HPV: What is HPV

Let’s start at the beginning: The Gardasil vaccine was fast tracked to licensure by the Food and Drug Administration in 2006. In 2014, the original vaccine was replaced with Gardasil 9. The FDA approval letter states, “We did not refer your application to the Vaccines and Related Biological Products Advisory Committee....” and where they also instructed Merck to “To conduct a 10-year study extension” and a “a study with approximately 10,000 persons.” All while the vaccine is on the market and being used in the general population. The 2020 version also received “accelerated approval.” Source: (1) FDA, approval letter

What is Gardasil? 

It is vaccine for a sexually transmitted disease that was originally tested in fewer than 1,200 children under the age of 16: Source: (2) NY Times

There are more than 100 types of human papillomaviruses (HPVs). Of them, about 40 types of HPV are sexually transmitted and 15 of these types are most associated with cervical cancers and genital warts in women and men. The types of HPV that can cause genital warts are not the same as the types of HPV that can cause cancers. The vaccine only contains some of the many HPV strains associated with cervical cancer. 

What are the risks of developing HPV?

The CDC says HPV is naturally cleared from the body most the time on its own and doesn’t usually cause any other health problems. They go on to say, “Most people with HPV do not know they are infected and never develop symptoms or health problems from it. Some people find out they have HPV when they get genital warts. Women may find out they have HPV when they get an abnormal Pap test result.”  Source: (3) CDC, HPV Fact Sheet

About 11,000 American women are diagnosed with cervical cancer every year and about 4,000 women die. The small minority of women, who do not clear the HPV virus, can develop cervical cancer and die IF they do not get regular Pap test screening. Cervical cancer was once one of the most common causes of cancer death for American women. The cervical cancer death rate dropped significantly with the increased use of the Pap test. Source: (4) AmericanCancerSociety

• Important to note vaccines are big business and all about the money: It broke records, making $1.5 BILLION for Merck during its first quarter as the most profitable vaccine in the world. Source: (5) Fierce Pharma, Gardasil Profits

Getting the Vaccine to Market:

• When Merck conducted clinical trials for Gardasil 9,  they used the original Gardasil as a placebo per the FDA.
• The Gardasil clinical trials had numerous exclusion criteria. People who were not allowed to participate in the trials were people with severe allergies; prior abnormal Pap test results; over four lifetime sex partners; a history of immunological disorders and other chronic illnesses; reactions to vaccine ingredients, including aluminum, yeast, and benzonase; or a history of drug or alcohol abuse - yet Merck now recommends Gardasil for all of these groups.
• It was developed by NIH researchers per the Journal of the National Cancer Institute.
• It uses GMO technology that was sold by NIH to Merck. 
• It was fast-tracked to licensure using questionable surrogate markers for efficacy as conducted by Ingenta.
• It used a bioactive aluminum “placebo” as a bogus control in clinical trials; see page 9 of the FDA's original application. Bioactive aluminum is linked to Gulf War Syndrom according to this PubMed study and is toxic and causes autoimmunity in pediatric patients during this study by Sage Journal.
• According to Merck: It was only tested in 1,000 adolescent girls and boys in combination with the federally recommended Tdap and meningococcal vaccines. 
• It was said to increase death by 370% and Kennedy accused them of committing fraud in this Investment Watch article.
• It is a vaccine for a sexually transmitted disease that was tested in fewer than 1,200 children under the age of 16 ... using a bioactive aluminum “placebo” as a bogus control in clinical trials. 
• It is a vaccine that by Dec. 13, 2013, had generated nearly 30,000 adverse reaction reports to the U.S. government, including 140 deaths (Source: VAERS database)- which is only a fraction of the numbers of Gardasil reactions, injuries, and deaths that have actually occurred because most doctors either do not report to the government or make reports directly to Merck.
• The vaccine paid $6 million to 49 victims of Gardasil damage, 26 DEATHS in one year, from 2010 to 2011.  A pittance of money to pay for lives lost.

