This book explores the controversial relationship between physicians and the pharmaceutical industry, identifies the ethical tensions and controversies, and proposes numerous reforms both for medicine's own professional integrity and for effective public regulation of the industry.
The leading ethical position on placebo-controlled clinical trials is that whenever proven effective treatment exists for a given condition, it is unethical to test a new treatment for that condition against placebo. Invoking the principle of clinical equipoise, opponents of placebo-controlled trials in the face of proven effective treatment argue that they (1) violate the therapeutic obligation of physicians to offer optimal medical care and (2) lack both scientific and clinical merit. We contend that both of these arguments are mistaken. (...) Clinical equipoise provides erroneous ethical guidance in the case of placebo-controlled trials, because it ignores the ethically relevant distinction between clinical trials and treatment in the context of clinical medicine and the methodological limitations of active-controlled trials. Placebo controls are ethically justifiable when they are supported by sound methodological considerations and their use does not expose research participants to excessive risks of harm. (shrink)
: The "difference position" holds that clinical research and therapeutic medical practice are sufficiently distinct activities to require different ethical rules and principles. The "similarity position" holds instead that clinical investigators ought to be bound by the same fundamental principles that govern therapeutic medicine—specifically, a duty to provide the optimal therapeutic benefit to each patient or subject. Some defenders of the similarity position defend it because of the overlap between the role of attending physician and the role of investigator in (...) a research trial. This overlap is maximal when the same physician occupies both roles with respect to a particular patient-subject. We address the ethical tensions inherent in that role conflict and argue that the tensions are real but manageable. The difference position provides a sound ethical framework within which to manage those tensions, while the similarity position is unsatisfactory because it seeks to deny the existence of the tensions. (shrink)
As the debate over how to manage or discourage physicians? financial conflicts of interest with the drug and medical device industries has become more heated, critics have questioned or dismissed the concept of ?conflict of interest? itself. A satisfactory definition relates conflict of interest to concerns about maintaining social trust and distinguishes between breaches of ethical duty and temptations to breach duty. Numerous objections to such a definition have been offered, none of which prevails on further analysis. Those concerned about (...) conflicts of interest have contributed to misunderstandings, however, by failing to demonstrate when social arrangements leading to temptations to breach duties are in themselves morally blameworthy. Clarifying ?conflict of interest? is important if we are eventually going to develop productive modes of engagement between medicine and for-profit industry that avoid the serious ethical pitfalls now in evidence. (shrink)
A basic question of medical ethics is whether the norms governing medical practice should be understood as the application of principles and rules of the common morality to medicine or whether some of these norms are internal or proper to medicine. In this article we describe and defend an evolutionary perspective on the internal morality of medicine that is defined in terms of the goals of clinical medicine and a set of duties that constrain medical practice in pursuit of these (...) goals. This perspective is developed by means of a critical examination of the essentialist conception of the internal morality of medicine advocated by Edmund Pellegrino and the critique of internal morality approaches by Robert Veatch and Tom Beauchamp. (shrink)
The definition of ‘medical humanities’ may be approached via three conceptions—the humanities as a list of disciplines, as a program of moral development, and as a supportive friend. The conceptions are grounded by linking them to three narratives—respectively, the history of the modern liberal arts college; the history of Petrarch and the studia humanitatis of the early Renaissance; and the life of Sir William Osler. The three conceptions are complementary, each filling gaps in one or more of the others. Getting (...) clearer on a definition of ‘medical humanities’ is practically important if this field is to take its rightful place within health professions education and practice. (shrink)
The doctrine of clinical equipoise is appealing because it appears to permit physicians to maintain their therapeutic obligation to offer optimal medical care to patients while conducting randomized controlled trials (RCTs). The appearance, however, is deceptive. In this article we argue that clinical equipoise is defective and incoherent in multiple ways. First, it conflates the sound methodological principle that RCTs should begin with an honest null hypothesis with the questionable ethical norm that participants in these trials should never be randomized (...) to an intervention known to be inferior to standard treatment. Second, the claim that RCTs preserve the therapeutic obligation of physicians misrepresents the patient-centered orientation of medical care. Third, the appeal to clinical equipoise as a basic principle of risk-benefit assessment for RCTs is incoherent. Finally, the difficulties with clinical equipoise cannot be resolved by viewing it as a presumptive principle subject to exceptions. In the final sections of the article, we elaborate on the non-exploitation framework for the ethics clinical research and indicate issues that warrant further inquiry. (shrink)
Some ethical issues facing contemporary medicine cannot be fully understood without addressing medicine's internal morality. Medicine as a profession is characterized by certain moral goals and morally acceptable means for achieving those goals. The list of appropriate goals and means allows some medical actions to be classified as clear violations of the internal morality, and others as borderline or controversial cases. Replies are available for common objections, including the superfluity of internal morality for ethical analysis, the argument that internal morality (...) is merely an apology for medicine's traditional power and authority, and the claim that there is no single, "core" internal morality. The value of addressing the internal morality of medicine may be illustrated by a detailed investigation of ethical issues posed by managed care. Managed care poses some fundamental challenges for medicine's internal morality, but also calls for thoughtful reflection and reconsideration of some traditionally held moral views on patient fidelity in particular. (shrink)
Cosmetic surgery is a fast-growing medical practice. In 1997 surgeons in the United States performed the four most common cosmetic procedures443,728 times, an increase of 150% over the comparable total for 1992. Estimated total expenditures for cosmetic surgery range from $1 to $2 billion. As managed care cuts into physicians' income and autonomy, cosmetic surgery, which is not covered by health insurance, offers a financially attractive medical specialty.
