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HPV Vaccines are a Betrayal of the Public Trust

By NORMA ERICKSON | SANEVAX | MARCH 27, 2013

Last week, multiple news articles reported 44% of American parents refusing Gardasil or Cervarix for their children. Between 2008 and 2010, the percentage of parents concerned about the safety of these two vaccines nearly quadrupled. As of 2010, only 32% of eligible girls were vaccinated against HPV. What is wrong with this picture?

Excerpts from national news sources, March 18-22, 2013:

  • USA Today The percentage of parents who say they won’t have their teen daughters vaccinated against the human papillomavirus increases, even though physicians increasingly recommend the vaccinations. Concerns about safety and side effects for the human papillomavirus (HPV) vaccine have increased among parents: 16% cited these fears as the main reason they did not have their daughters vaccinated in 2010, up from 5% in 2008…
  • Medpage Today Parents increasingly say they are worried about the safety of the human papillomavirus (HPV) vaccine and don’t intend to vaccinate their teen daughters… But there is no similar pattern for two other vaccines aimed at adolescents…
  • CNN Health Concerns of mothers and fathers about the safety of the HPV vaccine grew each year, from 4.5% in 2008 to 16.4% in 2010… The number of parents who said they would not vaccinate their children for HPV increased from 38.9% in 2008 to 43.9% in 2010. The main concern was safety.
  • CBS News One of the main reasons parents said they didn’t want their children vaccinated against HPV was because of safety concerns.
  • Bloomberg The number of girls who received either injection (Gardasil or Cervarix) rose to about one-third in 2010 from 16 percent in 2008…
  • FiercePharma A growing share of U.S. parents say they won’t vaccinate their daughters… And that leaves Merck’s Gardasil and GSK’s Cervarix with a shrinking market.
  • The New York Timessuggesting, the need for interventions beyond clinical recommendations like possibly ‘state and federally designed social marketing campaigns.’… Without brushing aside the need to address safety concerns, the increasing rates of HPV vaccine refusal suggest that widespread vaccination will require more than marketing campaigns. Medical professionals need to look for ways to tell a better story to parents and teens about HPV, vaccination and cancer. (emphasis added)

Taxpayer funded social marketing campaigns? Look for ways to ‘tell a better story’ to parents? Who are these people kidding? What happened to investigative journalism? What happened to fact-finding? What happened to fair and balanced journalism?

Has no one considered the possibility that the 43.9% of parents refusing this particular vaccine might have some valid concerns? When will people realize there is a huge difference between ‘increasingly concerned about the safety’ and ‘increasingly aware of the potential risks’? After all, this would not be the first time a prescription medication approved by the FDA as ‘safe and effective’ turned out to be nothing of the sort. Will HPV vaccines be next?

HPV vaccination programs worldwide are based on two assumptions. First, HPV vaccines will prevent cervical cancer and save lives. Second, HPV vaccines will pose no risk of serious side effects. Therefore, it would make sense to vaccinate as many pre-adolescent girls as possible to reduce the worldwide burden of cervical cancer. What happens if both of these assumptions are not based on factual evidence?[1]

Medical Consumers Want to Know:

  1. Since HPV vaccines have never been shown to prevent cervical cancer, why are they being promoted as cervical cancer vaccines?1
  2. Since the majority of HPV infections and a great proportion of abnormal lesions associated with cervical cancer development clear spontaneously without medical treatment, how can these factors be used as ‘end-points’ during clinical trials to reliably predict the number of cervical cancer cases that could be prevented by HPV vaccines?1
  3. How can the clinical trials make an accurate estimate of the risk associated with HPV-vaccines if they are methodologically biased to produce false negatives?1
  4. Why are HPV vaccines marketed so aggressively in developed countries, when 85.5% of annual cervical cancer cases and 87.9% of annual cervical cancer deaths occur in developing countries?[2]
  5. How can passive adverse event monitoring systems (voluntary reporting with no penalty for failure to report), such as those used by most vaccine surveillance systems world-wide, allow the medical regulatory agencies to make accurate estimates on the real frequency of HPV-vaccine related adverse reactions?
  6. How can accurate estimates of the real frequency of HPV-vaccine related adverse reactions be made if appropriate follow-up and thorough investigations of suspected vaccine reactions are not conducted?

The FDA granted Merck’s HPV vaccine, Gardasil, fast track approval in June of 2006, despite the fact that this HPV vaccine failed to meet the FDA criteria for fast track approval.[3] FDA approval of GSK’s HPV vaccine, Cervarix, followed shortly after in January 2007.

