The 2022-2023 Bioethics Public Seminar Series will conclude next month with a webinar from Center Assistant Professor Jennifer McCurdy, PhD, BSN, MH, HEC-C, on “How Brain Death Declarations Can Harm, and Why Legal Exemptions Should Be the Rule.” This virtual event is free to attend and open to all individuals.
According to U.S. law and The Uniform Determination of Death Act (UDDA), an individual can be declared dead by either cardiac or neurological criteria. The latter, known colloquially as brain death, allows a physician to withdraw patients from medical devices against the wishes of families and other surrogates. While once seemingly settled, the concept of death by neurological criteria has increasingly become a topic of controversy, both technically and philosophically.
This seminar will argue that the UDDA should make New Jersey-style legal exemptions to brain death declaration a national guideline, thus allowing individuals to claim a religious exemption when they disagree that brain death is, in fact, death. Why? Because the concept of brain death is based on a specific eurochristian worldview that is not held in common by many reasonable people in U.S. society. The imposition of those unshared worldviews on patients and their loved ones through force of law causes unjustified and avoidable trauma, furthers epistemic injustices, and generates distrust.
Jennifer L. McCurdy is an assistant professor in the Center for Bioethics and Social Justice within the Michigan State University College of Human Medicine. She is a clinical and social bioethicist and educator whose work focuses on understanding and eliminating racial and colonial injustices in contemporary health settings and communities. She currently engages medical students at MSU in curricula related to social context and ethics issues in healthcare. Her current research focuses on brain death policy, Black birthing family safety, and Indigenous representation in bioethics.
Center Assistant Professor Jennifer McCurdy, PhD, BSN, MH, HEC-C, presented “Beyond Patient Behavior: Using Structural Competency to Create Health Equity” at the Michigan State Medical Society (MSMS) 26th Annual Conference on Bioethics: Contemporary Challenges in Clinical Bioethics in November. McCurdy’s presentation explored the social, political, and economic contexts that act as barriers to patients care and impede physicians’ ability to effectively treat them.
McCurdy asked those in attendance the following questions: Have you ever experienced moral distress or frustration associated with the medical “system?” Have you ever been unable to treat a patient for whom treatment exists, based on factors that are out of your control? What were those factors?
Using a case example, McCurdy discussed factors that determine the health status of an individual, such as behaviors, cultural norms, and biology. She also discussed social determinants of health, such as poverty, inadequate or no housing, lack of access to education, and lack of access to healthcare. McCurdy also outlined structural determinants of health, pointing to social structures, political structures and policy, and economic structures and policy—the “causes of the causes.”
How can physicians help? They are uniquely positioned in spaces that connect the medical world and the patients’ worlds, where they can observe recurrent barriers to care. They can work to create change at individual, interpersonal, and institutional levels. McCurdy also outlined how physicians’ involvement in the community, in policy, and in research can create structural change and therefore improve health equity.
Related reading
Neff J, Holmes SM, Knight KR, Strong S, Thompson-Lastad A, McGuinness C, Duncan L, Saxena N, Harvey MJ, Langford A, Carey-Simms KL, Minahan SN, Satterwhite S, Ruppel C, Lee S, Walkover L, De Avila J, Lewis B, Matthews J, Nelson N. Structural Competency: Curriculum for Medical Students, Residents, and Interprofessional Teams on the Structural Factors That Produce Health Disparities. MedEdPORTAL. 2020 Mar 13;16:10888. doi: 10.15766/mep_2374-8265.10888. PMID: 32342010; PMCID: PMC7182045.
Gruen RL, Campbell EG, Blumenthal D. Public roles of US physicians: community participation, political involvement, and collective advocacy. JAMA. 2006 Nov 22;296(20):2467-75. doi: 10.1001/jama.296.20.2467. PMID: 17119143.
