SaneVax Open Letter to Margaret Hamburg: When was the FDA informed of viral DNA in Gardasil?

September 10, 2012

The Honorable Margaret A. Hamburg, M.D., Commissioner September 10, 2012
U. S. Food and Drug Administration (FDA)

10903 New Hampshire Ave.

Silver Spring MD 20993-0002

Dear Dr. Hamburg:

In a public announcement, the FDA stated:

“Since the early development of Gardasil, FDA and the manufacturer (Merck and Co., Inc.) have known that after purification of the vaccine, small quantities of residual recombinant HPV L1-specific DNA fragments remain in the vaccine.” ¹

This letter requests copies of the documents from the FDA showing:

1) The date when the FDA and the manufacturer first knew small quantities of residual recombinant HPV- L1-specific DNA fragments remain in the vaccine.

2) The physical condition of the HPV- L1-specific DNA fragments in the Gardasil® vaccine.

We are asking these questions because we have read the news report about Dr. Sin Hang Lee’s testimony delivered to the coronial court in New Zealand. During the inquest, Dr. Lee claimed to have discovered HPV L1 gene DNA fragments in the postmortem blood and spleen from a teenage girl who suffered a sudden unexpected death 6 months after the last dose of Gardasil® vaccination. The original pathologist reported he could not determine the cause of death in this case.

We have also read the advanced copy of a scientific report authored by Dr. Lee, being published in a peer-reviewed journal, entitled “Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil®.”² In this article, Dr. Lee stated:

“The detected HPV DNA was found to be firmly bound to the insoluble, proteinase-resistant fraction, presumably of amorphous aluminum hydroxyphosphate sulfate (AAHS) nanoparticles used as adjuvant. The clinical significance of these residual HPV DNA fragments bound to a particulate mineral-based adjuvant is uncertain after intramuscular injection, and requires further investigation for vaccination safety.”

Since the above-requested information is of paramount importance regarding the safety of HPV vaccines and consequently the protection of public health and safety, please know that this communication is being published as an open letter available on the internet to enhance public awareness. Copies are also being sent to the following interested parties:

Darrell Issa, Chairman, Oversight and Government Reform Committee

Representative Dan Burton (R-5-IN)

Senator Barbara Mikulski (D-MD)

Senator Charles Grassley (R-IA)

Senator Tom Harkin (D-IA)

Senator Orrin Hatch (R-UT)

We are looking forward to receiving the documents requested from the FDA so that our experts can analyze whether or not there is a potential link between the residual HPV L1 gene DNA fragments reported by the manufacturer and the various side effects observed in the vaccine recipients.

Thank you for your assistance,

Norma Erickson, President

SaneVax Inc.

Signed on behalf of the Board of Directors, SaneVax, Inc.

Rosemary Mathis, Vice President Victim Support

Freda Birrell, Secretary

Linda Thompson, Treasurer

Stephen Tunley, Australian Liaison

References:

1. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm276859.htm
2. http://dx.doi.org/10.1016/j.jinorgbio.2012.08.015

How to Create a Vaccine Safety Advocate

 

August 7, 2012

By Norma Erickson, President

Chris Tarsell: Gone but not forgotten

One would think everyone at the FDA and CDC would be a staunch vaccine safety advocate, but apparently that is not necessarily the case. How do you change a parent from someone who trusts their doctor and health authorities, following all of their advice into a determined vaccine safety advocate who is skeptical of health authorities?

Imagine for a moment you have one child, a lovely daughter, your pride and joy, who is away at college. She is the picture of health, bright, talented and athletic with dreams and ambitions, and well on her way to reaching her goals.

Then, one peaceful evening you hear a knock on the door. It is the police, there to inform you that your daughter was found dead in her bed for no apparent reason and with no signs of foul play. This happened in June 2008, when every parent’s worst nightmare became a reality for Emily Tarsell. Christina Tarsell had died in her sleep less than 3 weeks after her third and final injection of Gardasil^®.

The nightmare continued. A complete autopsy could not determine a cause for her daughter’s death. Then after seeing a television interview with victims of Gardasil, Emily began to suspect a link between her daughter’s death and Gardasil.

