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Volumn 30, Issue 1, 2000, Pages 41-71

The redemption of thalidomide: Standardizing the risk of birth defects

Author keywords

Drugs; Normalization; Risk; Social worlds; Standardization; Technology

Indexed keywords

THALIDOMIDE;

EID: 0034131566     PISSN: 03063127     EISSN: None     Source Type: Journal    
DOI: 10.1177/030631200030001002     Document Type: Article
Times cited : (31)

References (98)
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    • Ken Alder, 'Making Things the Same: Representation, Tolerance and the End of the Ancien Régime in France', Social Studies of Science, Vol. 28, No. 4 (August 1998), 499-545; Alexandre Mallard, 'Compare, Standardize and Settle Agreement: On Some Usual Metrological Problems', ibid., 571-601; Stefan Timmermans, Sudden Death and the Myth of CPR (Philadelphia, PA: Temple University Press, 1999).
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    • The architecture of difference: Visibility, control, and comparability in building a nursing intervention classification
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    • Stefan Timmermans, Geoffrey Bowker and Susan Leigh Star, 'The Architecture of Difference: Visibility, Control, and Comparability in Building a Nursing Intervention Classification', in Marc Berg and Annemarie Mol (eds), Differences in Medicine: Unraveling Practices, Techniques and Bodies (Durham, NC: Duke University Press, 1998), 202-25.
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    • note 2
    • Berg, op. cit. note 2. At the most basic level, the initial decision of whether a standard should be instituted is left up to the discretion of others.
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    • The de-scription of technical objects
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    • note
    • We draw freely on quotations from transcripts: see the section on 'Transcripts', above.
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    • Chicago, IL & London: The University of Chicago Press
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    • The rôle of the organization in the production of techno-scientific knowledge
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    • For a detailed discussion of the 'normalization of deviance', see Diane Vaughan, The Challenger Launch Decision: Risky Technology, Culture, and Deviance at NASA (Chicago, IL & London: The University of Chicago Press, 1996); Vaughan, 'The Rôle of the Organization in the Production of Techno-Scientific Knowledge', Social Studies of Science, Vol. 29, No. 6 (December 1999), 913-43.
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    • New York: Aldine de Gruyter
    • Anselm Strauss, Continual Permutations of Action (New York: Aldine de Gruyter, 1993); Adele Clarke, Discipling Reproduction: Modernity, American Life, Science, and 'The Problems of Sex' (Berkeley: The University of California Press, 1998); Clarke, 'Social Worlds/Arenas Theory as Organizational Theory', in David Maines (ed.), Social Organization and Social Process: Essays in Honor of Anselm Strauss (New York: Aldine de Gruyter, 1991), 119-58.
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    • Anselm Strauss, Continual Permutations of Action (New York: Aldine de Gruyter, 1993); Adele Clarke, Discipling Reproduction: Modernity, American Life, Science, and 'The Problems of Sex' (Berkeley: The University of California Press, 1998); Clarke, 'Social Worlds/Arenas Theory as Organizational Theory', in David Maines (ed.), Social Organization and Social Process: Essays in Honor of Anselm Strauss (New York: Aldine de Gruyter, 1991), 119-58.
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    • Social worlds/Arenas theory as organizational theory
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    • Anselm Strauss, Continual Permutations of Action (New York: Aldine de Gruyter, 1993); Adele Clarke, Discipling Reproduction: Modernity, American Life, Science, and 'The Problems of Sex' (Berkeley: The University of California Press, 1998); Clarke, 'Social Worlds/Arenas Theory as Organizational Theory', in David Maines (ed.), Social Organization and Social Process: Essays in Honor of Anselm Strauss (New York: Aldine de Gruyter, 1991), 119-58.
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    • London: Andre Deutsch
    • Readers wishing to fill out this brief account might consult: Sunday Times Insight Team, Suffer the Children: The Story of Thalidomide (London: Andre Deutsch, 1979); Teff Harvey, Thalidomide: The Legal Aftermath (Farnborough, Hants.: Saxon House, 1976); Sir Alan Marre, Thalidomide - 'Y' List Inquiry (London: HMSO, 1978); William McBride, Killing the Messenger (Cremorne, Australia: Eldorado, 1994); Kida Mitsushiro, Thalidomide Embryopathy in Japan (Tokyo: Kodanska, 1987); Jacques Paulus, Le Procès de la Thalidomide (Paris: Gallimard, 1963); Murray Rosen, The Sunday Times Thalidomide Case: Contempt of Court and the Freedom of the Press (London & New York: British Institute of Human Rights, 1979).
    • (1979) Sunday Times Insight Team, Suffer the Children: The Story of Thalidomide
  • 26
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    • Farnborough, Hants.: Saxon House
    • Readers wishing to fill out this brief account might consult: Sunday Times Insight Team, Suffer the Children: The Story of Thalidomide (London: Andre Deutsch, 1979); Teff Harvey, Thalidomide: The Legal Aftermath (Farnborough, Hants.: Saxon House, 1976); Sir Alan Marre, Thalidomide - 'Y' List Inquiry (London: HMSO, 1978); William McBride, Killing the Messenger (Cremorne, Australia: Eldorado, 1994); Kida Mitsushiro, Thalidomide Embryopathy in Japan (Tokyo: Kodanska, 1987); Jacques Paulus, Le Procès de la Thalidomide (Paris: Gallimard, 1963); Murray Rosen, The Sunday Times Thalidomide Case: Contempt of Court and the Freedom of the Press (London & New York: British Institute of Human Rights, 1979).
