HPV Strains

HPV

  

The Human Papilloma Virus (HPV) is the cause of both genital and non-genital warts. This is a very common family of viruses.  There are actually more than 100 different strains of HPV.  Of these, approximately 30 exist in the genital area and can cause genital warts (condyloma acuminata).  These 30 strains can be further broken down to “high” and “low” risk strains.

 

 

High risk strains may show up in a Pap smear and may rarely develop into cancer.  There are approximately 13 high-risk strains of HPV. Two strains (16 & 18) are believed to cause about 70% of all cervical cancer.

Low risk strains can sometimes cause changes in a Pap smear, but do not progress to cancer. Two of the low risk-risk strains (6 and 11) are most likely to cause genital warts.

There are 40 strains of HPV that can affect the anal and genital tracts and these are further divided into low risk and high risk strains.

 

Thirteen strains are considered high risk, or more likely to progress to high grade lesions (HSIL, CIN 2 or 3) and possibly cancer, if not cleared by the immune system. These strains are: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. Strains 16 and 18 are by far the most common types, and one or both are present in approximately 70% of cervical cancers worldwide. Despite this strong link, only a very small percentage of high risk HPV infections will ever become invasive cancer (estimated at 2%). The time between initial exposure and the development of cancer can vary from months to years, but the average time is thought to be 15 years. Unfortunately, the high risk HPV strains do not usually cause any symptoms to alert someone that they have the infection. The low risk strains are not considered a risk for cervical cancer, but they can cause low grade lesions (CIN 1) and several of these strains can cause genital warts.

GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]

 

GARDASIL is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine:

Cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18

Genital warts (condyloma acuminata) caused by HPV types 6 and 11

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:

Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS)

Cervical intraepithelial neoplasia (CIN) grade 1

Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3

Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3

GARDASIL, Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant, is a non-infectious recombinant quadrivalent vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, and 18. The L1 proteins are produced by separate fermentations in recombinant Saccharomyces cerevisiae and self-assembled into VLPs. The fermentation process involves growth of S. cerevisiae on chemically-defined fermentation media which include

vitamins, amino acids, mineral salts, and carbohydrates. The VLPs are released from the yeast cells by cell disruption and purified by a series of chemical and physical methods. The purified VLPs are adsorbed on preformed aluminum-containing adjuvant (Amorphous Aluminum Hydroxyphosphate Sulfate). The quadrivalent HPV VLP vaccine is a sterile liquid suspension that is prepared by combining the adsorbed VLPs of each HPV type and additional amounts of the aluminum-containing adjuvant and the final

purification buffer.

GARDASIL is a sterile suspension for intramuscular administration. Each 0.5-mL dose contains approximately 20 mcg of HPV 6 L1 protein, 40 mcg of HPV 11 L1 protein, 40 mcg of HPV 16 L1 protein, and 20 mcg of HPV 18 L1 protein.

Each 0.5-mL dose of the vaccine contains approximately 225 mcg of aluminum (as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, < 7 mcg yeast protein/dose, and water for injection.

The product does not contain a preservative or antibiotics.

CERVARIX® PRODUCT INFORMATION  Human Papillomavirus Vaccine Types 16 and 18

(Recombinant, AS04 adjuvanted)

 

CERVARIX contains recombinant C-terminally truncated L1 proteins from human papillomavirus (HPV) type-16 and type-18 each assembled as virus-like particles (VLPs)…

The HPV-16 and HPV-18 L1 antigens are prepared by recombinant DNA technology using a Baculovirus expression system in Trichoplusnia ni cells.

HPV-16 and HPV-18 L1 antigens in CERVARIX are adjuvanted with AS04. This AS04 adjuvant system comprises aluminium hydroxide (Al(OH)3) and 3-O-desacyl-4’-monophosphoryl lipid A (MPL). The MPL within AS04 enhances the initiation of the immune response through the activation of innate immunity, leading to an improved cellular and humoral adaptive immune response.

Each 0.5ml dose of CERVARIX contains 20 micrograms each of HPV-16 L1 and HPV-18 L1 proteins, 0.5 milligrams of Al(OH)3 and 50 micrograms of MPL. CERVARIX also contains sodium chloride (NaCl) 4.4 mg, sodium phosphate – monobasic (NaH2PO4.2 H2O) 624 micrograms and water for injection as excipients. CERVARIX does not contain a preservative.

Cervarix vaccine causing severe reactions

Cervarix vaccine causing severe reactions

MORE than 1300 schoolgirls have experienced adverse reactions to the controversial cervical cancer jab.

Doctors have reported girls aged just 12 and 13 have suffered paralysis, convulsions and sight problems after being given the vaccine.

Dozens were described as having pain “in extremity” while others suffered from nausea, muscle weakness, fever, dizziness and numbness.

The vaccine is being given to girls under a government program to prevent women from developing cervical cancer. Ministers say it will ultimately save 700 lives a year.

Some have dubbed it the “promiscuity jab” because it is given to girls to protect against the sexually-transmitted HPV virus, which causes 70 per cent of cervical tumours.

Last night campaigners called for the vaccination campaign to be suspended.

