Japan bans Gardasil – debunking myths about the HPV vaccine

One of the most popular zombie memes and tropes of the anti-vaccination movement is that Japan bans Gardasil – oh noes! Of course, like a lot of the junk information passed along by the anti-vaccine crowd, it’s completely false, unless you’re willing to take anything they say on faith.

There are a couple of consistent trends in the anti-vaccine movement. They claim that vaccines cause autism (disproved with the highest quality of evidence); and they maintain that the HPV vaccines cause all kinds of harm to teens and young adults. And there are literally mountains of data derived from numerous huge epidemiological studies that the Gardasil cancer preventing vaccine is one of the safest vaccines on the market (and that’s a high bar to exceed, given the high safety profiles of all vaccines).

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.

So if you really want to prevent cancer, one of the best ways available to you is getting the HPV vaccine. The idea is so simple, yet is clouded by the myths about HPV vaccines – one of the most popular, of course, is that Japan bans Gardasil. Let’s examine this fable with a critical and skeptical eye.

The tl;dr version – Japan did no such thing.

Japan bans Gardasil – the facts

 

Over the past few years, the anti-vaccine activists have pushed a few myths regarding the Japanese Health Ministry’s actions regarding HPV vaccine, specifically Gardasil. But they get most of the story 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. And the health ministry agrees that there probably isn’t a causal relationship between the vaccine and the events.

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 adverse events 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.

There probably are a number of broken arms observed after a child receives the HPV vaccine. This happens because teens break their arms from playing sports, falling in a bathtub, or just being a kid. That does not mean there is causality, or even correlation. Unless you want to invent some implausible situation where the HPV vaccine weakens bones. Oh no. I might have given some anti-vaccine “researcher” an idea.

Actually, epidemiological studies, that try to rule out confounding factors, have shown that the incidence of chronic fatigue syndrome (similar to the 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.

Moreover, 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. In case there’s some misinterpretation of the health ministry’s actions, it was not a ban – they just withdrew recommendations. Intelligent and rational Japanese parents (I’m assuming it’s the majority) can still legally get the vaccine for their children.
  2. Since I don’t want to leave any stone unturned, this decisions does not meant that the vaccine has been pulled from the market. Again, teenagers can still get the vaccine.
  3. This move by the health ministry was a very unusual, since in 2010, Japan’s parliament added the HPV vaccine to the mandatory vaccination schedule. Hopefully, this committee of the health ministry will look at the numbers from a statistical and scientific point of view and fix this stupidity.
  4. 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 hard to define in severity) is way on the side of the HPV vaccine. I don’t get what the Health Ministry was thinking.
  5. 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.
  6. 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.

Class action lawsuit

 

Surprisingly (or maybe unsurprisingly), Japanese attorneys sense an economic windfall, and they filed a class-action lawsuit against the two manufacturers of the vaccines — Merck & Co (manufacturer of Gardasil) and GlaxoSmithKline (manufacturer of the bivalent HPV vaccine, Cervarix). The lawsuit includes 12 plaintiffs, aged 10-20 years; however, the attorneys claim that they’re looking for more.

Now the anti-Gardasil subdivision of the anti-vaccination league has jumped all over this lawsuit as “proof” that the vaccine is dangerous. But let’s look at this (or really, any) anti-vaccine lawsuit with a typical skeptical eye:

  1. Anyone can claim anything and just filing a lawsuit doesn’t show anything. There are lawsuits all over the world that try to make claims about all kinds of things – most of them are unsuccessful.
  2. The plaintiff’s attorneys may (or may not) have evidence supporting their claims. That’s their job. But they look for evidence that supports their a priori conclusions. They appeal to emotions. Generally, the purpose of courts is to weigh the evidence on both sides and declare a winner. We’re not even close to that point, so this lawsuit is evidence of nothing.
  3. Moreover, courts don’t get to decide science. And they don’t actually use the scientific method to make those decisions. Real science tell us a lot about HPV vaccines – they are extremely safe and extremely effective. They prevent cancers.

A lawsuit, as evidence of some issue with Gardasil, has no standing whatsoever in a discussion about the benefits and risks of Gardasil. Only science matters, and a pending lawsuit, which is years from being decided, is nearly worthless on the scale of evidence about a vaccine.

So that’s that. Japan bans Gardasil? No. Is that clear enough to those who want to make that claim?

Editor’s note: This article was originally published in June 2013 and republished again with more revisions in November 2015. Because of some more information about Japan and Gardasil, I’ve extensively updated this article.

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!