    • (1976) Thalidomide: The Legal Aftermath
    • Harvey, T.1
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    • London: HMSO
    • Readers wishing to fill out this brief account might consult: Sunday Times Insight Team, Suffer the Children: The Story of Thalidomide (London: Andre Deutsch, 1979); Teff Harvey, Thalidomide: The Legal Aftermath (Farnborough, Hants.: Saxon House, 1976); Sir Alan Marre, Thalidomide - 'Y' List Inquiry (London: HMSO, 1978); William McBride, Killing the Messenger (Cremorne, Australia: Eldorado, 1994); Kida Mitsushiro, Thalidomide Embryopathy in Japan (Tokyo: Kodanska, 1987); Jacques Paulus, Le Procès de la Thalidomide (Paris: Gallimard, 1963); Murray Rosen, The Sunday Times Thalidomide Case: Contempt of Court and the Freedom of the Press (London & New York: British Institute of Human Rights, 1979).
    • (1978) Thalidomide - 'Y' List Inquiry
    • Marre, A.1
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    • Cremorne, Australia: Eldorado
    • Readers wishing to fill out this brief account might consult: Sunday Times Insight Team, Suffer the Children: The Story of Thalidomide (London: Andre Deutsch, 1979); Teff Harvey, Thalidomide: The Legal Aftermath (Farnborough, Hants.: Saxon House, 1976); Sir Alan Marre, Thalidomide - 'Y' List Inquiry (London: HMSO, 1978); William McBride, Killing the Messenger (Cremorne, Australia: Eldorado, 1994); Kida Mitsushiro, Thalidomide Embryopathy in Japan (Tokyo: Kodanska, 1987); Jacques Paulus, Le Procès de la Thalidomide (Paris: Gallimard, 1963); Murray Rosen, The Sunday Times Thalidomide Case: Contempt of Court and the Freedom of the Press (London & New York: British Institute of Human Rights, 1979).
    • (1994) Killing the Messenger
    • McBride, W.1
  • 29
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    • Tokyo: Kodanska
    • Readers wishing to fill out this brief account might consult: Sunday Times Insight Team, Suffer the Children: The Story of Thalidomide (London: Andre Deutsch, 1979); Teff Harvey, Thalidomide: The Legal Aftermath (Farnborough, Hants.: Saxon House, 1976); Sir Alan Marre, Thalidomide - 'Y' List Inquiry (London: HMSO, 1978); William McBride, Killing the Messenger (Cremorne, Australia: Eldorado, 1994); Kida Mitsushiro, Thalidomide Embryopathy in Japan (Tokyo: Kodanska, 1987); Jacques Paulus, Le Procès de la Thalidomide (Paris: Gallimard, 1963); Murray Rosen, The Sunday Times Thalidomide Case: Contempt of Court and the Freedom of the Press (London & New York: British Institute of Human Rights, 1979).
    • (1987) Thalidomide Embryopathy in Japan
    • Mitsushiro, K.1
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    • Paris: Gallimard
    • Readers wishing to fill out this brief account might consult: Sunday Times Insight Team, Suffer the Children: The Story of Thalidomide (London: Andre Deutsch, 1979); Teff Harvey, Thalidomide: The Legal Aftermath (Farnborough, Hants.: Saxon House, 1976); Sir Alan Marre, Thalidomide - 'Y' List Inquiry (London: HMSO, 1978); William McBride, Killing the Messenger (Cremorne, Australia: Eldorado, 1994); Kida Mitsushiro, Thalidomide Embryopathy in Japan (Tokyo: Kodanska, 1987); Jacques Paulus, Le Procès de la Thalidomide (Paris: Gallimard, 1963); Murray Rosen, The Sunday Times Thalidomide Case: Contempt of Court and the Freedom of the Press (London & New York: British Institute of Human Rights, 1979).
    • (1963) Le Procès de la Thalidomide
    • Paulus, J.1
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    • London & New York: British Institute of Human Rights
    • Readers wishing to fill out this brief account might consult: Sunday Times Insight Team, Suffer the Children: The Story of Thalidomide (London: Andre Deutsch, 1979); Teff Harvey, Thalidomide: The Legal Aftermath (Farnborough, Hants.: Saxon House, 1976); Sir Alan Marre, Thalidomide - 'Y' List Inquiry (London: HMSO, 1978); William McBride, Killing the Messenger (Cremorne, Australia: Eldorado, 1994); Kida Mitsushiro, Thalidomide Embryopathy in Japan (Tokyo: Kodanska, 1987); Jacques Paulus, Le Procès de la Thalidomide (Paris: Gallimard, 1963); Murray Rosen, The Sunday Times Thalidomide Case: Contempt of Court and the Freedom of the Press (London & New York: British Institute of Human Rights, 1979).
    • (1979) The Sunday Times Thalidomide Case: Contempt of Court and the Freedom of the Press
    • Rosen, M.1
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    • Anticancer drug development: The way forward
    • Tom Connors, 'Anticancer Drug Development: The Way Forward', Oncologist, Vol. 1, No. 3 (1996), 180-81.
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    • London: UCL Press; New York: St Martins Press
    • It is important to note that there had already been considerable support for the introduction of new legislation to regulate the pharmaceutical industry at the time of the thalidomide disaster, in the USA and in other countries: see John Abraham, Science, Politics and the Pharmaceutical Industry (London: UCL Press; New York: St Martins Press, 1995).
