As the scope of available drug therapies expands, spending on prescription drugs has become the fastest-growing category of total spending on health care in the United States. Recently, that growth has slowed and that slowdown reflects changes in both the supply and demand for prescription drugs. This book examines the innovation, development and complexity issues present in the pharmaceutical industry.

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.

* provides an in-depth discussion of recent advances in sterilization * identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions * explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results * New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture.

* 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.

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.

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.

The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.

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.

Increased governance of international trade through supra-national institutions such as the World Trade Organization (WTO) has meant that national trade and organisational strategies need to be compatible with the norms of global institutions. Global institutional change impacts national economies and necessitates adaptation in ways that balance adherence to emerging norms while maintaining broad socioeconomic national objectives. This book focuses on two sector-specific global institutional changes initiated and implemented by the WTO in 2005 and examines how India's textile and pharmaceutical industries coped with these changes through coordinated efforts in the multi-level national institutional system comprised of the state, industry and individual business organisations. The findings of the book, which show both convergence and divergence across the two industries in the processes and outcomes of dealing with global institutional change, would be of interest to national policymakers as well as to scholars in multiple disciplines interested in the study of institutions and institutional change.

In a world that is changing, everybody in business wants to know how to achieve and maintain success. This is the case whether your business is local, national, or global, and no matter the products or services you provide. This book sets out the impressive rise of Tiens Group, which started locally, expanded nationally, and now operates globally from its headquarters in China. The book provides not only an analysis of the factors that have contributed to the success, but also sets out examples of how these factors can be adapted to other business enterprises. In this book, you will discover deep insight into how notions such as swap and transcendence assist in business development, a sense of how Chinese businesses have developed across the world, and an understanding of how both clear focus and an ability to adapt are critical to business success.

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.

There is plenty of controversy surrounding pharmaceuticals, but it cannot be denied that the pharmaceutical industry is both socially beneficial and profitable. Regulators are expected to ensure that the economic success of the industry does not come at the expense of public safety, yet they have also assumed a cooperative role by providing advice on regulation and by targeting unmet medical needs. Concerns over regulatory standards, conflicts of interest, and the manipulation of information on drug safety and effectiveness have led to public mistrust and a greater need for transparency between the pharmaceutical industry and government regulators. Transparency, Power, and Influence in the Pharmaceutical Industry evaluates the progress made in holding the pharmaceutical industry responsible for creating transparency in the industry, from development to market. The contributors to this volume examine the various mechanisms introduced to make the regulatory process more informative and situate these efforts within the larger project of enhancing the safety of drugs, vaccines, and other products.

How often do we stop to recognize what pharmaceutical advertisements are telling us? Broadcast Pharmaceutical Advertising in the United States: Prime Time Pill Pushers engages with this question to include how pharmaceutical companies are shaping the meaning of drug interventions for individuals and the ways in which pharmaceutical advertisements frame issues of identity and representation for patients and health care. Such issues highlight how patients are being framed as consumers in these advertisements, which then permits the commodification of health care to be celebrated. Such a celebration has strong ideological implications, including definitions of "the good life," patient agency, and the role of DTCAs in such depictions. By defining and discussing medicalization, pharmaceuticalization, and commodity fetishism, this book introduces how the term "pharmaceutical fetishism" can act as a means for describing the commodification of brand-name pharmaceutical drugs, which, via advertising and promotional culture, ignores large-scale production and for-profit motives of "big pharma."

In the last quarter of the 20th century, politicians in Washington, as well as interest groups, regulatory policy makers, and drug industry leaders were forced to confront the hot-button issue of pharmaceutical regulation. The struggle always centered on product innovation, consumer protection, and choice in the free market. As the American economy stuttered in the late 1970s, the stakes were extremely high for the powerful drug industry and the American public. At the center of this drama was the Food and Drug Administration, which was censured from both the left and right of the political spectrum for being too strict and too lenient in the application of its regulatory powers. Lucas Richert explores the FDA, drugs, and politics in the context of the watershed Reagan era, a period when the rhetoric of limited government, reduced regulation, and enhanced cooperation between businesses and U.S. regulatory agencies was on the ascent. As he investigates the controversies surrounding Laetrile, Reye's Syndrome, Oraflex, patient package inserts, diet pills, and HIV/AIDS drugs, Richert argues that the practical application of conservative economic principles to the American drug industry was A Prescription for Scandal.

