HPV vaccine for your 11 year old son and daughter may soon be mandatory in your state thanks to the combination of two very bad things.
Update3/10/18: Victory for the People All Four Florida Senate Bills Were Defeated and Withdrawn on 3/10/2018.
The first bad thing is criminal activity by drug makers Merck and Glaxo Smith Kline (GSK) that manufacture Gardasil and Cervarix. These criminal activities involve marketing a vaccine as a cancer preventive when no long term studies have been done to show this. The vaccines were approved without proper safety testing or long term safety monitoring. The HPV vaccines are in fact, causing harm to young women who have no recourse in the US since vaccine manufacturers are exempt from liability by Congressional mandate. However outside the US, criminal charges have been filed against the vaccine manufacturers in Spain.(18) Japan and other countries have curtailed advertising and have reduced use of these vaccines.(21)(25,26)(32)
The second very bad thing is the deplorable stupidity of your elected state representatives who after being spoon fed vaccine marketing propaganda have been deceived into proposing mandatory HPV vaccination for all 11 year old school girls and boys. The net result could very well be one of the greatest medical scandals in history.
Diane Harper MD on HPV Vaccine Efficacy
Diane Harper, the most authoritative expert on HPV Vaccine, was principle investigator for Merck’s Gardasil and GSK’s Cervarix Clinical trials used for FDA approval. She later became whistle blower and went public with information indicating the vaccines are dangerous and useless for prevention of cervical cancer. Diane Harper is a professor and chair of the department of Family and Geriatric Medicine at the University of Louisville.
HPV Vaccine only Temporary Immunity
In this video from 2011, Diane Harper MD expresses her concern that HPV vaccines provide only temporary immunity against selected HPV strains lasting 5-8 yrs, depending on vaccine. She says a full 15y years of immunity coverage is needed to prevent cervical cancer. There is no long term data to show prevention of cervical cancer. However, computer modeling projects that HPV vaccine programs reduces cervical cancer rates to 9-14 per 100,000. PAP Smear Cytology screening programs in the US have already reduced cervical cancer rates to 8 per 100,000, and in Dr Harpers opinion, HPV vaccine is unlikely to reduce this rate any further.
Video filmed at the American Association for the Advancement of Science Meeting in Washington, D.C., on February 18, 2011, Dr. Stan Maloy talks with Diane Harper, M.D., M.P.H,
The unethical and sleazy techniques used by vaccine makers Merck and GSK to push their agenda for mandatory vaccination is described by Sara Abiola, JD, PhD and Michelle M. Mello, JD, PhD in their 2012 article. (2) This is criminal behavior.
Merck promoted school-entry mandate legislation by serving as an information resource, lobbying legislators, drafting legislation, mobilizing female legislators and physician organizations, conducting consumer marketing campaigns, and filling gaps in access to the vaccine. Legislators relied heavily on Merck for scientific information. Most stakeholders found lobbying by vaccine manufacturers acceptable in principle, but perceived that Merck had acted too aggressively and nontransparently in this case.
Adverse Effects of HPV Vaccine – Premature Ovarian Failure
The American College of Pediatricians has expressed opposition to mandatory HPV vaccination in this statement: “The College is opposed to any legislation which requires HPV vaccination for school attendance.” The American College of Pediatricians has issued a warning statement about POV (Premature Ovarian Failure) caused by HPV vaccines. (5,6)(22,23) See: Ovarian Failure After HPV Vaccine by Scott S. Field, MD January 2016.
CNS Demyelinating Disease – Devastating Adverse Effect of HPV Vaccination
Perhaps the most devastating adverse effect of HPV Vaccination is demyelinating CNS disease in teenage boys and girls after HPV vaccination, transforming previously active healthy teenagers into quadriplagics on ventilators. Many such case reports can be found in the medical literature.(45-60) Personal accounts of this devastating outcome can be found online reported by family members.
Other serious adverse effects include cerebral vasculitis and neurological disease.(11) Onset of multiple sclerosis, an autoimmune neurological condition, after HPV vaccination has have been reported.(29) Severe somatoform and dysautonomic syndromes after HPV vaccination has been reported in Italy (30) and Japan(44).
In Sweden, cluster analysis shows complex regional pain syndrome (CRPS), postural orthostatic tachycardia syndrome (POTS), and chronic fatigue syndrome (CFS) after human papillomavirus (HPV) vaccines. Dr Poddighe wrote in Immunol Res. 2014 that these types of vaccine reactions are: ” autoimmune/inflammatory syndromes induced by vaccine adjuvants (ASIA)“ (33)
Watch This HPV Documentary: Sacrificial Virgins is a documentary series in three parts written and narrated by Joan Shenton and directed by Andi Reiss. It is a co-production between Meditel Productions and Yellow Entertainment. Below is the 3-part series.
Watch this Danish documentary on HPV Vaccine Injured Young Girls in Denmark:
TV2 Denmark Documentary on HPV Vaccine Shows Lives of Young Women Ruined.
TV2 one of Denmark’s national television stations aired a documentary on Thursday, March 26, 2015, on HPV vaccines entitled, The Vaccinated Girls – Sick and Betrayed. It focused on the condition of 3 girls suffering from serious new medical conditions after being vaccinated against HPV with Gardasil.
10% Of Girls Vaccinated Visit the ER Within 42 days
An 8 year Canadian study of HPV adverse events in 195,270 females receiving 528,913 doses of HPV vaccine reveals that 10% of girls vaccinated visited the ER within 42 days. (41) See Liu, Xianfang C., et al. “Adverse events following HPV vaccination, Alberta 2006–2014.” Vaccine 34.15 (2016): 1800-1805.
Politician Stupidity Award – Vote Them Out
In Florida, a bill was introduced January 4th by Sen. José Javier Rodríguez (Dem). This Senate Bill 1558, “Women’s Cancer Prevention Act” would take effect on July 1st, mandating HPV vaccination for all 11 and 12 year old children returning to school (males and females).