    • (1995) Science, Politics and the Pharmaceutical Industry
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    • The kefauver-harris amendment after sixteen years
    • December
    • John C. Krantz, 'The Kefauver-Harris Amendment after Sixteen Years', Military Medicine, Vol. 143, No. 12 (December 1978), 883. The actual number of approved drugs was much higher, but the proportions are similar.
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    • Lexington, MA: Lexington Books
    • See, for example, Carolyn H. Asbury, Orphan Drugs: Medical versus Market Value (Lexington, MA: Lexington Books, 1985); Leo E. Hollister, Irvine H. Page, Carl C. Pfeiffer and Maurice B. Visscher, 'The Kefauver-Harris Amendments of 1962: A Critical Appraisal of the First Five Years', Journal of Clinical Pharmacology, Vol. 8, No. 2 (March-April 1968), 69-73.
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    • The kefauver-harris amendments of 1962: A critical appraisal of the first five years
    • March-April
    • See, for example, Carolyn H. Asbury, Orphan Drugs: Medical versus Market Value (Lexington, MA: Lexington Books, 1985); Leo E. Hollister, Irvine H. Page, Carl C. Pfeiffer and Maurice B. Visscher, 'The Kefauver-Harris Amendments of 1962: A Critical Appraisal of the First Five Years', Journal of Clinical Pharmacology, Vol. 8, No. 2 (March-April 1968), 69-73.
    • (1968) Journal of Clinical Pharmacology , vol.8 , Issue.2 , pp. 69-73
    • Hollister, L.E.1    Page, I.H.2    Pfeiffer, C.C.3    Visscher, M.B.4
  • 38
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    • Bethesda, MD: National Library of Medicine
    • A US National Library of Medicine bibliography listed 1495 citations out of more than 4600 between January 1963 and July 1997: see K. Patrias, R.L. Gordner and S. Groft, Thalidomide: Potential Benefits and Risks (Bethesda, MD: National Library of Medicine, 1997).
    • Thalidomide: Potential Benefits and Risks , pp. 1997
    • Patrias, K.1    Gordner, R.L.2    Groft, S.3
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    • note
    • These numbers were provided by participants at the FDA and NIH meetings in September 1997; we could not find anything else about these new thalidomide cases.
  • 40
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    • note
    • Among the conditions are: skin disorders (Prurigo Nodularis and Photodermatitis, Leprosy and Erythema Nodosum Leprosum, Behcet's Disease, and Pyoderma Gangrenosum); immunologic and rheumatologic disorders (Lupus Erythematosus, Arthritis, Crohn's Disease and Ulcerative Colitis); haematologic and oncologic disorders (Glioma, Prostate Cancer, Graft versus Host Disease, Kaposi's Sarcoma, and Breast Cancer); and infectious diseases (Tuberculosis, HIV/AIDS and AIDS Wasting Syndrome, and Apthous Ulcers).
  • 41
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    • note
    • A full discussion of the safety and efficacy data falls beyond the scope of this paper. As part of the New Drug Application submission, the sponsor has to propose an indication for the drug, and then provide data from different clinical studies to back up the indication. In the case of thalidomide, the indication of the drug was for the acute treatment of moderate to severe Erythema Nodosum Leprosum, and as maintenance therapy for prevention and suppression of ENL recurrence. Dr Jonathan Wilkin, Director of the Division of Dermatological and Dental Drug Products, provided the non-approvable recommendation. His biggest objection related to the safety of the drug. Even if the drug was affecting ENL lesions, too little was known about the total effect of the drug on the patients. Problems with the data consisted of the lack of bioequivalency between drugs, the lack of research protocols, uncertainty about the source of neurotoxicity, and insufficient data on drug metabolism. The director also pointed out that many of the potential patients belonged to vulnerable populations, and he expressed concern for 'off-label' use of physicians. He strongly felt the need for a randomized clinical trial. Dr Wilkin summarized his review of Celgene's datasets in the following way: 'My conclusions are that I would recommend that this be non-approvable given the current information for efficacy and safety for erythema nodosum, the systematic syndrome, and also for erythema nodosum leprosum, confined to the cutaneous lesions' [u, 30].
  • 42
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    • Gendered medical science: Producing a drug for women
    • Fall In the case of thalidomide, the risk includes severe disability or abortion of the afflicted foetus
    • Thalidomide is similar to diethylstilboestrol (DES) in its potential for benefits and potential for harm. Susan Bell's analysis of the history of the FDA's approval of DES points out that a great deal of medical attention was focused on DES, because of this high stakes benefit-risk analysis: S.E. Bell, 'Gendered Medical Science: Producing a Drug for Women', Feminist Studies, Vol. 21, No. 3 (Fall 1995), 469-500. In the case of thalidomide, the risk includes severe disability or abortion of the afflicted foetus.
    • (1995) Feminist Studies , vol.21 , Issue.3 , pp. 469-500
    • Bell, S.E.1
  • 43
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    • note
    • Because of the low numbers of thalidomide babies born in the USA, no victims association exists there. The Canadian association has reached out to the US thalidomiders, and presents itself as their spokesperson.
  • 44
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    • note
    • The participants did not explain how one 'proves' a missed period.
  • 46
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    • note
    • In the USA, some physicians are opposed, usually for religious reasons, to prescribing contraception, as well as to abortion.
