How Effective and Safe is Gardasil?

Many of our supporters have expressed concern about the moral dimensions of Gardasil promotion as well as health and safety concerns. The links below are provided for your information and consideration. HLI Ireland does not necessarily endorse all the views expressed in all the links below.

HLI Ireland's press release affirming the moral dimensions and Bishop Cullinan's statement

New Evidence Demolishes Claims of Safety and Effectiveness of HPV Vaccine

HPV Vaccine Can Make You Susceptible to More Serious Strains of HPV

Articles taken from Mercola.com

 

 

New Evidence Demolishes Claims of Safety and Effectiveness of HPV Vaccine

Story at-a-glance

  • A systematic review of pre- and post-licensure trials of the HPV vaccine shows that its effectiveness is not only overstated (through the use of selective reporting or “cherry picking” data) but also completely unproven
  • As of mid-August 2012, VAERS has received 119 reports of death following HPV vaccination. Reported adverse events also include: 894 reports of disability and 517 life-threatening adverse events
  • Adverse events reports of cervical abnormalities and cervical cancer are occurring four to five years after HPV vaccination, and have rapidly increased between 2011 and 2012
  • A large-scale HPV study reported HPV vaccine reduced HPV-16 infections by a mere 0.6% in vaccinated versus unvaccinated women
  • High-risk HPV infections were diagnosed in vaccinated women up to more than 6% more frequently than in unvaccinated women, and the increased rate of infections by carcinogenic HPV types in vaccinated women has been found to be 4-10 times higher than the reduction of HPV 16/18 infections

By Dr. Mercola

There are currently two HPV vaccines on the market, but if there was any regard for sound scientific evidence, neither would be promoted as heavily as they are.

 

The first, Gardasil, was licensed by the US Food and Drug Administration (FDA) in 2006. It is now recommended as a routine vaccination for girls and women between the ages of 9-26 in the US. On October 25, 2011, the CDC's Advisory Committee on Immunization Practices also voted to recommend giving the HPV vaccine to males between the ages of 11 and 21. The second HPV vaccine, Cervarix, was licensed in 2009.

 

Were it to be discovered that the HPV vaccine, in fact, does not effectively prevent cancer, then young women (and now boys) are being exposed to clearly unacceptable health risks. And that's precisely what a recent study has concluded...

Review of HPV Trials Conclude Effectiveness is Still Completely Unproven

Published online on September 24,1 a systematic review of pre- and post-licensure trials of the HPV vaccine by a Canadian team shows that its effectiveness is not only overstated (through the use of selective reporting or "cherry picking" data) but also completely unproven.

 

The summary states it quite clearly:

"We carried out a systematic review of HPV vaccine pre- and post-licensure trials to assess the evidence of their effectiveness and safety. We find that HPV vaccine clinical trials design, and data interpretation of both efficacy and safety outcomes, were largely inadequate. Additionally, we note evidence of selective reporting of results from clinical trials (i.e., exclusion of vaccine efficacy figures related to study subgroups in which efficacy might be lower or even negative from peer-reviewed publications).

 

Given this, the widespread optimism regarding HPV vaccines long-term benefits appears to rest on a number of unproven assumptions (or such which are at odd with factual evidence) and significant misinterpretation of available data.

 

For example, 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.

 

Likewise, 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).

 

We thus conclude that further reduction of cervical cancers might be best achieved by optimizing cervical screening (which carries no such risks) and targeting other factors of the disease rather than by the reliance on vaccines with questionable efficacy and safety profiles." [Emphasis mine]

It is truly mindboggling, and a true testament to the conflicts of interest manipulating public health guidelines, that the HPV vaccine has received such robust backing by health officials and legislators alike.

 

Back in 2007, just a year after Gardasil's introduction to the market, Texas Governor Rick Perry went so far as signing an executive order mandating sixth-grade girls to be vaccinated against HPV. Not surprisingly, Perry's former chief of staff was then a Merck lobbyist. Fortunately, the Legislature subsequently overturned his order.

