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Author: Marc A. Rodwin Publisher: ISBN: Category : Languages : en Pages : 10
Book Description
In this symposium of The Journal of Law, Medicine & Ethics, 16 authors investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs and what is corrupted. This introductory essay summarizes each article, discusses the key theme that run through the articles, and provides SSRN web links to access each of the 16 articles. The articles are organized into five topics: (1) systemic problems, (2) medical research, (3) medical knowledge and practice, (4) marketing, and (5) patient advocacy organizations.Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption -- that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. We will see that the pharmaceutical industry's own purposes are often undermined. In addition, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, and the Food and Drug Administration's oversight of pharmaceutical marketing. As a result, practitioners may think they are using reliable information to engage in sound medical practice while actually relying on misleading information and therefore prescribe drugs that are unnecessary or harmful to patients, or more costly than equivalent medications. At the same time, patients and the public may believe that patient advocacy organizations effectively represent their interests while these organizations actually neglect their interests.
Author: Marc A. Rodwin Publisher: ISBN: Category : Languages : en Pages : 10
Book Description
In this symposium of The Journal of Law, Medicine & Ethics, 16 authors investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs and what is corrupted. This introductory essay summarizes each article, discusses the key theme that run through the articles, and provides SSRN web links to access each of the 16 articles. The articles are organized into five topics: (1) systemic problems, (2) medical research, (3) medical knowledge and practice, (4) marketing, and (5) patient advocacy organizations.Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption -- that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. We will see that the pharmaceutical industry's own purposes are often undermined. In addition, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, and the Food and Drug Administration's oversight of pharmaceutical marketing. As a result, practitioners may think they are using reliable information to engage in sound medical practice while actually relying on misleading information and therefore prescribe drugs that are unnecessary or harmful to patients, or more costly than equivalent medications. At the same time, patients and the public may believe that patient advocacy organizations effectively represent their interests while these organizations actually neglect their interests.
Author: Anna Laskai Publisher: Springer Nature ISBN: 3030447901 Category : Social Science Languages : en Pages : 298
Book Description
This book discusses the influence of the pharmaceutical industry on the practice of medicine, and the observed and potential pitfalls of such partnerships. It argues that the pharmaceutical industry has become indispensable to many of the activities of the medical profession across the pharmaceutical product lifecycle, and examines the regulatory, ethical, professional and institutional difficulties that arise from these interactions. With data drawn from over 80 qualitative accounts from medical, pharmaceutical, regulatory and healthcare professionals, this book uses both Hungary and the Netherlands as case studies to demonstrate the potential problem of undue pharmaceutical industry influence within the relationships fostered with the profession of medicine. Chapters systematically describe the lifecycle of a pharmaceutical product from research to distribution, demonstrating the interdependency of industry and medicine. Arguing that the medical profession should be a buffer between the pharmaceutical industry interests and patient interests, the book explores how undue industry influence weakens the ability of the medical profession to do so. Using the theory of institutional corruption, the book aims to analyze how conflict of interest and the weakening of institutional imperatives is a result of institutional interactions rather than individual actions. Appropriate for students and researchers of the pharmaceutical industry, corporate corruption, and those working in NGOs and policy making, this unique volume is an comprehensive look at the complex relationship between medicine and pharmacy.
Author: Donald W. Light Publisher: ISBN: Category : Languages : en Pages : 0
Book Description
Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised Congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA's prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication: independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few if any new clinical benefits; and the creation of a National Drug Safety Board.
Author: Thomas Fulda Publisher: CRC Press ISBN: 9781439804261 Category : Medical Languages : en Pages : 714
Book Description
Get an invaluable view of the impact of economics and politics on pharmaceuticals in the United States Pharmacy and pharmaceutical drug use are highly regulated and the various regulatory forces interact with diverse goals. Pharmaceutical Public Policy is a comprehensive review of the legislation, trends, business developments, and policy interpretations that have shaped drug use during the last 50 years. This unique single source explains drug regulatory activity, the major insurance and payment systems, and the impact of economics and politics on drug use in the United States. Leading experts provide a thorough and objective look at public policy issues, making this text perfect for upper level undergraduate and graduate level pharmacy, medical, and public health educators and students. Pharmacists and pharmacy students must learn more than just the physical sciences and clinical aspects of the pharmaceutical industry. The rationale for policies, rules, and regulations is integral to understanding how to best serve patients and make the entire pharmaceutical sector more equitable and cost-effective. Pharmaceutical Public Policy examines the most pressing issues facing the industry, including control of the rising costs for drugs and ensuring correct drug usage by patients. This insightful text offers an in depth perspective of the policies and the debates that surround them. Chapters are well-referenced and many include helpful figures and tables to illustrate facts and ideas. Topics in Pharmaceutical Public Policy include: pharmacy law and regulation Medicare and prescription drug coverage FDA drug approval process Medicaid and prescription drugs public health pharmacy Department of Veterans Affairs pharmacy programs Department of Defense pharmacy programs innovative state drug program practices state and federal regulation of pharmacy the future of the pharmaceutical industry managed care pharmacy PBM’s (pharmacy benefit managers) risk minimization importation and reimportation biotechnology and pharmacogenetics policy and issues product promotion competition between drugs drug insurance design patient compliance abuse of prescription drugs health care systems and insurance in Europe much more Pharmaceutical Public Policy is a one-of-a-kind resource that explains just who the players are and the complexity of the issues that are examined in most pharmaceutical policy debates, and is perfect for pharmacy students, educators, other health professionals, trade association leaders, and policymakers.
