Is Gardasil Dangerous? Is It Even Useful?
I thought this would be a much shorter post when I started researching and writing it a few months ago. But as I dug deeper into the topic, I realized the history and politics of this HPV vaccine involved a number of twists and turns that seriously threaten public health rather than protect it. And not just in the US but worldwide.
I know you’re busy and am sorry the piece is so long. If you make it through to the end, you’ll have learned a great deal about how Big Pharma companies like Merck, the US Food & Drug Administration (FDA), our National Institutes of Health (NIH), and big advertising agencies work together in ways that place profit over our health and well being.
The case of Gardasil is especially egregious because the vaccine targets young children. – Joan
HUMAN PAPILLOMAVIRUS (HPV) & CERVICAL CANCER
“Almost everyone who has been sexually active will contract an asymptomatic HPV infection at some point, but in almost all cases, the body clears the virus on its own within two years without complications. Even when vaginal or cervical HPV infection does not resolve spontaneously and becomes chronic, it often takes decades to progress to invasive cervical cancer.” (Raines & Fisher, 2018)
The Human Papillomavirus (HPV) is the most common sexually transmitted disease in the US. The US Centers for Disease Control and Prevention (CDC) says that almost every sexually active male and female has the virus at some point. It’s also known that HPV usually resolves on its own without causing any serious health risks.
Over 150 different kinds of HPV have been identified but not all of them are problematic. “Some kinds of HPV may cause problems like genital warts. Some kinds of HPV can also cause cancer of the cervix, vagina, vulva, or anus. Most of these problems are caused by types 6, 11, 16 or 18.” (US FDA, 2018)
NOTE ON THE TWO VERSIONS OF THE GARDASIL VACCINE:
The US Food & Drug Administration (FDA) approved Merck’s HPV vaccine, Gardasil, on June 8, 2006 for females 9-26 years of age to protect against cervical, vulvar and vaginal cancers caused by HPV types 16 and 18 and genital warts caused by HPV types 6 and 11.
Merck has been embroiled in controversy about the vaccine’s safety and efficacy ever since.
The original (quadrivalent, recombinant*) Gardasil vaccine was also approved for use in 120 other countries around the world. (Haupt & Sings, 2011)
* “A recombinant vaccine is a vaccine produced through recombinant DNA technology. This involves inserting the DNA encoding an antigen (such as a bacterial surface protein) that stimulates an immune response into bacterial or mammalian cells, expressing the antigen in these cells and then purifying it from them.” (Nature, 2019) GARDASIL 9
Gardasil 9, an HPV 9-valent vaccine (recombinant), was initially approved by the FDA in 2014 for use in both males and females aged 9-26 years. On June 13 2018 the FDA extended its approval for use in older males and females, aged 27-45 years.
A press release from Merck to its investors announcing this new extended market claimed Gardasil 9 “is indicated in the United States in females 9 through  years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58; precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV types 6 and 11.” (Merck, 6/13/2018) Starting in late 2016, the original, quadrivalent Gardasil, became unavailable for distribution in the US, replaced by Gardasil 9. According to Merck and the FDA, “efficacy data for Gardasil can be extrapolated to Gardasil 9, since the two vaccines are manufactured similarly and the original Gardasil targeted 4 of the 9 HPV strains covered by Gardasil 9.” (OncLive, 10/7/2018)
In its press release to investors about Gardasil 9’s having been approved for men and women ages 27-45, Merck noted that “Gardasil 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of Gardasil 9 or Gardasil (emphasis added).” (Merck, 6/13/2018)
In this post I’m going to follow the convention of referring to both versions as ‘Gardasil’. You can read more about the original quadrivalent Gardasil compared to Gardasil 9 here.
WEB MD ON GARDASIL: 2011
The following is from a WebMD article, Children’s Vaccines – Human Papillomavirus (HPV) Vaccine: What You Need to Know posted on 2/1/2011, 4 years 8 months after Gardasil entered the market.
“HPV vaccine is an inactivated (not live) vaccine which protects against four major types of HPV.
“These include two types that cause about 70% of cervical cancer and two types that cause about 90% of genital warts. HPV vaccine can prevent most genital warts and most cases of cervical cancer.
“Protection from HPV vaccine is expected to be long-lasting. But vaccinated women still need cervical cancer screening because the vaccine does not protect against all HPV types that cause cervical cancer.
HPV vaccine is routinely recommended for girls 11 and 12 years of age. Doctors may give it to girls as young as 9 years.
The HPV4 vaccine (the type recommended for prevention of genital warts in girls) may also be given in three doses to boys aged 9 to 26.
“Why is HPV vaccine given to girls at this age?
“It is important for girls to get HPV vaccine before their first sexual contact — because they have not been exposed to HPV. For these girls, the vaccine can prevent almost 100% of disease caused by the four types of HPV targeted by the vaccine….
“HPV vaccine does not appear to cause any serious side effects.” (emphasis added)
Contrary to this misinformation posted by WebMD in 2011, the story of how Merck’s HPV vaccine, Gardasil, came to be on the market and pushed so hard by the federal government, ad agencies employed by Merck and doctors is a scandal.
ADVERSE REACTIONS TO GARDASIL
Reports of adverse effects from Gardasil began as soon as the vaccine went on the market in 2006. The chart below is a summary of 28,137 adverse effects after HPV vaccination reported to VAERS (Vaccine Adverse Event Reporting System) by patients, their families and physicians as of 13 November 2012, 23 months after WedMD posted its statement about the apparent safety of the vaccine.
