Common Sense Health: Guarding Against Gardasil

 

By: Maureen McDonnell

Facts not fear should guide our decisions about the HPvaccine.
Of course we want to protect our children and ourselves against the most common sexually transmitted disease: Human Papilloma Virus (HP) that an estimated 20 million Americans are now infected with. Unquestionably if the body does not clear it, this virus can turn into a persistent infection which can lead to the development of genital warts and or cervical (as well as other types of) cancer. However, the question some of us are asking is: without long term safety studies, why is the vaccine to prevent HPnow being recommended (and in some states mandated) for all 11 year old girls and boys? Many of us are also wondering if vaccines are always the safest, best and only way to prevent the spread of infections.
Epidemiological studies report that sexually active men and women are at the greatest risk for developing an HPinfection and that 74% of infections occur between the ages of 14 and 24. These studies also estimate that 80% of sexually active women will acquire an HPinfection by age 50. Just as important a fact however is that 90% of HPinfections clear on their own within 2 years and in younger women, they often clear within a year.
Diane Harper, MD was the principal investigator and lead research scientist in the development of the vaccine for HP. She appears in the new film that questions the safety of vaccines entitled: The Greater Good (GreaterGoodMovie.org) in which she expresses concern about the rush to market the HPvaccine after only 15 months of an originally scheduled four-year trial. She says the vaccine should not have been “face-tracked” in this way and is troubled by the reports of many adverse reactions including Juvenile ALS, pancreatitis, and autoimmune problems. She also states that the vaccine has only been shown to provide protection from HPfor 5 years. The question then begs to be answered if most women are not becoming sexually active until on average age 17.3 why are we vaccinating children as young as 9 years old?
Barbara Loe Fisher, the founder and director of the National Vaccine Information Center (NVIC.org) in Washington, DC who appears with Dr. Harper in the film discusses her opposition to “forced” vaccination policies as well as her concern over the sheer number of vaccines children now receive. In the 1980’s children received approx 11 vaccines before entering kindergarten, and now 3 decades later they receive anywhere from 36-45 vaccines prior to the age of 5. It should also be noted that during this same time period Autism rates increased in children from 3 per 10,000 to 1 in 110 (1 in 93 in North Carolina), Asthma increased by 300% and many other chronic illnesses including Diabetes, Cancer, ADHD, etc. have escalated beyond anyone’s prediction or expectation.
Several physicians interviewed for the film expressed their dismay regarding the fact that since the release of Gardasil, in 2006, the Vaccine Adverse Event Recording System (VAERS) received and recorded over 15,000 incidences of adverse reactions. Additionally, the Judicial Watch group (after obtaining records from FDA via the Freedom of Information Act) reported in October 2011, 47 deaths associated with the HPvaccine.
A few facts to consider regarding HP, cervical cancer and the vaccine:

