Updated – Japan and HPV vaccine – debunking myths

Editor’s note: This article was originally published in June 2013. It has been revised and updated to include recent developments with the HPV cancer preventing vaccine and Japan’s Health Ministry.

The comments have been closed for this article. Please comment at the revised article.

I enjoy refuting myths about cancer prevention and cures, for only one reason–because there are real cancer cures and preventions that people overlook. Frankly speaking, there really is only a handful of ways to prevent cancer backed by real scientific evidence–and one of the most important ones is receiving the HPV vaccine.

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 related to which cancers. Because HPV is sexually transmitted, most of the infections occur near the mouth, throat, anus and genital areas–and most HPV related cancers begin there.

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.

Japan and HPV vaccine

 

Over the past 2-3 years, myths have appeared regularly regarding the Japanese Health Ministry’s actions regarding HPV vaccine, specifically Gardasil. Of course, the antivaccine groups have jumped all over it, and still get most of the about Japan and HPV vaccine all wrong.

According to a English newspaper in Japan,

The health ministry decided June 14 to withdraw its recommendation for a vaccination to protect girls against cervical cancer after hundreds complained about possible side effects, including long-term pain and numbness.

The Ministry of Health, Labor and Welfare is not suspending the use of the vaccination, but it has instructed local governments not to promote the use of the medicine while studies are conducted on the matter.

So far, an estimated 8.9 million people have received the vaccination, out of which, 176 cases of possible side effects, including body pain, have been reported. (Note, the Health Ministry was investigating 43 adverse events out of around 3.3 million HPV vaccinations.)

The ministry’s task force have focused closely on those cases. However, a cause-and-effect relationship between the vaccination and the pain and numbness could not be established, so the task force members called for further studies by the ministry.

The ministry’s investigation is expected to take several months. It will then decide whether to reinstate or continue to withhold its recommendation for the vaccination.

The health ministry has decided to withhold recommendation of the HPV vaccination because they noticed 176 adverse events, for which they reject a causal relationship to the vaccine. In other words, 0.0019% of cases, or about 1.9 events in 100,000 vaccinations, a number so small that it’s pretty close to impossible to affix any statistical significance to it, and probably is significantly below the rate observed in the general population in controlled epidemiological studies.

In fact, those numbers could represent random background “noise” – that is, there are some number of events, similar to a suspected adverse events, that could be expected in any random sampling of vaccinated or unvaccinated individuals.  There can be no finding of correlation (let alone plausibility or causality) based on this type of observation of “adverse events” after receiving the vaccine.

Epidemiological studies, that try to rule out confounding factors, have shown that the incidence of chronic fatigue syndrome (similar to so called adverse events in Japan) are substantially higher than the 1.9 out of 100,000 – it ranges from 250-725 out of 100,000. There is absolutely no way to say “these events result from the vaccine” when the absolute risk of CFS is so high with or without vaccines.

The Health Ministry failed to provide the public with data concerning the level of these side effects in the general population. Nor how soon after vaccination. Nor anything potentially useful in a scientific analysis. And this provides its citizens with a dangerous false dichotomy – either vaccinate and risk some neurological disorder (that, on evidence alone, is nearly a zero risk), or don’t.

Japan is a fairly scientific and rational country – yet they came to this asinine conclusion?

Facts about Japan and HPV vaccine

 

  1. The Japanese Health Ministry withdrew its recommendation for Gardasil based on the flimsiest of evidence. The numbers were so small, and apparently so random, no reasonable scientist would find that there is evidence that these were actually Gardasil-related events.
  2. Just to be clear, the vaccine hasn’t been pulled from the market nor has it been outlawed; teenagers can still get the vaccine. And this was a very unusual move, since only 3 years ago, Japan’s parliament added the HPV vaccine to the mandatory schedule. Hopefully, this committee will look at the numbers from a statistical and scientific point of view and fix this stupidity.
  3. About 2700 women in Japan die every year from HPV related cancers. So, because of complaints about unrelated events, Japan withdrew its recommendation because of 43 cases of “body pain” while possibly allowing 2700 women to die in the future from an HPV related cancer. Simple math says that the benefit to cost ratio (especially when the so called cost of “body pain” is somewhat bogus) is way on the side of the HPV vaccine. I don’t get what the Health Ministry was thinking.
  4. A recent study in Japan diagnosed the patients with something similar to postural orthostatic tachycardia syndrome (POTS, a condition in which a change from the supine position to an upright position causes an abnormally large increase in heart rate, called tachycardia). But like another POTS and Gardasil study that was poorly controlled and provided no evidence, observational studies, without any controls or without any context to what the rate of POTS may be among young women (it’s high), there’s no value here.
  5. The incidence of adverse events among a cumulative total of 8,898,000 females, who had been vaccinated in Japan within the period between the initiation of sales of the vaccine and the end of March 2014, was examined, and it was reported that the total number of adverse events, such as chronic pain and motor impairment, was 176; this is equivalent to 2.0 per 100,000 vaccinations. Although subsequent studies did not provide scientific or epidemiologic evidence to confirm the causal relationship between these symptoms and HPV vaccine ingredients, the suspension of recommendations for vaccination has continued to the present, consequently decreasing the vaccination rate to nearly 0%.
 