Megan Hoberg and Pamela Hoekwater of Legal Aid of Western Michigan presented at the December 1st Bioethics for Breakfast session, offering their insight and expertise on the topic “Medical Legal Partnerships: A Tool to Help Address the Social Determinants of Health.” Bioethics for Breakfast is generously sponsored by Hall, Render, Killian, Heath & Lyman.
The session provided an overview of medical legal partnerships (MLPs) and their impact, discussing the Legal Aid of Western Michigan (LAWM) partnership with Cherry Health—Michigan’s largest Federally Qualified Health Center that operates in six counties. Speakers Hoberg and Hoekwater defined a medical legal partnership as “an integration of lawyers into the health care setting to help clinicians, case managers, and social workers address structural problems at the root of so many health inequities.” MLPs are increasing in popularity across the U.S. and can result in patient success stories, provider satisfaction, and increased recognition and reputation from organizations in the community.
They explained that a big part of MLPs involves screening for issues that might not have an obvious legal component to them. They shared four legal aid practices that relate directly to different social determinants of health: family law, housing, public benefits, and individual rights. One component of an MLP is training the health organization’s work force to help identify potential legal needs in the patient setting.
A memorandum of understanding (MOU) between the relevant stakeholders is generally a starting point to form MLPs. Hoberg and Hoekwater shared that there are a variety of ways that MLPs are funded, including AmeriCorps/Equal Justice Works, private donors, law firms, bar associations, health organizations, and foundations. They shared the evolution of their partnership with Cherry Health, which started with a pilot program and now includes a full-time on-site attorney and community health worker. The MLP currently focuses on maternal infant health and the senior population. The MLP operates as a multi-step process that begins with a referral to the MLP team through the electronic health record which leads to a meeting between the patient and attorney.
Hoberg and Hoekwater also shared challenges associated with MLPs, such as stability of funding, balancing legal and medical ethics, systems integration, and internal communication. Challenges aside, they shared both quantitative and qualitative data that supports the positive impact of MLPs. One example of a specific impact is patients reporting improved mental health and lower levels of stress and anxiety.
It was clear during the question and answer potion that attendees were interested in learning more about how they can pursue forming MLPs at their organizations, and how they can help their patients receive the legal support they need.
Megan Hoberg is a Staff Attorney with Legal Aid of Western Michigan (LAWM). Previously, she worked as the Medical Legal Partnership Attorney, for the MLP LAWM maintains with Cherry Health. Megan’s perspective sheds light on how MLPs operate on a daily basis and the impact they produce for patient/client communities. Megan was drawn to MLPs during her time at Wayne State University Law School, when she served as a student attorney for The Legal Advocacy for People with Cancer Clinic and earned the 2020 Outstanding Clinical Student Team Award from the Clinical Legal Education Association (CLEA). Starting her career in healthcare and bioethics, working with MLPs and poverty law allows her to use her legal training to advance public health goals in an interdisciplinary setting. She is a member of the following organizations: State Bar of Michigan Professional Ethics Committee, Women Lawyers Association of Michigan, and American Society for Bioethics and Humanities.
Pamela Hoekwater serves as the Executive Director for Legal Aid of Western Michigan (LAWM). She has over 20 years’ experience in poverty law work since starting her legal career as a Staff Attorney in 2001 and has developed innovative partnerships with local agencies to integrate legal services in the community, including the YWCA, Goodwill Industries, and Hope Network. Having helped launch LAWM’s first medical legal partnership (MLP) in 2017, Pam holds a unique perspective and expertise as to the challenges of maintaining and advancing MLPs. Notably, she contributed to the formation of the Medical Legal Partnership with Cherry Health, which has been fully funded and staffed since 2019. Pam strives to advance social justice and equity through her participation/leadership in the following organizations: Resource Committee for Michigan Justice For All Commission, State Bar of Michigan Diversity and Inclusion Advisory Committee, Michigan State Planning Body, and Legal Services Association of Michigan.
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.
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.
