Affiliations: Faculty of Social Welfare, Niigata University of Health and Welfare, Niigata, Japan | Institute of Clinical and Social Pharmacy, Saitama, Japan | Postgraduate student of Niigata University of Health and Welfare, Niigata, Japan | Drug Information Center Asahi, Osaka, Japan | Graduate School of Human Science, Waseda University, Tokyo, Japan
Note: [] Address for correspondence: Kiyohiko Katahira, Director of the Institute of Clinical and Social Pharmacy, Misato, Saitama, Japan. Tel.: +81 48 955 7511; Fax: +81 48 955 7516; E-mail: katahirakiyohiko@gmail.com
Abstract: BACKGROUND: Plaintiffs of the gefitinib (Iressa) lawsuits in Japan started in 2004 were defeated in the Supreme Court in 2013. The Court judged it was not possible to foresee the outbreak of deaths caused by interstitial pneumonia due to gefitinib from death cases before approval of this drug. OBJECTIVE: We attempted to verify validity of this judgment. METHODS: We estimated the 95% confidence interval (CI) of the proportion of onset and death cases among 23 onset and 13 death cases occurring from “within 1 week” to “within 4 weeks” from clinical data before approval of this drug using data admitted to the Court. RESULTS: For death cases, all of the upper limits of the 95% CI exceeded 50% within 1–4 weeks. This fact suggested that the cases of acute interstitial pneumonia were included in the clinical trial before the approval of gefitinib. CONCLUSION: It was possible to foresee the outbreak of death cases after drug approval. This conclusion showed the Court's ruling was not reasonable and was unscientific.
