The HPV vaccine, specifically the Gardasil 9-valent version, is one of the handful of ways to actually prevent cancer. Along with the hepatitis-B vaccine, the HPV vaccine helps prevent future incidence of dangerous cancers. Unfortunately, a Japanese HPV vaccine lawsuit has been filed in that country by 64 women.
Gardasil has had a tumultuous history in Japan. The vaccine is no longer recommended for Japanese teens, based on an unscientific analysis of evidence related to adverse events. The Japanese Health Ministry accepted supposed “adverse events” after Gardasil vaccine as causal, even though the rate of these adverse events after vaccination was LOWER than the general non-vaccinated population. It was total incompetence on the part of the Health Ministry.
Let’s take a look at this lawsuit in Japan – and we need to see what it really means.
Japanese HPV vaccine lawsuit
The Japan Times, an English-speaking news publication, reported recently that 64 Japanese women were suing the Japanese government and the two manufacturers of the HPV vaccine, Merck & Co (Gardasil) and GlaxoSmithKline (Cervarix, a bi-valent HPV vaccine). The plaintiffs, mostly teenagers, are demanding ¥15 million (about US$142,000) in damages each, for a total of ¥960 million (about US$9.1 million), and increased amounts later depending on the women’s symptoms.
The women claim that “the cervical cancer vaccines have caused nerve disorders and other problems due to the excessive immune reactions they caused.” Their attorneys also believe that the government acted illegally to approve the “ineffective” vaccines. Of course, they also state that the drug manufacturers bear the burden of the product liability.
Since their claims go against the vast and robust body of evidence that, over and over, supports the incredible safety and effectiveness of the HPV cancer preventing vaccine, it’s difficult to take this lawsuit seriously. Nevertheless, there are a number of reasons why this lawsuit means very little:
- The filing of a lawsuit is not a presumption of guilt or civil liability. This is one of the points that the anti-vaccination crowd always gets wrong (among so many) – they believe that the filing of a lawsuit itself means that the plaintiffs have won. Only a jury and judge (followed by appeals) can find the evidence credible or not, and then decide for or against the plaintiffs.
- The Japanese tort system is much more favorable to plaintiffs than litigation-friendly system in the USA. Thus, the risk-reward for a Japanese attorney to file a lawsuit is pretty low.
- Whatever the courts decide, it is still not science. Courts and juries can be swayed by emotional appeals and a false balance between evidence presented by one side versus the other. Courts should give weight to higher quality evidence of real science, but sometimes they don’t.
- And let me remind the reader again – just because an adverse event occurs temporally after a vaccination, it does not mean the vaccine caused it. That has to be determined by large population epidemiological studies which are unbiased and neutral. It can’t be based on a claim of a handful of teens who, to be certain, believe that their neurological symptoms are related to the vaccine. Even though, their symptoms happen to teens whether or not they’ve been vaccinated.
It appears that the sharks are circling the Japanese government and the HPV vaccine manufacturers to make some money. And it probably results from that incompetent Health Ministry ruling about the vaccine.
The real HPV vaccine science
I have reviewed a number of large population studies published in high quality journals. These studies are unbiased and detailed. They provided conclusive evidence that the HPV cancer preventing vaccine is safe and very effective.
Here are some of those reviews:
- In one large study, that included nearly 200,000 young females who had received the vaccine, the researchers found that the vaccine was only associated with same-day syncope (fainting) and skin infections in the two weeks after vaccination. The authors stated that, “this study did not detect evidence of new safety concerns among females 9 to 26 years of age secondary to vaccination with HPV4.”
- In another huge study, that included nearly 1 million young females, a HPV vaccinated cohort was compared to an unvaccinated cohort. The authors concluded that “this study identified no safety signals with respect to autoimmune, neurological, and venous thromboembolic events after the qHPV vaccine had been administered.”
- Gardasil does not cause blood clots.
- Eight years of post licensure studies have shown no significant relationship between the vaccine and serious adverse events.
- An eight year clinical trial comparing the HPV vaccine vs. a saline control group showed no difference in adverse events.
- Even though there was no plausibility, researchers found that the HPV vaccine was unrelated to an increase the risk of multiple sclerosis (MS) or some other acquired central nervous system demyelinating syndrome (CNS ADS).
- Another huge study, including nearly 2 million doses of HPV quadrivalent vaccine, showed no increase risk of multiple sclerosis or other demyelinating neurological disorders in vaccinated vs. unvaccinated groups.
- A review of all of the post-licensure studies of quadrivalent HPV vaccines provide strong evidence that Gardasil is extremely safe.
In other words, large studies, which included millions of doses of the HPV vaccine, completely refute the claims of the participants in the Japanese HPV vaccine lawsuit.
- The validity of this lawsuit has not been decided by courts.
- Nevertheless, courts don’t decide what is good and bad science. They’re generally not equipped to do so.
- The vast consensus of real science has already decided that the HPV vaccine is safe and very effective.
- Nonetheless, anti-vaccine types will use this lawsuit to say “Gardasil is dangerous.” They’re wrong.