Pain and Profits tells the story of how a common ailment--the headache--became the center of a multibillion-dollar pharmaceutical industry in the United States. Despite the increasing authority of the medical profession in the twentieth century, treatment of this condition has remained largely in the hands of the public. Using the headache as a case study, and advertising as a significant source of information, Jan McTavish traces the beginnings of the modern over-the-counter industry. The American pharmaceutical industry developed from nineteenth-century suppliers of plant-derived drugs for both professional and home care. Two branches of the industry evolved over time--the ethical branch, which sold products only with prescriptions, and the nostrum branch, which was noted for its energetic marketing techniques. At the end of the century, they were joined by German companies that combined a strong commitment to science with aggressive salesmanship. Since German drugs were both highly effective in treating headaches and commonly available, suffers wanting quick relief could easily obtain them. The result was a new kind of "legitimate" pharmaceutical industry that targeted consumers directly. Historians of medicine as well as more general readers interested in the history of the headache will enjoy this fascinating account of the creation of the modern pharmaceutical industry.

In 2010, Thea Cacchioni testified before the US Food and Drug Administration against flibanserin, a drug proposed to treat low sexual desire in women, dubbed by the media the "pink Viagra." She was one of many academics and activists sounding the alarm about the lack of science behind the search for potentially lucrative female sexual enhancement drugs. In her book, Big Pharma, Women, and the Labour of Love, Cacchioni moves beyond the search for a sexual pharmaceutical drug for women to ask a broader question: how does the medicalization of female sexuality already affect women's lives? Using in-depth interviews with doctors, patients, therapists, and other medical practitioners, Cacchioni shows that, whatever the future of the "pink Viagra," heterosexual women often now feel expected to take on the job of managing their and their partners' sexual desires. Their search for sexual pleasure can be a "labour of love," work that is enjoyable for some but a chore for others. An original and insightful take on the burden of heterosexual norms in an era of compulsory sexuality, Cacchioni's investigation should open up a wide-ranging discussion about the true impact of the medicalization of sexuality.

The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. Contract Research and Development Organizations: Their Role in Global Product Development has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants. Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs.

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.  

According to the World Health Organization, one-third of the global population lacks access to essential medicines. Should pharmaceutical companies be ethically or legally responsible for providing affordable medicines for these people, even though they live outside of profitable markets? Can the private sector be held accountable for protecting human beings' right to health? This thought-provoking interdisciplinary collection grapples with corporate responsibility for the provision of medicines in low- and middle-income countries. The book begins with an examination of human rights, norms, and ethics in relation to the private sector, moving to consider the tensions between pharmaceutical companies' social and business duties. Broad examinations of global conditions are complemented by case studies illustrating different approaches for addressing corporate conduct. Access to Medicines as a Human Right identifies innovative solutions applicable in both global and domestic forums, making it a valuable resource for the vast field of scholars, legal practitioners, and policymakers who must confront this challenging issue.

This book overviews and integrates the business and technical issues that pharmaceutical companies need to know in order to combat the major global problem of counterfeit medicines. In addition to discussion of the problems, the author Davison addresses analytical techniques scientists use to detect counterfeits and presents some possible solutions to the threat of counterfeit medical products. Coverage moves from basic overview of the problem, costs / risks to consumers (toxic products, mistrust of drug companies) and business (revenue loss, public trust), government oversight and regulation, authentication strategies (packaging, analytical techniques), product tracking and supply chain, and case studies from around the globe.

Advocates of rapid access to medicines and critics fearful of inadequate testing both argue that globalization will supersede national medical practices and result in the easy transfer of pharmaceuticals around the world. In Pharmacopolitics, Arthur Daemmrich challenges their assumptions by comparing drug laws, clinical trials, and systems for monitoring adverse reactions in the United States and Germany, two countries with similarly advanced systems for medical research, testing, and patient care. Daemmrich proposes that divergent ""therapeutic cultures""--the interrelationships among governments, patients, the medical profession, and the pharmaceutical industry--underlie national differences and explain variations in pharmaceutical markets and medical care. Daemmrich carries the United States-Germany comparison from 1950 to the present through case studies of Terramycin (an antibiotic), thalidomide (a sedative), propranolol (a heart medication), interleukin-2 (a cancer therapy), and indinavir (an AIDS drug). He points to different political constructions of ""the patient"" in the United States and Germany to clarify important differences in government policies and in the distribution of power among key social actors. Daemmrich advises that international regulatory harmonization and globalization in medicine must retain flexibility for social and political variation between countries, even as they achieve technical standardization.

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.