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).