In 1945–46, representatives of the U.S. government made similar discoveries in both Germany and Japan, unearthing evidence of unethical experiments on human beings that could be viewed as war crimes. The outcomes in the two defeated nations, however, were strikingly different. In Germany, the United States, influenced by the Canadian physician John Thompson, played a key role in bringing Nazi physicians to trial and publicizing their misdeeds. In Japan, the United States played an equally key role in concealing information about (...) the biological warfare experiments and in securing immunity from prosecution for the perpetrators. The greater force of appeals to national security and wartime exigency help to explain these different outcomes. (shrink)
Among those who criticize the concept of a common refrain is that we really have no idea what futility means. For example, physicians seem to disagree on whether a treatment being futile means that it has a less than 5% chance of working or a 20% chance of working. If the concept is so unclear, then it seems a thin reed upon which to base a momentous ethical decision—namely, that the physician's judgment should be allowed to override the wishes of (...) the competent patient or the patient's duly appointed surrogate. (shrink)
With breathtalung speed, traditional criminal prohibitions against assisted suicide have been declared unconstitutional in twelve states, including California and New York. This poses great promise and great peril. The promise is that competent terminally ill patients, as a compassionate measure of last resort, will have the option of putting an end to their suffering by physician-assisted suicide. More sigmficant, legally permitting this controversial option may be a catalyst for doctors, health care institutions, and society to improve the care of the (...) dying. PAS should be limited only to those relatively few competent patients who continue to suffer intolerably despite unrestrained efforts to palliate and who face a continued existence that they regard as worse than death. When dying patients know they will not be abandoned to miserable and pointless suffering if palliative care fails, they will be fortified to cope better with the process of dying.The immediate peril is that PAS will become a quick fix, available on demand to any patient diagnosed as terminally ill, thus bypassing palliative care and producing premature deaths. (shrink)
A recent statement from multiple critical care societies appropriately focuses on communication and negotiation as the major approach to the sorts of cases that have previously been labeled with the term futility. Unfortunately, the statement persists in addressing futility in a way that I have argued is unsatisfactory. Schneiderman, Jecker, and Jonsen now respond to the statement and make a number of helpful points. However, in a few ways, I also find their response off target. I will address the key (...) points of the discussion in a way that is consistent with a position I took some years ago and that I still believe to be appropriate. I... (shrink)
Before asking what U.S. bioethics might learn from a more comprehensive and more nuanced understanding of Islamic religion, history, and culture, a prior question is, how should bioethics think about religion? Two sets of commonly held assumptions impede further progress and insight. The first involves what “religion” means and how one should study it. The second is a prominent philosophical view of the role of religion in a diverse, democratic society. To move beyond these assumptions, it helps to view religion (...) as lived experience as well as a body of doctrine and to see that religious differences and controversies should be welcomed in the public square of a diverse democratic society rather than merely tolerated. (shrink)
Those concerned over the excessive commercialization of health care, to the detriment of both professional and patient-centered values, commonly propose remedies that assume that meaningful change can occur largely within the health care sector. I argue instead that a major shift in the public culture and political discourse of the U.S. will be required if the commercialization of health care is to be adequately addressed. The notion that health and health care are commodities to be bought and sold in the (...) market is encouraged by the ideology that is preferably called economism, though also today labeled neoliberalism, market fundamentalism, market triumphalism, and other terms. This ideology has been successful in pushing aside alternative accounts and policies over the past four decades, so that economism-inspired policies seem both commonsensical and inevitable. This dominance of the public political discourse hides two important facts about economism — it is a quasi-religious ideology that pretends to be a reflection of economic science; and it is shot through with internal contradictions that ultimately render it self-defeating as a guide to policy. Advocates for reduced commercialism in health care must directly address economism and attempt to educate the public and policymakers about its flaws. (shrink)
Pay-for-performance represents an effort to improve the quality of health care by paying physicians more if they meet specified target measures. There are both empirical and theoretical reasons to be deeply suspicious of P4P schemes applied at the level of the individual physician or health provider. Most P4P programs were implemented before there were any good data to demonstrate that they achieved the desired results. Once such schemes were in use, the available data are far from reassuring. Common findings are (...) that providers may do more of the specific procedure that is being measured, but in the process may neglect to do other things that equally affect quality of care. Payers often find that the cost of implementing a P4P program far exceeds the value of the very modest resulting improvements; and payments may unfairly benefit providers who are already meeting quality targets while disadvantaging those who make the most strenuous efforts to improve. (shrink)
