Precision medicine and the fragmentation of solidarity (and justice).Leonard M. Fleck -2022 -Medicine, Health Care and Philosophy 25 (2):191-206.detailsSolidarity is a fundamental social value in many European countries, though its precise practical and theoretical meaning is disputed. In a health care context, I agree with European writers who take solidarity normatively to mean roughly equal access to effective health care for all. That is, solidarity includes a sense of justice. Given that, I will argue that precision medicine represents a potential weakening of solidarity, albeit not a unique weakening. Precision medicine includes 150 targeted cancer therapies (mostly for metastatic (...) cancer), all of which are extraordinarily expensive. Our critical question: Must a commitment to solidarity as defined mean that all these targeted cancer therapies should be guaranteed to all within each country in the European Union, no matter the cost, no matter the degree of effectiveness? Such a commitment would imply that cancer was ethically special, rightfully commandeering unlimited resources. That in itself would undermine solidarity. I offer multiple examples of how current and future dissemination of these targeted cancer drugs threaten a commitment to solidarity. An alternative is to fund more cancer prevention efforts. However, that too proves a threat to solidarity. Solidarity, with or without a sense of justice, is too abstract a notion to address these challenges. Further, we need to accept that we can only hope to achieve “rough justice” and “supple solidarity.” The precise practical meaning of these notions needs to be worked out through a fair and inclusive process of rational democratic deliberation, which is the real and practical foundation of just solidarity. (shrink)
AI diagnoses terminal illness care limits: just, or just stingy?Leonard Michael Fleck -2024 -Journal of Medical Ethics 50 (12):818-819.detailsI agree with Jecker et al that “the headline-grabbing nature of existential risk (X-risk) diverts attention away from immediate artificial intelligence (AI) threats…”1 Focusing on very long-term speculative risks associated with AI is both ethically distracting and ethically dangerous, especially in a healthcare context. More specifically, AI in healthcare is generating healthcare justice challenges that are real, imminent and pervasive. These are challenges generated by AI that deserve immediate ethical attention, more than any X-risk issues in the distant future. Almost (...) 50 years ago, John Knowles edited a volume titled Doing Better and Feeling Worse: Health in the United States. We are ‘doing better’ because numerous advances in medical technologies are saving more lives and improving the quality of our lives. But we are ‘feeling worse’ because the additional costs are unsustainable, are threatening funding for other social goods and are increasing injustices regarding the allocation of those resources. This is precisely the situation we are faced with regarding AI in medicine today. Exploding healthcare costs have generated increasing pressure to control those costs, often with unjust consequences. AI is touted as a critical mechanism for controlling healthcare costs, often with little thought given to justice-relevant consequences. Consider, for example, …. (shrink)
Whoopie Pies, Supersized Fries.Leonard M. Fleck -2012 -Cambridge Quarterly of Healthcare Ethics 21 (1):5-19.detailsThe annual cost of healthcare in the United States reached $2.5 trillion in 2009 (about 17.6% of GDP) with projections to 2019 of about $4.5 trillion (about 20% of likely GDP).
