 PM
From: Robert S.	Read Replies (1) \| Respond to of 17367

News for our FDA warrior: Public Policy Forum to Focus on Safety Issues Related to Faster Drug Approvals Senior U.S. Health Officials to Address Public Health Risks Tied to New Procedures BOSTON--(BW HealthWire)--March 30, 1999--Facing a growing number of charges that it is sacrificing public safety in favor of speedier introduction of new prescription drugs in the U.S., the FDA will speak to the issue at a public policy forum May 6 in Philadelphia. The forum is aimed at sponsoring drug companies, consultants, policy makers, regulators, and others closely tied to the pharmaceutical industry. Dr. Kenneth W. Kizer, Under Secretary for Health in the U.S. Department of Veterans Affairs, and Dr. Janet Woodcock, Director of FDA's Center for Drug Evaluation Research (CDER), will address these and related issues at the meeting sponsored by the Tufts Center for the Study of Drug Development. Veteran Affairs operates the nation's largest integrated health care system. CDER reviews all applications for new prescription drugs proposed for use in the U.S., and is responsible for monitoring the quality of drugs sold here. ''Drug safety is a critical issue that concerns everyone--patients, health care providers, hospitals, managed care organizations, and pharmaceutical firms,'' said Kenneth I. Kaitin, Director of the Tufts Center. ''While a number of high profile drugs have recently been withdrawn from the market, the real question is whether the rate of withdrawals has increased given the fact that more drugs are being marketed than ever before.'' Kaitin said that the pace of new drug development has quickened in recent years, but noted that the FDA has speeded the drug approval process at the direction of the Congress: ''Speed vs. safety is a real dilemma. We believe open discussion and a review of the facts serves everyone.'' Kizer will discuss how to improve drug safety through the use of market forces in government run health care. In addition to the public safety issue, Woodcock will speak on how well pre-market toxicity testing can predict post-marketing safety. She will also present her agency's view on whether existing post-marketing surveillance systems are sufficient to quickly and accurately identify unexpected drug toxicities. Based in Boston, Mass., and affiliated with Tufts University, the Tufts Center for the Study of Drug Development (www.tufts.edu/med/research/csdd) provides independent research on the development, regulation, and utilization of new drugs and biopharmaceuticals. Among other activities, it sponsors public forums where government, industry, academia, and public health advocates can exchange views on drug and biotechnology product development and regulation. For more information, call the Tufts Center at 617-636-2187.