  • 50% of men and women will acquire an HPinfection in their lifetime.
  • Persistent infections can lead to genital warts in men and women and cervical cancer in women.
  • 90% of HPinfections clear on their own. A quote from the National Cancer Institute “It is important to note however that the great majority of high risk HPinfections go away on their own and do not cause cervical cancer. (2)
  • HPhas been detected in 99.7% of all cervical cancers making it the highest level of association for a specific cause of a major human cancer. (3)
  • The American Cancer Society estimated that “in 2007 about 11,150 cases of cervical cancer would be diagnosed in the US and an estimated 3,6770 of those women would die from the disease.” (1)
  • For women in the US, Cervical Cancer represents 1.6% of all cancers diagnosed and 1.3% of deaths.
  • Cervical cancer typically takes 20 years to develop.
  • Pap smears remain the only proven method for cervical cancer prevention and is primarily responsible for the decline in mortality from cervical cancer.
  • The CDC states that about 30% of cancers will not be prevented with the vaccine.
  • Cervical cancer is also associated with other risk factors: smoking, increased age, presence of other STD’s and a suppressed immune system.
  • Not all persistent infections develop into precancerous lesions and not all precancerous lesions persist to become cervical cancer. (4)
  • The manufacturer of the vaccine spent over 100 million dollars in advertising the first year the vaccine was on the market.
  • Sales of Gardasil topped 2 Billion dollars in 2008.
  • Spain withdrew 76,000 doses of the vaccine in 2009 after reports of women being hospitalized after receiving the vaccine.
  • According to a poll conducted by the National Vaccine Information Center there have been more reactions and deaths associated with Gardasil than with any other vaccine. The original study followed 1200 girls ages 16-26 for a period of 15 months prior to the release of Gardasil. It was not tested on 9-11 year olds.
  • The vaccine contains 225mcg of Aluminum (a known neurotoxin) and Polysorbate 80
  • Congress passed a law in the 80s which does not allow an individual to sue a vaccine manufacturer for damages caused by a vaccine. One must go through the Vaccine Compensation Court. To date, that court has awarded over 2 Billion in damages associated with vaccines.
  • There are an estimated 6000 cases per year of HPassociated neck and head cancers in men. The duration and efficacy of Gardasil in males has not been established beyond 3 years. (Read Gardasil’s FDA Biologics License Application for indication in males for genital warts). Compare 6000 cases of men with HPrelated cancers with 215,000 incidents of lung cancer and 182,000 individuals diagnosed with breast cancer per year.
  • Men who have sex with men are 17 times more likely to develop anal cancer. But research has shown the vaccine provides heterosexual males with wart protection for 2.9 years, not homosexual men.
  • A study in the New England Journal of Medicine stated that the use of condoms decreases the risk of acquiring HPby 70%.
  • 100 HPgenotypes have been identified. Most infect the epithelium and cause benign plantar warts. Approx 40 types are responsible for mucosal infection. HP16 and HP18 cause approx 70% cervical cancers worldwide.
  • HPV 6 and 11 cause 90% genital warts in men and women.

This is not an easy list of facts to wade through. But as we make our individual choices regarding whether we or our 9-11 year old children should receive this vaccine, it is these very facts, not fear that needs to be the basis from which we make our decisions. Recently, in California, Governor Jerry Brown signed into law a bill that permits children as young as nine to be presented with information on cervical cancer and subsequently receive the HPvaccine in school without their parents knowledge or consent! It’s also interesting to note (while you are digesting that piece of information) that when the Governor of Texas (and Republican presidential hopeful) Rick Perry tried to mandate that all 11-year-old girls in his state receive the vaccine, it was discovered that his chief of staff was a former lobbyist for Merck. As Barbara Loe Fisher is quoted as saying “That’s not science, that’s politics!”

A few unanswered questions about Gardasil:

  1. The vaccine is produced in Saccharomyces Cerevisiae (Baker’s yeast). So it is contraindicated for people with a yeast problem. However, many individuals with candida or yeast have never been tested for or diagnosed with it and therefore would not be aware that they are potential candidates for having an adverse reaction to the vaccine.
  2. Because it is not a live vaccine, co-administration with other vaccines (given at the same time) is permitted. Really? In all the research done for this article, I did not find one study in which the (long and short term) reactions of administering Gardasil at the same time as other vaccines was looked at.
  3. It is also recommended that the vaccine can be given with minor acute illnesses and or if immune-suppressed. If physicians, the FDA, the CDC, and the American Academy of Pediatrics actually listened to thousands of parents of children who developed autism after receiving immunizations while sick, no one would ever give vaccines at a time when a child or teen was sick, was showing signs of illness or was just recovering from an illness.

