Trust and the Pandemic

One of the necessary requirements of a doctor-patient relationship is the establishment of trust in that relationship. A vulnerable patient presents to a physician who theoretically has the skill and knowledge necessary to help resolve the patient’s problem. Ultimately, the patient has to trust the information and treatment recommendations of his or her physician. Even in situations where the initial diagnosis turns out to be incorrect, it is the trust bond between the patient and physician that allows the two to proceed to other diagnostic and treatment options. If trust is lost, it is less likely the patient will have confidence in the information or treatment suggestions by that physician, often resulting in the patient looking elsewhere for treatment.

On a larger scale, the general population must trust the information and recommendations from their Public Health experts before they will be willing to follow treatment protocols, such as those presently in place for the COVID-19 pandemic. Loss of trust in those public health officials, for any reason, will not only lead the public to look for other sources of information and treatment options, it will also make them less likely to follow guidelines and restrictions currently in place, particularly if those guidelines and restrictions are viewed as inconvenient or harmful.

What does the public do when the usual trusted sources of information on the pandemic are shown to provide false information? Take for instance the recent CBS News story on long lines for testing at Cherry Health in Grand Rapids, MI. It turned out the long car lines awaiting virus testing at this particular testing facility were artificially exaggerated, with both the news network and the health system denying responsibility for the falsehood. Purposefully falsifying the data being shown to the public ostensibly being used to determine healthcare policy related to the pandemic does nothing to foster trust by the general population in either the health system or the news media.

What does the public do when two publicly acknowledged experts on the current pandemic claim the data that the CDC has provided them (and the public) are not only inaccurate but the two experts disagree as to whether the actual data represents an overestimation or underestimation of the problem? This link from the Philadelphia Inquirer quotes Dr Deborah Birx as saying “[t[here is nothing from the CDC that I can trust” in expressing her concern that the number of COVID-19 deaths reported by the CDC are inflated. The same article reports Dr Anthony Fauci expressing concern that the same CDC death toll represents an underestimation. It is no wonder that increasing friction is growing in multiple regions of the US as people struggle with the continued personal safety concerns regarding the virus and the growing economic disruption caused by our personal and public responses to the pandemic. Jerry Risser provided a thoughtful blog entry of the bioethical issues of this public health vs economics struggle (absent this present blog entry’s concern of data reliability)

A recent May 14th podcast from the New England Journal of Medicine (NEJM) provided some optimism in an interesting behind the scenes overview of how a respected medical journal like the NEJM determines how to provide reliable information on the current Pandemic. It is approximately 19 minutes of audio and is well worth review. While the NEJM is not perfect, they transparently discuss how they go about providing reliable, trustworthy medical information to the medical doctors on the front lines treating medical problems in general, and this pandemic in particular. They openly discuss several problems that NEJM has with the sheer magnitude of current data juxtaposed with the goal of getting information out to the public in a timely manner (8:15), the question of actual content selected for publication (complications vs clinical trials – 11:00), issues of best evidence (randomized trials vs how to treat the patient in front of the doctor right now- 12:10) and determining strategies to assist in opening up the economy (14:40). One gets the sense after listening to the podcast that smart people are truly trying to get the best data to the front-line people in public health in order to provide the best care possible and that is reassuring.

I suspect (trust?) that many other medical journals, public health authorities, federal, state and local government officials are working to do the same. One of my patients reminded me that even if that is not the case, Proverbs 3:5-6 is reassuring.

Covid-19, Economics and Bioethics

Bioethics, in its essence, is multi-disciplinary. It involves medicine, philosophy, theology, political science, and supernumerary other scholarly fields. And, of course and, perhaps, unfortunately, economics. Bioethics is blessed, and plagued, by its confluence of academic influences, and operates within their inevitable, intersecting, conflicting, uncomfortable gray areas. The Covid-19 pandemic speaks to the bioethical implications that go beyond who gets ventilators and when do we get a vaccine to even more elemental questions. Can we survive the economic paralysis that comes from a quarantine designed to arrest or slow the spread of the novel coronavirus in the United States? Was it “worth it” to force a government shutdown of many industries in an effort to keep our population as safe as possible….and, perhaps, forestall further economic devastation…and, even if so, what is our endgame?