According to The New York Times, the CDC Advisory Committee on Immunization Practices recommended adding HPV vaccines to the immunization schedule in the U.S. despite the fact that 64% of the advisory committee members had potential conflicts of interest which were either never disclosed or left unresolved at the time they voted. 3% of the members actually voted on matters they had been barred from considering by ethics officers. News like this certainly does little to enhance the level of public trust.

Is it possible for the FDA to objectively monitor the safety and efficacy of HPV vaccines? One has to wonder since Congress tightened the rules on outside consulting after similarly undisclosed conflicts of interest were discovered within advisory committees at the FDA.

As if this is not enough, the United States Department of Health and Human Services, via the National Institutes of Health, Office of Technology Transfer receives royalties on each HPV vaccine sold worldwide. This happens because technologies used in the production of HPV vaccines were developed at NIH and subsequently patented by them. For three of the last five years, HPV vaccines based on recombinant papillomavirus capsid proteins have ranked #1 based on royalties from product sales.[4]

Marketing Gardasil to the public under these circumstances is a typical case of unconstrained government self-dealing. The major patent holder (National Cancer Institute/NCI), the regulator (FDA) and the vaccination policy maker (CDC) are all divisions of the Department of Health and Human Services (DHHS). These self-dealings typically benefit some administrators, not the government or tax payers.  For example, Dr. Julie Gerberding, as the Director of the CDC, approved the use of Gardasil for cervical cancer prevention as a public health policy is now the president of Merck’s Vaccine division promoting the sales of Gardasil.

How much revenue is generated for the NIH from international sales of HPV vaccines? In November 2010, Dr. Eric Suba submitted a Freedom of Information Request to the Office of Government Information Services to discover the amount. It seems the financial details of the partnership between the NIH, Merck and GlaxoSmithKline are exempt from disclosure. (Read the response he received here.) Apparently, transparency in government does not apply to the top 20 revenue producing patent(s) developed at taxpayer expense. Why is the public not allowed to share in celebrating the success of products they financed?

Three Strikes for Gardasil?

  1. September 2011: Recombinant HPV DNA L1 protein fragments, possibly attached to the aluminum adjuvant, were discovered in 100% of Gardasil samples tested. There was no subsequent investigation. The FDA simply declared the ‘expected’ presence of residual DNA is not a safety factor. No documentation was provided. The fact that HPV vaccines were approved by governments worldwide based on manufacturers’ assertions that the vaccines contained ‘no viral DNA’ was completely ignored.[5], [6] The possibility of recombinant HPV DNA fragments being attached to aluminum adjuvant particles was also ignored.
  2. August 2012: One of the antigens used in Gardasil was discovered in central nervous system samples from two girls who died after being vaccinated with Gardasil. No cause of death was identified upon autopsy in either case.[7] HPV-16 L1 gene DNA fragments of vaccine origin apparently attached to aluminum adjuvant particles were also discovered in post mortem blood and spleen samples of a girl who died 6 months after Gardasil injections.[8], [9]
  3. February 2013: It was discovered that the naked HPV 16 L1 gene fragments bound to aluminum particles by ligand exchange in Gardasil have acquired a non-B conformation. This conformational change may have stabilized the HPV 16 gene fragments in Gardasil preventing their normal enzymatic degradation in vaccine recipients.[10], [11] Non-B DNA conformations and their relationship to diseases has been studied since the 1960’s. Based on current scientific knowledge, the human genetic consequences of these non-B DNA structures are approximately 20 neurological diseases, approximately 50 genomic disorders and several psychiatric diseases.[12], [13] The impact of injected foreign non-B DNA on human health is totally unknown.

Why have none of these discoveries sparked a single investigation in any country? Why is no one concerned when genetically modified viral DNA fragments are found in vaccines that are reported to have no viral DNA? Why is no one worried about those viral DNA fragments being attached to aluminum (a known toxin) possibly creating a new chemical compound of unknown toxicity? Why are no red flags raised when those viral DNA fragments attached to aluminum acquire a non-B conformation – something known to be associated with multiple debilitating diseases? Anyone with an ounce of common sense should demand to know why those charged with approval, recommendation and safety monitoring of these vaccines appear to be utterly unconcerned about the future health implications of any one of these discoveries, much less all three of them.

What kind of ‘expert’ advice is being given to YOUR government health officials?

Israel’s Advisory Committee on Infectious Diseases and Inoculations held a teleconference on 30 January 2013, to discuss the proposed introduction of HPV vaccines into the country’s school inoculation program among other issues. The official transcript of that meeting, dated 11 February 2013, provides some interesting insights for medical consumers who question HPV vaccine safety.