Public Reason, Bioethics, and Public Policy: A Seductive Delusion or Ambitious Aspiration?Leonard M. Fleck -forthcoming -Cambridge Quarterly of Healthcare Ethics:1-15.detailsCan Rawlsian public reason sufficiently justify public policies that regulate or restrain controversial medical and technological interventions in bioethics (and the broader social world), such as abortion, physician aid-in-dying, CRISPER-cas9 gene editing of embryos, surrogate mothers, pre-implantation genetic diagnosis of eight-cell embryos, and so on? The first part of this essay briefly explicates the central concepts that define Rawlsian political liberalism. The latter half of this essay then demonstrates how a commitment to Rawlsian public reason can ameliorate (not completely resolve) (...) many of the policy disagreements related to bioethically controversial medical interventions today. The goal of public reason is to reduce the size of the disagreement by eliminating features of the disagreement that violate the norms of public reason. The norms of public reason are those norms that are politically necessary to preserve the liberal, pluralistic, democratic character of this society. What remains is reasonable disagreement to be addressed through normal democratic deliberative processes. Specific issues addressed from a public reason perspective include personal responsibility for excessive health costs, the utility of a metaphysical definition of death for organ transplantation, and the moral status of excess embryos generated through IVF and/or their use in medical research. (shrink)
Alzheimer's and Aducanumab: Unjust Profits and False Hopes.Leonard M. Fleck -2021 -Hastings Center Report 51 (4):9-11.detailsAccelerated approval of aducanumab for mild Alzheimer's by the U.S. Food and Drug Administration on June 7, 2021, has generated substantial medical, scientific, and ethical controversy. That approval was contrary to the nearly unanimous judgment of the FDA's Advisory Committee that little reliable evidence existed of significant benefit, even though the drug did reduce β‐amyloid. Three major ethical problems were created by this approval: (1) Medicare resources would be unjustly squandered, given the drug's $56,000 annual price and the 3.1 million (...) older potential American patients needing the drug; (2) physicians will feel ethically compelled to provide the drug to desperate, insistent patients, given FDA approval and in spite of side effects of brain bleeds and brain swelling; (3) and false hopes are generated for patients. A needed corrective by the federal government would reduce reimbursement to the bare cost of producing the drug (plus only a modest profit) until a phase IV trial has been successfully completed. (shrink)
Vexing Vaccine Ethics: Denying ICU Care to Vaccine Refusers.Leonard M. Fleck -2024 -American Journal of Bioethics 24 (7):92-94.detailsPark and Davies (2024) address the question of whether vaccine status can be an ethically legitimate criterion for the allocation of scarce medical resources, such as access to an ICU bed and venti...
Abortion, Artificial Wombs, and the “No Difference” Argument.Leonard Michael Fleck -2023 -American Journal of Bioethics 23 (5):94-97.detailsDe Bie et al. (2023) call attention at the conclusion of their essay to the “novel questions” generated by complete ectogenesis. The question I explore is how complete ectogenesis from conception t...
First Come, First Served in the Intensive Care Unit: Always?Leonard M. Fleck &Timothy F. Murphy -2018 -Cambridge Quarterly of Healthcare Ethics 27 (1):52-61.detailsAbstract:Because the demand for intensive care unit (ICU) beds exceeds the supply in general, and because of the formidable costs of that level of care, clinicians face ethical issues when rationing this kind of care not only at the point of admission to the ICU, but also after the fact. Under what conditions—if any—may patients be denied admission to the ICU or removed after admission? One professional medical group has defended a rule of “first come, first served” in ICU admissions, (...) and this approach has numerous moral considerations in its favor. We show, however, that admission to the ICU is not in and of itself guaranteed; we also show that as a matter of principle, it can be morally permissible to remove certain patients from the ICU, contrary to the idea that because they were admitted first, they are entitled to stay indefinitely through the point of recovery, death, or voluntary withdrawal. What remains necessary to help guide these kinds of decisions is the articulation of clear standards for discontinuing intensive care, and the articulation of these standards in a way consistent with not only fiduciary and legal duties that attach to clinical care but also with democratic decision making processes. (shrink)
Personalized Medicine's Ragged Edge.Leonard M. Fleck -2012 -Hastings Center Report 40 (5):16-18.detailsThe phrase "personalized medicine" has a built-in positive spin. Simple genetic tests can sometimes predict whether a particular individual will have a positive response to a particular drug or, alternatively, suffer costly and debilitating side effects. But little attention has been given to some challenging issues of justice raised by personalized medicine. How should we determine who would have a just claim to access particular treatments, especially very expensive ones? How effective do those treatments need to be?If there were a (...) thick, bright line separating minimal responders from maximal responders, then we could allocate these treatments in a fair and cost-effective way. But there is no bright line. The .. (shrink)
TheDobbs Decision: Can It Be Justified by Public Reason?Leonard M. Fleck -2023 -Cambridge Quarterly of Healthcare Ethics 32 (3):310-322.detailsJohn Rawls has held up as a model of public reason the U.S. Supreme Court. I argue that the Dobbs Court is justifiably criticized for failing to respect public reason. First, the entire opinion is governed by an originalist ideological logic almost entirely incongruent with public reason in a liberal, pluralistic, democratic society. Second, Alito’s emphasis on “ordered liberty” seems completely at odds with the “disordered liberty” regarding abortion already evident among the states. Third, describing the embryo/fetus from conception until (...) birth as an “unborn human being” begs the question of the legal status of the embryo/fetus, as if an obiter dictum settled the matter. Fourth, Alito accuses the Roe court of failing to exercise judicial restraint, although Alito argued to overturn Roe in its entirety. In brief, the Dobbs opinion is an illiberal, disingenuous, ideological swamp that swallows up public reason and the reproductive rights of women. (shrink)
ECMO: What Would a Deliberative Public Judge?Leonard Michael Fleck -2023 -American Journal of Bioethics 23 (6):46-48.detailsI fundamentally agree with Childress et al. (2023) in the scenario they have constructed with Mr. J. None of the arguments they critically assess are ethically persuasive enough to justify removing...
