What You Need to Know About the ‘Science’ Behind Gardasil

The HPV vaccine Gardasil was granted European license in February 2006, followed by U.S. Food and Drug Administration (FDA) approval that same year in June. Gardasil was controversial in the U.S. from the beginning, with vaccine safety activists questioning the quality of the clinical trials used to fast track the vaccine to licensure.

Lauded as a silver bullet against cervical cancer, there have been multiple continuing reports since it was licensed that Gardasil vaccine has wrought havoc on the lives of young girls (and young boys) in the U.S. and in countries across the world. Serious adverse reactions reported to the Vaccine Adverse Event Reporting System (VAERS) in relation to Gardasil include but are not limited to:

Post-marketing experiences and adverse events reported during post-approval use listed on the Gardasil vaccine insert include blood and lymphatic system disorders such as autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura and lymphadenopathy; pulmonary embolus; pancreatitis; autoimmune diseases; anaphylactic reactions; arthralgia and myalgia (musculoskeletal and connective tissue disorders); nervous system disorders such as acute disseminated encephalomyelitis, Guillain-Barré syndrome, motor neuron disease, paralysis, seizures and transverse myelitis; and deep venous thrombosis, a vascular disorder.

According to “Manufactured Crisis — HPV, Hype and Horror,” a film by The Alliance for Natural Health, there have also been cases of 16-year-old girls developing ovarian dysfunction, meaning they’re going into menopause, which in turn means they will not be able to have children.

Despite such serious effects, the U.S. Centers for Disease Control and Prevention (CDC) and FDA allege the vast majority, or even all, of these tragic cases are unrelated to the vaccine, and that Gardasil is safe.

The Plaintiff’s Science Day Presentation on Gardasil video features Robert F. Kennedy Jr., chairman and chief legal counsel for Children’s Health Defense, an organization originally founded in 2016 as World Mercury Project and renamed in 2018 to focus on exposing and eliminating multiple harmful exposures contributing to the epidemic of chronic ill health among children. The video details the many safety problems associated with Merck’s HPV vaccine, Gardasil.

The information presented is based on publicly available government documents. Kennedy notes that, if what he says about Merck in this video presentation were untrue, they would be considered slanderous.

However, Kennedy says he is not concerned about being sued for slander. He says he knows Merck won’t sue, “because in the U.S., truth is an absolute defense against slander” and Merck knows that, were the company to sue for slander, Kennedy would file discovery requests that would unearth even more documents detailing Merck’s fraudulent activities.

Kennedy’s presentation does not go into the biological mechanisms by which Gardasil causes harm. He directs parents and pediatricians to the Children’s Health Defense website to read peer reviewed medical literature sources for that information.

Instead, Kennedy’s presentation focuses on what he describes as Merck’s fraudulent clinical trials of Gardasil vaccine, which were used to gain FDA approval. While this article provides you with a summary of the key points, I urge you to watch Kennedy’s presentation in its entirety, as this information may well save you or your child a lifetime of heartache and exorbitant medical expenses.

Gardasil by the numbers

According to Merck, Gardasil will “eliminate cervical cancer and other HPV-associated cancers.” While that may sound impressive, just how great is a woman’s risk of dying from cervical cancer in the U.S. to begin with?

According to Kennedy, National Cancer Institute (NCI) data show the mortality rate for cervical cancer is 1 in 43,478 (2.3 per 100,000), and the median age of cervical cancer death is 58.

To eliminate that one death, all 43,478 must pay $420 — the average cost of the three Gardasil injections. According to Kennedy, 76 million American children have been mandated by the U.S. Centers for Disease Control and Prevention to receive the vaccine, providing Merck with an annual revenue of $2.3 billion.

When you crunch the numbers, you realize that the cost of using Gardasil to save one life is $18.3 million. Meanwhile, compensation paid by the Vaccine Court for the death of a child maxes out at $250,000.

Put another way, $18.3 million is being spent in an effort to save a life from a disease, while the U.S. Health and Human Services values human life at just a quarter of a million dollars per person when a person dies from using a government recommended vaccine in that effort.

As noted by Kennedy, some will argue that $18.3 million is a reasonable cost for saving a life, but the criteria we should use, he says, when evaluating the cost of saving a life is whether there are less expensive ways to achieve the same goal.