Ron Dagan, MD, is Professor of Pediatrics and Infectious Diseases at the Ben-Gurion University of the Negev in Beer-Sheva, Israel, and Director of the Pediatric Infectious Disease Unit at the Soroka University Medical Center, also in Beer-Sheva. An active researcher and international lecturer, Dr. Dagan’s work focuses on new conjugate vaccines. His expert advice to Israel’s Advisory Committee regarding potential HPV vaccine implementation is as follows (translation provided-emphasis added):

We are dealing with injections, some of which given in 3 [separate] doses, which are delivered to teenage girls. Many side effects are to be expected. During the week following the vaccine delivery of the injections many serious events which are not related/linked to the vaccination are expected: fainting, deaths and convulsions/fits. This needs to be taken into account. Even if it is not rational, if these events happen in class they may damage the general perception/status of the vaccinations. This is happening all over the world all the time. We have already dealt with a similar issue in relation to the delivery of MMT with TD and Polio and we have accepted the nurse’s proposal to split these between grades 1 and 2. The nurses are suitable to make recommendations to the committee in relation to this issue. In relation to the side effects, we need to be prepared in advance and not simply react after the fact. I propose we consult with the English representatives as to how they’ve gone about this. We must prepare for the delivery of the new vaccine. The nurses need to know they are going about this in the way they are most comfortable with (/have the most control over/familiarity with).

If this is an example of the expert advice vaccination programs are based on, it’s no wonder medical consumers are questioning HPV vaccine safety, efficacy and need. Many side effects are to be expected? Fainting, deaths, convulsions and fits occurring during the week following vaccination – yet not related to the vaccine? Preparing in advance for side effects? Consulting with other countries to see how they handled the problem? Are countries around the world being offered similar expert advice?

So, what will it take to solve the HPV vaccine uptake problem?

Parental concerns about HPV vaccine safety are not going to go away in response to social media campaigns. Teaching medical professionals to ‘tell a better story’ is not going to make parents change their mind about Gardasil, Cervarix, or any future HPV vaccine. Platitudes and unsubstantiated reassurances are no longer sufficient.

The time has come for government health authorities to make HPV vaccine manufacturers prove their claims or pull their products from the market. Medical consumers want scientifically proven facts – Safe, Affordable, Necessary and Effective – nothing less is acceptable.

References:

[2] WHO/ICO Information Centre on HPV and Cervical Cancer (HPV Information Centre). Human Papillomavirus and Related Cancers in World. Summary Report 2010.

[3] Too fast or not too fast: the FDA’s approval of Merck’s HPV vaccine Gardasil. Tomljenovic/Shaw 2012

[4] Top 20 Commercially Successful Inventions, NIH

[5] SaneVax to FDA: Recombinant HPV DNA found in multiple samples of Gardasil

[6] Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil® Lee 2012

[7] Death after Quadrivalent Human Papillomavirus (HPV) Vaccination: Causal or Coincidental? Tomljenovic/Shaw 2012

[8] Detection of human papillomavirus L1 gene DNA fragments in postmortem blood and spleen after Gardasil® vaccination—A case report Lee 2012

[9] Death after Quadrivalent Human Papillomavirus (HPV) Vaccination: Causal or Coincidental? Tomljenovic/Shaw 2012

[10] Topological conformational changes of human papillomavirus (HPV) DNA bound to an insoluble aluminum salt—A study by low temperature PCR, Lee 2013

[11] Gardasil: New Study Brings More Safety Questions to Light, Erickson 2013

[12] Non-B DNA conformations, mutagenesis, and disease, Wells 2007

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India’s Supreme Court to study violations in licensing and trials for Cervarix and Gardasil

Many of these young women had been coerced into accepting the vaccine

By CHRISTINA ENGLAND | VACTRUTH | JANUARY 9, 2013

On January 7, 2013, Ms. Leslie Carol Botha, Women’s Health Educator and long-time advocate for HPV vaccine safety awareness [1], released an urgent article entitled: India Women Activists Historic Writ of Petition Accepted by Supreme Court over Unethical Trialing of HPV Vaccines, Gardasil® and Cervarix®.

Based on the press release issued by Kalpana Mehta, Nalini Bhanot and V. Rukmini Rao, representing Gramya Resource Centre for Women from Andhra Pradesh, titled, “India Supreme Court Accepts Writ of Petition on Gardasil & Cervarix Licensing & Trial Violations” implicating the Drug Controller of India, PATH, ICMR and others, ordering the government of India to immediately respond. [2]

Botha outlined the course of history that led to this groundbreaking hearing, as well as the violations that occurred during the clinical trials and the undisclosed international agenda among the Bill & Melinda Gates Foundation (BMGF), the Program for Appropriate Technology in Health (PATH) and the World Health Organization (WHO) to unduly influence the Indian government to adopt the vaccines for introduction in the public sector. Botha also detailed the Petitioners’ requests and reliefs as stated in the Writ of Petition, filed on October 29, 2012.