No long term studies have published (or even done) to show HPV vaccination in fact reduces the rate of women’s cancer.(42)
Immediate Action Required
1) Contact Senator Jose Javier Rodriguez, sponsor of SB 1558 and ask him to withdraw his bill, SB 1558.
2) Contact Representative Amy Mercado, sponsor of HB 1343 and ask her to withdraw her bill, HB 1343.
Needless to say, these two Mandatory HPV Vaccine bills must be stopped, and these two politicians must be voted out of office. Call your Congressman and voice your opposition now before any more harm can be done.
Still need more information? Read this article by Megan Heimer January 3, 2016 The HPV Vaccine: What You Need to Know About the Dumbest Vaccine Ever
CALL TO ACTION:
1. CALL and EMAIL the sponsors of each bill and ask them to withdraw their bill, using the talking points listed below.
Contact information for Senator Rodriguez and Representative Mercado:
State Senator Jose Javier Rodriguez (SB 1558 “The Women’s Cancer Prevention Act”):
State Rep. Amy Mercado (HB 1343)
2. CALL and EMAIL your Florida State Senator and Representative and ask them to OPPOSE SB 1558 and HB 1343. Ask them NOT to become a co-sponsor.
Florida residents can find their state representatives here: http://www.myfloridahouse.gov/Sections/Representatives/myrepresentative.aspx
Update3/10/18: Victory for the People All Four Florida Senate Bills Were Defeated and Withdrawn on 3/10/2018.
FAKE NEWS ? – Study: HPV vaccine highly-effective at preventing cancers
Rae Daniel Feb 6, 2018 New study from Finland reported as showing HPV Vaccine effective at reducing cervical cancer rates. In actuality, the Finnish study shows reduction in HPV rates, not in cervical cancer rates.(38-40) No long term study has shown reduction in cervical cancer rates from HPV vaccination.(42)
Update 1/2017 : Leslie, Douglas L., et al. “Temporal association of certain neuropsychiatric Disorders Following Vaccination of children and adolescents: a Pilot case–control study.” Frontiers in psychiatry 8 (2017): 3.
Update April 2018: Government Court Concedes Girl Killed By HPV Vaccine
Click Here for pdf of court ruling Christina Tarsell HPV Vaccine Special Master final Ruling 2017
Update 2018: Aluminum in Vaccines as Cause of Immune Activation in the Brain. International scientists have found autism’s cause. What will Americans do? BY J.B. HANDLEY April 2, 2018 “there’s an ongoing, permanent immune-system activation in the brains of autistic people.”
Jeffrey Dach MD
7450 Griffin Road Suite 190
Davie, Florida 33314
Video on Vaccines – Pediatrician Dr Zajac MD and MBA
Articles with Related Interest
Links and References
Header Image Courtesy of Patriots and Paulies.
1) Harper, Diane M., and Leslie R. DeMars. “HPV vaccines–a review of the first decade.” Gynecologic oncology 146.1 (2017): 196-204.
Three dose efficacy preventing CIN 2 or worse by any HPV type is about 62% for both Cervarix and Gardsail9; the three dose efficacy preventing CIN 3 or worse by any HPV type is 93% for Cervarix and 43% for Gardasil, with no data for Gardasil9. All three vaccines lead to reduced numbers of colposcopies and excisional cervical therapies. Head to head trials indicate that Cervarix has superior immunogenicity compared to Gardasil for T-cell and B-cell functions for both HPV 16 and 18; there are no data for Gardasil9’s comparable immunogenicity. The immunogenicity data for HPV 18/45 induced by Gardasil and Gardasil9 indicates that long term surveillance for HPV 18/45 disease breakthrough must be in place.
Diane Medved Harper is a professor and chair of the department of Family and Geriatric Medicine at the University of Louisville.
(2) Am J Public Health. 2012 May; 102(5): 893–898.
Pharmaceutical Companies’ Role in State Vaccination Policymaking: The Case of Human Papillomavirus Vaccination Michelle M. Mello, JD, PhD,corresponding author Sara Abiola, JD, PhD, and James Colgrove, PhD
Objectives. We sought to investigate roles that Merck & Co Inc played in state human papillomavirus (HPV) immunization policymaking, to elicit key stakeholders’ perceptions of the appropriateness of these activities, and to explore implications for relationships between health policymakers and industry.
Methods. We used a series of state case studies combining data from key informant interviews with analysis of media reports and archival materials. We interviewed 73 key informants in 6 states that were actively engaged in HPV vaccine policy deliberations.
Results. Merck promoted school-entry mandate legislation by serving as an information resource, lobbying legislators, drafting legislation, mobilizing female legislators and physician organizations, conducting consumer marketing campaigns, and filling gaps in access to the vaccine. Legislators relied heavily on Merck for scientific information. Most stakeholders found lobbying by vaccine manufacturers acceptable in principle, but perceived that Merck had acted too aggressively and nontransparently in this case.
Conclusions. Although policymakers acknowledge the utility of manufacturers’ involvement in vaccination policymaking, industry lobbying that is overly aggressive, not fully transparent, or not divorced from financial contributions to lawmakers risks undermining the prospects for legislation to foster uptake of new vaccines.
In June 2006, the Food and Drug Administration approved the first vaccine against human papillomavirus (HPV), the sexually transmitted virus implicated in three quarters of all cases of cervical cancer. Gardasil, produced by Merck & Co Inc, was licensed for vaccination of females aged 9 to 26 years for the prevention of cervical cancer and genital warts.1 The same month, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention recommended routine vaccination of girls aged 11 to 12 years, with catch-up vaccination of females aged 13 to 26 years.2 A remarkable burst of legislative activity followed. Within a year, legislation relating to the vaccine was introduced in 41 states and the District of Columbia, including bills in 24 states that would mandate HPV vaccination for 6th-grade girls.3
Interest in the political forces behind HPV legislation remains high.4 Following media reports that Merck was heavily involved in promoting school-entry mandates, questions arose about the extent and appropriateness of industry involvement in vaccine policy. The presidential candidacy of Texas Governor Rick Perry recently prompted a new round of public and media scrutiny of the issue after opponent Representative Michele Bachmann accused the governor of ordering girls to receive the HPV vaccination because of his financial and political ties to Merck.5 We aimed to investigate these industry roles and elicit key stakeholders’ perceptions of their appropriateness and effects on policy outcomes.
