Prescription For The People

Cover -- Contents -- Acknowledgments -- Introduction -- Part I. Toxic Impacts -- 1. People Everywhere Are Struggling to Get the Medicines They Need -- 2. The United States Has a Drug Problem -- 3. Millions of People Are Dying Needlessly -- 4. Cancer Patients Face Particularly Deadly Barriers to Medicines -- 5. The Current Medicine System Neglects Many Major Diseases -- Part II. Profits over Patients -- 6. Corporate Research and Development Investments Are Exaggerated -- 7. The Current System Wastes Billions on Drug Marketing -- 8. The Current System Compromises Physician Integrity and Leads to Unethical Corporate Behavior -- 9. Medicines Are Priced at Whatever the Market Will Bear -- 10. Pharmaceutical Corporations Reap History-Making Profits -- Part III. Patently Poisonous -- 11. The For-Profit Medicine Arguments Are Patently False -- 12. Medicine Patents Are Extended Too Far and Too Wide -- 13. Patent Protectionism Stunts the Development of New Medicines -- 14. Governments, Not Private Corporations, Drive Medicine Innovation -- 15. Taxpayers and Patients Pay Twice for Patented Medicines -- Part IV. Trading Away Our Health -- 16. Medicines Are a Public Good -- 17. Medicine Patents Are Artificial, Recent, and Government-Created -- 18. The United States and Big Pharma Play the Bully in Extending Patents -- 19. Pharma-Pushed Trade Agreements Steal the Power of Democratically Elected Governments -- Part V.A Better Remedy -- 20. Current Law Provides Opportunities for Affordable Generic Medicines -- 21. There Is a Better Way to Develop Medicines -- 22. Human Rights Law Demands Access to Essential Medicines -- Conclusion -- Notes -- Index

Raises key questions about topics in the pharmaceutical industry, including how the risks of side effects are weighed, if privatization of that risk is prudent, and the high prices for 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 medicinesâ€"and health care at largeâ€"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 drugsâ€"coupled with the broader trends in overall health care costsâ€"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.

This hard-hitting expose does for prescription drugs what "Silent Spring" did for pesticides, revealing the hidden dangers of the most commonly prescribed medications--and what the consumer can do to minimize the risks of serious side effects.

The introduction of new medicines has dramatically improved the quantity and quality of individual and public health while contributing trillions of dollars to the global economy. In spite of these past successes--and indeed because of them--our ability to deliver new medicines may be quickly coming to an end. Moving from the beginning of the twentieth century to the present, A Prescription for Change reveals how changing business strategies combined with scientific hubris have altered the way new medicines are discovered, with dire implications for both health and the economy. To explain how we have arrived at this pivotal moment, Michael Kinch recounts the history of pharmaceutical and biotechnological advances in the twentieth century. Kinch relates stories of the individuals and organizations that built the modern infrastructure that supports the development of innovative new medicines. He shows that an accelerating cycle of acquisition and downsizing is cannibalizing that infrastructure Kinch demonstrates the dismantling of the pharmaceutical and biotechnological research and development enterprises could also provide opportunities to innovate new models that sustain and expand the introduction of newer and better breakthrough medicines in the years to come.

The opioid crisis in the United States has come about because of excessive use of these drugs for both legal and illicit purposes and unprecedented levels of consequent opioid use disorder (OUD). More than 2 million people in the United States are estimated to have OUD, which is caused by prolonged use of prescription opioids, heroin, or other illicit opioids. OUD is a life-threatening condition associated with a 20-fold greater risk of early death due to overdose, infectious diseases, trauma, and suicide. Mortality related to OUD continues to escalate as this public health crisis gathers momentum across the country, with opioid overdoses killing more than 47,000 people in 2017 in the United States. Efforts to date have made no real headway in stemming this crisis, in large part because tools that already existâ€"like evidence-based medicationsâ€"are not being deployed to maximum impact. To support the dissemination of accurate patient-focused information about treatments for addiction, and to help provide scientific solutions to the current opioid crisis, this report studies the evidence base on medication assisted treatment (MAT) for OUD. It examines available evidence on the range of parameters and circumstances in which MAT can be effectively delivered and identifies additional research needed.

The pharmaceutical industry has come under intense criticism in recent years. One poll found that 70% of the sample agreed that drug companies put profits ahead of people. Is this perception accurate? Have drug companies traded ethics for profits and placed people at risk? In Profits before People? Leonard J. Weber exposes pharmaceutical industry practices that have raised ethical concerns. Providing systematic ethical analysis and reflection, he discusses such practices as compensating physicians for serving as speakers or consultants, providing incentives to physicians to enroll patients as subjects in clinical research, and advertising prescription drugs to the public through the mass media. Weber's critique of the industry is stern. While acknowledging that new industry guidelines are promising, he finds much room for improvement in the way drug companies market their products. Yet Weber makes a strong case that profits and ethics can coexist and that they are not mutually exclusive. In an effort to understand the proper place of commerce in disseminating information about new drugs, the book aims to clarify basic responsibilities and to help identify sound ethical practices. It recognizes that ethics and law are not the same, that "having a right" is different from "doing the right thing," and that taking ethics seriously means recognizing that the law does not answer all questions about what is right. Weber points the way to more demanding standards and better practices that might begin to restore confidence in the drug industry.

Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.