Activism, drug regulation, and the politics of therapeutic evaluation in the AIDS era: A case study of ddC and the 'surrogate markers' debate

Social Studies of Science

Volumn 27, Issue 5, 1997, Pages 691-726

  Epstein, Steven ^a,b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b Department of Sociology   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AIDS RELATED COMPLEX; ARTICLE; CLINICAL PROTOCOL; DRUG CONTROL; HISTORY; HUMAN; POLITICS; TECHNIQUE; THERAPY; UNITED STATES;

AIDS-RELATED COMPLEX; CLINICAL PROTOCOLS; DRUG AND NARCOTIC CONTROL; HISTORY, 20TH CENTURY; HUMANS; METHODS; POLITICS; THERAPEUTICS; UNITED STATES;

EID: 0031255650     PISSN: 03063127     EISSN: None     Source Type: Journal    
DOI: 10.1177/030631297027005001     Document Type: Article

References (147)

1. A growing literature on clinical trials and drug regulation suggests the relevance of the sociology of scientific knowledge to this domain. On clinical trials, see Harry Milton Marks, Ideas as Reforms: Therapeutic Experiments and Medical Practice, 1900-1980 (unpublished doctoral dissertation, Massachusetts Institute of Technology, 1987); Evelleen Richards, 'The Politics of Therapeutic Evaluation: The Vitamin C and Cancer Controversy', Social Studies of Science, Vol. 18 (1988), 653-701; Richards, Vitamin C and Cancer: Medicine or Politics? (London: Macmillan; New York: St Martin's Press, 1991); Brian Wynne, 'Unruly Technology: Practical Rules, Impractical Discourses and Public Understanding', Social Studies of Science, Vol. 18 (1988), 147-67, esp. 162-63; Marcia Lynn Meldrum, 'Departing From the Design': The Randomized Clinical Trial in Historical Context, 1946-1970 (unpublished doctoral dissertation, State University of New York at Stony Brook, 1994); J. Rosser Matthews, Quantification and the Quest for Medical Certainty (Princeton, NJ: Princeton University Press, 1995); Caroline Jean Acker, 'Addiction and the Laboratory: The Work of the National Research Council's Committee on Drug Addiction, 1928-1939', Isis, Vol. 86 (1995), 167-193. On drug regulation, see Henk J.H.W. Bodewitz, Henk Buurma and Gerard H. de Vries, 'Regulatory Science and the Social Management of Trust in Medicine', in Wiebe E. Bijker, Thomas P. Hughes and Trevor J. Pinch (eds), The Social Construction of Technological Systems: New Directions in the Sociology and History of Technology (Cambridge, MA: MIT Press, 1987), 243-59; Sheila Jasanoff, The Fifth Branch: Science Advisers as Policymakers (Cambridge, MA: Harvard University Press, 1990); John Abraham, 'Distributing the Benefit of the Doubt: Scientists, Regulators, and Drug Safety', Science, Technology, & Human Values, Vol. 19, No. 4 (Autumn 1994), 493-522; Theodore M. Porter, Trust in Numbers: The Pursuit of Objectivity in Science and Public Life (Princeton, NJ: Princeton University Press, 1995), 203-16. The analysis in this paper presumes, and contributes to, the literature that extends the sociology of scientific knowledge to the study of biomedicine. See Richards (1991, above); Monica J. Casper and Marc Berg, 'Constructivist Perspectives on Medical Work; Medical Practices and Science and Technology Studies', Science, Technology, & Human Values, Vol. 20, No. 4 (Autumn 1995), 395-407.
2. A growing literature on clinical trials and drug regulation suggests the relevance of the sociology of scientific knowledge to this domain. On clinical trials, see Harry Milton Marks, Ideas as Reforms: Therapeutic Experiments and Medical Practice, 1900-1980 (unpublished doctoral dissertation, Massachusetts Institute of Technology, 1987); Evelleen Richards, 'The Politics of Therapeutic Evaluation: The Vitamin C and Cancer Controversy', Social Studies of Science, Vol. 18 (1988), 653-701; Richards, Vitamin C and Cancer: Medicine or Politics? (London: Macmillan; New York: St Martin's Press, 1991); Brian Wynne, 'Unruly Technology: Practical Rules, Impractical Discourses and Public Understanding', Social Studies of Science, Vol. 18 (1988), 147-67, esp. 162-63; Marcia Lynn Meldrum, 'Departing From the Design': The Randomized Clinical Trial in Historical Context, 1946-1970 (unpublished doctoral dissertation, State University of New York at Stony Brook, 1994); J. Rosser Matthews, Quantification and the Quest for Medical Certainty (Princeton, NJ: Princeton University Press, 1995); Caroline Jean Acker, 'Addiction and the Laboratory: The Work of the National Research Council's Committee on Drug Addiction, 1928-1939', Isis, Vol. 86 (1995), 167-193. On drug regulation, see Henk J.H.W. Bodewitz, Henk Buurma and Gerard H. de Vries, 'Regulatory Science and the Social Management of Trust in Medicine', in Wiebe E. Bijker, Thomas P. Hughes and Trevor J. Pinch (eds), The Social Construction of Technological Systems: New Directions in the Sociology and History of Technology (Cambridge, MA: MIT Press, 1987), 243-59; Sheila Jasanoff, The Fifth Branch: Science Advisers as Policymakers (Cambridge, MA: Harvard University Press, 1990); John Abraham, 'Distributing the Benefit of the Doubt: Scientists, Regulators, and Drug Safety', Science, Technology, & Human Values, Vol. 19, No. 4 (Autumn 1994), 493-522; Theodore M. Porter, Trust in Numbers: The Pursuit of Objectivity in Science and Public Life (Princeton, NJ: Princeton University Press, 1995), 203-16. The analysis in this paper presumes, and contributes to, the literature that extends the sociology of scientific knowledge to the study of biomedicine. See Richards (1991, above); Monica J. Casper and Marc Berg, 'Constructivist Perspectives on Medical Work; Medical Practices and Science and Technology Studies', Science, Technology, & Human Values, Vol. 20, No. 4 (Autumn 1995), 395-407.
3. A growing literature on clinical trials and drug regulation suggests the relevance of the sociology of scientific knowledge to this domain. On clinical trials, see Harry Milton Marks, Ideas as Reforms: Therapeutic Experiments and Medical Practice, 1900-1980 (unpublished doctoral dissertation, Massachusetts Institute of Technology, 1987); Evelleen Richards, 'The Politics of Therapeutic Evaluation: The Vitamin C and Cancer Controversy', Social Studies of Science, Vol. 18 (1988), 653-701; Richards, Vitamin C and Cancer: Medicine or Politics? (London: Macmillan; New York: St Martin's Press, 1991); Brian Wynne, 'Unruly Technology: Practical Rules, Impractical Discourses and Public Understanding', Social Studies of Science, Vol. 18 (1988), 147-67, esp. 162-63; Marcia Lynn Meldrum, 'Departing From the Design': The Randomized Clinical Trial in Historical Context, 1946-1970 (unpublished doctoral dissertation, State University of New York at Stony Brook, 1994); J. Rosser Matthews, Quantification and the Quest for Medical Certainty (Princeton, NJ: Princeton University Press, 1995); Caroline Jean Acker, 'Addiction and the Laboratory: The Work of the National Research Council's Committee on Drug Addiction, 1928-1939', Isis, Vol. 86 (1995), 167-193. On drug regulation, see Henk J.H.W. Bodewitz, Henk Buurma and Gerard H. de Vries, 'Regulatory Science and the Social Management of Trust in Medicine', in Wiebe E. Bijker, Thomas P. Hughes and Trevor J. Pinch (eds), The Social Construction of Technological Systems: New Directions in the Sociology and History of Technology (Cambridge, MA: MIT Press, 1987), 243-59; Sheila Jasanoff, The Fifth Branch: Science Advisers as Policymakers (Cambridge, MA: Harvard University Press, 1990); John Abraham, 'Distributing the Benefit of the Doubt: Scientists, Regulators, and Drug Safety', Science, Technology, & Human Values, Vol. 19, No. 4 (Autumn 1994), 493-522; Theodore M. Porter, Trust in Numbers: The Pursuit of Objectivity in Science and Public Life (Princeton, NJ: Princeton University Press, 1995), 203-16. The analysis in this paper presumes, and contributes to, the literature that extends the sociology of scientific knowledge to the study of biomedicine. See Richards (1991, above); Monica J. Casper and Marc Berg, 'Constructivist Perspectives on Medical Work; Medical Practices and Science and Technology Studies', Science, Technology, & Human Values, Vol. 20, No. 4 (Autumn 1995), 395-407.
