"This book uses the cases of several landmark drugs to discuss the history of the pharmaceutical industry, and discusses what could be next"--Provided by publisher.

For the world's largest prescription drug manufacturers, the last few years have been a harrowing time. Recently, Pfizer's Lipitor, GlaxoSmithKline's Advair, AstraZeneca's Seroquel, and Sanofi-Aventis and Bristol-Myers Squibb's Plavix all came off patent in the crucial U.S. market. This so-called "patent cliff" meant hundreds of billions of dollars in lost revenue and has pharmaceutical developers scrambling to create new drugs and litigating to extend current patent protections. Having spent most of his career in drug discovery in "big pharma," Dr. Li now delivers an insider's account of how the drug industry ascended to its plateau and explores the nature of the turmoil it faces in the coming years. He begins with a survey of the landscape before "blockbuster drugs," and proceeds to describe how those drugs were discovered and subsequently became integral to the business models of large pharmaceutical companies. For example, in early 1980s, Tagamet, the first "blockbuster drug," transformed a minor Philadelphia-based drug maker named SmithKline & French into the world's ninth-largest pharmaceutical company in terms of sales. The project that delivered Tagamet was nearly terminated several times because research efforts begun in 1964 produced no apparent results within the first eleven years. Similar stories accompany the discovery and development of now-ubiquitous prescription drugs, among them Claritin, Prilosec, Nexium, Plavix, and Ambien. These stories, and the facets of the pharmaceutical industry that they reveal, can teach us valuable lessons and reveal many crucial aspects about the future landscape of drug discovery. As always, Dr. Li writes in a readable style and intersperses fascinating stories of scientific discovery with engaging human drama.

"Beginning in the 1970s, several scientific breakthroughs promised to transform the creation of new medicines. As investors sought to capitalize on these Nobel Prize-winning discoveries, the biotech industry grew to thousands of small companies around the world. Each sought to emulate what the major pharmaceutical companies had been doing for a century or more, but without the advantages of scale, scope, experience, and massive resources. How could a large collection of small companies, most with fewer than 50 employees, compete in one of the world's most breathtakingly expensive and highly regulated industries? This book shows how biotech companies have met the challenge by creating nearly 40% more of the most important treatments for unmet medical needs. Moreover, they have done so with much lower overall costs. The book focuses on both the companies themselves and the broader biotech ecosystem that supports them. Its portrait of the crucial roles played by academic research, venture capital, contract research organizations, the capital markets, and pharmaceutical companies shows how a supportive environment enabled the entrepreneurial biotech industry to create novel medicines with unprecedented efficiency. In doing so, it also offers insights for any industry seeking to innovate in uncertain and ambiguous conditions. Looking to the future, it concludes that biomedical research will continue to be most effective in the hands of a large group of small companies as long as national healthcare policies allow the rest of the ecosystem to continue to thrive"--

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.

The contemporary opioid crisis is widely seen as new and unprecedented. Not so. It is merely the latest in a long series of drug crises stretching back over a century. In White Market Drugs, David Herzberg explores these crises and the drugs that fueled them, from Bayer’s Heroin to Purdue’s OxyContin and all the drugs in between: barbiturate “goof balls,” amphetamine “thrill pills,” the “love drug” Quaalude, and more. As Herzberg argues, the vast majority of American experiences with drugs and addiction have taken place within what he calls “white markets,” where legal drugs called medicines are sold to a largely white clientele. These markets are widely acknowledged but no one has explained how they became so central to the medical system in a nation famous for its “drug wars”—until now. Drawing from federal, state, industry, and medical archives alongside a wealth of published sources, Herzberg re-connects America’s divided drug history, telling the whole story for the first time. He reveals that the driving question for policymakers has never been how to prohibit the use of addictive drugs, but how to ensure their availability in medical contexts, where profitability often outweighs public safety. Access to white markets was thus a double-edged sword for socially privileged consumers, even as communities of color faced exclusion and punitive drug prohibition. To counter this no-win setup, Herzberg advocates for a consumer protection approach that robustly regulates all drug markets to minimize risks while maintaining safe, reliable access (and treatment) for people with addiction. Accomplishing this requires rethinking a drug/medicine divide born a century ago that, unlike most policies of that racially segregated era, has somehow survived relatively unscathed into the twenty-first century. By showing how the twenty-first-century opioid crisis is only the most recent in a long history of similar crises of addiction to pharmaceuticals, Herzberg forces us to rethink our most basic ideas about drug policy and addiction itself—ideas that have been failing us catastrophically for over a century.

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.

Drugs like Lipitor, Plavix, Taxol, and Zoloft are integral in today's medicinal world. These widely used products save lives and improve the quality of lives, playing a crucial role in everything from cholesterol management to cancer treatment. These advances in medicine were brought into existence after nuanced process of creation, featuring a wide range of chemical and pharmacological experimentation and discovery. Top Drugs: Their History, Pharmacology, and Synthesis provides an in-depth study on ten prominent drugs, outlining the chemistry behind each one's creation. Jie Jack Li, a medicinal chemist and an expert on drug discovery, offers a thorough analysis of the landscape of current drug development. The comprehensive text is divided by health issues, including cardiovascular, cancer, metabolic diseases, and infectious diseases. Each section features individual chapters on significant drugs, outlining the chemistry and history of the drug's discovery. Li begins each chapter with the product's history, providing necessary context. Li then proceeds to describe the mechanism of action, structure-activity relationship (SAR), bioavailability, metabolism, toxicology, the discovery route, and the process route. Top Drugs: Their History, Pharmacology, and Synthesis will acclimate students, scientists, and interested laypersons to the world of chemistry and drug discovery.