Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs


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.




Institutional Corruption and the Pharmaceutical Policy


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.




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


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.




Institutional Corruption Theory in Pharmaceutical Industry-Medicine Relationships


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.




Pharmaceuticals, Corporate Crime and Public Health


Book Description

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




Forbidden Knowledge


Book Description

Terence Young exposes the pharmaceutical industry secrets and cultural myths that thwart our safe use of prescription drugs.... Everyone should read it before their next visit to a doctor. — DR. NANCY OLIVIERI, MD, physician and professor When it comes to drug safety, Big Pharma holds all the power, and it’s time for patients to take it back. Tens of millions of patients in North America take prescription drugs, but the safety of these drugs is often based on medical myths. We are led to believe that if a medication isn’t safe, the government would never allow it on the market and that doctors would never prescribe a drug that isn’t proven effective. Who controls these narratives? And do they always have the best interests of patients in mind? In an in-depth study of the enormous influence the pharmaceutical industry has over our health, drug safety advocate Terence Young explores how those with the most to gain financially are also those who wield all the power in health care — and withhold the knowledge that is critical to the safety of patients. Forbidden Knowledge reveals the truth you need to know about prescription drugs and what to do about it. It will empower you to partner with your doctor to talk openly and plainly about medications to help avoid serious adverse drug reactions. This is your survival guide to Big Pharma.




Exposed


Book Description

A sharp exposé of the roots of the cost-exposure consensus in American health care that shows how the next wave of reform can secure real access and efficiency. The toxic battle over how to reshape American health care has overshadowed the underlying bipartisan agreement that health insurance coverage should be incomplete. Both Democrats and Republicans expect patients to bear a substantial portion of health care costs through deductibles, copayments, and coinsurance. In theory this strategy empowers patients to make cost-benefit tradeoffs, encourages thrift and efficiency in a system rife with waste, and defends against the moral hazard that can arise from insurance. But in fact, as Christopher T. Robertson reveals, this cost-exposure consensus keeps people from valuable care, causes widespread anxiety, and drives many patients and their families into bankruptcy and foreclosure. Marshalling a decade of research, Exposed offers an alternative framework that takes us back to the core purpose of insurance: pooling resources to provide individuals access to care that would otherwise be unaffordable. Robertson shows how the cost-exposure consensus has changed the meaning and experience of health care and exchanged one form of moral hazard for another. He also provides avenues of reform. If cost exposure remains a primary strategy, physicians, hospitals, and other providers must be held legally responsible for communicating those costs to patients, and insurance companies should scale cost exposure to individuals’ ability to pay. New and more promising models are on the horizon, if only we would let go our misguided embrace of incomplete insurance.




The Risks of Prescription Drugs


Book Description

Few people realize that prescription drugs have become a leading cause of death, disease, and disability. Adverse reactions to widely used drugs, such as psychotropics and birth control pills, as well as biologicals, result in FDA warnings against adverse reactions. The Risks of Prescription Drugs describes how most drugs approved by the FDA are under-tested for adverse drug reactions, yet offer few new benefits. Drugs cause more than 2.2 million hospitalizations and 110,000 hospital-based deaths a year. Serious drug reactions at home or in nursing homes would significantly raise the total. Women, older people, and people with disabilities are least used in clinical trials and most affected. Health policy experts Donald Light, Howard Brody, Peter Conrad, Allan Horwitz, and Cheryl Stults describe how current regulations reward drug companies to expand clinical risks and create new diseases so millions of patients are exposed to unnecessary risks, especially women and the elderly. They reward developing marginally better drugs rather than discovering breakthrough, life-saving drugs. The Risks of Prescription Drugs tackles critical questions about the pharmaceutical industry and the privatization of risk. To what extent does the FDA protect the public from serious side effects and disasters? What is the effect of giving the private sector and markets a greater role and reducing public oversight? This volume considers whether current rules and incentives put patients' health at greater risk, the effect of the expansion of disease categories, the industry's justification of high U.S. prices, and the underlying shifts in the burden of risk borne by individuals in the world of pharmaceuticals. Chapters cover risks of statins for high cholesterol, SSRI drugs for depression and anxiety, and hormone replacement therapy for menopause. A final chapter outlines six changes to make drugs safer and more effective. Suitable for courses on health and aging, gender, disability, and minority studies, this book identifies the Risk Proliferation Syndrome that maximizes the number of people exposed to these risks. Additional Columbia / SSRC books on the privatization of risk and its implications for Americans: Bailouts: Public Money, Private ProfitEdited by Robert E. Wright Disaster and the Politics of InterventionEdited by Andrew Lakoff Health at Risk: America's Ailing Health System-and How to Heal ItEdited by Jacob S. Hacker Laid Off, Laid Low: Political and Economic Consequences of Employment InsecurityEdited by Katherine S. Newman Pensions, Social Security, and the Privatization of RiskEdited by Mitchell A. Orenstein




Corruption and Global Justice


Book Description

Corruption is a pervasive problem for global justice: Gillian Brock presents a much-needed philosophical treatment. She offers a new framework for allocating responsibility for corruption, providing the analytical tools we need to tackle the global injustice that it causes.




Preventing Regulatory Capture


Book Description

Leading scholars from across the social sciences present empirical evidence that the obstacle of regulatory capture is more surmountable than previously thought.