I write this as a veterinarian, a bioethicist, a small business owner, a father of three high schoolers suddenly thrust into “e-learning,” and the son and son-in-law of octogenarians. If those seem conflicting interests, then they are indeed representative of just what a mess this pandemic finds our society. We aren’t unique but, in so many ways American, have managed to find ourselves the world leaders in Covid-19 deaths, infections, tests and are the economic “canary-in-the coal-mine” for the industrial world.

The Atlantic, hardly a shill for the Trump administration or its apologists, has a sober assessment, two months into the general national “quarantine” zeitgeist that has been our reality in most of America. The complex effects of the coronavirus on our economics are described in this piece, one that also looks at what those economic effects have on other nations and, yes, the mental and physical health of our own citizens. It isn’t pretty. Macroeconomics is a bioethics issue.

Americans have now been forced to face, and decide between, our competing ethics of safety (a biggie in contemporary society), personal liberty (autonomy, in ethical lingo, another biggie) and self-sacrifice for a greater civic good (mostly read about in vintage World War II texts, but bringing on a new significance). And it seems we can’t begin to reconcile them, so we just retreat into support of one of the first two, claiming the third as its moral anchor. As we are seeing, this is no way to orchestrate a response to a pandemic that has left (as of this writing) over 80,000 Americans dead and an economy that currently can only be measured by the Great Depression levels of unemployed, but really should only begin to be assessed the way we do tornado damage…when the sun comes up and the clouds lift.

There are no numbers to encourage us. Yet, reports tell us that there are available hospital beds and ventilators, and that the navy ships brought in to our urban “hot spots” to offer more space were (thankfully) never needed. We succeeded in “flattening the curve,” that goal that was always our fundamental one when we paralyzed our economy and society many weeks ago. So what is the goal now? Is it avoiding a new wave that will create a curve that needs flattening again? Is it a quick or gradual reversal of the paralysis of the economy that lets us eat out, shop in malls, have gatherings with friends, play sports and see marching bands perform, and worship in community again? Governors have played a primary role here, perhaps an illustration of the wisdom of federalism to some, the limitations of the same when dealing with a pandemic across fifty free borders to others. It is inescapably political in an election year…do you want to see people die or go bankrupt? That is our apparent binary choice, and our political polarization has already entrenched the position of each side.

I reinforce to my clients who are making decisions for my patients, their pets, as well as to my own children, should they be listening, that every decision we make has consequences, and virtually none makes everyone a winner. The Atlantic article mentions the profound economic devastation that comes to our health if we enter an economic abyss. Some of that is already realized. That bioethical decisions are inextricably economic should be painfully obvious to all. It has always been the “elephant in the room,” sometimes at a micro- and others at a macro-level. We have viewed economics as, at best, a stern taskmaster who wants to ruin a good thing and, at worst, the archenemy of bioethics. In the West at least, we have been blessed by wealth to make high-level bioethical decisions. The challenge of who gets dialysis was answered by “everyone,” because we found a way to pay for it without creating economic devastation. When that wealth erodes, we are on a different playing field. Covid-19 shows us what happens when a bioethical decision runs headlong into economics. Again, it isn’t pretty.

Fundamentally, we need to decide what human dignity and human flourishing look like in a modern society. Justice for all, and with particular attention paid to those at the margins, always dictate this. The margins we face in Covid-19 are, of course, the elderly, the immune-compromised, the chronically ill. But they are also those who struggle in good times to make financial ends meet and who are suddenly out of work weeks after the highest level of employment in recent history. Some are facing mental health and addiction crises. Global poverty, and its accompanying hunger and death, will rise. Whether one out of five or one out of ten, whether in North America or sub-Saharan Africa, we have a group of people at the margins. The number will inevitably widen as the storm damage is fully assessed. To fail to account for them in our public health decisions is inept and insensitive. To ignore the power of a disease caused by a novel virus for which no nation in the world has yet achieved “herd immunity” is no better.

Be careful how strongly you support either position. Those who lead, ultimately, are successful when they disappoint those who follow them equally. This is not a Solomonic baby-splitting, but the hard work of public policy and personal behavior. We will give up (and already have given up, to a great extent) some things that are excruciatingly painful losses. Our Western obsession with safety, with the quest for immortality that cannot be realized, for choosing death on our own terms and in our own time, has come under attack. Now we can be safer, but lose our prosperity, or remain wealthy but sacrifice many more thousands of our own. We can’t have both. Our public health decisions must recognize that national and global economics are bioethical, human flourishing, epidemiological decisions that cannot be ignored. A cavalier approach to loss of human life is ghastly, and an economy that fails means a health care system that fails.

