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Introduction to Part IV
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- By Michael A. Santaro, Rutgers University, New Jersey
- Michael A. Santoro, Rutgers University, New Jersey, Thomas M. Gorrie
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- Book:
- Ethics and the Pharmaceutical Industry
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- 04 December 2009
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- 31 October 2005, pp 363-368
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Summary
The goals of this book have been to understand the factors behind the growing tension in the relationship between the pharmaceutical industry and society and to chart a sustainable path for that relationship in the twenty-first century. The extraordinary authors assembled in this volume have gone a long way toward achieving these goals. The insights and recommendations offered by these authors have been diverse, multifaceted, and far-reaching, and it would do them an injustice to attempt to summarize them pithily. Nevertheless, it is possible to discern a few basic themes. The chapters in this final section underscore these themes and point out paths to a sustainable future for the industry.
Public health and private enterprise: an imperfect match
One theme that has emerged is that the tensions between the industry and society derive from real conflicts that are endemic to the free market economic system and the current regulatory environment. Many of the authors have in one manner or other made the case that the interests of the pharmaceutical industry and society are imperfectly aligned. What is good for the bottom line of the drug companies is not always good for society. In this volume we have seen numerous examples of this divergence, such as research agendas that are guided by market size rather than medical need; marketing practices and objectives that emphasize increasing sales without regard for the medical priority of conditions treated; and monopolistic pricing policies that maximize revenue at the explicit cost of broad access.
Introduction to Part III
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- By Michael A. Santaro, Rutgers University, New Jersey
- Michael A. Santoro, Rutgers University, New Jersey, Thomas M. Gorrie
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- Book:
- Ethics and the Pharmaceutical Industry
- Published online:
- 04 December 2009
- Print publication:
- 31 October 2005, pp 251-259
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Summary
INTRODUCTION: INTELLECTUAL PROPERTY RIGHTS VERSUS HEALTHCARE RIGHTS
The most controversial ethical and public policy issues involving the pharmaceutical industry arguably derive from the dynamic tension between healthcare's dual status as an economic commodity and a moral right. Fundamentally, this tension is an ongoing dialogue about competing rights, i.e., property rights versus the right to affordable healthcare. This section considers the conflicts arising from the pharmaceutical industry's assertion of strong intellectual property rights and the attempts by some advocates to erode these rights in order to honor the right to affordable access to drugs.
A recurring theme of this book has been the disjunction that sometimes exists between public health needs and the profit-maximizing behavior of pharmaceutical companies. In the case of intellectual property this disjunction is not only a function of free-market dynamics; it is also a result of deliberate government intervention. The patent system is a not-so-finely tuned government regulatory mechanism that can, in effect, ratchet up the intensity of this gap. Patent laws grant state-protected monopolies to inventors in order to spur innovation. The exercise of those patent rights, however, also leads to higher prices and limited access.
Some industry leaders well understand that the fates of their companies are inextricably bound with the healthcare needs of the communities in which they operate. In his chapter, William Weldon, the CEO of Johnson & Johnson, one of the world's largest diversified healthcare companies with significant interests in the pharmaceutical industry, argues that the fundamental source of tension between industry and society is a “basic conflict: between funding priorities for providing access to current healthcare, and the need to provide incentives for developing better treatments in the future.
Introduction to Part II
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- By Michael A. Santaro, Rutgers University, New Jersey
- Michael A. Santoro, Rutgers University, New Jersey, Thomas M. Gorrie
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- Book:
- Ethics and the Pharmaceutical Industry
- Published online:
- 04 December 2009
- Print publication:
- 31 October 2005, pp 127-135
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Summary
It would seem logically impossible to be both exquisitely subtle and affrontingly obvious at the same time. However, a widely viewed television commercial managed to do just that. The ad displayed the name of the product as a smiling, middle-aged man threw a football through the center of a car tire. We are not told what kind of product is being promoted. Subtle, it would seem, until one learns that the product being advertised is a drug – for erectile dysfunction. In retrospect, knowing what the product purports to do, the ad seems appallingly suggestive. Indeed, one feels pretty dumb for not getting it in the first place. Another recent ad eschews subtlety and goes right for the jugular. An impossibly thin, glamorous woman suddenly falls to the floor. Her cholesterol level is flashed on the screen along with the name of the drug.
With clever and hard-hitting ads peddling drugs as one might sell soap or beer, it is no wonder that many are concerned about the effects of direct-to-consumer advertising. Such suspicions are further fueled by the fact that this seemingly ubiquitous advertising is coming at a time when overall drug spending is rising and new drug prices climb ever higher. That much of direct-to-consumer advertising (DTCA) is for so-called “lifestyle” drugs – for erectile dysfunction or hair loss, for example – only serves to add to the tawdry image of the drug companies.