 

It's important to realize that the HPV vaccine only protects against a small select set of HPV viruses that can lead to cell abnormalities that in some instances can cause cervical cancer, if the abnormalities are not identified and treated. So in reality, it's a misnomer to call it an anti-cancer vaccine. And it's massively misleading, if not a deliberate deception, to claim it "will" save lives.

 

Today, six years after licensure, we STILL have absolutely no proof, not a shred of actual evidence, indicating that Gardasil actually prevents cancer in the long-term and/or reduces cervical cancer mortality. What we have instead, is tens of thousands of adverse event reports and 122 deaths, as of mid-August.

Media Reports on Merck Study, But Ignores Canadian Review

What makes this issue so infuriating is the complete lack of transparency about the potential risks of the vaccine. Just days after the online release of the featured Canadian review, which obliterates claims of both safety and effectiveness, the Wall Street Journal2 reported that:

 

"A new study of Merck and Co's Gardasil cervical-cancer vaccine showed it was associated with fainting on the day of inoculation and skin infections two weeks afterward, but no link with more serious health problems was found. ...The Gardasil study – led by the Kaiser Permanente Vaccine Study Center in Oakland, California – was required by the U.S. Food and Drug Administration and the European Medicines Agency to provide an additional look at the vaccine's safety in a large group of people. It was funded by Merck.

 

...More than 200 categories of illnesses such as asthma, diabetes, nervous-system disorders and medical conditions such as attention deficit disorder, back pain and other injuries were reviewed. In most cases the condition existed before the vaccine was given. There were 14 deaths recorded among girls and women in the study but the causes, including car accidents, congenital heart problems, suicide, lupus and pneumonia, weren't linked to the vaccine..."

 

There's not a single mention of the Canadian review. Likewise, WebMD's HPV page,3 which was reviewed by Kimball Johnson, MD on August 13, 2012, plainly states:

 

"No serious HPV vaccine side effects have been found, although fainting spells following injection have been reported in teens and young adults. Sometimes soreness occurs at the injection site."

 

This kind of blatant hiding of potential adverse effects leaves me speechless... Where is the journalistic integrity and accountability? WebMD is the second most visited health web site on the entire web (Mercola.com is fourth), so to say they have an influence over the health choices made by the average US citizen would be an understatement. The general belief is that it's a first-rate, trustworthy source of "independent and objective" information about health, but as I reported two years ago, the site is in fact heavily influenced by the pharmaceutical industry.

The HPV Vaccine Risks You're Not Being Told About

As of August 13, 2012, VAERS has received 119 reports of death following HPV vaccination,4 as well as:

  • 894 reports of disability
  • 517 life-threatening adverse events
  • 9,889 emergency room visits
  • 2,781 hospitalizations

And WebMD had the gall to misinform the public by stating that there have been NO serious side effects associated with HPV vaccination! What parent would not consider even the remote potential for permanent disability and/or death worthy of at least a brief mention?

 

Recent data pulled by VAERS research analyst Janny Stokvis5 also show a dramatic and recent increase in abnormal pap smears, cervical dysplasia, and cervical cancer following HPV vaccination.

 

Bear in mind that cervical cancer typically does not strike until your late 40's. According to 2005 -2009 data by the National Cancer Institute,6 the median age at diagnosis for cervical cancer in the US is 48. Only .2 percent of those diagnosed with cervical cancer were under the age 20, so it's quite rare in this age group. It is estimated that 12,170 American women will be diagnosed with cervical cancer in 2012.7 Because we're dealing with relatively low numbers to begin with, it makes the rapid increases detailed below all the more worrisome – especially when you consider that the vaccine is supposed to REDUCE cancer incidence.