TAKING ACTION

On October 29, 2012, activists Kalpana Mehta and Nalini Bhanot, along with Dr. Rukmini Rao, President of the Gramya Resource Centre for Women in India, filed a writ petition with the Supreme Court of India under Article 32 of The Constitution of India for Women. The petition was filed against:

  • Drug Controller General of India
  • Indian Council of Medical Research

  • State of Andhra Pradesh

  • State of Gujarat
  • PATH International

  • GlaxoSmithKline Asia Private Limited

  • MSD Pharmaceuticals Private Limited

(A writ petition is a document filed to the court that includes an introduction to the issue and an explanation why a petition is needed as a means of preventing irreparable harm. The explanation is supported with allegations by the Petitioner and a memorandum of the issues raised.) [3]

The petition outlines a series of serious allegations regarding the HPV vaccines Gardasil and Cervarix. Petitioners Kalpana Mehta, Nalini Bhanot and Dr. Rukmini Rao reported that the two HPV vaccines were illegally brought into the states of Andhra Pradesh and Gujarat and subsequently administered to thousands of young, vulnerable Indian children before the vaccines were known to be safe.

The three Petitioners told the court that even though the Indian government and the above organizations knew the HPV vaccines were of dubious value and of speculative benefits, they continued to allow a trial using both the Gardasil and Cervarix vaccines without regard to the potential endangerment of the lives of adolescent girls.

The petition outlined how the above organizations vaccinated tens of thousands of vulnerable girls aged between 10-14 years and then abandoned them without providing any information on potential adverse reactions, scheduling follow-up examinations, or 0ffering post-vaccine treatment.

THE UNETHICAL EXPERIMENT

The vaccines were introduced to the public sector by carrying out a trial vaccinating 16,000 adolescent girls (10-14 years) in Andhra Pradesh and an equal number in Gujarat. The petitioners believed that by vaccinating children with HPV vaccines while being fully aware of the potential dangers, the organizations involved knowingly put the lives of tens of thousands of children at risk from potentially serious vaccine-related adverse reactions and death.

The Petitioners stated that the unlicensed HPV vaccines only became licensed midway through the project:

“These vaccines had not been assessed with respect to safety and efficacy for the Indian population where adolescent girls are overwhelmingly anemic and malnourished. No steps were taken to ensure the health and safety of the girls. They were not screened adequately for contraindications. On the contrary, they were told that the vaccine had no adverse effects, not even those that were acknowledged by the manufacturers. Referral and treatment of serious adverse effects was not planned and as a result, private doctors and government hospitals were not aware that the girls coming to them in serious condition were subjects of vaccine trials. No monitoring of the program was done. No course correction was made. After vaccination, the girls were dumped with no follow up.”

To further support their claims, the Petitioners shared a statement, which had been published on the WHO website:

“The short (2-3 years) post marketing surveillance periods of these vaccines do not permit final assessments of possible rare or long-term adverse effects.”  [4]

All girls were vaccinated by the U.S.-based NGO (Non Government Organization) and PATH (Program for Appropriate Technology in Health).

DEATH AND DECEPTION

As stated in the petition, the project was discontinued only after several women’s organizations reported:

  • deaths among the participants
  • the use of vulnerable population
  • lack of informed consent

The Petitioners accused project leaders of falsification of the records and stated that the project had been carried out with severe lack of monitoring, stating that PATH and the Indian Council of Medical Research (ICMR) as well as state authorities covered up the adverse effects and deaths that have been described in the petition:

Some of the girls died. Some suffered serious adverse effects. Some of the girls developed autoimmune diseases that would require lifelong care. The manufacturers themselves acknowledged adverse events such as anaphylactic shock, seizures and paralysis, motor neuron disease, blood clots, eye, ear and vascular problems and even death, and problems affecting the nervous system, the immune system, the musculoskeletal system, the blood and lymphatic system, the respiratory system, the gastrointestinal system and the vascular system. In the PATH project, these adverse events were grossly under reported and hidden. Records were falsified. Deaths that took place were stated as having nothing to do with the administering of the vaccines and were described as deaths due to suicides, insecticide poisoning and snake bites.” 

In an interview, Kalpana Mehta told me there had been gross anomalies in the death-related documentation, indicating a cover-up and that even the age of the girl who died failed to match the projects records. She said:

“The dates of postmortems were poorly documented and inaccurate and instead of being written on hospital stationary many had been written on plain paper without signatures.”

CONFLICTS OF INTEREST

The citizens of India have every right to be concerned. It appears that their government officials have fallen prey to collusion of international agencies and non-governmental organizations (NGOs), including the Bill and Melinda Gates Foundation, PATH and WHO. They have allowed tens of thousands of young, vulnerable, rural Indian children to be involved in the HPV vaccine experiment, with no benefit.

