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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID -- Ignore unavailable to you. Want to Upgrade?

To: Maurice Winn who wrote (1740)	12/29/2002 7:42:54 AM
From: The Dodgy Ticker	Read Replies (1) \| Respond to of 1762

Maurice, Have you seen this? To:John Metcalf who wrote (7623) From: Robert C. Jonson Saturday, Dec 28, 2002 11:58 AM Respond to of 7630 John, Here is a "Letter to the Editor" in the WSJ (either last Wed. or Thurs.) from Lester M. Crawford, Deputy Commissioner of the FDA re The FDA's policy on experimental drugs: Title: The FDA's True Policy on Experimental Drugs" Cancer patient Edie Bacon's Nov. 29 editorial-page essay, and the Dec. 6 Letters reacting to it, about her inability to obtain a potentially life-saving experimental drug were poignant, and Ms. Bacon's deep concern about her lack of access to a treatment that she believes to be beneficial is understandable. The policies of the FDA, however, are not an obstacle to the use of experimental treatments outside clinical trials. Such use would not prompt, as Ms. Bacon appears to believe, an FDA request for additional studies. The FDA, categorically, does not attach special significance to adverse events reported from such expanded access programs as Ms. Bacon has tried to join. We recognize that these programs involve less-controlled use of new drugs, and we assess the reported data accordingly. The development of a new medication is not slowed by side effects occurring outside clinical trials. The FDA strongly supports expanded use of promising therapies for serious and otherwise untreatable diseases. In the past two years alone, 10,000 patients with myeloid leukemia have been given access to Gleevec; Iressa, a medication that's currently being reviewed for lung cancer, has been made available to 15,000 patients. So far, 67 patients have been given outside-trial access to ET-743, the drug that Ms. Bacon wants to use. The FDA encourages patients to participate, when appropriate, in well-designed clinical trials. Information about studies is available at clinicaltrials.gov. To obtain an experimental drug under expanded access, patients should first contact the manufacturer. If the result is unsatisfactory, our Office of Special Health Issues (301/827-4460) can often provide helpful information about access to experimental drugs. Best wishes to all for the New Year, Bob