  • 47
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    • From local to global: Resolving uncertainty about the safety of DES in menopause
    • Similarly, Susan Bell found that science helped to preserve medical power in the case of DES approval in 1941: S.E. Bell, 'From Local to Global: Resolving Uncertainty About the Safety of DES in Menopause', Research in Sociology of Health Care, Vol. 11 (1994), 41-56.
    • (1994) Research in Sociology of Health Care , vol.11 , pp. 41-56
    • Bell, S.E.1
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    • Selective compliance with biomedical authority and the uses of experimental knowledge
    • Margaret Lock and Patricia Kaufert (eds), New York: Cambridge University Press
    • It is interesting to note how the physicians in this debate constructed patient's 'non-compliance' in terms of demographic factors and health care beliefs. It did not seem to occur to them that non-compliance could be a deliberate strategy. For discussions of this issue, see: Emily K. Abel and Carole Browner, 'Selective Compliance with Biomedical Authority and the Uses of Experimental Knowledge', in Margaret Lock and Patricia Kaufert (eds), Pragmatic Women and Body Politics (New York: Cambridge University Press, 1998), 310-26; Linda M. Hunt, Brigitte Jordan and Susan Irwin, 'Views of What's Wrong: Diagnosis and Patients' Concepts of Illness', Social Science and Medicine, Vol. 28, No. 9 (May 1989), 956-56; Norman Fineman, 'The Social Constructions of Compliance: A Study of Health Care and Social Service Providers in Everyday Practice', Sociology of Health and Illness, Vol. 13, No. 3 (September 1991) 354-73; Aiwha Ong, 'Making the Biopolitical Subject: Cambodian Immigrants, Refugee Medicine and Cultural Citizenship in California', Social Science and Medicine, Vol. 40, No. 9 (April 1995), 1243-57.
    • (1998) Pragmatic Women and Body Politics , pp. 310-326
    • Abel, E.K.1    Browner, C.2
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    • Views of what's wrong: Diagnosis and patients' concepts of illness
    • May
    • It is interesting to note how the physicians in this debate constructed patient's 'non-compliance' in terms of demographic factors and health care beliefs. It did not seem to occur to them that non-compliance could be a deliberate strategy. For discussions of this issue, see: Emily K. Abel and Carole Browner, 'Selective Compliance with Biomedical Authority and the Uses of Experimental Knowledge', in Margaret Lock and Patricia Kaufert (eds), Pragmatic Women and Body Politics (New York: Cambridge University Press, 1998), 310-26; Linda M. Hunt, Brigitte Jordan and Susan Irwin, 'Views of What's Wrong: Diagnosis and Patients' Concepts of Illness', Social Science and Medicine, Vol. 28, No. 9 (May 1989), 956-56; Norman Fineman, 'The Social Constructions of Compliance: A Study of Health Care and Social Service Providers in Everyday Practice', Sociology of Health and Illness, Vol. 13, No. 3 (September 1991) 354-73; Aiwha Ong, 'Making the Biopolitical Subject: Cambodian Immigrants, Refugee Medicine and Cultural Citizenship in California', Social Science and Medicine, Vol. 40, No. 9 (April 1995), 1243-57.
    • (1989) Social Science and Medicine , vol.28 , Issue.9 , pp. 956-956
    • Hunt, L.M.1    Jordan, B.2    Irwin, S.3
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    • The social constructions of compliance: A study of health care and social service providers in everyday practice
    • September
    • It is interesting to note how the physicians in this debate constructed patient's 'non-compliance' in terms of demographic factors and health care beliefs. It did not seem to occur to them that non-compliance could be a deliberate strategy. For discussions of this issue, see: Emily K. Abel and Carole Browner, 'Selective Compliance with Biomedical Authority and the Uses of Experimental Knowledge', in Margaret Lock and Patricia Kaufert (eds), Pragmatic Women and Body Politics (New York: Cambridge University Press, 1998), 310-26; Linda M. Hunt, Brigitte Jordan and Susan Irwin, 'Views of What's Wrong: Diagnosis and Patients' Concepts of Illness', Social Science and Medicine, Vol. 28, No. 9 (May 1989), 956-56; Norman Fineman, 'The Social Constructions of Compliance: A Study of Health Care and Social Service Providers in Everyday Practice', Sociology of Health and Illness, Vol. 13, No. 3 (September 1991) 354-73; Aiwha Ong, 'Making the Biopolitical Subject: Cambodian Immigrants, Refugee Medicine and Cultural Citizenship in California', Social Science and Medicine, Vol. 40, No. 9 (April 1995), 1243-57.
    • (1991) Sociology of Health and Illness , vol.13 , Issue.3 , pp. 354-373
    • Fineman, N.1
  • 51
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    • Making the biopolitical subject: Cambodian immigrants, refugee medicine and cultural citizenship in California
    • April
    • It is interesting to note how the physicians in this debate constructed patient's 'non-compliance' in terms of demographic factors and health care beliefs. It did not seem to occur to them that non-compliance could be a deliberate strategy. For discussions of this issue, see: Emily K. Abel and Carole Browner, 'Selective Compliance with Biomedical Authority and the Uses of Experimental Knowledge', in Margaret Lock and Patricia Kaufert (eds), Pragmatic Women and Body Politics (New York: Cambridge University Press, 1998), 310-26; Linda M. Hunt, Brigitte Jordan and Susan Irwin, 'Views of What's Wrong: Diagnosis and Patients' Concepts of Illness', Social Science and Medicine, Vol. 28, No. 9 (May 1989), 956-56; Norman Fineman, 'The Social Constructions of Compliance: A Study of Health Care and Social Service Providers in Everyday Practice', Sociology of Health and Illness, Vol. 13, No. 3 (September 1991) 354-73; Aiwha Ong, 'Making the Biopolitical Subject: Cambodian Immigrants, Refugee Medicine and Cultural Citizenship in California', Social Science and Medicine, Vol. 40, No. 9 (April 1995), 1243-57.
