The aim of this paper is to discuss a key question in the history and philosophy of medicine, namely how scholars should treat the practices and experimental hypotheses of modern life science laboratories. The paper seeks to introduce some prominent historiographical methods and theoretical approaches associated with biomedical research. Although medical scientists need no convincing that experimentation has a significant function in their laboratory work, historians, philosophers, and sociologists long neglected its importance when examining changes in medical theories or progress (...) in scientific knowledge. The reason appears to have been the academic influence of the then dominant tradition in the history of ideas, but was also due to a misconception of what could usefully be termed the view on “historical ontology.” During the last two decades, there have been many books and research articles that have turned towards the subject, so that the study of experimental practice has become a major trend in the contemporary history and philosophy of medicine. A closer look at the issue of laboratory research shows that concepts in medicine and the life sciences cannot be understood as historically constant, free-standing ideas, but have to be regarded as dependent on local research settings. They often carry particular “social memories” with them and thus acquire important ethical implications. (shrink)

ArgumentUsing 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 reached its limits and was transformed when the product faced international distribution. Moving from Paul Ehrlich's initial technological notion ofWertbestimmungreferring 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. (shrink)

ArgumentIt is well known that the development of a diphtheria anti-toxin serum evolved in a competitive race between two groups of researchers, one affiliated with Emil Behring in Berlin and Marburg, and another affiliated with Émile Roux in Paris. Proceeding on the basis of different theoretical assumptions and experimental practices, the two groups developed a therapeutic serum almost simultaneously. But the standardized substance they developed took on very different forms in the two countries. In Germany the new serum was marketed (...) in the private sphere and subjected to state regulations, becoming a kind of prototype of industrial medications. In France, however, the same substance was marketed as a gift of science to humanity and distributed through the communal health care system. This article demonstrates how a new medication emerged from the efforts to produce, market, regulate, distribute, and apply it in the two respective countries. It attributes the difference to the negotiations between the respective actors (scientists, industrialists, politicians, officers, and the public) and institutions (firms, academies, private and public institutes, legislative bodies, professional corporations). I develop this argument on three different levels: First, I stress the importance of the institutional foundations of serum production; second, I illustrate the decisive role played by existing “ways of regulating” in the rapid development of new legal statutes; and third, I describe the consequences that flowed from the respective administrative organization of marketing and dissemination. In sum, I explore how an experimental object was transformed into an object of the public health system and stabilized by administrative means. (shrink)

One of Ludwik Fleck’s ideas about the development of scientific knowledge is that—once a system of interpretation is in place—the process that follows can be characterised as one of inertia: any new evidence comes under a strong pressure to be incorporated into the established frame. This can result in what Fleck called a harmony of illusions when contradictory evidence becomes almost invisible or is incorporated into the established frame only by huge efforts.The paper analyses early explanations of the tuberculin reaction (...) as a case study of Fleck’s argument. For Robert Koch, who had presented tuberculin in 1890, the compound was supposed to be a diagnostic tool and a cure for tuberculosis. His conception of its effect was rather peculiar, but strictly in line with ideas on the pathogenesis of infectious diseases he had developed much earlier. After tuberculin was released in late 1890, whether Koch’s conception was convincing depended on the place that a given observer had in the medical world in late-nineteenth-century Germany. Inside Koch’s group, the status of the tuberculin reaction remained stable and tuberculin retained its value as a diagnostic and curative tool. On the other hand, observers from outside that thought collective, and in particular from clinical medicine, soon pointed to flaws in its conception. These critics developed a rather different picture of tuberculin as a mysterious and dangerous drug. No reconciliation followed and what we find instead in German medicine around the year 1900 is the presence of rather contradictory concepts and practices surrounding Koch’s wonder cure. (shrink)