Emily and her doctors filed reports with the Vaccine Adverse Event Reporting System (VAERS). Amazingly, she received no communication from the CDC, FDA, or any other government agency charged with the investigation of deaths reported after vaccination. Apparently, talking to the parents of the deceased person is not a part of an investigation into the circumstances surrounding a death after vaccination. The CDC/FDA provided no answers.

Emily subsequently learned that Merck, the vaccine manufacturer, had filed a VAERS report stating falsely that a viral infection caused her daughter’s death, even though there was absolutely no evidence Chris had a viral infection. Emily challenged Merck about the false statement. She provided letters and documents from doctors to show there was no evidence to support Merck’s statements. It took a year before Merck back downed from their false statement.

Watch this investigative news report filmed shortly after Chris’s death to confirm the statements above.

Finding no help from governmental authorities, Emily had no choice but to investigate on her own. Since Chris’s death, she has learned that the vaccine was falsely advertised and there is no evidence it will prevent cervical cancer. She was never informed that Chris was at low risk of developing cervical cancer and that the incidence of cervical in this country is very low. She realized consumers are intentionally uninformed by the medical and pharmaceutical establishment. If the true risks and benefits were known, consumers would decline the vaccine.

She has met and grieved with many other families whose daughters were injured or died following Gardasil. She co-authored a study based on victim’s reports which shows a strong correlation between adverse symptoms and increasing doses of Gardasil (Report concerning a survey of adverse events following inoculations with Gardasil). She now realizes, as the nightmare continues, that her only daughter died from a vaccine she didn’t need that serves little to no public or private good.

These three astounding discoveries changed Emily from a trusting medical consumer into a dedicated vaccine safety advocate:

1. The apparent lack of initiative or concern by health authorities who are supposed to investigate adverse reactions and deaths following vaccination
2. False reports from the vaccine manufacturer.
3. False advertising regarding the safety and efficacy of Gardasil and lack of true information about cervical cancer prior to injections.

Emily has made it her personal mission to spread the word in the hope of preventing other families from experiencing what she has. She works tirelessly to make sure people have all the facts so they can decide whether Gardasil^® benefits outweigh the risks prior to consenting to vaccination

Read more about Chris and Emily here.

Watch a video tribute to Christina Tarsell here.

Visit our site at www.sanevax.org.

SANEVAX GARDASIL VACCINE VICTIM OF THE WEEK!

Before you become a victim, investigate before you vaccinate. The life you save may be your child's.

Victim of Gardasil Vaccine: Naomi from Australia

Naomi from Australia

July 31, 2011 By admin 5 Comments

Naomi, Australia: Prior to Gardasil, Naomi was a happy, healthy 25 year old completing her Bachelor’s degree while working full-time in administration. She was about to embark on a Post Graduate Degree in Journalism. Despite being kept busy by work and study, she found the time to go out with friends and dance at their favorite club almost every weekend.
During 2008 and 2009, Naomi’s health mysteriously began to deteriorate into a myriad of inexplicable symptoms including dizziness, nausea, joint pain, a collapsing knee, loss of balance, chronic fatigue and weakness.
Even though she visited a multitude of health professionals, including both general practitioners and specialists, who performed a broad range of tests; no one was able to say what was wrong with her.
Tests confirmed an autoimmune reaction and an MRI showed some demyelination in Naomi’s brain similar to that experienced by MS patients. However, nothing was definitive. She was given pain killers and steroids, but no real explanation.

Just prior to Christmas in 2009, Naomi by chance read an article in the newspaper about a possible link between Gardasil and multiple sclerosis.
She collected her medical file and created a timeline. It showed that her symptoms had begun within weeks of receiving her first vaccination. The onset of the worst symptoms coincided with the receipt of her last vaccination. Immediately, she began to research on the internet. What she discovered was a plethora of other girls with stories just like hers.
Fourteen months after her last vaccination, Naomi is still on steroids. She was forced to discontinue her post graduate studies. She is unable to work full time and sometimes unable to work at all. Naomi still experiences daily symptoms including chronic fatigue and some neurological difficulties.
Despite maintaining a brave face throughout the Gardasil ordeal, Naomi feels like a shadow of who she once was or, could have been.
Naomi created this video, based on her experiences. She would like anyone who is considering an HPV vaccine to watch her video first. You can access it through the following link:

www.twitvid.com/5213A

Written by Norma Erickson, Vaccines Examiner

Christopher Shaw and Lucija Tomljenovic have once again hit the nail on the head when it comes to revealing the truth behind HPV vaccination policies and practices. Parents, you owe it to your child to be informed. INVESTIGATE BEFORE YOU VACCINATE.