 

The following data is for girls ages 14 to 26.8 According to Stokvis, some of the reports of cervical abnormalities are occurring four to five years after HPV vaccination, so we're just now starting to see some of the longer-term ramifications, since the vaccine has only been on the market for six years.

Read full article [here ...]

 

HPV Vaccine Can Make You Susceptible to More Serious Strains of HPV

Story at-a-glance

  • Sixty percent of women who received the Gardasil vaccine had a higher risk of being infected with another strain (type) of human papillomavirus (HPV)
  • Unvaccinated women had lower rates of the non-vaccine high-risk strains of HPV
  • Most HPV infections do not lead to cancer and, instead, clear up on their own within two years

By Dr. Mercola

The US Centers for Disease Control and Prevention (CDC) recommends that all 11- and 12-year olds (both girls and boys) receive the human papillomavirus (HPV) vaccine.

 

Touted as "anti-cancer" vaccines even though they've not been proven to prevent cancer, Gardasil and Cervarix have been embroiled in controversy from the start.

 

At issue, initially, was that Gardasil had been fast tracked to licensure in the US in 2006 without adequate scientific evidence that it had been proven safe and effective for girls under age 16 and that it was not appropriate for government to recommend and mandate the vaccination of school children against a sexually transmitted disease (STD) that could not be transmitted in an education setting.1,2 Then came California bill AB499, which permits minor children as young as 12 years old to be vaccinated with HPV and other STD vaccines without parental knowledge or parental consent.

 

As more children and teens have received HPV vaccines, adverse reaction reports have been pouring in to the Vaccine Adverse Events Reporting System (VAERS). Meanwhile, the HPV vaccine's effectiveness has continued to be questioned as well.

Now, research presented at the 2015 annual meeting of the American Association for Cancer Research showed that women who were vaccinated against HPV had a higher risk of developing non-vaccine strains of the virus.3

Women Vaccinated for HPV May Be at Higher Risk of HPV Infection

In an analysis of nearly 600 women between the ages of 20 and 26, 60 percent of those who had received the original Gardasil vaccine, which protects against only four strains (types) of HPV (6,11,16,18), had a higher risk of being infected with another non-vaccine HPV virus strain.

 

The unvaccinated women had lower rates of the non-vaccine high-risk strains of HPV, which suggests getting vaccinated may make you more susceptible to being infected with other strains of HPV.

 

The researchers' solution to the problem was to suggest women who already have gotten three doses of the original four-strain Gardasil vaccine now get another shot of a new Gardasil vaccine, which contains nine different HPV strains.

 

In December 2014, the US Food and Drug Administration (FDA) approved Gardasil 9 that includes five additional HPV types (31, 33, 45, 52, 58) not found in the original vaccine. So if you have already received one or more doses of the original Gardasil vaccine, you may actually be at a higher risk of being infected with the five additional HPV types than if you had never been vaccinated at all.

 

And if you're already infected with one of the four to nine types of HPV viruses in either the original or new Gardasil vaccines, getting vaccinated will not eliminate the infection. Not to mention, there are more than 100 different strains of HPV, 30 of which are sexually transmitted, and about 15 of them have been associated with development of cancer but only IF HPV infection persists over a long period of time and regular pap screen tests are not conducted to identify and treat pre-cancerous cervical lesions.

 

Gardasil's Effectiveness Seriously Questioned

In 2012, a systematic review of pre- and post-licensure trials of the HPV vaccine by researchers at the University of British Columbia showed that the vaccine's effectiveness is not only overstated (through the use of selective reporting or "cherry picking" data) but also unproven. In the summary of the clinical trial review, the authors stated quite clearly:4

 

"We carried out a systematic review of HPV vaccine pre- and post-licensure trials to assess the evidence of their effectiveness and safety. We found that HPV vaccine clinical trials design, and data interpretation of both efficacy and safety outcomes, were largely inadequate.

