Gov. Nikki Haley Rejects Gardasil: A Moment of Sanity in a Sea of Corporate-Sponsored Confusion

Nikki Haley, Governor of South Carolina, made headlines on Tuesday by vetoing a bill initiated by the Democrats which would provide sixth graders with government-sponsored information encouraging parents to get the human papillomavirus (HPV) vaccine for their children as well as one free HPV vaccine for seventh graders. Haley has received a barrage of criticism for her actions, and charges of hypocrisy for having previously sponsored a bill in 2007 that would have mandated the HPV vaccine in South Carolina, even though she ultimately withdrew her backing because the bill did not contain an opt-out provision. While the current bill had broad bipartisan support, Governor Haley rejected it as unnecessary and because it would be a precursor to a vaccine mandate entirely dependent on government funding. More importantly, however, Haley was quoted as saying her previous support of a human papillomavirus vaccine mandate was a mistake: now that she hasa 14 year-old daughter she feels differently about "what I am going to do as a parent and what I want for my child."1 

Instead of relying onher own common sense and intuition as a parent to reject Gardasil, all Governor Haley had to do was look at real science, including the results of a study published on June 21, 2012, in the Journal of the Royal Society of Medicine. This study reviewed the claims made by the Programme for Appropriate Technology in Health (PATH) -- a charity supported by Bill Gates -- aggressively advocating the introduction of a government-funded program for HPV vaccine in India, a country which it asserts"has the largest burden of cancer of the cervix of any country worldwide."2  The Indian government had suspended research on the feasibility and safety of the HPV vaccine in April 2010, after the death of four girls in the two Indian states where HPV research was being carried out. The evidence presented in the Royal Societystudy refutes the claim that India has a large burden of cervical cancer, and rejects the arguments favoring a government-sponsored HPV vaccination program. Professor Allyson Pollock, one of the study authors, concluded that "HPV vaccine, which is among the most expensive vaccines on the market, is not justified as a health care priority for India."3 

While we support Governor Haley's courage in standing up for a parent's right to determine the healthcare given to their children, which is laudable, we would offer Governor Haley,along with every governor in America, every state and federal legislator, and every pediatrician, pharmacist, and nurse, a reality check. Mandating, or even encouraging or supporting,the human papilloma virus vaccine is tantamount to promoting a public health fraud, and intentionally and with malice aforethought, placing millions of young girls' and boys' lives at risk for debilitating injury, including death. 

Our public health policies, including vaccination, have been formed not by independent, qualified scientists, but rather by lobbyists who have paid for access to politicians at the state and federal levels, bringing forth hand-picked, highly compromised scientists and physicians to promote a fallacy and make it codified by law that the HPV vaccine will prevent cervical cancer and save countless lives when, in fact, independent science shows just the opposite. Therefore, we are offering you an opportunity to review actual scientific evidence that would convince any responsible and reasonable parent, politician, or physician that this vaccine should be banned, not mandated. 

While the Democrats in South Carolina moan about lost opportunities to save lives and to cut back on health care costs, what they seem clueless and grossly irresponsible about are the facts; once again allowing ideology to trump science. Even Governor Jerry Brown of California, demonstrated his unbridled promotion of the Gardasil vaccine by signing into law in October 2011, a bill which gives 12 year-old children the right to choose the HPV vaccine not only without parental approval, but without even parental notification!4  The scientific facts are that the HPV vaccine is dangerous, even deadly. The major HPV vaccine in question is, of course, Gardasil, Merck's premier product that has lifted it out of the financial doldrums since the ignominious removal of Vioxx from the market in 2004. 

We spoke with Cindy Bevington, an investigative journalist, who says we should all be very concerned about these repeated attempts to force Gardasil on our children because there is absolutely no proof that using this vaccine will lead to the prevention of cervical cancer. Bevington broke the story in 2007 that Dr. Diane Harper, the lead investigator for the clinical trials of both Gardasil and its competitor, Cervarix, considered the HPV vaccine to be not only unnecessary, but "a huge public health experiment." Dr. Harper revealed to Bevington that the current rate of cervical cancer in the US is so low, that every single 12 year-old girl would need to be vaccinated for the next 60 years to reduce the rate of cervical cancer at all.5  The news was a disappointment to the legislative campaign to mandate Gardasil across the nation to 12-year old girls, which was being heavily pushed by Merck together with ALEC and their spokespeople, Women in Government. Since then, despite all the advertising, Gardasil is nowhere near as successful as Merck was hoping for. 

During the push to require Gardasil for children in Indiana, Bevington went to the hearings and observed Indiana legislators actually weeping, begging for the vaccine to be mandated as they spoke about lives lost to cervical cancer without it! Why have we become such an anti-scientific nation? We have been misled scientifically into believing that this vaccine will save lives when in fact the opposite is true. The remarkable claims of Gardasil's benefits to women in the war on cancer are quite simply ridiculous, inaccurate, fraudulent, and are not supported by the science -- even that science funded by Merck itself.  We could ask where is the New York Times, the Washington Post, the LA Times, CBC, Fox,or CNN? Where are the journalists and the resources they have at their disposal to uncover these facts? Is this a truth they do not want to know because they would then be forced to report it? The Gardasil story is just one example of the bias in official media,both conservative and liberal. Here, then, are 10 facts that would seem that no Governor, Federal official, or legislator has taken the time to study. If so, we would have a different approach to mandating Gardasil in the 50 states. 