Conscientious Objection and PVS: Proceed with Caution.Leonard Michael Fleck -2025 -American Journal of Bioethics 25 (3):49-51.detailsVolume 25, Issue 3, March 2025, Page 49-51.
Just caring: Oregon, health care rationing, and informed democratic deliberation.Leonard M. Fleck -1994 -Journal of Medicine and Philosophy 19 (4):367-388.detailsThis essay argues that our national efforts at health reform ought to be informed by eleven key lessons from Oregon. Specifically, we must learn that the need for health care rationing is inescapable, that any rationing process must be public and visible, and that fair rationing protocols must be self-imposed through a process of rational democratic deliberation. Part I of this essay notes that rationing is a ubiquitous feature of our health care system at present, but it is mostly hidden (...) rationing, which is presumptively unjust. Part II argues that the need for health care rationing is inescapable. Although Oregon is flawed as a model of health rationing, it gives us worthy moral lessons for health reform at the national level, which I analyze and defend in Part III. The most significant of these lessons is the importance of rational democratic deliberation in articulating fair rationing protocols for a community. In Part IV I sketch the philosophic justification for this approach and respond to some important criticisms from Daniels. Keywords: cost containment, democratic deliberation, fairness, justice, rationing CiteULike Connotea Del.icio.us What's this? (shrink)
On being genetically "irresponsible".Judith Andre,Leonard M. Fleck &Thomas Tomlinson -2000 -Kennedy Institute of Ethics Journal 10 (2):129-146.details: New genetic technologies continue to emerge that allow us to control the genetic endowment of future children. Increasingly the claim is made that it is morally "irresponsible" for parents to fail to use such technologies when they know their possible children are at risk for a serious genetic disorder. We believe such charges are often unwarranted. Our goal in this article is to offer a careful conceptual analysis of the language of irresponsibility in an effort to encourage more care (...) in its use. Two of our more important sub-claims are: A fair judgment of genetic irresponsibility necessarily requires a thick background description of the specific reproductive choice; and there is no necessary connection between an act's being morally wrong and its being irresponsible. These are distinct judgments requiring distinct justifications. (shrink)
Just caring: Health reform and health care rationing.Leonard M. Fleck -1994 -Journal of Medicine and Philosophy 19 (5):435-443.detailsHealth reform must include health care rationing, both for reasons of fairness and efficiency. Few politicians are willing to accept this claim, including the Clinton Administration. Brown and others have argued that enormous waste and inefficiency must be wrung out of our health care system before morally problematic cost constraining options, such as rationing, can be justifiably adopted. However, I argue that most of the policies and practices that would diminish waste and inefficiency include implicit (and therefore morally problematic) rationing. (...) Critics of rationing see as its most morally and psychologically troubling feature that an identified individual is denied potentially beneficial care. That psychic anguish may not be eliminable, and perhaps ought not be eliminated. But if rationing protocols are fairly adopted through a process of free and informed rational democratic deliberation to which all have access, the moral objections are largely overcome. Such a process is possible only if implicit rationing is recognized and rejected. Keywords: Justice, health care rationing, health reform, democratic decision-making CiteULike Connotea Del.icio.us What's this? (shrink)
