Hostname: page-component-cd9895bd7-mkpzs Total loading time: 0 Render date: 2024-12-23T07:47:39.598Z Has data issue: false hasContentIssue false
  • English
  • Français

Drug Trials and Evidence Bases in International Regulatory Context

Published online by Cambridge University Press:  01 March 2007

John Abraham
John Abraham
Affiliation:
Department of Sociology and Centre for Research in Health and Medicine (CRHaM), School of Social Sciences, Arts D Building, University of Sussex, Falmer, Brighton BN1 9SN, UK E-mail: [email protected]
Get access

Abstract

The complex ways in which technical challenges of trial design provoke, and are provoked by, ethical, commercial and political factors are considered. It is suggested that the quality of the drug trial evidence base greatly depends on the how ethical, commercial and political priorities are set, and not merely on standardized techniques of data processing. Whether such standardized techniques are raising or lowering the quality of safety information about new drugs, and the protection of patients on clinical trials is explored. It is revealed that these international standards, intended to define valid evidence-based medicine for drug trials, are not themselves robustly evidence-based. It is argued that the internationalized regulatory standards developed to frame the evidence base for drug safety and efficacy are frequently inconsistent with furthering patients’ well-being and public health. Rather, those standards reflect a regulatory culture of neoliberal corporate bias, and have been powerfully shaped by the commercial and political interests of the pharmaceutical industry and regulatory institutions. It is questionable that regulatory agencies are thoroughly and robustly scrutinizing the claims that pharmaceutical firms make about their products. New political and regulatory arrangements that could facilitate more ethical drug trials in the interests of patients and public health are proposed.

Keywords

drug trialsinternational regulatory standardspharmaceutical industry
Type
Articles
Information
BioSocieties , Volume 2 , Issue 1: Special Issue: The Construction and Governance of Randomised Controlled Trials , March 2007 , pp. 41 - 56
Copyright
Copyright © London School of Economics and Political Science 2007