Author: R. Whitaker Publisher: Springer ISBN: 113751602X Category : Social Science Languages : en Pages : 397
Book Description
Psychiatry Under the Influence investigates the actions and practices of the American Psychiatric Association and academic psychiatry in the United States, and presents it as a case study of institutional corruption.
Author: Marc A. Rodwin Publisher: ISBN: Category : Languages : en Pages : 0
Book Description
Prescribing drugs for uses that the FDA has not approved -- off-label drug use -- can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight by prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. Public policy should address the cause and control the practice. To manage inappropriate off-label drug use, off-label prescriptions must be tracked in order to monitor the risks and benefits and the manufacturers' conduct. Even more important, reimbursement rules should be changed so that manufacturers cannot profit from off-label sales. When off-label sales pass a critical threshold, manufacturers should also be required to pay for independent testing of the safety and effectiveness of off-label drug uses and for the FDA to review the evidence. Manufacturers should also finance, under FDA supervision, programs designed to warn physicians and the public about the risks of off-label drug use.
Author: National Academies of Sciences, Engineering, and Medicine Publisher: National Academies Press ISBN: 0309477891 Category : Medical Languages : en Pages : 399
Book Description
In 2015, building on the advances of the Millennium Development Goals, the United Nations adopted Sustainable Development Goals that include an explicit commitment to achieve universal health coverage by 2030. However, enormous gaps remain between what is achievable in human health and where global health stands today, and progress has been both incomplete and unevenly distributed. In order to meet this goal, a deliberate and comprehensive effort is needed to improve the quality of health care services globally. Crossing the Global Quality Chasm: Improving Health Care Worldwide focuses on one particular shortfall in health care affecting global populations: defects in the quality of care. This study reviews the available evidence on the quality of care worldwide and makes recommendations to improve health care quality globally while expanding access to preventive and therapeutic services, with a focus in low-resource areas. Crossing the Global Quality Chasm emphasizes the organization and delivery of safe and effective care at the patient/provider interface. This study explores issues of access to services and commodities, effectiveness, safety, efficiency, and equity. Focusing on front line service delivery that can directly impact health outcomes for individuals and populations, this book will be an essential guide for key stakeholders, governments, donors, health systems, and others involved in health care.
Author: Peter Gotzsche Publisher: CRC Press ISBN: 1908911123 Category : Medical Languages : en Pages : 251
Book Description
PRESCRIPTION DRUGS ARE THE THIRD LEADING CAUSE OF DEATH AFTER HEART DISEASE AND CANCER. In his latest ground-breaking book, Peter C Gotzsche exposes the pharmaceutical industries and their charade of fraudulent behaviour, both in research and marketing where the morally repugnant disregard for human lives is the norm. He convincingly draws close co
Author: John Braithwaite Publisher: Routledge ISBN: 1135072906 Category : Social Science Languages : en Pages : 451
Book Description
First published in 1984, this book examines corporate crime in the pharmaceutical industry. Based on extensive research, including interviews with 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala, the book is a major study of white-collar crime. Written in the 1980s, it covers topics such as international bribery and corruption, fraud in the testing of drugs and criminal negligence in the unsafe manufacturing of drugs. The author considers the implications of his findings for a range of strategies to control corporate crime, nationally and internationally.
Author: Andreas Seiter Publisher: World Bank Publications ISBN: 0821383876 Category : Medical Languages : en Pages : 240
Book Description
This book offers policy makers a hands-on approach, tested in the World Bank’s field work in many countries, for developing policies that improve access to safe, effective medicines in health systems of low- and middle-income economies.
Author: Marc A. Rodwin
Author: Marc A. Rodwin
Author: Anna Laskai
Author: Donald W. Light
Author: Thomas Fulda
Author: R. Whitaker
Author: Marc A. Rodwin
Author: National Academies of Sciences, Engineering, and Medicine
Author: Peter Gotzsche
Author: John Braithwaite
Author: Andreas Seiter