Programme

(T017)
STS for pharmaceuticals and public health policy
Location 116
Date and Start Time 02 September, 2016 at 09:00
Sessions 4

Convenors

  • Conor Douglas (Maastricht University) email
  • Courtney Davis (King's College London) email
  • John Abraham (King's College London) email
  • Stuart Hogarth (King's College London) email

Mail All Convenors

Short Abstract

What is the relationship between pharmaceuticals and the policies that govern them? How can societal challenges in this area be addressed to achieve health outcomes? We seek papers exploring the dynamics through which pharma technoscience has been, could be, and should be, shaped by other means.

Long Abstract

The path pharmaceuticals and associated diagnostic devices travel from developmental stages within laboratories, through clinical development, and ultimately to the patient is highly precarious, though potentially lucrative. While the techno-scientific bases of such products are extremely complex, the work of Abraham (1995), Davis (2015, with Abraham), Hogarth and Salter (2010), Douglas et al. (2015) and others have shown they are also social, economic, legal and political accomplishments. Understanding the nature and socially significant implications of how these political, economic and legal dynamics shape pharmaceuticals and diagnostics underpins this track's motivation. While major shifts are underway in medicine's focus on how to understand fundamentals of disease via advanced genomic and bio-marker technologies, the possibility of more evidence-based evaluation of scientific claims-making about pharmaceutical treatment of disease is also progressing. The business models of pharmaceutical/diagnostic companies, government policies/ideologies, organization and philosophies of regulatory agencies, the medical profession's production of knowledge, and patient advocacy all play a role in determining the trajectory of these technologies in our society. We seek to extend research at the STS-pharmaceutical nexus by inviting papers that explore this trajectory with a view to evaluating the implications for public health. This includes: political economy of pharmaceutical/diagnostic industry; patents, markets and innovation; (de)regulation, innovation and availability of valuable therapies; law, transparency and public accountability of industrial/regulatory science, the medical-industrial complex and pharmaceutical knowledge production, political dynamics of drugs for rare diseases; pharmaceutical coverage decision-making in the context of healthcare sustainability ; the role of patients in development and regulatory processes.

This track is closed to new paper proposals.

Papers

"The most generous statement justifiable": Analytic capabilities and investigative norms in the regulation of the anti-influenza drug Relenza

Author: Shai Mulinari (Lund University)  email

Short Abstract

Relenza was launched in the late 90’s. This paper investigates why FDA and European regulators came to divergent interpretations regarding Relenza efficacy, and why the FDA approved the drug despite an overwhelmingly negative opinion in its Antiviral Drug Products Advisory Committee.

Long Abstract

Glaxo Wellcome launched the anti-influenza drug Relenza in the late 90's. Although heralded as breakthrough treatments, the efficacy of Relenza and its sister drug Tamiflu has been the subject of much debate, especially after many countries decided to stockpile the drugs to safeguard public health in event of a major influenza outbreak. In the midst of controversies, which are still unfolding, medical researchers have been puzzled by the fact that the FDA approved much more cautious efficacy statements than European regulators. This paper investigates (1) why FDA and European regulators came to divergent interpretations regarding Relenza efficacy, and (2) why the FDA approved the drug despite an overwhelmingly negative opinion in its Antiviral Drug Products Advisory Committee. It is argued that European regulators displayed considerably weaker analytic capabilities and investigative norms, which may be linked to the relatively weaker potency of European regulatory authorities. Consequently, European regulators were not in position to thoroughly scrutinize the manufacturer's analyses and knowledge-claims, which is reflected in assertions more favorable to the drug in European labels. It also argued that the FDA, to neutralize the Advisory Committee's negative advice, used the agency's analytic capabilities to help construct an argument for approval. This involved finding "the most generous statement justifiable" regarding efficacy; still, FDA's efficacy assertions were more moderate than European regulators' assertions. It is suggested that FDA's collaborative and "constructivist" approach was motivated, at least in part, by an institutional culture ushered by the FDA Modernization Act of 1997 that incentivized cooperation with industry.

