In his highly regarded history of the rise of clinical trials in America, HarryMarks describes how their widespread adoption resulted largely fromthe efforts of ‘therapeutic reformers’ who sought to replace the individualexpertise of clinicians with the ‘science of controlled experiment’. Thetransition described by Marks resembles in many respects the transition fromthe ‘truth-to-nature’ objectivity of individual experts to a ‘mechanical’ formof objectivity portrayed by Daston and Galison. In particular,Marks details the passage from a regime of trust in expertise and experts to (...) aregime based on the mechanical generation of data, the elimination ofhuman judgement and the adoption of a ‘view from nowhere’ where individual and group idiosyncrasies are systematically suppressedthrough recourse to quantitative methods.[...]. (shrink)

This paper builds on previous work that investigated anticancer drugs as ‘informed materials’, i.e., substances that undergo an informational enrichment that situates them in a dense relational web of qualifications and measurements generated by clinical experiments and clinical trials. The paper analyzes the recent transformation of anticancer drugs from ‘informed’ to ‘informing material’. Briefly put: in the post-genomic era, anti-cancer drugs have become instruments for the production of new biological, pathological, and therapeutic insights into the underlying etiology and evolution of (...) cancer. Genomic platforms characterize individual patients’ tumors based on their mutational landscapes. As part of this new approach, drugs targeting specific mutations transcend informational enrichment to become tools for informing their targets, while also problematizing the very notion of a ‘target’. In other words, they have become tools for the exploration of cancer pathways and mechanisms. While several studies in the philosophy and history of biomedicine have called attention to the heuristic relevance and experimental use of drugs, few have investigated concrete instances of this role of drugs in clinical research. (shrink)

In his highly regarded history of the rise of clinical trials in America, HarryMarks describes how their widespread adoption resulted largely fromthe efforts of ‘therapeutic reformers’ who sought to replace the individualexpertise of clinicians with the ‘science of controlled experiment’. Thetransition described by Marks resembles in many respects the transition fromthe ‘truth-to-nature’ objectivity of individual experts to a ‘mechanical’ formof objectivity portrayed by Daston and Galison. In particular,Marks details the passage from a regime of trust in expertise and experts to (...) aregime based on the mechanical generation of data, the elimination ofhuman judgement and the adoption of a ‘view from nowhere’ where individual and group idiosyncrasies are systematically suppressedthrough recourse to quantitative methods.[...]. (shrink)

There has been some concern m recent years that economic interests in the biotechnology area could, particularly through patenting, have a constricting influence on scientific research. Despite this concern, there have been no studies of this phenomenon beyond isolated cases. In this article we examine the evolution of the biomedical field of hybridoma/monoclonal antibody research with detailed examples of the three types of patent claims that have emerged there—basic claims, claims on application techniques, and claims on specific antibodies. We analyze (...) the impact of these claims and their legal histories on the free flow of scientific information and, the activity of scientific researchers. We conclude that such patent claims present severe restrictions for both, not only in the monoclonal area but in general, amounting to a subtle but significant shift in the political economy of science and technology. (shrink)

