Richard Gale and Gary Null PhD
Progressive Radio Network, December 17, 2019
The history of the Gardasil vaccine illustrates the lack of oversight on the part of our health authorities when it comes to reviewing the pharmaceutical industry’s testing of vaccines for efficacy and safety. Before receiving FDA approval, the HPV vaccine Gardasil was tested on fewer than 1,200 girls. Subsequent trials included many more participants. However, in the early trials only 27% of the enrolled girls were actually administered the complete three-vaccine series. Another remarkable misstep in the trials was that no girls under age 15 participated, despite the fact that the vast majority girls given the vaccine today are under that age. Nevertheless, the vaccine was fast tracked by the FDA in 2006. Rushing this vaccine through the regulatory hurdles is an example of gross negligence. Seventeen girls died before and after the trial; nevertheless without any compelling evidence the CDC states none of these deaths were due to the vaccine.
In 2014, approximately 60% of all American girls and 42% of American boys aged 13-17 received at least one HPV shot. Merck’s shameful methodology during Garadsil’s pre- and post-licensure trials was reviewed in a 2012 analysis by scientists at the University of British Columbia and published in the journal Current Pharmaceutical Design. The research team didn’t mince words in their assessment of the flawed trials:
“We carried out a systematic review of HPV vaccine pre- and post-licensure trials to assess the evidence of their effectiveness and safety. We found that HPV vaccine clinical trials design, and data interpretation of both efficacy and safety outcomes, were largely inadequate. Additionally, we note evidence of selective reporting of results from clinical trials (i.e., exclusion of vaccine efficacy figures related to study subgroups in which efficacy might be lower or even negative from peer-reviewed publications). Given this, the widespread optimism regarding HPV vaccine’s long-term benefits appears to rest on a number of unproven assumptions (or such which are at odds with factual evidence) and significant misinterpretation of available data.”
Early doubts about the FDA’s approval of Gardasil came from an unlikely source, Dr. Diane Harper, a consultant for Merck and a chief scientist overseeing the clinical trials to evaluate Gardasil’s safety and efficacy. After receiving FDA approval, Dr. Harper publicly questioned Gardasil’s efficacy and public health value compared to the successes in preventing HPV infections from conventional PAP smears. Among her concerns was that no data showed that Gardasil remains effective after 5 years. A truly effective HPV vaccine, on the other hand, would need to be efficacious for 15 years in order to prevent cervical cancer. And that too is misleading. The median age for early diagnosis for cervical cancer is age 50 and cervical cancer’s median age for death is 58. And cervical cancer only represents less than 3 percent of all cancers and representing approximately one one hundredth of the US population. Yet, the CDC is targeting children who have negligible risk cervical cancer. And now the vaccine is being administered to boys with zero risk of dying. After factoring for the profit boon Merck receives from Gardasil, $2.3 billion annually, we believe the motive for the government forcing a vaccine that will have little efficacy in reducing of cervical cancer rates has little to do with protecting public health.
In addition, Dr. Harper estimated that every American 11 year old girl would have to be vaccinated for the next 60 years in order to have any measurable effect on rates of cervical cancer. Gardasil’s efficacy in protecting against HPV infection has also been criticized due to the fact that it originally only targeted four of the more than one hundred HPV strains in circulation. In 2014, the FDA approved Gardasil-9, which supposedly protects against nine strains. Scientists from the University of Texas presented research at the 2015 meeting of the American Association for Cancer Research revealing that vaccinated women were at a significantly higher risk to become infected with HPV strains not contained in the vaccine when compared to unvaccinated women. Another study published in the Journal of the American Medical Association (JAMA) demonstrated the ineffective nature of Gardasil in women with existing HPV infections. The authors concluded that Gardasil offers no benefit to women recovering from HPV during a 12-month period. The research team stated that they “see no reason to believe that there is therapeutic benefit of the vaccine elsewhere because the biological effect of vaccination among already infected women is not expected to vary by population.” In fact, a paper out of the University of California at Berkeley and appearing in the October 2013 issue of Molecular Cytogenetics came to public attention last year to suggest that cervical cancer may not be caused by the human papilloma virus. If the theory is correct then the HPV vaccines do not prevent cervical cancer and are utterly useless.