In 2006 the original Gardasil was licensed for 11-12-year-old girls. Gardasil was granted Fast Track approval by the FDA after only a six-month review process. Within weeks of Gardasil’s FDA approval, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to recommend three doses of the vaccine for all 11 and 12-year-old girls with a “catch-up” schedule for females between the ages of 13 and 26. In 2014 again licensed for use by females and males ages 9 to 45 years. In June 2018 the FDA granted Merck a priority review of its application to expand Gardasil 9 to 27-45 year olds of both sexes. Yet, the CDC states, "it is not recommended for people over 26 years old."

FAST-TRACKED, POORLY TESTED, DECEPTIVE, AND SELECTIVE DATA REPORTING AND NO LONG-TERM STUDIES......In the Gardasil trials, there were three groups:- The saline placebo group had 0% reports of injury (about 360 participants)- The 'AAHS control' group (Amorphous Aluminum Hydoxyphosphate Sulfate), approx 9900 people.- The Gardasil vaccine group, approx 10,000 people. GARDASIL. HPV VACCINE FLAWED CLINICAL TRIALS: DECEPTIVE TESTING: Of the 16 HPV vaccine randomized trials, only two used an inert saline placebo. Ten of the sixteen compared the HPV vaccine against a neurotoxic aluminum adjuvant, and four trials used an already-approved aluminum-containing vaccine as the comparison. One does not have to be a scientist to understand that using aluminum-containing placebos is likely to muddy the comparison between the treatment and control groups. GOLD STANDARD WAS NOT USED. 

COMBINING ALUMINUM GROUP AND PLACEBO GROUP TO BLUR RESULTS: Merck combined the groups receiving the genuine saline placebo and the group receiving the spiked aluminum into a single column and in the final report,  called it the "placebo" group. The merger of the two control groups makes it impossible to compare results for Gardasil versus the saline placebo or the aluminum placebo versus the saline placebo. The AAHS group and the Gardasil group had a similar adverse event rate.  Since the recorded serious adverse events in the Gardasil group and the combined "placebo" group were similar, it was declared that there was no concern. Even in the original placebo group, it appears that the carrier solution included polysorbate 80, sodium borate, and L-histidine.In addition, Merck appears to have taken the precaution of removing half the aluminum from the vaccines administered to this study group (most likely to decrease adverse reactions). Both of these tactics are deceptive. If injecting AAHS is safe, no problems should have shown up in the AAHS control group. 

At the end of the trial, Gardasil was given to most, if not all, of the participants in the placebo and aluminum groups, so there is no long-term tracking for the placebo group or the aluminum group. Merck's AAHS is a proprietary adjuvant. As far as I know, they have not released the formula and have not allowed outside scientists to study it. Investigators dismissed reports of serious adverse events and did not collect adverse events data systematically. Trials were not designed to capture long-term data for safety analysis. Merck added a new metric of "new medical conditions", which was never done before in clinical trials (and not part of clinical guidelines outlined by the FDA or WHO). More than 50% of all clinical trial participants reported "new medical conditions". These "new medical conditions", which happened after the injection of Gardasil or the aluminum shot, were not counted as adverse reactions in the trial results even though previously healthy participants voiced their concerns to the trial investigators. How is a "new medical condition" different from a vaccine reaction, a suspected reaction, or a serious adverse event? Who decides whether a "new medical condition" is related to the vaccine or not? It was solely left to the opinion of the trial investigator without medical examination or looking at medical records. Since the recorded serious adverse events in the Gardasil group and the aluminum group were similar, it was declared that there was no concern. All of this information casts a dubious light on the Gardasil clinical trials. 

Scientific researchers view double-blind placebo trials as the gold standard for testing new drugs. To minimize bias, investigators randomly assign patients to either a “treatment” group or a “control” (placebo) group and then compare health outcomes. The standard practice is to compare a new drug against a “pharmacologically inert” placebo.

