Unhealthy Pharmaceutical Regulation Innovation: Politics and Promissory Science (2013)

“European and American drug regulators govern a multi-billion-dollar pharmaceutical industry selling its products on the world’s two largest medicines markets. This is the first book to investigate how effectively American and supranational EU governments have regulated innovative pharmaceuticals regarding public health during the neo-liberal era of the last 30 years. Drawing on years of fieldwork, John Abraham and Courtney Davis demonstrate that pharmaceutical regulation and innovation have been misdirected by commercial interests and misconceived ideologies, which induced a deregulatory political culture contrary to health interests. They dismantle the myth that pharmaceutical innovations necessarily equate with therapeutic advances and explain how it has been perpetuated in the interests of industry by corporate bias within the regulatory state, unwarranted expectations of promissory science, and the emergent patient-industry complex. Endemic across both continents, the misadventures of pharmaceutical regulation are shown to span many therapeutic areas, including cancer, diabetes, antibiotics, and irritable bowel syndrome. The authors propose political changes needed to redirect pharmaceutical regulation in the interests of health.”

“Abraham and Davis provide new insights into how the neo-liberal regime that has developed since the 1980s has profoundly biased the way the Food and Drug Administration and the European Medicines Agency deal with drug approvals and safety to the detriment of the patients they are supposed to be protecting. This book should be the starting point for anyone interested in understanding the forces that are shaping the medicines we take.”

Joel Lexchin, Professor of Health Policy, York University (Canada)

“Unhealthy Pharmaceutical Regulation explores the changes in the regulation of innovative pharmaceuticals in the neo-liberal period since 1980 covering the two regions that comprise the world’s largest medicines markets: the USA and the EU. This era witnessed the reduction in state intervention on business activity and the liberalisation of markets. In medicine, where evidence-based research is critical, empirical realists Abraham and Davis produce convincing evidence that the deregulatory changes were made in the commercial interests of the pharmaceutical industry, rather than public health. Eight years of research into the regulation of the pharmaceutical industry is brought together here in a single comprehensive resource. The authors successfully develop key theories with their empirical research, drawing widely upon interviews, and documentary and archival analysis. Pharmaceutical studies as an emerging field within the social sciences is marked by the 1995 publication of Abraham’s book Science, Politics and the Pharmaceutical Industry. This work applied theories from political sociology and political science to research in the pharmaceutical industry. In Unhealthy Pharmaceutical Regulation,  Abraham and Davis build on this work, exploring five theories key to understanding pharmaceutical regulation during the neoliberal period: Neoliberal Theory; Capture Theory; Corporate Bias Theory; Disease-Politics Theory; and Expectations/Marketing Theory. These are then brought to bear on case studies in later chapters. Abraham and Davis present a longitudinal macro- and meso-level analysis in the form of a political economy of the regulation of ‘innovative’ drugs during the neoliberal period, which offers the reader the context through which to later explore the case studies. The latter provides readers with a more micro-level perspective on a number of innovative pharmaceuticals in the context of key neoliberal deregulatory reforms, and within the framework of the theoretical perspectives referred to above. These allow the reader to explore to what extent those theories stack up against the evidence. The drugs and illnesses examined cover a number of therapeutic areas, from discussion of medicines developed to treat serious and life-threatening illnesses such as cancer, to others aimed at caring for non-life-threatening conditions, for example irritable bowel syndrome. Ultimately, all of these case studies demonstrate how the neoliberal corporate bias, which underpinned the deregulatory reforms, impacted upon the micro-social level of the decision making and regulatory outcomes of specific drugs, with detrimental effects on public health. This latest work from Abraham and Davis offers an extremely comprehensive discussion of the changes in drug regulation in Europe and the USA under neoliberalism. Through drawing on extensive fieldwork, they demonstrate how, in both these regions, the interests of the regulators and industry have become intertwined, with the former seeing the latter as partners or clients. Therefore, alterations in pharmaceutical regulation have been made in the commercial interests of companies, rather than those of patients and public health, with the result being that pharmaceutical innovations have not necessarily led to therapeutic advances. Abraham and Davis argue that when the interests of patients and the pharmaceutical industry do not coincide, it is the responsibility of regulatory agencies to ensure that they put patients first: ‘the lesson from the neo-liberal era is that regulatory standards need to be raised and extended in the interests of public health, rather than lowered and loosened’ (p.275). However, for this to happen, greater independence of the regulators from commercial influence is needed. Abraham and Davis end with practical suggestions of how this can be achieved. Most importantly, they argue that the industry and regulatory bodies need to be completely separated. This could be achieved, for example, through appointing agency heads that have a record of independence. Funding of the regulatory agencies should not come directly from the industry, but rather via the taxpayer, with governments recouping the costs from industry. Finally, they propose that scientists employed by the regulatory agencies, rather than the drug manufacturer, should conduct pre-market testing of innovative pharmaceuticals. In sum, Unhealthy Pharmaceutical Regulation is essential reading for all those interested in the field of pharmaceutical regulation, and it will be of great benefit to policy-makers, regulators, scholars, and students alike.”

