September 27, 2011
MERCK has made public their "exclusion" criteria for the Gardasil HPV vaccine in documents filed with ClinicalTrials.gov, for clinical trial #NCT01096134, a.k.a. "Mother Daughter Initiative." If these "exclusion criteria" were known by, and applied to families in the United States of America, prior to the vaccination of their child, virtually none of the 22,000 girls and boys listed by the CDC's VAERS reporting system as being injured by the Gardasil HPV vaccine, would have been allowed to be vaccinated, and 100 deceased HPV vaccinated children, would still be alive today. Family medical histories of children injured by the Gardasil HPV vaccine have been compiled by the non-profit group, "TRUTH ABOUT GARDASIL," who has issued this statement.
After months and months of intensive research Truth About Gardasil has discovered that Merck the manufacturer of HPV vaccines have the potential to cause harm to people with certain pre-existing conditions that are not mentioned in the Physicians Product Insert (1)
In the clinical studies (2, 3, 4, 5, 6) we have found that certain individuals have been excluded from the clinical study groups. They are:
- Allergies to any component of the vaccine
- History of a severe allergic reaction
- Known history of any allergies to food or medicine
- Immunocompromised, Immunodeficient or has an autoimmune condition
- History of any condition, therapy, lab abnormality or other circumstance such that it is not in the best interest of the participant to participate
- Clinically significant disease or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise the outcome of this study.
- Have a weakened immune system or other immune problems
The Gardasil® vaccine produced by Merck contains AAHS (amorphous aluminum hydroxyphosphate sulfate) also termed MAA (Merck Aluminum Adjuvant) (7, 8, 42) There is no effort at disclosure of the sulfate in the product under item 4. Contraindications of the Physicians Package Insert. (1) People with an allergy to any type of sulfate have the potential to be at risk for an adverse event that could result in anaphylactic response which is life threatening. (7)
Merck also has not disclosed to the public that during the trials those who received the Gardasil® vaccination that 73.3% of the participants acquired a new medical condition as stated on page 139. (7) It is also now known that many irregularities are present in both reports to the FDA in regards to the composition of the placebo. (8, 9, 10)
To prove safety of the HPV VLP vaccine Gardasil® this now disputed composition placebo (42) was compared to the HPV vaccine. They took the difference between the two. (8, 9, 20) "The proportions of subjects who reported serious adverse experiences, or who discontinued due to an adverse experience were low and comparable to placebo recipients." (20) The contents of the placebo (42) were not divulged in this document.
It has not been disclosed to the public that the disputed composition placebos (42) had an adverse event rate of 76.3% This proves to Truth About Gardasil that the AAHS (MAA — amorphous aluminum hydroxyphosphate sulfate(42))which targets a strong Th2 response (41,42) along with the other ingredients of the HPV-VLP vaccine (9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate) have the potential to be the real reason behind all the adverse events (1–10%) that have been reported to VAERS (Vaccine Adverse Reporting System) to date.
The adverse events in VRPBAC, 17-November-2010, (20) show that out of 1945 subjects with follow-up there were 1346 (69.2%) with one or more adverse experiences in the Gardasil group and out of 1950 subjects with follow-up there were 1252 (64.2%) with one or more adverse experiences in the Placebo (42) group. This tells us that the placebo (42) with this high of a percentage rate could only mean that the placebo (42) is in reality the carrier solution with AAHS which means it probably contained all of the ingredients listed above.