But government health experts insisted the Cervarix vaccine was safe and that the 1340 reports was to be expected, given that more than 700,000 girls were vaccinated last year.

They also said many of the reactions resulted from the act of injection, and said there was no evidence that the jab caused any of the serious conditions, such as paralysis.

Cancer charities urged parents to continue allowing their daughters to have the jabs, saying any risks were so minor and unproven that they could not outweigh the benefit of possibly saving lives.

The vaccination program of young secondary school girls began in September last year following clinical trials on more than 18,000 women under the age of 26.

Critics have claimed that not enough pre-pubescent girls were involved.

The vaccine, which is administered in three doses, is also being given to girls aged 17 and 18. By 2011, all those under the age of 18 will have been vaccinated.

The drug safety watchdog, the Medicines and Healthcare products Regulatory Agency, said doctors had made 1340 reports listing 2891 different adverse effects.

Most were minor complaints such as rashes, swelling on the injection site, pain or allergic reactions, but there were many more worrying problems.

Four girls had convulsions, one had a seizure and one had an epileptic fit. There were several cases of paralysis.

There were almost 20 cases of blurred vision and one girl was reported as developing anorexia.

Researchers Suggest Insufficient Evidence of Efficacy of HPV Vaccine

Researchers Suggest Insufficient Evidence of Efficacy of HPV Vaccine

(NaturalNews) There is not enough evidence to confidently state that two popular vaccines against the human papillomavirus (HPV) will reliably prevent against the development of cervical cancer, according to two articles published in the New England Journal of Medicine.

“Despite great expectations and promising results of clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer,” wrote Charlotte J. Haug, editor of The Journal of the Norwegian Medical Association, in the first article. “With so many essential questions still unanswered, there is good reason to be cautious.”

Haug noted that Merck’s Gardasil and GlaxoSmithKlein’s Cervarix have only been studied clinically for six and a half years at the most, and have only been on the market since 2006. This means that researchers still do not know if the vaccines are effective against HPV over the long term, or what cancer-related side effects they might have. For example, protecting the body from infection with certain HPV strains might have unforeseen immunological side effects, reducing the body’s resistance to other varieties.

Due to the newness of both vaccines, it is also not yet been possible to see whether they actually reduce cervical cancer rates. Normally, it takes years of HPV infection before cancer can develop – more time than either drug has been studied.

In the second article, a pair of Harvard researchers noted that HPV vaccination is not necessarily a cost-effective way to protect against cervical cancer. Current screening methods such as Pap smears have been very effective in reducing the death rate of cervical cancer already, but such tests must continue even after receiving an HPV vaccine. Even at their best, the vaccines do not protect against all cervical cancer strains that can cause cancer; a woman who has already been exposed to one of the strains in the vaccine will get no benefit from it.

“I believe the vaccine is a great advance,” said Philip Davies of the European Cervical Cancer Association, “but we have to implement it properly to get the benefits, and that hasn’t happened.”

Well, Well, Well: Bad is bad

Well, Well, Well: Bad is bad

I’m honoured, and not at all surprised, to hear from Dr Mansi (“Merck Frosst responds,” Letters, Feb 5 – Feb 11, 2009). He obviously cares a lot about Gardasil and has put out some highly sensitive radar for commentary on it, which is good—this is a conversation we need to be having. 

Cervical cancer and other HPV-linked diseases are horrible, on that he and I agree—but that’s probably where our agreement ends. And despite his authoritative tone, I offered no misinformation. 

 

Mansi cites a US Centers for Disease Control (CDC) study that found no significant difference in adverse events between a Gardasil-vaccinated group and a non-Gardasil group. But a very recent study published in the Canadian Medical Association Journal found Gardasil to cause adverse reactions five to 26 times more often than other vaccines. That’s 500 per cent more, at the low end. The study was based on 114 000 young women who had received Gardasil compared to young women who had received other vaccines. 

 

But to bring in the perspective of someone with a little more credibility than I as a journalist might have, I spoke with neuroscientist and UBC professor Chris Shaw. Dr Shaw’s research has turned up some alarming links between aluminum hydroxide (used in vaccines) and neurological damage—something called neuro-inflammation, which is linked to autism, epilepsy, Alzheimer’s, Parkinson’s, ALS and autoimmune disease.

 

Gardasil contains aluminum, and although aluminum adjuvants—the non-viral component of vaccines, designed to stimulate immune response—have been used in vaccines for decades, Shaw says they either haven’t ever been properly tested for safety, or the evidence has been tossed aside. 

 

“Attenuated microbes alone don’t give a sustained immune response, but aluminum does,” he explains. “Without an adjuvant that stimulates a long-lasting immune response, vaccines just don’t work all that well.” 

 

But aluminum generates molecules called tau proteins, which form the clumps in the brain that we see with neurological disease. “What I’ve seen in the lab is the reason my daughter’s never had a vaccine,” he tells me. “The way the aluminum danger is usually dismissed is that we ingest aluminum all the time, but digestive systems have ways to excrete it. When it is injected, it’s an entirely different thing.”