4. A growing literature on clinical trials and drug regulation suggests the relevance of the sociology of scientific knowledge to this domain. On clinical trials, see Harry Milton Marks, Ideas as Reforms: Therapeutic Experiments and Medical Practice, 1900-1980 (unpublished doctoral dissertation, Massachusetts Institute of Technology, 1987); Evelleen Richards, 'The Politics of Therapeutic Evaluation: The Vitamin C and Cancer Controversy', Social Studies of Science, Vol. 18 (1988), 653-701; Richards, Vitamin C and Cancer: Medicine or Politics? (London: Macmillan; New York: St Martin's Press, 1991); Brian Wynne, 'Unruly Technology: Practical Rules, Impractical Discourses and Public Understanding', Social Studies of Science, Vol. 18 (1988), 147-67, esp. 162-63; Marcia Lynn Meldrum, 'Departing From the Design': The Randomized Clinical Trial in Historical Context, 1946-1970 (unpublished doctoral dissertation, State University of New York at Stony Brook, 1994); J. Rosser Matthews, Quantification and the Quest for Medical Certainty (Princeton, NJ: Princeton University Press, 1995); Caroline Jean Acker, 'Addiction and the Laboratory: The Work of the National Research Council's Committee on Drug Addiction, 1928-1939', Isis, Vol. 86 (1995), 167-193. On drug regulation, see Henk J.H.W. Bodewitz, Henk Buurma and Gerard H. de Vries, 'Regulatory Science and the Social Management of Trust in Medicine', in Wiebe E. Bijker, Thomas P. Hughes and Trevor J. Pinch (eds), The Social Construction of Technological Systems: New Directions in the Sociology and History of Technology (Cambridge, MA: MIT Press, 1987), 243-59; Sheila Jasanoff, The Fifth Branch: Science Advisers as Policymakers (Cambridge, MA: Harvard University Press, 1990); John Abraham, 'Distributing the Benefit of the Doubt: Scientists, Regulators, and Drug Safety', Science, Technology, & Human Values, Vol. 19, No. 4 (Autumn 1994), 493-522; Theodore M. Porter, Trust in Numbers: The Pursuit of Objectivity in Science and Public Life (Princeton, NJ: Princeton University Press, 1995), 203-16. The analysis in this paper presumes, and contributes to, the literature that extends the sociology of scientific knowledge to the study of biomedicine. See Richards (1991, above); Monica J. Casper and Marc Berg, 'Constructivist Perspectives on Medical Work; Medical Practices and Science and Technology Studies', Science, Technology, & Human Values, Vol. 20, No. 4 (Autumn 1995), 395-407.
5. A growing literature on clinical trials and drug regulation suggests the relevance of the sociology of scientific knowledge to this domain. On clinical trials, see Harry Milton Marks, Ideas as Reforms: Therapeutic Experiments and Medical Practice, 1900-1980 (unpublished doctoral dissertation, Massachusetts Institute of Technology, 1987); Evelleen Richards, 'The Politics of Therapeutic Evaluation: The Vitamin C and Cancer Controversy', Social Studies of Science, Vol. 18 (1988), 653-701; Richards, Vitamin C and Cancer: Medicine or Politics? (London: Macmillan; New York: St Martin's Press, 1991); Brian Wynne, 'Unruly Technology: Practical Rules, Impractical Discourses and Public Understanding', Social Studies of Science, Vol. 18 (1988), 147-67, esp. 162-63; Marcia Lynn Meldrum, 'Departing From the Design': The Randomized Clinical Trial in Historical Context, 1946-1970 (unpublished doctoral dissertation, State University of New York at Stony Brook, 1994); J. Rosser Matthews, Quantification and the Quest for Medical Certainty (Princeton, NJ: Princeton University Press, 1995); Caroline Jean Acker, 'Addiction and the Laboratory: The Work of the National Research Council's Committee on Drug Addiction, 1928-1939', Isis, Vol. 86 (1995), 167-193. On drug regulation, see Henk J.H.W. Bodewitz, Henk Buurma and Gerard H. de Vries, 'Regulatory Science and the Social Management of Trust in Medicine', in Wiebe E. Bijker, Thomas P. Hughes and Trevor J. Pinch (eds), The Social Construction of Technological Systems: New Directions in the Sociology and History of Technology (Cambridge, MA: MIT Press, 1987), 243-59; Sheila Jasanoff, The Fifth Branch: Science Advisers as Policymakers (Cambridge, MA: Harvard University Press, 1990); John Abraham, 'Distributing the Benefit of the Doubt: Scientists, Regulators, and Drug Safety', Science, Technology, & Human Values, Vol. 19, No. 4 (Autumn 1994), 493-522; Theodore M. Porter, Trust in Numbers: The Pursuit of Objectivity in Science and Public Life (Princeton, NJ: Princeton University Press, 1995), 203-16. The analysis in this paper presumes, and contributes to, the literature that extends the sociology of scientific knowledge to the study of biomedicine. See Richards (1991, above); Monica J. Casper and Marc Berg, 'Constructivist Perspectives on Medical Work; Medical Practices and Science and Technology Studies', Science, Technology, & Human Values, Vol. 20, No. 4 (Autumn 1995), 395-407.
6. A growing literature on clinical trials and drug regulation suggests the relevance of the sociology of scientific knowledge to this domain. On clinical trials, see Harry Milton Marks, Ideas as Reforms: Therapeutic Experiments and Medical Practice, 1900-1980 (unpublished doctoral dissertation, Massachusetts Institute of Technology, 1987); Evelleen Richards, 'The Politics of Therapeutic Evaluation: The Vitamin C and Cancer Controversy', Social Studies of Science, Vol. 18 (1988), 653-701; Richards, Vitamin C and Cancer: Medicine or Politics? (London: Macmillan; New York: St Martin's Press, 1991); Brian Wynne, 'Unruly Technology: Practical Rules, Impractical Discourses and Public Understanding', Social Studies of Science, Vol. 18 (1988), 147-67, esp. 162-63; Marcia Lynn Meldrum, 'Departing From the Design': The Randomized Clinical Trial in Historical Context, 1946-1970 (unpublished doctoral dissertation, State University of New York at Stony Brook, 1994); J. Rosser Matthews, Quantification and the Quest for Medical Certainty (Princeton, NJ: Princeton University Press, 1995); Caroline Jean Acker, 'Addiction and the Laboratory: The Work of the National Research Council's Committee on Drug Addiction, 1928-1939', Isis, Vol. 86 (1995), 167-193. On drug regulation, see Henk J.H.W. Bodewitz, Henk Buurma and Gerard H. de Vries, 'Regulatory Science and the Social Management of Trust in Medicine', in Wiebe E. Bijker, Thomas P. Hughes and Trevor J. Pinch (eds), The Social Construction of Technological Systems: New Directions in the Sociology and History of Technology (Cambridge, MA: MIT Press, 1987), 243-59; Sheila Jasanoff, The Fifth Branch: Science Advisers as Policymakers (Cambridge, MA: Harvard University Press, 1990); John Abraham, 'Distributing the Benefit of the Doubt: Scientists, Regulators, and Drug Safety', Science, Technology, & Human Values, Vol. 19, No. 4 (Autumn 1994), 493-522; Theodore M. Porter, Trust in Numbers: The Pursuit of Objectivity in Science and Public Life (Princeton, NJ: Princeton University Press, 1995), 203-16. The analysis in this paper presumes, and contributes to, the literature that extends the sociology of scientific knowledge to the study of biomedicine. See Richards (1991, above); Monica J. Casper and Marc Berg, 'Constructivist Perspectives on Medical Work; Medical Practices and Science and Technology Studies', Science, Technology, & Human Values, Vol. 20, No. 4 (Autumn 1995), 395-407.
