The Refusers: Vaccine Protest Music Gone Viral

By Norma Erickson, President

Your Right

The first public performance of a now quite controversial rock band was in July 2010 at the American Rally for Personal Rights. In the tradition of protest songs during civil rights and anti-war movements, The Refusers presented their protest music as a tribute to vaccine-injury victims past, present and future.

Michael Belkin and his band use a unique musical style they have dubbed ‘Innoc-You-Rock’ to focus listeners’ attention on controversial vaccine issues. Their hard-hitting lyrics provide a direct counterpoint to what they see as “government issued vaccine propaganda and the current medical establishment’s policy of vaccinate first, ask questions later.”

The Refusers’ name was chosen in direct response to the American Medical Association’s position on informed consent, which says:

“Your patient should have an opportunity to ask questions to elicit a better understanding of the treatment or procedure, so that he or she can make an informed decision to proceed or to refuse a particular course of medical intervention.”

Michael Belkin categorically states, “The AMA’s position on informed consent does not say ‘except vaccines.’ Vaccination choice is a fundamental human right. Any doctor who fails to inform you about the risks associated with vaccines, or who contends you do not have the right to refuse vaccination is violating their own medical code of ethics.”

What motivated Mr. Belkin to organize his vaccination protest band?

Flashback fourteen years: Michael is a successful, self-employed quantitative strategist happily married to the woman of his dreams. Lyla Rose was born with no complications – a healthy, happy baby girl. At five weeks of age, she is taken for a check-up and a booster shot of Hepatitis B vaccine. 15 hours later, Michael’s baby girl was gone.

Michael states that although the coroner initially stated Lyla’s brain was swollen (encephalitis), the cause of death ultimately ruled as Sudden Infant Death Syndrome (SIDS). The swollen brain and the hepatitis B vaccine were not mentioned in the final autopsy report.

Knowing that SIDS is a diagnosis of exclusion and brain inflammation is not SIDS, Michael’s research began. He discovered the following quote from Merck’s Home Health Manual:

Encephalitis can occur in the following ways:

• A virus directly infects the brain.
• A virus that caused an infection in the past becomes reactivated and directly damages the brain.
• A virus or vaccine triggers a reaction that makes the immune system attack brain tissue (an autoimmune reaction).

Michael found himself attending any applicable government meeting he could. He attended a workshop at the National Academy of Sciences, Institute of Medicine on “Neo-Natal Death and the Hepatitis B Vaccine” and an Advisory Committee on Immunization Practices meeting on the safety of the hepatitis B vaccine. He obtained the entire VAERS database on hepatitis B adverse events reports and investigated it thoroughly.

In May of 1999, seven months after the tragic loss of his daughter, Michael Belkin presented the following testimony to Congress:

Michael continues to work within the system to promote vaccine safety and preserve the right to vaccine choice for many years. Although he experiences some small successes, Michael ultimately gets to the point where he feels he is beating his head against a brick wall. Those in charge of vaccination rules, regulations and policy-making just do not seem to care. Tired and wanting to return to a somewhat normal life, Michael takes some time off from vaccine safety and consent issues.

During his respite, he witnesses the development and marketing of several additional vaccines. He watches the autism rate climb to a previously unheard of level. He witnesses a substantial increase in the size of the VAERS database. He witnesses the increase in chronic and debilitating diseases in young people throughout the United States.

Michael went on to have two healthy unvaccinated children. He witnessed apartheid-like exclusionary policies being instituted against children whose parents chose to try and preserve their health and well-being. He witnessed people losing their jobs because they decided one vaccine or another was not in their best interest. He witnessed schools, daycares, and even medical professionals exclude people based on their vaccination status.

Michael Belkin decided enough was enough. The only option left was to take his message to the streets via a medium that might catch the attention of the average American medical consumer. Michael, his 11-year old unvaccinated son Sebastian, Steve Newton and Joey Walbaum decided to use their musical talents organize a protest band that would publicly stand up for everyone’s right to refuse vaccination.

The Refusers take great pride in their young drummer, Sebastian Belkin – a real deal healthy refuser – and visible proof that the unvaccinated are not the threat to public health and safety they are being portrayed as. Sebastian is the epitome of a normal healthy young man, not to mention talented.

Their strategy appears to be working. The Refusers first video, shown below, has officially gone viral with over 280,000 views. First Do No Harm, is also the title cut of the band’s soon to be released CD.

Michael Belkin and The Refusers have obviously found an effective way to get their message to those who need to hear it.

Listen to more music from The Refusers here.

New Study: HPV Vaccine and Evidence of Herd Immunity or Type Replacement?

By Norma Erickson, President

 

HPV Vaccine: Herd Immunity?

 

Medical professionals rely on studies published in medical journals to keep abreast of new developments in their field. What happens when published studies raise more questions than answers? Where does that leave trusting medical consumers?

On July 12, 2012, Australia became the first country in the world to formally offer taxpayer sponsored HPV vaccines to their young men. HPV vaccines have been advertised as ‘cervical cancer’ vaccines. Boys obviously do not have a cervix, so how do you ‘sell’ males on the idea of a three shot series of the most expensive vaccine on the market?

Miracle of miracles – almost immediately press reports begin to come in from around the world about a new study that supposedly demonstrates evidence of HPV vaccinations providing protection to the unvaccinated population. What an outstanding way to convince boys it is their duty to protect those around them.

Unfortunately, none of the articles reporting this ‘miraculous’ development provide a link to the actual study so a person can check for themselves. So much for responsible journalism!

“Vaccine-Type Human Papillomavirus and Evidence of Herd Protection After Vaccine Introduction,” by Jessica A. Kahn, MD, MPH, et al., was accepted for publication in April 2012 by the medical journal Pediatrics, but will not be formally published until August.¹

Historically, academic ‘experts’ paid directly or indirectly by the industry have cherry-picked populations with a high prevalence rate of HPV infections or cervical cancer to generate a set of data. They extrapolate the ‘scientific’ data obtained from irrelevant populations to promote a vaccine with questionable value or an analytically inaccurate HPV test for use in the general population.

In 2001, a group of employees of the National Cancer Institute, a major patent holder and financial beneficiary of HPV vaccines, did just that when they used a population with an extremely high cervical cancer rate in a subpopulation of Costa Rica during development of the HPV ‘cancer’ vaccine and an HPV test for cervical cancer screening.² Then they helped expedite approval of HPV vaccines and an inaccurate HPV test through the Food and Drug Administration to be used in populations with little threat of cervical cancer progression.

In their most recent study, Jessica A. Kahn and her coauthors have done the same thing by using a cherry-picked subset of African American women with an extremely high rate (68.3%) of HPV infection for a statistical analysis to justify wide spread implementation of the HPV vaccination policy through so called “herd protection.” The authors conveniently ignore the fact that most American women under the care of gynecologists in private practice have a less than 10% HPV infection rate even when the most sensitive nested PCR amplification is used for detection. They also ignore the fact that African American women usually carry different strains of HPV viruses than women from other ethnic backgrounds.³

It is well known that test results obtained in a population with high disease prevalence rates cannot be extrapolated to a population with a low prevalence of the disease. These authors knowingly misapply their statistical data to support this “herd protection” hypothesis as if HPV infection had become a contagious disease like influenza in the classrooms of all high schools throughout the world.

It is unfortunate that their opinion, supported by public funding, is published in the official journal of the American Academy of Pediatrics as a continued medical education material to influence the practice of the pediatricians, policy-makers and health authorities.

This is particularly true when a careful reading of Khan et al.’s article reveals the following points:

1. Vaccine-type HPV infections reportedly decreased by 21.9% in vaccinated participants; but vaccine-type HPV infections also showed a decrease of 14.8% in the unvaccinated group when compared to the data from 2006-07. These changes are especially remarkable given that many participants were sexually experienced, presumably exposed to HPV, and only 1 HPV vaccine dose was required to be considered “vaccinated” in this analysis.
2. The authors should know there are 3 subtypes of HPV-18, namely the European, the Asian-American and the African subtypes.⁴ In the U.S., 91% of the HPV-18 isolates from white women are reported to be of the European and Asian-American variants, and 64% of the HPV-18 isolates from African American women belong to the African variants.⁵ The production of the Gardasil^® HPV-18 VLPs uses the HPV L1 gene from the SW756 cell line⁶ which carries an African subtype of HPV-18.⁴ Therefore, any “herd protection,” even if conveyed to a subset of African American women by Gardasil^® vaccination, cannot be automatically extrapolated to other races or ethnicities.
3. Why do the authors of the study consider one shot of Gardasil^® to give the participants vaccinated status when the recommended dose is a series of three injections? If one shot is enough, is three too many?
4. The study utilized the Roche Linear Array for HPV typing. According to World Health Organization documentation, only 8 of 17 datasets in a worldwide survey using the Roche Linear Array assay reported a 100% proficiency result in HPV genotyping.^{7 (table 2)} In 7 of the 17 testing sets, false positive HPV types were detected by the Roche Linear Array assay.^{7 (table 3)} This information brings the entire study into question.
5. The authors of the study state, “the overall HPV prevalence increased “modestly” between the two studies.” How can this happen if the vaccine provides herd immunity?

Consider the following data taken from the soon to be published article regarding this ‘modest’ overall increase in HPV infections. This chart is a representation of HPV prevalence changes discovered when the post-vaccination surveillance group of 2009-10 was compared to the pre-vaccination surveillance data from 2006-07:

HPV	All	Vaccinated	Non-vaccinated
Any Type	8.5% increase	9.0% increase	1.8% increase
High Risk Type	1.1% increase	5.2% increase	7.5% reduction
Vaccine Type (16/18/11/6)	18.3% reduction	21.9% reduction	14.8% reduction
High Risk Vaccine Type	14.2% reduction	17.8% reduction	12.0% reduction
Non-Vaccine Type	14.0% increase	15.2% increase	7.6% increase
Non-Vaccine High Risk Type	7.6% increase	13.6% increase	2.7% reduction

Why was there no statistically significant change in HPV infection rates among the unvaccinated participants? Does this mean that other types of HPV are taking over the role of the vaccine-suppressed HPV types in the vaccinated? If so, will the other types become more dangerous than the suppressed ones?

