Fleck’s address on the ethical and legal issues of precision medicine is available to watch on YouTube, along with other content from the conference. Fleck’s address begins around the 11-minute mark of the video.
An audience of in-person and virtual conference attendees included lawyers, policy expects, and medical professionals. Many countries were represented among attendees, including the Netherlands, Spain, Portugal, Lithuania, Serbia, Italy, France, and Germany. This engaged audience was, in one sense, familiar to Fleck, who has long been collaborating with European researchers, including multiple groups from Erasmus University.
Fleck shared what he describes as a “wow” moment from his presentation:
“I had included a video link to an ad for the drug Opdivo (nivolumab) for non-small cell lung cancer. There are several variants of this ad, all with a common theme: “A Chance to Live Longer.” These ads have been shown (I am sure) thousands of times on U.S. TV. They clearly give the misleading impression that anyone taking this drug can expect significant life-prolongation (leaving it to the viewer’s imagination what that length of time might be). Most of the audience gasped and laughed as they watched the ad. Keep in mind that only in the U.S. and New Zealand may such drug ads appear on TV. So, this was a somewhat startling phenomenon for this audience.”
An hour of discussion followed Fleck’s lecture, exploring the complex questions related to drug costs and public policy. At the heart of these questions is Fleck’s definition of the “wicked problem”: no matter what choices we make, we are at risk of creating new problems that are just as bad, ethically and politically, as the allocation problem we are trying to solve.
Fleck said, “The other concept that was new to most people in the audience was “onco-exceptionalism,” the idea that cancer was morally special and deserving of something close to unlimited resources to provide any degree of benefit from treatment, no matter how small the benefit or how costly the benefit might be.”
Keynote lecture description
Metastatic cancer and costly precision medicines generate highly complex problems of health care justice. Targeted cancer therapies yield only very marginal gains in life expectancy for most patients at a very high cost, thereby threatening the just allocation of limited healthcare resources. Philosophers have high hopes for the utility of their theories of justice in addressing resource allocation challenges; however, none of these theories adequately address the “wicked” ethical problems that have resulted from these targeted therapies.
What we need instead, bioethicist Leonard M. Fleck argues, is a political conception of health care justice, following Rawls, and a fair and inclusive process of rational democratic deliberation governed by public reason. His account assumes that we have only limited healthcare resources to meet unlimited healthcare needs generated by emerging medical technologies. The primary ethical and political virtue of rational democratic deliberation is allowing citizens to fashion autonomously shared understandings of how to fairly address the complex problems of healthcare justice generated by precision medicine. While ideally just outcomes are a moral and political impossibility, “wicked” problems can metastasize if rationing decisions are made invisibly—in ways effectively hidden from those affected by those decisions. As Fleck demonstrates, a fair and inclusive process of democratic deliberation could make these “wicked” problems visible, and subject, to public reason.
Leonard M. Fleck, PhD, and Karen Smith, LMSW, PhD, HEC-C, presented at the October 13 Bioethics for Breakfast session, offering their insight and expertise on the topic “Demystifying End-of-Life Care.” Bioethics for Breakfast is generously sponsored by Hall, Render, Killian, Heath & Lyman. The presentation portion of the session was recorded and is available to watch on our website.
The State of Michigan has recently approved the MI POST (Michigan Physician Order for Scope of Treatment), which allows a patient and physician to have in place directions (orders) on care to go between levels of treatment. Such orders typically specify the kind of care a terminally ill patient would want or refuse in an emergency situation outside a hospital setting. Such orders are agreed to by a competent patient or their representative and the attending physician. A POST document is often part of a larger advance care planning document.
Most patients do not have an advance directive or a POST. What happens when that patient is actively dying and the attending physician believes a Do Not Attempt Resuscitation order (DNAR) is in the best interest of that patient? Should that decision by the physician require the written consent of the patient’s family for that DNAR order? And what are the consequences for the patient if the family cannot reach agreement? If you were that patient, what would you regard as the most reasonable course of action? How would you ensure your wishes are followed?
Presenters Fleck and Smith gave some background on what it means to have a natural death and a managed death, noting that the majority of Americans today die a managed death. Smith explained that durable power of attorney and MI POST are the two state-authorized methods for directing end-of-life wishes. Fleck asked attendees to consider the following questions: Are the policies and practices in place regarding terminally ill incapacitated patients good enough? Are they the best we can do? What might we do better? What do we see as the main deficiencies in current policy and practice?
The presentation also explored how policy can protect patients and prevent suffering at the end of life and presented multiple case examples regarding terminal care in the ICU. Discussion during the Q&A portion focused on family disagreements in the ICU, the value of healthcare literacy and common misconceptions that stem from popular culture, and what happens when the court system is involved with end-of-life decisions.
Varkey B. Principles of Clinical Ethics and Their Application to Practice. Medical Principles and Practice. 2021;30:17-28. DOI: 10.1159/000509119. Free PubMed Central access.
About the speakers
Leonard M. Fleck, PhD, is a Professor in the Center for Bioethics and Social Justice and the Department of Philosophy at Michigan State University. Fleck’s interests focus on medical ethics, health care policy, priority-setting and rationing, and reproductive decision-making. He explores the role of community dialogue (rational democratic deliberation) in addressing controversial issues of ethics and public policy related to emerging genetic technologies. More recently, he has completed a book-length manuscript that addresses a number of ethical and policy issues related to precision medicine, primarily in a cancer treatment context. He also completed another book that addresses several contemporary issues related to bioethics and religion from a Rawlsian public reason perspective.
