Public Reason, Bioethics, and Public Policy: A Seductive Delusion or Ambitious Aspiration?

Can 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.

Precision Medicine and Rough Justice: Wicked Problems.

What 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.

Teaching Bioethics Today: Waking from Dogmatic Curricular Slumbers.

The 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."

The Dobbs Decision: Can It Be Justified by Public Reason?

John 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.

Precision medicine and the fragmentation of solidarity (and justice).

Solidarity 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.

Alzheimer's and Aducanumab: Unjust Profits and False Hopes.

Accelerated 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 ß-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.

Heritable Human Genome Editing: The Public Engagement Imperative.

In the view of many, heritable human genome editing (HHGE) harbors the remedial potential of ridding the world of deadly genetic diseases. A Hippocratic obligation, if there ever was one, HHGE is widely viewed as a life-sustaining proposition. The national go/no-go decision regarding the implementation of HHGE, however, must not, in the collective view of the authors, proceed absent thorough public engagement. A comparable call for an "extensive societal dialogue" was recently issued by the International Commission on the Clinical Use of Human Germline Genome Editing. In this communication, the authors lay out the foundational principles undergirding the formation, modification, and evaluation of public opinion. It is against this backdrop that the societal decision to warrant or enjoin the clinical conduct of HHGE will doubtlessly transpire.

Some Lives Matter: The Dirty Little Secret of the U.S. Health Care System.

Our 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.

Precision QALYs, Precisely Unjust.

Warwick Heale has recently defended the notion of individualized and personalized Quality-Adjusted Life Years (QALYs) 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 (and lose two years of potential life). Likewise, Heale argues that personal commitments of an individual (religious or otherwise), 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.

Healthcare Priority-Setting: Chat-Ting Is Not Enough Comment on "Swiss-CHAT: Citizens Discuss Priorities for Swiss Health Insurance Coverage".

CHAT has its limits. It is a three-hour exercise. However, the real world problems of healthcare rationing and priority-setting are too complex for a three-hour exercise. What is needed, as a supplement, are sustained processes of rational democratic deliberation that can address the challenges to healthcare justice posed by costly emerging medical technologies, such as these targeted cancer therapies.

Controlling Healthcare Costs: Just Cost Effectiveness or "Just" Cost Effectiveness?

Meeting healthcare needs is a matter of social justice. Healthcare needs are virtually limitless; however, resources, such as money, for meeting those needs, are limited. How then should we (just and caring citizens and policymakers in such a society) decide which needs must be met as a matter of justice with those limited resources? One reasonable response would be that we should use cost effectiveness as our primary criterion for making those choices. This article argues instead that cost-effectiveness considerations must be constrained by considerations of healthcare justice. The goal of this article will be to provide a preliminary account of how we might distinguish just from unjust or insufficiently just applications of cost-effectiveness analysis to some healthcare rationing problems; specifically, problems related to extraordinarily expensive targeted cancer therapies. Unconstrained compassionate appeals for resources for the medically least well-off cancer patients will be neither just nor cost effective.

First Come, First Served in the Intensive Care Unit: Always?

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.

How Should Therapeutic Decisions about Expensive Drugs Be Made in Imperfect Environments?

Clinicians must inevitably make therapeutic decisions under nonideal conditions. They practice in circumstances that involve incomplete evidence. They deliver care in health care systems that are complex and poorly coordinated. Each of the patients that they take care of is unique while research offers evidence regarding relatively homogeneous populations of patients. Under these circumstances, many parties-medical scientists, reviewing agencies, insurers, and accountable care organizations-can and should contribute to optimizing the development, approval, funding, and prescription of therapies-particularly expensive and marginally beneficial therapies. In aggregate, they should aspire to achieve a pattern of fair, cost-effective therapeutic decisions to ensure a sustainable health care system. Here we offer some suggestions regarding decisions that physicians might pursue to facilitate fair and cost-effective patient care.

Choosing Wisely.

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.

Just caring: assessing the ethical and economic costs of personalized medicine.

Personalized medicine has been touted as a revolutionary form of cancer care. It has been portrayed as precision medicine, targeting with deadly accuracy cancer cells and sparing patients the debilitating broad-spectrum side effects of more traditional forms of cancer therapy. But personalized medicine still has its costs to patients and society, both moral and economic costs. How to recognize and address those issues will be the focus of this essay. We start with these questions: Does everyone faced with cancer have a moral right to the most effective cancer care available, no matter what the cost, no matter whether a particular individual has the personal ability to pay for that care or not? Or are there limits to the cancer care that anyone has a right to at social expense? If so, what are those limits and how are those limits to be determined? Are those limits a matter of both morality and economics? I will answer this last question in the affirmative. This is what I refer to as the "Just Caring" problem in health care.