Spliced: Boundary-work and the establishment of human gene therapy
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Human gene therapy (HGT) aims to cure disease by inserting or editing the DNA of patients with genetic conditions. Since foundational genetic techniques came into use in the 1970s, the field has developed to the point that now three therapies have market approval, and over 1800 clinical trials have been initiated. In this article I present a brief history of HGT, showing how the ethical and practical viability of the field was achieved by key scientific and regulatory actors. These parties carefully articulated gene therapy’s scope, limiting it to therapeutic interventions on somatic cells, and cultivated alliances and divisions that bolstered the field’s legitimacy. At times these measures faltered, and then practitioners and sometimes patients would invoke an ethical imperative, posing gene therapy as the best solution to life and death problems. I suggest that we consider how boundary-work stretches out from science to enlist diverse publics, social formations and the natural world in the pursuit of legitimacy.
Keywordshuman gene therapy history biotechnology genomics gene transfer boundary-work
This article benefited greatly from feedback offered by Jesper Lassen, Peter Sandøe, Samuel Taylor-Alexander and the Work in Progress group led by Silvia Camporesi at KCL’s Department of Social Science Health and Medicine. This project, as part of the Consortium for Designer Organisms, is funded by the University of Copenhagen’s Excellence Fund for Interdisciplinary Research.
- AdSAT Working Group (2002) Assessment of adenoviral vector safety and toxicity: Report of the national institutes of health Recombinant DNA Advisory Committee (NIH Report). Human Gene Therapy 13(1): 3–13.Google Scholar
- Anderson, W.F. (1982) Human Genetic Engineering: Hearings before the Subcommittee on Investigations and Oversight of the Committee on Science and Technology. (Testimonial) U.S. House of Representatives, 97th Congress, 2nd Session, no. 170, Washington DC.Google Scholar
- Anonymous (1988) Gene therapy in man: Recommendations of the European medical research councils. The Lancet 331(8597): 1271–1272.Google Scholar
- Anonymous (2002) The trials of gene therapy. Nature 420(6912): 107.Google Scholar
- Barber, S. and Border, P. (2015) Mitochondrial donation. (Standard Note SN/SC/6833) House of Commons Library.Google Scholar
- Bowker, G.C. and Star, S.L. (1999) Sorting Things Out: Classification and its Consequences. Cambridge, MA: MIT Press.Google Scholar
- Campbell, P., Maranto, G., Cantor, C.R., Glantz, L.H. and Miller, F.H. (1998) Gene therapy: Legal, financial and ethical issues. Boston University Journal of Science and Technology Law 4(3): 110.Google Scholar
- Check, E. (2003) Harmful potential of viral vectors fuels doubt over gene therapy. Nature 423(6940): 573–574.Google Scholar
- Clothier Committee (1992) Report of the committee on the ethics of gene therapy. Human Gene Therapy 3(5): 519–523.Google Scholar
- Comfort, N. (2013) The Science of Human Perfection: How Genes became the Heart of American Medicine. New Haven, CT, London: Yale University Press.Google Scholar
- Committee on Government Reforms (2000) Human Subject Research Protections. Hearing before the Subcommittee on Criminal Justice, Drug Policy and Human Resources of the Committee on Government Reforms. Washington DC: US Government Printing Office.Google Scholar
- Culver, K.W. et al (1991) Correction of ADA deficiency in human T-lymphoctyes using retroviral-mediated gene transfer. Transplantation Proceedings. 23(1): 170–171.Google Scholar
- Devlin, H. (2015) Britain’s House of Lords approves conception of three-parent babies. The Guardian, 24 February, http://www.theguardian.com/politics/2015/feb/24/uk-house-of-lords-approves-conception-of-three-person-babies.
- Dworkin, R.B. (1990) Science, society, and the expert town meeting: Some comments on Asilomar. Southern California Law Review 51(6): 1471–1482.Google Scholar
- EMA (European Medicines Agency) (2012) Glybera, alipogene tiparvovec. EPAR summary for the public, pp. 1–3.Google Scholar
- Epstein, S. (1995) Impure Science: AIDS, Activism and the Politics of Knowledge. Berkeley, CA: University of California Press.Google Scholar
- European Parliament and the Council of the European Union (2001) Directive 2001/20/EC.Google Scholar
- Fischer, M.M.J. (2004) Emergent Forms of Life and the Anthropological Voice. Durham, NC: Duke University Press.Google Scholar
- Fortun, M. (2008) Promising Genomics: Iceland and deCODE Genetics in a World of Speculation. Berkeley, CA: University of California Press.Google Scholar
- Frederikson, D.S. (1991) Asilomar and recombinant DNA: The end of the beginning. In: K.E. Hanna (ed.) Biomedical Politics. Washington DC: National Academies Press, pp. 258–298.Google Scholar
- Frist, B. (2002) Protecting Human Subjects in Research: Are Current Safeguards Accurate? Hearing before the Subcommittee on Public Health of the Committee of Health, Education, Labour and Pensions United States Senate. Washington DC: US Government Printing Office.Google Scholar
- Gaspar, H.B. et al (2011) Long-term persistence of polyclonal T cell repertoire after gene therapy for X-linked severe combined immunodeficiency. Science Translational Medicine 3(97): 97–99.Google Scholar
- Gieryn, T. (1991) Cultural Boundaries of Science: Credibility on the Line. Chicago, IL: University of Chicago Press.Google Scholar
- Genetic Alliance UK (2014) Avoiding mitochondrial disease. Response to the Nuffield Council of Bioethics, pp. 1–3.Google Scholar
- Gore, A. (1982) Human Genetic Engineering: Hearings before the Subcommittee on Investigations and Oversight of the Committee on Science and Technology. Opening address, U.S. House of Representatives, 97th Congress, 2nd Session, no. 170, Washington DC.Google Scholar
- Gore, A. (1984) Human Gene Therapy: A Background Paper. Washington DC: U.S. Congree, Office of Technology Assessment.Google Scholar
- House of Commons Science and Technology Committee (2014) Mitochondrial donation. Correspondence relating to evidence hearing, 22 October.Google Scholar
- Human Fertilisation and Embryo Authority (2014) Mitochondrial donation: An introductory briefing note, http://www.hfea.gov.uk/6896.html.