GARDASIL, HPV VACCINE COURT CASE IN LOS ANGELES January 2019Merck is accused of ...—committing fraud during its clinical trials—using a noninert and toxic placebo in the control group“Merck’s own data show that the chances of getting an autoimmune disease from this vaccine are 1000 times the risk of dying from cervical cancer. Birth defects among children conceived during the study period were 5 times those of the control group and miscarriages were doubled over background rates. Reproductive problems among vaccinated girls were 10 times the background rates. Finally, Merck’s own data showed that administering the Gardasil vaccine to girls who had previous exposure to HPV actually raised their risk of developing precancerous lesions (or worse) by almost 45%.”
RFK JR. presents Gardasil vaccine facts and science from clinical trials.https://childrenshealthdefense.org/.../rfk-jr-video-and.../

PRESS RELEASE ON GARDASIL

January 2016

The American College of Pediatricians issued a press release entitled: Primary Concerns About the Human Papillomavirus Vaccine

“It has recently come to the attention of the College that one of the recommended vaccines [HPV] could possibly be associated with the very rare but serious condition of premature ovarian failure (POF), also known as premature menopause.

Most primary care physicians are probably unaware of a possible association between HPV4 and POF and may not consider reporting POF cases or prolonged amenorrhea (missing menstrual periods) to the Vaccine Adverse Event Reporting System (VAERS).”

The overwhelming majority (76%) of VAERS reports since 2006 with ovarian failure, premature menopause, and/or amenorrhea are associated solely with Gardasil®.

A causal relationship between human papillomavirus vaccines (if not Gardasil® specifically) and ovarian dysfunction cannot be ruled out at this time."

Primary author: Scott S. Field, MD

January 2016 

Full release is here: http://www.acpeds.org/.../1.26.16-New-Concerns-about-the...

"Nevertheless there are legitimate concerns that should be addressed: long-term ovarian function was not assessed in either the original rat safety studies or in the human vaccine trials... Few other vaccines besides Gardasil® that are administered in adolescence contain polysorbate 80. Prelicensure safety trials for Gardasil used placebo that contained polysorbate 80 as well as aluminum adjuvant. ...The essential lack of saline placebos and the majority of participants taking hormonal contraceptives in those studies preclude meaningful data to rule out an effect on ovarian function."

Dr. Sin Hang Lee released evidence involving the Global Advisory Committee on Vaccine Safety (GACVS), and he has filed an open-letter of complaint to the Director-General of the World Health Organization, Dr. Margaret Chan. In this letter, Dr. Lee states: “I have come into possession of documentation which leads me to believe multiple individuals and organizations deliberately set out to mislead Japanese authorities regarding the safety of the human papillomavirus (HPV) vaccines, Gardasil® and Cervarix®”

http://www.westonaprice.org/.../officials-cover-up.../

WHAT IS THE MECHANISM OF HARM? DR. LEE OFFERS HIS FINDINGS...

1. FOREIGN HPV DNA FOUND IN GARDASIL. 

2. ALUMINUM ADJUVANT BINDS TO IT AND HELPS IT ENTER CELLS CAUSING PROBLEMS.

Dr. Sin Hang Lee is a pathologist and former Director of Milford Medical Laboratory Inc. He is well-known for using cutting-edge DNA sequencing for molecular diagnoses. 

He was asked by some moms to find out why their children died after the HPV vaccine (Gardasil). He found viral HPV DNA in the blood and the vaccines, which is not suppose to be present. But Merck claims no vial HPV DNA is present in their vaccines. Merck's propreitary aluminum adjuvant in the vaccine binds with this viral HPV DNA. The aluminum adjuvant acts as a vehicle and helps the viral HPV DNA get into the cells. The body does not recognize this foreign DNA. This method of the viral HPV DNA entering cells is not the normal process of infection with the normal HPV virus. Therefore, this can cause abnormal immune response, heart issues, POTS,  other problems and death.

He speaks about it in this video from AutismOne Conference 2016

Viral DNA bound to aluminum may mediate HPV vaccination side effects

https://www.youtube.com/watch?v=mNzXbbbAdXw

Dr. Lee was able to confirm the contamination of Gardasil® with recombinant HPV DNA firmly attached to the aluminum adjuvant contained in the vaccine.

