Since the 1950s, the American pharmaceutical industry has been heavily criticized for its profit levels, the high cost of prescription drugs, drug safety problems, and more, yet it has, together with the medical profession, staunchly and successfully opposed regulation. "Pills, Power, and Policy" offers a lucid history of how the American drug industry and key sectors of the medical profession came to be allies against pharmaceutical reform. It details the political strategies they have used to influence public opinion, shape legislative reform, and define the regulatory environment of prescription drugs. Untangling the complex relationships between drug companies, physicians, and academic researchers, the book provides essential historical context for understanding how corporate interests came to dominate American health care policy after World War II.

The art of solving a structure from powder diffraction data has developed rapidly over the last ten years to the point where numerous crystal structures, both organic and inorganic, have been solved directly from powder data. However, it is still an art and, in contrast to its single crystal equivalent, is far from routine. The art lies not only in the correct application of a specific experimental technique or computer program, but also in the selection of the optimal path for the problem at hand. Written and edited by experts active in the field, and covering both the fundamental and applied aspects of structure solution from powder diffraction data, this book guides both novices and experienced practitioners alike through the maze of possibilities.

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

Everyone expects something from the drug industry. Physicians and patients, investors, regulators and administrators all have an active interest. Everyone wants to know what makes drugs 'work' medically and economically. Why are drugs so expensive? Is it the drug companies or investors who demand high profits? What governs the pharmacoeconomics? Why are so few diseases treatable?
This book opens the windows and doors of the industry telling the story of drug development by using real stories from inside the process.
* Co-written by Graham Lees and Tamas Bartfai who has been involved in the development of drugs taken by more that 20 million people every day
* Opens the windows and doors of the most regulated industry in the world, the pharmaceutical industry
* Tells the story of drug development by using real examples based on current research and events
* Provides an objective, lucid account of the successes and failures, shortcomings and constraints of the pharmaceutical and biotech industries
* Gives insights into the development of new drugs to combat multiple conditions including cancer and pain
* Balanced, unbiased account of how better to translate basic science into drug discovery

Today, most people use prescription medications. Every year, the multi-billion dollar pharmaceutical industry produces new medicines that treat everything from arthritis to AIDS, from high cholesterol to depression. But, despite recent controversies regarding the safety of drugs, consumers know little about the medications that they ingest and inject. How are these new medicines invented? How do consumers know that drugs are safe and effective? How are they tested? Who regulates their production - and who watches the regulators? How do drug companies produce the vast quantities needed for the marketplace, and why do they market their drugs as they do? The New Medicines leads the reader through the maze of the modern drug industry - from bench to bedside - and provides consumers with a step-by-step understanding of how new medicines are created, approved, marketed, and sold. In addition to explaining how drugs reach the medicine cabinet, the author - an experienced researcher and teacher - provides the scientific and business background for understanding the current controversial issues surrounding new medicines, such as:

• The rise and fall of the COX-2 inhibitors, Vioxx and Celebrex, and the process by which they were invented, approved, and re-evaluated.
• The saga of the cancer drug Erbitux and its creator, the company Imclone, made famous as the centerpiece of the Martha Stewart insider-trading scandal
• The strengths and weaknesses of the approval process of the Food and Drug Administration
• The controversial new marketing techniques of the pharmaceutical industry

An in-depth look at big pharma's flagship company
The Merck Druggernaut takes readers inside Merck, the world's second most profitable drug company and maker of the world's bestselling drug, Prilosec. Consistently named one of Fortune magazine's Most Admired Companies, Merck struggles to maintain its reputation for being the most ethical of the big drug makers, refusing to slash research and development budgets in the face of declining profits, falling stock market prices, and questionable accounting. Author Fran Hawthorne, one of the leading journalists covering healthcare, has written an excellent examination of a business paragon with much-needed insight on the cutthroat world of pharmaceuticals. It's a story that will interest the business world as well as consumer and healthcare advocates by detailing the vital issues in medicine and healthcare today. More than just a compelling story of success in a difficult industry, more than simply the biography of one of big business's most recognizable names, The Merck Druggernaut takes a thoughtful look at some of the major issues of our time and the way those issues intertwine with the world of business.