Ms. Mehta says:

“Even a government appointed inquiry committee found gross irregularity with the consent process. Indian law provides for compensation for violation of the informed consent procedure in addition to the compensation for death and injury suffered by trial subjects. However even after two years the government has failed to act on its own inquiry.

This inquiry committee also noted that by taking vaccines free of cost from the manufacturers, the project was mired in conflict of interest. It also took strong exception to PATH ensuring itself for the project but leaving the girls uninsured.”

INFERTILITY CONCERNS

By this time, a massive 24,000 girls had already been vaccinated and, according to the petitioners, many of these young women had been coerced into accepting the vaccine. Parents were reassured, without scientific basis, that the vaccines would not impact their children’s future fertility.

Concerned about this information, the Petitioners stated:

“As of now there is alarming news of menopause setting in a 16 year-old girl from Australia, where the doctor has found Gardasil to be the only probable cause of this rarest of rare mishap.” [5]

Since the petition was submitted, yet more information on the similar plight of girls in Australia has come to light. The Sunday Telegraph has published a story, first reported in the British Medical Journal, of a previously healthy 16 year-old girl whose premature menopause may be linked to the Gardasil vaccination. [6]

According to The Telegraph, Dr. Ward told reporters that women’s fertility must be protected at all costs. Ms. Botha has been echoing Dr. Ward’s words for years. She has stressed on many occasions that vaccinating girls at menarche – the onset of menstruation, which is the most fragile reproductive time of a woman’s life – is dangerous:

“As the female hormone levels of estrogen and progesterone decrease during the premenstrual phase, the female body begins the process of releasing the uterine lining in the act of menstruation. The decrease in hormones actually affects a woman’s energy levels and her emotions. The immune system becomes more compromised, and that translates to a lowered defense system to fight off invading, foreign toxins.” [7]

CONCLUSION

There has been no evidence to suggest that any of the above crucial issues were ever considered by any of the organizations involved in these vaccination trials.

Time and again, according to the petition, PATH has denied that it carried out a trial in India. It insists that what it was doing was merely a post-licensure study. This explanation was unacceptable to the Indian government’s inquiry. It concluded that by whatever name PATH chooses to call its exercise, under the Indian Drugs and Cosmetics Act, it was indeed a clinical trial and all safeguards should have been observed. Yet PATH and WHO have hailed the trial a resounding success in order to carry on vaccinating other vulnerable communities in the third world with dangerous, potentially life-threatening vaccines.

Undeterred by the government’s silence and WHO pronouncements, the Petitioners have strongly recommended that the court cancel the product licenses for Gardasil and Cervarix and withdraw both vaccinations from the market until their safety and efficacy is proven, as per Indian regulation. Their stance on licensing resonates with democracy as the Indian Parliamentary Standing Committee on Health and Family Welfare has indeed determined that the drug regulations currently favor pharmaceutical companies unduly, leaving consumers at the mercy of untried, irrational formulations.

Acknowledgements

The author offers her sincerest gratitude to Kalpana Mehta, Nalini Bhanot and V. Rukmini Rao for their tireless efforts to restore justice and health to vulnerable populations everywhere, especially in India at this time, and for their willingness to share their petition to the court with VacTruth.

References

1. http://holyhormones.com/womens-health/cancer-womens-health/cervical-cancer…

2.  http://holyhormones.com/womens-health/cancer-womens-health/cervical-cancer/india-supreme-court-accepts-writ-of-petition-on-gardasil-cervarix-licensing-trial-violations/

3.  http://www.ehow.com/facts_6739641_meaning-writ-petition_.html

4.  http://www.who.int/immunization/HPV_ Grad_Adol_girls.pdf

5.  http://pop.org/content/teenage-girl-becomes-infertile-after-gardasilvaccination

6.  http://www.dailytelegraph.com.au/news/hpv-vaccine-link-to-infertility-needs-to-be-tested-says-miranda-devine/story-e6freuy9-1226528052334

7.  http://vactruth.com/2010/01/13/website-documents-over-300-gardasil-horror-stories/


Does Gardasil cause premature menopause and infertility?

UK TELEGRAPH | DECEMBER 3, 2012

A north coast doctor has published a paper in the British Medical Journal warning that the premature menopause of a healthy 16-year-old girl may be linked to the Gardasil vaccination.

Dr Deirdre Little and her co-author, obstetrician Dr Harvey Ward from the University of NSW, are urging further testing of the Australian vaccine for the sexually transmitted human papillomavirus (HPV), which causes cervical cancer.

“Fertility is not a small matter. It should not be placed at risk by an absence of published research,” said Dr Little.