Bioethics and the Study of Health Care Economics

A recent Technology Review article by Peter Dizikes featured a review of the academic work of Dr. Amy Finkelstein, an MIT economics professor who arguably has changed the way we understand the economic impact of health insurance. Though not the primary focus of her work, her results have also led to a better understanding of health care itself. The article may be found HERE. Though a significant part of the article is biographical of Dr. Finkelstein’s academic career and is interesting in its own right, I want to focus on a couple of her findings for this blog entry.

The main study upon which the article focused was the result of an opportunity she identified in 2008 when the State of Oregon increased its enrollment in its Medicaid program by 10,000 people via a random lottery. This allowed her to compare the new enrollees health care access and behavior against a similar control group that had been randomly denied similar access. Some interesting new insights emerged. For instance, it was assumed that since the uninsured people routinely used the ER to access medical care, providing them Medicaid insurance would increase their access to routine care thus decreasing their use of ER care. What Dr. Finkelstein found was that the new Medicaid enrollees increased their visits to the ER and this increase remained elevated for at least 2 years compared with the control group. In fact, the new Medicaid group showed increased doctor visits overall, as well as increased prescription drug use and increased hospitalizations. Their out-of-pocket medical expenses and unpaid medical debt both decreased. And, while their physical health measures did not change appreciably, they reported increased good health and had less incidence of depression.

Additionally, the article summarized seven other interesting findings from Dr. Finkelstein’s body of work thus far. I will leave the reader to explore the whole article for these details. One result of a 2020 study that was particularly interesting to me as a physician was the current practice of so-called “hotspotting”, the practice of providing pro-active care to high-risk populations in an attempt to reduce the patient’s hospital readmissions. Dr. Finkelstein showed that hotspotting appears to have no significant benefit in reducing readmission rates of those patients. It is good to determine whether or not our medical protocols, which sound reasonable on their face and therefore appear justified, are in fact accomplishing their intended results, particularly since these programs require both additional time and financial resources.

The reason to highlight Dr. Finkelstein’s work in a bioethics blog is to reinforce the importance of using good data to make informed decisions in health care. Understanding the true effects of medical policies in health care access, insurance or provision is just as necessary as debating their bioethical challenges, as the former may make the latter debates either more fruitful or completely unnecessary.

COVID-19 and the Vulnerable

April 2020 is over and not a moment too soon.  As we enter May, it is reported that over 60,000 people in America have died of COVID-19.  There is a measure of relief that some of the most dire predictions of ICU hospitalizations and deaths have not materialized. As many have suggested, a good dose of humility is needed when it comes to predictive models.

Since I last blogged in early March, I have read with great interest some of the many writings about the intersection of COVID-19 and bioethics.  Early on, some wondered how big a threat COVID-19 actually was to people who lived outside of Asia.  That quickly changed into an important discussion about how we should triage patients in case there was not enough ventilators for all who needed one. (See, for example, the discussion at www.cbhd.org).  Others have expressed concerns about how the use of our cell phones as tracking devices to trace COVID-19’s spread might encroach upon our privacy rights.  Still others have noted the racial disparities that have arisen during the pandemic, leading Dr Clyde Yancy of Northwestern University to conclude, “A 6-fold increase in the rate of death for African Americans due to a now ubiquitous virus should be deemed unconscionable.  This is a moment of ethical reckoning.” These and many issues are worth detailed consideration. 

Currently, some are focused on the ethics of reopening the economy. See, for example, the paper recently posted by The Hastings Center on this topic. The issue is not whether businesses should open, but how and when they should.  Of course, as you might suspect, there are multiple factors to consider, including the possible return of COVID-19 if social distancing rules are not observed.  But others argue that extensive damage has already been done to the economy and that it is worth the risk to reopen things again. 

In the midst of all this, it is important to consider the toll that this has taken upon those who are among the vulnerable.  Recently, in its series “Voices from the Pandemic,” The Washington Post published the comments of Gloria Jackson, a 75-year old resident of Minnesota. Her statement is heart-wrenching in many ways, because she gives a voice to some of the unspoken fears of many elderly citizens. These words in particular stood out to me:  

“I spent my career working for the federal government at Veterans Affairs. I raised my kids by myself . . . I pay taxes and fly a flag outside my house because I’m a patriot, no matter how far America falls. But now in the eyes of some people, all I am to this country is a liability? I’m expendable? I’m holding us back?”

