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Author: John Abraham
Publisher: Taylor & Francis
ISBN: 1000951308
Category : Social Science
Languages : en
Pages : 201
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Book Description
Drug disasters from Thalidomide to Opren, and other less dramatic cases of drug injury, raise questions about whether the testing and control of medicines provides satisfactory protection for the public. In this revealing study, John Abrahan develops a theoretically challenging realist approach, in order to probe deeply into the work of scientists in the pharmaceutical industry and governmental drug regulatory authorities on both sides of the Atlantic. Through the examination of contemporary controversial case studies, he exposes how the commercial interest of drug manufacturers are consistently given the benefit of the scientific doubts about medicine safety and effectiveness, over and above the best interests of patients.; A highly original combination of philosophical rigour, historical sensitivity and empirical depth enables the "black box" of industrial and government science to be opened up to critical scrutiny much more than in previous social scientific study. All major aspects of drug testing and regulation are considered, including pre- clinical animal tests, clinical trials and postmarketing surveillance of adverse drug reactions. The author argues that drug regulators are too dependent on pharmaceutical industry resources and expertise, and too divorced from public accountability. The problem of corporate bias is particularly severe in the UK, where regulatory decisions about medicine safety are shrouded in greater secrecy than in the US.; Since the purpose of drug regulation should be to maximize the safety and effectiveness of medicines for patients, the public needs and deserves policies to counteract corporate bias in drug testing and evaluation. John Abraham's realist analysis provides a robust basis for policy interventions at the institutional and legislative levels. He proposes that corporate bias could be reduced by more extensive freedom of information, greater autonomy of government scientists from pharmaceutical industry, the development of independent drug testing by the regulatory authority, increased patient representation on regulatory committees, and more frequent and thorough oversight of regulatory performance by the legislature. This book should be of interest to anyone who cares about how medicines should be controlled in modern society. It should prove particularly rewarding for students and researchers in the sociology of science and technology, science and medicines policy, medical sociologists, the medical and pharmaceutical professions, and consumer organizations.
Author: John Abraham
Publisher: Taylor & Francis
ISBN: 1000951308
Category : Social Science
Languages : en
Pages : 201
Get Book Here
Book Description
Drug disasters from Thalidomide to Opren, and other less dramatic cases of drug injury, raise questions about whether the testing and control of medicines provides satisfactory protection for the public. In this revealing study, John Abrahan develops a theoretically challenging realist approach, in order to probe deeply into the work of scientists in the pharmaceutical industry and governmental drug regulatory authorities on both sides of the Atlantic. Through the examination of contemporary controversial case studies, he exposes how the commercial interest of drug manufacturers are consistently given the benefit of the scientific doubts about medicine safety and effectiveness, over and above the best interests of patients.; A highly original combination of philosophical rigour, historical sensitivity and empirical depth enables the "black box" of industrial and government science to be opened up to critical scrutiny much more than in previous social scientific study. All major aspects of drug testing and regulation are considered, including pre- clinical animal tests, clinical trials and postmarketing surveillance of adverse drug reactions. The author argues that drug regulators are too dependent on pharmaceutical industry resources and expertise, and too divorced from public accountability. The problem of corporate bias is particularly severe in the UK, where regulatory decisions about medicine safety are shrouded in greater secrecy than in the US.; Since the purpose of drug regulation should be to maximize the safety and effectiveness of medicines for patients, the public needs and deserves policies to counteract corporate bias in drug testing and evaluation. John Abraham's realist analysis provides a robust basis for policy interventions at the institutional and legislative levels. He proposes that corporate bias could be reduced by more extensive freedom of information, greater autonomy of government scientists from pharmaceutical industry, the development of independent drug testing by the regulatory authority, increased patient representation on regulatory committees, and more frequent and thorough oversight of regulatory performance by the legislature. This book should be of interest to anyone who cares about how medicines should be controlled in modern society. It should prove particularly rewarding for students and researchers in the sociology of science and technology, science and medicines policy, medical sociologists, the medical and pharmaceutical professions, and consumer organizations.
