Antiseptic Rhetoric: Crisis Standards of Care

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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.

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Continue reading “Antiseptic Rhetoric: Crisis Standards of Care”

Abortion Restrictions and Compulsory Organ Donation

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

By Parker Crutchfield, PhD, and Emily Carroll

The Texas legislature recently passed a law prohibiting abortion of a fetus older than six weeks. The law allows abortions after six weeks in life-threatening emergencies, but not when the pregnancy results from rape or incest. The law is extraordinarily restrictive and additionally deputizes citizens to enforce the law, providing a $10,000 bounty for successful civil suits of people involved in the “aiding and abetting” of abortion. The Supreme Court of the United States recently neglected to halt the law, which meant it went into effect.

We can’t be sure of the exact thoughts of those who enact or support the bill. However, there are some claims that such people often hold. In an article set to appear in Cambridge Quarterly of Healthcare Ethics, we argue that these claims imply that if one supports restrictions on abortion, one must also support compulsory organ donation. In other words, if you support restrictions on abortion, to remain intellectually consistent you must also support a corresponding degree of compulsory organ donation.

The Duty to Protect

Our argument starts with a claim common to those who oppose a woman’s right to choose to have an abortion. This claim is that a mother has a duty to protect her fetus.

The duty to protect is supposed to be a special obligation that holds between mother and fetus. Special obligations are those that hold between people in virtue of some relation between them. We have many obligations to other people; most apply regardless of how we are related to them. But special obligations arise only in the context of certain relationships, such as those that hold between parent and child. Most people agree that a mother or father’s obligations to their child are different from those that they have to strangers. Here’s one example: a parent has a duty to protect their child, but no such duty to protect a stranger who lives in a distant locale. There are other ways to explain the duty to protect, but the one we prefer is that special obligations kick in when one person’s life is vulnerable to another person’s actions (Goodin, 1986). The more one person’s well-being is vulnerable to another person’s actions, the more the second person must protect the first. Thus, on this view the mother has such a strong duty to protect the fetus that she must allow it to use her body, willing or not.

From Prohibited Abortion to Compulsory Organ Donation

But there are other implications of this line of argument. What’s true of the mother-fetus relationship is also true of the parent-child relationship. If a fetus has full moral status, then so does a child. And children are highly vulnerable to their parents. Their well-being is significantly affected by their parents’ actions. This is true not only of their social and emotional well-being, but also of their physical well-being. This is especially true of children who need organ or tissue donation.

Children who need blood products or a kidney, liver, heart, lung, or any other organ are highly vulnerable to their parents’ actions. At a minimum, the child is vulnerable to the parent’s cooperation with the healthcare team’s treatment plan. But the child who needs an organ or tissue donation is also vulnerable to the parent’s biology. In particular, a parent may be the most biologically compatible potential donor. For parents who are a compatible donor for their child, the child’s well-being is extremely vulnerable to their parent’s actions. In a society where organs and tissues are a scarce resource, the child’s vulnerability to a biologically compatible parent is a matter of life and death.

Children who need organ or tissue donation to survive are about as vulnerable to their biologically compatible parents as a fetus is to its mother. If a mother must donate her body to her fetus unless doing so emergently threatens her life, then a parent must donate organs and tissues unless doing so emergently threatens their life. This obligation would hold for both mothers and fathers. If a child needs a kidney and their father is a match, he must donate his kidney to his child, even if he doesn’t want to. Donating a kidney is not emergently life-threatening, nor is donating a variety of other organs and tissues. If mothers shouldn’t have a choice to terminate a fetus, parents should not have a choice about whether to donate organs and tissues.

A Policy Proposal

To be clear: we are not arguing that abortion is wrong or that it should be allowed. Nor are we arguing that tissue and organ donation should be compulsory. Rather, we are drawing out the implications of the anti-choice position. There are ways out of this implication, but they are unfriendly to the anti-choice position. For example, they may wish to accept that mothers have a duty to protect the fetus, but deny that they do so in virtue of the vulnerability of the fetus to the mother. Such a strategy is not likely to help their position, as other available accounts of special obligations are even less supportive (such as the view that special obligations only arise when someone voluntarily takes them on (Brake, 2010), which clearly isn’t the case when someone seeks an abortion).

For people who support the Texas law, intellectual consistency demands they also support compulsory organ donation. Thus, supporters should also consider legislation compelling parents to donate organs and tissues to their children, even if they don’t want to, and even if doing so presents a significant risk to the parent. Indeed, they should also want to deputize citizens to enforce the law, such that there is a $10,000 bounty on biologically compatible parents who fail to donate.

But if such a policy is unacceptable, so is the Texas law.

Photo of Parker Crutchfield

Parker Crutchfield, PhD, is Associate Professor in the Department of Medical Ethics, Humanities, and Law at Western Michigan University Homer Stryker M.D. School of Medicine. His research interests include biomedical and public health ethics, moral psychology, and epistemology. His book, Moral Enhancement and the Public Good, was released by Routledge in 2021.

Emily Carroll is a third-year medical student at Western Michigan University Homer Stryker M.D. School of Medicine. She completed her undergraduate studies in psychology and biology at McGill University. Her research interests in medical school include bioethics and public health.

