FDA Information on Gardasil – Betrayal of the Public Trust?

By Norma Erickson, President

 

In response to the recent announcement by SANE Vax Inc. of the discovery of genetically modified HPV DNA residue in multiple vials of Gardasil, the FDA posted the following page on their site, FDA Information on Gardasil – Presence of DNA Fragments Expected, No Safety Risk. The FDA lists several ‘key facts’ in an obvious attempt to allay any fears which may have arisen over the discovery of foreign DNA in yet another ‘safe and effective’ vaccine. Unfortunately, these ‘key facts’ raise more questions than answers.

In spite of the fact the FDA claims their mission is, helping the public get the accurate, science-based information they need to use medicines, there are no scientific references and no indication that these ‘key facts’ are anything more than damage control statements. American medical consumers deserve better from an agency funded by taxpayers and entrusted with the mission of being responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices…… (FDA mission statement)

According to the Consumer Justice Group, in the last 27 years, there have been 31 drugs approved ‘safe and effective’ by the FDA which were subsequently withdrawn from the market due to safety concerns not uncovered during clinical trials. No one will ever know the true cost in human suffering resulting from adverse reactions to these 31 FDA approved ‘safe and effective’ medications.

Medical consumers worldwide are not willing to risk their children’s health and perhaps their very lives on a vaccine that ‘might’ prevent cancer 20 to 30 years down the road. Parents are not willing to wait until the adverse events post Gardasil vaccination reaches the same numbers as Vioxx did before the vaccine is withdrawn from the market.

Medical consumers around the world are no longer willing to accept the FDA’s ‘word’ when it comes to HPV vaccines and their children’s health and safety. They are demanding scientific proof of the claims made by the FDA and vaccine manufacturers.

FDA ‘Key Facts,’ and questions raised by SANE Vax Inc. on behalf of medical consumers:

  • Gardasil does contain recombinant HPV L1-specific DNA fragments, but these are not contaminants. DNA encoding the HPV L1 gene is used in the vaccine manufacturing process to produce the virus-like particles that make up the vaccine. The presence of these DNA fragments is expected, is not a risk to vaccine recipients, and is not a safety factor. DNA is the “blueprint” for the majority of living organisms and carries the genetic instructions for how cells function and grow.
    1. Do these ‘expected’ DNA fragments contain plasmid?
    2. Please explain why, if these HPV rDNA fragments are ‘expected,’ why did the manufacturer have to invent a patented process to remove them?
    3. Please provide the DNA sequences of all ‘expected’ HPV DNA fragments in the vaccine.
    4. Provide copies of all scientific studies that prove these DNA fragments are ‘not a risk to vaccine recipients.’
    5. Do the above referenced studies include studies regarding the potential safety concerns of these ‘expected’ DNA fragments being tightly bound to aluminum hydroxyphosphate micro-particles?
  • The vaccine manufacturing process is highly regulated under FDA’s current good manufacturing practice requirements, including inspections conducted by FDA of the manufacturing processes and facilities.
    1. Please publish all reports of FDA inspections of the four manufacturing facilities from which the Gardasil samples tested at Milford Medical Laboratory originated since Gardasil’s FDA approval, including the DNA sequences of the detectable residual HPV DNA molecules and the quantity of total HPV DNA per Gardasil dose.
  • 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. Gardasil does not contain DNA from other HPV genes or any full-length infectious HPV genomes.
    1. If Merck and Co., Inc. and the FDA knew small quantities of residual recombinant HPV L1-specific DNA fragments remain in Gardasil, why do marketing and information packets from around the world specifically state the vaccine contains ‘no viral DNA’?
    2. Please publish the manufacturer’s dated report, stating the acceptable quantities and the sequences of the residual recombinant HPV L1-specific DNA fragments that remain in the vaccine.
    3. Is the FDA aware that injected naked microbial or viral DNA need not be either full-length or ‘infectious’ to potentially cause a health problem?
  • As it does with all vaccines, FDA continues to monitor the safety of Gardasil. For example, FDA recently evaluated the results of a postmarketing study, which included 189,629 females ages 9 to 26 years, 51% of whom were 9 to 15 years of age to assess the risk for onset of new autoimmune diseases after vaccination with Gardasil. Examples of these types of diseases include juvenile rheumatoid arthritis, lupus, multiple sclerosis, etc. The results of this study showed that there is no elevated risk for onset of new autoimmune disease associated with the use of Gardasil.
    1. Did the 189,629 females selected for postmarketing study include cases reported to VAERS?
    2. Is the FDA aware there are 75 vaccines approved for use in the United States and for the first five years after the approval of HPV vaccines, adverse events reported after HPV vaccinations account for a full 16% of the entire VAERS database? See the analysis here.
    3. Why does this fact not raise a red flag prompting an investigation?
  • FDA also continually reviews all reports of the Vaccine Adverse Event Reporting System after vaccination with Gardasil, and there is no evidence of unusual clinical patterns or high reporting rates of adverse events, including autoimmune diseases.
    1. Is the FDA aware of the fact that out of 75 FDA approved vaccines, adverse injury reports post-HPV vaccination account for the following percentages of VAERS reports for all vaccines?
      • 24% of all life-threatening events
      • 26% of all emergency room visits
      • 25% of all hospitalizations
      • 33% of all extended hospital stays
      • 36% of all disabling events
    2. Why do the above statistics, verifiable here, not raise a red flag requiring investigation?
    3. Did the FDA consider cases of immune-based acute disseminated encephalomyelitis after Gardasil injections (1-7) evidence of unusual clinical patterns? If not, why not?