7. A growing literature on clinical trials and drug regulation suggests the relevance of the sociology of scientific knowledge to this domain. On clinical trials, see Harry Milton Marks, Ideas as Reforms: Therapeutic Experiments and Medical Practice, 1900-1980 (unpublished doctoral dissertation, Massachusetts Institute of Technology, 1987); Evelleen Richards, 'The Politics of Therapeutic Evaluation: The Vitamin C and Cancer Controversy', Social Studies of Science, Vol. 18 (1988), 653-701; Richards, Vitamin C and Cancer: Medicine or Politics? (London: Macmillan; New York: St Martin's Press, 1991); Brian Wynne, 'Unruly Technology: Practical Rules, Impractical Discourses and Public Understanding', Social Studies of Science, Vol. 18 (1988), 147-67, esp. 162-63; Marcia Lynn Meldrum, 'Departing From the Design': The Randomized Clinical Trial in Historical Context, 1946-1970 (unpublished doctoral dissertation, State University of New York at Stony Brook, 1994); J. Rosser Matthews, Quantification and the Quest for Medical Certainty (Princeton, NJ: Princeton University Press, 1995); Caroline Jean Acker, 'Addiction and the Laboratory: The Work of the National Research Council's Committee on Drug Addiction, 1928-1939', Isis, Vol. 86 (1995), 167-193. On drug regulation, see Henk J.H.W. Bodewitz, Henk Buurma and Gerard H. de Vries, 'Regulatory Science and the Social Management of Trust in Medicine', in Wiebe E. Bijker, Thomas P. Hughes and Trevor J. Pinch (eds), The Social Construction of Technological Systems: New Directions in the Sociology and History of Technology (Cambridge, MA: MIT Press, 1987), 243-59; Sheila Jasanoff, The Fifth Branch: Science Advisers as Policymakers (Cambridge, MA: Harvard University Press, 1990); John Abraham, 'Distributing the Benefit of the Doubt: Scientists, Regulators, and Drug Safety', Science, Technology, & Human Values, Vol. 19, No. 4 (Autumn 1994), 493-522; Theodore M. Porter, Trust in Numbers: The Pursuit of Objectivity in Science and Public Life (Princeton, NJ: Princeton University Press, 1995), 203-16. The analysis in this paper presumes, and contributes to, the literature that extends the sociology of scientific knowledge to the study of biomedicine. See Richards (1991, above); Monica J. Casper and Marc Berg, 'Constructivist Perspectives on Medical Work; Medical Practices and Science and Technology Studies', Science, Technology, & Human Values, Vol. 20, No. 4 (Autumn 1995), 395-407.
8. A growing literature on clinical trials and drug regulation suggests the relevance of the sociology of scientific knowledge to this domain. On clinical trials, see Harry Milton Marks, Ideas as Reforms: Therapeutic Experiments and Medical Practice, 1900-1980 (unpublished doctoral dissertation, Massachusetts Institute of Technology, 1987); Evelleen Richards, 'The Politics of Therapeutic Evaluation: The Vitamin C and Cancer Controversy', Social Studies of Science, Vol. 18 (1988), 653-701; Richards, Vitamin C and Cancer: Medicine or Politics? (London: Macmillan; New York: St Martin's Press, 1991); Brian Wynne, 'Unruly Technology: Practical Rules, Impractical Discourses and Public Understanding', Social Studies of Science, Vol. 18 (1988), 147-67, esp. 162-63; Marcia Lynn Meldrum, 'Departing From the Design': The Randomized Clinical Trial in Historical Context, 1946-1970 (unpublished doctoral dissertation, State University of New York at Stony Brook, 1994); J. Rosser Matthews, Quantification and the Quest for Medical Certainty (Princeton, NJ: Princeton University Press, 1995); Caroline Jean Acker, 'Addiction and the Laboratory: The Work of the National Research Council's Committee on Drug Addiction, 1928-1939', Isis, Vol. 86 (1995), 167-193. On drug regulation, see Henk J.H.W. Bodewitz, Henk Buurma and Gerard H. de Vries, 'Regulatory Science and the Social Management of Trust in Medicine', in Wiebe E. Bijker, Thomas P. Hughes and Trevor J. Pinch (eds), The Social Construction of Technological Systems: New Directions in the Sociology and History of Technology (Cambridge, MA: MIT Press, 1987), 243-59; Sheila Jasanoff, The Fifth Branch: Science Advisers as Policymakers (Cambridge, MA: Harvard University Press, 1990); John Abraham, 'Distributing the Benefit of the Doubt: Scientists, Regulators, and Drug Safety', Science, Technology, & Human Values, Vol. 19, No. 4 (Autumn 1994), 493-522; Theodore M. Porter, Trust in Numbers: The Pursuit of Objectivity in Science and Public Life (Princeton, NJ: Princeton University Press, 1995), 203-16. The analysis in this paper presumes, and contributes to, the literature that extends the sociology of scientific knowledge to the study of biomedicine. See Richards (1991, above); Monica J. Casper and Marc Berg, 'Constructivist Perspectives on Medical Work; Medical Practices and Science and Technology Studies', Science, Technology, & Human Values, Vol. 20, No. 4 (Autumn 1995), 395-407.
9. A growing literature on clinical trials and drug regulation suggests the relevance of the sociology of scientific knowledge to this domain. On clinical trials, see Harry Milton Marks, Ideas as Reforms: Therapeutic Experiments and Medical Practice, 1900-1980 (unpublished doctoral dissertation, Massachusetts Institute of Technology, 1987); Evelleen Richards, 'The Politics of Therapeutic Evaluation: The Vitamin C and Cancer Controversy', Social Studies of Science, Vol. 18 (1988), 653-701; Richards, Vitamin C and Cancer: Medicine or Politics? (London: Macmillan; New York: St Martin's Press, 1991); Brian Wynne, 'Unruly Technology: Practical Rules, Impractical Discourses and Public Understanding', Social Studies of Science, Vol. 18 (1988), 147-67, esp. 162-63; Marcia Lynn Meldrum, 'Departing From the Design': The Randomized Clinical Trial in Historical Context, 1946-1970 (unpublished doctoral dissertation, State University of New York at Stony Brook, 1994); J. Rosser Matthews, Quantification and the Quest for Medical Certainty (Princeton, NJ: Princeton University Press, 1995); Caroline Jean Acker, 'Addiction and the Laboratory: The Work of the National Research Council's Committee on Drug Addiction, 1928-1939', Isis, Vol. 86 (1995), 167-193. On drug regulation, see Henk J.H.W. Bodewitz, Henk Buurma and Gerard H. de Vries, 'Regulatory Science and the Social Management of Trust in Medicine', in Wiebe E. Bijker, Thomas P. Hughes and Trevor J. Pinch (eds), The Social Construction of Technological Systems: New Directions in the Sociology and History of Technology (Cambridge, MA: MIT Press, 1987), 243-59; Sheila Jasanoff, The Fifth Branch: Science Advisers as Policymakers (Cambridge, MA: Harvard University Press, 1990); John Abraham, 'Distributing the Benefit of the Doubt: Scientists, Regulators, and Drug Safety', Science, Technology, & Human Values, Vol. 19, No. 4 (Autumn 1994), 493-522; Theodore M. Porter, Trust in Numbers: The Pursuit of Objectivity in Science and Public Life (Princeton, NJ: Princeton University Press, 1995), 203-16. The analysis in this paper presumes, and contributes to, the literature that extends the sociology of scientific knowledge to the study of biomedicine. See Richards (1991, above); Monica J. Casper and Marc Berg, 'Constructivist Perspectives on Medical Work; Medical Practices and Science and Technology Studies', Science, Technology, & Human Values, Vol. 20, No. 4 (Autumn 1995), 395-407.
10. A growing literature on clinical trials and drug regulation suggests the relevance of the sociology of scientific knowledge to this domain. On clinical trials, see Harry Milton Marks, Ideas as Reforms: Therapeutic Experiments and Medical Practice, 1900-1980 (unpublished doctoral dissertation, Massachusetts Institute of Technology, 1987); Evelleen Richards, 'The Politics of Therapeutic Evaluation: The Vitamin C and Cancer Controversy', Social Studies of Science, Vol. 18 (1988), 653-701; Richards, Vitamin C and Cancer: Medicine or Politics? (London: Macmillan; New York: St Martin's Press, 1991); Brian Wynne, 'Unruly Technology: Practical Rules, Impractical Discourses and Public Understanding', Social Studies of Science, Vol. 18 (1988), 147-67, esp. 162-63; Marcia Lynn Meldrum, 'Departing From the Design': The Randomized Clinical Trial in Historical Context, 1946-1970 (unpublished doctoral dissertation, State University of New York at Stony Brook, 1994); J. Rosser Matthews, Quantification and the Quest for Medical Certainty (Princeton, NJ: Princeton University Press, 1995); Caroline Jean Acker, 'Addiction and the Laboratory: The Work of the National Research Council's Committee on Drug Addiction, 1928-1939', Isis, Vol. 86 (1995), 167-193. On drug regulation, see Henk J.H.W. Bodewitz, Henk Buurma and Gerard H. de Vries, 'Regulatory Science and the Social Management of Trust in Medicine', in Wiebe E. Bijker, Thomas P. Hughes and Trevor J. Pinch (eds), The Social Construction of Technological Systems: New Directions in the Sociology and History of Technology (Cambridge, MA: MIT Press, 1987), 243-59; Sheila Jasanoff, The Fifth Branch: Science Advisers as Policymakers (Cambridge, MA: Harvard University Press, 1990); John Abraham, 'Distributing the Benefit of the Doubt: Scientists, Regulators, and Drug Safety', Science, Technology, & Human Values, Vol. 19, No. 4 (Autumn 1994), 493-522; Theodore M. Porter, Trust in Numbers: The Pursuit of Objectivity in Science and Public Life (Princeton, NJ: Princeton University Press, 1995), 203-16. The analysis in this paper presumes, and contributes to, the literature that extends the sociology of scientific knowledge to the study of biomedicine. See Richards (1991, above); Monica J. Casper and Marc Berg, 'Constructivist Perspectives on Medical Work; Medical Practices and Science and Technology Studies', Science, Technology, & Human Values, Vol. 20, No. 4 (Autumn 1995), 395-407.
