THE HPV VACCINE ( GARDASIL) – SAFETY CONCERNS

THE HPV VACCINE ( GARDASIL) – SAFETY CONCERNS

~ Dr. Neville Wilson. December 2015

 

The Human Papillomavirus (HPV) vaccine was introduced with the declared aim of reducing the incidence of cervical cancer.

The earlier vaccine, Gardasil, was fast tracked to licensing in 2006, for use by females under the age of 16 years, and promoted as a protective vaccine against 4 strains of HPV, 6,11,16 & 18.

HPV strains 6 and 11 are known to contribute to 90% of genital warts and do not cause cancer. They are called “non-oncogenic”. (1)

HPV strains 16 and 18, on the other hand, have been shown to contribute to over 70% of all cervical cancers, the most prevalent being the HPV 16 strain (50%-60%) and the HPV 18 strain (10%-20%) These are the “oncogenic” strains. (2)

These strains, however, are prevalent amongst white, and not black females, in whom the most prevalent oncogenic strains are subtypes 16,18,56,39 and 66.  Gardasil does therefore not provide protection against subtypes 56,39 and 66, common causes of cervical cancer in black African females. (3)

There are more than 100 different HPV strains of which about 30 only are sexually transmitted, and of which approximately 15 may be associated with the onset of cervical cancer.

The lag period between the oncogenic HPV infection and the development of invasive cervical cancer is 15 to 20 years.

The brief period of vaccine study, prior to fast tracking by the USA government in 2006, (without evidence of safety) does not therefore allow sufficient time to evaluate whether the vaccine can prevent cervical cancer or not.

This fact can only be established after 15 to 20 years of vaccine use.

The vaccine may thus be regarded as prophylactic against certain strains of HPV, but it cannot be claimed to be preventative, since there is no factual data at present to make such a claim.

While some studies have shown a high level of antibody activity against virus like particles (VLPs) that resemble the natural HPV virus, but without the viral DNA, these measurements are merely surrogate markers, and cannot be interpreted as a hard end point predictions of cancer protection.

Long term predictions of cancer prevention, or prevention of deaths from cancer, based on surrogate marker extrapolations are not scientifically valid, and cannot be made with any certainty.

It is vitally important that young persons who are given the Gardasil vaccine recognize that no guarantees can be given about the prevention of cervical cancer, and it remains critically important that regular PAP smears are undertaken in order to detect any pre-cancerous cervical lesions.

If regular PAP smears are performed in sexually active females, and are the only safe way of detecting cervical cancer, then the questionable benefits of the HPV must be weighed against the real risk of harm caused by the vaccine, as has been reported in the world-wide media.

The HPV is ubiquitous in sexually active males and females, with most strains being asymptomatic, or not causing any serious harm to the host.

The vast majority of HPV infections have been shown to clear spontaneously by an efficient and natural immune system, with most HPV strains disappearing  spontaneously, without treatment, within a period of 2 years or less.

Only a minority of these infections, (fewer than 1%), are likely to progress to cancer, and this may depend on several lifestyle factors such as long term use of oral contraceptives, high parity, early initiation of sexual activity, multiple sex partners, tobacco smoking, immune-suppression, low socio-economic status, poor diet and insufficient anti-oxidant intake. (5)

Despite the success of the HPV vaccine in reducing the incidence of pre-cancerous lesions caused by the HPV 16 and HPV18 strains, there is no evidence that the vaccine can, or will, prevent cervical cancer or death from cancer.

 

GARDASIL 9 – Indications for Use:

In Dec 2014 the FDA approved Gardasil 9,  that included 5 additional HPV types (31,33,45,52,58), and which was intended as an addition to the previous 3 shots of the original quadrivalent (4 strains) Gardasil vaccine.

The expanded nonavalent (9 strains) vaccine does not, however, cover all known strains of HPV, since there are more than 100 identified HPV strains.

The GARDASIL package insert highlights the prescribing information for clinicians and patients, and is indicated for the prevention of :

(a)           Cervical, vulvar, vaginal and anal cancer caused by HPV strains 16 and 18.

