Hostname: page-component-586b7cd67f-t7czq Total loading time: 0 Render date: 2024-11-20T08:48:52.776Z Has data issue: false hasContentIssue false
  • English
  • Français

Packaging BCG: Standardizing an Anti-Tuberculosis Vaccine in Interwar Europe

Published online by Cambridge University Press:  01 June 2008

Christian Bonah
Christian Bonah*
Affiliation:
Université Louis Pasteur, Strasbourg, France
Get access Rights & Permissions [Opens in a new window]

Argument

Using the example of the anti-tuberculosis vaccine BCG during the 1920s and 1930s, this article asks how a labile laboratory-modified bacteria was transformed into a genuine standard vaccine packaged and commercialized as a pharmaceutical product. At the center of the analysis lies the notion of standardization inquiring why and how a local laboratory process with standard operating procedures (SOPs) reached its limits and was transformed when the product faced international distribution. Moving from Paul Ehrlich's initial technological notion of Wertbestimmung referring to a practice physiologically testing the effects of ill-defined antitoxins, the concept of standardization is extended to pharmaceutical and economical meanings implying quality control for biological therapeutic agents produced by a variety of industrial entrepreneurs. Following the request for product uniformity, two ways to maintain levels of compatibility and commonality are depicted opposing SOPs and end-product control. Furthermore, standardization is understood as a spiral, never ending process where progressive transformation of the vaccine in its production and medical uses periodically recreated the necessity of standardization. Developments analyzed are thus understood as a stabilization process aligning laboratory settings, products, and practices with medical theories and practices through technical, bureaucratic, and organizational systems. A paradox of the analysis is that standardization as a historical phenomenon and moment in the history of drug development was initially linked to a problem of under-determination of what was to be standardized and to a knowledge gap before it could become a central concept for quality control.

Type
Research Article
Information
Science in Context , Volume 21 , Issue 2 , June 2008 , pp. 279 - 310
Copyright
Copyright © Cambridge University Press 2008