    • (1995) Social Science and Medicine , vol.40 , Issue.9 , pp. 1243-1257
    • Aiwha, O.1
  • 52
    • 85018849838 scopus 로고    scopus 로고
    • note
    • As was widely publicized in the US news media, several health maintenance organizations do not cover contraceptives for women, although they do cover the male impotency drug Viagra.
  • 53
    • 0004032597 scopus 로고
    • New York: Doubleday
    • People diagnosed with leprosy were escorted by law officials to Carville, their possessions were burned and, if they died, their graves would often be marked with assumed names. Carville was basically a total institution modelled after a prison: Erving Goffman, Asylums (New York: Doubleday, 1961); Zachary Gussow, Leprosy, Racism, and Public Health (Boulder, CO: Westview Press, 1989).
    • (1961) Asylums
    • Goffman, E.1
  • 54
    • 0003520934 scopus 로고
    • Boulder, CO: Westview Press
    • People diagnosed with leprosy were escorted by law officials to Carville, their possessions were burned and, if they died, their graves would often be marked with assumed names. Carville was basically a total institution modelled after a prison: Erving Goffman, Asylums (New York: Doubleday, 1961); Zachary Gussow, Leprosy, Racism, and Public Health (Boulder, CO: Westview Press, 1989).
    • (1989) Leprosy, Racism, and Public Health
    • Gussow, Z.1
  • 55
    • 0001967353 scopus 로고
    • note 27
    • Susan Bell's discussion of the use of DES to regulate human females echoes many of these same themes. She found that medical scientists in the DES case described the bodies of their patients as uncontrolled because they sometimes were nauseous and vomited after taking the drug (Bell, op. cit. note 27, 490). Bell also highlights the fact that women do not always have 28-day cycles, but that DES-controlled bodies could, showing DES's potential to create 'a well-regulated human female' (ibid., 492).
    • (1989) Leprosy, Racism, and Public Health , pp. 490
    • Bell1
  • 56
    • 0001955173 scopus 로고    scopus 로고
    • Susan Bell's discussion of the use of DES to regulate human females echoes many of these same themes. She found that medical scientists in the DES case described the bodies of their patients as uncontrolled because they sometimes were nauseous and vomited after taking the drug (Bell, op. cit. note 27, 490). Bell also highlights the fact that women do not always have 28-day cycles, but that DES-controlled bodies could, showing DES's potential to create 'a well-regulated human female' (ibid., 492).
    • Leprosy, Racism, and Public Health , pp. 492
  • 57
    • 85018830340 scopus 로고    scopus 로고
    • note
    • There was uncertainty regarding thalidomide's possible effects on sperm. The researchers decided that it was better to take precautions.
  • 58
    • 85018851202 scopus 로고    scopus 로고
    • note
    • 'STEPS Information Packet for Prescribers and Patients'. The packet contains two brochures published by the Planned Parenthood organization: one about emergency contraception, the other about 'your contraceptive choices'. The packet notes: 'Remember that the only method of birth control that is 100% effective is not having sex at all'.
  • 59
    • 0030256947 scopus 로고    scopus 로고
    • note 15
    • There is a large literature on precedents with similar outcomes. See, for example: Clarke (1998), op. cit. note 15; Sarah Franklin, Embodied Progress: A Cultural Account of Assisted Conception (London & New York: Routledge, 1997); Anne Donchin, 'Feminist Critiques of New Fertility Technologies: Implications for Social Policy', Journal of Medicine and Philosophy, Vol. 21, No. 5 (October 1996), 475-98; Faye Ginsberg and Rayna Rapp (eds), Conceiving the New World Order: The Global Stratification of Reproduction (Berkeley: University of California Press, 1995); Valerie Hartouni, Cultural Conceptions: On Reproductive Technologies and the Remaking of Life (Minneapolis: University of Minnesota Press, 1997); Emily Martin, The Woman in the Body: A Cultural Analysis of Reproduction (Boston, MA: Beacon Press, 1987).
    • (1998)
    • Clarke1
  • 60
    • 0030256947 scopus 로고    scopus 로고
    • London & New York: Routledge
    • There is a large literature on precedents with similar outcomes. See, for example: Clarke (1998), op. cit. note 15; Sarah Franklin, Embodied Progress: A Cultural Account of Assisted Conception (London & New York: Routledge, 1997); Anne Donchin, 'Feminist Critiques of New Fertility Technologies: Implications for Social Policy', Journal of Medicine and Philosophy, Vol. 21, No. 5 (October 1996), 475-98; Faye Ginsberg and Rayna Rapp (eds), Conceiving the New World Order: The Global Stratification of Reproduction (Berkeley: University of California Press, 1995); Valerie Hartouni, Cultural Conceptions: On Reproductive Technologies and the Remaking of Life (Minneapolis: University of Minnesota Press, 1997); Emily Martin, The Woman in the Body: A Cultural Analysis of Reproduction (Boston, MA: Beacon Press, 1987).