 

Which brings me back to Gardasil and double-blind trials. When we’re comparing two groups, and the control group has been given other vaccines or an aluminum-containing placebo, reactions between the two groups will be similar. And that’s exactly the kind of comparison that has mostly been made in clinical trials. What we need for an accurate picture is to compare vaccinated with completely unvaccinated groups over a long period of time. 

 

As to approval given by Health Canada and other health agencies, we need only to have a look at history, to read accounts like that of former Health Canada employee and whistleblower Dr Shiv Chopra to be reminded of how things work. 

 

“Vaccines are a business, like any other,” the Cochrane Library Review reminds us. “The only difference is that governments are co-sponsors with industry … overestimation of the threat by the target diseases, suppression of data on adverse events and exaggeration of effectiveness are frequent. In the case of population vaccination programs, both governments and industry have conflicts of interest.” 

 

And financial interests, as we all know, tend to trump safety. “Merck lobbied every opinion leader, women’s group, medical society, politician, and went directly to the people—it created a sense of panic that says you have to have this vaccine now,” Dr Diane Harper—cervical cancer researcher, vaccine developer and professor of medicine at Dartmouth Medical School—told the New York Times last August.

 

Mansi insists that the full burden of disease prevented by Gardasil is being overlooked, but we may in fact not be decreasing the burden of disease at all. By continually over-stimulating the immune systems of our children we may be trading one tragedy for another, much greater one. 

As to the comment encouraging readers to consult physicians—absolutely, but it is fair to remind the public where physicians get their information on drugs and vaccines.

Vaccinating teens during menstrual phase may increase adverse reactions

Vaccinating teens during menstrual phase may increase adverse reactions

Why has there not been any mention of the potentially adverse effects of Merck’s cervical cancer vaccination, Gardasil® in relationship to the timing of the inoculation and where a young woman is in her menstrual cycle? This information is especially critical considering the vaccination is recommended for adolescent girls from the age of nine to young women up to 26-years.

…SHAME, SHAME, SHAME ON BOTH INDSUTRIES

Gardasil®, as well as other immunizations administered to adolescent women, are dispensed without regard to where a woman is within her menstrual cycle. During Gardasil®’s, clinical trial period, FDA approval, and during the two years it has been on the market, not one article has been written about how a young woman might tolerate the injection during premenstruum; nor is there any information in the Patient Product Information or the Prescribing Information on the Gardasil® web site, that cites any corollary to adverse reactions to the injection in relationship to the menstrual cycle.

Withholding this information is nothing less than a crime against women

Earlier this month the Center for Disease Control (CDC) released report on the number of adverse reactions to Merck Pharmaceutical’s Gardasil® vaccine for cervical cancer. According to the report over 14,796 adverse events have been reported to the Vaccine Adverse Events Reporting System (VAERS) since 2006 when the controversial vaccine for cervical cancer was approved by the Food and Drug Administration (FDA) and introduced to the mass market. Since the 2006 approval, nearly 8-million adolescent girls and young women have currently received the Gardasil® vaccination.

While Wall Street reported Merck’s 1.5-billion dollar revenue3 windfall from the sale of the Gardasil®, fifteen deaths and two lawsuits are amongst the nearly 8,000 reports, according to the CDC. On August 14, 2008 the National Vaccine Information Center (NVIC) sent out an email blast with more shocking statistics; there are now 35 confirmed deaths. On July 22, 2008, The Board of Directors of Merck & Co., declared a quarterly dividend of $0.38 per share on the Company’s common stock for the fourth quarter of 2008.

If one does the quick math, it becomes obvious that nearly 10% of the women who received the Gardasil® vaccination experienced an adverse reaction. In our humble opinion, that is an incredibly high percentage. Add that to the number of unknown and unreported incidents of an adverse reaction to Gardasil®, and the percentage could actually be far greater. David Kessler, former Commissioner of the FDA reported in an article in JAMA — June 2,1993, Vol. 269, No.21; “…it is estimated that only between 1-10% of immunization events are reported to the Vaccine Adverse Events Reporting System;” a figure supported by two NVIC investigations.

NVIC also reported that “In New York, only one out of 40 doctor’s offices or 2.5% confirmed that they report a death or injury following vaccination” leaving 97.5% of vaccine related deaths and disabilities unreported.

The percentage of adverse reactions to Gardasil® could indeed, be significantly higher than researchers have estimated.

…ADVERSE REACTIONS

It is possible and probable that some of the adverse reactions to the Gardasil® vaccine are due to the shot being administered during the paramenstrum. It is also possible and probable that some of the adverse reactions to the vaccination may be hormonally related to the premenstrual phase — and not due to the vaccination.

Based on the current research and the unacceptable number of adverse reactions and unexplained fatalities “coincidentally” related to the Gardasil® inoculations, it would behoove Merck Pharmaceuticals to include menstrual cycle evaluation with the overall guidelines in the Gardasil® Patient Product Information and the Prescribing Information. For that matter, every pharmaceutical company producing and marketing drugs to women should also have this information in their product and patient information.

