S.A.N.E. Vax, Inc. Asks FDA to Rescind Approval of Gardasil™: Inappropriate Endpoint and Unreliable HPV Genotyping Methods Used for Vaccine’s Efficacy Evaluation

TROY, Mont.--(BUSINESS WIRE)--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 the fact 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.”

“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 and cervical cancers combined in any female population, including the subjects enrolled in the Gardasil™ 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™ 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...”

Consequently, the FDA has allowed Merck & Co., Inc. to market Gardasil™ as a cancer vaccine, when in fact it has only been proven to prevent “not a true biologic entity”- a reversible CIN2 change.

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 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.

S.A.N.E. Vax, Inc. is a non-profit organization established to promote safe, affordable, necessary, effective vaccines and vaccination practices.