Negative Reactions to Gardasil as reported by VAERS (Vaccine Adverse Event Reporting System) as of 11/13/2012
Statistics gathered by the Vaccine Adverse Event Reporting System (VAERS), operated by the US Centers for Disease Control & Prevention (CDC) and the US Food & Drug Administration )FDA), belie WebMD’s conclusion about the apparent safety of the HPV vaccine. VAERS’ purpose is to serve as “an early warning system to detect possible safety issues with U.S. vaccines”. (CDC, 2017)
As of July 14 2018, 12+ years after Gardasil hit the market, VAERS had received reports of 58,936 adverse reactions following Gardasil vaccinations – including 139 cervical cancers, 931 life threatening events, 15,672 emergency room visits, and 5,894 hospitalizations.
Negative Reactions to Gardasil as reported by VAERS (Vaccine Adverse Event Reporting System) as of 7/14/2018
Serious complications of HPV vaccination are still being reported in the US and other countries around the world.
“Although U.S. health officials have continued to deny a causal connection, Japanese researchers have pointed out that the temporal association with post-Gardasil clinical symptoms such as “chronic regional pain syndrome, orthostatic intolerance, and/or cognitive dysfunction” suggests a causal relationship with the vaccine. Other health issues associated with HPV vaccination include nervous and immune system disorders such as postural orthostatic tachycardia syndrome (POTS), chronic fatigue syndrome, blood clots, acute respiratory failure and cardiac arrest.
“Also widely reported are menstrual abnormalities and premature ovarian failure.” (Raine & Fisher, 2018)
While VAERS statistics do not necessarily PROVE a vaccine CAUSED a reaction, they do serve the CDC’s purpose of being “an early warning system to detect possible safety issues with U.S. vaccines”.
Some VAERS data strongly suggest causality. For example, “In 2009, investigators reported that the U.S. Vaccine Adverse Events Reporting System (VAERS) showed 28 reports of anaphylaxis already reported after receipt of Gardasil, with 25 cases occurring on the same day as vaccination.” (Mercola, 2019)
US GOVERNMENT PAYS OUT MILLIONS TO GARDASIL VICTIMS
A 2014 article in The Washington Times titled “U.S court pays $6 million to Gardasil victims” reported that as of April 2013, less than seven years after Gardasil first went on market in the US:
– Lind, 2014
More recently, the National Vaccine Information Center (NVIC) published an article titled ‘Can HPV Vaccine Cause Injury and Death?’ which stated:
“As of July 1, 2018, 387 claims have been filed to the federal Vaccine Injury Compensation Program (VICP) for 14 deaths and 373 injuries that occurred after HPV vaccination. To date, the U.S. Court of Claims has compensated 128 of the 387 children and adults who filed claims for HPV vaccine injuries.
“For example, an HPV vaccine injury claim was filed and awarded by the VICP for Christina Tarsell. Christina was a 21-year-old college student majoring in studio arts at Bard College when she received a series of three Gardasil shots. A talented athlete, artist and honor roll student, she died suddenly and without explanation shortly after the third shot in June 2008. Ten years later, in 2018, the government conceded the case and awarded compensation to her mother for Christina’s vaccine-related death.” (National Vaccine Information Center, 2018)
Federal Vaccine Court Ruled Gardasil Killed Christina Tarsell
The National Vaccine Information Center is a non-profit, independent clearinghouse for information on diseases and vaccine science, policy, law and the ethical principle of informed consent.
SERIOUS CONFLICT OF INTEREST BETWEEN VACCINE PROMOTERS & VACCINE DEVELOPERS
Are you aware that money collected from US tax payers is used to finance the development of new drugs and vaccines by Big Pharma companies? Gardasil is a case in point.
Through an interesting licensing arrangement, the huge commercial success of the Gardasil HPV vaccine puts money into the coffers of both Merck and the US government’s Department of Health and Human Services (DHHS).
A National Institutes of Health (NIH) research team invented the technology for the ‘virus-like particles’ (VLPs) that made the Gardasil vaccine possible.
An article in the Institutes’ February 23 2007 newsletter described the partnership between NIH research scientists and Merck in developing Gardasil:
“From Lab to Market: The HPV Vaccine” celebrated the technology developed at NIH which Merck turned into their Gardasil HPV vaccine. The article states: “Perhaps no other recent product on the market demonstrates successful health care technology transfer better than the human papillomavirus (HPV) vaccine, Gardasil, produced by Merck & Co. and approved by the FDA in June 2006.”
How did the technology developed by researchers at NIH make its way to Merck and into the marketplace?
In a May 2006 review appearing in The Journal of Clinical Investigation, the NIH researchers disclosed their commercial interests in Gardasil: “Conflict of interest: The authors, as employees of the National Cancer Institute, NIH, are inventors of the HPV VLP vaccine technology described in this Review. The technology has been licensed by the NIH to the 2 companies, Merck and GlaxoSmithKline, that are developing the commercial HPV vaccines described herein.”
So NIH developed the VLP technology and then licensed it to Merck and GlaxoSmithKline for to turn it into their respective, best-selling HPV vaccines.
Under this business arrangement, various agencies of the US government work together to develop technology that is then licensed to commercial companies to market the resulting product for-profit – and the government receives money from the licensing. The Department of Health & Human Services calls these kinds of arrangements ‘Public-Private Partnerships’ and DHHS agencies have aggressively pursued them. Makes sense since DHHS makes a lot of money on them.
NIH launched its ‘Program on Public-Private Partnerships’ in 2005, the year before Merck began marketing Gardasil. On NIH’s web-site, the Institutes’ program managers concede that this kind of technology transfer carries unavoidable ethical risks. They acknowledge that “the potential for conflict of interest exists any time the NIH and NIH staff engage with non-Federal entities to achieve mutual goals.”
