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Generic: The Unbranding of Modern Medicine Reprint Edition
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The turbulent history of generic pharmaceuticals raises powerful questions about similarity and difference in modern medicine.
Generic drugs are now familiar objects in clinics, drugstores, and households around the world. We like to think of these tablets, capsules, patches, and ointments as interchangeable with their brand-name counterparts: why pay more for the same? And yet they are not quite the same. They differ in price, in place of origin, in color, shape, and size, in the dyes, binders, fillers, and coatings used, and in a host of other ways. Claims of generic equivalence, as physician-historian Jeremy Greene reveals in this gripping narrative, are never based on being identical to the original drug in all respects, but in being the same in all ways that matter.
How do we know what parts of a pill really matter? Decisions about which differences are significant and which are trivial in the world of therapeutics are not resolved by simple chemical or biological assays alone. As Greene reveals in this fascinating account, questions of therapeutic similarity and difference are also always questions of pharmacology and physiology, of economics and politics, of morality and belief.
Generic is the first book to chronicle the social, political, and cultural history of generic drugs in America. It narrates the evolution of the generic drug industry from a set of mid-twentieth-century "schlock houses" and "counterfeiters" into an agile and surprisingly powerful set of multinational corporations in the early twenty-first century.
The substitution of bioequivalent generic drugs for more expensive brand-name products is a rare success story in a field of failed attempts to deliver equivalent value in health care for a lower price. Greene’s history sheds light on the controversies shadowing the success of generics: problems with the generalizability of medical knowledge, the fragile role of science in public policy, and the increasing role of industry, marketing, and consumer logics in late-twentieth-century and early twenty-first century health care.
- ISBN-109781421421643
- ISBN-13978-1421421643
- EditionReprint
- PublisherJohns Hopkins University Press
- Publication dateSeptember 1, 2016
- LanguageEnglish
- Dimensions6 x 0.85 x 9 inches
- Print length376 pages
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Editorial Reviews
Review
―Somatosphere
An excellent and recommended history of how the generic drug market came to be.
―Library Journal
Fascinating and thought-provoking.
―History Wire: Where the Past Comes Alive
Dr. Greene's gripping and eye-opening accounts of the scientific, social, and political debates that happened along the way keep the reader hooked and engaged. . . [He] is both scholar and storyteller, interspersing fascinating historical narratives with complex scientific discussion.
―P&T Community
Greene should be congratulated for bringing this subject to life―with a mix of anecdote, scholarship, and elegant prose.
―Lancet
As Jeremy Greene lays out in his excellent book, the story of the generic drug industry is is far more complicated―and far more interesting than most of us might guess . . . [Greene] provides readers with a useful framework for understanding how we got to where we are and how we might apply the lessons of the past to the challenges we face today.
―Health Affairs
Greene turns the concept of generic as 'ho-hum' on its head with this jam-packed survey of the effects culture, medicine, and politics have exerted on today's ubiquitous generic drugs for the last 50 years.
―Publishers Weekly
Jeremy Greene's Generic: The Unbranding of Modern Medicine fascinates because the very meaning of the key term 'generic' is so unstable. Every time the reader thinks they have a handle on its dimensions, another four open up.
―Joseph Dumit, Somatosphere
Greene's book is a dizzying historical-political-social-cultural account of the forms generic drugs have taken over past several decades.
―Somatosphere
Generic: The Unbranding of Modern Medicine comes from a physician and historian who offers a history of not just the development of generic drugs, but how they differ from the original. Within his examination are important insights on how drugs are made, what parts of a pill really matter, issues of therapeutic similarity and difference, and more. It's a wide-ranging history that embraces ethical, scientific, health, and economic issues and it provides insights on the history of generic drugs in America and the problems associated with scientific and medical changes in the public eye. The result is a survey that belongs in any health collection and many a general-interest holding.
―The Midwest Book Review
This fine, stimulating, and entertaining book offers much food for thought.
―Nicolas Rasmussen, Journal of the History of Medicine and Allied Sciences
Well written and informative . . . bring[s] to life a tangled web of competing interests.