In the case of HPV infection and cervical cancer, there’s ample evidence showing that inexpensive PAP smears are the most effective way to identify an HPV infection, and by treating it to prevent it from turning into cancer.

Why tolerance for Gardasil-induced harm should be extremely low

By law, Merck must demonstrate that the HPV vaccine is safe. By legal definition, “The word safety means the relative freedom from harmful effect to persons affected, directly or indirectly, by a product when prudently administered, taking into consideration the character of the product in relation to the condition of the recipient at the time.”

Kennedy points out that, in the case of the HPV vaccine, recipients are healthy preteen and teen girls and boys, for whom the risk of dying from cervical cancer and other related HPV cancers is zero. Remember, the median age of cervical cancer death is 58.

The median age of detection is 50. What this means, Kennedy stresses, is that the threshold for tolerance of vaccine-associated risks should be extremely low, since the risk of death at the time it’s given is nil.

What’s more, the HPV vaccine is a mandated requirement in some jurisdictions, and available without parental consent in others, which further lowers the bar of tolerance for vaccine-induced risks. In other words, especially when it comes to mandated use of the vaccine or use by teens without parental knowledge or consent, there should be virtually no conceivable risk associated with the Gardasil vaccine.

As for determining the risk associated with a medical intervention prelicensure, the gold standard in medicine is double-blind placebo-controlled trials. In such a trial, one group of people, typically in the thousands, receives the experimental drug product, while the other half receives a placebo, an inert substance such as saline or a sugar pill that has no chemical or biological effects that might muddy the waters and interfere with the evaluation of the drug effects.

What’s more, to control for the placebo effect, no one knows which of the participants received the medication or the placebo until the very end of the trial. Lastly, drug trials typically last for several years, as it’s well-known that many side effects are latent and don’t show up until years down the road.

Cancer, for example, can take four to five years to develop after exposure to a carcinogenic substance. For less carcinogenic yet still harmful substances, cancer may take decades to develop.

How Merck committed fraud in its Gardasil safety testing

Kennedy says the fraud Merck committed in its safety testing is (a) testing Gardasil against a toxic placebo, and (b) hiding a 2.3% incidence of autoimmune disease occurring within seven months of vaccination.

In his presentation, Kennedy shows Table 1 from the package insert for Gardasil, which looks at vaccine injuries at the site of injection. It shows that Gardasil was administered to 5,088 girls; another 3,470 received the control, amorphous aluminum hydroxyphosphate sulfate (AAAH) — a neurotoxic aluminum vaccine adjuvant that has been associated with many serious vaccine injuries in the medical literature.

A third group, consisting of 320 individuals, received a proper placebo (saline). In the Gardasil and AAAH control groups, the number of injuries were fairly close; 83.9% in the Gardasil group and 75.4% in the AAAH control group. Meanwhile, the rate of injury (again, relating to injuries at the injection site only), was significantly lower at 48.6%.

Next, he shows Table 9 from the vaccine insert, which is the “Summary of girls and women 9 through 26 years of age who reported an incident condition potentially indicative of a systemic autoimmune disorder after enrollment in clinical trials of Gardasil, regardless of causality.” These conditions include serious systemic reactions, chronic and debilitating disorders and autoimmune diseases.

Now all of a sudden, there are only two columns, not three as shown for the injection site injuries. The column left out is that of the saline placebo group. Kennedy points out that Merck cleverly hides the hazards of Gardasil by combining the saline group with the aluminum control, thereby watering down the side effects reported in the controls. “They hide the saline group as a way of fooling you, your pediatrician and the regulatory agency,” Kennedy says.

Looking at the effects reported in the two groups, 2.3% of those receiving Gardasil reported an effect of this nature, as did 2.3% of those receiving the AAAH (aluminum) control or saline placebo. The same exact ratio of harm is reported in both groups, which makes it appear as though Gardasil is harmless.

In reality, we know very little about Gardasil vaccine safety from the data as presented, since the vast majority of the controls were given a toxic substance, and they don’t tell us how many of those receiving a truly inert substance developed these systemic injuries. Still, we can draw some educated guesses, seeing how the injection site injury ratios between Gardasil and the aluminum group were similar.

