Dr. Fleck presents on public funding for whole genome sequencing at International Bioethics Retreat

Leonard Fleck photo

Dr. Leonard Fleck, professor in the Center for Ethics, participated in a keynote debate this month as part of the 24th annual International Bioethics Retreat that was presented virtually from Paris. Each year, “experts in medicine, philosophy, law, and health policy are invited from around the world to present their current research projects.”

Within the debate format, Dr. Fleck addressed the question: “Whole Genome Sequencing: Should It Be Publicly Funded?” Dr. Fleck defended the affirmative in this debate, while Dr. Leslie Francis of the University of Utah defended the negative. Continue reading below for Dr. Fleck’s summary of the debate.

Whole Genome Sequencing: Should It Be Publicly Funded?

Below are the key elements in the affirmative side of that debate, as well as acknowledgment of legitimate points made by Dr. Francis.

We can start with the question of what Whole Genome Sequencing [WGS] is. It refers to creating a complete map of all three billion base pairs of DNA in an individual. Next, how might WGS be used? It can be used for preventive, diagnostic, therapeutic, reproductive, and public health purposes? It can be used by adults as part of a preventive strategy, i.e., identifying genetic vulnerabilities to disorders that might be managed or prevented through behavioral change. WGS can be used diagnostically to correctly identify very rare disorders that otherwise will require a costly and painful diagnostic odyssey. This is most often true in the case of infants.

WGS is used therapeutically in the case of metastatic cancer. Both the patient and cancer tumors would be mapped in order to find a genetic driver of the cancer that could then be attacked with a targeted cancer therapy, such as trastuzumab to attack a HER2+ breast cancer. WGS can be used in a reproductive context to do non-invasive prenatal assessment of a fetus. Likewise, some advocate using WGS to do neonatal genetic screening in place of the heel stick and blood draw that will test for 56 childhood genetic disorders. WGS could test for hundreds of very rare genetic disorders that can affect children. The public health context is very visible right now as we do WGS of the COVID variants now emerging.

Why public funding? The key argument is that it is a matter of health care justice. WGS costs about $1000 for the sequencing itself, and another $2000 for the analysis, interpretation, and counseling. Insurers will generally not pay for WGS. Roughly, only the top quintile in the U.S. economic spectrum can afford to pay for WGS out of pocket. This can yield significant health advantages for them, most especially avoiding various sorts of genetic harms. More precisely, the relatively wealthy might learn of one or more health risks through WGS that would suggest the need for additional testing and therapeutic interventions, all of which would be paid for by their insurance. The less financially well off may have good health insurance but be unaware of the need to use it in a timely way without the advantage of WGS. One possible result is that a curable disease becomes incurable when symptoms are clinically evident. This is an injustice that can be avoided if access to WGS is publicly funded.

My esteemed debate partner Dr. Francis emphasized that the ethics issues are much more complex than simply matters of health care justice. The distinctive feature of any form of genetic testing is that it yields considerable information about any number of first-degree relatives who may or may not want an individual to know that information. If we do WGS on a neonate, for example, we might discover that neonate has an APOE 4/4 variant for early dementia. That means at least one parent has that vulnerability, which they might not wish to know. In addition, do those parents have any obligation to notify any other relatives of their potential vulnerability? What if, instead, it was a BRCA1 mutation for breast or ovarian cancer? More problematic still, what if WGS is used at public expense in prenatal screening with the result that some parents choose to have an abortion. Would advocates for a Right to Life view have a right to object to their tax dollars being used to facilitate access to a procedure to which they conscientiously object? This is why we have debates.

Dr. Fleck presents on precision medicine at international virtual symposium

Leonard Fleck photo

Center Acting Director and Professor Dr. Leonard Fleck spoke earlier this month at a virtual symposium presented by University of Groningen in Groningen, Netherlands.

The event’s theme was “Barriers and future directions of personalized medicine: from the bench to the patients.” Dr. Fleck’s presentation was titled “Precision Medicine/Ethical Ambiguity: Rough Justice, Wicked Problems, fragmented Solidarity.” The symposium was funded by the European Union’s Horizon 2020 research and innovation program. As one of several keynote speakers, Dr. Fleck provided an ethicist perspective. Dr. Fleck has provided a summary of his presentation below.

