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Submission of Statement on the °»Epidemiological study to evaluate the efficacy and safety of HPV vaccines (cervical cancer vaccines)°… to evaluate the efficacy and safety of HPV vaccines (cervical cancer vaccines)°…

2015-12-01

Medwatcher Japan submitted its statement on the °»Epidemiological study to evaluate the efficacy and safety of HPV vaccines°… to the Minister of Health, Labour and Welfare dated on December 1, 2015.

The statement was prepared to reveal issues regarding the °»Epidemiological study to evaluate the efficacy and safety of HPV vaccines (cervical cancer vaccines)°… (hereafter referred to as °»the study°…) of which outline was presented at the ministry°«s councils held on November 27th, 2015. Medwatcher Japan considers that the study should not be conducted unless the issues raised in the statement are not solved.

<Gist of the Statement>
1. Drs. Tadao Kakizoe and Takayuki Enomoto should be excluded from co-investigators.

2. Beginning the descriptive epidemiological study that aims to reveal frequencies and relative factors of °»pain and other various symptoms including motor dysfunction°… without identifying target symptoms is extremely inappropriate; investigators should first evaluate currently reported pathological conditions of patients and identify symptoms to be studied.

3. In identifying symptoms to be studied, Drs. Shuichi Ikeda, Kusuki Nishioka, and Shunpei Yokota, who have been treating a number of patients and presenting their findings, should be included as co-investigators.

4. Information including protocols and questionnaires of the study°«s three sub-studies should be disclosed.