Full Article

The Role of Male Circumcision in the Prevention of Human Papillomavirus and HIV Infection

Effect of Male Circumcision on the Prevalence of High-Risk Human Papillomavirus in Young Men: Results of a Randomized Controlled Trial Conducted in Orange Farm, South Africa (The Journal of Infectious Diseases 2009;199:14–19)

Background.  A causal association links high-risk human papillomavirus (HR-HPV) and cervical cancer, which is a major public health problem. The objective of the present study was to investigate the association between male circumcision (MC) and the prevalence of HR-HPV among young men.

Methods.  We used data from a MC trial conducted in Orange Farm, South Africa, among men aged 18–24 years. Urethral swab samples were collected during a period of 262 consecutive days from participants in the intervention (circumcised) and control (uncircumcised) groups who were reporting for a scheduled follow-up visit. Swab samples were analyzed using polymerase chain reaction. HR-HPV prevalence rate ratios (PRRs) were assessed using univariate and multivariate log Poisson regression.

Results.  In an intention-to-treat analysis, the prevalences of HR-HPV among the intervention and control groups were 14.8% (94/637) and 22.3% (140/627), respectively, with a PRR of 0.66 (0.51–0.86) ( ). Controlling for propensity score and confounders (ethnic group, age, education, sexual behavior [including condom use], marital status, and human immunodeficiency virus status) had no effect on the results.

Conclusions.  This is the first randomized controlled trial to show a reduction in the prevalence of urethral HR-HPV infection after MC. This finding explains why women with circumcised partners are at a lower risk of cervical cancer than other women.

Trial registration.  ClinicalTrials.gov identifier: NCT00122525.

Full Study

Commentary: The Role of Male Circumcision in the Prevention of Human Papillomavirus and HIV Infection (The Journal of Infectious Diseases 2009;199:1–3)

 

Cervarix

CERVARIX Human papillomavirus (HPV) vaccine

“This report summarises the adverse reactions suspected to have been caused by Cervarix human papillomavirus (HPV) vaccine in the UK. This includes reports received between 14 April 2008 and 3rd December 2008.”

 Suspected Adverse Reaction Analysis (pdf)

Gardasil trials update–”New Medical Conditions”

Gardasil trials update–”New Medical Conditions”

By Cynthia A. Janak

…I found an interesting document on the FDA website about my favorite topic, Gardasil.

Subject: Clinical Review of Biologics License Application Supplement for Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil®) to extend indication for prevention of vaginal and vulvar cancers related to HPV types 16 and 18.

Dated September 11, 2008

http://www.fda.gov/cber/products/gardasil/gardasil091108.pdf

This document is 187 pages long and I was scanning this document for adverse events. I did find something interesting starting on their page 132; it was Table 73, titled “New Medical Conditions” Days 1–15…

The total study participants were 5088 for Gardasil and 3790 for the Placebo. (Now let us remember that this group includes the Alum and carrier solution placebos.) The participants that they were able to follow-up with were 5012 for Gardasil and 3725 for the Placebo group.

What caught my eye with this table was the fact that these participants did not have these conditions prior to the study. I surmise this because of the title “New Medical Conditions”. So in essence these individuals were probably healthy average people with active lives and families.

Here is what I found.

Continued

Gardasil Mandated For New U.S. Citizens

Gardasil Mandated For New U.S. Citizens

If at first you don’t succeed, try, try, again. That’s exactly what the giant drug company Merck has done; it changed its lobbying target and now has the federal government mandating injections of its vaccine for legal immigrants, ensuring a continuous return on its product development investment.

Continued

National Vaccine Information Center Says Government Denies Gardasil Risks

National Vaccine Information Center Says Government Denies Gardasil Risks

The National Vaccine Information Center (NVIC) is calling on the Centers for Disease Control (CDC) and Food and Drug Administration (FDA) to publicly release the study design, data and names of principal investigators involved in a statement this week maintaining that Gardasil vaccine is safe with no serious side effects. NVIC will also be calling on the newly elected President and members of Congress to remove the nation’s vaccine safety monitoring system from the Department of Health and Human Services (DHHS) and place it in a separate entity reporting directly to Congress to restore trust in the nation’s public health laws based on federal mass vaccination policies.

The CDC and FDA are alleging that the vast majority – if not all – of the approximately 9,000 HPV vaccine adverse events, including 27 deaths, reported to the federal Vaccine Adverse Event Reporting System (VAERS) are not causally related to the Gardasil vaccine based on internal analysis, including review of medical records of girls and women vaccinated in HMO’s participating in the federal Vaccine Safety Datalink (VSD) Project and other closed government operated databases.

“Transparency in government is essential to trust in government and replication is the hallmark of good science,” said NVIC co-founder and president Barbara Loe Fisher. “Parents of young girls and women cut down in their prime – some of them paralyzed or dead within hours or days of getting Gardasil vaccine – deserve better answers than a whitewashing of this vaccine’s very serious side effects. Until there is an independent confirmation of these unverified findings by individuals and companies without financial ties to the government or industry, it is not credible.”