11. A growing literature on clinical trials and drug regulation suggests the relevance of the sociology of scientific knowledge to this domain. On clinical trials, see Harry Milton Marks, Ideas as Reforms: Therapeutic Experiments and Medical Practice, 1900-1980 (unpublished doctoral dissertation, Massachusetts Institute of Technology, 1987); Evelleen Richards, 'The Politics of Therapeutic Evaluation: The Vitamin C and Cancer Controversy', Social Studies of Science, Vol. 18 (1988), 653-701; Richards, Vitamin C and Cancer: Medicine or Politics? (London: Macmillan; New York: St Martin's Press, 1991); Brian Wynne, 'Unruly Technology: Practical Rules, Impractical Discourses and Public Understanding', Social Studies of Science, Vol. 18 (1988), 147-67, esp. 162-63; Marcia Lynn Meldrum, 'Departing From the Design': The Randomized Clinical Trial in Historical Context, 1946-1970 (unpublished doctoral dissertation, State University of New York at Stony Brook, 1994); J. Rosser Matthews, Quantification and the Quest for Medical Certainty (Princeton, NJ: Princeton University Press, 1995); Caroline Jean Acker, 'Addiction and the Laboratory: The Work of the National Research Council's Committee on Drug Addiction, 1928-1939', Isis, Vol. 86 (1995), 167-193. On drug regulation, see Henk J.H.W. Bodewitz, Henk Buurma and Gerard H. de Vries, 'Regulatory Science and the Social Management of Trust in Medicine', in Wiebe E. Bijker, Thomas P. Hughes and Trevor J. Pinch (eds), The Social Construction of Technological Systems: New Directions in the Sociology and History of Technology (Cambridge, MA: MIT Press, 1987), 243-59; Sheila Jasanoff, The Fifth Branch: Science Advisers as Policymakers (Cambridge, MA: Harvard University Press, 1990); John Abraham, 'Distributing the Benefit of the Doubt: Scientists, Regulators, and Drug Safety', Science, Technology, & Human Values, Vol. 19, No. 4 (Autumn 1994), 493-522; Theodore M. Porter, Trust in Numbers: The Pursuit of Objectivity in Science and Public Life (Princeton, NJ: Princeton University Press, 1995), 203-16. The analysis in this paper presumes, and contributes to, the literature that extends the sociology of scientific knowledge to the study of biomedicine. See Richards (1991, above); Monica J. Casper and Marc Berg, 'Constructivist Perspectives on Medical Work; Medical Practices and Science and Technology Studies', Science, Technology, & Human Values, Vol. 20, No. 4 (Autumn 1995), 395-407.
12. A growing literature on clinical trials and drug regulation suggests the relevance of the sociology of scientific knowledge to this domain. On clinical trials, see Harry Milton Marks, Ideas as Reforms: Therapeutic Experiments and Medical Practice, 1900-1980 (unpublished doctoral dissertation, Massachusetts Institute of Technology, 1987); Evelleen Richards, 'The Politics of Therapeutic Evaluation: The Vitamin C and Cancer Controversy', Social Studies of Science, Vol. 18 (1988), 653-701; Richards, Vitamin C and Cancer: Medicine or Politics? (London: Macmillan; New York: St Martin's Press, 1991); Brian Wynne, 'Unruly Technology: Practical Rules, Impractical Discourses and Public Understanding', Social Studies of Science, Vol. 18 (1988), 147-67, esp. 162-63; Marcia Lynn Meldrum, 'Departing From the Design': The Randomized Clinical Trial in Historical Context, 1946-1970 (unpublished doctoral dissertation, State University of New York at Stony Brook, 1994); J. Rosser Matthews, Quantification and the Quest for Medical Certainty (Princeton, NJ: Princeton University Press, 1995); Caroline Jean Acker, 'Addiction and the Laboratory: The Work of the National Research Council's Committee on Drug Addiction, 1928-1939', Isis, Vol. 86 (1995), 167-193. On drug regulation, see Henk J.H.W. Bodewitz, Henk Buurma and Gerard H. de Vries, 'Regulatory Science and the Social Management of Trust in Medicine', in Wiebe E. Bijker, Thomas P. Hughes and Trevor J. Pinch (eds), The Social Construction of Technological Systems: New Directions in the Sociology and History of Technology (Cambridge, MA: MIT Press, 1987), 243-59; Sheila Jasanoff, The Fifth Branch: Science Advisers as Policymakers (Cambridge, MA: Harvard University Press, 1990); John Abraham, 'Distributing the Benefit of the Doubt: Scientists, Regulators, and Drug Safety', Science, Technology, & Human Values, Vol. 19, No. 4 (Autumn 1994), 493-522; Theodore M. Porter, Trust in Numbers: The Pursuit of Objectivity in Science and Public Life (Princeton, NJ: Princeton University Press, 1995), 203-16. The analysis in this paper presumes, and contributes to, the literature that extends the sociology of scientific knowledge to the study of biomedicine. See Richards (1991, above); Monica J. Casper and Marc Berg, 'Constructivist Perspectives on Medical Work; Medical Practices and Science and Technology Studies', Science, Technology, & Human Values, Vol. 20, No. 4 (Autumn 1995), 395-407.
13. Meldrum, op. cit. note 1, 384-86.
14. On AIDS treatment activism, see Steven Epstein, Impure Science: AIDS, Activism, and the Politics of Knowledge (Berkeley, CA: University of California Press, 1996); Dennis Altman, Power and Community: Organizational and Cultural Responses to AIDS (London: Taylor & Francis, 1994); Peter S. Arno and Karyn L. Feiden, Against the Odds: The Story of AIDS Drug Development, Politics, and Profits (New York: Harper Collins, 1992); Gena Corea, The Invisible Epidemic: The Story of Women and AIDS (New York: Harper Collins, 1992); Douglas Crimp and Adam Rolston, AIDS Demographics (Seattle, WA: Bay Press, 1990); Gilbert Elbaz, The Sociology of AIDS Activism: The Case of ACT UP/New York, 1987-1992 (unpublished doctoral dissertation, City University of New York, 1992); Debbie Indyk and David A. Rier, 'Grassroots AIDS Knowledge: Implications for the Boundaries of Science and Collective Action', Knowledge: Creation, Diffusion, Utilization, Vol. 15 (September 1993), 3-43; Jonathan Kwitny, Acceptable Risks (New York: Poseidon Press, 1992); Cindy Patton, Inventing AIDS (New York: Routledge, 1990); Paula A. Treichler, 'How to Have Theory in an Epidemic: The Evolution of AIDS Treatment Activism', in Constance Penley and Andrew Ross (eds), Technoculture (Minneapolis, MN: University of Minnesota Press, 1991), 57-106.
