If HPV vaccines were consumer goods would they still be on the market?

by Stephen Tunley

The latest statistics from the USA’s Vaccine Adverse Events Reporting System (VAERS) statistics concerning the serious side effects and deaths associated with HPV vaccines such as Gardasil make for chilling reading.

In summary a single investigation of the VAERS database, widely accepted as being 10-100 times under reported about, shows the following:

1. 148 deaths recorded after HPV vaccinations,
2. Over 3,000 hospitalizations and
3. More than 6,000 who did not recover from the new medical conditions experienced after HPV vaccines.

The picture is not pretty and were you to add a zero or two to these numbers to account for under-reporting, the picture is frightening indeed. It’s important to note that the statistics are for events occurring primarily in the USA; not taking into account other countries, which have faced very similar health issues.

In the case of Gardasil for some reason the same safety issues that govern say; automobiles, baby equipment, tires, peanut butter and more do not apply. Vaccines appear to be subject to very different standards, standards where it is quite acceptable to have deaths, life threatening and life changing illness associated with your product. Standards where reports made to anyone from the manufacturer, to the regulator(s), to the so-called experts result in scant investigations by those who have worryingly close ties to the industry which they are supposed to be investigating.

To put this in perspective, imagine if Gardasil were a car associated with the same level of deaths (to date over 148) and tens of thousands of serious adverse events; would the car still be on the road? I do not think so.

Consider Toyota in January 21, 2010 recalled 4.1 million vehicles sold in the U.S. and Europe to fix faulty accelerator (gas) pedals which had a tendency to get stuck, causing unintended acceleration. In November the previous year 5.3 million cars were recalled as they believed that ill-fitting floor mats-had a tendency to trap pedals. In total, Toyota has recalled more than 9 million cars worldwide for pedal-related flaws. That’s nearly the same as the total number of all vehicles sold in the U.S. in 2009. The House Oversight and Government Reform Committee announced plans to investigate whether the Japanese-based automaker had needlessly put the public at risk.

What committee is reviewing the considerable health issues that surround HPV vaccines? To date, the answer is none.

If Gardasil were a baby sling, it would have been pulled from the market after just 3 deaths as was the case with the Infantino baby sling – one million were recalled in March, 2010.

More than 400,000 drop-side cribs made by Simplicity in the USA were recalled in July 2009 after an 8-month-old child in Houston suffocated.

Yet many tens of thousands of serious adverse reactions and over 148 deaths temporally associated with Gardasil do not appear to issue a single raised eyebrow amongst those charged with overseeing safety, by this I mean in the USA the FDA, in Europe the EMA, and the TGA in Australia!

In 1982 Tylenol recalled 31 million bottles of the product after 7 Deaths. I resisted putting ‘just’ before 7 but it sure puts the issues to do with Gardasil into perspective!

So why is Gardasil treated differently? The fact is it should not be. It’s a product just like Tylenol or Toyota. Consumers pay for it (directly or via tax imposts) and it should be governed by the same rules as any other product i.e. it should be a product fit for use and if it’s not then it should be recalled immediately.

I cannot imagine any person of sound mind going ahead and purchasing a baby sling from Infantino if they knew it had caused, or could cause, a single death, yet they will merrily march their daughters, and now sons, to the local medical center and have them vaccinated with a vaccine that has demonstrated considerable and very serious health issues associated with it?

But it gets worse. Gardasil has not only far too many deaths and serious health issues associated with it, there is no proof that it works!

Lack of proven efficacy:

• HPV vaccines have not been proven to prevent even one case of cervical cancer.
• HPV infections are only one of several risk factors contributing to the development of cervical cancer.
• When detected, HPV infections are easily managed and rarely proceed to cervical cancer.
• At least 50% of sexually active men and women are exposed to HPV at some point in their lives.
• 90% of these infections clear on their own within two years without incident.
• Those exposed to vaccine relevant HPV types may experience an increased risk of precancerous lesions if vaccinated.
• HPV vaccines would have to be effective for at least 15 years to prove effective at preventing cervical cancer.
• Yet, HPV vaccine efficacy begins to wane at 5 years!
• Symptoms experienced after HPV vaccinations are lasting longer than 5 years in some girls.
• Pap screening has already been proven to be a safe and effective means of controlling cervical cancer. It’s also very inexpensive and causes no significant health issues. No one has died from a PAP smear.
• 11% of the population has been exposed to HPV regardless of sexual status according to Dr Diane Harper a researcher who was involved in the safety and efficacy trials for the Human Papillomavirus (HPV) vaccine – Gardasil, in a paper published in the Journal of Vaccines & Vaccination that “We do not know how long the vaccine will last, the HPV types covered by the vaccine are limited, and the very safe alternative of PAP screening with early detection and treatment is a proven successful program. Gardasil is not likely to extend a woman’s life in countries with cytology (PAP) screening…”