- In June 2006 NVIC questioned the quality and quantity of Merck’s pre-licensure Gardasil vaccine safety data in girls under age 16 and, in 2007, issued three reports analyzing serious Gardasil adverse events reported to VAERS;

- In 2007, Merck lobbied in many states for Gardasil vaccine mandates but failed in most;

- During 2008, about 20 percent of all vaccine adverse event reports to VAERS were related to Gardasil even though it is not a mandated vaccine like most others;

- Last week, reports that Merck’s Gardasil sales are falling dramatically and are not offsetting similar declining sales of other drugs associated with safety concerns prompted Merck to lower profit projections and layoff employees.

NVIC was founded in 1982 and worked with Congress on the 1986 National Childhood Vaccine Injury Act. The non-profit watchdog group advocates for safer vaccine policies and the legal right for Americans to make informed, voluntary decisions about vaccination.

Source
Barbara Loe Fisher
National Vaccine Information Center

Government denies Gardasil risks

NVIC President Barbara Loe Fisher says government denies Gardasil risks and calls for transparency.

http://www.businesswire.com/multimedia/home/20081024005429/en/1709995

HPV Documents

Judicial Watch has posted links to the adverse event reports below and continues to monitor VAERS reports submitted to the FDA in relation to Gardasil.

You can view the following documents at Judicial Watch

Special Reports

• Judicial Watch Special Report: Examining the FDA’s HPV Vaccine Records – June 30, 2008
• Examining the FDA’s HPV Vaccine Records – Appendices – June 30, 2008

Documents Uncovered

• Vaccine Adverse Effects Report System (VAERS) serious effects report from January 1, 2008 to June 10, 2008 – June 30, 2008
• Vaccine Adverse Effects Report System (VAERS) cumulative deaths report – June 30, 2008
• Vaccine Adverse Effects Report System (VAERS) reports on Guillane-Barre Syndrome, spontaneous abortions, and all life-threatening cases from 2008 – June 30, 2008
• Vaccine Adverse Effects Report System (VAERS) cumulative Gardasil adverse effects report (Warning, this is a very large file) – June 30, 2008
• Merck’s application to the FDA to patent the Gardasil vaccine – February 22, 2008
• Merck’s report to the FDA giving the details of Gardasil and its clinical test results – February 22, 2008
• A transcript of the Vaccines and Related Biological Products Advisory Committee’s meeting to discuss Gardasil – February 22, 2008
• Document from the FDA giving a determination of Regulatory Review Period for Purposes of Patent Extension for Gardasil – February 22, 2008 
• Gardasil Related Deaths Reported to VAERS as of September 7, 2007
• Gardasil Related Deaths Reported to VAERS as of May 11, 2007 
• Vaccine Adverse Event Reporting System (VAERS) Reports as of September 7, 2007
• Vaccine Adverse Event Reporting System (VAERS) Reports as of May 11, 2007

Legal Documents

• Judicial Watch complaint against the FDA

Press Releases

• Judicial Watch Uncovers New FDA Records Detailing Ten New Deaths & 140 “Serious” Adverse Events Related to Gardasil (June 30, 2008)
• Judicial Watch Uncovers New FDA Records Detailing Deaths in 1,824 Adverse Reaction Reports Related to HPV Vaccine (October 4, 2007) 
• Judicial Watch Uncovers Three Deaths Relating to HPV (May 3, 2007)

News Stories, Reports and Informational Links

• New England Journal of Medicine
  • Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions
• Guide to State Legislation About Mandatory HPV Vaccination

HPV and Cervical Cancer: One Less or One More?

 HPV and Cervical Cancer: One Less or One More? 

There are at least 100 types of Human Papillomaviruses that have been discovered. Some types of HPV may cause genital warts while at least 30 types may go on to cause precancerous lesions, if the conditions are right. The Gardasil vaccine targets 4 types of HPV. Type 6 and 11 targets the prevention of genital warts, and type 16 and 18 targets the prevention of cervical cancer. 
 
Gardasil package insert- http://www.fda.gov/cber/label/gardasilLB.pdf 
 
VAERS Reports- http://www.medalerts.org/vaersdb/ (use code HPV4 under vaccine) 
 
Merck’s Licensing Trial- http://www.fda.gov/cber/review/hpvmer060806r.pdf 
 
HPV vaccine efficiency against high grade lesions: Future II Study:  
 
http://content.nejm.org/cgi/content/full/356/19/1915 
 
We’ve heard repeatedly that Gardasil is a cancer vaccine. That it is an STI vaccine. Let’s take a look at what is known, what is not known, and what has been lost in the hype. 
 
It is known that babies and children under 7 can have HPV passed on in utero, at birth and after birth. 