Solidarity is a fundamental social value in many European countries, though its precise practical and theoretical meaning is disputed. In a health care context, solidarity means roughly equal access to effective health care for all. However, I argued that precision medicine represents a threat to solidarity. Precision medicine includes ninety targeted cancer therapies (mostly for metastatic cancer). The “targets” of these therapies are certain genetic features of a cancer, mutations responsible for “driving” that cancer’s expansion. These targeted therapies have prices of €100,000 (roughly 117,500 USD) to €150,000 (roughly 176,300 USD) annually or for a course of treatment. Our critical question: Must a commitment to solidarity mean that all these targeted cancer therapies are included in a benefit package guaranteed to all 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 undermines solidarity. I offered multiple examples of how current and future dissemination of these drugs challenges a commitment to solidarity. An alternative is to fund more cancer prevention efforts. However, that too proves a threat to solidarity. Solidarity is too abstract a notion to address these challenges. We need instead the notion of “just solidarity.” 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 fair and inclusive processes of rational democratic deliberation, which is the real foundation of solidarity.

New health care justice article from Dr. Fleck in ‘Cambridge Quarterly of Healthcare Ethics’

Leonard Fleck photoCenter Acting Director and Professor Dr. Leonard Fleck has an article in the July 2019 issue of Cambridge Quarterly of Healthcare Ethics. “Precision QALYs, Precisely Unjust” addresses issues of health care justice and cost effectiveness.

Abstract: 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.

The full text is available online via Cambridge University Press (MSU Library or other institutional access may be required to view this article).

Dr. Fleck presents on elder ethics at International Bioethics Retreat in Paris

Leonard Fleck photoCenter Acting Director and Professor Dr. Leonard Fleck recently presented at the 2019 International Bioethics Retreat, held in Paris, France on June 26-28. Dr. Fleck chaired a session titled “In the Clinic” which featured topics on clinical ethics and medical decision-making.

In a session titled “Elder Ethics,” Dr. Fleck presented a talk on “Whither Frailty: Ethical, Economic, Medical and Policy Challenges.” Dr. Fleck addressed four key questions: (1) How should frailty be defined as a medical phenomenon? (2) What should be the scope and limits of respect for autonomy in the case of the frail elderly? (3) What should be the scope and limits of acceptable risk of harm to the frail elderly in the case of aggressive medical or surgical interventions? This question pertains to the responsibilities of physicians and surgeons in proposing such interventions. (4) What issues of health care justice deserve the attention of policymakers when it comes to meeting the health care needs of the frail elderly?

The first problem refers to the complexity of frailty as a medical phenomenon. Frailty is not disability; frailty is primarily associated with the elderly. Some researchers describe frailty as “accelerated aging.” Roughly 38% of individuals over age 90 would be described as being frail. Individuals may be frail and not have any life-threatening medical problems. Most of the frail elderly are able to make medical decisions for themselves, which is why there is the ethical issue of respect for patient autonomy versus justified medical paternalism. Among the behavioral traits of the frail elderly would be reduced activity (prolonged bed rest), very slow mobility, weight loss, extreme old age, diminished handgrip strength, polypharmacy, and social isolation. Clearly, frailty exists along a complex spectrum requiring considerable acuity of judgment to avoid ethical missteps.

To illustrate the potential for ethical missteps, labeling an elderly individual as “frail” can result in inappropriate paternalistic decisions, negative stereotypes, and discrimination. Alternatively, failure to identify an elderly individual as frail can result in overly aggressive medical treatment (and a range of avoidable medical harms) as well as a lack of attention (and resources) that might better address the social needs of the frail elderly that would represent a greater net benefit than aggressive medical treatment.

We might wish to go to the research literature for some guidance. However, there is little actual research regarding the frail elderly and aggressive medical or surgical care. Further, it is difficult to imagine how such research could be accomplished in a way that was not ethically problematic. This makes the responsibilities of physicians in clinical practice who care for the frail elderly all the more challenging.

Dr. Fleck concluded with two points: (1) From the perspective of health care justice, from the perspective of what a just and caring society ought to do, resources should be redirected from aggressive medical care for the frail elderly to their social service needs. However, the fragmented system for financing health care in the U.S. gets in the way of easily making this re-allocation of resources. (2) Soft paternalism will often be ethically justified in caring for the frail elderly considering aggressive medical care. A non-committal stance on the part of physicians in these circumstances, under the ethical guise of respect for patient autonomy, will most often be neither just, nor caring, nor respectful of patient needs and their considered values.

Dr. Fleck presents at Centre for Cancer Biomarkers Symposium in Norway

Leonard Fleck photoCenter Professor Dr. Len Fleck recently traveled to Bergen, Norway to present a keynote address at the 6th Annual Centre for Cancer Biomarkers (CCBIO) Symposium. Dr. Fleck’s presentation, “Just Caring Challenges: Visible Biomarkers and Invisible Rationing,” addressed some of the critical ethical issues related to the use of biomarkers in cancer research and clinical care.

