Commentary and Reflections: The Ongoing Construction of Pharmaceutical Regimes
Introduction
Institutional change in biomedicine has a specific historical character that hinges on the socioeconomic and political reconstitution of the field. This field has witnessed, among other dramatic transformations, jurisdictional expansion and technological rationalization, the rise of new sources of biomedical knowledge and the production of new identities based on health (Clarke et al. 2010; Bell and Figert 2012). I draw on these transformations to call attention to the contingent processes of institutional change as described in the chapters by Greene (2015, Chapter 5, this volume), Samsky (2015, Chapter 6, this volume) and Cuthbertson (2015, Chapter 7, this volume). More narrowly, the focus of this discussion will be the recent emergence of pharmaceutical medicine as a form of health governance. The basic premise is that new forms of socioeconomic and political relations emerge at the juncture of pharmaceutical medicine and health which produce a realignment of power relations in the field of biomedicine under the burgeoning pharmaceuticalization of health (Biehl and Eskerod 2007).
Two central processes underlie the dynamics of this realignment in the field of biomedicine. The first describes the struggle between socioeconomic and political organizational actors to structure the field of biomedicine after their own interests. In this framework, transformation in the field occurs following shifts in the relative costs of exchange that lead actors to alter the rules of the game through which exchange takes place (North 1990). These institutional rules are rights and prohibitions, rewards and sanctions, norms and conventions and other social structures that shape human interaction in socioeconomic and political exchanges. They reduce uncertainty because they constrain certain kinds of behavior such as free riding (Phelps 1985). They also constitute the very components of the field of action (Scott and Davis 2010). Strategically, change occurs as a result of marginal adjustments to rules, norms and sanctions that comprise institutional life. This interest-driven perspective involves actors and organizations that develop sufficient bargaining strength to use the polity to maximize their objectives. Naturally, the rules of the game, including formal and informal constraints, tend to be highly stable in many areas of modern life and are therefore resistant to marginal adjustments. For example, the corporate founders of the Mectizan Donation Program Samsky (2015) interviewed inveighed against the World Health Organization (WHO) over its perceived encroachment on their program and chaffed at their dependence on it. This dependence was unavoidable since the WHO “had access to all the clinics in the thickets of Africa” (Samsky 2015:122). Similarly, resistance to marginal adjustments occurred when the WHO was pressured by the International Federation of Pharmaceutical Manufacturers Association (IFPMA), among others, to reduce its “activist” stance vis-à-vis the use of off-patent medicines as essential medicines because of its waning authority to direct global health (Greene 2015).
One method for understanding these transformations in the biomedical sphere is to highlight historical trends. Greene focuses on the program of essential medicines to show how various processes, such as sociopolitical transformation, jurisdictional expansion and technological rationalization have been wrought by the intersection of interests around this program (see Greene 2011, 2015). Samsky and Cuthbertson use another approach to investigate institutional change in biomedicine. They employ a case-study strategy and examine particular programs such as donated medicine or particular practices such as depression diagnostics to locate the overarching structure of institutional change in those programs and practices (see Samsky 2015; Cuthbertson 2015).
Both methodological perspectives articulate nicely with the conceptual dimensions of Clarke et al.’s (2003) schema of biomedicalization. The central idea, for example, that institutional change in biomedicine entails transformation in knowledge and practices, signaling resistance to monopolistic control of medicines can be located in Greene, Samsky and Cuthbertson’s different approaches to addressing pharmaceutical inequities. Information about pharmaceuticals proliferates through every kind of available media. This expansion produces an increasingly heterogeneous body of knowledge and practices. In turn diversification of knowledge and practices mobilizes health social movements including patient rights’ groups, self-help and contested illness movements to wrest control of healthcare from traditional providers (see Brown et al. 2004; Banaszak-Holl, Levitsky and Zald 2010).
Furthermore, since the 1970s, new standards for drug approval and new linkages between public and private agencies have transformed knowledge and practices in biomedicine. Today corporate revanchism takes place through the practice of co-opting public entities as Samsky’s discussion of “Dr Bishop’s” clash with the WHO over the Ivermectin Donation Program demonstrates. Because knowledge and practices have changed so dramatically, regulation is uneven and market share can still determine who creates the terms under which the sector operates even when the state intervenes. Cuthbertson’s discussion of the AUGE/GES programs in Chile shows that although the Chilean government authorized the widespread provision of depression medication, its implementation was thoroughly dependent on pharmaceutical companies, such as GlaxoSmithKline, Pfizer and Laboratorios Andrómaco.
In the remaining sections of this commentary, I address the emergence of pharmaceutical health governance by delineating some important conceptual issues related to institutional change in biomedicine and then link them to Greene’s analysis of essential medicines and access, Samsky’s investigation of the Mectizan and Zithromax Donation Programs and Cuthbertson’s study of depression in Chile.
Institutions and Institutional Change
The institutions of biomedicine consist of cognitive, normative and regulative structures and activities that provide stability and meaning to social behavior (Scott and Davis 2010). These repeatable, stable patterns of behavior are based on rules, norms, values and shared understandings or shared knowledge about common practices in the field. In its earliest formulation, medicalization described a process of structural formation whereby the medical profession was able to establish hegemonic practices largely aimed at expansion of jurisdictional authority (Conrad 2005). The expansion of medical judgment, observation and control into nearly all life processes in modern societies results from the combined success of science and technology, the decline of traditional moral paradigms, the rise of higher education and the burgeoning of the profession and related fields. Science, as the dominant account of the ordering of the natural world, provides medicalizing processes with a powerful cognitive anchor. It is probably not too much of an exaggeration to claim that, despite residual spiritual beliefs, people in Western societies tend to take a scientific-secular paradigm for granted. This paradigm hinges on the incompatibility of scientific rationality with irrational (i.e., traditional) beliefs. Moreover, the social power of the paradigm is based on the efficaciousness of its technologies. Any incompatibility that is too great will lead to the erosion of support for traditional moral reasoning in the face of technical-scientific rationality. Since biomedicine presents itself as nothing if not rational, the expansion of medical authority in formerly protected institutional spheres seems inevitable.
In all these cases, the transformation of the medical field has been so thorough that it has taken on a heterogeneous character marked by decentered institutional and organizational governance regimes, greater commodification, new social forms of practice and new forms of subjectivity, among other aspects (Clarke et al. 2003). Importantly, it involves the transformation of the social, political, economic and cultural organization of not only medicine but adjacent societal sectors that provide its resources.
This transformation is particularly apparent with respect to the burgeoning power and authority of pharmaceutical medicine. Pharmaceuticalization is a process that emerges from a pharmaceutically informed definition of health and illness. Over the past thirty years pharmaceutical companies and their agents have acquired considerable political, economic and biomedical authority as a result of both increasing market power, and a cultural narrative that promotes pharmaceuticals as central to treatment of health disorders. Pharmaceuticalization is often depicted as a reduction of healthcare to the treatment of disease solely with medicines. Yet, other dimensions of pharmaceuticalization include questions about what constitutes treatment access, what its socioeconomic and political prerequisites are and what its implications are for definitions of health and disease. Samsky describes how mass drug administration in Tanzania is aimed at a community such that the environment becomes pharmaceuticalized in much the same way that earlier sanitation, pesticide and clean water campaigns sought to purge unhealthy areas of disease. Cuthbertson describes another aspect of pharmaceuticalization in which the biomedicalization of public health (depression in this case) is shaped by the alignment and misalignment of the corporate interests of pharmaceutical companies alongside those of the Chilean state.
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