(b)          Genital warts (condyloma accuminata) caused by HPV types 6 and 11, as well as precancerous lesions caused by HPV types 6.11,16 & 18 in girls and boys from age 9 to 26.

It is also indicated in boys and men from age 9 to 26 for the prevention of :

(a)           anal cancer caused by types 16 &18, and

(b)          genital warts caused by HPV 6 & 11, as well as precancerous lesions caused by types 6,11,16 & 18.

Gardasil does NOT provide protection against disease from vaccine and non-vaccine HPV types to which a person may have been previously exposed through sexual activity. (6)

Nor is the vaccine intended to be used for the treatment of active external genital lesions, cervical, vulvar, vaginal and anal cancers.

Gardasil has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine.

 

Of note is the fact that NOT ALL VULVAR, VAGINAL AND ANAL CANCERS ARE CAUSED BY HPV.

Gardasil manufacturers claim that Gardasil will only protect against vulvar, vaginal and anal cancers caused by HPV 16 &18, and “does not protect against genital diseases not caused by HPV”.

The manufacturer also advises that “vaccination with Gardasil may not result in protection in all vaccinated recipients”, so its purported benefits cannot be guaranteed.

They also state that “Gardasil has not been demonstrated to prevent HPV related CIN 2/3 or worse in women older than 26 years of age”.

 

 

HOW EFFECTIVE IS THE HPV VACCINE ?

 

The following comments have been placed on the Physicians for Life website:

“The HPV vaccine protects against a virus that in 98% of cases is not the cause of cervical cancer”.

“The HPV vaccine prevents a type of cancer that can be easily caught and treated by promoting regular gynaecological examinations and Pap smear tests”.

“ The HPV vaccine offers less protection than what  promotion  of safe sex practices could accomplish”.

“ The HPV vaccine protects from 4 strains of virus that are not frequent among Nigerians and black women in general, out of more than 100 strains of HPV, all of which the immune system can clear up on its own in 90% of cases”. (7)

 

REPORTS OF ADVERSE OUTCOMES:

As of 13 May 2013 Vaccine Adverse Event Reporting System (VAERS) had received 29,686 reports of adverse events following HPV vaccination, including 136 reports of death, as well as 922 reports of disability and 550 life threatening adverse events.

According to Freedom of Information gained by Judicial Watch, the USA Government Watchdog, the National Vaccine Injury Compensation Programme (VICP) has awarded $5,877,710 to 49 victims of harm resulting from the HPV vaccine. (8)

Regarding the possible adverse outcomes from the Gardasil vaccination, the manufacturer states that “adverse reactions noted in clinical trials were largely of a minor nature, like headache, fever, nausea, dizziness and local injection site reactions”.

They also acknowledge that syncope (sudden collapse) and seizure activity were noted in some trials, but suggest that these events were usually transient and “typically responds to restoring cerebral perfusion by maintaining a supine or trendellenberg position”.

The unfortunate reality is that many recipients of the Gardasil vaccine do not regard their post-vaccination reactions as trivial, transient or non-severe, and have reported long-lasting disabilities characterized by paralysis, speech disorders, and severe systemic reactions, while in some cases parents have reported fatal outcomes.

( The long list of vaccine induced injuries and deaths is outlined by Journal Watch , October 19, 2011. )

 

GARDASIL : TRIALS AND SAFETY CONCERNS:

 

In the 7 clinical trials in which 18,083 individuals were administered Gardasil, 5 were compared to a group receiving an aluminium containing injection (control group), 1 was compared to a saline containing placebo, and 1 was uncontrolled.

Common injection site adverse reactions occurred more frequently in the Gardasil group, than the control groups.

These clinical trials did not use a true placebo to study vaccine safety, but compared Gardasil against a bio-active aluminium containing placebo, reducing the distinctive differences between the study group and the control group.

Both the control group and the vaccine study groups used products that contained aluminium as an adjuvant, so the differences between the 2 groups was not significant.

This method makes the vaccine appear to be safer than what it is, a warning issued by the AAP in their Judicial Report, Aug 25, 2008. It is therefore not a valid study !