Medical consumers around the globe are asking the same questions. They will no longer accept semantics games, changing definitions, or public relations statements. Medical consumers demand scientific evidence.

If the FDA is actually protecting the public health, there should be no problem providing scientific documentation answering the questions above. Anything less than full compliance is a betrayal of the public trust, not to mention a violation of the public’s right to informed consent. Notions of equal treatment should be cast aside under the circumstances–can the FDA really support exposing our boys to these significant health risks?

References:

  1. Sutton I, Lahoria R, Tan I, Clouston P, Barnett M. CNS demyelination and quadrivalent HPV vaccination. Mult Scler. 2009; 15:116-9.
  2. Wildemann B, Jarius S, Hartmann M, Regula JU, Hametner C. Acute disseminated encephalomyelitis following vaccination against human papilloma virus.  Neurology. 2009;72:2132-3.
  3. Mendoza Plasencia Z, González López M, Fernández Sanfiel ML, Muñiz Montes JR. Acute disseminated encephalomyelitis with tumefactive lesions after vaccination against human papillomavirus. Neurologia. 2010; 25:58-9.
  4. Chang J, Campagnolo D, Vollmer TL, Bomprezzi R. Demyelinating disease and polyvalent human papilloma virus vaccination. J Neurol Neurosurg Psychiatry. 2010 Oct 9. doi:10.1136/jnnp.2010.214924
  5. DiMario FJ Jr, Hajjar M, Ciesielski T. A 16-year-old girl with bilateral visual loss and left hemiparesis following an immunization against human papilloma virus. J Child Neurol. 2010; 25:321-7.
  6. Balamoutsos G, Bouktsi M, Paschalidou M, Tascos N, Milonas I.  A report of five cases of CNS demyelination after quadrivalent human papilloma virus vaccination: could there be any relationship?  (Abstract No. P297)- Poster Access : www.guthyjacksonfoundation.org/services/download.php?2297.pdf+374
  7. Rossi M, Bettini C, Pagano C. Bilateral papilledema following human papillomavirus vaccination. J Med Cases. 2011; 2:222-4.

 

Comments

  1. Thank you SaneVax for asking the hard questions.

    • Everyone needs to be asking the same questions. They are all questions that should have been asked and answered prior to approval for marketing.

  2. The FDA was possibly unaware of the presence of aluminium bound recombinant HPV DNA. When its presence was revealed by Dr Sin Hang Lee, FDA could surely not tolerate being in a position where they were obliged to say “Thank you for the information”! The only way out was for them to state that its presence was to be expected.

    In this connection, in an attempt to minimalise negative publicity, FDA stated without any evidence to back it up that the vaccine is safe and effective.

    Medical consumers are grossly mislead by these terms as most no doubt regard “safe” as minimal or absence of risks, and “effective” (in the case of Gardasil) as being effective against cervical cancer. There is no documentation to support this.

    The discovery of the DNA poses several additional problems for FDA and Merck. FDA stated that the DNA is not a contaminant because its presence was expected. But if that is so, then it is an ingredient and its presence should have been specified in the patent application and product information.