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Abraham, J. (1994). Negotiation and accommodation in expert medical risk assessment and regulation: an institutional analysis of the benoxaprofen case. Policy Sciences, 27, 53–76.CrossRefGoogle Scholar
Abraham, J. (1995). Science, politics and the pharmaceutical industry: Controversy and bias in drug regulation. London and New York: UCL Press and St Martin’s Press.Google Scholar
Abraham, J. (2002a). The pharmaceutical industry as political player. The Lancet, 360, 1498–1502.Google Scholar
Abraham, J. (2002b). Making regulation responsive to commercial interests: Streamlining drug industry watchdogs. British Medical Journal, 325, 1164–1169.Google Scholar
Abraham, J., & Davis, C. (2006). Testing times: The emergence of the Practolol disaster and its challenge to British drug regulation in the modern period. Social History of Medicine, 19, 127–147.CrossRefGoogle Scholar
Abraham, J., & Lewis, G. (2000). Regulating medicines in Europe: Competition, expertise and public health. London: Routledge.Google Scholar
Abraham, J., & Lewis, G. (2002). Citizenship, medical expertise and the capitalist regulatory state in Europe. Sociology, 36, 67–89.Google Scholar
Abraham, J., & Sheppard, J. (1997). Democracy, technocracy and the secret state of medicine: Expert and non-expert perspectives. Science, Technology and Human Values, 22, 139–167.Google Scholar
Abraham, J., & Sheppard, J. (1999). The therapeutic nightmare: The battle over the world’s most controversial sleeping pill. London: Earthscan.Google Scholar
AIDS Action Council (1996). Analysis of H.R. 3199: The FDA Revitalization Act (web document, no longer available). Washington, DC: AIDS Action Council.Google Scholar
Angell, M. (2004). The truth about the drug companies. New York: Random House.Google Scholar
Anon. (1988). US FDA’s expedited drug plan unveiled. Scrip, 1356, 18.Google Scholar
Anon. (1992). WHO stresses interest in ICH. Scrip, 1708 (10 April), 16.Google Scholar
Anon. (1993a). EFTA countries progress with EC directives. Scrip, 1867, 6.Google Scholar
Anon. (1993b). ICH2—status of tripartite harmonisation initiatives. Scrip, 1872 (12 November), 19.Google Scholar
Anon. (2000). ICH progress on single dossier. Scrip, 2522 (15 March), 17.Google Scholar
Brown, J.S., Kaitin, K.I., McAuslane, N., Thomas, K.E., & Walker, S.R. (1996). Population exposure required to assess clinical safety: Report to the ICH working group. Drug Information Journal, 30, 17–27.CrossRefGoogle Scholar
Corrigan, O. (2003). The limitations of current ethical regulations. In Abraham, J.& Lawton Smith, H.(Eds), Regulation of the pharmaceutical industry, 195–211. London and New York: Palgrave.Google Scholar
Edgar, H., & Rothman, D.J. (1990). New rules for new drugs: The challenge of AIDS to the regulatory process. The Milbank Quarterly, 68 (Suppl. 1), 111–142.CrossRefGoogle Scholar
Epstein, S. (1996). Impure science: AIDS activism and the politics of knowledge. Berkeley: University of California Press.Google Scholar
Ferris, M.J. (1992). A review of the Japanese regulatory system. In Griffin, J.P.(Ed.), Medicines: Regulation, research and risk. Belfast: Queen’s University Press.Google Scholar
Foster, C. (2003). Regulation for ethical purposes: Medical research on humans. In Abraham, J.& Smith, H. Lawton (Eds), Regulation of the pharmaceutical industry, 181–194. London and New York: Palgrave.Google Scholar
Gale, E.A.M. (2001). Lessons from the glitazones. The Lancet, 357, 1870–1875.Google Scholar
Garutti, R.J. (1994). Clinical safety data management: Definitions and standards for expedited reporting. In D’Arcy, P.F. & Harron, D.W.G. (Eds), Proceedings of the second International Conference on Harmonisation. Belfast: IFPMA.Google Scholar
Gordon, A.J. (1994). Clinical safety data management ICH guideline—Recommendations and reasoning. In D’Arcy, P.F. & Harron, D.W.G. (Eds), Proceedings of the second International Conference on Harmonisation. Belfast: IFPMA.Google Scholar
Halliday, R.G., Drasdo, A.L., Lumley, C.E., & Walker, S.R. (1997). The allocation of resources for R & D in the world’s leading pharmaceutical companies. R & D Management, 27, 63–77.Google Scholar
Healy, D. (2004). Let them eat Prozac. New York and London: New York University Press.Google Scholar
House of Commons (2005). Inquiry into the influence of the pharmaceutical industry: Health Select Committee Report, vol. 1, HC 42-1. London: Stationery Office.Google Scholar
ICH (1994a). Clinical safety data management: Definitions and standards for expedited reporting, 27 October.Google Scholar
