Accounts of change in contemporary research in industry and the academy often note the increasing coexistence of market and academic norms and practices. This article suggests that, at least in industry, these conflicting norms and practices are often preserved by loose coupling between market pressures and the research organization. Based on a two-year case study, this article examines the imposition of tight coupling at an industry lab that had previously been able to maintain some of the norms and practices associated (...) with the academy. Tight market coupling limited the role of judgment in the governance of research. First, a market-based quantitative project selection system delegitimized expert judgment. As a result, projects with obvious market and technical uncertainties were more difficult to justify. Second, objective, market-based oversight also limited the role of expert judgment. Tracking the return on investment of scientists’ hours with time cards had the effect of discouraging time spent on learning or exploratory work. In many cases, researchers argued that displacement of judgment for a quantitative governance system caused work to shift away from research and toward product development. (shrink)

Intersemiotic translation (IT) was defined by Roman Jakobson (The Translation Studies Reader, Routledge, London, p. 114, 2000) as “transmutation of signs”—“an interpretation of verbal signs by means of signs of nonverbal sign systems.” Despite its theoretical relevance, and in spite of the frequency in which it is practiced, the phenomenon remains virtually unexplored in terms of conceptual modeling, especially from a semiotic perspective. Our approach is based on two premises: (i) IT is fundamentally a semiotic operation process (semiosis) and (ii) (...) IT is a deeply iconic-dependent process. We exemplify our approach by means of literature to dance IT and we explore some implications for the development of a general model of IT. (shrink)

A topic of growing importance within philosophy of science is the epistemic implications of the organization of research. This paper identifies a promising approach to social epistemology—nonideal systems design—and uses it to examine one important aspect of the organization of research, namely the system of patenting and licensing and its role in structuring the production and dissemination of knowledge. The primary justification of patenting in science and technology is consequentialist in nature. Patenting should incentivize research and thereby promote the development (...) of knowledge, which in turn facilitates social progress. Some have disputed this argument, maintaining that patenting actually inhibits knowledge production. In this paper, I make a stronger argument; in some areas of research in the US—in particular, research on GM seeds—patents and patent licenses can be, and are in fact being, used to prohibit some research. I discuss three potential solutions to this problem: voluntary agreements, eliminating patents, and a research exemption. I argue against eliminating patents, and I show that while voluntary agreements and a research exemption could be helpful, they do not sufficiently address the problems of access that are discussed here. More extensive changes in the organization of research are necessary. (shrink)

The controversy over the old ideal of “value-free science” has cooled significantly over the past decade. Many philosophers of science now agree that even ethical and political values may play a substantial role in all aspects of scientific inquiry. Consequently, in the last few years, work in science and values has become more specific: Which values may influence science, and in which ways? Or, how do we distinguish illegitimate from illegitimate kinds of influence? In this paper, I argue that this (...) problem requires philosophers of science to take a new direction. I present two case studies in the influence of values on scientific inquiry: feminist values in archaeology and commercial values in pharmaceutical research. I offer a preliminary assessment of these cases, that the influence of values was legitimate in the feminist case, but not in the pharmaceutical case. I then turn to three major approaches to distinguish legitimate from illegitimate influences of values, including the distinction between epistemic and non-epistemic values and Heather Douglas’ distinction between direct and indirect roles for values. I argue that none of these three approaches gives an adequate analysis of the two cases. In the concluding section, I briefly sketch my own approach, which draws more heavily on ethics than the others, and is more promising as a solution to the current problem. This is the new direction in which I think science and values should move. (shrink)

Recent success of Indian engineers, businessmen, as well as other technically qualified professionals has created an obsession with knowledge and creativity. Documents like India as a Knowledge Superpower have proliferated and we continually hear the mantra of investing in and harnessing of human capital. There are, however, several strands of human capital in India and not all of them harness knowledge and creativity. People on whom drugs are being tested represent one such human capital, which, even though it is being (...) energetically mobilized to provide India with a strategic advantage in the world market, also highlights the contradictions within India’s shifting imaginary, economy and politics. Drug trials in India, in the context of neoliberal globalization, not only challenge and complicate, but also operate within a constellation of divisions — labor/capital, west/non-west, colonial/sovereign, national/global and so on. In this article I analyze how the people on whom drug testing is being done in India are being ‘harnessed’ as human capital, which leads to politicization of ‘bare life’ through ‘inclusive-exclusion’. (shrink)