In Summary: When I was in college, I vividly recall a conversation that took place around our very Irish Catholic dinner table. At this particular family gathering, my uncle, a priest, was visiting. When I pronounced, that after 17 years of Catholic school, I had some serious questions regarding the infallibility of the Pope; my uncle turned to me and said “if you question this basic tenet of the church, you will be excommunicated!” Excommunicated…. Really…for questioning something that seems so unreasonable? “Absolutely and unequivocally” he said.
We now live in a time when vaccines have become the Holy Grail of the pharmaceutically- dominated medical system, and the belief that they are the only safe and effective method for eradicating disease is a basic tenet of this system. Those of us in the nursing and medical profession who challenge these beliefs are considered by some to be heretics. However, with insufficient safety data and reports of mild, severe and even fatal adverse reactions, challenge we must. It is our moral obligation to question why we are subjecting 11-year-old girls and boys to a vaccine for an infection that 90% of the time clears on its own and for which the idea that the benefits outweigh the risks remains uncertain
In closing I would to thank my colleague, friend and renowned physician Stuart Freedenfeld, MD for lending his perspective on this often fear-infused and confusing topic: “Cervical cancer is a disease that takes the life of perhaps 3 women out of every 10,000 women in this country. In my medical training I was taught that cervical cancer death is completely preventable with yearly Pap smears. Over time we discovered that Pap screening as infrequently as every 3 years would be just as effective in preventing death from this disease. The vast majority of women who succumb to cervical cancer are women who do not get screened or are immune deficient such as those suffering with advanced HI. To now take that reality and scare the American public, and more specifically the American children, into unwarranted fear about developing cancer if they do not rush off and get this set of vaccines is an outrage and an affront to our collective responsibility to those children.
I have always been particularly uneasy about injecting DNA virus material into our bodies but when that DNA is combined with 225 mcg of aluminum, the safety of which has never been tested in humans, and 50 mcg of polysorbate 80, then I have very serious concerns about the safety of this substance that we are proposing to inject into a child to protect against a disease that they almost certainly would never be harmed by.”
References:
1. Jemal A, Siegel R, Ward E et al. Cancer statistics, 2007. CA Cancer J Clin. 2007; 57:43-66.
2. Markowitz LE, Dunne EF, Saraiya M etal. Quadrivalent human papillomavirus vaccine: recommendations of the AdvisoryCommittee on Immunization Practices(ACIP). MMWR Recomm Rep. 2007;56(RR-2):1-24.
Franco EL, Villa LL, Sobrinho JP et al. Epidemiology of acquisition and clearance of cervical human papillomavirus infection in women from a high-risk area for cervical cancer. J Infect Dis. 1999;
180:1415-23.
3. Walboomers JM, Jacobs M, Manos MMet al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999; 189:12-9.
4. Saslow D, Castle PE, Cox JT et al. American Cancer Society Guideline for Human Papillomavirus (HP) Vaccine Use to Prevent Cervical Cancer and Its Precursors. CA Cancer J Clin. 2007; 57:7-28.

Additional References:

British Journal of Cancer (2006) 95, 1459–1466. doi:10.1038/sj.bjc.6603469 www.bjcancer.com
Published online 21 November 2006
N Engl J Med, Quadrivalent Vaccine against Human Papilloma virus to Prevent Anogenital Diseases
2007;356:1928-43.
N England J Medicine, Efficacy of Quadrivalent HPVaccine against HPInfection and Disease in Males, Anna R. Giuliano, Ph.D et al, , Feb 2011
The Greater Good Movie
(greatergoodmovie.org)

Maureen McDonnell has been a registered nurse for 34 years (in the fields of: childbirth education, labor and delivery, clinical nutrition, and pediatrics.) She is the former national coordinator of the Defeat Autism Now! Conferences and is the co-founder of Saving Our Kids, Healing Our Planet. Her published articles on autism and health can be found at sokhop.com. In addition to writing a monthly column Common Sense Approaches to Women’ Health., she is the owner of Nutritionist’s Choice multi vitamin: www. NutritionistsChoice.com. Presently Maureen is the Medical Coordinator for the Imus Ranch for Kids with Cancer. She and her husband H Hanson have five grandkids and feel blessed to be living in the beautiful mountains of WNC


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