Under section 11.1, titled Updated Post licensure Safety Surveillance there is no mention of any reports received by Merck were reported to the VAERS (Vaccine Adverse Event Reporting System). In paragraph 5 under this title it states that "A query of the NWAES database performed on 14-Jun-2010 revealed that 37,884 spontaneous reports have been received from 1-June-2006 through 31-May-2010; 4,598 reports (12%) were considered serious. The 5 most frequently reported adverse experiences included no adverse event (8096), inappropriate schedule of drug administration (6975), drug exposure during pregnancy (3289), dizziness (3098), and syncope (3089). (18)
Presently in the VAERS data base it states (queried June 1, 2006 — September 20, 2011) that there have been 23,388 reports, 3,111 serious, 444 life threatening, 763 disabled, 103 died, 9,115 we believe were so severe that they required the individual to go to the emergency room. There is a difference of over 14,000 reports. We understand that they could be coming from other countries but the numbers are staggering considering that they may only be 1–10% reporting.To put a better perspective on what this could mean we did a study of the symptoms reported to the VAERS database. These are only a sample of the symptoms that have been reported to VAERS: Autism — 4, Autoimmune disorder — 75, IgE increased — 17 , blindness — 72 , Blood pressure decreased — 199, cardiac arrest — 15, cardiac failure (cumulative) — 4, Cardio-respiratory arrest — 1, cervical dysplasia — 157, Cervix carcinoma (stage 0=8, stage 1=2, stage 3=1), convulsion — 1120, deafness — 37, Demyelination — 60, Depression — 148, dizziness (cumulative) — 3151, Encephalomyelitis — 7, Encephalopathy — 16, Eosinophil count increased — 14, Eosinophil percentage increased — 14, Epstein-Barr (cumulative) 119, facial palsy — 138, facial paresis — 51, Fibromyalgia — 27, Headache — 2349, Hodgkin's disease — 24, Immune system disorder — 25, Infertility — 5, injected limb mobility decreased — 188, Joint swelling — 160, loss of consciousness — 1540, malaise — 805, memory impairment — 64, Menstruation (cumulative) — 209, mental disorder — 26, Migraine — 287, Multiple sclerosis — 89, muscular weakness — 385, Myalgia — 620, Nausea — 2271, Nervous system disorder — 51, ovarian (cumulative) — 60, Paraesthesia — 855, Paralysis — 82, Premature (baby — 32, delivery — 10, labour — 90, menopause — 2), pulmonary embolism — 49, Rash (cumulative) — 2178, smear cervix abnormal — 430, Syncope — 3412, Tremor — 550, Vomiting — 1260, these are individual symptoms that have been reported and do not reflect individual reports. (21) (Cumulative = several different types with initial symptom)
With all of this data that has been accumulated one has to go back to the ingredients of the vaccine and why do they cause the reaction rates that they do. We are only going to concern ourselves with the carrier solution because we do not feel that the HPV-VLP rDNA is of a concern here.
In a study published in the Journal of Inorganic Biochemistry (11) states that Aluminum (42) Hydroxide injections lead to motor deficits and motor neuron degeneration. (11, 12, 13, 14, 42) We do not know if the Hydroxy (12, 13, 14) is Hydroxyl or Hydroxyl radical. If this is indeed the Hydroxyl radical then there is also a problem as this free radical can cause damage to oxidative cells particularly red blood cells. (16, 17)
Further, this HPV-VLP vaccine is constructed to target the Th2 immune response. (18, 42) According to the Merck Manual (19) The Th2 response promotes "IgE production and development of allergic disorders." (33)
It is a known fact that people with allergies or a family history of same could have elevated levels of IgE (36) and histamine (22, 42) receptors. It is also a known fact that people due to heredity or oxidative stress (42) could be glutathione deficient. (20–32) Both of these conditions if a vaccine is administered without proper pre-vaccination testing have the potential to produce an adverse event in the individual. From what we have seen in the clinical trials people with allergies are omitted but the vaccine is prescribed to this section of the population anyway without concern to the possible risks involved. Up to 30% of the general population has IgE-mediated allergic diseases. (36)
We have also discovered that certain types of individuals seem to be more prone to having a reaction of some type. These are Athletes (23, 25,26) and Overweight (27, 28, 29, 30) individuals. Another thing we have found that they all have in common is family history of allergies/auto-immune disease and higher levels of testosterone. This may be indicative of elevated IgE levels and lower glutathione due to oxidative stress. (27, 28, 29, 30)
Merck has also endeavored to have Gardasil® approved for vaccination of older females. It is a scientific fact that as we age our glutathione level diminishes. (31–35) This target population, considering the adverse events reported above, have a higher possibility of having a "New Medical Condition" due to glutathione deficiency that would require medication and/or intervention.
