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HPV Vaccine

How Your Doctor Has Been Instructed to Recommend the…

April 30, 2020September 3, 2020
by Rodef

Instructions for Boosting Vaccination Rates
in Medical Offices

5 Ways to Boost HPV Vaccination Rates

Human Papillomavirus (HPV) for Healthcare Professionals

CDC (Centers for Disease Control)

“Bundle your recommendation for all adolescent vaccines, including HPV vaccine, in the same way, on the same day. You can start the vaccine discussion with, “Now that your child is 11, he/she needs three vaccines to help protect against meningitis, HPV cancers, and whooping cough. We’ll give these shots during today’s visit. Do you have any questions about these vaccines?” “

Here’s how one doctor provides her patients with informed consent.

“When I recommend pre-teen vaccines, I recommend all three of the vaccines that we intend to do the same way basically… I do give a little bit of information about each vaccine because that’s my informed consent. Just like when I talk about infant vaccines. So, I can talk about all three pre-teen vaccines in about a minute and have my informed consent done at the same time, and kind of avoid the too much information thing.

“So this is how I present things to parents. Today there are three vaccines that I’d like to do… The second one prevents the HPV infection, which is extremely common, in fact, most of us get HPV in our lives and can go on to cause multiple different forms of cancers. That vaccine is given in a series of two. The second one would be given six to 12 months from now.”

Read and watch more

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Is Your Doctor an HPV Vaccine is Cancer Prevention Champion?

The HPV Vaccine Is Cancer Prevention Champion is an annual award given jointly by the Centers for Disease Control and Prevention (CDC), American Cancer Society (ACS)external icon, and Association of American Cancer Institutes (AACI)external icon. This award recognizes clinicians, clinics, practices, groups, and health systems that are going above and beyond to foster HPV vaccination among adolescents in their communities.

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Dr. Diane Harper on informed consent:

An Interview with Dr. Diane M. Harper, HPV Expert
Huffington Post
March 18 2010
Marcia G. Yerman, contributor

“The most important point that I have always said from day one, is that the use of this vaccine must be done with informed consent and complete disclosure of the benefits and harms of Pap screening and HPV vaccines. The decision to be vaccinated must be the woman’s (or parent’s if it is for a young child), and not the physician’s or any board of health, as the vaccination contains personal risk that only the person can value.

HPV Vaccine

Other HPV Vaccine Damage

April 30, 2020August 4, 2021
by Rodef

From the documentary on HPV vaccines entitled, “The Vaccinated Girls – Sick and Betrayed.” https://www.sott.net/article/305663-SOTT-Exclusive-The-origins-of-the-HPV-vaccine-A-case-of-corruption-in-science

Serious Injury in Females and Males

Menstrual Cycle Evaluation and Women’s Health: An Overlooked Biomarker for Vaccine Injury

Nexus Magazine
February -March 2020
Leslie Carol Botha

…
“When hormone messaging is skewed, due to toxins crossing the blood–brain barrier or toxic deposits on the cell receptor sites, preventing hormonal messages from getting through to the cell, there is a breakdown in communication and functioning that will lead to alterations in our mental, emotional and physical health. During puberty, the endocrine system is preparing itself for the reproductive cycle. It is a transitionary time, and like any other transition, fragile in nature. If skewed, the timing of the mechanisms of action may be thrown off and the outcome forever changed.

“In one of my first conversations with the US Food and Drug Administration (FDA) about the introduction of Gardasil as a vaccine to be administered at puberty, I let them know that I was disappointed at their approval of this vaccine for 9 to 26-year-old girls during the most fragile time of their life, menarche, the time of first menstruation.
…

“Menstruation, as mentioned above is the final stage in an average month-long process. I am also going to be using a term, “paramenstruum”, which is the combination of the premenstrual and menstrual phases of the cycle.
…

“If conception does not take place after ovulation and our body prepares for menstruation and the release of the uterine lining, hormone levels fall, along with immunity, which becomes more compromised. In fact, the entire neuro–immune–endocrine system is involved.
…

“Many years back, I became aware of a study on the timing of breast cancer surgery and perimenopausal women. The study was based on the work and research of Dr William Hrushesky, who wrote some compelling pieces about the paramenstruum and chronic illness in the 1990s. Basically, the study outcomes showed that if a woman had surgery during a window of time on either side of ovulation she would experience a better outcome than surgery scheduled during the paramenstruum. Incidents due to surgery during the paramenstruum include infections, side effects and even death.
…

“Why the dramatic difference? Researcher William J.M.
Hrushesky, MD, senior oncologist at the Albany VA Medical Center in Albany, NY,
speculates that a woman’s immune defenses are likely to vary with her menstrual
cycle and may become most potent with ovulation. So her ability to fight
disease may be significantly higher at that point of her cycle.”
…

“A little known fact with huge implications: When immunity drops during the paramenstruum, alcohol and drugs reactions will affect us much more than in the pre- ovulatory phase of the cycle when hormones are rising.
…

“… my primary focus for this book is to help mothers and daughters become aware of the vital role that menstruation and immunity plays when women are being administered drugs and vaccines or opting for surgery. If the vaccine is going to be mandated for school entry, one of the choices you have as a parent or student is to not schedule vaccination during the paramenstruum.
…

“Not only did the required use of birth control during the safety trials of Gardasil mask and hinder ovarian function and therefore invalidated the safety data, hormonal contraceptives also masked hormonal fluctuations, including the decrease in hormone levels and immunity prior to menstruation.

“In other words, there was “callous disregard” for vaccinating during a phase of the menstrual cycle when there may be a potential risk for more severe adverse reactions.

“There were no studies conducted on vaccination at puberty (also masked by hormonal birth control) and no studies on vaccination during the paramenstruum.
…

“While it may be impossible to collect data after the effect, it is my humble opinion that every doctor’s responsibility is to not only record the “first day of the last menstrual cycle” in a young woman’s medical record, but it is also their duty to advise against vaccination during the paramenstruum.

“In addition, there are now ongoing studies or reports on health outcomes of girls who were on hormonal contraception during vaccination, other than reports of premature menopause. What other health problems are they experiencing? Early onset of osteoporosis? Depression, anxiety and/or suicidal ideation due to infertility? Possible divorce due to their inability to have children? Are rates of gynaecological cancers (which are on the rise) being recorded in these young women? What are the long-term health effects of being thrown into menopause in their twenties and thirties?

“I believe one of the reasons why girls who are not on birth control and who experience repeated post- vaccination adverse injuries is due to their fluctuating hormones. Their body is constantly trying to achieve homeostasis, and find balance post-vaccine injury. Their body seeks to build immunity and defenses during the preovulatory phase, when hormone levels are the highest, only to come crashing down during the paramenstruum phase when hormone levels decrease and immunity becomes compromised.”

When The FDA Wants To Impose Gardasil To Women And Men Aged 27 Through 45 Years, It Invents A Magic Rate Via A New Criterion

Dr. Nicole Delépine

Graph - Increase in cervical cancer in Norway after HPV vaccine

“Medicine becomes propaganda: 88% efficiency: the magic and misleading rate manufactured and used by the FDA to falsify communication on Gardasil [1] and extend its indications.

…
“With the cancer registries, we have indisputable statistical data covering all the populations of four countries followed 7 to 9 years (from 2007 to 2016). These data tell a completely different story from the golden legend of the laboratories spread by the FDA. In all the countries that have largely vaccinated their young girls, the incidence of invasive cancers has increased sharply (sometimes exceeding 100%) in the vaccinated age groups [15] [16] that would justify that the responsible agencies impose a moratorium of at least several years and that independent studies be conducted to understand the phenomenon.”

Japan Leading The World In Exposing Fraud with Gardasil HPV Vaccine
…injuries and death

Vera Sharav
November 29, 2019

“In Japan, young women and girls suffering from severe chronic generalized pain following vaccination with Merck’s Gardasil® or GSK’s Cervarix®, have organized and are speaking out.

“The issues are being debated at public hearings, at which scientific presentations have been made by independent medical experts who validated the women’s suffering with documented evidence of the severe nature of the pain related to the HPV vaccine.”

Cervarix vaccine issues trigger health notice

Japan Times
June 15, 2013

“The health ministry has issued a nationwide notice that cervical cancer vaccinations should no longer be recommended for girls aged 12 to 16 because several adverse reactions to the medicines have been reported.

‘“It is necessary to gather information immediately to accurately grasp how often (the side effects) are occurring,” said Mariko Momoi, who chairs the panel at the Health, Labor and Welfare Ministry that decided to suspend the recommendation. Momoi is vice president of the International University of Health and Welfare.

…
“The two vaccines sold in Japan are Cervarix, made by GlaxoSmithKlein PLC of Britain, and Gardasil, made by Merck Sharp & Dohme, known as Merck & Co. in the United States.