3) Letters to the Editor Does the HPV Vaccine Prevent Cervical Cancer?
ln reply: Existing HPV vaccines provide protection against high-risk HPV types that are known to cause cervical dysplasia, which leads to cervical cancer. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommends routine HPV vaccination at 11 to 12 years of age1 based on randomized controlled trials that demonstrate effective prevention against precancerous cervical lesions (cervical intraepithelial neoplasia 2 and 3).2,3 Because invasive cervical cancer is rare in the United States, studies have not yet established an association between HPV vaccination and a lower incidence of cervical cancer. However, the intent of HPV vaccination is ultimately to prevent cervical cancer.
KENNETH W. LIN, MD, MPH Associate Deputy Editor for AFP Online
3) Tomljenovic, L., J. P. Spinosa, and C. A. Shaw. “Human papillomavirus (HPV) vaccines as an option for preventing cervical malignancies:(how) effective and safe?.” Current pharmaceutical design 19.8 (2013): 1466.Human papillomavirus HPV vaccines for preventing cervical malignancies how effective and safe Tomljenovic Spinosa Shaw Current pharm des 2013
We carried out a systematic review of HPV vaccine pre- and post-licensure trials to assess the evidence of their effectiveness and safety. We find that HPV vaccine clinical trials design, and data interpretation of both efficacy and safety outcomes, were largely inadequate. Additionally, we note evidence of selective reporting of results from clinical trials (i.e., exclusion of vaccine efficacy figures related to study subgroups in which efficacy might be lower or even negative from peer-reviewed publications). Given this, the widespread optimism regarding HPV vaccines long-term benefits appears to rest on a number of unproven assumptions (or such which are at odd with factual evidence) and significant misinterpretation of available data. For example, the claim that HPV vaccination will result in approximately 70% reduction of cervical cancers is made despite the fact that the clinical trials data have not demonstrated to date that the vaccines have actually prevented a single case of cervical cancer (let alone cervical cancer death), nor that the current overly optimistic surrogate marker-based extrapolations are justified. Likewise, the notion that HPV vaccines have an impressive safety profile is only supported by highly flawed design of safety trials and is contrary to accumulating evidence from vaccine safety surveillance databases and case reports which continue to link HPV vaccination to serious adverse outcomes (including death and permanent disabilities). We thus conclude that further reduction of cervical cancers might be best achieved by optimizing cervical screening (which carries no such risks) and targeting other factors of the disease rather than by the reliance on vaccines with questionable efficacy and safety profiles.
4) Megan Heimer January 3, 2016 The HPV Vaccine: What You Need to Know About the Dumbest Vaccine Ever
5) Colafrancesco, Serena, et al. “Human papilloma virus vaccine and primary ovarian failure: another facet of the autoimmune/inflammatory syndrome induced by adjuvants.” American Journal of Reproductive Immunology 70.4 (2013): 309-316.
PROBLEM:Post-vaccination autoimmune phenomena are a major facet of the autoimmune/inflammatory syndrome induced by adjuvants (ASIA) and different vaccines, including HPV, have been identified as possible causes.
METHOD OF STUDY:The medical history of three young women who presented with secondary amenorrhea following HPV vaccination was collected. Data regarding type of vaccine, number of vaccination, personal, clinical and serological features, as well as response to treatments were analyzed.
RESULTS:All three patients developed secondary amenorrhea following HPV vaccinations, which did not resolve upon treatment with hormone replacement therapies. In all three cases sexual development was normal and genetic screen revealed no pertinent abnormalities (i.e., Turner’s syndrome, Fragile X test were all negative). Serological evaluations showed low levels of estradiol and increased FSH and LH and in two cases, specific auto-antibodies were detected (antiovarian and anti thyroid), suggesting that the HPV vaccine triggered an autoimmune response. Pelvic ultrasound did not reveal any abnormalities in any of the three cases. All three patients experienced a range of common non-specific post-vaccine symptoms including nausea, headache, sleep disturbances, arthralgia and a range of cognitive and psychiatric disturbances. According to these clinical features, a diagnosis of primary ovarian failure (POF) was determined which also fulfilled the required criteria for the ASIA syndrome.
CONCLUSION:We documented here the evidence of the potential of the HPV vaccine to trigger a life-disabling autoimmune condition. The increasing number of similar reports of post HPV vaccine-linked autoimmunity and the uncertainty of long-term clinical benefits of HPV vaccination are a matter of public health that warrants further rigorous inquiry.
6) Little, Deirdre Therese, and Harvey Rodrick Grenville Ward. “Adolescent premature ovarian insufficiency following human papillomavirus vaccination: a case series seen in general practice.” Journal of investigative medicine high impact case reports 2.4 (2014): 2324709614556129.
Three young women who developed premature ovarian insufficiency following quadrivalent human papillomavirus (HPV) vaccination presented to a general practitioner in rural New South Wales, Australia. The unrelated girls were aged 16, 16, and 18 years at diagnosis. Each had received HPV vaccinations prior to the onset of ovarian decline. Vaccinations had been administered in different regions of the state of New South Wales and the 3 girls lived in different towns in that state. Each had been prescribed the oral contraceptive pill to treat menstrual cycle abnormalities prior to investigation and diagnosis. Vaccine research does not present an ovary histology report of tested rats but does present a testicular histology report. Enduring ovarian capacity and duration of function following vaccination is unresearched in preclinical studies, clinical and postlicensure studies. Postmarketing surveillance does not accurately represent diagnoses in adverse event notifications and can neither represent unnotified cases nor compare incident statistics with vaccine course administration rates. The potential significance of a case series of adolescents with idiopathic premature ovarian insufficiency following HPV vaccination presenting to a general practice warrants further research. Preservation of reproductive health is a primary concern in the recipient target group. Since this group includes all prepubertal and pubertal young women, demonstration of ongoing, uncompromised safety for the ovary is urgently required. This matter needs to be resolved for the purposes of population health and public vaccine confidence.
