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.

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.

"Tobbell analyzes the political and economic history of the alignment of the pharmaceutical industry, academic institutions and their faculty and organized medicine. This book is essential reading for policymakers and their staff as well as persons who study the history of health policy and those who contribute to it through medical research, advocacy and journalism. " -Daniel Fox, author of The Convergence of Science and Governance: Research, Health Policy, and American States "Dominique Tobbell’s vivid, balanced and probing account of pharmaceutical politics is a significant, needed analysis of the relationships between the pharmaceutical industry, university researchers, the medical profession and government in the Cold War period. More than this, Pills, Power, and Policy shows why it continues to be difficult to agree in the United States on the relative roles of corporate enterprise, government regulation, technological innovation, freedom to prescribe, and consumer marketing and protection, all played out against the rising costs of health care. Timely and thought-provoking."--Rosemary A. Stevens. DeWitt Wallace Distinguished Scholar, Department of Psychiatry, Weill Cornell Medical College "A superb and compelling account of the creation of one of America’s most reviled entities: Big Pharma. With clarity and subtlety, Pills, Power, and Policy weaves together the political, economic, and the medical to reveal the entangled history behind our modern pharmaceutical predicament."--Andrea Tone, Ph.D., Professor of History & Canada Research Chair in the Social History of Medicine, McGill University “Pills, Power and Policy provides an outstanding description and analysis of the evolution of drug policy. It is an extremely important contribution to our understanding of the political, scientific, and economic nature of pharmaceutical regulation." -Daniel S. Greenberg, Washington journalist and author of Science, Money and Politics: Political Triumph and Ethical Erosion

Challenges our understanding of health, risks, facts, and clinical trials [Payot]

Continuing his pioneering theoretical explorations into the relationships among biosciences, the market, and political economy, Kaushik Sunder Rajan introduces the concept of pharmocracy to explain the structure and operation of the global hegemony of the multinational pharmaceutical industry. He reveals pharmocracy's logic in two case studies from contemporary India: the controversial introduction of an HPV vaccine in 2010, and the Indian Patent Office's denial of a patent for an anticancer drug in 2006 and ensuing legal battles. In each instance health was appropriated by capital and transformed from an embodied state of well-being into an abstract category made subject to capital's interests. These cases demonstrate the precarious situation in which pharmocracy places democracy, as India's accommodation of global pharmaceutical regulatory frameworks pits the interests of its citizens against those of international capital. Sunder Rajan's insights into this dynamic make clear the high stakes of pharmocracy's intersection with health, politics, and democracy.

Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...

A book with historical scope and unsettling revelations, "Prescription for Profit" shows how the lure of huge profits has dramatically changed medical research. Marsa chronicles the extraordinary rise of the American pharmaceutical industry, from the mass production of penicillin during World War II to the heady postwar days when vast government grants helped scientists conquer polio and crack the genetic code. of photos.

During her two decades at The New England Journal of Medicine, Dr. Marcia Angell had a front-row seat on the appalling spectacle of the pharmaceutical industry. She watched drug companies stray from their original mission of discovering and manufacturing useful drugs and instead become vast marketing machines with unprecedented control over their own fortunes. She saw them gain nearly limitless influence over medical research, education, and how doctors do their jobs. She sympathized as the American public, particularly the elderly, struggled and increasingly failed to meet spiraling prescription drug prices. Now, in this bold, hard-hitting new book, Dr. Angell exposes the shocking truth of what the pharmaceutical industry has become–and argues for essential, long-overdue change. Currently Americans spend a staggering $200 billion each year on prescription drugs. As Dr. Angell powerfully demonstrates, claims that high drug prices are necessary to fund research and development are unfounded: The truth is that drug companies funnel the bulk of their resources into the marketing of products of dubious benefit. Meanwhile, as profits soar, the companies brazenly use their wealth and power to push their agenda through Congress, the FDA, and academic medical centers. Zeroing in on hugely successful drugs like AZT (the first drug to treat HIV/AIDS), Taxol (the best-selling cancer drug in history), and the blockbuster allergy drug Claritin, Dr. Angell demonstrates exactly how new products are brought to market. Drug companies, she shows, routinely rely on publicly funded institutions for their basic research; they rig clinical trials to make their products look better than they are; and they use their legions of lawyers to stretch out government-granted exclusive marketing rights for years. They also flood the market with copycat drugs that cost a lot more than the drugs they mimic but are no more effective. The American pharmaceutical industry needs to be saved, mainly from itself, and Dr. Angell proposes a program of vital reforms, which includes restoring impartiality to clinical research and severing the ties between drug companies and medical education. Written with fierce passion and substantiated with in-depth research, The Truth About the Drug Companies is a searing indictment of an industry that has spun out of control.

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.

As one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and criminal - succeeds in guiding (and where neccessary contraining) it. The rules of behavior that may be considered to apply to today's pharmaceutical industry have emerged over a very long period and the process goes on. Even the immensely detailed standards for quality, safety and efficacy laid down in drug law and regulation during the second half of the twentieth century have their limitations as tools for ensuring that the public interest is well served. In particular, national and regional regulatory agencies are heavily dependent on industrial data for their decision-making, their standards and competence vary, and even the existing network of agencies does not cover the entire world. What is more there are many areas of law and regulation affecting the industry, concerning for example the pricing of medicines, the conduct of clinical studies, the health protection of workers and concern for the environment. In some fields it is indeed hardly possible to maintain standards through regulation.Professor N.M. Graham Dukes, a physician and lawyer with long term experience in industrial research management, academic study and international drug policy, provides here a powerfully documented analysis into the way this industry thinks, acts, and is viewed, and examines the current trends pointing to change.*Provides a balanced picture of the current role of the pharmaceutical industry in society*Includes indices of conventions, laws, and regulations; as well as judicial and disciplinary cases*This is the only book addressing the legal implications of big pharma activities and ethical standards