Access driven networks for therapeutic goods production in Brazil

Authors: Marilena Correa (State University of Rio de Janeiro)  email
Maurice Cassier (CNRS)  email
Koichi Kameda (CERMES3 and IMS/UERJ)  email

Short Abstract

This paper is based on research (Cassier & Corrêa 2003; 2014; Kameda, 2012) on the political economy of social-technical arrangements that boosted the local production and circulation of medicines and tests in Brazil, focusing on laboratorial work and technological development in the name of access

Long Abstract

Until the 1990s technology incorporation in Brazil followed the classical model of import substitution, as other countries in the South. The advent of new therapies against Aids challenged public health Policies to assure access to life saving drugs. Furthermore, the State faced strong pressure by civil society groups. This led to local production of complex medicines as ARVs within copying programs, conducted through informal networks with circulations of experts between Brazilian universities, companies and research institutes, which resulted in a remarkable technological learning in local level. Innovation benefited from copying in the public and private laboratories (Cassier&Corrêa, 2012). The 1996 IP law, which reinstated the pharmaceutical patenting in the country, had a strong impact on the ARVs copying, notably after the 2000s, leading the State and patient associations to make use of TRIPS flexibilities (compulsory licensing and patent opposition). Moreover, the previous experience of production through networks was, in part, responsible for the formation in the 2000s of technological consortia and public-private partnerships to locally develop and produce therapeutic goods addressing the public health system demands. This paper is based on 15 years research (Cassier&Corrêa, 2003; 2014; Kameda, 2012) analysing the political economy of social-technical arrangements that boosted the local production and circulation of devices (medicines and tests) following from the laboratorial work to the technological development of such tools until access in public health programs in Brazil. Our research is based on documentation analysis, fieldwork (case studies) and interviews with public policy makers, industrialists, researchers and activists

An examination of the development of the HPV vaccine

Author: Shaun Geer (UC Davis)  email

Short Abstract

This paper looks at the development of the HPV vaccine, and particularly the interaction between corporate, state, and academic actors in developing an epistemic thing and commodifying it.

Long Abstract

I draw upon Rheinberger's(1997) work on epistemologies as the basic unit at which science is done, and apply this to all of the different actors which interacted with the HPV vaccine, looking at the discourse and practice around epistemic things which drives action around corporate, state, and academic actors. My paper focuses on the following epistemic things: the components of what will eventually be the HPV vaccine, the packaged, completed form of this vaccine, and the medicalized female body. Different groups interact around and through these objects in way similar to that described by Star et. al. (1989) discussion of boundary objects. Generally, the literature treats the actor examining a new border object as being accommodating; that is, by examining what the other group wants and needs from the actor and then embodying that in such a way in that both groups benefit and thus want to maintain both the relationship to the object itself and other actors through the border object. However, my analysis adds an examination of what asymmetrical power does to interactions through boundary objects. Finally, I look at how different discourses and practices affect the alignment of actors around epistemic things, and how the changing of the focus on the carcinogenic aspects of the HPV virus effectively changed the relationship between the female body and state actors.

Benzodiazepines trajectory in Uruguay: implications for public health

Authors: Andrea Bielli (Universidad de la República, Uruguay)  email
Gabriela Bruno (Universidad de la República, Uruguay)  email
Nancy Calisto (Universidad de la República, Uruguay)  email
Santiago Navarro (Universidad de la República, Uruguay)  email
María Pilar Bacci Mañaricua (Universidad de la República, Uruguay)  email

Short Abstract

This paper analyses the trajectory of benzodiazepines in Uruguay's health system, where recently these drugs have been deemed a public health problem. We trace the evolution of local academic discussions and regulatory measures from their introduction to this Latin American country up to the present.

Long Abstract

This paper analyzes the trajectory of benzodiazepines in Uruguay and its implication on public health. The use of benzodiazepines led to a major international debate especially during the 1980s, but Uruguayan authorities and physicians have never been engaged in an active discussion about it.