I appreciate Ms. Jackson’s forthrightness.  Bioethics needs to speak directly to these fears in order to remind her (and others like her) that she is a valued member of society. Even if her health should fail, she will be treated with compassion.  No one is expendable.

COVID-19 has shone a bright light on the needs of the most vulnerable of our society. We overlook them at our peril.

Causes of Death Coding in COVID-19 Pandemic

Reporting causes of death is an important function in our society, and involves a number of people in completing each death certificate:

  • Pronouncer of death – may be a physician
  • Certifier of death – usually a physician; assigns cause of death
  • Funeral director – completes the demographic information, next of kin, and burial information portions of the death certificate
  • Local registrar or health department – registers the death certificate, and has long term management responsibility of same

The Office of Vital Statistics performs statistical analysis and reports on the mortality data, which are used in many ways, including surveillance of diseases, tracking of national deaths in emergencies and pandemics, and to justify health spending. Any misinformation along the way will impact not only the individual death certificate, but also all the data that includes that death certificate.

Death certificates are legal records. The physician as certifier of death “determines and accurately records the sequence of medical conditions that resulted in death. When the physician signs the certificate, he or she has legally certified that, to the best of his or her knowledge, the individual died for the reasons listed under the cause of death.” (CDC online course on “Improving Cause of Death Reporting (Web Based),” WB2959)

The Cause of Death (COD) portion of the death certificate entails two main sections. Part Ia is where the immediate cause of death is listed, and subsections Ib, Ic, and Id detail the sequence of events, listed backwards in time, that culminated in the proximate cause of death. Any other diseases or conditions that may have contributed to the person’s demise are listed in Part II.   The COD is the important part of the death certificate as far as vital statistics are concerned. The use of “suspected,” “probable,” or “possible” has been previously discouraged in the listed COD on death certificates. In fact, the above-referenced course currently offered by the CDC does not include such possibilities.

But that has changed with the COVID-19 pandemic. The World Health Organization issued its International Guidelines for Certification and Classification (Coding) of COVID-19 as Cause of Death on 20 April 2020.  They declared, “A death due to COVID-19 is defined for surveillance purposes as a death resulting from a clinically compatible illness . . .” New ICD-10 codes have been developed. For cases in which the virus has been identified, the code is U07.1; and when it has not been identified, but COVID-19 is “probable” or “suspected,” the code is U07.2. (p. 8/14).

The CDC’s National Vital Statistics, likewise, published new “Guidance for Certifying Deaths Due to Coronavirus Disease 2019 (COVID-19)” in April.  They indicated that the Underlying Cause of Death (UCOD) “should be reported on the lowest line used in Part I” of the death certificate. Although the document encourages testing if possible, the completion of a death certificate does not require it:

In cases where a definite diagnosis of COVID–19 cannot be made, but it is suspected or likely (e.g., the circumstances are compelling within a   reasonable degree of certainty), it is acceptable to report COVID–19 on a  death certificate as “probable” or “presumed.”

The advice goes further, to say that if COVID-19 is involved, “it is likely the UCOD and thus, it should be reported on the lowest line used in Part I of the death certificate.”

What are the ramifications of such changes to death certificates?

  •  Possibly inflated COVID-19 death counts
  •  Perhaps (unfairly) increased federal aid to areas with inflated COVID-19 deaths
  •  Under-reporting of other causes of death, and resulting lack of attention to  appropriate health concerns
  •  Loss of veracity in the persons responsible for completing the death certificates       
  •  Loss of trust in a system that has been manipulated

None of these is desirable, and all will cost us in the end.

 

Negative QALY Scores and Voluntary Euthanasia

I am all about saving money. I also enjoy reading the bioethical insights of Wesley Smith. His recent commentary in National Review entitled “Bioethicists: Euthanasia Will Save Money and Facilitate Organ Donations” naturally caught my eye. This blog has discussed the ethical problems with euthanasia and organ donation previously (see HERE and HERE). The focus of the remainder of this blog entry is to challenge the use of negative Quality-Adjusted Life Years (QALYs) as a utilitarian determinant of healthcare resource management, particularly with respect to voluntary euthanasia.

