One of the most important questions in the ethics of human clinical research asks what obligations investigators owe the people who enroll in their studies. Research differs in many ways from standard care - the added uncertainties, for instance, and the nontherapeutic interventions such as diagnostic tests whose only purpose is to measure the effects of the research intervention. Hence arises the question whether a physician engaged in clinical research has the same obligations toward research subjects that he owes his (...) medical patients, or whether they differ in any fundamental way.Perhaps the most common answer is that the relationship is the same. Investigators, like physicians, are said to be fiduciaries of the volunteers who enroll in research trials. Each owes the best available medical care, which means that a physician can only justify enrolling his patient in research if the study meets the requirements of clinical equipoise, namely, that there is legitimate disagreement within the medical community as to whether the standard treatment or the investigational intervention is superior. (shrink)

One of the most important questions in the ethics of human clinical research asks what obligations investigators owe the people who enroll in their studies. Research differs in many ways from standard care - the added uncertainties, for instance, and the nontherapeutic interventions such as diagnostic tests whose only purpose is to measure the effects of the research intervention. Hence arises the question whether a physician engaged in clinical research has the same obligations toward research subjects that he owes his (...) medical patients, or whether they differ in any fundamental way.Perhaps the most common answer is that the relationship is the same. Investigators, like physicians, are said to be fiduciaries of the volunteers who enroll in research trials. Each owes the best available medical care, which means that a physician can only justify enrolling his patient in research if the study meets the requirements of clinical equipoise, namely, that there is legitimate disagreement within the medical community as to whether the standard treatment or the investigational intervention is superior. (shrink)

Book reviewed in this article: Balancing Act: The New Medical Ethics of Medicine's New Economics. By E. Haavi Morreim.

The discussion about complementary and alternative medicine is sometimes rather heated. “Quackery!” the cry goes. A large proportion “of unconventional practices entail theories that are patently unscientific.” “It is time for the scientific community to stop giving alternative medicine a free ride. There cannot be two kinds of medicine — conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work.” “I submit that (...) if these treatments cannot withstand the test of empirical research, … then we have wasted a lot of time and effort. The time has been wasted on all the people who have spent years learning falsehoods about acupuncture points and the principles of homeopathy. And the patients have wasted their time, money, and efforts receiving treatments that were not what they were represented to be or were harmful.”. (shrink)

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now (...) are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now (...) are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)

The discussion about complementary and alternative medicine is sometimes rather heated. “Quackery!” the cry goes. A large proportion “of unconventional practices entail theories that are patently unscientific.” “It is time for the scientific community to stop giving alternative medicine a free ride. There cannot be two kinds of medicine — conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work.” “I submit that (...) if these treatments cannot withstand the test of empirical research, … then we have wasted a lot of time and effort. The time has been wasted on all the people who have spent years learning falsehoods about acupuncture points and the principles of homeopathy. And the patients have wasted their time, money, and efforts receiving treatments that were not what they were represented to be or were harmful.”. (shrink)

Public discussion of new medical trials is desirable, but not moment‐by‐moment disclosure of patients' ups and down. Nor is such disclosure necessary: the public is not entitled to all information about a trial as soon as it is available. What should be given the press, and what withheld, cannot be decided without appreciating the surprising number and intricate interrelations of the parties' needs and interests.

Tort and contract law have not kept pace with the stunning changes in medicine's economics. Physicians are still expected to deliver the same standard of care to everyone, regardless whether it is paid for. Health plans increasingly face liability for unfortunate outcomes, even those stemming from society's mandate to keep costs down while improving population health. This book sorts through the chaos. After reviewing the inadequacies of current tort and contract law, Morreim proposes that an intelligent assignment of legal (...) liability must rest on an intelligent division of labor between health plans and providers, beginning with the question "who should be doing what, for the best delivery of health care." She also provides a comprehensive reference source of case law, commentary, and empirical literature. (shrink)

The federal government's introduction in 1983 of DRG‐based reimbursement for Medicare patients shook the entire health care industry into the vigorous and dramatic cost containment efforts which today are reshaping health care in America.

The “futility debate” turns on intractable conflicts of deeply held beliefs about the value of life. It raises practical moral dilemmas of how best to permit parties to honor their own values without coercing unwilling others.

