HPV vaccine causes primary ovarian insufficiency – myth

The HPV vaccine causes primary ovarian insufficiency (POI) – a belief unsupported by evidence. And the claim appears to be based on anti-vaccine ideology instead of real science.

Yes, I know, this story seems to repeat itself, but stay tuned, this is a good one. So let’s examine this myth from a scientific aspect and show how the HPV vaccine is actually unrelated to POI.

HPV and the cancer preventing vaccine

 

I know I repeat this section a lot, but because people may read one of the HPV vaccine articles on this blog rather than all of them, I want to make sure readers know about HPV and the cancer preventing HPV vaccine.

So what is HPV? Genital human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the USA. There are more than 40 HPV sub-types that can infect the genital areas of males and females. Additionally, some HPV types can also infect the mouth and throat. HPV is generally transmitted from personal contact during vaginal, anal or oral sex.

HPV is linked to cancers in men and women, and because there are so many subtypes, research has established which HPV types are linked to certain cancers, including cervicalvulvarvaginal, and anal cancers.

Genital warts are caused by HPV. Although genital warts are generally benign (though unsightly), there is a small chance they develop into cancers.

Various precancerous lesions of the cervix, vulva, vagina, and anus can be caused by several HPV subtypes.

HPV is believed to cause nearly 5% of all new cancers across the world, making it almost as dangerous with regards to cancer as tobacco. According to the CDC, roughly 79 million Americans are infected with HPV–approximately 14 million Americans contract HPV every year. Most individuals don’t even know they have the infection until the onset of cancer. About 27,000 HPV-related cancers are diagnosed in the USA every year.

So, if you read nothing I wrote above, you should walk away understanding that HPV causes cancer. And some very horrible cancers.

What is the HPV vaccine? The original HPV quadrivalent vaccine, known as Gardasil (or Silgard in Europe) or the bivalent Cervarix version, can prevent infection from the human papillomavirus, substantially reducing the risk of HPV-related cancers.

The new version of Gardasil, recently cleared by the US Food and Drug Administration, protects teens and young adults from 9 subtypes of HPV, helping prevent more cancers.

Currently in the United States, the Advisory Committee on Immunization Practices (ACIP) recommends that preteen girls and boys aged 11 or 12 are vaccinated against HPV. The immunization is also recommended for teenage girls and young women up to the age of 26 who did not receive it when they were younger, and teenage boys and young men up to the age of 21.

A while ago, I posted an article about how to actually prevent cancers. There are no magical panaceas that prevent any of the 250 or so cancers. There’s no magical supplement or pill. There are just a few ways to prevent cancers–stop smoking, stay out of the sun, lose weight, avoid radiation, and get the HPV vaccine.

Gardasil prevents at least 6 types of cancer, and that’s better than all the “natural” supplements that you could consume.

 
 

 

What is primary ovarian insufficiency?

 

Primary ovarian insufficiency, formerly known as premature ovarian failure, is defined as the cessation of normal ovarian function before age 40 years. It is the scientifically accurate term for the condition that was previously referred to as premature menopause or premature ovarian failure.

Some studies suggest rates of 22 cases of POI per 100 000 person years in girls 15–19 years of age in the era prior to HPV vaccine introduction. Additionally, researchers have stated that POI occurs in about 1% of all women under the age of 40.

In other words, the background, non-HPV vaccine rate, of POI has always been relatively high.

HPV vaccine causes primary ovarian insufficiency

 

A recent article by Gruber and Shoenfeld proposed a possible link between Gardasil and POI, based on some very weak (almost useless) evidence. Gruber and Shoenfeld seem to ignore widespread and robust evidence that the HPV vaccine isn’t related to POI. For example, a case control study of nearly 1 million teenage girls showed no incidence of POI within 180 days of HPV vaccine.

A broad, unbiased review by Hawkes et al. of the safety of the HPV vaccines have found – almost nothing.

In the nearly 9 years since the introduction of the HPV vaccine, which included over 170 million doses of Gardasil, only six cases of POI have been reported after an HPV vaccination. That’s an incidence rate of around 0.003 per 100,000 far below the non-HPV vaccine risk of around 22 per 100,000. In other words, and I know this is not proper statistics, getting the HPV vaccine theoretically reduces the risk of POI. Again, my statistical example would cause my statistics professor in grad school have a stroke.

