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Standards, Orphan Drugs, and Pharmaceutical Markets

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Calculating the Social

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Abstract

Standards have been integral to the development of modern medicine. From the international classification of illnesses to the promotion of evidence-based medicine, standards, protocols, and guidelines have shaped the conduct of medical practitioners and the delivery of health care since the late nineteenth century (Timmermans and Berg, 2003). In the case of medicine, standards offer the promise of ensuring the safety of pharmaceutical products or medical devices. Standards are further used to ensure the consistency of how data is gathered, how decisions are made over organ transplants (Hogle, 1995) and the sequence of procedures that should be used to resuscitate patients following cardiac arrest (Timmermans and Berg, 1997). Standardization involves making objects or social practices conform to particular technical and social visions of order. As scholars within the field of science and technology studies have documented, the work of standardization is intimately bound up with the construction of techno-economic networks (Fujimura, 1992, Latour, 1988). Standards are integral to the development of large-scale systems such as international clinical trials (Petryna, 2009), and to the minuscule calibrations of instruments on the lab bench (Jordan and Lynch, 1998). Here, standards play a double-edged role: they facilitate the creation of enduring networks that pattern technical, economic, and social activity, but they close off certain technological and policy options.

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Bibliography

  • Abraham, J. (1995), Science, Politics, and the Pharmaceutical Industry: Controversy and Bias in Drug Regulation (New York: St. Martin’s Press).

    Google Scholar 

  • Aggressive Research Intelligence Facility (2004a) Recombinant Human Alpha-Liduronidase for the Treatment of Patients with Mucopolysaccharidosis Type 1 (Birmingham).

    Google Scholar 

  • Aggressive Research Intelligence Facility (2004b) Recombinant Human Alphagalactosidase for the Treatment of Patients with Fabry’s Disease (Birmingham).

    Google Scholar 

  • Alster, N. (1991), ‘Henri Termeer’s Orphan Drug Strategy’, Forbes 147, pp. 202–7.

    Google Scholar 

  • Asbury, C. H. (1985), Orphan Drugs: Medical Versus Market Value (Lexington MA: Lexington Books).

    Google Scholar 

  • Asbury, C. H. (1986), ‘Collaborative Efforts on Behalf of Orphan Diseases’, in I. H. Scheinberg and J. M. Walshe (eds), Orphan Diseases and Orphan Drugs (Manchester: Manchester University Press).

    Google Scholar 

  • Asbury, C. H. (2007), ‘Orphan Drugs’, in J. Swarbrick (ed.), Enclyclopedia of Pharmaceutical Technology (New York: Informa Healthcare).

    Google Scholar 

  • Ashton, G. (2001), ‘Growing Pains for Biopharmaceuticals’, Nature Biotechnology 19, pp. 307–11.

    Article  Google Scholar 

  • Brewer, G. J. (ed.) (1983), Orphan Drugs and Orphan Diseases: Clinical Realities and Public Policy (New York: Alan R. Liss).

    Google Scholar 

  • Burls, A., D. Austin, and D. Moore (2005), ‘Commissioning for Rare Diseases: View from the Frontline’, British Medical Journal 331, pp. 1019–21.

    Article  Google Scholar 

  • Calabro, S. (2006), ‘The Price of Success’, Pharmaceutical Executive, pp. 3–12.

    Google Scholar 

  • Daemmrich, A. and G. Krücken (2000), ‘Risk Versus Risk: Decision-making Dilemmas of Drug Regulation in the United States and Germany’, Science as Culture 9, pp. 505–34.

    Article  Google Scholar 

  • Dean, M. (1999), Governmentality: Power and Rule in Modern Society (London: Sage Publications).

    Google Scholar 

  • Department of Health (2004), National Designation and Funding of Treatment for Patients with Lysosomal Storage Disorders, http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4092210.pdf, date accessed 1 October 2009.

    Google Scholar 

  • Epstein, S. (2007), Inclusion: The Politics of Difference in Medical Research (Chicago: University of Chicago Press).

    Book  Google Scholar 

  • Foucault, M. (1978), The History of Sexuality, Vol. 1. The Will to Knowledge (London: Penguin).

    Google Scholar 

  • Foucault, M. (1991), ‘Governmentality’, in G. Burchell, C. Gordon, and P. Miller (eds), The Foucault Effect: Studies in Governmentality (London: Harvester Wheatsheaf).