Shaw and Tomljenovich: Estimates of HPV Vaccine Safety and Efficacy

August 1, 2012 By admin Leave a Comment

[SaneVax: Christopher Shaw and Lucija Tomljenovic have once again hit the nail on the head when it comes to revealing the truth behind HPV vaccination policies and practices. In a recent letter to the editor of the American Journal of Public Health, they disclose that when comparing the adverse events reported after Gardasil to all other vaccines in the targeted age group, Gardasil alone is associated with over 60% of all serious adverse reactions in the VAERS database, including over 80% of all permanent disabilities. As a parent, are you willing to have your daughter risk permanent disability or death to take a vaccine that has not been proven to prevent a single case of cervical cancer?]

Who Profits From Uncritical Acceptance of Biased Estimates of Vaccine Efficacy and Safety?

Tomljenovic L, Shaw CA.

Source

At the time of the writing, Lucija Tomljenovic and Christopher A. Shaw were with the Neural Dynamics Research Group, University of British Columbia, Vancouver, Canada.

Abstract

We read with great interest the analysis by Mello et al.(1) on how Merck & Co., Inc. (Merck) influenced state human papillomavirus (HPV) vaccination policymaking. The exclusive reliance on Merck for scientific information on behalf of the legislators is unfortunate, especially in the light of independent research which has repeatedly warned that drug companies may manipulate clinical trial designs and subsequent data analysis and reporting to make their drugs look better and safer.(2-4) Indeed, careful scrutiny of Gardasil clinical trials shows that their design, as well as data reporting and interpretation, were largely inadequate.(4-6) (Am J Public Health. Published online ahead of print July 19, 2012: e1-e2. doi:10.2105/AJPH.2012.300837).

Access entire article via this link, or email the authors via the links above.

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.

Post-Gardasil Syndrome: Raquel from Spain three years later

Post-Gardasil Syndrome: Raquel from Spain three years later

By Norma Erickson, President

Gardasil: Safe, Affordable, Necessary and Effective is not too much to ask for.

The traditional media seems to overlook the fact that all of the victims of severe adverse reactions after HPV vaccines were originally trusting medical consumers who were simply following their doctor’s advice. They listened to the professionals when told that Gardsil or Cervarix vaccines could save their daughters from being a victim of cervical cancer. They were certainly not anti-vaccine, or they would not be in the position they are in now. This is the story of one of those families.

February 2009, at 14 years of age, Raquel received her second injection of Gardasil. A few hours later she was in a coma battling for her life. See her original story here.

It’s been over three years since Raquel suffered severe adverse effects after the second dose of Gardasil. She and her family suffered for two years wondering if they would ever see an end to her illness.

Now, they would like to let everyone who has been battling similar events that
Raquel is recovered! All of her neurological exams are now normal. She has not yet been discharged from hospital visits, but she leads a normal life.

With great effort she has completed her studies. Much to her credit, she has decided to continue school next year to become a nurse. Raquel wants to dedicate her life to healing others who have suffered like her.

Raquel’s parents have been beside her every step of the way during her long and arduous recovery. They believe all experiences in life, even very harmful, help us to find our way. They believe Raquel’s illness helped her find her vocation.

Raquel realizes that she is a lucky young woman. She could have been confined to a wheelchair indefinitely, but is not. With the assistance of doctors who attended her and the unconditional support of her family, she has overcome her illness.

Perhaps the most difficult thing for her parents to overcome was the helplessness of seeing how Health Authorities and some doctors wanted to dismiss her side effects to the vaccine as psychological, incidental, or coincidence.

