The FDA has proposed allowing the testing of experimental drugs on terminally ill patients once the drugs have passed the first safety testing phase, but before they have received final approval. The plan has already sparked controversy, with physicians staking out positions both for and against the proposed rule change.
Cancer doctor Dean Gesme, of the Minnesota Oncology Hematology Professional Association, charged that the rules will engender false hope in patients, when less than 10 percent of drugs beginning phase I safety trials are eventually adopted as viable treatments. Among these, most provide only incremental benefits; few are life-savers.
Testing these drugs on terminally ill patients would be unfair to the patients, and would potentially delay approval by obscuring the drugs' long-term effects.
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FDA Wants Big Pharma to Use Terminally Ill Patients as Guinea Pigs for Unapproved Drugs http://www.naturalnews.com/022635.html
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