Synopses & Reviews
Blockbuster drugs-each of which generates more than a billion dollars a year in revenue-have revolutionized the industry since the early 1980s, when sales of Tagamet alone transformed a minor Philadelphia-based firm into the world's ninth-largest pharmaceutical company. In Blockbuster Drugs
, Jie Jack Li tells the fascinating stories behind the discovery and development of these highly lucrative medicines, while also exploring the tumult the industry now faces as the "patent cliff"
Having spent most of his career in drug research and development, Li brings an insider's eye to the narrative as he recounts the tales of discovery behind such drugs as Tagamet, Zantac, Claritin, Prilosec, Nexium, Serouquel, Plavix, and Ambien. As he discusses each breakthrough, Li also shows that scientific research is filled with human drama-serendipitous discoveries, sudden insights, tense confrontations. For instance, the author tells of James Black, who persisted in the research that led to Tagamet-and that would ultimately win him a Nobel Prize-despite pressure from top executives to pursue "more profitable" work. The book shows how research behind Prilosec combined creativity, international cooperation, and luck-the turning point being a chance encounter of American and Swedish scientists at a conference in Uppsala. There are also tales of fabulous rewards--George Rieveschl, the chemist who invented Benadryl, made a fortune on royalties-and of unjust desserts. Finally, Li shows that for the world's largest prescription drug manufacturers, recent years have been harrowing, as many popular drugs have come off patent in the U.S. market, meaning hundreds of billions of dollars in lost revenue.
Anyone who enjoys tales of scientific discovery, or is curious about the history behind the prescriptions they take, or wants a revealing inside look at the pharmaceutical industry will find this book well worth reading.
"Li (Laughing Gas, Viagra and Lipitor: The Human Stories Behind the Drugs We Use) surveys Big Pharma's 'golden age' with a nostalgic yet thoughtful history of the science and personalities behind drugs that changed the lives of countless patients while making billions of dollars for the companies that brought them to market. The author examines five classes of blockbusters that gave Big Pharma both esteem and fortunes: from Tagament and Prilosec for peptic ulcers to blockbuster allergy treatments such as Benadryl and Claritin, to blood thinners that refined old-line heparin, to the modern conquest of pain with drugs descended from opium 'one of the first medicines for man.' Li also engagingly relates the tales of the human conflict often involved with discovery, like a precipitous one-year drop in profits that resulted from a feud between an American drug company and one of its Canadian counterparts. Drug discovery is now getting more attention from academia as new products wane, Li notes, but he decries Big Pharma's 'merger mania' and its tarnished reputation, especially following Merck's abrupt withdrawal of anti-inflammatory Vioxx because it led to increased risk of heart attacks and strokes among those taking it. Nevertheless, Li delights in the 'creativity, serendipity and perseverance' of big drug discoveries lessons he hopes may prompt a renaissance in the industry." Publishers Weekly Copyright PWxyz, LLC. All rights reserved.
"Once again, with his latest book, Jack Li has produced a wonderfully fascinating and rich history of the so-called 'Blockbuster Drugs.' From the treatment of ulcers and acid reflux, to the control of allergies, and the conquest of pain, Dr. Li weaves a beautiful tale of these extraordinary medicines, familiar to all. The book is full of detail, with an extensive bibliography, and, for the molecular connoisseur, includes chemical structures in the Appendix. Dr. Li is rapidly becoming a premiere figure for writing about medicines for the educated population!" -- Gordon W. Gribble, The Dartmouth Professor of Chemistry, Dartmouth University
"This enjoyable book describes more than a century of progress in the development of many major new medicines for the treatment of human illness. It provides deep insights into the process of innovation and also the remarkable individuals responsible for it. The accounts are understandable to the non-scientist but also valuable to researchers and practitioners of modern medicine. There is a nice balance between the human, historical and medical sides of drug discovery -- one of the most consequential activities of our times." -- E.J. Corey, Nobel Laureate, Harvard University
"Jie Jack Li takes us through the ages of pharmaceuticals in this informative and engaging book. Professor Li links the medical world with its much broader cultural background in a way that will appeal to many. If you are interested in the past, present, and future of the medicines you take and the background to their production, look no further than this book." --New York Journal of Books
and#8220;In this important new book, Gabriel traces the surprisingly dynamic relationship between intellectual property and the economics and politics of the pharmaceutical industry. Medical Monopoly narrates the formation and reorganization of the and#8216;ethical pharmaceutical industryand#8217; in the nineteenth and early twentieth centuries around questions of patents, trademarks, and a series of mutually defining alliances made between the medical profession and the modern pharmaceutical enterprise. Gabrieland#8217;s research in preparation for this volume has been meticulous, and his narrative pacing will help audiences from many different fields engage with the provocative story he has to tell. The resultant work is an elegant demonstration of the power of historical analysis in understanding the present-day connections between patents, trademarks, medical science, and the marketplace, with substantial implications for contemporary policy and practice.and#8221;
and#8220;In this lively account, Gabriel takes us back to the nineteenth and early twentieth centuries to explore the early histories of the manufacturing, marketing, patenting, and regulation of drugs and their roles in transforming the practice of American medicine. Marrying a keen eye for detail with attention to the larger picture, Gabriel explores the tensions between beneficence and business in the emergent pharmaceutical industry. This meticulously researched book establishes Gabriel as one of the nationand#8217;s experts on the pharmaco-medical enterprise in America from the early Republic to the Progressive Era.and#8221;
and#8220;Medical Monopoly is a fascinating book about the history of intellectual property (IP) rights in pharmaceuticals. Gabriel traces the role that patents and trademarks played in the development of the pharmaceutical industry, explores the question of whether IP rights promoted research and development, and identifies the changing attitudes of physicians and scientists to the propriety of patenting drugs. The book reaches a number of conclusions that are surprising to the contemporary student of both IP and pharmaceuticals, and Gabriel does a nice job of marshaling the massive amount of evidence he uncovered into a chronological narrative. This important work will be of interest to historians of patents and trademarks; to historians of medicine, science, and technology; and to scholars of contemporary IP and science policy.and#8221;
andquot;This fascinating book serves as a pointed reminder that the sources of therapeutic rationale are just as much tied to the production and regulation of therapies as the collective decision-making on ethical practice.andquot;
andquot;In his thought-provoking and well-researched book, Gabriel explores the evolution of patenting, and to a lesser extent, trademark registration, in the American pharmaceutical industry. It is a fascinating and timely contribution.andquot;
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 and 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.