 

 The current study shows that high-risk HPV DNA can be detected both in the oral and genital mucosa of infants during the first 3 years of life and that some HPV infections are persistent. HPV DNA has been mostly detected during the first year of infancy, reaching the peak (21%) in oral samples at 6 months of age. This increase might have resulted from both diminished maternal HPV antibodies in infants [21] and newly acquired HPV infections. In addition to vertical transmission, HPV infections might be transmitted horizontally from other family members (e.g., via caring hands or by autoinoculation) [22–24]. The present study showed a decreasing rate of carriage of high-risk HPV DNA during the first year of life, but HPV DNA was still detectable in 10% of mucosal samples obtained at the 3-year follow-up visit. This finding is in line with some earlier studies [25, 26], but the percentage of positive results is lower in the present study than in a study in which the rate of detection was 45%  
 
The results of the present study showed that 36%–42% of infants acquired high-risk HPV DNA in oral or genital mucosa, and 11%–14% of HPV DNA–positive infants cleared virus during the 3-year follow-up period. Both cumulative incidence and clearance rates ran in parallel for oral and genital mucosa. (1)  

 

 

 

 

 
Papillomaviruses are ubiquitous. They have been passed down for millions of years within the human population, mammals, and within all vertebrates. Therefore, it is not only a sexually transmitted infection. 

 “It’s a very tricky virus. To put it in some perspective, the virus family is 100 million years old. Papillomavirus is in, effectively, all the vertebrates: snakes, amphibians, birds, and almost all the mammals. This virus coevolved with the vertebrate kingdom, and it’s just part of what it is to be alive. It’s a virus that’s extraordinarily successful at persisting and passing itself down to the next generation not just in people, but in any animal you’ve ever seen. So it’s something we just have to deal with.” (2) 

 

 

 

 

 The FDA has known for the last four years that HPV is not the cause of cervical cancer, unless the infection is persistent, according to their own admission according to the March 7, 2007 Reclassification Petition: 

 “Based on new scientific information published in the past 15 years, it is now generally agreed that identifying and typing HPV infection does not bear a direct relationship to stratification of the risk for cervical cancer. Most acute infections caused by HPV are self-limiting [1, 4-7]. It is the persistent HPV infection that may act as a tumor promoter in cancer induction [8-11]. Identifying and typing HPV is an important tool for following patients with persistent HPV infection. Repeated sequential transient HPV infections, even when caused by “high-risk” HPVs, are characteristically not associated with high risk of developing squamous intraepithelial lesions, a precursor of cervical cancer.” (3) 

 

 

 

 

 So, it appears it is the persistent infection, not simply aquiring the virus, that determines the cancer risk. What else may increase the risk?  Third world countries, demographics, life style, nutrition, birth control pill use, and sexual activity also increase the incidences and push the percentages of cervical cancer rates upwards. The cervical cancer rate in the U.S. is 1%, while 80% occurs in third world countries. (4)  

“HPV is primarily a problem of poverty, of the underdeveloped portions of the world…but I want to emphasize that major parts of the world, for instance the Soviet Union, the Islamic world, have not even been surveyed, so in many cases we don’t know how severe it is…” (5)

 

 

 

 

 The American Cancer Society provides a detailed list of risk factors with explanations as to why each of these factors increases the risk. It can be viewed at:  

http://www.cancer.org/docroot/CRI/content/…al_cancer_8.asp .
 
Before a vaccine program for HPV is recommended for all young girls, or eventually boys, it is important to know all routes of transmission, the age of susceptibility, along with who is at higher risk for not clearing the infection naturally. 

  
Infection with high-risk human papillomaviruses (HPV) is the most significant risk factor for cervical cancer and it may be possible to prevent this malignancy by immunisation. Before immunisation programmes can be designed, however, it is necessary to know the age of acquisition and all routes of infection for these viruses. Sexual transmission is well documented and vertical transmission has also been demonstrated, although the frequency of transmission remains controversial. We previously showed that vertical transmission frequently results in persistent infection, and now present data on the prevalence of HPV-16 DNA (the most prevalent high-risk HPV type) in healthy children. Buccal samples from 267 healthy children aged 3-11 years were tested for HPV DNA by generic PCR (MY09/MY11), and a HPV-16 specific nested PCR. Reverse transcriptase (RT)-PCR was used to determine the prevalence of transcriptionally active HPV-16 infection in a subset of children. HPV-16 DNA was detected by nested PCR in 138 of 267 (51.7%) samples, whereas HPV DNA was detected in only 45 (16.8%) specimens by generic PCR, that has a lower analytical sensitivity. There were no significant differences in prevalence according to age or sex. Early region mRNA was detected by RT-PCR in six (11.3%) of 53 HPV-16 E5 DNA positive samples. HPV-16 E5 DNA sequences from 10 children confirmed the identity of the sequences detected and identified 13 HPV-16 variants. (6) 

 

  
Since HPV is not a threat to most young girls or women of any age and HPV infection can be detected with pap smear screening, along with the majority of women who will clear the virus naturally, then who does benefit from the vaccine? Logically, you would assume the high risk population. And you may be asking yourself, “Why vaccinate young girls?” Let’s take a look at the four safety and effectiveness quadrants: 
 
Quadrant I: Non-Sexually Active  
No Gardasil vaccine  
 
Quadrant II: Non-Sexually Active 
Receives Gardasil vaccine  
 
Quadrant III: Sexually Active 
No Gardasil vaccine  
 
Quadrant IV: Sexually Active 
Receives Gardasil vaccine 
 
 
Now let’s look at the Likely Outcomes of each quadrant: 