Merck’s use of AAAH, a neurotoxic aluminum adjuvant instead of a biologically inactive placebo, effectively nullifies its prelicensure Gardasil safety testing.

As noted by Peter Gotzche with the Cochrane Center in 2016, when he co-filed an unofficial complaint against the European Medical Agency for bias in its assessment of the HPV vaccine, “The use of active comparators probably increased the occurrence of harms in the comparator group, thereby masking harms caused by the HPV vaccine.”

Risk evaluation

When making an informed decision, you need to know both sides of the equation — the risk you’re trying to avoid, and the risk you’re taking on. Recall that, on average, 1 in 43,478 women will die from cervical cancer.

If 2.3% of girls develop an autoimmune disease from Gardasil, then that translates into 1,000 per 43,500. Even if a 1 in 43,478 chance of dying from cancer is gone, does it makes sense to trade that for a 1 in 43 chance of getting an autoimmune disease?

And how many parents are comfortable giving a child a substance knowing there’s a 1 in 43 chance that this substance will cause a lifelong disability? Yet that’s the choice parents have been fooled into making.

Protocol 18

Merck has not disclosed how many clinical safety trials (also called protocols) it conducted for Gardasil. A slide in Kennedy’s presentation shows a listing of several of the ones known, including protocol 18. Kennedy says this clinical trial is critical because that was the one that FDA used as its basis for giving Merck a license to market the vaccine for use in children as young as 9 years old.

Protocol 18 is the only trial in which the target audience, 9- through 15-year-old girls and boys, was tested prelicensure. The other trials looked at the vaccine’s safety in 16- through 26-year-olds. Protocol 18 included just 939 children — “a very, very tiny group of people,” Kennedy says, “for a product that is going to be marketed to millions of children around the world.”

Aside from its small cohort size, protocol 18 is also filled with “fraud and flimflam,” according to Kennedy. Merck presented protocol 18 to the FDA and HHS as the only safety trial that used a true nonbioactive inert placebo. This, however, was a misrepresentation.

Instead of pure saline, the placebo used in protocol 18 contained a carrier solution composed of polysorbate 80, sodium borate (borax, which is banned for food products in the U.S. and Europe), genetically modified yeast, L-histidine and DNA fragments. In essence, the “placebo” was all of the vaccine components with the exception of the aluminum adjuvant and the antigen (viral portion).

Very little if any safety testing has been done on these ingredients, so their biological effects in the body are largely unknown. What we can say for sure is that these are not inert substances like saline. Still, the 596 children given the carrier solution control “fared much better than any other cohort in the study,” Kennedy says.

None of them had any serious adverse events in the first 15 days. Now, here’s where Merck committed fraud yet again. As Kennedy points out, Table 20 in protocol 18 shows that Merck cut the amount of aluminum used in the Gardasil vaccine by half.

“They tested a completely different formulation,” he says. “And, obviously, they took the amount of aluminum out to reduce the amount of injuries and mask the really bad safety profile of this vaccine …

Since Merck deceptively cut the amount of aluminum — Gardasil’s most toxic component — in half, the data from that study does not support the safety of the standard Gardasil formulation. Since protocol 18 data are not based on the Gardasil vaccine formulation, the trial constitutes scientific fraud.”

Exclusion criteria — Another bag of tricks

Kennedy also describes another trick used by Merck to skew results: exclusion criteria. By selecting trial participants that do not reflect the general population, they mask potentially injurious effects on vulnerable subgroups.

For example, individuals with severe allergies and prior genital infections were excluded, as were those who’d had more than four sex partners, those with a history of immunological or nervous system disorders, chronic illnesses, seizure disorders, other medical conditions, reactions to vaccine ingredients such as aluminum, yeast and benzonase, and anyone with a history of drug or alcohol abuse.

Yet Merck recommends Gardasil for all of these unstudied groups. Merck’s investigators also had unlimited discretion to exclude anyone with “any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives.”

Merck also used “sloppy protocols to suppress reports of vaccine injury,” Kennedy says. For example, only 10% of participants were given daily report cards to fill out, and they were only to be filled out for 14 days post-vaccination. What’s more, these report cards only collected information about vaccination site effects, such as redness, itching and bruising.