15. On AIDS treatment activism, see Steven Epstein, Impure Science: AIDS, Activism, and the Politics of Knowledge (Berkeley, CA: University of California Press, 1996); Dennis Altman, Power and Community: Organizational and Cultural Responses to AIDS (London: Taylor & Francis, 1994); Peter S. Arno and Karyn L. Feiden, Against the Odds: The Story of AIDS Drug Development, Politics, and Profits (New York: Harper Collins, 1992); Gena Corea, The Invisible Epidemic: The Story of Women and AIDS (New York: Harper Collins, 1992); Douglas Crimp and Adam Rolston, AIDS Demographics (Seattle, WA: Bay Press, 1990); Gilbert Elbaz, The Sociology of AIDS Activism: The Case of ACT UP/New York, 1987-1992 (unpublished doctoral dissertation, City University of New York, 1992); Debbie Indyk and David A. Rier, 'Grassroots AIDS Knowledge: Implications for the Boundaries of Science and Collective Action', Knowledge: Creation, Diffusion, Utilization, Vol. 15 (September 1993), 3-43; Jonathan Kwitny, Acceptable Risks (New York: Poseidon Press, 1992); Cindy Patton, Inventing AIDS (New York: Routledge, 1990); Paula A. Treichler, 'How to Have Theory in an Epidemic: The Evolution of AIDS Treatment Activism', in Constance Penley and Andrew Ross (eds), Technoculture (Minneapolis, MN: University of Minnesota Press, 1991), 57-106.
16. On AIDS treatment activism, see Steven Epstein, Impure Science: AIDS, Activism, and the Politics of Knowledge (Berkeley, CA: University of California Press, 1996); Dennis Altman, Power and Community: Organizational and Cultural Responses to AIDS (London: Taylor & Francis, 1994); Peter S. Arno and Karyn L. Feiden, Against the Odds: The Story of AIDS Drug Development, Politics, and Profits (New York: Harper Collins, 1992); Gena Corea, The Invisible Epidemic: The Story of Women and AIDS (New York: Harper Collins, 1992); Douglas Crimp and Adam Rolston, AIDS Demographics (Seattle, WA: Bay Press, 1990); Gilbert Elbaz, The Sociology of AIDS Activism: The Case of ACT UP/New York, 1987-1992 (unpublished doctoral dissertation, City University of New York, 1992); Debbie Indyk and David A. Rier, 'Grassroots AIDS Knowledge: Implications for the Boundaries of Science and Collective Action', Knowledge: Creation, Diffusion, Utilization, Vol. 15 (September 1993), 3-43; Jonathan Kwitny, Acceptable Risks (New York: Poseidon Press, 1992); Cindy Patton, Inventing AIDS (New York: Routledge, 1990); Paula A. Treichler, 'How to Have Theory in an Epidemic: The Evolution of AIDS Treatment Activism', in Constance Penley and Andrew Ross (eds), Technoculture (Minneapolis, MN: University of Minnesota Press, 1991), 57-106.
17. On AIDS treatment activism, see Steven Epstein, Impure Science: AIDS, Activism, and the Politics of Knowledge (Berkeley, CA: University of California Press, 1996); Dennis Altman, Power and Community: Organizational and Cultural Responses to AIDS (London: Taylor & Francis, 1994); Peter S. Arno and Karyn L. Feiden, Against the Odds: The Story of AIDS Drug Development, Politics, and Profits (New York: Harper Collins, 1992); Gena Corea, The Invisible Epidemic: The Story of Women and AIDS (New York: Harper Collins, 1992); Douglas Crimp and Adam Rolston, AIDS Demographics (Seattle, WA: Bay Press, 1990); Gilbert Elbaz, The Sociology of AIDS Activism: The Case of ACT UP/New York, 1987-1992 (unpublished doctoral dissertation, City University of New York, 1992); Debbie Indyk and David A. Rier, 'Grassroots AIDS Knowledge: Implications for the Boundaries of Science and Collective Action', Knowledge: Creation, Diffusion, Utilization, Vol. 15 (September 1993), 3-43; Jonathan Kwitny, Acceptable Risks (New York: Poseidon Press, 1992); Cindy Patton, Inventing AIDS (New York: Routledge, 1990); Paula A. Treichler, 'How to Have Theory in an Epidemic: The Evolution of AIDS Treatment Activism', in Constance Penley and Andrew Ross (eds), Technoculture (Minneapolis, MN: University of Minnesota Press, 1991), 57-106.
18. On AIDS treatment activism, see Steven Epstein, Impure Science: AIDS, Activism, and the Politics of Knowledge (Berkeley, CA: University of California Press, 1996); Dennis Altman, Power and Community: Organizational and Cultural Responses to AIDS (London: Taylor & Francis, 1994); Peter S. Arno and Karyn L. Feiden, Against the Odds: The Story of AIDS Drug Development, Politics, and Profits (New York: Harper Collins, 1992); Gena Corea, The Invisible Epidemic: The Story of Women and AIDS (New York: Harper Collins, 1992); Douglas Crimp and Adam Rolston, AIDS Demographics (Seattle, WA: Bay Press, 1990); Gilbert Elbaz, The Sociology of AIDS Activism: The Case of ACT UP/New York, 1987-1992 (unpublished doctoral dissertation, City University of New York, 1992); Debbie Indyk and David A. Rier, 'Grassroots AIDS Knowledge: Implications for the Boundaries of Science and Collective Action', Knowledge: Creation, Diffusion, Utilization, Vol. 15 (September 1993), 3-43; Jonathan Kwitny, Acceptable Risks (New York: Poseidon Press, 1992); Cindy Patton, Inventing AIDS (New York: Routledge, 1990); Paula A. Treichler, 'How to Have Theory in an Epidemic: The Evolution of AIDS Treatment Activism', in Constance Penley and Andrew Ross (eds), Technoculture (Minneapolis, MN: University of Minnesota Press, 1991), 57-106.
19. On AIDS treatment activism, see Steven Epstein, Impure Science: AIDS, Activism, and the Politics of Knowledge (Berkeley, CA: University of California Press, 1996); Dennis Altman, Power and Community: Organizational and Cultural Responses to AIDS (London: Taylor & Francis, 1994); Peter S. Arno and Karyn L. Feiden, Against the Odds: The Story of AIDS Drug Development, Politics, and Profits (New York: Harper Collins, 1992); Gena Corea, The Invisible Epidemic: The Story of Women and AIDS (New York: Harper Collins, 1992); Douglas Crimp and Adam Rolston, AIDS Demographics (Seattle, WA: Bay Press, 1990); Gilbert Elbaz, The Sociology of AIDS Activism: The Case of ACT UP/New York, 1987-1992 (unpublished doctoral dissertation, City University of New York, 1992); Debbie Indyk and David A. Rier, 'Grassroots AIDS Knowledge: Implications for the Boundaries of Science and Collective Action', Knowledge: Creation, Diffusion, Utilization, Vol. 15 (September 1993), 3-43; Jonathan Kwitny, Acceptable Risks (New York: Poseidon Press, 1992); Cindy Patton, Inventing AIDS (New York: Routledge, 1990); Paula A. Treichler, 'How to Have Theory in an Epidemic: The Evolution of AIDS Treatment Activism', in Constance Penley and Andrew Ross (eds), Technoculture (Minneapolis, MN: University of Minnesota Press, 1991), 57-106.
20. On AIDS treatment activism, see Steven Epstein, Impure Science: AIDS, Activism, and the Politics of Knowledge (Berkeley, CA: University of California Press, 1996); Dennis Altman, Power and Community: Organizational and Cultural Responses to AIDS (London: Taylor & Francis, 1994); Peter S. Arno and Karyn L. Feiden, Against the Odds: The Story of AIDS Drug Development, Politics, and Profits (New York: Harper Collins, 1992); Gena Corea, The Invisible Epidemic: The Story of Women and AIDS (New York: Harper Collins, 1992); Douglas Crimp and Adam Rolston, AIDS Demographics (Seattle, WA: Bay Press, 1990); Gilbert Elbaz, The Sociology of AIDS Activism: The Case of ACT UP/New York, 1987-1992 (unpublished doctoral dissertation, City University of New York, 1992); Debbie Indyk and David A. Rier, 'Grassroots AIDS Knowledge: Implications for the Boundaries of Science and Collective Action', Knowledge: Creation, Diffusion, Utilization, Vol. 15 (September 1993), 3-43; Jonathan Kwitny, Acceptable Risks (New York: Poseidon Press, 1992); Cindy Patton, Inventing AIDS (New York: Routledge, 1990); Paula A. Treichler, 'How to Have Theory in an Epidemic: The Evolution of AIDS Treatment Activism', in Constance Penley and Andrew Ross (eds), Technoculture (Minneapolis, MN: University of Minnesota Press, 1991), 57-106.
