Dr. Valles gives “culture of health” seminar for The London School of Economics and Political Science

“Housing security’s place in a ‘Culture of Health’: Lessons from the pandemic housing crises in the U.S. and England”

Sean Valles photo

Center Director and Associate Professor Sean A. Valles, PhD, gave a seminar last month for The London School of Economics and Political Science Department of Philosophy, Logic and Scientific Method. Valles presented “Housing security’s place in a ‘Culture of Health’: Lessons from the pandemic housing crises in the U.S. and England” as part of the department’s “Conjectures and Refutations” series.

Dr. Valles has provided a summary of his talk below. A recording is available to watch on YouTube via the LSE Philosophy channel.

People experiencing homelessness had been suffering extreme health and economic hardships before the COVID-19 pandemic, and even more so during it. The notion that housing is a human right is gradually picking up momentum in both the U.S. and England. And that ethical recognition is combining with a growing set of scientific evidence of the effectiveness of “housing first” policies, which provide stable long-term housing to people experiencing homelessness, rather than shuffling people in and out of temporary shelters. Every person ethically deserves safe housing, and failing to provide this has also resulted in a system that cruelly (and at great expense) pushes suffering people into emergency rooms and prisons.

England earned praise for its “Everyone In” program, which was aimed to provide safe housing for every person experiencing homelessness beginning early in the pandemic. By contrast, cities across the U.S. continued defying CDC recommendations by bulldozing temporary encampments set up by people experiencing homelessness, including in Lansing. Meanwhile both the U.S. and England banned evictions of renters who fell behind on their rent during the pandemic, but both also failed to make realistic long-term plans for how to secure housing and income for people who have no way of paying past-due rent once the eviction bans expire.  On both sides of the Atlantic, the pandemic inspired governments to stumble toward recognizing how essential housing is for good health in general and also dealing with this fact. The challenge now is to keep up the momentum, and push for universal housing, since trying to survive without secure housing was already difficult before the pandemic, and will remain so after it ends.

FDA Approval of New Alzheimer’s Drug May Harm More Than It Helps

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This post is a part of our Bioethics in the News series

By Jennifer Carter-Johnson, PhD, JD

On June 7, 2021, the United States Food and Drug Administration (FDA) approved a controversial new Alzheimer’s Disease drug—aducanumab—to be sold by Biogen under the name Aduhelm. Alzheimer’s disease is estimated to currently be affecting over 6 million Americans plus their families, who must watch the mental decline of their loved ones and provide increasing levels of care as the disease progresses.

Controversy

Unfortunately, the approval of Aduhelm has generated a large amount of controversy because the FDA approval came despite the rejection of the studies of the drug’s efficacy by the FDA advisory committee. The opposition to the FDA’s approval has been so heated that three of the eleven-person advisory committee have resigned.

Detailed discussions of the science behind Alzheimer’s disease and the Aduhelm clinical studies can be found elsewhere. In summary, as Alzheimer’s disease progresses, protein plaques—amyloid and tau—build up in the patients’ brain. The progression of these plaques correlated with decreased mental acuity in patients. Therefore, drug candidates that target these plaques have been of interest to scientists for many years.

While the clinical data associated with Aduhelm supported a decrease in brain plaques in early-stage Alzheimer’s patients, the data did not show that decreasing plaques by the drug resulted in slowed progression of Alzheimer’s disease. In addition, the data showed that some patients have brain swelling as a result of the drug. Using this data, the FDA approved Aduhelm for broad use for all Alzheimer’s patients.

FDA Approval Process

Generally, to gain approval to sell a new drug, a company will complete a series of clinical trials to determine if a drug candidate is safe and effective for a given disease. Safety and efficacy are balanced against each other and consideration is given to the severity of the disease to determine if approval will be granted. As an example, a highly effective drug that is also highly toxic would not be approved as a simple headache remedy but may be approved as a treatment against a fast-growing, inoperable form of brain tumor. Conversely, an ineffective drug should never be approved no matter how safe it is—such are the wares of snake-oil salesmen of the past.

