1

HPV Vaccines – HPV Vaccines – CervarixCervarix™™ and Gardasil and Gardasil™™

Presentation to a selection of cross party members of the Scottish Parliament

Tuesday 25th September 2012

2

HPV Vaccine CervarixHPV Vaccine Cervarix• Cervarix (GlaxoSmithKline) is a genetically engineered vaccine intended to protect

females against the diseases caused by infection with Human Papillomavirus types 16 and 18.

• HPV is a virus from the papillomavirus family that is capable of infecting humans. The majority of infections cause no symptoms; some HPV types are associated with warts; others associated with cancers of the cervix, vulva, penis, oropharynx and anus.

• High Risk Cancerous types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 68, 69, 73, 82

• Cervarix only covers two of these high risk strains claiming 70% of infections, however on average 30% of girls will be left unprotected.

• 70% of infections clear on their own, without medical intervention or symptoms in 1 year and 90% in 2 years.

3

Introduction to Dr Sin Hang Lee, MDIntroduction to Dr Sin Hang Lee, MD• It is not transient HPV infections, but the persistent infection with the same high-risk

genotype that may lead to cervical cancer …. Therefore it is the persistent infection and the presence of other risk factors that determines cervical cancer risk.Dr. Sin Hang Lee -Pathologist, Milford HospitalDirector, Milford Medical Laboratory, Milford, CT

• Dr. Lee is known for using the nested PCR/DNA sequencing technology for reliable detection and genotyping of HPV in clinical specimens. He is the author of the chapter, “Guidelines for the Use of Molecular Tests for the Detection and Genotyping of Human Papillomavirus from Clinical Specimens” in a Methods in Molecular Biology volume published by Humana Press in July 2012.

• Dr. Lee has published the first peer-reviewed article on residual HPV DNA found in Gardasil®, entitled “Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil®” in the Journal of Inorganic Biochemistry accessed http://dx.doi.org/10.1016/j.jinorgbio.2012.08.015

4

High prevalence of human papillomavirus type 16 infection High prevalence of human papillomavirus type 16 infection among children and young womenamong children and young women• High prevalence of human papillomavirus type 16 infection among children, aged

between 3-11, Journal of Medical Virology, Volume 61, issue 1, pages 70-75, May 2000. In the first group of 267 tested, 138 (51.7%) samples were positive with HPV-16http://onlinelibrary.wiley.com/doi/10.1002/(SICI)1096-9071(200005)61:1%3C70::AID-JMV11%3E3.0.CO;2-Y/abstract

• The May 2006 FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) Report states if a woman is pre-infected by a vaccine-relevant HPV and is administered the HPV vaccines then there is an increased risk of incidences of pre-cancerous lesions by:

• 44.6% - post Gardasil; 32.5% - Post Cervarix• There is no scientific evidence to determine if the HPV vaccines will prevent cervical

cancer.

5

Parliamentary ResponsesParliamentary Responses• In letter dated 7th July 2011, Ms Milton, UK Health Minister stated: “There is a possibility

that other HPV strains could replace HPV 16 and 18 following the introduction of the HPV Vaccination Programme. However, there is no data with which to determine whether and how quickly this would take place.”

• Ms Milton replied to a parliamentary question stating that from November 2011, 5 million doses of HPV vaccine were delivered and there were 6066 ‘suspected adverse reactions’ reported on the MHRA database of which 1046 were considered to be serious. This represents a staggering 17% of the total reports. (The MHRA has indicated that their database of statistics does not reflect the true picture of adverse reactions).

• In letter dated 18th October 2010, Shona Robison, Minister for Heath stated: “In discharging our duty to ensure persons are able to give informed consent, we recognize that there is a need to employ an element of discretion in the disclosure of information. At times, as you will appreciate, it is possible that giving too much information or placing too much emphasis on minor risks may cause unnecessary confusion or alarm.”

6

7

Data calculated from CRUK 2008Data calculated from CRUK 2008

Age group DeathsRate per 100,000

population Deaths DeathsPopulation calculated

Female deaths Female rates % Cum %

0-4 0 0.05-9 0 0.010-14 0 0.0 7,187,500

15-19 0 0.020-24 6 0.3 0.6 0.6 2,061,40025-29 26 1.3 2.7 3.3 2,005,90030-34 36 1.9 3.8 7.1 1,910,100

35-39 50 2.2 5.2 12.3 2,241,500

40-44 56 2.4 5.9 18.2 2,377,10045-49 88 4.0 9.2 27.4 2,207,80050-54 70 3.6 7.3 34.7 1,924,80055-59 77 4.2 8.0 42.7 1,845,10060-64 73 3.9 7.6 50.3 1,861,300

65-69 84 5.9 8.8 59.1 1,432,50070-74 79 6.2 8.3 67.4 1,275,400

75-79 86 7.7 9.0 76.4 1,112,40080-84 106 12.1 11.1 87.4 875,50085+ 120 13.1 12.5 100.0 913,600

All ages 957 3.1 31,231,900

8

Analysis of Data AvailableAnalysis of Data Available• As there are three jabs given then let us say that over these 4 years there were 1.67

million recipients (5 million / 3).