The article upon which Smith is commenting appeared in Clinical Ethics on March 10th by David Shaw and Alec Morton and was entitled “Counting the cost of denying assisted suicide” (full article behind firewall – abstract HERE). The authors briefly review the use of QALYs as used within the UK National Health System to determine cost/benefit of allocating medical resources. They explain the concept of negative QALYs, effectively time spent living (and suffering) in a state worse than death. They argue improvement occurs in the overall NHS net QALYs when there is reallocation of actual medical resources consumed “by patients who are denied assisted dying [and therefore experience negative QALYs]…instead be used to provide additional (positive) quality-adjusted life years for patients elsewhere in the healthcare system who wish to continue living and to improve their quality of life.” The argument essentially is that voluntary euthanasia prevents additional negative QALYs in the person requesting euthanasia and increases positive QALYs in one or more individuals in the population at large through the reallocation of the medical resources presently consumed by the person requesting euthanasia. Following the voluntary euthanasia and medical resource re-allocation, the NHS system is subsequently more efficient or economical since there are overall higher system QALYs given the same resources.

For this macabre exercise in utilitarian QALY mathematics to make sense, one has to grant that there is a state in life that is worse than death (by definition death is a QALY = zero). Individuals with terminal diseases and/or chronic pain stipulate their current state is indeed worse than death and therefore they experience a QALY less than zero – a negative QALY. They further believe they have no hope of ever achieving a state of positive QALY so argue their best option is voluntary euthanasia to reach death (so no more negative QALYs). Given all of this subjective stipulation, one might counter that other states of life might also exist that are also worse than death, such as the act of voluntary euthanasia. Perhaps it causes a transitional state of QALY much, much less than zero (something that “regular dying” does not)(since we are all just stipulating here) Any additional stipulations like this potentially further challenge their nice calculus.

Given the above, and perhaps more concerning, it is unclear (at least to this author) why Shaw and Morton used QALYs to score an act of voluntary euthanasia. It is unlikely that an individual goes through a similar calculus to determine whether his or her life is worth living with respect to the general population. He or she is deciding whether or not they want to continue living. They are not using a QALY score to justify their voluntary euthanasia decision to the population at large. So why the QALY score? Might such a calculus be used by one group to mathematically or scientifically justify imposing euthanasia upon another group, particularly within a system where medical resources are (becoming more) limited? Maybe it is just a way to suggest to those of us who find voluntary euthanasia morally wrong that it can’t be all that bad?

After all, it does save money.

Who gets the Ventilator?

Anyone watching the news coverage of the COVID-19 pandemic here in the US during the past week could not have avoided considering this generic question. Some are living in regions where the question is much more personalized – “If there really are not enough to go around, will I get a ventilator if I need one?” Ethically allocating a scarce resource such as a ventilator during a global pandemic caused by a virus that can strike anyone and potentially cause death by respiratory failure is clearly one of the great bioethical challenges facing us. What follows is a brief, blog length, discussion of some of the pertinent concerns followed by links to more detailed exploration, written by bioethicists who have considered these issues in greater detail.

In the last blog entry, Joy Riley touched on the issue of one individual refusing a ventilator for the expressed benefit of others. While the whole story was more complex, the facts do remind us that treatment (and therefore utilization of scarce resources) should start by determining what the patient actually wants and whether the resource in question can have any meaningful benefit in that patient’s care. Jon Holmund began the discussion of what processes and protocols may ethically change during the pandemic with resource scarcity and what others should remain in force.

My last entry touched on the four Principles of Bioethics (Autonomy, Justice, Beneficence and non-Maleficence) as a simple outline. The Principles are often referenced in guiding the one-to-one ethical relationship between the doctor and patient. Limited resource allocation affecting a population as a whole would seem to demand a different or additional ethical framework. Utilitarianism is often used in this context since it is an ethical system that desires to maximize some good (happiness, pleasure, health), theoretically scalable by maximizing that good for a whole population. Some problems with utilitarianism are determining exactly what that good should be as a population and agreeing on exactly how to measure it.