The FDA also has an Accelerated Approval pathway to allow drugs for diseases that have few treatments to proceed to market more quickly. It is under this accelerated path that the FDA approved Aduhelm. The accelerated pathway allows companies to use biomarker changes rather than disease improvement to show efficacy in the drug approval process. The FDA used the decrease in amyloid plaques as the biomarker for approval of the new Alzheimer’s drug—despite the fact that the clinical trial studies were submitted to show efficacy against disease progression. Moreover, the advisory committee was not informed of potential accelerated approval. Only after the clinical trial data was found unacceptable by the advisory committee did the FDA switch to the accelerated approval pathway. Perhaps most importantly, other drug candidates have been abandoned after amyloid plaque removal did not halt progression of the disease, so biomarkers may not be effective ways to judge the halt of Alzheimer’s progression.

The accelerated approval is, in effect, a contingent approval. Biogen will be allowed to sell Aduhelm, but it must gather data as to whether the drug is actually effective. If clinical data does not eventually support reduced disease progression, then the FDA can rescind the approval, and Biogen will no longer be able to sell the drug. The FDA’s approval of the Aduhelm may be harmful in the long run for several reasons.

Medicine IV infusion
Image description: A close-up photo of an IV drip containing clear liquid. Image source: stux/Pixabay.

Trust in FDA

The move by the FDA to approve Aduhelm could lead to a decrease in trust in the agency. First, the controversial nature of its approval over the recommendations of the scientists who reviewed the data created a controversy that is playing out across the news media as people wonder why an ineffective drug has been approved.

In fairness, the accelerated approval process is contingent, but due to the way the accelerated approval was used scientists did not have the opportunity to weigh-in on the use of biomarkers in that approval. That way in which the accelerated approval process was tapped, only after the regular approval process seemed doomed to fail, may well erode trust that the FDA evenly applies its own rules. Additionally, it is very difficult to rescind these accelerated approvals, and if the drug approval is rescinded public perception will likely be highly negative. Finally, according to Biogen it may take up to nine years to gather the data to complete the required studies.

New Drug Development

Aduhelm is not the only drug candidate in its class in clinical trials for Alzheimer’s disease treatment. Other drug candidates that include patients who receive a placebo rather than the drug candidate are undergoing clinical trials. Since these studies tend to be double-blinded—neither the doctor nor the patient knows if the drug or the placebo has been administered—patients will likely drop out of these other studies in order to be assured of receiving some drug. Thus, Alzheimer’s drug development will be slowed, in favor of a drug that has no demonstrable efficacy. Additionally, these new drug manufacturers may also ask for similar approval, based on biomarkers that may not be indicative of clinical effectiveness.

False Hope

Patients and Alzheimer’s advocates pushed for approval of this drug. But a drug with contingent approval may give these patients and their families false hopes. We have seen in Right to Try legislation–legislation allowing patients to use un-approved drugs in the FDA approval pipeline–both a fundamental lack of understanding of the FDA approval process as well as the desperation of patients for whom there are no clear treatment options. I have argued before that Right to Try laws prey on the emotionally fragile. Here the FDA’s controversial accelerated approval may have the same result—patients clamoring for a drug that does not work.

In addition, the cost of the drug will be borne by insurance companies that may well decide not to cover the drug. While the drug is approved for all stages of Alzheimer’s, clinical studies were only aimed at early-stage disease. In effect, the FDA has shifted its responsibility as gatekeeper for effective drugs to insurance companies for whom profit is a driving force.

Drug Cost

The cost of Aduhelm in light of the lack of efficacy data presents its own problems. Biogen has indicated that the average yearly cost of Aduhelm will be $56,000, not including the cost of doctors, hospital or clinic visits, and supplies to receive the infusions, or the cost of brain scans to monitor for swelling and brain bleeds as side effects. This cost, like most drugs, will be passed on to consumers through direct payments, increased insurance premiums, and higher budget expenditures for Medicare and Medicaid. One study reported that if 500,000 people on Medicare are prescribed the drug, it would cost $29 billion per year with copays of over $11,000 per year.

Biogen defends its pricing of the drug. According to its own press release, Biogen “established the price of Aduhelm based on the overall value this treatment is expected to bring to patients, caregivers, and society.” This expected value seems high for a drug that may not work but admittedly reflects normal drug company calculations in a system where insurance covers most prescriptions and the uninsured either do without or rely on the generosity of the drug company.

