HPV (Human Papilloma Virus) & Cervical Cancer Vaccine: Merck's Gardasil®

December 2007
Overview

In Canada, the funding of a new Human Papillomavirus (HPV) vaccine program—as detailed in the 2007 federal government budget—is making Canadian taxpayer history; it’s the costliest vaccine yet. Are we getting value for our money? What unknown health risks will young girls face who submit to this vaccine? Here’s an overview of information we’ve collected:

• FDA documents reveal HPV vaccine may increase your risk of cancer if you already have HPV. In trials, Gardasil increased risk by 44.6% of developing high-grade precancerous lesions in women who are already sero-positive and PCR-positive for vaccine-relevant genotypes of HPV. However, pre-screening for HPV infections has not been included in the vaccination program.
  See:   “VRAN HPV Vaccine Analysis” by Susan Fletcher, 2008-07-31, PDF 62kb
  “Gardasil—my error is the smoking gun” by Cynthia A. Janak, RenewAmerica.us, 2007-12-11
  FDA Reclassification Petition “07p-0210-ccp0001-01-vol1”, PDF
• The actual cause of cervical cancer is a persistent HPV infection: A “persistent HPV infection that may act as a tumor promoter in cancer induction”, according to journalist Cynthia A. Janak’s assessment of FDA document “Reclassification Petition for Human Papillomavirus (HPV) DNA, Nested Polymerase Chain Reaction (PCR) Detection” published March 7, 2007. “It is the persistent infection, not the virus, that determines the cancer risk”.
  See: “FDA and HPV—when did they know the truth?” by Cynthia A. Janak, RenewAmerica.us, 2007-12-12
• Reactions and deaths following adminstration of HPV vaccine in the U.S.: “Since the approval of Gardasil, thousands of young women and girls have been adversely affected by this vaccine.” Cynthia Janak’s July 8, 2008 article “Gardasil Tragedies – Where are the Reports?” puts a human face to the vaccine victims.As of July 3, 2008:
  * 15 patients have died See: VAERS: Vaccine Adverse Events Reporting System—Search for “HPV4” and “Patient Died”
  * 105 reactions were considered life threatening See: VAERS: Vaccine Adverse Events Reporting System—Search for “HPV4” and “Life Threatening”
  * 255 patients were hospitalized
  * 1236 patients had not recovered at the time of the report
  * 159 patients are disabled at the time of the report
  * 6697 reported incidents + 2141 (newly found as multiple entries in reports) = 8838 Total
  In the U.S., vaccine reactions are available to the public via VAERS, the U.S.A.’s official Vaccine Adverse Events Reporting System. These statistics reflect the American experience. Canada does not have a publicly accessible vaccine adverse events monitoring system, thus preventing the public from knowing the degree to which vaccine reactions and injuries are occurring in this country.Judicial Watch, the public interest group that investigates and prosecutes government corruption, has published a special report on injuries and deaths following Gardasil. See: “Judicial Watch Uncovers New FDA Records Detailing Ten New Deaths & 140 “Serious” Adverse Events Related to Gardasil” June 2008
• Excessive cost: Merck’s Gardasil, the vaccine to be used for this program, will cost approximately $400 per person injected. The federal government is contributing $300 million, estimated to be about one third of the vaccine cost nationwide. The other two thirds must come from the provinces, bringing the total cost nationwide for this one vaccine to almost one billion dollars. This cost is to cover the specified 3 doses of Gardasil for all females 9–13 years as well as females 14–26 years who are deemed to be reasonably sure of not already being infected with one or more of the 4 HPV types in the vaccine.
• FDA approval was NOT based on actual cancer prevention: FDA did not approve Gardasil based on the vaccine’s actual prevention of cervical cancer but on the prevention of precancerous lesions. How effective is Gardasil in decreasing the incidence of cervical cancer? No one knows because this question has not yet been answered. As of April 2007, Gardasil vaccine has never been proven to decrease the actual incidence of cervical cancer. See: “Gardasil – the Cervical Cancer Vaccine?”, Cancer Monthly, April 18, 2007.
• Lack of testing in 9–13 yr olds: The Gardasil monograph states: “efficacy of the vaccine in this age group [9–13 yr olds] has not been demonstrated”.
• Lack of evidence of duration of protection: The only evidence of duration of protection stated on the Gardasil monograph is: “A subset of participants (n=241) in the Phase II quadrivalent vaccine study has been followed for 60 months after dose 1 with high sustained vaccine efficacy and no evidence of waning immunity.” This means that the only test for duration of efficacy was in a minor sample of 241 older females, few of whom tested positive for any of the HPV types in the vaccine in a study that lasted a mere 5 years after the first dose of vaccine was given. Therefore, it can be said that, in general, the duration of any long term efficacy has not been demonstrated and is unknown. In fact, there’s already been talk of the need for booster shots.
• Benefit of Gardasil to 9–13 year olds is dubious: Due to the unknown duration of efficacy in older women, the benefit of Gardasil to 9–13 year olds is even more dubious than statement two reveals. To be reliably effective, HPV vaccine would need to be given reasonably near the time when one or more of the HPV types in the vaccine enters the body. This time is an unknown factor; vaccine efficacy could wane long before virus infiltration occurs or a child might already be infected at the time of vaccination. HPV infection occurs through skin-to-skin contact that’s not necessarily due to sexual activity.
• Safety in conjunction with other vaccines is questionable: The Gardasil monograph states that Gardasil “has no components that have been found to adversely affect the safety or efficacy of other vaccines.” Does this mean that Merck has looked for adverse affects and not found any or that they just haven’t bothered to look? Certainly the accumulation of ingredients aluminum and polysorbate, both known to cause cancer in lab animals and to alter immune response, together with similar types of ingredients in other vaccines is cause for concern. And Merck’s statement doesn’t mean that the vaccine as a whole does not affect safety or efficacy. Simultaneous injection of Gardasil with other taxpayer funded vaccines (such as meningococcal, chickenpox, DPT or influenza vaccines) could result in lowered efficacy and/or more adverse reactions.
• Gardasil could cause other types of cancer: Unlike other drugs, vaccines are never tested for their ability to produce cancer. Gardasil could provoke other types of cancer, including cervical cancer that’s associated with HPV types not in the vaccine. In addition, Gardasil has been very aggressively marketed with no emphasis on the fact that it can only possibly prevent HPV infection, not clear HPV that’s already present; it may actually cause an increase in cervical cancer due to a false feeling of security in the females who receive it.
• Gardasil does not guarantee safety from HPV: Since vaccination with Gardasil is obviously not a guarantee of freedom from HPV infection with vaccine type virus or others, regular Pap screening tests with their incumbent costs will still be needed.
• Rate of targeted HPV infections is extremely low: The National Advisory Committee on Immunization (NACI), the panel of “experts” who recommended funding of Gardasil states: “It [HPV infection] is not a nationally notifiable disease in Canada and, to date, no population-based studies have been published.” A study estimating the American population prevalence of HPV infection published in the Feb 28, 2007 edition of the Journal of the American Medical Association found that only 3.4% of women aged 14–59 yrs were infected with one of the HPV types in Gardasil; only 2% were infected with one of the two types that are in the vaccine and are associated with cervical cancer.
• Incidence of cervical cancer is low: Annually, U.S. statistics (and we can assume that Canadian statistics follow suit) show only 3–4 cases of cervical cancer per 100,000 females aged 9–26 years. In her article “Not So Miraculous”, Dr. Moira Terese Dolan, M.D. states in reference to the U.S.: “Gardasil’s reduction of pre-cancers by 12.2% in the general population would mean that instead of 30–40 cases of cancer, there would only be 26–35 cancers. So it would take vaccination of a million girls to prevent cancer in 4–5 girls. About 37% die from cervical cancer, so that would prevent 1–2 deaths. So $360 million [U.S] in vaccine would prevent 1–2 [U.S] deaths.”
• HPV is usually benign: The March 21, 2007 article on fwdailynews.com states: “75% or more of girls and women may test positive for HPV at some points in their lives. But, in adolescents, in 75–90% of those cases, the virus clears up on its own within 8–12 months, including those that may be cancer-causing”.
• Pap screening already works: According to the NACI, “the time it takes for an infection to progress to invasive cervical cancer can vary widely, with typical progression estimated to take up to 10 years or longer.” And that’s why Pap screening has been very effective in reducing cervical cancer.

