S.A.N.E. VAX, Inc, a non-profit organization request that the FDA rescind its approval for Gardasil™ as a vaccine to prevent cervical cancer or to prevent genotype-specific human papillomavirus (HPV) infection due to use of an inappropriate primary endpoint and unreliable HPV genotyping methods for efficacy evaluation
EXCERPT: Dear Dr. Hamburg: …This research revealed the fact that in November 2001 the VRBPAC committee allowed the vaccine manufacturer, Merck & Co., Inc., to use: CIN 2/3, AIS, or cervical cancer; i.e. CIN 2/3 or worse by histology- with virology to determine the associated HPV type- as the primary endpoint in the evaluation of a vaccine to prevent cervical cancer. [1] Using this primary endpoint for statistical calculation in the clinical trials invalidates the claimed efficacy of Gardasil™ as a vaccine to prevent cervical cancer. Read entire letter to FDA Director Margaret Hamburg