Also ignored were autoimmune problems, seizures and menstrual cycle disruptions experienced by many of the girls. They also did not follow up with those who reported serious side effects. Merck also granted broad discretionary powers to its paid investigators to determine what they thought constituted a reportable adverse event and to dismiss potential vaccine reactions.

The researchers did not systematically collect adverse event data, which is the whole point of doing a safety study in the first place, and by not paying for the additional time required by investigators to fill out time-consuming adverse event reports, Merck effectively incentivized the dismissal of side effects.

Many of the illnesses and injuries reported were also classified as “new medical conditions” rather than adverse events, and no rigorous investigation of these new conditions were performed.

According to Kennedy, at the time of the vaccine’s approval, 49.5% of the Gardasil group and 52% of the controls (who received either the aluminum adjuvant or the vaccine carrier solution) had “new medical history” after the seventh month (Table 303, which included protocols 7, 13, 15 and 18), many of which were serious, chronic diseases.

Risk evaluation, take 2

Taking all of this into account, here’s how the risk-benefit equation looks now: The 1 in 43,478 chance of dying from cervical cancer may have been removed (assuming the vaccine actually works), but by taking the vaccine there is now a 1 in 43 chance of getting an autoimmune disease, and a 1 in 2 chance of developing some form of serious medical condition.

More lies

According to Kennedy, Merck also submitted fraudulent information to its Worldwide Adverse Experience System and the federal Vaccine Adverse Effects Reporting System (VAERS) about the death of Christina Tarsell, one of its study participants.

“Merck claimed that Chris’ gynecologist had told the company that her death was due to viral infection. Chris’ gynecologist denies that she ever gave this information to Merck. To this day, Merck has refused to change its false entry on its own reporting system,” Kennedy says.

“Furthermore, Merck lied to the girls participating in these studies, telling them that the placebo was saline and contained no other ingredients. And No. 2, that the study in which they were participating was not a safety study. They were told that there had already been safety studies and that the vaccine had been proven safe …

They made it so that the girls were less likely to report injuries associated with the vaccine, because they believed the vaccine they were receiving had already been proven safe and that any injuries did experience, maybe a month, two months or three months after the vaccine must just be coincidental and had nothing to do with the vaccine.”

Does Gardasil prevent cervical cancer?

So, what about the claims the HPV vaccine prevents cervical cancer? If a girl or woman is trading a 1 in 43,478 chance of dying from cervical cancer for a 1 in 2 chance of developing a serious medical condition, it better be near 100% effective, wouldn’t you say? However, according to Kennedy’s presentation, there’s scant evidence to support such claims.

In fact, it’s nearly impossible to prove the efficacy of the HPV vaccine. Why? Because the target age for inoculation is 11, and the median age of death from cervical cancer is 58. There’s a time gap of 47 years there. So, all Gardasil can offer, at this time, is the hope that 47 years down the line, all 11-year-olds who received the vaccine will be cancer free.

What’s more, with such a tiny risk (1 in 43,478) there would need to be an enormous lifelong cohort to determine whether the vaccine actually decreased cancer deaths five decades down the line.

To get around the 47-year lag time, Merck used surrogate endpoints. None of the clinical trials actually tested whether the vaccine can prevent cancer. Instead, the vaccine was tested to see if it could prevent the development of CIN2 and CIN3 lesions, which are considered precancerous cervical lesions. As noted by Kennedy:

“Under Merck’s’ hypothetical theory, the reduction of precancerous lesions would translate into fewer cases of cervical cancer in 20 to 30 years. This gimmick of using ‘surrogate endpoints’ allowed Merck to shorten the clinical trials to a few years and get approvals for a drug that is utterly unproven to prevent cancer.

Since correlation does not prove causation, nobody knows if HPV virus actually causes cancer or whether it is a co-variable like yellow fingers and lung cancer.”

