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Antiseptic Rhetoric: Crisis Standards of Care

Comments open through October 20

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

By Leonard M. Fleck, PhD

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.

Hospital bed illustration
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 Fleck photo

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.

Continue reading “Antiseptic Rhetoric: Crisis Standards of Care” →

Karen Kelly-Blake presents at American Sociological Association annual conference

Photo of Karen Kelly-Blake

Center Assistant Director and Associate Professor Karen Kelly-Blake, PhD, recently presented at the 116th American Sociological Association Virtual Annual Meeting, held August 6-10, 2021. Dr. Kelly-Blake was an invited panelist for the session “Racism: A Pre-existing Health Condition.” Her presentation was entitled “A Question of Justice: The Covert Costs of Racial/Ethnic Concordance in the Medical Workforce.”

Over the past century U.S. medical workforce demographics have shifted. Moving away from a white male dominated profession, there has been a “widening capacity” trend toward increasing gender, ethnic, racial, and linguistic representation. Commonly, that push is linked to notions of desirable doctor/patient identity matching, described here as “concordance.” Notably that trend is accompanied by rhetoric covertly shaping the professional lives of Black, Indigenous, and Latino physicians underrepresented in medicine (URiM). Improving patient trust, access and health outcomes are frequently mentioned benefits figuring into such parity rhetoric. Indeed, URiM physicians provide a substantial proportion of medical care to the underserved. Quite possibly such workforce patterns reflect focused altruism to serve “one’s own.” Paradoxically, policy initiatives that influence URiM’s futures in the medical workforce may well carry hidden unanticipated consequences.

Dr. Kelly-Blake reported on the findings of a 2000-2015 scoping literature review considering the nature of medical workforce policy strategies. She posed the question of whether those strategies might not unevenly affect URiM physicians, selectively placing service expectations not similarly placed on their White counterparts. Findings suggest that selectively placing service expectations not similarly placed on their White counterparts along with unexamined assumptions of racial/ethnic concordance between patient and physician may place an undue burden on URiMs disproportionately tasked with ameliorating persistent inequities in our health care system.

To learn more about Dr. Kelly-Blakes work on this topic, listen to our podcast episode Medical Workforce Diversity and the Professional Entry Tax: Bogdan-Lovis and Kelly-Blake – Episode 6.

Upcoming webinar on the relationship between the criminal legal system, structural racism, and health

Monday, September 13, 2021; 1:00-2:30 PM ET
Zoom registration: bit.ly/bsj-hfhs-sept13

Trauma, Community Health and the Criminal Legal System

Why should we care about the effects of incarceration and policing on communities and their health? This virtual panel discussion and audience Q&A on the relationship between the criminal legal system, structural racism, and health will also explore terminology—including “mass incarceration”—and explore different ways of thinking about trauma.

This webinar is co-presented by the Michigan State University Center for Bioethics and Social Justice and the Henry Ford Health System Health Disparities Research Collaborative. Panelists include Jennifer Cobbina, PhD, and Christina DeJong, PhD, from the Michigan State University School of Criminal Justice, Carmen McIntyre Leon, MD, from Wayne State University School of Medicine, and Center for Bioethics and Social Justice Director Sean A. Valles, PhD. Henry Ford Health System Health Disparities Research Collaborative Director Christine Joseph, PhD, will moderate the session.

This webinar is free to attend and open to all individuals. A recording will be available following the event.

About the panelists

Jennifer Cobbina, PhD

Jennifer Cobbina is an Associate Professor in the School of Criminal Justice at Michigan State University. She received her PhD in criminal justice at the University of Missouri-St. Louis in 2009. Her primary research focuses on community responses to police violence and the strategies that communities employ to challenge police expansion and end state sanctioned violence. Her research also examines the intersection of race, gender, and how neighborhood contexts shapes crime and criminal justice practices. Finally, her work focuses on corrections, prisoner reentry and the understanding of recidivism and desistance from crime. She is the author of Hands Up, Don’t Shoot: Why the Protests in Ferguson and Baltimore Matter and How They Changed America.