Raquel and her family relied on Health Authorities when they decided to take the vaccine. To them, it is incredible and incomprehensible that the Health Authorities did not care about Raquel´s health after she suffered what was obviously an adverse reaction to the vaccine.

They now know their daughter will have a bright and happy future. They also know it could have very easily not turned out so well. They count themselves among the lucky ones.

Are Raquel’s parents vaccine safety advocates? You bet they are! They now dedicate a substantial amount of time and effort in an attempt to make sure what happened to their daughter never happens to another child. They encourage parents to do their research before they decide whether or not a vaccine is right for their children. They do not want anyone else to have to go through the horrors their family did for the last three years.

Raquel’s mother has a personal message to other vaccine-injury victims:

“I would like to tell all young people concerned to be patient. As long as there is life, never give up. If a treatment is not working, try something else. There are medical professionals out there who care about your health. I wish you strength and hope.”

Influenza 2012: Potential Conflicts of Interest and the Role of Media

By Stephen Tunley, Director, SaneVax Inc.

Where is objective journalism?

During the last few weeks in Australia we have seen an increase in the number of news reports (print and broadcast) regarding this seasons Flu outbreak. A number of them have quoted Dr Alan Hampson who has provided his ‘expert’ opinion and encourages all to get the Flu shot as this year’s Flu will be worse than last year’s and so on, and so on…..

What the media fails to explain is that the good Dr Hampson, spent a large part of his career working for Australian vaccine manufacturer CSL, the same manufacturer which recently admitted

“ .. its (flu) vaccine production methods probably triggered seizures in children, in the first results from its two-year investigation into the Fluvax fits.

But … refused to say if it would pay compensation to the families of children hospitalised after being immunised with Fluvax, which has been banned for paediatric use after sending one in 100 children into febrile fits in 2010.

The preliminary results of CSL’s two-year investigation conclude that its manufacturing methods may have failed to fully split the viruses used to make flu vaccines.

As a result, gene fragments and lipids from “inactivated virus” — as well as “residual whole virus or clusters of both” — may have created higher levels of immune-stimulating hormones, known as cytokines.”

Basically they screwed up – and 1 in 100 Aussie kids who received the shots got very ill.

The same Dr Hampson who recommends everyone get vaccinated against the flu this year because of the ‘dire threat’ of a serious flu season was responsible for developing influenza vaccine production processes for part of his time at CSL. He is Chairman of the Influenza Specialist Group an organisation whose financial support comes mainly from sponsorship from Abbot, Baxter, and CSL, pharmaceutical companies involved in the manufacture and sale of flu vaccine in Australia. In addition, he is also Editor in Chief of the International Journal “Influenza and Other Respiratory Viruses”, which lists as among its major sponsors two pharmaceutical companies Roche and Sanofi Pasteur. Roche via its Genentech subsidiary manufacture Tamiflu and Sanofi Pasteur the flu vaccine Intanza.

Given the reliance and general trust medical consumers place upon the opinions of these so called ‘medical experts’ the media has a responsibility to point out any potential of conflicts of interest; or find experts who are not conflicted?

Attachment 1:

Dr Alan Hampson, BSc, MSc, M.D. (Hon), FASM, OAM.

Dr Alan Hampson is a virologist with over 40 years experience working with influenza. His career includes responsibility for developing influenza vaccine production processes and senior R&D positions (Research & Development Manager) with the Australian biopharmaceutical group CSL Limited, and subsequently as Deputy Director and operational head of the WHO Collaborating Centre for Reference and Research on Influenza, Melbourne, from its designation in 1992 until his retirement in September 2005. Since retirement Alan has maintained an active role both in Australia as a consultant, Chairman of the Australian Influenza Specialist Group (ISG), a member of Australian Government advisory committees on influenza and pandemic preparedness, and internationally with the WHO including membership of its Pandemic Taskforce (now the International Health Regulations Roster of Experts) and Editor in Chief of the international journal ‘Influenza and Other Respiratory Viruses’. He also holds an appointment as Honorary Senior Research Fellow, School of Applied Sciences and Engineering, Monash University Gippsland Campus. Alan has received numerous awards and recognition for his contribution to public health, including: recipient of the Asia Pacific Society for Medical Virology Excellence Award (2006); an Honorary Doctorate of Medicine from the University of Melbourne (2006); the Order of Australia Medal for his contributions to public health, particularly with respect to influenza (2007); and was made a Fellow of the Australian Society for Microbiology (FASM) in (2007).