No cancer prevention claims can be made for Gardasil

The problem with these endpoints is that “only a tiny fraction of CINs ever progress to cancer,” Kennedy says, and “How can you call something ‘precancerous’ when it was never going to result in cancer?” As noted in a 2010 study published in the American Journal of Epidemiology:

“Misclassification of exposure and surrogate endpoints of disease can obscure causal relations. Using data from the Atypical Squamous Cells of Undetermined Significance/Low-Grade Squamous Intraepithelial Lesion Triage Study … the authors explored the impact of exposure (human papillomavirus (HPV) detection) and endpoint (histologic cervical precancer) classification on their mutual association …

CIN3 is an imperfect diagnosis of precancer and an immediate surrogate for cancer because not all CIN3 invades, such lesions are occasionally caused by noncarcinogenic HPV genotypes that are unlikely to invade, CIN3 can be a false positive diagnosis, and the classification is not perfectly reproducible.”

According to Kennedy, Merck’s internal ethics protocols actually state that marketers must avoid making claims based on the surrogate endpoints, meaning they cannot market Gardasil as a vaccine that prevents cervical cancer. All marketers can say is that it helps prevent risk factors for cervical cancer:

“A surrogate endpoint is a regulatory ‘stand-in’ for an ultimate endpoint, based on the assumption that a drug that affects the surrogate endpoint will also affect the ultimate endpoint. Often, surrogate endpoints are ‘risk factors’ for ultimate endpoints.

Surrogate endpoints are used when effects on ultimate endpoints have not been demonstrated … For these products, the indication is the surrogate, not the ultimate, endpoint. Promotion cannot make any claim vis-à-vis the ultimate endpoint.”

Most cervical cancers are not associated with HPV after all

Another study cited by Kennedy that raises serious doubts about Merck’s claim that Gardasil will eliminate cervical cancer was published in 2008 in the journal Gynecologic Oncology. According to this paper, “Only 28.2% of women with CIN2 or CIN3 confirmed by biopsy were infected exclusively by HPV type 16 or 18, a finding that places in doubt the degree of protection afforded by HPV vaccination.”

Similarly, a 2014 study in the Journal of Experimental Therapeutics and Oncology found that “The prevalence of HPV in premalignant and malignant cervical lesions … was 39.5% and 33.3% respectively.”

In other words, it appears HPV may be involved in just one-third of cervical cancers, which lowers the potential of young girls benefiting from this vaccine even further. It also decimates Merck’s claim that the HPV vaccine will eliminate cervical cancer. At best, it might eliminate one-third of cases.

Risk evaluation, take 3

But it gets worse, because there’s a possibility Gardasil could cause cancer. The Gardasil insert admits it has never been evaluated for carcinogenicity or genotoxicity, yet its ingredients “include potential carcinogens and mutagens, including aluminum and human DNA,” Kennedy says.

He goes on to show the results of Merck’s study protocol 13 (Table 17: Applicant’s analysis of efficacy against vaccine-relevant HPV types CIN 2/3 or worse among subjects who were PCR positive and seropositive for relevant HPV types at day 1.)

What this protocol showed is that women who had previous exposure to the HPV strains used in the vaccine had a 44.6% increased risk of developing CIN2 and CIN3 lesions after vaccination. Taking the dubious efficacy of Gardasil into account, and the fact that it may only impact one-third of cervical cancer cases, the risk-benefit lineup when taking the vaccine now looks like this:

• There is still a chance of dying from cervical cancer unrelated to HPV
• There is a 1 in 43 chance of getting an autoimmune disease
• There is a 1 in 2 chance of developing a serious medical condition
• If someone has ever been exposed to any of the nine HPV strains included in the vaccine prior to getting Gardasil the risk of developing CIN2 and CIN3 cervical lesions is raised by 44.6%, which may raise the risk of cervical cancer

Widespread Gardasil use may trigger more virulent HPV infections

“To make things even worse, there are recent scientific studies that suggest a phenomenon known as type replacement,” Kennedy says. “Type replacement” refers to when the elimination or suppression of one viral strain allows a more virulent strain to colonize.

The study, “Shift in Prevalence of HPV Types in Cervical Cytology Specimens in the Era of HPV Vaccination,” published in the journal Oncology Letters in 2016 — which analyzed the association between the prevalence of 32 types of HPV virus in 615 women who had abnormal cervical cytopathology — reported that:

“… HPV16, which is recognized as the main HR-HPV type responsible for the development of cervical cancer, was observed in 32.98% of HPV participants, followed by HPV42 (18.09%), HPV31 (17.66%), HPV51 (13.83%), HPV56 (10.00%), HPV53 (8.72%) and HPV66 (8.72%).