So here we have a situation “in which the same departments that are tasked with regulating the health and safety of medical products are also profiting from them”.
Here’s a summary of how that happened with Gardasil:
The inventors of the VLP technology were scientists employed by the Laboratory of Cellular Oncology at NIH’s National Cancer Institute’s Center for Cancer Research.
NIH filed for and received patents for the technology they invented. The commercial rights to the invented technology are owned by DHHS.
NIH has neither the authority or ability to turn technology into commercial products so it created an Office of Technology Transfer (OTT), whose job is to oversee technology transfer of “medical knowledge from NIH laboratories to other organizations for the purpose of developing that knowledge into medical products to enhance the public health.”
Merck commercialized an HPV vaccine using NIH’s technology and has generated billions of revenue from the resulting Gardasil product.
As per their licensing agreement with Merck, NIH’s OTT has received millions of dollars from Gardasil’s sales.
“When new products invented at NIH clear the requisite regulatory hurdles at the Food and Drug Administration (FDA) and reach the market, OTT then shares in the profits. They also distribute the rewards back to the scientific teams whose products have succeeded in reaching the commercial stage: when license fees flow into OTT’s coffers, the Federal employees who invented the technology are entitled by NIH policy to a share of the royalties.”
The ‘public-private partnership’ between the government and Merck also provided Gardasil with favorable treatment at key decision points – and this special treatment gave financial rewards to both parties.
– Blaxill, 2010
Hmm. The NIH is charged with protecting public health but when it uses its considerable clout to advocate for commercialization of technology it develops – and then profits from the resulting products – public safety is threatened.
The organization tree below shows the path Gardasil took to reach the market – starting with government-funded research at NIH done under the auspices of the Department of Health and Human Services to getting fast-tracked through the FDA’s approval process and finally passing through various governmental agencies that promoted policy making this vaccine appear necessary for public health and simultaneously also creating a market for it, then on to the Office of Technology Transfer that set the terms of the licensing agreement with Merck that pays fees back to the Department of Health and Human Services.
Note: I've searched for the exact terms of the OTT's licensing arrangement with Merck for Gardasil. If you have access to this information, please send it and I'll add it to this article.
Here are links to the entire three-part article by Mark Blaxill in case you want to learn more about the conflicts of interest inherent in Gardasil’s development, questions about whether the FDA adequately investigated the vaccine’s safety before approving it for marketing, and safety issues that have arisen since Merck launched Gardasil in 2006:
Conflicts of interest in vaccine development and regulation
Celebrating the invention of a new market
Collecting the licensing fees
How stringent was FDA’s safety review for Gardasil?
A different view of the Gardasil trial data
The FDA downplayed deaths during the clinical trial
ACIP’s recommendation for universal vaccination of young females
The body count rises
Lack of diligence in post licensure safety surveillance
Revolving door culture
The early victims of Gardasil look for justice
Here are a few examples relevant to the development and promotion of the HPV vaccines from a 2018 article titled How NIH Uses U.S. Tax Dollars to Secure Profits for Vaccine Developers and Manufacturers: Today, taxpayer-supported research to develop new drugs and vaccines is voraciously patented by universities and drug companies for outsized Wall Street profits when the research rightfully belongs to taxpayers (Vaccine Reaction Staff, 2018):
Officials at the National Institutes of Health (NIH) dole out millions of dollars “to academic institutions and vaccine manufacturers to improve vaccine technology, find new, lucrative markets and boost vaccine marketability—functions that guarantee the profitability of corporations, but do not always ensure the well being of taxpayers, the public and patients.”
“Development of the human papillomavirus (HPV) Gardasil and Cervarix vaccines is a case in point. The initial research was funded by the NIH, National Cancer Institute, University of Rochester, Georgetown University and the University of Queensland, which licensed them to Merck and GlaxoSmithKline. In 2015, Merck made $1.9 billion on its Gardasil franchise. Soon, aggressive domestic and overseas marketing of the expensive HPV vaccines began, even as the vaccines themselves got poor marks for both safety and effectiveness.”
“As HPV vaccine safety and efficacy problems persisted, the NIH acknowledged the vaccine was widely shunned by mothers of both boys and girls, adolescents and many in poor and ethnic communities. But that did not stop the NIH from continuing its subsidy of the vaccine industry with tax dollars, this time helping with actual marketing.”
Take a look at the full article for more eye opening information.
WEB MD ON GARDASIL: 2018
In 2018, seven years after WebMD declared “HPV vaccine does not appear to cause any serious side effects”, they changed their tune and listed some reported adverse reactions to Gardasil ranked by likelihood and severity.
COMMON SIDE EFFECTS (less severe)
Redness Of Skin
Signs And Symptoms At Injection Site
INFREQUENT SIDE EFFECTS (less severe)
Collection Of Clotted Blood In An Organ, Space Or Tissue
Feel Like Throwing Up
Fibrous Thickening Of Skin
Upper Abdominal Pain
RARE SIDE EFFECTS (severe)
Blood Clot In A Deep Vein Of The Extremities
Inflamed Spinal Cord
Inflammation Of The Lining Of The Stomach And Intestines
Life Threatening Allergic Reaction
Low Platelet Count And Bleeding From Immune Response
Obstruction Of A Blood Vessel By A Blood Clot
Pelvic Inflammatory Disease
RARE SIDE EFFECTS (less severe)
Chronic Trouble Sleeping
Destruction Of Red Blood Cells By Body’s Own Antibodies
Not Feeling Well
Swollen Lymph Nodes
– WebMD, 2018
You’ll note that WebMD does not include DEATH as a possible serious adverse reaction to Gardasil – yet even in the VAERS compilation above from 13 November 2012, 126 deaths after HPV vaccination had already been reported in the US alone.