Over the past decade, the management of clinical trials of pharmaceuticals has become a veritable industry, as evidenced by the emergence and proliferation of contract research organizations (CROs) that co‐ordinate and monitor trials. This article focuses on work performed by one CRO involved in the introduction of new software, modelled on industrial production processes, into clinical trial practices. It investigates how this new management technique relates to the work performed in the clinic to ensure that trial participants comply with the (...) protocol. Using an analytical distinction between ‘classical’ management work and invisible work, the article contextualizes the meaning of compliance in the clinic and suggests that the work involved in producing compliance should be taken into consideration by those concerned with validity of trials, as clinical trials are put under private industrial management. The article builds on participant observation at a Swedish university hospital and interviews the nurses, dieticians, doctors and a software engineer, all part of a team involved in pharmaceutical drug trials on a potential obesity drug. (shrink)

In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects’ compliance to study protocols. Concern with these two critical issues leads drug companies to approach clinicians (...) and research subjects with an attitude of mistrust and the desire to exert control over their activities. This orientation results in an institutionalization of mistrust that structures the relationships and activities required for the clinical development of new pharmaceutical products. (shrink)

The potential for financial conflicts of interest (COIs) to damage the credibility of scientific research has become a significant social concern, especially in the wake of high-profile incidents involving the pharmaceutical, tobacco, fossil-fuel, and chemical industries. Scientists and policy makers have debated whether the presence of financial COIs should count as a reason for treating research with suspicion or whether research should instead be evaluated solely based on its scientific quality. This paper examines a recent proposal to develop criteria for (...) evaluating the credibility of research without considering its source of funding. It concludes that proposals of this sort are likely to be either ineffective or impractical in many cases. Nevertheless, this does not imply that all research funded by those with an interest in the outcome must be placed under a cloud of suspicion; there are conditions under which research is at much more serious risk of being corrupted than in other cases, and attention to these conditions can guide productive responses to financial COIs. (shrink)

The pharmaceutical industry, in its marketing efforts, often turns to “key opinion leaders” or “KOLs” to disseminate scientific information. Drawing on the author's fieldwork, this article documents and examines the use of KOLs in pharmaceutical companies’ marketing efforts. Partly due to the use of KOLs, a small number of companies with well-defined and narrow interests have inordinate influence over how medical knowledge is produced, circulated, and consumed. The issue here, as in many other cases of institutional corruption, is that a (...) few actors have accumulated the power to shape the information on which many others base their decisions. Efforts to address this corruption should focus on correcting large imbalances in the current political economy of medical knowledge. A sequestration of pharmaceutical research and development on one hand from pharmaceutical marketing on the other, though difficult to achieve, would address this and many other problems. (shrink)

One way to make philosophy of science more socially relevant is to attend to specific scientific practises that affect society to a great extent. One such practise is biomedical research. This paper looks at contemporary U.S. biomedical research in particular and argues that it suffers from important epistemic, moral and socioeconomic failings. It then discusses and criticises existing approaches to improve on the status quo, most prominently by Thomas Pogge (a political philosopher), Joseph Stiglitz (a Nobel-prize winning economist) and James (...) Robert Brown (a philosopher of science). Finally, it sketches an alternative proposal and argues for its superiority. The proposal has four components: changing the intellectual property regime; instituting independent clinical research; aligning innovators' and patients' interests; and enacting additional regulation. (shrink)