21. On AIDS treatment activism, see Steven Epstein, Impure Science: AIDS, Activism, and the Politics of Knowledge (Berkeley, CA: University of California Press, 1996); Dennis Altman, Power and Community: Organizational and Cultural Responses to AIDS (London: Taylor & Francis, 1994); Peter S. Arno and Karyn L. Feiden, Against the Odds: The Story of AIDS Drug Development, Politics, and Profits (New York: Harper Collins, 1992); Gena Corea, The Invisible Epidemic: The Story of Women and AIDS (New York: Harper Collins, 1992); Douglas Crimp and Adam Rolston, AIDS Demographics (Seattle, WA: Bay Press, 1990); Gilbert Elbaz, The Sociology of AIDS Activism: The Case of ACT UP/New York, 1987-1992 (unpublished doctoral dissertation, City University of New York, 1992); Debbie Indyk and David A. Rier, 'Grassroots AIDS Knowledge: Implications for the Boundaries of Science and Collective Action', Knowledge: Creation, Diffusion, Utilization, Vol. 15 (September 1993), 3-43; Jonathan Kwitny, Acceptable Risks (New York: Poseidon Press, 1992); Cindy Patton, Inventing AIDS (New York: Routledge, 1990); Paula A. Treichler, 'How to Have Theory in an Epidemic: The Evolution of AIDS Treatment Activism', in Constance Penley and Andrew Ross (eds), Technoculture (Minneapolis, MN: University of Minnesota Press, 1991), 57-106.
22. On AIDS treatment activism, see Steven Epstein, Impure Science: AIDS, Activism, and the Politics of Knowledge (Berkeley, CA: University of California Press, 1996); Dennis Altman, Power and Community: Organizational and Cultural Responses to AIDS (London: Taylor & Francis, 1994); Peter S. Arno and Karyn L. Feiden, Against the Odds: The Story of AIDS Drug Development, Politics, and Profits (New York: Harper Collins, 1992); Gena Corea, The Invisible Epidemic: The Story of Women and AIDS (New York: Harper Collins, 1992); Douglas Crimp and Adam Rolston, AIDS Demographics (Seattle, WA: Bay Press, 1990); Gilbert Elbaz, The Sociology of AIDS Activism: The Case of ACT UP/New York, 1987-1992 (unpublished doctoral dissertation, City University of New York, 1992); Debbie Indyk and David A. Rier, 'Grassroots AIDS Knowledge: Implications for the Boundaries of Science and Collective Action', Knowledge: Creation, Diffusion, Utilization, Vol. 15 (September 1993), 3-43; Jonathan Kwitny, Acceptable Risks (New York: Poseidon Press, 1992); Cindy Patton, Inventing AIDS (New York: Routledge, 1990); Paula A. Treichler, 'How to Have Theory in an Epidemic: The Evolution of AIDS Treatment Activism', in Constance Penley and Andrew Ross (eds), Technoculture (Minneapolis, MN: University of Minnesota Press, 1991), 57-106.
23. On AIDS treatment activism, see Steven Epstein, Impure Science: AIDS, Activism, and the Politics of Knowledge (Berkeley, CA: University of California Press, 1996); Dennis Altman, Power and Community: Organizational and Cultural Responses to AIDS (London: Taylor & Francis, 1994); Peter S. Arno and Karyn L. Feiden, Against the Odds: The Story of AIDS Drug Development, Politics, and Profits (New York: Harper Collins, 1992); Gena Corea, The Invisible Epidemic: The Story of Women and AIDS (New York: Harper Collins, 1992); Douglas Crimp and Adam Rolston, AIDS Demographics (Seattle, WA: Bay Press, 1990); Gilbert Elbaz, The Sociology of AIDS Activism: The Case of ACT UP/New York, 1987-1992 (unpublished doctoral dissertation, City University of New York, 1992); Debbie Indyk and David A. Rier, 'Grassroots AIDS Knowledge: Implications for the Boundaries of Science and Collective Action', Knowledge: Creation, Diffusion, Utilization, Vol. 15 (September 1993), 3-43; Jonathan Kwitny, Acceptable Risks (New York: Poseidon Press, 1992); Cindy Patton, Inventing AIDS (New York: Routledge, 1990); Paula A. Treichler, 'How to Have Theory in an Epidemic: The Evolution of AIDS Treatment Activism', in Constance Penley and Andrew Ross (eds), Technoculture (Minneapolis, MN: University of Minnesota Press, 1991), 57-106.
24. Richards (1988), op. cit. note 1.
25. On core sets and debates over how their dimensions and composition might best be conceived, see H.M. Collins, Changing Order: Replication and Induction in Scientific Practice, 2nd edn (Chicago, IL: The University of Chicago Press, 1992), 142-45; Brian Wynne, 'Public Uptake of Science: A Case for Institutional Reflexivity', Public Understanding of Science, Vol. 2 (1993), 321-37; Hilary Arksey, 'Expert and Lay Participation in the Construction of Medical Knowledge', Sociology of Health & Illness, Vol. 16 (1994), 448-68; Mike Michael and Lynda Birke, 'Enrolling the Core Set: The Case of the Animal Experimentation Controversy', Social Studies of Science, Vol. 24 (1994), 81-95; Evelleen Richards, '(Un)boxing the Monster', ibid., Vol. 26 (1996), 323-56.
26. On core sets and debates over how their dimensions and composition might best be conceived, see H.M. Collins, Changing Order: Replication and Induction in Scientific Practice, 2nd edn (Chicago, IL: The University of Chicago Press, 1992), 142-45; Brian Wynne, 'Public Uptake of Science: A Case for Institutional Reflexivity', Public Understanding of Science, Vol. 2 (1993), 321-37; Hilary Arksey, 'Expert and Lay Participation in the Construction of Medical Knowledge', Sociology of Health & Illness, Vol. 16 (1994), 448-68; Mike Michael and Lynda Birke, 'Enrolling the Core Set: The Case of the Animal Experimentation Controversy', Social Studies of Science, Vol. 24 (1994), 81-95; Evelleen Richards, '(Un)boxing the Monster', ibid., Vol. 26 (1996), 323-56.
27. On core sets and debates over how their dimensions and composition might best be conceived, see H.M. Collins, Changing Order: Replication and Induction in Scientific Practice, 2nd edn (Chicago, IL: The University of Chicago Press, 1992), 142-45; Brian Wynne, 'Public Uptake of Science: A Case for Institutional Reflexivity', Public Understanding of Science, Vol. 2 (1993), 321-37; Hilary Arksey, 'Expert and Lay Participation in the Construction of Medical Knowledge', Sociology of Health & Illness, Vol. 16 (1994), 448-68; Mike Michael and Lynda Birke, 'Enrolling the Core Set: The Case of the Animal Experimentation Controversy', Social Studies of Science, Vol. 24 (1994), 81-95; Evelleen Richards, '(Un)boxing the Monster', ibid., Vol. 26 (1996), 323-56.
28. On core sets and debates over how their dimensions and composition might best be conceived, see H.M. Collins, Changing Order: Replication and Induction in Scientific Practice, 2nd edn (Chicago, IL: The University of Chicago Press, 1992), 142-45; Brian Wynne, 'Public Uptake of Science: A Case for Institutional Reflexivity', Public Understanding of Science, Vol. 2 (1993), 321-37; Hilary Arksey, 'Expert and Lay Participation in the Construction of Medical Knowledge', Sociology of Health & Illness, Vol. 16 (1994), 448-68; Mike Michael and Lynda Birke, 'Enrolling the Core Set: The Case of the Animal Experimentation Controversy', Social Studies of Science, Vol. 24 (1994), 81-95; Evelleen Richards, '(Un)boxing the Monster', ibid., Vol. 26 (1996), 323-56.
29. On core sets and debates over how their dimensions and composition might best be conceived, see H.M. Collins, Changing Order: Replication and Induction in Scientific Practice, 2nd edn (Chicago, IL: The University of Chicago Press, 1992), 142-45; Brian Wynne, 'Public Uptake of Science: A Case for Institutional Reflexivity', Public Understanding of Science, Vol. 2 (1993), 321-37; Hilary Arksey, 'Expert and Lay Participation in the Construction of Medical Knowledge', Sociology of Health & Illness, Vol. 16 (1994), 448-68; Mike Michael and Lynda Birke, 'Enrolling the Core Set: The Case of the Animal Experimentation Controversy', Social Studies of Science, Vol. 24 (1994), 81-95; Evelleen Richards, '(Un)boxing the Monster', ibid., Vol. 26 (1996), 323-56.
30. In keeping with Steven Shapin's injunction against the telling of global metanarratives about credibility and its workings in scientific practice, this study seeks to understand a specific, if instructive case marked by highly public negotiations and crucially involving the participation of 'lay experts': see Steven Shapin, 'Cordelia's Love: Credibility, Validity, and the Social Studies of Science', Perspectives on Science, Vol. 3 (1995), 255-75, esp. 261.