Christina DeJong, PhD

Christina DeJong is an Associate Professor in the School of Criminal Justice at Michigan State University. Her research interests focus on gender, sexuality, crime, and justice. Dr. DeJong’s current work is focused on Queer Criminology, specifically the homicide of transgender people in the United States and how sexuality shapes juvenile offending. She is also currently studying bullying and misconduct in academe. Dr. DeJong received her PhD in Criminal Justice and Criminology from University of Maryland. She is an associated faculty member with the MSU Center for Gender in Global Context.

Carmen McIntyre Leon, MD

Carmen McIntyre Leon completed undergraduate studies at the University of Michigan, attended Wayne State University for medical school, and the Medical College of Pennsylvania (now Drexel) for psychiatry residency and NIMH research fellowship. She worked as medical director for partial programs, inpatient units, research units, and SUD/Methadone programs before returning to Michigan, eventually co-founding Community Network Services, an adult community mental health provider in Oakland County. After a brief stint in New Zealand she returned to Detroit to help lead the newly created Detroit Wayne Mental Health Authority as the Chief Medical Director. She is now the Associate Chair for Community Affairs and Director of Public Psychiatry Fellowship with the Wayne State University School of Medicine Department of Psychiatry and Behavioral Neuroscience; and Chief Medical Officer for the Michigan Department of Corrections.

Sean A. Valles, PhD

Sean A. Valles is director and associate professor in the Center for Bioethics and Social Justice in the Michigan State University College of Human Medicine. Dr. Valles is a philosopher of health specializing in the ethical and evidentiary complexities of how social contexts combine to create patterns of inequitable health disparities. His work includes studying the challenges of responsibly using race and ethnicity concepts in monitoring health disparities, scrutinizing the rhetoric of the COVID-19 pandemic as an ‘unprecedented’ problem that could not be prepared for, and examining how biomedicine meshes with public health and population health. Dr. Valles received his PhD in History and Philosophy of Science from Indiana University Bloomington.

Christine Joseph is a Senior Epidemiologist in the Department of Public Health Sciences at Henry Ford Health System. Her research interests include racial/ethnic health disparities, adolescent health, asthma and allergic disease, adherence, and school-based health management. She has experience in the design and implementation of community-based and pragmatic clinical trials. Dr. Joseph has worked on a variety of studies focusing on vulnerable populations and social determinants of health, and has publications in the areas of asthma, food allergy, sleep, LGBTQ health, and health literacy.

Don’t Scapegoat Immigrants for the COVID-19 Pandemic Surge

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

By Larissa Fluegel, MD, MHS, and Sean A. Valles, PhD

The U.S. COVID-19 pandemic summer surge has inspired a public search for answers as to why wide vaccine availability has not been sufficient to prevent a new wave of infections. Certain answers are plausible, such as blaming the surge on some combination of the more infectious delta variant spread, vaccination rates remaining too low on average and excessively low for some populations, a relaxation of formal disease control restrictions, as well as more nuanced informal social habits such as diminished mask-wearing, more indoor parties, etc. Yet others cast blame onto a much less plausible target: immigrants.

Florida Governor Ron DeSantis blames President Joe Biden for being too lax on the southern U.S. border immigration enforcement, suggesting that Biden has been “helping [to] facilitate” the pandemic. Governor Greg Abbott of Texas took things further, ordering that state law enforcement could “begin pulling over vehicles whose drivers are transporting migrants who pose a risk of carrying COVID-19.” Both of these responses to the pandemic spread are unethical, incoherent, and ineffectual. Accusations against Latin American immigrants are unethical and misguided.

For many reasons, blaming those immigrants crossing the southern U.S. border for negative health outcomes is problematic. Such targeted blame is dehumanizing to immigrants—it promotes negative stereotypes that perpetuate discrimination, mistreatment and health disparities, and by extension, it is detrimental to non-immigrants’ health. Moreover, it is a form of blame shifting that prevents authorities and the public from effectively taking responsibility for community-wide problems.

Image description: a black and white photo of an individual holding a sign that reads “Hamilton was an immigrant. Einstein was a refugee.” They are wearing a long jacket and a tricorne hat. Image source: Victoria Pickering/Flickr.