Does this mean the manufacturer targeted the wrong types of HPV for this population? Or, does it simply mean the vaccine doesn’t work?

Does this article provide evidence of herd immunity or potentially dangerous HPV mutation/type replacement?

Is this simply another example of the quality one can expect from industry sponsored ‘scientific studies’ destined to be blindly accepted and widely quoted to influence worldwide health policies?

This study raised far more questions than it answered. Medical consumers deserve better.

References:

1. Kahn JA, Brown DR, Ding L, Widdice LE, Shew ML, Glynn S, Bernstein DI. Vaccine-Type Human Papillomavirus and Evidence of Herd Protection After Vaccine Introduction. Pediatrics. 2012 Jul 9. [Epub ahead of print] http://pediatrics.aappublications.org/content/early/2012/07/03/peds.2011-3587.abstract
2. HPV co-factors related to the development of cervical cancer: results from a population-based study in Costa Rica. Hildesheim A, Herrero R, Castle PE, Wacholder S, Bratti MC, Sherman ME, Lorincz AT, Burk RD, Morales J, Rodriguez AC, Helgesen K, Alfaro M, Hutchinson M, Balmaceda I, Greenberg M, Schiffman M. Br J Cancer. 2001 May 4;84(9):1219-26.PMID: 11336474 [PubMed - indexed for MEDLINE] Free PMC Article Free textRelated citations
3. Dunne EF, Unger ER, Sternberg M, McQuillan G, Swan DC, Patel SS, et al. Prevalence of HPV infection among females in the United States. JAMA 2007; 297: 813-9.
4. Lurchachaiwong W, Junyangdikul P, Termrungruanglert W, Payungporn S, Sampatanukul P, Tresukosol D, Niruthisard S, Trivijitsilp P, Karalak A, Swangvaree S, Poovorawan Y.: Whole-genome sequence analysis of human papillomavirus type 18 from infected Thai women. Intervirology 2010, 53:161-166
5. Xi LF, Kiviat NB, Hildesheim A, Galloway DA, Wheeler CM, Ho J, Koutsky LA. Human papillomavirus type 16 and 18 variants: race-related distribution and persistence. J Natl Cancer Inst. 2006 Aug 2;98(15):1045-52.
6. Hofmann KJ, Neeper MP, Markus HZ, Brown DR, Müller M, Jansen KU. Sequence conservation within the major capsid protein of human papillomavirus (HPV) type 18 and formation of HPV-18 virus-like particles in Saccharomyces cerevisiae. J Gen Virol. 1996 Mar;77 ( Pt 3):465-8
7. http://jcm.asm.org/content/early/2012/04/19/JCM.00840-12.abstract

Gardasil Victim's Mom Speaks About Vaccine Injury: SANEVAX Vaccine Injury Victim Support Line

When vaccine injury occurs and our medical community fails to recognize or diagnose the injury, mothers all over the world turn to SANEVAX, INC. for support. Our victim support line is a lifeline to mothers of the victims of Gardasil and other vaccines. One mother tells her experience regarding the support she received in this very frightening time in her life.

PRLog (Press Release) - Sep 30, 2011 - As the mother of a girl who has suffered injury due to the Gardasil, the HPV vaccine, I know first hand how important the Victims Hotline at SANEVAX.ORG is. We live in a small city in Wyoming with limited medical resources. When my daughter became ill in March of 2011, the medical community in our community was unable and unwilling to treat her. I was advised by our pediatrician that nothing could be done for my daughter and that I should take her home and ‘wait and see’ and ‘hope for the best.’

But I knew in my heart that was not what we should do. I knew that it simply was not enough. So, I searched online and found SANEVAX and the Victim’s Hotline . I contacted several of the names on the hotline via email. I received immediate responses from them. Many of the volunteers were mothers of Gardasil victims. The information the volunteers shared with me was invaluable and it helped save my daughter’s life. The hotline volunteers shared contact information for medical practitioners, and alternative practitioners with experience in treating Gardasil victims. I was also provided practical information about other therapies victim used with success.

At the time, I was desperate, frustrated, angry, confused and scared but the support and information I received from the hotline volunteers gave me real hope that my daughter would recover. I will never be able to thank the Hotline volunteers enough for their willingness to help, to listen, and most of all, to share what they knew from their own personal experiences. My daughter’s condition is much improved, due in large part, to the information and support I received from the hotline. I am eternally grateful to them.

According to VAERS (the Vaccine Adverse Event Reporting System), as of August 2011, there were 23,388 victims reporting injuries resulting from the Gardasil vaccine This number includes both male and female victims, although female victims currently outnumber male victims. It is believed that the incidence of injury is widely under-reported to due to misinformation and that the actual number of victims is much higher than current statistics reflect.

Despite the alarming number of reported injuries related to the Gardasil vaccine, the vaccine continues to be administered to both boys and girls ages 9 to 26 across the nation and it may soon be a required vaccination in many states. Those who have been injured by Gardasil continue to suffer its devastating effects and more children are vaccinated and become victims every day. All of these victims and their families are searching for information and support that is not easily found in the medical community or in their circles of friends and family. Consequently, the need for Hotline Volunteers is tremendous.

The Hotline is a valuable resource for parents and victims to use to talk to others in their home state, across the nation, and around the world regarding their child’s injury resulting from Gardasil. Hotline Volunteers are most often parents of victims, a concerned person or relative close to a victim of Gardasil, or sometimes a Gardasil victim. Volunteers have a thorough understanding of Gardasil Vaccine Injury. Hotline Volunteers do not offer medical advice at any time to anyone. However, contact information for medical practitioners, alternative medicine practitioners, and an abundance of useful information is offered free of charge. Finally, and perhaps most importantly, Hotline Volunteers can provide emotional support to victims and their families.

As a result of the recent media coverage of the political debates and the mention of the controversy surrounding Gardasil, we anticipate the possibility of more victims of Gardasil coming forward in the coming months. It is the goal of the Sane Vax Hotline to offer those victims and their families support and provide them with helpful information. We currently have volunteers in fifteen states and hope to have at least one Hotline Volunteer in every state soon. Sane Vax also has Hotline Volunteers in thirteen countries around the world.

If you or someone you know is interested in becoming a Hotline Volunteer, please send an email to sanevax@charter.net, and enter “VACCINE HOTLINE” in the email’s subject line. Please go to SANEVAX for more information on injuries resulting from Gardasil and how you can help.

By SANEVAX Contributing Author
DeAnna Martinez

SOURCES:

Victim Hotline http://sanevax.org/resources/vaccine-victimw-hotline/

SANEVAX Website http://sanevax.org/

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THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.

Black Monday for Gardasil

Michele Bachmann states ‘Vaccine is not without Peril’ -
CNN’s Elizabeth Cohen Reacts with HPV Vaccine Damage Control -
Merck Plays Wolf in Sheep’s Clothing with Susan G. Komen Foundation

PRLog (Press Release) – Sep 14, 2011 – When the Monday night CNN / Tea Party Express Republican candidates’ presidential debate turned to the constitutionality of healthcare mandates, Representative Bachmann voiced her opinion as the mother of three daughters and the foster mother for 23 other foster girls when she stated: ‘To have innocent little 12-year old girls be forced to have a government injection through an executive order is just flat out wrong. That’s a violation of a liberty interest.’

On Tuesday morning, Bachmann was interviewed on CNN’s American Morning and shared that a mother approached her after the debate and spoke about the very serious consequences her daughter experienced after getting Gardasil.

Bachmann is speaking for millions of parents who believe that mandating a government injection is wrong. She also spoke about the pressure placed on families by doctors and educators even if there is an ‘opt-out’ clause. According to Bachmann ‘Little girls who have a negative reaction to this potentially dangerous drug don’t get a mulligan. They don’t get a do-over. The parents don’t get a do-over.’ 1

Bachmann also blasted Texas Governor Rick Perry with the question that the parent of every adversely injured child is asking ‘is this [vaccine] about life or millions of dollars?’

Everyone by now knows that Perry retorted that Merck’s political action committee gave his campaign $5,000.

In what year was that Governor Perry? It appears the Merck has donated over $25,000 over the course of Perry’s career: $1,000 in 2000; $5,000 in 2002; $10,000 in 2004; $1,000 in 2005; $5,000 in 2006; $2,500 in 2008 and $5,000 in 2010.1

The figure is actually very low for a state as large as Texas….could it be that donations are being funneled from elsewhere – say from a relatively new biotechnological company in Texas? The comment below was posted to an article written by Ed Silverman of Pharmalot fame titled: “Rick Perry And The Gardasil Controversy, Take Two”

‘Interesting to note that a company in Texas with which Rick Perry has a connection with is Gradalis Inc. Move the letters around and it spells Gardasil. In May 2010, Perry’s office gave $3 million to fund G-Con, another Texas Pharma, owned 10% by Gradalis, Inc. The executives of G-Con and the CEO of Gradalis have all given substantial thousands to Perry’s campaign. It was rumored back in 2007 that Perry made a lot of people wealthy, including his family, by mandating the Gardasil vaccine in the State of Texas. If there is government involvement, there is no free market.’2

Gradalis Inc. is a fully integrated biotechnological company in Dallas Texas that focuses on the development, manufacturing and commercialization of drugs, vaccines, tools and diagnostics, primarily in the area of cancer.3 Gradalis? Gardasil? Hmm…

Damage Control at CNN

Meanwhile, back at CNN Elizabeth Cohen did multiple interviews with the station’s news anchors on the HPV vaccine – it was obvious her job for the day was to emphatically state in every way she could that the HPV vaccines are safe – and any adverse injuries reported from Gardasil including paralysis are ‘coincidental.’ Might one ask how much Merck spends on advertising on CNN –or, the other major media networks, for that matter?4

National media outlets are now quick to jump on the bandwagon as doctors and public health leaders speak out to correct misinformation regarding the safety of HPV vaccines that prevent cervical cancer after Bachmann attacked the vaccines as “dangerous” when she related her conversation with the mother of an adversely injured girl mother who blames the shots for her daughter’s mental retardation.