    • Embodied Progress: A Cultural Account of Assisted Conception , pp. 1997
    • Franklin, S.1
  • 61
    • 0030256947 scopus 로고    scopus 로고
    • Feminist critiques of new fertility technologies: Implications for social policy
    • October
    • There is a large literature on precedents with similar outcomes. See, for example: Clarke (1998), op. cit. note 15; Sarah Franklin, Embodied Progress: A Cultural Account of Assisted Conception (London & New York: Routledge, 1997); Anne Donchin, 'Feminist Critiques of New Fertility Technologies: Implications for Social Policy', Journal of Medicine and Philosophy, Vol. 21, No. 5 (October 1996), 475-98; Faye Ginsberg and Rayna Rapp (eds), Conceiving the New World Order: The Global Stratification of Reproduction (Berkeley: University of California Press, 1995); Valerie Hartouni, Cultural Conceptions: On Reproductive Technologies and the Remaking of Life (Minneapolis: University of Minnesota Press, 1997); Emily Martin, The Woman in the Body: A Cultural Analysis of Reproduction (Boston, MA: Beacon Press, 1987).
    • (1996) Journal of Medicine and Philosophy , vol.21 , Issue.5 , pp. 475-498
    • Donchin, A.1
  • 62
    • 0030256947 scopus 로고    scopus 로고
    • Berkeley: University of California Press
    • There is a large literature on precedents with similar outcomes. See, for example: Clarke (1998), op. cit. note 15; Sarah Franklin, Embodied Progress: A Cultural Account of Assisted Conception (London & New York: Routledge, 1997); Anne Donchin, 'Feminist Critiques of New Fertility Technologies: Implications for Social Policy', Journal of Medicine and Philosophy, Vol. 21, No. 5 (October 1996), 475-98; Faye Ginsberg and Rayna Rapp (eds), Conceiving the New World Order: The Global Stratification of Reproduction (Berkeley: University of California Press, 1995); Valerie Hartouni, Cultural Conceptions: On Reproductive Technologies and the Remaking of Life (Minneapolis: University of Minnesota Press, 1997); Emily Martin, The Woman in the Body: A Cultural Analysis of Reproduction (Boston, MA: Beacon Press, 1987).
    • (1995) Conceiving the New World Order: The Global Stratification of Reproduction
    • Ginsberg, F.1    Rapp, R.2
  • 63
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    • Minneapolis: University of Minnesota Press
    • There is a large literature on precedents with similar outcomes. See, for example: Clarke (1998), op. cit. note 15; Sarah Franklin, Embodied Progress: A Cultural Account of Assisted Conception (London & New York: Routledge, 1997); Anne Donchin, 'Feminist Critiques of New Fertility Technologies: Implications for Social Policy', Journal of Medicine and Philosophy, Vol. 21, No. 5 (October 1996), 475-98; Faye Ginsberg and Rayna Rapp (eds), Conceiving the New World Order: The Global Stratification of Reproduction (Berkeley: University of California Press, 1995); Valerie Hartouni, Cultural Conceptions: On Reproductive Technologies and the Remaking of Life (Minneapolis: University of Minnesota Press, 1997); Emily Martin, The Woman in the Body: A Cultural Analysis of Reproduction (Boston, MA: Beacon Press, 1987).
    • Cultural Conceptions: On Reproductive Technologies and the Remaking of Life , pp. 1997
    • Hartouni, V.1
  • 64
    • 0030256947 scopus 로고    scopus 로고
    • Boston, MA: Beacon Press
    • There is a large literature on precedents with similar outcomes. See, for example: Clarke (1998), op. cit. note 15; Sarah Franklin, Embodied Progress: A Cultural Account of Assisted Conception (London & New York: Routledge, 1997); Anne Donchin, 'Feminist Critiques of New Fertility Technologies: Implications for Social Policy', Journal of Medicine and Philosophy, Vol. 21, No. 5 (October 1996), 475-98; Faye Ginsberg and Rayna Rapp (eds), Conceiving the New World Order: The Global Stratification of Reproduction (Berkeley: University of California Press, 1995); Valerie Hartouni, Cultural Conceptions: On Reproductive Technologies and the Remaking of Life (Minneapolis: University of Minnesota Press, 1997); Emily Martin, The Woman in the Body: A Cultural Analysis of Reproduction (Boston, MA: Beacon Press, 1987).
    • (1987) The Woman in the Body: A Cultural Analysis of Reproduction
    • Martin, E.1
  • 66
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    • note
    • 1, 52].
  • 67
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    • London: The Women's Press
    • Implicitly, and sometimes quite explicitly during the meetings, various participants voiced the view that the lives of thalidomide babies were not worth living, and that their births should be avoided at all costs. A consumer advocate, for example, noted the family trauma, divorce and 'everything else that goes with it' that disability causes [d, 154]. Others similarly pointed to the drawbacks and negatives of disabled life, even equating it with 'child abuse', 'misery' and 'suffering' [f, 97]. While most disability advocates fiercely object to such depictions and assumptions of disabled people as problem prone, victimized and somehow deficient, the thalidomiders labelled themselves 'victims'. There is a broad literature on the topic of objection to the stereotyping of the disabled: see, for example, Jenny Morris, Pride Against Prejudice: Transforming Attitudes to Disability (London: The Women's Press, 1991).