Author: John Abraham
Publisher:
ISBN: 9781003421405
Category : MEDICAL
Languages : en
Pages : 0
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Book Description
Drug disasters from Thalidomide to Opren, and other less dramatic cases of drug injury, raise questions about whether the testing and control of medicines provides satisfactory protection for the public. In this revealing study, John Abrahan develops a theoretically challenging realist approach, in order to probe deeply into the work of scientists in the pharmaceutical industry and governmental drug regulatory authorities on both sides of the Atlantic. Through the examination of contemporary controversial case studies, he exposes how the commercial interest of drug manufacturers are consistently given the benefit of the scientific doubts about medicine safety and effectiveness, over and above the best interests of patients.; A highly original combination of philosophical rigour, historical sensitivity and empirical depth enables the "black box" of industrial and government science to be opened up to critical scrutiny much more than in previous social scientific study. All major aspects of drug testing and regulation are considered, including pre- clinical animal tests, clinical trials and postmarketing surveillance of adverse drug reactions. The author argues that drug regulators are too dependent on pharmaceutical industry resources and expertise, and too divorced from public accountability. The problem of corporate bias is particularly severe in the UK, where regulatory decisions about medicine safety are shrouded in greater secrecy than in the US.; Since the purpose of drug regulation should be to maximize the safety and effectiveness of medicines for patients, the public needs and deserves policies to counteract corporate bias in drug testing and evaluation. John Abraham's realist analysis provides a robust basis for policy interventions at the institutional and legislative levels. He proposes that corporate bias could be reduced by more extensive freedom of information, greater autonomy of government scientists from pharmaceutical industry, the development of independent drug testing by the regulatory authority, increased patient representation on regulatory committees, and more frequent and thorough oversight of regulatory performance by the legislature. This book should be of interest to anyone who cares about how medicines should be controlled in modern society. It should prove particularly rewarding for students and researchers in the sociology of science and technology, science and medicines policy, medical sociologists, the medical and pharmaceutical professions, and consumer organizations.
Author: Olga Zvonareva
Publisher: State University of New York Press
ISBN: 143847993X
Category : History
Languages : en
Pages : 218
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Book Description
Over the last one hundred years, the Russian pharmaceutical industry has undergone multiple dramatic transformations, which have taken place alongside tectonic political shifts in society associated with the rise and fall of the Soviet Union and the emergence of a post-Soviet order. Pharmapolitics in Russia argues that different versions of the Russian pharmaceutical industry took shape in a co-productive process, equally involving political ideologies and agendas, and technoscientific developments and constraints. Drawing on interviews, documents, literature, and media sources, Olga Zvonareva examines critical points in the history of the pharmaceutical industry in Russia. This includes the emergence of Soviet drug research and development, the short-lived neoliberal turn of the 1990s, and the ongoing efforts of the Russian government to boost local pharmaceutical innovation, which in turn produced a now widely shared vision of an independent and self-sufficient nation. The resulting industrial organizations and practices, she argues, came to embed and transmit particular imaginaries of the nation and its future.
Author: Alfonso Gambardella
Publisher: Cambridge University Press
ISBN: 0521451183
Category : Business & Economics
Languages : en
Pages : 236
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Book Description
This book examines an increasingly important phenomenon for competitiveness and innovation in industry: namely, the growing use of scientific principles in industrial research. Industrial innovation still arises from systematic trial-and-error experiments with many designs and objects, but these experiments are now being guided by a more rational understanding of phenomena. This has important implications for market structure, firm strategies, and competition. Science and innovation focuses on the pharmaceutical industry. It discusses the changes that the notable advances in the life sciences in the 1980s have brought to the strategies of drug companies, the organization of their internal research, their relationships with scientific institutions, the division of labor between large pharmaceutical firms and small research-intensive suppliers, the productivity of drug discovery, and the productivity of R&D.
Author: Hans Löfgren
Publisher:
ISBN: 9788187358664
Category : Drug accessibility
Languages : en
Pages : 349
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Book Description
Some papers presented at a conference held at Hyderabad in September 2010.
