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.

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

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.

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.

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

THE PHARMACEUTICAL INDUSTRY IS BROKEN From the American hedge fund manager who drastically hiked the price of an AIDS pill to the children's cancer drugs left intentionally to expire in a Spanish warehouse, the signs of this dysfunction are all around. A system built to drive innovation and improve patient care has been distorted to maximise profits. In Sick Money, the investigative journalist who exposed a billion-pound British price-hiking scandal goes inside the global battle over high drug prices. From secret deals to patients forced to turn to the black market, Billy Kenber reveals how medicines have become nothing more than financial assets. He offers a diagnosis of an industry in crisis - and a prescription for how it could be fixed.

The pharmaceutical industry is broken. From the American hedge fund manager who hiked the price of an AIDS pill from $17.50 to $750 overnight to the children's cancer drugs left intentionally to expire in a Spanish warehouse, the signs of this dysfunction are all around. A system that was designed to drive innovation and patient care has been relentlessly distorted to drive up profits. Medicines have become nothing more than financial assets. The focus of drug research, how drugs are priced and who has access to them is now dictated by shareholder value, not the good of the public. Drug companies fixated on ever-higher profits are being fined for bribing doctors and striking secret price-gouging deals, while patients desperate for life-saving medicines are driven to the black market in search of drugs that national health services can't afford. Sick Money argues that the way medicines are developed and paid for is no longer working. Unless we take action we risk a dramatic decline in the pace of drug development and a future in which medicines are only available to the highest bidder. In this book investigative journalist Billy Kenber offers a diagnosis of an industry in crisis and a prescription for how we can fight back.

Brand-name pharmaceutical companies can delay generic competition that lowers prices by agreeing to pay a generic competitor to hold its competing product off the market for a certain period of time. These so-called "pay-for-delay" agreements have arisen as part of patent litigation settlement agreements between brand-name and generic pharmaceutical companies. "Pay-for-delay" agreements are "win-win" for the companies: brand name pharmaceutical prices stay high, and the brand and generic share the benefits of the brand's monopoly profits. Consumers lose, however: they miss out on generic prices that can be as much as 90 percent less than brand prices. For example, brand-name medication that costs $300 per month, might be sold as a generic for as little as $30 per month. This book examines the "pay-for-delay' program and how drug company pay-offs cost consumers billions.

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.

In the 1940s chemists discovered that "barbasco," a wild yam indigenous to Mexico, could be used to mass-produce synthetic steroid hormones. Barbasco spurred the development of new drugs, including cortisone and the first viable oral contraceptives, and positioned Mexico as a major player in the global pharmaceutical industry. Yet few people today are aware of Mexico's role in achieving these advances in modern medicine. In "Jungle Laboratories," Gabriela Soto Laveaga reconstructs the story of how rural yam pickers, international pharmaceutical companies, and the Mexican state collaborated and collided over the barbasco. By so doing, she sheds important light on a crucial period in Mexican history and challenges us to reconsider who can produce science.

Soto Laveaga traces the political, economic, and scientific development of the global barbasco industry from its emergence in the 1940s, through its appropriation by a populist Mexican state in 1970, to its obsolescence in the mid-1990s. She focuses primarily on the rural southern region of Tuxtepec, Oaxaca, where the yam grew most freely and where scientists relied on local, indigenous knowledge to cultivate and harvest the plant. Rural Mexicans, at first unaware of the pharmaceutical and financial value of barbasco, later acquired and deployed scientific knowledge to negotiate with pharmaceutical companies, lobby the Mexican government, and ultimately transform how urban Mexicans perceived them. By illuminating how the yam made its way from the jungles of Mexico, to domestic and foreign scientific laboratories where it was transformed into pills, to the medicine cabinets of millions of women across the globe, "Jungle Laboratories" urges us to recognize the ways that Mexican peasants attained social and political legitimacy in the twentieth century, and positions Latin America as a major producer of scientific knowledge.

