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Regarding the MHLW councils on cervical cancer vaccines (HPV vaccines) held on January 20th, 2014

2014-01-22

It is erroneous for the Ministry of Health, Labour and Welfare councils (*1) held on January 20th, 2014 to draw the conclusion at this moment of denying the causality of vaccine ingredients with frequently reported widespread pain or dyskinesia after HPV vaccination and of determining as psychogenic responses induced by painful stimulation of needle piercing the skin as well as anxiety.

This conclusion was drawn by denying three (1 to 3) out of four possible causes considered; 1) neurological disorders, 2) intoxication, 3) immunological responses, and 4) psychogenic responses. In doing so, an approach was taken to deny the causalities of 1) to 3) based on the presence of cases that cannot be explained by these three causes.

For example, the following was stated as one of the grounds denying neurological disorders, °»in general, involuntary movements associated with neurological disorders are uncontrollable but there are cases of which involuntary movements stopped when collecting blood,°… without referring the percentage of such cases. As there is no evidence, however, that all of the cases with side effects presenting various symptoms are associated with a single cause, the presence of cases unable to explain with neurological disorders does not deny the causality of many other accountable cases. The review approach taken is obviously unscientific. The principal investigator of the MHLW study group, Prof. Shuichi Ikeda at Shinshu University, also expressed his concerns, °»it may be difficult to attribute all of the cases to psychogenic and/or sociological responses.°… (*2)

In addition, new drugs like HPV vaccines may cause unknown side effects. The MHLW councils, however, easily denied the causal relationships in cases of which side effects became apparent one month or more after the vaccine inoculation on the ground of °»general medical perspective.°… As such, there are many problems related to the deliberation (*3) which led to the pre-determined conclusions. We must say that it was far from revealing the causes of various side effects.

Even after the treatment system was organized by the MHLW study group, a half of the victims remain unrecovered and are still suffering from side effects. The attitude of the councils jumping to conclusions without any sufficient scientific consideration is extremely insincere to those girls. If the active recommendation for HPV vaccination is to resume without conducting any true causality investigations, it is obvious that further more girls will be victimized.

We, therefore, strongly request for sufficient deliberation on causes of side effects at the next meeting and thereafter.

(*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

(*2) Morning edition, January 21st, 2014, Shinano Mainichi Shimbun Newspaper

(*3) Medwatcher Japan will publish a detailed analysis of those problems on this website.