Biological medicines in the age of biotech: Public policy issues

Science and Public Policy

Volumn 24, Issue 1, 1997, Pages 53-62

  Morris, Norma ^a  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0003089768     PISSN: 03023427     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (44)

1. See V Berridge. AIDS in the UK: the making of policy 1981-1994 (Oxford University Press, Oxford, 1996) page 134.
2. The World Health Report 1996: fighting disease; fostering development (World Health Organisation, Geneva, 1996).
3. G S Wilson, The Hazards of Immunisation (Athlone Press, London, 1967).
4. "Guidelines for national authorities on quality assurance for biologies", Technical Report Series 822 (World Health Organisation, Geneva, 1992).
5. J Abraham and M Charlton, "Controlling medicines in Europe: the harmonisation of regulatory toxicology assessed", Science and Public Policy, 22(6), December 1995, pages 354-362.
6. S L Jeffcoate , M J Corbel, P Minor, G C Schild, Proceedings of the Royal Society of Edinburgh, 1993, 101B, pages 20-226.
7. WC Cockburn, B Hobson, J W Lightbown, J Lyng and D Macgrath, "The international contribution to the standardization of biological substances. II. Biological Standards and the World Health Organization 1947-1990. General considerations, Biologicals, 19, 1991, pages 257-264.
8. Data published by Pharmaceutical Research and Manufacturers of America, Biotechnology in Development Medicines, PhRM 6/96, 1996.
9. See, for example, C T Caskey, "DNA-based medicine: prevention and therapy", in D Kevles and L Hood (editors), The Code of Codes: Scientific and Social Issues in the Human Genome Project (Harvard University Press, Cambridge, Ma, 1992); Animal-to-Human Transplants: the ethics of xenotransplantation. (Nuffield Council on Bioethics, London, 1996).
10. See, for example, C T Caskey, "DNA-based medicine: prevention and therapy", in D Kevles and L Hood (editors), The Code of Codes: Scientific and Social Issues in the Human Genome Project (Harvard University Press, Cambridge, Ma, 1992); Animal-to-Human Transplants: the ethics of xenotransplantation. (Nuffield Council on Bioethics, London, 1996).
11. S Crook, J Pakulski and M Waters, Postmodemization: change in advanced society (Sage, London, 1992).
12. Review of the Scientific Basis of Standardization and Quality Control/Safety Monitoring of Biological Substances used in Medicine. A Report to the UK National Biological Standards Board (National Biological Standards Board, 1996) (forthcoming: preprints available from NBSB, London).
13. See European Union Directives on cytokines and growth factors, and recombinant-produced hormones; President Bill Clinton, Vice-President AI Gore, Reinventing the regulation of drugs made from biotechnology: national performance review (US Food and Drug Administration, Washington, 1995).
14. P Martin, "The American gene therapy industry and the social shaping of a new technology", The Genetic Engineer and Biotechnologist, 15(2&3), 1995, pages 155-167.
15. B B Aggarwal and E Pocsik, "Cytokines: from clone to clinic", Archives of Biochemistry and Biophysics, 292(2), February 1992, pages 335-359.
16. A Colman, "Production of proteins in the milk of transgenic livestock; problems, solutions, and successes", American Journal of Clinical Nutrition, 63(4), April 1996, pages 639S-45S.
17. See for example R Taylor, "A pig in a poke? Xenotransplants and infectious disease". Nature Medicine, 1 (8), August 1995.
18. See for example US National Vaccine Plan - 1994, Department of Health and Human Services/ Public Health Service (US GPO, Washington, 1994).
19. Formal reviews of public-sector bodies by government-appointed teams, which ask the questions: is this function still necessary? Does it have to be carried out by the public sector? Is it optimally organised? See also Public Sector Research Establishments: Government Response to the Multi-Departmental Scrutiny: Cm2991 (HMSO, London, 1995).
20. S Jasanoff, The Fifth Branch: Science Advisers as Policymakers (Harvard University Press, Cambridge MA, 1990).
21. The situation in the UK, and Europe generally, contrasts with that in the USA where recourse to the judiciary is much more common: see ,for example, R Brickman, S Jasanoff and T Ilgen, Controlling Chemicals; The Politics of Regulation in Europe and the United States (Cornell University Press, Ithaca and London, 1985) ; S Jasanoff, see reference 19.