People with a family history of auto-immune disease are also excluded from the trials for the protection of the participant as was stated above. We know of many individuals that have a history of auto-immune diseases(42) who have received the vaccination to their detriment. Presently, there is quite a bit of research that has been done and is being done into the relationship between glutathione deficiency and auto-immune disease. (36-40)
In essence these vaccines have the very real possibility of causing allergies (42), hyper-IgE syndrome, and a myriad of other symptoms that Merck and GlaxoSmithKline either have a treatment for or have ongoing studies to treat these conditions and/or symptoms.
These vaccines are creating new clientele for therapy's manufactured by Merck and GlaxpSmithKline. It is our belief that this comes under your jurisdiction in regards to the anti-trust laws.
Therefore: Truth About Gardasil is demanding a full investigation with disclosure as to this conflict of presenting a vaccine that has the potential to cause "New Medical Conditions" to approximately 75% of the population aged from 11 thru 26 and any adult female that decides to receive this vaccine. This could require the individual to be forced to purchase medications to alleviate symptoms and/or conditions promoted by these vaccines.
Truth About Gardasil is also demanding that based on this knowledge that both HPV vaccines be removed from distribution and administration until a proper investigation into these practices which have the potential to increase revenues by creating "New Medical Conditions" to the population of healthy individuals and immediately commences a full safety investigation into the HPV vaccines and their potential to cause harm to the general population.
Note: Here is the original patent for the vaccines. In this patent you will find the means in which both vaccines can be produced. United States Patent, Number: 5,437,951, Date of Patent: August 1, 1995. The subsequent patent was held by Merck which also details both combinations. United States Patent, Number: 5,821,087, Date of Patent: October 13, 1998.
These vaccines are given in multiple doses which is called challenge and re-challenge * Drug Injury, Liability, Analysis and Prevention, Second Edition, James T. O'Donnell, Pharm.D., M.S., FCP, ABCP, FACN, CNS, R.Ph., Chapter 10, Evaluation of Medical Causation, Donald H. Marks, M.D., Ph.D. , B. Riddell's criteria, Page 146 ,
(1) Physicians Package Insert, http://www.fda.gov/downloads/BiologicsBloodVaccines/
(2) A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007 AM1)
(3) Human Papilloma Virus (HPV) Type-Specific Antibody
(4) Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting
(5) Mother — Daughter Initiative (MDI) in Cervical Cancer Prevention
(7) Canterbury District Health Board
(10) HPV reports to FDA — oversight, errors and/or omission. That is the question. http://www.renewamerica.com/columns/janak/110919
(11) Aluminum Hydroxide injections lead to motor deficits and motor neuron degeneration. Journal of Inorganic Biochemistry
Volume 103, Issue 11, November 2009, Pages 1555-1562
The Eighth Keele Meeting on Aluminium , doi:10.1016/j.jinorgbio.2009.05.019 Christopher A. Shawa, b, c, Corresponding Author Contact Information, E-mail The Corresponding Author, Michael S. Petrikc
(12) Departments of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada
(13) Experimental Medicine, University of British Columbia, Vancouver, British Columbia, Canada
(14) Graduate Program in Neuroscience, University of British Columbia, Vancouver, British Columbia, Canada
Received 17 April 2009; revised 26 May 2009; Accepted 29 May 2009. Available online 20 August 2009.
(15) Collins English Dictionary — Complete and Unabridged © HarperCollins Publishers 1991, 1994, 1998, 2000, 2003
(16) Hydroxy is adj, (Chemistry / Elements & Compounds) (of a chemical compound) containing one or more hydroxyl groups, [hydro- + oxy(gen)]
(17) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC88911/?tool=pmcentrez — ...in the gaseous phase. H2O2 acts as an oxidant by producing hydroxyl free radicals (•OH) which attack essential cell components, including lipids, proteins, and DNA. It has been proposed that exposed sulfhydryl groups and double bonds are particularly targeted (38).