In the issue of the COVID-19 pandemic, one utility is maximizing access to ventilators or, perhaps more broadly, maximizing the number of lives saved. This sounds promising. But what happens when two people (or more) need, and want, the same ventilator at the same time. How do you determine who gets the ventilator? Utilitarianism does not necessarily answer this question or the many following: Is it “first come-first served”? Do we draw straws (a lottery)? Is it the person who can “pay the highest price”? The person who “needs it immediately”? The person who only needs it for a short time (so that the ventilator can be used again to help someone else)? Does the ventilator go to the person who is responsible for saving other lives (such as a nurse, food supplier, ventilator maker – and if so, how does one prioritize among these)? Assuming these decisions can initially be made, can we change that decision later? For instance, if someone has been using the ventilator for a (long) while, is it ever ethical to remove that person so that someone else “has a chance”? If not, is it ethical to somehow prevent them from being selected for ventilator access in the first place?

None of the preceding questions are easily answered, particularly in the heat of the moment, and are therefore best answered, if they can be, at the outset. Once determined, they should be made public as transparent guidelines. If agreeable to all involved, then applicable equally to all involved, and implemented fairly as specifically outlined. No guidelines will be exhaustively perfect in their ability to stratify and prioritize access to save the lives of all involved – the best that may be accomplished is to save the greatest number of lives until the scarcity of ventilators is resolved or the pandemic has run its course.

Agreeing on an ethically acceptable method to allocate scarce resources in a theoretical pandemic is very difficult, even in the abstract; actually implementing such a plan during the emergency of the real pandemic warrants nothing short of divine guidance.

For those interested in reading further and/or deeper, the Center for Bioethics and Human Dignity has an excellent resource page with multiple links to other references. I found Dr. John Kilner’s “Criteria for the Allocation of Limited Healthcare Resources” very helpful.

Love in a Time of Pandemic

Last month’s story of Italian priest Don Giuseppe Berardelli giving up his ventilator so a younger patient could use it was an attention-grabber. The truth of the matter was a bit different, but the end result was, somewhat predictably, unchanged. Berardelli did refuse a ventilator, due to medical reasons. At the hospital, sometime in the night of March 15-16, the beloved, jovial, and accessible 72-year-old priest died from the coronavirus. He was one of at least 60 priests who succumbed to the SARS-CoV-2 virus during one month in Italy.

Physicians and dentists in Italy who have lost their lives to the coronavirus are listed here. In a similar vein, Medscape Medical News is maintaining (and adding to) a list, “In Memoriam: Healthcare Workers Who Have Died of COVID-19.” These are not the only victims, however. The frontlines are multitudinous, from people who work as clerks or deliverers of goods, to first responders, to all those caring for the ill (personally or professionally). These are exposed to increased risk of contracting the virus, and possibly dying from it. But these are not the first, nor will they be the last, to incur risk in such a manner.

History has much to teach us about staying at one’s post in difficult times. One of the prime examples is Martin Luther, who stayed in Wittenberg in 1527, in the midst of a bubonic plague outbreak. In response to multiple queries, he wrote a tract, “Whether One May Flee from a Deadly Plague.” His conclusion was that, unless someone can accomplish your duties in your absence, your presence is required.

  • Preachers and pastors: “For when people are dying, they most need a spiritual ministry which strengthens and comforts their consciences by word and sacrament and in faith overcomes death.”
  • Mayors and judges: “To abandon an entire community which one has been called to govern and to leave it without official or government, exposed to all kinds of danger such as fires, murder, riots, and every imaginable disaster is a great sin.”
  • Public servants like city physicians and city clerks: These “should not flee unless they furnish capable substitutes who are acceptable to their employer.”

Citing Matthew 7:12, Luther concluded that “we are bound to each other in such a way that no one may forsake the other in his distress but is obliged to assist and help him as he himself would like to be helped.”

Luther did not neglect the complementary side of the issue: prudent care of our bodies. He wrote, “I am of the opinion that all the epidemics, like any plague, are spread among the people by evil spirits who poison the air or exhale a pestilential breath which puts a deadly poison into the flesh.” Therefore, Luther recommended that one keep one’s distance from those ill (if they did not require help), set up hospitals to care for the sick, “help purify the air, administer medicine, and take it.” Luther, like the priests and health care professionals referenced above, provides a strong example of love in a time of pandemic.

