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A free open access ebook is available upon publication. Learn more at www.luminosoa.org.Capitalizing a Cure takes readers into the struggle over a medical breakthrough to investigate the power of finance over business, biomedicine, and public health. When curative treatments for hepatitis C launched in 2013, sticker shock over their prices intensified the global debate over access to new medicines. Weaving historical research with insights from political economy and science and technology studies, Victor Roy demystifies an oft-missed dynamic in this debate: the reach of financialized capitalism into how medicines are made, priced, and valued. Roy's account moves between public and private labs, Wall Street and corporate board rooms, and public health meetings and health centers to trace the ways in which curative medicines became financial assets dominated by strategies of speculation and extraction at the expense of access and care. Provocative and sobering, this book illuminates the harmful impact of allowing financial markets to determine who heals and who suffers and points to the necessary work of building more equitable futures.

New Drugs, Fair Prices addresses the important question of how we might get the innovative new medicines we need at prices we can afford. Today, this debate is impassioned but sterile. One side calls for price controls, discounting their impact on investment in innovation. The other points to miraculous new therapies, disregarding their affordability and social inequity. This polarized argument creates more heat than light, threatening the social contract between the industry and society on which pharmaceutical innovation depends. This ground-breaking book takes a wholly new perspective on the issue and raises the debate to a more informed and productive level. Drawing on interviews with more than 70 experts across the pharmaceutical innovation world and combining a diverse literature from scientific, political, economic and business domains, it describes how a sustainable and affordable supply of new medicines is possible only by balancing pharmaceutical innovation's complex, adaptive ecosystem. By considering how each of the ecosystem's seven habitats work and interact with the others, it makes a comprehensive set of recommendations for achieving that ecosystem balance. The core message of New Drugs, Fair Prices is important to anyone who ever has needed or will ever need a medicine: we can have a sustainable supply of new medicines that are both innovative and affordable if we manage the pharmaceutical innovation ecosystem intelligently.

The prescription drug delivery system—how a drug gets from the manufacturer to the patient—is complicated. More than 4.4 billion prescriptions are written for drugs each year for Americans who then pick up these prescriptions at 60,000 drugstores or receive them from doctors or hospitals or online pharmacies. Chapter 1 is about how Americans pay for prescription drugs and where that money goes. Chapter 2 is about the process, beginning with the manufacturer's development of a drug, the different steps through which the drug travels before arriving in a patient's hands, how this is paid for, and what the costs are at each step along the way.

Award-winning journalist and New York Times bestselling author Gerald Posner reveals the heroes and villains of the trillion-dollar-a-year pharmaceutical industry and delivers “a withering and encyclopedic indictment of a drug industry that often seems to prioritize profits over patients (The New York Times Book Review).Pharmaceutical breakthroughs such as anti­biotics and vaccines rank among some of the greatest advancements in human history. Yet exorbitant prices for life-saving drugs, safety recalls affecting tens of millions of Americans, and soaring rates of addiction and overdose on pre­scription opioids have caused many to lose faith in drug companies. Now, Americans are demanding a national reckoning with a monolithic industry. “Gerald's dogged reporting, sets Pharma apart from all books on this subject” (The Washington Standard) as we are introduced to brilliant scientists, incorruptible government regulators, and brave whistleblowers facing off against company exec­utives often blinded by greed. A business that profits from treating ills can create far deadlier problems than it cures. Addictive products are part of the industry's DNA, from the days when corner drugstores sold morphine, heroin, and cocaine, to the past two decades of dangerously overprescribed opioids. Pharma also uncovers the real story of the Sacklers, the family that became one of America's wealthiest from the success of OxyContin, their blockbuster narcotic painkiller at the center of the opioid crisis. Relying on thousands of pages of government and corporate archives, dozens of hours of interviews with insiders, and previously classified FBI files, Posner exposes the secrets of the Sacklers'rise to power—revelations that have long been buried under a byzantine web of interlocking companies with ever-changing names and hidden owners. The unexpected twists and turns of the Sackler family saga are told against the startling chronicle of a powerful industry that sits at the intersection of public health and profits. “Explosively, even addictively, readable” (Booklist, starred review), Pharma reveals how and why American drug com­panies have put earnings ahead of patients.

This book is a volume in the Penn Press Anniversary Collection. To mark its 125th anniversary in 2015, the University of Pennsylvania Press rereleased more than 1,100 titles from Penn Press's distinguished backlist from 1899-1999 that had fallen out of print. Spanning an entire century, the Anniversary Collection offers peer-reviewed scholarship in a wide range of subject areas.

In Prescription for the People, Fran Quigley diagnoses our inability to get medicines to the people who need them and then prescribes the cure. He delivers a clear and convincing argument for a complete shift in the global and U.S. approach to developing and providing essential medicines—and a primer on how to make that change happen. Globally, 10 million people die each year because they are unable to pay for medicines that would save them. The cost of prescription drugs is bankrupting families and putting a strain on state and federal budgets. Patients'desperate need for affordable medicines clashes with the core business model of the powerful pharmaceutical industry, which maximizes profits whenever possible. It doesn't have to be this way. Patients and activists are aiming to make all essential medicines affordable by reclaiming medicines as a public good and a human right, instead of a profit-making commodity. In this book, Quigley demystifies statistics and terminology, offers solutions to the problems that block universal access to medicines, and provides a road map for activists wanting to make those solutions a reality.

Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicines—and health care at large—more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugs—coupled with the broader trends in overall health care costs—is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.