Blaming immigrants is dehumanizing

There is a long history of dehumanizing immigrants to the U.S., although such dehumanization is generally done selectively. Immigrants such as Charlize Theron and Albert Einstein are treasured, while others are despised for having the “wrong” skin color, accent, occupations, and so on. Dehumanizing and targeting immigrants has been part and parcel of U.S. history, from 19th century church-burning riots that terrorized Irish immigrants, and the overtly racist Chinese Exclusion Act, to current cases of medical abuse and neglect in migrant detention centers. Philosopher David Livingstone Smith traces these sorts of systemic cruelties to a process of dehumanization in which we find ways of convincing ourselves to think of certain groups of people as somehow less than human. To convince ourselves we seek justifications such as depicting immigrants as vermin infecting or invading a country. According to Livingstone Smith, such depictions then give us permission to act aggressively against those groups and to “exclude the target of aggression from the moral community.”

In sum, we find ways to give ourselves permission to dismiss the ethics of how we treat certain groups of people. With such misplaced permission, we decide that certain groups, in this case select immigrants, don’t count as fellow humans worth caring about, and so abuse doesn’t really count as abuse. It’s this sort of misguided logic that also explains Governors Abbott and DeSantis’ school mask requirement bans. Paradoxically, their purported attempt to reign-in government restrictions on individuals simultaneously reveals disregard for the ways in which harsh immigration enforcement strategies negatively impact the lives of immigrants.

Blaming immigrants promotes unrealistic, unhealthy negative stereotypes

Blaming immigrants promotes negative stereotypes that perpetuate discrimination, social mistreatment, and unjust health disparities. Since early in the pandemic, anti-Asian racism and xenophobia mixed in with COVID-19 politics has led to a worldwide phenomenon of hate crimes against anyone appearing to be of Asian descent, and vicious expressions of misguided blame directed at anyone from the same vague region as where the pandemic originated. Historically, and erroneously, people in the U.S. have associated immigrants with human disease and contagion. Immigration authorities have long scrutinized immigrant health when deciding who can enter or remain in the U.S. Additionally, there is a false perception that immigrant illnesses are predominantly acquired before entry to the U.S.; it is instead most often the case that immigrants tend to struggle with worsening health as they spend more time adopting U.S. cultural norms, including unhealthy eating habits.

Stereotypes about “unsanitary” immigrants represent cruel and unjustified blame shifting. For example, consider meat processing plants which have been hot spots for COVID-19 outbreaks. Staffed predominantly by an immigrant workforce, those workers face abusive and unsanitary working conditions (an open secret in the industry for over a century) that foster disease outbreak. Laying blame for this suffering on immigrant workers, or immigration generally, is a horrendous ethical mistake. Statements by public figures like Governors Abbott and DeSantis contribute to morally skewed views about immigrant health.

Unhealthy negative stereotypes hurt people and cost all Americans a lot of money

Another pragmatic consideration is how those immigrants who do fall ill interface with the U.S. health care system. Negative stereotypes about immigrants among health care providers lead to substandard and/or improper care. In fact, the anticipation of being mistreated coupled with fear among those with an undocumented immigration status serve to dissuade immigrants from seeking needed care. Such fears might even discourage some from getting the COVID-19 vaccine. In this way, blaming immigrants contributes to worsening the pandemic. (A related irony is that nearly 1 in 3 doctors are themselves immigrants.)

There is a public health concern to this sequence. Delaying or avoiding care harms immigrants as well as those around them. To avert transmission, contagious diseases need to be treated in a timely manner. Not doing so leads to an underestimation of actual disease distribution and burden. A correct estimation is necessary to determine the right amount of resources and timely measures necessary to contain them. It is a waste of public resources to have those in need use emergency rooms for care that, if identified and delivered in a timely manner, could have been averted before the situation worsened. Part of the motivation for the Affordable Care Act was to  increase access to regular necessary care, yet undocumented immigrants were excluded from benefitting from the Act, despite the fact that providing coverage would have improved public health and probably saved the public money as well. For example, consider strep throat, a condition that is easily treatable with inexpensive antibiotics. Left untreated, strep throat can get complicated and potentially cause serious long-term heart problems. Untreated strep throat might drive a person to seek care in an emergency department. Yet another example is an untreated dental cavity that might lead to a dental abscess or a deep skin infection of the mouth and neck, again possibly resulting in an emergency room visit. Once there, correct diagnosis would require fluid cultures and expensive MRI or CT imaging. The cost of delayed care is borne by all of us. Some combination of insurance companies, hospitals, or government pay those excess fees, passing along costs to everyone else.