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

Anonymous. 1927. “Prophylactic vaccination of the newly born against tuberculosis.” British Medical Journal 7 May:845–846.Google Scholar
Beddies, Thomas and Schmiedebach, Heinz-Peter. 2004. “‘Euthanasie’-Opfer und Versuchsobjekte. Kranke und behinderte Kinder in Berlin während des Zweiten Weltkriegs.” Medizinhistorisches Journal 39:165–196.Google Scholar
Bernard, Léon. 1930. “La conférence internationale de la tuberculose d'Oslo.” Bulletin de l'Académie de Médecine 28 October:255–259.Google Scholar
Bonah, Christian. 2003. “Le drame de Lübeck : la vaccination BCG, le ‘procès Calmette’ et les Richtlinien de 1931.” In La Médecine expérimentale au tribunal: Implications éthiques de quelques procès médicaux du XXe siècle européen, edited by Bonah, Christian, Lepicard, Étienne, and Roelcke, Volker, 65–94. Paris: Éditions des Archives Contemporaines.Google Scholar
Bonah, Christian. 2005. “The ‘experimental stable’ of the BCG vaccine: safety, efficacy, proof, and standards, 1921–1933.” Studies in History and Philosophy of Biological and Biomedical Sciences 36:696–721.CrossRefGoogle ScholarPubMed
Bonah, Christian. 2006. “‘As safe as milk or sugar water.’ Perceptions of the risks and benefits of the BCG vaccine in the 1920's and 1930's in France and Germany.” In The risks of medical innovation. Risk perception and assessment in historical context, edited by Schlich, Thomas and Troehler, Ulrich, 71–92. London: Routledge.CrossRefGoogle Scholar
Bonah, Christian. 2007. L'expérimentation humaine. Discours et pratiques en France, 1900–1940. Paris: Les Belles Lettres.Google Scholar
Bonah, Christian and Menut, Philippe. 2002. “La longue marche d'un vétéran. Dossier BCG.” La Recherche 356:70–73.Google Scholar
Bonah, Christian and Menut, Philippe. 2004. “BCG vaccination around 1930 – dangerous experiment or established prevention? Practices and debates in France and Germany.” In Twentieth Century Ethics of Human Subjects Research: Historical Perspectives on Values, Practices, and Regulations, edited by Roelcke, Volker and Maio, Giovanni, 111–127. Stuttgart: Steiner.Google Scholar
Bosanquet, Cecil and Eyre, John. 1916. Serums, Vaccines and Toxins in Treatment and Diagnosis. London: Cassell and Company.Google Scholar
Calmette, Albert. [1920] 1928. L'infection bacillaire et la tuberculose chez l'homme et chez les animaux, 3rd revised edition. Paris: Masson.Google Scholar
Calmette, Albert. 1927a. La vaccination préventive contre la tuberculose par le BCG. Paris: Masson.Google Scholar
Calmette, Albert. 1927b. “Sur la vaccination préventive des enfants nouveau-nés contre la tuberculose par le BCG.” Annales de l'Institut Pasteur 41:201–232.Google Scholar
Calmette, Albert. 1930a. “Criminal Medicine: From Koch to Calmette. A reply by Professor Calmette.” The Anti-Vivisection and Humanitarian Review October.-November:167.Google Scholar
Calmette, Albert. 1930b. AIP, Fonds Calmette, Note du Ministère de l'Intérieur [du Reich] à la presse datée du 8 juillet 1930 concernant les accidents de Lübeck, 3 pages.Google Scholar
Calmette, Albert. 1930c. “Sur la vaccination préventive de la tuberculose par le BCG. Son innocuité et ses effets sur la réduction de la mortalité générale infantile.” Bulletin de l'Académie de Médecine 14 January:58–68.Google Scholar
Calmette, Albert. 1933. AIP: CAL/B 8, Letter of Calmette to J. R. Molher, US Department of Agriculture, June 30, 1933.Google Scholar
Calmette, Albert, Guérin, Camille, Weill-Hallé, Benjamin, Nègre, Léopold, Boquet, Alfred, Wilbert, , and Turpin, Raymond. 1925. “Essai de prémunition contre l'infection tuberculeuse de l'homme et des animaux. 2e note.” Bulletin de l'Académie de Médecine, 16 June:681–689.Google Scholar
Calmette, Albert, Guérin, Camille, Nègre, Léopold, and Boquet, Alfred. 1926. “Prémunition des nouveau-nés contre la tuberculose par le vaccin BCG.” Annales de l'Institut Pasteur 40:89–133.Google Scholar
Calmette, Albert and de Potter, Frans. 1926. “Sur le titrage (standardisation) des tuberculines.” Annales de l'Institut Pasteur 40:353–397.Google Scholar
Calmette, Albert and Guérin, Camille. 1924. “Vaccination des bovidés contre la tuberculose et méthode nouvelle de prophylaxie de la tuberculose bovine.” Annales de l'Institut Pasteur 38:371–398.Google Scholar
Calmette, Albert, Guérin, Camille, and Weill-Hallé, Benjamin. 1924. “Essais d'immunisation contre l'infection tuberculeuse.” Bulletin de l'Académie de Médecine, 24 June:787–796.Google Scholar
