Whats In A Name Generics And The Persistence Of The Pharmaceutical Brand In American Medicine
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| Author | : Jeremy A. Greene |
| Publisher | : |
| Total Pages | : 0 |
| Release | : 2012 |
| Genre | : |
| ISBN | : |
This paper explores the complex role that brand names have played in the maintenance of therapeutic standards within twentieth-century American medicine. What made a generic drug generic in the second half of the twentieth century -- and by extension, what made a nonproprietary drug not proprietary in the first half -- was dependent on changing drug branding practices and evolving standards of evidence attached to claims of therapeutic efficacy and safety. This article maps three eras of shifting oppositions between branded and unbranded pharmaceuticals. First, an era of "ethical marketing," extending from before the Pure Food and Drug Act of 1906 into roughly the 1930s, which pitted nonproprietary or "ethical" pharmaceuticals against proprietary or patent medicines; second, an era of ascendant brand-name prescribing from the 1930s until roughly the 1960s, as manufacturers of innovative and patent-protected "specialty" drugs depicted generic production as a form of counterfeiting; and finally, an era of generic backlash from the 1960s onwards, which assumed the interchangeability of branded and generic drugs. This article uses clinical, popular, policy, and trade literature to explore the enduring roles of brand-logic in the face of generic competition in the American drug market.
| Author | : Holly Fernandez Lynch |
| Publisher | : Columbia University Press |
| Total Pages | : 499 |
| Release | : 2015-09-08 |
| Genre | : Business & Economics |
| ISBN | : 0231540078 |
In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
| Author | : Cori Hayden |
| Publisher | : Duke University Press |
| Total Pages | : 137 |
| Release | : 2022-12-26 |
| Genre | : Social Science |
| ISBN | : 1478023678 |
In The Spectacular Generic, Cori Hayden examines how generic drugs have transformed public health politics and everyday experiences of pharmaceutical consumption in Latin America. Focusing on the Mexican pharmacy chain Farmacias Similares and its proprietor, Víctor González Torres, Hayden shows how generics have become potent commodities in a postpatent world. In the early 2000s, González Torres, a.k.a. “Dr. Simi,” capitalized on the creation of new markets for generic medicines, selling cheaper copies of leading-brand drugs across Latin America. But Dr. Simi has not simply competed with the transnationals; his enterprise has also come to compete with the Mexican state, reorganizing the provision of medicine and basic health care for millions of people. Hayden juxtaposes this story with Dr. Simi’s less successful efforts in Argentina, where he confronted a radically different configuration of pharmaceutical politics. Building from these diverging trajectories, Hayden illuminates the politics of generic substitution as a question that goes beyond substituting one drug for another. Generic politics can radically reshape the relations among consumers, states, and pharmaceutical markets, even as they have yet to resolve the problems of cost and access.
| Author | : Scott H. Podolsky |
| Publisher | : JHU Press |
| Total Pages | : 324 |
| Release | : 2015-01-15 |
| Genre | : Medical |
| ISBN | : 1421415941 |
A compelling analysis of nearly seven decades of antibiotic reform, framing our current efforts to stave off a post-antibiotic era. Winner of the CHOICE Outstanding Academic Title of the Choice ACRL In The Antibiotic Era, physician-historian Scott H. Podolsky narrates the far-reaching history of antibiotics, focusing particularly on reform efforts that attempted to fundamentally change how antibiotics are developed and prescribed. This sweeping chronicle reveals the struggles faced by crusading reformers from the 1940s onward as they advocated for a rational therapeutics at the crowded intersection of bugs and drugs, patients and doctors, industry and medical academia, and government and the media. During the post–World War II “wonder drug” revolution, antibiotics were viewed as a panacea for mastering infectious disease. But from the beginning, critics raised concerns about irrational usage and overprescription. The first generation of antibiotic reformers focused on regulating the drug industry. The reforms they set in motion included the adoption of controlled clinical trials as the ultimate arbiters of therapeutic efficacy, the passage of the Kefauver-Harris amendments mandating proof of drug efficacy via well-controlled studies, and the empowering of the Food and Drug Administration to remove inefficacious drugs from the market. Despite such victories, no entity was empowered to rein in physicians who inappropriately prescribed, or overly prescribed, approved drugs. Now, in an era of emerging bugs and receding drugs, discussions of antibiotic resistance focus on the need to develop novel antibiotics and the need for more appropriate prescription practices in the face of pharmaceutical marketing, pressure from patients, and the structural constraints that impede rational delivery of antibiotics worldwide. Concerns about the enduring utility of antibiotics—indeed, about a post-antibiotic era—are widespread, as evidenced by reports from the Centers for Disease Control and Prevention, academia, and popular media alike. Only by understanding the historical forces that have shaped our current situation, Podolsky argues, can we properly understand and frame our choices moving forward.