In these trials common systemic adverse reactions occurred more frequently in the 5088 persons receiving Gardasil vaccine, compared to the 3790 using  either the aluminium or saline containing control.

The most common of these reported effects were headache (12.3% vs 11.2%), and fever (8.3%vs 6.5%).

Across the clinical studies 258 out of 29,323 reported a severe adverse reaction, but the researchers  claimed that only 0.04% of these were vaccine related.

The study investigators reported 40 deaths in the entire study population, 21 being in the Gardasil group (0.1%), and 19 in the  control groups (0.1%).

These reported adverse events and deaths were considered by the researchers to be “consistent with events expected in healthy adolescent and adult populations”.

The number of Systemic Autoimmune adverse disorders detected in the clinical trials were 245 (2.3%) for Gardasil, and 218 (2.3%) for placebo controlled groups, for females aged 9 to 45 years and males aged 9 to 26 years.

(These figures were reported by the trial researchers and have been called into question by researchers at the University of British Columbia in Canada. ) (9)

 

POST MARKETING EXPERIENCE:

 

Adverse events following Gardasil injections were reported during the post approval period of use, and included blood disorders, respiratory tract disorders, rashes, gastrointestinal disorders, musculo-skeletal disorders, neurological disorders, infections and vascular disorders.

Because these reactions were reported voluntarily it is not known how many reactions were not reported, since it is estimated that only 10% of adverse reactions are generally reported voluntarily.

The true figure is likely to be greater than that reported.

 

SELECTIVE REPORTING BY RESEARCHERS ?

In 2012 Researchers at the University of British Columbia in Canada, conducted a systematic review of HPV vaccine pre and post-licensure trials to assess the evidence of their effectiveness and safety.

They reported, “We found that HPV vaccine clinical trials design, and data interpretation of both efficacy and safety outcomes, were largely inadequate”

They also noted “evidence of selective reporting of results from clinical trials (ie., exclusion of vaccine efficacy figures related to study subgroups in which efficacy might be lower or even negative from peer-reviewed publications)”

The BC Researchers also checked the claims by vaccine manufacturers that Gardasil will reduce cervical cancers by up to 70 %. They wrote,

“the claim that HPV vaccination  will result in approximately 70% reduction of cervical cancers is made despite the fact that the clinical trials data have not demonstrated to date that the vaccines have actually prevented a single case of cervical cancer (let alone cervical cancer death), nor that the current overly optimistic surrogate marker-based extrapolations are justified.”

The Researchers also examined the basis for claims of safety for the HPV vaccines and found theses wanting.

‘The notion that HPV vaccines have an impressive safety profile is only supported by highly flawed design of safety trials and is contrary to accumulating evidence from vaccine safety surveillance databases and case reports which continue to link HPV vaccination to serious adverse outcomes (including death and permanent disabilities)”

The Researchers concluded that cervical screening (PAP smears) were a safer and more reliant method for detection and prevention of cervical cancer.

They wrote, “ further reduction of cervical cancers might be best achieved by optimizing cervical screening (which carries no such risks) and targets other factors of the disease rather than by the reliance on vaccines with questionable efficacy and safety profiles” (9)

 

 

JUDICIAL WATCH REPORTS :

 

Documents obtained from the Food and Drug Administration (FDA) by Judicial Watch, under the Freedom of Information Act, reveal the details of 26 young females who died shortly after receiving the Gardasil vaccine between 1 September 2010 and 15 September 2011.

The VAERS Line List Report (22 September 2011) details the circumstances of several young females who attended Emergency Rooms in the USA, or were admitted to hospital, with conditions diagnosed as “life threatening “ or “serious”.

As of August 2014, 170 deaths following administration of the HPV vaccine have been reported to VAERS.

 

SERIOUS ADVERSE EVENTS:

 

The heart-breaking testimonies of young women who were seriously afflicted following vaccination with Gardasil should prompt serious concerns about the continued support and claims of safety for the vaccine.

Naomi Snell is a 28 year old woman who is leading a class action civil claim against Merck, following 2 strokes and partial paralysis, after having received the Gardasil vaccine.