So, let’s review these six cases, just to be thorough:

The article by Gruber and Shoenfeld (who also was one of the coauthors of the third case study listed above) reviews the case studies as part of their proposed evidence that Gardasil and POI are related. However, in a curious editorial decision, failed to mention the temporal relationship between the HPV vaccination and the appearance of symptoms.

In fact, five of the six cases only appeared after the full course of 3 vaccinations, and none of them were less than a few months after the last vaccination. It stretches the credibility of the relationship of these cases with the HPV vaccine if the timeline is so long, especially since there is limited or no biological plausibility that HPV vaccine is related to POI.

Shoenfeld has attempted to provide a biologically plausible mechanism for many rare conditions post-HPV vaccination by claiming the existence of “autoimmune syndrome induced by adjuvants” (ASIA). However, a review by Hawkes and others of the research disputes the existence of ASIA, and the National Vaccine Injury Compensation Program has rejected ASIA as a vaccine injury.

Even in a recent paper, Shoenfeld admits that “every attempt for an epidemiological study has so far failed to deliver a connection.” Sometimes, the absence of evidence is evidence of absence.

Debunking HPV vaccine causes POI

 

A December 2015 article by Hawkes and Buttery examined the link between the cancer preventing HPV vaccine and POI – they found several troubling issues:

  1. There is no biological plausibility. So to establish a potential correlation, large epidemiological studies are required. Sadly, many people will accept implausible relationships unless evidence disproves it, even if there’s no evidence of a relationship based on several large epidemiological studies.
  2. As of today, the evidence of the relationship between HPV vaccines and POI are based on a handful of case studies. In general, case studies cannot provide evidence of a causal link, but casual readers of scientific studies overstate their value. This causes the creation of a hypothesis, despite lack of even observational evidence for that hypothesis, that scientists have to debunk. See #1 again.
  3. The worst part of these studies is a high degree of conflicts of interest, a typical accusation of the antivaccination community against nearly every scientific article published about vaccines.Yehuda Shoenfeld is acting as an expert witness for two of the three women who were featured in the case studies. In other words, Shoenfeld, whether deliberately or not, published articles that support her claims about the vaccine and POI – worse yet, she did not declare that conflict in those papers. This could lead to retraction of those articles.The paper by Colafrancesco et al. was also published to be used as a part of the litigation regarding the HPV vaccine and POI.Surprisingly, Shoenfeld and Tomljenovic did not dispute these claims. And as I’ve mentioned previously, Tomljenovic’s ties to antivaccination groups is impressive. For example, he has received substantial funding (at least US$950,000) from the Dwoskin Family Trust, a well-known antivaccination group.

    As Hawkes and Buttery state regarding Tomljenovic’s COI,

    It could be argued that the COI statement ‘The authors thank the Dwoskin Family Foundation for support’ is inadequate to describe this level of funding. Additionally, in three other studies written by Tomljenovic over the same time period, she states that her work was funded by the Katlyn Fox Foundation. This is another antivaccine organization and it could be reasonably expected that this COI should have been stated.

When real scientists publish about vaccines, they are absolutely transparent about COIs, if there are any. Apparently, those rules are not applicable to the antivaccination “researchers.”

The conclusions

David Hawkes and Jim P Buttery have presented a powerful deconstruction of the “evidence,” more like lack thereof, that claims that the HPV vaccine causes primary ovarian insufficiency.

There is no biological plausibility.

There are no epidemiological studies that show correlation between the vaccine and POI.

All of the claims are based on six case studies, one of the least reliable forms of scientific evidence, whose authors have serious conflicts of interest, as they have a personal interest in the legal cases for these studies, or receive huge amounts of funding from antivaccination groups.

As Hawkes and Buttery conclude in their article,

While postlicensure safety surveillance is critical for all vaccines, including HPV vaccines, young women deserve better than being scared by the overinterpretation of a handful of distressing cases presented without thought to potential bias.

Gardasil is safe, it prevents HPV, and it prevents cancer. And the myth that HPV vaccine causes primary ovarian insufficiency – debunked.

Key citations:

 

 

The Original Skeptical Raptor
Chief Executive Officer at SkepticalRaptor
Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!