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 LiaisonReferences:
Mindanoiha says
September 14, 2012 at 10:10 amIn a nutshell.
FDA, Nov 2010
“GARDASIL is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection”. (Package insert info: similar wording).
June 2011
Recombinant HPV DNA fragments attached to aluminium adjuvant were found in all samples of Gardasil. The analysis was carried out through SaneVax’ initiative by an independent lab, based on a technology which is streets ahead of that used by either FDA or Merck itself.
The statement concerning absence of viral DNA was removed from the package insert information.
July 2011
FDA stated that they are developing and investigating new technologies to try to identify specific biological process that reflect virus activity, so that FDA scientists can determine if a vaccine substrate is safe to make vaccines on.
Oct 2011
“FDA Information on Gardasil – Presence of DNA Fragments Expected, No Safety Risk”.
No evidence for absence of safety risk yet been given.
– So now we can rest assured.
Pamela Prudchenko says
February 26, 2013 at 11:59 pmMy comments are in regard to the large amount of adverse reactions to receiving the Gardasil vac. There seems to be enough evidence and people with problems to start a large class action law suit against the makers of Gardasil, I believe it’s Merck. It’s not about the money, but it’s the point that this vac. should no longer be on the market.
It seems today and it is a shame that the lobbying efforts of the pharmaceutical industry for the most part has eroded all of our government and medical agencies.
Mel Smith says
September 15, 2012 at 3:28 pmIf the FDA would stop hiding the mineral Sodium Chlorite and trying to ban it…the world would be a healthier place to live for all of us..
Sodium Chlorite mixed with Citric Acid, turns into Chlorine Dioxide,(MMS) and is the most powerful pathogen killer known to man. When you take MMS it will kill off the HPV virus with no known side effects, as it does with all viruses and negative Bacteria that enter our boidies.
I have been taking MMS for 5 years now and I have not even had a cold or flu since I started taking MMS. Big Pharma and the FDA have been trying to hide these results from the public, as Big Pharma will lose millions if the public choose to use MMS instead of their poisonous chemical medicines. Just go to
http://www.jimhumble.biz and read all about what it is and how it can save thousands of lives every year., and one maybe you.
Godfrey says
September 16, 2012 at 1:54 pm.INEFFICACY OF THE HPV VACCINE SEEN BY DOCTOR OF DEEP PERÚ
From its inception until the appearance of cervical carcinoma (UCC), takes on average 25 to 30 years, the research of this vaccine have begun in 2000, it is evident that the scientific efficacy of this new vaccine will be determined the years 2025 – 2030.
HPV not causes definitely the (CCU); at the onset of this disease involves multiple risk factors, including the suspected HPV, but scientificaly is proven by epidemiology and statistics that the sex is what generates this disease .: Mix in 130.000 nuns found not any UCC.
http://www.portalesmedicos.com/publicaciones/articles/1832/1/Epidemiologia-del-carcinoma-del-cuello-uterino.html
To accept that a virus or a bacteria causes a infection disease must unfailingly fulfill the five Koch’s postulate
http://www.xatakaciencia.com/salud/los-postulados-de-koch
1 – The agent must be present in every case of the disease and absent from healthy.
2 – The agent must not appear in other diseases.
3 – The agent to be isolated in pure culture from disease lesions.
4 – The agent of causing disease in a susceptible animal being inoculated.
5 – The agent must again be isolated lesions in experimental animals.
http://es.scribd.com/doc/44558220/MICROBIOLOGIA-1
Consequently, HPV not fulfill not any principle of Koch’s postulate. by not meeting this postulate, that is accepted as dogma in medicine, scientifically we must be ensure that the HPV is not the causative agent to the UCC..
Until August 2012 this vaccine produced only in the United States: 265.640 adverse events ( 264,162 females, 9490 males and 5290 unknow sex); permnent disability 8910( 8890 females, 90 males and 110 unknow sex), 1220 deaths (1011 females, 70 males and 140 unknow sex), abnormal PAP 4930, cervical dysplasia 1970 and cervical cancer 570
http://holyhormones.com/vaccinations/hpv-vaccine/hpv-vaccine-adverse-events-reported-to-vaers-as-of-july-13-2012/
http://therefusers.com/?s=cervarix
The Vaccine efects advers reactions (VAERS) ensures that only complaint between 1% to 10% of the adverse effects produced by this evil vaccine;this figures shown are calculated according to the statements of the VAERS: to 10%.