Fran Hawthorne (New York, NY) is the Assistant Managing Editor at Crain's New York Business. She has been covering business for more than twenty years for such publications as Fortune, BusinessWeek, and Institutional Investor, with a prevailing interest in healthcare and pharmaceuticals. At Crain's, she spearheads the publication of two to three special healthcare issues per year.

This book provides a complete approach to the economics of financing medicines and policy implications for the efficiency and equity of health systems. In all health systems with majority public financing, pharmaceutical reimbursement is one of the key factors in policies of change and transformation of health services in order to face the future with guarantees of financial sustainability.The initial chapters seek to answer questions about the efficiency with which the public sector intervenes in the pharmaceutical industry: Is the present system of drug patents efficient and fair? What would be the best way to control drug prices? Is it possible to encourage competition in this market for the patient's benefit? The remainder of the book provides evidence on the impact of instruments and policies aimed at rationalising and controlling pharmaceutical expenditure: What can we expect from the application of reference pricing systems? When, how and where should the user be made to share the cost of medicines? What economic and non-economic incentives should be applied to drug prescription? Jaume Puig-Junoy has performed an invaluable task in creating a cohesive, and analytically rigorous book of specially commissioned chapters on this pertinent topic. The Public Financing of Pharmaceuticals will appeal to academics and researchers involved in public finance, health policy, health economics, industrial organisation and the pharmaceutical markets in Europe and in the US, where there is increasing public interest in drug coverage. The book is also intended for a wide variety of professionals in the health industries and policymakers.

Drugs play a crucial role in saving lives, restoring health, and preventing diseases and epidemics. But they need to be safe, efficacious, of good quality, and used rationally. This means that their production, import/export, storage, supply and distribution should be subject to government control through prescribed norms and standards and an effective regulatory system. Substandard and counterfeit drugs proliferate primarily in an environment where drug regulation has proved ineffective. This publication presents a synthesis of studies on drug regulation carried out in 10 countries: Australia, Cuba, Cyprus, Estonia, Malaysia, the Netherlands, Tunisia, Uganda, Venezuela, and Zimbabwe in 1998-1999. It gives an overview of the development of drug regulation in these countries as well as the resources available and the strategies applied in drug regulation implementation at the time the studies were conducted. An analysis of the strengths and weaknesses in drug regulation in these countries is also provided.

The first book to details the history and social implications of the little blue pill Since its introduction in 1998, Viagra has launched a new kind of sexual revolution. Quickly becoming one of the most sought after drugs in history, the little blue pill created a sea change within the pharmaceutical industry-from how drugs could be marketed to the types of drugs put into development-as well as the culture at large. Impotency is no longer an embarrassing male secret; now it is called "erectile dysfunction," and is simply something to "ask your doctor" about. And over 16 million men have. The Rise of Viagra is the first book to detail the history and the vast social implications of the Viagra phenomenon. Meika Loe argues that Viagra has changed what qualifies as normal sex in America. In the quick-fix, pill-for-everything culture that Viagra helped to create, erections can now be had by popping a pill, making sex on demand, regardless of age or infirmity, and, potentially, for the rest of one's life. Drawing on interviews with men who take the drug, their wives, doctors and pharmacists as well as scientists and researchers in the field, this fascinating account provides an intimate history of the drug's effect on America. Loe also examines the quest for the female Viagra, the impact of the drug around the world, the introduction of new erection drugs, like Levitra and Cialis, and the rapid growth of the multi-billion dollar pharmaceutical industry. This wide-ranging book explains how this medical breakthrough and cultural phenomenon have forever changed the meaning of sex in America.