22. See, for example, B Wynne "Public understanding of science", in S Jasanoff, G E Markle, J C Petersen and T Pinch (editors), Handbook of Science and Technology Studies (Sage, London, 1994); For an analysis of the value of lay knowledge in relation to questions about environmental health and safety see A Irwin, Citizen Science: A Study of People, Expertise and Sustainable Development A Irwin, 1995, London: (Routledge, London, 1995); A Irwin and B Wynne (editors), Misunderstanding Science (Cambridge University Press, Cambridge, 1996).
23. See, for example, B Wynne "Public understanding of science", in S Jasanoff, G E Markle, J C Petersen and T Pinch (editors), Handbook of Science and Technology Studies (Sage, London, 1994); For an analysis of the value of lay knowledge in relation to questions about environmental health and safety see A Irwin, Citizen Science: A Study of People, Expertise and Sustainable Development A Irwin, 1995, London: (Routledge, London, 1995); A Irwin and B Wynne (editors), Misunderstanding Science (Cambridge University Press, Cambridge, 1996).
24. See, for example, B Wynne "Public understanding of science", in S Jasanoff, G E Markle, J C Petersen and T Pinch (editors), Handbook of Science and Technology Studies (Sage, London, 1994); For an analysis of the value of lay knowledge in relation to questions about environmental health and safety see A Irwin, Citizen Science: A Study of People, Expertise and Sustainable Development A Irwin, 1995, London: (Routledge, London, 1995); A Irwin and B Wynne (editors), Misunderstanding Science (Cambridge University Press, Cambridge, 1996).
25. See reference 1.
26. S Epstein, "The construction of lay expertise: AIDS activism and the forging of credibility in the reform of clinical trials", Science, Technology and Human Values, 20, pages 408-437.
27. J S Allan, "Xenotransplantation at a crossroads: prevention versus progress", Nature Medicine, 2(1), January 1996, pages 18-21.
28. For example the Committee on the Ethics of Gene Therapy (1989), Gene Therapy Advisory Committee (1993), Genetic Advisory Commission (June 1996) set up by the UK government: IFGene Conferences, and publications such as the Declaration on the Protection of the Human Genome (UNESCO, Paris, 1995); GenEthics News (bimonthly); Genethics: debating issues and ethics in genetic engineering (Ciba, Basel. 1995).
29. For example the Committee on the Ethics of Gene Therapy (1989), Gene Therapy Advisory Committee (1993), Genetic Advisory Commission (June 1996) set up by the UK government: IFGene Conferences, and publications such as the Declaration on the Protection of the Human Genome (UNESCO, Paris, 1995); GenEthics News (bimonthly); Genethics: debating issues and ethics in genetic engineering (Ciba, Basel. 1995).
30. For example the Committee on the Ethics of Gene Therapy (1989), Gene Therapy Advisory Committee (1993), Genetic Advisory Commission (June 1996) set up by the UK government: IFGene Conferences, and publications such as the Declaration on the Protection of the Human Genome (UNESCO, Paris, 1995); GenEthics News (bimonthly); Genethics: debating issues and ethics in genetic engineering (Ciba, Basel. 1995).
31. See, for example, J Morgan, "Eugenics revisited - trends in behavioural genetics", Scientific American. June 1993, pages 92-100.
32. See, for example, Report of the Committee on the Ethics of Gene Therapy (Clothier Report) (HMSO, London, 1992); Nuffield Council on Bioethics, Genetic Screening: Ethical Issues (Nuffield Foundation, London, 1993); Institute of Medicine, Assessing Genetic Risks: Implications for Health and Social Policy (National Academy of Sciences, Washington, 1993); R J Pokorski, "Genetic information and life insurance", Nature, 376, July 1995, pages 13-14; E Draper, Risky Business: Genetic Testing and Exclusionary Practices in the Hazardous Workplace (Cambridge University Press, Cambridge, 1991).