Jenny Tetlock is a 13 year old female who suffered a degenerative muscle disease and crippling paralysis following Gardasil vaccination.

More recently, 12 year old Meredith Probaska, from  Waukesha, died a few hours after receiving the HPV vaccine.

While these devastating adverse effects may be rare, as stated by Dr. Geoffrey Swait of the Milwaukee Health Department, they are real to the families who have lost their daughters to a potentially lethal vaccine.

Officials at the Center for Disease Control (CDC) in the USA attribute reports of seizures, paralysis, brain disorders, rheumatoid arthritis, lupus, heart attacks, blood clotting, strokes and death in young girls and women as just “a coincidence”.

Taking a more responsible view was a Danish TV programme recently (26 March, 2015) highlighting the sudden onset of serious and disabling effects suffered by 3 young females following their vaccinations with Gardasil vaccine.

A Swedish study (10) concluded that no evidence supported the association between exposure to HPV vaccine and auto-immune, neurological or venous thromboembolic adverse events, (11), while in Scotland, Health Advisors in 2009, adopted a precautionary view, and decided to review the vaccine programme because of inadequate evidence of efficacy.

In the UK, the Sunday Express (31/05/2009) reported that more than 1300 British girls had reported adverse reactions to Cervarix, a HPV vaccine, ranging from paralysis to convulsions and sight problems.

Rebecca Ramage, a 13 year old teenager from Surry was paralysed soon after receiving the HPV vaccine.

In Germany, authorities questioned the many claims of a 70% risk reduction for cervical cancer by the HPV vaccine, and stated that it was unethical to use an untested vaccine on girls in the age group of 12 to 13 years.

Similar cases of vaccine injury have been reported in the Netherlands, where authorities have criticized claims of vaccine effectiveness as “misleading information”.

Dr Diane Harper, a HPV researcher, and who was involved in the HPV trials, stated that because of the faulty trial design, the claims of safety are invalid.

 

Dr Bernard Dalbergue, a former pharmaceutical industry physician with the company that manufactures Gardasil, is reported to have stated that the vaccine is “dangerous and useless”, and that “approval of the GARDASIL vaccine was not  based on valid studies, but on financial profit, a fact that was well recognized at the time of its approval”.

The Japanese Government withdrew support for the HPV vaccine schedule following reports of serious post vaccine adverse effects by young women, such as long-term pain, numbness, paralysis and infertility”.

 

REPORTS FROM IRELAND:

 

A TV3 Documentary aired on Irish Television (14/12/15) featured 4 Irish families who related stories of crippling harm suffered by their daughters following vaccination with Gardasil vaccine.

Laura Smyth, Kelly Power, Abbey Colohan, and Carol-Ann Fitzpatrick, each in turn, related the crippling effects they were suffering following vaccination with Gardasil.

Dr. Kevin Connelly, of the National Immunization Advisory Committee, refused to accept that these reported adverse effects were linked to the Gardasil vaccine, stating repeatedly that these events were “coincidental”, and also occurred in unvaccinated girls.

The parents of these unfortunate adolescent females had recorded their experiences on a support website called REGRET. (Reactions and Effects of Gardasil Resulting in Extreme Trauma).

On 6 October 2015 parents representing the Irish Support Group, REGRET, had met with a group of 15 TDs and Senators at the Irish Parliament for the purpose of detailing the serious adverse effects suffered by a large group of Irish adolescent females who had received the HPV vaccine.

Problems listed by these concerned parents were : Recurring seizures or fainting, various autoimmune effects, chronic fatigue, persistent severe headaches, blurred vision, chronic joint pain, muscle pain, memory impairment, poor concentration and menstrual problems.

Added concerns expressed by these parents was the withholding of vital pre-vaccination information, contained in the vaccine package inserts ( Patient Information Leaflet – PIL), from parents and children, which clearly conceded the potential for vaccine harm.

Packaged warnings from the vaccine manufacturer reports state that 1/40 (2.5%) of trial participants reported a “serious adverse event” after receiving the vaccine, and 1/30 (3.3%)  reported a new auto-immune condition.

