S.A.N.E. Vax, Inc. asks FDA to rescind approval of Gardasil

Written by Norma Erickson

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…”

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.