“Mika Matsufuji, 46, who represents an association of cervical cancer vaccination victims’ parents, said the health panel’s decision was a “big step forward.” Her daughter, who was vaccinated with Cervarix in 2011, lost the ability to walk and is now in a wheelchair, she said.”

FEDERAL VACCINE COURT RULES: GARDASIL KILLED CHRISTINA TARSELL

May 8, 2018

Christina Tarsell was given the Gardasil vaccine when she was 21 years old
Days after the vaccine, Christina died
Her cause of death was determined “unknow”, but expert immunologists determined that her death was from a heart arrhythmia induced by an autoimmune reaction to the HPV vaccine

“Eight years later, the federal vaccine court finally ADMITTED her death was due to the HPV vaccine.”

The HPV Vaccination can cause very serious Side Effects!

November 9, 2019

…
“He also had two severe relapses, which forced him both times to rest again for several days. Once I had him even registered for a low level tournament, because he again begged me that he wanted to compete. We had to cancel it.

“The pain was also not going away and mostly his shoulder was hurting, sometimes his wrists, sometimes some muscles, even his lungs, but the pain was never predictable.

“One day my wife looked into the calendar and saw an appointment coming up: The third HPV vaccination!

“I said “Wait a minute!”, and yes, we found out that everything that happened to our son was aligned to the first and second HPV vaccination!!!

“I tried to google side effects and did not find many in the US. Just a few weak hints on side effects on a governmental web site.

“Then I found a post of a guy who was working for the German Athletic Sports Association. He was claiming that 15 of their athletes got the HPV vaccination and all of them had similar symptoms as Quentin. All of them had severe fatigue symptoms, all of them had a lot of pain and all of them had a serious decline in their performance.

“Then I googled more and more, and found so many stories about similar symptoms, even deaths caused by cardiac arrest after the HPV vaccination. Remember, Quentin’s heart rate was going up dramatically!”

Colton Berrett Dies After Being Unable To Cope With His Gardasil HPV Vaccine Injuries

January 8, 2018

“A number of vaccines within the past few years have come under intense scrutiny, and rightfully so. When you hear somebody say, “the science is clear”, it’s actually not. This is evident by the fact that hundreds of studies have been published in reputable peer-reviewed journals raising multiple causes for concern when it comes to vaccines, like the role of vaccine ingredients and where and how they disseminate throughout the body, for example. “

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.

“Just as important to these parents is to raise awareness of the safety issues surrounding the HPV vaccine so that other parents can be in a position to make a truly informed decision on this issue. The group feels that the information provided by the HSE is incomplete and biased, downplaying the safety issues while exaggerating its effectiveness.”

The Current Status of Worldwide Injuries from the HPV Vaccine

Anna Cannon of REGRET speaking at international symposium on “The Current Status of Worldwide Injuries from the HPV Vaccine” held in Tokyo
March 24, 2018
with Medwatcher Japan.

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W.H.O. SAYS ‘IT’S IN YOUR HEAD’

The HighWire with Del Bigtree
January 24, 2020

“Listen to this W.H.O. Director’s explanation for why thousands are falling ill after Gardasil vaccination. Watch the original video here https://www.who.int/news-room/events/… starting at time code 1:36:50 on Tuesday afternoon second part.”

Watch more

HPV Vaccine

HPV Vaccine and Ovarian Failure

April 30, 2020October 23, 2020
by Rodef

Does Gardasil Cause Premature Menopause in Young Girls?

Does anyone need Gardasil?

August 5, 2013
Dr. Deirdre Little

“…the reason I’m actually here and have been asked to speak was because of a case that I wrote up and had published in the British Medical Journal late last year and I’ll just tell the story. This young girl she was approaching matriculation in New South Wales which is a phenomena that starts at the at the beginning of year 12, which is in the September of the year before, so she was coming up to that and she had noticed that for some period of time, almost 2 years, her periods had become irregular and scant and then they’d stopped and then she’d developed hot flashes and had no more periods…”

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New Concerns about the Human Papillomavirus Vaccine

American College of Pediatricians
January 2016

“Many adolescent females are vaccinated with influenza, meningococcal, and tetanus vaccines without getting Gardasil®, and yet only 5.6% of reports related to ovarian dysfunction since 2006 are associated with such vaccines in the absence of simultaneous Gardasil® administration. The overwhelming majority (76%) of VAERS reports since 2006 with ovarian failure, premature menopause, and/or amenorrhea are associated solely with Gardasil®. When VAERS reports since 2006 are restricted to cases in which amenorrhea occurred for at least 4 months and is not associated with other known causes like polycystic ovary syndrome or pregnancy, 86/89 cases are associated with Gardasil®, 3/89 with CervarixTM, and 0/89 with other vaccines administered independently of an HPV vaccine.5 Using the same criteria, there are only 7 reports of amenorrhea from 1990 through 2005 and no more than 2 of those associated with any one vaccine type.

“Few other vaccines besides Gardasil® that are administered in adolescence contain polysorbate 80.6 Pre-licensure safety trials for Gardasil® used placebo that contained polysorbate 80 as well as aluminum adjuvant.2,7 Therefore, if such ingredients could cause ovarian dysfunction, an increase in amenorrhea probably would not have been detected in the placebo controlled trials. Furthermore, a large number of girls in the original trials were taking hormonal contraceptives which can mask ovarian dysfunction including amenorrhea and ovarian failure.2 Thus a causal relationship between human papillomavirus vaccines (if not Gardasil® specifically) and ovarian dysfunction cannot be ruled out at this time.”

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Adolescent Premature Ovarian Insufficiency Following Human Papillomavirus Vaccination

A Case Series Seen in General Practice

Journal of Investigative Medicine High Impact Case Reports
October-December 2014
Deirdre Therese Little and Harvey Rodrick Grenville Ward

“Abstract
“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…”

Human Papilloma Virus Vaccine and Primary Ovarian Failure: Another Facet of the Autoimmune/Inflammatory Syndrome Induced by Adjuvants

American Journal of Reproductive Immunology
July 2013
Serena Colafrencesco, Carlo Perricone, Lucija Tomljenovic, Yehuda Shoenfeld

“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.”

Injecting Aluminum: Healthy girls bedridden or infertile

Dr. Yehuda Shoenfeld
June 8, 2017

“People see these cases in which… after the vaccine…healthy girls who were athletic… and suddenly the find themselves wheel-chaired or bedridden.

“Another aspect is primary ovarian failure. This means, that these young girls, suddenly they find themselves not being able to be pregnant… the aluminium destroyed or affected the maturation of the eggs in the ovaries…”

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HPV Vaccine

HPV Vaccine: Safety Research/Clinical Trials

April 30, 2020September 3, 2020
by Rodef

What Do the Clinical Trials Really Tell Us?

Gardasil started as a vaccine against four types of

Gardasil vaccine package insert

Section:
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

“GARDASIL 9 has not been evaluated for the potential to cause carcinogenicity, genotoxicity or impairment of male fertility. GARDASIL 9 administered to female rats had no effects on fertility [see Pregnancy (8.1)].”

Please note:

Section 8.1 did not evaluate impairment to female fertility, only pregnancy outcomes. 2. The testing was only for female rats and not for women.
“A genotoxin is a chemical or agent that can cause DNA or chromosomal damage. Such damage in a germ cell (sperm or egg) has the potential to cause a heritable altered trait (germline mutation). DNA damage in a somatic cell (any cell except a germ cell) may result in a somatic mutation, which may lead to malignant transformation (cancer)¹.”
“Mutagenesis is a process by which the genetic information of an organism is changed, resulting in a mutation. It may occur spontaneously in nature, or as a result of exposure to mutagens. It can also be achieved experimentally using laboratory procedures².”

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Examining the FDA’s HPV Vaccine Records

Detailing the Approval Process, Side-Effects, Safety Concerns and Marketing Practices of a Large-Scale Public Health Experiment

Judicial Watch Special Report
June 30, 2008

“This Judicial Watch Special Report is an analysis of records obtained from the Food and Drug Administration (FDA) concerning a recent vaccine called Gardasil. Gardasil helps protect against four types of human papillomavirus (HPV). The vaccine was approved in May 2006 and was created and marketed by Merck & Company Incorporated.

“The records include Merck’s patent and drug information submitted to the FDA, transcripts and briefing material from approval meetings, and reports documenting health, safety, and efficacy test results, as well as Vaccine Adverse Event Reporting System (VAERS) documents detailing 8,864 cases of adverse effects experienced by people after receiving the Gardasil vaccine. VAERS reports show that at least eighteen people have died after receiving Gardasil.1 Many health officials believe that adverse reactions to medications are widely underreported, therefore the actual number of adverse events occurring after vaccination with Gardasil is likely to be higher.