The prevalence of HR-HPV types, which may be suppressed directly (in the case of HPV16 and 18), or possibly via cross-protection (in the case of HPV31) following vaccination, was considerably lower in participants ≤22 years of age (HPV16, 28.57%; HPV18, 2.04%; HPV31, 6.12%), compared with participants 23–29 years of age (HPV16, 45.71%; HPV18, 7.86%; HPV31, 22.86%), who were less likely to be vaccinated.

Consequently, the present study hypothesizes that there may be a continuous shift in the prevalence of HPV types as a result of vaccination. Furthermore, the percentage of non-vaccine HR-HPV types was higher than expected, considering that eight HPV types formerly classified as ‘low-risk’ or ‘probably high-risk’ are in fact HR-HPV types.

Therefore, it may be important to monitor non-vaccine HPV types in future studies, and an investigation concerning several HR-HPV types as risk factors for the development of cervical cancer is required.”

Vaccine injuries and mortality rates found in Merck’s pre-clinical studies

We’ve already covered some of the vaccine injuries, such as autoimmune disorders, shown in Merck’s pre-clinical studies. Here are several more data points to consider:

• A 25% miscarriage rate for both Gardasil and AAHS controls. In the U.S., the miscarriage rate for the general public is 12.5%, which means miscarriages doubled compared to the normal background rate
• The rate of birth defects were five times higher in the Gardasil group than the AAHS group (five babies born with congenital deformation versus none)
• Within seven months of inoculation, 10.9% of women receiving Gardasil reported reproductive disorders, compared to just 1.2% in the control group that received the carrier solution (protocol 18)
• The death rate in the U.S., according to 2014 CDC statistics is 4.37 per 10,000. In the Gardasil clinical trials, the death rate was 8.5 per 10,000 — nearly double the background mortality rate of the general public
• According to Merck’s own studies, the risk of dying from Gardasil is 37 times greater than the risk of dying from cervical cancer

Risk evaluation, take 4

How’s the Gardasil risk-benefit looking now?

• There is still a chance of dying from cervical cancer unrelated to HPV
• There is a 1 in 43 chance of getting an autoimmune disease
• There is a 1 in 2 chance of developing a serious medical condition
• If someone has ever been exposed to any of the nine HPV strains included in the vaccine prior to getting Gardasil, the risk of developing CIN2 and CIN3 cervical lesions is raised by 44.6%
• The risk of dying from Gardasil is 37 times greater than the risk of dying from cervical cancer

In other words, Gardasil vaccinations appear to increase the overall risk of death by 370%, the risk of autoimmune disease by 2.3% and the risk of a serious medical condition by 50%.

Post-licensing data

To get an idea of how Gardasil is faring in the real world, we turn to VAERS. Unfortunately, vaccine adverse events reporting is voluntary, and investigations have revealed less than 1% of adverse events that occur after vaccination are ever reported to VAERS. Still, despite that debilitating shortcoming, “Gardasil has distinguished itself as the most dangerous vaccine ever invented,” Kennedy says.

Between 2006 and November 2018, more than 60,000 adverse events following HPV vaccination were reported, 8,782 of which were categorized as “serious,” including 439 deaths. Compared to the meningitis vaccine Menactra, which is given to the same age group (teens), Gardasil has:

• 85% more emergency room visits
• 125% higher hospitalization rate
• 100% more life-threatening events
• 265% more disabilities

In 2015, the Australian Department of Health Therapeutic Goods Administration (TGA) reported that the rate of adverse events following Gardasil vaccination is 17 times greater than the cervical cancer rate throughout an Australian woman’s lifetime, and this study limited its analysis to anaphylaxis, fainting, allergic reactions and hospitalizations. This is just a handful of the many injuries linked to this vaccine.

Kennedy goes on to review findings from a number of different countries, including India, Japan, Denmark and Colombia, and how those countries have responded to findings of harm. He also notes that in countries with strong HPV vaccine coverage, cervical cancer rates have actually started creeping upward rather than downward.