FDA

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

Tuesday, February 15, 2011 by: Rosemary Mathis, Director of SANE VAX, INC.
Tags: Gardasil, FDA, health news

eTrust Pro Certified

Most Viewed Articles
Popular on Facebook
BACK INTO THE CLOSET: Why U.S. reporters are not allowed to write about rainbow events in nations where being gay is still condemned
Depopulation test run? 75% of children who received vaccines in Mexican town now dead or hospitalized
A family destroyed: Six-month-old dies after clinic injects baby with 13 vaccines at once without mother's informed consent
Biologist explains how marijuana causes tumor cells to commit suicide
Companies begin planting microchips under employees' skin
BAM! Chipotle goes 100% non-GMO; flatly rejecting the biotech industry and its toxic food ingredients
INVESTIGATION: Three days before Dr. Bradstreet was found dead in a river, U.S. govt. agents raided his research facility to seize a breakthrough cancer treatment called GcMAF
ECONOMIC SLAVERY FOR ALL: While we were distracted with the Confederate flag flap, Congress quietly forfeited our entire economic future via fast-track trade authority
NJ cops bust teenagers shoveling snow without a permit
Chemotherapy kills cancer patients faster than no treatment at all
McDonald's in global profit free fall as people everywhere increasingly reject chemically-altered toxic fast food
March Against Monsanto explodes globally... World citizens stage massive protests across 38 countries, 428 cities... mainstream media pretends it never happened
Italian court rules mercury and aluminum in vaccines cause autism: US media continues total blackout of medical truth
The 21 curious questions we're never allowed to ask about vaccines
SCOTUS same-sex marriage decision may have just legalized the concealed carry of loaded firearms across all 50 states, nullifying gun laws everywhere
Orthorexia Nervosa - New mental disorder aimed at people who insist on eating a clean diet
Vicious attack on Dr. Oz actually waged by biotech mafia; plot to destroy Oz launched after episode on glyphosate toxicity went viral
Nearly every mass shooting in the last 20 years shares one surprising thing? and it's not guns
Delicious
(NaturalNews) 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.

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.

For more information, visit http://sanevax.org/

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.

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.

SANE Vax, Inc. is involved in the ground-breaking production of the One More Girl Documentary which will premier in 2012. Please join our cause by contributing to this project by contacting Ryan Richardson, Producer at ryan@onemoregirlfilm.com.

For more information, please visit our site at http://sanevax.org/.

Explore more on Gardasil by searching on GoodGopher.com, the search engine for truth seekers.
Join over four million monthly readers. Your privacy is protected. Unsubscribe at any time.
comments powered by Disqus
Take Action: Support NaturalNews.com by linking back to this article from your website

Permalink to this article:

Embed article link: (copy HTML code below):

Reprinting this article:
Non-commercial use OK, cite NaturalNews.com with clickable link.

Follow Natural News on Facebook, Twitter, Google Plus, and Pinterest

Colloidal Silver

Advertise with NaturalNews...

Support NaturalNews Sponsors:

Advertise with NaturalNews...

GET SHOW DETAILS
+ a FREE GIFT

Sign up for the FREE Natural News Email Newsletter

Receive breaking news on GMOs, vaccines, fluoride, radiation protection, natural cures, food safety alerts and interviews with the world's top experts on natural health and more.

Join over 7 million monthly readers of NaturalNews.com, the internet's No. 1 natural health news site. (Source: Alexa.com)

Your email address *

Please enter the code you see above*

No Thanks

Already have it and love it!

Natural News supports and helps fund these organizations:

* Required. Once you click submit, we will send you an email asking you to confirm your free registration. Your privacy is assured and your information is kept confidential. You may unsubscribe at anytime.