• Cancer Research UK shows deaths at 2.4/100,000 therefore if the vaccine is 70% effective we save 1.7 lives/100,000.

• The adverse effects identified in November 2011 by Ms Milton are showing at 363/100,000 of which 63/100,000 were considered serious over the four year period, which equates on a per annum basis to 53 times the total adverse effects and 10 times the serious adverse effects than the lives that may be saved.

• Cost of vaccinating each recipient is around £270 therefore £27 million/100,000.

• In 8.5 years from the age of 12 we could expect at best to save 1 life at a cost of around £27million.

• Is this economical considering that PAP screening must carry on because 30% of oncogenic HPV infections are not included in the vaccine, and the treatment costs for those injured must be incurred?

9

HPV Vaccine GardasilHPV Vaccine Gardasil• Gardasil was fast tracked by the FDA in June 2006 even although it did not qualify

under the rules governing the fast tracking of medications.

• Like Cervarix, Gardasil protects against two high risk HPV strains 16 and 18, but includes strains 6 and 11 for genital warts. HPV 16/18 are reported to be responsible for 70% of cervical cancer cases worldwide – this may not be true for the United Kingdom.

• Gardasil was approved without an appropriate safety trial – June 2006. The vast majority of clinical trials used Merck’s proprietary AAHS adjuvant as a ‘control’ solution, proving only that Gardasil was no more dangerous than the aluminium adjuvant used in the vaccine.

• Duration of protection can only be given as 5 years – that is the longest study that has been carried out.

• Inappropriate end point – clinical trials of Gardasil used CIN2/3 as endpoints to evaluate the vaccine’s efficacy. Since only 22% of CIN 2 lesions normally progress to cervical cancer, using them as an endpoint artificially increases the reported efficacy of the vaccine.

10

HPV Vaccine VAERS Reports as at July 2012HPV Vaccine VAERS Reports as at July 2012Description Total

Disabled 891

Deaths 119

Did Not Recover 5,412

Abnormal Pap Smear 493

Cervical Dysplasia 197

Cervical Cancer 57

Life Threatening 509

Emergency Room 9,801

Hospitalized 2,749

Extended Hospital Stay 220

Serious 3,683

Total Adverse Events 26,564

Estimate d 1 to 10% o f po pulatio n re po rting – July 2012

11

HPV Vaccines Adverse Reactions as reported to the HPV Vaccines Adverse Reactions as reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) U.S. Vaccine Adverse Event Reporting System (VAERS) • List of Adverse Events as reported to VAERS by doctors or mothers of injured girls

(These are many of the symptoms being experienced by girls around the world after vaccination with Gardasil and Cervarix)

• Abortion,/Stillbirth/Miscarriage, Addison's Disease, Adrenal failure, Adrenal issues, Allergies, Anxiety/Panic attacks, Appetite loss, Arthritis, Asthma attacks, Autistic - like symptoms, Autoimmune Disease (Lupus / Mixed Connective Tissue Disease), Back pain, Bacterial Vaginosis, Bladder issues, Bleeding gums, Blindness, Bloated, Blood Sugar Issues, Bloody stools, Brain fog, Brain Inflammation, Brain lesions, Bronchitis, Cervical cancer, Chemical sensitivity, Chest pains, Convulsions, Chronic Fatigue Syndrome, Constipation, Cytomegalovirus (CMV), Death, Degenerative disk disease, Dehydration, Depression, Diabetes, Diarrhea, Dizziness, Dyslexia, Dysplasia, Early Onset of Menopause, Enlarged fallopian tubes, Enlarged liver, Epstein Barr Virus (EBV), Extreme pain in the tailbone area , Fainting, Fatigue, Fertility problems, Fever, Fever blisters, Fibromyalgia, Food allergies, Gallbladder issues, Genital Warts, Gray film on teeth, Guillain-Barre Syndrome, Hair growth in strange places, Hair loss, Hallucinations, Hand / Leg Weakness, Hasimoto's Disease, Head pressure, Headache, Hearing loss (Permanent), Hearing loss (Temporary), Hearing sensitivity, Heart Palpitations, Heart arrhythmia, High levels of metals in blood: aluminium, mercury, Hot / Cold Intolerance, HPV, Infertility, Insomnia, Itching, IUD discomfort, Joint pain, Kidney Failure, Kidney issues, Knee pain, Leaky Gut Syndrome, Light sensitivity, Lip spots, Liver Failure, Loss of bladder control, Lupus,