“Judicial Watch obtained these records under the provisions of the Freedom of Information Act (FOIA), 5 U.S.C. § 552. The request, asking for documents concerning Gardasil, was originally submitted to the FDA on May 9, 2007. The FDA produced documents on May 15, 2007; September 13, 2007; February 27, 2008, and June 10, 2008. Judicial Watch uncovered thousands of pages of material pertaining to Gardasil, which is designed to prevent cervical cancer. The controversial vaccine was fast-tracked for approval by the FDA despite concerns about Gardasil’s safety and long-term effects. The vaccine is still in the testing stages (final report due September 30, 2009), but it is already being administered to thousands of young girls and women.…”

DNA Contamination in HPV vaccines

A serious safety issue that should not be swept under the regulatory carpet.

Professor Joe Cummins
Article first published Sept. 12, 2012

“When the Human Papilloma Virus (HPV) vaccine Gardasil was recently found to be contaminated with DNA, the US Food and Drug Administration (FDA) lost no time in declaring that the DNA was not a contaminant but a harmless by-product of vaccine production. I disagree; that extraneous DNA is potentially harmful. It should also be noted that the safety and efficacy of HPV vaccines have been controversial from the start (see [1] The HPV Vaccine Controversy and other articles in the series, SiS 41).”

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What the Gardasil Testing May Have Missed

Slate Magazine
December 17, 2017
Frederik Joelving

” An eight-month investigation by Slate found the major Gardasil trials were flawed from the outset, however, and that regulators allowed unreliable methods to be used to test the vaccine’s safety. While these flaws do not mean Gardasil caused the rare crippling illnesses reported by the media, they are troubling. Public health officials use trials like these both to determine safety and, as evidenced by Merck’s statement above, to reassure the public when concerns like the ones about Gardasil arise. A flawed study design can complicate both tasks. “
…

“European health regulators worried about Merck’s methods during a review of the company’s marketing application for Gardasil 9, the latest version of the vaccine, but have not made their concerns public. In an internal 2014 EMA report about Gardasil 9 obtained through a freedom-of-information request, senior experts called the company’s approach “unconventional and suboptimal” and said it left some “uncertainty” about the safety results.”

Why Is Slate Questioning Gardasil?

Slate Magazine
December 17, 2017
Susan Matthews

“From my perspective, this story has important ramifications for public health. Because even if it turns out that Gardasil does not cause autoimmune disorders in anyone (which is possible), the fact remains that these trials were designed in a way that meant they would probably be unable to reliably assess this potential relationship. And to me, that’s worrying because clinical trials, particularly those used to assess medicine that will be used on large numbers of people prophylactically, ought to be able to make such assessments. And if we’ve been failing on this front, we should know that, so we can correct for it. This is how science is supposed to work.”

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Statistical Shenanigans with Gardasil Research

Hormones Matter
May 8, 2013
Chandler Mars, PhD

“Something’s hinky in the land of Gardasil surveillance and it’s not just the vaccine. It’s the statistics used in one of their widely reported surveillance studies on Gardasil-suspected autoimmune conditions. From the medical marketing and even the abstract of the study, which is all that most will ever read, it looks like there is no connection between the vaccine and the onset of autoimmune conditions. Indeed, all of the major media reported the appropriate PR:

“One organization even failed to change the url before directly copying the press release from another agency; (guess which one, I was surprised). It is unlikely that anyone read this study before blasting the PR far and wide. Otherwise, if they had read the dubious and creatively contorted statistical manipulations, the headlines would have been much different. Perhaps, Researchers Choose Statistics Least Likely to Find Results in Gardasil Study, would have been more appropriate.”

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FDA approved Gardasil 9: Malfeasance or Stupidity?

Norma Erickson
December 17, 2014

“Malfeasance is when a public official violates the public trust by performing an act that is wrongful, legally unjustified, or contrary to law. Nonfeasance is the failure to act where there is a duty to act. Misfeasance is conduct that is lawful but inappropriate. Perhaps, when it comes to the recent approval of Gardasil 9 all of these apply.

“10 December 2014: The FDA approved the use of a reportedly ’new and improved’ version of Gardasil, which will be marketed as Gardasil 9. According to the FDA approval letter, this action was taken without consultation with VRBPAC (the Vaccines and Related Biological Products Advisory Committee) which is responsible for reviewing and evaluating data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products.

“The FDA approval letter, signed by Marion Gruber, Director of Office of Vaccines Research and Review CBER, states the reason for bypassing the advice of VRBPAC writing:

‘”We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.”

“So, the Office of Vaccines Research and Review, Center for Biologics Evaluation and Research (CBER) committee took it upon themselves to decide there were ”no concerns or controversial issues” regarding the approval of Gardasil 9?

“This division of CBER decided there would be no benefit from ”an advisory committee discussion”?”

Read more
Read the FDA letter to Merck here

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Footnotes[+]

Footnotes
↑1	https://www.ncbi.nlm.nih.gov/pubmed/19157059
↑2	https://en.wikipedia.org/wiki/Mutagenesis

HPV Vaccine

Validity of the HPV Vaccine

April 30, 2020September 9, 2020
by Rodef

HPV Vaccine: Does it prevent cancer? Do we need it?

About Gardasil

Merck’s original Gardasil vaccine was the first FDA approved HPV vaccine. It targeted HPV types 6, 11, 16, and 18. Gardasil was granted Fast Track approval by the FDA after only a six month review process.¹⁰ According to the FDA, Fast Track approval is a program designed to accelerate the review of medications targeting “serious conditions and fill an unmet medical need.”¹¹ To meet the criteria of “unmet need”, a drug must demonstrate a greater benefit over the currently available treatment.

…

Despite the availability of effective treatment options for the detection and prevention of cervical cancer, Gardasil was granted Fast Track status and an accelerated approval by the FDA.¹⁴ Accelerated approval is designed to allow drugs to be approved before they show any clinical benefit to the patient. Approval is based on findings associated with use of a “surrogate endpoint”, such as a physical marker, laboratory finding such as antibody levels or “other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit.”¹⁵ In other words, Gardasil did not have to demonstrate true effectiveness – prevention of cervical cancer – prior to being determined to be effective and granted approval and licensed by the FDA.

Invasive cervical cancer from an unresolved HPV infection can take decades¹⁶ to develop, and as a result, Merck’s pre-licensing studies of Gardasil, limited to five years,¹⁷ could not clinically confirm that its vaccine could actually prevent cervical cancer. …

…

Over time, it became clear that Merck’s original Gardasil vaccine formulation was inadequate in addressing all the HPV types of concern. As a result, Merck increased the number of types of HPV from four to nine and on December 10, 2014, its 9-valent recombinant vaccine (Gardasil 9) received FDA approval for use in females ages 9 through 26 years of age, for the prevention of genital warts associated with HPV Types 6 and 11 and for the prevention of anal, cervical, vaginal, and vulvar cancers associated with HPV Types 16, 18, 31, 33, 45, 52, and 58.¹¹² The FDA also approved Gardasil 9 for use in males ages 9 through 15 for the prevention of genital warts associated with HPV Types 6 and 11 and for the prevention of anal cancer associated with HPV Types 16, 18, 31, 33, 45, 52, and 58.¹¹³ In addition to doubling the amount of HPV protein antigen contained in the original Gardasil, Merck’s Gardasil 9 increased the amount of bioactive aluminum adjuvant to from 225 mcg to 500mcg.

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Journal of the Royal Society of Medicine

January 21, 2020

We conducted a critical appraisal of published Phase 2 and 3 efficacy trials in relation to the prevention of cervical cancer in women. Our analysis shows the trials themselves generated significant uncertainties undermining claims of efficacy in these data. There were 12 randomised control trials (RCTs) of Cervarix and Gardasil. The trial populations did not reflect vaccination target groups due to differences in age and restrictive trial inclusion criteria. The use of composite and distant surrogate outcomes makes it impossible to determine effects on clinically significant outcomes. It is still uncertain whether human papillomavirus (HPV) vaccination prevents cervical cancer as trials were not designed to detect this outcome, which takes decades to develop. Although there is evidence that vaccination prevents cervical intraepithelial neoplasia grade 1 (CIN1) this is not a clinically important outcome (no treatment is given). Trials used composite surrogate outcomes which included CIN1. High efficacy against CIN1+ (CIN1, 2, 3 and adenocarcinoma in situ (AIS)) does not necessarily mean high efficacy against CIN3+ (CIN3 and AIS), which occurs much less frequently. There are too few data to clearly conclude that HPV vaccine prevents CIN3+. CIN in general is likely to have been overdiagnosed in the trials because cervical cytology was conducted at intervals of 6–12 months rather than at the normal screening interval of 36 months. This means that the trials may have overestimated the efficacy of the vaccine as some of the lesions would have regressed spontaneously. Many trials diagnosed persistent infection on the basis of frequent testing at short intervals, i.e. less than six months. There is uncertainty as to whether detected infections would clear or persist and lead to cervical changes.