Enough serious side effects have been reported after Gardasil use that the vaccine may turn out to be riskier than the cervical cancer it claims to prevent – Dr Diane Harper, HPV Vaccine Researcher
GARDASIL’S SAFETY RELATIVE TO OTHER VACCINES: IN THE UNITED KINGDOM 1/1 2005 – 4/22/2015
Here’s a way to look at Gardasil’s safety relative to other vaccines:
ADVERSE DRUG REACTIONS REPORTED FOR VARIOUS VACCINES IN THE UK FOR THE TEN YEAR PERIOD 1/1/2005 – 4/22/2015
Not reassuring, is it?
THE VAST MAJORITY OF CERVICAL CANCER DEATHS OCCUR IN POORER COUNTRIES
Some strains of HPV may eventually lead to cervical cancer and cancers of adjacent organs – but this is a rare occurrence in the US and other developed countries. “Overall, the annual incidence rate of cervical cancer in the developed world is very low. Just 8 in 100,000 develop cervical cancer each year in the United States thanks to cervical cancer screening.” And only a small number of those 8 die from their cervical cancers. (McGovern, 2017)
So the risk of developing cervical cancer if you get regular Pap smears is very low (8 in 100,000) and the risk of dying if you do get cervical cancer is considerably lower than that. Wouldn’t it therefore be preferable to work on getting more women screened than to create a pricey vaccine and then put pressure on parents and their children to receive multiple doses of it?
Click on the image below to make it large enough to read:
85% of Cervical Cancer Mortality Occurs in Less Developed Countries
The map shows countries sized by number of cervical cancer deaths. Numbers represent age-standardized mortality rates.
As the map above makes clear, there’s a huge disparity between deaths from cervical cancer in developed countries compared to places like East Africa, Middle Africa and India. This is attributable to the wide availability of cervical cancer screenings in the developed countries and their relative lack in the less developed ones.
“Cervical cancer is almost 100 percent preventable. Screening and treatment can detect and eliminate pre-cancerous lesions before cancer develops, and vaccines have been developed that are effective against the strains of the human papillomavirus that cause most cervical cancer.
“But every year, more than 500,000 women are diagnosed with cervical cancer and over 266,000 women die from the disease. An overwhelming majority of these women (over 85 percent) live and die in low- and middle-income countries. Cervical cancer ranks as the leading cause of cancer and cancer deaths for women in sub-Saharan Africa. And Eastern Africa suffers from by far the highest mortality rate in the world at 27 cervical cancer deaths for every 100,000 women – nine times the rate in the United States.” (Winner, 2016)
So perhaps HPV vaccinations are worth their risks in these countries but not in the US and other countries with good access to cervical cancer screening and treatment.
NEVERTHELESS, MASS HPV VACCINATION TAKES PLACE HERE IN THE US
Merck started targeting girls with ads promoting Gardasil as a “cervical cancer vaccine”. Now they’ve moved on to include boys too.
“Since 2006, HPV vaccines have been recommended in a three-dose series given over six months. In 2016, CDC changed the recommendation to two doses for persons starting the series before their 15th birthday. The second dose of HPV vaccine should be given six to twelve months after the first dose.” (Immunization Action Coalition, 2019)
TWO OF MERCK’S ADS FOR GARDASIL
The American Cancer Society and the CDC, accompanied by Merck’s extensive advertising campaign for Gardasil, strongly push for mass HPV vaccination of girls and boys – and now women and men up to 45 years old – in the US.
“The American Cancer Society (ACS) has set an aggressive goal to achieve an 80 percent uptake rate among American children with two doses human papillomavirus (HPV) vaccine by 2026. To gain that coverage, 14 million more preteen children would need to complete the two-dose series, for a total of 57.62 million doses above and beyond the number of vaccinations given to date.” Merck is the sole producer of HPV vaccine in the US. Each pricey dose of Gardasil puts $168 to $204 into the company’s coffers. “The rationale ACS has given for setting the 80 percent HPV vaccine coverage goal is based on the number of reported cancers and cancer deaths associated with chronic HPV infection in the United States. “The Centers for Disease Control (CDC) estimates that about 42,700 (24,400 in women and 18,300 in men) are diagnosed with an HPV-related cancer annually. HPV is believed to be responsible for 63 to 91 percent of cervical, anal, vaginal, oropharyngeal, vulvar, and penile cancers. “According to the CDC, invasive cancers are not generally tested for the presence of HPV in most cancer registries, so data are estimated based on the finding of HPV DNA in special studies used (as) a reference for making estimates. (emphasis added) “Of note is the fact that, in 2005, a year before the first four-strain HPV vaccine, Gardasil, was licensed and recommended for all 12-13 year old girls, the American Cancer Society estimated that there were 10,370 cervical cancer cases with 3,710 deaths. Compared to the estimated 13,240 cervical cancer cases and 4,170 deaths in 2018, this represents an increase in cervical cancer cases in the U.S. after a decade of HPV vaccine use among adolescents (emphasis added). The CDC reported that by 2017, 71 percent of adolescent girls had received more than one dose of HPV vaccine and there was a 68 percent coverage rate among all adolescents.” (Raines & Fisher, 2018) If Gardasil is so effective at preventing cervical cancer, what accounts for this increase in cervical cancer? You may have noticed in the VAERS charts earlier in this post that cervical cancer is listed as one of the adverse side effects reported after HPV vaccination.