    In fact, it was stated that the vaccine contained no viral DNA – until after the discovery of the presence of aluminium bound recombinant DNA. After that the package insert information was revised to include its presence.

    FDA presented this statement:
    “DNA is the “blueprint” for the majority of living organisms and carries the genetic instructions for how cells function and grow”
    It is interesting to dwell on the reasons for the statement. One reason may be an attempt by FDA to calm down concern about the presence of DNA. However, the statement is disgracefully misleading as FDA knows that aluminum bound recombinant DNA is a far cry from just “DNA”.

    As SaneVax previously has pointed out, 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?

  3. Godofredo Arauzo says:

    INEFICACIA DE LA VACUNA CONTRA EL PVH VISTO POR
    MEDICO DEL PERÚ PROFUNDO
    La eficacia científica de esta vacuna recién se determinará los años 2025-2030 porque las investigaciones se han iniciado la década del 2000. Desde su inicio hasta la aparición del Carcinoma del cuello uterino (CCU), demora en promedio 25 a 30 años.
    El PVH definitivamente no origina el (CCU); en la aparición de esta patología intervienen múltiples factores de riesgo, entre ellos se sospecha que puede ser el PVH; sí está comprobado que el acto sexual es el que genera esta enfermedad:
    Mix en 130,000 monjas no halló ningún CCU. http://www.portalesmedicos.com/publicaciones/articles/1832/1/Epidemiologia-del-carcinoma-del-cuello-uterino.html
    Para aceptar que un virus a bacteria es el que origina una enfermedad tiene que cumplir indefectiblemente los 5 principios del Postulado de Koch: . http://www.xatakaciencia.com/salud/los-postulados-de-koch
    1- El agente debe estar presente en cada caso de la enfermedad y ausente en los sanos.
    2- El agente no debe aparecer en otras enfermedades.
    3- El agente ha de ser aislado en un cultivo puro a partir de las lesiones de la enfermedad.
    4- El agente ha de provocar la enfermedad en un animal susceptible de ser inoculado.
    5- El agente ha de ser aislado de nuevo en las lesiones de los animales en experimentación.
    1. Principio: no se ha encontrado el PVH físico en ningún carcinoma del cuello uterino (CCU), se ha encontrado su ADN por inmunología, que puede interpretarse como que el virus está presente o que es un residuo inmunológico. y su detección por inmunología no se ha conseguido en todos los CCU sino hasta el 90% de CCU: No cumple este primer principio;
    2. Principio: El agente aparece también en las verrugas no aparece solamente en los CCU: Tampoco cumple este principio;
    3. Principio: No se ha aislado cultivando a partir de un CCU: No cumple este principio
    4. Principio: Al inocular el PVH a un animal de laboratorio, produce la enfermedad. Cómo no se ha aislado del CCU, no se ha inoculado a un animal de laboratorio. Incumple este principio y
    5. Como no se inoculó porque no se halló en un CCU, no reproduce el CCU. Incumplió también este principio.
    En consecuencia, el PVH no cumple ningún principio del postulado de Koch. al no cumplir este postulado que es aceptado como dogma en el mundo, científicamente se puede asegurar que no es el agente causante del CCU.
    Hasta Marzo de este año han muerto 95 niñas; hasta el 2009 se habían producido 20,000 reacciones adversas y más de mil daños invalidantes irreversibles.
    La VAERS informa: que han producido 376 Papanicolaou anormales; 108 verrugas anogenitales, 224 infecciones con el PVH, 41 cánceres del cuello uterino, 21,634 efectos adversos y 95 muertes, después de la vacunación.