But, there’s no evidence that the HPV shot — or any other vaccine — causes retardation, says O. Marion Burton, president of the American Academy of Pediatrics.5

Mental retardation is the wrong term – the correct term is ‘brain damage’ from the neurotoxins in the vaccine crossing the blood-brain barrier affecting the endocrine and autoimmune systems.

Wolf in Sheep’s Clothing

Merck & Co’s marketing department timing couldn’t have been much worse with their BusinessWire press release Tuesday announcing a new partnership with the Susan G. Komen Foundation. ‘Merck Partners with Susan G. Komen for the Cure(R) on Historic Initiative to Help Address Cervical and Breast Cancer in Developing Nations,’ seemed to do little except cast further doubt on the integrity of the pharmaceutical giant.6

The big bad wolf is hiding once again in sheep’s clothing while portraying their humanitarian interest in partnering with the foundation to disseminate breast and cervical cancer information to women in Africa. According to the release Merck will be contributing ‘$3 million over three years to the Pink Ribbon–Red Ribbon initiative to help address both cervical and breast cancer in sub-Saharan African nations by supporting disease education, screening and treatment efforts as well as increased access to cervical cancer vaccination.”

After one gets over the initial ‘Awww ain’t that nice…’ it becomes pretty clear that Merck is using the foundation to develop new markets for their vaccine in countries where no adequate vaccine injury tracking systems exist, not to mention cervical screening.

Women who supported the Komen Foundation are already speaking out on Facebook. One woman writes: ‘This absolutely disgusts me! My grandmother struggled with breast cancer for years. All contributions from her funeral were donated to the Susan G. Komen for the Cure foundation. How dare these money hungry drug lords attempt to conceal their cruel and merciless intentions by allying with such a wonderful foundation. Completely sickening.’

SANE Vax Inc. agrees with Bachmann when she stated in another interview with CNN after the debate that Perry’s admission that he could have done things differently didn’t change the situation.

“It’s not enough to say, ‘I’m sorry. I was wrong.’ You have to get it right the first time,” Bachmann said.

It is time for medical consumers to be aware that Merck, the FDA, and CDC did not get the HPV vaccine right the first time. The adverse injuries and deaths to innocent previously healthy adolescents took one time…..one decision to get the vaccine series….. and for them there is no turning back either.

We can only move forward now that Bachmann has opened the door and exposed the ‘wolves in sheep’s clothing.’ It is time for their reckoning.

Sources:
1. CNN – http://edition.cnn.com//2011/POLITICS/09/13/truth.squad. …
2. Pharmalot – http://www.pharmalot.com/2011/08/rick-perry-and-the-gard …
3. Gradalis Inc. http://www.gradalisinc.com/
4. CNN – http://cnnpressroom.blogs.cnn.com/2011/09/13/senior-medical-correspondent-elizabeth-cohen-fact-checks-the/?iref=allsearch
5. USA Today – http://yourlife.usatoday.com/health/story/2011-09-13/Scientists-say-Bachmann-misstates-facts-on-HPV-vaccines/50390580/1
6. BusinessWire – http://www.marketwatch.com/story/merck-partners-with-susan-g-komen-for-the-curer-on-historic-initiative-to-help-address-cervical-and-breast-cancer-in-developing-nations-2011-09-13?reflink=MW_news_stmp
7. CBS News – http://www.cbsnews.com/8301-503544_162-20105175-503544.html

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SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.

SANE Vax Inc. Discovers Potential Bio-hazard Contaminant in Merck’s Gardasil™ HPV 4 Vaccine

By Leslie Carol Botha, Vice President of Public Relations


Gardasil victim found to have HPV DNA in her blood 2 Years Post-Vaccination
13 different vaccine vials – 13 different lots of Gardasil from around the world tested
Results – 100% contamination with HPV Recombinant DNA.

SANE Vax Inc. contracted with an independent lab to test for contamination and found HPV recombinant DNA (rDNA) in 13 vaccine vials. The Gardasil vials with different lot numbers were from New Zealand, Australia, Spain, Poland, France and three states in the U.S. 100% of the samples tested positive for the presence of the genetically modified HPV DNA.

Dr. Sin Hang Lee, a pathologist at the Milford Hospital pathology laboratory well-known for using cutting-edge DNA sequencing for molecular diagnoses, was initially contracted to examine a single sample of Gardasil for possible contamination. This sample tested positive for recombinant HPV-11 and HPV-18 residues, both of which were firmly attached to the aluminum adjuvant.

In a certified letter mailed to FDA Commissioner, Dr. Margaret Hamburg on August 29, 2011, SANE Vax Inc. requested ‘the FDA investigate the extent of the HPV DNA contamination in the Gardasil HPV4 vaccine currently on the market and take appropriate actions to ensure public safety regarding future shipments.’ 1.

Why Did SANE Vax Inc. Investigate Possible Gardasil Contamination?

The mother of a sexually naïve adolescent girl who developed acute onset Juvenile Rheumatoid Arthritis within 24 hours of her last injection of the Gardasil™ series contacted SANE Vax Inc. looking for more information.

In an effort to help her now very sick daughter the mother went to an MD practicing naturopath who conducted a toxicity test that eventually found HPV DNA in the girl’s blood. The significance of this finding is that it is highly unusual to find HPV DNA in the blood. HPV, if present in the body, exists in the epithelial (skin and mucosa) membranes. HPV or its DNA, by itself does not survive for any great length of time in the bloodstream. Why was the HPV DNA in her bloodstream two years post-vaccination?

Natural vs. Recombinant DNA

According to Dr. Lee, “‘Natural HPV DNA does not remain in the bloodstream for very long. However, the HPV DNA in Gardasil™ is not ‘natural’ DNA. It is a recombinant HPV DNA (rDNA) – genetically engineered – to be inserted into yeast cells for VLP (virus-like-particle) protein production. rDNA is known to behave differently from natural DNA. It may enter a human cell, especially in an inflammatory lesion caused by the effects of the aluminum adjuvant, via poorly understood mechanisms.

“Once a segment of recombinant DNA is inserted into a human cell, the consequences are hard to predict. It may be in the cell temporarily or stay there forever, with or without causing a mutation. Now the host cell contains human DNA as well as genetically engineered viral DNA.”

What is a Recombinant DNA Virus?

Recombinant DNA (rDNA) refers to novel DNA molecules engineered by joining natural or synthetic DNA segments to other DNA molecules so that they can replicate in a living cell. The possibility for these replicable forms of DNA as uncertain toxic substance or as environmental hazard has been a concern since rDNA technology was invented in 1973. Thus, rDNA is considered a potential biohazard, and NIH has mandated that research institutions monitor and regulate its use.2.

All recombinant or genetically engineered DNAs are considered potential biohazards if injected intramuscularly into the body. Merck’s Gardasil™ HPV4 vaccine is administered intramuscularly – as are many other vaccines. However, Gardasil™ is the first vaccine found to be contaminated by a genetically engineered DNA used to manufacture virus-like particle proteins for the vaccine.

SANE Vax Inc. believes the FDA should have required Merck to test for, evaluate and quantify the risks of residual recombinant HPV DNA in Gardasil™ before granting approval for marketing the vaccine. SANE Vax Inc. believes the FDA should require every lot of Gardasil™ be tested for residual HPV DNA prior to shipment.

Gardasil Patient Product Insert Stated No Viral DNA’s in the Vaccine.

In fact, Merck’s Gardasil™ Patient Product Inserts stated that there is ‘no viral DNA’ in the Gardasil vaccine. That is until April 2011 – when the line was glaringly absent from U.S. product inserts. 3.

The European Medicines Agency on line literature still states: ‘Gardasil is an adjuvanted non-infectious recombinant quadrivalent vaccine prepared from the highly purified virus-like particles (VLP’s) of the major capsid L1 protein of HPV types 6, 11, 16 and 18. The VLP’s contain no viral DNA; they cannot infect cells, reproduce or cause the disease.’ 4.

SANE Vax Inc.’s research found that 100% of the 13 samples tested were contaminated with viral HPV DNA residue, including a synthetic construct for HPV11 major capsid protein L1 gene, a recombinant DNA genetically engineered specifically for manufacturing of the Gardasil vaccine. All DNA residue discovered was firmly attached to the insoluble aluminum adjuvant in the vaccine, requiring a new protocol for detection.5

Dr. Lee firmly stated: “Based on medical literature and some of the FDA/Merck’s own publications, adventitious (coming from an outside source) DNA in an injectable protein-based vaccine may increase the risk of autoimmune disorders and gene mutation which may lead to malignancies.”

Merck, the FDA, CDC and the NCI Owe Medical Consumers Answers

SANE Vax Inc. wants to know how many adolescents who have suffered adverse reactions post Gardasil vaccination have HPV DNA in their blood. What are the medical ramifications should HPV DNA remain in the bloodstream for an extended period of time?

Does the aluminum adjuvant become the carrier for HPV DNA causing said DNA to remain in the blood and/or organs for an extended length of time?

Since viral DNA cannot replicate by itself (it needs a host cell) what happens if genetically engineered viral DNA enters a human host cell?