Universal access to health care is still a dream rather than a reality in the United States. This is partly because a rule of rescue, by impelling us to help people in need, urges us to ignore the limits of our health care policies wherever those limits would adversely affect a given individual. As the rule of rescue undermines whatever limits we set on health care entitlements, it can thwart the cost containment so essential to expanding access. Rather than accept (...) unlimited expense, we have thus far declined to universalize health care. The situation is exacerbated by an economic insulation shielding patients and physicians from the costs of care, prompting both to regard health care as free, an unlimited right. To reverse this costly entitlement mentality and place reasonable limits on rescue, patients must exercise greater personal responsibility for the costs of their care by directly experiencing some of the economic consequences of their health care decisions. Several mechanisms are available to accomplish this goal without posing economic barriers to needed care or penalizing people for becoming ill. Keywords: Clinton health plan, rationing, rule of rescue CiteULike Connotea Del.icio.us What's this? (shrink)

In response to rapidly rising health care costs in the United States, federal and state governments and private industry are instituting numerous and diverse cost-containment plans. As devices for coping with a scarcity of resources, such plans present serious challenges to physicians' traditional single-minded devotion to patient welfare. Those which contain costs by directly limiting medical options or by controlling physicians' daily clinical decisions can threaten the quality of medical care by allowing economic authorities to make essentially medical judgments. In (...) contrast, other plans coax compliance by arranging incentives, e.g., offering financial rewards for successful cost containment. While they allow for clinical freedom, these plans create conflicts between physicians' fiduciary obligations to their patients and the competing interests of the payers. Such conflicts arise as physicians try to work within governmental or corporate cost containment policies, and also as they attempt to streamline clinical efficiency. Throughout, issues of justice emerge as physicians seek to reconcile their own patients' claims upon limited common resources with others' equally legitimate claims. (shrink)

Cost‐containment pressures impose fiscal responsibilities upon physicians that can conflict with their fiduciary commitment to patients. Should the law permit health care providers to adjust standards of care according to patients' financial resources? The legal concept of “rebuttable presumption” should be used to reconceive the traditional requirement of a uniform standard of care.

In recent years a number of commentators have discussed the importance of measuring quality of life in health care. We want to know whether an intervention will help people to live better, not just longer, and whether some treatments cause more trouble than they are worth. New technologies promise wondrous benefits. But when millions of people have no insured access to health care, and when many others face increasingly stringent limits on care, technologies’ high costs require us to choose what (...) we should do from the broader universe of what we can do.The challenges to measuring QL are formidable. Researchers debate whether to measure general QL or disease-specific QL; whether to focus on functional status such as the patient's ability to walk and dress himself, or on the value people ascribe to that functional status; whether to seek the values of the general public, or to concentrate on people actually affected by a given disease or disability. (shrink)

In recent years a number of commentators have discussed the importance of measuring quality of life in health care. We want to know whether an intervention will help people to live better, not just longer, and whether some treatments cause more trouble than they are worth. New technologies promise wondrous benefits. But when millions of people have no insured access to health care, and when many others face increasingly stringent limits on care, technologies’ high costs require us to choose what (...) we should do from the broader universe of what we can do.The challenges to measuring QL are formidable. Researchers debate whether to measure general QL or disease-specific QL; whether to focus on functional status such as the patient's ability to walk and dress himself, or on the value people ascribe to that functional status; whether to seek the values of the general public, or to concentrate on people actually affected by a given disease or disability. (shrink)

Human clinical research has become a huge economic enterprise (Morin et al. 2002; Noah 2002). Because the human subject at the center can be so easily marginalized, many commentators recommend spec...

Several prominent cases have recently highlighted tension between the interests of individuals and those of the broader population in gaining access to health care resources. The care of Helga Wanglie, an elderly woman whose family insisted on continuing life support long after she had lapsed into a persistent vegetative state, cost approximately $750,000, the majority of which was paid by a Medi-gap policy purchased from a health maintenance organization. Similarly, Baby K was an anencephalic infant whose mother, believing that all (...) life is precious regardless of its quality, insisted that the hospital where her daughter was born provide mechanical ventilation, including intensive care, whenever respiratory distress threatened her life. Over the hospital's objections, courts ruled that aggressive care must be provided. Much of Baby K's care was covered by her mother's HMO policy. In the 1993 case of Fox v. HealthNet, a jury awarded $89 million to the family of a woman whose HMO had refused, as experimental, coverage for autologous bone marrow transplant in treating her advanced breast cancer. (shrink)