Harrison analyzes how the U.S. research pharmaceutical industry, faced with domestic political opposition to the prices it charged for prescription drugs, chose to pursue its policy goal of greater appropriability of its intellectual property through the institutions of foreign economic policymaking. As Harrison explains, a new body of literature has developed to analyze the emergence of intellectual property as a major international trade issue. For many researchers, the inclusion of trade related intellectual property (TRIPS) into the Uruguay round of the General Agreement on Tariffs and trade (GATT) negotiations marks an important demonstration of the political influence of U.S. knowledge-intensive industries. However, as he demonstrates, a more thorough specification of the domestic political environment reveals that the research pharmaceutical industry was incapable of achieving its domestic policy objectives at the same time that it is credited with immense international political power. By providing a theory of institutional choice, Harrison reconciles this incongruity. He explains the strategic choices of the research pharmaceutical industry as a function of the transaction costs associated with pursuing its policy objectives within a variety of institutional alternatives. He concludes that he internationalization of intellectual property rights was a result of the changing domestic political environment in which the research pharmaceutical industry found itself the loser in a series of domestic economic policy battles. A thoughtful analysis of particular important to scholars, researchers, and policy makers involved with international trade, intellectual property, the pharmaceutical industry, and public policy.

This book is intended for scientists, engineers, physicians, business people, and service providers at all levels who are interested in and support the process of life science commercialization. - The authors provide a hands-on template for success based on their years of experience practicing and teaching bioentrepreneurship and consulting to clients, students, economic development agencies, and faculty around the world.

Eyecare Business: Marketing and Strategy will help you gain a competitive edge in the changing world of eyecare. Covers the basics of marketing, finance, strategy development, management, communication, and technology. Self-assessment exams serve as educational tools. Short teaching cases, clinical examples, and exercises help you adapt theory and concepts to your own practice. Action plans at the end of each chapter help jump-start the development of your own eyecare marketing program.

Who wins the race to turn molecules into medicines? How much does it cost? What factors influence the choice of synthetic routes and reaction mechanisms? How can pharmaceutical companies protect their discoveries? In From Bench to Market, Walter Cabri and Romano Di Fabio chart the process of industrial chemical synthesis, from the first discovery of a molecule to its entry in the marketplace as a drug. Using real case histories of drug development from several therapeutic areas, they discuss all aspects related to the process research for bulk production, including comparison between different synthetic routes, key methodologies and reaction mechanisms, costs, patent competition, and crystalline forms.

This book is intended to help newly graduated chemists, particularly organic chemists, at all levels from bachelors to post-doctorates, find careers in the North American pharmaceutical industry. It will serve as a practical, detailed guiedbook for job seekers as well a reference work for faculty advisers, research supervisors, development officers, employment agents, and personnel managers in the industry. The book gathers in a single volume the fundamentals of getting an industrial job as a medicinal or process chemist, and covers all aspects of a chemist's job--scientific, financial, and managerial--within a pharmaceutical/biotechnology company. Other scientists looking for jobs as analytical or physical chemists and even biochemists and biologists will find the book useful. The valuable appendix is a unique compendium of 365 commercial, governmental, or non-profit institutions that comprise the North American pharmaceutical industry.
Key Features
* Learn How To:
* Discover the 12 permanent, big-pharma jobs for B.S. chemists
* Use the 500+ company index to locate potential employers
* Track pharma openings with 190+ corporate and chemist-specific job banks
* Add industry veterans to your employment network
* Find the 50+ companies offering paid summer internships to students
* Include the one resume item that wins interviews for B.S. and M.S. chemists
* Express a knowledgeable preference for drug discovery or development
* Research over 360 drug companies through their Web sites
* Discover the 70+ firms offering stock purchase plans or stock options3/4and which two represent big pharma
* Find out your salary offer in time to negotiate your wages

This study examines the effect of existing regulations on US pharmaceutical firms. The author explores the indirect spillovers from the regulatory use of international price comparisons and the threat from parallel trade, concluding that competition promises more efficiency and incentives.