Dr. Fleck addressed two main problems in his lecture. First, the ragged edge problem. One of the primary purposes of finding biomarkers is to determine whether a cancer drug is likely to be effective for a particular metastatic cancer patient. However, rarely will a biomarker yield a simple answer. Most often, the biomarker will be expressed along a continuum. If a drug were very inexpensive and side effects tolerable, it would be easy to say that the ethically right choice would be to respect patient autonomy. But these drugs all cost more than $100,000 for a course of treatment. Consequently, if a drug has a 20% chance of having a beneficial effect, there is a conflict between considerations of justice and respect for patient autonomy. Invisible rationing (just not offering the drug to the patient) can bypass this conflict, but invisible rationing is ethically problematic so far as justice is concerned.

Secondly, recent liquid biopsies can identify eight common cancers at a very early stage–in the form of circulating cancer cells in the blood–at a cost of $500. However, the critical question would need to be raised: How often would 170 million adults (all anxious about cancer) in the U.S. have a just claim to access that test? Every six months? Every year? Note that each such offering of that test to that population would cost $85 billion. Would that represent either a just or prudent use of health care resources?

The CCBIO symposium was well-attended by an international mix of junior and senior researchers and scholars. Dr. Fleck had the opportunity to meet with many European researchers to discuss their respective work in the field of cancer research.

Dr. Fleck also gave a public lecture at the University of Bergen’s Centre for the Study of the Sciences and the Humanities, titled “Precision Medicine, Ethical Ambiguity: Rough Justice, Ragged Edges.” Dr. Fleck addressed precision medicine as it currently exists, in particular the costly FDA-approved targeted cancer therapies. Treatments for patients with metastatic cancers, which are not curative, can cost $100,000 to $475,000 per treatment course. For example, 30% of patients who are candidates for CAR T-cell immunotherapy will not gain more than an extra year of life. As things are now, we do not know before the fact who those patients might be. But one goal of biomarker research is to identify before the fact who those marginal responders most likely will be, so that we could save money by denying those patients access to this therapy. As a citizen of a just and caring society, would you endorse the research to accomplish that result? Why or why not? This is what Dr. Fleck calls “rough justice.”

Healthcare cost article from Dr. Fleck published in April ‘Cambridge Quarterly of Healthcare Ethics’

Leonard Fleck photoCenter Professor Dr. Leonard Fleck has a new article published in the April 2018 issue of Cambridge Quarterly of Healthcare Ethics. The article, “Controlling Healthcare Costs: Just Cost Effectiveness or “Just” Cost Effectiveness?,” appears in a special section on justice, healthcare, and wellness.

Abstract: 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.

The full text is available online through Cambridge University Press (MSU Library or other institutional access may be required to view this article).

Book review from Dr. Fleck published in ‘Hastings Center Report’

Leonard Fleck photoA new book review by Center Professor Dr. Leonard Fleck has been published in the September/October 2017 Hastings Center Report. Titled “Despairing about Health Disparities,” Dr. Fleck reviews the book Understanding Health Inequalities and Justice: New Conversations across the Disciplines, edited by Mara Buchbinder, Michele Rivkin-Fish, and Rebecca Walker (University of North Carolina Press, 2016).

Abstract: I 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. (1) 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 (2) 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, (3) the question is which of these scholarly approaches is most useful for improving health policy.

The full text is available via Wiley Online Library (MSU Library or other institutional access may be required to view this article).

Just Caring: Health Reform, Cost Control, and the Fate of Children with Life-Altering Illnesses

Leonard Fleck photoCenter Professor Dr. Leonard Fleck recently gave a keynote address at the 2017 Pediatric Bioethics Day at Norton Children’s Hospital in Louisville, KY, held on September 20.

Titled “Just Caring: Health Reform, Cost Control, and the Fate of Children with Life-Altering Illnesses,” Dr. Fleck’s talk started out with a short string of cases related to children with life-altering illnesses. He brought up the Jimmy Kimmel case (recently born infant with hypoplastic left heart syndrome), in part because a very explicit connection was made with the House-approved repeal of the Affordable Care Act (ACA). He also brought up childhood cancer cases, some capable of being effectively addressed by contemporary medicine, others not capable of being effectively addressed but raising ethics issues related to cost/health care justice as well as unnecessary harms related to aggressive treatment.