Dr. Lee’s stated: “The finding of these foreign DNA fragments in the post-mortem samples six months after vaccination indicates that some of the residual DNA fragments from the viral gene or plasmid injected with Gardasil® have been protected from degradation in the form of DNA-aluminum complexes in the macrophages; or via integration into the human genome.

Undegraded viral and plasmid DNA fragments are known to activate macrophages, causing them to release tumor necrosis factor, a myocardial depressant which can induce lethal shock in animals and humans.”

"After conducting extensive research, Dr. Lee found that in 100% of lab samples tested, fragments of HPV-11, HPV-16, and HPV-18 L1 DNA firmly attached to Merck’s proprietary aluminum adjuvant. Dr. Lee found HPV-16 L1 gene DNA fragments admixed with HPV-18 and/or HPV 11 L1 gene DNA in all samples. These HPV DNA fragments were firmly bound to the amorphous aluminum hydroxyphosphate sulfate (AAHS) particles used as an adjuvant in the vaccine formulation."

"Dr. Lee also found that the HPV DNA fragments were not only bound to Merck’s proprietary aluminum adjuvant, but they had also adopted a non-B conformation, thereby creating a novel (new) chemical compound of unknown toxicity." When he tried to publish his findings, he encountered global censorship.

sources:

Video from Autism One Conference 2016

Viral DNA bound to aluminum may mediate HPV vaccination side effects

https://www.youtube.com/watch?v=mNzXbbbAdXw

http://www.businesswire.com/.../SaneVax-Announces-Medical...

http://naturalsociety.com/independent-lab-confirms-viral.../

other related article about Dr. Lee

http://vaccineimpact.com/.../gardasil-vaccine-becomes.../

GARDASIL

WHAT IS THE MECHANISM OF HARM?

ALUMINUM, MOLECULAR MINICRY

Article: Are aluminum adjuvants plus Gardasil a uniquely damaging neuroinflammatory cocktail?

by Claire Dwoskin on July 28, 2016

Highlights:

1. "In an ordinary clinical trial, investigators compare a group that receives a drug with another group that receives a harmless placebo. Not so with vaccine clinical trials, many of which use placebos that contain an aluminum adjuvant."

2. "This phenomenon, where cross-reactivity occurs and the vaccine-induced antibodies are able to bind not only the target foreign antigen (i.e., the HPV virus) but also host proteins, can be the result of molecular mimicry, where a foreign antigen shares a structural similarity with a particular self-antigen. Consequently, host antibodies which are raised in response to vaccination or infection (whatever the case may be), will not only recognize and attack the particular foreign antigen, but also the host antigen which is structurally similar to it."

3. "This is one of many examples of the molecular mimicry phenomena, which shows that overly vigorous and/or aberrant immune responses to either infections or vaccinations, while protective, can also be detrimental to the host."

4. "...cross-reactivity due to molecular mimicry “is generally accepted as a mechanism by which vaccines can trigger autoimmune diseases.” 

5. According to Kanduc, “the number of viral matches and their locations make the occurrence of side autoimmune cross-reactions in the human host following HPV16-based vaccination almost unavoidable.”

6. "Microgliosis represents “an intense reaction…to pathogenic insults” and astrogliosis similarly occurs when the “astrocytic defense mechanisms [are] overwhelmed in pathological conditions.” This type of glial activation can produce “irreversible neurodestructive and pro-inflammatory processes in the brain,” according to Tomljenovic and Shaw."

7. With its triple findings from behavioral tests and serum and brain tissue analyses, the mouse study validates the case study report, which concludes that Gardasil (and Cervarix) are “inherently unsafe” for at least some individuals. 

8. Although it is clear that much more needs to be done to tease out the specific mechanisms whereby HPV (and other) vaccines and aluminum adjuvants can trigger autoimmune disease, the combined results of the carefully conducted mouse and human Gardasil studies cannot be easily dismissed. Together, the two studies’ results indicate that there is good reason to be cautious about aluminum-containing HPV vaccines—particularly now that the reformulated Gardasil-9 vaccine contains more than twice the amount of aluminum as its quadrivalent predecessor. 