Speaking out

It is unfortunately fashionable across the U.S. and Europe to blame immigrants for social problems. Economic and social problems are quickly blamed on immigrants. Conversely, the available evidence points to immigrants being economically and socially beneficial to their respective new country.

We, the authors, come to this issue as people who have committed their professional lives to making healthcare and health policy more humane—seeking to help our future physicians and our colleagues treat patients as complex human beings deserving of care, rather than revenue streams to be maximized. Similarly, we see immigration discussions falling prey to the same mistake so common in healthcare, wherein powerful decision-makers, such as politicians, lose sight of their shared humanity with the people whose lives depend on them. We need to demand better from our political leaders and importantly, we need to speak out when politicians dehumanize immigrants.

Larissa Fluegel photo
Sean A. Valles photo

Larissa Fluegel, MD, MHS, is an Assistant Professor with the Center for Bioethics and Social Justice and the College of Human Medicine at Michigan State University where she teaches social context of clinical decisions.

Sean A. Valles, PhD, is Associate Professor and Director of the Michigan State University Center for Bioethics and Social Justice. He is author of the 2018 book Philosophy of Population Health: Philosophy for a New Public Health Era (Routledge Press).

Join the discussion! Your comments and responses to this commentary are welcomed. The authors will respond to all comments made by Thursday, September 2, 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 “Don’t Scapegoat Immigrants for the COVID-19 Pandemic Surge” →

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” →

Dr. Kelly-Blake presents at Michigan nutrition and dietetics conference

Photo of Karen Kelly-Blake

Center Assistant Director and Associate Professor Karen Kelly-Blake, PhD, recently presented at the Michigan Academy of Nutrition and Dietetics 2021 Virtual Spring Conference. Dr. Kelly-Blake presented on “Dietitian and Client Base Mismatch: Are There Ethical Implications?”

In this information age, the ways patients gather information about their health and how they process this information to make decisions, within the constraints of their particular social context, is of utmost importance. Dr. Kelly-Blake explained the value and ethical aspects of shared decision-making to enhance nutrition adherence goals, help practitioners understand the constraints of the dietitian and client dyad mismatch, and address this mismatch with the goal of advancing professional practice.

Pandemic and Endemic COVID-19 Ethics: Lessons from the history of tuberculosis

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

By Karen M. Meagher, PhD

Recent U.S. headlines are starting to reflect a dawning public awareness that health experts have long suspected: COVID-19 might be with us for a long time. In January 2021, almost 90% of coronavirus expert respondents to a poll by Nature considered it “likely” or “very likely” that the virus will continue to circulate somewhere on the globe for years to come. As vaccine rollout continues, the crisis in India has yet again revealed the devastating consequences of pandemic mismanagement. Only two infectious diseases have been successfully eradicated globally: smallpox, and the lesser-known rinderpest. A world in which COVID-19 is endemic might be one that requires long-term public health planning and requires bioethics to recalibrate. The global health and social impact of the pandemic makes COVID-19 challenging to compare to other infectious diseases. However, ongoing multidisciplinary analysis of tuberculosis (TB) provides one demonstration of the possible contributions of bioethics looking forward.

Pandemics as social levelers

A bacterial as opposed to viral infection, TB outbreaks peaked in different places across the world throughout the 1700s and 1800s (Barnes, 2020). During such periods, TB affected people across social strata. Affluent instances of TB contributed to the emergence of social narratives romanticizing TB as a condition striking those with a more sensitive and artistic temperament (Bynum, 2012). Prior to the emergence of germ theory, TB was considered a hereditary condition, running in families with such temperamental proclivities. The notoriety of some TB patients bears resemblance to early celebrity cases of COVID-19 that circulated on social media, normalizing infection while illustrating both recovery and vulnerability. The social and cultural variability of such notoriety is also significant, with India’s highly publicized celebrity suicides during lockdown requiring more analysis to tease apart the mental health impact of COVID-19. Meanwhile, the death of well-known human rights advocates, such as actor Vira Sathidar, from COVID-19 has prompted reflection on the pandemic’s cost to India’s creativity in addition to the devastating loss of life.

