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The politics and bio-ethics of regulatory trust: case-studies of pharmaceuticals

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Abstract

Drawing on case studies from the modern era of pharmaceutical regulation in the UK, US and Europe, I examine how the extent and distribution of trust between regulators, the pharmaceutical industry, and the medical profession about drug testing and monitoring influences knowledge and regulatory judgements about the efficacy and safety of prescription drugs. Introducing the concepts of ‘acquiescent’ and ‘investigative’ norms of regulatory trust, I demonstrate how investigative norms of regulatory trust—which deter pharmaceutical companies from assuming that their data analyses will be accepted without independent de-construction—drive up bioethical and regulatory standards of drug assessment in the interests of health. By contrast, acquiescent norms of regulatory trust, which are associated with industrial capture and professional closure of interests, promote permissive standards allowing patients to take pharmaceuticals with greater risks to health and less evidence of therapeutic efficacy.

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Notes

  1. They are called ‘spontaneous’ because there is no experimental design—no sampling and no control group.

  2. Interview with former member of CSM during 1970s and 1980s, Sheffield, 28 September 2001.

  3. Interview with senior scientist at Medicines Division during 1970s and 1980s, London, 30 May 2001.

  4. See footnote 2.

  5. After about 6 years in the regulatory process, in December 1984, the FDA did approve nomifensine as an effective antidepressant despite the fact that the clinical trial evidence did not meet the regulatory standards, which they themselves advocated. It is beyond the scope of this paper to examine the reasons behind that decision.

  6. In 2004 the CPMP changed its name to the Committee for Human Medicinal Products (CHMP).

  7. Interview with former member of CPMP, 20 January 2005.

  8. Propanidid was also suspended by the Italian drug regulatory authorities in 1984 because of safety concerns over cremophor (Anon 1984a).

  9. Interview with a former member of CSM involved in review of Althesin, 18 July 2001.

  10. Interview with another former member of CSM involved in review of Althesin, 19 June 2001.

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Acknowledgement

I am grateful to Ray De Vries and two anonymous referees for their comments on an earlier version of this paper.

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Authors and Affiliations

  1. Department of Sociology, School of Social Science and Cultural Studies, University of Sussex, Arts D Building, Falmer, Brighton, BN1 9SN, UK

    John Abraham

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Abraham, J. The politics and bio-ethics of regulatory trust: case-studies of pharmaceuticals. Med Health Care and Philos 11, 415–426 (2008). https://doi.org/10.1007/s11019-008-9155-x

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