Tag: resource allocation

Leonard Fleck presents on cancer care at annual American Society for Bioethics and Humanities conference

Leonard Fleck photo

Last month at the 23rd Annual Conference of the American Society for Bioethics and Humanities (ASBH), Center Professor Leonard Fleck, PhD, presented on “Precision Health, Ethical Ambiguity: How Much Cancer Can We Afford to Prevent?” as part of a session on health care allocation and cost. Dr. Fleck has provided a summary of his presentation below.

“Precision medicine” and “precision health” seem to complement one another. We want an effective targeted cancer therapy for our metastatic cancer, but would rationally prefer to prevent the emergence of a life-threatening cancer–the goal of precision health. In a recent book, The First Cell: And the Human Costs of Pursuing Cancer to the Last, Azra Raza, an oncologist, argues that we are wasting tens of billions of dollars annually on extraordinarily expensive cancer therapies that yield only marginal gains in life expectancy. Raza believes these resources (not resources from heart disease or anything else) should be redirected to destroying cancer in its earliest stages, those “first cells.”

A new liquid biopsy (GRAIL) can detect 50 different cancers in very early stages by examining cell-free DNA at a cost of $800. However, 200 million anxious U.S. adults would be candidates for this test annually at an aggregate cost of $160 billion. From the perspective of health care justice, who should pay for these tests? Who should be denied access to these tests at social expense? Should only individuals with a strong family history of cancer have a moral right to this test at social expense? That would cover only 10% of cancers diagnosed in any given year.

We might say individuals known to be at elevated risk for cancer should have these tests paid for as a social expense. That would include smokers and sun worshippers at risk for lung cancer and melanoma. Would non-smokers and responsible sunscreen appliers have just cause for a grievance, i.e., paying for the irresponsible?

Would justice or efficiency require foregoing $160 billion in metastatic cancer care to pay for this preventive effort? What would a “just enough” balancing of therapeutic objectives look like? The basic economic and ethical problem is that we would be paying $160 billion annually that we knew would yield negative results more than 99% of the time. This is not obviously either a wise or just use of social resources. Moreover, this situation calls attention to the “statistical lives vs. identifiable lives” problem.

The “statistical lives” are the lives we would hope to save from metastatic cancer with the liquid biopsy test. These are nameless and faceless lives, unlike the identifiable lives that are the patients with metastatic cancer who want access to the hyper-expensive targeted therapies that might extend their lives a few months, maybe an extra year or so. In contrast, the hope is that each statistical life saved would result in extra decades of life for that individual.

A key ethical question is whether statistical lives and identifiable lives in this situation are of equal moral weight. Or are the identifiable lives with metastatic cancer more “morally worthy” of social resources because they are suffering and near dying? Or, as Raza contends, are we ethically obligated to shift resources from metastatic cancer patients (who have been effectively treated up to this point) to preventive efforts associated with liquid biopsies hoping to save more lives and life years? How do you, my currently healthy readers, think we ought to decide?

Related reading: If Whole Genome Sequencing is So Cheap and Quick, Why Shouldn’t Everyone Have It Done?

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.

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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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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 Restrictions; We Should Tolerate and Regulate Clinical Use of Human Germline Editing

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Lungs for Sarah Murnaghan Raise Ethical Questions

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series. For more information, click here.

By Tom Tomlinson, Ph.D.

Sarah’s Murnaghan’s sad predicament. has been much in the news the last several weeks. Sarah is a 10-year-old girl with advanced cystic fibrosis (CF) who was critically ill in an intensive care unit in Philadelphia. Seeing a double lung transplant as her only hope for survival, her desperate parents made a highly public appeal to Health and Human Services Secretary Kathleen Sebelius and members of Congress to suspend the policies of the Organ Procurement and Transplant Network (OPTN), which don’t permit children younger than 12 to be put on the waiting list for lungs from adult donors.

Expressing sympathy for Sarah and her parents, Secretary Sebelius nevertheless refused to change the rules, leading Eric Golub at The Washington Times to call her a “death panel bureaucrat.” Sarah’s parents then went to a Federal District Court judge, who issued an injunction ordering the OPTN to put Sarah on the adult list, and later another child with CF. In response, OPTN developed an interim policy on June 10, which is set to expire on July 1.

Sarah quickly received a double-lung transplant from an adult donor on June 12. As of this writing, she remains on a ventilator in the intensive care unit at Children’s Hospital in Philadelphia.

Most discussion of this case has focused on the plight of Sarah and her parents, who have been especially adept at using social networks to capture media attention on behalf of their daughter. Related worries have been expressed about having the organ distribution system driven by sympathy for individual patients who manage to capture the public’s heart.