The COVID-19 pandemic has brought to public attention the phrase “crisis standards of care.” This is not a phrase that is especially meaningful to most members of the public. My concern, speaking as a medical ethicist, is that it is not intended to be especially meaningful for the broad public. Instead, it is what I would describe as a bit of “antiseptic rhetoric” intended to cleanse the public conscience of otherwise troubling ethical choices health professionals might be required to make during a pandemic.
Of course, antisepsis is generally good. It prevents potentially life-threatening infections. However, very aggressive antisepsis aimed at creating a hyper-sterile environment can result in an immune system that is “uneducated,” ill-prepared for a powerful pathogen that manages to elude our antiseptic efforts. My concern is that the use of antiseptic rhetoric around COVID-19, as with the phrase “crisis standards of care,” weakens the capacity of the public to understand and thoughtfully address the troubling and tragic ethics issues generated by COVID-19 in both the health care and political sectors of our social life.
Image description: A grey and white illustration of a single empty hospital bed sitting underneath a light that is shining down onto the bed. Image source: Izwar Muis/Pixabay.
The antiseptic meaning of “crisis standards of care” is that there are too many patients who need care all at once, and consequently, the normal expectations for timely and effective care will not be met. Delays will occur. As a patient, you might be parked in a hallway on a gurney for a few hours until a room becomes available. This is annoying, but hardly cause for an anxiety attack. However, this is very far removed from the reality that patients are facing in Idaho, Montana, Georgia, Florida, and several other states where the Delta variant of COVID-19 has overwhelmed the hospital system.
I was prompted to think about crisis standards of care by a recent article in the New York Times, “’I just cry all the time’: Non-Covid patients despair over delayed care.” The article tells the story of Mary O’Donnell, age 80, who needed a five-hour back surgery procedure that was postponed indefinitely due to the hospital being filled up. She was going to need multiple days in the hospital after surgery. Her concern was that she would be permanently impaired if the surgery were not performed very soon.
Of course, the person who would occupy the bed she needed would be a COVID-19 patient with a life-threatening condition. That person might survive, but maybe not. Mary O’Donnell did not have a life-threatening condition. She was “merely” at risk for losing the functioning of her legs. That is a terrible sentence to write, but it was the medical and ethical reality. This is rationing: painful, tragic, unfortunate, and sometimes unjust.
Here is another headline that better elucidates the meaning of crisis standards of care. “After 169 hospitals, a dad finally got the Covid-19 care he needed—and changed dozens of skeptics’ minds.” Robby Walker, age 52, needed ECMO (extracorporeal membrane oxygenation) to save his life—to serve as an artificial heart and lungs for him. That was in Florida. He ended up being transported by air to a hospital in Connecticut that had an ECMO bed. Readers should realize that this could hardly be the fate of hundreds of other COVID-19 patients needing ECMO. Reed Hickson, age 49 and the father of twelve in Texas, was unable to find an available ECMO bed in all of Texas. He died. That is what “crisis standards of care” means in practice.
Patients with advanced cancers or advanced heart disease needing surgical treatment will have those surgeries postponed with unknown consequences. Maybe a delay of those weeks will make no difference for that cancer; it will be effectively managed. Maybe the cancer has already metastasized, and the fate of that patient is sealed. Maybe the cancer will metastasize in those intervening weeks. Again, this is what “crisis standards of care” means in practice. It is health care rationing that necessarily implies problems of health care justice.
If there are not enough ICU beds or ventilators, then those scarce life-saving resources will go to patients who are judged most likely to survive. How is that judgment made? Can the public be confident it is made fairly? Is it ethically more important to save the most lives or the most life-years? This is a critical distinction.
Another phrase that has attracted some media attention pertains to a hospital invoking “universal do-not-resuscitate orders” for COVID-19 patients. Some right-wing media sites have warned COVID-19 patients that they must stay away from hospitals because hospitals have agreed not to treat COVID-19 patients but just let them die. No doubt those same sites are falsely pushing ivermectin as a treatment you can administer to yourself in the quiet of your own bedroom. What the phrase “universal do-not-resuscitate order” does mean is that if a COVID-19 patient codes in the ICU, there will be no effort to resuscitate them. The justification for a policy that would likely elicit anxiety, anger, and horror in much of the public is that such an effort would put at risk the lives of the health professionals attempting that effort. Further, the patient would most likely, not certainly, die despite that effort.