(18) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1097753
(19) Merck Manual
(20) GARDASIL® (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) VRBPAC Briefing Document, Presented to VRBPAC on 17-November-2010, page 14
(21) MedAlerts.org, http://www.medalerts.org/
(22) Possible role of histamine in pathogenesis of autoimmune diseases: Implications for immunotherapy with histamine-2 receptor antagonists, Medical Hypotheses, Volume 39, Issue 4, Pages 349-355, H. Nielsen, J. Hammer
(23) "College Sports Scholarships," "The importance of hormones in female athletic competition,"
(24) Time, "A Link Between Autism and Testosterone?" by Eben Harrell, January 15th of 2009.
(25) Antioxidant, Blood Booster and Cell Detoxifier
(26) Genetics Home Reference, Glutathione synthetase deficiency, Reviewed December 2006, http://ghr.nlm.nih.gov/condition/glutathione-synthetase-deficiency
(27) Plasma Interleukin-6 levels, glutathione peroxidase and isoprostane in obese women before and after weight loss. Association with cardiovascular risk factors, Maria Bougoulia, Athanassios Triantos, George Koliakos ,Biochemistry Department, Aristotele University Medical School, Thessaloniki, Greece http://www.hormones.gr/preview.php?c_id=153
(28) Int J Sport Nutr Exerc Metab. 2001 Dec;11(4):451-65.,
(29) Journal of Clinical Endocrinology & Metabolism , doi:10.1210/jc.2005-0438, The Journal of Clinical Endocrinology & Metabolism Vol. 90, No. 10 5588-5595 Copyright © 2005 by The Endocrine Society
(30) The full report, "Pathogenesis of polycystic ovary syndrome: What is the role of obesity?" appears in Metabolism (2004;53:358-376).
(31) Journal of Endocrinology (2000) 167, 447–452
(32) Julius M, Lang CA, Gleiberman L, Harburg E, DiFranceisco W, Schork A. Glutathione and morbidity in a community-based sample of elderly. J Clin Epidemiol 1994;47:1021–6.[Medline]
(33) Richie JP, Skowronski L, Abraham P, Leutzinger Y. Blood glutathione concentrations in a large-scale human study. Clin Chem 1996;42:64–70.[Abstract/Free Full Text]
(34) American Journal of Clinical Nutrition, Vol. 71, No. 5, 1194-1200, May 2000, © 2000 American Society for Clinical Nutrition , Direct correlation of glutathione and ascorbate and their dependence on age and season in human lymphocytes
(35) Carcinogenesis, vol.19 no.10 pp. 1873-1875, 1998. Age and gender dependent levels of glutathione and glutathione S-transferases in human lymphocytes.
(36) Autism Spectrum Disorders and Allergy: Observation from a Pediatric Allergy/immunology Clinic, Harumi Jyonouchi , Posted: 06/15/2010; Expert Rev Clin Immunol. 2010;6(3):397-411. © 2010 Expert Reviews Ltd. http://www.medscape.com/viewarticle/721702
(37) Direct correlation of glutathione and ascorbate and their dependence on age and season in human lymphocytes, American Journal of Clinical Nutrition, Vol. 71, No. 5, 1194-1200, May 2000
(38) Dr. Paul Cheney: Evidence for Glutathione Deficiency in CFS. Paper delivered at the Third Annual Congress of BioEnergetic Medicine held in Orlando, Florida, Feb 5-7, 1999
(39) Neuroscience (2007), Depletion of reduced glutathione enhances motor neuron degeneration in vitro and in vivo. L Chi, Y Ke, C Luo, D Gozal, R Liu,
(40) Glutathione S-transferase polymorphisms in MS, Neurology 2000;54:552, © 2000 American Academy of Neurology
(41) Effect of Alternative Aluminum Adjuvants on the Absorption and Immunogenicity of HPV16 L1 VLPs in Mice http://www.landesbioscience.com/journals/vaccines/CaulfieldHV3-4.pdf
(42) Aluminum Vaccine Adjuvants: Are they Safe? pp.2630-2637 (8) Authors: L. Tomljenovic, C. A. Shaw, Current Medicinal Chemistry, Volume 18 Issue 17, ISSN: 0929-8673, http://vaccinexchange.files.wordpress.com/2011/05/tomljenovic_shaw-cmc-published2.pdf
© Cynthia A. Janak