This article systematically reviews published studies of the association of pharmaceutical industry funding and clinical trial results, as well a few closely related studies. It reviews two earlier results, and surveys the recent literature. Results are clear: Pharmaceutical company sponsorship is strongly associated with results that favor the sponsors' interests.

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)

Anecdotes have shown that some articles on profitable drugs are constructed by and shepherded through publication by pharmaceutical companies and their agents, whose influence is largely invisible to readers. This is ghost-management, the substantial but unrecognized research, analysis, writing, editing and/or facilitation behind publication. Publicly available documents suggest that these practices extremely widespread affecting up to 40% of clinical trial reports in key periods but it has been unclear how representative these documents are. This article presents the results of an (...) investigative sampling of the self-presentation of publication planning services, and presents this and other evidence of a sizable publication planning industry. Thus different lines of evidence indicate that ghost-management is a common and important phenomenon, strongly affecting the published medical literature in the service of marketing. (shrink)

In 2003, the pharmaceutical company Biovail received a spate of negative publicity around a program for its heart medication Cardizem LA. For a three-month period Biovail paid US doctors US$1000 (and their office managers US$150) for patient data when at least 11 of their patients renewed a prescription to Cardizem. Doctors who signed up for the trial but who did not keep 11 patients on the drug received US$250 for participation. According to Biovail, this was a research trial, meeting US (...) federal regulations for research trials – the consulting firm that had designed the trial had guaranteed that it would meet US criteria. The trial was expected to provide data that would help ‘in designing future clinical trial programs’, according to Biovail’s vice-president of finance. In addition, the results would eventually be published. However, the program was originally presented as a marketing campaign, and was being handled by Biovail’s sales department and sales force. According to ethicists who commented on the case, a US$1000 payment to doctors was unusually high for a post-marketing research trial, and a US$150 payment to office managers was thought to raise novel ethical conflicts. Cardizem is a drug intended for long-term use, so paying doctors to get patients started on a course of treatment could lead to substantial profits from these prescriptions. In line with this, immediate comments from professional ethicists and representatives of medical associations focused on questions about whether the Biovail campaign amounted to paying doctors to prescribe specific drugs. And that is a concern for the obvious reason that it has the potential to compromise doctors’ decisions about best care. Payments for prescriptions place doctors in ethically difficult situations: Peter Singer, a medical ethicist, says ‘There is clearly the potential for [physicians’] conflict of interest’ (Toronto Globe and Mail, 2003). Physicians’ decision-making is the most common locus of discussion in medical ethics.. (shrink)

It is by now no secret that some scientific articles are ghost authored – that is, written by someone other than the person whose name appears at the top of the article. Ghost authorship, however, is only one sort of ghosting. In this article, we present evidence that pharmaceutical companies engage in the ghost management of the scientific literature, by controlling or shaping several crucial steps in the research, writing, and publication of scientific articles. Ghost management allows the pharmaceutical industry (...) to shape the literature in ways that serve its interests. This article aims to reinforce and expand publication ethics as an important area of concern for bioethics. Since ghost-managed research is primarily undertaken in the interests of marketing, large quantities of medical research violate not just publication norms but also research ethics. Much of this research involves human subjects, and yet is performed not primarily to increase knowledge for broad human benefit, but to disseminate results in the service of profits. Those who sponsor, manage, conduct, and publish such research therefore behave unethically, since they put patients at risk without justification. This leads us to a strong conclusion: if medical journals want to ensure that the research they publish is ethically sound, they should not publish articles that are commercially sponsored. (shrink)

The prehistory of science and technology studies -- The Kuhnian revolution -- Questioning functionalism in the sociology of science -- Stratification and discrimination -- The strong programme and the sociology of knowledge -- The social construction of scientific and technical realities -- Feminist epistemologies of science -- Actor-network theory -- Two questions concerning technology -- Studying laboratories -- Controversies -- Standardization and objectivity -- Rhetoric and discourse -- The unnaturalness of science and technology -- The public understanding of science -- (...) Expertise and public participation -- Political economies of knowledge. (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)

This chapter discusses some strategies pharmaceutical companies employ to establish influence and even hegemony over domains of medical knowledge: marketing products via medical research and education. The chapter thus contributes to understanding the political economy of knowledge in this industry. As a counterpart to traditional epistemology, studying the political economy of knowledge shifts attention from individual claims and their justifications to some of the forces available to shape terrains on which claims are produced, distributed, and consumed.Of pharmaceutical companies’ clinical research, (...) 70–75% is performed by contract research organizations. CROs conduct trials with one eye to the drug approval process and the other to the marketing of products. On the basis of trial data, analyzed by pharmaceutical company statisticians and scientists, publication planners design suites of scientific manuscripts and hire ghostwriters to write them. These are then given to academic authors, who generally have had little prior connection to the research, analysis, or writing. The manuscripts are published in medical journals appropriate for the audiences the companies wish to reach.The doctors and researchers with whom companies engage most closely are generally termed key opinion leaders. In addition to authoring manuscripts, KOLs serve companies in a number of roles, but most prominently as speakers—at professional meetings, in after-dinner and similar settings arranged by sales representatives, and in continuing medical education courses, which doctors must take to keep their licenses. Research, education, and marketing, then, are often fused. (shrink)