FULL ARTICLE:

Health authorities and the media relentlessly repeat the mantra that vaccines are unequivocally safe, and many uninformed consumers cling to this mantra like a lifeboat. More often than not, however, consumers know little or nothing about the vaccine safety testing process and assume that vaccine manufacturers and regulatory institutions have exercised due diligence in ensuring that vaccines are as safe as possible.

In an ordinary clinical trial, investigators compare a group that receives a drug with another group that receives a harmless placebo. Not so with vaccine clinical trials, many of which use placebos that contain an aluminum adjuvant. What are the implications of using aluminum-based placebos that are not innocuous or inert but instead are “intrinsically capable of stimulating pathological immune and neuro-inflammatory responses”? This is one of the critically important questions that Dr. Yehuda Shoenfeld and colleagues at Tel Aviv University and University of British Columbia researchers Lucija Tomljenovic and Christopher Shaw address in a July 2016 study in Immunologic Research about aluminum adjuvants and the quadrivalent Gardasil vaccine that ostensibly protects against four types of human papillomavirus (HPV).

Dr. Shoenfeld and colleagues begin and end with the assertion that aluminum-containing placebos represent both a scientifically and ethically inappropriate choice for vaccine clinical trials, given aluminum’s well-documented neuro- and immunotoxic properties. Moreover, Gardasil (as well as the Cervarix HPV vaccine) uses newer-generation aluminum adjuvants that induce a far more forceful immune response than conventional aluminum adjuvants (which are far from benign to begin with). The more powerful aluminum adjuvants have a correspondingly stronger “reactogenicity” (the term used to describe the degree to which a vaccine provokes adverse reactions).

In their study, Dr. Shoenfeld’s research team assessed behavioral and inflammatory markers in four groups of young female mice after injecting the mice (in amounts equivalent to human exposure) with either Gardasil vaccine (or Gardasil plus pertussis toxin), aluminum adjuvant, or a vehicle control (solution of sodium chloride and histidine - Gardisil carrier solution). The researchers found pronounced and highly statistically significant behavioral differences between the groups at both three and six months post-injection. At six months, the aluminum-injected group showed reduced exploratory behavior, and the mice in all three treatment groups (Gardasil and aluminum) were less likely to exhibit escape-oriented behaviors (a marker of depression) compared with the control group. The researchers note that “the extent of adverse neurological manifestations was similar in the three treatment groups whose only common denominator was the [aluminum] compound.”

In addition to the behavioral tests, the researchers examined the potential of mice blood samples to bind proteins extracted from mice brain tissue. If such binding was observed in Gardasil-injected mice but not in aluminum or placebo-injected mice (as the latter two groups would not mount an anti-HPV antibody response), it would indicate that the antibodies raised against HPV following Gardasil vaccination, have not only the ability to bind to HPV antigens but also the neural proteins present in the host’s brain. This phenomenon, where cross-reactivity occurs and the vaccine-induced antibodies are able to bind not only the target foreign antigen (i.e., the HPV virus) but also host proteins, can be the result of molecular mimicry, where a foreign antigen shares a structural similarity with a particular self-antigen. Consequently, host antibodies which are raised in response to vaccination or infection (whatever the case may be), will not only recognize and attack the particular foreign antigen, but also the host antigen which is structurally similar to it. 

A well-known example of molecular mimicry is found in the etiology of the anti-phospholipid syndrome (APS), which is an autoimmune multi-systemic disease associated with recurrent fetal loss, thromboembolic phenomena, and neurological, cardiac and dermatological adverse manifestations. APS is characterized by the presence of pathogenic auto-antibodies against a molecule known as β2-glycoprotein I. The infectious triggers of APS are well recognized (ie, syphilis, leprosy and varicella to name a few). Likewise, tetanus vaccination may also trigger APS by producing antibodies which target both the tetanus toxoid and the β2 glycoprotein I, due to structural similarity between these two molecules. This is one of many examples of the molecular mimicry phenomena, which shows that overly vigorous and/or aberrant immune responses to either infections or vaccinations, while protective, can also be detrimental to the host. 

