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.

For nearly three decades, methadone hydrochloride has been the primary means of treating opiate addiction. Today, about 115,000 people receive such treatment, and thousands more have benefited from it in the past. Even though methadone's effectiveness has been well established, its use remains controversial, a fact reflected by the extensive regulation of its manufacturing, labeling, distribution, and use. The Food and Drug Administration regulates the safety and effectiveness of methadone, as it does for all drugs, and the Drug Enforcement Administration regulates it as a controlled substance. However, methadone is also subjected to a unique additional tier of regulation that prescribes how and under what circumstances it may be used to treat opiate addiction. Federal Regulation of Methadone Treatment examines current Department of Health and Human Services standards for narcotic addiction treatment and the regulation of methadone treatment programs pursuant to those standards. The book includes an evaluation of the effect of federal regulations on the provision of methadone treatment services and an exploration of options for modifying the regulations to allow optimal clinical practice. The volume also includes an assessment of alternatives to the existing regulations.

Valium. Paxil. Prozac. Prescribed by the millions each year, these medications have been hailed as wonder drugs and vilified as numbing and addictive crutches. Where did this “blockbuster drug” phenomenon come from? What factors led to the mass acceptance of tranquilizers and antidepressants? And how has their widespread use affected American culture? David Herzberg addresses these questions by tracing the rise of psychiatric medicines, from Miltown in the 1950s to Valium in the 1970s to Prozac in the 1990s. The result is more than a story of doctors and patients. From bare-knuckled marketing campaigns to political activism by feminists and antidrug warriors, the fate of psychopharmacology has been intimately wrapped up in the broader currents of modern American history. Beginning with the emergence of a medical marketplace for psychoactive drugs in the postwar consumer culture, Herzberg traces how “happy pills” became embroiled in Cold War gender battles and the explosive politics of the “war against drugs”—and how feminists brought the two issues together in a dramatic campaign against Valium addiction in the 1970s. A final look at antidepressants shows that even the Prozac phenomenon owed as much to commerce and culture as to scientific wizardry. With a barrage of “ask your doctor about” advertisements competing for attention with shocking news of drug company malfeasance, Happy Pills is an invaluable look at how the commercialization of medicine has transformed American culture since the end of World War II.

The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.