Karen Smith, LMSW, PhD, HEC-C, has been a member of hospital ethics committees for over 20 years. She is currently the Director of Ethics Integration for Henry Ford Health, a six-hospital system in metro Detroit. Smith publishes on issues related to clinical ethics the hospital setting. She specializes in death and dying issues and often works to educate the public on Advance Directive issues. She has been on the National Board for the Funeral Consumers Alliance which is a non-profit organization dedicated to providing the public education and advocacy related to after death needs.
The 2022-2023 Bioethics Public Seminar Series begins next month with a webinar from Center Professor Leonard M. Fleck, PhD, on “Precision Medicine and Distributive Justice: Wicked Problems for Democratic Deliberation.” This virtual event is free to attend and open to all individuals.
Wednesday, November 16, 2022 1:30-2:30 PM EST (UTC−05:00) Zoom webinar registration: bit.ly/bioethics-fleck
Metastatic cancer and costly precision medicines generate extremely complex problems of health care justice. Targeted cancer therapies yield only very marginal gains in life expectancy for most patients at very great cost, thereby threatening the just allocation of limited health care resources. Philosophic theories of justice cannot address adequately the “wicked” ethical problems associated with these targeted therapies. Following Rawls, Fleck argues for a political conception of health care justice, and a fair and inclusive process of democratic deliberation governed by public reason. The virtue of democratic deliberation is that citizens can fashion autonomously and publicly shared understandings to fairly address the complex problems of health care justice generated by precision medicine. “Wicked” problems can metastasize if rationing decisions are made invisibly. A fair and inclusive process of democratic deliberation can make these “wicked” problems visible, and subject, to fair public reason constraints. What constrained choices do you believe you would endorse with your fellow citizens as being “just enough”?
Leonard M. Fleck, PhD, is a professor in the Center for Bioethics and Social Justice and the Department of Philosophy at Michigan State University. Dr. Fleck’s interests focus on medical ethics, health care policy, priority-setting and rationing, and reproductive decision-making. He explores the role of community dialogue (rational democratic deliberation) in addressing controversial issues of ethics and public policy related to emerging genetic technologies. More recently, he has completed a book-length manuscript that addresses a number of ethical and policy issues related to precision medicine, primarily in a cancer treatment context. He also completed another book that addresses several contemporary issues related to bioethics and religion from a Rawlsian public reason perspective.
What are we willing to accept as limits on access to very expensive marginally beneficial healthcare in our society?
Center Professor Leonard M. Fleck’s latest book, Precision Medicine and Distributive Justice: Wicked Problems for Democratic Deliberation, is now available from Oxford University Press. Fleck’s work as a philosopher and medical ethicist has focused on health care policy, and the role of community dialogue in addressing controversial issues of ethics and public policy related to emerging genetic technologies.
In an interview about this book, Fleck spoke of beginning democratic deliberation work around 1980 as part of a research project regarding changes to the Medicare program. He described the importance of involving members of the community in conversations about what values and considerations should shape the kinds of limits they would be willing to live with in terms of accessing needed healthcare. That project, centered in an Indiana community, shaped his work moving forward. The interview that follows explores the importance of democratic deliberation regarding the use of targeted cancer therapies.
The following interview has been edited for length and clarity.
Book cover, copyright Oxford University Press.
Who is the ideal audience of this book?
The ideal audience would be a broad segment of the public that needs to be aware of the kinds of challenges, the ethical and public policy challenges, that are associated with precision medicine. Its high cost and its marginal benefit.
How would you broadly define precision medicine?
Typically, precision medicine is defined as providing the right drug at the right time and the right dose for the right medical problem. Right now, mostly what we’re talking about is cancer, that is, metastatic cancer. What we’re talking about are the molecular features of a metastatic cancer that a particular individual has. The drugs that are used to attack that cancer are drugs that are designed for the very, very, very specific molecular features of a particular cancer. Some of those features get to be defined in really sharp terms. Researchers and physicians no longer talk about a stomach cancer or a lung cancer—I mean they they’ll use those terms, but the recognition is that the nature of the cancer, in terms of what we’re going to try to do about it from a therapeutic perspective, that’s going to be determined by the molecular signature of that cancer.
What is democratic deliberation, and why is it important? How does it apply to this topic of precision medicine and healthcare justice?
I always start off with what I call the “Just Caring” problem. What does it mean to be a just and caring society when we have only limited resources—money—to meet virtually unlimited healthcare needs? And that’s a very, very broad problem that applies to all of healthcare, certainly in the United States today. With regard to cancer, the issue is that these targeted cancer therapies, and the so-called immunotherapies which are among the targeted cancer therapies, are extraordinarily costly. They typically apply to relatively small groups of patients, measurable in a few thousand rather than one hundred thousand. For the vast majority of these patients, receiving one of these very expensive drugs is only going to yield extra months of life, if that, as opposed to a lot of extra years.
I’ve spent 50 years of my life thinking about this issue. And it’s only grown and become more complex over those 50 years, because of all the emerging life prolonging medical technologies that have come to be.