Outdoor Play and Tuberculosis print from 1922
Image description: Print from 1922 shows a girl sitting by a window watching children playing outdoors. The title reads “Outdoor Play and Tuberculosis,” with the text: “Outdoor play is as necessary to health as food or sleep. At home, let the children play in the yard or on a well-guarded roof. At school, ample open air playgrounds must be provided. The city that fails to provide public playgrounds may be forced to provide tuberculosis sanatoria.” Image source: public domain/GetArchive.

Hopes for eradication

In the early 1900s, incidence of TB declined as living and nutrition conditions improved, and as populations acquired natural immunity. Some of these improvements were prompted by critiques of industrialization, which contributed to crowded and inhumane living and working conditions (Barnes, 2020).And yet, the same romantic narratives that normalized TB in the affluent also reflected and fostered social indifference to—and scapegoating of—the poor living with TB (Bynum, 2012). The development of effective antibiotic treatment and a childhood vaccine accelerated population health gains in the 1940s and 1970s respectively. The relative influence of economic, political, and biomedical casual factors in driving the decline of TB continues to generate debate across epidemiology and social sciences. Public health gains during this century shaped hopes for global TB eradication.

Rising inequality

However, the 1990s marked a time of increased recognition of resurgent TB across all nations. As with the recent COVID-19 surge in India, a social model of health is needed to account for resurgence of TB. 20th century rates were simultaneously influenced by global policy failure to address health needs of those in poverty, cultural and political events, and new pathogen variants. The rise of HIV and AIDS produced a distinct yet overlapping pandemic, as the immunocompromised are especially vulnerable to TB co-infection. Multidrug resistant tuberculosis (MDR-TB) had been developing alongside use of antibiotics. Medical anthropologist and physician Paul Farmer has been widely critical of global economic policy, which influenced bifurcated standards of care in affluent Western nations and the global south and to the rise of MDR-TB. The moral valence of communities worth investing in is also intertwined with histories of colonialism and ongoing racial and class dynamics that we have seen recapitulated during COVID-19 within the U.S. and globally.

Resistance and its social meaning

Antimicrobial resistance raises a distinct set of ethical issues, from obligations of antimicrobial stewardship to imperatives for drug and diagnostic tool development. The potential for development of COVID-19 vaccine resistance is an ongoing concern. Some fear that SARS-CoV-2 variants have mutations that render them uninhibited by (resistant to) neutralizing antibodies, thereby creating the possibility of “escaping” the immune system response seen in the already infected and/or vaccinated. The development of immune escape is a crucial factor in determining whether COVID-19 becomes endemic. The social implications of pathogen genomics are multifaceted:

  1. First, identification of new variants is now viewed by media organizations as newsworthy, influencing public perception of how outbreaks occur. The history of TB demonstrates that public interest could wane if media organizations in affluent nations lose interest in their novelty.
  2. Second, genomic surveillance illustrates one of the most promising areas of precision public health, requiring ethical guidance for establishing trust, transparency, and community welfare. However, the history of TB demonstrates the continuing global disparities in global health surveillance laboratory capacity.
  3. Third, Emily Martin’s ethnographic work on American understandings of immunity demonstrates the interplay between depictions of the body and pathogens, expert and lay experiences of disease, and social ideals (Martin, 1994). COVID-19 has undoubtedly altered human views of their relationship to microbes and will continue to do so in unanticipated ways.

Economics & TB

Currently, almost one quarter of the world’s population lives infected with tuberculosis. Many have a latent TB infection, which is not contagious. However, if untreated, latent TB can develop into active TB. The World Health Organization estimates that 10 million people fell ill and 1.4 million people died from TB in 2019. India leads the world in TB cases, an often-noted harbinger of its potential role in COVID-19 global health outcomes. The social determinants of health continue to need greater policy attention: 49% of people with TB continue to face catastrophic costs, defined as greater than 20% of annual household income. Drug resistance exacerbates these economic barriers: around 80% of people with MDR-TB face catastrophic costs. The economics of COVID-19 echo these relationships. As I write, members of the World Trade Organization are negotiating details of waiving COVID-19 vaccine intellectual property rights.

  • Black and white photo of a tuberculosis ward of the Hasköy Hospital for Women
    Image description: Black and white photo of a tuberculosis ward of the Hasköy Hospital for Women in the late 19th century. Image source: public domain/GetArchive.
  • A row of empty beds in a hospital ward in Assam, India in response to the 2020 COVID-19 pandemic
    Image description: A row of empty beds in a hospital ward in Assam, India in response to the 2020 COVID-19 pandemic. Image source: AnjanBorah/Wikimedia Commons.

