Friday, September 30, 2011

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, 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


Victim Hotline


# # #

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.

Tuesday, September 20, 2011

Father of Injured Gardasil Girl Matches Caplan’s Bio-Unethical $10,000 Bet

By Leslie Carol Botha
September 20, 2011

In a striking move, Australian businessman and father of a Gardasil injured girl, Stephen Tunley matched University of Pennsylvania Bioethicist, Dr. Art Caplan’s $10,000 reward for ‘proof of Bachmann vaccine claims.’

Dr. Caplan made headline news after Presidential Candidate Michelle Bachmann, speaking as the mother of three daughters and the foster mother of 23 other adolescent girls publicly called “Gardasil – a potentially dangerous vaccine.’ Bachmann was approached by a mother of a Gardasil injured girl after the Thursday Republican Tea Party debate, and told her daughter was now ‘retarded’ (also known as brain damaged).

Caplan’s response was to place a wager on Bachmann’s ‘incredibly irresponsible falsehood.’

‘If she can produce a case in one week starting today verified by three medical experts that she and I pick of a woman who became ‘retarded’ (her words) due to HPV vaccine I will donate that to a charity of her choice.’ 1.

On Monday, September 19, 2011, SANE Vax Inc. issued a press release on what we feel is a blatant and unprecedented HIPPA violation by exposing a family of an injured child to media scrutiny. 2.

In addition, SAVE Vax Inc. emailed an Open Letter to Dr. Caplan, on September 18 stating our objections to his unethical bet.

‘On behalf of the parents of a group of neurologically injured teenage girls after HPV vaccination, we feel obligated to question your ‘bio’-ethics as you challenge Republican presidential candidate Michele Bachmann with a $10,000 bet to prove a claim that a vaccine to prevent cervical cancer caused mental retardation. We represent many parents of teenage girls who have suffered a variety of central nervous system (CNS) dysfunctions, including various degrees of mental ‘retardation’ (impairment) as a sequelae of Gardasil® vaccination injuries. It is hard to believe that as bioethicist you openly instigate violation of the HIPAA law.

‘Now, SANE Vax Inc. challenges you, Dr. Caplan. Prove the vaccine Gardasil® has prevented a single case of cervical cancer. We have not found such a case in the world literature, or in the published clinical trial materials. The endpoints used for evaluating the efficacy of Gardasil® were largely self-reversible precancerous changes, not true cancer as defined in any pathology textbooks.’3.

By Monday morning SANE Vax Inc. President, Norma Erickson received this response.

‘Find the case, present it to michelle bachmann, let the doctors we agree on confirm HPV vaccine as the cause and I pay. You have until thursday.’

Arthur Caplan
Emanuel & Robert Hart Director of
The Center for Bioethics and
Sidney D Caplan Professor of Medical Ethics
University of Pennsylvania
3401 Market St. Suite 320

Alerted to the emailed response, Stephen Tunley, researched funding sources for the University of Pennsylvania Bioethics Department and to no one’s surprise found that their primary funding source was none other than the National Institutes of Health.

Outraged, Tunley matched Caplan’s wager – and upped the ante by adding the issue of financial disclosure in the following challenge:

Dear Dr. Caplan

I would like to offer you $10,000 to you to prove that Gardasil did not and does not cause the issues discussed by Ms. Bachman and others. Of course when I win, you might care to donate the monies to SANE Vax. However and unlike your gutless prove it by Thursday deadline – I am happy to keep this offer open for a while.

On a personal note I find it revolting that a ‘bioethicist” would engage in such a bet. Surely your responsibilities are to investigate, consider and approach this with an open mind. But I guess you have long since not been a “real” bioethicist and now are really a ‘vaxapologist!’

One more question: will the $10,000 be sourced from your pockets or from the bioethics centre? As you know, but perhaps many others don’t know, funding for the center comes from a range of sources – including the NIH, which as we say down-under has ‘skin in the game” by being a co-patent holder for Gardasil and receives royalties from its sale.

A wee bit of conflict of interest and perhaps a challenge for you and your supposed ethics! Interesting that this was not disclosed by you!