Sociology

“Unhealthy Pharmaceutical Regulation is an impressive and important book. John Abraham and Courtney Davis focus on the reforms in pharmaceutical regulation in the United States and Europe in the period since 1995—reforms shaped by neoliberal political agendas. A key argument is that the reforms, though presented as in the interest of patients, have in fact been primarily in the interest of the pharmaceutical industry. The regulatory focus has shifted from ensuring safety and efficacy to speeding up drug approval, and while the latter is presented as benefiting patients by fostering innovation, the failure adequately to explore safety and efficacy prior to a medicine’s approval has had negative consequences for them.  The authors build up their argument in a careful, thorough manner, with detailed attention to a range of evidence. After a brief introduction discussing neoliberalism and the call for looser regulation, the first chapter delineates different social science approaches to pharmaceutical regulation and describes the authors’ theoretical and methodological approach. The research, carried out over eight years, includes interviews with regulators and scientists involved in drug approval processes along with extensive documentary research. Five theoretical approaches are described. The first, regulatory capture, focuses on the relationship between the regulatory agency, such as the U.S. Food and Drug Administration (FDA), and the industry, examining how the industry may actively seek to capture the regulatory agency or may do so more passively via the rotation of individuals from industry into agency and vice versa. The second, corporate bias theory, locates regulation in a broader political context of government policies responsive to industry interests, as with neoliberal policies from around 1980 onward. Here there is no need for direct capture of regulatory agencies, since corporate interests are placed at the forefront of the political agendas that shape the expectations and demands on regulatory bodies. The third, disease-politics theory, argues that the regulatory agencies responded to pressure from patient activists, particularly AIDS activists, who wanted easier and speedier access to new drugs. The fourth, reputational theory, a variant of disease-politics theory, argues that regulatory agencies seek to defend their reputations in the face of patient activism. The fifth, expectations theory, focuses on the role of industry marketing in generating patient and public expectations of technological innovation. The second, lengthy chapter examines the political economy of innovative drug regulation, mapping the regulatory reforms in Europe and the United States since 1995, the year when a centralized approval agency for Europe, the European Medicines Evaluation Agency (EMEA, now EMA), was established. One change was that EMEA and the FDA were increasingly funded from fees charged to pharmaceutical companies. Another was the introduction of “accelerated approval” by the FDA and “conditional marketing” by the EMEA. These categories were supposed to be restricted but in practice were used quite widely. Their introduction was presented as a response to patient activism, but while activism was used as a justification, the authors argue convincingly that it was not crucial. However, the speeding up of approval encouraged two significant developments. One was the willingness to rely on post approval evaluation to provide much of the salient information on safety and efficacy, even though in practice the agencies did not subsequently pressure pharmaceutical companies to carry out the appropriate trials they had promised. The other was an increased willingness to accept surrogate outcomes as adequate for drug evaluation, when frequently the links between the surrogate measures and the medicine’s impact on actual morbidity and mortality proved to be poorly related. A further feature of the new regulatory regimes was a tendency to conflate innovation with therapeutic advance—a new medicine might involve a mechanism with an innovative mode of action, but this innovation might not represent any therapeutic advance. Indeed, many innovative medicines did not. Chapters 3, 4, and 5 provide case studies of new medicines approved since 1995, all of which were eventually withdrawn by one of the regulatory agencies: medicines for diabetes, lung cancer, and irritable bowel syndrome respectively. These case studies show in considerable detail the factors underpinning the agencies’ decisions and the dangers to which they exposed patients because of the failure to obtain adequate information on side effects and adverse drug reactions prior to approval, as well as their tendency to regard the possible gains from the new medicine, such as greater consumer choice, as outweighing any identified side effects, even when the medicine did not represent any therapeutic advance. The case studies illuminate very effectively the operation of the agencies’ approval processes and how companies were typically given the benefit of the doubt. Chapter 6, the final substantive chapter, explores the way in which agencies sought to manage the increased risks associated with the regulatory reforms. Here the authors use several examples to demonstrate how the agencies typically chose to try to keep drugs on the market, even if they had toxic effects for some individuals: by trying to identify those who might be adversely affected (though often adverse effects were unpredictable), by restricting the pool of patients for whom a medicine was recommended, or by advising that it should be used only for a relatively short duration (even when the data showed that some were adversely affected after an even shorter period). In the conclusion the authors use the data they have collected to argue that while each theoretical approach has something to offer, that of neo-liberal corporate bias provides the best understanding of regulatory reforms since 1995—reforms that have served neither patients’ interests nor wider public health. This book should be required reading not only for those interested in health, medicines, and the pharmaceutical industry, but also for those interested in neoliberal politics and policies.” American Journal of Sociology