Because FDA approval is contingent, the FDA can remove the drug from the market if the required data do not show efficacy. However, the money paid for the failed treatment regime will not be refunded. Patients are paying to take this risk.

In the end, the FDA’s approval of Aduhelm will impact the way the agency is perceived, and the way other companies approach the drug approval process. Neither of these changes will be for the better.

Jennifer Carter-Johnson photo

Jennifer Carter-Johnson, PhD, JD, is Associate Dean for Academic Affairs and Associate Professor of Law at the Michigan State University College of Law.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Monday, July 5, 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.

Continue reading “FDA Approval of New Alzheimer’s Drug May Harm More Than It Helps”

Bioethics for Breakfast: Caring with and for undocumented physicians and patients

Bioethics for Breakfast Seminars in Medicine, Law and Society

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

About the Speaker

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.

Bioethics for Breakfast: Mental Health Care Access: Making the Dollars and “Common Sense” Case for Parity

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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.

Related Resources

About the Speakers

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.

Bioethics for Breakfast: Health Reform Unmentionables: Long-Term Care

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Anne Montgomery and Sarah Slocum, co-directors of Altarum’s Program to Improve Eldercare, presented at the December 10 Bioethics for Breakfast session, offering perspectives and insight on the topic “Health Reform Unmentionables: Long-Term Care.”

While past Bioethics for Breakfast events were held in person, this year’s series is taking place virtually. The series is generously sponsored by Hall, Render, Killian, Heath & Lyman.

A lot of attention has been given recently to the social, political, ethical, and economic challenges associated with long-term care. Nursing homes and long-term care facilities have suffered during the COVID-19 pandemic, but at the same time, the pandemic has given these issues more public visibility. There are several large questions to consider: What are the major challenges facing long-term care today? How should long-term care be financed? What would motivate individuals to purchase long-term care insurance? What are the consequences for Medicaid if we see increased reliance on Medicaid for long-term care funding (keeping in mind continued growth of the elderly population and dementing illness)? What policy options are available for addressing all these challenges? Should those policy options be left to the states? What, if any, is the role of the federal government?

Discussing financing, proposals, and reforms related to long-term care insurance in the U.S., Sarah Slocum reminded attendees of our present-day circumstances by giving a brief overview of Medicare and Medicaid, beginning in the 1965 when they were passed at the federal level. The original design did not include long-term care. By the 1980s, the version of Medicaid could bankrupt entire families if one member of a married couple needed to enter a nursing home. In the 1990s, spousal impoverishment provisions were enacted to protect the assets of individuals. Many states began regulating long-term care insurance, however, policies remained very expensive and were very hard to market. For those who did choose to purchase long term care insurance, their premiums increased as they got older. Bringing us to the present, Slocum discussed Michigan reforms that began to be planned in 2017. One option that the Michigan legislature will have to consider is a 0.5-1% payroll tax contribution for all individuals to fund a long-term care program. Slocum shared the example of a new program in the state of Washington, noting that watching how well the program does could help inform decisions made in Michigan and other states.

Anne Montgomery then offered insight into policy considerations at the federal level, based on her work in Washington, D.C. The cost of long-term care insurance remains a challenge to many people. Additionally, one in five middle-income seniors will become impoverished, typically turning to Medicaid to cover their long-term care costs. More than half of Americans who enter old age today will have a long-term care need for constant attendance, something that is very costly. Montgomery shared the possibility of federal social insurance, though that possibility depends on how legislation is drafted and considered by Congress. Discussing Medigap, Montgomery suggested adding long-term care services and supports to the existing coverage. Montgomery also brought forth the need for a bigger and better trained long-term care workforce, and the need for other infrastructure and home and community-based service improvements. Montgomery then shared predictions on what the Biden administration may be looking to do beginning in 2021, touching on the Affordable Care Act and the Center for Medicare and Medicaid Innovation. Finally, Montgomery discussed the need for culture change and quality improvement within nursing homes, such as moving to a person-centered model.