While benzodiazepine use grew up in the country, some professionals were concerned about the overprescription of these pharmaceuticals but there was never an specific policy developed by the health authorities. Today, benzodiazepines are still commonly used, especially by general practitioners, and long-term users are not exceptional in Uruguay. And while some physicians believe the debate on benzodiazepines is "outdated", benzodiazepines have very recently been deemed by a local group of academics a national public health problem.

This paper traces the evolution of academic discussions and health authorities' measures over benzodiazepines since from their introduction to the country up to the present. We discuss how a controversy that seems closed in other countries, is still open and has clear implications for the public health in a Latin American country like Uruguay. To do this, we will build on the analysis of national academic papers on benzodiazepines published from 1960 to 2015, 35 in-detph interviews to general practitioners, family physicians, psychiatrists and psychologists, and two health authorities. This paper contributes to the field of pharmaceutical studies and the discussion on pharmaceuticals and public health policy from the particular case of a country that is strongly dependent on international pharmaceutical knowledge production and international regulatory policies.

Blockbuster diagnostics? The pharmaceuticalisation of the IVD industry.

Author: Stuart Hogarth (King's College London)  email

Short Abstract

This paper discusses a number of trends in the diagnostics industry which are worthy of sociological analysis and which collectively might be understood as constituting a form of pharmaceuticalisation.

Long Abstract

In recent years pharmaceuticalisation has emerged as an alternative to medicalisation in medical sociology (and in STS work on biomedicine), shifting attention from the collective authority of the medical profession to the corporate power of the pharmaceutical industry. In the light of this it is perhaps puzzling that the nascent sociology of diagnosis has thus far paid little attention to the influence of the diagnostics industry. In an attempt to begin to address that lacuna, this paper discusses a number of trends in the diagnostics industry which are worthy of sociological analysis and which collectively might be understood as themselves constituting a form of pharmaceuticalisation. These trends include: the adoption of business models and commercial strategies characteristic of big pharma (including consumer advertising and the search for what are termed 'blockbuster diagnostics'); the inter-penetration of the two industries and their regulatory regimes through pharmacogenomics; and new regulatory demands for the more systematic collection of evidence on safety and effectiveness. This paper will explore the relationship between the pharmaceuticalisation of the diagnostics industry and the emergence of the molecular diagnostics sector and ask whether these trends mark the emergence of a discrete niche within the IVD industry or the beginning of a fundamental socio-technical transition.

Boundary work in the regulatory evaluation of pharmaceuticals

Authors: Jarno Hoekman (Utrecht University)  email
Wouter Boon (Utrecht University)  email

Short Abstract

We present a longitudinal case-study of a European policy instrument that facilitates early patient access to pharmaceuticals that address unmet medical needs. We focus on the boundary work of companies and regulators to delineate levels of evidence for market access and define unmet medical need.

Long Abstract

We conducted an in-depth longitudinal case-study of a European policy instrument to facilitate early patient access to pharmaceuticals that address unmet medical needs. Following institutional theory, we argue that rules to evaluate techno-scientific products always contain ambiguities. Actors will interpret, contest and act upon these ambiguities in different ways depending on their strategic interests. In line with an interest-based approach (Abraham and Davis 2013), we expect that regulators aim to protect public health and will therefore consistently reduce ambiguities in that direction, while companies have a commercial interest and thus exploit ambiguities to obtain early market access for their products.

We examine this process using a mixed qualitative-quantitative approach based on interviews, archival documents and quantitative indicators of marketing authorisation applications by companies. The various methods allow us to study how companies and regulators delineate 'sufficient levels of evidence' to gain market access and how they define 'unmet medical need'.

Our results indicate that the boundary work by regulators and companies has a regulative component (legal definitions of evaluation criteria), normative component (ordering of evaluation criteria) and cognitive component (construction of evaluation routines). The work done by actors has led to two divergent logics by which pharmaceuticals reach the market early. For some pharmaceuticals there is consensus about unmet medical need after which evidentiary standards become the subject of negotiation between regulators and companies. For others, companies present pharmaceuticals with lower levels of evidence to regulators after which unmet medical need is to be actively constructed to legitimize market access.