Cassier, Maurice. 2005. “Appropriation and commercialization of the Pasteur Anthrax vaccine.” Studies in History and Philosophy of Biological and Biomedical Sciences 36:722–742.CrossRefGoogle ScholarPubMed
Dahl, Matthias. 2002.“‘. . . deren Lebenserhaltung für die Nation keinen Vorteil bedeutet.’ Behinderte Kinder als Versuchsobjekte und die Entwicklung der Tuberkulose-Schutzimpfung”. Medizinhistorisches Journal 37:57–90Google Scholar
Feldberg, Georgina. 1995. Disease and class. Tuberculosis and the shaping of modern North American society. New Brunswick: Rutgers University Press.Google Scholar
Geison, Gerald. 1995. The Private Science of Louis Pasteur. Princeton: Princeton University Press.Google Scholar
Gradmann, Christoph. 2005. Krankheit im Labor. Robert Koch und die medizinische Bakteriologie. Göttingen: Wallstein.Google Scholar
Gradmann, Christoph. 2001. “Robert Koch and the Pressures of Scientific Research: Tuberculosis and Tuberculin.” Medical History 45:1–32.CrossRefGoogle Scholar
Gradmann, Christoph. 2000. “Money and Microbes: Robert Koch, Tuberculin and the Foundation of the Institute for Infectious Diseases in Berlin 1891.” History and Philosophy of the Life Sciences 22:51–71.Google Scholar
Greenwood, Major. 1927. “Prophylactic vaccination of the newly born against tuberculosis.” British Medical Journal 14 May:896–897.CrossRefGoogle Scholar
Guérin, Camille. 1935. “La lutte contre la tuberculose. Le vaccin BCG. Son histoire.” Revue médicale Guérir June:14–16.Google Scholar
Hahn, Susanne. 1995. “Der ‘Lübecker Totentanz’: Zur Rechtlichen und Ethischen Problematik der Katastrophe bei der Erprobung der Tuberkuloseimpfung 1930 in Deutschland.” Medizinhistorisches Journal 30:61–79.Google Scholar
Inserm. 2004. Expertise collective. Tuberculose. Place de la vaccination dans la maîtrise de la maladie. Paris: Inserm.Google Scholar
Institut Pasteur. 1932. Les Nouveaux Laboratoires de Recherches sur la Tuberculose et de Préparation du BCG à l'Institut Pasteur. Paris: Masson.Google Scholar
Keating, Peter. 1988. “Vaccine therapy and the problem of opsonins.” Journal of the History of Medicine and Allied Sciences 43:275–296.CrossRefGoogle ScholarPubMed
Menut, Philippe. 2001. “The Lübeck catastrophe and its consequences for anti-tuberculosis BCG vaccination.” In Singular Selves: Historical Issues and Contemporary Debates in Immunology, edited by Moulin, Anne-Marie and Cambrosio, Alberto, 202–210. Amsterdam: Elsevier.Google Scholar
Menut, Philippe. 2003. “Ethique et ethos de la recherche biomédicale en France: l'introduction de la vaccination par le BCG, 1921–1933.” In La Médecine expérimentale au tribunal: Implications éthiques de quelques procès médicaux du XXe siècle européen, edited by Bonah, Christian, Lepicard, Étienne, and Roelcke, Volker, 95–124. Paris: Éditions des Archives Contemporaines.Google Scholar
Murard, Lion and Zylberman, Patrick. 1996. L'hygiène dans la République. La santé publique en France ou l'utopie contrariée 1870–1918. Paris: Fayard.Google Scholar
Reuland, Andreas. 2004. Menschenversuche in der Weimarer Republik. Norderstedt: Books on Demand.Google Scholar
Rosenthal, Sol Roy. 1957. BCG vaccination against tuberculosis. Boston: Little, Brown.Google Scholar
Société des Nations, Organisation d'Hygiène. 1928. Rapport de la conférence technique pour l'étude de la vaccination antituberculeuse par le BCG. Tenue à l'Institut Pasteur de Paris du 15 au 18 octobre 1928. Geneva: Société des Nations.Google Scholar
Tuberculosis Research Office – World Health Organization. 1949. The Conference on European BCG Programmes Conducted with the Assistance of the Joint Enterprise, Copenhagen, Denmark, 8th to 12th September 1949. Copenhagen.Google Scholar
Tuberculosis Research Office – World Health Organization. 1954. Mass BCG Vaccination Campaigns 1948–1951. Copenhagen.Google Scholar
Wallgren, Arvid. 1927. “Observations critiques sur la vaccination antituberculeuse de Calmette.” Acta Pediatrica 7:120–137.CrossRefGoogle Scholar
Weill-Hallé, Benjamin and Turpin, Raymond. 1925. “Premiers essais de vaccination antituberculeuse de l'enfant par le bacille Calmette-Guérin (BCG).” Bulletins et Mémoires de la Société médicale des Hôpitaux de Paris 49 (39):1589–1601.Google Scholar
Worboys, Michael. 1992. “Vaccine therapy and laboratory medicine in Edwardian Britain.” In Medical Innovations in Historical perspective, edited by Pickstone, John, 84–103. Houndmills: MacMillan.CrossRefGoogle Scholar