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What If HPV Does NOT Cause Cervical Cancer?

Norma Erickson and Peter H. Duesberg, PhD
January 20, 2015

The title of a paper recently published by McCormack et al in Molecular Cytogenetics says it all, ‘Individual karyotypes at the origins of cervical carcinomas .’ If the findings in this paper are true, a vaccine against human papillomavirus (HPV) is extremely unlikely to protect against cervical cancer.

“According to this paper neither genetic predisposition nor HPV infections are necessary for the development of cervical cancer. All cervical cancer cells investigated during the course of this study contained new abnormal karyotypes. The clonality (genetic makeup) of these new abnormal karyotypes indicates the cervical cancers originated with these karyotypes – NOT from a virus.

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Religious Exemption and Halacha – Gardasil (HPV)

RodefShalom613
March 2019

Jewish women in general, and especially women who keep taharas hamishpacha (according to Rabbi Dr. Moshe Tendler) have a very low incidence of cervical cancer to begin with (http://www.cirp.org/library/disease/cancer/menczer1/) . It is so low in fact, that pap smears (which are responsible for the dramatic decline in cervical cancer deaths in the US) hadn’t been routine in Israel…

Read more

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Human Papillomavirus (HPV) Disease and Vaccine Information

National Vaccine Information Center (NVIC)

More than 90 percent of those who become infected naturally clear the infection from the body within two years.⁴ Antibodies to the HPV type causing the infection remain in the body to help prevent future infections but the protection may not be life-long.⁵“

…
Using the MedAlerts search engine, as of May 31, 2019, the federal Vaccine Adverse Events Reporting System (VAERS) contains more than 62,393 reports of HPV vaccine reactions, hospitalizations, injuries and deaths and, includes 503 related deaths, 6,286 hospitalizations, and 3,018 disabling conditions. Nearly 47 percent of the reported serious adverse events occurred in children and teens 12-17 years of age.

(Please note that, according to government sources, only about 1% of injuries are reported to VAERS; this means that the damage is likely 99% higher.)

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The Truth About HPV Progression

Dr. Diane Harper was a lead researcher in Merck’s Gardasil clinical trials. Also a practicing OB/GYN, she has a unique and invaluable perspective on the efficacy, safety, and social issues of HPV vaccines.

Watch more

∼∼∼∼∼∼∼

Dr. Harper on the Pap Smear vs HPV Vaccine

An Interview with Dr. Diane M. Harper, HPV Expert

My examination of the Gardasil vaccine continues with an in-depth interview of Dr. Diane M. Harper.
Huffington Post
March 18, 2010
Marcia G. Yerman, Contributor

• No population benefit in reduction of cervical cancer incidence in the United States with HPV vaccination as long as screening continues.
• Incidence rate of cervical cancer in the United States based on screening is 7/100,000 women per year.
• Incidence rate of cervical cancer if women are only vaccinated with Gardasil is 14/100,000 per year (twice the rate of cervical cancer if young women vaccinated with Gardasil do not seek Pap testing at 21 years and the rest of their life).
• Incidence rate of cervical cancer with Cervarix vaccination is 9/100,000 per year– better than with Gardasil, but still more than with screening alone.
• Incidence of cervical cancer without screening and without vaccination is nearly 90/100,000 per year. The combination of HPV vaccine and screening in the U.S. will not decrease the incidence of cervical cancer to any measurable degree at the population level. Those women who do not participate in Pap screening, and who are vaccinated, will have some personal benefit for five years for Gardasil and 7.4 years for Cervarix (maybe longer), but they will not affect the population rates.

Do you believe that the Gardasil vaccine, as it currently stands, could present more risks to a young girl or woman than the possibility of cervical cancer?

Pap smears have never killed anyone. Pap smears are an effective screening tool to prevent cervical cancer. Pap smears alone prevent more cervical cancers than can the vaccines alone.

Gardasil is associated with serious adverse events, including death. If Gardasil is given to 11 year olds, and the vaccine does not last at least fifteen years, then there is no benefit – and only risk – for the young girl. Vaccinating will not reduce the population incidence of cervical cancer if the woman continues to get Pap screening throughout her life.

If a woman is never going to get Pap screening, then a HPV vaccine could offer her a better chance of not developing cervical cancer, and this protection may be valued by the woman as worth the small but real risks of serious adverse events. On the other hand, the woman may not value the protection from Gardasil as being worth the risk knowing that 1) she is at low risk for a persistent HPV infection and 2) most precancers can be detected and treated successfully. It is entirely a personal value judgment.”

Has the original Gardasil marketing campaign of “one less” muddied the waters and misinformed the public, who heretofore believed that a Pap smear was sufficient to protect them from cervical cancer?

If women were participating in Pap screening, or if as a parent you educated your daughter to seek Pap screening at the appropriate age (21 years) for her entire life, then she would have been very unlikely to be at risk for being “one” and would not be “one less.” She would not have been “one” to begin with!

Yes, the marketing campaign was designed to incite the greatest fear possible in parents, so that there would be uptake of the vaccine. If parents and girls were told the benefits and harms of Pap screening and HPV vaccines as described above, an informed and valued decision would have been able to be made. Many may have chosen to continue with a lifetime of Pap screening and forgo the vaccines, with the unknowns of duration of efficacy and safety unable to be answered for many more years.”‘

Related Articles:

HPV Vaccine: Safety Research/Clinical Trials
HPV Vaccine and Ovarian Failure
Other HPV Vaccine Damage
How Your Doctor Has Been Instructed to Recommend the HPV Vaccine
How Profitable is the HPV Vaccine?

Childhood Cancers

Vaccines & Cancer

April 14, 2020September 24, 2020
by Rodef

Compilation of Section 13 of various vaccine package inserts

How Vaccines Can Cause Childhood Cancers

What health organizations say about childhood cancers

American Cancer Society

“Cancers can be caused by DNA changes that keep oncogenes turned on, or that turn off tumor suppressor genes …

“Some children inherit DNA changes (mutations) from a parent that increase their risk of certain types of cancer. …

“But most childhood cancers are not caused by inherited DNA changes. …

“Acquired mutations are only in the person’s cancer cells and will not be passed on to his or her children. … “

“But the causes of DNA changes in most childhood cancers are not known¹.”

The National Cancer Institute:

“A number of studies are examining suspected or possible risk factors for childhood cancers, including early-life exposures to infectious agents; parental, fetal, or childhood exposures to environmental toxins such as pesticides, solvents, or other household chemicals; parental occupational exposures to radiation or chemicals; parental medical conditions during pregnancy or before conception; maternal diet during pregnancy; early postnatal feeding patterns and diet; and maternal reproductive history. Researchers are also studying the risks associated with maternal exposures to oral contraceptives, fertility drugs, and other medications; familial and genetic susceptibility; and risk associated with exposure to the human immunodeficiency virus (HIV)².”

What about vaccines?

Vaccines include many of the cancer risk factors cited above:

Carcinogenic chemicals
Foreign fragmented DNA which can cause DNA mutations and are tumorigenic.
Infectious agents – Known and unknown viruses and retroviruses which can turn off tumor suppressor genes and which can be cancer causing.

Among the toxins in vaccines associated with cancers are:

Formaldehyde:

Formaldehyde is a known human carcinogen. It has been associated with several different types of cancers, particularly cancers of the hematopoietic and lymphatic systems, nasopharyngeal cancer, and lung cancer. Tests done on formaldehyde toxicity have focused on inhalation, drinking, and contact with skin; no tests have been performed to determine the toxicity of injected formaldehyde. It is a known DNA adduct, a chemical that bonds to a piece of DNA. This is a process which could be the start of a cancerous cell since when a chemical binds to DNA, the DNA gets damaged, resulting in abnormal replication³.

25 of the 53 vaccines listed by the CDC have formaldehyde in them, including DTaP, Hib, HPV, Hep A, Hep B, Influenza, Meningitis, and Polio.

beta-Propiolactone:

“… No information is available on the chronic (long-term), reproductive, developmental, or carcinogenic effects of beta-propiolactone in humans. Squamous cell carcinomas of the forestomach have been reported in orally exposed rats. In dermally exposed rodents, skin tumors have been observed⁴.”

Foreign DNA – Aborted fetal stem cell DNA:

Several live virus vaccines are cultured on human embryonic stem cell lines taken from aborted human fetuses in the 1960s. They are identified as MRC-5 and WI-38; the DNA in the aborted fetal cell lines had been fragmented under the supposition that injecting whole DNA is dangerous, but fragments are not⁵.