The discussion portion of the session included questions about how hospice and palliative care interface with long-term care insurance, how family caregivers could be compensated under a new model, and the overall appetite of the American public for the changes discussed by Slocum and Montgomery.

Related Resources

About the Speakers

Anne Montgomery
Anne Montgomery is Co-Director at Altarum’s Program to Improve Eldercare, where she oversees a portfolio of quality improvement and research projects focused on older adults and long-term services and supports. Montgomery has more than two decades of policy experience working on Medicare, Medicaid and related programs. Montgomery served as a Senior Advisor for the U.S. Senate Special Committee on Aging, where she developed policy included in the Affordable Care Act, including policy to upgrade quality in the nursing home sector; expand options for states offering home and community-based services; improve direct care worker training; and improve state Medicaid assessment processes. Montgomery also worked for the House Ways & Means Committee, the Government Accountability Office and the Alliance for Health Policy in Washington, D.C., and was awarded the Atlantic Fellowship in Public Policy to conduct comparative analysis of family caregiver policy in the U.S. and the UK. Montgomery received an MS in Journalism from Columbia University.

Sarah Slocum
Sarah Slocum joined the Altarum Program to Improve Elder Care in the fall of 2016. As Co-Director of Altarum’s Program to Improve Eldercare, Ms. Slocum strives to improve the quality of life and care for frail elders living with disability. Just prior, she served 13 years as Michigan’s State Long Term Care Ombudsman, leading advocacy for Michigan citizens living in long term care facilities. She has led policy change efforts in the state Medicaid program, long term care regulations, the Certificate of Need program, and with the Michigan legislature. Ms. Slocum has testified on nursing home quality before the U.S. Senate Special Committee on Aging. She has worked for over three decades in aging and long term care advocacy at the state and national levels. Ms. Slocum received an MA in Bioethics from the Michigan State University College of Human 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.

Dr. Fleck published in ‘Hastings Center Report’ on Black Lives Matter and inequities in the U.S. healthcare system

Leonard Fleck photo

In the current issue of the Hastings Center Report, Center Acting Director and Professor Dr. Leonard Fleck shared a perspective on “Some Lives Matter: The Dirty Little Secret of the U.S. Health Care System.”

Abstract: Our health care system in the United States reflects the inequities that are part of the larger society, which is why our system for financing access to needed and effective health care is so complicated and unfair.

Visit the journal’s website for free access to the full text. Dr. Fleck is one of more than 200 Hastings Center Fellows.

The White House outbreak: How to criticize irresponsible leaders without getting stuck in the illness blame game

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This post is a part of our Bioethics in the News series

By Sean A. Valles, PhD

In a twist of fate, there was an outbreak of COVID-19 at a White House celebration of the nomination of Amy Coney Barrett for the Supreme Court of the United States. This elicited a wide range of reactions to seeing a gathering of opponents of strict COVID-19 control measures being hurt by the very pandemic they have downplayed. While others have worried about the moral philosophy of taking pleasure in others’ suffering, or the hypocrisy of evading rules one publicly espouses, I have a different worry. A poll shortly after the White House outbreak found that a majority of respondents believed that Trump had acted “irresponsibly” in how he had handled his personal risk of infection from people he interacted with. While I do not worry about the president being blamed for his illness, I do worry about the wider cultural practices of 1) victim-blaming by attributing a person’s illness to their personal moral failure, and 2) insisting that health is a matter of individual choice. While the distinction might not seem important at first, I will argue there is an important difference between victim-blaming the ill and holding leaders accountable for setting bad examples with their conduct and other leadership failures. The first kind of blame is toxic in a society, and the second kind of blame is an important part of a well-functioning democracy.

President Donald Trump in the Oval Office nominating Amy Coney Barrett to the Supreme Court
Image description: President Donald J. Trump and First Lady Melania Trump pose for a photo with Judge Amy Coney Barrett, the President’s nominee for Associate Justice of the Supreme Court of the United States, her husband Jesse and their children on Saturday, Sept. 26, 2020, in the Oval Office of the White House. Image source: Official White House Photo by Andrea Hanks.