The research by Shoenfeld’s group shows that the molecular mimicry phenomenon might also be relevant in explaining some of the neurological adverse events reported following HPV vaccination.  The reason for this is as Tomljenovic and Shaw have observed, that cross-reactivity due to molecular mimicry “is generally accepted as a mechanism by which vaccines can trigger autoimmune diseases.”  The microglia act as the primary form of active immune defense in the brain, and other glial cells called astroglia are responsible for maintenance of brain homeostasis.

The researchers note that their cross-reactivity findings in mice are consistent with work conducted by Kanduc in humans, who identified considerable amino acid sequence similarity between the Gardasil vaccine antigen and a number of human proteins. According to Kanduc, “the number of viral matches and their locations make the occurrence of side autoimmune cross-reactions in the human host following HPV16-based vaccination almost unavoidable.”

The mouse study findings also corroborate and amplify a prior case study report by Tomljenovic and Shaw describing immunohistochemical analysis of brain tissue specimens from two young women who died after receiving the Gardasil vaccine. Immunohistochemistry is a method for demonstrating the presence and location of antigens in tissue using antibodies that recognize the target antigen. In both cases, the standard autopsies had previously failed to ascertain an exact cause of death. Case 1 experienced progressively worsening neurological symptoms following her first Gardasil injection and died in her sleep six months after her third Gardasil booster. She showed no notable neuroinflammatory changes upon autopsy using an unspecified histological protocol. Case 2 developed a variety of symptoms after her first injection and died two weeks after the second booster. The autopsy report for Case 2 found cerebral changes consistent with encephalopathy and indicative of a “focally disrupted blood-brain barrier.”

The World Health Organization’s Global Advisory Committee on Vaccine Safety (GACVS) critiqued the Tomljenovic and Shaw case study but did so on the basis of several extremely careless and factually incorrect statements, as rebutted by leading scientist Sin Hang Lee of Milford Molecular Diagnostics. One of the objections of the GACVS was that there was “no evidence of inflammation on autopsy”—despite the fact that the autopsy for Case 2 found evidence of encephalopathy. In addition, Tomljenovic and Shaw point out that their fine-tuned analyses of brain tissue from the two deceased young women, unlike the autopsies, used microglia- and astroglia-specific markers that were able to identify “exceptionally intense micro- and astrogliosis in all brain tissue sections examined” from both cases. Microgliosis represents “an intense reaction…to pathogenic insults” and astrogliosis similarly occurs when the “astrocytic defense mechanisms [are] overwhelmed in pathological conditions.” This type of glial activation can produce “irreversible neurodestructive and pro-inflammatory processes in the brain,” according to Tomljenovic and Shaw.

With its triple findings from behavioral tests and serum and brain tissue analyses, the mouse study validates the case study report, which concludes that Gardasil (and Cervarix) are “inherently unsafe” for at least some individuals. Although it is clear that much more needs to be done to tease out the specific mechanisms whereby HPV (and other) vaccines and aluminum adjuvants can trigger autoimmune disease, the combined results of the carefully conducted mouse and human Gardasil studies cannot be easily dismissed. Together, the two studies’ results indicate that there is good reason to be cautious about aluminum-containing HPV vaccines—particularly now that the reformulated Gardasil-9 vaccine contains more than twice the amount of aluminum as its quadrivalent predecessor. The next time vaccine experts loudly proclaim that vaccine safety is unassailable, consider whether the researchers exhibited any genuine curiosity about adverse events to begin with. It’s not possible to find what you don’t look for.

http://info.cmsri.org/.../are-aluminum-adjuvants-plus...

Personal stories

http://www.mygardasilstory.com.au/

Real court cases results:

http://www.mctlawyers.com/vaccine-injury/cases/