    • (1991) Pride Against Prejudice: Transforming Attitudes to Disability
    • Morris, J.1
  • 68
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    • Face and Politeness Interaction in Pharmacist-Physician Interaction
    • October
    • Bruce L. Lambert, 'Face and Politeness in Pharmacist-Physician Interaction', Social Science and Medicine, Vol. 43, No. 8 (October 1996), 1189-98.
    • (1996) Social Science and Medicine , vol.43 , Issue.8 , pp. 1189-1198
    • Lambert, B.L.1
  • 69
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    • Industrial and occupational change in pharmacy: Prescription for feminization
    • Barbara F. Reskin and Patricia A. Roos (eds), Philadelphia, PA: Temple University Press
    • Polly A. Phipps, 'Industrial and Occupational Change in Pharmacy: Prescription for Feminization', in Barbara F. Reskin and Patricia A. Roos (eds), Job Queues, Gender Queues: Explaining Women's Inroads into Male Occupations (Philadelphia, PA: Temple University Press, 1990), 111-28.
    • (1990) Job Queues, Gender Queues: Explaining Women's Inroads into Male Occupations , pp. 111-128
    • Phipps, P.A.1
  • 70
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    • Dispensing legitimacy: The influence of professional, organizational, and legal controls on pharmacist behavior
    • Sim B. Sitkin and Kathleen M. Sutcliffe, 'Dispensing Legitimacy: The Influence of Professional, Organizational, and Legal Controls on Pharmacist Behavior', Research in the Sociology of Organizations, Vol. 8 (1991), 269-95.
    • (1991) Research in the Sociology of Organizations , vol.8 , pp. 269-295
    • Sitkin, S.B.1    Sutcliffe, K.M.2
  • 71
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    • "Why didn't you say just that?": Dealing with issues of asymmetry, knowledge, and competence in the pharmacist/client encounter
    • January
    • Alison Pilnick, '"Why Didn't You Say Just That?": Dealing with Issues of Asymmetry, Knowledge, and Competence in the Pharmacist/Client Encounter', Sociology of Health and Illness, Vol. 20, No. 1 (January 1998), 29-51.
    • (1998) Sociology of Health and Illness , vol.20 , Issue.1 , pp. 29-51
    • Pilnick, A.1
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    • International comparative analysis and explanation in medical sociology: Demystifying the halcion anomaly
    • February
    • John Abraham and Julie Sheppard, 'International Comparative Analysis and Explanation in Medical Sociology: Demystifying the Halcion Anomaly', Sociology, Vol. 32, No. 1 (February 1998), 141-62; US Congress, Council on Competitiveness and FDA Plans to Alter the Drug Approval Process at the FDA, Hearings before the Committee on Government Operations (Washington, DC, 1992).
    • (1998) Sociology , vol.32 , Issue.1 , pp. 141-162
    • Abraham, J.1    Sheppard, J.2
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    • Hearings before the Committee on Government Operations Washington, DC
    • John Abraham and Julie Sheppard, 'International Comparative Analysis and Explanation in Medical Sociology: Demystifying the Halcion Anomaly', Sociology, Vol. 32, No. 1 (February 1998), 141-62; US Congress, Council on Competitiveness and FDA Plans to Alter the Drug Approval Process at the FDA, Hearings before the Committee on Government Operations (Washington, DC, 1992).
    • (1992) Council on Competitiveness and FDA Plans to Alter the Drug Approval Process at the FDA
  • 74
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    • Berkeley: University of California Press
    • Steven Epstein, Impure Science: AIDS, Activism, and the Politics of Knowledge (Berkeley: University of California Press, 1996); Derreck Vogel, 'When Consumers Oppose Consumer Protection: The Politics of Regulatory Backlash', Journal of Public Policy, Vol. 10, No. 4 (October-December 1990), 449-70.
    • (1996) Impure Science: AIDS, Activism, and the Politics of Knowledge
    • Epstein, S.1
  • 75
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    • When consumers oppose consumer protection: The politics of regulatory backlash
    • (October-December 1990)
    • Steven Epstein, Impure Science: AIDS, Activism, and the Politics of Knowledge (Berkeley: University of California Press, 1996); Derreck Vogel, 'When Consumers Oppose Consumer Protection: The Politics of Regulatory Backlash', Journal of Public Policy, Vol. 10, No. 4 (October-December 1990), 449-70.
    • Journal of Public Policy , vol.10 , Issue.4 , pp. 449-470
    • Vogel, D.1
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    • Cambridge, MA: Harvard University Press, esp. Chapter 8, 'FDA's Advisory Network'
    • Sheila Jasanoff, The Fifth Branch: Science Advisors as Policymakers (Cambridge, MA: Harvard University Press, 1990), esp. Chapter 8, 'FDA's Advisory Network', 152-79.
    • (1990) The Fifth Branch: Science Advisors As Policymakers , pp. 152-179
    • Jasanoff, S.1
  • 78
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    • note
    • Because of the low numbers of patients in orphan indications, the FDA allows historically controlled data and does not require the stringent standard of randomized control.