More—with trepidation—on COVID

Let us stipulate at the outset: first, that so much—far too much? –is being written on the COVID-19 outbreak, and wisdom is a precious commodity; second, that although your correspondent is an MD, he is as bewildered as anyone by the storm of reports, claims, data, projections, arguments; and third, that whatever public comity may appear to pertain now, in due time we likely will be at one another’s throats with blame about who should have been better prepared or done what when, and there will be plenty of blame to go around.  Our leaders, national and regional, are especially to blame, but the evidence abounds that too many of us took this too lightly throughout January and February.

This being a bioethics blog, however, a few comments about some ethical issues in an outbreak, from a 2018 paper on the subject.  The paper in question raised three major topics: ethics of treatment research, triage, and the duty (by doctors and other health professionals) to provide care.

The last point first: it is well established that the covenantal duty of doctors in particular is a willingness to efface self-interest for the interests of the patient.  There is no dispute that this duty is being followed faithfully by the doctors, nurses, and others who are caring for people sick from COVID-19.  But a related duty of society is to do what it can to limit the risk to the caregivers themselves.  This is clearly pressured by, for example, the limitation on personal protective equipment (PPE) supplies.  We owe it to the medical community to provide them with what they need.

Next, triage:  try as we might, and fail as we might (and always seem to) to prepare in advance for a possible outbreak, surprise never fails to assert itself, and shortages of things that really matter loom.  At this writing, I have no idea whether New York City’s capacity to care for the sick is destined to, or is already, hopelessly overrun “under any scenario,” as Gov. Cuomo said this morning, or whether we can take any comfort in the assertion this evening by Dr. Birx that “there are still ICU beds and ventilators” in New York.  In early March, an infamous discussion at the American Hospital Association projected as many as 1.9 million people needing ICU care nationwide, and about half of those needing ventilator care, and it is further widely said that the typical ICU stay, even for someone relatively young, is 2-3 weeks.  Numbers far fewer than that would outstrip our national capacity, it appears.   Then again, the real shortage may not be ventilators, but the doctors to manage them.

These concerns also arose in the first Ebola outbreak a few years ago, and much-discussed principles of allocating scarce resources apply.  First and foremost is to try to alleviate the shortage through the best possible resource management.  Failing that, if hard choices must be made, then the likelihood of achieving clinical success is a top criterion.  But that requires clinical judgment that may be uncertain, requiring a lottery system, or a registry (as is done for organ transplantation).  Perhaps most controversial is to make an attempt to prefer treating people who are judged, if treatment succeeds, to have more life to live or more potential lifetime contribution to society to offer.  In that case, who decides, and how one decides, become very dubious judgments to make.

In the moment, there may not be enough critical care resources to go around, and doctors have to make a hard choice to treat one person but not another.  Physicians in Italy are reported to have faced exactly this choice this month.  Another principle, easy to say but hard to follow (talk is cheap!), is that triage “should not be a bedside decision,” that is, the treating doctor should not be forced to make a choice, but a previously-settled decision process should be applied.  I do not know whether that was or is possible in Italy, or in New York, or elsewhere in the U.S. or the world during this outbreak.

If we indeed are committed to care for and conserve our most precious care resource, our doctors, then that, in addition to limits on the number of available beds, might be adduced in favor of a so-called “universal” or “unilateral” decision that resuscitation (CPR) of some patients—which will increase the risk of the doctors and nurses getting infected—simply will not be attempted if their heart stops, regardless of whether the patient desires the attempt.  I know of no evidence that this is being done anywhere, but it is the subject of some speculation in the press.  The proper process is for a careful end-of-life conversation to happen between doctor and patient, before being confronted with the need, so that the patient’s wishes and the doctor’s professional recommendation can be considered.  But if that did not happen for people seriously ill with COVID-19, it may be too late when the illness strikes.  Those of us “of a certain age” are wise to consider this question in advance—viral outbreak or no.

Finally, the ethics of experimental treatment during a disease outbreak are governed by a well-defined regime of human subject research.  The key principles follow the Belmont principles reviewed by Mark McQuain on this blog on March 17, and include that risks to subjects must be limited as much as possible; that the necessary research risks not be excessive compared to the potential benefit to the subject at hand or society at large; that informed consent be properly obtained and documented; and that vulnerable people or those less advantaged not be denied access to potentially promising treatment nor be disproportionately placed at risk or have their vulnerabilities taken advantage of.