Join the discussion! Your comments and responses to this commentary are welcomed. The authors will respond to all comments made by Thursday, October 7, 2021. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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Continue reading “Abortion Restrictions and Compulsory Organ Donation”

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.

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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.

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

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

Bioethics for Breakfast Seminars in Medicine, Law and Society

Mark G. Kuczewski, PhD, of the Loyola University Chicago Stritch School of Medicine presented at the April 22 Bioethics for Breakfast session, offering perspectives and insight on the topic “Caring with and for undocumented physicians and patients.” Bioethics for Breakfast is generously sponsored by Hall, Render, Killian, Heath & Lyman.

The session addressed the contributions of undocumented immigrants to our communities in the United States, including those of DACA (Deferred Action for Childhood Arrivals) physicians, to our healthcare system; the limits that exclusionary practices place on the contributions of undocumented immigrants to our healthcare system; and approaches to facilitating better care of undocumented immigrants in the healthcare system.

Dr. Kuczewski shared facts about undocumented immigrants in the U.S.: they number approximately 10-12 million, approximately two-thirds have lived in the U.S. for more than 10 years, they cannot buy a full-priced policy on an ACA exchange, they commit crimes at lower rates than U.S. citizens, an increasing percentage are of Asian origin, and there are fewer in the U.S. now than in 2010. He pointed out that excluding these individuals from obtaining health insurance through the Affordable Care Act ends up harming the overall pool of people in the insurance marketplace.

Dr. Kuczewski also explained how U.S. immigration policies have changed since the Clinton administration and now those policies have created barriers to entering the U.S. lawfully and with authorization, with regard to application rules and the quota system.

“This is a people issue,” said Dr. Kuczewski, adding that the stable population of 10-12 million undocumented immigrants in the U.S. have healthcare needs, and need to be able to seek care. Using the example of someone in need of kidney dialysis, he pointed out that the usual route of getting Medicare coverage is not an option because federal benefits are not available to undocumented immigrants. Dr. Kuczewski highlighted the importance of hospitals and clinics caring for undocumented patients and advocating for them, in order to foster trust over fear, and in turn help to avoid negative impacts on public health.

Finally, Dr. Kuczewski discussed the challenges for DACA recipients who matriculate through medical school while being ineligible for federal student loans. The discussion portion of the session explored the importance of educating people, including politicians, on revisions to the ACA, and avenues for advocacy work for schools and universities, students, medical professionals, and instructors. Related resources are linked below.

Related Resources

About the Speaker

Mark G. Kuczewski, PhD
Mark G. Kuczewski, PhD, is the Fr. Michael I. English, S.J., Professor of Medical Ethics and the director of the Neiswanger Institute for Bioethics at the Loyola University Chicago Stritch School of Medicine. Mark is a past president of the American Society for Bioethics and Humanities (ASBH) and a Fellow of the Hastings Center. He has been engaged in bedside clinical ethics issues for more than 25 years. For the last decade, he has been an articulate spokesperson for the just and equitable treatment of immigrant patients. He created the Sanctuary Doctor website with Drs. Johana Mejias-Beck and Amy Blair to assist clinicians in supporting immigrant patients. He led the effort to make the Stritch School of Medicine the first medical school in the nation to openly welcome applicants who are DACA recipients.

About Bioethics for Breakfast:
In 2010, Hall, Render, Killian, Heath & Lyman invited the Center for Bioethics and Social Justice to partner on a bioethics seminar series. The Center and Hall Render invite guests from the health professions, religious and community organizations, political circles, and the academy to engage in lively discussions of topics spanning the worlds of bioethics, health law, business, and policy. For each event, the Center selects from a wide range of controversial issues and provides two presenters either from our own faculty or invited guests, who offer distinctive, and sometimes clashing, perspectives. Those brief presentations are followed by a moderated open discussion.

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

Bioethics for Breakfast Seminars in Medicine, Law and Society

Malkia Newman, Anti-Stigma Team Supervisor at CNS Healthcare, and Dr. Debra A. Pinals of MDHHS and the University of Michigan presented at the Feb. 25 Bioethics for Breakfast session, offering perspectives and insight on the topic “Mental Health Care Access: Making the Dollars and “Common Sense” Case for Parity.” Bioethics for Breakfast is generously sponsored by Hall, Render, Killian, Heath & Lyman.

People with mental health disabilities face disproportionately high rates of poverty, housing and employment discrimination, and criminalization. The upheaval caused by the coronavirus outbreak has exacerbated these disparities for those disabled prior to the crisis, while exposing more people to trauma, loss, and uncertainty. Considering mental health care from a justice and equity perspective, this session examined the following: 1) What social and ethical challenges are embedded in the current mental health epidemic? 2) How might such challenges be effectively addressed? 3) What community-based models can improve access? 4) What are the cost benefits of equitable treatment vs. cost of untreated mental healthcare in the U.S.?

