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Contents
Acknowledgments
Introduction
I. The Limits of Commercial Interests
1. Ethics and For-Profit Business
2. The Pharmaceutical Industry and Its Stakeholders
II. Marketing to Healthcare Professionals
3. Drug Companies and Healthcare Professionals: The Ethics Agenda
4. Medical Professionalism and Scientific Integrity
5. The Industry's Code: Not Good Enough
6. Drug Samples: The Most Important Gifts
7. Marketing Is Not Objective Education
8. Medical Education: Industry at Arm's Length
9. Clinical Research and the Limits of Commercial Interests
III. Marketing to the Public
10. Citizens and Consumers
11. Direct-to-Consumer Advertising: Conflicting Interests
12. Direct-to-Consumer Advertising: Better Is Better
Conclusion
Notes
Index
[FMO]Acknowledgments]
I am indebted to many individuals for supporting this project and for assistance in completing the manuscript, including Robert Hall, Carol Bayley, Michael McManus, Jessica Seck, Margaret Weber, and Gloria Albrecht. Thank you. I am particularly grateful to Thomas Schindler for repeated and careful review of the manuscript and for very helpful advice.
The School of Business at Gonzaga University provided the opportunity to begin to identify the issues addressed in this book by permitting me to teach a short course to MBA students on "Ethics and the Pharmaceutical Industry" while a Visiting Professor of Business Ethics in 2002-2004. The faculty "phased retirement program" at the University of Detroit Mercy made it possible for me to complete this project upon my return.
Working with different healthcare organizations as an ethics consultant has required that I apply ethical perspectives and analysis to a variety of issues and situations. In the process, I have learned that the most important contribution that an ethicist can make is to keep the focus on high ethical standards. I have attempted to apply that lesson here.
Profits before People?
[Introduction]
"It has all gone terribly wrong for the dozen or so manufacturers that make up 'big pharma.'" This statement introduced a review of the pharmaceutical industry's problems in a March 2005 article in The Economist.1 The once well-respected drug companies are now being subjected to fierce criticism.
[EXT]They stand accused of focusing on "me-too" drugs which confer little clinical benefit over existing medicines; rushing these to market through cunning clinical trials designed to make them look better than they are; and suppressing data to the contrary. The industry is also lambasted for expensive, aggressive and misleading direct-to-consumer advertising, which sometimes creates conditions to fit the drugs, rather than the other way around.]2
[FL]There is little trust that drug companies will do the right thing: a February 2005 Kaiser Family Foundation poll of 1,200 Americans found that 70 percent agreed that drug companies put profits ahead of people.3
When the pharmaceutical company Merck announced in the fall of 2004 that it was taking its blockbuster pain drug Vioxx (rofecoxib) off the market because of evidence that its use contributed to increased risks of heart attacks or strokes, some gave Merck credit for taking that action before it was mandated by the Food and Drug Administration (FDA). But many were not impressed by the company's overall Vioxx-related performance. There had been earlier warning signs of the risks associated with the use of Vioxx4 and Merck's response at that time had been to continue to market the medication aggressively. By the time Merck made the decision to cease marketing Vioxx, millions of people were taking the drug, at a potential and unnecessary risk to their cardiovascular health. Vioxx was among the most heavily marketed, most widely used, and most profitable medicines, a case study of the way commercial interests can influence decisions about the marketing and use of drugs.
The FDA convened a panel of experts to advise on whether to permit the marketing of Vioxx and the other two painkillers in the class of drugs known as COX-2 inhibitors (Celebrex and Bextra). After the panel endorsed continued availability of these drugs, the Center for Science in the Public Interest did background checking and found that 10 of the 32 members of the advisory group had direct financial ties with the drug companies that make these drugs (received consulting fees, speaker fees, or research money from them).5 "If the 10 advisors had not cast their votes, the committee would have voted 12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx not return to the market. The 10 advisors with company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx's return."6 They were permitted to participate and vote despite the obvious questions about their objectivity. It is an important sign of the times that FDA panel reports are received with some skepticism precisely because of the potential influence of drug companies on these deliberations.
The pharmaceutical industry plays a key role in the American healthcare system and has had and continues to have an enormous influence on the practice of medicine. It sponsors much of the medical research being done; it produces the medicines that doctors prescribe and millions of people take; it sends out thousands of sales representatives to interact directly and frequently with physicians about the available drugs; it finances many of the continuing education programs physicians attend; it advertises drugs directly to the public, who are told to "ask your doctor" about the products; it contributes heavily to political campaigns and has a strong lobbying voice at the federal and state levels. It is a powerful industry whose practices affect the health and healthcare of many millions of people.
