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One of the most popular zombie memes and tropes of the anti-vaccine movement is that Japan banned Gardasil, the HPV vaccine. And like most of those zombie memes and tropes, the facts are a lot different than the anti-vaccine claims. Per usual.

Although I don’t quite understand the reasoning, the anti-vaccine religion absolutely hates Gardasil, possibly more than any other vaccine. These zealots maintain that the HPV vaccines cause all kinds of harm to teens and young adults. Yet, 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.

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 banned Gardasil. Let’s examine this fable with a critical and skeptical eye.

Spoiler alert – Japan did no such thing.

Japan’s Health Ministry has made a fundamental error that has caused harm to its children. Photo by Steven Diaz on Unsplash.

All about HPV and HPV vaccines

I know I add this section to every article I write about HPV vaccines. It is updated almost every time with additional information about HPV or the vaccine. Moreover, there are readers who want to know more about HPV, and this section can help someone get up-to-speed quickly.

Genital and oral human papillomavirus (HPV) infections are the most common sexually transmitted infections (STI) in the USA. HPV is generally transmitted from personal contact during vaginal, anal or oral sex.

It’s important to note that there are more than 150 strains or subtypes of HPV that can infect humans – however, only 40 of these strains are linked to one or more different cancers. Of those 40 strain, most are fairly rare.

Although the early symptoms of HPV infections aren’t serious and many HPV infections resolve themselves without long-term harm, HPV infections are causally linked to many types of cancers in men and women. According to current medical research, here are some of the cancers that are linked to HPV:

In addition, there is some evidence that HPV infections are causally linked to skin and prostate cancers. The link to skin cancer is still preliminary, but there is much stronger evidence that HPV is linked to many prostate cancers.

HPV is believed to cause nearly 5% of all new cancers across the world, making it almost as dangerous as tobacco in that respect. According to the CDC, roughly 79 million Americans are infected with HPV – approximately 14 million Americans contract a new HPV every year. Most individuals don’t even know they have the infection until the onset of cancer. The CDC also states that over 43,000 HPV-related cancers are diagnosed in the USA every year. It may be several times that amount worldwide.

There were two HPV vaccines on the world market before 2014. GSK, also known as GlaxoSmithKline, produced Cervarix, a bivalent (protects against two HPV strains) vaccine. It has been withdrawn from the US market (although available in many other markets), because of the competition from the quadrivalent (immunizes against four different HPV strains) and 9-valent (against nine HPV strains) Gardasil vaccines.

Merck manufactures Gardasil, probably the most popular HPV vaccine in the world. The first version of the vaccine, quadrivalent Gardasil, targets the two HPV genotypes known to cause about 70% of cervical cancer and two other HPV genotypes that cause genital warts. In Europe and other markets, Gardasil is known as Silgard.

The newer Gardasil 9, approved by the FDA in 2014, is a 9-valent vaccine, protecting against HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. It targets the four HPV strains found in the quadrivalent version, along with five additional ones that are linked to cervical and other HPV-related cancers. Both versions of Gardasil are prophylactic, meant to be given to females or males before they become exposed to possible HPV infection through intimate contact.

Gardasil is one of the easiest and best ways to prevent a few dangerous and, to abuse the definition slightly, common cancers that afflict men and women. Without a doubt, the HPV vaccine prevents cancer.

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.

Let me sum this all up so that if you come away from this section with nothing else, you get this summary. HPV is a sexually transmitted disease. HPV causes 43,000 cancers a year in the USA alone. The HPV vaccine prevents becoming infected by HPV, which means you are protected from these cancers.

Let’s hope they’ve all been vaccinated against HPV. Photo by Banter Snaps on Unsplash.

Japan banned 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 the HPV vaccine, specifically Gardasil. But they get most of the story all wrong.

According to an 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. This is quite a bit different than the claim that “Japan banned Gardasil.” Moreover, 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 Gardasil vaccinations showed a temporal link to some adverse events, though not a causal link. Moreover, this is a number so small that it’s pretty close to impossible to affix any statistical significance to it, and it 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 is some number of events, similar to 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 teen. That does not mean there is causality or even a correlation between the vaccine and a broken arm. 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 scientific analyses. 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?

Iconic Mt. Fuji. Photo by Fezbot2000 on Unsplash.

Japan banned Gardasil – the start of this myth

According to an article in Vox,

… coverage rates for the HPV vaccine have plummeted from 70 percent in 2013 to less than 1 percent today. This happened after a preliminary (and allegedly fraudulent) mouse study showing the vaccine caused brain damage was spread by the media, along with unconfirmed video reports of girls in wheelchairs and having seizures after getting immunized.