How will this now ‘genetically-engineered cell’ replicate? Will it mutate the host cell leading towards cancer?

How will genetically engineered cells affect the reproductive health of future generations?

How does the immune system react to the detection of a combination viral DNA and human DNA in what was once a ‘normal’ cell? Will the immune system fight the now genetically engineered human cell?

Medical consumers need to have these questions answered by Merck, the FDA, CDC, and NCI.

SANE Vax Inc.’s Position

SANE Vax Inc. believes the FDA and Merck should be transparent and tell medical consumers the potential health impacts the contaminant HPV DNA has brought upon the vaccinated children of the world. High rates of autoimmune disorders, 380 reports of abnormal pap tests, 137 reports of cervical dysplasia, and 41 reports of cervical cancer including Carcinoma in situ or Cervix carcinoma or Cervix carcinoma stage 0 or Cervix carcinoma stage I or Cervix carcinoma stage III 6 warrants an immediate investigation into Gardasil’s™ safety and efficacy.

SANE Vax Inc. believes the FDA and Merck should have tested, evaluated and quantified the risk of the residual recombinant HPV DNA in Gardasil™ before vaccine approval.

SANE Vax Inc. believes that both the FDA and Merck were at least negligent and perhaps fraudulent when claiming there was ‘no HPV (viral) DNA’ in the Gardasil™ vaccine.



Sources:

1. SANE Vax Inc. Letter to FDA Requesting Investigation into Gardasil Contamination

2. Policy on the use of Bio-hazardous Agents and Recombinant DNA in Research and Teaching Laboratories at the University of North Carolina at Greensboro

3. Gardasil™ Patient Product Insert

4. EMEA Scientific Discussion on Gardasil

5. Gardasil Contaminants by Country

6. VAERS Data

SANE Vax to FDA: Recombinant HPV DNA found in multiple samples of Gardasil

September 2, 2011


http://sanevax.org/sane-vax-to-fda-recombinant-hpv-dna-found-in-multiple-samples-of-gardasil/



The Honorable Margaret A. Hamburg, M.D., Commissioner August 29, 2011
U. S. Food and Drug Administration (FDA)
10903 New Hampshire Ave.
Silver Spring MD 20993-0002
Dear Dr. Hamburg:

At the request of medical consumers concerned about HPV vaccine safety and efficacy, SANE Vax Inc. has retained a private laboratory to test a number of samples of HPV 4 Gardasil™ (Merck) for possible contamination by human papillomavirus (HPV) DNA in the vaccine lots distributed to physicians.

The laboratory has informed SANE Vax Inc. that one hundred percent of thirteen (13) samples of Gardasil™ taken from lots #1437Z, #1511Z, # 0553AA, #NL35360, #NP23400, #NN33070, #NL01490, #NM25110, #NL39620, #NK16180, #NK00140, #NM08120 and #NL13560, currently being marketed in the U.S.A., Australia, New Zealand, Spain, France, and Poland have been found to be positive for HPV DNA.

One of the HPV DNA fragments detected in the vaccine is part of a synthetic construct (GenBank Locus SCU55993) for HPV11 major capsid protein L1 gene, a recombinant DNA genetically engineered specifically for manufacturing of the Gardasil vaccine. Its unique sequence is copied below for your reference.



Because one hundred percent of the samples tested were positive for HPV DNA contamination, SANE Vax Inc. requests the FDA investigate the extent of the HPV DNA contamination in the Gardasil HPV4 vaccine currently on the market and take appropriate actions to ensure public safety regarding future shipments.

The SANE Vax Inc. data, including the electropherograms of short target sequencing used to validate the HPV DNA detected in the thirteen (13) Gardasil samples, each with a different lot number, are available for your review, provided appropriate safeguards are in place to protect the proprietary processes and information utilized by our laboratory to test the samples.

Thank you for your immediate attention to this matter.

Respectfully,
Norma Erickson, President SANE Vax Inc.
154 Cecil Drive
Troy MT 59935
Signed on behalf of the Board of Directors, SANE Vax, Inc.
Leslie Carol Botha, Vice President of Public Relations
Janny Stokvis, Vice President of Research
Rosemary Mathis, Vice President, Victim Support
Freda Birrell, Secretary
Linda Thompson, Treasurer

Cervarix Vaccine Programme to Cost UK Government £5.5 Billion

Cervarix Vaccine Programme to Cost UK Government £5.5 Billion Over 73 Years Before Targeted Annual Number of Women’s Lives are Saved.


FOR IMMEDIATE RELEASE



PRLog (Press Release) – May 18, 2011 – Let’s bypass the usual conversation on arbitrating a price on the value of a person’s life. The Cervarix programme in the United Kingdom may become bankrupt before even saving one woman’s life from cervical cancer.

Freda Birrell, Secretary of SANE Vax Inc. has been communicating with government officials in the United Kingdom for the past two years about the global concerns regarding the safety and efficacy of the HPV vaccines. Unfortunately, it appears the UK government just like the U.S. CDC and FDA – do not perceive the value of their constituent’s lives; nor do they appear to be concerned over the death and injuries of previously healthy adolescent girls in their respective countries. Children are our future! When the government of any country turns their back on them, it is cause for great public concern.

Birrell determined if the life of a child is not valued by the government then it was time to analyze present information they can relate to – in this case a financial investment in a vaccine programme that will cost the UK government billions before a return is seen on their investment. Sad but true.

Birrell and her analytical team have compiled data and graphs from Cancer UK Research on cervical cancer mortality rates in a document titled: HPV 2 Cervarix Economic Costs in the United Kingdom.

The analytical team developed an economic formula to determine the cost of the Cervarix programme to the UK government by using Cancer UK Research data and making basic assumptions on cost of vaccination for targeted demographic per annum. By doing so, they determined how long it will take before perceived benefits/results of the vaccination programme will be apparent. The data translates into a hefty financial subsidy benefiting GlaxoSmithKline, but an alarmingly low rate of return for the UK government and its citizens.

HPV 2 Cervarix Economic Costs in the United Kingdom [visit http://sanevax.org/news-blog/wp-content/uploads/2011/05/ ... for more information.]

According to Cancer Research UK – female mortality rates from cervical cancer rise slightly between ages 20 to 24 – but do not peak until age 45 to 49 – with the greatest increase in women over the age of 80. (Table 1 & 2)

Cancer Research UK reports mortality rates from cervical cancer decreased from 8.3 deaths per 100,000 in 1971 to 2.4 deaths in 2008. (Table 3)

Analysis assumptions based on available data from Cancer Research UK and the UK government on the vaccination programme follows:

• Total deaths (Cancer Research UK) to age 84 at 837 per year.
• 75% of deaths saved with the vaccination program i.e. 628 per year. *
• Cost per person vaccinated – £200.00 assumed.
• Average no. of vaccinations administered per year (12 year olds) at 378,289.
• The Cancer Research UK deaths/5 year groups have been divided by 5 for an average annual figure of deaths due to cervical cancer.
• JCVI assumes HPV2 Cervarix vaccination efficacy will last 10 years. **
• It will take 73 years to vaccinate a total cycle of the female population (12 year olds to 84 year olds)




* Cervarix vaccine was introduced to protect against HPV 16 & 18, the two viruses associated with 70% of cervical cancer cases. There have been indications that this vaccine may provide additional benefits due to cross-reactivity.

** Booster shots not included in calculations

In a dramatic table, Birrell has compiled an Analysis of the Annual HPV Vaccination Programme that shows that the first deaths saved from cervical cancer – (based on administration of Cervarix to 12 year old adolescent girls in 2008) will not be seen until the year 2016 (1.2 deaths per 100,000) at a cost to the government of £75,657,800 annually with a total cost of £681 million.

In other words…over 75 million £ will have been spent each year on the vaccine programme for 9 years to save one life….which Cancer Research UK has shown to be the mortality rate for this age group. (Table 2)

Now are you listening?

But wait there is more…according to Birrell’s research –

• It will take 28 years to save the first 628 lives, the annual target at a cost of £3.2 million for each life saved.

• It will take 73 years to save 628 lives annually – At a cost of £340,360 for each life saved.

The analysis also projects a total of 16,227 lives in the UK will be saved in total over the first 73 years – with an average of only 222 lives saved annually. In addition, it will take 240 years before the cost of a life saved falls below £150,000.

Add in the fact that the vaccine efficacy is only expected to last 10 years, meaning the girls first administered the vaccination series in their teens will need a booster in their 20’s…and so on up the ladder. Those pro-inflated costs and the costs associated with recommended annual pap screening were not included in Birrell’s analysis. Costs associated with vaccine adverse injuries were also not used in this equation.

Birrell was unable to uncover information in the public domain on the financial benefits to the UK government from this vaccination programme – justifiably raising serious questions over the Pharma/government agenda behind the HPV Vaccine programme.

Bottom line – bottom dollar – the UK government will spend £5.5 billion over the first 73 years of the vaccination programme with the expectation of saving 628 lives each year but with the current efficacy being only expected to last 10 years then these costs are grossly underestimated if a booster jab is introduced. If no booster jab is introduced and the efficacy falls at around age 22, it would render the previous ten years a total waste of public funds, accomplishing nothing more than giving false hope to all the participants who believed they would be ‘armed for life’ against cervical cancer.

SANE Vax Inc. can see no economic justification for this programme. We believe the UK government has been misled by the pharmaceutical industry regarding the risk to benefit profile of HPV vaccine programmes. Should other government leaders start doing the math regarding the cost of each life saved, we believe they would unveil HPV vaccination programmes as a colossal waste of public health funds with very few benefits to their constituents.