This second case series of adolescent POI/POF increases evidence suggesting that the hypothesis of an association between HPV vaccine and premature ovarian demise needs to be tested.
7) Tomljenovic, Lucija, et al. “HPV vaccines and cancer prevention, science versus activism.” Infectious Agents and Cancer 8.1 (2013): 6.
The rationale behind current worldwide human papilloma virus (HPV) vaccination programs starts from two basic premises, 1) that HPV vaccines will prevent cervical cancers and save lives and, 2) have no risk of serious side effects. Therefore, efforts should be made to get as many pre-adolescent girls vaccinated in order to decrease the burden of cervical cancer. Careful analysis of HPV vaccine pre- and post-licensure data shows however that both of these premises are at odds with factual evidence and are largely derived from significant misinterpretation of available data.
8) Nicol AF, Andrade CV, Russomano FB, Rodrigues LLS, Oliveira NS, Provance DW. HPV vaccines: a controversial issue? Brazilian Journal of Medical and Biological Research. 2016;49(5):e5060. doi:10.1590/1414-431X20155060.\
Controversy still exists over whether the benefits of the available HPV vaccines outweigh the risks and this has suppressed uptake of the HPV vaccines in comparison to other vaccines. Concerns about HPV vaccine safety have led some physicians, healthcare officials and parents to withhold the recommended vaccination from the target population. The most common reason for not administering the prophylactic HPV vaccines are concerns over adverse effects. The aim of this review is the assessment of peer-reviewed scientific data related to measurable outcomes from the use of HPV vaccines throughout the world with focused attention on the potential adverse effects. We found that the majority of studies continue to suggest a positive risk-benefit from vaccination against HPV, with minimal documented adverse effects, which is consistent with other vaccines. However, much of the published scientific data regarding the safety of HPV vaccines appears to originate from within the financially competitive HPV vaccine market. We advocate a more independent monitoring system for vaccine immunogenicity and adverse effects to address potential conflicts of interest with regular systematic literature reviews by qualified individuals to vigilantly assess and communicate adverse effects associated with HPV vaccination. Finally, our evaluation suggests that an expanded use of HPV vaccine into more diverse populations, particularly those living in low-resource settings, would provide numerous health and social benefits.
Since the quadrivalent HPV vaccine was approved by the FDA in the USA in June 2006, it will take at least another 15-20 years before the long-term efficacy of these vaccines becomes evident. In December 2014, the FDA approved the so-called HPV9 Gardasil¯ vaccine that includes direct protection against HPV types 31, 33, 45, 52 and 58 in addition to the HPV types 6, 11, 16 and 18 of the quadrivalent vaccine.
While the reduction in the occurrence of genital warts conferred by the HPV types present in the vaccines strongly suggests an ultimately lower incidence of HPV-positive cancers, the time period since the initial vaccinations has not been sufficient to determine the absolute reduction in cervical cancer, the major benefit expected.\\\
We also strongly believe that a regular systematic review of the literature by qualified individuals with no financial interests should be conducted. In many instances, financial resources originate from parties within the competitive HPV vaccine market, which certainly have economic interests, causing major complications in interpreting the results and conclusions from the various studies.
9) Aşkın, Özge. “Anogenital HPV.” Fundamentals of Sexually Transmitted Infections. InTech, 2017. Duration of efficacy is a key question when discussing the HPV vaccines. All three vaccines provide very high immunogenicity with antibody titers that are higher than the natural infections and remain high enough to prevent new infections. Booster doses’ necessity is still unknown. Up to now, it has been shown that the duration of vaccines may last 5–9 years. But more studies are needed about these important issues [35, 38].
The development of HPV vaccine is a milestone in the prevention of HPV-related infections and probably in the prevention of cervical cancer.
10) Is There Objective Evidence that the Current HPV Vaccination Programs are not Justified?
Posted by Celeste McGovern on Mar 1, 2017 10:03:19 AM
In closing, Dr. Tomljenovic challenges her audience with a question: Is it ethical to put at risk of death or a disabling autoimmune disease at a pre-adolescent age for a vaccine that has not yet prevented a single case of cervical cancer, a disease that may develop 20-30 years after exposure to HPV, when the same can be prevented with regular PAP screening which carries no risks? Probably not.
Death after Quadrivalent Human Papillomavirus (HPV) Vaccination:Causal or Coincidental?
11) Death after Quadrivalent Human Papillomavirus (HPV) Vaccination:Causal or Coincidental? Tomljenovic L, Shaw CA (2012) Death after Quadrivalent Human Papillomavirus (HPV) Vaccination: Causal or Coincidental? Pharmaceut Reg Affairs S12:001.
Abstract Background: The proper understanding of a true risk from vaccines is crucial for avoiding unnecessary adverse reactions (ADRs). However, to this date no solid tests or criteria have been established to determine whether adverse events are causally linked to vaccinations. Objectives: This research was carried out to determine whether or not some serious autoimmune and neurological ADRs following HPV vaccination are causal or merely coincidental and to validate a biomarker-based immunohistochemical (IHC) protocol for assessing causality in case of vaccination-suspected serious adverse neurological outcomes. Methods: Post-mortem brain tissue specimens from two young women who suffered from cerebral vasculitistype symptoms following vaccination with the HPV vaccine Gardasil were analysed by IHC for various immunoinflammatory markers. Brain sections were also stained for antibodies recognizing HPV-16L1 and HPV-18L1 antigen which are present in Gardasil. Results: In both cases, the autopsy revealed no anatomical, microbiological nor toxicological findings that might have explained the death of the individuals. In contrast, our IHC analysis showed evidence of an autoimmune vasculitis potentially triggered by the cross-reactive HPV-16L1 antibodies binding to the wall of cerebral blood vessels in all examined brain samples. We also detected the presence of HPV-16L1 particles within the cerebral vasculature with some HPV-16L1 particles adhering to the blood vessel walls. HPV-18L1 antibodies did not bind to cerebral blood vessels nor any other neural tissues. IHC also showed increased T-cell signalling and marked activation of the classical antibody-dependent complement pathway in cerebral vascular tissues from both cases. This pattern of complement activation in the absence of an active brain infection indicates an abnormal triggering of the immune response in which the immune attack is directed towards self-tissue. Conclusions: Our study suggests that HPV vaccines containing HPV-16L1 antigens pose an inherent risk for triggering potentially fatal autoimmune vasculopathies. Practice implications: Cerebral vasculitis is a serious disease which typically results in fatal outcomes when undiagnosed and left untreated. The fact that many of the symptoms reported to vaccine safety surveillance databases following HPV vaccination are indicative of cerebral vasculitis, but are unrecognized as such (i.e., intense persistent migraines, syncope, seizures, tremors and tingling, myalgia, locomotor abnormalities, psychotic symptoms and cognitive deficits), is a serious concern in light of the present findings. It thus appears that in some cases vaccination may be the triggering factor of fatal autoimmune/neurological events. Physicians should be aware of this association.
