Dispute over HPV vaccinations

The dispute over reported side effects from cervical cancer vaccines has been taken to the courts as dozens of women and girls sued the government and pharmaceutical makers this week for damages over health problems they suffered after they were vaccinated.

While the human papillomavirus (HPV) vaccines continue to be widely used overseas as an effective defense against cervical cancer, the government stopped recommending the vaccination for schoolgirls in 2013 as allegations of side effects surfaced — and has since not reinstated the recommendation despite calls from medical organizations to do so.

The judiciary is expected to hand down its decision based on scientific grounds. In the meantime, the pending court case should not stop the government from providing help to the women and girls suffering from the health problems. The government should also seek to establish a system for collecting and analyzing information on possible side effects from vaccines to see whether there is a causal link between the vaccines and the health problems that the recipients are experiencing. The lack of such a system in this country is blamed for the controversy surrounding the HPV vaccines.

The vaccines were developed to prevent infection from the virus that is the primary cause of cervical cancer. It was approved in Japan in 2009. Government subsidies beginning the following year sharply expanded their use, and the Health, Labor and Welfare Ministry started recommending in April 2013 that schoolgirls aged 12 to 16 be vaccinated. However, the ministry suspended its proactive recommendation after just two months in response to complaints of side effects — resulting in steep decline in the use of the vaccines.

According to the ministry, 2,945 of some 3.39 million women and girls who received the vaccine shots by the end of this April — or 0.09 percent — complained of health problems ranging from headache, nausea and fatigue to loss of memory and numbness in their hands and legs. A September 2015 survey showed that at least 186 girls had not recovered from the symptoms — with the conditions of 135 of them so severe as to interfere in their daily lives, such as going to school or work.

The 63 plaintiffs in the lawsuits filed Wednesday with district courts in Tokyo, Nagoya, Osaka and Fukuoka say their health problems were clearly the result of the vaccination since the symptoms emerged after they got the shots, and charge that the HPV vaccines’ effectiveness in preventing cervical cancer have not been proven. They blame the government for approving the vaccines without confirming the safety and effectiveness — and the makers of the vaccines for marketing faulty products and failing to specify the risks posed by their products — and are demanding at least ¥15 million each in compensation.

While the government has continued to suspend its proactive recommendation for use of the HPV vaccines three years on, they are still categorized as publicly subsidized routine vaccinations and available to those who request it.

The health ministry says the causal link between the vaccines and the reported health problems is unclear. A panel of experts at the ministry in 2014 determined that the side effects were “psychosomatic reactions” triggered by the pain of the vaccine shots and related anxieties on the part of the recipients. At the same time, the ministry is providing compensation for the medical bills of affected recipients in cases when the causal link between the health problems and the vaccinations cannot be ruled out.

Health authorities in other advanced nations say the safety of the HPV vaccines is not in doubt despite reports of side effects. The makers of the vaccines say their benefits in preventing cervical cancer have been proven and outweigh any risks. The World Health Organization, in a statement by its advisory committee on vaccine safety in December, noted that as a result of the continuing suspension of the health ministry’s recommendations for HPV vaccinations, young women in Japan “are being left vulnerable to HPV-related cancers that otherwise could be prevented” and warned that “policy decisions based on weak evidence, leading to lack of use of safe and effective vaccines, can result in real harm.”

Medical organizations in Japan are also calling for a resumption of the HPV vaccination recommendation. The Japan Society of Obstetrics and Gynecology says that otherwise the nation could “become the only country continuing to show a marked increase of cervical cancer in the future.”

Some experts, however, warn against hasty decisions. Questions have been raised about the ministry panel’s conclusion blaming the side effects on psychological factors, since it does not explain why the symptoms emerge only with the HPV vaccinations and not other vaccines. Some doctors point to the possibility that elements contained in the HPV vaccines caused disorders in the recipients’ immune and nerve systems.

The lack of consensus on the issue is blamed partly on the absence of a system in Japan to collect and analyze information on vaccine side effects. In the absence of such a mechanism, for example, it could be left unclear whether all of the reported health problems have been caused by the vaccinations or include symptoms induced by other factors. To avoid this lack of clarity, an epidemiological study comparing the rate of incidence of the symptoms between two groups of people of the same generation — one who received the vaccine shots and the other who didn’t — will be needed.

While such studies are commonly done in other advanced countries, Japan lacks a mechanism for a large-scale analysis connecting people’s vaccination records and their medical information data. While the health ministry began research with medical institutions nationwide on teenage girls complaining of similar long-term pain who have not received an HPV vaccination, it is expected to take some time before results can be obtained. The dispute over the HPV vaccines should promote efforts to establish a system for such research in this country.