# # #

Press Release:
http://www.prlog.org/11496237-cervarix-vaccine-programme-to-cost-uk-government-55-billion.html PDF File – HPV 2 Cervarix Economic Costs in the United Kingdom
http://sanevax.org/news-blog/wp-content/uploads/2011/05/SV-HPV-2-Cervarix-Economic-Costs-05.14.2011.pdf




SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.

Gardasil – The Grim Reaper – Mounting Injuries Last as Long as Vaccine Efficacy

Gardasil – The Grim Reaper – Mounting Injuries Last as Long as Vaccine Efficacy

By Leslie Carol Botha
April 25, 2011

PR Log

FOR IMMEDIATE RELEASE

PRLog (Press Release) – Apr 25, 2011 – It is becoming hard to comprehend why the United States government; FDA, CDC and the NCI have blatantly turned their backs on the thousands of families whose daughters and sons have been severely injured by Merck’s Gardasil vaccination. GlaxoSmithKline is not off the hook on this either as mounting injuries from Cervarix (approved in the US in 2009) are now being reported to VAERS. How many deaths and how many injuries is it going to take before these vaccines are taken off the market?

The latest VAERS reports include:

• 376 abnormal pap smears post HPV vaccination
• 108 reports of anogenital warts found after HPV vaccination
• 224 reports of papillomavirus infections found after HPV vaccination
• 41 reports of cervical cancer after HPV vaccination
• 21,634 Adverse Events
• 95 Deaths

The numbers reflect approximately, 1 to 10% of the adverse event population reporting. Medical consumers and physicians do not often think that vaccinations harm people – and therefore injuries and illnesses are not immediately associated with the vaccine.

HPV vaccines have been administered to adolescent girls and boys whose parents believed in the government’s vaccine program. They followed their physician’s advice – and have been deceived. What does that say about a government ‘for the people’?

SANE Vax, Inc. is outraged at the injustice shown to these families who now suffer from loss of life or diminished quality of life; outraged by their financial helplessness as they pay for mounting medical bills not covered by health insurance companies.

It is apparent in this country – the only one’s innocent until proven guilty are the government and corporations – who have protected themselves from liability. For the rest of us – well, we are guilty until proven innocent – and the burden of proof lies on our shoulders.

SANE Vax, Inc. has prepared a Global Concerns about HPV Vaccines Fact Sheet that includes the peer reviewed analysis, research documents and data that prove the culpability of Merck, GlaxoSmithKline, the CDC, FDA, and NCI in regards to fast tracking the HPV vaccines to medical consumers. The SANE Vax Team believes it is time to hold them accountable for their actions. The Fact Sheet is posted on the SANE Vax, Inc. web site at http://sanevax.org/news-blog/2011/04/sanevax-presents-gl …

The HPV Vaccine Fact Sheet was created so that it could be shared globally with politicians, physicians, the media and anyone looking for an overview of the concerns about the Gardasil and Cervarix travesty.

We are hoping readers will post the fact sheet to their Social Media Network sites and circulate the fact sheet far and wide. If we cannot get through to our government – then we, the people, need to make it our responsibility to educate other innocent medical consumers to prevent the Grim Reaper from striking down more innocent adolescents.

SANE Vax Inc. is dedicated in our efforts to remove Gardasil and Cervarix from the market until independent studies on their safety and efficacy are conducted. We have become internationally recognized and known for the research and work we have done on this issue. Conversely, we are now being contacted by more mothers whose daughters have been adversely affected by HPV vaccines. Most of these injuries have not been reported to VAERS. We have even heard of a new death – another previously healthy teenage girl who went to bed on a Sunday night and never got up to go to school the next morning.

Read the comments from mothers and other innocent girls affected by HPV vaccines. The government and Big Pharma must be held accountable for the innocent lives they have destroyed. Government agencies and pharmaceutical companies have become the Grim Reaper.

“My 15 year old autistic daughter was given all three Gardasil injections in 2009, and hasn’t been well since. She’s struggled her entire life with development delay, OCD, stuttering, and a seizure disorder that hasn’t reared its head since she was 9, so we’re not unfamiliar with hardships. Shortly after her last Gardasil injection, she began to have chronic vaginal itching, low grade fevers, severe headaches, abdominal pains, dizziness, leg pains, heart racing, heightened sense of her heartbeat and blood flow, fatigue, and an overall feeling of illness. I’m sure there are other symptoms that I’ve passed off as growing pains, hormones, you name it. I’m relieved to find this group, and join the ranks as another frustrated, determined mother, who is ready to see the makers and distributors of this “vaccine” be accountable for what they have done to our daughters.”

“My daughter who has just turned 14 years old has been unable to attend school due to fatigue and nausea and other symptoms since last December 2010. When I took her to her G.P. and had all the usual blood tests done they returned as normal. I did mention to the doctor that my daughter had had her second HPV injection at school just before she began to feel sick, but she dismissed any connection. The third vaccination injection is due this Thursday and I have decided to not allow my daughter have this final injection. Is this o.k. for her not to complete the vaccination programme as I am now suspecting that there may be a connection between the vaccination and her illness? My daughter has just started back to school this week after an absence of over three months. She is attending for only a few hours per day as she is too fatigued to manage any more than that.”

“I just had an MRI completed for my lower lumbar spine; I had a minor sports injury. Results read “bladder distention was noted.” I completed my Gardasil vaccine over a year and a half ago, and two months after started noticing extra pressure and pain in my abdomen, and enlarged lymph nodes. Prior to the vaccine, I never experienced any of my “symptoms” and Gardasil is the biggest regret of my life. It was pushed upon me by my 3 doctors for years, promising it was safe, and there were no side effects associated. After I started complaining about tiredness and abdomen pain, major side effects were being brought to my attention. I feel deceived, lied to, and tricked. I experience discomfort and occasional pain when I am intimate with my partner. I have trouble urinating, and urinate frequently now. I am 24 years old, and devastated about my experience and findings. I am depressed and fearful of other complications it may cause in the future and can only be hopeful that I didn’t damage and will not pass on any complications to a child.”

“I am writing to u because I was also affected by Gardasil. I now have limbic encephalitis, which is the swelling of the brain, along with heart palpitations which don’t let me sleep, extremely bad headaches, body pain every morning, bone problems, anxiety problems, the list goes on forever. If you can please contact me, I would really appreciate it.”

# # #

SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.

SANE Vax, Inc. Declares Major Victory in Gardasil Awareness Campaign

In a long awaited decision(1), the US FDA has ruled against Merck's supplemental biologics license application (sBLA) for an indication to use GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in women ages 27-45. This was Merck’s 4th request to expand Gardasil use to an older population of women.

SANE Vax, Inc. applauds the FDA on their decision. According to Norma Erickson, President, "This decision is a major victory for medical consumers around the world. I would like to personally thank the SaneVax Team as well as each one of the medical professionals, scientific researchers and educators who have helped get the truth behind the development, testing, approval and marketing of this vaccine out to the public. All of their hard work is empowering medical consumers worldwide to say, "Enough is enough! If it is not Safe, Affordable, Necessary and Effective - we don't need it!"

Leslie Carol Botha, Vice-President of Public Relations for SANE Vax, Inc. made this statement: “it is obvious the SANE Vax Gardasil Awareness Media Campaign has been effective. We have communicated our concerns to the FDA on multiple occasions using science based peer reviewed analysis, and at the same time we have written and distributed hundreds of press releases and articles documenting not only the research but the damage Gardasil has done to previously healthy adolescents. We can proudly say medical consumers, and doctors, as well as our government are paying attention to our concerns.

FDA Ruling an Admission of Guilt?

A press release issued by Merck on April 6, states that: “An indication for adult women was not granted; instead, the Limitations of Use and Effectiveness for GARDASIL was updated to state that GARDASIL has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age. End of study data from the clinical study evaluating the use of the vaccine in this age group was also added to the prescribing information.”(2)

SANE Vax Inc., believes Gardasil has not been demonstrated to prevent CIN 2/3 or worse in women younger than 26 years old either. Clinical trials used an endpoint insufficient to clearly demonstrate efficacy in this arena. Therefore, we believe that Gardasil needs to be taken off the market until an independent study on the vaccine’s safety and efficacy is conducted.

SANE Vax, Inc. will continue our campaign until Gardasil is taken off the market.

On October 25, 2010 SANE Vax Inc., issued a Business Wire press release asking the FDA to rescind approval of Gardasil because of “Inappropriate Endpoint and Unreliable HPV Genotyping Methods Used for Vaccine’s Efficacy Evaluation” following formal letters sent to Margaret Hamburg, FDA Commissioner, and former Chair of VRBPAC, Jack Stapleton.

In a letter addressed to Dr. Margaret Hamburg, the FDA commissioner, Ms. Norma Erickson, President of S.A.N.E. Vax, Inc. stated her research team has revealed the fact that in November 2001 the VRBPAC (Vaccines and Related Biological Products Advisory Committee) mistakenly allowed the vaccine manufacturer to use “CIN 2/3, AIS, or cervical cancer; i.e. CIN 2/3 or worse by histology- with virology to determine the associated HPV type- as the primary endpoint in the evaluation of a vaccine to prevent cervical cancer.”(3)

In the press release “Erickson pointed out that in the natural history of cervical cancer development only a small fraction of the CIN 2 lesions will progress to CIN 3 lesions; and only a small fraction of CIN 3 lesions will progress to cervical cancer. Therefore, there are many more CIN 2 lesions than CIN3 lesions and cervical cancers combined in any female population, including the subjects enrolled in the Gardasil™ clinical trials. As a result, the overwhelming majority of the “CIN 2/3 or worse” cases used for evaluation of efficacy and listed in the VRBPAC Background Document on Gardasil™ HPV Quadrivalent Vaccine presented at the May 18, 2006 VRBPAC Meeting must have been CIN 2 lesions.