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

Former Merck scientists file suit against Merck under False Claims Act

NaturalNews) On April 27, 2012, a formal complaint was filed in the Eastern Pennsylvania Federal District Court accusing Merck of a longstanding scheme to mislead and defraud Government health authorities worldwide. Two of Merck's former employees have accused the pharmaceutical giant of marketing multivalent MMR vaccines under false pretenses. According to the complaint, these vaccines have been mislabeled, misbranded, adulterated and falsely certified as having a 95% efficacy rate.

Before the lawsuit was filed, 21 doctors¹ added their voices to other groups of doctors who are calling for MMR vaccines to be used as a regular booster every 4 - 8 years, in order to control mumps outbreaks. These doctors all assume that the mumps component of all MMR vaccines have the 95 - 98% efficacy promised by Merck.

However, the court documents filed by two Merck virologists meticulously detail how Merck ostensibly manipulated test results ² for decades in order to create a false 95% efficacy rate for the mumps component of their multivalent MMR vaccines.

The former Merck virologists contend that the multivalent mumps component has a vastly reduced efficacy which is directly responsible for mumps outbreaks during the last decade which prompted international calls for MMR booster shots every 4 - 8 years.

Virologists Stephen Krahling and Joan Wlochowski describe how Merck had to recertify the mumps component in 2000, in order to comply with regulatory requirements in order for the mumps component to be included in two new multivalent MMR vaccines. The usual test, which had certified the mumps component's efficacy in the 60's, failed when used in 2000. They claim the results were so low Merck decided to change its own test protocol by testing the vaccine against the weakened mumps vaccine virus instead of the wild (naturally circulating) mumps virus.

When that modification didn't result in the desired 95% efficacy figure, Merck's executive directors of vaccine research, Drs Alan Shaw and Emilio Emini, instructed Drs David Krah and Mary Yagodich to implement a vast array of modifications to testing procedures³, then, allegedly pressured both Krahling and Wlochowski to participate.

When these modifications also failed to demonstrate the desired 95% efficacy rate, it is alleged that Drs Shaw and Emini instructed Drs Krah and Yagovich to abandon "gold standard" testing, and implement a new procedure, supposedly with the agreement of FDA, which included adding animal antibodies to human blood samples taken both pre and post vaccination⁴.

By combining the very low levels of human antibodies with animal antibodies, a much higher total level of virus neutralization was obtained than could occur from human antibodies alone. The human antibody levels alone would never protect in the real world against wild mumps. But after adding animal antibodies, the human blood samples which had previously failed under the old "gold standard" testing were retested using the "enhanced" protocols and passed with flying colors. New 'enhanced' tests showed 100% efficacy, not against wild mumps virus, but against the mumps vaccine virus.

However, combining the animal and human antibodies led to a new problem. In some of the tests more than 80% of pre-vaccine blood samples now showed up as immune. Usually, the highest number of pre-vaccine immune results any scientist could expect is 10%. Further manipulations of the animal antibody levels failed to bring the pre-vaccine blood test results down to the expected 10% levels.

According to the complaint, Merck then implemented additional 'creative' strategies to show a lack of seroconversion in immune samples in an attempt to reduce the pre-vax level to the expected 10% because had the FDA seen the high numbers of "immune" pre-vaccine samples they would have easily detected the fraudulent test procedures.

Krahling and Wlochowski worked with the same team conducting these tests, but were outraged at what they deemed to be gross scientific deception and fraudulent practices.

When Drs Krahling and Wlochowski attempted to stop what they saw as, "wholesale fabrication of test data to reach its preordained 95% efficacy threshold," Merck allegedly made various attempts to prevent them, including threatening to jail Dr. Krahling should he inform the FDA.