Malkia Newman addressed the first question above on the social and ethical challenges embedded in the current mental health epidemic. Through sharing her personal life story, Ms. Newman focused on trauma, stigma, and disparities in behavioral healthcare. Ms. Newman defined types of trauma, focusing on inter-generational trauma. She noted that racism and social inequities are now regarded by many as a health crisis, especially in light of the COVID-19 pandemic. Stigma that individuals face can include many layers, and that stigma can exacerbate mental health and substance use disorders. With regard to mental health disparities, she shared that access to mental health care is only one piece—quality treatment, addressing the shortage of qualified providers, and the need for equitable funding of treatment for all individuals is also crucial. Many in the U.S. are facing financial insecurity, which can also exacerbate mental illness and be a barrier to accessing treatment. Bringing forth the idea of resilience, Ms. Newman ended by sharing her hope for the future, that “resilience can spring forth, and resilience can be taught.”

Dr. Debra A. Pinals provided a physician and policymaker perspective, first addressing the question: why is mental health relegated to second tier status in healthcare financing? There is a long history of viewing mental illness, including substance use disorders, as not being “real” illness—blame, stigma, and stereotypes still play a part in this attitude. Stigma “allows the discrimination of someone based on a label.” However, it is very important to understand that these are illnesses that have causes and treatments. COVID-19 may be putting more focus on mental health, and that may be one positive thing to come from the pandemic. What community-based models can improve access? Dr. Pinals discussed the problems with the current crisis system and the involvement of law enforcement when responding to a crisis, and then put forth a new model that would involve a behavioral health response, specially-trained law enforcement as a backup, and many other pieces related to community services and supports. Referencing her paper on crisis services, Dr. Pinals shared that improving access has to be accessible, interconnected, effective, and just. Dr. Pinals also discussed building out Certified Community Behavioral Health Clinics (CCBHCs) in Michigan, and the siloed nature of current services. Dr. Pinals emphasized the need to understand the existing disparities in mental health services, also discussing the prison system, the opioid epidemic, and child welfare impacts.

During the discussion portion, both speakers discussed the need to make space for people’s stories, particularly within the context of policy work. Ms. Newman shared the importance of including both behavioral health professionals and individuals with mental illness during the planning process for policies and programs, such that their input is actively included. Further discussion touched on teletherapy access and programs for youth and families.

Related Resources

About the Speakers

Malkia Newman
Malkia Newman is Anti-Stigma Team Supervisor at CNS Healthcare. Behavioral health conditions are common in Malkia’s family. Suicidal, unemployed, and homeless, Malkia accessed care at CNS Healthcare in 2004. Once stabilized, she was able to pursue a job with the CNS Healthcare Anti-Stigma Program in 2005. The Peer-Led program challenges stigma and provides community education on a number of different behavioral health topics. Using poetry, singing and other creative expressions, Malkia shows that “hope and recovery is possible.” The program has reached over 100,000 people in Detroit, Lansing, Marquette, MI; Washington, D.C., New York City, Houston, San Antonio, Las Vegas, Chicago, Phoenix, Honolulu, Hawaii, and Nova Scotia, Canada.

Debra A. Pinals, MD
Debra A. Pinals, MD, is the Medical Director of Behavioral Health and Forensic Programs for the Michigan Department of Health and Human Services, Director of the Program in Psychiatry, Law, & Ethics, Clinical Professor of Psychiatry at the University of Michigan Medical School, and Clinical Adjunct Professor at the University of Michigan Law School. Dr. Pinals’ roles have included serving as the Assistant Commissioner of Forensic Services as well as the Interim State Medical Director for the Massachusetts Department of Mental Health. She has worked in outpatient and inpatient settings, forensic and correctional facilities, emergency rooms and court clinics, has received public service awards, and has been an expert witness in many cases. She is Board Certified in Psychiatry, Forensic Psychiatry, and Addiction Medicine.

About Bioethics for Breakfast:
In 2010, Hall, Render, Killian, Heath & Lyman invited the Center for Ethics to partner on a bioethics seminar series. The Center for Ethics and Hall Render invite guests from the health professions, religious and community organizations, political circles, and the academy to engage in lively discussions of topics spanning the worlds of bioethics, health law, business, and policy. For each event, the Center selects from a wide range of controversial issues and provides two presenters either from our own faculty or invited guests, who offer distinctive, and sometimes clashing, perspectives. Those brief presentations are followed by a moderated open discussion.

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

Bioethics for Breakfast Seminars in Medicine, Law and Society

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

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

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

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

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

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

Related Resources

About the Speakers

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

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

About Bioethics for Breakfast:
In 2010, Hall, Render, Killian, Heath & Lyman invited the Center for Ethics to partner on a bioethics seminar series. The Center for Ethics and Hall Render invite guests from the health professions, religious and community organizations, political circles, and the academy to engage in lively discussions of topics spanning the worlds of bioethics, health law, business, and policy. For each event, the Center selects from a wide range of controversial issues and provides two presenters either from our own faculty or invited guests, who offer distinctive, and sometimes clashing, perspectives. Those brief presentations are followed by a moderated open discussion.

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

Leonard Fleck photo

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

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

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

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

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

By Sean A. Valles, PhD

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

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

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

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

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

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

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

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

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

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, November 5, 2020. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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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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