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]]> http://caretolive.com/2008-05-28/fdas-richard-pazdur-cares-little-for-the-scientific-process-and-the-needs-of-desperate-patients/#comment-1109 FDA’s Richard Pazdur Cares Little for the Scientific Process and the Needs of Desperate Patients · Prostate Cancer Wed, 28 May 2008 11:36:11 +0000 http://caretolive.com/2008-05-28/fdas-richard-pazdur-cares-little-for-the-scientific-process-and-the-needs-of-desperate-patients/#comment-1109 [...] prostate cancer blog wrote an interesting post today onHere’s a quick excerpt There was ample of evidence of survival benefit conferred by Provenge as a treatment in contrast to Dr. Pazdur’s statement: “Believe me, if there were a clear survival effect, the drug would be approved,”. In fact, Dr. Pazdur’s focus on the statistical flaws showed that the main problem in the FDA drug approval process as practiced by Dr. Pazdur is a slavish following of rigid statistical rules without properly factoring in clinical knowledge required to give meaning to such numerical data. Th [...] […] prostate cancer blog wrote an interesting post today onHere’s a quick excerpt There was ample of evidence of survival benefit conferred by Provenge as a treatment in contrast to Dr. Pazdur’s statement: “Believe me, if there were a clear survival effect, the drug would be approved,”. In fact, Dr. Pazdur’s focus on the statistical flaws showed that the main problem in the FDA drug approval process as practiced by Dr. Pazdur is a slavish following of rigid statistical rules without properly factoring in clinical knowledge required to give meaning to such numerical data. Th […]

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