Erickson quoted a scientific report in which the National Cancer Institute (NCI), the inventor of the HPV vaccine technology and co-developer of Gardasil™, concluded "CIN 2 is not a true biologic entity but an equivocal diagnosis of pre-cancer, representing an admixture of HPV infection and pre-cancer. The existence of CIN 2 biopsy results as a clinical entity may be the consequence of the inaccuracies of colposcopy and colposcopically directed biopsy, which could result in less-than-perfect representation of the underlying disease state. That CIN 2 is the least reproducible of all histopathologic diagnoses may in part reflect sampling error...”

Consequently, the FDA has allowed Merck & Co., Inc. to market Gardasil™ as a cancer vaccine, when in fact it has only been proven to prevent “not a true biologic entity”- a reversible CIN2 change.” (2)

SANE Vax Inc. believes the FDA has opened the door to formally question the validity of the end point utilized in Merck’s initial Gardasil clinical trials. The shadow of doubt has been cast – but not until after the vaccine caused severe damages and untimely deaths to the very population Gardasil was designed to protect.

Sources:
1. Expand or Not Expand–That's the Question/Will FDA Approve Merck’s 4th Request to Expand Gardasil - visit http://www.prlog.org/11126388-expand-or-not-expandthats-the-questionwill-fda-approve-mercks-4th-request-to-expand-gardasil.html for more info
2. U.S. Prescribing Information for GARDASIL® Updated; Indication Not Granted for Use in Adult Women - visit http://www.merck.com/newsroom/news-release-archive/vaccine-news/2011_0406.html?WT.svl=content&WT.pi=content+Views for more info
3. S.A.N.E. Vax, Inc. Asks FDA to Rescind Approval of Gardasil™: Inappropriate Endpoint and Unreliable HPV Genotyping Methods Used for Vaccine’s Efficacy Evaluation - visit http://www.businesswire.com/news/home/20101025005268/en/S.A.N.E.-Vax-Asks-FDA-Rescind-Approval-Gardasil%E2%84%A2 for more info
4. visit http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/default.htm for more info

# # #


SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.

Abortion Stillbirth Events from Gardasil Far Exceed All other Vaccines

According to a National Vaccine Information Center (NVIC – http://nvic.org) MedAlerts blog entry written in November 2010, the incidents of abortion and still birth events from the HPV4 vaccine, Gardasil supersedes the same event from all other vaccinations.

The research and post was written by Steven M. Rubin, Ph.D., a computer scientist who maintains the online searchable VAERS database, MedAlerts. He has managed this database voluntarily and independent of his official work since 2003 and has worked with the NVIC since 2005. 1.

In his blog entry on MedAlerts, Dr. Rubin states that “It has been suggested that the H1N1 Flu vaccine causes miscarriages. This month, I want to see if the claim is supported by VAERS data.” 2.

Dr. Rubin explains how it is determined whether a VAERS event resulted in a miscarriage. “VAERS uses the MedDRA symptom classification, which organizes all known symptoms at five levels of detail. At the second level of detail is an entry “Abortions and stillbirth” which has under it “Abortion related conditions and complications”, “Abortions spontaneous”, “Stillbirth and foetal death” and “Abortions not specified as induced or spontaneous”. Each of these is further refined into specific symptoms. So it seems that this second-level term (or as it is known in MedDRA, the High-Level Group Term or HLGT) is a valid way to identify miscarriages.”

He surmised the data would “surely favor vaccines that have been given for 21 years over those that have been recently introduced, because such vaccines will have been given much more, and so will have produced many more symptoms. In other words, this graph should de-emphasize the H1N1 Flu vaccine, which has existed for just one year. We should see relatively few H1N1-related miscarriage events compared with the “Seasonal” Flu vaccine which has been administered to many more patients.
However, the VAERS data proved him wrong. Dr. Rubin acknowledges the “results are shocking. First of all, the H1N1 Flu vaccine has appeared in miscarriage events more often than almost any other vaccine.

And then he states:
But the graph has more shocking results for us. The H1N1 Flu vaccine appears in many of the abortion/stillbirth cases, but not the most. The “winner,” appearing in 297 of the VAERS records associated with miscarriage, is Gardasil (vaccine code HPV4)! Once again, this vaccine is a newcomer, having only existed for 4 years.
His advice to pregnant women is to “read the product manufacturer’s insert for the vaccine they are considering and speak with one or more trusted health care professionals before making a decision about vaccination during pregnancy.”

According to a recently released study; New Adjuvanted Vaccines in Pregnancy: What is Known About Their Safety?
“Owing to the fact that pregnant women are usually excluded from the majority of clinical trials on vaccines, little is known about the side effects of adjuvants during pregnancy. There are only a few published studies on the safety of adjuvanted vaccines during pregnancy. These studies, however, concentrated on the extreme effects of adjuvanted vaccines on pregnancy (i.e., teratogenic effects). No attention has been paid to more subtle effects, such as effects on placental development or fetal weight or the effects of the vaccine or its adjuvant on the maternal immune system. During normal pregnancy, the maternal immune system adapts to accommodate the semiallogeneic fetus and interference with this immune system may interfere with normal pregnancy.3

SANEVax is outraged that a vaccine that is a “relative newcomer” has the highest incident of induced abortions and stillbirth rates higher than any other vaccine on the market. There is no doubt the vaccine’s safety and efficacy has not been thoroughly investigated. And independent investigation on the safety and efficacy of the HPV vaccines, Gardasil and Cervarix must be conducted before there are more injuries and deaths.
There is currently no vaccine specifically approved by the FDA for use during pregnancy in the United States. Caveat Emptor – let the consumer beware!

One More Girl
It is obvious that the pharmaceutical marketing campaign promises of ‘One Less Girl’ at risk for cervical cancer and ‘armed for life’ have turned into a global travesty as each day ONE MORE GIRL suffers and adverse reaction or and/or death – or the death miscarriage/stillbirth of her baby after taking Gardasil or Cervarix.

Please support the ONE MORE GIRL Documentary http://www.kickstarter.com/projects/1995527181/one-more-girl-documentary – so the truth about the damage done to innocent girls can be told to prevent this global travesty from ever occurring again.
Sources:
1. Steven M. Rubin Biography http://www.nvic.org/about/Steven-Rubin-Profile.aspx
2. MedAlerts, http://medalerts.org/analysis/archives/263
3. New Adjuvanted Vaccines in Pregnancy: What is Known About Their Safety? 01/13/2011; Expert Rev Vaccines. 2010;9(12):1411-1422. © 2010 Expert Reviews Ltd. http://www.medscape.com/viewarticle/734891

15,000 Reasons to Support One More Girl Documentary Reporting on Gardasil Vaccine Injury and Death

As reports of injury and death related to the Gardasil HPV Vaccine continue to rise, a documentary is being developed to tell the story from the eyes of the victims and the parents. The Truth About Gardasil will soon be revealed.


PRLog (Press Release) – Jan 17, 2011 – There are now almost 15,000 signatures on the National Vaccine Information Center (NVIC) Investigate Gardasil Vaccine Risks NOW! petition, http://www.nvic.org/Petition.aspx. The goal is to reach 30,000 signatures and to send a strong message to President Barack Obama, his Administration, Congress and the world “to investigate the expedited licensing and universal use recommendation by federal health agencies that all girls aged 11-12 years old and young women up to age 26 receive three doses of Gardasil. The petition on behalf of families is urging the President and Congress to take action to minimize the human and economic costs of Gardasil vaccination for individuals and the public in order to protect the lives of Americans who trust the government to ensure that vaccines licensed for public use are safe, effective and necessary.”

SANEVax is reporting that as of January 15, there are now 21,171 adverse reactions and 91 deaths reported to the Vaccine Adverse Event Reporting System. This is an estimated 1 to 10% of injuries and deaths reported. The United States government needs to know that medical consumers are demanding that an independent study be conducted on the safety and efficacy of Gardasil before the vaccine damages one more adolescent girl or boy.
Signing the petition – does not cost anything but your time…and your time is needed now. Once you read through the signatures and comments on the petition, you will begin to understand the global travesty unfolding before our very eyes. These are just a few of the comments that have been posted to the petition over the last week.

# 14,989
04:01, Jan 14, Joellen Leary, New York
My niece has experienced many seizures with damages done to her brain.

# 14,980
03:37, Jan 13, Jocelyne Gervais, Canada
A daughter's friend on FB died from Gardasil.

# 14,979
16:33, Jan 12, Michael G. White, South Carolina
Our 13 yr old daughter had a major uticaria outbreak 5 weeks after her 3rd gardasil shot. She now has had 3 major outbreaks in total. We are treating with Prednisone. This is a daily nightmare. We MUST get some help from Merck and our FDA/CDC agencies.

# 14,976
09:05, Jan 11, Cheryl Koehn, California
My daughter had all three shots and 5 weeks after her second shot she was hospitalized and diagnosed with Juvenile Rheumatoid Arthritis, rare but still a side effect. She is 15 now and that was over two years ago and she is still in pain and has to endure giving herself two shots a week and taking other medications.

# 14,969
21:19, Jan 08, Jen Shawley, Pennsylvania
Daughter has epilepsy now. Had shot when she was 14. Is 16 now and cannot drive. Just had another grand mal 2 weeks ago. Seizures don’t run in our family, but funny how doc keeps blaming family history??? She is on high doses of meds 4500mg plus 2500 mg of another and shes still having seizures. God is her only answer to help her through this because these doctors don't know what there doing & meds are not working. Gardasil IS NOT SAFE!!!!! I cry every night because she didn't want this shot and I was pressured into doing the right thing for her by these stupid idiots that turn the other cheek to these side effects!!! God help us and heal these children. Make the families aware of the truth and keep are children safe. In your Holy name I pray, Amen…

The ‘One Less Girl’ campaign has turned into ONE MORE GIRL adversely injured.