Choosing Wisely.Leonard M. Fleck -2016 -Cambridge Quarterly of Healthcare Ethics 25 (3):366-376.detailsAbstract:The American College of Physicians in its ethics manual endorsed the idea that physicians ought to improve their ability to provide care to their patients more parsimoniously. This elicited a critical backlash; critics essentially claimed that what was being endorsed was a renamed form of rationing. In a recent article, Tilburt and Cassel argued that parsimonious care and rationing are ethically distinct practices. In this essay I critically assess that claim. I argue that in practice there is considerable overlap between (...) what they term parsimonious care and what they define as rationing. The same is true of the Choosing Wisely campaign endorsed by the American Board of Internal Medicine. In both cases, if the goal is to control healthcare costs by reducing the use of marginally beneficial care that is not cost effective, then a public conversation about the justness of specific choices is essential. (shrink)
Just Caring: In Defense of Limited Age-Based Healthcare Rationing.Leonard M. Fleck -2010 -Cambridge Quarterly of Healthcare Ethics 19 (1):27.detailsThe debate around age-based healthcare rationing was precipitated by two books in the late 1980s, one by Daniel Callahan and the other by Norman Daniels. These books ignited a firestorm of criticism, best captured in the claim that any form of age-based healthcare rationing was fundamentally ageist, discriminatory in a morally objectionable sense. That is, the elderly had equal moral worth and an equal right to life as the nonelderly. If an elderly and nonelderly person each had essentially the same (...) medical problem requiring the same medical treatment, then they had an equal right to receive that treatment no matter what the cost of that treatment. Alternatively, if cost was an issue because the benefits of the treatment were too marginal, then both the elderly and nonelderly patients requiring that treatment ought to be denied it. If there were something absolutely scarce about the treatment, then some fair process would have to be used to make an allocation decision. (shrink)
(1 other version)Miscellaneous.Leonard M. Fleck -2002 -Hastings Center Report 32 (2):35-36.detailsIt's not only necessary, but possible, if the public can be educated.
Just Solidarity: The Key to Fair Health Care Rationing.Leonard M. Fleck -2015 -Diametros 43:44-54.detailsI agree with Professor ter Meulen that there is no need to make a forced choice between “justice” and “solidarity” when it comes to determining what should count as fair access to needed health care. But he also asserts that solidarity is more fundamental than justice. That claim needs critical assessment. Ter Meulen recognizes that the concept of solidarity has been criticized for being excessively vague. He addresses this criticism by introducing the more precise notion of “humanitarian solidarity.” However, I (...) argue that these notions are still not precise enough and are in need of behavioral translation, especially in relation to the problem of fair health care rationing. More specifically, I argue that translation ought to take the form of a well-ordered process of rational democratic deliberation, which I describe and defend in this essay. Such a process is what is required to construct a working model of just solidarity as opposed to a merely abstract idealization of just solidarity. (shrink)
Children and Organ Donation: Some Cautionary Remarks.Leonard M. Fleck -2004 -Cambridge Quarterly of Healthcare Ethics 13 (2):161-166.detailsMy task is to provide some critical commentary on the preceding essays. My unfortunate conclusion will be that the issues that are their primary focus are more likely to become more ethically intractable over the next several years as medicine progresses. I do not see any easy or obvious way to avoid this conclusion.
Justice, hmos, and the invisible rationing of health care resources.Leonard M. Fleck -1990 -Bioethics 4 (2):97–120.detailsIf we accept the premise that some sort of rationing of access to health care resources is necessary to contain escalating health care costs effectively, then we need to ask how that rationing might be accomplished most fairly. Calabresi and Bobbitt have argued in their book Tragic Choices that there is no 'perfectly fair' or even 'reasonably fair' way to bring this about.
Precision Public Health Equity: Another Utopian Mirage?Leonard Michael Fleck -2024 -American Journal of Bioethics 24 (3):98-100.detailsGalasso calls for “the actualization of the public health potential of precision medicine….as the best realistic contribution to health equity” (Galasso 2024, 83). Unfortunately, this is wishful th...