Developing a Canadian Orphan Drug Policy: A Stalled Initiative

Author: Carlos Novas (Carleton University)  email

Short Abstract

This paper will explore the political-economic, patient advocacy and policy nexus that has contributed to the absence of a Canadian orphan drug policy from the mid-1990s to the present.

Long Abstract

This paper explores the absence of a Canadian orphan drug policy. While other jurisdictions such as the United States developed orphan drug legislation in 1983, and the European Union developed orphan drug regulations in 1999, Canada has not followed suit. In contrast to these jurisdictions which developed specific legislation and regulations in relation to orphan drugs, Health Canada in a mandate issued in 1996 claimed that Canada did not need to develop an orphan drug policy as Canadian's had access to these pharmaceuticals through the normal drug approval process. More recently, Health Canada (2012) announced an Orphan Drug Framework that promised to spur research into new treatments for rare diseases and encourage patient participation. Despite consultations with the pharmaceutical industry and patients' organizations, Canada still does not have an orphan drug policy. What makes the Canadian case interesting and puzzling is that a well-organized patient advocacy movement exists in the form of the Canadian Organization for Rare Disorders. This paper will explore the political-economic, patient advocacy and policy nexus that has contributed to the absence of a Canadian orphan drug policy.

FDA Approval of Flibanserin for Female Hypoactive Sexual Desire Disorder: A Rhetorical Study

Author: Judith Segal (University of British Columbia)  email

Short Abstract

The presenter attended FDA meetings on Female Sexual Dysfunction, ahead of an application for approval of flibanserin as a treatment. The paper analyzes the rhetoric leading to approval, and asks why arguments persuasive to the FDA have been unpersuasive to women who might be candidates for the drug.

Long Abstract

Flibanserin (Addyi) is a drug to treat Female Hypoactive Sexual Desire Disorder. The drug was presented for approval, for the third time, to the FDA in February 2015. In June 2015, an expert panel recommended the FDA approve the drug, and in August, the FDA did approve it. The story of flibanserin's approval goes back to the summer of 2014, and the launch of the largely pharma-funded campaign, Even the Score—and to October 2014, when the FDA held patient-focused meetings on the "unmet need" for an HSDD drug. I attended those meetings as a rhetorical observer, and noted, for example, that the language used there already assumed disease in the women who were recruited to report on their experience of low desire for their long-term male partners. By the language of the FDA staff who interviewed the patient panelists (mostly funded for their appearance that day by Sprout Pharmaceuticals, then owner of flibanserin), these women were there to talk about their "symptoms." The flibanserin case presents additional matters of rhetorical interest—not least, the appropriation by Even the Score of a feminist language to promote an arguably anti-feminist agenda. Addyi is now on sale in the U.S. and its market numbers have been low: only 227 prescriptions were written in its first four weeks of sale. A rhetorician's further question is then, how is it that arguments so persuasive to the FDA have turned out to be unpersuasive to women who might be candidates for the drug?

Health Fiction, Performativity, and Pharmaceuticalzation: A Preliminary Remark on "Fictitious Health" in contemporary Biomedicalization

Author: Kan-Lin Hsu (Tunghai University)  email

Short Abstract

The author proposes the concepts of health fiction and fictitious health inspired by Karl Polanyi and Michael Callon to characterize the role of epidemiological studies in policy campaigns and pharmaceutical marketing as well as in reinforcing the tendency of pharmaceuticalization.

Long Abstract

In the wake of technoscientific transformation in biomedicine, scholarly efforts have been made to conceptualize the emerging form of medicalization and its social consequences. Concepts such as biomedicalization, pharmaceuticalization, biohealth and surplus health, among others, are heuristic in capturing our understandings of health and illness.