Leonard M. Fleck, PhD
So, if we had a $100,000 drug and this was going to give somebody three extra years of life, my guess is that most of us, democratic deliberators charged with determining how to spend our money on a whole range of healthcare interventions, including, of course, cancer, would say it’s a lot of money, but if we’re giving somebody three extra years, we ought to do that. And we ought to do that, we might say, because we think about, what are we spending now for purposes of giving a patient with HIV an extra year of life? A patient on a four-drug combination? The answer there would be $35,000 a year. And if we spend a $100,000 to give somebody three extra years of life, then that’s $33,000 a year. So it seems like if we’re spending money for the HIV positive patient at that level, we ought to be willing to spend that same amount of money to help cancer patients.
However, things are a lot more complicated than that simple example would suggest. So, in the case of cancer, one of the basic problems that I didn’t make perfectly clear in my earlier remarks is that even though I talked about a molecular feature of a cancer that is usually described as the driver of that metastatic cancer, and that is the target one of the targeted therapies, the fact of the matter is that in metastatic cancer there are going to typically be multiple drivers of a cancer. Most of them will be suppressed by the dominant driver. What happens in practice is that we’ve identified the dominant driver of the cancer, we give the individual a drug to kill that dominant driver, which it successfully does. And then another new driver emerges within that tumor, and then the tumor continues to grow, the cancer progresses. Now we may have another drug for that new driver, which will have roughly the same effect. It’ll kill that new driver and make room for yet another driver. But now, then, we’re providing to individuals several drugs in a row that have costs of $100,000 or $200,000 each. So, we’re spending a lot more money for a lot less good for these cancer patients. And so, the question for democratic deliberation is, what do we owe, under what particular circumstances, as a matter of what a just and caring society ought to be, to patients with metastatic cancer for whom there are these very expensive drugs that are only going to yield, for most patients, marginal benefit?
What I would ask an audience to imagine, when I’m working with an audience of individuals from the community, is that everybody in that room is probably very healthy. They have no idea what their future health vulnerabilities might be. Some people might say, well, we’ve got heart disease in the family, or some family history suggests cancer, but there’s still lots and lots of other health problems that you could have that could be deadly. The question is, if you don’t want to spend all your money on healthcare, and you don’t want to spend everybody else’s money on healthcare, then, collectively, what would you see as being reasonable investments of limited healthcare resources for addressing healthcare needs? Cancer needs, heart needs, Alzheimer’s disease needs, diabetic needs, psychiatric needs, needs associated with various kinds of disability. When you, in a thoughtful and objective way, try to consider the whole range of healthcare needs, where should we invest the limited dollars that we’re willing to provide? Right now, it’s 18% of our gross domestic product, roughly $4.1 trillion. Where are we willing to invest those dollars?
What led you to work that focuses on precision medicine? Was it natural from the other health policy work you have done, specifically work on allocating resources?
It was related both to allocating resources, because the cost of these drugs just leapt out at me, starting roughly in around 2010 or so. But the other thing was that I had been looking at a whole range of ethics and policy issues related to emerging genetic technologies. This was one of the newer elements associated with these emerging genetic technologies. This was a product of the Human Genome Project. Plus, the research that had been going on with regard to cancer, as researchers began to understand the extent to which cancer is this extraordinarily complex disease, that there’s not just sort of one or two or three drivers of these cancers. That there are different biological features of the cancer that are responsible for the cancer being so vigorous in multiplying. In brief, there’s that combination of the cost of these drugs and what that would do to distort the just allocation of health resources in our society, and the genetic features of these cancers that turned out to be so extraordinary genetically complex.
Something that strikes me, discussing these very expensive targeted therapies, is where does palliative care fit into the discussion of precision medicine?
For oncologists who are treating patients, for patients who have read something about precision medicine, for patients who have looked at some of the ads that are associated with precision medicine that have been on television, it’s very difficult to convince any of those patients that palliative care is something that they needed to give serious consideration to. Because it looked like these drugs could give them some very significant extensions of their life. And, of course, the fact of the matter is that there’s some percentage of patients who will get one or two or three extra years of life. There’s a teeny tiny percentage of patients who we call super responders, who might get seven, eight, ten extra years of life or more. At the moment we have no way of identifying before the fact how particular patients are going to respond to these drugs.
What happens is that patients imagine to themselves, I could be that person. Somebody is going to be a super responder, just like somebody ultimately wins that half a billion dollar lottery prize. How do I know it’s not me if I don’t buy a lottery ticket? How do I know it’s not me if I don’t take on this targeted cancer therapy? And if the first therapy doesn’t work, I heard that there’s a second and a third. And so as long as they seem to be doing something by way of controlling my cancer, of course I want that. I don’t want palliative care. So that’s sort of the psychological logic behind the reluctance of both patients and oncologists to recommend palliative care before it is just absolutely clear that nothing else is going to work.
What is one overall takeaway someone should get from this book? What is the question you want folks to continue thinking about?
What are we willing to accept as limits on access to very expensive marginally beneficial healthcare in our society? I want readers to think about the just caring problem, which is an extraordinarily complex problem. I’ve spent 50 years of my life thinking about this issue. And it’s only grown and become more complex over those 50 years, because of all the emerging life prolonging medical technologies that have come to be. Not just with regard to cancer, but with regard to heart disease, liver disease, lung disease, diabetes, and every other area of medicine that we care to name.