  • 79
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    • London: Macmillan
    • The advisory committee meeting consisted of presentations and discussion about the safety, efficacy and indication of thalidomide, and a discussion of the distribution system. We do not focus on the presentation of scientific evidence, but note that by all accounts the documentation of thalidomide's safety was insufficient. The FDA's own scientific safety reviewers, and the advisory panel, rejected the drug's safety claims largely because the historical and experimental trials did not come close to meeting the standards of clinical trials in the 1990s (see also note 26). The efficacy claims were also shaky: one committee member stated that 'I have faith that the drug is effective, but scientifically I don't believe the data support that it's effective. . . . If this weren't an orphan drug, it would not have been at this level of a meeting' [k, 66]. For an account of the inconclusiveness of scientific data in the controversy of the effectiveness of Vitamin C as a therapy against cancer, see Evelleen Richards, Vitamin C and Cancer: Medicine or Politics? (London: Macmillan, 1991), esp. 192-236.
    • (1991) Vitamin C and Cancer: Medicine or Politics? , pp. 192-236
    • Richards, E.1
  • 80
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    • note
    • The members of the FDA advisory committee were aware that the biggest market for thalidomide consisted of AIDS patients, but because there was considerably more research on the effects of thalidomide on ENL than on other conditions, the application was made for that condition, and assigned to the dermatology section for review.
  • 81
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    • Distributing the benefit of the doubt: Scientists, regulators, and drug safety
    • Autumn
    • 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; R.D. Mann, Adverse Drug Reactions: The Scale and Nature of the Problem and the Way Forward (Carnforth, Lanes.: Parthenon, 1987).
    • (1994) Science, Technology, & Human Values , vol.19 , Issue.4 , pp. 493-522
    • Abraham, J.1
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    • Banned in US for causing birth defects, thalidomide returns as an AIDS drug
    • 2 June
    • See, for example, Jonathan Welsh, 'Banned in US for Causing Birth Defects, Thalidomide Returns as an AIDS Drug', The Wall Street Journal (2 June 1995), B1.
    • (1995) The Wall Street Journal , pp. B1
    • Welsh, J.1
  • 84
    • 85018849811 scopus 로고    scopus 로고
    • Celgene's board includes a former FDA commissioner, Arthur Hull Hayes
    • Celgene's board includes a former FDA commissioner, Arthur Hull Hayes [http://www.celgene.com].
  • 85
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    • note 17
    • This is the topic of the book by the Sunday Times Insight Team, op. cit. note 17.
    • Sunday Times Insight Team
  • 86
    • 85018798798 scopus 로고    scopus 로고
    • note 54
    • Abraham, op. cit. note 54.
    • Abraham1
  • 87
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    • note
    • Except for the drugs which are part of a system of mandatory restricted distribution.
  • 88
    • 0030333020 scopus 로고    scopus 로고
    • New bottles, old wine: Hidden cultural assumptions in a computerized explanation system for migraine sufferers
    • December
    • Diana Forsythe, 'New Bottles, Old Wine: Hidden Cultural Assumptions in a Computerized Explanation System for Migraine Sufferers', Medical Anthropology Quarterly, Vol. 10, No. 4 (December 1996), 551-74.
    • (1996) Medical Anthropology Quarterly , vol.10 , Issue.4 , pp. 551-574
    • Forsythe, D.1
  • 91
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    • note
    • This case study underscores that when two parties negotiate from widely varying power positions, it is difficult to reach a mutually satisfying compromise.
  • 92
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    • Refusing prenatal diagnosis: The meanings of bioscience in a multicultural world
    • Winter
    • For a similar case where such assumptions were unwarranted, see Rayna Rapp, 'Refusing Prenatal Diagnosis: The Meanings of Bioscience in a Multicultural World', Science, Technology, & Human Values, Vol. 23, No. 1 (Winter 1998), 45-71.
    • (1998) Science, Technology, & Human Values , vol.23 , Issue.1 , pp. 45-71
    • Rapp, R.1
  • 93
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    • note
    • We thank Marc Berg and a persistent anonymous reviewer for their comments regarding abortion.
  • 94
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    • Baltimore, MD: Johns Hopkins University Press
    • Standardization does not always solidify the position of the most powerful actors. A different anonymous reviewer pointed out that the 1962 drug efficacy amendments, which established the rôle of clinical trials as the gold standard for drug testing, were vehemently opposed by different medical groups. Our point is that standardization solidifies power relationships, whether they are new or already existing. See also Carol Weisman, Women's Health Care: Activist Traditions and Institutional Change (Baltimore, MD: Johns Hopkins University Press, 1998).
    • (1998) Women's Health Care: Activist Traditions and Institutional Change
    • Weisman, C.1
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    • How to be universal: Some cybernetic strategies, 1943-70
    • February
    • Geoffrey Bowker, 'How to be Universal: Some Cybernetic Strategies, 1943-70', Social Studies of Science, Vol. 23, No. 1 (February 1993), 107-27; see also Porter, op cit. note 2.
    • (1993) Social Studies of Science , vol.23 , Issue.1 , pp. 107-127
    • Bowker, G.1
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    • note 2
    • Geoffrey Bowker, 'How to be Universal: Some Cybernetic Strategies, 1943-70', Social Studies of Science, Vol. 23, No. 1 (February 1993), 107-27; see also Porter, op cit. note 2.
    • (1993) Social Studies of Science , vol.23 , Issue.1
    • Porter1
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    • Constructing "do-able" problems in cancer research: Articulating alignment
    • May
    • Joan Fujimura, 'Constructing "Do-able" Problems in Cancer Research: Articulating Alignment', Social Studies of Science, Vol. 17, No. 2 (May 1987), 257-93.
    • (1987) Social Studies of Science , vol.17 , Issue.2 , pp. 257-293
    • Fujimura, J.1


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