Precision Medicine and Rough Justice: Wicked Problems.Leonard M. Fleck -2024 -Cambridge Quarterly of Healthcare Ethics 33 (1):1-4.detailsWhat exactly is a “wicked problem”? It is a social or economic problem that is so complex and so interconnected with other issues that it is extraordinarily difficult or impossible to resolve. This is because all proposed resolutions generate equally complex, equally wicked problems. In this essay, I argue that precision medicine, especially in the context of the U.S. healthcare system, generates numerous wicked problems related to distributive justice. Further, I argue that there are no easy solutions to these wicked (...) problems. The need for trade-offs is inescapable. Rough justice is the best outcome we can hope for, and that outcome requires a commitment to processes of public reason that are fair and inclusive. (shrink)
DRGs: Justice and the invisible rationing of health care resources.Leonard M. Fleck -1987 -Journal of Medicine and Philosophy 12 (2):165-196.detailsAre DRGs just? This is the primary question which this essay will answer. But there is a prior methodological question that also needs to be addressed: How do we go about rationally (non-arbitrarily) assessing whether DRGs are just or not? I would suggest that grand, ideal theories of justice (Rawls, Nozick) have only very limited utility for answering this question. What we really need is a theory of “interstitial justice,” that is, an approach to making justice judgments that is suitable (...) to assessing the social practices and institutions that comprise the interstices of our social life as opposed to its basic structure. Rawls's appeal to “our considered moral judgments” provides us with a useful starting point for this task, which we shall discuss in the first part of this essay. In the second part, we shall actually assess DRGs from the perspective of interstitial justice. What we shall show is that DRGs violate a large number of our considered judgments regarding a just approach to financing health care for the elderly in a cost-effective manner. This is true to such an extent that efforts to reform DRGs and make them fairer, such as the recent effort by Robert Veatch, should be abandoned. In the concluding section of the essay we discuss one especially pernicious feature of DRGs, namely, that they represent an invisible approach to rationing access to health care. In the minds of many this is one of the virtues of DRGs. That claim needs critical examination. (shrink)
Teaching Bioethics Today: Waking from Dogmatic Curricular Slumbers.Leonard M. Fleck -forthcoming -Cambridge Quarterly of Healthcare Ethics:1-8.detailsThe Dobbs decision has precipitated renewed medical, political, and professional interest in the issue of abortion. Because this decision handed responsibility for regulation of abortion back to the states, and because the states are enacting or have enacted policies that tend to be very permissive or very restrictive, the result has been legal and professional confusion for physicians and their patients. Medical education cannot resolve either the legal or ethical issues regarding abortion. However, medical education must prepare future physicians for (...) caring for patients seeking abortion-related services. Physicians must be prepared to interact appropriately (sensitively and with integrity) with patients or colleagues whose views on abortion differ significantly from their own. This essay describes our educational effort to achieve that objective. The motto that governed this exercise was “No Easy Answers.”. (shrink)
Despairing about Health Disparities.Leonard M. Fleck -2017 -Hastings Center Report 47 (5):43-44.detailsI have never doubted that the problem of inequalities in health status and access to needed care is a difficult ethical and political challenge. After reading the essays in Understanding Health Inequalities and Justice: New Conversations across the Disciplines, edited by Mara Buchbinder, Michele Rivkin-Fish, and Rebecca Walker, I concluded that despair was the only suitable response in the face of daunting ethical and political complexity. The editors of this volume have three questions in mind that they asked contributors to (...) address. How do scholars from various disciplines approach relations between health inequalities and ideals of justice? Social scientists want to offer empirical descriptions of inequalities in health status across a range of social groups, but there are numerous ways of offering such descriptions. Are they all “correct”? Philosophers and medical ethicists want to make normative judgments regarding which inequalities matter, ethically speaking. So do we need to know when considerations of justice are relevant to assessing health inequalities and which considerations of justice are most relevant in specific contexts? Ultimately, the question is which of these scholarly approaches is most useful for improving health policy. (shrink)
Just caring: screening needs limits.Leonard Michael Fleck -2020 -Journal of Medical Ethics 46 (4):253-254.detailsThis personal narrative tugs at the heart strings. However, personal narratives are not sufficient to justify public funding for any screening policy. We have to take seriously the ‘just caring’ problem. We have only limited resources to meet virtually unlimited health care needs. No doubt, screening tests often save lives. The author wants public funding for prostate-specific antigen screening for prostate cancer. However, why only prostate cancer? Numerous cancers at various stages can be screened for. Are all of them equally (...) deserving of public funding? What about screening for a very long list of other life-threatening medical disorders? There is nothing ethically special about cancer. Where does the money come from to pay for all these screening tests? Do we reduce expensive life-prolonging care for patients in late-stage diseases? Ultimately, a balance must be struck between saving statistical lives through screening and saving identifiable lives in the intensive care unit. Achieving a just balance requires rational democratic deliberation as justification for these choices, not personal narratives. (shrink)
Just Caring: The Challenges of Priority‐Setting in Public Health.Leonard M. Fleck -2007 - In Rosamond Rhodes, Leslie P. Francis & Anita Silvers,The Blackwell Guide to Medical Ethics. Malden, MA: Wiley-Blackwell. pp. 323–340.detailsThe prelims comprise: The Scope of Public Health: Challenges and Choices Health Care Justice and Public Health: When Is Enough Enough? Setting Public Health Priorities Justly: The Limits of Moral Theory References.