Given the high rate of recovery for people with HPV infections, the widespread use of the vaccine is highly suspect. Even the National Cancer Institute has stated that “[m]ost high-risk HPV infections occur without any symptoms, go away within 1 to 2 years, and do not cause cancer.” In fact, 90% of all cases of HPV disappear within 2 years. Cervical cancer is highly curable when detected early. The regular use of pap smears have helped decrease the incidence of cervical cancer in the United States by over 50% since the 1970s. Examining health data from Finland and the UK , Dr. Harper and her colleagues concluded that HPV vaccinations give a false sense of security to many young women and girls who in turn opt out of regular pap smear tests. According to Dr. Harper, this trend has resulted in exponential increases in recent HPV rates.
Even more alarming, Gardasil has gained notoriety as one of the most dangerous vaccines for its serious life-threatening adverse effects. The National Vaccine Information Center, a watch-dog organization investigating vaccine injury trends and federal policies, reported that
“After the original Gardasil vaccine was licensed for 11-12 year old girls and young women, thousands of adverse reaction reports were filed for: sudden collapse with unconsciousness within 24 hours, seizures, muscle pain and weakness, disabling fatigue, Guillain-Barre Syndrome (GBS), facial paralysis brain inflammation, rheumatoid arthritis, lupus, blood clots, premature ovarian failure, optic neuritis, multiple sclerosis, strokes, heart and other serious health problems, including death.23 Similar reports have been filed for the Gardasil-9 vaccine…”
As of May 2019, the federal Vaccine Adverse Event Reporting System (VAERS) has received over 62,000 cases of adverse reactions from the HPV vaccine, including 503 deaths, over 6,200 hospitalizations and over 3,000 disabling injuries. Forty-seven percent of these vaccine injuries occurred in children and teens between 12-17 years of age. Despite the large number of injury and death claims associated with Gardasil that have been filed to the federal vaccine injury compensation court, less than a third have been accepted with victims being compensated.
Robert Kennedy Jr has undertaken a thorough investigation into the fraud found in the documentation of the Merck trials that led to the FDA’s approval of Gardasil. Based on his calculations, 2.3 percent of girls in Merck’s trials came down with autoimmune conditions within seven months from receiving the full vaccine regimen. This percentage was the same for those girls receiving the aluminum-containing adjuvant as well. In other words, “women are 100 times more likely to suffer serious adverse effects from the Gardasil vaccine than they are to be protected from cervical cancer.”
Dr. Stanley Plotkin, regarded as the “godfather of vaccination” and author of Plotkin’s Vaccines, the bible for the pro-vaccine industry and described by Bill Gates as an “indispensible guide to the enhancement of the well-being of our world,” has often given testimony in vaccine injury hearings to argue for vaccine safety and against the evidence that vaccines are associated with autism and a variety of autoimmune diseases. During a 2018 deposition hearing under oath Plotkin stated that the use of aluminum-containing placebos is a “recognized control” and there is no credible evidence to suggest the adjuvant was contributing to severe autoimmune illnesses. His argument against the need to conduct longer trials to monitor the long term health of vaccine recipients — the Gardasil trials were only monitored for 14 days — was that unlike pharmaceutical drugs there is no need because vaccines are administered only intermittently and separated by longer periods of time. His argument for why no studies have been conducted or sponsored by the CDC that compare vaccinated with unvaccinated populations is because “it would be considered malpractice not to vaccinate a child.” Despite this irrational statement given that there are hundreds of thousands of unvaccinated children in the US, a retrospective study would be perfectly feasible and not particularly costly. The Vaccine Data Link database, which the public does not have access to, already contains records for many thousands of people who are not vaccinated. Therefore, the data is already at our fingertips yet federal officials refuse to permit such a study to be performed. The results may be devastating to the vaccine regime
Last year, Italians took to the streets in a massive protest against a mandatory vaccination law. The independent Italian laboratory Corvelva studied the contents in seven vaccines, including Gardasil. The findings led to a national scandal that became known as “vaccinegate” as ingredients were discovered to be quite different than that being reported to Italian health officials. Gardasil-9 was loaded with foreign bacterial DNA: an enormous 54 percent of the vaccine’s total DNA, including human and mouse DNA. Out of 338 different contaminants found, only 22 percent could be identified. Although the vaccine is suppose to protect against 9 different HPV strains, only 7 antigen strains were found in the vaccines analyzed.