We argue that a turn toward virtue ethics as a way of understanding medical professionalism represents both a valuable corrective and a missed opportunity. We look at three ways in which a closer appeal to virtue ethics could help address current problems or issues in professionalism education—first, balancing professionalism training with demands for professional virtues as a prerequisite; second, preventing demands for the demonstrable achievement of competencies from working against ideal professionalism education as lifelong learning; and third, avoiding temptations to (...) dismiss moral distress as a mere “hidden curriculum” problem. As a further demonstration of how best to approach a lifelong practice of medical virtue, we will examine altruism as a mean between the extremes of self-sacrifice and selfishness. (shrink)
A less analytic and more wholistic approach to philosophy, described as best overall fit or seeing how things all hang together, is defended in recent works by John Rawls and Richard Rorty and can usefully be applied to problems in philosophy of medicine. Looking at sickness and its impact upon the person as a central problem for philosophy of medicine, this approach discourages a search for necessary and sufficient conditions for being sick, and instead encourages a listing of true and (...) interesting observations about sickness which reflect the convergence of a number of different viewpoints. Among the relevant viewpoints are other humanities disciplines besides philosophy and the social sciences. Literature, in particular, provides insights into the meaning and the uniqueness of episodes of sickness in a way that philosophers may otherwise fail to grasp. (shrink)
A review of the philosophical debate on theoretical models for the physician-patient relationship over the past fifteen years may point to some of the more productive questions for future research. Contractual models have been criticized for promoting a legalistic and minimalistic image of the relationship, such that another form of model (such as convenant) is required. Shifting from a contractual to a contractarian model (in keeping with Rawls' notion of an original position) provides an adequate response to many criticisms of (...) this type. A deeper criticism, however, is one that advocates a shift to a virtue-based approach. A creative amalgam between a contractarian model and elements of the virtue-based approach, combined with appropriate empirical investigation, may yield richer models in the future. (shrink)
*The opinions expressed are the views of the author and do not necessarily reflect the policy of the National Institutes of Health, the Public Health Service, or the U.S. Department of Health and Human Services.
Minogue's criticism of MacIntyre and Gorovitz's concept of medicine as a science of individuals is flawed by an assumption of the perfectibility of science that is not well supported by experience to date. More significantly, both Minogue and MacIntyre and Gorovitz have been led astray by choosing to use the malpractice issue as a philosophical point of departure for an inquiry into medical error. The problem of error in medicine, and moral culpability for error, is of great philosophical interest but (...) requires a more detailed contextual approach than these two studies provide. CiteULike Connotea Del.icio.us What's this? (shrink)
Presently, the pharmaceutical industry funds about half of the costs of continuing medical education programs in the U.S. This contributes to the ethical problems that pervade the relationship between medicine and the pharmaceutical industry: trustworthiness and conflicts of interest. The problems are exacerbated by rationalizations prevalent on both sides that deny the ethical concerns. Commercialism and commercial bias are highly visible at large CME gatherings, and available data, while scanty, back up the view that physician attendees' subsequent prescribing practices are (...) influenced by the commercial message. The industry believes that it will recoup $3.56 in increased sales for every dollar that it invests in CME. New guidelines instituted by the Accreditation Council for Continuing Medical Education in 2004 may succeed in reducing excessive commercial influence, especially since the Department of Health and Human Services has also warned the industry of possible anti-kickback violations if firewalls are not erected between CME funding and marketing of drugs. Critics counter that early indicators of improvement are lacking. (shrink)
As early as the 1960s and 1970s, astute commentators began to call into question the degree of influence that the pharmaceutical industry was exercising over all aspects of medical research, education, and practice in the U.S. More recently, a spate of books and articles demonstrates that the issue has only become more serious in the last decade or two.My focus in this paper will be on the industry’s influence on medical education. The influence that the industry exerts on undergraduate and (...) graduate medical education often occurs through the system of pharmaceutical sales representatives, who also “detail” drugs to practitioners; or through the influence that the industry exerts over medical research. I will therefore devote my attention here primarily to the system of continuing medical education by which practitioners receive information about medical advances. The pharmaceutical industry currently supports about one-half of the costs of CME in the U.S., so it seems appropriate to question the degree of industry influence over the content of CME. (shrink)