I’d like to add that ideally, ethically, I think we’re inclined to say, if we have a somewhat costly life prolonging care that’s effective, then everybody with the relevant need ought to have access to that if we are a just and caring society. If somebody has an inflamed appendix that is life threatening if they don’t receive the necessary surgery, then they ought to receive that surgery, whether they’re rich or poor, insured or uninsured. They ought not to be allowed to die. You will get, I think, very broad agreement in our society that that’s a just and reasonable kind of moral commitment we ought to make. It gets more difficult, though, to make that commitment when it comes to these extraordinarily expensive cancer drugs. And part of the problem is that in the United States probably no more than half of us are employed at places where we’re provided with very comprehensive health insurance, and where we’re not responsible for paying very much of the cost of our healthcare. But for the other half of the population who typically are working in lower wage jobs, who may be provided with some health insurance but it’s very marginal, it’s bare bones insurance. It’s the sort of insurance that requires that individuals pay 30 or 40% of the cost of these cancer drugs. And, of course, that’s impossible for individuals making $15, $20, $25, even $30 an hour. For a $150,000 drug, they cannot pay $30,000, and so they don’t get it. Nevertheless, they are paying through taxes, and through their insurance premiums, for others who would have access to these drugs. So that’s one of the fundamental inequities in our society, and the targeted cancer therapies make that inequity, I think, more visible. It doesn’t seem as if, as a society, we’re willing to address that challenge. However, that is one of the preeminent ethical challenges that must be addressed if we are to be a just and caring society.
By Sean A. Valles, Director and Associate Professor, Center for Bioethics and Social Justice, College of Human Medicine, Michigan State University
Pessimism about the future is rising around much of the world. Meanwhile, the social institutions of democracy are experiencing slipping public support. The global COVID-19 pandemic has also drawn attention to the importance and fragility of trust.
Unfortunately, none of this should be considered new. The pandemic arrived more than a decade into a trend of declining trust in social institutions. More recently, news reports of fraud and corruption, such as misuses of pandemic relief funds, can push us to see the world as filled with people undeserving of our trust or care. Such an observation can start to look like a moral justification for our own selfishness: “the system is corrupt so I’m just going to get mine and look out for myself.”
We do not need to resign ourselves to selfishness and isolation.
Image description: Cropped shot of a group of surgeons wearing blue scrubs and face masks performing a medical procedure in an operating room. Image source: PeopleImages/iStock.
Economist Elinor Ostrom won the Nobel Prize for showing how examples from around the globe undercut the pessimistic but widespread view among scholars that the “tragedy of the commons” is practically inevitable—the idea that fishers are doomed to selfishly overfish the waters they share with other fishers, etc. That theory of inevitable selfishness and tragedy is rooted in assumptions of human nature that intuitively resonate with a lot of people, which made Ostrom’s debunking work all the harder. Not coincidentally, Garrett Hardin, the creator of a supremely pessimistic view of humanity, was a vocal racist and nativist who saw his pessimism about cooperation as grounds for treating the less privileged peoples of the world as potential invaders threating to take resources from the metaphorical “lifeboat” occupied by the privileged. Extreme pessimism about the possibility of cooperation and solidarity is toxic.
Extreme pessimism about human nature oversimplifies human behavior. Even overtly bad and apparently selfish behavior by others can be evidence of the possibility of future cooperation. For instance, recent research on academic dishonesty by students has found that cheating and plagiarism are driven in part by a desperate desire to be allowed to continue learning as part of a school’s community.
I see the COVID-19 pandemic as a series of failed but fixable attempts at ethical collaboration, and not evidence that cooperation is hopeless during crisis. Yes, the pandemic was rife with selfish acts from those previously mentioned cases of financial misconduct, extending to the problem of wealthy countries quickly buying up much of the global vaccine supply. Disturbingly, many people have felt ethically self-assured in their selfishness, such as a professor who approached me after one of my pandemic ethics lectures, complaining to me that COVID-19 vaccines were surely unethical because they allowed “the weak” to survive nature’s culling.
Despite the innumerable examples of bad behavior, there were also innumerable attempts at cooperation that either succeeded or showed enough of a spark of success that future success seems possible. Consider the case of Dorothy Oliver and Drucilla Russ-Jackson, who defied conventional wisdom about the stubbornness of vaccine skeptics by using kindness and respectful human connections to convince nearly their entire rural Alabama town to get COVID-19 vaccinations. At the global level, the World Health Organization, World Bank, and Gavi the Vaccine Alliance (among many others) all made strides toward helping ease the unethical burdens of the pandemic harming the vulnerable of the world. Each organization was in large part prevented from doing better, however, due to running into needless hurdles such as national governments resisting attempts to get more transparency in their national public health data.
International development is an endeavor based on a fundamental optimism: the conviction that helping faraway strangers is a worthwhile task. As became increasingly clear over the 20th century, ethically helping faraway strangers is no easy task. We can easily hurt those whom we seek to help. But as with the instructive failed efforts during the pandemic, the point is that it remains possible for cooperative efforts to do better next time.
In the spirit of the desire to always do better next time in international development, the Center for Values in International Development has partnered with the Michigan State University Center for Bioethics and Social Justice. Our centers share a fundamental optimism that despite the injustices of the world, and the world’s mixed track record of attempts to make them better, the goal of creating a more equitable world is well worth working for.
One obstacle faced by our two Centers’ endeavors is that global health work and global development work remain partly stuck in their own silos, such as in the ways national and international agencies divide up their roles. Yes, effective and meaningful international development work does need to include the development of societies’ health infrastructure, but not to the exclusion of focusing on wider, intersectional issues of healthcare justice. Sectoral segmentation works against wider inclusion, the acknowledgment of intersectionalities, and consideration of structural issues in how we view human wellbeing. It remains all too common to think of health development work as another slice of the overall pie of development needs, alongside transportation development, housing development, better sewage treatment, financial management capacity strengthening, etc.