Cervical cancer in the United States has been at record lows for the past two decades. Currently, only an estimated 3,600 women die of cervical cancer each year. The spectacular success in lowering the death rate from cervical cancer can be attributed to annual Pap screening -- between 1955 and 1992 deaths from cervical cancer declined 74% and continue to decline annually by 4%.6  Part of the success of Pap screening lies in the fact that cervical cancer, unlike most other cancers, is very slow growing, and takes an average of 20 years to develop. With screening, there is ample opportunity to catch and successfully treat cervical cancer before it gets out of hand, so a vaccine would not improve upon this already very low rate of cervical cancer death.

 

It is estimated that virtually all women in the US experience a series of human papilloma virus infections throughout their lifetimes. What the makers of Gardasil try to hide is the well-documented fact that 90% of all HPV infections go away of their own accord within two years without causing any disease and with no treatment or intervention of any kind.7  Our immune systems are designed to clear this virus.

The Gardasil clinical trials never evaluated whether or not the vaccine could prevent cancer. Because cervical cancer normally takes 20 to 40 years to develop, it would be too expensive to study a vaccine for that length of time. So instead, Merck's scientists decided arbitrarily that the presence of atypical cervical cells was a valid substitute for cancer. They used this hypothesis despite the fact that there is no evidence that the types of cervical lesions they chose as their endpoint would eventually lead to cancer.8  Merck has never acknowledged that their entire premise for the efficacy of Gardasil rests on pure speculation. In fact, many if not most atypical cervical cells resolve on their own without intervention.9  

Results of Merck's efficacy study published in a 2007 article in the New England Journal of Medicine claim that Gardasil is 98% effective at preventing high-grade cervical lesions. But the article itself reveals that Merck manipulated the data by excluding women and girls who did not follow the exact protocol. When all women in the study were considered, vaccine efficacy dropped to 44%. But even these numbers only actually reflect cervical lesions associated with HPV 16 and 18. When Merck looked at Gardasil's ability to prevent all cervical lesions, Gardasil was only 17% effective!10 And again, their definition of "effective" rests solely on the unfounded assumption that certain types of cervical lesions turn into cancer.

More damning is Merck's own acknowledgement that in their controlled studies, a percentage of girls actually developed serious cervical lesions following Gardasil. The vaccine seemed to cause the most lesions in girls with pre-existing HPV 16 or 18 infections, but also in girls who had no pre-existing HPV infections.11  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, they have actually discouraged this practice, presumably so as not to draw attention to the danger.12  Anything to maintain the fantasy that this is a safe and effective vaccine. 

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.13 ,14  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 the protection was so limited? 

7. Gardasil is only effective for 5 years in girls, and even less time in boys; Vaccinating prepubescent children is useless. 

Despite the sentimental 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.15  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.  The limited studies in males that exist show that the vaccine wanes by three years.16 

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!17  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 proven to be protective.

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 anal/rectal cancer among men in the United States, 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 cancerat all. Yet, Merck's statistics regarding their cancer substitute penile/perianal/perineal intraepithelialneoplasia (PIN) listed in their 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!18 

Most significantly, Gardasil has been associated with an unacceptable number of serious,life-altering adverse events following vaccination. Dr. Diane Harper, lead researcher in the Gardasil and Cervarix clinical trials went on record to say that the rate of serious adverse events associated with Gardasil is greater than the incidence of cervical cancer itself!19 

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 of 2006, including seizures, anaphylaxis, paralysis, transverse myelitis, LouGehrig's disease (ALS), acute disseminated encephalomyelitis (ADEM),opsoclonus-myoclonus syndrome (uncontrollable movement of the eyes back andforth and jerking movements of the extremities), brachial neuritis, loss ofvision, 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-Barre Syndrome, abnormal Pap smears and even cervical cancer.20, 21, 22  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 to 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.23  But most tragically, as of May 2012, the death toll from Gardasil is now at 111!24  

It is not possible to know exactly how many children have been injured or died from the Gardasil vaccine because the reporting system is voluntary and estimates are that as few as 5% ofadverse events are ever actually reported. Indeed, to give just one current example, the Swiss pharmaceuticalgiant, Roche, is being investigated after a routine inspection found that it had failed to properly assess 80,000 cases of possible adverse drug reactions, including 15,161 deaths!25  

The efforts by Merck, GlaxoSmithKline, ALEC, the CDC, the FDA and the rest of the medical establishment to force our sons and daughters to be vaccinated against human papilloma virus will not stop. We have to be vigilant against this stealth menace if we want to protect our children against what clearly is a form of medical fascism, and preserve our right to make decisions for ourselves and our children free of government interference. We applaud Gov. Haley's veto of the covert mandate of Gardasil in South Carolina, but the fight is far from over. It is up to us to do our homework and tell our representatives in no uncertain terms why we will not agree to risking our children's lives in this greatest of public health experiments that stands to benefit only the drug companies and their supporters. 