Conclusion: Allocating government funds for this vaccine is a shameful waste of Canadian taxpayers’ money. More importantly, lack of evidence of Gardasil’s safety and effectiveness for the 9–26 year olds targeted makes this program a public health experiment that endangers our precious young women. Don’t buy into it; take action! Learn more about the vaccine or contact your governmental representative today; follow the links below.

More information:

* “Human papillomavirus, vaccines and women’s health: questions and cautions“
August 1, 2007 – CMAJ: Canada’s Leading Medical Journal
Abby Lippman, PhD, Ryan Melnychuk, PhD, Carolyn Shimmin, BJ and Madeline Boscoe, RN DU
* “Our girls are not guinea pigs: Is an upcoming mass inoculation of a generation unnecessary and potentially dangerous?”  by Cathy Gulli – MacLeans Magazine (please note, MacLeans has removed this article from their website, Internet Archive has captured page 1 only at the link above)
* “Democracy, or Orson Welles’ 1984?”
June 9, 2007 – BMJ: British Medical Association Journal
Hilary Butler
* Collection of Gardasil articles
2007 – Whale
* “Gardasil – the Cervical Cancer Vaccine? FDA Approval Not Based On Actual Cancer Prevention”
April 18, 2007 – Cancer Monthly
* “Not so Miraculous: Telling the Truth about the New Vaccine Gardasil”
Medical Accountability Network – Dr. Moira Dolan, MD
* Alliance for Human Research Protection Interview with Dr. Diane Harper, researcher and Gardasil developer:
* FWFamilyNews.com Interview with Dr. Diane Harper, researcher and Gardasil developer
* Vaccination Liberation Information Article
* WomentoWomen.com Article
* Canadian Women’s Health Network Article
* National Vaccine Information Center Press Release
VRAN letters to government officials:
* Dec 12, 2007, To Dr. David Butler-Jones, Canada’s chief medical officer of health, Subject: URGENT! Gardasil vaccine may increase risk of cervical cancer. PDF format 36kb
Contact your governmental representative:
* Find your Federal MP’s email address using your Postal Code
* Email the Prime Minister: Right Hon. Stephen Harper
Harper.S@parl.gc.ca
* Write to your MP or the Prime Minister; you may send mail postage-free to any Member of Parliament, addressed to:
House of Commons
Parliament Buildings
Ottawa, Ontario
Canada K1A 0A6
* Find your MPP’s contact information in the Legislative Assembly section of your province’s website:
Alberta www.gov.ab.ca
British Columbia www.gov.bc.ca
Manitoba www.gov.mb.ca
New Brunswick www.gov.nb.ca
Newfoundland and Labrador www.gov.nl.ca
Northwest Territories www.gov.nt.ca
Nova Scotia www.gov.ns.ca
Nunavut www.gov.nu.ca
Ontario www.gov.on.ca
Prince Edward Island www.gov.pe.ca
Quebec www.gouv.qc.ca
Saskatchewan www.gov.sk.ca
Yukon www.gov.yk.ca