In my work, I emphasize the importance of distinguishing between the healthcare system vs. the health system. The healthcare system is just one part of the much larger set of social institutions that steer the health of populations, such as the agricultural systems that determine which foods are available in markets and at what prices. So, while healthcare (hospitals, medicines, and such) should get only a slice of the budgetary pie in international development budgets, it is important to remember that housing policies are health policies too; the same goes for transportation policies and numerous other policies. Housing security is crucial for a healthy life. Transportation is essential for meeting other life needs (shopping, accessing healthcare, etc.), while poor transportation policies can lead to air pollution and other unwanted side effects.
The language that began emerging in the 2000s is that we need “health in all policies.” That phrase has two meanings. First, it’s a call to action, asking that we make sure a society’s policies are conducive to health. For instance, development programs that encourage farmers to grow cash crops also need to take into account health impacts, such as the availability of crucial food crops and the related impacts on community nutrition. Second, “health in all policies” is a description of the way the world works. Development programs seeking to change agriculture and other vital parts of social life simply are also health policies, whether we recognize it or not. International development work affects the health of societies in innumerable ways, and often ways that get too little attention. The Center for Values in International Development brings much-needed explicit attention and analysis to the ethical dimensions of international development work and humanitarian response; we need ethics in all policies. The Center for Bioethics and Social Justice enthusiastically joins in that effort, since there is health in all policies, and our Center specializes in getting attention and analysis to the ways that such health impacts positively or negatively contribute to making health systems more “compassionate, respectful, and responsive to people’s needs, so that equity, inclusion and social justice are available to all.”
Bioethics, Public Reason, and Religion is a new book from Center Professor Leonard M. Fleck, PhD. Published this month by Cambridge University Press as part of the Cambridge Elements Bioethics and Neuroethics series, the book is available to read online for free until August 26.
Fleck explores Rawlsian political liberalism, the limits of religious integrity, and examines the issues of physician aid-in-dying, the use of embryos in medical research, abortion, and the artificial womb.
Image description: The book cover of Bioethics, Public Reason, and Religion by Leonard M. Fleck has art that is a light blue abstract painting with tones of yellow and red. Image courtesy of Cambridge University Press.
“Given the United States Supreme Court Dobbs decision, this volume is especially timely since it is doubtful that the Dobbs decision could pass the public reason test—though readers are free to disagree with that conclusion,” said Fleck.
Summary: Can religious arguments provide a reasonable, justified basis for restrictive (coercive) public policies regarding numerous ethically and politically controversial medical interventions, such as research with human embryos, pre-implantation genetic diagnosis, or using artificial wombs? With Rawls, we answer negatively. Liberally reasonable policies must address these controversial technologies on the basis of public reasons accessible to all, even if not fully agreeable by all. Further, public democratic deliberation requires participants to construct these policies as citizens who are agnostic with respect to the truth of all comprehensive doctrines, whether secular or religious. The goal of these deliberations is practical, namely, to identify reasonable policy options that reflect fair terms of cooperation in a liberal, pluralistic society. Further, religious advocates may participate in formal policymaking processes as reasonable liberal citizens. Finally, public reason evolves through the deliberative process and all the novel technological challenges medicine generates for bioethics and related public policies.
Print copies of the book are also available for pre-order. The volume is a slim paperback, clearly written, and accessible for an undergraduate bioethics course that addresses several of these controversial bioethics issues as matters for public policy decision-making.
Leonard M. Fleck, PhD, and Irving E. Vega, PhD, presented at the March 24 Bioethics for Breakfast session, offering perspectives and insight on the topic “Aducanumab, Alzheimer’s: Having That Conversation.” Bioethics for Breakfast is generously sponsored by Hall, Render, Killian, Heath & Lyman. This session was the second of a two-part series on the theme “Paradoxes of Aging: Living Longer and Feeling Worse.” The presentation portion of the session was recorded and is available to watch on our website.
Aducanumab, a drug designed to treat Alzheimer’s disease, has been the focus of intense medical, scientific, social, and ethical controversy. The FDA Advisory Commission voted almost unanimously not to approve the drug. The research trials failed to show that aducanumab offered significant clinical benefit to patients in the early stages of Alzheimer’s, and notably the enrollment of Black and Latino patients was disproportionately low. It came as a surprise that the FDA itself ultimately gave its approval to the drug, which costs $28,000 per year and is administered monthly through infusion in a hospital setting.
Fleck provided background on Aducanumab and the clinical trials carried out by the developer, Biogen, that led them to seek FDA approval. He defined the different stages of Alzheimer’s disease, noting that over six million Americans currently have been diagnosed with some degree of Alzheimer’s. Fleck also outlined the FDA’s approval process, including their vote to grant emergency use authorization with the expectation of phase four clinical trials completed within nine years. He also pointed out that Aducanumab’s effects are limited to mild cognitive impairment and mild Alzheimer’s, with no benefit in more advanced stages. However, there have been no other Alzheimer’s disease drugs in the past twenty years with promise of significant benefit.
