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A book that takes you inside the culture of surveillance that pits healthcare providers against their patientsDoctors and pharmacists make critical decisions every day about whether to dispense opioids that alleviate pain but fuel addiction. Faced with a drug crisis that has already claimed more than a million lives, legislatures, courts, and policymakers have enlisted the help of technology in the hopes of curtailing prescriptions and preventing deaths. This book reveals how this “Trojan horse” technology embeds the logics of surveillance in the practice of medicine, forcing care providers to police their patients while undermining public trust and doing untold damage to those at risk.Elizabeth Chiarello draws on hundreds of in-depth interviews with physicians, pharmacists, and enforcement agents across the United States to take readers to the frontlines of the opioid crisis, where medical providers must make difficult choices between treating and punishing the people in their care. States now employ prescription drug monitoring programs capable of tracking all controlled substances within a state and across state lines. Chiarello describes how the reliance on these databases blurs the line between medicine and criminal justice and pits pain sufferers against people with substance-use disorders in a zero-sum game.Shedding critical light on this brave new world of healthcare, Policing Patients urges medical providers to reaffirm their roles as healers and proposes invaluable policy solutions centered on treatment, prevention, and harm reduction.

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.

Pharmaceuticals constitute a relatively small share of the total Health Care expenditure in most developed economies, and yet they play a critical role in the ongoing debate over how best to advance, improve, and afford Health Care. Despite this, and perhaps because of this, the industry has had, for many years, an outsized claim to fame and controversy, praise and criticisms, and support and condemnation. Unfortunately, many participants in the debate do not fully understand the complexities of the industry and its role in the overall Health Care system. The analytical tools of economics provide a strong foundation for a better understanding of the dynamics of the pharmaceutical industry, its contribution to Health and Health Care, and its dual and often conflicting priorities of affordability and innovation, as well as the various Private and Public Policy initiatives directed at the sector. Everyone is affected by Big Pharma and the products they produce. At the Drug store, the physician's office, in front of the television, in everyday conversations, Drugs are a part of our lives. Society shapes our values toward Drugs and Drugs shape society. ('The Pill'and minor tranquilizers are good examples.) And, of course, the way Congress deliberates and Big Pharma responds has a huge impact on how Drugs affect our lives. This book is well-researched on the subject of the pharmaceutical industry, its struggles with Government, and its relationship to the consumer from the early twentieth century until the present. The Dynamic Tension between the three participants – Government, Big Pharma, and the People – is described and explained to lead to an understanding of the controversies that rage today. The author describes how the Government, its many investigatory efforts, and the ultimate legislative results affect the industry and the consequences of their activities are explored in light of their effects on other players, including the patients and consumers who rely on both Government and Big Pharma for their well-being and who find sometimes unexpected consequences while giving special attention to the attitudes, beliefs, and misadventures of less-than-optimal Drug use. Stakeholders are identified with physicians as a major focus, as well as describing the significance of prescriptions as social objects and the processes by which physicians make choices on behalf of their patients. The author ties it all together with how Big Pharma affects and is affected by each of these groups. The author utilizes his 50-plus years'experience as an academic, practicing pharmacist, and Big Pharma employee to describe the scope of the pharmaceutical industry and how it affects us on a daily basis, concluding with an inside look at Big Pharma and how regulations, marketing, and the press have affected their business, both good and bad.

With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs. Features: Regulatory and statistical interactions throughout the drug development continuum The critical role of the statistician in relation to the changing regulatory and healthcare landscapes Statistical issues that commonly arise in the course of drug development and regulatory interactions Trending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors'decades of experience in the pharmaceutical industry and academia, and extensive regulatory experience, comes through in the many examples throughout the book.

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.