Here is a hard question: if you are a patient with a cancer or advanced heart disease needing surgery that has been postponed, how should you feel about that policy? You can survive, you want to survive, and you need that bed. Alternatively, if you are a COVID-19 patient in the ICU with a somewhat uncertain prognosis, how should you feel about that policy? These are the painful realities of crisis standards of care. This is health care rationing.
These are policies and policy choices that need public awareness, public understanding, and public legitimation. This requires hospitals and political leaders willing to take the risks associated with informing and engaging the public in discussion of the hard ethical choices that COVID-19 has thrust upon us. Antiseptic language may be innocuous (and politically desirable). However, the immune system of a democratic society, public reason, requires robust, honest, exacting language to strengthen its ability to resist infectious obfuscation and viral disingenuousness.
Leonard M. Fleck, PhD, is Professor in the Center for Bioethics and Social Justice and the Department of Philosophy at Michigan State University.
Join the discussion! Your comments and responses to this commentary are welcomed. The authors will respond to all comments made by Wednesday, October 20, 2021. With your participation, we hope to create discussions rich with insights from diverse perspectives.
You must provide your name and email address to leave a comment. Your email address will not be made public.
The headline in New York Times Magazine reads: “Scientists can now sequence an entire genome overnight.” This is amazing. It took ten years and $3 billion to do the first mapping of the human genome, all three billion base pairs. Today the entire genome of any individual can be mapped for less than $1000. Why is that important? There are preventative, diagnostic, therapeutic, reproductive, and public health reasons. The public health reasons are most evident with the speed with which all the variants of COVID-19 have been mapped.
Having one’s genome mapped can provide an individual with some foreknowledge of health risks to which they might be vulnerable (always keeping in mind environmental factors linked to inherent genetic risks, also keeping in mind the uncertainty and probabilities associated with the vast majority of health risks identified in this way). The risks of medical harm related to genetic ignorance can be reduced. A family of genes referred to as P450 determine whether we are normal, fast, or slow metabolizers of drugs. If we are fast metabolizers, a normal dose will be metabolized too quickly with diminished effectiveness. If we are slow metabolizers, a normal dose will accumulate to potentially life-threatening levels in some cases. Roughly 7% of 1200 FDA approved medications are affected by actionable germline inherited pharmacogenes. Even more importantly, 18% of outpatient U.S. prescriptions (more than four billion per year) are affected by actionable germline pharmacogenomics.
Whole Genome Sequencing (WGS) can assist future possible parents to determine the best reproductive option if they know they represent specific genetic risks to future possible children, e.g., if each were a carrier for a mutated cystic fibrosis gene. In addition, WGS can be used to make accurate diagnoses of very rare disorders that would otherwise require harmful, invasive, diagnostic odysseys. This will be very important in the context of infants in the NICU or children in the PICU.
Image description: A technician loads DNA samples into a desktop genomic sequencing machine at the Cancer Genomics Research Laboratory, part of the National Cancer Institute’s Division of Cancer Epidemiology and Genetics (DCEG). Image source: Daniel Sone/National Cancer Institute/Unsplash.
I remind students that unlike normal medical tests that only yield information about the person who has the test, genetic tests tell us about genetic features of a range of close relatives. Hence, if a genetic test identifies a serious health vulnerability in me, that information can be used to alert other family members of that same vulnerability of which they might otherwise have been ignorant (and which might well be medically manageable before clinical symptoms emerge that might then suggest an irreversible disease process). The therapeutic potential of WGS is most evident today in the case of metastatic cancer. WGS can provide base-pair resolution of an entire tumor genome in a single run, thereby revealing the unique mutations and genomic alterations in the cancer tissue. This will often allow the identification of a targeted cancer therapy, such as imatinib, that targets the distinctive genetic features of a cancer, such as chronic myelogenous leukemia.