Bringing up concerns of social justice, Fleck discussed the cost Aducanumab within U.S. health spending, particularly within the Medicare program. It is estimated that 85% of the estimated 3.1 million Americans with a mild Alzheimer’s diagnosis are Medicare eligible, meaning the annual cost to Medicare would be in the hundreds of billions of dollars for the drug and its associated costs. Fleck asked attendees to consider whether this spending would be a just use of limited health care resources.
Vega offered attendees questions to consider: is there sufficient evidence about the safety of the drug? Is there sufficient evidence about the effectiveness of the drug? Does the treatment address health disparities in Alzheimer’s disease? He discussed the biology of Alzheimer’s disease, outlining its effect on the brain, and pointing out what is still unknown about the disease. After defining scientific rigor, Vega walked attendees through concerns about the Aducanumab clinical trials, such as participant age and the inadequate representation of Black, Hispanic, American Indian or Alaska Native, and Native Hawaiian or Pacific Islander populations.
Focusing on these disparities, Vega shared facts pertaining to Black Americans being twice as likely to have Alzheimer’s compared to non-Latino white Americans, and Latino Americans being 1.5 times as likely, compared to non-Latino white Americans. Disparities exist with increased likelihood of comorbidities like stroke, heart disease, obesity, and diabetes. Given these facts, Vega shared concern for observed adverse side effects of Aducanumab, particularly brain swelling, microbleeds, and slow brain bleeding.
Questions from attendees generation discussion about advocacy work, insurance companies, and direct and indirect costs of Alzheimer’s disease. Fleck and Vega noted the cost of care for an individual with Alzheimer’s, in a long term care facility, is typically in the $80,000-$100,000 range per year. Indirect costs include the lost wages of caregivers, and stress experienced by loved ones. Vega also importantly pointed out the context of the approval of Aducanumab: a global pandemic, COVID-19 vaccine development, and the subsequent spread of misinformation. Attendees also participated in polling questions with hypothetical situations, asking whether they agreed or disagreed with the scenarios. Responses were varied, highlighting the complexities of the topic.
Leonard M. Fleck, PhD, is a professor in the Center for Bioethics and Social Justice and the Department of Philosophy at Michigan State University. Fleck’s interests focus on medical ethics, health care policy, priority-setting and rationing, and reproductive decision-making. He explores the role of community dialogue (rational democratic deliberation) in addressing controversial issues of ethics and public policy related to emerging genetic technologies. More recently, he has been working on a book-length manuscript that addresses a number of ethical and policy issues related to precision medicine, primarily in a cancer treatment context.
Irving E. Vega, PhD, obtained his undergraduate degree in Biology from the University of Puerto Rico-Mayaguez Campus. He continued his research training in the Department of Cell Biology and Neuroscience at the Graduate School of New Brunswick, Rutgers University, earning his PhD. Vega completed a postdoctoral fellowship in the Neuroscience Department at Mayo Clinic Jacksonville, where he developed his research career focusing on the pathobiology of Alzheimer’s disease. Vega joined the faculty as an associate professor in the Department of Translational Neuroscience at the Michigan State University College of Human Medicine campus in Grand Rapids, MI in 2014. His research focuses on molecular and biochemical mechanisms that modulate the accumulation of pathological tau proteins in Alzheimer’s disease and related dementias. Vega is also working on ethnic disparities and the influence of ethnoracial factors on blood biomarkers in Alzheimer’s disease.
Anne K. Hughes, PhD, MSW, and Dawn Opel, JD, PhD, presented at the December 2 Bioethics for Breakfast session, offering perspectives and insight on the topic “Social Determinants of Elders’ Health.” Bioethics for Breakfast is generously sponsored by Hall, Render, Killian, Heath & Lyman. This session was the first of a two-part series on the theme “Paradoxes of Aging: Living Longer and Feeling Worse.” The presentation portion of the session was recorded and is available to watch on our website.
Elders in the U.S. contend with chronic illness, disability, mental health disorders, and a host of other co-morbid conditions. The COVID-19 pandemic has illuminated the complex web of social, medical, and economic challenges faced by the elderly.
Anne K. Hughes, PhD, MSW, highlighted common concerns about aging and explained how those concerns affect LGBTQ+ older adults: cognitive and/or physical decline, isolation, financial/legal, living situations, and meaning making/legacy. Hughes shared the importance of health professionals asking questions rather than making assumptions when working with sexual and gender minority older adults. She also noted research showing health disparities at greater levels when compared to heterosexual older adults, even noting that much of the research data currently available is not inclusive of bisexual, transgender, or gender non-conforming older adults.
Dawn Opel, JD, PhD, presented on older adults and food insecurity in America. She addressed the invisibility of older adults experiencing hunger in America, lessons from the COVID-19 pandemic, programs and services available for older adults in Michigan, and the future of food security for older adults. Regarding food insecurity, many older adults are living alone, and they may use trade-offs such as skipping their grocery trip to instead pay the rent or utility bill. The pandemic also made visible the reliance on unpaid caregiving and volunteerism for access to food. Sharing data that projects more than 20 percent of the U.S. population will be over the age of 65 by 2030, Opel asked attendees to consider the actions needed now to invest in infrastructure for the future.
Discussion during the Q&A portion included the concept of aging in place, with multiple attendees sharing personal anecdotes about older adults in their lives who wish to remain independent in their homes. Broadly, both speakers touched on the importance of having conversations early on with older adults in our lives, in order to be as prepared as possible before there is a crisis situation. Discussion also touched on the technological divide, having conversations with primary care physicians, and potential policy improvements that could improve the burden on those in paid and unpaid caregiving roles.