If a competent adult refuses medical treatment, physicians and public officials must respect her decision. Coercive medical paternalism is a clear violation of the doctrine of informed consent, which protects patients'rights to make medical decisions even if a patient's choice endangers her health. The same reasons for rejecting medical paternalism in the doctor's office are also reasons to reject medical paternalism at the pharmacy, yet coercive medical paternalism persists in the form of premarket approval policies and prescription requirements for pharmaceuticals. In Pharmaceutical Freedom Jessica Flanigan defends patients'rights of self-medication. Flanigan argues that public officials should certify drugs instead of enforcing prohibitive pharmaceutical policies that disrespect people's rights to make intimate medical decisions and prevent patients from accessing potentially beneficial new therapies. This argument has revisionary implications for important and timely debates about medical paternalism, recreational drug legalization, human enhancement, prescription drug prices, physician assisted suicide, and pharmaceutical marketing. The need for reform is especially urgent as medical treatment becomes increasingly personalized and patients advocate for the right to try. The doctrine of informed consent revolutionized medicine in the twentieth century by empowering patients to make treatment decisions. Rights of self-medication are the next step.

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.

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.

As the most common health-care intervention, prescription drug use shares the most important characteristics of the health-care system in the United States. When everything works well, it makes possible breathtakingly successful applications of science to the prevention and cure of human suffering. But everything doesn‘t always work well. Pharmaceu

The field of endeavors known as'regulatory science'has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline. In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop.

Medicaid is a federal-state entitlement program that pays for health care and related services on behalf of certain low-income individuals. Prescription drugs are an optional Medicaid benefit and all states cover outpatient drugs. States can create formularies, or lists of preferred drugs, but federal rules tend to result in comprehensive coverage, even for beneficiaries enrolled in Medicaid managed care plans. Pharmaceutical manufacturers that voluntarily participate in Medicaid are required to pay rebates to states on covered outpatient drugs, which help Medicaid receive manufacturers'lowest or best price. States then share the rebate they receive from pharmaceutical manufacturers with the federal government. This book discusses Medicaid prescription drug pricing and policies.

Many doctors want to know more about the FDA not only so that they might better understand the issues and how they are related to their practice, such as off label-drug usage, but also to enrich their professional lives and allow them to more deeply understand the many FDA related articles written in the popular press. It is further based on the notion that doctors prefer a formal way to learn about FDA. The Agency is a truly vast subject engaging thousands of lawyers, regulators, scientists, physicians, writers, legislators and many others directly and indirectly. This book is an introductory overview written from a physician's perspective for physicians. It is organized along lines that emphasize issues most interesting to physicians. Much of it deals with nomenclature and definitions, since as is true of all fields, one must understand the special concepts and vocabulary of the field.

In the late 1980s, the median time for FDA to approve a new drug application (NDA) was 29 months. Industry, consumer groups, and FDA agreed that the time from submission of a drug or biologics application to FDA's decision was unacceptably long. Patient advocates argued that a drug in review--and therefore not available for sale--could be the difference between life and death. Manufacturers argued that prolonged review times affected their ability to recoup the costs of research and development. This book examines the FDA's review of drug applications, with a focus on the Prescription Drug User Fee Act (PDUFA) and issues for reauthorization in 2012.

This book explores the trends and FDA response to national drug shortages. In recent years, hospitals and health care professionals have increasingly reported nationwide shortages of prescription drugs, including those that are life-saving and life-sustaining. Drug shortages directly threaten public health by preventing patients from accessing medications that are essential to their care. For example, recent shortages of oncology drugs have sparked concerns from health care professionals about how to care for cancer patients that need such medications in order to survive. During shortages, physicians may have to ration their supplies, delay treatments, or use alternative medications that may be less effective for the condition, carry unwanted side effects, or are most costly.

This is the first book to examine how effectively American and supranational EU governments have regulated innovative pharmaceuticals during the last 30 years regarding public health. It explains why pharmaceutical regulation has been misdirected by commercial interests and misconceived ideologies.

Pharmacy and the US Health Care System offers a complete source of current information about the features of the US health care system including the personnel and institutions, as well as concise reports on trends, regulations, policy and finances.