The pharmaceutical industry is now being subjected to criticism and challenge as never before in the age of scientific medicine. There has been increased critical attention paid to the methods that the industry uses to promote its products and to influence medical decisions. Much of the criticism is coming from physicians, often focused on the ways in which industry practices affect the quality of patient care and the professionalism and integrity of healthcare providers. The cost of prescription medications has been a major focus of concern among the public, one reflected in the debate about the provisions of the Medicare drug coverage legislation passed in 2003.
The number of recently published books critical of the pharmaceutical industry and of the general effects of commercialization on healthcare constitutes further evidence that a new era has begun.7 The authors are generally well-respected and serious critics, most with long experience and impressive credentials. To cite three examples: Jerome Kassirer (On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health) is a former editor in chief of The New England Journal of Medicine; Marcia Angell (The Truth About the Drug Companies: How They Deceive Us and What to Do About It) also held that position; Donald Barlett and James Steele (Critical Condition: How Health Care in America Became Big Business--and Bad Medicine) are Pulitzer Prize-winning journalists. Though the various books differ somewhat in their intent and in their selected points of focus, a common contention is that medical science and patient care suffer because of some of the ways in which businesses relate to practicing physicians, to medical researchers, to patients and the public, and to government and regulators.
The industry remains both wealthy and powerful, but the voices of the critics are getting stronger and louder. The message of the critics is clear: in the search for corporate profits, the drug industry, often with the complicity of medical professionals, engages in practices that can and frequently do lead to poor quality medical care and to treatment that is unnecessarily costly. The pharmaceutical industry contributes to important improvements in medical care, to be sure, but it also engages in practices that produce avoidable harmful effects. So say the critics.
These assessments of the role of the pharmaceutical industry help to identify practices that need systematic ethical analysis and reflection. Taking the critics seriously does not mean, of course, accepting their perspectives and/or their recommendations uncritically. They tell the kind of stories, though, that help to explain why it is necessary to establish and implement high ethical standards regarding such company practices as compensating physicians for serving as speakers or consultants, covering the cost of continuing medical education programs, providing incentives to physicians to enroll patients as subjects in clinical research projects, and advertising prescription drugs to the public through the mass media. The emerging critical literature is very helpful in identifying the issues that need more attention.
This book is a study of the place of commercial interests in marketing prescription drugs. For some, "marketing" simply means advertising; when they hear a comment about the marketing of prescription drugs, the first picture that comes to mind is the TV commercial that they just saw. For others, prescription drug "marketing" includes the visits of the sales representatives to doctors' offices. As used here, "marketing" includes these practices as well as many others. Companies market their products through all the ways in which they bring attention to their products, all the ways they spread the word about the benefits of their products, and all the ways that they establish relationships between themselves and the professionals who make treatment decisions. Accordingly, a study of drug marketing practices needs to include, in addition to advertising and visits by sales representatives, the industry's role in education, the provision of sample medications, even some clinical research practices. These are all methods that can be used to promote the use of a company's prescription drugs.
As a work of ethics, this book is not a descriptive study of the place of commercial interests in marketing prescription drugs. It is, rather, an effort to understand the proper place of commercial interests in marketing prescription drugs. A major part of the ethicist's task is to clarify the nature of the relevant responsibilities and to help identify good ethical practices regarding the identified issues. The ultimate goal is to assist in answering the practical ethics question ("What is the right or best thing to do in these circumstances, all relevant responsibilities considered?"). Both the perspectives of the critics and the guidelines that the industry itself has adopted have made some contributions here, but much more needs to be done. The lack of confidence in the pharmaceutical industry is, fundamentally, a doubt about the industry's ethics: a concern that the drug companies are engaged in practices that represent the wrong priorities; a conviction that big pharma is failing to understand its basic responsibilities.
Ethics and the law are clearly not the same. What is legally permissible is not always an ethically acceptable business practice. Lynn Sharp Paine has put it this way: "Our system of government guarantees us rights that it may be unethical to exercise on certain occasions. Terminology may make it easy to lose sight of the distinction between 'having a right' and 'the right thing to do,' but the distinction is critical."8 Taking ethics seriously means recognizing that the law does not answer all questions about what is right. Law may establish the ethical minimum, but the most important ethical judgments often need to be made in a context of legal permissibility. What should we do when we can take different approaches, all of which are legally acceptable? One legally permissible way of marketing pharmaceuticals may well be considerably more appropriate, all relevant ethical responsibilities considered, than another legally permissible way. The analysis and reflection involved in "doing ethics" are intended to lead to the identification of the right or best practice and the reasons for concluding that one course of action is the right or best practice. The fact that the law does not prohibit a particular industry practice is a not a reasonable basis either for engaging in it or for defending it.