The authors of an article in the Annals of Medicine state “medical ethics demand that vaccination should be carried out with the participant’s full and informed consent. This necessitates an objective disclosure of the known or foreseeable vaccination benefits and risks. The way in which HPV vaccines are often promoted to women indicates that such disclosure is not always given from the basis of the best available knowledge. For example, while the world’s leading medical authorities state HPV vaccines are an important cervical cancer prevention tool, clinical trials show no evidence that HPV vaccination can protect against cervical cancer” (12)

REGRET  have drawn attention to the fact that since the current rate of cervical cancer incidence in Ireland is only 13/100,000 (0.013%) the reported benefits of this vaccine do not outweigh the risks.

Responses from spokespersons for the HSE were a complete denial of any connection between the vaccine and these adverse events , describing them as “coincidental “.

Neither was there any demonstration of support by these health spokespersons for the policy of full and informed consent as a prerequisite for HPV vaccination.

 

In a Joint Committee on Health and Childcare, convened in Ireland on 3 December, 2015, Dr. Colette Bonner, Chief Medical Officer in the Department of Health, dismissed the claims by parents of the injured girls that Gardasil vaccination was causal and “advised the girls to receive medical advice from their doctors and be guided by this advice”, adding that Gardasil was “an important cancer preventing vaccine”.

While the official HSE policy statement endorses claims of vaccine safety and efficacy, uncertainty reigns amongst many parents, and public concerns about safety and efficacy appear to be increasing.

A 2011 Report concludes that “the HPV vaccines appear safe and effective. Additional clinical research on the vaccines on women outside the currently approved age ranges and in males is necessary. Studies on longer-term outcomes, including cervical cancer and the emergence of new viral genotypes are also necessary”.(13)

A later clinical report, in 2013, however, states that “the widespread optimism regarding HPV vaccine’s long-term benefits appears to rest on a number of unproven assumptions at odd with factual evidence” and that “the claim that HPV vaccination will result in approximately 70% reduction of cervical cancers is made despite the fact that the clinical trials data have not demonstrated to date that the vaccines have actually prevented a single case of cervical cancer, let alone cervical cancer death”. (14)

Reports of adverse events following HPV vaccination are currently under review by the European Medicines Agency (EMA), which according to their press releases, is seeking to further clarify aspects of their safety profile. (Vaccine impact.com)

The Press Release by the EMA on 13 July reveals a strong bias in favour of HPV vaccine safety, and ignores the many reports of vaccine harm being reported.

Having focused on 2 rare conditions which have been linked to the HPV vaccine, namely CRPS (Complex Regional Pain Syndrome) and POTS (Postural Orthostatic Tachycardia Syndrome), the EMA reported in a Press Release on 5 November 2015, that its Pharmacovigilance Risk Assessment Committee (PRAC) “does not support that CRPS and POTS are caused by the HPV vaccine” and that the “benefits of HPV vaccine continue to outweigh the risks”.

These conclusions have been challenged in a report by Norma Erickson, charging that the more commonly reported crippling effects of the vaccine have been ignored by the EMA.  (15)

 

ADDED RISKS TO HEALTH:

While these and many similar reports of vaccine damage have been circulated through the world press, there appear to more sinister ways in which the HPV vaccine can impair health.

 

At its 2015 Annual Meeting, the American Association for Cancer Research reported findings from an analysis of 600 females, between the ages of 20 and 26 years, who had received the original 4 strain Gardasil vaccine.

Their findings were an increased risk of developing an infection from non-vaccine strains of HPV by recipients of the 4 strain HPV vaccine.

The unvaccinated females had a lower rate of infection from HPV than those who had been vaccinated.

In other words, the vaccinated females who were given the 4 strain HPV vaccine were at greater risk of acquiring one of the other HPV strains not covered by the vaccine.

It appears that the immunity against non-vaccine strains had been compromised by administration of the HPV vaccine, rendering the vaccinated females more susceptible to infection from some of the more than 100 other strains of HPV.

The response of these researchers was to administer a further dose of 9 strain HPV vaccine ! (Did the researchers fail to understand their own findings ?)

It is obvious that such a strategy would not improve immunity, and would more likely compromise immunity!