Several prominent cases have recently highlighted tension between the interests of individuals and those of the broader population in gaining access to health care resources. The care of Helga Wanglie, an elderly woman whose family insisted on continuing life support long after she had lapsed into a persistent vegetative state, cost approximately $750,000, the majority of which was paid by a Medi-gap policy purchased from a health maintenance organization. Similarly, Baby K was an anencephalic infant whose mother, believing that all (...) life is precious regardless of its quality, insisted that the hospital where her daughter was born provide mechanical ventilation, including intensive care, whenever respiratory distress threatened her life. Over the hospital's objections, courts ruled that aggressive care must be provided. Much of Baby K's care was covered by her mother's HMO policy. In the 1993 case of Fox v. HealthNet, a jury awarded $89 million to the family of a woman whose HMO had refused, as experimental, coverage for autologous bone marrow transplant in treating her advanced breast cancer. (shrink)

Responding to the failings of peers can be difficult, but as professionals physicians should not leave the moral management of errant colleagues to chance. Distinguishing levels of adverse outcomes helps physicians more clearly assess each others' conduct and respond appropriately to those who threaten the integrity of the profession.

Responding to the failings of peers can be difficult, but as professionals physicians should not leave the moral management of errant colleagues to chance. Distinguishing levels of adverse outcomes helps physicians more clearly assess each others' conduct and respond appropriately to those who threaten the integrity of the profession.

In recent years, science and the courts have created new options whereby prospective parents can avoid the birth of a diseased or defective child. We can ascertain the likelihood that certain genetic diseases will be transmitted; We can detect a number of fetal abnormalities in utero ; we have legal permission to abort for any reason, including fetal abnormality. With these new options come new questions concerning our moral obligations toward our prospective offspring. An important conceptual question concerns whether such (...) congenital diseases and defects constitute harms to the children who bear them. In this essay I shall examine the prevailing analysis of harm, the "Otherwise-Condition" approach, which denies that we can predicate harm of such abnormalities. I will show first that this analysis is inadequate even to account for certain very ordinary, clear cases of harm. It thus is suspect regardless of its stance on congenital anomalies. Second, it sets up an ill-considered connection between harm and causation – a connection which renders its harm ascriptions slippery, arbitrary. Finally, this analysis cannot be squared with certain of our deeply entrenched moral intuitions. By thus rebutting this most influential definition of harm, I will have opened the door to the possibility of ascribing harm for congenital disease and defect. Keywords: Harm, Otherwise-condition, Congenital anomaly * I would like to thank A. D. Woozley, Derek Parfit, Daniel Devereux, and the editors and reviewers of the JMP for their helpful comments on earlier drafts of this paper. CiteULike Connotea Del.icio.us What's this? (shrink)

As managed care organizations provide an increasing proportion of citizens' health care, the move toward asking individuals to help control costs by taking more responsibility for their health is likely to intensify. Economic, medical, and legal responses to lifestyle‐induced health care costs raise concerns as well as possibilities for using resources responsibly.

Traditional medical approaches to moral issues found in the clinical setting can, if properly understood, enlighten our philosophical understanding of moral issues. Moral problem-solving, as distinct from ethical and metaethical theorizing, requires that one reckon with practical complexities and uncertainties. In this setting the quality of one's answer depends not so much upon its content as upon the quality of reasoning which supports it. As the discipline which especially focuses upon the attributes of good-quality reasoning, philosophy therefore has much to (...) contribute to the clinical enterprise of moral (and medical) problem-solving. (shrink)

David Hyman and Charles Silver are quite right. Opinion 6.01 in the American Medical Association's Code of Medical Ethics is difficult to defend. Ties between compensation and outcomes need not mislead patients into thinking that results are guaranteed; they are widely used in other fields with considerable success, even if they have some disadvantages; they can potentially bring patients more actively into decision-making about whether and from whom to purchase which medical care; and, if carefully tuned, they can promote quality (...) by aligning providers’ welfare more closely with patients’.The purpose of this commentary is thus not to disagree with the fundamental thesis that result-based compensation arrangements can be appropriate and useful in the health-care setting. Rather, the objective is to “cut the next swath,” so to speak. While Hyman and Silver are right that RBCAs have potential to do good, they may be overly optimistic about benefits, while underestimating the potential limitations and hazards. (shrink)