Dr. Fleck painted a statistical picture of the very large problem of escalating health care costs in the U.S., primarily as background for better understanding the “big picture” behind the problem of health care justice. He introduced seven different conceptions of justice, which are all part of our everyday understanding of how resources ought to be distributed fairly. The basic question we are seeking to answer would be this: What are the just claims to limited health care resources for children who have a broad range of expensive health care needs, the outcomes of which might vary considerably and have significant uncertainty attached to them?

Dr. Fleck reviewed a few elements of the ACA that were directly relevant to the fate of children with life-altering illnesses. For example, what effect has Medicaid expansion had on these children in the different states? Or what effect has the pre-existing condition clause of the ACA had on children with life-altering illnesses (forbidding insurance companies from discriminating against such children, either as children or future possible adults)?

Dr. Fleck then critically examined the American Health Care Act as passed in the House, and then the Senate counterpart of that bill. He addressed what he saw as the key injustices in those bills, the biggest being that it would achieve cost control largely through practices that were forms of invisible rationing (something he has written about extensively). Likewise, Dr. Fleck assessed the implications of the contraction of Medicaid for children with life-altering illnesses. This included the corruption of protections for pre-existing conditions and the inadequacy of state-based “high risk” pools allegedly as adequate protection of the health care rights and needs of such children.

Finally, Dr. Fleck discussed precision medicine in relation to cancer in children, keeping in mind the very high cost of these targeted therapies and the limited (marginal) success that has largely been true, especially in relation to solid cancers. There has been a lot of half-truths and hyperbole in this regard. There are in fact many extremely costly drugs for children with a range of life-threatening problems: some very effective, some not. Dr. Fleck used examples such as hemophilia (especially Factor VIII resistant), Gaucher, cystic fibrosis, Pompe, Fabry, Duchenne, etc. In this connection Dr. Fleck wanted to tease out the ethical challenges: If we cannot afford or justify doing EVERYTHING medically possible for all these children, then how should priorities be justifiably set? What should be the role of rational democratic deliberation in addressing these justice-relevant issues? Is bedside rationing ever morally justifiable in these circumstances? If so, how would we distinguish just bedside rationing from unjust bedside rationing decisions?

Dr. Fleck presents at International Bioethics Retreat in Paris

Leonard Fleck photoCenter Professor Dr. Leonard Fleck recently traveled to Paris to attend and present at the International Bioethics Retreat, held June 26-28.

Dr. Fleck chaired a session titled “Rights, Responsibilities, and Justice.” He also presented the talk “Last Chance Therapies: LVADs AND a Heart Transplant?” Dr. Fleck has provided the summary below of his talk.

In a recent review article [Journal of the American College of Cardiology 2015; 65: 2542-55] the authors assessed expanded dissemination of left ventricular assist devices [LVADs], used in late stage heart failure. About 650,000 Americans experience heart failure annually. About 5.8 million Americans are in some stage of heart failure now with 300,000 deaths annually. A heart transplant would yield more than ten extra years of life for at least half these patients, but only 2300 hearts are available for transplant annually. LVADs are now offered either as Destination Therapy [DT] or as a Bridge to Transplant [BTT]. The ethically troubling proposal suggested by these authors is that individuals in late-stage heart failure [Stage IV] in the future should first be given an LVAD; then, if complications develop, they should be a candidate for a heart transplant. This is, in fact, what was done for former Vice-President, Dick Cheney, who had suffered five heart attacks, starting at age 37. Prior to his LVAD and heart transplant at age 71 he had had bypass surgery, several stents, an implantable cardiac defibrillator, a pacemaker, and numerous cardiac drugs.

What I argued in this presentation is that the proposal in the journal article above is deeply flawed from the perspectives of fairness and health care justice. From a utilitarian perspective more life-years of higher quality would be lost rather than gained because patients needing a heart transplant after LVAD complications have poorer prospects. From an egalitarian perspective only patients with excellent insurance would be able to afford this option, which would likely have overall costs of the two transplants of almost a million dollars. As things are now, fairness is undermined when some patients get both BTT and a heart transplant, two shots at prolonged life at the expense of someone else on the transplant list. This is what happened in the case of Dick Cheney. Some relatively younger individual (who for medical reasons might not have had the LVAD option) died prematurely, having access to neither an LVAD nor a heart transplant, while Cheney had two chances for life prolongation.