| Author | : Andrew E. Skodol |
| Publisher | : American Psychiatric Pub |
| Total Pages | : 762 |
| Release | : 2021-03-31 |
| Genre | : Medical |
| ISBN | : 1615373748 |
The subject of personality -- what makes each of us unique and different from one another -- has long been a topic of universal fascination. From a medical perspective, research on personality disorders has expanded with the advent of standardized diagnostic systems. This continuing and increased activity and progress in the field spurred the development of this third edition of The American Psychiatric Association Publishing Textbook of Personality Disorders. With an emphasis on updating the information most relevant to clinicians, this new edition features contributions from established experts in the field as well as a new generation of scientists. Dozens of tables, illustrative figures, and real-life case examples summarize the vast data that continue to accumulate in five key areas: Clinical concepts, including theories of personality disorders, as well as their manifestations, assessment, and diagnosis. This opening section also describes the Alternative DSM-5 Model for Personality Disorders in detail. Risk factors for, and the etiology and impact of, personality disorders. This section of the book examines data on prevalence, sociodemographics, and levels of functional impairment associated with personality disorders. It offers both a developmental and a genetic/neurobiological perspective and describes the symptomatic and functional outcomes of personality disorders. Treatment options across therapeutic modalities. A new, cutting-edge chapter argues for the early identification of borderline psychopathology in children and young adolescents, in an effort to prevent full-blown disorder later in life. Additional chapters delve into an array of individual psychotherapies, pharmacotherapeutic options, and group, family, and couples therapies. Guidance on forming and maintaining a therapeutic alliance and on avoiding boundary violations in treating patients with personality disorders is provided. Special problems, populations, and settings, including suicide, substance use disorders, antisocial behavior, personality pathology in general medical settings, and personality disorders among active-duty military. The usefulness of translational research to deepen understanding of the biopsychosocial nature of the personality disorders, particularly borderline personality disorder. This comprehensive textbook is an essential resource for clinicians looking to stay on the vanguard of a rapidly growing field.
| Author | : Anne Pollock |
| Publisher | : Duke University Press |
| Total Pages | : 277 |
| Release | : 2012-10-02 |
| Genre | : History |
| ISBN | : 082235344X |
In Medicating Race, Anne Pollock traces the intersecting discourses of race, pharmaceuticals, and heart disease in the United States over the past century, from the founding of cardiology through the FDA's approval of BiDil, the first drug sanctioned for use in a specific race. She examines wide-ranging aspects of the dynamic interplay of race and heart disease: articulations, among the founders of American cardiology, of heart disease as a modern, and therefore white, illness; constructions of "normal" populations in epidemiological research, including the influential Framingham Heart Study; debates about the distinctiveness African American hypertension, which turn on disparate yet intersecting arguments about genetic legacies of slavery and the comparative efficacy of generic drugs; and physician advocacy for the urgent needs of black patients on professional, scientific, and social justice grounds. Ultimately, Pollock insists that those grappling with the meaning of racialized medical technologies must consider not only the troubled history of race and biomedicine but also its fraught yet vital present. Medical treatment should be seen as a site of, rather than an alternative to, political and social contestation. The aim of scholarly analysis should not be to settle matters of race and genetics, but to hold medicine more broadly accountable to truth and justice.
| Author | : Ann H. Kelly |
| Publisher | : Routledge |
| Total Pages | : 164 |
| Release | : 2013-09-13 |
| Genre | : Medical |
| ISBN | : 1135759278 |
What is the value of medical research? With contributions from anthropologists, sociologists and activists, this approach brings into focus the forms of value – social, epistemic, and economic – that are involved in medical research practices and how these values intersect with everyday living. Though their work covers wide empirical ground –from HIV trials in Kenya and drug donation programs in Tanzania to industry-academic collaborations in the British National Health Service – the authors share a commitment to understanding the practices of medical research as embedded in both local social worlds and global markets. Their collective concern is to rethink the conventional ethical demarcations betwweenpaid and unpaid research services in light of the social and material organisation of medical research practices. . Rather than warn against economic incursions into medical knowledge and health practice, or, alternatively, the reduction of local experience to the standards of bioethics, we hope to illuminate the array of practices, knowledges, and techniques through which the value of medical research is brought into being. This book was originally published as a special issue of Journal of Cultural Economy.
| Author | : Joseph M. Gabriel |
| Publisher | : University of Chicago Press |
| Total Pages | : 345 |
| Release | : 2014-10-24 |
| Genre | : History |
| ISBN | : 022610821X |
During most 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.
| Author | : E. Cloatre |
| Publisher | : Springer |
| Total Pages | : 216 |
| Release | : 2013-08-06 |
| Genre | : Law |
| ISBN | : 1137313277 |
The desperate need for a vast part of the global population to access better medicines in more certain ways is one of the biggest concerns of the modern era. Pills for the Poorest offers a new perspective on the much-debated issue of the links between intellectual property and access to medication. Using ethnographic case studies in Djibouti and Ghana, and insights from actor-network theory, it explores the ways in which TRIPs and pharmaceutical patents are translated in the daily practices of those who purchase, distribute, and use (or fail to use) medicines in sub-Saharan Africa. It suggests that focusing on routine practices and the material deployment of intellectual property significantly enriches our understanding of the complex dynamics that animate the field of access to medicines and helps relocate the role of law within those processes. It demonstrates how intellectual property affects access to medicines in ways that are often discreet, indirect and forgotten. By exploring these complex mechanisms, it seeks to ask questions about the modes of actions of pharmaceutical patents, but also, more generally, about the complexity of legal objects.
| Author | : Jeremy A. Greene |
| Publisher | : Johns Hopkins University Press |
| Total Pages | : 375 |
| Release | : 2016-09-01 |
| Genre | : Medical |
| ISBN | : 142142164X |
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.
