Risk of authoritarianism: fibrinogen-transmitted hepatitis C in Japan

SummaryIn 1977, the US Food and Drug Administration revoked all licences for fibrinogen concentrate because of the risk for hepatitis infection and suspected lack of effectiveness. However, in Japan, fibrinogen concentrate was used routinely for treatment of obstetric bleeding until 1988. Even in 1997, academic texts by Japanese authorities in obstetrics still recommended that obstetricians use the product. An estimated 10 000 cases of hepatitis C infection are attributable to use of fibrinogen in Japan and are a result of authoritarianism that hindered effective policy changes. Scientists have a duty to refine repeatedly the quality of their evidence, and policymakers need to adjust existing policies continually to accord with the latest scientific evidence.