When you get angry – and the SANE Vax Team hopes you become furious over this medical experiment injuring thousands of innocent girls and harming thousands of families, we are asking that you take the time to sign the petition is support of this families, and then, donate whatever you can to the production of the most important documentary of the 21st century, One More Girl. http://www.onemoregirlfilm.com .

This provocative film documents the stories of the numerous girls adversely affected by the HPV vaccines – giving these young women and their families a chance to speak out – share their dismay and sense of betrayal for simply believing the pharmaceutical and medical industries were protecting them when marketing HPV vaccines for the prevention of cervical cancer. Filled with stories of anguish, loss of innocence, guilt on the part of mothers who encouraged their daughter’s to get the vaccine – and financial devastation as families use their hard-earned savings to find a cure for their daughter’s illness, leaving no viewer untouched. Interviews with mothers whose daughters lost their lives after receiving the vaccine bring tears to your eyes – raising the question of how the marketing of a medical experiment got by the world’s health regulatory agencies.

ThinkExist Productions is working in conjunction with two advocacy groups, TruthAboutGardasil.org (http://truthaboutgardasil.org) and S.A.N.E.Vax, Inc. (http://sanevax.org) to include the history, research, and data both organizations have compiled over the last four years. Combined, the organization’s global networks include concerned activists in 120 countries and every state in the U.S. In addition to telling the stories of adverse reactions and death, the documentary will also cover the social/political trail of deception over the global mass marketing of the HPV vaccines.

The preview of One More Girl can be viewed at http://www.kickstarter.com/projects/1995527181/one-more-girl-documentary.
There are 15,000 reasons to sign the NVIC Investigate Gardasil Vaccine Risks NOW! petition and to donate the to the production of the One More Girl documentary. Let us show the world that medical consumers are standing together on this issue.
Most importantly, the girls adversely injured by Gardasil want to tell their stories – to prevent others from being injured – and to be remembered as the victims of a vaccination program gone bad.

Sign the petition and donate today.

On behalf of the 21,000 adversely injured and the families of the 91 girls who have died, we thank you.

Please visit our site at http://sanevax.org/

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THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.

One More Girl Unveils Truth behind HPV Vaccine Travesty - Documentary Hailed as Social/Political Statement on Marketing of Global Medical Experiments

Jan 11, 2011 – Ryan Richardson and brother, David, announce the debut of a special preview of their new documentary, One More Girl

This provocative film documents the stories of the numerous girls adversely affected by the HPV vaccines – giving these young women and their families a chance to speak out – share their dismay and sense of betrayal for simply believing the pharmaceutical and medical industries were protecting them when marketing HPV vaccines for the prevention of cervical cancer. Filled with stories of anguish, loss of innocence, guilt on the part of mothers who encouraged their daughter’s to get the vaccine – and financial devastation as families use their hard-earned savings to find a cure for their daughter’s illness, leaving no viewer untouched. Interviews with mothers whose daughters lost their lives after receiving the vaccine bring tears to your eyes – raising the question of how the marketing of a medical experiment got by the world’s health regulatory agencies.

Donielle Richardson, 18 year old sister of the Richardson brothers was also adversely injured by Gardasil and it was her adverse reaction and long road to recovery that motivated the Richardson family to research other Gardasil injured girls. Their discoveries compelled them to create a documentary powerful enough to prevent this type of travesty from happening to any medical consumer – ever again.

ThinkExist Productions is working in conjunction with two advocacy groups, TruthAboutGardasil.org (http://truthaboutgardasil.org) and S.A.N.E.Vax, Inc. (http://sanevax.org) to include the history, research, and data both organizations have compiled over the last four years. Combined, the organization’s global networks include concerned activists in 120 countries and every state in the U.S. In addition to telling the stories of adverse reactions and death, the documentary will also cover the social/political trail of deception over the global mass marketing of the HPV vaccines.

The preview of One More Girl can also be found on http://www.kickstarter.com/projects/1995527181/one-more- .... Kick Starter – Fund & Follow Creativity is a unique site for film producers and aficionados to preview documentary concepts and donate funds for the completion of the films. This is a new and exciting concept that puts film production back into the hands of the people who appreciate the power of documentary story telling instead of allowing the film industry to determine the nature and content of the message.

One More Girl anticipates the necessary funding will be raised in 90 days and has plans to go into full production the second quarter of 2011. The documentary release date is tentatively scheduled for the summer of 2012.

ThinkExist Productions,TruthAboutGardasil.org, and SA.N.E.Vax, Inc. plan to market One More Girl globally – and will enter the film into various film festivals. One More Girl promises to be a powerful documentary exposing the truth about HPV vaccines.

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THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.

Global Concerns about Gardasil–Stating the Obvious-93 countries Visit the SANEVax Site in 104 Days

Vaccine Injury is a GLOBAL issue. 93 countries visit SANEVax since new website opened in September. Is this an indicator of how widespread the issue is?

Jan 06, 2011 – On September 16, 2010 five women active on the HPV vaccine issue Norma Erickson, Leslie Carol Botha, Rosemary Mathis, Freda Birrell and Janny Stokvis launched a new website – SANEVax.org – as a clearinghouse of research, data and peer reviewed analysis/studies for professionals (attorneys, researchers, physicians, politicians) and consumers searching for information not only regarding the HPV vaccines, Gardasil® and Cervarix®, but other vaccinations of concern as well.

The SANEVax mission is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine. Our primary goal is to provide the information necessary for you to make informed decisions regarding your health and well-being. We also provide referrals to helpful resources for those unfortunate enough to have experienced vaccine-related injuries.

Obviously, the SANEVax message and mission drew immediate world wide attention. As of December 30, visitors from 93 countries have visited the site – as well as visitors from every state in the U.S. Average length of time on the site is over 6 minutes.

SANEVax.org has become known the world over for its research-based press releases, articles and letters to government officials protesting continued distribution and administration of the HPV vaccines until an independent study on their safety and efficacy has been conducted.

Those countries in order of ranking are: United States, Italy, Canada, United Kingdom, Ireland, Australia, France, Netherlands, Spain, India, New Zealand, Belgium, China, Malaysia, Germany, Singapore, Norway, Greece, Switzerland, United Arab Emirates, Sweden Philippines, Slovakia, Finland, Portugal, Russian Federation, Israel, Poland, Thailand, Romania, Brazil, Taiwan, South Africa, Mexico, republic of Korea, Japan, Austria, Saudi Arabia, Puerto Rico, Indonesia, Hungary, Egypt, Czech Republic, Colombia, Bulgaria, Luxembourg, Hong Kong, Estonia, Viet Nam, Turkey, Slovenia, Serbia, Pakistan, Denmark, Croatia, Ukraine, Republic of Moldova, Malta, Lithuania, Latvia, Jamaica, Islam Republic of Iran, Iceland, Ecuador, Chile, Virgin Islands, U.S., Uganda, Trinidad and Tobago, Seychelles, San Marina, Qatar, Peru, Northern Mariana Islands, Nigeria, Nicaragua, Netherlands, Antilles, Morocco, Macedonia, Kuwait, Kenya, Jordan, Guatemala, Guam, Grenada, Georgia, Bolivia, Bangladesh, Bahrain, Bahamas, Argentina, Angola, Algeria and Albania.

In addition, the SANEVax Facebook account now has over 2000 confirmed friends and is growing weekly.

Global Concerns about Gardasil? Isn’t the obvious – obvious?

Please visit the site at http://sanevax.org/ .

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THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.

A Gardasil Girl – A Mother Speaks Out

A mother's struggle after her daughter becomes injured by the HPV Vaccine Gardasil. Where does she turn for help? The horrible reality of what is occurring to our children after vaccination with the HPV Vaccine.

Jan 02, 2011 – The Daily Guggie Daly
by Jodie Speakman

“My daughter, Victoria, has been ill since February 2008. She had her first Gardasil vaccination November 2007. Her second vaccination was in the beginning of February 2008. Immediately after her second vaccination, Victoria experienced severe diarrhea, vomiting and was nauseous for about eight weeks. She had blood work done many times and doctors thought it was just a virus. On March 31, 2008, she had her first seizure.

My daughter has had several CT scans, MRI’s, MRA’s, EEG’s, blood work and was hospitalized at an epilepsy center in the video EEG monitoring unit for two separate weeks in May 2008 and September 2008. She attempted to undergo a spinal tap in September 2009, but doctors were unable to obtain any fluid. On November 11, 2009, she underwent a lumbar puncture with fluoroscopy. She was put on many different seizure medications, however, after normal EEG results, she was taken off all medications. Her SED rate was high and she did have protein in her urine, but doctors do not seem concerned. I was told that her red blood are small and that she may have Thalasemia, but this apparently is not concerning either.

My daughter has been seen by several neurologists, a psychiatrist, psychologist, several neuropsychologists, an immunologist, several infectious disease doctors, and also treated a at Wellness Center for a period of time. My daughter currently experiences the following symptoms: non-epileptic seizures, severe jerking movements of her whole body, especially her mouth and extremities, migraines, fainting, tremors, twitches, numbness, intermittent leg paralysis, hand/arm paralysis and facial paralysis, tingling, staring or blank episodes, eye pain, joint pain, neck pain, back pain, memory loss, confusion, brain fog, regression, mood swings and severe chronic fatigue. She continues to have bouts of nausea and diarrhea and stomach pain. She has not been in school since April 2008. My daughter cannot be left home alone. She cannot go to school, go out with her friends or work or has little “normalcy” in her life. She has very few good days and always says she doesn’t feel good. Victoria should have graduated high school in June 2009 and would have been enrolled in college.