Potential Safety Issues:

• In the September 2008 FDA closing statement on Gardasil it was noted that 73.3% of girls in the clinical trials developed “new medical conditions” post vaccination. 17 girls died on the clinical trials. (No inert placebo was used during the vast majority of clinical trials, which means the vaccines were proven no more dangerous than the active ingredients in the control solution.)
• Recombinant HPV DNA L1 gene DNA fragments possibly attached to the aluminum adjuvant, were discovered in 100% of samples tested Gardasil in 2011. To date there has been no serious investigation as to potential health impacts. The FDA simply declared the ‘expected’ presence of residual DNA is not a safety factor. No documentation was provided in support of this. The fact HPV vaccines were approved by Governments worldwide based on manufacturers’ assertions that the vaccines contained ‘no viral DNA’ was ignored completely [5] , [6] The possibility of recombinant HPV DNA fragments being attached to aluminum adjuvant particles was also ignored.
• One of the antigens used in Gardasil was discovered in the 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 discovered in postmortem blood and spleen samples of a girl who died 6 months Gardasil Effective injections. [8] , [9] 
• 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. 

Note – the above was taken from this article – http://sanevax.org/hpv-vaccines-betrayal-of-the-public-trust/

In recent years there has-been a tremendous and as yet uninvestigated rise in Chlamydia, which is a sexually transmitted infection (STI) that can affect women and men, following the introduction of HPV vaccines. If left untreated, chlamydia can causes pelvic inflammatory disease (PID) in women, all of which can lead to chronic pain and infertility. Chlamydia may have no symptoms, but can easily be treated with antibiotics. (See the charts below for information from the United States following the introduction of HPV vaccines in late 2006, early 2007.)

Now for the good news, the manufacturer of Gardasil, Merck have sold hundreds of millions of vials of Gardasil resulting in billions of dollars of revenue from the product worldwide and now are working on a vaccine for…. Yep – you guessed it – Chlamydia!

So the company that is plausibly linked to a product that has (for some reason as yet unknown) has led to a rise in pretty serious STD, will at some stage launch a vaccine to fight it. Now that’s an integrated marketing strategy if ever I saw one.

But wait there’s more … sadly a lot more.

In the USA the regulator that oversees products like Gardasil – the FDA -is largely funded by virtue of the fees it charges Pharma and others to approve the product it regulates. This is the same position in Australia, where the TGA is along similar lines Funded.

In the USA the senior agency to the FDA is the NIH All which is in fact a share holder in the patent behind Gardasil and benefits from its success via the receipt of increasing patent income.

One more thing and it’s a big one. If your baby or automobile product is defective and proved it led to a single death, the manufacturer can be taken to court, sued and if the case proven, liable for considerable damages.

This is not the case with vaccines where the ability to sue the manufacturer was removed by the creation of the Vaccine Injury Compensation Program in 1988. This leaves those damaged by vaccines to apply for compensation under VICP, which is funded by a tax on each vaccine administered.

Now, the powers that be add insult to injury. If the injury experienced after a vaccine is not listed on the very limited table of injuries and occur within the time frame listed, it is up to the consumer to find experts who can prove their injury was caused or exacerbated by the vaccine. When it comes to HPV vaccines, the consumer is on their own because there are NO injuries listed on the VICP injury table – these vaccines are too new to have established a track record for damages.

Contrast this to a normal court case where it would be up to the manufacturer to prove their product did NOT cause the damage.

Sadly, the same is true in many other countries where the ability to sue a vaccine manufacturer is limited, or has been removed by statute.

HOWEVER, there is one country where government health officials appear to actually be concerned about what happens to their citizens after vaccinations. Interestingly, Japan has recently stopped recommending the continued use of HPV vaccines until a safety investigation has been completed.

So there you have it. One set of rules for vaccine manufacturers and a completely different set of rules for everyone else.

It’s time for this farce to stop. There is absolutely no basis that supports Gardasil is a product fit for use. It does not do what it purports to do, damages far too many that receive it, leads to some pretty horrible health effects and consequences . Yet the manufacturer stands above being sued by virtue of legislation.

This product must be recalled and recalled now. A truly independent review of what happened and why needs to be conducted with the ability to amend / repeal legislation, overhaul the regulators, and ensure the disclosure of conflicts that exist between the manufacturer so called independent experts and the regulators.

In the meantime, as a parent wake up, do the research before you vaccinate – or your child could be one more ignored VAERS statistic – is that the future you want for them?

Stephen Tunley is the director of SaneVax, Inc. where this first appeared. 

image source