 
Quadrant I Outcome: No risk of cervical cancer 
Quadrant II Outcome: No medical benefit of the vaccine 
Quadrant III Outcome: HPV presence is self-limiting and will not lead to cervical cancer 
Quadrant IV Outcome: 44.6% increase risk of precancerous lesions. No reduction in cancer risk 

 
If you are thinking there must be a typo in Quadrant IV Outcomes, it isn’t. That does indeed say a 44.6% INCREASE risk of precancerous lesions and no reduction in cancer risk, for those who are sexually active and receives the Gardasil vaccine. Gardasil has the potential to increase the risk of precancerous cervical lesions by 44.6% in women who already carry HPV in a harmless state. According to an FDA VRBPAC document: 

 
“PCR-based HPV detection device with provision for accurate HPV genotyping is more urgently needed now because vaccination with Gardasil of the women who are already sero-positive and PCR-positive for vaccine-relevant genotypes of HPV has been found to increase the risk of developing high grade lesions by 44.6%. (7) 
 
 
“…Another thing that has not been totally talked about is this is a prophylactic vaccine. It is not a therapeutic vaccine. Anybody who has HPV today is not going to directly benefit from the vaccine. We still need to do the research to develop therapeutic vaccines and certainly in the meantime to improve screening tests for these and any other papillomaviruses. We need to develop a comprehensive network of clinics, especially in the third world. “(8) 
 
 
“…Finally, there is compelling evidence that the vaccine lacks therapeutic efficacy among women who have had prior exposure to HPV and have not cleared previous infection (PCR positive and seropositive), which represented approximately 6% of the overall study populations.” (9) 

 

 

 

 

 So, it is already known that vaccinating women with Gardasil will provide no protection if they have prior exposure to the virus, nor provide protection to those who have not cleared previous infections. However, if the vaccine is given to a woman who carries the HPV in a harmless state, it has the potential to active the virus from a harmless state into an active state, and thus cause precancerous lesions to develop. What happens if we start vaccinating American women when there is evidence that the vaccine may increase lesions by 44.6%? Cervical cancer rates will skyrocket!  
 
Therefore, the only group left that may benefit from the vaccine are young girls who have not had sex. But does Gardasil vaccine work? That remains to be seen. And there is a caveat to that however. Let’s take a look: 

“We do know that serologic titers declined steadily following the third shot, as you saw from Neal’s presentation. The response is extraordinarily robust to these particles, but we simply don’t have a timeline on what amount of serologic capability will be left after, say, 10 years or 15 years. We don’t know how long protective immunity will persist and whether it would be restimulated quickly through memory cells upon exposure to an actual infecting agent. But it may become necessary to have booster shots somewhere down the line, especially if 10- or 12-year-old children are being vaccinated, and maybe somewhere in their 20s or 30s and maybe there’s going to be a divorce and a second marriage where there’s a reexposure to other sources may require booster shots later in life. We simply don’t know.” (10)  
 
 
“At least 15 oncogenic HPV types have been identified, 4 so targeting only 2 types may not have had a great effect on overall rates of preinvasive lesions. Findings from the FUTURE II trial showed that the contribution of nonvaccine HPV types to overall grade 2 or 3 cervical intraepithelial neoplasia or adenocarcinoma in situ was sizable. In contrast to a plateau in the incidence of disease related to HPV 
types 16 and 18 among vaccinated women, the overall disease incidence regardless of HPV type continued to increase, raising the possibility that other oncogenic HPV types eventually filled the biologic niche left behind after the elimination of HPV types 16 and 18.” (11)  
 
“…a cautious approach may be warranted in light of important unanswered questions about overall vaccine effectiveness, duration of protection, and adverse effects that may emerge over time.” (12) 
 
And: 
 
“…that only either two or four of the types of 46 that can infect mucosa are even included. We don’t know, but I frankly do strongly suspect that when we do eradicate or minimize the HPV 16 and 18, that their very, very close relatives will fill in. Nature abhors the vacuum and these ecological niches are going to be vacant when HPV 16 and 18 and 6 and 11 are minimized, and I’m deeply concerned that there’ll be backfill of those ecologic niches by these very, very similar types. I think it’s imperative to expand the coverage in the vaccines.  
We don’t know, however, because the studies have never been done, whether a cocktail with 14 types would be equally effective against all 14 or whether they might actually conflict with each other. We simply don’t know. We don’t suspect that there’s much cross protection of one type to any other even similar type. So far the evidence doesn’t suggest that. We also do not know if these vaccines would be effective in the context of immunodeficient diseases. Certainly HIV/AIDS stands out, but other parasitic diseases, even malnutrition or chronic illness. In a study I did, people with end-stage renal failure were reactivating their latent HPV in middle-age years, so immune capacity and capability makes a big difference. (13) 

 

 

 

 

According to the New England Journal of Medicine sited above, you will find that Gardasil has a 13% effectiveness and that serotype replacement is a concern.  
The 13-17% effectiveness is seen only for the lower grade neoplasias (the ones most likely to regress on their own) and no statistically significant effectiveness at all against actual cervical cancer.  
 