―Phillip Broadwith, Chemistry World
A theoretical and empirical primer that explains the success and failure of generics and what it means to choose between generic and brand name drugs. Extensively researched and documented, Generic is the first book to chronicle the development of generics, and will probably be the key reference on the topic for some time . . . A book that should be read by anybody with a serious interest in contemporary healthcare.
―Debra Swoboda, Sociology of Health and Illness
The generic drug industry. . . has been glorified as the antidote to exorbitant drug prices, and vilified as the purveyor of poisonous (or at least less effective) counterfeit drugs. Yet in Generic, Jeremy Greene has a far more nuanced, and far more interested, tale to tell. . . Greene's vitally important book. . . explicitly asks us to consider how much the tensions concerning times and places examined in the book are the same as those we face today. . . or at least similar enough in ways that we should find relevant. The answer is, very much.
―Scott H. Podolsky, Studies in the History and Philosophy of Science
Physician/historian Greene provides a thoroughly researched discussion about generic products derived from innovative or brand-name drugs, focusing on their "social, political, and cultural history" . . . Greene ably argues for generic by providing inside details about the drug approval process.
―Choice
. . . Generic is an excellent example of how to intelligently construct a modern material history, grounded in the logics of the everyday.
―Medical Anthropology Quarterly
. . . recommended reading for anyone interested in postwar developments in U.S. health care and for scholars and analysts of contemporary pharmaceutical politics.
―Bulletin of the History of Medicine
Greene’s book is a pioneering work. His study is particularly relevant for historians of medicine and health but will be of interest for readers from history and sociology of science, as well as other social scientists who specialize in drug regulation.
―Isis
A detailed, well-documented and engaging account . . . The audience for Generic is broad. Pharmacists who appreciate the history of our profession will enjoy learning about the events and actions that formed the current state of drug policy . . . Generic could serve as the basis for a revealing graduate seminar in the pharmacy social and administrative sciences. Finally, pharmacy and medical historians and sociologists including those without a health emphasis should find this book useful as generic drugs are used as a specific example of the interplay between science, the professions, industry, government, other regulators, and consumers in shaping contemporary health policy.
―Duane M. Kirking, PharmD, PhD, University of Michigan College of Pharmacy, Pharmacy in History
An enlightening and passionately written work, Generic opens the 'black box' of the pharmaceutical world. This book will deeply impact the way we imagine and practice medicine in the future.
―Siddhartha Mukherjee, Assistant Professor of Medicine, Columbia University, author of The Emperor of All Maladies: A Biography of Cancer
An extraordinarily timely and important contribution to our understanding of health practice and public policy. The status of generics is a significant subject in itself, and also a tool to think with, linking physiology and policy, business history and clinical options. Generic is a book that should be read by anyone with a serious interest in contemporary health care.
―Charles E. Rosenberg, Professor of the History of Science and the Ernest E. Monrad Professor in the Social Sciences, Harvard University
Jeremy Greene brings his knowledge and wisdom as both historian and physician to bear on the economics and politics of branding, marketing, and consumerism in health care. Most intriguingly, he asks fundamental questions about what it means to say one drug is the same as another. Fascinating and eye-opening.
―Susan Strasser, Richards Professor of American History, University of Delaware, author of Satisfaction Guaranteed: The Making of the American Mass Market
Generic is a gem. Original, multi-layered, and powerfully narrated, the book unearths the history and value of generic drugs. While illuminating the dynamic interface of medicine, public health, and the marketplace in the US and beyond, Greene has crafted a vital compass that can greatly help us to understand and navigate the pharmaceutical present.
―João Biehl, Susan Dod Brown Professor of Anthropology, Princeton University, author of Will to Live: AIDS Therapies and the Politics of Survival
The story of generic drugs is rife with intrigue, deceit, complex scientific debate, legislative wrangling, backstabbing, internecine warfare among health professions and government regulators, under-the-table deals worth billions of dollars, headline-grabbing prison sentences for trusted officials, and power struggles among monied interest groups. But Jeremy A. Greene’s Generic is not just a lurid story: it is also rich with lessons in the negotiating of health policy, the brokering of legitimate scientific disputes to craft the best possible regulatory decisions for the public health, the struggles to make health care more affordable for as many citizens as possible, and the transformation of the global pharmaceutical marketplace. A provocative, thoughtful, and comprehensive look into an industry that took on big pharma and organized medicine.