    Google Scholar 

  • Foucault, M. (1994), ‘On the Government of the Living’, in P. Rabinow (ed.), Ethics: Subjectivity and Truth (New York: New Press).

    Google Scholar 

  • Foucault, M. (2001a), ‘“Omnes et singulatim”: Toward a Critique of Political Reason’, in J. D. Faubion (ed.), Power: Essential Works of Foucault, 1954–1984 (London: Allen Lane).

    Google Scholar 

  • Foucault, M. (2001b), ‘The Politics of Health in the Eighteenth Century’, in J. D. Faubion (ed.), Power: Essential Works of Foucault, 1954–1984 (London: Allen Lane).

    Google Scholar 

  • Foucault, M. (2004), ‘The Crisis of Medicine or the Crisis of Antimedicine?’, Foucault Studies 1, pp. 5–19.

    Google Scholar 

  • Fujimura, J. H. (1992), ‘Crafting Science: Standardized Packages, Boundary Objects and Translation’, in A. Pickering (ed.), Science as Practice and Culture (Chicago: University of Chicago Press).

    Google Scholar 

  • Haffner, M. E. (2001), ‘Rare Diseases and Orphan Drugs: The US Experience’, Pharmaceuticals Policy and Law 3, pp. 37–40.

    Google Scholar 

  • Haffner, M. E. (2003), ‘The Current Environment in Orphan Drug Development’, Drug Information Journal 37, pp. 373–9.

    Google Scholar 

  • Haffner, M. E. (2006), ‘Adopting Orphan Drugs: Two Dozen Years of Treating Rare Diseases’, New England Journal of Medicine 354, pp. 445–7.

    Article  Google Scholar 

  • Haffner, M. E., J. Whitley, and M. Moses (2002), ‘Two Decades of Orphan Drug Development’, Nature Reviews Drug Discovery 1, pp. 821–5.

    Article  Google Scholar 

  • Haraway, D. J. (1997), Modest_Witness@Second_Millennium. FemaleMan©_Meets_OncoMouse™: Feminism and Technoscience (New York: Routledge).

    Google Scholar 

  • Hedgecoe, A. (2004) The Politics of Personalised Medicine: Pharmacogenetics in the Clinic (Cambridge: Cambridge University Press).

    Book  Google Scholar 

  • Henkel, J. (1999), ‘How TV Launched the Orphan Drug Law’, FDA Consumer Magazine.

    Google Scholar 

  • Hogle, L. F. (1995), ‘Standardization across Non-standard Domains: The Case of Organ Procurement’, Science Technology Human Values 20, pp. 482–500.

    Article  Google Scholar 

  • Hollis, A. (2005), ‘Drugs for Rare Diseases: Paying for Innovation’, Paper presented at Health Services Restructuring: New Evidence and New Directions, held at Queen’s University, Canada, November 17–18, 2005.

    Google Scholar 

  • Jordan, K. and M. Lynch (1998), ‘The Dissemination, Standardization and Routinization of a Molecular Biological Technique’, Social Studies of Science 28, pp. 773–800.

    Article  Google Scholar 

  • Karch, F. (1982), Orphan Drugs (New York: M. Dekker).

    Google Scholar 

  • Lakoff, A. (2008), ‘The Right Patients for the Drug: Pharmaceutical Circuits and Codification of Illness’, in E. J. Hackett, O. Amsterdamska, M. Lynch, and J. Wajcman (eds), The Handbook of Science and Technology Studies, 3rd edn (Cambridge, MA: MIT Press).

    Google Scholar 

  • Latour, B. (1988), The Pasteurization of France (Cambridge, MA: Harvard University Press).

    Google Scholar 

  • Maeder, T. (2003), ‘The Orphan Drug Backlash’, Scientific American, pp. 80–7.

    Google Scholar 

  • Marks, H. M. (1997), The Progress of Experiment: Science and Therapeutic Reform in the United States, 1900–1990 (Cambridge, MA: Cambridge University Press).

    Google Scholar 

  • Maye, J. (1980), ‘L.A. Victim of Rare Disease’, Los Angeles Times Jun 27.

    Google Scholar 

  • Mciver, S. (2004), The Views of the Public about Funding Enzyme Replacement Therapy (Birmingham).

    Google Scholar 

  • Meyers, A. (1988), ‘Working Toward Passage of Orphan Drug Act: An Example of Determination’, American Medical Writers Association Journal 3, pp. 3–7.