13) video <iframe width=”560″ height=”315″ src=”https://www.youtube.com/embed/XBr1knRaRCc” frameborder=”0″ allow=”autoplay; encrypted-media” allowfullscreen></iframe>
Lucija Tomljenovic, PhD Session 7: 4th International Symposium on Vaccines in Leipzig, Germany April, 2016
Diane Harper researcher
90% of HPV cleared by immune system
HPV trials only 3 years in duration
efficacy of vaccine too short to prevent cervical cancer
Manitoba vaccine efficacy on preventing cervical dysplasia and in-situ CA -ineffective
CArcinoma in situ less in non-vaccinated over 3 years observation.
14) Mahmud, Salaheddin M., et al. “Effectiveness of the quadrivalent human papillomavirus vaccine against cervical dysplasia in Manitoba, Canada.” Journal of Clinical Oncology 32.5 (2014): 438-443.
The median length of follow-up after enrollment was 3.1 years (range, 0.1 to 5.4). Overall, the 3-year cumulative probability of LSIL (3.7%) and HSIL (2.6%) was slightly higher in the nonvaccinated cohort compared with the vaccinated cohort (3.3% and 2.3%, respectively), whereas that of ASCUS was similar (2.8%). No invasive cancers were detected in either cohort, but 12 vaccinated females (0.3%) and 22 nonvaccinated females (0.2%) had CIS during follow-up.
15) HPV Vaccine Controversy Ethics Economics Equality By Tanya Donahou
HPV Vaccine Controversy: Ethics, Economics, and Equality By Tanya Donahou, MD/MPH candidate, Boston University Schools of Medicine and Public Health, Class of 2013
Vaccine prevents CIN
16) Herweijer, Eva, et al. “Quadrivalent HPV vaccine effectiveness against high‐grade cervical lesions by age at vaccination: A population‐based study.” International journal of cancer 138.12 (2016): 2867-2874.
In conclusion, we show effectiveness of opportunistic qHPV vaccination for preventing CIN2+ and CIN3+ lesions, with greater effectiveness observed in girls younger at vaccination initiation.
Reply to above
17) Forced-Vaccinations-For-the-Greater-Good-Tomljenovic — By Lucija Tomljenovic, PhD
18) HPV (Gardasil) injury scandals worldwide, why is U.S. media silent? Parents beware.
BY J.B. HANDLEY December 7, 2016
How Effective Is the HPV Vaccine at Preventing Cancer? A Closer Look…
By Jeanne Lenzer | November 23, 2011 12:51 pm
Unfortunately, while the two HPV vaccines on the market may decrease the serious illness and death from cervical cancer, no study has proved that at this point, since no study has been conducted long enough to observe the development of cervical cancer or cervical cancer deaths.
Conclusive studies with the most important, clinically relevant end points should precede wide uptake of any intervention. The data currently rely on surrogate end points (markers of possible cancer) and are simply not conclusive. So we can’t truly say how effective the vaccine is.
Wake Forest medical researcher Curt Furberg, a former FDA advisor and co-author of the textbook Fundamentals of Clinical Trials, told me, “Getting data from markers is a first step. But we have burned our fingers too many times with surrogate markers. You should try to determine the real health benefit. Everything will be up in the air until we have the answer to the question: Will it prevent cancer? And until we have that answer, we should limit its use to girls enrolled in studies of the vaccine.”
Here are some other reasons why the HPV vaccines may not be as effective as advertised:
Duration of Protection:
An important issue raised by Diane Harper, an HPV researcher, is how long the vaccine will remain effective. She says the antibody titers in women who receive the vaccine fall off over time—i.e., the vaccine loses effectiveness. “One third of women lose antibody titers and hence protection from HPV by 5 years,” and “at 8.5 years, 15 percent have lost all detectable antibody titers to HPV-16, which leaves them completely unprotected from HPV-16 and -18, the only two cancer-causing strains that Gardasil was supposed to protect against.”
Harper says because of the vaccine’s limited duration, it likely won’t decrease the cervical cancer rate significantly below where it is with the routine Pap screening currently in use, although it may postpone cancer until later in life. Booster shots could presumably extend the effectiveness of the vaccine, she says, but we don’t yet have data on that. (Harper has received funding from Merck and GlaxoSmithKline for research on their HPV vaccines.)
20) Preventing Cervical Cancer Investigating costs, access, marketing, and effectiveness of vaccines By Donald W Light · Published 2017
While numerous studies that show the vaccines are cost-effective assume they prevent cancer, independent critics point out we don’t know and “the real impact of HPV vaccination on cervical cancer will not be observable for decades
Merck states that Gardasil 9 “does not eliminate the necessity for girls to undergo recommended cervical cancer screening later in life.
“The duration of immunity of Gardasil 9 has not been established” (MerckVaccines 2017).
To the extent that marketing lulls women into believing they are covered and no longer need routine screening, cancer rates could increase (Lenzer 2011).
Evidence that HPV vaccines prevent cancer is indirect because the latency period of fifteen to twenty years exceeds the time since use began.