Despite these efforts, Dr Krahling made numerous calls to FDA. These calls remained unanswered until Dr. Krahling reported to the FDA that Dr. Krah had removed and/or destroyed Dr. Krahling's evidence.

An FDA agent then came and interviewed Dr. Krah, who apparently told the agent whatever was necessary to allay their concerns. The agent made no attempt to interview any other personnel, check any facilities, laboratory notebooks, or samples to corroborate what had been reported to them.

The lawsuit claims that to this day, Merck has consistently misrepresented the potency by simply quoting the 40 year old data from the pre-MMR monovalent mumps vaccine, thereby misrepresenting the efficacy of four multivalent vaccines: MMR, MMRII, Europe's MMRvaxpro, and ProQuad, which is MMR plus chickenpox.

According to the two whistleblowers, not only have all the multivalent MMR vaccines been sold under false pretenses, but, as a result of this LACK OF EFFICACY, there have been numerous mumps outbreaks worldwide prompting calls for regular MMR boosters throughout life. These mumps outbreaks were predicted by Merck's Dr Krah⁶in 2001, yet Merck allegedly 'willfully' withheld this information from multiple governments while consistently claiming there was no need for a new mumps component.⁸

The question is, "If the mumps component is actually 95% effective, as stated, would experts be calling for lifelong boosters every 4 - 8 years?"

Has Merck turned over a new leaf since the recent Vioxx Scandal? Do they still put profit before people? Read the complaint, follow the court case, examine the evidence, and decide for yourself.

References:
1. http://journals.cambridge.org
2. Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
3. See pgs 10 and 11 - Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
4. See page 12 - Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
5. See page 22 No. 64 - Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
6. See page27/d82; 28/85 and page 40 first two lines - Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
7. See page 29/86 - Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
8. See page 29/87 - Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf

By Hilary Butler, Contributing Author from New Zealand.

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


Learn more: http://www.naturalnews.com/036298_Merck_scientists_False_Claims_Act.html#ixzz1ywbgZ6om

Gone after Gardasil: Acceptable collateral damage?

(NaturalNews) According to government health authorities, medical 'experts,' and the pharmaceutical industry adverse events after vaccinations are extremely rare. The attitude of these organizations toward individuals who do experience an adverse reaction to vaccines was recently summed up quite clearly in an article titled, The Value of Life, Statistically Speaking by Rick Jones, CFO magazine which stated:

"Inoculating children to prevent infectious disease transmission is good for society from both health and financial perspectives, but some initially healthy children may suffer adverse reactions, injury, or even death. For vaccines, the enormous societal benefits trump the tragedies of the few."



In other words, those who suffer adverse reactions, injury and even death are viewed as acceptable collateral damage, nothing more than statistics. Allow us to introduce you to a small sample of the statistically 'rare' adverse events after receiving the HPV vaccine, Gardasil:

Jessie Ericzon: Jessie was one of those rare individuals who truly had a zest for life. In her universe everyone deserved a fair chance and she made it her personal mission to make sure everyone around her had one. She excelled at everything she tried; truly an individual who had the world by the tail.

All of her hopes and dreams came to an abrupt end on February 22, 2008. That is the day her parents discovered her dead on the bathroom floor a mere 40 hours after her third injection of Gardasil.
Jessie's parents are left to deal with the fact that their precious daughter is indeed 'One Less' woman who will have to deal with cervical cancer.'

Chris Tarsell: Chris was discovered dead in her college dorm room bed 18 days after her third dose of Gardasil. Her abrupt departure from this world has left a multitude of people wondering what happened to this sweet, spirited, generous and caring individual who had been such a credit to the human race.

Chris's coroner could not identify a cause of death in this previously healthy girl. Are those left behind supposed to believe some strange, 'coincidental' force of nature took her life as alleged by the CDC? Chris's death was not thoroughly investigated by the CDC/FDA. One would think they would at least talk with the family to gather information regarding pre- and post-injection symptoms? Shouldn't they do a statistical analysis of post injection deaths to determine the probability of these deaths being "coincidences"? Such an analysis was done by Dr. James Garrett in a report posted at www.gardasil-and-unexplained-deaths.com . This report concluded it is statistically untenable to claim that none of the reported deaths was related to Gardasil. Where are the government health agencies charged with protecting the health and safety of the people who pay their wages? Why are they using inadequate data provided largely by the manufacturer to track vaccine safety? Why is the fox guarding the hen house?

