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

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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.

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New essay from Libby Bogdan-Lovis in ‘Narrative Inquiry in Bioethics’

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Center for Ethics Assistant Director Libby Bogdan-Lovis has an essay in the latest issue of Narrative Inquiry in Bioethics. In her essay, “The Trip to the Dentist,” Bogdan-Lovis writes about her mother, and of a specific experience that would greatly influence subsequent end-of-life decision-making.

The essay appears in the Summer 2020 issue of the journal, which is published by Johns Hopkins University Press. The issue is centered on “Living with Alzheimer Disease and Other Types of Dementia: Stories from Caregivers.”

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

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Dr. Fleck presents on precision medicine at international virtual symposium

Leonard Fleck photo

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

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

Solidarity is a fundamental social value in many European countries, though its precise practical and theoretical meaning is disputed. In a health care context, solidarity means roughly equal access to effective health care for all. However, I argued that precision medicine represents a threat to solidarity. Precision medicine includes ninety targeted cancer therapies (mostly for metastatic cancer). The “targets” of these therapies are certain genetic features of a cancer, mutations responsible for “driving” that cancer’s expansion. These targeted therapies have prices of €100,000 (roughly 117,500 USD) to €150,000 (roughly 176,300 USD) annually or for a course of treatment. Our critical question: Must a commitment to solidarity mean that all these targeted cancer therapies are included in a benefit package guaranteed to all in the European Union, no matter the cost, no matter the degree of effectiveness? Such a commitment would imply that cancer was ethically special, rightfully commandeering unlimited resources. That in itself undermines solidarity. I offered multiple examples of how current and future dissemination of these drugs challenges a commitment to solidarity. An alternative is to fund more cancer prevention efforts. However, that too proves a threat to solidarity. Solidarity is too abstract a notion to address these challenges. We need instead the notion of “just solidarity.” We need to accept that we can only hope to achieve “rough justice” and “supple solidarity.” The precise practical meaning of these notions needs to be worked out through fair and inclusive processes of rational democratic deliberation, which is the real foundation of solidarity.

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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

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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.

Can’t make it? All webinars are recorded! Visit our archive of recorded lecturesTo receive reminders before each webinar, please subscribe to our mailing list.

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

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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.

Related Resources

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.
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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.

Parker Crutchfield photo

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.

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. 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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How might lack of access impact maternity care options for rural women in Michigan?

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The Center for Ethics and Humanities in the Life Sciences is excited to announce the first event of the 2020-2021 Bioethics Public Seminar Series (formerly the Bioethics Brownbag & Webinar Series). 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.

Maternity Care Deserts in Rural Michigan

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Andrea Wendling, MD

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U.S. physician shortages affect rural healthcare access, including access to maternity care. OB deserts, which are geographical high-risk areas for care delivery, exist in the Upper Peninsula and northeast Lower Peninsula of Michigan. How might lack of access impact maternity care options for rural women in our state? Dr. Wendling will present recent work that identified and characterized access points for prenatal and delivery care in Michigan’s rural counties and explored access to Trial of Labor After Cesarean (TOLAC) services for rural Michigan women. We will discuss how lack of access may impact maternity care choices for rural women and will strategize ways to address this issue.

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Join us for Dr. Wendling’s online lecture on Wednesday, September 23, 2020 from noon until 1 pm ET.

Andrea Wendling, MD, is a Professor of Family Medicine and Director of the Rural Medicine Curriculum for Michigan State University’s College of Human Medicine. She has received the Rural Professional of the Year Award from the Michigan Center for Rural Health and was named the Outstanding Educator of the Year by the National Rural Health Association in 2020. Dr. Wendling is Assistant Editor for the Family Medicine journal and a founding Associate Editor of Peer-Reviewed Reports in Medical Education and Research (PRIMER). She participates on rural workforce research groups for the National Rural Health Association (NRHA) and Association of American Medical Colleges (AAMC) and has presented and published in the areas of medical education and the rural health workforce. Dr. Wendling is a family physician in rural Northern Michigan.

Can’t make it? All webinars are recorded! Visit our archive of recorded lecturesTo receive reminders before each webinar, please subscribe to our mailing list.

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“There’s no proof that anything works!” The ethics of COVID-19 research

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By Robyn Bluhm, PhD

The New York Times Magazine recently published a long-form story about the tension between treating patients with COVID-19 by any means that might improve their chances of survival and recovery, and enrolling them in clinical trials to establish the safety and efficacy of these treatments, thus improving care both for future patients and for those who survived the trial. As with many stories about health care in the current pandemic, this article both raises perennial issues in bioethics and shows them in their starkest form: the seriousness of the condition of these patients and the lack of knowledge about how best to help them mean that the ethical dilemma described in the story is particularly clear. But a closer look at work in bioethics and the epistemology of clinical research suggests that, while the dilemma is clear, there are more ways forward than the two incompatible ways portrayed in the story.