Congress has exhibited a strong and ongoing interest in facilitating the development of new, innovative pharmaceuticals for the marketplace while reducing the cost of drugs to consumers. Policies pertaining to funding for research and development (R&D), intellectual property protection, and cooperative ventures have played an important role in the economic success of the pharmaceutical sector. Industry-specific legislation, also work to encourage innovation in the pharmaceutical sector while facilitating the entry of lower cost generic competition. While many factors contribute to innovation in the brand pharmaceutical industry and its ability to bring new and inventive products to the marketplace, this sector is facing significant issues associated with loss of revenue for additional R&D due to patent expirations and generic competition. This book examines the challenges associated with striking the proper balance between lower cost drugs and maintaining an innovative domestic pharmaceutical sector.

Prescription drug abuse is a serious and growing public health problem. According to the Centers for Disease Control and Prevention, drug overdoses, including those from prescription drugs, are the second leading cause of deaths from unintentional injuries in the U.S., exceeded only by motor vehicle fatalities. Unlike addiction to heroin and other drugs that have no accepted medical use, addiction to some controlled substances can be unknowingly financed by insurance companies and public programs, such as Medicare. This book examines the prescription drug abuse problem in the U.S., along with doctor shopping and the role of Medicaid in this health care crisis.

Few people realize that prescription drugs have become a leading cause of death, disease, and disability. Adverse reactions to widely used drugs, such as psychotropics and birth control pills, as well as biologicals, result in FDA warnings against adverse reactions.The Risks of Prescription Drugs describes how most drugs approved by the FDA are under-tested for adverse drug reactions, yet offer few new benefits. Drugs cause more than 2.2 million hospitalizations and 110,000 hospital-based deaths a year. Serious drug reactions at home or in nursing homes would significantly raise the total. Women, older people, and people with disabilities are least used in clinical trials and most affected.Health policy experts Donald Light, Howard Brody, Peter Conrad, Allan Horwitz, and Cheryl Stults describe how current regulations reward drug companies to expand clinical risks and create new diseases so millions of patients are exposed to unnecessary risks, especially women and the elderly. They reward developing marginally better drugs rather than discovering breakthrough, life-saving drugs. The Risks of Prescription Drugs tackles critical questions about the pharmaceutical industry and the privatization of risk. To what extent does the FDA protect the public from serious side effects and disasters? What is the effect of giving the private sector and markets a greater role and reducing public oversight? This volume considers whether current rules and incentives put patients'health at greater risk, the effect of the expansion of disease categories, the industry's justification of high U.S. prices, and the underlying shifts in the burden of risk borne by individuals in the world of pharmaceuticals. Chapters cover risks of statins for high cholesterol, SSRI drugs for depression and anxiety, and hormone replacement therapy for menopause. A final chapter outlines six changes to make drugs safer and more effective.Suitable for courses on health and aging, gender, disability, and minority studies, this book identifies the Risk Proliferation Syndrome that maximizes the number of people exposed to these risks.Additional Columbia / SSRC books on the privatization of risk and its implications for Americans:Bailouts: Public Money, Private ProfitEdited by Robert E. WrightDisaster and the Politics of InterventionEdited by Andrew LakoffHealth at Risk: America's Ailing Health System-and How to Heal ItEdited by Jacob S. HackerLaid Off, Laid Low: Political and Economic Consequences of Employment InsecurityEdited by Katherine S. NewmanPensions, Social Security, and the Privatization of RiskEdited by Mitchell A. Orenstein

How the FDA became the world's most powerful regulatory agencyThe U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Reputation and Power traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints.Daniel Carpenter describes how the FDA cultivated a reputation for competence and vigilance throughout the last century, and how this organizational image has enabled the agency to regulate an industry as powerful as American pharmaceuticals while resisting efforts to curb its own authority. Carpenter explains how the FDA's reputation and power have played out among committees in Congress, and with drug companies, advocacy groups, the media, research hospitals and universities, and governments in Europe and India. He shows how FDA regulatory power has influenced the way that business, medicine, and science are conducted in the United States and worldwide. Along the way, Carpenter offers new insights into the therapeutic revolution of the 1940s and 1950s; the 1980s AIDS crisis; the advent of oral contraceptives and cancer chemotherapy; the rise of antiregulatory conservatism; and the FDA's waning influence in drug regulation today.Reputation and Power demonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested.Some images inside the book are unavailable due to digital copyright restrictions.