* What are the principal features of the system responsible for the production, regulation, distribution and funding of therapeutic drugs? * What are the major problem areas and issues of policy concern that have arisen in the pharmaceutical sector and how have the participants - particularly the State - responded to such controversies? Medicines, and the policy issues they raise, are the subject of this book. Therapeutic drugs are widely used - some on a routine basis, others in a highly selective and specialized fashion. Although we take the availability of such potent agents for granted, there stands behind them a complex and sophisticated system of scientific innovation, industrial production, State audit, and professional distribution. Major issues of price, innovation, safety, professional practice and consumer autonomy arise. Pharmaceuticals account for about ten per cent of health care costs, they are produced by a flagship industrial sector, they are jealously guarded by key professional groups, they raise formidable questions of quality and safety, and they are watched over by a vigilant and vociferous consumer movement. Managing Medicines seeks to disentangle these issues and come up with concrete suggestions as to how we might move forward in an area of public policy that is hotly disputed. It will be of interest to health professionals and policy makers as well as students of public health, nursing studies, social policy and social work.

Drug coverage for seniors is better addressed by private-sector plans than by forcing manufacturers to offer Federal Supply Schedule discounts to the retail sector.

"Vital reading for anyone who wants to understand the public's decades-long love affair with vitamin supplements. Rima Apple deftly explores the science, politics, history, marketing, and mystique that have kept vitamins a hot-button issue for the American public."--Bonnie Liebman, Director of Nutrition, Center for Science in the Public Interest "Have you taken your vitamins today?" That question echoes daily through American households. Thanks to intensive research in nutrition and medicine, the importance of vitamins to health is undisputed. But millions of Americans believe that the vitamins they get in their food are not enough. Vitamin supplements have become a multibillion-dollar industry. At the same time, many scientists, consumer advocacy groups, and the federal Food and Drug Administration doubt that most people need to take vitamin pills. Vitamania tells how and why vitamins have become so important to so many Americans. Rima Apple examines the claims and counterclaims of scientists, manufacturers, retailers, politicians, and consumers from the discovery of vitamins in the early twentieth century to the present. She reveals the complicated interests--scientific, professional, financial--that have propelled the vitamin industry and its would-be regulators. From early advertisements linking motherhood and vitamin D, to Linus Pauling's claims for vitamin C, to recent congressional debates about restricting vitamin products, Apple's insightful history shows the ambivalence of Americans toward the authority of science. She also documents how consumers have insisted on their right to make their own decisions about their health and their vitamins. Vitamania makes fascinating reading for anyone who takes--or refuses to take--vitamins. It will be of special interest to students, scholars, and professionals in public health, the biomedical sciences, history of medicine and science, twentieth-century history, nutrition, marketing, and consumer studies. Rima D. Apple teaches at the University of Wisconsin, Madison, where she holds a joint appointment in the Department of Consumer Science and the Women's Studies Program. She is the author of Mothers and Medicine: A Social History of Infant Feeding, 1890-1950 and editor of Women, Health, and Medicine in America: A Historical Handbook.

To retain their usefulness, cultures that manufacture economically valuable products must be uncontaminated, viable, and genetically stable. Maintaining Cultures for Biotechnology and Industry gives practical advice necessary to preserve and maintain cells and microorganisms important to the biotechnology and pharmaceutical industries in ways that ensure they will continue to be able to synthesize those valuable metabolites. This book covers not just those strains currently being used but also those yet to be discovered and engineered.
This text is essential for anyone working with cultures who wants to avoid the frustration of losing strains and needs to be able to devise and evaluate new strategies for preservation.
Key Features
* Written by hands-on experts in their respective fields
* Contains helpful tables and protocols for preserving or maintaining cells, cultures and viruses
* Discusses means to preserve cells by freezing, lyophilization, drying, cyoprotection, spore storage, continuous propagation and subculturing when absolutely necessary, and others
* Gives information needed to test cultures for stable retention of important characteristics
* Gives principles needed to devise and evaluate preservation strategies for newly identified and newly engineered cells and organisms
* Lists culture sources for each class of organism
* Includes information for characterizing and monitoring recombinant organisms, especially important because of their propensity for genetic stability
* Discusses the history of the continually evolving field of culture preservation
* Examines the importance of genetically stable cultures as it relates to maintaining patent positions

This international directory of pharmaceutical manufacturers includes 1,046 firms in 50 countries. They are arranged alphabetically by country and company name.

