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Despite the pharmaceutical industry's notable contributions to human progress, including the development of miracle drugs for treating cancer, AIDS, and heart disease, there is a growing tension between the industry and the public. Government officials and social critics have questioned whether the multibillion-dollar industry is fulfilling its social responsibilities. This doubt has been fueled by the national debate over drug pricing and affordable healthcare, and internationally by the battles against epidemic diseases, such as AIDS, in the developing world. Debates are raging over how the industry can and should be expected to act. The contributions in this book by leading figures in industry, government, NGOs, the medical community, and academia discuss and propose solutions to the ethical dilemmas of drug industry behavior. They examine such aspects as the role of intellectual property rights and patent protection, the moral and economic requisites of research and clinical trials, drug pricing, and marketing.
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
For decades, medical professionals have betrayed the public's trust by accepting various benefits from the pharmaceutical industry. Both drug company representatives and doctors employ artful spin to portray this behavior positively to the public, and to themselves. In Hooked, Howard Brody argues that we can neither understand the problem, nor propose helpful solutions until we identify the many levels of activity connecting these purportedly noble industries. We can pass laws and enact regulations, but ultimately the medical profession must take responsibility for its own integrity. Hooked is a wake-up call for anyone expecting high quality, ethical medical care.
In some parts of the world spending on pharmaceuticals is astronomical. In others people do not have access to basic or life-saving drugs. Individuals struggle to afford medications; whole populations are neglected, considered too poor to constitute profitable markets for the development and distribution of necessary drugs. The ethnographies brought together in this timely collection analyze both the dynamics of the burgeoning international pharmaceutical trade and the global inequalities that emerge from and are reinforced by market-driven medicine. They demonstrate that questions about who will be treated and who will not filter through every phase of pharmaceutical production, from preclinical research to human testing, marketing, distribution, prescription, and consumption. Whether considering how American drug companies seek to create a market for antidepressants in Japan, how Brazil has created a model HIV/AIDS prevention and treatment program, or how the urban poor in Delhi understand and access healthcare, these essays illuminate the roles of corporations, governments, NGOs, and individuals in relation to global pharmaceuticals. Some essays show how individual and communal identities are affected by the marketing and availability of medications. Among these are an exploration of how the pharmaceutical industry shapes popular and expert understandings of mental illness in North America and Great Britain. There is also an examination of the agonizing choices facing Ugandan families trying to finance AIDS treatment. Several essays explore the inner workings of the emerging international pharmaceutical regime. One looks at the expanding quest for clinical research subjects; another at the entwining of science and business interests in the Argentine market for psychotropic medications. By bringing the moral calculations involved in the production and distribution of pharmaceuticals into stark relief, this collection charts urgent new territory for social scientific research. Contributors. Kalman Applbaum, João Biehl, Ranendra K. Das, Veena Das, David Healy, Arthur Kleinman, Betty Kyaddondo, Andrew Lakoff, Anne Lovell, Lotte Meinert, Adriana Petryna, Michael A. Whyte, Susan Reynolds Whyte
Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc.
Pharmaceutical Ethics is an important text, which aims to provide the ethical guidelines much needed by the pharmaceutical industry. By focusing on many of the central issues such as the ethical aspects of clinical trials, informed consent, physician or patient choice and pharmaceutical advertising, this text will provide very good coverage of an area which perhaps still lacks coherent instruction. * Covers ethical issues involved in the testing and use of pharmaceuticals on human beings * Investigates issues such as whether choice of drug should lie with the physician or the patient * Looks at a wide variety of subjects connected with pharmaceutical ethics. * Focuses specifically on the issues surrounding the pharmaceutical industry, not medicine in general. * Fulfils an important need in the Pharmaceutical Industry.
The pharmaceutical industry has come under intense criticism in recent years. One poll found that 70% of the sample agreed that drug companies put profits ahead of people. Is this perception accurate? Have drug companies traded ethics for profits and placed people at risk? In Profits before People? Leonard J. Weber exposes pharmaceutical industry practices that have raised ethical concerns. Providing systematic ethical analysis and reflection, he discusses such practices as compensating physicians for serving as speakers or consultants, providing incentives to physicians to enroll patients as subjects in clinical research, and advertising prescription drugs to the public through the mass media. Weber's critique of the industry is stern. While acknowledging that new industry guidelines are promising, he finds much room for improvement in the way drug companies market their products. Yet Weber makes a strong case that profits and ethics can coexist and that they are not mutually exclusive. In an effort to understand the proper place of commerce in disseminating information about new drugs, the book aims to clarify basic responsibilities and to help identify sound ethical practices. It recognizes that ethics and law are not the same, that "having a right" is different from "doing the right thing," and that taking ethics seriously means recognizing that the law does not answer all questions about what is right. Weber points the way to more demanding standards and better practices that might begin to restore confidence in the drug industry.
During most of the nineteenth century, physicians and pharmacists alike considered medical patenting and the use of trademarks by drug manufacturers unethical forms of monopoly; physicians who prescribed patented drugs could be, and were, ostracized from the medical community. In the decades following the Civil War, however, complex changes in patent and trademark law intersected with the changing sensibilities of both physicians and pharmacists to make intellectual property rights in drug manufacturing scientifically and ethically legitimate. By World War I, patented and trademarked drugs had become essential to the practice of good medicine, aiding in the rise of the American pharmaceutical industry and forever altering the course of medicine. Drawing on a wealth of previously unused archival material, Medical Monopoly combines legal, medical, and business history to offer a sweeping new interpretation of the origins of the complex and often troubling relationship between the pharmaceutical industry and medical practice today. Joseph M. Gabriel provides the first detailed history of patent and trademark law as it relates to the nineteenth-century pharmaceutical industry as well as a unique interpretation of medical ethics, therapeutic reform, and the efforts to regulate the market in pharmaceuticals before World War I. His book will be of interest not only to historians of medicine and science and intellectual property scholars but also to anyone following contemporary debates about the pharmaceutical industry, the patenting of scientific discoveries, and the role of advertising in the marketplace.