12

HPV Vaccine Adverse Events reported HPV Vaccine Adverse Events reported (continuation of symptoms)(continuation of symptoms)• Memory Loss (long-term), Memory Loss (short-term), Menstrual cycle changes, Metallic taste in

mouth, Migraines, Miscarriage, Mood Swings, Moles (Increase in number of), Mononucleosis, Multiple Sclerosis (MS), MS-like symptoms, Muscle aches, Muscle spasms, Muscle tension, Nausea, Neurological reactions to fungal metabolites, Neurological symptoms , Night sweats, Non-Hodgkin's Lymphoma, Numbness, Other types of cancer, Ovarian failure, Paleness, Paralysis, Pancreatitis, PCOS (Poly-Cystic Ovarian Syndrome), Pelvic Inflammatory Disease (PID), Pelvic pain, Personality changes, Pins / Needles in Extremities, Pleural effusion, Pneumonia, Postural Orthostatic Tachycardia Syndrome (Orthostatic Intolerance), Random twitching of extremities Rash, Raynaud's Phenomenon (loss of blood circulation to hands and/or feet), Regression, Rheumatoid arthritis, Ruptured ovarian cysts, Seizures, Sensitivity to commercially processed citric acid, MSG, sulfur and other additives, Severe nerve pain syndrome, Shortness of breath, Sleep Apnea, Slurred speech, Smell sensitivity, Sore throat, Sound sensitivity w/ Anxiety, Stomach ache, Stomach pain, Sudden drops in blood pressure, Swelling / Edema, Swollen lymph nodes, Thyroid Issues, Thrombosis Toothaches/Teeth Changes, Tremors: hand and/or leg, Uterine spasms, Urinary Tract Infection (UTI), Vision changes - long term, Vision loss (Permanent), Vision loss (Temporary), Vision Problems - abnormal pupillary function / dilation, Vomiting blood, Weight gain or loss (20 – 30 lbs.)

13

Analyses of HPV Vaccines against other VaccinesAnalyses of HPV Vaccines against other Vaccines

14

Spontaneous Abortions/Still Births following vaccination with Spontaneous Abortions/Still Births following vaccination with the HPV Vaccinesthe HPV Vaccines

Annual Numbers of HPV against all 9 OTHER Vaccines recommended for the age group 7 to 18 in the USA.

"Abortions/Still Births"

77%

71%67%60%

81%89%

50%0

10

20

30

40

50

60

70

80

May'2007 May'2008 May'2009 May'2010 May'2011 May'2012 TOTAL2006-12

Year Ending

Num

ber

HPV Vaccines

All 9 OtherVaccines

If all vaccines were created equally, HPV vaccines should represent around 10% of this adverse reaction but as you see it ranges from 5 times to 9 times greater than the average.

15

The ATHENA HPV Studies The ATHENA HPV Studies Required by the FDA as part of the licensing agreement.Required by the FDA as part of the licensing agreement.

The HPV vaccination is found to reduce 0.6% of the HPV-16 infections, while increasing the rate of other high-risk (carcinogenic) HPV infections among the vaccinated women by 2.6-6.2% compared to the non-vaccinated women. The latter increased rate of infections caused by carcinogenic HPVs other than HPV-16 and 18 in vaccinated women is 4 to 10 times higher than the reduction in HPV-16 infections.

The ATHENA human papillomavirus study: design, methods and baseline results.Wright TC, Stoler MH, Behrens CM et al, Am.J. Obstet.Gynecol 2012;206:46.e1-11HPV 16 and HPV 18 found in (Gardasil) vaccinated women:

16

The ATHENA HPV StudiesThe ATHENA HPV Studies

17

Genetically-Engineered HPV DNA discovered in Gardasil Genetically-Engineered HPV DNA discovered in Gardasil VaccineVaccine• September 2011 – despite the fact that Merck went to great lengths to assure government

health officials that Gardasil contained no viral DNA, viral DNA fragments firmly attached to the aluminium adjuvant were discovered in all 16 vials tested from various manufacturing facilities worldwide. The magnitude of potential health consequences that could result from this contamination is unknown.

• August 2012 – despite the fact that HPV DNA does not normally survive in human blood for more than 48 hours, HPV 16 DNA was discovered in the macrophages of post-mortem blood and spleen samples from a young woman who died 6 months after her third Gardasil injection. In addition, one of the antigens used in Gardasil was detected in samples of her brain. Neither of these findings is normal.

• There are only two ways HPV DNA could have remained in post-mortem tissues:• It was protected from normal degradation by being attached to the aluminium adjuvant,

or• it had integrated into the human genome.

• Either of these options poses potentially serious consequences that must be defined and disclosed.

18

HOW MUCH COLLATERAL DAMAGE IS ACCEPTABLE?HOW MUCH COLLATERAL DAMAGE IS ACCEPTABLE?

Jessie from New York died 40 hours after her third jab of Gardasil.No known cause of death established.

Chris from Maryland died 18 days after her third jab of Gardasil was found dead in her bed. No known cause of death established.

Annabelle age 14, from Quebec died in her bathtub 16 days after her second jab with Gardasil. No known cause of death established.

Megan from New Mexico was found dead in her bathtub after vaccination with Gardasil. No known cause of death established.

Jasmine from New Zealand died 6 months after her third Gardasil vaccination.No known cause of death established.

© SaneVax Inc. 2012

19

Introduction to the families whose daughters have been Introduction to the families whose daughters have been injuredinjured

• Gail and Neville Rhind, Livingston – daughter Kaitlyn

• Steve Hinks, Port Carlisle, Cumbria – daughter Lucy

• Lesley and Bruce McKenzie, Aberdeen – daughter Rachel

• Sherrel Halliday, Nairn – daughter Deborah