ICH (1994b). Guideline on the extent of population exposure to assess clinical safety for drugs intended for long-term treatment of non-life-threatening conditions, 27 October.Google Scholar
ICH (1995). Guideline on the need for carcinogenicity studies of pharmaceuticals, 29 November.Google Scholar
ICH (1996). Clinical safety data management: Periodic safety update reports, 6 November.Google Scholar
Idanpaan-Heikkila, J. (1998). Impact and implementation of ICH guidelines. In D’Arcy, P.F. & Harron, D.W.G. (Eds), Proceedings of the fourth International Conference on Harmonisation, 33–34. Belfast: IFPMA.Google Scholar
Jenner, F.A. (1977). Some of the problems and difficulties associated with clinical studies of antidepressant agents. British Journal of Clinical Pharmacology, 4 (Suppl. 2), 199S–207S.Google Scholar
McIntyre, A. (1999). Key issues in the pharmaceutical industry. Chichester: John Wiley & Sons.Google Scholar
Medawar, C. (1992). Power and dependence. London: Social Audit.Google Scholar
Medawar, C., & Hardon, A. (2004). Medicines out of control? Antidepressants and the conspiracy of goodwill. Amsterdam: Askant Academic Publishers.Google Scholar
Mirowski, P., & Van Horn, R. (2005). The contract organisation and the commercialisation of scientific research. Social Studies of Science, 35, 503–548.CrossRefGoogle Scholar
Moore, T.J. (1995). Deadly medicine: Why tens of thousands of heart patients died in America’s worst drug disaster. New York: Simon & Schuster.Google Scholar
Mrazek, M., de Jonchere, K., Petrova, G., & Mossialos, E. (2004). The pharmaceutical sector and regulation in the countries of central and eastern Europe. In Mossialos, E.Mrazek, M.& Walley, T.(Eds), Regulating pharmaceuticals in Europe: Striving for efficiency, equality and quality. Maidenhead: Open University Press.Google Scholar
Nakajima, H. (1996). The ICH programme: Accomplishments and impact on world health. In D’Arcy, P.F. & Harron, D.W.G. (Eds), Proceedings of the third International Conference on Harmonisation. Belfast: IFPMA.Google Scholar
Patients’ Coalition (1997). Testimony by Patients’ Coalition before the Committee on Commerce and Subcommittee on Health and the Environment. US House of Representatives, 23 April.Google Scholar
Petryna, A. (2006). Globalizing human subjects research. In Petryna, A.Lakoff, A.& Kleinman, A. (Eds), Global pharmaceuticals: Ethics, markets, practices. Durham, NC: Duke University Press.Google Scholar
Poggiolini, D. (1992). Research development and regulation: A background to harmonization. In D’Arcy, P.F.& Harron, D.W.G. (Eds), Proceedings of the first International Conference on Harmonisation. Belfast: IFPMA.Google Scholar
Reed, T. (2002). The regulation of medicines in central and eastern Europe. DPhil. thesis, University of Sussex.Google Scholar
Reed-Maurer, P. (1994). Restructuring the Japanese pharmaceutical industry. Scrip Magazine, May, 38–40.Google Scholar
Sjoberg, P. (1996). Data to support the extension of clinical trials. In D’Arcy, P.F. & Harron, D.W.G. (Eds), Proceedings of the third International Conference on Harmonisation. Belfast: IFPMA.Google Scholar
Tansey, I.P., Armstrong, N.A., & Walker, S.R. (1994). Trends in pharmaceutical innovation: The introduction of products on to the UK market, 1960–1989. Journal of Pharmaceutical Medicine, 4, 85–100.Google Scholar
Temple, R. (2002). Placebo-controlled trials and active controlled trials: Ethics and inference. In Guess, H.A.Kleinman, A.Kusek, J.W.& Engel, L.W. (Eds), The science of the placebo: Toward an interdisciplinary research agenda, 209–226. London: BMJ Books.Google Scholar
Ten Ham, M. (1998). Globalization of ICH standards. In D’Arcy, P.F.& Harron, D.W.G. (Eds), Proceedings of the fourth International Conference on Harmonisation, 486–488. Belfast: IFPMA.Google Scholar
US Congress (1987). FDA’s regulation of the new drug Merital, Committee on Government Operations, fifteenth report, 8 July. Washington: US GPO.Google Scholar
Vastag, B. (2004). Helsinki discord? A controversial declaration. Journal of the American Medical Association, 284, 2983–2985.Google Scholar
Walker, M.J. (1993) Dirty medicine: Science, big business and the assault on natural health care. London: Slingshot Publications.Google Scholar
Willman, D. (2000). How a new policy led to seven deadly drugs. Los Angeles Times, 20 December.Google Scholar
World Medical Association (2000). Ethical principles for medical research involving human subjects. Journal of the American Medical Association, 284, 3043–3045.Google Scholar
Wyatt-Walter, A. (1995). Globalisation, corporate identity and European technology policy. Journal of European Public Policy, 2, 427–446.Google Scholar