David Hyman and Charles Silver are quite right. Opinion 6.01 in the American Medical Association's Code of Medical Ethics is difficult to defend. Ties between compensation and outcomes need not mislead patients into thinking that results are guaranteed; they are widely used in other fields with considerable success, even if they have some disadvantages; they can potentially bring patients more actively into decision-making about whether and from whom to purchase which medical care; and, if carefully tuned, they can promote quality (...) by aligning providers’ welfare more closely with patients’.The purpose of this commentary is thus not to disagree with the fundamental thesis that result-based compensation arrangements can be appropriate and useful in the health-care setting. Rather, the objective is to “cut the next swath,” so to speak. While Hyman and Silver are right that RBCAs have potential to do good, they may be overly optimistic about benefits, while underestimating the potential limitations and hazards. (shrink)

A new economic phenomenon, in which physicians refer their patients to ancillary facilities of which they themselves are owners or substantial investors, presents a ‘laboratory’ for assessing philosophers' potential contributions to public policy issues. In this particular controversy, ‘prohibitionists’ who wish to ban all such self-referral focus on the dangers that patients and payers may receive or be billed for unnecessary or poor-quality care. ‘Laissez-fairists’, in contrast, argue that self-referral should be freely permitted, with a reliance on personal ethics and (...) internal professional monitoring to guard against abuse. Undue government regulation, they argue, infringes providers' and patients' economic freedom, and stifles the competition that can yield better quality care at lower prices. As this debate features basic values and large amounts of money, it has been marked by rancorous rhetoric, shallow argument, and muddled reasoning. The philosopher's first contribution, therefore, is to expose simplistic and fallacious arguments, whether empirical, conceptual, moral, or legal. Beyond this, the philosopher can help to identify the important values at stake and, perhaps, to identify resolutions that honor those values better than the more simplistic answers proffered previously. For abusive self-referral, as distinguished from kickbacks, the author recommends that civil remedies be favored over criminal prohibitions. She suggests that the doctrine of ‘bad faith breach of contract’ might appropriately be extended into this new area to provide a powerful means by which aggrieved patients and payers can hold physicians personally accountable for abusive self-referrals. Keywords: bad faith breach of contract, civil law, criminal law, self-referral, simplistic reasoning CiteULike Connotea Del.icio.us What's this? (shrink)

Professor Hall is to be congratulated on his thoughtful analysis of an issue that, as he rightly suggests, “is one of the most important issues that will confront health care tort law throughout the remainder of the century.”’ He argues that malpractice law currently can accommodate considerable latitude both for a conservative streamlining of medical practices in general and for a cost-sensitivity in individual treatment decisions. And he further argues that existing tort principles, such as the locality rule, can comfortably (...) be stretched to embrace still greater room for economics in the medical standard of care. I quite agree.Unfortunately, Hall's arguments do not go nearly far enough, for they are framed around a seriously oversimplified picture of the economic changes that are revolutionizing medicine in the United States. He envisions a fairly uniform, global set of resource constraints that generally pressure physicians to conserve on care—pressures that tort law can then encompass equally globally as it accepts more cost-efficient standards of care. However, neither the changing economics of medicine nor the resulting jurisprudential challenges are anywhere near this generalized. (shrink)

As they struggle to maintain high‐quality health care in the face of new economic limitations, physicians should not endanger their relationships with patients. But they should collectively revise the informal protocols that guide clinical decision making.

The ongoing economic overhaul of medicine creates two basic imperatives – boosting profits and containing costs – that pose special ethical and philosophical challenges for psychiatry. Because insurance coverage still favors inpatient care, pressures to raise renevues translate into a corresponding pressure on psychiatry as a whole to expand its diagnostic categories, and on individual psychiatrists to ascribe these diagnoses liberally and to hospitalize as many patients as possible. Reciprocally, cost containment requires all physicians to justify their care as clearly (...) as possible and to eliminate those interventions that are not of demonstrable value. Scientific outcome studies are markedly more difficult in psychiatry than elsewhere in medicine, particularly for psychotherapeutic as opposed to pharmacologic modes of care. An emphasis on biological over psychological conceptions of mental illness and treatment might result, not because it is more likely to be correct, but because it is easier to document in conventional ways and less expensive to deliver. An economicsdriven reorganization of psychiatry therefore poses serious philosophical challenges, not only for the profession and its future, but for the clinical care of patients. Keywords: cost containment, epistemology, ethics, economics, metaphysics, psychiatry CiteULike Connotea Del.icio.us What's this? (shrink)