Writing from a combined viewpoint inspired by Karl Polanyi's "commodity fiction" and Michel Callon's "performative market", this paper coins the term "fictitious health" to characterize how epidemiological studies help to redefining health for biopharmaceutical industries and public health policy. Firstly, epidemiological studies continuously conduct health fiction to the extent that they systematically produced statistically significant health outcomes varied with various risk factors and protecting factors, whilst health outcomes revealed in the statistical context have been fictitious in the sense that there is no "ceteris paribus" condition in the real world. Drawing on epidemiological studies required by regulation, secondly, policy campaigns and pharmaceutical marketing are able to perform the supposed efficacy of health promotion policy and health-enhancing products. The combination of health fiction and performing fictitious health, the author argues, powerfully reinforces the tendency of pharmaceuticalization.

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Knowledge management in multi-site clinical trials in Latin America.

Authors: Sara Valencia (University of Edinburgh)  email
Alessandro Rosiello (University of Edinburgh)  email

Short Abstract

Production of knowledge in clinical trials in Latin America is reshaped by the alliance with public health organizations, the meta-coordination of research activities between actors working in the trial, and their ability to learn, introduce, and transfer information through the network

Long Abstract

STS and post-colonialism studies approaches to clinical trials in Latin America countries have focused on drugs, and clinical trial governance systems by large pharmaceutical companies. However, the actual research activity conducted at clinical sites has been overlooked, and less attention has been paid to how knowledge is managed inter and intra organizationally by researchers.

In his work I report findings from the research I have been conducting on the outsourcing of the clinical evaluation of three dengue vaccine candidates in Brasil, Colombia, and Mexico. 55 Semi-structured interviews were conducted with research site members, sponsors, clinical monitors, ethics committee representatives, and regulatory agencies with the aim of study how research sites and sponsors produce scientific evidence and data, and coordinate their work during the trial.

This paper goes beyond the conventional pharmaceutical governance discourse by examining the differences between public and private funded projects, and contrasting highly experienced sites vs new sites, arguing that the production of scientific evidence in clinical trials, is the result of how knowledge is managed by and between a variety of agents in a complex and fragmented network. This means, that knowledge, information, and data are continuously transmitted, transformed and learned throughout the project; and the production of valid data depends on the sites' expertise, ability to learn, and knowledge about of volunteers and public health organizations.

This paper contributes to the debates on track STS for pharmaceuticals and public health policy by addressing issues on the complexity of knowledge production in multi site clinical trials

Pharmaceutical wholesaling and its regulation, an important stage to explore

Authors: Daniel Arhinful (NMIMR, University of Ghana)  email
Jean-Yves Le Hesran (IRD)  email
Carine Baxerres (IRD/ Université Paris Descartes/CNE)  email

Short Abstract

Based on ethnographic study of a large pharmaceutical wholesale market in Accra, Ghana, we analyse the links between state and market regulation and how they influence consumption by people and public health concerns.

Long Abstract

Pharmaceuticals provide an ideal window into studying contemporary societies and understanding how and why they change. We present data from two years ethnographic study of the pharmaceutical wholesale market at Okaishie "drug lane" in Accra, which hosts a large number of companies involved in the pharmaceutical wholesaling in Ghana. We question the current links between state regulation and market regulation, while taking into account the influence of transnational actors.

We examine sales practices in this market against the background of current national regulation by highlighting informal practices on both pharmaceuticals and actors. Some of them will be analysed as inherent to the way the business is thought in Ghana by key players including authorities. The various dynamics generated by the opening of the market to numerous pharmaceutical firms (mainly from "emergent" countries of Asia, like India and China, and from Western countries), to numerous importers who are also involved in marketing and their competitive financial pitch and the quality of supplied pharmaceuticals, seem to generate logically informal practices. The consideration of medicines against malaria subsidy program proposed by the Global Found will enrich the analysis. Finally, we will examine the underlying logical structure of the market - between economic elements and human relations aspects - and we will highlight its impact on consumption by people ("irrational" consumptions, self-medication, etc.), taking into account public health concerns (danger to miss malarial attacks vs spread of antimalarial resistances).