I do not know which way to turn for help. We have seen so many doctors and I can’t seem to find anyone willing to help my daughter. There are so many other young girls who have the same exact symptoms as my daughter and the one thing that all of the girls seem to have in common is the Gardasil vaccination. Many doctors are all over the country are beginning to question the safety and also the effectiveness of the vaccine. Other “doctor” are willing to “try” treatment, most of which is “homeopathic” in nature and extremely costly.

Once again, I must reiterate that there are so many other young girls experiencing negative symptoms.

Each day, I cry and wonder if Victoria will be next one to die from adverse reactions to Gardasil.

Please forward this information.

Thank you for your time and attention.

Jodi Speakman
jodispeaks@aol.com

For more information, go to http://sanevax.org/blog/?p=1644.

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THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.

FDA Approves Merck Gardasil for Anal Cancer: Deadly Choices?

December 30, 2010 Published in AGE OF AUTISM

SANEVAX Questions the FDA Approval of Merck's Gardasil for anal cancer. Dr. Julie Gerberding, head of the vaccine division for Merck, was the head of the CDC under President Bush, and was responsible for the pediatric vaccine schedule, which included adding Dr. Paul Offit's Merck vaccine RotaTeq during her watch. From SANEVAX, a watchdog group concerned with adverse reactions, including death, from the genital wart vaccine called Gardasil (and it's competitor from GlaxoSmithKline Cevarix.)

...According to the National Cancer Institute, an estimated 5,260 people will be diagnosed with anal cancer in 2010 (United States). 720 fatalities due to anal cancer are anticipated. The average age at diagnosis is 60. The data presented in a 1996 study indicates you are over 10 times more likely to die from an overdose of over-the-counter pain medications, such as aspirin, than you are to die of anal cancer. Merck made no mention of these facts anywhere in the documentation they presented to the FDA.

SaneVax wants to know, “In what universe does this make a convincing argument for vaccinating people ages 9 to 26?”

Read the full story at http://sanevax.org/blog/?p=1594.

HPV Vaccine (Gardasil and Cervarix) VAERS Reports - Injury Statistics Increasing at Rapid Rate

The injury and death related to the HPV Vaccines Gardasil and Cervarix continue to rise. How many will it take before the FDA takes action?

Dec 13, 2010 – One week ago SANE Vax researcher, Janny Stokvis of the Netherlands reported the latest VAERS data on deaths and injury from the HPV vaccines.

Those numbers stood at:

20,575 adverse reactions
352 reports of abnormal pap smears post vaccination
89 reported deaths (plus 5 reports submitted to the FDA obtained by Judicial Watch under the Freedom of Information Act (FOIA) now missing from VAERS)

As of December 13, 2010 new reports state:

20,915 adverse injuries - an increase of 340 adverse events in one week.
370 reports of abnormal pap smears post vaccination (18 new cases submitted in a week, three are related to Cervarix)

Reported deaths remain the same - 89 reported deaths (plus 5 reports submitted to the FDA obtained by Judicial Watch under the Freedom of Information Act (FOIA) now missing from VAERS)

On December 13, 2010 Medpage Today released this article:

Many Fail to Finish HPV Vaccine Series as Recommended (http://www.medpagetoday.com/Pediatrics/Vaccines/23873)

Researchers reported that many girls and young women may not be completing all three doses of the quadrivalent human papillomavirus vaccine in a timely fashion.

SANE Vax believes that it is high time to take into consideration that many girls are not completing the series because of adverse reactions to the HPV vaccines.

For more information, visit http://sanevax.org/.

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THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.

Gardasil Approval: FDA Apparently Does Not Follow Its Own Rules

Did the FDA grant approval for Gardasil the HPV Vaccine even though it didn't meet their criteria?

Dec 10, 2010 – According to FDA rules, in order to obtain ‘fast-track’ approval a new drug or medical treatment, two criteria must be satisfied. The drug/treatment must be for a serious disease and it must fill an unmet medical need. According to the FDA, filling an ‘unmet medical need’ is defined as, “providing a therapy where none exists or providing a therapy which may be potentially superior to existing therapy.”

There is no doubt cervical cancer is a serious disease. However, one has to question how Gardasil met the second criteria of filling an ‘unmet’ medical need. Due to regular cervical cancer screening and appropriate medical follow-up when abnormal cervical cells are detected, cervical cancer rates in the United States have dropped over 74% and continue to decline. This is the case in most developed countries around the world. So, where is the ‘unmet medical need?’

Another problem arises when HPV is purported to be a cause of cervical cancer. Several high-risk genotypes of human papillomavirus (HPV) have been associated with cervical cancer, but not established as a cause of cancer. Persistent HPV infections occurring from the same genotype, increase the risk of cancer. No one has determined whether or not persistent infections actually cause cancer without other risk factors being present.

The truth is 90% of all HPV infections clear on their own without medical intervention. Of the 10% left, only 5% of these will ever develop into cancerous cells. Cervical cancer takes between 5 and 15 years to develop. 95% of cervical cancer is treatable and curable. Almost all fatalities from cervical cancer can be avoided with good gynecological care. Again, where is the ‘unmet medical need?’

In addition to these two criteria, FDA guidelines say, if there are existing therapies for the disease a proposed drug/treatment is intended for a fast-track drug must show some advantage over available treatment(s), such as:

1. Showing superior effectiveness – Gardasil will not be able to show that for at least 10-15 years.

2. Avoiding serious side effects – there are no serious side effects to regular screening and appropriate follow-up.

3. Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome – not applicable to HPV vaccines.

4. Decreasing a clinically significant toxicity of an accepted treatment – again, not applicable to HPV vaccines.

Despite the fact that the only criteria Gardasil could have possibly met was the intent to combat a serious disease, the FDA granted fast-track approval for the product in June of 2006.

Now, American medical consumers have seen the post-HPV vaccination adverse events reports approaching 21,000 and there are 89 families who have ‘one less’ child. Perhaps, the FDA needs to study the rules.

Sources:
View http://www.fda.gov/downloads/Drugs/GuidanceComplianceReg ... for more information on FDA fast-track approval guidelines.

View http://www.infectiousdiseasenews.com/article.aspx?id=37036 for more information on HPV clearing on its own.

View http://womenshealth.about.com/cs/cervicalcancer/a/hpvcer ... for more information on the HPV connection to cervical cancer.

Please visit our site at http://sanevax.org/.

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THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.

To Expand or Not Expand–That's the Question....Will FDA Approve Merck’s 4th Request to Expand Gardasil?

Research submitted to the Center for Biologics Evaluation & Research (CBER) on Monday October 25, 2010 related to the adverse effects of the HPV Vaccines. Will the FDA respond?

Dec 06, 2010 – Leslie Carol Botha and Cynthia Ann Janak prepared an extensive power point for the FDA on HPV Vaccines Mechanisms of Action in Women – Endocrine Influence, HPV – Pre Testing and Immune System Involvement. The document was submitted to the Center for Biologics Evaluation & Research (CBER) on Monday October 25, 2010.

The information included in the presentation has implications not only for female adolescent health – but for women ages 26 to 45 and older who may be the next age group for HPV vaccination approval.

December 3, 2010 – HPV Vaccine VAERS reports (women ages 9 to 26)

20,575 adverse reactions
352 reports of abnormal pap smears post vaccination.
89 reported deaths – plus 5 reports submitted to the FDA, missing from VAERS, uncovered via the Freedom of Information Act (FOIA) by Judicial Watch

Botha and Janak’s intent is to provide research and data to support the hypothesis that the HPV vaccines may even be more dangerous in an older age group with hope of preventing FDA approval of Merck’s 4th request to expand Gardasil use to older women.

The FDA declined to make a comment about the research presented - nor did they choose to listen to a verbal presentation – nor did they attempt to answer any questions raised by the research presented. Instead Botha and Janak were told via email: The CBER team thanks you for the additional information since the last listening session. At this point, they do not want to have any additional listening sessions, and instead will answer in writing any questions you may have.

Botha and Janak did respond with one additional question:

With the additional information that was presented will the CBER review team be looking at the possibility of suspending the license of the HPV vaccines pending further safety review?

Although acknowledgment was received that the question would be forwarded to CBER, a response has yet to be received.

HPV Vaccine Mechanisms of Action in Women has been converted to a 63 page PDF file (may take some time to download) filled with research and documentation on issues not considered during HPV vaccine clinical trials – nor in any other vaccine or medical trial for that matter.

With all of the studies coming out about the relevance the endocrine system has to women’s health – it is time that the menstrual cycle be given its due as the regulating system in a woman’s body.

Botha and Janak raised the following issues/questions in the HPV Mechanisms of Action Presentation: (Research, data, documentation and corresponding links are documented in the PDF file.)

To read the full story, go to http://sanevax.org/blog/?p=1286.

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THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.

HPV Vaccine (Gardasil and Cervarix) VAERS Reports - Injury and Death Continue to Climb

The injury and death related to the HPV Vaccines Gardasil and Cervarix continue to rise. How many will it take before the FDA takes action?

The VAERS information is now being updated weekly for the HPV Vaccines. As of November 3, 2010 the reports are as follows:

20,575 adverse reactions
352 reports of abnormal pap smears post vaccination
89 reported deaths (plus 5 reports submitted to the FDA obtained by Judicial Watch under the Freedom of Information Act (FOIA) are now missing from VAERS)

Case numbers:
# 300741
# 314524
# 321405
# 325151
# 381305

The first four reports are on Judicial Watch.

Vaccine Adverse Effects Report System (VAERS) cumulative deaths report - June 16, 2009 - http://www.judicialwatch.org/files/documents/2009/vaersdeathsALL_20090616.pdf.

The other report is in here

Vaccine Adverse Effects Report System (VAERS) serious effects report from May, 2009 to September, 2010 - http://www.judicialwatch.org/files/documents/2010/VAERS-052009-to-092010.pdf

Please visit our site at http://sanevax.org/.

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THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.