http://www.noticiero.enkoria.com/2011/diez-menores-que-sufrieron-reaccion-adversa-a-la-vacuna-vph-d
http://www.pop.org/content/merck-researcher-admits-gardasil-guards-against-almost-nothing-985
Dr. Harper, who contributed to the development of the vaccine by Merck, reports that the vaccine was not investigated in children under 15 years and the vaccine given to children under 11 years is a big public experiment.
http://offtheradar.co.nz/vaccines/53-researcher-diane-harper-blasts-gardasil-hpv-marketing.html
The vaccine was approved to give girls uncontaminated with HPV, Dr. Howenstinc ensures that the women are vaccinated with HPV contaminated, have the possibility to acquire a 44.6% CCU
http://www.newswithviews.com / Howenstine/james170.htm.
Merck did not disclose that the vaccine was transgenic, the Sane Vax has discovered, which is transgenic because it has been found that the vaccine is contaminated with DNA recombinant vaccine Gardasil (DNArPVH) and has raised its concerns to the president of the FDA Margaret Hamburg. The FDA replied that the vaccine will not cause any damage transgenic
http://real-agenda.com/2011/09/16/vacuna-gardasil-contaminada-con-adn-recombinante-de-vph/
http://bolsonweb.com.ar/diariobolson/detalle.php?id_noticia=26075
A vaccinated child was ill with rheumatoid arthritis, which is an autoimmune disease. 24 hours after vaccination and found that the aluminum adhered to DNArPVH, two years after vaccination and in autopsy 6 months after death in a New Zeland girl Jazmine Renata which had recibed this deadly vaccines
http://www.mecfsforums.com/index.php?topic=9331.0
Management time to get market approval of a drug the FDA is at least three years, it is a drug for cancer 15 years, but the authorization Merck had only six months and the European Medicines Agency (EMA in English) only 9 months: To introduce the vaccine are using the marketing of fear
http://mujeresenaccion.over-blog.es/article-vph-la-vacuna-del-marketing-del-miedo-67210961.ht http://mujeresenaccion.over-blog.es/article-vph-la-vacuna -of-marketing-of-fear-67210961.ht
HPV is ubiquitous; lives in wild and domestic animals, pollute us from birth, is on the doorknobs, on towels, on nails, on fomites, in gloves and specula of gynecologists,. sexual intercourse is not the only means of contamination.
http://spa.myhealthygood.com/cancer-cervical-vacuna-contra-el-vph/investigadores-descubren-el-v
HPV also lives in the 400 nm outermost of our skin and mucous membranes. ,
If you live in our skin, our immune system produces cellular and humoral immunity is acquired or that our body is self vaccinatinge by PVHs living on our skin and mucous ..
http://www.conganat.org/seap/bibliografia/HPVToday/HPVToday007SEAP.pdf
The PVHs is not distributed uniformly worldwide. It has been found that in Canada HPV 18 only reaches 3%; is more often HPV 31, in my country Peru no studies have determined that HPV types predominate; Gardasil contains 225 mcg. aluminum and Cervarix 500 mcg, that produce the Alzheimer, Parkinson and autism, produce too neurotoxic and immune system disorders (Blaylock 2012) and Polisorbato 80, a powerful contraceptive, that in experimental animals produces sterility, atrophy of the testicles and disturbance organic and funtional of the organs of the reproduction; is carcinogenic and mutagenic; also contains sodium borate considered poison unused in medicinal preparations (NLM)
http://www.telefonica.net/web2/paramahamsa/vacunaninosalerta.html http://detenganlavacuna.wordpress.com/2010/11/09/gardasil-cervarix/
Have been discovered to date 200 types of HPV; HPV is not infectious, contagious; the intercourse is not only that the persons is contaminated
http://quimicaclinicauv.blogspot.com/2006/08/virus-del-papiloma-humano.html http://www-lab.biomedicas.unam.mx/smpv/queeshpv.htm
On 22-11-2010 FDA approved Gardasil for males aged 9 to 26 to prevent warts and cancer to the anus, is overkill
http://real-agenda.com/2011/09/16/vacuna-gardasil-contaminada-con-adn-recombinante-de-vph/
http://salud.aollatino.com/2011/02/02/aprueba-fda-nueva-indicacion-vacuna-tetravalente-vph-eeuu/
For the reasons since from deep Peru Huancayo, I believe that this vaccine is a fraud?, robbery?, swindle?, rough joke?.
The HPV is not scientifically proved for the moment that produce the UCC its effectiveness shall be verified just the years of 2025-2030.
Dr. Godofredo Arauzo
E mail: godo.ara@ gmail.com