We will not know for years how effectively HPV vaccines actually prevent cervical and related cancers or how the population of viral serotypes adapts.
21) Gardasil Shocker: Japan Withdraws Support for HPV Vaccine by Sarah Updated: January 25, 2018
Primary Ovarian Failure after HPV Vaccine
22) American College of Pediatricians Sounds Alarm About HPV Vaccine (Gardasil) by Sarah Updated: January 25, 2018
23) Ovarian Failure After HPV Vaccine Primary author: Scott S. Field, MD January 2016 The American College of Pediatricians
2. Little DT, and Ward HR. Adolescent premature ovarian insufficiency following human papillomavirus vaccination: a case series seen in general practice. J Inv Med High Imp Case Rep. 2014; doi: 10.1177/2324709614556129, pp 1-12.
3. Wise LD, Wolf JJ, Kaplanski CV, Pauley CJ, Ledwith BJ. Lack of effects on fertility and developemental toxicity of a quadrivalent HPV vaccine in Sprague-Dawley rats. Birth Defects Res B Dev. 2008; 83(6):561-572.
4. Segal L, Wilby OK, Willoughby CR, Veenstra S, Deschamps M. Evaluation of the intramuscular administration of CervarixTM vaccine on fertility, pre- and post-natal development in rats. Reprod Toxicol. 2011; 31:111-120.
5. Information available through http://wonder.cdc.gov/vaers.html.
7. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111287.pdf, p.373.
8. Vichnin M, Bonanni P, Klein NP, Garland SM, Block SL, Kjaer SK, et. al. An overview of quadrivalent human papillomavirus vaccine safety – 2006 to 2015. Pediatr Inf Dis J. 2015; doi: 10.1097/INF.0000000000000793, pp 1-48.
9. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111287.pdf, p.394,396.
24) Gardasil: Guarding or Gutting Our Youth? by Kelly Brogan MD
25) Gardasil Vaccine: Spain Joins Growing List of Countries to File Criminal Complaints
includes France, India, Japan, and many more.
26) Gardisal Vaccine FRANCE SAYS “NO” AS THEY BAN GARDASIL ADS
France says the award winning advertising campaign for Gardasil is false and misleading. The Sanevax Team wants to know – Where was the press coverage when this happened? Why did no one break the news to the public?
27) Colafrancesco S, Perricone C, Tomljenovic L, Shoenfeld Y. Human papilloma virus vaccine and primary ovarian failure: another facet of the autoimmune/inflammatory syndrome induced by adjuvants. Am J Reprod Immunol. 2013; 70:309-316.
28) Ferris D, Samakoses R, Block S et al. 4-valent human papillomavirus (4vHPV) vaccine in preadolescents and adolescents after 10 years. Pediatrics 2017;140:e20163947. doi: 10.1542/peds.2016-3947
29) Hu Y, Tornes L, Lopez-Alberola R. Two cases of pediatric multiple sclerosis after human papillomavirus vaccination. Presented at: ACTRIMS Forum 2018; February 1-3, 2018; San Diego, CA. Abstract #P088
30) Palmieri, Beniamino, et al. “Severe somatoform and dysautonomic syndromes after HPV vaccination: case series and review of literature.” (2016). Severe somatoform and dysautonomic syndromes after HPV vaccination 2016 Palmieri Beniamino
31) Chandler, Rebecca E., et al. “Current Safety Concerns with Human Papillomavirus Vaccine: A Cluster Analysis of Reports in VigiBase®.” Drug Safety 40.1 (2017): 81.
complex regional pain syndrome (CRPS), postural orthostatic tachycardia syndrome (POTS), and chronic fatigue syndrome (CFS)—have emerged with human papillomavirus (HPV) vaccines,
32) Beppu, Hirokuni, et al. “Lessons learnt in Japan from adverse reactions to the HPV vaccine: a medical ethics perspective.” Indian journal of medical ethics 2.2 (2017): 82-88. Lessons learnt in Japan adverse reactions to HPV vaccine medical ethics Beppu Indian j med ethics 2017
33) Gentili, Marta, et al. “On the relationship between human papilloma virus vaccine and autoimmune diseases.” (2014). Relationship between human papilloma virus vaccine and autoimmune diseases Gentili Marta 2014
34) Immunol Res. 2014 Dec;60(2-3):236-46. A sudden onset of a pseudo-neurological syndrome after HPV-16/18 AS04-adjuvated vaccine: might it be an autoimmune/inflammatory syndrome induced by adjuvants (ASIA) presenting as a somatoform disorder? Poddighe D1, Castelli L, Marseglia GL, Bruni P.
In last centuries, vaccines reduced the incidence of several infectious diseases. In last decades, some vaccines aimed at preventing also some cancers, where viruses play a causative role. However, several adverse events have been described after vaccines, but a causal relationship has been established only in a minority of cases. Here, we describe a pseudo-neurological syndrome occurred shortly after the administration of the bivalent HPV vaccine. Some autoimmune disorders, including neurological demyelinating diseases, have been reported after HPV vaccines, but the patient showed no organic lesions. The patient was diagnosed as having a functional somatoform syndrome, which was supposed to be autoimmune/inflammatory syndrome induced by adjuvants (ASIA), seen the temporal link with vaccination and the presence of anti-phospholipid autoantibodies. Immunological mechanisms of vaccines-and of adjuvants-have not been completely elucidated yet, and although there is no evidence of statistical association with many post-vaccination events, a causal link with vaccine cannot be excluded in some individuals.
35) Segal, Yahel, and Yehuda Shoenfeld. “Vaccines-the good, the bad, and the unkown.” Intern Med 281.3 (2017): 313-5. Vaccines the good the bad and the unkown Segal Yahel Yehuda Shoenfeld Intern Med 2017
36) Watad, Abdulla, et al. “The autoimmune/inflammatory syndrome induced by adjuvants (ASIA)/Shoenfeld’s syndrome: descriptive analysis of 300 patients from the international ASIA syndrome registry.” Clinical rheumatology 37.2 (2018): 483-493.