In the reproductive context WGS can be used as a non-invasive prenatal screening tool to offer a comprehensive assessment of the fetus. Likewise, WGS could be used at birth as a screening tool to offer a more comprehensive assessment of the infant than the current gene panel, which is only looking for fifty-six rare genetic disorders. This increases the opportunities for timely therapeutic interventions, when available.
Given all these potential therapeutic benefits, what would be the potential ethical challenges? Cost is an issue that raises health care justice problems. Though the sequencing itself costs less than $1000, the analysis, interpretation and counseling bring the cost to $3000 (though in the case of cancer treatment the cost will be $10,000). Few health insurers cover these costs. Should access to WGS then be publicly funded, as a matter of health care justice, perhaps as part of a basic benefit package guaranteed to all? If all 330 million Americans wanted WGS, the cost would be $990 billion. Would that be either a wise or just use of limited health care resources, given all sorts of other unmet health care needs in our society?
One of the main rationales for doing WGS is preventive, i.e., to identify significant health vulnerabilities whose risk of actualization can be reduced by behavioral change. However, the critical question is whether we can be very confident that most patients would commit to the required behavioral changes. Available medical evidence suggests pessimism in this regard, which would imply that WGS with this expectation represented a poor use of social resources. No one believes McDonald’s business plans are threatened by WGS.
If WGS is used to replace current neonatal screening practices, are the privacy rights of newborns put at risk, given later in life genetic vulnerabilities that would be revealed? Would these concerns be mitigated if only medically actionable information were revealed to parents, all other information being set aside until that child reached adulthood? However, what exactly is the scope of “medical actionability?” That child might be vulnerable to some serious genetic disorders much later in life. This would not be a concern for the child as a child. But that child might have older relatives for whom this information would have considerable potential relevance. What are the ethical issues associated with either revealing or failing to reveal that information to potentially “at-risk” relatives?
A very important feature of genetic information gleaned from neonatal WGS (and all WGS for that matter) is that the vast majority of that information will be either of unknown or highly uncertain significance. This will be especially true because of the thousands of mutations that would be part of anyone’s DNA. For parents of a newborn, such uncertainty could be distressing for years and years. However, there is also the uncertainty associated with the responsibilities of primary care physicians in this regard. Who is supposed to have responsibility for tracking changes in genetic knowledge regarding those genetic variations in an individual as medical research advances? And who would be responsible for conveying this new information to parents or adult children, and judging what should be told and when? This is a very complex medical information management problem, relative to which current physician complaints regarding the electronic medical record would fade into insignificance.
Let us assume that WGS is going to be done more thoughtfully and more parsimoniously, such as a diagnostic or therapeutic context where such information would be most useful. What will still happen is the discovery of all sorts of incidental genetic information, sometimes with frightening potential consequences. Imagine this bit of medical dialogue: “Mr. Smith, we were looking for the genetic roots of your heart disease (which we found), but we also discovered your genetic vulnerability to an early-onset form of dementia.” Many patients would not want to know this. How is a physician supposed to know what a patient does or does not want to know in this regard?
Finally, WGS could generate new problems of health care justice. Imagine that the incidental finding in the prior paragraph was a 10% lifetime risk of some serious but treatable cancer. I personally would not be especially distressed by such a finding. However, other individuals might be especially anxious and demand all manner of expensive diagnostic tests on a semi-annual basis to rule out any indications of disease initiation. Would that individual have a just claim to such resources at social expense?
To return to the title of this essay, perhaps the fact that WGS is quick, easy to do, and relatively inexpensive is insufficient reason to justify the promiscuous promulgation at social expense of this technology. Perhaps more thoughtful social and professional deliberation regarding the issues identified in this essay would yield less ethically fraught uses of WGS. Then again there could be the 2030 version of the electronic medical record with room for terabytes of genetic information and thousands of new tabs and subtabs!