Prenatal Genetic testing as instruments of governementalisation of public health

Author: Catherine Fallon (University of Liege )  email

Short Abstract

Genealogy of production of technical and financial regulations for prenatal genetic tests show how power and knowledge develop as entities intertwined within a dynamic relationship, supporting the emergence of socio technical networks and forms of resistance in this sector of public health

Long Abstract

Developments in genomics support the vision of the body as an "information network" and different experts construct models for the calculation of life in the development of policy regulation, developing specific policy frames- either at individual or at population level, on the basis of power strategies mobilizing and disseminating specific forms of knowledge which are disciplined and selective.

The contribution will present the recent evolution of the apparatuses producing the technical regulation and financial norms for the use of prenatal genetic testing (Belgian case study): what are the new control relations between subsidizing and control bodies and the hospitals; what are the new forms of cooperation between medical doctors, biomedical experts and psycho-sociologists in relation with the patients. A careful analysis of the genealogy of policy instruments (Lascoumes and LeGalès 2001) in this sector and on the emergence of regulatory networks with geneticists and clinicians and subsidizing bodies, arises questions on critical issues such as : Who has the resources (intellectual, technological or financial) to control the technology and its use ? what are the social, institutional and technological constrains? who defines and select the legitimate options ?

The analysis is not so much normative than critical, giving due attention to emergence of socio technical networks and of forms of resistance, and mobilizing the concept of "governementalisation of the state" (Foucault 2008) to analyse how power and knowledge develops as entities intertwined within a dynamic relationship in the new fields of public health.

Pricing orphan drugs, prizing rare diseases

Authors: Vololona Rabeharisoa (MINES ParisTech)  email
Liliana Doganova (Mines ParisTech)  email

Short Abstract

This communication looks at the emergence of orphan drugs markets, the intricacies between their testing and pricing, and debates on how to make rare diseases matter.

Long Abstract

In this communication, we look at the development of orphan drugs, e.g. drugs for rare diseases, as an interesting site for exploring the emergence of markets at the intersection of public health policies, regulatory measures, evidentiary practices, pricing mechanisms, patient activism, issues of social justice and moral sentiments.

Because of the small size of the targeted populations, orphan drugs could not pass the gold standard clinical trials that regulate the marketing of drugs, and were considered economically non viable by the industry. The 1983 American Orphan Drugs Act, and the 2000 European Directive on Orphan Medicinal Products, brought in economic incentives and scientific assistance to pharmaceutical and biotech firms willing to develop orphan drugs. These, and other legal measures, paved the way to the marketing of orphan drugs. They also raise criticisms against the "exceptional" regime, which some think rare disease patients and the industry benefit from, notably because orphan drugs tend to be very expensive and turn out to be "blockbusters of a new type", as some observers put it.

This communication draws on a preliminary fieldwork on initiatives launched by patient organizations in France, UK and in Europe, and on the dialogue these organizations establish with public authorities and the industry. We focus on how these initiatives and dialogue problematize the testing and the pricing of orphan drugs, and raise heated debates on how to make orphan drugs and rare diseases matter for the market and for society at large.

Primary healthcare and biotechnology innovation: developing cancer immunotherapy in Cuba

Author: Nils Graber (École des Hautes Études en Sciences Sociales)  email

Short Abstract

Since recently, clinical trials of cancer immunotherapy drugs are conducted in Cuba at the level of primary healthcare. We analyze the role of primary healthcare actors in the innovation process, with the attempt to show how it is linked to both public health policies and export strategy.

Long Abstract

The State-owned Cuban biopharmaceutical industry is experimenting cancer immunotherapy drugs in clinical trials for about 20 years. Yet this industry is facing difficulties to meet the global regulations for exporting its medicines, mainly due to the economic hardships in the island. Thus, some Cuban biotechnology centers have deployed a "double strategy" of clinical trials, one following global regulations thanks to foreign investments, while the other is adapted to the Cuban public health context. The latter aims to demonstrate the effect of cancer immunotherapy on the "real population of patients" in terms of transforming advanced cancer into "chronic diseases". This public health approach of clinical trials is based on the integration of primary healthcare centers as clinical sites, in which family doctors and nurses are trained in clinical research and oncology. Building on an ethnography of the trajectory of cancer immunotherapy in Cuba, we will argue that translational research is embedded in the public health system and its underlying ideology. The current development of these drugs relies on evidence-based research implying family healthcare professionals. Specific challenges are posed regarding the articulation of various levels of knowledge production - i.e. biotechnology centers, monitoring institutions, hospital oncology services, and primary healthcare institutions. Other stakes are related to the Cuban drugs agency policies affecting these practices. This paper will contribute to the analysis of social, economic, geopolitical, and ideological dimensions of pharmaceutical innovation, and shed light on the role of new actors - i.e. primary healthcare professionals - in this process.