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(1 other version)Just health care : Is beneficence enough?Leonard M. Fleck -1989 -Theoretical Medicine and Bioethics 10 (2).detailsFew in our society believe that access to health care should be determined primarily by ability to pay. We believe instead that society has an obligation to assure access to adequate health care for all. This is the view explicitly endorsed in the President's Commission Report Securing Access to Health Care. But there is an important moral ambiguity here, for this obligation may be construed as being either beneficence-based or justice -based. A beneficience-based construal would yield a much weaker obligation (...) with respect to the distribution of health care. In the first section of this paper I argue that the President's Commission is committed only to this weaker construal of this obligation. In the second section I argue that such a beneficence-based obligation is really rooted in a libertarian conception of justice, similar to that recently articulated by Engelhardt, and that this conception is seriously flawed when it comes to effecting a just distribution of health care. (shrink)
Multicancer Early Detection Screening Tools: Not Economically Efficient, Not Ethically Equitable, Marginally Medically Effective.Leonard M. Fleck -forthcoming -Cambridge Quarterly of Healthcare Ethics:1-14.detailsA screening test for more than 50 cancers at earlier stages would strike many as a godsend. Such a test would promise, prima facie, to save 160,000 lives annually from a premature death from cancer, reduce the intensity of medical treatment, and reduce social costs. In brief, this is what is promised by the Galleri test. We will delineate those claims in greater detail and critically assess them from medical, economic, and ethical perspectives. We conclude, with many others, that this (...) test lacks clinical validity and clinical utility. In addition, annual public funding of $100 billion for this test would be socially unaffordable; the opportunity costs would be unacceptable for both ethical and economic reasons. Further, the least well off with respect to cancer care would be made worse off if this test were publicly funded for everyone over the age of fifty. (shrink)
Precision QALYs, Precisely Unjust.Leonard M. Fleck -2019 -Cambridge Quarterly of Healthcare Ethics 28 (3):439-449.detailsWarwick Heale has recently defended the notion of individualized and personalized Quality-Adjusted Life Years in connection with health care resource allocation decisions. Ordinarily, QALYs are used to make allocation decisions at the population level. If a health care intervention costs £100,000 and generally yields only two years of survival, the cost per QALY gained will be £50,000, far in excess of the £30,000 limit per QALY judged an acceptable use of resources within the National Health Service in the United Kingdom. (...) However, if we know with medical certainty that a patient will gain four extra years of life from that intervention, the cost per QALY will be £25,000. Heale argues fairness and social utility require such a patient to receive that treatment, even though all others in the cohort of that patient might be denied that treatment. Likewise, Heale argues that personal commitments of an individual, that determine how they value a life-year with some medical intervention, ought to be used to determine the value of a QALY for them. I argue that if Heale’s proposals were put into practice, the result would often be greater injustice. In brief, requirements for the just allocation of health care resources are more complex than pure cost-effectiveness analysis would allow. (shrink)
Some Lives Matter: The Dirty Little Secret of the U.S. Health Care System.Leonard M. Fleck -2020 -Hastings Center Report 50 (5):3-4.detailsOur health care system in the United States reflects the inequities that are part of the larger society, which is why our system for financing access to needed and effective health care is so complicated and unfair.