    La VAERS asegura que se dan a conocer solamente del 1 al 10% de los efectos adversos y muertes por esta aciaga vacuna, en consecuencia se han producido 216,340 efectos adversos y 950 muertes solamente en USA y a todas los daños enumerados agregarles un cero.
    http://www.noticiero.enkoria.com/2011/diez-menores-que-sufrieron-reaccion-adversa-a-la-vacuna-vph-d http://www.noticiero.enkoria.com/2011/diez-menores-que-sufrieron-reaccion-adversa-a-la-vacuna-vph-d http://www.noticiero.enkoria.com/2011/diez-menores-que-sufrieron-reaccion-adversa-a-la-vacuna-vph-d
    La Dra. Harper, la que contribuyó a la elaboración de la vacuna por Merck, refiere que la vacuna no fue investigada en menores de 15 años y la vacuna dada a menores de 11 años es un gran experimento público. http://offtheradar.co.nz/vaccines/53-researcher-diane-harper-blasts-gardasil-hpv-marketing.html
    La vacuna fue aprobada para dar a niñas no contaminadas con el PVH; el Dr.Howenstinc publica que si se vacuna a mujeres contaminadas con el PVH, tienen la posibilidad de adquirir el CCU en un 44.6% http://www.newswithviews.com/Howenstine/james170.htm.
    La Sane vax ha descubierta la contaminación de la vacuna gardasil con el DNA del PVH y ha elevado su preocupación a la presidenta de la FDA Margaret Hamburg http://www.mecfsforums.com/index.php?topic=9331.0
    Para introducir la vacuna están utilizando el marketing del miedo: http://mujeresenaccion.over-blog.es/article-vph-la-vacuna-del-marketing-del-miedo-67210961.ht http://mujeresenaccion.over-blog.es/article-vph-la-vacuna-del-marketing-del-miedo-67210961.ht
    El PVH vive en los animales domésticos y silvestres; nos contaminamos desde que nacemos; se halla en las perillas de las puertas, en las toallas, en las uñas, en los fomites, en los guantes y espéculos de los ginecólogos. Se duda que el acto sexual sea el único medio de contaminación http://spa.myhealthygood.com/cancer-cervical-vacuna-contra-el-vph/investigadores-descubren-el-v
    EL PVH VIVE TAMBIÉN EN LOS 400 NANÓMETROS MÁS EXTERNOS DE NUESTRA PIEL,
    Sí vive en nuestra piel, nuestro sistema inmunológico produce inmunidad celular y humoral adquirida o sea que nuestro organismo está siendo vacunado EN FORMA NATURAL por los PVH que viven en nuestra piel y por inferencia podemos asegurar que también viven en las mucosas..
    http://www.conganat.org/seap/bibliografia/HPVToday/HPVToday007SEAP.pdf Esta vacuna es transgénica; las vacunas que se conocen, son de virus originales, SE DESCONOCE los daños que producirá y está preparada para prevenir la infección por los PVHs 16 y 18 http://www.larevistaintegral.com/4874/vacuna-papilomavirus-%C2%BFes-peligrosa.html/comment-page-1#comment-11649.
    Los PVHs no se distribuyen en el mundo de manera uniforme. Se ha comprobado que en el Canadá el PVH 18 sólo llega al 3%; es más frecuente el PVH 31; en mi patria Perú no hay estudios que hayan determinado que tipos de PVH predomina; Esta vacuna contiene 225 mcg. de aluminio, sospechoso de producir el Alzheimer y el Polisorbatol 80 que es un anticonceptivo potente y en los animales de experimentación produce esterilidad; es carcinogénico y mutagénico; contiene además el borato de sodio considerado veneno; no usado en las preparaciones medicinales. http://www.telefonica.net/web2/paramahamsa/vacunaninosalerta.html http://detenganlavacuna.wordpress.com/2010/11/09/gardasil-cervarix/
    Por las razones expuesta desde el Perú, profundo, Huancayo, considero que esta vacuna es un Fraude?, Robo?, Estafa?, Burla?.
    No está comprobada científicamente por el momento; su eficacia se comprobará recién los años del 2025-2030.
    Dr. Godofredo Arauzo
    E mail: godo.ara@gmail.com