Daniel M. Fox gives an incisive assessment of the critical collaboration between researchers and public officials that has recently emerged to evaluate the effectiveness and comparative effectiveness of health services. Drawing on research as well as his first-hand experience in policymaking, Fox's broad-ranging analysis describes how politics, public finance and management, and advances in research methods made this convergence of science and governance possible. The book then widens into a sweeping history of central issues in research on health services and health governance during the past century. Returning to the past decade, Fox looks closely at how policy informed by research has been made and implemented in public programs that cover pharmaceutical drugs in most American states. This case study illuminates how politics has informed the questions, methods, and reception of research on health services, and also sheds new light on how research has informed politics and public management. Looking toward the future, Fox describes the promise, as well as the fragility, of the convergence of science and governance, making his book essential reading for those struggling to revise health care in the United States over the next several years.

The process for developing new drug and biologic products is extraordinarily expensive and time-consuming. Although large pharmaceutical companies may be able to afford the cost of development because they can expect a large return on investment, organizations developing drugs to treat rare and neglected diseases are unable to rely on such returns. On June 23, 2008, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held a public workshop,'Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies,'which sought to explore new and innovative strategies for developing drugs for rare and neglected diseases.

The pharmaceutical industry is praised as a world leader in high technology innovation and the creator of products that increase both longevity and quality of life for people throughout the world. At the same time, the industry is also criticized for its marketing and pricing practices and for its apparent anticompetitive responses to generic competition. Even its research and development priorities are criticized as being too closely driven by the goal of maximizing shareholder value, rather than the health of the public. Unfortunately, many of the critics of the industry fail to understand the complexities of the industry and its role in the nations healthcare system. This book uses the tools of economic analysis to explore the conflicting priorities and aims of the pharmaceutical industry, from both an American and worldwide perspective. This is the second edition of a uniquely comprehensive and balanced discussion of pharmaceutical policy issues. All the chapters of the former edition have been fully re-written and extensively updated. In addition, the book includes six new chapters on emerging topics such as the broadened role of FDA regulations and the increasing diversity of the industry. An entire chapter is devoted to the biotechnology industry and one to alternative medicines, often called'nutraceuticals.'Another new chapter discusses segments of the industry that specialize in particular activities including generic drugs and drug delivery systems. The recent controversial expansion of Medicare to cover outpatient drugs is discussed in depth. The introduction is also updated to address the volatile pace of pharmaceutical innovation and how the pharmaceutical industry has responded to the emergence of managed care.

In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs'risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications'risk–benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.

In the tradition of the great investigative classics, Dangerous Doses exposes the dark side of America's pharmaceutical trade. Stolen, compromised, and counterfeit medicine increasingly makes its way into a poorly regulated distribution system—where it may reach unsuspecting patients who stake their lives on its effectiveness. Katherine Eban's hard-hitting exploration of America's secret ring of drug counterfeiters takes us to Florida, where tireless investigators follow the trail of medicine stolen in a seemingly minor break-in as it funnels into a sprawling national network of drug polluters. Their pursuit stretches from a strip joint in South Miami to the halls of Congress as they battle entrenched political interests and uncover an increasing threat to America's health. With the conscience of a crusading reporter, Eban has crafted a riveting narrative that shows how, when we most need protection, we may be most at risk.