Standpoint theory makes the claim that there are social positions from which privileged perspectives on knowledge can be obtained. This article describes some arguments that stake out relatively narrow grounds for the relevance of standpoint theory to science and technology: namely, the oppressed are in a potentially good position to understand social relations. Although these grounds seem narrow and apparently irrelevant to the bulk of the activity of the sciences, recent work in science and technology studies indicates that social relations (...) are topics and resources as much in physics and mathematics as in primatology and psychology. So, if we accept the arguments for standpoint theory, the social picture of science should lead us to recognize the wide-ranging applicability of standpoint theory to science. (shrink)

This paper adopts a symmetrical approach tocontroversies over R.H. MacArthur and E.O. Wilson'sequilibrium model of island biogeography, in order toshow how different interpretations of the model dependupon different philosophical understandings of theapplication of models and theories. In particular,there are quite distinct domains to which the modelcould apply; in addition, some equivocation amongthese domains is important to the model's success.Therefore, apparently inconsistent interpretations,interpretations that fit into roughly instrumentalist,realist and rationalist conceptions of science, may bemutually supporting in practice. Descriptions ofscientific practice, then, (...) should not adjudicate amongthese interpretations, but should instead recognizeways in which successful models translate amongdomains, and in so doing can become realistic,instrumentally successful, or rationally established.As complex social objects, models can afford complexrepresentational relations. (shrink)

Publication planning is the sub-industry to the pharmaceutical industry that does the organizational and practical work of shaping pharmaceutical companies' data and turning it into medical journal articles. Its main purpose is to create and communicate scientific information to support the marketing of products. This report is based mostly on information presented at the 2007 annual meeting of the International Society of Medical Planning Professionals, including a workshop entitled "Publication Planning 101/201", attended by one of us. We provide some analysis (...) of the role of publication planning in medical publishing, and its implications for the structuring of medical knowledge. (shrink)

This philosophical introduction to and discussion of social and political studies of science argues that scientific knowledge is socially constructed.

The deflationist turn in recent philosophy of science has attracted attention, in part because it promises to end debates about scientific realism. In its recommendation that we leave metaphysics behind to look at practice, deflationism constructs itself as an end‐of‐philosophy philosophy, accepting knowledge and the evidence for it at face value. Meanwhile, recent work in philosophy, sociology, and history of science that has focused on practice has underscored problems of such an acceptance: much scientific knowledge is not straightforwardly about the (...) natural world, and we would not want it to be. A concrete example from the history of comparative psychology illustrates this point, and illustrates the value of interpretive work on scientific knowledge. A focus on practice, then, does not end metaphysical discussion, but rather regrounds and reshapes it. (shrink)

“Scientific theories are maps of the natural world.” This metaphor is often used as part of a deflationary argument for a weak but relatively global version of scientific realism, a version that recognizes the place of conventions, goals, and contingencies in scientific representations, while maintaining that they are typically true in a clear and literal sense. By examining, in a naturalistic way, some relationships between maps and what they map, we question the scope and value of realist construals of maps—and (...) by extension of scientific representations. Deflationary philosophy of science requires more variegated stances. (shrink)

The Science Wars have not involved any violence, nor even threats of violence. Thus the label “wars” for this series of discussions, mostly one-sided and mostly located within the academy, is something of an overblown metaphor. Nonetheless, I will suggest that there are some respects in which the metaphor is appropriate. The Science Wars involve territory, albeit a metaphorical kind of territory. They inspire work that can be best interpreted as ideological, a result of disciplinary interests. Moreover, fellow participants in (...) the wars and others reward that ideological work.My goal in this is to display efforts to maintain a discipline's epistemic authority, the recognition that members of that discipline have legitimate claims to knowledge on a subject. The central section of the paper takes the form of a discussion of one recent contribution to the Science Wars, James Robert Brown's Who Rules in Science? My argument is at least somewhat generalizable beyond this book, and it therefore points to interesting phenomena related to epistemic authority. (shrink)

This chapter describes in very general terms the integration of clinical research and marketing, drawing on books by marketers and recent cases that have come to the public eye. The tools that have been used to accomplish this integration over the past half-century are various, but they all stem from a realization that in a rational world centered on health there need be no intrinsic divide between research and marketing. Most obviously, marketing drugs to physicians, who are professionals acting within (...) their own spheres, depends crucially on research. Physicians respond, and need to see themselves as responding, to fact, figures, and studies. The well-chosen images and vehicles for marketing campaigns must be subordinated to research. Yet at the same time research is a means of increasing sales. (shrink)

John Maynard Smith is the person most responsible for the use of game theory in evolutionary biology, having introduced and developed its major concepts, and later surveyed its uses. In this paper I look at some rhetorical work done by Maynard Smith and his co-author G.R. Price to make game theory a standard and common modelling tool for the evolutionary study of behavior. The original presentation of the ideas — in a 1973 Nature article — is frequently cited but almost (...) certainly rarely read. It took reformulation of the approach to create a usable model and an object of study. Perhaps paradoxically, the new model dealt with more abstract objects than did its predecessor, but because of that a better case could be made for its realism. The particular strategy of abstraction allowed game-theoretic modelling to gain a certain measure of autonomy from empirical problems, and thus to flourish. (shrink)