So Dr Caplan ‘man up;’ disclose your conflicts and take up the challenge!

Stephen Tunley
Sydney Australia
Father of Chescia Tunley – yet another young woman damaged by Gardasil
The ball is in your court now, Dr. Caplan.


1. Bioethicist Offers $10,000 Reward For Proof of Bachmann Vaccine Claims

2. Bioethicists Not So Ethical When It Comes to Gardasil Injuries

3. SANE Vax: Open Letter to Dr. Art Caplan, Bioethicist , University of Pennsylvania

Monday, September 19, 2011

Gardasil Contamination: EMA Steps Up to the Plate, FDA drops the Ball

By Norma Erickson, President
16 September 2011, in response to an inquiry about SANE Vax’s recent discovery of genetically engineered HPV DNA in Gardasil™[i], the following announcement was broadcast on radio out of Clonmel, County Tipperary, Ireland:

“The IMB (Irish Medicines Board) and European Medicines Agency (EMA) are aware of the recent communication from Sane Vax and following on from this, the EMA requested the marketing authorisation holder conduct an immediate assessment of the risk of contamination.

The IMB, through its participation in EU Scientific Committees is contributing to the ongoing EU assessment of this issue and will continue to do so at further EU meetings scheduled over the coming week. Any updates on the outcome of these discussions and any recommendations will be highlighted, as appropriate. At present, the balance of risks and benefits for the vaccine remains positive.

The Gardasil vaccine has been licensed for use in the EU since 2006. The IMB together with the EMA continue to monitor the benefit-risk profile of Gardasil.”

This is particularly good news for medical consumers in the 27 countries belonging to the European Union (Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom). An ‘immediate risk assessment’ should mean the marketing authorisation holder must now:

Determine the extent of the contamination
Determine any potential health risk that could result from HPV rDNA attached to aluminium adjuvant being injected into the human body
The critical issue here is not that the vaccine has residual DNA in it, but that the contaminating HPV DNA is genetically modified and firmly attached to the aluminium adjuvant – making it an unknown quantity as far as potential health risks.

Is recombinant (genetically engineered) HPV DNA, or adventitious DNA, capable of altering human DNA potentially initiating cancer, or a host of autoimmune disorders?

The manufacturer of Gardasil™, Merck, went to great lengths to assure government health authorities around the world there was no viral DNA in the vaccine.[ii] [iii] Merck repeatedly told health authorities that this vaccine only contained virus-like particles manufactured from the L1 protein – NO HPV DNA. Recognizing the potential health risks of residual DNA, government health officials relied on this assurance when they approved the vaccine for use in their countries.

The SANE Vax team believes the solution is simple. Gardasil™ does not meet the specifications the manufacturer put forth to gain approval for the use of their HPV vaccine. Therefore, Gardasil™ use should be discontinued until such time as the manufacturer can either remove all residual HPV DNA from the vaccine, or prove the residual HPV rDNA attached to the aluminium adjuvant poses no health risks when injected into the human body.

SANE Vax Inc would like to thank the EMA and IMB for ‘stepping up to the plate.’ We believe demanding an immediate risk assessment be performed by the authorisation holder is the only reasonable avenue available. Medical consumers around the globe will be watching and anxiously awaiting the outcome of your investigations into this matter.

SANE Vax Inc notified the FDA about the discovery of HPV rDNA contaminants in Gardasil™ before anyone else was informed.[iv] Why does this government agency remain strangely silent regarding the contamination of Gardasil™? Has the Food and Drug Administration in the United States ‘dropped the ball’?

Could it be that since the FDA failed to require the manufacturer to test for, evaluate and quantify the risks of residual recombinant HPV DNA in Gardasil™ before granting approval for marketing the vaccine, they just decided to take their toys and go home?

Medical consumers deserve better than that.