When a 16-year-old patient came to her North Bellingen surgery in 2009 complaining of having lost her period and experiencing hot flushes, six months after being given three Gardasil vaccinations, Dr Little had doubts.

But further investigation raised real concerns of a link. The doctors warn there may be a group of young women who should not be given the vaccine, which has been administered to teenage girls across Australia since 2007. It is due to be given to boys from next year.

“It’s important to be certain that fertility is protected at all costs, as premature menopause in a teenager is one of the most disastrous consequences,” said Dr Ward.

“We need to be certain that a vaccine does not diminish egg-bearing capacity.”

Premature menopause is rare in girls so young. But if there is a problem with the vaccine, Dr Little says it may go undetected because one third of teenage girls are on the pill, which prevents ovulation and masks the symptoms of ovarian failure. The doctors say further studies are needed.

Dr Little notified the Therapeutic Goods Administration (TGA) of a “possible adverse event following HPV vaccination”. She says while there have been no other notifications of premature menopause, four cases of “scant periods” have been reported.

Dr Little is an advocate of vaccination, which she regards as a “gift to medicine”, but is worried that Gardasil had been rushed into use without the “rigorous standards” applied to established vaccines.

Vaccine-maker CSL recorded a record profit this year because of higher than expected royalty payments from Gardasil as the vaccine spreads around the globe.

One case of premature menopause may not mean anything but the consequences for young women are so dire that further research is warranted.

 

Trace from Gardasil vaccine found in brains of two dead girls who were injected

Researchers find that vaccine antigen HPV-16-L1 crossed brain barrier.

By NORMA ERICKSON | SANEVAX | OCTOBER 25, 2012

For the first time in history, a biologically plausible mechanism of action has been discovered linking a vaccine to a serious adverse event. Gardasil has left behind its genetic fingerprint in post-mortem central nervous system samples of two girls who took this vaccine.

Two teenage girls from opposite ends of the world – both dead before their time have two additional things in common. They both took Gardasil to try and prevent cervical cancer and fragments of the HPV-16-L1 antigen used in Gardasil have been found in blood vessels within their brains.

The HPV-16-L1 protein is one of the antigens used in both Gardasil and Cervarix. An antigen is a toxin or other foreign substance that induces an immune response in the body. Theoretically, these antigens are not supposed to cross the blood brain barrier. However, according to a recently concluded case study this may not be the case.

Using a new immunohistochemical (IHC) protocol they developed, Drs. Chris Shaw and Lucija Tomljenovic examined post-mortem samples taken from the cerebellum, hippocampus, choroid plexus and watershed cortex of a 19 year-old girl; as well as post-mortem samples of the cerebellum, hippocampus, choroid plexus, portions of the brainstem (medulla, midbrain, pons), right basal ganglia, right parietal and left frontal lobes of a 14 year-old girl. They tested for the presence of two of the specific antigens used in both Gardasil and Cervarix: HPV-16-L1 and HPV-18-L1.

They discovered the presence of HPV-16-L1 particles within the blood vessels in the brain (cerebral vasculature) with some of these particles adhering to the blood vessel walls. For the average medical consumer, this is the equivalent of a Gardasil fingerprint and it should not be in brain tissues.

Does the presence of HPV-16-L1 particles inside these girls’ cerebral vasculature provide evidence of a “Trojan Horse” mechanism by which these particles adsorbed to aluminum adjuvant gain access to human brain tissue? Remember, both Gardasil and Cervarix contain HPV-16-L1 virus-like particles (VLP’s) of the recombinant major capsid (L1) protein adsorbed onto aluminum adjuvants.

Tomljenovic and Shaw also discovered that the antibodies against HPV-16-L1, which were used to detect the presence of HPV-16-L1 particles, were also binding to the wall of cerebral blood vessels in the brain samples.

Their IHC analysis also showed increased T-cell signaling and marked activation of the classical antibody-dependent complement pathway in cerebral vascular tissues from both cases. This pattern of complement activation, in the absence of an active brain infection, indicates an abnormal triggering of the immune response in which the immune attack is directed towards the blood vessels of the brain, thus triggering an autoimmune cerebral vasculitis.

Cerebral vasculitis is a serious disease which typically results in fatal outcomes when undiagnosed and left untreated. The fact that many of the symptoms reported to the Vaccine Adverse Event Reporting System (VAERS) following HPV vaccination are indicative of cerebral vasculitis, but are unrecognized as such (i.e. intense persistent migraines, syncope, seizures, tremors and tingling, myalgia, locomotor abnormalities, psychotic symptoms and cognitive deficits) is a serious concern in light of Tomljenovic and Shaw’s findings.

Finally, there was clear evidence of brain hemorrhages in both cases which further demonstrated that a serious injury to the cerebral vasculature occurred.

