Cervical cancer is preventable, and it can be detected early. If robust measures for prevention and early detection continue to be taken, cervical cancer could be eradicated in the future, at least in developed countries.
However, the reality in Japan throws cold water on such hope. Every year in our country, more than 10,000 women develop cervical cancer, and nearly 3,000 die. Cervical cancer is known as a "mother killer" because it causes many children to become motherless.
In my view, the Japanese government's lack of a scientific point of view in implementing public health and medical services policies is to blame for the country's current situation concerning cervical cancer. Today, I would like to express my personal opinion about the situation, as I sincerely want the public to understand how unfortunate and serious it is.
Cervical cancer is a type of cancer that occurs following infection with human papillomavirus (HPV), a common virus that exists everywhere around people. HPV spreads through genital contact and oral contact, affecting both males and females. About 50 percent to 80 percent of sexually active women will have HPV infection at some point in their lives. In most cases, the virus disappears on its own. In a small group of women, however, it does not go away for a long time, eventually resulting in cervical cancer.
There are more than 100 strains of HPV, of which HPV types 16 and 18 are known to be the most cancer-causing. Two types of HPV vaccines became available in the United States and Europe in and around 2006. Japan approved one of them in 2009 and the other in 2011. They are currently used in more than 130 countries.
Live vaccines, usually made from weakened germs or viruses, or parts of germs or viruses, are mainly administered by injection to improve the body's immunity to particular diseases. In contrast, the two approved HPV vaccines are synthetic, non-live ones that only contain inactivated HPV virus particles -- the protein shells of the HPV virus. Therefore, they cannot cause infection even while retaining the capability of strengthening the body's immune system.
In the process of cancer treatment, drugs, surgery and radiation therapy are applied. All of them have the potential, however slight, to cause adverse reactions or side effects. Vaccines are no exception. Nonetheless, vaccines are important because the health benefits they bring far outweigh the risk of adverse reactions.
Of the 130-plus countries where the two HPV vaccines are available, about 80 governments have introduced them into their national vaccination programs. In Japan, the Health, Labor and Welfare Ministry embarked on a provisional government-financed three-dose HPV vaccination program in November 2010 for teenage girls -- from those in the sixth year of primary school to those in the first year of high school. About 70 percent of girls in the age bracket were vaccinated across the country under the program.
In April 2013, routine HPV vaccination began under the Immunization Act. However, in June of that year -- just two months later -- the health ministry decided on the "temporary suspension of the proactive recommendation" for routine use of HPV vaccines.
The decision followed reports that some girls complained of such symptoms as chronic pain throughout the body, difficulty walking, eyesight decline, dizziness and decreased cognitive ability after receiving HPV vaccinations.
Consequently, Japan's nationwide rate of vaccination for HPV has plummeted to less than 1 percent. The health ministry's suspension is still in effect five years later.
Regarding the girls who suffered symptoms after receiving HPV vaccinations, I understand how painful indeed the situation must be for them and their families.
That said, I would like you to compare the following two sentences:
-- "After one gets vaccinated, a health problem develops."
-- "Because one gets vaccinated, a health problem develops."
Both sentences look similar, but, in fact, the situations described by them are dissimilar. The first simply shows a chronological sequence of events. The second describes a causal relationship between the two events.
The first sentence applies to what are known as "adverse events," a term that refers to any undesirable occurrence after vaccine use. This means the adverse event category includes cases that do not necessarily have a causal relationship with vaccination. So it is important to thoroughly analyze adverse event data to determine whether they really include adverse reactions to HPV vaccines.
Lack of pre-vaccination data
In Japan, there is no detailed data about HPV vaccine recipients' pre-immunization health conditions. In 2013, the health ministry missed an opportunity to carry out such research on its own when it suspended its proactive recommendation for routine use of HPV vaccines.
Well before the introduction of HPV vaccines in Japan, pediatricians and psychiatrists were aware that many young adolescents in the country complained of pain and poor health conditions even when their medical examinations showed nothing abnormal. After the health ministry's provisional HPV vaccination program was launched in 2010, some doctors who saw vaccine recipients complaining of various types of pain thought the symptoms reflected recipients' stress-related fear of HPV vaccine injection.
Some research teams in foreign countries have compiled reports on adverse events following HPV vaccination. A team of Scandinavian researchers conducted a comparative study on 3.98 million Danish and Swedish women and found that vaccinated women were diagnosed with demyelinating diseases -- disorders of the central and peripheral nervous system, including walking difficulty -- to the same extent as the comparable unvaccinated cohort.
Another comparative study covering 11 countries and one region found no difference between 1,000 women vaccinated against HPV and another 1,000 given hepatitis A vaccines as to the extent of adverse reactions to vaccination.
At the end of 2015, the municipal government of Nagoya released a preliminary report based on the findings of a massive survey it held on about 70,000 young women living in the city, HPV-vaccinated and unvaccinated, the first of its kind in Japan. The city asked women whether they had suffered any of the 24 symptoms that were reported to have appeared after HPV vaccinations. As for the extent of occurrence of those symptoms, the report said there was no difference between the two groups in terms of epidemiological statistics. In a related development, however, the municipal government acknowledged that "analysis" of the causal relationship between the survey's findings and vaccination was "impossible."
WHO: 'Weak evidence'
In 2014 and 2015, the World Health Organization issued statements declaring the safety of HPV vaccines based on investigations by the Global Advisory Committee on Vaccine Safety (GACVS) it launched in 1999. In the 2015 statement, the WHO warned that "[Japan's] policy decisions based on weak evidence, leading to lack of use of safe and effective [HPV] vaccines, can result in real harm."
In developed countries other than Japan, HPV vaccination rates have been very high in a positive reaction to the WHO's declaration of the safety of the vaccines. Those rates now stand at 70 percent to 90 percent in many European countries. The comparable rate in Japan remains alarmingly low at less than 1 percent.
In July 2016, a group of women in Japan filed a first round of suits against the state and two drugmakers, complaining about HPV vaccine ingredients and demanding compensation for serious symptoms they said had been caused by HPV vaccines. The number of plaintiffs has since increased to about 120 with the Tokyo, Osaka, Nagoya and Fukuoka district courts handling the suits. It is likely to take quite a long time for courts to hand down a final decision.
I am of the opinion that, to avert the recurrence of such unfortunate cases, the state should introduce a no-fault compensation system for HPV vaccination if certain conditions are met, instead of obliging plaintiffs to prove the liability of each defendant, to secure compensation. The state should seek an out-of-court settlement with the group of plaintiffs as early as possible together with relief measures for them. It is also important to proceed with studies on palliative treatment of the symptoms with which the plaintiffs continue to struggle.
Needless to say, the government should continue thoroughly and thoughtfully explaining to the public about the necessity of HPV vaccination. Once it can obtain the public's understanding, it should resume its proactive recommendation for use of HPV vaccines. In June 2018, the Japan Society of Obstetrics and Gynecology issued a statement calling on the health ministry to resume its proactive recommendation for vaccine use as early as possible.
Meantime, cervical cancer can be detected early through regular screening. However, the rate of cervical cancer screening in Japan stands at about 40 percent, much lower than 60 percent to 80 percent among Americans and Europeans. The government should endeavor to increase the screening rate in parallel with the promotion of HPV vaccination.
It is necessary for the government to prepare well to deal with vaccine-related issues in the future. To that end, the government should urgently establish a nationwide database linking chronologies of all vaccination programs and medical examinations as well as diagnoses at hospitals and clinics.
Special to The Yomiuri Shimbun
Kakizoe is president of the Japan Cancer Society and a past president of the National Cancer Center.
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