Insertional mutagenesis:

Through a process known as insertional mutagenesis, exogenous DNA can be incorporated into the cells of a host and cause carcinogenic mutations. Human embryonic stem cells are known to be tumorigenic⁶.

Insertional mutagenesis, called transcension at the time, was known since the 1960s when scientists Anker and Stroun discovered that exogenous bacterial DNA will be taken up and incorporated into the host DNA of animals. In the 1990s they discovered that free-floating DNA fragments were associated with cancers⁷ ⁸.

Whole, tumorigenic DNA was recently found in the Priorix Tetra Vaccine (for measles, mumps, rubella, and varicella) by Corvelva, an independent lab. Below is an image of a normal human genome (complete DNA) and the one found in the vaccine⁹.

Infectious Agents

Retroviruses:

“Integration of new DNA into a cellular chromosome can alter the activity of nearby genes, sometimes affecting subsequent cell growth. A potent form of insertional mutagenesis involves integration of retroviral DNA produced by reverse transcription, a required step in the replication of retroviruses. In recent years retroviral replication has been adapted to allow new gene addition by retroviral vectors. Early in the history of retrovirus research, analysis of insertional mutagenesis in laboratory animals was found at times to result in transformation, leading to the discovery of cellular proto-oncogenes. In-depth analysis of the genetic consequences showed that integration of retroviral DNA could alter the gene activity in a variety of ways¹⁰.”

“Insertional mutagenesis is a major concern with all of the integrating viral vectors and has been subjected to intense scrutiny since four cases of T-cell leukemia occurred in human pediatric patients with X-SCID 31–68 months after they received γ-retroviral vector-modified autologous HSC. This concern was further heightened when linker-mediated PCR analysis of lymphocytes from these patients revealed that insertional mutagenesis had occurred in all four patients and was at least partially responsible for the observed leukemogenesis¹¹.”

Virus-Chemical Carcinogen Interactions

Studies in the 1960s revealed a synergistic effect between viruses that would normally not form cancers and carcinogenic chemicals that were in too small doses to cause tumors. A 1961 report on a study in mice revealed tumor formation in rats that were simultaneously exposed to injected virus and carcinogens:

“Single doses of pairs of viruses and organic carcinogens (in amounts too small in themselves to induce tumors) were administered to male Swiss mice free of polyoma virus. Malignant tumors developed in groups of mice injected with five of the carcinogen-virus pairs. ¹²”.

The interaction between viruses and carcinogens was reviewed and confirmed by other studies¹³.

These studies raise the probability that vaccine viruses when combined with even small amounts of environmental pollutants, pesticides, and other toxic agricultural by products found in food, can induce cancer formation¹⁴.

Polio vaccine and cancer

HeLa Cells

In order to produce a vaccine, the virus first needs to be grown on a cellular medium. Salk initially used HeLa cells to grow the poliovirus and test the vaccine before it was manufactured for human use. HeLa cells were cells from the cervical cancer tumor of a women named Helen Lacks ¹⁵.

Cancer causing virus in the polio vaccine

In 1960, the Salk killed virus polio vaccine, grown in rhesus monkey kidney cell cultures, was discovered by Bernice Eddy, an NIH (National Institute of Health) scientist, to harbor a cancer causing virus. Later that year it was identified as SV40 (the 40th known simian (monkey) virus) which was shown to cause cancer in rodents. Despite her warnings, the vaccine was not withdrawn from the market and, with full knowledge of the health agencies, was given to more American children. In the US, 100 million children were given this vaccine between 1954 and 1963 when it was discontinued in favor of the live oral polio Sabin vaccine. The Sabin vaccine was grown on African Green Monkey cells since they were said to rarely be affected by SV40¹⁶. However, the vaccine seed stocks used for the Sabin vaccine were from the Salk vaccine. Despite the manufacturer’s claims to the contrary, it was discovered that the seed stocks from the Salk vaccine were not adequately tested to make sure that they were cleared of SV40. Potentially SV40-contaminated oral polio vaccine was given to children through 1999, when it was discontinued in the US and replaced by the inactivated vaccine.

“The absence of confirmatory testing of the seeds, as well as testimony of a Lederle manager, indicate that this claim of removal of SV40 and the testing for SV40 in all the seeds cannot be fully substantiated. These legal documents and testimony indicate that the scientific community should not be content with prior assumptions that SV40 could not have been in the oral polio vaccine. Only further investigation by outside scientific and independent researchers who can review the test results claimed in the January 1997 meeting and who can conduct their own independent evaluations by testing all the seeds and individual mono-valent pools will assure that SV40 has not been present in commercially sold oral poliovirus vaccine manufactured by Lederle¹⁷.”

Hilleman admits contamination and expects cancers

Maurice Hilleman, chief of Merck’s vaccine division at the time SV40 was found to have contaminated the polio vaccine, tested and found SV40 in the Sabin vaccine that was being put through clinical trials in Russia at the time. It was already known that other vaccines grown on living tissue contained carcinogenic viruses, such as the smallpox vaccine containing the leukemia virus. Hilleman felt that SV40 could have even worse long term cancer effects. There was no press release about these findings. Hilleman said this was a scientific affair within the scientific community. Watch the interview with Dr. Hilleman below as he describes this period.

Increased cancers

An analysis of the SEER government database from 1973-1993 showed greater rates of ependymomas (37%), osteogenic sarcomas (26%), other bone tumors (34%) and mesothelioma (90%) among those who were administered SV40 containing vaccines that those of an unexposed birth cohort¹⁸.

In 2001, the Institute of Medicine Immunization Safety Review Committee stated that:

“… in light of the biological evidence supporting the theory that SV40 contamination of polio vaccines could contribute to human cancers, the Committee recommends continued public health attention in the form of policy analysis, communication and targeted biological research¹⁹.”

Molecular biology and epidemiologic studies suggest that SV40 may now be passed from person to person by horizontal infection, in absence of a SV40 containing vaccine. SV40 footprints have been found in high prevalence in human brain and bone tumors, mesotheliomas, and lymphomas and with kidney diseases, and at lower prevalence in blood samples from healthy donors²⁰.

When Eddy discovered the tumorigenicity of the vaccine in 1960, her boss at the NIH did not believe her. Her discovery also threatened one of the country’s most important public-health programs and she was removed from her vaccine regulatory duties and her laboratory.

In the 1990s another NIH employee, Michele Carbone, studying the way SV40 induces cancer in animals, tested human mesothelioma tumour biopsies at the National Cancer Institute. He discovered that 60% contained SV40 DNA and in most of them, the monkey virus was active and producing proteins. He published his findings in the May 1994 edition of Oncogene; the NIH refused to publicize them; other employees promptly contested his findings. After leaving the NIH, Carbone discovered that SV40 disables tumour suppressor genes in human mesothelioma. In July 1997, he published his results in Nature Medicine²¹.

CDC on the polio vaccine and cancer

This page on the relationship between the polio vaccine and cancer caused by SV40 (image on right), web archived but removed from the CDC website in October 2019), denied that the OPV contained SV40²². However, another CDC webpage acknowledges that the Sabin vaccine also contained SV40: “Most of the contamination was in the inactivated polio [Salk] vaccine (IPV), but it was also found in oral polio [Sabin] vaccine (OPV)²³.”

To this day, despite a plethora of evidence showing otherwise, the CDC contends that the evidence is not sufficient to show that SV40 causes cancers in people²⁴.

Vaccine strain polio virus shedding

In March 1959, Albert Sabin published a paper in the British Medical Journal, Present Position of Immunization Against Poliomyelitis with Live Virus Vaccines²⁵, where he acknowledged that vaccine strain shedding of the polio virus was a known fact.They were monitoring the situation carefully and testing the feasibility of the oral polio vaccine in trials with hundreds of thousands of children.

Growing vaccines on human tumor cell lines

In 2001 an FDA document, “Designer” Cells as Substrates for the Manufacture of Viral Vaccines, discussed the use of cell lines made tumorigenic in order to grow particular viruses for vaccines which do not grown well on the standard substrates, such as the AIDS virus. Potential dangers of using these vaccines were reviewed, including the ability to cause cancer or infections in the recipient and mitigating factors, contamination by adventitious agents (toxins and viruses that are often infectious) for which assays to detect unknown agents may become available, and the risk of TSE, transmissible spongiform encephalopathy, and possible methods of detection ²⁶ ²⁷." target="_blank" rel="noopener noreferrer">https://wayback.archive-it.org/7993/20170404095417/https:/www.fda.gov/ohrms/dockets/ac/01/transcripts/3750t1_01.pdf[/ref].