In the case of this present outbreak, research ethics also require that experimental treatments be properly studied in adequately designed clinical trials.  Implications, IMO, include that people be randomly assigned to treatment alternatives.   It is true that “off-label” use of drugs that are available for other uses is legal when prescribed by a licensed physician, and such off-label use is not on its face evidence of malpractice.  However, society stands to benefit by collection of data about the COVID-19 disease and outcomes of treatment, and so even off-label use should be done in a clinical trial, not in a “right to try” approach.  Because COVID-19 can be so severe, and the need for treatment is so great, I am inclined to think that random assignment to a placebo is a suspect requirement, I must admit that the need to learn more about the natural course of COVID-19 infection probably requires a placebo group in most, if not every, clinical trial.  There is not enough prior knowledge to rely on comparing a past group with a current, treated group, to conclude whether a new treatment works.  But requiring a placebo further requires that the trial get done fast and carefully, so results are as clear as possible, and made pubic immediately.  We should have no doubt at all that everyone doing the trials wants that.

I note that the public registry of clinical trials includes several in the U.S., including a national, 3000-person study of whether hydroxychloroquine may prevent disease in people exposed to others with COVID-19 disease.

Bioethics and the COVID-19 National Emergency

What a difference a couple of days can make. In the last blog entry, Steve Phillips discussed the problems that fear and panic are causing as we deal the many unknowns of the COVID-19 pandemic. While the current incidence, prevalence, and mortality of COVID-19 lags behind that of seasonal influenza (as well as past influenza pandemics caused by novel influenza strains), the eventual morbidity and mortality remain unknown. This uncertainty has caused public panic, which has lead to significant disruption of life, as we know it. A national emergency was declared in the US last Friday, calming some fears but reinforcing others. Using the four Principles of Bioethics as a simple outline, the following are some of the bioethical implications of the current COVID-19 pandemic I have recently considered – there is certainly space to add others.

Autonomy: The highly infectious nature of the new virus and the risks for the population as a whole place severe restrictions on individual autonomy. An individual is really not free to do whatever he or she wishes to do at this time. Measures to blunt the rate of infection spread have limited travel and will eventually cause some to be quarantined, perhaps against their will. Necessary public health measures will conflict with individual health decisions and desires. Do all individuals have a right to be tested for COVID-19 (particularly now that the test will shortly be free of charge) because they have a right to know or demand to know, or will we defer to protocols of best practice in the face of currently limited test availability, all of which are admittedly our best statistical utilitarian “guesstimates” for the benefit of the population as a whole?

Justice: The details of the pending National Emergency legislation are still not well known as of this writing but will apparently provide financial support to individuals and businesses affected by COVID-19 and this is certainly good, given the considerable disruption already caused by the fear and panic related to the disease, and the projected future impact of the actual illness itself. It is interesting to me that one result of this legislation may be that, with accurate testing, an individual or business will get federal benefits for having COVID-19 related problems but may not for similar influenza related problems. This is despite the fact that from an individual morbidity and mortality standpoint, particularly on a global basis, both COVID-19 and influenza both can end up causing severe health and secondary financial consequences. Asked differently, does justice require federalizing other viruses (or diseases) that, on a case-by-case basis, cause similar individual financial disruption as we will see from COVID-19?

Beneficence: I believe most people want to be helpful to others and do the right thing. Any desire to help others is somewhat counter balanced by lack of knowledge of exactly how infectious is the COVID-19 and therefore what risks do we assume for ourselves and for our immediate family in any benevolent activity in which we engage. Deciding how to help others without harming oneself will become clearer as the public health data grows.

Non-maleficence: Our natural tendency for self-preservation in uncertain times has resulted in a rush to hoard food and supplies, causing a severe strain on supply of these resources. Supply chains in a global “just-in-time” inventory structure are much more fragile as a result of COVID-19 than many had anticipated. Important medications, medical supplies, standard foodstuffs and infant needs are suddenly in short supply and are concerning; recent news videos of fights at your local Cosco over the last role of toilet paper are concerning for other reasons. Calls have gone out asking citizens to “hoard less”; hopefully these pleas will not fall on deaf and selfish ears.

For the Christian, wisely loving our neighbors may be the best ethical guideline and will look different in various regions and will likely change over time as we get a better understanding of COVID-19. I echo the many prayers for the health and safety of all affected by this pandemic and an extra measure of the Lord’s wisdom and strength for those in public health rising to meet and resolve this national (and worldwide) emergency.