Blaming people for their ill health is a strategy with an awful track record. It doesn’t do any good for the people subjected to “you’re too fat” messages. It doesn’t do any good for survivors of sexual assault or domestic violence. When directed inward, we self-blame for failing to do enough de-stressing self-care, rather than directing our blame to more appropriate targets like the needlessly bad working conditions or economic insecurities that make us stressed in the first place. Repeated messages that “sickness is the result of individual moral failure” also reinforce stigma. Stigma is a nasty phenomenon, with a “corrosive impact on the health of populations” and is particularly bad in cases of infectious diseases like COVID-19 because it actively encourages people to hide their infection, which is obviously bad for them and for others who interact with them.

A second problem with blaming people for their ill health is that ethics of blaming individual behavior reflects a misunderstanding of how health behavior works in the first place. Seemingly individualistic choices like diet, condom use, smoking, alcohol consumption, etc. are not made independently. We choose such things in roughly the same way we “choose” our religions or the languages we speak at home. Yes, each of us can choose to practice an entirely different religion (or lack thereof), and each of us can learn and use a different language in the home. Some of us do. In all of these cases, though, the vast majority of us don’t venture too far from a combination of what we learned while growing up and the cues we get from the people we interact with. We eat the foods familiar, convenient, and affordable to us. We adopt the values and beliefs (including trust in aspects of the scientific endeavor) of our communities, etc. Individual choices exist, but they exist within larger social contexts that have powerful but subtle effects on our choices.

Each of our everyday behaviors related to COVID-19 exist in a complex ecosystem of influences. Mask wearing and other social distancing measures have become intensely politicized and tied to masculinity. Masks and other health behavior measures also create new inconveniences and financial expenses. Social pressures also vary vastly from one setting to the next—in one store there are prodding questions and judgmental stares for wearing a mask, at an adjacent store there are similar pressures on those who don’t wear a mask. How we move our bodies and (un)cover our faces within these intense social pressures is not simply an individual choice.

Take the case of one of the attendees of the party at the White House, University of Notre Dame President, the Rev. John I. Jenkins. He did not wear a mask at the indoor/outdoor party, shook hands with attendees, and otherwise did not follow the standards he had imposed on members of his own university. He knew better and did not do better. Many of us have likely also gone against our better judgment to fit the incautious social distancing norms of a setting. Whether it is the university president or the university student, this is indeed hypocritical, and irresponsible in a sense. But, such blame is aside from the point, and more importantly it contributes to the sort of harmful cultural practices mentioned earlier—especially victim-blaming and stigmatizing the ill. Pointing out hypocrisy and the assigning of blame for individual health behavior distracts from the far more damaging thing Jenkins and the other leaders at the White House party did. As cultural leaders, they undercut efforts to build new norms, like public mask-wearing, the habit of greeting people without needlessly touching hands, etc.

We ought to blame Trump, Jenkins, and many other leaders who attended that party. We ought to blame them for failing in their relationships to the people they lead. That is a devastating form of irresponsibility. And it is very important to separate that kind of blame and irresponsibility accusation from the destructive form of blame discussed above: blaming people for having irresponsible relationships with their bodies/health.

The “personal responsibility” blame game has been the go-to talking point of conservative governors as they use their power to obstruct or dismantle public health measures. “You shouldn’t have to order somebody to do what is just in your own best interest and that of your family, friends and neighbors,” according to Alabama Governor Kay Ivey. Scolding people about “personal responsibility” during a public health crisis is a strategy based on how one wishes the world worked and not how it is actually working. Along similar lines, abstinence-only sex education doesn’t work (“teenagers: be sexually responsible by just not having sex before marriage!”), and neither does “just say no to drugs” education. Jenkins was at least right to point out that his behavior was a failure of leadership. As many of my colleagues in population health science say, we need to build a “culture of health.” That will require leaders suited to the task, and we ought to blame them when they fail in that leadership. Just skip the personal health blaming.

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Sean A. Valles, PhD, is an Associate Professor with an appointment in the Michigan State University Lyman Briggs College and the Department of Philosophy (where he is also Associate Chair). His research spans a range of topics in the philosophy of population health, from the use of evidence in medical genetics to the roles played by race concepts in epidemiology. He is author of the 2018 book Philosophy of Population Health: Philosophy for a New Public Health Era. He is also co-editor (with Quill R. Kukla) of the Oxford University Press book series “Bioethics for Social Justice.”