The autoimmune/inflammatory syndrome induced by adjuvants (ASIA) is a recently identified condition in which the exposure to an adjuvant leads to an aberrant autoimmune response. We aimed to summarize the results obtained from the ASIA syndrome registry up to December 2016, in a descriptive analysis of 300 cases of ASIA syndrome, with a focus on the adjuvants, the clinical manifestations, and the relationship with other autoimmune diseases. A Web-based registry, based on a multicenter international study, collected clinical and laboratory data in a form of a questionnaire applied to patients with ASIA syndrome. Experts in the disease validated all cases independently. A comparison study regarding type of adjuvants and differences in clinical and laboratory findings was performed. Three hundred patients were analyzed. The mean age at disease onset was 37 years, and the mean duration of time latency between adjuvant stimuli and development of autoimmune conditions was 16.8 months, ranging between 3 days to 5 years. Arthralgia, myalgia, and chronic fatigue were the most frequently reported symptoms. Eighty-nine percent of patients were also diagnosed with another defined rheumatic/autoimmune condition. The most frequent autoimmune disease related to ASIA syndrome was undifferentiated connective tissue disease (UCTD). ASIA syndrome is associated with a high incidence of UCTD and positive anti-nuclear antibodies (ANA) test. Clinical and laboratory features differ from the type of adjuvant used. These findings may contribute to an increased awareness of ASIA syndrome and help physicians to identify patients at a greater risk of autoimmune diseases following the exposure to vaccines and other adjuvants. The ASIA syndrome registry provides a useful tool to systematize this rare condition.
37) The HPV Debacle: Suppressing Inconvenient Evidence By Vera Sharav
FAKE NEWS ?
38) FAKE NEWS – Study: HPV vaccine highly-effective at preventing cancers
Rae Daniel 5:24 PM, Feb 6, 2018
KANSAS CITY, Kan. — A new study has found that the HPV vaccine is highly-effective at preventing cancers in women. The Human Papillomavirus is one that can cause cancer such as cervical and head and neck. “Frequently young people, young men and women, and that’ll be the most common HPV related cancer in the next few years in the U.S.,” Dr. Kevin Ault with the University of Kansas Health System. A new preliminary report on the HPV vaccine came out in the International Journal of Cancer from Finland, one of the first countries that started using the HPV vaccine 15 years ago.
This is the study: No mention of the number of cases of cervical cancer in vaccinated group compared to placebo group in the article itself.
39) Gray, Penelope, et al. “Evaluation of HPV type‐replacement in unvaccinated and vaccinated adolescent females–Post‐hoc analysis of a community‐randomized clinical trial (II).” International Journal of Cancer (2018).
Efficacy of human papillomavirus (HPV) vaccines promises to control HPV infections. However, HPV vaccination program may lay bare an ecological niche for non-vaccine HPV types. We evaluated type-replacement by HPV type and vaccination strategy in a community-randomized trial executed in HPV vaccination naïve population. Thirty-three communities were randomized to gender-neutral vaccination with AS04-adjuvanted HPV16/18 vaccine (Arm A), HPV vaccination of girls and hepatitis B-virus (HBV) vaccination of boys (Arm B), and gender-neutral HBV vaccination (Arm C). Resident 1992-95 born boys (40,852) and girls (39,420) were invited. HPV typing of 11,396 cervicovaginal samples was performed by high throughput PCR. Prevalence ratios (PR) between arms and ranked order of HPV types, and odds ratio (OR) for having multiple HPV types in HPV16 or 18/45 positive individuals were calculated. 11,662 boys and 20,513 girls were vaccinated with 20-30% and 45-48% coverage, respectively. The ranked order of HPV types did not significantly differ between arms or birth cohorts. For the non-HPV vaccinated 1992-93 birth cohorts increased PR, between the gender-neutral intervention vs. control arms for HPV39 (PRA 1.84, 95% CI 1.12-3.02) and HPV51 (PRA 1.56, 95% CI 1.11-2.19) were observed. In the gender-neutral arm, increased clustering between HPV39 and the vaccine-covered HPV types 16 or 18/45 (ORA16=5.1, ORA18/45=11.4) was observed in the non-HPV vaccinated 1994-95 birth cohorts. Comparable clustering was seen between HPV51 and HPV16 or HPV18/45 (ORB16=4.7, ORB18/45=4.3), in the girls-only arm. In conclusion, definitively consistent post-vaccination patterns of HPV type-replacement were not observed. Future occurrence of HPV39 and HPV51 warrant investigation. This article is protected by copyright. All rights reserved.
40) Lehtinen, Matti, et al. “Impact of gender‐neutral or girls‐only vaccination against human papillomavirus—Results of a community‐randomized clinical trial (I).” International journal of cancer 142.5 (2018): 949-958.
Human papillomavirus (HPV) vaccine is efficacious but the real-life effectiveness of gender-neutral and girls-only vaccination strategies is unknown. We report a community-randomized trial on the protective effectiveness [(PE) = vaccine efficacy (VE) + herd effect (HE)] of the two strategies among females in virtually HPV vaccination naïve population. We randomized 33 Finnish communities into Arm A) gender-neutral vaccination with AS04-adjuvanted HPV16/18 vaccine (11 communities), Arm B) HPV vaccination of girls and hepatitis B-virus (HBV) vaccination of boys (11 communities) or Arm C) gender-neutral HBV vaccination (11 communities). All resident 39,420 females and 40,852 males born 1992-95 were invited in 2007-09. Virtually all (99%) 12- to 15-year-old participating males (11,662) and females (20,513) received three doses resulting in uniform 20-30% male and 50% female vaccination coverage by birth cohort. Four years later (2010-14) 11,396 cervicovaginal samples obtained from 18.5 year-old women were tested for HPV DNA, and prevalence of cervical HPV infections by trial arm and birth cohort was the main outcome measure. VEs against HPV16/18 varied between 89.2% and 95.2% across birth cohorts in arms A and B. The VEs against non-vaccine types consistent with cross-protection were highest in those born 1994-95 for HPV45 (VEA 82.8%; VEB 86.1%) and for HPV31 (VEA 77.6%, VEB 84.6%). The HEs in the non HPV-vaccinated were statistically significant in those born 1994-95 for HPV18 (HEA 51.0%; 95% CI 8.3-73.8, HEB 47.2%; 6.5-70.2) and for HPV31/33 in arm A (HEA 53.7%; 22.1-72.5). For HPV16 and 45 no significant herd effects were detected. PE estimates against HPV16/18 were similar by both strategies (PEA 58.1%; 45.1-69.4; PEB 55.7%; 42.9-66.6). PE estimates against HPV31/33 were higher by the gender-neutral vaccination (PEA 60.5%; 43.6-73.4; PEB 44.5%; 24.9-60.6). In conclusion, while gender-neutral strategy enhanced the effectiveness of HPV vaccination for cross-protected HPV types with low to moderate coverage, high coverage in males appears to be key to providing a substantial public health benefit also to unvaccinated females.