[i] SANE Vax Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil

[ii] Vaccines and Related Biological Products Advisory Committee (VRBPAC) Briefing Document-Gardasil

[iii] JVCI Statement on Human papillomavirus Vaccines

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

Bioethicists Not So Ethical When It Comes to Gardasil Injuries

September 19, 2011 By Leslie Carol Botha 1 Comment

Dr. Caplan et al., we are not willing to gamble with patient’s lives…..
However, you and some of your associates are apparently willing to do just that.

By Leslie Carol Botha, Vice-President Public Relations
Janny Stokvis - Researcher and VAERS Analyst

September 19, 2011

Time to get this story straight: – University of Pennsylvania bioethicist, Dr. Art Caplan1.recently committed what SANE Vax views as an unprecedented HIPAA violation by offering a $10,000 reward for ‘proof of Bachmann vaccine claims.’

Forcing a family to disclose their child’s health records publicly, in front of a maniacal witch burning media network out to get Presidential Candidate Michelle Bachmann, is unethical, immoral, unprofessional and unwarranted. Obviously the news of Gardasil contamination and Bachmann’s reference to the vaccine as potentially dangerous has dug a knife deep into the heart of the Pharma industrial beast.

Now, the beast thinks it can raise its ugly head publicly demanding this family sacrifice a child’s privacy to save Bachmann’s political face. Outrageous.

According to Forbes Magazine, ‘University of Pennsylvania bioethicist Art Caplan is so confident that Michele Bachmann’s claim that a young girl was made mentally retarded by injections of the Gardasil vaccine against human papilloma virus is false that he is offering to donate $10,000 to the charity of Bachmann’s choice if she can produce such a patient.

‘Caplan, who has made the offer via Twitter, to the Minneapolis Star Tribune, on the radio stations WTVN and WOR, also proposes that Bachmann should donate $10,000 to the charity of his choice if such a patient can be produced. He says her campaign hasn’t responded. He writes:

‘If she can produce a case in one week starting today verified by three medical experts that she and I pick of a woman who became ‘retarded’ (her words) due to HPV vaccine I will donate that to a charity of her choice.’ 2.

Charity of Bachmann’s choice? Dr. Caplan, you should be writing a check to the victim’s family to cover the medical costs incurred by the contaminated vaccine. In fact, the entire industry better get their checkbooks ready – because families are lining up ready to speak out and be counted.

In addition to Caplan, ‘another bioethicist, Steven Miles of the University of Minnesota, has offered $1,000 if a patient whose brain was damaged by an HPV vaccine can be produced. The bioethicists are making a pretty safe bet, because the odds of finding a reputable medical expert who will say a case of mental disability was caused by Gardasil is close to nil.’ 2.

Define ‘reputable’ – one who is paid to be beholden to Merck? Sirs, you are doing the 23,388 adversely injured adolescents and the 102 families whose daughters and sons have died HPV post-vaccination a disgraceful disservice with your pompous attitudes.

SANE Vax Inc. believes that Caplan and Miles are violating HIPAA’s (Health Insurance Portability and Accountability Act) Patient Privacy Act guaranteeing privacy rights under federal law by focusing the media’s biased pharmaceutical spotlight on innocent families forcing them into the media limelight to disclose their adolescent’s medical history to the public. 3.

All this mother in Florida did was take advantage of the opportunity to let Bachmann know there is a problem with Gardasil. Where is the crime in that? All Bachmann did was publicly report what the mother told her…why should she be raked over the coals…unless of course there is something to hide?

Why not focus on a girl whose mother has already spoken out on the issue to try and find the cause of her brain damage. That is what ‘mental retardation’ is isn’t it?

Hobart Indiana mother Amy Pingel has been very vocal in her efforts to get media attention to the fact that Gardasil can cause serious side effects, including seizures, neurological problems and even paralysis. She believes her daughter is proof.

Her daughter, Zeda was a normal, healthy 13-year-old who loved her family, her friends and her phone. She once was a popular cheerleader and A-B student, who texted and talked tirelessly. Now, she is silent. She is strapped to her wheelchair, her head leaning against a head rest, her eyes wandering, seemingly sightless. She can neither walk, eat, nor speak.4.

