La naissance des biotechnologies pharmaceutiques en France (1887-1914) : Le sérum antidiphtérique de l’Institut Pasteur

Abstract : The successful results of the treatment of diphtheria by serum taken from horses immunized against the diphtheria toxin, were disclosed by Émile Roux at the International Congress of Hygiene held in Budapest on September 5, 1894. The Behring’s-Roux’ method (it would be unfair to attribute serotherapy to the French, since the German contribution has been decisive) resulted in a 2 to 3 fold decrease of the lethality among the sick children included in the clinical trials. Actually the series of tests of anti-diphtheria sera certainly constitutes the first set of random human clinical trial of a drug. The production of serum followed simple and easily reproducible procedures. In about a year, serotherapy had become the dominant treatment of diphtheria, and death toll was reduced from about 50% to 10-15 % and even less in most countries in Europe and out of Europe. Diphtheria serotherapy had become “the herald of modern medicine”, i. e. a medical approach to a disease exclusively based on the development of the scientific programme of microbiology. Serotherapy introduced decisive changes in the manner infectious diseases were considered. Everyone now expected that they will, sooner or later, be defeated by the same or similar scientific strategies. It did not matter much that sera against other microbes did not keep their promises: the belief in the efficiency of sera did not fade out in the public. The production of anti-diphtheria sera could be taken as the birth of pharmaceutical biotechnologies, more than the production of anti-anthrax vaccines and of vaccine itself. It anyway imposed the fast passage from laboratory to industry. The entirely novel drug introduced to a series of problems which had not previously been imagined. In Germany, the production of antidiphtheria serum was, from its very beginning, the result of a close collaboration between laboratories, industry and the relevant Imperial Health Services, thus joining already existing administrative and technical structures. In France, pharmaceutical industry merely did not exist and had to be built up. The Institut Pasteur was cleaver enough to retain the monopoly of production and quality control of anti-diphtheria serum, actually of all sera to be later produced. However, well controlled norms of quality were not part of the culture of the new-born Institut Pasteur. The production of sera and their trade by the Institut Pasteur forced the latter to introduce German-derived procedures and norms concerning the standardization of sera. The Institut also had to develop the production of sera under highly controlled conditions in continuously adapted and improved facilities located in Marnes-la-Coquette, a small town in the vicinity of Paris. The production and trade of anti-diphtheria serum clearly is at the origin of both the international reputation and of the wealth of Institut Pasteur which guaranteed its independence with respect to French universities. Not only did it contribute to firmly establish the institution in the French medical and scientific landscape, but it also permitted Émile Roux to implement his long term project: physically couple the laboratories to a production center and to a hospital where new drugs, whatever of biological or chemical origin, would be tested on patients. Indeed, the budgetary surplus left by the sales of anti-diphteria serum permitted the the building of a private hospital primarily devoted to infectious diseases, a kind of model hospital, and the creation of laboratories of chemistry including a fast growing laboratory of therapeutic chemistry, itself largely inspired by German chemistry. The project of Émile Roux was fulfilled a few years before WWI and was taken as a model by several foreign countries such as Brazil.
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Presses universitaires de France, 582 p. (non paginé), 2013, Science, histoire et société. Travaux de recherche, Dominique Lecourt, 978-2-13-062475-2
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Gabriel Gachelin, Yves Bottineau-Fuchs, Annick Opinel, Philippe Rivoirard, Patrice Bourdelais. La naissance des biotechnologies pharmaceutiques en France (1887-1914) : Le sérum antidiphtérique de l’Institut Pasteur. Presses universitaires de France, 582 p. (non paginé), 2013, Science, histoire et société. Travaux de recherche, Dominique Lecourt, 978-2-13-062475-2. 〈pasteur-01588486〉

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