Annabelle Morin: Annabelle ended up in the hospital with aphasia (the inability to understand spoken or written words) and great difficulty standing 16 days after her first dose of Gardasil. None of her family knew Gardasil had been administered, so no connection was made between her symptoms and the vaccine. 15 days after her second injection, this 14-year-old, French Canadian girl came home from school, had her dinner and went to take a bath and read a book. Half an hour later, with no warning, she was gone.

Once again, the coroner could not identify a cause of death. Did this spur a complete investigation to find out what may have caused her death? No! Canadian health authorities seem no more concerned than their counterparts in the United States.

One more precious life cut short leaving family, friends and neighbors wondering why no one seems to care what happened. Why is more investigation done for an accidental death than one that no one, including the coroner, can explain?

Jasmine Renata: Jasmine received her first injection of Gardasil in September 2008. One month later, she developed warts on her hand and very dry skin. The warts were taken care of, but shortly after the second shot, they returned along with bouts of dizziness, numbness and tingling in her hands, abdominal pain and memory losses.

On March 17, 2009, Jasmine got her third and final dose of Gardasil. Her condition quickly deteriorated. She became more agitated, continuing to complain of tingling in her hands and feet, along with various other new symptoms. Her memory losses were so severe she could not remember simple things like how to grate carrots. Shortly after, she began to experience chest pains and rapid heartbeat.

Just a little over 6 months after her third injection of Gardasil, this once healthy, hard-working 18 year-old girl died in her sleep. The 22 of September 2009 was the last day of her life. Jasmine's coroner ruled out drug and alcohol abuse as potential causes of her death. But, much like the other girls, no cause of death could be established. How do the health authorities in New Zealand respond when a young woman dies suddenly with no apparent cause? Unfortunately for the Renata family, they responded much like those in the United States and Canada. They do not appear to be concerned - just another coincidence, apparently.

Megan Hild: At 20 years old, Megan was happy and healthy. She was studying radiology in college and looking forward to her planned marriage after graduation. She held life in the palm of her hand.

Megan was living away from home while attending college, so her mother was not totally aware of the health problems she experienced after taking Gardasil. Megan's new medical conditions included unexplained rashes, severe stomach pains, migraines, extreme fatigue and vaginal bleeding. Imagine the shock when shortly after speaking with Megan on the phone her precious daughter was found on her knees in the shower of her college apartment - dead. Only after her sudden death would mom discover the new medical conditions Megan had after her Gardasil shots.

Megan's mother will not have the opportunity to watch her daughter's dreams come true. She, her family and Megan's fiance are left with nothing to hold onto but a piece of paper that reads, "Cause of death, unknown."

Megan's mother is still trying to grapple with the belief that a vaccine meant to protect her daughter's future health may have taken her life. She does not understand why no one in a position to investigate seems to care. She does not understand why health officials appear quite content to allow the cause of Megan's death to remain 'undetermined.'

These young women represent a small fraction of those who paid the ultimate price following Gardasil vaccination. It is common knowledge that only 1 to 10% of adverse reactions are actually reported to the Vaccine Adverse Event Reporting System (VAERS). Are these young women representative of 50 other devastated families or, 500 others? No one knows.

Try explaining to those left behind that their loss is acceptable for society's benefit when the only benefit Gardasil is clinically proven to provide is a 0.6% reduction in HPV 16 infections, and a 1.1% reduction in HPV 18 infections in vaccinated women versus unvaccinated women, providing they were not previously exposed to these two types of HPV prior to being vaccinated. (ATHENA study referenced below)

What about the 108 death reports filed with VAERS after HPV vaccine administration? How many others world-wide do they represent? 1,080? 10,800? Once again, no one knows. At what point does the collateral damage become unacceptable?