SOME STATES HAVE MADE GARDASIL VACCINATIONS MANDATORY FOR CHILDREN
Three US states have enacted legislation making HPV vaccinations mandatory for school entry into secondary schools. As of November 11 2018, these are:
RHODE ISLAND Males & females: August 2015, grade 7 (1 dose); August 2016, grade 8 (2 doses); August 2017, grade 9 (3 doses)
VIRGINIA Females: October 2008, grade 6, 3 doses (with dose 1 prior to grade 6)
DISTRICT OF COLUMBIA Females: January 2009, (number of doses not specified)
– Immunization Action Coalition, 11/11/2018
The legislatures and executive branches in many US states and territories have pushed for HPV vaccinations. “Since 2006, legislators in at least 42 states and territories have introduced legislation to: require the vaccine, fund the vaccine or educate the public or school children about the HPV Vaccine. At least 25 states and territories have enacted legislation – including Colorado, District of Columbia, Illinois, Indiana, Iowa, Louisiana, Maine, Maryland, Michigan, Minnesota, Missouri, Nevada, New Mexico, New York, North Carolina, North Dakota, Oregon, Puerto Rico, Rhode Island, South Dakota, Texas, Utah, Virginia, Washington and Wisconsin.” (National Conference of State Legislatures, 6/12/2018)
You can check the Gardasil “HPV Vaccine: State Actions and Introduced Legislation 2017-2018” in your state here.
“The Advisory Committee on Immunization Practices (ACIP) recommends administering the vaccine to girls and boys between 11 and 12 years of age, before they become sexually active. ACIP recommends an immunization schedule of 2 doses before the 15th birthday and 3 doses after the 15th birthday.
“Aside from recommendations by ACIP, school vaccination requirements are decided mostly by state legislatures. Some state legislatures have granted regulatory bodies such as the health department the power to require vaccines, but they still need the legislature to provide funding.
“The debate in states has centered, in part, around school vaccine requirements, which are determined by individual states. Some stakeholders who support access to the vaccine do not support a school mandate, citing concerns about the drug’s cost, safety, and parents’ rights to refuse. Still, others may have moral objections related to a vaccine mandate for a sexually transmitted disease. Financing is another concern. If states make the vaccine mandatory, they must also address funding issues, including Medicaid and CHIP coverage, youth who are uninsured, and whether to require coverage by insurance plans. This has caused some to push for further discussion and debate about whether or not to require the vaccine.
“The CDC announced that the HPV vaccine is available through the federal Vaccines for Children (VFC) program in all 50 states, Washington DC and the eight US territories. VFC provides vaccines for children ages nine to 18 who are covered by Medicaid, Alaskan-Native or Native American children, and some underinsured or uninsured children.” (National Conference of State Legislatures, 6/12/2018)
(See Rick Perry and HPV vaccine-maker have deep financial ties for information on the former Texas governor’s financial ties to Merck.)
COUNTRIES THAT DO NOT REQUIRE OR RECOMMEND HPV VACCINATION
Unlike the US, a variety of countries around the world do not recommend HPV vaccination and/or have filed lawsuits against its manufacturer. Two examples:
After receiving 100’s of complaints received from Japanese citizens about possible serious side effects after HPV vaccinations, Japan’s health ministry decided to formally withdraw its recommendation for the vaccinations on 14 June 2013. “In an attempt to avoid completely alienating the World Health Organization, which recommends the HPV vaccine used by many developed nations, the Ministry of Health, Labor and Welfare insisted that it is not suspending the use of the vaccine, but simply instructed local Japanese governments not to promote it until more study is conducted on its safety.” (Pope, 2014)
About 25% of all cervical cancer deaths world wide are in India and cervical cancer is India’s second leading cause of cancer deaths. Nevertheless, citing concerns about the efficacy, safety and cost effectiveness of HPV vaccinations, India’s health ministry recently decided against including HPV vaccines in the country’s national immunization program. (Narayanan, 1/17/2018) & (Jayachand & Raman, 8/28/2018)
AMERICAN COLLEGE OF PEDIATRICIANS ISSUED A WARNING ABOUT GARDASIL IN 2016
In January 2016, the American College of Pediatricians decided it needed to warn physicians and the American public about its safety concerns regarding the HPV vaccines Gardasil and Cervarix (GlaxoSmithKline withdrew its Cervarix vaccine from the US market on October 22, 2016): “The American College of Pediatricians (The College) is committed to the health and well-being of children, including prevention of disease by vaccines. It has recently come to the attention of the College that one of the recommended vaccines could possibly be associated with the very rare but serious condition of premature ovarian failure (POF), also known as premature menopause.”
The College urged that these legitimate concerns about HPV vaccinations be addressed:
“Long-term ovarian function was not assessed in either the original rat safety studies or in the human vaccine trials.”
“Most primary care physicians are probably unaware of a possible association between HPV4 and POF and may not consider reporting POF cases or prolonged amenorrhea (missing menstrual periods) to the Vaccine Adverse Event Reporting System (VAERS).”
“Potential mechanisms of action have been postulated based on autoimmune associations with the aluminum adjuvant used and previously documented ovarian toxicity in rats from another component, polysorbate 80.”
Since licensure of Gardasil® in 2006, there have been about 213 VAERS reports … involving amenorrhea, POF or premature menopause, 88% of which have been associated with Gardasil®. The two-strain HPV2, CervarixTM, was licensed late in 2009 and accounts for 4.7 % of VAERS amenorrhea reports since 2006, and 8.5% of those reports from February 2010 through May 2015. This compares to the pre-HPV vaccine period from 1990 to 2006 during which no cases of POF or premature menopause and 32 cases of amenorrhea were reported to VAERS.”