Last year, the Journal of Toxicology and Environmental Health published a study conducted by Baruch College professor Gayle DeLong that reviewed fertility rates in the National Health and Nutrition Examination Survey database of 8 million American women. DeLong observed that a statistically significant decrease in childlessness for women between 25-29 years of age since 2007, a year after Gardasil was launch until 2015. This was based upon a study in the British Medical Journal of a 16 year old girl who was diagnosed with premature ovarian failure following HPV vaccines. A later study published in the BMJ reviewing 12 Australian girls who came down with primary ovarian insufficiency, which leads to infertility, placed the blame on Polysorbate-80 as one of the vaccine ingredients. In 2016, the American Academy of Pediatrics issued a warning about Polysorbate-80 and premature ovarian failure. Gardasil contains 50 mcg of the synthetic emulsifier commonly used in soaps and cosmetics. The VAERS database also cites 48 autoimmune injuries associated with ovarian damage due to Gardasil. Other reproductive failures reported in VAERS includes spontaneous abortions, amenorrhea (i.e., the absence of menstruation periods) and irregular menstruation. Her study concludes that 35 percent of vaccinated women could not get pregnant compared to 60 percent who did not receive Gardasil. Another study out of the Institute for Virology, Vaccines and Sera in Serbia, reported by the Children’s Health Defense, noted that the large amount of nanoaluminum adjuvant in the HPV vaccines (Gardasil-9 has 1500 micrograms!) contributes to “hyperimmunisation” that can lead to antiphospholipid syndrome and fertility impairment.
DeLong’s study came under enormous attack from pro-vaccine sources, including David Gorski from the Science Based Medicine network, with demands to the journal for retraction. The study was finally retracted on December 10th this year. What is more important and being systematically ignored is that Merck never conducted fertility impact nor potential cancer etiology studies on Gardasil before its entry to the market.
Furthermore, the push to mandate the HPV vaccine ignores the statistics in other nations that clearly show an increase in cervical cancer since the introduction of the vaccine. The vaccine was introduced in Australia and the UK in 2006 and 2008 respectively; in both nations, cancer rates have increased substantially. Back in 2006, the Vaccine and Related Biological Products Advisory Committee warned that the vaccine might increase the risk of cervical lesions and cancer. That warning has come true; a VARBPAC report estimates a 44 percent greater likelihood of cervical lesions among Gardasil recipients.
Efforts to legislate bills for implementing the HPV vaccine started almost immediately after the vaccine was approved, according to a University of Virginia study on the history of HPV legislation. This included a large publicity campaign to make parents fearful of the risks of cervical cancer and the need for public financing. These attempts were made by the American Legislation Exchange Council (ALEC) in its efforts to get the vaccine admitted into states’ required vaccination schedules. Similarly, a Harvard investigation into the Gardasil vaccine’s maker Merck’s role in immunization policy-making uncovered that the company was in fact drafting the legislation to mandate the vaccine. It also made special efforts to target women legislators and physicians to assist in consumer marketing campaigns. Merck’s lobbying activities in Washington have always been among the most aggressive on K Street. Virginia was one of the first states to enact a statewide school entry mandate for Gardasil; yet five years later, a Medical University of South Carolina analysis found that the mandate had no impact whatsoever on overall compliance.
Today as more states are removing religious-based vaccine exemptions and mandating compliance to the CDC’s vaccine schedule for all school children, including those attending private schools, we should be deeply worried that efforts to include Gardasil in the mandated schedule will get passed in state legislative bodies. As we have seen this is one of the mostly poorly studied vaccines now being administered to tens of millions of boys and girls, adolescents and young women across the nation. It is one of the most dangerous and scientifically unsound experiments ever launched upon the American public en masse. Fortunately, efforts by groups such as Robert Kennedy’s Children’s Health Defense are proceeding to drag Merck into the courtroom for medical research misconduct in order to get its HPV vaccine fast tracked. Given Gardasil’s enormous health risks to children, it is incumbent for parents and individuals to educate themselves about the heinous deceptions behind this vaccine and support efforts to have it removed from the market.