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  • Joan Rothchild Hardin

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)


Source: Fredenburg 2014 HPV Webinar

NOTE ON THE TWO VERSIONS OF THE GARDASIL VACCINE:

GARDASIL (quadrivalent)


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 [45] 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.

Routine Vaccination

  • 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.


Source: The Truth About Cancer

ADVERSE REACTIONS TO GARDASIL


Source: By Jefferey Jaxen

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


Source: holyhormones.com

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


Source: learntherisk.org

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 t