- Isasi, R.M., Nguyen, T.M. and Knoppers, B.M. (2006) National Regulatory Frameworks Regarding Human Genetic Modification Technologies. A report for the Genetics and Public Policy Centre, Montreal.Google Scholar
- Kay, L.E. (2000) Who Wrote the Book of Life? A History of the Genetic Code. Stanford, CA: Stanford University Press.Google Scholar
- Keller, E.F. (2000) The Century of the Gene. Cambridge, MA: Harvard University Press.Google Scholar
- Kerr, A. and Shakespeare, T. (2002) Genetic Politics: From Genetics to Genome. Cheltenham, UK: New Clarion Press.Google Scholar
- Knorr-Cetina, K. (1999) Epistemic Cultures: How the Sciences Make Knowledge. Cambridge, MA: Harvard University Press.Google Scholar
- Koenig, B. (1988) The technological imperative in medical practice: The social creation of a ‘routine’ treatment. In: M. Lock and R. Gordon (eds.) Biomedicine Examined. Dordrecht, The Netherlands: Kluwer Academic Publishers.Google Scholar
- Latour, B. (1987) Science in Action. Cambridge, MA: Harvard University Press.Google Scholar
- Lindee, S. (2005) Moments of Truth in Genetic Medicine. Baltimore, MD: John Hopkins University Press.Google Scholar
- Lu, D.R. et al (1993) Stage 1 clinical trial of gene therapy for haemophilia B. Science in China 36(11): 1342–1351.Google Scholar
- Lock, M. (2008) Biomedical technologies, cultural horizons and contested boundaries. In: E.J. Hackett, O. Amsterdamska, M. Lynch and J. Wajcman (eds.) Handbook of Science and Technology Studies, Third Edition. Cambridge, MA; London: MIT Press.Google Scholar
- Nelkin, D. and Lindee, S. (1995) The DNA Mystique: The Gene as Cultural Icon. New York: W. H. Freeman.Google Scholar
- NIH (2013) NIH guidelines for research involving recombinant or synthetic nucleic acid molecules, http://oba.od.nih.gov, accessed November 2013.
- Orkin, S. and Motulsky, A. (1995) Report and recommendations of the panel to assess the NIH investment in research on gene therapy. Bulletin of Medical Ethics 116: 10–11.Google Scholar
- President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1982) Splicing Life: A. Report on the Social and Ethical Issues of Genetic Engineering with Human Beings. Washington DC: U.S. Government Printing Office.Google Scholar
- Rabeharisoa, V. and Callon, M. (2002) The Involvement of Patients’ Associations in Research. UNESCO report, Oxford, UK and Malden, MA.Google Scholar
- Rabinow, P. (1996) Making PCR: A Story of Biotechnology. Chicago, IL; London: The University of Chicago Press.Google Scholar
- Randall, C., Mandelbaum, B. and Kelly, T. (1980) Letter from three general secretaries. Letter to congress, Washington, DC.Google Scholar
- Rapp, R. (1999) Testing Women, Testing the Fetus: Women and Prenatal Diagnosis. New York: Routledge.Google Scholar
- Schmek, H.M. (1981) U.S. agency disciplines gene therapy researcher. The New York Times, http://www.nytimes.com/1981/05/29/us/us-agency-disciplines-gene-splicing-researcher.html.
- Stolberg, S.G. (1999) The biotech death of Jesse Gelsinger. The New York Times Magazine, 28 November, http://www.nytimes.com/1999/11/28/magazine/the-biotech-death-of-jesse-gelsinger.html?pagewanted=all.
- Thompson, C. (2005) Making Parents: The Ontological Choreography of Reproductive Technologies. Cambridge, MA: MIT Press.Google Scholar
- Uniqure (2012) uniQure’s Glybera® first gene therapy approved by European Commission. Press release. Amsterdam, The Netherlands.Google Scholar
- Wailoo, K. and Pemberton, S. (2006) The Troubled Dream of Genetic Medicine: Ethnicity and Innovation in Tay-Sachs, Cystic Fibrosis, and Sickle Cell Disease. Baltimore, MD: John Hopkins University Press.Google Scholar
- Zallen, D.T. (2000) U.S. gene therapy in crisis. Genetics and Society 16(6): 272–275.Google Scholar