Property rights, payments, and urgent public health needs

Greed is a common concern—a risk, from one perspective, an indictment, from another—raised regarding medical care and the people who profit from providing certain aspects of it.  Nurses don’t get rich.  Doctors, in rich nations, often do.  Public hospitals generally don’t; private, for-profit ones do, and manage their work to make sure they do. 

There’s a much richer ethical tradition than can be recounted here that doctors should not be about profit.  Indeed, key tenets underwriting the understanding of medicine as a learned profession are that the physician enters a covenantal, not transactional, relationship with the patient, and that the physician is duty-bound to efface his self-interest when the patient’s care so requires.  One can argue about the precise boundaries of that, but the principles, even with today’s corporate medicine, still seem generally accepted.   The ancient Christian church gave us the “holy unmercenaries,” saints (generally physicians) who lived in extreme poverty and did not accept payment. 

But the most relevant collective culprit in out time seems to be the Western pharmaceutical industry, which is, to be sure, lucrative, providing high-tech medicines at often high prices.  The principle that the inventor has a right to profit from his invention has led to the standard practice of issuing and protecting patents, which prevent cheap alternatives from becoming available for a number of years.  The idea is that the inventor has those years to make a reasonable profit before the right to praceice the invention becomes more generally available—unless the inventor grants a license to the patent, which of course comes at a price.

The most common remedy for proposed is to limit the price that can be charged.  This is an issue of policy and justice, but not so much one of ethics as of public policy.  The old search for the “just price”—what should something cost—foundered, because the most workable answer turned out to be the market price, assuming that seller and buyer are on equal footing.

A related proposal is that drug companies ought to be non-profit.  The challenges here are that the modern drug industry employs many people, most of whom cannot be considered under the same terms as physicians—they have not taken a covenantal oath to society.  They’re doing jobs, making a living.  Also, being not-for-profit doesn’t eliminate the need for large amounts of money to develop and make drugs.  Countering this is the charge that the prices could or should be lower, that the real costs are not so high to justify pricing, and so on.  These are complex matters that will not be solved on principle but will be the source of ongoing policy disputes that will take on the form of a negotiation, of sorts.

But if one grants that the drug maker is due a reasonable, or even a handsome, profit, then one can still ask, if the medical need is sufficiently acute, when does just, merciful care of suffering people–some rich, many not so much, some from rich countries, many not so much so—demand that the product not be considered a proprietary invention, but a public good?

This question is surfacing as the prospect of one or move COVID-19 vaccines becomes more likely.  The general press has recently reported on various prospective pricing plans from the manufacturers.  Some intend prices that are a bit higher than others, some are discussing charging poor countries less than rich countries, and so on.

A more provocative proposal is to eliminate the property protection from COVID drugs or vaccines.  Recent arguments have held that in no circumstance should patents be enforced, so that inventions would be immediately open on a broad basis, and that one nation should not be able to prefer a product made by a native country be available first to its own citizens; or that, perhaps more simply, that all COVID-related inventions should be placed in an open-access repository for widespread availability.  The fundamental argument is that all such inventions are, and should be, global public goods.

Counter arguments are that people who create new drugs, vaccines, or other products to meet critical needs should be reasonably rewarded, and that not allowing this creates a disincentive to them to make the attempt in the first place.  A government that supports such work has a reason for claiming some consideration when it comes to pricing, and also arguably has a greater moral responsibility to its own citizens than to those of other nations.  Part of that government support arguably includes a duty to provide incentive to the inventors and producers in the first place.

Expect to hear more about this in the general press in the months ahead.

Abortion, Res judicata, Stare decisis and the “Rightness of Things”

Oddly, I enjoy reading Supreme Court decisions, particularly the dissents, even though I am not a lawyer. I gain similar enjoyment watching a good game of chess even though I am not a great chess player. Nerd that I am, I think I become smarter for the effort in both cases. I beg the reader’s indulgence on the legal background before getting to the ethical or theological portion of this blog entry but, after all, the case regards abortion, which usually demands a legal “walk in the weeds”.

Three weeks ago, the New York Times reported on a recent Supreme Court decision (June Medical Services, LLC et al v. Russo) that struck down a Louisiana law that attempted to place restrictions upon physicians who perform abortions by requiring them to have admitting privileges at nearby hospitals in case there were complications. In overturning the law, Judge Breyer, writing for the 5-4 majority opinion, made the case that requiring physicians to have said admitting privileges would reduce the number of physicians performing abortions in Louisiana, creating a burden on access to abortion. He was able to cite precedent with an almost identical Texas law that was struck down by the Court in 2016 (Whole Woman’s Health v. Hellerstedt)

There are many legal and ethical rabbit holes to explore in both cases. For the sake of brevity, I have picked one. Chief Justice Roberts was the fifth and deciding vote for the majority in the present case. What makes this interesting is that he joined the dissent in the earlier Texas decision, a decision he admits that he remains convinced was decided incorrectly, but voted recently with the majority to use the precedent of that prior case to strike down the Louisiana law. He wrote a separate concurring opinion to explain himself. In it, he begins:

“I joined the dissent in Whole Woman’s Health and continue to believe that the case was wrongly decided. The question today however is not whether Whole Woman’s Health was right or wrong, but whether to adhere to it in deciding the present case.”

My translation of this is: “Our first decision was terrible but instead of fixing our error, we should make a second terrible decision based upon the first – that way, at least we are consistent.”

And, legally, consistent they are.

