Rooting Out Institutional Corruption To Manage Inappropriate Off Label Drug Use
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Author | : Anna Laskai |
Publisher | : Springer Nature |
Total Pages | : 298 |
Release | : 2020-05-06 |
Genre | : Social Science |
ISBN | : 3030447901 |
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 | : 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 | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 377 |
Release | : 2013-06-20 |
Genre | : Medical |
ISBN | : 0309269393 |
The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
Author | : |
Publisher | : World Bank Publications |
Total Pages | : 180 |
Release | : 2000 |
Genre | : Political Science |
ISBN | : 9780821346006 |
Much of the devastation caused by the recent earthquake in Turkey was the result of widespread corruption between the construction industry and government officials. Corruption is part of everyday public life and we tend to take it for granted. However, preventing corruption helps to raise city revenues, improve service delivery, stimulate public confidence and participation, and win elections. This book is designed to help citizens and public officials diagnose, investigate and prevent various kinds of corrupt and illicit behaviour. It focuses on systematic corruption rather than the free-lance activity of a few law-breakers, and emphasises practical preventive measures rather than purely punitive or moralistic campaigns.
Author | : John Braithwaite |
Publisher | : Routledge |
Total Pages | : 451 |
Release | : 2013-10-08 |
Genre | : Social Science |
ISBN | : 1135072906 |
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 | : Graham Dukes |
Publisher | : Edward Elgar Publishing |
Total Pages | : 419 |
Release | : 2014-06-27 |
Genre | : Business & Economics |
ISBN | : 1783471107 |
The pharmaceutical industry exists to serve the community, but over the years it has engaged massively in corporate crime, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health documents the pr
Author | : Jerry Avorn, M.D. |
Publisher | : Vintage |
Total Pages | : 476 |
Release | : 2008-12-10 |
Genre | : Medical |
ISBN | : 0307489752 |
If you believe that the latest blockbuster medication is worth a premium price over your generic brand, or that doctors have access to all the information they need about a drug’s safety and effectiveness each time they write a prescription, Dr. Jerry Avorn has some sobering news. Drawing on more than twenty-five years of patient care, teaching, and research at Harvard Medical School, he shares his firsthand experience of the wide gap in our knowledge of the effectiveness of one medication as compared to another. In Powerful Medicines, he reminds us that every pill we take represents a delicate compromise between the promise of healing, the risk of side effects, and an increasingly daunting price. The stakes on each front grow higher every year as new drugs with impressive power, worrisome side effects, and troubling costs are introduced. This is a comprehensive behind-the-scenes look at issues that affect everyone: our shortage of data comparing the worth of similar drugs for the same condition; alarming lapses in the detection of lethal side effects; the underuse of life-saving medications; lavish marketing campaigns that influence what doctors prescribe; and the resulting upward spiral of costs that places vital drugs beyond the reach of many Americans. In this engagingly written book, Dr. Avorn asks questions that will interest every consumer: How can a product judged safe by the Food and Drug Administration turn out to have unexpectedly lethal side effects? Why has the nation’s drug bill been growing at nearly 20 percent per year? How can physicians and patients pick the best medication in its class? How do doctors actually make their prescribing decisions, and why do those decisions sometimes go wrong? Why do so many Americans suffer preventable illnesses and deaths that proper drug use could have averted? How can the nation gain control over its escalating drug budget without resorting to rationing or draconian governmental controls? Using clinical case histories taken from his own work as a practitioner, researcher, and advocate, Dr. Avorn demonstrates the impressive power of the well-conceived prescription as well as the debacles that can result when medications are misused. He describes an innovative program that employs the pharmaceutical industry’s own marketing techniques to reduce use of some of the most overprescribed and overpriced products. Powerful Medicines offers timely and practical advice on how the nation can improve its drug-approval process, and how patients can work with doctors to make sure their prescriptions are safe, effective, and as affordable as possible. This is a passionate and provocative call for action as well as a compelling work of clear-headed science.
Author | : J. Edgardo Campos |
Publisher | : World Bank Publications |
Total Pages | : 484 |
Release | : 2007-04-04 |
Genre | : Business & Economics |
ISBN | : 0821367269 |
Corruption... How can policymakers and practitioners better comprehend the many forms and shapes that this socialpandemic takes? From the delivery of essential drugs, the reduction in teacher absenteeism, the containment of illegal logging, the construction of roads, the provision of water andelectricity, the international trade in oil and gas, the conduct of public budgeting and procurement, and the management of public revenues, corruption shows its many faces. 'The Many Faces of Corruption' attempts to bring greater clarity to the often murky manifestations of this virulent and debilitating social disease. It explores the use of prototype road maps to identify corruption vulnerabilities, suggests corresponding 'warning signals,' and proposes operationally useful remedial measures in each of several selected sectors and for a selected sampleof cross cutting public sector functions that are particularlyprone to corruption and that are critical to sector performance.Numerous technical experts have come together in this effort to develop an operationally useful approach to diagnosing and tackling corruption. 'The Many Faces of Corruption' is an invaluable reference for policymakers, practitioners, andresearchers engaged in the business of development.
Author | : Ajit Mishra |
Publisher | : Oxford University Press, USA |
Total Pages | : 364 |
Release | : 2005 |
Genre | : Business & Economics |
ISBN | : |
The Major Issues Covered By The Book Include Colluson, Misgovernance, Corruptible Law Enforcers, Bribe-Seeking Bureaucracy, Electoral Competition, And Special Interest Politics. The Book Uses Tools From Mainstream Economic Analysis And Provides Insights On How To Fight Corruption.
Author | : Philip Gounev |
Publisher | : |
Total Pages | : 334 |
Release | : 2010 |
Genre | : Bribery |
ISBN | : 9789544771621 |
Systematically examines, across all 27 EU Member States, how organised crime uses corruption as a tool. The study is based on more than 150 interviews with corruption specialists and more than 120 statistical and survey indicators on corruption and organised crime. The study focuses on how organised and white collar criminals use corruption to target public institutions (politicians, police, judiciary, and customs), as well as how it is used for the operation of key criminal markets (cigarettes, drugs, prostitution, car-theft, and extortion-racketeering). The study also examines how private sector company employees are corrupted by organised criminals. Although the study does not map the specifics of how corruption is used in each EU Member State, six in-depth studies (on Bulgaria, France, Greece, Italy, Netherlands, and Spain) provide a more in-depth look in the situation in these countries.