31. My analysis is based in part on extensive study of documentary sources, including scientific and medical journal articles; discussions in both the mass media and the gay press; activist publications; government documents; and transcripts of conferences and meetings. In addition, I rely on interview data drawn from open-ended interviews with many of the participants in the United States, including AIDS researchers, AIDS treatment activists, and government health officials. Some of the material presented in this study also appears in Epstein, op. cit. note 3.
32. The CD4 count is a laboratory test that determines the number of CD4 cells (also called 'helper T cells' or, more colloquially, 'T cells') per cubic millimeter of blood. Because HIV, the human immunodeficiency virus, infects and destroys CD4 cells, the progression of HIV disease typically is marked by a gradual decline in CD4 count. A 'normal' CD4 count ranges between 600 and 1200 cells per cubic millimeter. Persons with fewer than 200 cells per cubic millimeter are considered at risk of contracting the opportunistic infections associated with AIDS.
33. On the role of 'standing-for' (or metonymic) relationships in the construction of scientific credibility, see Shapin, op. cit. note 6.
34. On the sociology of testing, see also Donald MacKenzie, Inventing Accuracy: A Historical Sociology of Nuclear Missile Guidance (Cambridge, MA: MIT Press, 1990); Trevor Pinch, '"Testing - One, Two Three . . . Testing!": Toward a Sociology of Testing', Science, Technology, & Human Values, Vol. 18, No. 1 (Winter 1993), 25-41; Adele Clarke and Theresa Montini, 'The Many Faces of RU486: Tales of Situated Knowledges and Technological Contestations', ibid., 42-78.
35. On the sociology of testing, see also Donald MacKenzie, Inventing Accuracy: A Historical Sociology of Nuclear Missile Guidance (Cambridge, MA: MIT Press, 1990); Trevor Pinch, '"Testing - One, Two Three . . . Testing!": Toward a Sociology of Testing', Science, Technology, & Human Values, Vol. 18, No. 1 (Winter 1993), 25-41; Adele Clarke and Theresa Montini, 'The Many Faces of RU486: Tales of Situated Knowledges and Technological Contestations', ibid., 42-78.
36. On the sociology of testing, see also Donald MacKenzie, Inventing Accuracy: A Historical Sociology of Nuclear Missile Guidance (Cambridge, MA: MIT Press, 1990); Trevor Pinch, '"Testing - One, Two Three . . . Testing!": Toward a Sociology of Testing', Science, Technology, & Human Values, Vol. 18, No. 1 (Winter 1993), 25-41; Adele Clarke and Theresa Montini, 'The Many Faces of RU486: Tales of Situated Knowledges and Technological Contestations', ibid., 42-78.
37. See, for example, Samuel Broder, 'Controlled Trial Methodology and Progress in Treatment of the Acquired Immunodeficiency Syndrome (AIDS): A Quid Pro Quo', Annals of Internal Medicine, Vol. 110 (15 March 1989), 417-18.
38. See the published report of the study in Tze-Chiang Meng, Margaret A. Fischl et al., 'Combination Therapy with Zidovudine and Dideoxycytidine in Patients with Advanced Human Immunodeficiency Virus Infection: A Phase I/II Study', Annals of Internal Medicine, Vol. 116 (1 January 1992), 13-20.
39. John S. James, 'ddc Background', AIDS Treatment News, No. 145 (21 February 1992). [Note: I access this newsletter through the Internet, where no page numbers are cited.]
40. All quotes from Meng et al., op. cit. note 12, 18-19.
41. G'dali Braverman, taped interview (San Francisco, CA, 17 December 1993).
42. On FDA licensing procedures and how they have been modified in recent years in response to the pressures exerted both by AEDS activists and by proponents of deregulation, see Albert R. Jonson and Jeff Stryker (eds), The Social Impact of AIDS in the United States (Washington, DC: National Academy Press, 1993), Chapter 4.
43. David Feigal, taped interview (Bethesda, MD, 1 November 1994).
44. All quotes from James, op. cit. note 13.
45. Gina Kolata, 'AIDS Researcher Seeks Wide Access to Drugs in Tests,' New York Times (26 June 1989), A-1.
46. Warren J. Blumenfeld, 'FDA, Buyers Clubs Negotiate New Relationship', Advocate (19 November 1991), 62-63.
47. Gina Kolata, 'Patients Going Underground to Buy Experimental Drugs', New York Times (4 November 1991), A-1.
48. Ibid.
49. Rachel Nowak, 'Conditional Approval Touted', Nature, Vol. 352 (8 August 1991), 464.
50. Quotes from Blumenfeld, op. cit. note 20, 63.
51. All quotes from John S. James, 'ddc: AZT Combination Approval Recommended', AIDS Treatment News, No. 150 (1 May 1992).
52. Bodewitz, Buurma & de Vries, op. cit. note 1.
53. John S. James, 'Why No Antivirals: A Case History of Failed Trial Design', AIDS Treatment News, No. 81 (29 June 1989).
54. These examples were offered by Susan Ellenberg at the 'Alternative Approaches to Clinical Trials in AIDS: Ethics and Methodology' Panel at the 1991 Annual Meeting of the American Association for the Advancement of Science (Washington, DC, 17 February 1991, author's field notes).
55. Andrew R. Moss, 'Laboratory Markers as Potential Surrogates for Clinical Outcomes in AIDS Trials', Journal of Acquired Immune Deficiency Syndromes, Vol. 3, Supplement 2 (1990), S69-S71; David Amato and Stephen W. Lagakos, 'Considerations in the Selection of End Points for AIDS Clinical Trials', ibid., S64-S68.
56. Andrew R. Moss, 'Laboratory Markers as Potential Surrogates for Clinical Outcomes in AIDS Trials', Journal of Acquired Immune Deficiency Syndromes, Vol. 3, Supplement 2 (1990), S69-S71; David Amato and Stephen W. Lagakos, 'Considerations in the Selection of End Points for AIDS Clinical Trials', ibid., S64-S68.
57. Surrogate Endpoints in Evaluating the Effectiveness of Drugs Against HIV Infection and AIDS (Washington, DC: Institute of Medicine of the National Academy of Sciences, mimeo of conference transcript, 11-12 September 1989).
58. This account is from Moss, op. cit. note 29, esp. S71.
59. See the discussion in Kwitny, op. cit. note 3, 225, 297, 331.
60. Amato & Lagakos, op. cit. note 29, S66.
61. 'Design of Clinical Trials - End Points' (open discussion), Journal of Acquired Immune Deficiency Syndromes, Vol. 3, Supplement 2 (1990), S75.
62. Stephen W. Lagakos and Daniel F. Hoth, 'Surrogate Markers in AIDS: Where Are We? Where Are We Going?' (Editorial), Annals of Internal Medicine, Vol. 116 (1 April 1992), 599-601, at 600.
63. Surrogate Endpoints, op. cit. note 30, 100-01.
64. 'A Barrier Falls at the FDA', PI Perspectives, No. 10 (April 1991). [Note: I access this newsletter through the Internet, where no page numbers are cited.]
65. Paul Cotton, 'HIV Surrogate Markers Weighed', JAMA, Vol. 265 (20 March 1991), 1357, 1361-62.
66. John S. James, 'Drug Development: What's Needed Now?', AIDS Treatment News, No. 98 (8 March 1990).
67. Tim Kingston, 'The Coming Storm Over Expedited Drug Approval', San Francisco Bay Times (June 1991), 10-12.
68. John S. James, 'Expanded Access to Experimental Drugs: Interview with David Feigal, MD, of the FDA', AIDS Treatment News, No, 175 (30 May 1993).
69. Feigal, interview, see note 17.
70. Kingston, op. cit. note 40, 12.
71. Henry A. Waxman, letter to Dr David Kessler (Washington, DC, 10 April 1991).
72. Martin Delaney, letter to Congressman Henry Waxman (San Francisco, 2 May 1991).
73. Meeting transcript, Antiviral Drugs Advisory Committee (Bethesda, MD: Food and Drug Administration, 13-14 February 1991, mimeo).
74. 'A Barrier Falls', op. cit. note 37.