Roberts’ problem with the Supreme Court’s Texas decision rested not with the specific medical or ethical questions as to whether physicians performing abortions should have admitting privileges at local hospitals or whether such requirement truly placed a limiting burden on women seeking abortion but rather the legal technicality of whether or not those questions had been previously and properly adjudicated. Res judicata (claim preclusion) prevents cases from being (potentially repeatedly) re-adjudicated between the same parties. Roberts joined Alito’s dissent, arguing the Texas case was an example of res judicata and should never have been heard. In Alito’s words: “The Court favor[ed the] petitioners with a victory that they did not have the audacity to seek”

With the Texas decision now law, Robert’s recent decision was to give precedent to that previous decision. Stare decisis (“to stand by things decided”) allows us to rely that courts will not change laws erratically. Robert’s sixteen page separate concurring opinion decided the Court’s 5-4 recent decision and was his attempt to justify giving precedent to a previous case he still believes was wrongly decided. Justices Thomas, Alito, Gorsuch and Kavanaugh each wrote dissents effectively having none of his argument.

All this brings me to the bioethics portion of this blog entry regarding this case. If Supreme Court decisions are not concerned with determining right and wrong (per Roberts), then what are they concerned with? Decisions having to do with abortion literally have lives hanging in the judicial balance. Justice Thomas, writing in his dissent in Whole Woman’s Health said:

“Our law is now so riddled with special exceptions for special rights that our decisions deliver neither predictability nor the promise of a judiciary bound by the rule of law.”

He went even further in his dissent in this present case, stating that the Court was unbound by the Constitution itself, when the Court concluded…

“…that Louisiana’s law is unconstitutional under our precedents. But those decisions created the right to abortion out of whole cloth, without a shred of support from the Constitution’s text. Our abortion precedents are grievously wrong and should be overruled.”

Justice Thomas is indirectly talking about the legitimacy of the Court. Theologian Richard John Neuhaus discussed the problems of legitimacy that courts will face when the Law deviates from what he called the “Rightness of Things”. In a speech he delivered at the centennial celebration of the School of Law at Valparaiso University in the late 1970s, he concluded (as do I):

“[W]ith regard to law, there is nothing in store but a continuing and deepening crisis of legitimacy if courts persist in systematically ruling out of order the moral traditions in which western law has developed and which bears, for the overwhelming majority of the American people, this society’s sense of right and wrong. There is in store a continuing and deepening crisis unless a transcendent moral purpose is reasserted by which the state can be brought under critical judgment, unless it is made clear once again that the state is not the source but the servant of the law.

“With apologies to Spinoza, transcendence abhors a vacuum. Today there is such a vacuum in the public space of American law and politics. Unless it is democratically filled by the living moral traditions of the American people, it will surely be filled, as has so tragically happened elsewhere, by the pretensions of the modern state. As the crisis of legitimacy deepens it will lead — not next year, maybe not in twenty, but all too soon —to totalitarianism or to insurrection or to both.”

The Problem with Retractions

It is not uncommon, at least in my small town, for our local newspaper to publish, usually on its front page, the news of a malpractice case, complete with the initial accusations of incompetence directed against the physician in question and description of the horrible medical outcome suffered by the patient. The physician’s reputation is at least called into question, if not ruined, by accusations that appear at the time to be accurate reporting of the factual events. In most of these cases, often after one or two years of lengthy court proceedings, the physician is found to be completely innocent of any wrong doing. The newspaper, if they publish a follow-up at all, place a short update article buried in an obscure section in the middle of the paper. That article rarely has the excitement and prominence of the initial article and the physician’s reputation remains tarnished or at least clouded despite the absence of any wrong doing or error on his or her part.

Similarities can be seen with retractions in prominent medical journals, with obviously more national or international impact. Take the recent publications in both the New England Journal of Medicine (NEJM) and the Lancet of reportedly large population studies showing both the lack of efficacy and potential life-threatening side-effects of hydroxychloroquine in treating COVID-19. Both of these studies were reported by all of the national news networks in the US, further fueling the ongoing oddly hyper-political situation that has plagued the COVID-19 pandemic.

This past week, both the NEJM and the Lancet posted retractions of the COVID-19 hydroxychloroquine studies. In similar fashion to the malpractice articles in my local newspaper, the retractions, at least initially, did not receive the secondary reporting enjoyed by the original articles. To their credit, the Lancet stamped “RETRACTED” over the link to the original article and provided an explanation of their retraction. The NEJM only placed a small thin red banner with small text “This article has been retracted” above the article at the original link, which I overlooked when I first viewed the original link.

Lack of fanfare is not the only problem with the retracted medical studies. As reported recently in Science, the data in the flawed Lancet article has affected other ongoing reputable studies:

“But the Lancet paper, despite its retraction, will make it more difficult to continue current trials, [says Nicholas White, who runs one of the largest pre-exposure prophylaxis trials of hydroxychorquine for COVID-19]. Published on 22 May, the [now retracted Lancet] study claimed, supposedly based on data from 96,000 patients around the world, that hydroxychloroquine and chloroquine, whether given alone or in combination with another drug, caused a steep increase in deaths. That led many regulatory agencies to ask scientists to halt their trials and make sure they were not harming their patients. Recovery and Solidarity [other ongoing studies] were temporarily halted but resumed after a safety committee took a look at the data… Many other studies are still on pause.”

The point in today’s blog entry is not to determine whether hydroxychloroquine should be used to treat COVID-19 or to solve the politization of the COVID-19 pandemic. Rather, like the previous blog entry on “Trust and the Pandemic”, it is to point out that retracted studies in reputable medical journals, published for whatever reason, deserve substantially more attention when they are retracted than the follow-up given to small town malpractice headlines. While discovering the truth is important in both cases, failure to correct the latter only affects the reputation of an honest small town physician; failure to correct the former may affect the health and welfare of us all.

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.

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.

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.