Anne K. Hughes, PhD, MSW, is Director and Associate Professor in the School of Social Work at Michigan State University. She was previously the director of the PhD program. She is co-founder of the MSU Consortium for Sexual and Gender Minority Health Across the Lifespan, an interdisciplinary research consortium established within the College of Social Science in 2019. Prior to coming to MSU Dr. Hughes had 14 years of clinical practice experience. Dr. Hughes’ research focuses primarily on older adults with chronic conditions and improving healthcare services for underserved older adults, particularly LGBTQ+ older adults. Dr. Hughes has received external funding for her research from: Patient-Centered Outcomes Research Institute (PCORI), the John A. Hartford Foundation, and the National Institutes of Health. She is a Hartford Faculty Scholar in Geriatric Social Work and a Fellow in the Gerontological Society of America.
Dawn Opel, JD, PhD, is Director of Research & Strategic Initiatives and General Counsel of the Food Bank Council of Michigan, where she oversees research, data, legal, and compliance functions of the organization. A lawyer and researcher, her career has included positions in academic, nonprofit, and government sectors, and broadly, she works to build strategic partnerships for social innovation. Dr. Opel’s particular focus is developing capacity in Michigan for food-as-medicine interventions in the clinical setting, and she is currently involved in the implementation and sustainability of fresh food pharmacies for chronic disease self-management in federally-qualified health centers (FQHCs). She holds a PhD from Arizona State University and a JD from the University of North Carolina School of Law. Dr. Opel is adjunct assistant faculty at Michigan State University in the College of Arts & Letters.
Mark G. Kuczewski, PhD, of the Loyola University Chicago Stritch School of Medicine presented at the April 22 Bioethics for Breakfast session, offering perspectives and insight on the topic “Caring with and for undocumented physicians and patients.” Bioethics for Breakfast is generously sponsored by Hall, Render, Killian, Heath & Lyman.
The session addressed the contributions of undocumented immigrants to our communities in the United States, including those of DACA (Deferred Action for Childhood Arrivals) physicians, to our healthcare system; the limits that exclusionary practices place on the contributions of undocumented immigrants to our healthcare system; and approaches to facilitating better care of undocumented immigrants in the healthcare system.
Dr. Kuczewski shared facts about undocumented immigrants in the U.S.: they number approximately 10-12 million, approximately two-thirds have lived in the U.S. for more than 10 years, they cannot buy a full-priced policy on an ACA exchange, they commit crimes at lower rates than U.S. citizens, an increasing percentage are of Asian origin, and there are fewer in the U.S. now than in 2010. He pointed out that excluding these individuals from obtaining health insurance through the Affordable Care Act ends up harming the overall pool of people in the insurance marketplace.
Dr. Kuczewski also explained how U.S. immigration policies have changed since the Clinton administration and now those policies have created barriers to entering the U.S. lawfully and with authorization, with regard to application rules and the quota system.
“This is a people issue,” said Dr. Kuczewski, adding that the stable population of 10-12 million undocumented immigrants in the U.S. have healthcare needs, and need to be able to seek care. Using the example of someone in need of kidney dialysis, he pointed out that the usual route of getting Medicare coverage is not an option because federal benefits are not available to undocumented immigrants. Dr. Kuczewski highlighted the importance of hospitals and clinics caring for undocumented patients and advocating for them, in order to foster trust over fear, and in turn help to avoid negative impacts on public health.
Finally, Dr. Kuczewski discussed the challenges for DACA recipients who matriculate through medical school while being ineligible for federal student loans. The discussion portion of the session explored the importance of educating people, including politicians, on revisions to the ACA, and avenues for advocacy work for schools and universities, students, medical professionals, and instructors. Related resources are linked below.
Related Resources
Open access article: Kuczewski MG, Mejias-Beck J, Blair A. Good Sanctuary Doctoring for Undocumented Patients. AMA Journal of Ethics. 2019;21(1):E78-85. DOI: 10.1001/amajethics.2019.78.
Mark G. Kuczewski, PhD Mark G. Kuczewski, PhD, is the Fr. Michael I. English, S.J., Professor of Medical Ethics and the director of the Neiswanger Institute for Bioethics at the Loyola University Chicago Stritch School of Medicine. Mark is a past president of the American Society for Bioethics and Humanities (ASBH) and a Fellow of the Hastings Center. He has been engaged in bedside clinical ethics issues for more than 25 years. For the last decade, he has been an articulate spokesperson for the just and equitable treatment of immigrant patients. He created the Sanctuary Doctor website with Drs. Johana Mejias-Beck and Amy Blair to assist clinicians in supporting immigrant patients. He led the effort to make the Stritch School of Medicine the first medical school in the nation to openly welcome applicants who are DACA recipients.
About Bioethics for Breakfast: In 2010, Hall, Render, Killian, Heath & Lyman invited the Center for Bioethics and Social Justice to partner on a bioethics seminar series. The Center and Hall Render invite guests from the health professions, religious and community organizations, political circles, and the academy to engage in lively discussions of topics spanning the worlds of bioethics, health law, business, and policy. For each event, the Center selects from a wide range of controversial issues and provides two presenters either from our own faculty or invited guests, who offer distinctive, and sometimes clashing, perspectives. Those brief presentations are followed by a moderated open discussion.
