By Leslie Carol Botha
In a long awaited decision1 the US FDA has ruled against Merck’s supplemental biologics license application (sBLA) for an indication to use GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in women ages 27-45. This was Merck’s 4th request to expand Gardasil use to an older population of women.
SANE Vax, Inc. applauds the FDA on their decision. According to Norma Erickson, President,
“This decision is a major victory for medical consumers around the world. I would like to personally thank the SaneVax Team as well as each one of the medical professionals, scientific researchers and educators who have helped get the truth behind the development, testing, approval and marketing of this vaccine out to the public. All of their hard work is empowering medical consumers worldwide to say, ‘Enough is enough! If it is not Safe, Affordable, Necessary and Effective – we don’t need it!’
Leslie Carol Botha, Vice-President of Public Relations for SANE Vax, Inc. made this statement:
“It is obvious the SANE Vax Gardasil Awareness Media Campaign has been effective. We have communicated our concerns to the FDA on multiple occasions using science based peer reviewed analysis, and at the same time we have written and distributed hundreds of press releases and articles documenting not only the research but the damage Gardasil has done to previously healthy adolescents. We can proudly say medical consumers, and doctors, as well as our government are paying attention to our concerns.”
FDA Ruling an Admission of Guilt?
A press release issued by Merck on April 6, states that: “An indication for adult women was not granted; instead, the Limitations of Use and Effectiveness for GARDASIL was updated to state that GARDASIL has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age. End of study data from the clinical study evaluating the use of the vaccine in this age group was also added to the prescribing information.”2
SANE Vax Inc., believes Gardasil has not been demonstrated to prevent CIN 2/3 or worse in women younger than 26 years old either. Clinical trials used an endpoint insufficient to clearly demonstrate efficacy in this arena. Therefore, we believe that Gardasil needs to be taken off the market until an independent study on the vaccine’s safety and efficacy is conducted.
SANE Vax, Inc. will continue our campaign until Gardasil is taken off the market.
On October 25, 2010 SANE Vax Inc., issued a Business Wire press release asking the FDA to rescind approval of Gardasil because of “Inappropriate Endpoint and Unreliable HPV Genotyping Methods Used for Vaccine’s Efficacy Evaluation” following formal letters sent to Margaret Hamburg, FDA Commissioner, and former Chair of VRBPAC, Jack Stapleton.
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.”3
In the press release “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.” 2.
SANE Vax Inc. believes the FDA has opened the door to formally question the validity of the end point utilized in Merck’s initial Gardasil clinical trials. The shadow of doubt has been cast – but not until after the vaccine caused severe damages and untimely deaths to the very population Gardasil was designed to protect.
U.S. Prescribing Information for GARDASIL® Updated; Indication Not Granted for Use in Adult Women