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, November 5, 2020. 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.

More Bioethics in the News from Dr. Valles: We Need Healthier Schools, and Student Activists Are Stepping Up; Recognizing Menstrual Supplies as Basic Health Necessities: The Bioethics of #FreePeriodsTrump’s Attempt to Reignite the Coal Industry Is Another Health Policy BlunderPolitics and the Other Lead Poisoning: The Public Health Ethics of Gun ViolenceClimate Change and Medical Risk

Continue reading “The White House outbreak: How to criticize irresponsible leaders without getting stuck in the illness blame game”

Does YouTube widen health literacy disparities?

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The 2020-2021 Bioethics Public Seminar Series (formerly the Bioethics Brownbag & Webinar Series) continues next month. 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.

Is Seeking Information on Social Media Harmful to Your Health?

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Anjana Susarla, PhD

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Zoom registration: bit.ly/bioethics-susarla

Studies of health literacy in the United States, such as the National Assessment of Adult Literacy conducted in 2003, estimated that only 12% of adults had proficient health literacy skills. This talk will examine how social media platforms such as YouTube widen such health literacy disparities by steering users toward questionable content. Extracting thousands of videos purporting to be about diabetes, I verified whether the information shown conforms to valid medical guidelines. Using methods from computer science called deep learning, I identify medical terms in these videos and then classify videos based on whether they encode a high or low degree of medical information. Using data from aggregate engagement with these videos, I discover that videos that are popular are less likely to contain validated medical information. A study on the most popular videos on COVID-19 likewise found that a quarter of videos did not contain medically valid information.

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Join us for Dr. Susarla’s online lecture on Wednesday, November 18, 2020 from noon until 1 pm ET.

Anjana Susarla is a Professor of Information Systems at the Eli Broad College of Business. Her work has appeared in several academic journals and peer-reviewed conferences such as Academy of Management Conference, Information Systems Research, International Conference in Information Systems, Journal of Management Information Systems, Management Science and MIS Quarterly. Her op-eds and research have been quoted and published in several media outlets such as the Associated Press, Business Insider, Chicago Tribune, The Conversation, Fast Company, Houston Chronicle, Huffington Post, Michigan Public Radio, Marketplace Morning Report, Nasdaq, National Public Radio, Newsweek, Nieman Lab, the Nikkei, Pew Research, Quartz, Salon, the Week, Wired and the World Economic Forum.

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Bioethics for Breakfast: Health Care Deserts: What is Happening in Rural America?

Bioethics for Breakfast Seminars in Medicine, Law and Society

Dr. Steve Barnett and Dr. Kelly Hirko presented at the October 8th Bioethics for Breakfast session, offering perspectives and insight on the topic “Health Care Deserts: What is Happening in Rural America?”

While past Bioethics for Breakfast events were held in person, this year’s series is taking place virtually. The series is generously sponsored by Hall, Render, Killian, Heath & Lyman.

The session focused on the challenges faced by rural health care. Rural populations tend to be older with more chronic health conditions, poorer, and uninsured or underinsured. Before the pandemic, rural hospitals were already stretched thin. A record 18 hospitals closed in 2019. Since then, another 14 have closed in the first half of 2020. Experts say that more would have closed if it weren’t for grants and loan money approved by Congress through the Cares Act. But now many hospitals have already gone through that relief money and are unsure how they will pay back federal loans, even as they are bracing for a possible increase in coronavirus cases over the winter. Of the 1,300 small critical care hospitals across the United States, 859 took advantage of Medicare loans.

What policy options are available for meeting these challenges? We want health care delivered efficiently, but we also want equitable access to needed health care. To what extent is equitable access threatened by hospital closures and difficulty recruiting young physicians?