―John P. Swann, author of Academic Scientists and the Pharmaceutical Industry: Cooperative Research in Twentieth-Century America
Review
The story of generic drugs is rife with intrigue, deceit, complex scientific debate, legislative wrangling, backstabbing, internecine warfare among health professions and government regulators, under-the-table deals worth billions of dollars, headline-grabbing prison sentences for trusted officials, and power struggles among monied interest groups. But Jeremy A. Greene’s Generic is not just a lurid story: it is also rich with lessons in the negotiating of health policy, the brokering of legitimate scientific disputes to craft the best possible regulatory decisions for the public health, the struggles to make health care more affordable for as many citizens as possible, and the transformation of the global pharmaceutical marketplace. A provocative, thoughtful, and comprehensive look into an industry that took on big pharma and organized medicine.
-- John P. SwannBook Description
The turbulent history of generic pharmaceuticals raises powerful questions about similarity and difference in modern medicine.
From the Inside Flap
Generic drugs are familiar objects in clinics, drugstores, and households around the world. We like to think of these tablets, capsules, patches, and ointments as being interchangeable with their brand-name counterparts: why pay more for the same? And yet they are not quite the same. They differ in price, in place of origin, in color, shape, and size, in the dyes, binders, fillers, and coatings used, and in a host of other ways. Claims of generic equivalence, as physician-historian Jeremy Greene reveals, are never based on being identical to the original drug in all respects, but in being the same in all ways that matter.
Decisions about which differences are significant and which are trivial in the world of therapeutics are not resolved by simple chemical or biological assays alone. Questions of therapeutic similarity and difference are also always questions of pharmacology and physiology, of economics and politics, of morality and belief. Generic is the first book to chronicle the social, political, and cultural history of generic drugs in America. It narrates the evolution of the generic drug industry from a set of mid-twentieth-century "schlock houses" and "counterfeiters" into an agile and surprisingly powerful set of multinational corporations in the early twenty-first century.
Greene's history sheds light on the controversies shadowing the success of generics: problems with the generalizability of medical knowledge, the fragile role of science in public policy, and the increasing role of industry, marketing, and consumer logics in late twentieth-century and early twenty-first-century health care. This edition features a new preface in which Greene explores shortages and price hikes on off-patent drugs, strategies by which old drugs can paradoxically become more expensive, and the role of historical analysis in present-day pharmaceutical policy.
Greene turns the concept of generic as 'ho-hum' on its head with this jam-packed survey of the effects culture, medicine, and politics have exerted on today's ubiquitous generic drugs for the last 50 years.--Publishers Weekly
An excellent and recommended history of how the generic drug market came to be.--Library Journal
Greene should be congratulated for bringing this subject to life--with a mix of anecdote, scholarship, and elegant prose.--Lancet
A useful framework for understanding how we got to where we are and how we might apply the lessons of the past to the challenges we face today.--Health Affairs
An excellent example of how to intelligently construct a modern material history, grounded in the logics of the everyday.--Medical Anthropology Quarterly
Recommended reading for anyone interested in postwar developments in U.S. health care and for scholars and analysts of contemporary pharmaceutical politics.--Bulletin of the History of Medicine
Jeremy A. Greene is a professor of medicine and the history of medicine and the Elizabeth Treide and A. McGehee Harvey Chair in the History of Medicine at Johns Hopkins University School of Medicine. He is the author of Prescribing by Numbers: Drugs and the Definition of Disease and the coeditor of Prescribed: Writing, Filling, Using, and Abusing the Prescription in Modern America.
--John P. Swann, author of Academic Scientists and the Pharmaceutical Industry: Cooperative Research in Twentieth-Century America "Isis"From the Back Cover
Generic drugs are familiar objects in clinics, drugstores, and households around the world. We like to think of these tablets, capsules, patches, and ointments as being interchangeable with their brand-name counterparts: why pay more for the same? And yet they are not quite the same. They differ in price, in place of origin, in color, shape, and size, in the dyes, binders, fillers, and coatings used, and in a host of other ways. Claims of generic equivalence, as physician-historian Jeremy Greene reveals, are never based on being identical to the original drug in all respects, but in being the same in all ways that matter.