Introduction: Charting a Sustainable Path for the Twenty-First Century Pharmaceutical Industry
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- By Michael A. Santaro, Rutgers University, New Jersey
- Michael A. Santoro, Rutgers University, New Jersey, Thomas M. Gorrie
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- Book:
- Ethics and the Pharmaceutical Industry
- Published online:
- 04 December 2009
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- 31 October 2005, pp 1-6
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This industry delivered miracles, and now they're throwing it all away. They just don't get it.
Dr. Roy Vagelos, former Chairman, Merck & Co.The unraveling of the “grand bargain”
Perhaps no business engages the worlds of science, medicine, economics, health, human rights, government, and social welfare as much as the pharmaceutical industry. As the twenty-first century begins, however, there is growing controversy and even hostility in the relationship between the pharmaceutical industry and the public. The millions of individuals, families, and communities throughout the world that have been stricken by the scourge of AIDS offer the most tragic human face to this controversy, but it is no overstatement to say that the pharmaceutical industry impacts the life of virtually every person in the world.
What we are witnessing is the unraveling of a “grand bargain” between the pharmaceutical industry and society. This grand bargain was a complex, implicit social contract that allowed the modern global pharmaceutical industry to emerge in the second half of the twentieth century. Although the industry prospered immensely, society also enjoyed a bountiful array of life-saving and life-enhancing drugs. As the twenty-first century begins, however, this grand bargain is in tatters and public mistrust and resentment of the industry run feverishly high. Many feel that the enormous industry profits are not sufficiently matched by contributions to the common good. What factors are behind this growing tension between the pharmaceutical industry and society?
Preface
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- By Michael A. Santaro, Rutgers University, New Jersey, Thomas M. Gorrie, Johnson and Johnson
- Michael A. Santoro, Rutgers University, New Jersey, Thomas M. Gorrie
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- Book:
- Ethics and the Pharmaceutical Industry
- Published online:
- 04 December 2009
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- 31 October 2005, pp xxvii-xxx
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Summary
The chapters in this book are written by authors with diverse experiences and perspectives. They come from government and industry, from advocacy organizations and academia, as well as from the scientific and medical communities. It is a notable sign of the force and maturity of globalization that most of the contributors, regardless of their nationality or backgrounds, quite naturally address these issues by considering different international perspectives. Although not every voice and every relevant issue appears in these pages, we believe we have made an unprecedented effort to gather a highly diverse and talented group of authors to address a broad spectrum of the issues that dominate the relationship between the pharmaceutical industry and society in a global context.
The diversity of viewpoints among the contributors is mirrored in the differing perspectives of the editors. Together, since the year 2000, we have taught a class at Rutgers Business School on the ethical and regulatory issues facing the pharmaceutical industry. Sometimes much to the unintended amusement of our students, and we hope occasionally to their enlightenment, we have sharply, though collegially, disagreed on many matters affecting the pharmaceutical industry. Our disagreements are perhaps rooted in two fundamentally different perspectives. First, Dr. Gorrie believes that healthcare is a commodity purchased by the individual or society, the provision of which is made through that most social of institutions, insurance. Government's role is to ensure that the economically disadvantaged have access to healthcare. By contrast, Prof.
Introduction to Part I
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- By Michael A. Santaro, Rutgers University, New Jersey
- Michael A. Santoro, Rutgers University, New Jersey, Thomas M. Gorrie
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- Book:
- Ethics and the Pharmaceutical Industry
- Published online:
- 04 December 2009
- Print publication:
- 31 October 2005, pp 9-20
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Summary
INTRODUCTION
Pharmaceutical research is a complex social enterprise. It involves persons, commerce, and the advancement of medical knowledge, and it raises a broad array of ethical, scientific, and public policy issues. The chapters in this section analyze and suggest reforms in a number of these areas, including (1) the conflicts that arise between the profit maximization objectives of pharmaceutical companies and the ethical requirements of scientific research and medicine, particularly in regard to safety concerns and the diseases that are targeted; (2) the ethical safeguards for conducting research involving human subjects, particularly vulnerable subjects such as children and citizens of third world countries; (3) the patient's right to be included in drug trials that offer hope for terminal medical conditions, as well as the public health implications of including minority populations in drug trials; and (4) the scientific and ethical issues underlying stem cell research.
MEDICINE, SCIENCE, AND PROFIT MAXIMIZATION: AN UNEASY MIX
The dictates of medical and scientific ethics are sometimes at odds in clinical research, as for example in the administration of placebos to patients in control groups. Such conflicts arise because physicians are trained to cure and treat patients by administering therapeutic remedies, whereas scientists seek to establish facts and advance knowledge. For the most part, however, the advancement of knowledge and the betterment of patients ultimately are complementary goals.
It is the interjection of profit motivation into drug research that creates the greatest ethical challenges.