– American College of Pediatricians (2016)
MERCK TOLD FDA IN 2006 GARDASIL INCREASES CERVICAL CANCER RISK 44% FOR SOME WOMEN
And there’s also this from a 2018 article by health and nutrition writer Sarah Pope titled “Merck: Gardasil Increases Cervical Cancer 44% for Women Most at Risk”:
“In case you haven’t noticed, the pharmaceutical industry is highly effective at getting news articles and research that are unfavorable toward vaccination removed from large media websites. “One such story that was quickly removed from the large media website Examiner tackled the very touchy subject of greatly elevated cervical cancer risk in women vaccinated with Gardasil if they are already sexually active and exposed to HPV prior to injection.
“In cases of prior exposure, women are at a 44.6% increased risk for precancerous lesions or full blown cervical cancer.
“This shocking data that is rarely (if ever?) discussed in the doctor’s office … was presented to the FDA on May 18, 2006 during the Gardasil approval process. The presenter of this shocking research was none other than Merck, the manufacturer of Gardasil.
“This troubling data was discovered by Merck scientists during Gardasil safety trials. Even more disturbing, the FDA did not respond by requiring HPV screening prior to vaccination with Gardasil or even requiring a simple warning about it on the package insert.” (Pope, 2018)
INTERVIEWS WITH DR DIANE HARPER, HPV VACCINE RESEARCHER DURING MERCK’S & GSK’S CLINICAL TRIALS
Dr Diane Harper, HPV Vaccine Researcher
Diane Harper, MD, was a paid consultant for both Merck (manufacturer of Gardasil) and GlaxoSmithKline (manufacturer of Cervarix) during their clinical trials. She was responsible for assembling a research team to recruit participants, delivering health care during the study, collecting biological specimens at the correct time, and retaining subjects over the entire time frame of the study.
2009 CBS NEWS INTERVIEW WITH DR HARPER
Speaking with CBS’s Sharyl Attkisson in 2009 about Gardasil’s risks, benefits and aggressive marketing, Dr Harper said more complete risk-vs benefit information should be given to young girls and their parents so they can make an informed decision about receiving the vaccine.
She also pointed out that available data for Gardasil showed the vaccination lasts only five years – no data shows it remains effective beyond five years. “If we vaccinate 11 year olds and the protection doesn’t last… we’ve put them at harm from side effects, small but real, for no benefit,” says Dr. Harper.”
Harper questioned Merck’s outright claim that Gardasil prevents cervical cancer. “The number of women who die from cervical cancer in the US every year is small but real. It is small because of the success of the Pap screening program.”
– Attkisson, 2009
2010 HUFF POST INTERVIEW (updated 2017)
Marcia Yerman for The Huffington Post reported the following exchanges during an in depth interview with Dr Harper in 2010: Yerman: Could you clarify the content and context of the statements that you made at the 4th International Public Conference on Vaccination in October 2009, which have been so widely read and misquoted? Specifically the reported quote, “The rate of serious adverse effects is greater than the incidence rate of cervical cancer.” Harper: “The rate of serious adverse events reported is 3.4/100,000 doses distributed. The current incidence rate of cervical cancer in the United States is 7/100,000 women. This is what I said.” Yerman: Can you point out specific “misstatements” that Merck has promulgated about the Gardasil vaccine? Harper: “Less misstatements, than incomplete statements. For instance, the cumulative incidence of HPV infections for women in the U.S. through the age of 50 years old is 80%. That statement is true. That statement infers that nearly every one is infected with HPV at least one point in their life. “What is left out is that 95% of all HPV infections are cleared spontaneously by the body’s immune system. The remaining 5% progress to cancer precursors. Cancer precursors, specifically CIN 3, progresses to invasive cancer in the following proportions: 20% of women with CIN 3 progress to invasive cervical cancer in five years; 40% progress to cervical cancer in thirty years. There is ample time to detect and treat the early precancers and early stage cancers for 100% cure. “Other examples include inferences that Gardasil will last a lifetime, with no mention of boosters or limited protection possible. Regarding wart protection promotion, there is no mention that the data showed protection against genital warts in men for only a 2.4-year period of time. “Gardasil is not really a cervical cancer vaccine. The vaccine prevents HPV infection. not the development of cervical cancer.” – Yerman, 2010, updated 2017 The entire Interview with Dr. Diane M. Harper, HPV Expert, is worth reading for you to draw your own conclusions. 2011 NPR INTERVIEW In a 2011 National Public Radio interview with Richard Knox, Dr Harper weighed in with more:
Harper stated she believes the vaccine was being oversold. Her mind was changed when the vaccine makers began lobbying state legislatures to MANDATE vaccinations for school children.
“Ninety-five percent of women who are infected with HPV never, ever get cervical cancer,” she says. “It seemed very odd to be mandating something for which 95 percent of infections never amount to anything.”
Rather than relying on a vaccine, she pointed out that “Pap smear screening is far and away the biggest thing a woman can do to protect herself, to prevent cervical cancer.”
Harper also had an additional objection to mandating HPV vaccination for 11 year olds: Studies show that vaccines protect against HPV for only four or five years so children vaccinated at 11 would likely not be protected during their most sexually active teen years.
– Knox, 2011
INTERVIEW WITH ANOTHER FORMER MERCK RESEARCHER
Dr Bernard Dalbergue, former pharmaceutical industry physician, speaks out about Gardasil
Another researcher, Dr Bernard Dalbergue, a former pharmaceutical industry physician employed by Gardasil’s manufacturer Merck, was interviewed in the April 2014 issue of the French magazine Principes de Santé (Health Principles). He predicted that Gardasil would become the greatest medical scandal of all time. Salient points from the interview:
Merck knew the Gardasil vaccine would prove to be worthless when they released the vaccine on the US market. It is ineffective and very pricey.