75. Antiviral Drugs Advisory Committee, op. cit. note 46, 162-63.
76. Cotton, op. cit. note 38, 1362.
77. Paul Cotton, 'FDA "Pushing Envelope" on AIDS Drug', JAMA, Vol. 266 (14 August 1991), 757-59, at 757.
78. Ibid., 759.
79. Donald Abrams, taped interview (San Francisco, CA, 16 December 1993).
80. Jasanoff, op. cit. note 1, 178, 229.
81. Cotton, op. cit. note 50, 757.
82. Gina Kolata, 'US Panel Backs Sale of Experimental AIDS Drug', New York Times (20 July 1991), A-1.
83. See James, op. cit. note 25.
84. Feigal, interview, see note 17.
85. Michael C. Botkin, 'ddC's Bumpy Road', Bay Area Reporter (7 May 1992), 20, 23.
86. Gina Kolata, 'A New AIDS Drug Nears Approval', New York Times (22 April 1992), A-22.
87. Botkin, op. cit. note 58, 20.
88. Ibid.
89. Jon Cohen, 'Searching for Markers on the AIDS Trail', Science, Vol. 258 (16 October 1992), 388-90, at 388 (brackets are Cohen's).
90. Deborah Cotton, taped interview (Boston, MA, 25 October 1994).
91. Cohen, op. cit. note 62, 389-90.
92. Both quotes from ibid., 390.
93. Margaret A. Fischl, 'Combination Therapy: Now and the Future' (paper presented at the Harvard AIDS Institute - AIDS Clinical Research Symposium, Berlin, 8 June 1993).
94. 'Effectiveness of AZT/ddC Combination Depends on Pretreatment Immune Cell Count', News From NIAID (7 June 1993), press release.
95. Jon Cohen, AIDS reporter for Science (personal communication, 7 February 1995).
96. 'The Effectiveness of AZT Alone, ddC Alone or AZT/ddC Combination is Similar Overall For Patients with Advanced HIV Disease', News from NIAID (10 June 1993), press release.
97. M. Fischl, 'The Safety and Efficacy of Zidovudine (ZDV) and Zalcitabine (ddC) or ddC Alone Versus ZDV' (paper presented at Session WS-B25-1, IX International Conference on AIDS, Berlin, 10 June 1993).
98. Author's field notes, IX International Conference on AIDS (Berlin, 10 June 1993).
99. Jean-Pierre Aboulker and Ann Marie Swart, 'Preliminary Analysis of the Concorde Trial' (Letter to the Editor), Lancet, Vol. 341 (3 April 1993), 889-90.
100. Anthony J. Pinching, 'Alpha Trial: Main Findings' (paper presented at Session WS-B24-3, IX International Conference on AIDS, Berlin, 10 June 1993).
101. A.J. Pinching, 'Surrogate Markers in Clinical Trials: Uses and Potential Misuses' (paper presented at the Harvard AIDS Institute-AIDS Clinical Research Symposium, Berlin, 7 June 1993).
102. John S. James, 'AZT, Early Intervention, and the Concorde Controversy', AIDS Treatment News, No. 173 (23 April 1993).
103. The press conference was held in Berlin on 9 June 1993 (author's field notes).
104. Larry Kramer, 'AZT Is Shit' (Editorial), Advocate (18 May 1993), 80.
105. Cotton, interview, see note 63.
106. Douglas Richman, taped interview (San Diego, CA, 1 June 1994).
107. Margaret A. Fischl, Kenneth Stanley et al., 'Combination and Monotherapy with Zidovudine and Zalcitabine in Patients with Advanced HIV Disease', Annals of Internal Medicine, Vol. 122 (1 January 1995), 24-32, esp. 25.
108. Stephen Lagakos, taped interview (Boston, MA, 27 October 1994).
109. Susan Ellenberg, taped interview (Rockville, MD, 25 April 1994).
110. Fischl et al., op. cit. note 80, 30.
111. Lagakos, interview, see note 81.
112. Martin Hirsch, taped interview (Boston, MA, 25 October 1994).
113. Ibid.
114. Fischl et al., op. cit. note 80, 30.
115. Richman, interview, see note 79.
116. Mark Harrington, 'The Crisis in Clinical AIDS Research' (New York: Treatment Action Group, 1 December 1993, mimeo), 13-14, 16.
117. Cotton, interview, see note 63.
118. Ibid.
119. Edward A. Wyatt, 'Rushing to Judgment', Barron's, Vol. 74 (15 August 1994), 23.
120. John S. James, 'BARRON'S: "Do We Have Too Many Drugs for AIDS?"', AIDS Treatment News, No. 205 (19 August 1994).
121. Feigal, interview, see note 17.
122. Derek Link, taped interview (New York City, 20 April 1994).
123. Gina Kolata, 'Debate Reopens on AIDS Drug Access', New York Times (12 September 1994), A-16.
124. 'Public Hearings at FDA Juxtapose Old Cries of Access With Those of Integrity, Accountability', TAGline, Vol. 1 (October 1994), 2.
125. Thomas F. Gieryn, 'Boundary Work and the Demarcation of Science from Non-Science: Strains and Interests in Professional Ideologies of Scientists', American Sociological Review, Vol. 48 (December 1983), 781-95; Gieryn, 'Boundaries of Science', in S. Jasanoff et al. (eds), Handbook of Science and Technology Studies (Thousand Oaks, CA, London & New Delhi: Sage Publications, 1995), 393-443; Jasanoff, op. cit. note 1.
126. Thomas F. Gieryn, 'Boundary Work and the Demarcation of Science from Non-Science: Strains and Interests in Professional Ideologies of Scientists', American Sociological Review, Vol. 48 (December 1983), 781-95; Gieryn, 'Boundaries of Science', in S. Jasanoff et al. (eds), Handbook of Science and Technology Studies (Thousand Oaks, CA, London & New Delhi: Sage Publications, 1995), 393-443; Jasanoff, op. cit. note 1.
127. Thomas F. Gieryn, 'Boundary Work and the Demarcation of Science from Non-Science: Strains and Interests in Professional Ideologies of Scientists', American Sociological Review, Vol. 48 (December 1983), 781-95; Gieryn, 'Boundaries of Science', in S. Jasanoff et al. (eds), Handbook of Science and Technology Studies (Thousand Oaks, CA, London & New Delhi: Sage Publications, 1995), 393-443; Jasanoff, op. cit. note 1.
128. Anthony Fauci, taped interview (Bethesda, MD, 31 October 1994).
129. David D. Ho et al., 'Rapid Turnover of Plasma Virions and CD4 Lymphocytes in HIV-1 Infection', Nature, Vol. 373 (12 January 1995), 123-26; Xiping Wei et al., 'Viral Dynamics in Human Immunodeficiency Virus Type 1 Infection', ibid., 117-22.
130. David D. Ho et al., 'Rapid Turnover of Plasma Virions and CD4 Lymphocytes in HIV-1 Infection', Nature, Vol. 373 (12 January 1995), 123-26; Xiping Wei et al., 'Viral Dynamics in Human Immunodeficiency Virus Type 1 Infection', ibid., 117-22.
131. Gina Kolata, 'New AIDS Finding on Why Drugs Fail', New York Times (12 January 1995), A-1.
132. Lagakos, interview, see note 81.
133. 'With Good Intentions, Overzealous Researchers May Be Setting the Stage for Yet Another Colossal Failure', TAGline, Vol. 2 (January 1995), 5.
134. 'With Its First Protease Trial Completed, Roche Races to FDA With Lukewarm Results, Activists Cry "Foul"', TAGline, Vol. 1 (July 1994), 1.
135. John S. James, '"Access" and "Answers": FDA Antiviral Advisory Meeting, September 12-13', AIDS Treatment News, No. 207 (16 September 1994).
136. Braverman, interview, see note 15.
137. Peter Staley, 'The Responsibilities of Empowerment' (New York: Treatment Action Group, undated, ca. 1995, mimeo).
138. Harrington, op. cit. note 89, 11-12 (my ellipsis and brackets).
139. David Barr, taped interview (New York City, 28 April 1994).
140. See Richards (1991), op. cit. note 1.
141. For an analysis of the specific strategies by which activists constituted themselves as credible players in the eyes of the biomedical research establishment, see Steven Epstein, 'The Construction of Lay Expertise: AIDS Activism and the Forging of Credibility in the Reform of Clinical Trials', Science, Technology, & Human Values, Vol. 20, No. 4 (Autumn 1995), 408-37.
142. Quoted in Cotton, op. cit. note 38, 1362.
143. Harrington, op. cit. note 89, 7.
144. Jim Eigo, at the 'Alternative Approaches' Panel, op. cit. note 28.
145. Moisés Agosto, taped interview (New York City, 26 April 1994).
146. Marks, op. cit. note 1.
147. Wynne, op. cit. note 1, 162-63.