Research vs. Rebuttal

If indeed, these bioethicists were ethical, they would be doing the research instead of using their ‘authority’ to refute the claim.

Instead, SANE Vax Inc. has gathered research for them since their arrogance is standing in the way of bioethics.

According to VAERS – the following reports have been listed for HPV, HPV2 & HPV 4 and ‘mental disorders.’ This is an estimated 1 to 10% of the vaccine-injured population reporting.

VAERS Analysis HPV, HPV2, HPV4 –
U.S. & Foreign HPV4
U.S. Only
Acute Disseminated Encephalomyelitis (ADEM) 21

Encephalitis 53

Demyelination 60

Psychotic Disorder 14

Abnormal Behaviour 49

Cognitive Disorder 22

Mental Status Changes 41

Nuclear Magnetic Resonance Imaging Brain Abnormal 132

Speech Disorder 90

Myelitis Transverse 30

Facial Palsy 138

Encephalitis is known to be an infection that involves inflammation of the brain that can cause mental retardation. 5.

According to Wikipedia – Encephalomyelitis is a general term for inflammation of the brain and spinal cord, describing a number of disorders including:

Acute disseminated encephalomyelitis or postinfectious encephalomyelitis, a demyelinating disease of the brain and spinal cord, possibly triggered by vaccination or viral infection; Encephalomyelitis disseminata, a synonym for multiple sclerosis; and Myalgic encephalomyelitis, a syndrome involving inflammation of the central nervous system with symptoms of muscle pain and fatigue; the term has sometimes been used interchangeably with chronic fatigue syndrome 6.

The following peer-reviewed studies point out the links between Encephalitis and HPV Vaccines:

Demyelinating disease and polyvalent human papilloma virus vaccination
J Neurol Neurosurg Psychiatry doi:10.1136/jnnp.2010.214924

Since its inception, the polyvalent vaccine against the human papilloma virus (HPV), Gardasil, has generated some controversies as a temporal relationship between the administrations of the vaccine and the development of a few autoimmune diseases, such as acute disseminated encephalomyelitis (ADEM), multiple sclerosis (MS) and Guillain–Barre syndrome have been reported. We encountered two cases whose initial presentation of CNS demyelination followed in close time relationship the administration of Gardasil vaccine and we discuss their possible association.

Meningococcal and Human Papilloma Virus Vaccine Associate Recurrent Acute Disseminated Enchephalomyelitis
Juan Carlos Muniz, MD, Stanley Krolczyk, DO, RPH; Lise Casady, ARNP, University of South Florida

A report of five cases of CNS demyelination after quadrivalent human papilloma virus vaccination: could there be any relationship?
26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) & 15th Annual Conference of Rehabilitation in MS (RIMS) 13.10.2010 – 16.10.2010

Acute disseminated encephalomyelitis with tumefactive lesions after vaccination against human papillomavirus
Neurología. 2010;25(1):58-69

Bilateral Papilledema Following Human Papillomavirus Vaccination Case Report
J Med Cases • 2011;2(5):222-224

Acute Disseminated Encephalomyelitis Following Vaccination Against Human Papilloma Virus
American Academy of Neurology, Neurology 2009;72:2132–2133.

Wildemann et al. present a case of aggressive acute disseminated encephalomyelitis (ADEM) following immunization with the polyvalent human papillomaviruses (HPV) vaccine. The time between vaccine exposure and onset of illness provides evidence for a cause-effect relationship.

The author goes on to note “…it is important to monitor the occurrence of immune-mediated diseases that are occurring after vaccination with Gardasil®”

Gentlemen – it is high time you acknowledge there is a problem with the HPV vaccines. Medical consumers know it, and researchers and medical professionals are aware. Get your checks ready because we are coming to collect.