But there is a larger problem in which Sarah’s story is embedded: how to design a fair and effective system for distributing a scarce resource that falls far short of the need. In 2011, 351 patients needing lung transplant died on the waiting list. Until we have the capacity to grow a new set of lungs from our stem cells, not everyone who needs a lung transplant to survive will receive one. In the meantime, how should we decide who goes to the front of the line?

Well, speaking of lines, how about “first come, first served”? We use this method all the time to guard against favoritism. If I want to secure tickets to a very popular play, I get in line, whether at the box office, or on the Web. Whether I get tickets or not will depend on nothing else about me—not how rich or famous or educated or influential I happen to be. Of course we know that in real life I have a better chance of getting tickets if I know the producer. But that observation just emphasizes how much we think real life falls short of the ethical ideal that “first come, first served” exemplifies.

Why not do this with lung transplants? Transplant centers put candidates on the OPTN waiting list, and when a lung becomes available, the person who’s been on the list longest gets first dibs. In fact, this is the system that was used for distributing lungs to both adults and children up to 2005. The reasons for changing it are instructive.

First, time on the waiting list may have little to do with how badly someone needs a transplant, and it turns out this is especially true for patients needing a lung transplant. Mr. Smith at #1 may be healthy enough to wait quite a little longer, while Mr. Jones at #10 will surely die within weeks without the transplant. So is it “fair” to Mr. Jones if we give the transplant to Mr. Smith? We will have considered each of them equally with respect to time on the waiting list. But we’ve not treated them equally with respect to the urgency of their need, because if we did, the transplant would go to Mr. Jones.

OK, then, urgency of need is a very compelling consideration when without the transplant the patient stands at the brink of death. So let’s make that our rule. Transplants will go to the sickest first. Mr. Jones is still on the ventilator in the ICU, and is not expected to survive to leave the hospital without a lung transplant. Mr. Smith is at home with increasing difficulty breathing due to his lung disease, and is clearly on a downhill trajectory. But he is managing to survive out of the hospital. Urgency of need dictates that Mr. Jones should get the next available lung. But because he’s already so sick, Mr. Jones is much less likely than Mr. Smith to survive the transplant procedure and leave the hospital, and if he is discharged, he is also likely to die sooner despite the transplant. So we will have treated our two candidates equally with respect to the urgency of their need, but not with respect to extending their life. We count the shorter time that Mr. Jones is given for more than the time Mr. Smith could have had.

And here’s another complication. Setting concerns for fairness to one side, we should also guard against making people worse off. That’s what happens when those who “need” a transplant are transplanted too early. The transplant procedure itself is a risky business, and life with the transplanted organ can be a precarious affair, with survival complicated by the serious and sometimes lethal side effects of immunosuppressive drugs. More than half of lung transplant patients are dead 5 years later. Many patients with slowly progressing disease will live longer if they wait longer.

Rather than picking just one of these conflicting criteria, and thereby sacrificing the other ethically important factors, a group of lung disease and transplant experts developed the Lung Allocation Score (LAS), which OPTN adopted in 2006. Supported by evidence from OPTN and other sources, they identified a number of clinical measures that predict the length of two kinds of survival: survival without transplant; and survival post-transplant. The LAS is basically the difference between these: (survival post-transplant) – (survival without transplant x 2). The higher the LAS score, the higher the priority to receive a donated lung. This calculation incorporates two ethical criteria at once. First, it gives a higher priority to those with a predicted higher net benefit. And second, because survival without transplant is subtracted twice, it also gives weight to urgency of need.

This system, which is continually being refined as more evidence is accumulated, applies to all recipients 12 years old and above. Because there aren’t very many patients younger than 12, there wasn’t a solid base of evidence on which to extend the LAS scoring to them, and so those patients were prioritized based on waiting list time. Until Sarah Murnaghan, that is, who got put on the adult list with an LAS score. We can hope she does at least as well as adults with similar scores, despite the lack of solid evidence that she will.

To end, let’s bring this back to Sarah and pediatric patients like her. Suppose that we develop the evidence to support extending LAS scoring to younger patients, who will then go on the list alongside adults with equal or higher LAS scores. The fact that she is a child will make no difference. A 5-year predicted net survival for a 10-year-old gets no more weight than a 5-year survival for a 35-year-old. Should it get more weight?

References:

tomlinsonTom Tomlinson, Ph.D., is the Director of the Center for Ethics and Humanities in the Life Sciences and a Professor of Philosophy at Michigan State University.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made between July 3 and July 12. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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