Research Ethics Committees and the 'club regulation' of pharmaceutical research

Author: Adam Hedgecoe (Cardiff Unviersity)  email

Short Abstract

This paper explores UK RECs as form of hybrid 'club regulation'.

Long Abstract

While there is a long history of agenda setting research on the post-trial regulation of pharmaceutical products, pre-trial regulation is less well examined. Over the past few years, a growing body of work on research ethics review (a crucial aspect of pre-trial regulation) has begun to shed light on this area. The aim of this paper is, via historical and ethnographic data, to map out the broader theoretical context within which research ethics review takes place. To do so, this paper explores the nature of UK research ethics committees in the context of changes to the British regulatory state over the past 30-40 years. Drawing on the work of Michael Moran this paper argues that RECs exist as a curious hybrid between 'club regulation' (which empowers professional self-regulation and the exclusion of democratic oversight) and the 'modernist' style of regulation that succeeded it in the 1970s and 1980s. Thus while RECs are situated within a modernist context of 'governance frameworks', 'SOPs' and audit, REC decision making remains rooted in the relationship-focused, style of regulation characteristic of pre-1970s club government. This paper will examine the advantages and disadvantages of such a system, and explore its implications for broader pharmaceutical regulation.

Scenario studies with coverage decision-makers for drugs for rare diseases

Author: Conor Douglas (Maastricht University)  email

Short Abstract

When futures are uncertain, and technological developments stand to have large impacts, scenario studies can be used as a tool for strategic foresight. This paper reports on an intuitive logic scenarios study with drug coverage decision-makers in Canada on the issue of drugs for rare diseases.

Long Abstract

Technological developments in DNA sequencing are altering the understanding of the underlying pathology of many common conditions resulting in their stratification into more rare subtypes. These developments have also facilitated the characterisation of other new disease, which has led to growth in rare monogenetic disorders that now totals approximately 7000. Changes in the understanding of diseases have been accompanied by major parts of the pharmaceutical sector altering their research and development strategies away from blockbuster drugs, and towards "niche busters" that target smaller populations yet still garner significant sales due to their high prices. These developments stand to provide hope for some patients in cases in which treatments have not been previously available - as is the case for drugs for rare diseases. The very high cost of these drugs (also known as orphan drugs) is resulting in access issues for patients and significant challenges for public health care systems - in particular the pharmaceutical reimbursement plans. What is more, there is often a relative dearth of evidence -and thus considerable uncertainty- regarding the benefits and harms of such treatments. When futures are uncertain, and technological developments stand to have large impacts, scenario studies can be deployed to prepare for an array of social and technical changes. This paper reports on an intuitive logic scenarios study with drug coverage decision-makers in Canada on the issue of drugs for rare diseases. Findings from this scenario study will be presented along with policy recommendations for moving forward

The Politics of Knowledge Production in Carcinogenic Risk Assessment

Author: John Abraham (King's College London)  email

Short Abstract

Building on realist theoretical frameworks in STS and drawing on fieldwork in Europe and the US spanning over a decade, this paper examines how political, economic and institutional interests have reshaped definitions of pharmaceutical carcinogens, and considers the implications for public health