 

Japan’s Health Ministry is wrong

 

The World Health Organization still recommends the HPV vaccine.  A large case-controlled epidemiological study of 200,000 women, evidence that stands up to scientific scrutiny, showed that the HPV vaccine is safe. A similar quality study of over 1 million women concluded that it was safe. And the vaccine works.

In November 2015, the European Medicines Agency determined that HPV vaccines are unrelated to the development of either POTS or CRPS (complex regional pain syndrome, which may related to what was observed in Japan). They concluded that there is no causal link, and that observations of POTS and CRPS are not different from the rates that would be observed irrespective of vaccination status in these demographic groups.

Moreover, the agency also dismissed the hypothesis that the HPV cancer preventing vaccine was related, either temporally or causally, to chronic fatigue syndrome (CFS).

In other words, valid evidence, published in important biomedical journals and supported by a team of scientific experts, completely invalidated any link between HPV vaccines and any of these things claimed as adverse effects of the vaccine.

Sadly, Japan’s Health Ministry is having a difficult time walking back their initial reasoning, and to resume recommending HPV vaccination of its teens.  Part of the problem is that they are faced with inflammatory videos (like this one) that look scary but show absolutely no link between the vaccine and this condition. Maybe the Health Ministry ought to see scary videos of women who are being told that they have cervical cancer.

The Health Ministry has been hit with a better organized antivaccination movement in a country that greatly fears harm to their children from environmental hazards, even if it is not founded on anything close to real science.

In fact, the situation in Japan is getting worse. Now the Health Ministry is telling physicians to record any POTS, CRPS or other CFS-like symptoms after vaccination. Again, this will not show any type of causality without controls, especially for confounding data, nor comparison to the general population. Further, looking for such issues is the surest way to confirmation or observation bias.

Unsurprisingly, the Japan Society of Obstetrics and Gynecology is pleading with the Health Ministry to commence recommending the HPV cancer preventing vaccine once again:

As HPV vaccine use in combination with cervical cancer screening including Pap test is indispensable for the prevention of cervical cancer, recommendations for HPV vaccination must be resumed. While continuing to help Japanese people develop evidence-based knowledge and obtain the latest information regarding the HPV vaccine and appropriately managing symptoms after vaccination, the JSOG strongly demands the early resumption of recommendations for HPV vaccination, with the aim of eradicating cervical cancer.

The safety and effectiveness of HPV vaccines is beyond doubt. And HPV vaccine prevents cancer–and that makes it one of the great medical advances of our time.

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!
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  • guest
    • shay simmons

      He must be doing something right.

      • Oh, he’s one of those who believe that lies are actually truths. LOL.

  • shay simmons

    Japan is a fairly scientific and rational country – yet they came to this asinine conclusion?

    They’ve done it before with other vaccines; if nothing else, Japan’s knee-jerk reaction to vaccine-related incidents (remember what happened when they stopped the MMR?) serves as a warning for other countries.

  • Bunt Bunt
  • Todd W.

    I’ve noticed over the years that MHLW applies the precautionary principle to an absurd degree. Not just in this case, but with other vaccines as well, they have either suspended recommendations or halted use altogether of some vaccines based on scant evidence of any causal connection to alleged adverse reactions. Then, when they study the cases, it pretty much invariably comes out that there is no connection.

    Now, if there is reasonable cause to suspect some connection between a vaccine and a large number of reported cases, especially those clustered together temporally or geographically, then sure, study it to see if there’s some kind of pattern there. But make sure there is enough evidence to warrant suspension.

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  • Jill Patton

    Japan obviously really cares about its population enough to listen to public concern, consider cases of suspected injury and withdraw a product while they investigate. English speaking countries like USA, Australia and UK, don’t listen, don’t care, don’t investigate, threaten any medical/scientist who dares to question the safety of any vaccine and belittle parents who have to deal with the emotional and financial cost of vaccine injury/death (all to protect the “herd”).

    • Your reading skills are amazing. Just amazing.

      The cases are NOT related to Gardasil. I make that claim based on evidence, not lies, misinformation, anecdotes, ignorance and emotional stories that show no causal association whatsoever. Evidence, that includes millions of patients across the world. Evidence substantiated by the CDC, EMA, WHO and many others.

      Bring evidence, published in a real high impact journal. Then you have standing. Otherwise, you’re just an ignorant science denying fool.

      • Hoter

        But there are no big impact journals anymore, they are all melting down due to funding bias and publication bias. The editors of them all agree.

        • shay simmons

          Every editor of every big impact scientific journal? Schure.

          • Hoter

            BMJ, Lancet and NEJM. that’s three of the biggest, who else can you name?

            • shay simmons

              According to SJR, in descending order the top ten impact journals in science and medicine are:

              CA – A Cancer Journal for Clinicians

              Annual Review of Immunology

              Nature Reviews – Genetics

              Nature Reviews – Immunology

              Nature Reviews – Cancer

              Physiological Reviews

              Immunity

              Genome Research

              Cancer Cell

              NEJM

              I have read the articles by editors of the three you mentioned urging improvements in the peer review process. Can you provide a link to the articles where they state that their journals are melting down due to funding and publication bias?

            • You’re full of donkey feces. Bring evidence, or, as I like to say, STFU.

            • Hoter

              Ahh, the ass of medical research eeehawwws into action. Poop