In addition to name and address, other information such as telephone and fax number, and key personnel are also listed, where available.

Completing the directory, is a listing of 124 Contract Manufacturers in 19 countries of ethical and/or non-prescription pharmaceuticals. These are arranged alphabetically by country and company name.

How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control. With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing.

"The challenge in all settings is to make the difficult decisions in a way that is defensible, justifiable, ethical, and equitable"

So write Nick Freemantle and Suzanne Hill in their introduction to this important discussion on decision making in the reimbursement of pharmaceuticals. Based around a programme supported by the World Health Organization, chapters by leading academics involved in the research tackle such major issues as international pharmaceutical policy, tensions in licensing policies, priority setting, and relationships between the stakeholders.

Chapters include
Development of marketing authorisation procedures for pharmaceuticals
Interpreting clinical evidence
International pharmaceutical policy: health creation or wealth creation?
Development of fourth hurdle policies around the world
Economic modelling in drug reimbursement
Priority setting in health care: matching decision criteria with policy objectives
Tensions in licensing and reimbursement decisions: case of riluzole for amytrophic lateral sclerosis
Relationship between stakeholders: managing the war of words
Medicine and the media: good information or misleading hype?
How to promote quality use of cost-effective medicines
Using economic evaluation to inform health policy and reimbursement: making it happen and making it sustainable
Pricing of pharmaceuticals
Evaluating pharmaceuticals for health policy in low and middle income country settings.

Besides the controversial issues there is a wealth of practical information including economic modelling and the experiences from the WHO programme, providing readers with workableexamples. This is essential reading for clinical researchers in pharmaceuticals and policy makers everywhere.

Nanotechnology in Ophthalmology is a comprehensive and up-to-date reference on the role and applications of nanotechnology in ophthalmology, from drug delivery and treatment of ocular diseases to toxicity issues. Written by experts from the nanotechnology, ophthalmology, and pharmacology fields, this book has a unique, broad and diverse scope, including chapters on nanosensor-based diagnostic tools, delivery of nanobiomaterials, implantable materials and devices, delivery of nanobiomaterials, nanotechnology for medical and surgical treatment, regenerative medicine, and more. This book provides a valuable reference to researchers working in the areas of ophthalmology, nanoscience and pharmacology, and clinical fellows who are interested in nanoophthalmology as a reference for their practice and research.

Everyone knows that antidepressant drugs are miracles of modern medicine. Professor Irving Kirsch knew this as well as anyone. But, as he discovered during his research, there is a problem with what everyone knows about antidepressant drugs. It isn't true. How did antidepressant drugs gain their reputation as a magic bullet for depression? And why has it taken so long for the story to become public? Answering these questions takes us to the point where the lines between clinical research and marketing disappear altogether. Using the Freedom of Information Act, Kirsch accessed clinical trials that were withheld, by drug companies, from the public and from the doctors who prescribe antidepressants. What he found, and what he documents here, promises to bring revolutionary change to the way our society perceives, and consumes, antidepressants. The Emperor's New Drugs exposes what we have failed to see before: depression is not caused by a chemical imbalance in the brain; antidepressants are significantly more dangerous than other forms of treatment and are only marginally more effective than placebos; and, there are other ways to combat depression, treatments that don't only include the empty promise of the antidepressant prescription. This is not a book about alternative medicine and its outlandish claims. This is a book about fantasy and wishful thinking in the heart of clinical medicine, about the seductions of myth, and the final stubbornness of facts.

Since the 1950s, the American pharmaceutical industry has been heavily criticized for its profit levels, the high cost of prescription drugs, drug safety problems, and more, yet it has, together with the medical profession, staunchly and successfully opposed regulation. "Pills, Power, and Policy" offers a lucid history of how the American drug industry and key sectors of the medical profession came to be allies against pharmaceutical reform. It details the political strategies they have used to influence public opinion, shape legislative reform, and define the regulatory environment of prescription drugs. Untangling the complex relationships between drug companies, physicians, and academic researchers, the book provides essential historical context for understanding how corporate interests came to dominate American health care policy after World War II.