An earlier study in 2012 revealed the same phenomenon of increased risk of infection following administration of the HPV vaccine.

In this study the HPV vaccine only marginally (0.6%) reduced the incidence of HPV type 16, in vaccinated females compared to unvaccinated females.

Type 16 is an oncogenic strain that may have a 10% to 20% risk of advancing to cervical cancer. But the vaccine only reduced this risk by 0.6 %.

Of greater concern is the finding that the vaccinated females had a greater risk of developing an infection from another HPV strain than those who were not vaccinated.

The difference was 6.25% increased risk for the vaccinated females, compared to a 2.6% increased risk for unvaccinated females.

These findings again suggest that protection against a large number of HPV types is reduced by the administration of the HPV vaccine.

It appears likely, therefore, that HPV vaccine reduces immunity and increases risk against many unidentified strains of HPV.

 

IMPLICATIONS FOR PRIOR INFECTIONS

 

:

These examples of reduced immunity are supported by findings that are documented in the CDC Infection Fact Sheet. (16)

 

Any recipient of the HPV vaccine who has previously been exposed to HPV strains 16 or 18, may increase their risk for developing a precancerous cervical lesion by as much as 44.6% following administration of the HPV vaccine.

It is possible for persons seeking the HPV vaccine to have had a prior infection with the HPV. Administration of the vaccine in these cases may increase the risk of a further infection by another HPV.

A prior infection in a person not receiving the HPV vaccine is likely to be at less risk of infection, with the likelihood of the HPV infection resolving spontaneously.

 

INFERTILITY CONCERNS:

 

Infertility concerns, following HPV vaccination, have been reported in the USA, UK and Japan. The vaccine solvent Tween 80 (Polysorbate 80) present in Gardasil, and other vaccines, has been shown in rat studies to damage ovaries and cause infertility.

Gardasil also contains L-histadine which may increase clot formation 5-fold when combined with surfactants, such as Polysorbate 80, also present in Gardasil. (17)

 

 

 

THE IMPORTANCE OF PAP SMEARS:

 

From the available evidence it is clear that PAP smears are a safe and effective form of detection and prevention of cervical cancer, without the risk of compromised immunity or direct adverse events arising from the HPV vaccines.

Cervical cancer rates throughout the world have dropped where PAP smears are routinely undertaken.

The widespread availability and promotion by Health Authorities of the HPV vaccines may lull parents and adolescents into adopting a false sense of security, assuming that  “getting the shot” will provide protection against cervical cancer.

The published claims of cervical cancer protection by the vaccine manufacturer are not supported by the data and are false.

Risks for HPV infection and transmission can be markedly reduced by choosing abstinence from sexual activity in adolescence, or by the use of condoms.

Being vaccinated with the Gardasil HPV vaccine does not guarantee protection against a HPV infection or cervical cancer, or death from cancer, in the present or in the future, and claims to the contrary are misleading and false.

Dr Neville Wilson.

30 November, 2015.

 

REFERENCES:

 

1. NEJM 2002; 347(21): 1645-1651
2. NEJM 2003; 348: 518-527
3. www.physiciansforlife.org/content/view/2372/2/
4. Natl Cancer Inst Manager 2003; 31:20-8
5. Editorial: NEJM 2008;(359:861-862)
6. JAMA 2007; 298(7):743-753
7. www.physiciansforlife.org/content/view/2372/2/
8. Press Release March 12 2013, Market watch.com March 20,2013. Journal Watch Press Release.
9. Current Pharmaceutical Design 2012, Sept 24 (Epub ahead of print )
10. BMJ 2013, Oct 9: 347:15906
    1. Vaccine 2011, Oct 26:29(46)
    2. Annals of Medicine 2013 Mar; 45(2): 182-83
    3. J Clinic Pharm Ther 2011 Feb; 36(1) :1-9
    4. Curr Pharm Design 2013; 19(8): 1466-87
    5. Report by Norma Erickson at SaneVax.org
    6. CDC. Gov Genital HPV Infection Fact Sheet Feb 23, 2015
    7. www.physiciansforlife.org/content/view/2372/2/

 

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