The average age for a woman to develop cervical cancer, if the conditions are right, is approximately 48. The true effectiveness or the real dangers of this vaccine will not be known for at least a decade or more. With 19 high-risk types of HPV that can cause cancer and Gardasil only targets two, what happens with the rest of them? They may very well step-in and proliferate, as noted above. 
 
If you read through the package insert provided above, you will see that the claims for effectiveness in preventing cervical cancer are based on indirect efficacy measurements. When you look at the number of subjects, the age of the subjects, and the duration of the trials, you will see that there is no proof that even one case of cervical cancer has been prevented by this vaccine.  
 
Gardasil contains 225mcg of Aluminum (amorphous aluminum hydroxyphosphate sulfate adjuvant), which is a known neurotoxin. Neither Merck nor the FDA ever disclosed how much Aluminum was used in the placebo. In the clinical trials, it appears the aluminum and saline groups were lumped together instead of a saline group alone. If you look at Table 6, page 10, it has a chart with a saline placebo group and an aluminum placebo group. Adverse Experience and Systemic Reactions in the aluminum and saline groups were combined. That can skew results as Aluminum plays a major part in side effects, and a reactive placebo can artificially increase the appearance of safety in a clinical trial. Merck nor the FDA do not reveal in public documents how many 9 to 15 year old girls were in the clinical trials either, or how many received the Hep B vaccine along with Gardasil or the aluminum placebo.  
 
 
Cervical cancer is preventable, treatable, and curable. Women who receive regular Pap smears, DNA testing for HPV, are not in the high-risk categories, or have appropriate follow-up care, don’t develop cervical cancer. It is more of a concern for women who don’t have access to good healthcare, are not getting regular Pap smears, and women who are not receiving follow-up and treatment. While HPV affects us all to some degree, cervical cancer does not. With so many unknowns and knows to date, the HPV vaccine should be carefully weighed-Does the possible small benefit of 13% effectiveness outweigh the risk? Might it be better health wise, and more cost efficient, to educate young girls on the risks of unprotected sex, condom use, regular pap screening, and what HPV is, versus a vaccine that can damage them for life?  
 
  
REFERENCES: 
 
1. Clinical Infectious Diseases, 2005. High-Risk Types of Human Papillomavirus (HPV) DNA in Oral and Genital Mucosa of Infants during Their First 3 Years of Life: Experience from the Finnish HPV Family Study.

http://www.journals.uchicago.edu/doi/full/10.1086/498114 
 
 
2. Center For American Progress. “PREVENTING HPV, EASY AS 1, 2, 3 SHOTS? ENSURING ACCESS TO THE NEW ANTI-CANCER VACCINES” (pg 23) http://www.americanprogress.org/kf/hpv_event_transcript.pdf 
 
 
3. Reclassification Petition, March 7, 2007. (pg 7) 
http://www.fda.gov/ohrms/dockets/dockets/0…001-01-vol1.pdf 
 
4. Preparing for the introduction of HPV vaccines: policy and programme guidance for countries. WHO 2006.  
http://www.who.int/reproductive-health/pub…ccines/text.pdf 
 
 
5. Center For American Progress. “PREVENTING HPV, EASY AS 1, 2, 3 SHOTS? ENSURING ACCESS TO THE NEW ANTI-CANCER VACCINES” (pg. 13) http://www.americanprogress.org/kf/hpv_event_transcript.pdf  
 
 
6. J. Med. Virol. 61:70-75, 2000. © 2000 Wiley-Liss, Inc. High prevalence of human papillomavirus type 16 infection among children Philip S. Rice 1 2, Christine Mant 1 2, John Cason 1 2, Jon M. Bible 1 2, Peter Muir 1 2, Barbara Kell 1 2, Jennifer M. Best 1 2 * 1Richard Dimbleby Laboratory of Cancer Virology, Department of Infection, Guy’s, King’s College, London, United Kingdom 2St. Thomas’ School of Medicine, King’s College London, St. Thomas’ Hospital, London, United Kingdom.  
http://www3.interscience.wiley.com/cgi-bin…ETRY=1&SRETRY=0 
 
7. Reclassification Petition – Human Papillomavirus (HPV) DNA Nested Polymerase Chain 
There are at least 100 types of Human Papillomaviruses that have been discovered. Some types of HPV may cause genital warts while at least 30 types may go on to cause precancerous lesions, if the conditions are right. The Gardasil vaccine targets 4 types of HPV. Type 6 and 11 targets the prevention of genital warts, and type 16 and 18 targets the prevention of cervical cancer. 
 
Gardasil package insert- http://www.fda.gov/cber/label/gardasilLB.pdf 
 
VAERS Reports- http://www.medalerts.org/vaersdb/ (use code HPV4 under vaccine) 
 
Merck’s Licensing Trial- http://www.fda.gov/cber/review/hpvmer060806r.pdf 
 
HPV vaccine efficiency against high grade lesions: Future II Study:  
 
http://content.nejm.org/cgi/content/full/356/19/1915 
 

Reaction (PCR) Detection Device (K063649 ) http://www.fda.gov/ohrms/dockets/dockets/07p0210/07p-0210-ccp0001-01-vol1.pdf