Japan and Taiwan in the wake of bio-globalization : drugs, race and standards

Thesis (Ph. D. in History and Social Study of Science and Technology (HASTS))--Massachusetts Institute of Technology, Program in Science, Technology and Society, 2005.

Bibliographic Details
Main Author: Kuo, Wen-Hua
Other Authors: Michael M.J. Fischer.
Format: Thesis
Language:eng
Published: Massachusetts Institute of Technology 2007
Subjects:
Online Access:http://hdl.handle.net/1721.1/39195
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author Kuo, Wen-Hua
author2 Michael M.J. Fischer.
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Kuo, Wen-Hua
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description Thesis (Ph. D. in History and Social Study of Science and Technology (HASTS))--Massachusetts Institute of Technology, Program in Science, Technology and Society, 2005.
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spelling mit-1721.1/391952019-04-11T08:20:11Z Japan and Taiwan in the wake of bio-globalization : drugs, race and standards Kuo, Wen-Hua Michael M.J. Fischer. Massachusetts Institute of Technology. Program in Science, Technology and Society. Massachusetts Institute of Technology. Program in Science, Technology and Society. Program in Science, Technology and Society. Thesis (Ph. D. in History and Social Study of Science and Technology (HASTS))--Massachusetts Institute of Technology, Program in Science, Technology and Society, 2005. Also issued in a 2 v. set, printed in leaves. MIT Dewey Library copy: 2 v. set. Includes bibliographical references (p. 518-545). This is a study of Japan and Taiwan's different responses to the expansion of the global drug industry. The thesis focuses on the problematic of "voicing," of how a state can make its interests heard in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH is a unique project that facilitates the formation of a single global market by creating universal standards for clinical trials and drug approvals. Tracing, through "slow motion" ethnography, step by step, why Japan claims a racial difference requires additional local clinical trials with "Asian bodies," this thesis rejects conventional interpretations of protectionism for Japan's resistance to globalization. It argues that more than protectionism is involved, and that a rich ethnographic understanding of Japan's medical infrastructure is required to understand the claim of biological, cultural, and national differences, as well as biostatistical arguments about the ambiguities of "extrapolation" of clinical data from one place to another. (cont.) The inherent ambiguities of efforts to create "bridging" studies as a temporary solution to these problematics created a deadlock in the ICH, and provided an opening for Taiwan, another Asian state, which does not enjoy formal recognition from the world, to speak for itself to this conference, and to create the fragile, but politically critical, possibility of becoming a clinical trial center for Asian populations. The language of genomics and biostatistics become in the more recent period the vehicles for both Japanese and Taiwanese efforts at "voicing" their concerns. Both genomics and biostatistics look different in these contexts than they do from the United States or European Union. In sum, (1) Japan's and Taiwan's response, as well as "global ethnographic objects" such as the ICH, provide important tools to rethink the comparative method as well as universalizing claims of harmonization. (2) Race, culture, and the nation-state are transformed as categories through the contemporary reworkings of genomics and biostatistics. (3) The thesis demonstrates that abstract accounts of the spread of clinical trials and resistance in various parts of the world are not to be trusted unless they include detailed probings of local understandings, identity issues, and problems of voicing. by Wen-Hua Kuo. Ph.D.in History and Social Study of Science and Technology (HASTS 2007-10-19T20:29:09Z 2007-10-19T20:29:09Z 2005 2005 Thesis http://hdl.handle.net/1721.1/39195 67767409 eng M.I.T. theses are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. See provided URL for inquiries about permission. http://dspace.mit.edu/handle/1721.1/7582 545 p. application/pdf a-ja--- a-ch--- Massachusetts Institute of Technology
spellingShingle Program in Science, Technology and Society.
Kuo, Wen-Hua
Japan and Taiwan in the wake of bio-globalization : drugs, race and standards
title Japan and Taiwan in the wake of bio-globalization : drugs, race and standards
title_full Japan and Taiwan in the wake of bio-globalization : drugs, race and standards
title_fullStr Japan and Taiwan in the wake of bio-globalization : drugs, race and standards
title_full_unstemmed Japan and Taiwan in the wake of bio-globalization : drugs, race and standards
title_short Japan and Taiwan in the wake of bio-globalization : drugs, race and standards
title_sort japan and taiwan in the wake of bio globalization drugs race and standards
topic Program in Science, Technology and Society.
url http://hdl.handle.net/1721.1/39195
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