In 2014 the FDA convened a meeting to discuss the use of tumorigenic cell lines from human tumors in the production of vaccines.

“…three examples of human tumor derived cells that are proposed for use as vaccine cell substrates.vaccine cell substrates. … The A549 lung adenocarcinoma cell line, which is proposed for use for adenovirus-vectored vaccines for antigens like influenza, HIV or anthrax.CEM derived cells, which come from a lymphoblastic T cell leukemia, proposed for use in an inactivated HIV vaccine, and HeLa cells, which comes from cervical carcinoma, proposed for use for an AAV-vectored HIV vaccine.

…

“So the big question that we really have to consider, then, is: Is there a potential risk for making vaccines in tumor derived cells? The theoretical risk comes from the fact that, in contrast to many other products, vaccines are often difficult to purify to high levels. And that then leads to the question of whether residual cellular components from tumor-derived cells could pose a safety concern²⁸.”

Sometime afterwards, the FDA initiated a biologics research project to investigate the dangers of latent cancer causing viruses in tumorigenic cell lines.

“The use of tumorigenic and tumor-derived cells is a major safety concern due to the potential presence of viruses such as retroviruses and oncogenic DNA viruses that could be associated with tumorigenicity. Therefore, detection of persistent, latent DNA viruses, and endogenous retroviruses in vaccine cell substrates is important for vaccine safety, particularly in the development of live viral vaccines, where there are no or minimal virus inactivation and removal steps during vaccine manufacturing²⁹.”

Vaccine safety testing

“Mutagen and carcinogen are two physical, chemical or biological factors that may cause changes in normal cell division in organisms. Approximately, 90% of the carcinogens are mutagens. The somatic cell mutations can cause cancers. The main difference between mutagen and carcinogen is that mutagen causes a heritable change in the genetic information of an organism whereas carcinogen causes or promotes cancer in animals and humans. Mutagenesis is the mechanism by which the change in the genetic material occurs…” ³⁰

Per section 13 of all vaccine package inserts, vaccines have not been tested for carcinogenicity, mutagenicity, or impairment of fertility [in humans]³¹.

Why not?

Related: Increase in Childhood Cancers

Footnotes[+]

Footnotes
↑1	https://www.cancer.org/cancer/cancer-in-children/risk-factors-and-causes.html
↑2	https://childhoodcancer-mccaul.house.gov/resources/facts-and-figures
↑3	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4439668/
↑4	https://www.epa.gov/sites/production/files/2016-09/documents/beta-propiolactone.pdf
↑5	https://www.youtube.com/watch?v=hlRYLMKv4Qo&feature=youtu.be
↑6	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3564302/
↑7	https://cor-mariae.com/threads/vaccination-and-genetic-change.4626/
↑8	https://bit.ly/2Vl3DTX
↑9	https://www.corvelva.it/speciale-corvelva/vaccinegate-en/vaccinegate-mrc-5-contained-in-priorix-tetra-complete-genome-sequencing.html
↑10	https://www.sciencedirect.com/science/article/abs/pii/S1525001620300010
↑11	https://www.sciencedirect.com/topics/agricultural-and-biological-sciences/insertional-mutagenesis
↑12	https://sci-hub.tw/10.1126/science.134.3494.1985
↑13	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC441248/?page=7
↑14	https://cor-mariae.com/threads/vaccination-and-genetic-change.4626/
↑15	https://vaccinecancerconnection.wordpress.com/2016/08/16/hela-cells-the-continuing-contamination-of-cancer-and-vaccine-research/#mo
↑16, ↑19	https://www.nvic.org/vaccines-and-diseases/Polio-SV40/BLFTestimonySV40.aspx
↑17	https://www.ncbi.nlm.nih.gov/pubmed/11205211
↑18	https://www.ncbi.nlm.nih.gov/pubmed/10472327/
↑20	https://infectagentscancer.biomedcentral.com/articles/10.1186/1750-9378-2-13#Abs1
↑21	https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(04)16746-9/fulltext
↑22	https://web.archive.org/web/20110307094146/http:/cdc.gov/vaccinesafety/updates/archive/polio_and_cancer_factsheet.htm
↑23	https://www.cdc.gov/vaccinesafety/concerns/concerns-history.html Simian Virus 40 (SV40) – 1955–1963
↑24	https://www.cdc.gov/vaccinesafety/concerns/concerns-history.html
↑25	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1993129/?page=18
↑26	https://web.archive.org/web/20180308010130/https://www.fda.gov/ohrms/dockets/ac/01/briefing/3750b1_01.htm
↑27		↑28	https://www.scribd.com/doc/246682536/FDA-Meeting-Human-Tumors-for-Vaccine-Manufacture
↑29	https://www.fda.gov/vaccines-blood-biologics/biologics-research-projects/investigating-viruses-cells-used-make-vaccines-and-evaluating-potential-threat-posed-transmission
↑30	https://pediaa.com/difference-between-mutagen-and-carcinogen/
↑31	http://www.healthalertphilly.org/VaccinesSECTION13.htm

Childhood Cancers

Increase in Childhood Cancers

April 12, 2020September 24, 2020
by Rodef

https://www.cancer.gov/images/cdr/live/CDR776061.jpg

Childhood Cancer Statistics

United States

While survival rates of five years or more for childhood cancers have increased in the US from 58% in the 1970’s to the current rate of 84%, the incidence of childhood cancer has been increasing over the past decades. About 11,050 children under the age of 5 will be diagnosed in 2020, and about 1,190 are expected to die. Cancer is the second leading cause of death in children ages 1 to 14, accidents being the first¹.

Overall, among children and adolescents (ages 0 to 19) in the United States, the most common types of cancer are leukemias, brain and central nervous system tumors, and lymphomas. Among children (ages 0 to 14 years), the most common types of cancer are leukemias, followed by brain and other central nervous system tumors, lymphomas, soft tissue sarcomas (of which half are rhabdomyosarcoma), neuroblastoma, and kidney tumors (1). Among adolescents (ages 15 to 19 years), the most common types of cancer are brain and other central nervous system tumors and lymphomas, followed by leukemias, gonadal (testicular and ovarian) germ cell tumors, thyroid cancer, and melanoma².

Government statistics, from 1975-2016, show an overall increase of 13 per 100,000 cases to 18.5 per 100,000 cases for the following cancers in children ages 0-19:

Bone and Joint
Brain and Other nervous
Kidney and Renal pelvis
Leukemia
Acute lymphocytic leukemia
Non-Hodgkins lymphoma
Soft tissue

Only Hodgikin’s lymphoma has decreased in incidence during this time period³.

Australia

According to research published in the Medical Journal of Australia, cancer increased 1.2% per year between 2005 and 2015, and is expected to rise 7% more over the next 20 years⁴.

Global

Worldwide statistics (see image at right) show that childhood cancers are increasing for children between 0-19 years. Childhood cancers have increased from 124.0 per million person years in the 1980s to 140.6 per million person years in 2001-2010⁵.

The largest increase was seen in infants. In children less than 5 years old, cancer rates increased for both common types of childhood leukemia, one brain tumor subtype, neuroblastoma and hepatoblastoma (except Southern Asia). Hepatoblastoma, which is a rare liver tumor, had the largest increase in incidence in 11 out of 15 regions, ranging from 1.9-6.5 percent per year). The only cancer to decrease over that period was astrocytic tumors in the brain⁶.

Related: Vaccines and Cancer

Footnotes[+]

Footnotes
↑1	https://www.cancer.org/cancer/cancer-in-children/key-statistics.html
↑2	https://www.cancer.gov/types/childhood-cancers/child-adolescent-cancers-fact-sheet
↑3	https://seer.cancer.gov/csr/1975_2016/results_merged/sect_28_childhood_cancer.pdf
↑4	https://medicalxpress.com/news/2020-02-childhood-cancer-sight.html
↑5	https://sci-hub.tw/https://doi.org/10.1016/S1470-2045(17)30186-9 page10
↑6	https://medicalxpress.com/news/2019-04-cancer-young-children-worldwide.html

WHO

WHO Global Vaccine Safety Summit

March 24, 2020October 3, 2023
by Rodef

On December 2-3, 2019, the World Health Organization (WHO) hosted a vaccine safety summit in which leading scientists, researchers, and doctors from around the world attended. Discussion on the second day included acknowledgment that the status of vaccine safety is rather precarious, the science isn’t up-to-date and long-term adverse effects are not well-known and are hard to study.

Here are some outtakes from the summit:

Professor Heidi Larson:

There’s a lot of safety science that’s needed and without good science we can’t have good communications… it absolutely needs the science as the backbone. You can’t repurpose the same old science to make it sound better if you don’t have the science that’s relevant to the new problems.
We need much more investment in safety science.