 

Additionally, we note evidence of selective reporting of results from clinical trials (i.e., exclusion of vaccine efficacy figures related to study subgroups in which efficacy might be lower or even negative from peer-reviewed publications).

 

Given this, the widespread optimism regarding HPV vaccines long-term benefits appears to rest on a number of unproven assumptions (or such which are at odds with factual evidence) and significant misinterpretation of available data.

 

For example, 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.

 

Likewise, 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).

 

We, thus, conclude that further reduction of cervical cancers might be best achieved by optimizing cervical screening (which carries no such risks) and targeting other factors of the disease rather than by the reliance on vaccines with questionable efficacy and safety profiles." [Emphasis mine]

 

Gardasil Might Increase the Risk of Precancerous Lesions?!

In 2012, research also revealed that the HPV vaccine reduced HPV type-16 infections by only 0.6% in vaccinated women vs. unvaccinated women – and, similar to the featured study, data showed other high-risk HPV infections were diagnosed in vaccinated women 2.6% to 6.2% more frequently than in unvaccinated women.5

 

There are also suspicions that Gardasil HPV vaccine might actually paradoxically increase your risk of cervical cancer if you are actively infected at the time of vaccination This pre-licensure information came straight from Merck and was presented to the FDA prior to approval.6

 

According to Merck's own research, if you have been exposed to HPV-16 or -18 before you get a Gardasil shot, you may increase your risk of developing precancerous lesions, or worse, by 44.6 percent!

 

Health officials report that about 79 million Americans are actively infected with the sexually transmitted HPV virus, and 14 million are newly infected each year. The CDC even states, "HPV is so common that nearly all sexually active men and women get it at some point in their lives."7

 

At face value, this sounds far more frightening than it actually is because most HPV infections do not lead to cancer and, instead, clear from the body naturally within two years with no complications.

 

There's usually no treatment necessary and often no adverse health effects felt whatsoever in 90 percent of HPV infection cases! Likewise, cervical cancer accounts for less than one percent of all cancer deaths in the US, while anal cancer is associated with approximately 300 deaths a year. So, this vaccine is not addressing a major public health threat, no matter which way you look at it.

 

The Risks of HPV Vaccine Are Significant

By mid-March 2015, the HPV vaccine Gardasil had generated more than 35,000 adverse reaction reports to the US government, including more than 200 deaths.8

 

This is probably a gross underestimate, because, although a federal law was passed in 1986 (the National Childhood Vaccine Injury Act) mandating that doctors and other vaccine providers report serious health problems or deaths that occur after vaccination to VAERS, there are no legal penalties for vaccine providers not reporting and it is estimated that perhaps less than 10 percent of the vaccine adverse events that do occur are reported to VAERS.9

 

Health problems associated with the Gardasil vaccine include immune-mediated inflammatory neurodegenerative disorders, suggesting that something is causing the immune system to overreact in a detrimental way—sometimes fatally. A growing body of medical literature demonstrates that the HPV vaccine is linked to nervous and immune system disorders in some young women and girls.

 

In one case study published in the Journal of Investigative Medicine,10 researchers described the case of a 14-year-old girl who developed postural orthostatic tachycardia syndrome (POTS) with chronic fatigue two months following Gardasil vaccination.

 

POTS is a disorder of the autonomic nervous system, which controls functions in your body such as your heart rate, balance, digestion, bladder control, and sleep. While rare, incidence of POTS appears to be increasing and emerging evidence suggests it may be an autoimmune disorder, in which your immune system mistakenly attacks your own body.

 

In the case study, POTS fulfilled the criteria for a condition known as autoimmune/auto-inflammatory syndrome induced by adjuvants (ASIA), highlighting the underlying mechanisms of how vaccines, and particularly their adjuvants (such as aluminum), may be triggering disease. Gardasil contains an aluminum adjuvant, which is designed to hyper-stimulate the immune system to provoke a strong antibody response.