All vaccines can cause cases of Guillain-Barré syndrome, paralysis of the lower limbs, vaccine-induced MS, and vaccine-induced encephalitis.
“I predict that Gardasil will become the greatest medical scandal of all times because at some point in time, the evidence will add up to prove that this vaccine, technical and scientific feat that it may be, has absolutely no effect on cervical cancer and that all the very many adverse effects which destroy lives and even kill, serve no other purpose than to generate profit for the manufacturers.”
There is far too much financial interest for these medicines to be withdrawn.
– Health Impact News, 9/30/2018
You can read more of Dr Dalbergue’s interview about Gardasil in Merck’s Former Doctor Predicts that Gardasil will Become the Greatest Medical Scandal of All Time
THE PERCEIVED NEED FOR A HPV VACCINE IS FAULTY
The following quote is an excerpt from an open letter to the French Parliament and the citizens of France urging against making vaccination with the HPV vaccine mandatory. It was written by Gérard Delépine, MD, a French orthopedic surgeon/oncologist/statistician and published on 7/23/2018:
“In countries whose populations have access to smear screening, it has led to a considerable reduction in the incidence of cervical cancer (from 40 to 60%). In contrast, the introduction of vaccination has not reduced the incidence or mortality of cervical cancer. Contrary to what is promised by laboratory-related physicians and by many global health authorities, vaccination campaigns have even been followed by an increase in the incidence of cancer.
“Immunization advocates claim that a high vaccination coverage rate reduces the risk of invasive cancer of the cervix. Yet the comparison of incidence and mortality rates with vaccine coverage rates shows the opposite.” (DES Daughter Network, 2018)
“Cervical cancer incidence in the US has not fallen since June 2006, when Gardasil was introduced here. “Cervical cancer tends to occur in midlife and is most frequently diagnosed in women between the ages of 35 and 44. It rarely develops in women younger than 20.
“Cervical cancer was once one of the most common causes of cancer death for American women. The cervical cancer death rate dropped significantly with the increased use of the Pap test. (This screening procedure can find changes in the cervix before cancer develops. It can also find cervical cancer early − when it’s small and easier to cure.) But it has not changed much over the last 15 years.” (American Cancer Society, 2018)
THE FDA’S MISTAKE IN APPROVING GARDASIL
Numerous respected experts have spoken out against Gardasil since its release. “An eight-month investigation revealed shocking flaws in Merck’s clinical trial design, which effectively prevented assessment of safety.” (Mercola, 9/29/2018)
A few weeks after Gardasil first appeared on the market in June 8 2006, there were warnings that Merck’s clinical trials, which the FDA had used to fast track Gardasil to licensure, contained serious methodological flaws. For example, on June 27 2006, the nonprofit National Vaccine Information Center (NVIC) issued a press release titled Merck’s Gardasil Vaccine Not Proven Safe for Little Girls. (Mercola, 9/29/2018)
During the vaccine’s clinical trial, serious adverse events that occurred outside of a two-week period post-vaccination were recorded as ‘medical history’ rather than as ‘adverse effects’. (Mercola, 9/29/2018)
Numerous experts have raised “concerns that the pre- and post-licensure safety studies of the fast-tracked Gardasil vaccine were both overstated and misleading, with reported results selectively chosen to increase the appearance of positive results. The Food and Drug Administration (FDA) allowed Merck to use an aluminum containing placebo as a control in safety studies, even though Gardasil contains an aluminum adjuvant, effectively increasing the appearance of safety. (Raine & Fisher, 2018)
Furthermore, the cervical cancer rate in the US is low – only 12 per 100,000. by Merck’s own admission, Gardasil may CAUSE 2,300 serious adverse events per 100,000. (Mercola, 12/8/2018)
Merck’s trial data shows Gardasil may actually INCREASE a woman’s risk of precancerous lesions or full blown cervical cancer by 44.6% if she had been exposed to HPV strains 16 or 18 prior to vaccination. (Pope, 2018) & (Mercola, 12/8/2018)
Nearly 90% of Gardasil recipients and 85% of aluminum placebo recipients in the trials, who were followed up on, reported one or more adverse events within 15 days of vaccination. (Mercola, 9/28/2018)
Merck scientists discovered this alarming data during its safety trials on Gardasil and presented it to the FDA in 2006 during the Gardasil approval process. The FDA nevertheless fast tracked approval of the vaccine rather than requiring HPV screening prior to vaccination – or even requiring a warning on the package insert. The whole story was then quashed and not presented to doctors or the public. (Pope, 2018)
According to Merck’s own research, if you have been exposed to HPV strains 16 or 18 prior and then get vaccinated, you may increase your risk of precancerous lesions by 44.6 percent (Mercola, 9/29/2018)
HPV infection is spread through sexual contact and research has demonstrated that using condoms can reduce risk of HPV infection by 70 percent, which is far more effective than the HPV vaccine. (Mercola, 9/29/2018)
Although Gardasil vaccine recommendations were targeting 12- to 13-year-old girls, Merck did not reveal how many girls under age 16 were in the prelicensure trials (eventually Merck admitted that number was only 1,200 girls, followed for less than two years). .(Mercola, 9/29/2018)
NVIC cofounder and president Barbara Loe Fisher said in 2006, “Nobody at Merck, the CDC or FDA know if the injection of Gardasil into all preteen girls — especially simultaneously with hepatitis B vaccine — will make some of them more likely to develop arthritis or other inflammatory autoimmune and brain disorders as teenagers and adults.” (National Vaccine Information Center, 6/272006)
“With cervical cancer causing about 1 percent of all cancer deaths in American women due to routine pap screening, it was inappropriate for the FDA to fast track Gardasil. It is way too early to direct all young girls to get three doses of a vaccine that has not been proven safe or effective in their age group.” (National Vaccine Information Center, 6/272006)
Then there are also the huge number of young children who were sexually abused prior to receiving HPV vaccination. If 80% of sexually active people in the US have contracted HPV during their lifetimes, it’s highly likely child victims have also been exposed to HPV prior to receiving HPV vaccination. Studies by David Finkelhor, Director of the Crimes Against Children Research Center, found that 1 in 5 girls and 1 in 20 boys are victims of child sexual abuse and that children are most vulnerable to sexual abuse between ages 7 and 13. (National Center for Victims of Crime, 2012)
So the assertion that it’s safe to give HPV vaccinations to 9-11 year old children on the assumption that they don’t already have HPV is seriously flawed and exposes these already traumatized children to great risk from the vaccine.
