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.

Pandemic Priorities in the Face of Uncertainty

Last week, this space on this blog addressed concerns about overconfidence in judgments about the COVID pandemic, and intimated that some humility is in order, especially on the part of the experts doing the advising and opining.

Now turn the perspective around—humility is in order on the part of us non-experts, receiving and reacting to the experts’ advice.

At this writing, while precision is ever-elusive, it is clear that the number of infections is increasing at an accelerating rate in several states and localities across the United States.  How many of these infected people will require hospitalization, or will die, remains to be seen, but concerns are raised that hospital systems in some areas will be stressed—perhaps not to the degree that New York City or northern Italy saw earlier this year, we certainly hope not—but stressed nonetheless.

And there is a rush to apportion blame, especially to “the other side” of our current, apparently intractable political split.  But, again, humility is in order.

First, hindsight is 20-20, as the old saw goes, and it’s easy to find misjudgments among various public officials.  Some may prove to have been honest, some less so, but scapegoat-hunting seems of little use, except to try to win the next election.

Second, the public health officials have not been purposefully lying to us.  They have generally made their best efforts.  We might rightly take them to task for letting certain value judgments bleed into their scientific assessments.  But there remains much that we just don’t know. 

Third, wearing masks is not principally an issue of rights.  It’s a matter of prudence and neighborliness.  We should wear them in public.

Fourth, we can’t say exactly why the infection rate is increased.  More contact between people, sure.  But which ones?  That remains to be determined.  My local newspaper says today that in my county (San Diego County, CA), family parties of 10-20 people gathered in households appear to be the source of outbreaks.  And maybe gambling casinos. 

Fifth, what is really “essential?”  People need to be able to work and earn a living.  Perhaps we can grant them that, do everything we can to protect them and the rest of us in the process, and voluntarily limit exposures that really aren’t critical.  Some calls may be contentious, I know—should we limit hip replacements while folks can get their nails done, or buy marijuana of dubious medical need?  In a free society we don’t have a Platonic philosopher-king to walk us through that, but we might be willing to offer some tradeoffs and continue to try to help those who suffer loss because of it.

Sixth, we don’t know what outdoor group gatherings have or have not promoted spread.

Seventh, while there is merit from a civics standpoint in asserting that churches ought to be able to meet, there is also merit from a Christian citizens’ standpoint in bearing delays in meeting patiently, and laboring, as the hymn says, to “preach Christ, as love knows how, with witness true and virtuous life” (emphasis mine).

The above are only the opinions of your correspondent.  And the larger priority questions—of health care disparities, priorities of high-tech vs low-tech ethical issues, of different areas of medical care that are being “rationed” from time to time these days—are for future posts here.

Uncertainty, Arrogance, and Mourning in the time of Pandemic

As I write this I have been fielding messages from a friend and interlocutor who, a knowledgeable health industry professional, seems quite confident that had President Trump been successfully impeached—or, better, never elected—the COVID-19 pandemic would not have been such a trouble for us. 

And there may well be something, more than a little something, to this.  Catalogued charges of missed opportunities and willful neglect are well known.  At the same time, in some quarters anyway, Trump’s adversaries have not escaped criticism.

Of the first 100,000 or so deaths from COVID, about 40% are said to have occurred in nursing homes and assisted-living facilities for elderly people.  Joy Riley discussed the situation in a fine post on June 6.  But how accurate is the count?  We don’t know. The government can’t quite get the data, or its rules block collection of the data, or something. 

All the counts are imprecise.  The self-declared uncertainty in the IHME estimates appears rather narrower now than it did in April—it should, with more data—but it still gets wide after a while.  One doesn’t hear much about that uncertainty, unless you consult a site like five thirty-eight.  Lack of certainty does not mean that the modelers are purposefully misleading us, but, although they are making their best estimates to help guide public decision-making, it does guarantee that their projections will be “wrong.”  (The National Weather Service forecasts thunderstorms for Omaha next Monday night, June 22.  I think they are more likely to be accurate.)

How much of a greater outbreak will there be this fall?  We don’t know.  We can and should be concerned, and prudent, and considerate of our neighbors, but we don’t know.

Right now we’re overrun by people of all political persuasions, not just at one “end of the spectrum,” who are quite certain they are right and the other guys and gals are knee-walking stumblebums of the apocalypse.  Add in a dash of ulterior motive or hastiness and you get a lot of folks who, as President Reagan said, “know so many things that aren’t so.”  And then you get high-profile retractions

The pandemic is a poor topic for a bioethics blog because so much of bioethical discourse is about logical argument rather than decisions under uncertainty, or judgments unencumbered by data, and because there is a temptation to get on rather a high horse about matters.  Your correspondent confesses he is all too familiar with the latter.