Explain to these families why they are left to their own devices if they want to know what caused their child's death. Had these deaths occurred after the use of any product other than a vaccine, the offending product would have been promptly removed from the market pending the outcome of investigations to determine the cause of the problem.

There is no valid excuse for the situation to be different with vaccines. It is high time for the FDA/CDC and every other government health agency worldwide to man-up and actually do the job they are paid to do - protect public health and safety. Investigate each and every death thoroughly. Determine the causes.

It should not be up to the survivors to prove a causal relationship; it should be up to the manufacturer to show that none exists.

References:
1. http://www3.cfo.com
2. http://www.ncbi.nlm.nih.gov/pubmed/21944226 (see table 3, The ATHENA human papillomavirus study: design, methods, and baseline results.) http://www.scribd.com/fullscreen/80272698
3. http://sanevax.org/gone-after-gardasil-jessica-new-york/
4. http://sanevax.org/gone-after-gardasil-christina-maryland/
5. http://sanevax.org/gone-after-gardasil-annabelle-canada/
6. http://sanevax.org/gone-after-gardasil-jasmine-new-zealand/
7. http://sanevax.org/gone-after-gardasil-megan-new-mexico/

By Freda Birrell and Norma Erickson, SaneVax Inc.

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


Learn more: http://www.naturalnews.com/034890_Gardasil_collateral_damage_fatalities.html#ixzz1lh8v64l5

SaneVax Writes Open Letter to Kathleen Sebelius, Secretary of Health: Rescind approval of Gardasil® due to lack of efficacy during post-licensure monitoring

February 2, 2012

By Norma Erickson, President

According to a recently published, industry-sponsored study conducted on 12,852 young women, HPV vaccination was found to reduce HPV-16 infections a mere 0.6% in vaccinated women versus unvaccinated women. At the same time, other high-risk (carcinogenic) HPV infections were diagnosed in vaccinated women 2.6% to 6.2% more frequently than in the unvaccinated women. The increased rate of infections caused by carcinogenic HPV types other than those targeted by Gardasil® in vaccinated women is 4 to 10 times higher than the reduction in HPV 16/18 infections.[1]

These statistics are not exactly encouraging when it comes to demonstrating efficacy for Gardasil®. In fact, quite the opposite – these figures seem to indicate that women who receive Gardasil® may indeed increase their risk of developing cervical cancer from high-risk HPV types that are not targeted by the vaccine.

Medical consumers cannot afford to take the chance of increasing their risk of contracting a disease that has been virtually eradicated by good gynecological care in the United States (cervical cancer) by taking a series of HPV vaccines and hoping they will find out decades later the vaccine worked. It is certainly not a risk children should have to take.

Armed with the knowledge that any drug approved under the FDA’s accelerated approval process using a surrogate endpoint, such as Gardasil®, requires post-marketing studies “to verify and describe the drugs clinical benefit and to resolve remaining uncertainty as to the relation of the surrogate endpoint upon which approval was based to clinical benefit…[2],” the SaneVax Team felt compelled to appeal to the person in charge of FDA/CDC oversight, Kathleen Sebelius, Secretary of Health and Human Services.

On 31 January 2012, SaneVax Inc. sent an open letter to Ms Sebelius[3] asking her to rescind approval for Gardasil® based on the lack of efficacy demonstrated in the ATHENA study referenced above.

If the Department of Health and Human Services is truly interested in public health and safety, they will do the right thing and rescind Gardasil® approval until the manufacturer can provide scientifically sound data proving this new drug is actually effective.

In the meantime, medical consumers around the globe have a choice. Is poke and hope good enough for you and your children? Or, are you going to demand scientific proof of efficacy before submitting to HPV vaccination?





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[1] http://www.ncbi.nlm.nih.gov/pubmed/21944226 (see table 3, The ATHENA human papillomavirus study: design, methods, and baseline results.)

[2] http://www.fda.gov/ohrms/dockets/ac/03/briefing/3936B1_01_B-Attachment%201.pdf (57 FR 58942)

[3] Copy of letter to Kathleen Sebelius, Secretary of Health and Human Services

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