InvestmentWatchBlog

Merck has been accused of committing fraud in its Gardasil vaccine safety trials putting millions of young girls at risk for ovarian failure or even death.

via PrestigiousProof:

  • Gardasil is said to protect against cervical cancer, a disease that in the U.S., has a relatively low mortality rate of 1 in 43,478 (2.3 per 100,000)
  • In “The Plaintiff’s Science Day Presentation on Gardasil,” Robert F. Kennedy, Jr. reveals Merck data showing Gardasil increases the overall risk of death by 370%, risk of autoimmune disease by 2.3% and risk of a serious medical condition by 50%
  • Postmarketing and adverse events reported during use of the vaccine post-licensing are listed on the Gardasil vaccine insert and include blood and lymphatic system disorders, pulmonary embolus, pancreatitis, autoimmune diseases, anaphylactic reactions, musculoskeletal and connective tissue disorders, nervous system disorders and more
  • Merck’s use of a neurotoxic aluminum adjuvant instead of a proper placebo in its safety trials effectively renders its safety testing null and void, as the true extent of harm cannot be accurately ascertained

The HPV vaccine Gardasil was granted European license in February 2006,1 followed by U.S. Food and Drug Administration (FDA) approval that same year in June.2 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.3

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:4

  • Anaphylaxis
  • Guillain-Barre Syndrome
  • Transverse myelitis (inflammation of the spinal cord)
  • Pancreatitis
  • Venous thromboembolic events (blood clots)
  • Autoimmune initiated motor neuron disease (a neurodegenerative disease that causes rapidly progressive muscle weakness)
  • Multiple sclerosis
  • Sudden death

Postmarketing experiences and adverse events reported during post-approval use listed on the Gardasil vaccine insert5 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 film6 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,7 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 website8 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 in its entirety, as this information may well save you or your child a lifetime of heartache and exorbitant medical expenses.

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 insert9 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.”

But it gets worse, because there’s a possibility Gardasil could cause cancer. The Gardasil insert13 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,14 “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.”

Sources