1. Art Caplan

2. Bioethicist Offers $10,000 Reward For Proof of Bachmann Vaccine Claims

3.HHS Health Information Privacy

4. WISH TV Indianapolis, GOP debate puts questions over HPV vaccine back in the spotlight – 1 Hoosier mom blames daughter’s illness on vaccine

Filed Under: SANE Vax Press Releases Tagged With: adverse events, adverse reactions, Anal Cancer, Andrew Wakefield, autism, Autoimmune Diseases, cervarix, Cervical Cancer HPV, cervical cancer prevention, cervical cancer vaccine, flu vaccine, GlaxoSmithKline, HPV, HPV vaccine, HPV VACCINES, immunizations, Merck, pharmaceuticals, STD's, vaccinations, Vaccine Adverse Reactions

The Five Things You REALLY Need to Know about HPV Vaccines

By Tony Isaacs, Contributing Author
After the political tempest about Gardasil and mandatory HPV vaccinations which began at the GOP Tea Party debate, CNN posted an article on September 14th titled “The five things you need to know about the HPV debate”. The article could scarcely have been more pro-HPV vaccination than if Gardasil manufacturer Merck had ghost written it (a practice Merck is known for).

The article contended that the HPV vaccine controversy was mostly political and that HPV vaccines were safe. It also noted that we have been vaccinating children for many years. Besides missing the obvious difference between vaccinating against diseases spread by social contact in schools versus sexual contact in later years, the article’s contention that HPV vaccines are safe is a complete whitewash of the truth.

For those who prefer the truth over mainstream propaganda, here are five things you really need to know about HPV vaccines:

1. Merck needed a new cash cow to replace the billions in profits lost due to its evil drug Vioxx finally being pulled from the market after it caused upwards of 50,000 deaths. Gardasil became the new cash cow heir apparent. Contrary to mainstream misinformation, Gardasil has not been proven to be safe in either the short or the long term. Instead, Merck has once again used deception to portray it as safe and ignored evidence of harm, the same as they did with Vioxx when they hid evidence of harm, rigged studies, and paid scientists and doctors to put their name on articles and papers supporting Vioxx..

In the initial safety tests where Gardasil was compared against a placebo, instead of using a truly benign placebo such as saline solution Merck used a placebo which was identical to the Gardasil vaccine minus only the HPV virus components.
In addition to sodium chloride and water, the placebo also contained aluminum, polysorbate 80 and sodium borate.

Aluminum is a dangerous toxic metal. Even small amounts are deposited in the brain and it has been linked to Alzheimer’s and Parkinson’s Disease as well as memory loss and speech problems which mimic those diseases. It has also been linked to a wide variety of other health problems.
Side effects and severe allergic reactions listed for aluminum include rash, hives, itching, difficulty breathing, tightness in the chest; swelling of the mouth, face, lips, or tongue, loss of appetite, muscle weakness, nausea, slow reflexes, and vomiting.

According to the Polysorbate 80 Material Safety Data Sheet, it may be carcinogenic as well as mutagenic. When injected into prepubescent rats, polysorbate 80 caused abnormal growth of reproductive organs and made the rats sterile. When used intravenously with vitamins it has been known to cause anaphylactic shock.

Sodium borate is widely known for its use as a roach pesticide. The U.S. National Library of Medicine and the National Institutes of Health have declared sodium borate to be a dangerous poison. Listed side effects include: vomiting, collapse, coma, convulsions, low blood pressure and twitching of facial muscles, arms, hands, legs, and feet.

Many of the side effects for aluminum, polysorbate 80 and sodium borate coincide with those of the Gardasil victims who have been injured and killed by the vaccine. Thus it comes as no surprise that the side effects for the Gardasil vaccine in Merck’s trials were no greater than those of the toxic placebo they selected.

An analysis of the actual trial data for Gardasil reveals that a shocking 73.3 percent of the participants who received Gardasil acquired a new medical condition ranging from flu-like symptoms to paralysis. Almost 60% had systemic reactions. Though the “placebo” recipients had similar results, obviously no mere saline solution would have produced even a fraction of such reactions. The results would likely have been even higher if the study had lasted longer than 15 days.

