S.A.N.E Vax Objects to FDA Ruling for Gardasil Use for Anal Cancer in 9 to 26 year olds

Increasing Number of Consumers are Concerned over HPV Vaccine Safety. When will the FDA and the CDC take the initiative to investigate the side effects of the HPV Vaccines?

SANEVAX
For Immediate Release
December 27, 2010

PRLog

The FDA’s December 22, 2010 ruling to expand the use of Gardasil for anal cancer prevention is unacceptable, according to Norma Erickson, President of S.A.N.E Vax. Last Wednesday, the U.S. Food and Drug Administration approved Gardasil for the prevention of anal cancer and associated pre-cancer lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years. Immediately, the news flooded the media – with many postings on HIV/AIDS sites.

However, medical consumers are unaware the 2010 Gardasil® Patient Product Information (PPI) states if a woman has “…immune problems, like HIV infection, cancer, or takes medicines that affect the immune system” they must be reported to the health care provider.  This should be of grave concern to HIV/AID patients and their physicians who may consider the vaccine to “prevent” anal cancer.

Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females, and for the prevention of genital warts caused by types 6 and 11 in both males and females in the same age group.

This same demographic has reported over 20,915 adverse reactions – mostly from Gardasil to VAERS – the Vaccine Adverse Event Reporting System. In addition, 89 deaths and 382 abnormal pap tests post vaccination have been reported with an estimated 1 to 10% of the population filing, according to the National Vaccine Information Center.  The rate of deaths and adverse reactions are reported as a percentage of doses distributed, not doses actually administered, and therefore CDC statistics on reported injuries are not portraying the truth.
Data on adverse reactions from males ages 9 to 26 are just starting to be reported to VAERS.  Hundreds of social media sited, journalists, researchers and educators have joined forces to publicly decry the faulty science, data, research and fast-tracking of this vaccine through the FDA.

Of course, Merck & Co. denies a causal relationship between the adverse reactions and deaths to their award-winning vaccine. However, on December 20, the QMI News Agency in Canada reported a Quebec coroner can’t explain why a 14-year-old girl died after receiving a dose of the Gardasil vaccine. Even though coroner Michel Ferland’s report concludes the adolescent girl died from drowning, and while there is no evidence the shot killed the teenager, he is refusing to rule out a link between Gardasil and her death.

On December 13, Michael Smith, North American Correspondent, MedPage Today wrote an article titled: Many Fail to Finish HPV Series as Recommended stating that “…Many girls and young women may not be completing all three doses of the quadrivalent human papillomavirus vaccine in a timely fashion…” According to Dr. Lea Widdice, Cincinnati Children’s Hospital Medical Center; in a single-institution retrospective analysis, only 14% of girls and young women completed all three doses within seven months of the first, and only 28% did so within 12 months.

Although statistical data was cited for non-compliance, SANE VAX wants to know if the girls were surveyed for their reasons in not completing the vaccine series. Until the true reasons are known, consumers must remain wary about the potential health dangers from the administration of Gardasil and Cervarix.

According to the FDA there are limitations on the use and effectiveness of Gardasil:

• GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.
• GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity.
• GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, and vaginal cancers; CIN; VIN; or VaIN.
• GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine.
• Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL protects only against those vulvar and vaginal cancers caused by HPV 16 and 18.
• GARDASIL does not protect against genital diseases not caused by HPV.
• Vaccination with GARDASIL may not result in protection in all vaccine recipients.

According to the recently revised copy of “Cervical Cancer Prevention, Health Professional Version,” published by the National Cancer Institute (NCI):  “The finding of HPV viral DNA integrated in most cellular genomes of cervical carcinomas supports epidemiologic data linking this agent to cervical cancer however, direct causation has not been demonstrated.”

On October 19, 2010 S.A.N.E. Vax submitted a formal letter to Jack Stapleton, M.D., Chair Vaccines and Related Biological Products Advisory Committee regarding Valid endpoint and reliable HPV genotyping for expanded use  proposal of Gardasil® vaccine stating… “In the interest of promoting and protecting the public health, S.A.N.E. Vax, Inc. respectfully requests that expanded use for Gardasil® as an anal cancer preventive vaccine be delayed, until such time as the efficacy of the vaccine is properly evaluated using the true endpoint for anal cancer prevention, and a reliable HPV genotyping method for detection of type-specific HPV infections.”

The Gardasil vaccine campaign on unsuspecting and ill-informed medical consumers must be halted until an independent study demonstrates the safety and efficacy of the vaccine. As it stands, this is a classic case of pharma/government vs. medical consumers with monumental social/political implications. The HPV vaccine travesty will go down in history as an example of unethical experimental medical procedures harming the health and well being of the very people the vaccines were supposedly designed to protect.

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