* Finalist for the Edgar (R) Award in Best Fact Crime * New York Post, "The Post's Favorite Books of 2015" * Suspense Magazine's "Best True Crime Books of 2015" * Finalist for Foreword Reviews' INDIEFAB Book of the Year in True Crime * Publishers Weekly, Big Indie Book of Fall 2015 The king of the Florida pill mills was American Pain, a mega-clinic expressly created to serve addicts posing as patients. From a fortress-like former bank building, American Pain's doctors distributed massive quantities of oxycodone to hundreds of customers a day, mostly traffickers and addicts who came by the vanload. Inked muscle-heads ran the clinic's security. Former strippers operated the pharmacy, counting out pills and stashing cash in garbage bags. Under their lab coats, the doctors carried guns-and it was all legal... sort of. American Pain was the brainchild of Chris George, a 27-year-old convicted drug felon. The son of a South Florida home builder, Chris George grew up in ultra-rich Wellington, where Bill Gates, Springsteen, and Madonna kept houses. Thick-necked from weightlifting, he and his twin brother hung out with mobsters, invested in strip clubs, brawled with cops, and grinned for their mug shots. After the housing market stalled, a local doctor clued in the brothers to the burgeoning underground market for lightly regulated prescription painkillers. In Florida, pain clinics could dispense the meds, and no one tracked the patients. Seizing the opportunity, Chris George teamed up with the doctor, and word got out. Just two years later Chris had raked in $40 million, and 90 percent of the pills his doctors prescribed flowed north to feed the rest of the country's insatiable narcotics addiction. Meanwhile, hundreds more pain clinics in the mold of American Pain had popped up in the Sunshine State, creating a gigantic new drug industry. American Pain chronicles the rise and fall of this game-changing pill mill, and how it helped tip the nation into its current opioid crisis, the deadliest drug epidemic in American history. The narrative swings back and forth between Florida and Kentucky, and is populated by a gaudy and diverse cast of characters. This includes the incongruous band of wealthy bad boys, thugs and esteemed physicians who built American Pain, as well as penniless Kentucky clans who transformed themselves into painkiller trafficking rings. It includes addicts whose lives were devastated by American Pain's drugs, and the federal agents and grieving mothers who labored for years to bring the clinic's crew to justice.

In this unprecedented account of the dynamics of Nigeria's pharmaceutical markets, Kristin Peterson connects multinational drug company policies, oil concerns, Nigerian political and economic transitions, the circulation of pharmaceuticals in the Global South, Wall Street machinations, and the needs and aspirations of individual Nigerians. Studying the pharmaceutical market in Lagos, Nigeria, she places local market social norms and credit and pricing practices in the broader context of regional, transnational, and global financial capital. Peterson explains how a significant and formerly profitable African pharmaceutical market collapsed in the face of U.S. monetary policies and neoliberal economic reforms, and she illuminates the relation between that collapse and the American turn to speculative capital during the 1980s. In the process, she reveals the mutual constitution of financial speculation in the drug industry and the structural adjustment plans that the IMF imposed on African nations. Her book is a sobering ethnographic analysis of the effects of speculation and "development" as they reverberate across markets and continents, and play out in everyday interpersonal transactions of the Lagos pharmaceutical market.  

Sets forth tested and proven risk management practices in drug manufacturing

Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing.

"Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing" features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applicationsTested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processesRecent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturingCase studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturingBibliography and extensive references leading to the literature and helpful resources in the field

With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.

This searing indictment, David Healy's most comprehensive and forceful argument against the pharmaceuticalization of medicine, tackles problems in health care that are leading to a growing number of deaths and disabilities. Healy, who was the first to draw attention to the now well-publicized suicide-inducing side effects of many anti-depressants, attributes our current state of affairs to three. Key factors: product rather than process patents on drugs, the classification of certain drugs as prescription-only, and industry-controlled drug trials. These developments have tied the survival of pharmaceutical companies to the development of blockbuster drugs, so that they must overhype benefits and deny real hazards. Healy further explains why these trends have basically ended the possibility of universal health care in the United States and elsewhere around the world. He concludes with suggestions for reform of our currently corrupted evidence-based medical system.