2. Studies have actually shown that Gardasil and its sister vaccine Cervarix (from GlaxoSmithKline) provide no protection for women already exposed to the HPV virus and in fact present highly elevated risks for already exposed women as well as for expectant mothers.
The more sexually active a woman is, the greater the chances she will become exposed to HPV viruses. Likewise, the older a woman is the more sexual encounters she will likely have had and thus the greater the risk of HPV exposure. Information provided for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in May 2006 revealed that when the vaccine is administered to a woman with a dormant or harmless form of HPV, the virus can become activated, increasing the likelihood of precancerous lesions developing by a staggering 44.6 percent.

The Vaccine Adverse Event Reporting System (VAERS) has reported 45 cases of spontaneous abortion, or miscarriage, following vaccination with Gardasil. At the time the vaccine was approved, five babies had been born with congenital birth defects after their mothers had been immunized with Gardasil, as opposed to a placebo group that had zero. Later reports put the number of birth defects in the vaccinated group closer to 40.

3. Just this month it was announced that Gardasil has been discovered to be contaminated with a substance many government health and safety agencies classify as a bio-hazard. After months of research, SANE Vax Inc. has discovered a substance many government health and safety agencies classify as a bio-hazard. SANE Vax Inc. contracted with an independent lab to test for contamination and found HPV recombinant DNA (rDNA) in 100% of the samples tested. The 13 Gardasil vials, with different lot numbers were from New Zealand, Australia, Spain, Poland, France, and three states in the U.S. All contaminating recombinant HPV DNA was firmly attached to the aluminum adjuvant in the vaccine.

4. The lack of dangers in the prescribing information furnished to doctors by Merck and the VAERS requirement that only serious and life-threatening events be reported both likely play big roles in the under-reporting of Gardasil reactions. Doctors are reluctant to report deaths and injuries from anything they administered or performed in the first place, and the lack of information and guidelines have insured that they are far less likely to report anywhere near all the adverse reactions from Gardasil.

Other factors which help skew the picture of Gardasil dangers include:

*The rate of deaths and adverse reactions are reported as a percentage of doses distributed, not doses actually administered.
*Gardasil is given in a series of three injections. Thus the number of adverse reactions per number of patients is triple the adverse events per injection.
Even with under-reporting, Gardasil causes 400% more deaths than other common vaccines. The true magnitude of Gardasil’s harm and dangers could be horrendous. Reports for other vaccine deaths and adverse reactions are estimated to represent no more than 10% of the actual totals. With Gardasil, estimates range as low as only 1%.
If 10% are reporting, there could be as many as 690 deaths and over 190,000 adverse events from HPV vaccines in theU.S.and its territories alone. If only 1% of deaths and adverse events have been reported, the numbers could be 6, 900 deaths and over 1,900,000 adverse events.
5. Behind Gardasil’s huge trail of deception is a very large and mostly hidden trail of tears. If anyone doubts that Gardasil is causing deaths, permanent injuries and devastation of mothers, fathers and other family members they should check out the SANEVAX vaccine safety site created by mothers of daughters killed and injured by HPV vaccines ( There, they will find story after story illustrating the harm HPV vaccines can cause.

Here are just two examples:
“What is Wrong with the Gardasil Girls? Amy’s Story”
“The journey of a Gardasil victim’s mother from trusting vaccines to vaccine activist”
Parents and the general public richly deserve to be told the full truth to keep that trail from leading to an ever larger ocean of suffering.

Sources included:
The five things you need to know about the HPV debate
Merck Sponsored Study……
SANE Vax Inc. Announces the Discovery of Viral HPV DNA Contaminant in Gardasil
Gardasil’s Trail of Deception….
Gardasil Risks Magnified for Sexually Active and Expectant Mothers

Friday, September 16, 2011

SANE Vax Inc: Vaccine Safety and Efficacy Advocates Respond to AAP

Open Letter to Dr. O. Marion Burton, president, American Academy of Pediatrics

Re: Heart-broken moms offended by statements of AAP on Gardasil®

September 16, 2011

Dear Dr. Burton:

On behalf of the thousands of parents who have either lost their perfectly healthy teenage daughters, or been left to endure the physical/mental/emotional and financial hardship of being forced to deal with the permanent disabling effects of Gardasil® vaccination, SANE Vax Inc. is offended by the thoughtless, ignorant and offensive press release issued from the office of the American Academy of Pediatrics (AAP) on September 13, 2011.