Leonard M. Fleck, PhD, is Professor in the Center for Bioethics and Social Justice and the Department of Philosophy at Michigan State University.
Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, May 6, 2021. With your participation, we hope to create discussions rich with insights from diverse perspectives.
You must provide your name and email address to leave a comment. Your email address will not be made public.
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.
The 2020-2021 Bioethics Public Seminar Series continues later this month with a panel of MSU alumni. You are invited to join us virtually – events will not take place in person. Our seminars are free to attend and open to all individuals.
Controversies and Complexities in LGBTQ Health Care
Do you feel prepared to provide excellent care to your LGBTQ patients? Calls for social justice and corrective actions are being mounted by various and intersectional constituencies. These calls for social change must be reflected in improved clinical care, as well. What do LGBTQ patients want from their healthcare providers? Health professionals often think that they do not serve LGBTQ+ people, but Williams Institute data reports about 3-10% of the U.S. population of adults, depending on state, identify as a sexual and gender minority person. What are some of the ethical and clinical challenges that clinicians and patients face? This seminar will address these broadly understood health issues that impact the LGBTQ community, as we aim toward an inclusive and equitable health delivery system. Bring your questions and take part in this exciting and timely conversation with a panel of MSU alumni.
Join us for this online lecture on Wednesday, January 27, 2021 from noon until 1 pm ET.
Dr. Emily Antoon-Walsh
Emily Antoon-Walsh, MD, MA, FAAP (she/her), is a board-certified pediatrician who specializes in the care of hospitalized infants, children and adolescents. She graduated from the Michigan State University College of Human Medicine in 2013 with an MD and an MA from the Bioethics, Humanities and Society program. She completed her pediatric residency at Seattle Children’s Hospital/University of Washington. As a medical student she worked to improve medical education around LGBTQ issues. As a resident she interviewed trans youth and their parents about barriers to gender-affirming care. She now practices hospital pediatric medicine, which presents special challenges and also privileges in providing LGBTQ-affirming care for families. She works in a community hospital in Olympia, WA, where she lives with her wife and child who is a true Pacific Northwest baby and loves the outdoors on the rainiest, cloudiest of days.
Dr. Barry DeCoster
Barry DeCoster, PhD (he/him), is an Associate Professor of Bioethics and Philosophy at Albany College of Pharmacy and Health Sciences. His research interests focus on the overlapping areas of bioethics and philosophy of science & medicine. DeCoster is interested in how vulnerable patients—such as LGBTQ health, racial minority health, and women’s health—engage and respond to the particular needs of their communities. He is also interested in the lingering impact of the medicalization of LGBTQ health and how queer patients are themselves constructed as both ethical and epistemic agents. Dr. DeCoster received his B.S. in Biotechnology & Humanities from Worcester Polytechnic Institute, and his M.A. and Ph.D. in Philosophy from Michigan State University. He spent much time working at MSU’s Center for Ethics as a grad student, and remembers that time fondly as a source of mentorship. Dr. DeCoster enjoyed the opportunity to teach fantastic students for three years at MSU’s Lyman Briggs College.
Dr. Henry Ng
Henry Ng, MD, MPH, FAAP, FACP (he/they), is a physician, educator and advocate for LGBTQ health. Dr. Ng has been involved in LGBTQ health care since 2007 and he is currently a physician in the Center for LGBTQ+ Health and the Transgender Surgery and Medicine Program at the Cleveland Clinic Foundation. He completed his BS and his MD at Michigan State University. He completed his residency and chief residency in Internal Medicine/Pediatrics at MetroHealth Medical Center. In 2012, he completed a Master’s in Public Health degree at Case Western Reserve University with an emphasis on Health Promotion/Disease Prevention for LGBT populations. He served as an associate editor for the journal LGBT Health and is a senior associate editor for the journal Annals of LGBTQ Public and Population Health.
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