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The socio-political roots of pharmaceutical uncertainty in the evaluation of 'innovative' diabetes drugs in the European Union and the US

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  • Davis, Courtney
  • Abraham, John

Abstract

The prevalence of diabetes is growing in many countries. Prescription oral medications have been developed to treat the disease since the 1950s. More recently, a group of diabetes drugs, known as the glitazones, have been developed and introduced on to North American and European markets since the late 1990s. When first introduced, the glitazones were widely regarded as 'innovative' pharmaceuticals and have remained on the American and EU markets, among others, throughout the 2000s. Yet, enormous uncertainties about their therapeutic value have remained since they came on the market a decade ago. This paper investigates how socio-political systems of drug development and regulation generate such pharmaceutical uncertainty consequent upon the limited informational value that diabetes drug trials provide about the health risks and benefits of such medications when used in clinical practice. Drawing on documentary research and fieldwork interviews, the first in-depth analysis of regulation of 'innovative' pharmaceuticals in both the US and supranational EU is presented. It is argued that these pharmaceutical uncertainties can be explained by reference to four key factors: regulatory paradigms using surrogate markers for drug efficacy; drug approval standards in policy and legislation; ideological expectations of innovation within regulatory agencies; and pharmaceutical industry shaping of drug evaluation.

Suggested Citation

  • Davis, Courtney & Abraham, John, 2011. "The socio-political roots of pharmaceutical uncertainty in the evaluation of 'innovative' diabetes drugs in the European Union and the US," Social Science & Medicine, Elsevier, vol. 72(9), pages 1574-1581, May.
  • Handle: RePEc:eee:socmed:v:72:y:2011:i:9:p:1574-1581
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    References listed on IDEAS

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    1. Palmlund, Ingar, 2006. "Loyalties in clinical research on drugs: The case of hormone replacement therapy," Social Science & Medicine, Elsevier, vol. 63(2), pages 540-551, July.
    2. Doran, E. & Kerridge, I. & McNeill, P. & Henry, David, 2006. "Empirical uncertainty and moral contest: A qualitative analysis of the relationship between medical specialists and the pharmaceutical industry in Australia," Social Science & Medicine, Elsevier, vol. 62(6), pages 1510-1519, March.
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    Cited by:

    1. Gunn, Callum J. & Bertelsen, Neil & Regeer, Barbara J. & Schuitmaker-Warnaar, Tjerk Jan, 2021. "Valuing patient engagement: Reflexive learning in evidence generation practices for health technology assessment," Social Science & Medicine, Elsevier, vol. 280(C).
    2. Benedek, Gábor & Lublóy, Ágnes & Keresztúri, Judit Lilla, 2015. "Az orvosok közötti kapcsolatok szerepe az új gyógyszerek elfogadásában [The impacts of three types of social interaction on the spread of new types of drug]," Közgazdasági Szemle (Economic Review - monthly of the Hungarian Academy of Sciences), Közgazdasági Szemle Alapítvány (Economic Review Foundation), vol. 0(7), pages 786-810.

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