Specialty drugs are one of the fastest-growing areas of health care spending. There is no one set definition of specialty drugs, although insurers and other health care payers often characterize them as prescription products requiring extra handling or administration that are used to treat complex diseases including hepatitis C, multiple sclerosis, and cancer. High cost can trigger a specialty drug designation. Biologics, or drugs derived from living cells, are often but not always deemed to be specialty drugs. This book provides background on specialty drugs. To put specialty drug development, distribution, and spending in context, the book provides information about broader U.S. prescription drug pricing, insurance, and regulatory trends. Furthermore, this book explains the difference between coupons and other pharmaceutical assistance and incentive programs offered by manufacturers, pharmacies, states, and nonprofit organizations; outlines federal laws and regulations and private-sector policies relating to coupons and other financial incentives for consumers/patients to purchase prescription drugs; and introduces and analyzes innovation and competition policy issues associated with the pharmaceutical industry.

With decreasing profit margins, increasing cost pressures, growing regulatory compliance concerns, mounting pressure from generic drugs and increasing anxiety about the future of healthcare reimbursement, pharmaceutical manufacturers are now forced to re-examine and re-assess the way they have been doing things. In order to sustain profitability, these companies are looking to reduce waste (of all kinds), improve efficiency and increase productivity. Many of them are taking a closer look at lean manufacturing as a way to achieve these goals. Lean biomanufacturing re-visits lean principles and then applies them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes. A major goal of the book is to highlight those problems and issues that appear more specific or unique to biopharmaceutical manufacturing situations and to provide some insights into what challenges are the important ones to solve and what techniques, tools and mechanisms to employ to be successful.Following an introduction to lean biomanufacturing, the book goes on to discuss lean technologies and methods applied in biomanufacturing. Later chapters cover the creation and implementation of the Transition Plan, issues facing the biopharmaceutical industry, creating a lean approach towards biopharmaceutical processes and the contribution of simulation models in developing these processes. The final chapter covers examples of new technology innovations which help facilitate lean biomanufacturing. - A focus on the issues associated with the application of lean principles to biomanufacturing - Practical examples of factors which can affect biopharmaceutical processes - Coverage of key factors which require integration to run an efficient biopharmaceutical process

A Real Plan for Making Drugs Affordable–and Promoting Innovation, Too “This book is a necessity for understanding the pharmaceutical industry. Both the pluses and minuses of the present system are set forth with a judicious combination of historical narrative, economic analysis, and statistical data. The highly original proposals for reform will be a major stimulant to analysis and policy-making.” –Kenneth Arrow, Nobel Laureate in Economics, Professor Emeritus, Stanford University “This is a timely book by authors who know what they are talking about. They tackle a big problem: rising drug prices that are threatening to overwhelm us all–and especially those with limited or absent health care insurance. Will we drive people overseas for healthcare? Will there be social unrest? This book describes the problem and then offers a solution. Worth a careful read by everyone, pharmaceutical manufacturers and government policymakers especially.” –Roger Williams, M.D., Chief Executive Officer of the United States Pharmacopeia and a former senior official of the Food and Drug Administration “This book confounds two sets of skeptics: Those who say there's no way to resolve the conflict between the need to fund pharmaceutical research and our desire to keep medicine affordable; and those who think that economics never has anything good to say.” –Honorable Barney Frank, Congressman from Massachusetts “This book comes at the right time and could become the starting point of discussions, which will eventually lead us into new era in the healthcare care industry. It will without a doubt become a must for insiders of the pharma- and biotech industries.” –Dr. Jürgen Drews, retired President of Roche Pharmaceutical Group Global Research Acknowledgments viii About the Authors ix Introduction xi Chapter 1: Drugs and Drug Prices 1 Chapter 2: The American Way to Discover Drugs 21 Chapter 3: The Drug Industry Today 39 Chapter 4: Are Drug Companies Risky? 59 Chapter 5: How Not to Lower Drug Prices 77 Chapter 6: Squandering R & D Resources 103 Chapter 7: How to Lower Drug Prices 129 Appendix: Our Solution in Detail 155 Index 177

During her two decades at The New England Journal of Medicine, Dr. Marcia Angell had a front-row seat on the appalling spectacle of the pharmaceutical industry. She watched drug companies stray from their original mission of discovering and manufacturing useful drugs and instead become vast marketing machines with unprecedented control over their own fortunes. She saw them gain nearly limitless influence over medical research, education, and how doctors do their jobs. She sympathized as the American public, particularly the elderly, struggled and increasingly failed to meet spiraling prescription drug prices. Now, in this bold, hard-hitting new book, Dr. Angell exposes the shocking truth of what the pharmaceutical industry has become–and argues for essential, long-overdue change.Currently Americans spend a staggering $200 billion each year on prescription drugs. As Dr. Angell powerfully demonstrates, claims that high drug prices are necessary to fund research and development are unfounded: The truth is that drug companies funnel the bulk of their resources into the marketing of products of dubious benefit. Meanwhile, as profits soar, the companies brazenly use their wealth and power to push their agenda through Congress, the FDA, and academic medical centers.Zeroing in on hugely successful drugs like AZT (the first drug to treat HIV/AIDS), Taxol (the best-selling cancer drug in history), and the blockbuster allergy drug Claritin, Dr. Angell demonstrates exactly how new products are brought to market. Drug companies, she shows, routinely rely on publicly funded institutions for their basic research; they rig clinical trials to make their products look better than they are; and they use their legions of lawyers to stretch out government-granted exclusive marketing rights for years. They also flood the market with copycat drugs that cost a lot more than the drugs they mimic but are no more effective.The American pharmaceutical industry needs to be saved, mainly from itself, and Dr. Angell proposes a program of vital reforms, which includes restoring impartiality to clinical research and severing the ties between drug companies and medical education. Written with fierce passion and substantiated with in-depth research, The Truth About the Drug Companies is a searing indictment of an industry that has spun out of control.