The biggest problem with vaccine skepticism online is that

‘a lot of it is not misinformation’ and that there is ‘a lot of ambiguity in the safety field.’

The other thing that’s a trend and an issue is not just confidence in providers but confidence of healthcare providers. We have a very wobbly health professional front line that is starting to question vaccines and the safety of vaccines. That’s a huge problem.… If we lose that, we’re in trouble.

We’ve talked about it earlier, some of the challenges are that our frontline professionals are starting to question, or they don’t feel that they have enough confidence about the safety to stand up to it to the person asking them the questions.”

“I mean, most medical school curriculums, even nursing curriculums, I mean in medical school you’re lucky if you have a half day on vaccines, never mind keeping up-to-date with all this.

Prof. Stephen Evans, LSHTM:

It seems to me that adjuvants multiply the immunogenicity of the antigens that they are added to and that is their intention. It seems to me they multiply the reactogenicity in many instances and therefore it seems to me that it is not unexpected if they multiply the incidence of adverse reactions that are associated with the antigen but may not have been detected through lack of statistical power in the original studies.

Now I wonder if this thinking is correct and, if it is, whether this has some implications for the way we do pharmacovigilance because one vaccine that is has one antigen and an adjuvant and another vaccine that has a different antigen and no adjuvant, the reason for the difference is not immediately obvious.

…

The major health concern which we are seeing are accusations of long term, long term effects so what we have to bear in mind is that we don’t use adjuvants by themselves the adjuvant is used in combination with an antigen and an adjuvant may be give quite different responses depending on which antigen it is combined with, so the fact that an adjuvant is shown to be safe with one antigen might give a different response with another antigen because of other things that are with that with that second antigen including impurities.

So to come back to the (not clear) once again point to the regulator’s. It comes down to ensuring that we conduct the Phase Two and the Phase Three studies with adequate size and with the adequate appropriate measurement.

Prof. Heidi Larson

… the adverse events aren’t really about the vaccine but the vaccine experience. We’ve heard this morning about the Japan situation, we had a series of what had been assessed in the absence of any other organic links, psychosomatic reactions to vaccines … These are some of the girls in Japan whose mothers have court cases claiming that they were damaged by HPV vaccines … This is in Denmark. They’re all lined up. This was a group of girls … we’ve got the same problem … this was in Ireland, similar girls lining up in front of a health official … This is Columbia, six hundred girls across multiple schools in a district in Columbia had the same symptoms as these others place.

I just want to show you what’s been going on in YouTube to create mimic reactions. … We’re seeing a real change in the nature of these reactions because of social media. … This is … stress-related immunization reactions … This is a whole range of symptoms that are real symptoms. They may not have been cause by the contents of vaccines. They could be attributable more to the vaccination experience but it affects the whole confidence in the system if governments don’t know how to deal with all this.

Watch the entire summit proceedings here.

FDA

Does Pharma Funding Compromise the FDA?

March 24, 2020November 19, 2023
by Rodef

FDA sign in front of building

How the FDA Lost Independence

The FDA (Food and Drug Administration), a division of the US Department of Health and Human Services, is charged with overseeing the safety of food and pharmaceuticals. But how independent can an agency be when it is receiving funds in the form of user’s fees from the very companies they are supposed to be regulating?

A 2003 PBS’ Frontline article, How Independent is the FDA?, a compilation of excerpts from some of their interviews with agency insiders and watchdog groups (see more here), sheds light on how the FDA has moved from its mission of protecting the public health to protecting the health of the very companies whose drugs they are supposed to be independently reviewing.

Industry Pressure on the FDA and Scientists?

The individuals whose excerpts are included and the positions they held at the time of the interview include:

Sidney Wolfe, M.D., Director of Public Citizen’s Health Research Group from its founding in 1971;
Steven Galson, M.D., Acting director of the FDA’s Center for Drug Evaluation and Research;
Raymond Woosley, M.D., Vice President for Health Sciences at the University of Arizona, he was a top candidate to become FDA commissioner in 2002; and
John Kelly, M.D., Ph.D., Spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA), the industry’s lobbying organization.

Until 1992, the FDA was funded entirely by the US government, but in 1992, the Prescription Drug User Fee Act was enacted, requiring drug companies to pay the FDA to have their drugs reviewed and approved. This, Wolfe said, influenced the FDA to consider the industry to be their client, rather than the public. Additionally, he said, there are many individuals in the FDA’s drug division who are reluctant to go against the pharmaceutical companies and Congressional oversight, which used to hold the FDA accountable, has dwindled.

According to Woosley, the User Fee Act and pharma lobbying has skewed the balance of FDA activities away from safety. From the excerpt:

Is the balance of the FDA out of whack, in your opinion?

I think the FDA is so grossly underfunded for its mission that it is out of balance because of user fees. User fees enable the agency to hire people to work for the industry… The teams that are needed to do drug safety are infinitely more than what they’ve got right now. We don’t have a safety system in this country.

Why is the safety part resisted so adamantly? How do you explain it?

The budgets of the FDA are determined by lobbyists who call for money to be spent in certain ways. The user fee is negotiated to be spent on reviewers. Until recently, none of the money that was sent by the pharmaceutical industry for user fees could be used for drug safety. Now that’s changing — not to the rate I’d like to see it. Some of the money can now be spent for drug safety, but that was impossible until recently. It’s only because many of us have screamed that that has to change has it changed. …

What’s the lobbying in terms of safety?

Nothing. They’re not lobbying for safety. … The pharmaceutical industry doesn’t lobby for safety. They lobby for rapid review, rapid access to the marketplace. … When the papers came out from the Institute of Medicine talking about medical errors and medical harm, I thought surely there would be action taken and the agency would be given money to increase its safety net. But it hasn’t happened. …

Galson and Kelly don’t agree with the above assessments. Galson rejects the notion that the FDA is influenced by the pharmaceutical companies saying:

We don’t really feel pressure to please the industry. We feel quite independent among the scientists. We have a large number of mechanisms for assuring high quality of the reports that we do to make decisions about new drugs. We just reject that we’re actually influenced by that. In fact, what’s happened over the course of the user fee activity is we’ve been able to hire a lot more people, improve the expertise of the people that we do have, provide more tools to our employees. So we think it’s really helped the review process.

Kelly believes the User Fee Act has been beneficial to the public, allowing the FDA to approve more drugs in a more timely manner.

This is something that was largely pushed by the pharmaceutical industry. Give us some history from the industry’s perspective.

The pharmaceutical industry is remarkably productive. We develop a number of new medicines every year. Part of the challenge that we’ve found was occurring a number of years ago — that the FDA didn’t have the resources to do the reviews in a timely and effective way. So PDUFA was a way to help improve the resources available to the Food and Drug Administration so they could review pharmaceuticals.

This act has been very effective. It has improved the efficiency of the review process. It has not changed the standards or the review process, so the drugs that are ultimately approved by the Food and Drug Administration are determined by the FDA to be safe and effective. So PDUFA has worked very, very well in helping to improve timely access to beneficial medicines. …

Is it possible that FDA personnel are not susceptible to influence by the industry that pays most of their wages? Is it possible that it has not changed standards or review?

Consider the experience that Dr. Stuart Rich (read his interview here) recounted in his capacity as a consultant to the FDA. American Home Products, the American licensee of a European drug found to cause a fatal, incurable disease in Europe, planned to sell it in the US. Despite objection by many within the FDA, it was ultimately, and suspiciously, approved and went to market without the black box warning that the company had negotiated away.

Rich then published a paper in a medical journal about the dangers of the drug and was interviewed on national television about his report.

What did you say on the Today show?

… Basically, what I said was nothing that was not mentioned in the paper …– that the drug carrier risked a very high risk of developing this fatal disease; that it should not be prescribed lightly; … Do not prescribe it carelessly. Do not assume that there is no serious side effect, because, in fact, it’s a potentially serious drug.

So what happened right after your appearance?

Well, interestingly, I got a phone call from [an executive] from American Home Products. …Unchanged: When I got back to my office at the medical center earlier that morning, he called me directly. He told me he saw my interview on the Today show, and warned me that it was very dangerous for me to talk to the press about that; that if I had any issues regarding their product that I wanted to publish in a scientific journal, so be it. But if I spoke to the media about their drug, bad things would happen.

What did you understand that to mean, “Bad things would happen?” I mean, those are actually the words he used?

