China's heparin revisited: What went wrong and has anything changed?

摘要

China is the world's largest producer of crude heparin. In 2007, tainted Chinese crude heparin made its way into the global finished heparin supply chain killing 149 persons in 11 different countries including 81 deaths in the US. While China never formally admitted that it was the source of the tainted heparin, US and European regulatory officials determined that adulterated crude heparin was intentionally introduced (for economic gain) into the Chinese heparin supply and subsequently shipped to other countries for final pharmaceutical formulation. After China was implicated as the source, tainted heparin disappeared from the global heparin supply chain. This paper reviews the social and economic factors that were likely responsible for the Chinese incident and whether or not another economically-motivated case of crude heparin adulteration is possible in China.