For the average medical consumer, this evidence suggests that the antibodies produced in response to vaccination with the HPV-16-L1 may cause one’s immune system to attack its own blood vessels. HPV vaccines containing HPV-16-L1 antigens could therefore pose an inherent risk for triggering potentially fatal autoimmune vasculopathies.

There is little doubt that HPV vaccines are unsafe for some individuals. Who those individuals are and why they are more susceptible to serious adverse reactions than others remains unknown. More studies must be conducted to answer these questions.

The article by Drs. Chris Shaw and Lucija Tomljenovic entitled Death after qHPV vaccination: causal or coincidental, published in Pharmaceutical Regulatory Affairs today provides evidence of a biologically plausible mechanism of action linking a particular vaccine to serious adverse outcomes, perhaps for the first time in history. Although this study may not conclusively ‘prove’ causality, it seriously demonstrates the need for additional investigation. (Access entire article here.)

When reading this case study, one must understand the findings should be viewed with caution. This is a small sample size and there were no control samples available. However, the marked resemblance between the two cases strongly supports the present conclusions.

It is important to note that activation of the antibody-dependent complement pathway, as shown in Tomljenovic and Shaw’s analysis, typically occurs in neurodegenerative diseases which have an underlying immune trigger. This process is not a feature of a normal young brain.

Given that the autopsy in both cases revealed no major abnormality (anatomically, microbiologically or toxicologically) that might have been regarded as a potential cause of death; it appears plausible that the antigenic component of the HPV vaccine (HPV-16-L1) was indeed responsible for the fatal inflammation of the blood vessels.

Medical consumers need to know:

  • Vasculitis has long been recognized as a possible severe adverse reaction to vaccination.
  • Molecular mimicry (whereby the vaccine antigen resembles a host antigen) is generally accepted among medical professionals and scientists as a mechanism by which vaccines can trigger autoimmune diseases.
  • Tomljenovic & Shaw’s search of the VAERS database revealed numerous reports of post-HPV vaccination–associated vasculitis.
  • An analysis of these reports showed that post-HPV vaccination vasculitis-related symptoms most typically manifest within the first three to four months after vaccination, as was also reported in the two cases analyzed by Shaw and Tomljenovic.
  • Tomljenovic and Shaw also noted a striking similarity between the vasculitis-related symptoms reported to VAERS and those experienced by the two cases they examined.

Every vaccine carries some risk of adverse effects. Unlike most medications, vaccines are normally administered to healthy individuals. Therefore, it is all the more critical to identify those individuals who are at risk for serious adverse events after vaccines.

We consider ourselves a civilized society. The time has come to stop sacrificing the life and future of anyone for the greater good. The time has come to admit vaccine injuries occur, find out why and cure those already affected. Anything less is neither responsible, nor ethical.

Vasculitis and Vaccines: A Parent’s Primer

By NORMA ERICKSON | SANEVAX | OCTOBER 15, 2012

What is vasculitis?

Vasculitis is considered a rare group of disorders caused by inflammation of blood vessels. It is a condition which is easy to miss, or misdiagnose, because inflammation of blood vessels is capable of causing a wide range of symptoms which can be vague, generalized and/or non-specific depending upon whether veins or arteries are affected, where these blood vessels are located, how wide-spread the inflammation is, and the degree to which the blood flow is restricted in the affected area.[1] [2]

How vasculitis presents itself depends upon which tissues, organs or systems are affected, and to which degree they are affected by the impaired blood flow resulting from inflammation.

For example:

  • CNS (central nervous system) vasculitis[3] may cause headaches, confusion, changes in personality, seizures, vision problems, tingling, loss of feeling, weakness, paralysis or other neurological problems including permanent disability.
  • Churg-Strauss vasculitis[4] can have symptoms similar to asthma because of lung involvement. Can include shortness of breath, wheezing, chest pain, and coughing up blood.
  • Henoch-Schönlein purpura[5] can present as small raised purple areas under the skin (purpura) due to hemorrhage, abdominal pain, nausea, vomiting, joint pain, or blood in the urine (hematuria) because of its systemic involvement.
  • Temporal arteritis[6] can cause headache and tender thick blood vessels on the side of the forehead. Can also cause fatigue, loss of appetite (then weight), fever, heavy sweating, fever, joint and muscle pain.
  • Cutaneous vasculitis[7] may cause petechiae (small red dots), purpura, urticaria (hives), bruising, or ulcers of the skin.

The symptoms listed above are by no means an exhaustive list, but it does give you some idea of the various possible manifestations and how easily vasculitis can be mistaken for a multitude of other disorders.

What does vasculitis have to do with vaccines?