Decisions about which differences are significant and which are trivial in the world of therapeutics are not resolved by simple chemical or biological assays alone. Questions of therapeutic similarity and difference are also always questions of pharmacology and physiology, of economics and politics, of morality and belief. Generic is the first book to chronicle the social, political, and cultural history of generic drugs in America. It narrates the evolution of the generic drug industry from a set of mid-twentieth-century “schlock houses” and “counterfeiters” into an agile and surprisingly powerful set of multinational corporations in the early twenty-first century.
Greene’s history sheds light on the controversies shadowing the success of generics: problems with the generalizability of medical knowledge, the fragile role of science in public policy, and the increasing role of industry, marketing, and consumer logics in late twentieth-century and early twenty-first-century health care. This edition features a new preface in which Greene explores shortages and price hikes on off-patent drugs, strategies by which old drugs can paradoxically become more expensive, and the role of historical analysis in present-day pharmaceutical policy.
"Greene turns the concept of generic as 'ho-hum' on its head with this jam-packed survey of the effects culture, medicine, and politics have exerted on today's ubiquitous generic drugs for the last 50 years."―Publishers Weekly
"An excellent and recommended history of how the generic drug market came to be."―Library Journal
"Greene should be congratulated for bringing this subject to life―with a mix of anecdote, scholarship, and elegant prose."―Lancet
"A useful framework for understanding how we got to where we are and how we might apply the lessons of the past to the challenges we face today."―Health Affairs
"An excellent example of how to intelligently construct a modern material history, grounded in the logics of the everyday."―Medical Anthropology Quarterly
"Recommended reading for anyone interested in postwar developments in U.S. health care and for scholars and analysts of contemporary pharmaceutical politics."―Bulletin of the History of Medicine
Jeremy A. Greene is a professor of medicine and the history of medicine and the Elizabeth Treide and A. McGehee Harvey Chair in the History of Medicine at Johns Hopkins University School of Medicine. He is the author of Prescribing by Numbers: Drugs and the Definition of Disease and the coeditor of Prescribed: Writing, Filling, Using, and Abusing the Prescription in Modern America.
About the Author
Product details
- ASIN : 142142164X
- Publisher : Johns Hopkins University Press; Reprint edition (September 1, 2016)
- Language : English
- Paperback : 376 pages
- ISBN-10 : 9781421421643
- ISBN-13 : 978-1421421643
- Reading age : 18 years and up
- Item Weight : 1.2 pounds
- Dimensions : 6 x 0.85 x 9 inches
- Best Sellers Rank: #3,057,956 in Books (See Top 100 in Books)
- #1,560 in Pharmacies
- #3,254 in History of Medicine (Books)
- #11,093 in History & Philosophy of Science (Books)
- Customer Reviews:
About the author

Jeremy Greene is a physician, historian, and author whose writings capture the social lives and political stakes of everyday medical technologies. He is the William H. Welch Professor of Medicine and the History of Medicine at the Johns Hopkins University School of Medicine, where he directs the Institute of the History of Medicine and the Center for Medical Humanities and Social Medicine, and practices general internal medicine in an urban community health center. In addition to these books, Greene publishes widely in popular periodicals, health policy, public health, and clinical journals, and scholarly journals in the humanities and social sciences of health and medicine.
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- Reviewed in the United States on February 12, 2017Great book. Perhaps a little out of date but provides insights into another facet of the health care crisis.
- Reviewed in the United States on February 17, 2019The book Generic by Greene is best described as a history of the early days of the introduction of generic therapeutics. The approval of any new therapeutic by the FDA has been an evolving process. The current process is in a simple manner a three step process in humans, which itself occurs after in vitro and animal testing . Phase I typically examines the safety of the drug. Phase II looks at efficacy. Namely does it work. Phase III examines clinical effectiveness. The FDA process does not look at such things as comparative effectiveness and post approval there is no standard requirement for monitoring, and thus many effects that may result from usage are at best reported and catalogued.