    Google Scholar 

  • Mitchell, S. A. and E. Link (eds) (1976), Impact of Public Policy on Drug Innovation and Pricing: Proceedings of the Third Seminar on Pharmaceutical Public Policy Issues (Washington: American University).

    Google Scholar 

  • Moreira, T. (2007), ‘Entangled Evidence: Knowledge Making in Systematic Reviews in Healthcare’, Sociology of Health and Illness 29, pp. 180–97.

    Article  Google Scholar 

  • Mulkay, M., M. Ashmore, and T. Pinch (1987), ‘Measuring the Quality of Life: A Sociological Intervention Concerning the Application of Economics to Health Care’, Sociology 21, pp. 541–64.

    Article  Google Scholar 

  • National Institute for Health and Clinical Excellence (2006), ‘Appraising Orphan Drugs’, http://www.nice.org.uk/niceMedia/pdf/smt/120705item4.pdf, date accessed 1 October 2009.

    Google Scholar 

  • Novas, C. (2008), ‘Patients, Profits and Values: Myozyme as an Exemplar of Biosociality’, in S. Gibbon and C. Novas (eds), Biosocialities, Genetics and the Social Sciences: Making Biologies and Identities (London: Routledge).

    Google Scholar 

  • O’Malley, P. (2004), Risk, Uncertainty and Government (London: GlassHouse).

    Google Scholar 

  • Petryna, A. (2009), When Experiments Travel: Clinical Trials and the Global Search for Human Subjects (Princeton: Princeton University Press).

    Book  Google Scholar 

  • Rabinow, P. and N. Rose (2006), ‘Biopower Today’, BioSocieties 1, pp. 195–217.

    Article  Google Scholar 

  • Rose, N. (1999), Powers of Freedom: Reframing Political Thought (Cambridge: Cambridge University Press).

    Book  Google Scholar 

  • Scheinberg, I. H. and J. M. Walshe (eds) (1986), Orphan Diseases and Orphan Drugs (Manchester: Manchester University Press).

    Google Scholar 

  • Simon, F. (2006), ‘Market Access for Biopharmaceuticals: New Challenges’, Health Affairs 25, pp. 1363–70.

    Article  Google Scholar 

  • Simon, F. and P. Kotier (2003), Building Global Biobrands: Taking Biotechnology to Market (New York: Free Press).

    Google Scholar 

  • Sjögren, E. and C.-E Helgesson (2007), ‘The Q(u)ALYfying Hand: Health Economics and Medicine in the Shaping of Swedish Markets for Subsidized Pharmaceuticals’, Sociological Review 55, pp. 215–40.

    Article  Google Scholar 

  • Star, S. L. (1991), ‘Power, Technology and the Phenomenology of Conventions: On Being Allergic to Onions’, in J. Law (ed.), A Sociology of Monsters: Essays on Power, Technology and Domination (London: Routledge).

    Google Scholar 

  • Tambuyzer, E. T. (2000), ‘The European Orphan Medicinal Products Regulations and the Biotechnology-based Industry in Europe’, Journal of Commercial Biotechnology 6, pp. 340–4.

    Google Scholar 

  • Timmermans, S. and M. Berg (1997), ‘Standardization in Action: Achieving Local Universality through Medical Protocols’, Social Studies of Science 27, pp. 273–305.

    Article  Google Scholar 

  • Timmermans, S. and M. Berg (2003) The Gold Standard: The Challenge of Evidence-based Medicine and Standardization in Health Care (Philadelphia, PA: Temple University Press).

    Google Scholar 

  • United States Congress (1981) Hearings before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, Ninety-Seventh Congress, Orphan Drugs, HR 1663, March 9, 1981 (Washington: U.S. G.P.O).

    Google Scholar 

  • United States. Department of Health Education and Welfare (1979), ‘Significant Drugs of Limited Commercial Value’, pp. 1–82.

    Google Scholar 

  • Van Woert, M. H. and E. Chung (eds) (1985), Cooperative Approaches to Research and Development of Orphan Drugs (New York: Alan R. Liss).

    Google Scholar 

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Authors
  1. Carlos Novas
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Editor information

Editors and Affiliations

  1. Monash University, Australia

    Vaughan Higgins

  2. University of Bristol, UK

    Wendy Larner

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© 2010 Carlos Novas

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Novas, C. (2010). Standards, Orphan Drugs, and Pharmaceutical Markets. In: Higgins, V., Larner, W. (eds) Calculating the Social. Palgrave Macmillan, London. https://doi.org/10.1057/9780230289673_11

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