If you do a simple Google search for ‘vasculitis and vaccines,’ you will see over 500,000 results. Consider the following quotes from a few of the scientific articles referenced:

  • “A      14-year-old boy who had no relevant previous history and who was not      taking any drugs presented with a livedo reticularis (mottling of the      skin), fever, loss of weight, testicular pain, and paresthesias two months      after receiving the third dose of a hepatitis B vaccination. Inflammatory      parameters (ESR and CRP) were high. The patient met the ACR diagnostic      criteria for polyarteritis nodosa.”[8]      [9]
  • “Here      we describe 4 cases of new onset or relapsing antineutrophil cytoplasmic      antibodies associated vasculitis occurring in timely association with      influenza vaccination. In the literature different subtypes of vasculitis      have been repeatedly reported after influenza vaccination.”[10]
  • “…anecdotal      cases continue to be reported of autoimmune phenomena following influenza      vaccination, including SLE, RA, pericarditis and various forms of      vasculitis.”[11]
  • “Giant      cell arteritis (GCA) and polymyalgia rheumatica (PMR) are inflammatory      rheumatic diseases common in people over the age of 50 years. Herein, we      report 10 cases of previously healthy subjects who developed GCA/PMR      within 3 months of influenza vaccination (Inf-V). A Medline search      uncovered additional 11 isolated cases of GCA/PMR occurring after Inf-V.”[12]
  • “We      describe here a case of Henoch-Schönlein purpura (HSP) that occurred 10      days after administration of the meningococcal      polysaccharide vaccine and came to the attention of      a Vaccine Safety Datalink (VSD) investigator (but did not occur      in the VSD cohort). Periodic case reports have      linked vaccines to HSP.”[13]
  • “The      aim of this study was to characterize the adverse events of attenuated      measles vaccine in mainland China. …28 cases of Henoch-Schonlein      purpura (HSP) were reported.”[14]
  • “We      report the original case of cutaneous periarteritis nodosa that occurred      one month following vaccination against hepatitis B.”[15]
  • “We      report a case of biopsy proven vasculitis, presenting as mononeuritis      multiplex, following influenza vaccination. The clinical picture evolved      rapidly into a syndrome indistinguishable from axonal Guillain-Barré      syndrome. This suggests a differential diagnosis for post-vaccination      neuropathy, with implications for management. We believe this is the first      report in which there was an associated peripheral neuropathy at      presentation. It raises issues about the aetiology and pathogenesis of      vaccination associated neuropathy.”[16]

It is important to note that none of these studies have identified a direct causal relationship between the vaccine administered and the outcomes observed. Each one, however, exhibits a strong temporal association between the vaccine and the outcome. This means that the observed adverse events occurred within a time-frame where it is reasonable to consider the event was potentially caused by the vaccine.

In general, disorders caused by vasculitis are serious and need to be evaluated promptly. The problem is they may be difficult (even for doctors) to recognize because of the significant overlap of signs and symptoms with other more common conditions.

According to Dr. Yehuda Shoenfeld:[17] [18]

“Vaccination can have adverse autoimmune effects and may even trigger full-blown autoimmune disorders. At the moment, it is not possible to identify who is most prone to develop these side effects or disorders after immunization. Further research is needed to identify these individuals.”

The SaneVax Team could not agree more. More research does need to be done in the area of vaccine injuries – who is susceptible and why?

What do parents do while waiting for the research? 

Every time someone in your family receives a vaccination, have the person administering the vaccine record the name of the vaccine, the lot number and the expiration date. Keep a copy for your records.

Keep a journal of every new medical condition experienced after vaccination. Do not worry about whether or not you think it may be related to the vaccination – that is up to the experts to try and determine. The point is your written record may prove invaluable should you or your child actually be the victim of an adverse reaction to a vaccine.

Talk to your doctor if you suspect vasculitis or any other adverse reaction. Keep in mind that since adverse reactions to vaccines are considered rare, most physicians are not trained to recognize them. You may have to back up any concerns with your own research. Should you need to do this, stick to published scientific articles and studies. Medical professionals will not consider other sources credible.

If you and your doctor disagree, consider obtaining a second opinion. You have every right to do so.

Learn how vasculitis is typically diagnosed:

In general, disorders caused by vasculitis are serious and need to be evaluated promptly. The problem is they may be difficult for even doctors to recognize because of the significant overlap of signs and symptoms with other more commonly encountered disorders.

The diagnosis of any type of vasculitis involves tests to demonstrate the presence of a strong inflammatory process. Tests which reveal inflammation throughout the body include erythrocyte sedimentation rate, blood tests to reveal anemia/increased white blood cells, or tests to demonstrate the presence of immune complexes and/or antibodies circulating in the blood. An x-ray procedure called angiography can sometimes be used or biopsies taken from affected organs to demonstrate inflammation.[19]