An analysis of how we regulate the pharmaceutical industry: are we protecting patients or blocking the development of useful new drugs? This book is the first to offer a comprehensive examination of the pharmaceutical industry by following the tortuous course of a new drug as it progresses from early development to final delivery. Richard A. Epstein looks closely at the regulatory framework that surrounds all aspects of making pharmaceutical products today, and he assesses which current legal and regulatory practices make sense and which have gone awry. While critics of pharmaceutical companies call for ever more stringent controls on virtually every aspect of drug development and approval, Epstein cautions that the effect of such an approach will be to stifle pharmaceutical innovation and slow the delivery of beneficial treatments to the patients who need them. The author considers an array of challenges that confront the industry--conflicts of interest among government, academe, and the drug companies; intellectual property rights that govern patents; FDA regulation; pricing disputes; marketing practices; and liability issues, including those brought to light in the recent VIOXX case. Epstein argues that to ensure the continuing creativity, efficiency, and success of the pharmaceutical industry, the best system will feature strong property rights and clearly enforceable contracts, with minimal regulatory and judicial interference.

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 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, Joao 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

First made in the late 19th century, paracetamol is now widely used in a variety of pharmaceutical products. It is used as a painkiller and to reduce the temperature of patients with a fever. Aimed at post-16 students, this book provides a series of classroom activities, both written and practical, relating to paracetamol. The activities can be carried out singly, or as a coherent package, and are supported by a guide for teachers and technicians.

This book tells the story of two generations of Pietist ministers sent from Halle, in Brandenburg Prussia during the eighteenth century, to the German communities of North America. In conjunction with their clerical office, these ministers provided medical services using pharmaceuticals and medical texts brought with them from Europe. Their practice is an example of how different medical markets and medical cultures evolved in North America.

At the heart of the story is the Francke Orphanage, a famous religious and philanthropic foundation started in Halle in 1696. Pharmaceuticals from Halle were manufactured and sold throughout Europe as part of a commercial enterprise designed to support Francke's charitable goals. Halle's reputation for consistent product quality and safety soon spread to North America, where men and women became actively engaged in providing medical care to Lutheran and Reformed congregations along the east coast, mainly the backcountry of Pennsylvania, New Jersey, Maryland, and Virginia. The story continues to about 1810, when Halle's North American clergy had become independent from the motherhouse and American medical practice and education began to follow its own course.

Wilson draws upon a large array of correspondence, trading ledgers, and daybooks in European and American archives. Through these records she enables us to see firsthand the experience of men and women as both patients and practitioners. The result is a rare glimpse into the world of German medicine and the pharmaceutical trade in eighteenth-century North America.

Drug Design and Discovery in Alzheimer's Disease includes expert reviews of recent developments in Alzheimer's disease (AD) and neurodegenerative disease research. Originally published by Bentham as Frontiers in Drug Design and Discovery, Volume 6and now distributed by Elsevier, this compilation of the sixteen articles, written by leading global researchers, focuses on key developments in the understanding of the disease at molecular levels, identification and validation of molecular targets, as well as innovative approaches towards drug discovery, development, and delivery. Beginning with an overview of AD pharmacotherapy and existing blockbuster drugs, the reviews cover the potential of both natural and synthetic small molecules; the role of cholinesterases in the on-set and progression of AD and their inhibition; the role of beta-site APP clearing enzyme-1 (BACE-1) in the production of ss-amyloid proteins, one of the key reasons of the progression of AD; and other targets identified for AD drug discovery.

The biopharmaceutical industry as we know it today is going through a massive upheaval as a result of the uncertainty of healthcare reform and increasing regulatory pricing pressure. A wake-up call to all sectors of the healthcare value chain, Patient-Focused Network Integration in BioPharma: Strategic Imperatives for the Years Ahead explores patient-focused network integration as quite possibly the only way for organizational evolution to occur. The book discusses how to align enterprises with the patient at the center. It details the historical context of the biopharmaceutical value chain and the current set of challenges facing the industry, and then details the author's unique and sustainable agenda for change. The book traces the critical but often ignored relationships between hospitals, insurance companies, biopharma manufacturers, government regulators, and clinical scientists. For too long, these parties have been operating in a void, without recognizing the interconnectedness of their objectives, even though these objectives are often competing and misaligned. This book points out the gaps that exist and develops a set of recommendations regarding disease treatments, clinical development of new products, and collaboration between these players that can result in a sustainable solution to the healthcare mess. Each chapter can be viewed as an independent essay, in that it deals with a specific dimension of the healthcare value chain. However, together they provide an integrated discussion on how to begin the task of creating an integrated value chain network for healthcare. The book begins with the patient, and then works its way back down the value chain, all the way to the drug development and clinical trials stage of the value chain. The common thread throughout the chapters is the emphasis on collaboration, strategic alignment, and a focus on delivering value to the end patient. Very simply, all parties in the healthcare value chain network must align their strategic planning to derive innovation solutions. It is only through true collaboration and aligned thinking that the parties in the drug development, distribution, insurance payors, and hospital provider network can deal with the incredible complexity and massive challenges that face the industry. The book provides a compelling maturity model that enables readers to gauge the level of network integration their enterprise is at today, and where they need to move in the future.

This book is published in association with the Office of Health Economics. This book is a vital, non-technical guide illuminating recent developments within the five major European pharmaceutical markets. It clearly explains pharmaceutical regulatory policies on pricing and reimbursement, and their effects. Each chapter gives an overview of the current market, including aims, effectiveness, local markets, frameworks and politics, and then offers predictions for the next decade. Pharmaceutical executives with interests in marketing, market access and pricing will find this guide invaluable, as will health economists, government advisors and public affairs consultants. Public policy makers in areas such as the Department of Health and The Treasury and senior health service managers in hospitals will find it enlightening. It is also highly relevant to policy shapers in academia and the media, and undergraduate and postgraduate students of health economics, health policy, pharmaceutical economics and healthcare management. "This book aims not only to understand and discuss the mix of regulatory measures introduced by national policy makers in order to achieve their goals, but also to ascertain how these policies have actually shaped and influenced the characteristics and functioning of national pharmaceutical markets. In particular, each author has provided an analysis of existing pricing and reimbursement arrangements operating in their own country and an outline of policy scenarios that might emerge in the next decade." - Martina Garau and Jorge Mestre-Ferrandiz, in the Introduction.

Health activist, scholar, award-winning journalist, and cancer survivor Sharon Batt investigates the relationship between patient advocacy groups and the pharmaceutical industry as well as the contentious role of pharma funding. Over the past several decades, a gradual reduction in state funding has pressured patient groups into forming private-sector partnerships. This analysis of Canada's breast cancer movement from 1990 to 2010 shows that the resulting power imbalance undermined the groups' ability to put patients' interests ahead of those of the funders. A movement that once encouraged democratic participation in the development of health policy now eerily echoes the demands of the pharmaceutical industry.