At several places in this paper we have made use of a well-known rhetorical device: an argument was made; a character —dubbed “fictional reader” — was then evoked who voiced some objections against that particular argument; and finally, we answered those objections, thus bringing to a close, at least temporarily, our argument. The use of this device raises a question: “How is the presence of the ‘fictional reader” to be understood?” Is it a “mere” rhetorical tool, or does this character (...) designate some particular target? For instance, depending on the context, it could be seen as aimed at different straw men: traditionally minded sociologists, Whiggish historians, well-intentioned philosophers of science. Actually, none of these characters is behind the “fictional reader”. Rather, it refers, potentially, to any of the scientific actors (Milstein, Schwaber, Koprowski, Cohn, and so on) who inhabit our set of narratives. In other words, the “fictional reader” is an icon for the “native” reader/writer who simultaneously produces and questions the products of that particular literary activity known as scientific texts, by explicitly and implicitly raising the issue of the distinction between fact and technique.By following actors in their disputes about the novelty of K & M's contribution, it became apparent that it is not exactly clear which of the different elements of “hybridoma technology” should be regarded as “novel.” Was it the use of the P3 myeloma line? Was it the theoretical framework related to the notion of allelic exclusion? Was it ...? In each and every case, arguments can be made for or against the existence of a certain continuity or discontinuity with previous work. And in each case, the determination of novelty, as translated through the continuity/discontinuity issue, appeared to be hanging on the previous attribution of an epistemological status to the object that had allegedly been discovered: was it a fact or a technique?If one focuses on the relatively narrow network of immunogenetics, it could be argued that within that particular evidential context a series of “facts” had been established which, when transferred to other fields, such as the virological research being pursued in Koprowski's institute, were translated into a technique. However, as we have seen, even from an immunogenetic point of view the production of monoclonal antibodies can be viewed as being simultaneously a fact and a technique to establish that fact. Not only, as he himself noted,139 was Milstein not seeking to develop a technique for the production of monoclonal antibodies when the original experiments were carried out, but the significance later imputed to those experiments was not immediately attributed to them. The paper was seen as one among other papers that used cell fusion techniques to dissect the genetic control of antibody diversity. Distinctions that now appear crucial (e.g.: were the fusion partners two myelomas or a myeloma and a spleen cell?) were easily overlooked. At some point, around 1977, the production of monoclonal antibodies became a goal in itself, no longer linked to the initial immunogenetic network. The transformation of [MILSTEIN 75] into the foundational event of “hybridoma technology” was thus achieved. This transformation did not flow naturally from the original experiments. Rather, it involved specific investments which mobilized the activity of a large number of other scientific and industrial actors.140A tentative generalization can be deduced from our case study. The dichotomy between fact and technique that underlines much of contemporary science studies seem to be fundamentally misconceived, insofar as the determination of what counts as a fact and what counts as a technique is not possible on a priori grounds. Historians and sociologists of science are confronted with a field of heterogeneous interventions where particular pieces of work are constituted as discrete entities and simultaneously attributed a technical or a factual identity. “Novelty” and “innovation” are precisely the result of such polymorphic attributional processes. (shrink)

As we have seen, natural antibodies first emerged as an experimental phenomenon without a plausible theoretical explanation. They were originally denied the status of antibody; then, adjustments to the side-chain theory transformed them from a curiosity into a foundation of the theory. However, in accommodating natural antibodies, Ehrlich had opened several holes in his mechanism of antibody formation.Thus, by 1905, natural antibodies were clearly established as problematic. From the practical standpoint, it seemed unwise to maintain an identity between normal and (...) immune antibodies, given the therapeutic differences in their avidity. With the decline of Ehrlich's theory of antibody formation and the spread of Landsteiner's hapten technique for the production of antibodies against artificial antigens after World War I, the theoretical possibility of their existence as other than anomaly seemed more remote than ever. However, outside the theory and despite clinical considerations, natural antibodies remained a perplexing experimental phenomenon.49This is a somewhat different picture from that usually offered by historians of immunology. Debra Jan Bibel, for example, has recently written: “Ehrlich had no problem in accepting natural antibodies, since they were even predicted by his side-chain theory of antibody formation.:50 However, we have seen that far from being predicted by Ehrlich's side-chain theory, natural antibodies emerged as an anomaly and caused Ehrlich to significantly modify his theory in order to accommodate them. We have also seen that researchers opposed to Ehrlich's school, such as Bordet, initially accepted the existence of natural antibodies, before realizing what an important tool they would be for Ehrlich. Once natural antibodies came to be seen as a confirmation of Ehrlich's theory, attitudes changed and the very existence of natural antibodies was called into question. Other opponents of Ehrlich, such as Landsteiner, opposed natural antibodies from the beginning, before it came to be believed that there was an “infinity of antibodies,” which would make their existence impossible.51. (shrink)

The original version of this article unfortunately contained a mistake. Three entries are incorrect in the reference list. The corrected references are given below.