The press release criticizes the comment made by Republican presidential candidate, Michele Bachmann regarding Gardasil® side effects as ‘false statements’; and instead stated authoritatively ‘…it (Gardasil®) has an excellent safety record.’

Are you still practicing pediatrics? Physicians in the U.S. look to the AAP for guidelines yet the AAP seems to be oblivious to the latest Vaccine Adverse Event Reporting System. VAERS statistics clearly show that HPV Vaccines, Gardasil and Cervarix, have been associated with 22, 619 adverse reactions; 8,926 of those reports requiring emergency hospitalization; and 4,616 cases where the victim did not recover. Death reports stand at 102.

According to the National Vaccine Information Center, these figures reflect 1 to 10% of the vaccine injured population reporting.

The rate of anaphylaxis in young women post HPV vaccination has been found to be significantly higher by approximately – 5 to 20 fold – than those identified in comparable school-based vaccination programs. In fact, out of the 76 vaccines approved by the FDA the HPV vaccines make up 24% of the adverse injuries being reported.

The AAP is responsible for the health and welfare of our children. The Academy’s ignorance of vaccine injuries is deplorable and unacceptable.

Instead of showing compassion to victims and their families and making attempts to clarify or further investigate the possible causes for all these unexplained side effects, you simply dismissed them all by stating: ‘There is absolutely no scientific validity to this statement.’

This letter is to inform you that SANE Vax, Inc. has recently informed the FDA that the Gardasil® vaccine currently on the market has been found to be contaminated with residual recombinant HPV DNA. This hitherto unknown contaminant may have provided a scientific basis for Gardasil-induced autoimmune-based inflammatory diseases in various tissues, including inflammation in the joints and central nervous system. If the AAP is interested in this subject, perhaps using it as part of the AAP’s continuous medical education (CME) materials in place of those distributed by Merck, please read the hyperlinked documents below.

SANE Vax Inc. is wondering if Merck’s advertisements for Gardasil® in the AAP journals and cash contributions to sponsor various AAP CME programs that promote Gardasil® influenced the decision to issue the September 13 press release. In addition, is it possible that the $433,000 contribution made by Merck to the AAP might have influenced your position? Interesting to note: this was the same year the academy endorsed Merck’s HPV vaccine.

Perhaps the AAP should consult with Governor Rick Perry about disclosure.

Written by the SANE Vax Team on behalf of Gardasil® victims around the world,
Norma Erickson, President


1. How Independent are Vaccine Defenders? July 2008; Sharyl Attkisson CBS News


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

SANE Vax Inc. Announces the discovery of viral HPV DNA contaminant in Gardasil®

SANE Vax Inc. Discovers Potential Bio-Hazard Contaminant in Merck’s Gardasil® HPV4 Vaccine

SANE Vax Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil®

HPV Vaccine Fact Sheet

SANE Vax Inc. to Margaret Hamburg: Request the FDA Rescind Gardasil® Approval

Thursday, September 15, 2011

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… 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.

1. CNN – …
2. Pharmalot – …
3. Gradalis Inc.
4. CNN –
5. USA Today –
6. BusinessWire –
7. CBS News –

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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.

Tuesday, September 6, 2011

SANE Vax Inc. Announces the Discovery of Viral HPV DNA Contaminant in Gardasil

By Norma Erickson, President

Phone calls from mothers with children who have experienced adverse events after HPV vaccination is part of the everyday routine for members of the SANE Vax team. This one was different. A sexually naïve 13 year old girl from Toronto had developed acute juvenile rheumatoid arthritis within 24 hours after the third Gardasil™ injection. Two years later, her blood was tested by a local clinical laboratory and found to be positive for HPV DNA.

Local physicians could provide no explanation. Human papillomavirus is an epithelial virus which does not survive in the blood stream for long. HPV only thrives on skin and mucosal membranes. They could not explain why HPV was in her blood instead of HPV antibodies.