How corporations surveil and influence consumers using big data tools is a major area of research and public debate. However, few studies explore it in relation to physicians in the USA, even though they have been surveilled and targeted by the pharmaceutical industry since at least the 1950s. Indeed, in 2010, concerns about the pharmaceutical industry's undue influence led to the passing of the Physician Sunshine Act, a unique piece of transparency legislation that requires companies to report their financial ties (...) to physicians and teaching hospitals in a public database. This article argues that while the Sunshine Act has clearly helped expose important commercial influences on both prescribing and the scale of industry involvement with physicians, it has also, paradoxically, fuelled further commercial surveillance and marketing. The article casts new light on innovative pharmaceutical marketing approaches and the key role of data brokers and analytics companies in the identification, targeting, managing, and surveillance of physicians. We place this analysis within the political economies of the pharmaceutical industry, surveillance-based marketing, and transparency, and argue that policies to promote increased transparency must be tightly tied to policies that impede the commodification and use of transparency data for surveillance and marketing purposes. (shrink)

The issue of globalization of research is receiving considerable attention due to the increasing number of offshored R&D activities from the United States, Europe, and Japan. This paper explores this phenomenon and provides a model to analyze the factors that will likely contribute to a global transformation of clinical trials. By identifying the main characteristics of clinical trials, I aim to clarify the main driver of the relocation process of clinical research. I reviewed the relevant published articles to address the (...) research questions. The results of this study challenge the traditional thinking of cost-related factors as the major reason for offshoring cilinical trials and show the importance of the recruitment of human subjects in trials. Consequently, this paper suggests that “recruitment crisis” in home country as the main contribution and a key driver to offshore R&D activities, has been underestimated by previous studies. In particular, this study provides policy-decision makers with a new insight into the development issue surrounding the pharmaceutical industry. (shrink)

Introduction: Pharmaceutical companies offer various gifts to physicians to encourage them to prescribe their products. This collaboration has some negative and positive aspects. Different countries have established guidelines to limit the collaboration and reform such relationships. This study aims to determine the attitude of Bangladeshi medical students towards pharmaceutical gifts, physician-pharmacist collaboration, and associated factors. Methods: An online cross-sectional and correlational study was conducted through email and Google-Forms among Bangladeshi medical students. A total of 435 students from different medical colleges (...) completed the questionnaires in May and June, 2016. Results: Monthly parental income was moderate among the majority of medical students. Less than 16% had a physician or pharmacist parent. Most of the students were taught about medical ethics, but 73% were not taught about the ethics of physician-pharmacist collaboration. About 85% did not have any experience of interaction with marketing representatives. Drug samples and pennotepads were the most appreciated pharmaceutical gifts. Jewelry and gifts costing more than 100 thousand were said to be the least appreciated pharmaceutical gifts. Attitudes towards drug companies and representatives were assessed by fifteen statements. Medical students had a variety of attitudes regarding its ethical justification. Attitudes were correlated with gender, parental income, physician parents, academic years, and having been taught about pharmaceutical collaboration with physicians. Conclusion and Recommendations: medical students should elaborate on ethical reasoning before accepting pharmaceutical gifts. Medical colleges and curriculums should teach them about the interaction. A national guideline may be needed. (shrink)

The widespread impression that recent philosophy of science has pioneered exploration of the “social dimensions of scientific knowledge” is shown to be in error, partly due to a lack of appreciation of historical precedent, and partly due to a misunderstanding of how the social sciences and philosophy have been intertwined over the last century. This paper argues that the referents of “democracy” are an important key in the American context, and that orthodoxies in the philosophy of science tend to be (...) molded by the actual regimes of science organization within which they are embedded. These theses are illustrated by consideration of three representative philosophers of science: John Dewey, Hans Reichenbach, and Philip Kitcher.Author Keywords: Social dimensions of science; Logical positivism; Democracy; Context of discovery/justification; Goals of science. (shrink)