Overall the process tries to limit harm while attempting to deliver drugs which do what they are purported to do. The question however is: just what is the drug being tested? The drug is often an active ingredient which may be patented. The active ingredient may then be patented but the actual drug tested and approved, under a non-disclosure agreement with the FDA, may have inactive or even compounding ingredients that facilitate the activation and utilization of the patented drug. Thus the actual drug sold by the initial holder of the patent is the publicly identified chemical structure, plus other elements that may facilitate the utilization and assist in the overall efficacy. Such things may be the delaying of the breakdown of the prime element until well within the digestive tract or the enabling of timed release.
Now along come the generics. A generic is a copy of the prime patented molecule after the patent has expired. The other proprietary elements are not necessarily there, since they have never been disclosed. Thus if the drug only works by getting it to the small intestine and the NDA protected elements facilitate that, the exclusion of those elements may make the drug generic ineffective. Thus generics are same "but for" the key proprietary ingredients which are secret to the original patent holder and the FDA, never to be disclosed.
How does a generic get approved ? The FDA requires the following:
The generic drug is "pharmaceutically equivalent" to the brand.
The manufacturer is capable of making the drug correctly.
The manufacturer is capable of making the drug consistently.
The “active ingredient” is the same as that of the brand.
The right amount of the active ingredient gets to the place in the body where it has effect.
The "inactive" ingredients of the drug are safe.
The drug does not break down over time.
The container in which the drug will be shipped and sold is appropriate.
The label is the same as the brand-name drug’s label.
Relevant patents or legal exclusivities are expired.
Note, it does not require the same inactive ingredients. It does require "pharmaceutically equivalent". Now just what does that mean? The FDA notes:
generic drug needs to show that it is the same type of product (such as a tablet or an injectable) and uses the same time release technology (such as immediate-release, meaning for immediate effect of the drug, or extended-release, meaning one that is intended to slowly release the active ingredient over time).
There may be many issues here as well. But there are several interesting questions. First, not that these are the current 2019 FDA rules and generics have been around for quite a long time. Thus do these rules apply to all those previous generics? If not, what has been the evolution process? What risks if any do generics pose? Are generics the panacea for explosive pricing on all therapeutics? And the list goes on.
Green presents a history of the generic movement. It clearly is a battle between and amongst the members of Congress as well as the major Pharmas and they growing generic makers. The book presents the growth of this industry in a readable fashion and one can see the issues from the Mylan controversy going back decades not just of recent times.
Words like substitutability and similarity are examined in the context of the generic battle. The major Pharmas roles are presented and the development of various generic entities discussed.
The main weakness of the book in my opinion is that it lacks structure and seems to be limited to the earlier days of the generic introductions. The structure issue is that there is a going back and forth over the same ground and no linear temporal progression of the topics. The temporal issues in my opinion is the discussion of the early days and a lack of discussion of the more recent period.
One of the concerns we should have in my opinion is the outsourcing of generic drug production in China, India, and other countries. Although the FDA alleges it does maintain quality controls these controls can often be circumvented. Thus generics like levothyroxine could readily be adulterated by various means and since 10% ore more of the US population is exposed this could be a massive threat. Add all the generics together and the global outsourcing of production and we could have a major threat to US security, well in excess of any cyber threat.
Thus it would have been useful in my opinion of this tale had been equally focused on current times as well. Yet, overall this is a highly useful and timely presentation of a topic needing more effective consumer education.
- Reviewed in the United States on July 2, 2019Reference book for our medical clinic.
- Reviewed in the United States on February 15, 2015As a primary care physician, I thoroughly enjoyed Jeremy Greene's book. The author writes well and gives a clear narrative on a complicated topic. He writes without bias, and allows the reader to make his/her own judgment. The story of the generics in the US plays a crucial in the state of affairs of our healthcare system. This book is an excellent read.
- Reviewed in the United States on April 23, 2015Well written and informative to the uninitiated. Revealed the very capitalistic motives at play at the root of the issue. Revealed the lack of fairness in the handling of intellectual property across national boundaries. Lacked any compelling message as to what to do to make the situation optimal, or at least better than exists at present.