October 28, 2011
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Group, in the last 27 years, there have been 31 drugs approved ‘safe and effective’ by the FDA which were subsequently withdrawn from the market due to safety concerns not uncovered during clinical trials.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to wait until the adverse events post Gardasil vaccination reaches the same numbers as Vioxx did before the vaccine is withdrawn from the market.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.

Press Release here…. http://sanevax.org/fda-information-on-gardasil-betrayal-of-the-public-trust/