  4. Godofredo Arauzo says:

    INEFFECTIVE OF THE HPV VACCINE SEEN BY
    DOCTOR OF PERU DEPTH
    The scientific efficacy of this vaccine will be determined just the years 2025-2030 because research has begun the decade of 2000. From its inception until the appearance of carcinoma of the cervix (CCU), takes on average 25 to 30 years; definitely not the HPV causes the (CCU); in the onset of this disease involve multiple risk factors, among them are suspected to HPV. yes it is proven that sex generates this condition: Mix in 130.000 nuns found no CCU.
    To accept that a bacteria or virus causes a disease inevitably have to fulfill the Koch’s Postulates:.
    http://www.xatakaciencia.com/salud/los-postulados-de-koch
    1 – The agent must be present in every case of the disease and absent in the healthy.
    2 – The agent should not appear in other diseases.
    3 – The agent must be isolated in pure culture from lesions of the disease.
    4 – The agent has to cause the disease in an animal capable of being inoculated.
    5 – The agent must be isolated from new lesions in experimental animals.
    1. Principle: not found any physical HPV cervical carcinoma (CCU), has found only his DNA immunology, which can be interpreted as the virus is present or is a residual immunity. and immunological detection was not meet in all CCU;only 90% of CCU: does not fulfill this first principle;
    2. Principle: The agent also appears in the warts does not appear only in the CCU: not satisfy this principle;
    3. Principle: It have not been isolated cultivating from a growing CCU: Does not fulfill this principle
    4. Principle: The HPV inoculate a laboratory animal, produces the disease; as it have not been isolated from the CCU, it has not inoculated to laboratory animal; violates this principle and
    5. As it was not inoculated in laboratory animal because they was not found in a CCU, . also violated this principle.
    Consequently, HPV does not fulfill any principle of the Koch’s postulates; this postulates is accepted as dogma in the scientists physicia world to ensure that it is the causative agent of the CCU.
    Until March of this year, 95 girls had death; until 2009 had 20.000 adverse effects and more of one thausand disabled irreversible damage. The Vaccine Adverse Effects Reaction (VAERS) reports too that the vaccine produced abnormal Pap 376, anogenital warts 108, HPV infections 224, 41 cervical cancers, 21.634 adverse events and 95 death after vaccination. The VAERS say that is known only 1 to 10% of adverse effects and deaths from unlucky vaccine; therefore, have been 216.340 adverse effects and 950 death alone in the U.S. and all the damages listed add a zero.
    http://www.noticiero.enkoria.com/2011/diez-menores-que-sufrieron-reaccion-adversa-a-la-vacuna-vph-d
    Dra. Harper, who helped develop the vaccine by Merck, refers 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 for girls to not contaminated with HPV; Dr.Howenstinc say that if women infected with HPV is vaccinated, have the opportunity to acquire a 44.6% CCU
    http://www.newswithviews.com/Howenstine/james170.htm.
    Sane vax has discovered that the vaccine is contaminated with the DNA HPV and has raised its concerns to the president of the FDA Margaret Hamburg
    http://www.mecfsforums.com/index.php?topic=9331.0
    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-del-marketing-del-miedo-67210961.ht
    The HPVs lives in wild and domestic animals, we pollute us from first day of birth, is found in the doorknobs, in towels, in the nails, on fomites, in gloves and specula of gynecologists. It is doubtful that sex is the only means of contamination
    http://spa.myhealthygood.com/cancer-cervical-vacuna-contra-el-vph/investigadores-descubren-el-v
    The PVH live too in 400 nanometers more external of our skin; if he HPV live on our skin, our immune system produces cellular and humoral immunity or that our bodies are being vaccinated in a natural way; if the HPV live in our skin, by inference we can ensure that too they live too in the mucous membranes ..
    http://www.conganat.org/seap/bibliografia/HPVToday/HPVToday007SEAP.pdf
    This vaccine is genetically modified, the vaccines known are original virus known and the vaccine is prepared to prevent infection only by the HPV 16 and 18
    The HPV is not distributed uniformly over the world. The HPV 18 has been found in Canada in only 3%, more common is HPV 31, in my country Peru there are no studies that established the predominant HPV types;
    This vaccine contains 225 mcg. Aluminum, a suspected cause Alzheimer’s and Polisorbatol 80 which is a powerful contraceptive; in experimental animals produces sterility; is carcinogenic and mutagenic, also contains sodium borate considered poison, not used in medicinal preparations.
    http://www.telefonica.net/web2/paramahamsa/vacunaninosalerta.html
    http://detenganlavacuna.wordpress.com/2010/11/09/gardasil-cervarix/
    For the dangerous reasons from Peru, depth, Huancayo, I believe that this vaccine is a Fraud?, Robbery?, Swindle? , Rough joke?; it is not scientifically proven at the moment, its effectiveness, will be determinated just the years of 2025-2030.

    Dr. Godfrey Arauzo
    E mail: godo.ara @ gmail.com
    Phone: 05164252052

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  1. [...] FDA Information on Gardasil – Betrayal of the Public Trust? October 28, 2011 By Norma 2 Comments [...]

  2. [...] said DNA fragments are “expected” – you can read about that here.  In response, SaneVax Inc.’s article questions the FDA’s “Key Facts” & considers whether the public is being [...]

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