This whole issue had its beginning in a paper published in Science Reports, an online open-access journal run by Nature, which claimed that Gardasil given to mice caused neurological damage. In this study, mice were given a huge dose of the HPV vaccine (beyond what we would give to humans) along with a toxin to make the blood-brain barrier “leaky” to the HPV vaccine.

Of course, this is a good way to induce neurological changes, since generally, that barrier is impenetrable to anything that circulates in the blood, other than substances it actively transports into the brain. The toxin used by the researchers is simply not normal – it forcibly opened the blood-brain barrier to allow the extremely high dose of the HPV vaccine to reach the brain.

It was a terrible study which, wait for it, was recently retracted for a whole host of reasons. The retraction notice from Scientific Reports seems to side with the arguments presented by the critics of this research. The retraction notice clearly states:

The Publisher is retracting this Article because the experimental approach does not support the objectives of the study. The study was designed to elucidate the maximum implication of human papillomavirus (HPV) vaccine (Gardasil) in the central nervous system. However, the co-administration of pertussis toxin with high-levels of HPV vaccine is not an appropriate approach to determine neurological damage from HPV vaccine alone.

But it was too late. This began the downhill slide to Japan withdrawing recommending the cancer-preventing HPV vaccine, although not leading to “Japan banned Gardasil.”

Facts about Japan and the HPV vaccine

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. Since I don’t want to leave any stone unturned, these decisions do not mean that the vaccine has been pulled from the market. Again, teenagers can still get the vaccine. This move by the health ministry was 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. 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. 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. 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 be 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 anti-vaccine 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 the 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:

Anyone can claim anything – filing a lawsuit doesn’t provide us evidence anything. There are lawsuits all over the world that try to make claims about all kinds of things – most of them are unsuccessful. 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. Moreover, courts don’t get to decide science. And they don’t actually use the scientific method to make those decisions. Real science tells 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.

Obligatory cute animal photo. This is a Japanese macaque, or snow monkey, which is the only non-human primate that lives this far north. Photo by Fezbot2000 on Unsplash.

Consequences

Despite the claims of the anti-vaccine crowd in Japan, there are consequences of dropping the HPV recommendation by Japan’s Health Ministry. A new article published by Japanese researchers stated:

In Japan, the morbidity and mortality of cervical cancer have recently been on the rise. According to the Japanese Center for Cancer Control and Information Services, approximately 10,490 people were diagnosed with cervical cancer in 2014, and 2,710 people died from it in 2016. The incidence rate of cervical cancer by age has increased most acutely in younger women. Looking at the age-adjusted mortality rate over the past 10 years, death from cervical cancer has increased by 9.6%. Thus, in Japan, we are facing a problem of rising cervical cancer death rate, while the mortality rates in the five other major cancers have declined.

In plain English, that means that the rate of cervical cancer (which is only one of the different cancers linked to HPV) has been increasing. Compare this to countries like Australia, which has pushed the HPV vaccine since it was launched and has experienced a notable decline in HPV infections and cervical cancer.

The authors of this study concluded:

Both the effectiveness and the safety of HPV vaccine have been scientifically demonstrated worldwide. However, Japan’s health regulatory body, the MHLW, has not yet been willing to reverse their 2013 decision so as to resume its proactive recommendation of HPV vaccination. Unless Japan’s governmental proactive recommendation for the HPV vaccine is soon resumed, the HPV infection rates will increase. As HPV is associated not only with cervical cancer, but also cancers of the vulva, vagina, anus, and oropharynx, it is predictable that there will eventually be large numbers of HPV-caused cancer morbidities and mortalities across Japan. For the near foreseeable future, in the absence of any comprehensive national HPV vaccination program, our only hope to prevent a wave of cervical cancer will be by raising the cervical cancer examination rate. However, if the examination rate in Japan remains low as it is today, severe concerns about our future will be raised.

Summary

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

Despite the lack of a ban, Japan’s health ministry, using specious and retracted claims of neurological damage along with using the worst statistical analysis I’ve seen from a public health body, did withdraw recommendation of the vaccine.

The HPV vaccine uptake rate has dropped to near zero because of this insanity. Gardasil is demonstrably safe and demonstrably effective in preventing cancer. Do not buy into the anti-vaccine trope about Gardasil – Japan did not ban it, but what the country did do was almost as appalling. Men and women will contract and die of cancer in that country because of ignorance and false claims.

Gardasil prevents cancer and saves lives.

Key citations:

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