Business ethics is not primarily about individual behavior. In seeking to implement high ethical standards for marketing prescription drugs, the focus of attention here is not on the behavior of an individual sales representative or of a symposium speaker. It is more important to consider industry-wide practices, practices that may be, in fact, quite widely accepted as standard or appropriate. Given the nature and impact of this particular industry and the potential consequences of a particular marketing-related practice, does this practice reflect high ethical standards? Sustained and focused consideration on the relevant responsibilities just might point the way to more demanding ethics standards and better practices. And this, in turn, might begin to restore some confidence in the drug industry.
Despite it central role in healthcare, the pharmaceutical industry has not yet received much systematic attention in deliberations on healthcare ethics. Much more attention has been given to issues involved in the clinical provision of healthcare than to the issues involved in the business side of healthcare. This is beginning to change, but there is not yet a well-developed understanding of the demands of good healthcare business ethics. Neither healthcare professionals nor the public are very clear yet on how to draw the line between ethically acceptable and unacceptable practices in businesses providing healthcare services or products. And not one of the recent books on the pharmaceutical industry was explicitly framed as an ethics project.9 This one is.
The pharmaceutical industry is a for-profit industry. One essential part of the task of clarifying the ethical standards to which the industry should be held accountable in its marketing practices is, therefore, a review of the ethical responsibilities of for-profit business. In a discussion of the relationship of physicians to drug companies, David Blumenthal included the following comment: "As a for-profit business, the pharmaceutical industry should be expected to market its products aggressively within legal boundaries."10 In the context in which the statement is found, it seems clear that to market "aggressively" means to use enticements and to provide selective information on the benefits and risks of a company's drugs. It means company practices that can result in conflicts of interest for physicians and that might contribute to their having an incomplete understanding of the effects of the medications. It is less clear, though, what Blumenthal means by the phrase "should be expected." It might mean that, because for-profit companies sometimes act this way driven by their commercial interests, we should be prepared for the pharmaceutical industry to act this way. Or "should be expected" might mean that the industry should act in this way, that it is right that they do so. These are two very different meanings. The first is a recognition that the profit motive can be a very powerful incentive, so powerful that it can, at times, distort a company's understanding of its true ethical responsibilities. We should be prepared for pharmaceutical companies doing whatever is legal to sell their products because, under pressure to show high profits, they do not always engage in good ethical practices. According to the second meaning, always putting profits first and foremost (within legal boundaries) is, in fact, the ethical responsibility of for-profit business. In this understanding of ethics, pharmaceutical companies are acting properly in doing whatever is legal to sell their products, even when it might compromise the integrity of healthcare professionals and the quality of medical care. Given the world of difference between these two approaches to business ethics, it is essential to begin the reflections on appropriate ethics standards for the pharmaceutical industry by considering the right relationship between ethics and profit.
The first section of the book presents a framework for understanding the general ethical responsibilities of pharmaceutical companies, as for-profit businesses and as pharmaceutical companies. The following two sections divide the issues and concerns related to marketing prescriptions drugs between those raised by marketing to healthcare professionals and those raised by marketing to the public. In each case, the section begins with an effort to provide and explain the ethical vision and framework that informs the analysis of specific issues and that leads to the judgments that are made. A work of this sort requires a willingness on the part of the author to advocate a point of view and to take stands. Any one person's understanding and sensitivity are, of course, always limited and incomplete. Nevertheless, the effort to identify ethical standards that apply to the practices under consideration might assist others who are also seeking to clarify the limits of commercial interests as the pharmaceutical industry markets it products.
The critics have concluded that the pharmaceutical industry has gone terribly awry. In Angell's words: "Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the U. S. Congress, the Food and Drug Administration, academic medical centers, and the medical profession itself."11 The prescription drug industry is now being challenged to reform itself and the public is being challenged to insist that it is reformed. The purpose of this book is to consider the kinds of concerns and standards and marketing-related practices that the public can legitimately demand that the industry adopt, ones that reflect an acceptable balance between commercial interests and the needs of healthcare professionals, of patients, and of the public.
[PTO]I. The Limits of Commercial Interests]
Library of Congress Subject Headings for this publication:
Pharmaceutical industry -- Moral and ethical aspects -- United States.
Marketing -- Moral and ethical aspects -- United States.
Drug Industry -- ethics -- United States.
Drug Industry -- economics -- United States.
Marketing -- ethics -- United States.
Pharmaceutical Preparations -- United States.