The story begins by describing the clash between a critical-care physician faced with a COVID-19 patient whose condition was worsening, and a researcher who had enrolled that patient in a clinical trial. The former wanted to give the patient a higher-than-standard dose of the anticoagulant she was being treated with, even though this might mean that she would need to be withdrawn from the trial. The latter advocated for the importance of maintaining the integrity of the study, saying that acting on instinct instead of on evidence “was essentially ‘witchcraft’.”

Unsurprisingly, this characterization did not go over well with the other doctors in the meeting. A less contentious way of describing the situation might have been to say that, while doctors use their clinical judgment to make decisions about how best to use available evidence in caring for a particular patient, this only works when there is evidence available. And everyone agrees that, in the case of COVID-19, there is horrifyingly little evidence. This means that enrolling COVID-19 patients in clinical trials is not depriving them of standard care (care that such patients would ordinarily receive if not in the trial)–standard care for this condition does not yet exist.

Nurse with medical equipment illustrated image

Image description: An illustration of a health care worker wearing blue scrubs, head covering, and face covering. Surrounding them are a stethoscope, face mask, syringe and surgical tools, thermometer, and microscope. The background is light pink. Image source: sunshine-91/Vecteezy.

There is a lot to think about here. Importantly, it’s not the case that the doctors treating seriously ill patients had no idea what to do. They had a wealth of experience treating patients with severe viral infections, with acute respiratory distress syndrome, with cardiac arrest, or with pathological immune reactions (the “cytokine storm” sometimes seen in chemotherapy patients). Some of this knowledge informed the care of early COVID-19 patients, raising the question of which treatments could be successfully generalized to this new patient group.

The notion of generalizable knowledge is in fact central to research ethics. The Belmont Report, which guides research ethics oversight in the United States, draws a bright line between research and clinical practice on the basis of their ostensibly distinct goals. Research aims to provide generalizable knowledge, while clinical practice aims to benefit an individual patient. This way of drawing the distinction meant that when physicians depart from standardly-accepted care in the treatment of an individual patient, it does not count as research (and therefore does not require ethics review). It also leads to the problem described above: enrolling a patient in a research study requires that they forgo their right to individualized care and are treated according to study protocol. Deviations from the protocol, such as the one described in the opening of the New York Times story, are prohibited. Patients whose care does not follow the protocol will usually be withdrawn from the study.

But this sharp distinction between research and practice also makes assumptions about the kind of clinical research being conducted. Schwartz and Lellouch (1967) distinguish between “explanatory” and “pragmatic” approaches to clinical trials. Explanatory trials are designed to minimize the influence of any factors, other than the experimental therapy, that could affect the outcome being measured. These other factors include additional medications and the presence of comorbid disease. Pragmatic trials, by context, are designed to resemble actual clinical practice, where patients often take more than one medication and often have more than one health problem. Pragmatic trials may also enroll a wider variety of participants (especially older participants), permit alterations in the study protocol, be more flexible in the timing of outcome measurement; in general, they are more flexible in their design and analysis. A given trial will fall somewhere on the spectrum between “highly explanatory” and “highly pragmatic” in its design.

In the case of COVID-19, there are good reasons to favor trials that are more pragmatic. First, there are so many factors that might affect prognosis (or were previously thought to do so) – age, gender, weight, blood type, various pre-existing conditions – that the study population cannot be narrowly defined. If it is, then the results of the study will apply only to people in that narrow population. Second, care for critically ill patients is rapidly developing. Even in the absence of an established drug regimen, survival rates have been improving. This means that by the time a trial is completed, the experimental therapy will be implemented in a very different context of care. Perhaps more importantly, because of these first two reasons, a strict, explanatory trial is less likely to give generalizable knowledge than a more pragmatic one (Bluhm and Borgerson, 2018). Research that reflects clinical practice is more likely to be useful in improving clinical practice.

Robyn Bluhm photoRobyn Bluhm, PhD, is an Associate Professor with a joint appointment in the Department of Philosophy and Lyman Briggs College at Michigan State University. She is a co-editor of The Bloomsbury Companion to Philosophy of Psychiatry.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, September 3, 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. Bluhm: Philosophy, Mental Illness, and Mass Shootings; “Ask your doctor” – or just check Instagram?Antibiotics: No Clear CourseTo Floss or Not to Floss? That’s not the question

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Dr. Cabrera co-authors commentary in ‘AJOB Neuroscience’ neuroethics issue

Laura Cabrera photoCenter Assistant Professor Dr. Laura Cabrera and Dr. Robyn Bluhm, Associate Professor in the Department of Philosophy and Lyman Briggs College, are co-authors of a commentary published in the latest issue of AJOB Neuroscience.

In “Fostering Neuroethics Integration: Disciplines, Methods, and Frameworks,” Drs. Cabrera and Bluhm comment on two papers that are part of the journal’s special issue on the BRAIN 2.0 Neuroethics roadmap.

Drs. Cabrera and Bluhm are co-investigators on an ongoing NIH BRAIN Initiative project,
“Is the Treatment Perceived to be Worse than the Disease?: Ethical Concerns and Attitudes towards Psychiatric Electroceutical Interventions.”

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

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