Dr. Steve Barnett offered a hospital perspective, pointing out that many perceptions about rural America don’t necessarily reflect the truth. The majority of rural hospitals are designated as critical access hospitals. Physicians have been attracted to rural environments at a much lower rate than urban environments – this is a long-standing global problem. Dr. Barnett shared that physicians in rural America have misconceptions about the type of support they will receive from peers, about compensation, quality of care, and practice coverage. On a practical level, they also want to know where the nearest shopping mall is. On the subject of medical education, Dr. Barnett put forth two questions: How can we expose all medical students to rural communities? How can we admit students to medical school who have an interest in returning to their rural community? Regarding workforce shortages Dr. Barnett shared that the value of advanced practice nurses, nurse practitioners, and certified registered nurse anesthetists is being recognized.

Dr. Kelly Hirko then provided a patient perspective and offered potential policy considerations. Social determinants of health and health behaviors (like tobacco use) impact the rural patient population. The COVID-19 pandemic has rapidly hastened telehealth across the world. Using telehealth can be a tool to overcome access barriers and improve quality of rural health care. Dr. Hirko stressed the importance of broadband internet availability: limited availability in rural regions limits the uptake of telehealth. Dr. Hirko shared that more than one-third of rural Americans lack internet access in the home, with lower use of smartphones, computers, and tablets compared to urban populations. For these reasons, telehealth could contribute to unequal access to healthcare. Policy considerations she shared were to ensure availability and viability of rural healthcare facilities, and to maintain the healthcare workforce. Finally, Dr. Hirko discussed the need for efforts to improve rural health on a population level by increasing access to basic preventive services in order to address the root causes of poor outcomes in rural settings.

During the discussion portion, attendees offered questions related to telehealth barriers. While internet service may be available in a particular location, the cost of the service can still be a barrier to access. Wearable tech devices such as the Apple Watch, as well as other peripherals, have helped providers to get creative about measurements such as heart rate and blood pressure during telehealth visits.

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About the Speakers

Steve Barnett, DHA, CRNA, FACHE
Dr. Steve Barnett has served as a hospital chief operating officer and chief executive officer over the past 20 years. Currently Steve is serving as the President & CEO of McKenzie Health System. McKenzie Health System is a rural critical access hospital in Sandusky, Michigan and one of the founding members of the National Rural Accountable Care Organization. Steve has been a member of the Michigan Health and Hospital Association since 2001, served and chaired their Legislative Policy Panel and sits on the Small & Rural Hospital Council. Steve earned a Doctorate in Healthcare Administration from Central Michigan University.

Kelly Hirko, PhD, MPH
Dr. Kelly Hirko is an Epidemiologist, and community-based researcher at the Michigan State University College of Human Medicine’s Traverse City campus. Her research focuses on cancer disparities and the role of lifestyle factors and social determinants in cancer prevention and control. She is particularly interested in using implementation science approaches to effectively incorporate evidence-based interventions into underserved rural settings. Dr. Hirko earned her PhD in Epidemiologic Sciences from the University of Michigan School of Public Health and completed a post-doctoral fellowship in Epidemiology at the Harvard T.H. Chan School of Public Health before joining MSU in 2016.

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.

A COVID-19 Vaccine Won’t Stop the Pandemic

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This post is a part of our Bioethics in the News series

By Parker Crutchfield, PhD

As the COVID-19 pandemic continues to maim and kill thousands and devastate countless others, many are pinning their hopes of returning to a life resembling normal upon the development of a vaccine. The Centers for Disease Control and Prevention has even advised states and cities to be prepared to allocate up to 800 million doses of a vaccine in late October or early November. But it is highly unlikely that a vaccine will do much to stop the pandemic and related significant harm. For a vaccine to get us out of the pandemic, it needs to be developed, distributed, and received. Regardless of its development and distribution, if people don’t take it, then it won’t do any good. And there isn’t much reason to think that many people will take it, at least initially.

Image description: an illustration of a bottle with a white label that says “COVID-19 Vaccine” in black text. The bottle is different shades of blue with a dark blue background. Image source: Shafin Al Asad Protic/Pixabay.

Allocation Models

Recently, a team of scholars advocated for a scheme to allocate the eventual vaccine, the Fair Priority Model. This model, like most models of allocation, assumes that the vaccine will initially be scarce. On this assumption, the allocation then proceeds in phases, the first preventing the most significant harms such as death, the second preventing other serious harms and concomitant economic devastation, and the third addressing community transmission. Other models may set different priorities by, for example, putting health care workers or racial and ethnic minorities first in line.

