Christoph Gradmann and Jonathan Simon (eds), Evaluating and Standardizing Therapeutic Agents, 1890–1950 (Basingstoke: Palgrave Macmillan, 2010), pp. xiv + 266, £55.00, hardback, ISBN: 978-0-230-2-281-8.

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This collection of articles edited by Christoph Gradmann and Jonathan Simon, investigates an important, and timely topic: the history of the standardisation of therapeutic agents, or, to use the term chosen by the volume’s editors, Wertbestimmung. This word does not correspond precisely to the English term ‘standardisation’, since it contains also a dimension of ‘evaluation’ and ‘regulation’. The difficulty of defining what exactly standardisation/Wertbestimmung is, and how it unfolds in different sites, is at the very centre of this volume. The final essay by Alberto Cambrosio quotes Samuel Krislov’s apt formulation: ‘there is no standard way to define standards’. On the other hand, if Evaluating and Standardizing Therapeutic Agents does not provide a single definition of standardisation/Wertbestimmung, it conveys a good understanding of the importance of this topic and its central role in the development of twentieth-century medicine. The first part of this collection is composed of seven papers (by Cay-Rudiger Prull, Axel Huntelmann, Anne I. Hardy, Gabriel Gachelin, Jonathan Simon and Marianna Kaba) which discuss the case of diphtheria serum, the first and exemplary standardisation of a biological drug. Three of the four papers of the second part investigate other biological therapies: Michael Worboys studies Wright’s therapeutic vaccines, Jean-Paul Gaudilliere, the manufacture of sex hormones, and Ulrike Linder, polio vaccine. A fourth paper, by Christian Bonah, examines the standardisation of Strophanthin, a drug derived from a plant. The two parts are linked through insightful papers on the Danish State Serum Institution, by Anne Hardy, and on the development of international co-operation in the inter-war era, by Pauline Mazumdar. The latter paper focuses on the politics of standardisation, rather than on the fate of standardised substances. Mazumdar’s study also provides important insights on the development of international co-operation in the inter-war era. The majority of the papers in this volume are carefully researched case studies that illuminate different aspects of standardisation/Wertbestimmung in context. They point to the role of local scientific cultures of leading institutions (the Pasteur Institute in Paris, the Serology Institute in Copenhagen, St Mary’s Hospital in London), of charismatic individuals (Ehrlich, Roux, Madsen), relationships between researchers and clinicians, organisation of health care, state intervention, and international networks of collaboration and exchange. Papers by Huntelmann (on the regulation of diphtheria serum in Germany), Gaudilliere (on the production of hormones by Schering and Bayer) and Bonah (on standardisation of Strophanthin) dwell also on theoretical aspects of standardisation/Wertbestimmung. They discuss the contrasting roles of administrative and industrial cultures of standardisation; the differences between standardisation in a research laboratory and a production plant; the co-production of a given therapeutic agent, its clinical indications, and the criteria of its efficacy. The final, synthetic essay by Alberto Cambrosio, situates standardisation in a larger framework of regulatory practices in medicine, and argues that the early regulation of therapeutic sera and vaccines set the pattern for the later regulation of all pharmacologically active preparations. Drawing on the pioneering work of Ludwik Fleck, Cambrosio stresses the importance of the slow, meandering initiatives which, crisscrossing between research laboratories, production plants and regulatory instances, gradually led to the stabilisation of new therapies. A single volume cannot do full justice to a very rich and complex topic. Further studies will teach us more about the strategies of industrialists, the role of clinicians, and methods used to assess the efficacy and risks of therapeutic agents. In the meantime, the volume Evaluating and Standardizing Therapeutic Agents is an excellent introduction to the role of standardisation/Wertbestimmung as a boundary object which links heterogeneous networks and domains of study, and shapes the production of new medical knowledge and practices.