The forces that shape America's most powerful consumer agency Because of the importance of what it regulates, the FDA comes under tremendous political, industry, and consumer pressure. But the pressure goes far beyond the ordinary lobbying of Washington trade groups. Its mandate-one quarter of the national economy-brings the FDA into the middle of some of the most important and contentious issues of modern society. From'designer'babies and abortion to the price of prescription drugs and the role of government itself, Inside the FDA takes readers on an intriguing journey into the world of today's most powerful consumer agency. In a time when companies continue to accuse the FDA of nitpicking and needlessly delaying needed new drugs, and consumers are convinced that the agency bends to industry pressure by rushing unsafe drugs to market, Inside the FDA digs deep to reveal the truth. Through scores of interviews and real-world stories, Hawthorne also shows how and why the agency makes some of its most controversial decisions as well as how its recent reaction to certain issues-including the revolutionary cancer drug Erbitux, stem cell research, and bioengineering of food-may jeopardize its ability to keep up with future scientific developments. Inside the FDA takes a closer look at the practices, people, and politics of this crucial watchdog in light of the competing pressures and trends of modern society, revealing what the FDA is supposed to do, what it actually does-and fails to do-who it influences, and how it could better fulfill its mandate. The decisions that the FDA makes are literally life and death. Inside the FDA provides a sophisticated account of how this vitally important agency struggles to balance bureaucracy and politics with its overriding mission to promote the country's health.

From aspirin to Viagra to the latest cancer treatment, the Food and Drug Administration acts as a gatekeeper determining what medicines are legally available in the United States. But in fulfilling that regulatory role, Stephen Ceccoli argues, the FDA may inadvertently be promoting new drugs at the expense of public health.The FDA's initial mandate to protect health grew out of pharmaceutical-related disasters in the early 1900s. Later criticisms that the agency's approach impeded industry competitiveness and failed to meet public need, however, led to a political compromise on its mission. The new FDA has cut its review time nearly in half and allows direct-to-consumer advertising, off-label promotion of drugs, and the'fast-tracking'of treatments. Ceccoli convincingly shows that this approval process, while redressing valid complaints, is also creating a new complex of problems that must be resolved.

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.

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.

While well over one million small-time drug users languish in overcrowded prisons because of nonviolent drug offenses, tens of thousands of others get rich from legal and illegal drugs. Drug company representatives persuade doctors to prescribe inferior products. Children as young as two are routinely given powerful drugs. Legal drugs, taken exactly as prescribed, are a leading cause of illness and death. Scientists beholden to drug companies fabricate and misrepresent data. This eye-opening book richly documents disturbing trends in Western medicine and urges readers toward a broader understanding of drug use and abuse. Leavitt shows how and why American society must change its medical and policy approaches to drugs and re-orient medical practice to new ways of thinking.

In Defining Drugs, Parrish argues that the federal government became arbiter of pharmaceutical fact because the professions of pharmacy and medicine, as well as the pharmaceutical industry, could enforce these definitions and standards only through police powers reserved to government. Parrish begins his provocative study by examining the development of the social system for regulating drug therapy in the United States. He reviews the standards that were negotiated, and the tensions of the period between Progressivism and the New Deal that gave cultural context and historical meaning to drug use in American society. Parrish describes issues related to the development of narcotics policy through education and legislation facilitated by James Beal and Edward Kremers, and documents the federal government's evolving role as arbiter of market tensions between pharmaceutical producers, government officials, and private citizens in professional groups, illustrating the influence of government in writing enforceable standards for pharmaceutical therapies. He shows how the expansion of political rights for practitioners and producers has shifted responsibility for therapeutic consequences from individual practitioners and patients to government. This timely and controversial volume is written for the scholar and the compassionate practitioner alike, and a general public concerned with pharmacy regulation in a free society.

A government monopoly over drug regulation is not sacrosanct. This hard-hitting book describes the current regulation of drugs by the FDA and proposes a model for fundamental, yet workable, reform—including an innovative proposal for drug testing and certification review.