Desperate for answers, her mother called SANE Vax to see if there was any research available that might shed some light on her daughter’s situation. Not having any contradictory information available, the SANE Vax team agreed to contact some experts for their professional opinion.

Many phone calls and much research later, the only option left was to try to determine whether Gardasil could have been the possible source of HPV in the girl’s blood.

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

In order to understand the possible implications of such contamination, medical consumers must understand the following definitions:

There is no such thing as an independently ‘live virus’. Any and all viruses must be embedded in a host cell in order to reproduce.
‘Wild DNA’ is any DNA found in nature.
‘Viral DNA’ is any DNA isolated or derived from the genome of a virus.
‘Recombinant DNA’ is a DNA that has been artificially attached to DNA from another species or a man-made DNA construct, in other words, genetically modified.
‘Recombinant DNA,’ also known as genetically modified DNA, is considered a biohazard.[ii] [iii]
‘DNA residue’ is left-over DNA in a final product after the product has been purified to remove the DNA.
Any DNA can be adsorbed (attached) to aluminum adjuvant.
‘Mutagenesis’ is the formation or development of a genetic mutation. Gardasil has not been evaluated for mutagenesis.[iv]
‘Carcinogenesis’ is the initiation of cancer formation. Gardasil has not been evaluated for carcinogenesis.⁴
Concerned that recombinant DNA, if present, might have triggered some of the autoimmune-based inflammatory disorders and malignant tumors observed among children/young women after receiving Gardasil™ vaccinations, medical professionals and vaccine safety advocates from the United States, Australia, New Zealand, Spain, France, and Poland donated samples of Gardasil™ currently distributed in their countries to be examined.

In all, 13 different lot numbers were tested by Dr. Sin Hang Lee. One hundred percent of the samples were found to be contaminated with viral HPV DNA residues, firmly attached to the aluminum adjuvant.

At the time of Gardasil™ approval, both Merck and the FDA represented that there was no viral DNA in the vaccine.[v] [vi] [vii] Both the FDA and Merck knew, or should have known, that any residual recombinant HPV DNA left in the vaccine could pose a health risk to any medical consumer injected with Gardasil™.[viii] [ix]

Medical consumers need the answers to the following questions:

If recombinant HPV DNA attached to aluminum adjuvant enters a person’s blood, how long will it remain there?

What autoimmune-related disorders could result from this contamination?
Is it possible for this contamination to initiate gene mutations which may lead to cancer?
What genetic changes (mutagenesis) could occur should the residual HPV DNA enter and begin reproducing in a human cell?
SANE Vax 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. SaneVax believes the FDA should require every lot of Gardasil™ be tested for residual HPV DNA prior to shipment.

It is time for the manufacturer and the FDA to do their jobs. It is time to disclose the health impacts contaminant viral HPV DNA may have unleashed on unsuspecting medical consumers around the globe.

SANE Vax Inc. has sent a letter to Dr. Margaret Hamburg, FDA Commissioner to inform her of the contamination and request FDA investigation into the extent of HPV DNA contamination in the Gardasil HPV4 vaccine currently on the market. It was also requested that the FDA take appropriate actions to ensure public safety regarding future shipments.

Anything less than immediate action is not acceptable.


[i] DNA sequencing for molecular diagnoses

[ii] Potential Biohazards of Recombinant DNA




[iv] Gardasil: Highlights of Prescribing Information

[v] Developing an HPV vaccine to prevent cervical cancer and genital warts

[vi] Gardasil (Human Papillomavirus Vaccine) Questions and Answers – Gardasil, June 8, 2006, FDA

[vii] VRBPAC Briefing Document, FDA, 17 Nov 2010,see section 3.2, page 12

[viii] History, precedent, and progress in the development of mammalian cell culture systems for preparing vaccines: safety considerations revisited.

[ix] In vivo study of hepatitis B vaccine effects on inflammation and metabolism gene expression.

Monday, September 5, 2011

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.


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

Friday, September 2, 2011

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

September 2, 2011

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.

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