During much of the nineteenth century, physicians and pharmacists alike considered medical patenting and the use of trademarks by drug manufacturers unethical forms of monopoly; physicians who prescribed patented drugs could be, and were, ostracized from the medical community. In the decades following the Civil War, however, complex changes in patent and trademark law intersected with the changing sensibilities of both physicians and pharmacists to make intellectual property rights in drug manufacturing scientifically and ethically legitimate. By World War I, patented and trademarked drugs had become essential to the practice of good medicine, aiding in the rise of the American pharmaceutical industry and forever altering the course of medicine.
Drawing on a wealth of previously unused archival material, Medical Monopoly combines legal, medical, and business history to offer a sweeping new interpretation of the origins of the complex and often troubling relationship between the pharmaceutical industry and medical practice today. Joseph M. Gabriel provides the first detailed history of patent and trademark law as it relates to the nineteenth-century pharmaceutical industry as well as a unique interpretation of medical ethics, therapeutic reform, and the efforts to regulate the market in pharmaceuticals before World War I. His book will be of interest not only to historians of medicine and science and intellectual property scholars but also to anyone following contemporary debates about the pharmaceutical industry, the patenting of scientific discoveries, and the role of advertising in the marketplace.
During roughly the first two-thirds of the nineteenth century, medical patenting and the use of trademarks were considered unethical forms of monopoly by both the medical community and reputable drug manufacturers. Intellectual property rights were thought to monopolize the use of therapeutic substances unfairly, thereby inhibiting the progress of medical science. A prohibition on medical patenting was incorporated into codes of ethics by both the medical and pharmaceutical communities, and physicians that manufactured, used, or prescribed monopolized drugs could be, and were, ostracized from the medical community. As a result, the and#147;ethicaland#8221; drug manufacturers refrained from patenting or trademarking their goods for most of the century.
In sharing this history in full for the first time, Joseph M. Gabriel traces how, in the decades following the Civil War, those reputable drug manufacturers faced a significant problem. Both domestic chemical companies and foreign drug manufacturers introduced a wave of highly effective new medicines. Neither was constrained by the ethical prohibition against IP rights in the same way, and so they often protected their products by both patents and trademarks. Faced with a series of new products that were both clearly effective and also monopolized, the and#147;ethicaland#8221; drug manufacturers found it extremely difficult to compete.
As the medical market of the late nineteenth-century was increasingly flooded with patented and trademarked drugs, the older therapeutic logic began to fracture and so, by the turn of the century, the orthodox medical community had re-conceptualized the problem of monopoly as having little if nothing to do with the question of clinical effectiveness. The spellbinding history of this transition has clear relevance to contemporary debates about pharmaceutical patenting and the role of advertising in the medical marketplace.
About the Author
Dr. Jie Jack Li is currently an Associate Professor of Chemistry at the University of San Francisco. Before his independent academic career, he spent fifteen years in drug discovery at big pharma including Pfizer and Bristol-Myers Squibb Company. He is the author of Triumph of the Heart: The Story of Statins
(Oxford University Press, 2009), Modern Organic Synthesis in the Laboratory
(Oxford University Press, 2007), and Laughing Gas, Viagra, and Lipitor: The Human Stories Behind the Drugs We Use
(Oxford University Press, 2006).
Table of Contents
A Note about Terms
1 Medical Science and Property Rights in the Early Republic
2 Monopoly and Ethics in the Antebellum Years
3 In the Shadow of War
4 Therapeutic Reform and the Reinterpretation of Monopoly
5 The Ambiguities of Abundance
6 The Embrace of Intellectual Property
Conclusion: The Promise of Reform
Archival Collections Consulted