More than 80 million girls, young women and boys have received the HPV vaccine, and many have paid an extraordinarily high price, developing nervous system disorders, chronic fatigue and autoimmune diseases. (Mercola, 9/28/2018)
Darkness to Light COST OF GARDASIL SHOTS
“A patient paying out of pocket for Gardasil may pay over $190 per dose as of 2017. Three doses are required over a six-month period, making the total cost for the HPV vaccine $570 or more. On top of that, some doctors charge office visit fees when the vaccine is given.” (Fayed, 2017)
A 2/2/2019 headline on Health Impact News:
“AS MERCK’S GARDASIL U.S. SALES DECLINE PROFITS CONTINUE TO INCREASE AS VACCINE IS LAUNCHED IN CHINA”
“The pharmaceutical marketing trade publication, Fierce Pharma, announced this month (May 2018) that Merck has beat Wall Street expectations for their Gardasil vaccine sales during the first quarter of 2018, achieving 24% growth with $660 million for the HPV vaccine.
“The report notes that sales in the U.S. are declining, attributing the decline in sales to the CDC decision to reduce their recommendation of the Gardasil vaccine to be only two doses, instead of three.
“Nothing is mentioned about declining public opinion regarding Gardasil, nor the numerous lawsuits against the company outside the U.S.
“The increase in sales for Gardasil is attributed to their entrance into the China market. “Gardasil remains Merck’s top vaccine by sales.
“As we just reported in an article published at The Vaccine Reaction, U.S. taxpayers subsidized the development of Gardasil, and continue to fund their marketing of the vaccine (emphasis added).“
– Health Impact News, 2/2/2019
DR SUZANNE HUMPHRIES ON GARDASIL : INTERVIEW
Dr Suzanne Humphries “is a conventionally educated medical doctor who was a participant in conventional hospital systems from 1989 until 2011 as an internist and nephrologist. She left her conventional hospital position in good standing, of her own volition in 2011. Since then, she’s been furthering her research into the medical literature on vaccines, immunity, history, and functional medicine.” She is a well respected author and world wide lecturer on infant immunity, vitamin C, aluminum, and vaccination. (Humphries, undated)
In this illuminating and riveting interview with Polly Tommey, Dr Humphries walks us through the enormous Gardasil 9 package insert, explaining the serious flaws in the vaccine’s safety and efficacy research. The 49 minute video was released by VAXXED TV on 12/5/2016. Tommey is a leading autism advocate and activist.
MANUFACTURED CRISIS – HPV, HYPE & HORROR: ANOTHER DOCUMENTARY
This documentary film about HPV vaccines and what’s wrong with them is excellent and worth the 59 minutes it’ll take to watch it. The film features Gardasil victims, their parents, and researchers who point out what’s wrong with the vaccine and why mass vaccination is unwarranted. The film was released by the Alliance for Natural Health USA on 3/15/2018.
Both videos are especially important to watch if you’re someone who believes our country’s FDA is adequately protecting our health and regulating pharmaceutical companies.
Manufactured Crisis — HPV, Hype and Horror
REPORT ANY ADVERSE REACTIONS FROM VACCINES TO VAERS
If you are experiencing a medical emergency, seek immediate assistance from a healthcare provider or call 9-1-1. CDC and FDA do not provide individual medical treatment, advice, or diagnosis. If you need individual medical or health care advice, consult a qualified healthcare provider.
You can use this online form to report an adverse event to VAERS or use their new downloadable PDF. The form is available in English and Spanish.
A WARNING FROM DR MARCIA ANGELL, FORMER EDITOR-IN-CHIEF OF THE NEW ENGLAND JOURNAL OF MEDICINE
“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”
– Marica Angell, former Editor-in-Chief of The New England Journal of Medicine, one of the most prestigious peer-reviewed medical journals in the world
IF YOU’RE UP FOR READING MORE …
FROM THE BOOK HPV VACCINE ON TRIAL: SEEKING JUSTICE FOR A GENERATION BETRAYED:
Mary Holland, Kim Mack Rosenberg and Eileen Iorio’s 2018 book, The HPV Vaccine on Trial: Seeking Justice for a Generation Betrayed, tells the stories of young people who became disabled or died as a result of getting Gardasil injections:
Alexis Wolf, 13 years old.
In 2007, when Alexis was in 7th grade, she began the Gardasil series. After the second dose, her health deteriorated. After the third, she could no longer focus, sleep, eat, or behave normally. She started to have many seizures every day. She was put in psychiatric hospitals. A year and a half after her symptoms began, Alexis tested at a 4thgrade level. Today, at 25, Alexis still suffers from severe neurological injury, including daily seizures.