October 19, 2010 Jack Stapleton, M.D., Chair Vaccines and Related Biological Products Advisory Committee University of Iowa Hospital Clinic 200 Hawkins Drive Iowa City, Iowa 52242 SUBJECT: Valid endpoint and reliable HPV genotyping for expanded use proposal of GardasilTM vaccine Dear Dr. Stapleton: S.A.N.E. Vax, Inc. is a non-profit organization established to promote safe, […]
SaneVax Requests FDA Rescind Gardasil Approval
By: Norma Erickson 22 October 2010 On October 19, SaneVax, Inc. sent a formal letter to the FDA Commissioner requesting they rescind approval for Gardasil. Our team’s reasoning is entirely based on scientific facts described in detail in the attached letter to Dr. Hamburg. A copy of this was sent to every current member of […]
Gardasil: Supplemental Biologics Licensing Application for Use in Anal Cancer Prevention
VRBPAC Briefing Document Presented by Merck on 17 November 2010 Human papillomaviruses (HPV) cause a significant burden of benign and malignant anogenital disease in men and women. The HPV-related anogenital cancers all develop through a common pathogenetic process of neoplastic change that begins with the necessary event of HPV infection. After cervical cancer, the anogenital […]