Malkia Newman, Anti-Stigma Team Supervisor at CNS Healthcare, and Dr. Debra A. Pinals of MDHHS and the University of Michigan presented at the Feb. 25 Bioethics for Breakfast session, offering perspectives and insight on the topic “Mental Health Care Access: Making the Dollars and “Common Sense” Case for Parity.” Bioethics for Breakfast is generously sponsored by Hall, Render, Killian, Heath & Lyman.
People with mental health disabilities face disproportionately high rates of poverty, housing and employment discrimination, and criminalization. The upheaval caused by the coronavirus outbreak has exacerbated these disparities for those disabled prior to the crisis, while exposing more people to trauma, loss, and uncertainty. Considering mental health care from a justice and equity perspective, this session examined the following: 1) What social and ethical challenges are embedded in the current mental health epidemic? 2) How might such challenges be effectively addressed? 3) What community-based models can improve access? 4) What are the cost benefits of equitable treatment vs. cost of untreated mental healthcare in the U.S.?
Malkia Newman addressed the first question above on the social and ethical challenges embedded in the current mental health epidemic. Through sharing her personal life story, Ms. Newman focused on trauma, stigma, and disparities in behavioral healthcare. Ms. Newman defined types of trauma, focusing on inter-generational trauma. She noted that racism and social inequities are now regarded by many as a health crisis, especially in light of the COVID-19 pandemic. Stigma that individuals face can include many layers, and that stigma can exacerbate mental health and substance use disorders. With regard to mental health disparities, she shared that access to mental health care is only one piece—quality treatment, addressing the shortage of qualified providers, and the need for equitable funding of treatment for all individuals is also crucial. Many in the U.S. are facing financial insecurity, which can also exacerbate mental illness and be a barrier to accessing treatment. Bringing forth the idea of resilience, Ms. Newman ended by sharing her hope for the future, that “resilience can spring forth, and resilience can be taught.”
Dr. Debra A. Pinals provided a physician and policymaker perspective, first addressing the question: why is mental health relegated to second tier status in healthcare financing? There is a long history of viewing mental illness, including substance use disorders, as not being “real” illness—blame, stigma, and stereotypes still play a part in this attitude. Stigma “allows the discrimination of someone based on a label.” However, it is very important to understand that these are illnesses that have causes and treatments. COVID-19 may be putting more focus on mental health, and that may be one positive thing to come from the pandemic. What community-based models can improve access? Dr. Pinals discussed the problems with the current crisis system and the involvement of law enforcement when responding to a crisis, and then put forth a new model that would involve a behavioral health response, specially-trained law enforcement as a backup, and many other pieces related to community services and supports. Referencing her paper on crisis services, Dr. Pinals shared that improving access has to be accessible, interconnected, effective, and just. Dr. Pinals also discussed building out Certified Community Behavioral Health Clinics (CCBHCs) in Michigan, and the siloed nature of current services. Dr. Pinals emphasized the need to understand the existing disparities in mental health services, also discussing the prison system, the opioid epidemic, and child welfare impacts.
During the discussion portion, both speakers discussed the need to make space for people’s stories, particularly within the context of policy work. Ms. Newman shared the importance of including both behavioral health professionals and individuals with mental illness during the planning process for policies and programs, such that their input is actively included. Further discussion touched on teletherapy access and programs for youth and families.
Malkia Newman Malkia Newman is Anti-Stigma Team Supervisor at CNS Healthcare. Behavioral health conditions are common in Malkia’s family. Suicidal, unemployed, and homeless, Malkia accessed care at CNS Healthcare in 2004. Once stabilized, she was able to pursue a job with the CNS Healthcare Anti-Stigma Program in 2005. The Peer-Led program challenges stigma and provides community education on a number of different behavioral health topics. Using poetry, singing and other creative expressions, Malkia shows that “hope and recovery is possible.” The program has reached over 100,000 people in Detroit, Lansing, Marquette, MI; Washington, D.C., New York City, Houston, San Antonio, Las Vegas, Chicago, Phoenix, Honolulu, Hawaii, and Nova Scotia, Canada.
Debra A. Pinals, MD Debra A. Pinals, MD, is the Medical Director of Behavioral Health and Forensic Programs for the Michigan Department of Health and Human Services, Director of the Program in Psychiatry, Law, & Ethics, Clinical Professor of Psychiatry at the University of Michigan Medical School, and Clinical Adjunct Professor at the University of Michigan Law School. Dr. Pinals’ roles have included serving as the Assistant Commissioner of Forensic Services as well as the Interim State Medical Director for the Massachusetts Department of Mental Health. She has worked in outpatient and inpatient settings, forensic and correctional facilities, emergency rooms and court clinics, has received public service awards, and has been an expert witness in many cases. She is Board Certified in Psychiatry, Forensic Psychiatry, and Addiction Medicine.
About Bioethics for Breakfast: In 2010, Hall, Render, Killian, Heath & Lyman invited the Center for Ethics to partner on a bioethics seminar series. The Center for Ethics and Hall Render invite guests from the health professions, religious and community organizations, political circles, and the academy to engage in lively discussions of topics spanning the worlds of bioethics, health law, business, and policy. For each event, the Center selects from a wide range of controversial issues and provides two presenters either from our own faculty or invited guests, who offer distinctive, and sometimes clashing, perspectives. Those brief presentations are followed by a moderated open discussion.
MSU Bioethics 