Developing allocation models is important. But they all rest on a questionable assumption: that the people to whom the vaccine is allocated actually want it, or are at least willing to take it. Scarcity is just as much a matter of demand as it is a matter of supply.

Demand for a Vaccine

Recent evidence suggests that, generally, people won’t take the vaccine initially, even if offered. Almost 80% of people said they wouldn’t get it, if available, at least until others have done so, according to a recent CBS News poll. A return to something resembling normal life requires around 70-80% of the population to be immune.

Mistrust of the politicization of vaccine development or of the scientific practices involved may be responsible for much of the population’s apparent hesitation. But reasonable people may also simply not want to be first in line for a new immunity enhancer. Thus, whatever criteria are used, the allocation scheme must incorporate consideration of demand, not simply supply.

For example, the first allocation according to the Fair Priority Model should go to those people whose being vaccinated would most likely prevent death and who want the vaccine. If the vaccine is allocated to health care workers, the allocation must be to people who are health care workers and who want the vaccine. That is, demand for a vaccine should be just as much a component of allocation models as any other consideration.

Voluntary or Compulsory?

Allocation models must consider the population’s demand for a vaccine in order for such models to provide useful guidance on distribution. Given the apparent lack of demand, giving people the choice of whether to take the vaccine is unlikely to stop the pandemic any time soon. But demand only matters if people have an option. One way to avoid having to consider the population’s willingness to take the vaccine, and to dramatically decrease the time it takes to boost 70-80% of the population’s immunity, is to take that willingness out of the equation and make it compulsory.

Already some vaccinations are compulsory, depending on a person’s circumstances. Some have argued that the COVID-19 vaccine should be mandatory. One common principle in philosophy is that ought implies can. This means that what one’s moral obligations are hinges on what one can do. Even if one can justify compulsory COVID-19 vaccination, it’s unlikely that this is something that can be achieved. Compulsory vaccination is not something we can do, which means it’s not something we should do.

Consider, for example, the widespread reluctance to wear a mask and the flouting of social distancing guidelines. Wearing masks and social distancing are very minor burdens to bear for others’ well-being. While it is true that mask and social distancing mandates push against unrestrained permission to do what you want when you want to do it, others be damned, these intrusions are arguably minor (though are admittedly disruptive). Requiring 70-80% of the population to go someplace and get poked by a needle on multiple occasions or sprayed in the nose are much greater liberty intrusions. It is a pipe dream to think that a vaccine mandate would be accepted by the very same population who refuses to bear the more minor burdens of mask wearing and social distancing, which amounts to at least 29% of the population, enough to undermine our ability to stop the pandemic.

Different Baskets for Our Eggs

If administration of the COVID-19 vaccine is voluntary, not enough people will volunteer to get it. If administration is mandatory, still not enough people will get it. The vaccine’s allocation can only be either voluntary or mandatory. Either way, not enough people will get it, at least at first. The only conclusion to draw is that a vaccine is not going to stop the pandemic, at least any time soon. If ought implies can, we ought not pin our hopes upon a vaccine, because we cannot hope for it to work to stop the pandemic. There is no light at the end of the tunnel.

Image description: a narrow tunnel between two brick walls that leads to darkness. Image source: Peter H/Pixabay.

However, incentives and disincentives can change a person’s mind. Other than the incentive intrinsic to getting the vaccine—the preservation of human life and well-being—are there others that might make people more willing to get it, such as money or tax breaks? Or are there disincentives to vaccine refusal that might convince someone it is better to get it than it is to refuse? Carrots or sticks?

If neither, then we’re in for the long haul.

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Parker Crutchfield, PhD, is Associate Professor in the Program in Medical Ethics, Humanities, and Law at the Western Michigan University Homer Stryker M.D. School of Medicine, where he teaches medical ethics and provides ethics consultation. His research interests in bioethics include the epistemology of bioethics and the ethics of enhancement, gene editing, and research.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, October 8, 2020. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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More Bioethics in the News from Dr. Crutchfield: Trust and Transparency in Quarantine; Public Health Crisis Warrants Liberty RestrictionsWe Should Tolerate and Regulate Clinical Use of Human Germline Editing

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