33. See, for example, Report of the Committee on the Ethics of Gene Therapy (Clothier Report) (HMSO, London, 1992); Nuffield Council on Bioethics, Genetic Screening: Ethical Issues (Nuffield Foundation, London, 1993); Institute of Medicine, Assessing Genetic Risks: Implications for Health and Social Policy (National Academy of Sciences, Washington, 1993); R J Pokorski, "Genetic information and life insurance", Nature, 376, July 1995, pages 13-14; E Draper, Risky Business: Genetic Testing and Exclusionary Practices in the Hazardous Workplace (Cambridge University Press, Cambridge, 1991).
34. See, for example, Report of the Committee on the Ethics of Gene Therapy (Clothier Report) (HMSO, London, 1992); Nuffield Council on Bioethics, Genetic Screening: Ethical Issues (Nuffield Foundation, London, 1993); Institute of Medicine, Assessing Genetic Risks: Implications for Health and Social Policy (National Academy of Sciences, Washington, 1993); R J Pokorski, "Genetic information and life insurance", Nature, 376, July 1995, pages 13-14; E Draper, Risky Business: Genetic Testing and Exclusionary Practices in the Hazardous Workplace (Cambridge University Press, Cambridge, 1991).
35. See, for example, Report of the Committee on the Ethics of Gene Therapy (Clothier Report) (HMSO, London, 1992); Nuffield Council on Bioethics, Genetic Screening: Ethical Issues (Nuffield Foundation, London, 1993); Institute of Medicine, Assessing Genetic Risks: Implications for Health and Social Policy (National Academy of Sciences, Washington, 1993); R J Pokorski, "Genetic information and life insurance", Nature, 376, July 1995, pages 13-14; E Draper, Risky Business: Genetic Testing and Exclusionary Practices in the Hazardous Workplace (Cambridge University Press, Cambridge, 1991).
36. See, for example, Report of the Committee on the Ethics of Gene Therapy (Clothier Report) (HMSO, London, 1992); Nuffield Council on Bioethics, Genetic Screening: Ethical Issues (Nuffield Foundation, London, 1993); Institute of Medicine, Assessing Genetic Risks: Implications for Health and Social Policy (National Academy of Sciences, Washington, 1993); R J Pokorski, "Genetic information and life insurance", Nature, 376, July 1995, pages 13-14; E Draper, Risky Business: Genetic Testing and Exclusionary Practices in the Hazardous Workplace (Cambridge University Press, Cambridge, 1991).
37. In addition to the views and comments emerging from the discussions referenced above, a subcommittee of the International Bar Association (at the request of the Human Genome Organisation) has drawn up a draft International Convention on the Human Genome, addressing issues from genetic property to abortion: A Coughlan, "This week", New Scientist, 2054, 2 November 1996, page 8.
38. Advisory Group on the Ethics of Xenotranspiantation, set up by the UK Department of Health in 1995: report by Nuffield Council on Bioethics, Animal-to-Human Transplants: the ethics of xenotransplantation (Nuffield Council on Bioethics, London, 1996).
39. US Food and Drugs Administration, Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic Animals (PDA, Washington, 1995).
40. L E Chapman, T M Folks, D R Salomon, A P Patterson, T E Eggerman, P D Noguchi, "Xenotransplantation and xenogeneic infections", New England Journal of Medicine, 333, November 1995, pages 1498-1501.
41. For a succinct overview, see, for example, J Turney, "To know science is to love it?", in Public Understanding of Science Practice (COPUS, London, 1996): D Nelkin, "Science controversies", in S Jasanoff, G E Markle, J C Petersen and T Pinch (editors), Handbook of Science and Technology Studies (Sage, London, 1994).
42. For a succinct overview, see, for example, J Turney, "To know science is to love it?", in Public Understanding of Science Practice (COPUS, London, 1996): D Nelkin, "Science controversies", in S Jasanoff, G E Markle, J C Petersen and T Pinch (editors), Handbook of Science and Technology Studies (Sage, London, 1994).
43. C Limoges, "Expert knowledge and decision-making in controversy contexts", Public Understanding of Science, 2, 1993, pages 417-426.
44. For a general overview see A Irwin, Citizen Science: A Study of People, Expertise and Sustainable Development A Irwin, 1995, London: (Routledge, London, 1995) chapter 6.