“Bad things would happen” was the exact phrase he used. … I took the threat very, very seriously. I decided, OK, it’s a little unpredictable when you talk to the press anyway — sometimes you want to say a story, and it comes out a little differently — so maybe I wouldn’t talk to the media. I never did, from that point on, and I was approached by all of the major news stations — CBS, ABC, NBC. …

I never talked to the press again. Because I didn’t know what they had in mind. They are a very big, a very powerful company. …

Fortunately, he found other means with which to work to have the drug recalled, which is what ultimately happened. He concludes:

The drug approval process is a difficult one. I will tell you that I’ve had a lot of interaction with the FDA. The overall majority of the people are dedicated, hardworking, concerned, caring, wonderful people. But they’re human.

…

There is a very powerful pharmaceutical lobby called PhRMA that, like the other corporations in America, tries to have every legislation done in their best interest. One of the problems with the FDA today is a law where the pharmaceutical companies are actually paying the cost of the FDA. … There is a conflict there. It’s an overt conflict. It’s in the FDA’s best financial interest to be favorable to the pharmaceutical industry, because that’s where their support comes from. I think that was a bad law, and that probably should be changed. But working in those constraints, I think they’re doing the best they can.

…

The pharmaceutical industry is in the business of developing new drugs with the ultimate goal of improving our lives. There are financial interests involved. … There’s great profit in this industry.

… The public expects that a doctor will do his best, that a drug will be safe, that a hospital will be careful. They have every reason to expect that, and they are betrayed when they’re not. Accidents happen, but when it’s an intentional betrayal, that’s a problem. Hopefully, things will get better.

Additional Resources:
Politics, Profits & Pharma

FDA

Drug and Vaccine Approvals in Light of Pharma Funding

March 24, 2020November 5, 2020
by Rodef

The Prescription Drug User Fee Act

Calls by the pharmaceutical industry, as well as doctors and patients to speed up the drug approval process resulted in passage of the Prescription Drug User Fee Act in 1992. The act did help speed up the drug approval process, decreasing it from an average of 30 months to 16 months.

As explained in an article detailing the results of a POGO (Project on Government Oversight) investigation, FDA Depends on Industry Funding; Money Comes with “Strings Attached”, the act expires every five years, when the FDA must negotiate with the pharmaceutical industry to keep paying the fees. The result of the regulator negotiating with the very industry to be regulated means that the FDA is not free to use the money it receives from industry in any way it sees fit. In 1992 these fees were 35% of the FDA’s funding for drug review; by 2016 the fees made up 71% of oversight funding.

….In practice, the FDA has interpreted that to mean negotiate over how it spends the money and assesses drugs. The negotiations produce recommendations for Congress and an FDA “commitment letter” laying out goals for the agency. It’s unclear what would happen to the user fees if the FDA and industry didn’t agree on terms.

This arrangement gives the pharmaceutical industry extraordinary influence over its government overseer. It leaves the regulator beholden to the regulated.

The Act’s affect on drug approvals

Here are just three of many examples of drugs which should never have been approved:

… FDA reviewers and advisory committee members were unable to reconcile the patient testimonies with the data the drug maker had gathered. The “testimonies spoke of improvement; the data showed progressive worsening,” Unger wrote, using italics for emphasis.

The FDA’s decision ultimately rested with Robert Califf, the head of the agency, who formerly ran clinical trials for drug companies. Califf concluded that the drug’s “clinical benefit has not yet been established.”

He approved it anyway.

FDA Depends on Industry Funding; Money Comes with “Strings Attached”

In 2011, the FDA approved the blood thinner Xarelto to prevent strokes in heart patients despite the fact that the manufacturer-sponsored clinical trial on which the FDA based its decision had a potentially crippling flaw: it relied on faulty blood testing devices that had already been the subject of two FDA warning letters.

And

… Pradaxa, a new-generation blood thinner approved in 2010 and later named in many reports of deadly bleeding. The FDA approved Pradaxa on October 19, 2010, precisely the target date for FDA action—also known as the “PDUFA date”—dictated by the user fee regime’s accelerated timetables.

FDA Set Low Bar for Approval of Blood Thinners

The Act’s affect on vaccine safety

According to Children’s Health Defense, Rubber Stamping—The FDA and Vaccines—Conflicts of Interest Undermine Children’s Health: Part IV:

Captured agencies operate “essentially as…advocate[s] for the industries they regulate,” abrogating their duty to act in the public’s interest. Vaccine and drug fast-tracking provide a clear example of FDA regulatory capture. In 1992, Congress passed the Prescription Drug User Fee Act, allowing pharmaceutical companies to make payments to the FDA (called “user fees”) in exchange for expedited approval of drugs and biologics, including vaccines. Additional legislation in 2012 further facilitated “accelerated” approval by allowing the FDA to use surrogate endpoints to evaluate a drug or vaccine rather than waiting to assess longer-term clinical benefits….In fact, government authors who churn out boilerplate articles about vaccine safety exhibit a fondness for the notion that post-vaccination mishaps are simply a fluke. Industry, too, likes to tell the public that it has “guidelines and algorithms” to differentiate between a post-vaccination adverse event that “may” be causally related to a vaccine versus an event that is coincidental to vaccination.Even when the adverse event in question is a death “temporally associated with vaccination,” government researchers like to rely on the coincidence argument—all the while conceding that “loved ones and others might naturally question whether it was related to vaccination”! This, despite admitting to “rare cases where a known or plausible theoretical risk of death following vaccination exists,” …

…

With the FDA’s disproportionate reliance on user fees to fill out its budget, and silly arguments about “coincidences,” it is difficult to make a convincing case that the agency’s vaccine licensing decisions remain uncontaminated by pharmaceutical industry preferences. …

Related articles:
Does Pharma Funding Compromise the FDA?

Additional resources:

Blog

Instructions for Boosting Vaccination Rates in Medical Offices

5 Ways to Boost HPV Vaccination Rates

Is Your Doctor an HPV Vaccine is Cancer Prevention Champion?

Dr. Diane Harper on informed consent:

Serious Injury in Females and Males

Menstrual Cycle Evaluation and Women’s Health: An Overlooked Biomarker for Vaccine Injury

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When The FDA Wants To Impose Gardasil To Women And Men Aged 27 Through 45 Years, It Invents A Magic Rate Via A New Criterion

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Japan Leading The World In Exposing Fraud with Gardasil HPV Vaccine …injuries and death

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Cervarix vaccine issues trigger health notice

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FEDERAL VACCINE COURT RULES: GARDASIL KILLED CHRISTINA TARSELL

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The HPV Vaccination can cause very serious Side Effects!

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Colton Berrett Dies After Being Unable To Cope With His Gardasil HPV Vaccine Injuries

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R.E.G.R.E.T.

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The Current Status of Worldwide Injuries from the HPV Vaccine

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W.H.O. SAYS ‘IT’S IN YOUR HEAD’

Does Gardasil Cause Premature Menopause in Young Girls?

Does anyone need Gardasil?

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New Concerns about the Human Papillomavirus Vaccine

Adolescent Premature Ovarian Insufficiency Following Human Papillomavirus Vaccination

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Human Papilloma Virus Vaccine and Primary Ovarian Failure: Another Facet of the Autoimmune/Inflammatory Syndrome Induced by Adjuvants

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Injecting Aluminum: Healthy girls bedridden or infertile

What Do the Clinical Trials Really Tell Us?

Gardasil vaccine package insert

Examining the FDA’s HPV Vaccine Records

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DNA Contamination in HPV vaccines

What the Gardasil Testing May Have Missed

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Why Is Slate Questioning Gardasil?

Statistical Shenanigans with Gardasil Research

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HPV Vaccine: Does it prevent cancer? Do we need it?

About Gardasil

Journal of the Royal Society of Medicine

What If HPV Does NOT Cause Cervical Cancer?

Religious Exemption and Halacha – Gardasil (HPV)

Human Papillomavirus (HPV) Disease and Vaccine Information

The Truth About HPV Progression

An Interview with Dr. Diane M. Harper, HPV Expert

How Vaccines Can Cause Childhood Cancers

What health organizations say about childhood cancers

American Cancer Society

The National Cancer Institute:

What about vaccines?

Among the toxins in vaccines associated with cancers are:

Formaldehyde:

beta-Propiolactone:

Foreign DNA – Aborted fetal stem cell DNA:

Infectious Agents

Retroviruses:

Virus-Chemical Carcinogen Interactions

Polio vaccine and cancer

HeLa Cells

Cancer causing virus in the polio vaccine

Hilleman admits contamination and expects cancers

Increased cancers

CDC on the polio vaccine and cancer

Vaccine strain polio virus shedding

Growing vaccines on human tumor cell lines

Vaccine safety testing

Childhood Cancer Statistics

United States

Australia

Global

How the FDA Lost Independence

Industry Pressure on the FDA and Scientists?

The Prescription Drug User Fee Act

Instructions for Boosting Vaccination Rates
in Medical Offices

Japan Leading The World In Exposing Fraud with Gardasil HPV Vaccine
…injuries and death