Author: Elize Massard da Fonseca
Publisher: Springer
ISBN: 3319125656
Category : Political Science
Languages : en
Pages : 126
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Book Description
Brazil is renowned worldwide for its remarkable reforms in pharmaceutical regulation, which have enhanced access to essential medicines while lowering drug costs. This book innovates by analysing the generic drug reform in Brazil, demonstrating that pharmaceutical regulation is only partially influenced by non-state actors. Little is known about the institutional antecedents and policy process that channeled this regulatory reform. This is particularly intriguing because a regulatory shift in the pharmaceutical sector requires the participation of a number of stakeholders and interest groups in the policy process. Fonseca examines the generic drug reform’s causes and consequences. No study has approached the generic drug regulation in Brazil from this perspective. The Politics of Pharmaceutical Policy Reform: A Study of Generic Drug Regulation in Brazil, explores the following: · The politics of pharmaceutical regulation in Brazil over the last 25 years. · The political negotiations to approve the Generic Drug Act, which involved a hard-to-reach agreement between the pharmaceutical industry (national and multinational), the Ministry of Health, and Congress · The controversial decisions to regulate packaging and pharmaceutical equivalence. · The surprising success of Brazilian pharmaceutical firms, which became market champions in a sector largely dominated by multinational firms. · Comparative lessons from the Brazilian case for the political construction of regulatory standards to regulate generic drugs and its effects on global health. This book will interest political scientists and health policy scholars concerned with the political conflicts in the pharmaceutical sector. It argues against well-established approaches to regulatory capture such as control of the regulatory process by interest groups and policy diffusion. It can be used as evidence for graduate courses in public policy, health policy and political science. Because Brazil is one of the largest markets for pharmaceuticals in the world, business leaders and consultancy firms would also be interested.
Author: Simon J. Williams
Publisher: John Wiley & Sons
ISBN: 1405190841
Category : Social Science
Languages : en
Pages : 169
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Book Description
Drawing on the latest international sociological research, this monograph takes a critical look at contemporary developments, discourses, and debate on pharmaceuticals and society. Key issues covered include pharmaceuticals and medicalization and the science and politics of drug development, testing, and regulation Investigates the constructions of pharmaceuticals in professional and popular culture and the meaning and use of medications in everyday life Investigates pharmaceuticals, consumerism, and citizenship and the impact of innovation and expectations regarding pharmaceutical futures Written in a lively, accessible style, with many engaging and important insights from key international figures in the field
Author: Boris Hauray
Publisher: Routledge
ISBN: 100043236X
Category : Social Science
Languages : en
Pages : 270
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Book Description
In the context of a growing criticism on the influence of the pharmaceutical industry on physicians, scientists, or politicians, Conflict of Interest and Medicine offers a comprehensive analysis of the conflict of interest in medicine anchored in the social sciences, with perspectives from sociology, history, political science, and law. Based on in-depth empirical investigations conducted within different territories (France, the European Union, and the United States) the contributions analyze the development of conflict of interest as a social issue and how it impacts the production of medical knowledge and expertise, physicians’ work and their prescriptions, and also the framing of health crises and controversies. In doing so, they bring a new understanding of the transformations in the political economy of pharmaceutical knowledge, the politicization of public health risks, and the promotion of transparency in science and public life. Complementing the more normative and quantitative understandings of conflict of interest issues that dominate today, this book will be of interest to researchers in a broad range of areas including social studies of sciences and technology, sociology of health and illness, and political sociology and ethics. It will be also a valuable resource for health professionals, medical scientists, or regulators facing the question of corporate influence.
Author: Katherine Fierlbeck
Publisher: University of Toronto Press
ISBN: 1487529066
Category : Medical
Languages : en
Pages : 303
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Book Description
There is plenty of controversy surrounding pharmaceuticals, but it cannot be denied that the pharmaceutical industry is both socially beneficial and profitable. Regulators are expected to ensure that the economic success of the industry does not come at the expense of public safety, yet they have also assumed a cooperative role by providing advice on regulation and by targeting unmet medical needs. Concerns over regulatory standards, conflicts of interest, and the manipulation of information on drug safety and effectiveness have led to public mistrust and a greater need for transparency between the pharmaceutical industry and government regulators. Transparency, Power, and Influence in the Pharmaceutical Industry evaluates the progress made in holding the pharmaceutical industry responsible for creating transparency in the industry, from development to market. The contributors to this volume examine the various mechanisms introduced to make the regulatory process more informative and situate these efforts within the larger project of enhancing the safety of drugs, vaccines, and other products.
Author: C. Davis
Publisher: Springer
ISBN: 1137349476
Category : Medical
Languages : en
Pages : 442
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Book Description
This is the first book to examine how effectively American and supranational EU governments have regulated innovative pharmaceuticals during the last 30 years regarding public health. It explains why pharmaceutical regulation has been misdirected by commercial interests and misconceived ideologies.
