In a letter addressed to Dr. Margaret Hamburg, the FDA commissioner, Ms. Norma Erickson, president of S.A.N.E. Vax, Inc. stated her research team has revealed that in November 2001 the VRBPAC (Vaccines and Related Biological Products Advisory Committee) mistakenly allowed the vaccine manufacturer 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.”
In her letter to the Commissioner, Erickson pointed out that in the natural history of cervical cancer development only a small fraction of the CIN 2 lesions will progress to CIN 3 lesions, and only a small fraction of CIN 3 lesions will progress to cervical cancer. Therefore, there are many more CIN 2 lesions than CIN3 lesions in cervical cancers combined in any female population, including the subjects enrolled in the Gardasil’s clinical trials. As a result, the overwhelming majority of the “CIN 2/3 or worse” cases used for evaluation of efficacy and listed in the VRBPAC Background Document on Gardasil’s HPV Quadrivalent Vaccine presented at the May 18, 2006 VRBPAC meeting must have been CIN 2 lesions.
Erickson quoted a scientific report in which the National Cancer Institute (NCI), the inventor of the HPV vaccine technology and co-developer of Gardasil, concluded “CIN 2 is not a true biologic entity but an equivocal diagnosis of pre-cancer, representing an admixture of HPV infection and pre-cancer. The existence of CIN 2 biopsy results as a clinical entity may be the consequence of the inaccuracies of colposcopy and colposcopically directed biopsy, which could result in less-than-perfect representation of the underlying disease state. That CIN 2 is the least reproducible of all histopathologic diagnoses may in part reflect sampling error…”
Erickson further informed the Commissioner that the NCI knew the only reliable HPV genotyping method is a “PCR system with short target sequences”. However, such a reliable HPV genotyping method was never used to “determine the associated HPV type” in the clinical trials for evaluation of the efficacy of Gardasil to prevent type-specific HPV infections. Obviously, any data collected using unreliable methods cannot be used to reliably evaluate the efficacy of any drugs or vaccines, said Erickson.
Based on their recent research, S.A.N.E. Vax, Inc. requested a temporary suspension of the sales and marketing of Gardasil as a cervical cancer preventive until such time as the efficacy of the vaccine is properly re-evaluated using the true endpoint for cervical cancer prevention, and a reliable HPV genotyping method for the detection of type-specific HPV infections.
In view of the pending review of Merck’s new application for expanded use of Gardasil as a vaccine to prevent “anal dysplasia and cancer” in both men and women, Erickson also sent a letter to all members of the VRBPAC, requesting the Committee to use appropriate primary endpoint and reliable HPV genotyping methods to evaluate the efficacy of the vaccine, based on the same scientific arguments put forth in the letter addressed to the FDA Commissioner.
About the author:
THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine. Our primary goal is to provide the information necessary for you to make informed decisions regarding your health and well-being. We also provide referrals to helpful resources for those unfortunate enough to have experienced vaccine-related injuries.
Articles on this site are written by Norma Erickson, President and Leslie Carol Botha, women’s health educator, broadcast journalist and Vice-President Public Relations for SANE Vax, Inc. Other members include Rosemary Mathis, mother of a Gardasil-injured daughter and Vice President Victim Support; Janny Stokvis, Vice-President Research, Freda Birrell, Secretary and HPV vaccine lobbyist United Kingdom /Scotland, and Linda Thompson, Treasurer.
We are demanding the HPV vaccines be taken off the market until an independent study on their safety and efficacy has been conducted. Until then, we are committing our efforts to an educational media campaign to alert the public about the dangers of the HPV vaccines.
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