Endemics and social justice

The newly renamed MSU Center for Bioethics and Social Justice is an apt reflection of the shifting role of bioethics, including its attention to matters of population health. Emeritus faculty member Judith Andre notably argued bioethics is best understood as a multidisciplinary practice (Andre 2002). Bioethics practices must change in response to persistent and rising health inequities, including in infectious disease. TB outbreaks have affected community health for millennia, impacting residents of ancient Egypt and Greece. It is Ancient Greek, too, that provides the etymological differentiation between pandemic and endemic infections: pan, meaning “all,” en meaning “in,” and demos meaning “people.” We can sustain hope that COVID-19 will fade into the background, becoming another one of many common childhood coronavirus illnesses that does not confer serious symptoms. However, as this brief glimpse of the ethics and history of TB illustrates, COVID-19 merits distinct ethical analysis to avoid complacency.

Join the conversation

Global eradication of COVID-19 through universal vaccination requires a collective effort on a scale rarely achieved in human history. How do you think bioethics can generate new collaborations to sustain the global response to COVID-19? What values are relevant to you if COVID-19 becomes in the people as well as affecting all of us in this global emergency?

Photo of Karen M. Meagher

Karen M. Meagher, PhD, is an Assistant Professor of Biomedical Ethics Research at Mayo Clinic. Her main research interest is in ethics and social implications of human and pathogen genomics. She also holds the position of associate director of public engagement in which she leads a community engagement network for the Mayo Clinic Biobank in the Center for Individualized Medicine.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, May 27, 2021. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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Continue reading “Pandemic and Endemic COVID-19 Ethics: Lessons from the history of tuberculosis” →

Center for Bioethics and Social Justice: new name, mission, and leadership

Green Spartan helmet with text: Center for Bioethics and Social Justice, College of Human Medicine, Michigan State University

The MSU Center for Ethics and Humanities in the Life Sciences is proud to announce its new name: Center for Bioethics and Social Justice. This name change as of April 1 reflects an updated mission with a focus on social justice-oriented bioethics. The Center has a vision of a health system that is compassionate, respectful, and responsive to people’s needs, so that equity, inclusion, and social justice are available to all.

Photo of Sean Valles
Director Sean A. Valles, PhD

“Without an orientation, bioethics has no built-in real-world goals; it is merely a field of study. Doing social justice-oriented bioethics means we have a goal—advancing social justice in the real world with meaningful applications—as the north star for our journey as an institution,” said Center Director Sean A. Valles, PhD.

The updated name and mission follow the appointment of Valles as director earlier this year, along with the promotion of Karen Kelly-Blake, PhD, to assistant director.

“One key piece of the new name and mission is a rethinking and a recommitting of our identity,” said Valles. “The Center aims to be a hub for collaborations and conversations around the relationship between social justice and health. To do that, we will actively seek to engage with our college and university colleagues, local communities, and organizations in order to learn their concerns about the ways our society makes it hard to live a healthy life, and to begin trying to help.”

Photo of Karen Kelly-Blake
Assistant Director Karen Kelly-Blake, PhD

The Center’s mission is to educate health professionals with skills, knowledge, and attitudes necessary to contribute to a world in which health practices are equitable, inclusive, and bolstered by conditions of social justice; to research the nature of bioethics and enhance its applications to the pursuit of equitable, inclusive, and just healthy societies; and to engage researchers, clinicians, policymakers, and communities around shared interests in the attainment of a healthier and more just world.

“Building bridges among MSU experts and outward to communities is of value to everyone involved,” added Valles.

The Center began in 1977 with the formation of the Medical Humanities Program. In 1988, the program became the Center for Ethics and Humanities in the Life Sciences. Faculty in the Center are committed to teaching medical students in the College of Human Medicine and developing social context of clinical decisions content for the Shared Discovery Curriculum. Center faculty are also committed to research, scholarship, and public outreach and education—all working toward the goal of creating a more just world.

Visit the Center’s website to learn more about its faculty and outreach activities, such as public seminars, podcast episodes, and monthly blog posts that explore timely bioethics topics.

Related: Announcing Center Director Sean A. Valles and Assistant Director Karen Kelly-Blake

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.