Pharmaceutical Knowledge and Classification: The Development of Iressa and the Changing Diagnostic Practices of Lung Cancer

• Main Authors: Yeh-Han Wang, 王業翰
• Other Authors: Wen-Hua Kuo
• Format: Others
• Language: zh-TW
• Published: 2018
• Online Access: http://ndltd.ncl.edu.tw/handle/phy9mw

碩士 === 國立陽明大學 === 科技與社會研究所 === 106 === 　　This thesis investigates the development and use of Iressa, the first targeted drug treating lung cancer. From Science, Technology and Society (STS) perspective, it argues that Irressa is the exceptional case in which East Asia played a significant role in its development. More importantly, by analyzing how Iressa was "saved" from the controversial results in its early trials and how the subpopulational analysis and genetic selection consolidated its target users in late-stage trials, this thesis captures a crucial moment in biomedicine where the new paradigm for medical knowledge and clinical practice revolving around pharmaceuticals were introduced. The thesis also reveals the concepts like biomedical platforms and the infrastructure of classification are fundamental throughout the making of this paradigm, and they create useful interpretations as the drugs are on the market under the health insurance scheme. 　　Guided by concepts in recent STS scholarship in pharmaceutical development and clinical studies, this thesis has three findings. First, the classification is embedded in the clinical trials and serves as the infrastructure of knowledge production. The “co-evolution” between the drug and classification creates spaces where the knowledge-producing process could be manipulated. Second, the genetic knowledge is built on the connection between the established classification in trials. With the standardization of both subpopulational traits and molecular techniques, the genetic classification has become the right tool for patient selection. Third, the investigation of the new drug leads to the timely modification of the international guidelines and the local insurance reimbursement policy, which both precipitates the molecularization of medical practices. Therefore, the existing platforms go on a tinkering process of extension and connection under the framework of guidelines and socioeconomic factors.