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Submission of Position Document, ¡ÈCritique against MHLW Deliberation Results on HPV Vaccines (Cervical Cancer Vaccines) -Medwatcher Japan Strongly Opposes Resuming Active Recommendation for HPV Vaccination-¡É

2014-02-24

The MHLW deliberation results on HPV vaccines (cervical cancer vaccines) are unscientific with a pre-determined conclusion - Active recommendation for HPV vaccination should not be resumed -.

It is arbitrary and unscientific that the Ministry of Health, Labour and Welfare councils (*1) held on January 20th, 2014 is trying to conclude that generalized pain and dyskinesia after HPV vaccinations (cervical cancer vaccinations) are ¡Èpsychogenic responses.¡É Medwatcher Japan therefore submitted our position document to the Minister of Health, Labour and Welfare and the MHLW councils today (February 24th, 2014).

The summary of the position document is as follows:

1.The MHLW councils are unjust because their deliberations are arbitrary and unscientific.

Specifically, ¡¡

1) The analysis made by the MHLW councils was based on an assumption that side effects of HPV vaccines, novel vaccines, are caused by a single mechanism without presenting any scientific grounds;

2) The deliberations were made to draw a pre-determined conclusion by using an arbitrary logic, i.e. when considering hypothetical causes of various symptoms, they attributed to ¡Èpsychogenic responses¡É although there are some unaccountable cases; on the other hand, they denied hypotheses other than ¡Èpsychogenic responses¡É by reason that there are some unaccountable cases;

3) The MHLW councils have made a judgment based on the ¡Ègeneral medial perspective¡É, ignoring the possibility that new drugs may cause side effects that cannot be explained with known knowledge. The deliberations must be accused as something that forgot lessons learned from a numerous drug-induced disasters in the past; and

4) Without conducting a full-scale, scientific epidemiological survey, the MHLW councils are trying to deny the causal relationship between various symptoms and HPV vaccination by only arguing side effect information obtained so far although it represents only the tip of the iceberg.

2. HPV vaccines should be excluded from Japan¡Çs mandatory vaccination schedule
As Medwatcher Japan has been claiming, preventive effects of HPV vaccines on cervical cancer have not been medically established. As the ¡Èbenefits of vaccination¡É are not clear and the risk-benefit balance cannot be evaluated, there is not sufficient evidence to recommend all girls of the targeted age group in the nation by including HPV vaccines in the mandatory vaccination schedule. Considering the intent of the Preventive Vaccination Act, HPV vaccines should be excluded from Japan¡Çs mandatory vaccination schedule.

3.The reason for the suspension of active recommendation, inability to provide sufficient information, has not been resolved yet.

Let alone, the active recommendation for HPV vaccination should not be resumed because the government remains unable to provide sufficient information - the reason why the MHLW decided to suspend the active recommendation.

4.It may violate the right to self-determination.

Currently, the government fails to provide necessary information to girls and their parents to decide whether or not to receive HPV vaccines; it is virtually impossible to secure the informed consent. Despite that, imposing an obligation on girls and their parents to make efforts to receive HPV vaccinations because they are part of the mandatory vaccination schedule may be a violation of the right to self-determination.
From this point as well, the mandatory vaccination of HPV vaccines should be halted, let alone the active recommendation should not be resumed.

The full position document and others such as the Request on Cervical Cancer Vaccines are posted in this website. Please see them from the links below in the ¡ÈRelated Documents and URLs.¡É

Written Request on Cervical Cancer Vaccines (Human Papilloma Virus or HPV Vaccines) (Japanese)

The Real Answers on Cervical Cancer Vaccines (Japanese)

Opinions on Cost-Effectiveness of Cervical Cancer Vaccines (HPV vaccines) (Japanese)

(*1) The 7th meeting of Side Effects Review Group, Immunization and Vaccine Sub-Committee, Health Sciences Council, 2013; The 8th meeting of Safety Investigation, Pharmaceutical Safety Measurement Group, Pharmaceutical Affairs and Food Sanitation Council, 2013