Publication of pharmaceutical company-sponsored research in medical journals, and its presentation at conferences and meetings, is mostly governed by ‘publication plans’ that extract the maximum amount of scientific and commercial value out of data and analyses through carefully constructed and placed papers. Clinical research is typically performed by contract research organizations, analyzed by company statisticians, written up by independent medical writers, approved and edited by academic researchers who then serve as authors, and the whole process organized and shepherded through to (...) journal publication by publication planners. This paper reports on a conference of an international association of publication planners. It describes and analyzes their work in an ecological framework that relates it to marketing departments of pharmaceutical companies, medical journals and publishers, academic authors, and potential audiences. The medical research described here forms a new kind of corporate science, designed to look like traditional academic work, but performed largely to market products. (shrink)

The new prominence given to science for economic growth and industry comes with an increased policy focus on the promotion of commodification and commercialization of academic science. This paper posits that this increased interest in commodification is a new steering mechanism for governing science. This is achieved by first outlining what is meant by the commodification of scientific knowledge through reviewing a selection of literatures on the concept of commodification. The paper concludes with a discussion of how commodification functions as (...) a means for governing science. (shrink)

Roughly 40% of the sizeable medical research and literature on recently approved drugs is “ghost managed” by the pharmaceutical industry and its agents. Research is performed and articles are written by companies and their agents, though apparently independent academics serve as authors on the publications. Similarly, the industry hires academic scientists, termed key opinion leaders, to serve as its speakers and to deliver its continuing medical education courses. In the ghost management of knowledge, and its dissemination through key opinion leaders, (...) we see the pharmaceutical industry attempting to hide or disguise the interests behind its research and education. (shrink)

The author traces the ways in which various patients and collective associations of patients come to regard themselves as the users of future stem cell technologies. The author uses Althusser’s notion of interpellation, whereby an identity is the result of the situated encounter of a subject and an authority, to analyze the ways in which patient associations’ current involvement with basic research is related to the enactment of science as a series of technology development projects. The author argues that this (...) ‘‘project-ness’’ forms a certain privileged logic that interpellates patients and their associations in specific ways. Through the listings of illnesses circulated in the mass media, which are hoped to be treatable or curable with stem cell therapies, patients come to recognize themselves as the projected users of stem cell technologies. The author fleshes out the process of this userfication and the various responses made by patients and their associations when hailed by the entrepreneurial projects of stem cell research. (shrink)

This paper looks at the commodification of interferon, marketed by Hoffmann La Roche as Roferon A in 1986, as a case study that helps us understand the role of pharmaceutical industry in cancer research, the impact of molecular biology on cancer therapy, and the relationships between biotech start-ups and established pharmaceutical firms. Drawing extensively on materials from the Roche company archives, the paper traces interferon’s trajectory from observed phenomenon to product. Roche embraced molecular biology in the late 1960s to prepare (...) for the moment when the patents on some of its bestselling drugs were going to expire. The company funded two basic science institutes to gain direct access to talents and scientific leads. These investments, I argue, were crucial for Roche’s success with recombinant interferon, along with more mundane, technical and regulatory know-how held at Roche’s Nutley base. The paper analyses in some detail the development process following the initial success of cloning the interferon gene in collaboration with Genentech. It looks at the factors necessary to scale up the production sufficiently for clinical trials. Using Alfred Chandler’s concept of ‘organizational capabilities’, I argue that the process is better described as ‘mobilisation’ than as ‘translation’. (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)

Drawing on case studies from the modern era of pharmaceutical regulation in the UK, US and Europe, I examine how the extent and distribution of trust between regulators, the pharmaceutical industry, and the medical profession about drug testing and monitoring influences knowledge and regulatory judgements about the efficacy and safety of prescription drugs. Introducing the concepts of ‘acquiescent’ and ‘investigative’ norms of regulatory trust, I demonstrate how investigative norms of regulatory trust—which deter pharmaceutical companies from assuming that their data analyses (...) will be accepted without independent de-construction—drive up bioethical and regulatory standards of drug assessment in the interests of health. By contrast, acquiescent norms of regulatory trust, which are associated with industrial capture and professional closure of interests, promote permissive standards allowing patients to take pharmaceuticals with greater risks to health and less evidence of therapeutic efficacy. (shrink)