I concluded the presentation with a proposal for an ethically preferable alternative. (1) Individuals below age 70 with some form of heart failure could choose either the LVAD as DT or be placed on the transplant list. They could not choose both. If they choose the transplant list, they are rolling the dice. A good match might not be available before they die. If they choose the LVAD, 30% of those patients will die within a year, and 40% will gain 4 extra years of life, though of somewhat diminished quality. The serious complication rate for the LVAD is 70% (stroke, intestinal infections, device failure). (2) Some patients are in experimental protocols with a totally implantable artificial heart. If that device fails, they are immediately moved to the transplant list with top level urgency. They too would have to choose one way or the other. (3) Some patients (often younger) have life-threatening cardiac conditions that cannot benefit from an LVAD. They need to go the transplant list. They should not have to compete for a transplant with individuals who have already had an LVAD. It is essentially unfair that some individuals would get two chances for life prolongation while others would get none.

Dr. Fleck published in new ‘Ethics, Medicine and Public Health’ issue

Leonard Fleck photoCenter Professor Dr. Leonard Fleck has a new article in Ethics, Medicine and Public Health. Dr. Fleck’s article, “Just caring: Do we need philosophical foundations?,” appears in the April-June 2017 issue.

Abstract
The “Just Caring” problem asks: What does it mean to be a “just” and “caring” society when we have only limited resources (money) to meet virtually unlimited health care needs (linked to novel emerging medical technologies)? The practical implication of the “Just Caring” problem is that the need for health care rationing is inescapable. That means that some health care needs will not be met, even though those needs have moral weight, because meeting such needs is presumptively a matter of justice. How then can such rationing decisions be made justly or fairly? And who should have responsibility for making such decisions? Should such decision-making be the responsibility of legislative bodies, or administrators of health care institutions, or associations of physicians, or private insurers (in the United States), or employers (in the United States)? What should be the role of philosophers in addressing the problem of just health care rationing? After all, philosophers are supposed to be the experts when it comes to theories of justice. And, if philosophers are supposed to have such a role, are their judgments of health care justice going to be justified by appeal to ethical foundations of some sort? In this essay, I start by conceding that philosophers have had much to say about how we ought to conceptualize our understanding of the notion of justice. But the world has become enormously more complicated since Plato and Aristotle offered their reflections on justice. The same is true for Hume and Kant. Those perspectives seem remote and unhelpful about the problem of just health care rationing. The same would seem to be true about Rawls (1971) and Nozick (1974). Their theories of justice are simply too broad and too abstract to address the complex, heterogeneous problems of just health care rationing in the real world of health care we have today (though, as I show later, Rawls does have much to offer regarding the notion of public reason).1 In the first part of this essay I sketch out several concrete problems of health care rationing having to do with the allocation of targeted cancer therapies, drugs used to treat patients at risk for heart disease, drugs used to treat HIV+ patients, and drugs used to treat very rare diseases. This provides helpful context for the remainder of the essay. In the second part of this essay I argue that traditional theories of justice have only a limited role to play in addressing these problems of health care rationing. This is because no perfectly just answer can be given for the vast majority of real world problems of health care justice. Instead, what we need to settle for are non-ideal resolutions of these problems. Ultimately, I would defend a pluralistic conception of health care justice, which is another reason why we need to settle for non-ideal resolutions. Those non-ideal resolutions will have to emerge from broad, inclusive, fair processes of rational democratic deliberation. Those deliberations will be aimed at achieving a reflective balance of competing considerations of health care justice with respect to a very specific problem of health care rationing. In the third part of this essay, I argue that the role of philosophers is to protect the integrity of this public deliberative process, as opposed to seeking ethical foundations for their judgments of health care justice. This, I argue, entails three responsibilities for philosophers. First, these public deliberations need what we might call “just boundaries”. Those boundaries are defined by what I refer to as “constitutional principles of health care justice”. The role of philosophers is to articulate those constitutional principles and what counts as a reasonable balance among those principles as they are applied to specific problems of just health care rationing. Second, the role of philosophers is to articulate a specific understanding of “public reason”, which would govern those democratic deliberations. Here I have in mind the work of Rawls and his notions of “the rational” and “the reasonable” (Rawls, 1993). Third, philosophers have their traditional Socratic role of being thoughtful critics of the outcomes of these public deliberations, mindful of the fact that most outcomes will be non-ideally just. That is, philosophers must distinguish outcomes that are non-ideally “just enough” from those that are not “just enough”. Ultimately, the role of philosophers is not to construct or discover just foundations for these deliberative processes but to protect the fairness and integrity of the deliberative process itself.

The full text is available on the ScienceDirect website (MSU Library or other institutional access may be required to view this article).