Long Abstract

Building on realist theories of science, developed by Bhaskar (1975, 1979) within philosophy and brought to empirical fields of STS by Abraham (1995), this paper starts from the presupposition that the domains of 'the political' and of the 'natural world' are to some extent autonomous. From that starting point, it systematically investigates how politics has shaped the production of scientific knowledge in the field of pharmaceutical carcinogenic risk assessment. Drawing on years of fieldwork, including nearly 100 interviews and extensive documentary research in Europe and the US, involving pharmaceutical industry scientists, drug regulatory agencies, experts from key national and international scientific laboratories and committees, and relevant advocacy organizations, this paper explains how various economic, political and institutional interests have sought to change how pharmaceuticals are defined as carcinogens. This paper makes three principal points: one empirical; one policy-relevant; and one philosophical/methodological. Empirically, it is argued and demonstrated that the process of redefining what counts as pharmaceutical carcinogens over the last 30 years has been biased in favour of commercial interests with the blessing of drug regulators, violating scientific standards as it goes . Policy-wise, this has cemented a direction of assessment and decision-making against the interests of public health. Philosophically/methodologically, the research confirms the relative autonomy of the domains of 'politics', 'science', and 'nature' for it is precisely because the natural world is not entirely malleable by politics that the practices of particular scientists can be revealed as biased and inconsistent with scientific standards developed to accurately characterise that world.

The politics of rare diseases and orphan drugs in Europe

Author: Rob Hagendijk (Universiteit van Amsterdam)  email

Short Abstract

A co-productionist analysis of EU health policies for rare diseases. How scientific, political, ethical and economic concerns get reconfigured in ways that may affect future EU public health systems and societies writ large.

Long Abstract

The paper studies changes in how 'rare diseases' and 'orphan drugs' are dealt with in Europe. These policy domains are relatively small, but they are key elements in the changing landscape of public health. Combined with associated tensions in public health insurance systems they form a key testing ground for struggles about public health writ large.

Advances in the biomedical sciences, pharmaceutics and also informatics play an important role in all this. The European Medicines Agency (EMA) has been established in connection with these, but also as a part of neoliberal reforms of markets and governance. More recently patients, doctors and the EC have managed to establish 'rare diseases' as a distinct domain of emerging European public health policy. I will argue that on-going development processes have not just implications for medical practice, but also for the boundaries between market and state, medical professionals and pharmaceutical companies and for the position of public health insurance.

My analysis draws on the co-productionist approach developed in STS. In my view developments in the area of rare diseases and orphan drugs offer a vantage point for such a detailed co-productionist analysis. I will also draw on and discuss insights from politico-economic analysis, law, and European integration studies. Drawing on my own involvement in developments in the field or rare metabolic diseases, I will present some of the fault lines, on-going struggles and topical structures and their wider intellectual and political implications.

What do they know? On patients reporting drug safety issues

Author: Jasmin Engelhart (University of Vienna)  email

Short Abstract

Knowledge production about drug safety increasingly takes place outside of clinics and labs. I examine how the role of patients as formal reporters of adverse drug reactions is enacted in parliamentary discussion, data processing at a drug regulation authority and in newspaper coverage.

Long Abstract

Drug regulation faces an increasing dilemma between the need for quick access to potentially life-saving medicines and the need for data on the efficacy and safety of new drugs. As a response to these challenges, the focus in drug testing is currently shifting from pre-marketing clinical trials to post-marketing pharmacovigilance measures.

In 2010, the EU passed a pharmacovigilance directive which ordered member states to create opportunities for patients to report experiences of adverse drug reactions directly to drug regulation authorities. Apart from concerns about expertise that have been voiced about this amendment, questions arise how this changes the meaning of drug safety and what implications it might have for public health.

As drug safety is increasingly produced in various public and political arenas, I will present findings from empirical research that focusses on three moments at which drug safety is 'made' in the Austrian context: in processing of adverse drug reaction reports at the national drug regulation authority, during parliamentary debate about new pharmacovigilance legislation and in newspaper coverage about this change of law.

I examine roles which are ascribed to patients in the production of knowledge about drug safety in these contexts: are they providers of vital information, sand in the drug regulation process, lay experts (Epstein, 1996)? I will show how drug safety and patient knowledge are enacted in multiple ways in different practices and deepen our understanding of how values are ascribed to patients' contributions to medical and regulatory science.

This track is closed to new paper proposals.