41) Liu, Xianfang C., et al. “Adverse events following HPV vaccination, Alberta 2006–2014.” Vaccine 34.15 (2016): 1800-1805.
Results Over the period 195,270 females received 528,913 doses of HPV vaccine. Of those receiving at least one dose, 192 reported one or more AEFI events (198 AEFI events), i.e., 37.4/100,000 doses administered (95% CI 32.5–43.0). None were consistent with VTE. Of the women who received HPV vaccine 958 were hospitalized and 19,351 had an ED visit within 42 days of immunization. Four women who had an ED visit and hospitalization event were diagnosed with VTE. Three of these had other diagnoses known to be associated with VTE; the fourth woman had VTE among ED diagnoses but not among those for the hospitalization.
42) Tomljenovic, Lucija, and Christopher A. Shaw. “Human papillomavirus (HPV) vaccine policy and evidence-based medicine: Are they at odds?.” (2011). Human papillomavirus HPV vaccine policy evidence based medicine Are they at odds Tomljenovic Lucija Christopher Shaw 2011
All drugs are associated with some risks of adverse reactions. Because vaccines represent a special category of drugs, generally given to healthy individuals, uncertain benefits mean that only a small level of risk for adverse reactions is acceptable. Furthermore, medical ethics demand that vaccination should be carried out with the participant’s full and informed consent. This necessitates an objective disclosure of the known or foreseeable vaccination benefits and risks. The way in which HPV vaccines are often promoted to women indicates that such disclosure is not always given from the basis of the best available knowledge. For example, while the world’s leading medical authorities state that HPV vaccines are an important cervical cancer prevention tool, clinical trials show no evidence that HPV vaccination can protect against cervical cancer. Similarly, contrary to claims that cervical cancer is the second most common cancer in women worldwide, existing data show that this only applies to developing countries. In the Western world cervical cancer is a rare disease with mortality rates that are several times lower than the rate of reported serious adverse reactions (including deaths) from HPV vaccination. Future vaccination policies should adhere more rigorously to evidence-based medicine and ethical guidelines for informed consent
43) How Silencing of Dissent in Science Impacts Woman. The Gardasil Story
Leonard F. Vernon. Advances in Sexual Medicine, 2017,7,179-204. How Silencing of Dissent in Science Impacts Woman The Gardasil Story Leonard F Vernon Advances 2017
Peripheral sympathetic nerve dysfunction
44) Kinoshita, Tomomi, et al. “Peripheral sympathetic nerve dysfunction in adolescent Japanese girls following immunization with the human papillomavirus vaccine.” Internal Medicine 53.19 (2014): 2185-2200. Peripheral sympathetic nerve dysfunction following immunization with human papillomavirus vaccine HPV Kinoshita Tomomi Int Med 2014
Encephalo-Myelitis – White Matter Demyelinating syndrome
45) DiMario Jr, Francis J., Mirna Hajjar, and Thomas Ciesielski. “A 16-year-old girl with bilateral visual loss and left hemiparesis following an immunization against human papilloma virus.” Journal of child neurology 25.3 (2010): 321-327.Bilateral visual loss and left hemiparesis following immunization human papilloma virus HPV DiMario J child neurology 2010
Cervical transverse myelitis
46) Fernández-Fournier, Mireya, et al. “Early cervical myelitis after human papilloma virus vaccination.” Neurology-Neuroimmunology Neuroinflammation 1.3 (2014): e31.
47) Sekiguchi, Kenji, et al. “Two cases of acute disseminated encephalomyelitis following vaccination against human papilloma virus.” Internal Medicine 55.21 (2016): 3181-3184.
48) Bomprezzi, Roberto. “Acute disseminated encephalomyelitis following vaccination against human papilloma virus.” Neurology 74.10 (2010): 864-865.
49) Wildemann, B., et al. “Acute disseminated encephalomyelitis following vaccination against human papilloma virus.” Neurology 72.24 (2009): 2132-2133.
50) Sutton, I., et al. “CNS demyelination and quadrivalent HPV vaccination.” Multiple Sclerosis 15 (2009): 116-119. CNS demyelination and quadrivalent HPV vaccination Sutton Multiple Sclerosis 2009
60) Chang, Jason, et al. “Demyelinating disease and polyvalent human papilloma virus vaccination.” J Neurol Neurosurg Psychiatry 82.11 (2011): 1296-1298.
61) R.E.G.R.E.T. Support Group was set up by parents of Irish teenage girls who have developed serious health problems after entering secondary school. These parents are certain that the HPV vaccine (Gardasil) is the cause of their daughters’ otherwise unexplained illness.
The primary goal of the parents in the group is to get help for their daughters who, like many girls around the world, have experienced “Reactions and Effects of Gardasil Resulting in Extreme Trauma” (R.E.G.R.E.T). Many are not receiving effective medical treatment and cannot attend school regularly due to the debilitating health conditions they still suffer from.
61) Medwatcher Japan international symposium: ”The Current Status of Worldwide Injuries from the HPV Vaccine”. Tokyo on March 24, 2018, 340 participants. Video of presentations.
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