Rooting Out Institutional Corruption to Manage Inappropriate Off-Label Drug Use PDF Download

Author: Marc A. Rodwin
Publisher:
ISBN:
Category :
Languages : en
Pages : 0

View

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: Anna Laskai
Publisher: Springer Nature
ISBN: 3030447901
Category : Social Science
Languages : en
Pages : 298

View

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: Rachel Kim
Publisher: Routledge
ISBN: 135101269X
Category : Business & Economics
Languages : en
Pages : 142

View

Book Description
From a managerial perspective, the biopharmaceutical industry represents a competitive, fast-changing, intellectually-powered, innovation-driven sector. Many management scholars have studied this discontinuous era to make sense of strategic behavior and the cognition of firms and top managers. A past look at the biopharmaceutical industry provides answers to questions that most managers have. For example, what options do you have and what actions do you take when new firms enter your industry? In the 1970s, new biotechnology firms, funded by venture capitalists, appeared in the pharmaceutical industry with new knowledge. Successful pharmaceutical firms decided to collaborate with the new entrants and forge relationships to develop and create new, biotechnology engineered drugs. Thus, the addition of new biotechnology firms ushered in a new business model based on strategic alliances. Strategic alliances have now become an industrial norm called open innovation. The author looks at the historical path of the biopharmaceutical industry, particularly in the United States. While the pharmaceutical industry’s main contributions to society are substantial, there are pressing challenges the industry must face, such as an increase in infectious disease outbreaks or the global aging population, which require new types of care, additionally, mental health care and prescription painkiller addiction are persistent issues with economic repercussions to both federal and local governments. This book presents a holistic view of the biopharmaceutical industry, putting it in a historical context. It will best serve those who are eager to learn about this dynamic, fast-evolving industry and who would like to tackle current biopharmaceutical industry issues in the United States and be prepared for future industry challenges.

Author: Holly Fernandez Lynch
Publisher: Columbia University Press
ISBN: 0231540078
Category : Business & Economics
Languages : en
Pages : 499

View

Book Description
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
ISBN: 0309269393
Category : Medical
Languages : en
Pages : 377

View

Book Description
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: Transparency International
Publisher: Pluto Press
ISBN: 9780745325088
Category : Medical
Languages : en
Pages : 0

View

Book Description
TI has once again shown its ability to combine research and policy analysis not just to shine a light on the deeply embedded problems of corruption ... but to propose progressive solutions. Former World Bank President James Wolfensohn on the Global Corruption ReportIn the health sector, corruption is a matter of life or death. It can take many forms: from medical professionals who sell medicines or services that should be freely available, to high-level government officials who embezzle money from health budgets, to pharmaceutical companies that buy influence over research agendas. The impact of corruption is always felt by the end user -- the sick person who is forced to pay over the odds or who is given unsafe, counterfeit medicines. The 2006 edition of Transparency International’s Global Corruption Report shows the impact that corruption has on health care in rich and poor countries. From high-level bribery in Costa Rica to informal payments in Hungary, case studies from around the world explore the characteristics of the health sector that make it so prone to corruption. In a special section dedicated to corruption in HIV/AIDS, the report warns that the large sums being poured into fighting the world’s deadliest diseases need to be safeguarded against abuse. There is also a detailed analysis of the problems of the pharmaceutical system.The report also offers an annual round-up of worldwide developments and tracks major trends in more than 40 countries.The Global Corruption Report 2006 is the only report of its kind, and is an essential reference source for anyone who wants the latest research on how corruption affects everything from health to education and the oil and gas industries.

Author:
Publisher: World Bank Publications
ISBN: 9780821346006
Category : Political Science
Languages : en
Pages : 180

View

Book Description
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
ISBN: 1135072906
Category : Social Science
Languages : en
Pages : 451

View

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: J. Edgardo Campos
Publisher: World Bank Publications
ISBN: 0821367269
Category : Business & Economics
Languages : en
Pages : 484

View

Book Description
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: Financial Crisis Inquiry Commission
Publisher: Cosimo, Inc.
ISBN: 1616405414
Category : Political Science
Languages : en
Pages : 692

View

Book Description
The Financial Crisis Inquiry Report, published by the U.S. Government and the Financial Crisis Inquiry Commission in early 2011, is the official government report on the United States financial collapse and the review of major financial institutions that bankrupted and failed, or would have without help from the government. The commission and the report were implemented after Congress passed an act in 2009 to review and prevent fraudulent activity. The report details, among other things, the periods before, during, and after the crisis, what led up to it, and analyses of subprime mortgage lending, credit expansion and banking policies, the collapse of companies like Fannie Mae and Freddie Mac, and the federal bailouts of Lehman and AIG. It also discusses the aftermath of the fallout and our current state. This report should be of interest to anyone concerned about the financial situation in the U.S. and around the world.THE FINANCIAL CRISIS INQUIRY COMMISSION is an independent, bi-partisan, government-appointed panel of 10 people that was created to "examine the causes, domestic and global, of the current financial and economic crisis in the United States." It was established as part of the Fraud Enforcement and Recovery Act of 2009. The commission consisted of private citizens with expertise in economics and finance, banking, housing, market regulation, and consumer protection. They examined and reported on "the collapse of major financial institutions that failed or would have failed if not for exceptional assistance from the government."News Dissector DANNY SCHECHTER is a journalist, blogger and filmmaker. He has been reporting on economic crises since the 1980's when he was with ABC News. His film In Debt We Trust warned of the economic meltdown in 2006. He has since written three books on the subject including Plunder: Investigating Our Economic Calamity (Cosimo Books, 2008), and The Crime Of Our Time: Why Wall Street Is Not Too Big to Jail (Disinfo Books, 2011), a companion to his latest film Plunder The Crime Of Our Time. He can be reached online at www.newsdissector.com.