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Spliced: Boundary-work and the establishment of human gene therapy

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Abstract

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.

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Notes

  1. I use ‘gene transfer’ and ‘gene therapy’ interchangeably throughout this article.

  2. Another case from which to explore these questions is that of CRISPR/Cas-9 and associated gene editing techniques (TALENs, Zinc Finger Nucleases). Gene editing can theoretically make ultra-precise (single base) changes to the genome of almost any organism, suggesting the potential for safer and more accurate gene therapy. In April of this year a publication reported that CRISPR/Cas-9 was used in non-viable embryos with little success (Liang et al, 2015), sparking an uproar that rippled out of the gene therapy community and into the biosciences more broadly. This primary concern was the application of CRISPR/Cas-9 in embryos, where any changes induced would be passed on to subsequent generations (though in this case the embryos were terminated soon after the experiment). The case instigated an ultimately unsuccessful call for a moratorium on gene editing, investigations from the Nuffield Council on Bioethics in the United Kingdom and the National Academies of Sciences and Medicine in the United States, and culminated in an international summit held in December 2015, where technical, ethical and social issues were discussed. The debate has frequently conflated gene editing (the host of technologies) with germ-line interventions (applying those technologies to germ cells), and points to both the vulnerability of the germ line as a boundary, and the weight of concern and meaning the germ line bears.

  3. Notable exceptions are Paul Martin (1999), who shows among other things how gene therapy was coproduced with newly geneticised disease concepts, and Wailoo and Pemberton (2006) who explore genetic medicine more generally in relation to Tay Sachs, Sickle Cell Disease and CF.

  4. Martin (1999) suggests that public concerns over genetic modification arose from a broader, growing discontent with science and its promises, as well increasing opposition to contemporary political events such as the Vietnam War.

  5. Their concern was that this technology might have consequences for human health and the ecosystem, perhaps by creating new pathogens (Berg and Singer, 1995).

  6. Beta thalassaemia was an early HGT target because it was well characterised, with a known genetic cause (the beta-globin gene) and effect (an inadequate amount of beta-globin chains are produced, causing anaemia) (Anderson and Fletcher, 1980).

  7. The President’s Commission produced concrete results and included the formation of an RAC subcommittee for HGT, which issued recommendations through a ‘Points to Consider’ document, and provided prospective researchers advice (O’Reilly et al, 2013).

  8. The disease is characterised by one dysfunctional gene for the enzyme adenosine deaminase. Pre-clinical research in human cells, mice and non-human primates suggested that the team’s method held promise (Culver et al, 1991).

  9. The primary concern of Churchill et al (1998) is how this blurring compromises informed consent in gene therapy, and is well worth reading.

  10. The EWGT federated scientists from 18 European countries, and survives as the European Society of Gene and Cell Therapy (Cohen-Haguenauer, 1992).

  11. Susan Lindee points out that gene therapy was a commonly invoked end goal of genome mapping. In reality, the primary technological intervention the HGP has facilitated is abortion of afflicted embryos.

  12. The RACs’ remit was reduced on the suggestion of two advisory groups. Some felt the layer of oversight they provided impeded authorisations, others that it was simply unnecessary, since human trials had been underway for 5 years without serious safety issues (Marshall, 1996).

  13. For a review of vector types and their properties, see O’Reilly et al (2013).

  14. Often the immune response recognises the inserted gene as foreign and inhibits it; furthermore, many genes need their expression to be regulated, itself a complicated undertaking.

  15. A London-based X-SCID trial later reported similar results in their 10 patients, whose T-cell counts improved, though their humoral immunity remained below average (Gaspar et al, 2011).

  16. For an overview of European gene therapy regulation, see Klug et al (2012).

  17. mtDNA is DNA found outside the cell nucleus, and is passed down the maternal lineage (that is, children only inherit their mothers’ mtDNA).

  18. See HFEA (2014) for detail about how these two techniques work.

  19. Whether or not mtDNA transfer counts as gene therapy depends on who is asked. I have chosen to use it in this discussion because what counts as gene therapy more broadly is up for debate, and this particular case continues earlier conversations originating from gene therapy, most notably those concerned with the status of the germ line.

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Acknowledgements

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.

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  1. Department of Food and Resource Economics, The University of Copenhagen, Building C, room 3.101, Section for Consumption, Bioethics and Governance, Rolighedsvej 25, Copenhagen, 1958, Denmark

    Courtney Addison

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Addison, C. Spliced: Boundary-work and the establishment of human gene therapy. BioSocieties 12, 257–281 (2017). https://doi.org/10.1057/biosoc.2016.9

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