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TERATOLOGY SOCIETY 1998 PUBLIC AFFAIRS COMMITTEE SYMPOSIUM: THE NEW THALIDOMIDE ERA: DEALING WITH THE RISKS
Friedman, J. M. AND C. A. Kimmel. TERATOLOGY SOCIETY 1998 PUBLIC AFFAIRS COMMITTEE SYMPOSIUM: THE NEW THALIDOMIDE ERA: DEALING WITH THE RISKS. February BIRTH DEFECTS RESEARCH PART A: CLINICAL AND MOLECULAR TERATOLOGY. John Wiley & Sons, Ltd., Indianapolis, IN, 59(2):120-123, (1999).
The Teratology Society Public Affairs Committee Symposium was held on June 21, 1998, during the Society's annual meeting in San Diego, California. The symposium was organized and chaired by Dr. Carole Kimmel. The sysmposium was designed to consider the medical, social, and ethical implications of approving thalidomide, the most notorious human teratogen, for use in the United States.
Dr. Kimmel described briefly the previous marketing of thalidomide as a sedative in many countries outside of the U.S. She pointed out that the diseases for which thalidomide is currently being proposed are substantially more serious that those for which it was used initially.
As a result of the thalidomide tragedy in the early 1960s, substantive changes occurred in the regulatory framework for approval of new drugs by the U.S. Food and Drug Adminstration (FDA). More recently, there have been changes in practice that favor more rapid review and release of new drugs, with greater responsibility for safe use being placed on individual patients and their physicans.
The release of thalidomide poses several very serious questions, including the following:
o Should a drug that benefits some people, but is dangerious to others, be approved for marketing?
o If such a drug is released, how can its use be restricted to minimize the danger as much as possible?
o How can the interests of future children, who cannot directly participate in the decision-making process, be appropriately represented?
o If children with thalidomide embryoapath are born as a result of regulatory approval of the drug, who should shoulder the cost?
o How many babies with thalidomide embryopathy will it take to cause a change in the marketing or distribution of the drug?
Record Details:Record Type: DOCUMENT (JOURNAL/PEER REVIEWED JOURNAL)
Organization:U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF RESEARCH AND DEVELOPMENT
NATIONAL CENTER FOR ENVIRONMENTAL ASSESSMENT
EFFECTS IDENTIFICATION AND CHARACTERIZATION GROUP