Gary Null is the host of the nation'slongest-running public radio program, TheGary Null Show, and founder of the web-based Progressive Radio Network. A journalist and New York Times best-selling author who has written over70 books on nutrition, health, and socio-political 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). http://www.prn.fm.

Nancy Ashley is a freelance journalist with a medical background who is based in New York. She reports on health and science issues, and frequently works with Gary Null as a researcher and co-author. 

Endnotes

1. EnglishHS, Nikki Haley Vetoes Child Vaccination Bill, Calls it Taxpayer-FundedHealthcare Mandate, The Inquisitr,June 20, 2012, click here,accessed 6/21/12.

2. MattheijI, Pollock AM, Brhlikova P, Do Cervical Cancer Data Justify HPV Vaccination in India? Epidemiological Data Sources and Comprehensiveness, Journal of the RoyalSociety of Medicine, 2012; 105; 250-262, click here,accessed 6/22/12.

3. Media Release, Controversial vaccine trial should never have been run in India, researchers say, The Royal Society of Medicine, June 21, 2012, http://www.rsm.ac.uk/media/pr305.php, accessed 6/22/12.

4. McGreevyP, New law lets 12-year-olds consent to preventive care for STDs, LA Times, October 9, 2011, click here, accessed 6/21/12.

5. Interview with Cindy Bevington, June 21, 2012

6. Bevington C, Researcher, Diane Harper, Blasts Gardasil HPV Marketing,Off The Radar, click here, accessed September 15, 2011. 

7. Cervical Cancer, American Cancer Society,Cancer.org/cancer/cervical cancer/detailed guide click here, accessed October 15, 2011.

8. RothmanSM and Rothman DJ, Marketing HPV Vaccine: Implications for Adolescent Health and Medical Professionalism, JAMA 2009, 302(7); 781-786.

9. TomljenovicL and Shaw CA, Human Papillomavirus (HPV) Vaccine Policy and Evidence-Based Medicine: Are They at Odds? Annals of Medicine December 22, 2011; click here, accessed December 23, 2011.

10. LenzerJ, Should Boys be Given the HPV Vaccine? The Science is Weaker than the Marketing, Discover Magazine, November 14, 2011.

11. TomljenovicL and Shaw CA, Human Papillomavirus (HPV) Vaccine Policy and Evidence-BasedMedicine: Are They at Odds? Annals of Medicine December 22, 2011; click here,accessed December 23, 2011.

12. EricksonN, Dr. Sin Hang Lee: A case study in ethics don't pay,Sane Vax Inc, click here, accessed October 15, 2011.

13. HumanPapillomaviruses and Cancer, National Cancer Institute, September 7, 2011, click here, accessed January 3, 2012.

14. Haug CJ, Human Papillomavirus Vaccination -- Reasons for Caution, New England Journal of Medicine, August 21, 2008, 359; 861-862

15. TomljenovicL and Shaw CA, Human Papillomavirus (HPV) Vaccine Policy and Evidence-BasedMedicine: Are They at Odds? Annals of Medicine December 22, 2011; click here, accessed December 23, 2011.

16. Merck,Gardasil Package Insert, revised 2010, click here, accessed 6/21/12.

17. TomljenovicL and Shaw CA, Human Papillomavirus (HPV) Vaccine Policy and Evidence-BasedMedicine: Are They at Odds? Annals of Medicine December 22, 2011; click here,accessed December 23, 2011.

18. LenzerJ, Should Boys be Given the HPV Vaccine? The Science is Weaker than the Marketing, Discover Magazine, November 14, 2011

19. AtkissonS, Gardasil Researcher Speaks Out, CBSNews, August 29, 2009, http://www.cbsnews.com/2100-500690_162-5253431.html, accessed 6/21/12.

20. Examiningthe FDA's HPV Vaccine Records, JudicialWatch Special Report, June 30, 2008, click here, accessed September 16, 2011.

21. VAERS -- Vaccine Adverse Event Reporting System. http://vaers.hhs.gov/index, accessed October 14, 2011.

22. BothaLC, New Death Post-Gardasil Updated VAERS Figures & Report that HPV Vaccines Adverse Reactions are 50% Higher Than Other Age-Related Recommended Vaccines, November 29, 2011, Sane Vax, Inc., click here, accessed December 4, 2011.

23. RubinS, Blog Entry for October 2011, National Vaccine Information Center, posted December 29, 2011, http://medalerts.org/analysis/archives/394, accessed December 30, 2011.

24. VAERS -- Vaccine Adverse Event Reporting System. http://vaers.hhs.gov/index, accessed 6/21/12.

25. Reuters, Drug company Roche accused of not reporting possible drug side-effects, Fox News.com, June 22, 2012, click here, accessed 6/22/12.