 

A second study, published in the European Journal of Neurology,11 described six patients who developed POTS from six days to two months following HPV vaccination. In addition, deadly blood clots, acute respiratory failure, cardiac arrest and "sudden death due to unknown causes" have all occurred in girls after they've received the Gardasil vaccine.

 

Pap Smears Can Detect Cervical Cancer and Pre-Cancers Early On

 

It's also important to understand that if cervical cancer does occur, it is one of the most preventable and treatable forms of cancer. Routine pap smear testing is a far more rational, less expensive, and less dangerous strategy for cervical cancer prevention, as it can identify chronic HPV infection and may provide greater protection against development of cervical cancer than reliance on HPV vaccines that have not been adequately proven to be safe and effective.

 

Cervical cancer cases have dropped more than 70 percent in the US since pap screening became a routine part of women's health care in the 1960s, as it can detect pre-cancerous cervical lesions early so they can be effectively removed and treated.

 

In addition, the risks of getting or transmitting HPV infection can be greatly reduced, if not virtually eliminated, by choosing abstinence or use of condoms. Furthermore, even if adolescent girls and boys get vaccinated, there are still recommendations for girls and women to have pap screens every few years to detect any cervical changes that may indicate pre-cancerous lesions -- because there is little guarantee that either Gardasil or Cervarix will prevent HPV infection or cervical and other cancers.

 

Dr. Kunle Odunsi, deputy director and chairman of the Department of Gynecologic Oncology at Roswell Park Cancer Institute in Buffalo, New York, even told Live Science, "We need to remember that there are more than 80 HPV types, and some of them can still be associated with risk of cervical malignant disease12

In other words, getting vaccinated is not a guarantee that you won't contract an HPV infection that could theoretically cause cancer in the future if the infection becomes chronic. Odunsi went on to say that "future vaccines could include even more strains of the virus," which adds further credence to the fact that today's vaccines are in no way a foolproof solution. Additional risk factors that increase your chances of developing chronic HPV infection include:

  • Smoking
  • Co-infection with herpes, chlamydia, or HIV
  • Having multiple sex partners
  • Compromised immunity
  • Long-term use of hormonal contraceptives

 

Most of these are modifiable risk factors and you can boost your immune system health to help reduce your risk of contracting or having complications from HPV or other infections by following my nutrition plan, exercising, and optimizing your vitamin D levels. One of the simplest steps you can take is to eliminate your consumption of sugar and most non-vegetable carbohydrates.

 

The over-abundance of many processed foods in the typical Western diet simultaneously enhance inflammation while muting your immune system's ability to respond to and ultimately control infections.

 

Your Right to Informed Consent Is Under Attack

 

I cannot stress enough how critical it is to get involved and stand up for your fundamental human right to exercise informed consent to medical risk-taking and your legal right to obtain non-medical vaccine exemptions. This does not mean you have to opt out of all vaccinations if you decide that you want to get vaccinated or give one or more vaccines to your child.

 

The point is that everyone should have the right to evaluate the potential benefits and real risks of pharmaceutical products, including vaccines, and opt out of getting any vaccine or drug they decide is unnecessary or not in the best interest of their health or their child's health.

 

While it seems "old-fashioned," the only truly effective actions you can take to protect the right to informed consent to vaccination and legally obtain vaccine exemptions is to get personally involved with your state legislators and the leaders in your community.

 

Vaccine use recommendations are made at the federal level but vaccine laws are made at the state level, and it is at the state level where your action to protect your vaccine choices can have the greatest impact.

 

Signing up for the National Vaccine Information Center's free online Advocacy Portal at www.NVICAdvocacy.org not only gives you immediate, easy access to your state legislators so you can become an effective vaccine choice advocate in your own community, but when state and national vaccine issues come up, you will have the up-to-date information and call to action items you need at your fingertips to make sure your voice is heard. So please, as your first step, sign up for the NVIC Advocacy Portal.

 

Read full article [here ...]