The Thomas Kuhn of "The Structure of Scientific Revolutions" is often seen as an idealist or Neo-Kantian, as holding a constructivist as opposed to realist position. A close reading of the texts in question, keeping in mind Kuhn's interests as a historian, doesn't support this position, though it uncovers other interesting metaphysical commitments. In particular, Kuhn sees a degree of complexity in the world that entails that there will often be some conventionality in our theories. Some reasons for the readings (...) of Kuhn's as a "constructivist" are explored. (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)

A search of elements becomes necessary to facilitate the understanding of the origins of the Lacan´s significant, in the attempt to explain through structural linguistic, the limits of the Saussure´s influence. It is known that the Lacan´s significant, even though has the Saussure´s influence as a reference in epistemology, both “significant” must not be mistaken. It is usually attributed to Ferdinand de Saussure the invention of the theory of the linguistic sign. We will stand out, however, that this “invention” is (...) previous to the theories of the genevan linguist. We will observe the comments of Jean-Luc Nancy and Philippe Lacoue-Labarthe, to the point where these authors demonstrate that the displacement operated on the Saussure´s scheme will not depend on, as it is well known, the significant’s autonomy. It will be verified, therefore, how legitimate it is, the use of the significant´s term in the Lacan´s theory. (shrink)

Standpoint theory is based on the insight that those who are marginalized or oppressed have distinctive epistemic resources with which to understand social structures. Inasmuch as these structures shape our understanding of the natural and lifeworlds, standpoint theorists extend this principle to a range of biological and physical as well as social sciences. Standpoint theory has been articulated as a social epistemology and as an aligned methodological stance. It provides the rationale for ‘starting research from the margins’ and for expanding (...) the diversity of backgrounds and experience represented in scientific communities. (shrink)

Covering a broad range of topics, this text provides a comprehensive survey of the modelling of chaotic dynamics and complexity in the natural and social sciences. Its attention to models in both the physical and social sciences and the detailed philosophical approach make this an unique text in the midst of many current books on chaos and complexity. Including an extensive index and bibliography along with numerous examples and simplified models, this is an ideal course text.

This review discussed the effects of the impact of the Coronavirus Disease 2019 pandemic on the psychological wellbeing of people with Parkinson's disease focusing specifically on depressive symptoms, anxiety levels, sleep, and quality of life. Together with motor symptoms, psychological symptoms are common and disabling conditions in the clinical course of PD becoming a relevant topic as a result of the lockdown measure due to alter their everyday life. We searched on PubMed online electronic databases for English articles published between (...) January 2020 and 31 December 2021. Twenty-eight relevant studies were found and included in the review. Heterogeneous data emerged from the topics analyzed. Overall, data from depression studies showed significant depressive symptoms if the patient was analyzed longitudinally or vs. a control group consisting in healthy subjects, while these differences become minimal when the control group is a family member. Differently, in most of the studies reviewed there is no evidence of a statistically significant impact on anxiety disorders, nor on the quality of sleep. Conversely, PD patients showed a statistically significant negative impact of QoL compared with control groups or other neurological conditions. Although these findings must be interpreted carefully in the light of the studies' limitations, both in methodology and design, collectively our review showed that COVID-19 pandemic has had negative effects on the mental health of people with PD, due to disruption of healthcare services, loss of usual activities and supports and reduction in physical activity. (shrink)

Sergio Sismondo's “Boundary Work and the Science Wars” nicely exemplifies a hotly debated central issue. One side, let me call them the rationalists, tries to explain episodes in the history of science in terms of reason. They claim that scientists, past and present, believe what they do because of the evidence that they have at the time. The other side, following Sismondo, let me call them STSers , claim that social and other non-cognitive factors are the frequent (...) causes of belief. This disagreement naturally leads to a meta-level debate. Rationalists, such as myself, try to give reasons for believing the STSers are wrong-headed in their approach. And Sismondo replies with the claim that whether I realize it or not I am really doing boundary work – an explanation of my activity in terms of social factors. (shrink)

Ghost-Managed Medicine exposes the conspiracy to conceal all of the players in the marketing of drugs, including ghostwriters, key opinion leaders, patient advocacy organizations, contract research organizations, publication planners, and even medical journal editors and publishers. The credibility of the claims conveyed by the industry depends on the invisibility of these players.

Sergio Sismondo argues that pharmaceutical industry-sponsored research and ghostwriting produce genuine knowledge and science (albeit commercial science) not different from established medical science. In this essay I critically evaluate Sismondo' view and conclude that the commercial medical science that has created the ghostwriting industry is a corruption of science and not merely science done in a new corporate mode. Serious harm to patients has resulted from misrepresented commercial biomedical research.

1. L'esperienza e l'uomo.--2. Il mondo morale.