When the humble (we hope), uncertain, doing-their-best public health forecasters speak, it would help if they would take care to sort value judgments from judgment calls, if they would stay in their lane and point out where their expertise ends and their opinions begin, and if they would resist expanding their remit to make every social concern, as great as those may be, a “public health” issue, and therefore a matter of science, with the attendant risk of false precision and, indeed, category error.  As readers of this blog have recently been reminded, what is “essential,” or more important than something else, is not subject to measurement and experimental verification.

And the rest of us should give those forecasters some grace.

Gerald Seib of the Wall Street Journal recently wrote that there is no goodwill in America anymore.  Sixty percent of people in each major political party think the opposing party is “a serious threat” to the nation.  Forty percent of each party think that the opposing party is “evil.”  About 15 percent (give or take a little) of each party think that violence would be “somewhat justified” if the other side wins the next presidential election.

I once heard a story—no doubt apocryphal, I can’t find it, but it serves my purpose—that Abraham Lincoln, at a friend’s funeral, listened to several people speak then rose to eulogize his dead friend—and just cried and sat down without uttering a word.

Maybe there’s a lesson there.

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.

Essential Services

Until the pandemic, no one spent much time wondering about whether something was an “essential service”. This designation has granted necessary special exceptions to community mobility access restrictions created by government imposed “shelter-in-place“ orders instituted to slow the spread of the virus. Throughout the pandemic, determining what was and still is considered essential has been an interesting debate not without its bioethical issues .

Merriam-Webster Dictionary says that the adjective essential “implies belonging to the very nature of a thing and therefore being incapable of removal without destroying the thing itself or its character.” With respect to the COVID-19 pandemic, an essential service is one that provides for or protects the life of any person, as life is certainly one thing that everyone seems to agree pertains to the nature of a human being. Therefore, anyone whose job it is to provide for or protect the life of another is providing an essential service. Easily included in that group are those at the front lines of disease management such as doctors, nurses, and first responder EMTs. The list also requires jobs that provide distribution or protection of our daily needs such as grocers (“milk and bread”), pharmacies, utility workers, various government services, firefighters, police, transportation services and nursing home providers. The list then quickly expands to suppliers of those jobs like farmers, medical equipment manufacturers, gas stations, and, well, the list goes on.

In Denver, the list of essential services promulgated by the mayor initially did not contain liquor stores and recreational marijuana shops (though that list did include medical marijuana dispensaries). Within hours of the release of the initial essential services list, after a strong public outcry, those businesses were reclassified as essential. Apparently, a large number of Denver residents believed that services provided by liquor stores and recreational marijuana shops were essential to their lives.

More recently, various religious groups are arguing with their respective governors that their religious services are also essential and therefore churches deserve to be opened sooner rather than later. The variability between the various states as to how each relaxes its own public access restrictions has likely contributed to these disagreements leading to several lawsuits. The Supreme Court just ruled against a California church in a case balancing religious liberty and public health. While public health concerns were indeed cited as the main issue, also at issue was the classification/determination of how essential was the service in question (i.e into what tier was the church service placed compared with other non-religious, non-essential services). In other words, how essential was the non-essential service?

Answers to the questions about the essence of a human being provide the basis for our bioethics. One’s worldview affects those answers. The open debate as to whether human essence transcends death should at least give us pause to reconsider the ranking in our list of essential services.

Justice & George Floyd

When I blogged last month, I thought surely that May would be an improvement over April. I was wrong. Now, with 100k deaths from COVID-19, and after several days of protests across the country in response to the death of George Floyd, I can’t possibly imagine what the summer will be like.

I watched two different documentaries over the past week – one on the life of writer Mark Twain and one on the life of President Ulysses S Grant. Even though they were two distinct individuals, their attitudes toward the horrific treatment of African Americans in the 19th century seemed remarkably similar, at least compared to the surrounding culture. It was especially disheartening to see how quickly the Reconstruction of post-Civil War America faded back into institutionalized racism. It is even more disheartening to see how race remains an issue in so many areas of contemporary life.

I have blogged on this site before on the racial disparities in health care. COVID-19 has exposed these disparities even further. It no longer surprises me when a family of color rejects talk from medical personnel about end of life care for a loved one as nothing more than a suspicious attempt to be rid of an under-resourced patient. (For more insight into this topic, please see the powerful op-ed by Dr Jessica Zitter in The New York Times last year.)

I am a middle-aged white male, born and educated in the United States.

I have never experienced systemic injustice.

I am not an expert on race relations.

However, it seems to me that many people of faith from my generation are committing the same grievous sin that previous generations have committed: we stand quietly by while watching the power structures of this country – both political and economic – systemically eviscerate the most basic of rights, all the while proclaiming that we believe that humans have been created in the image of God. (Dr John Kilner’s book, Dignity and Destiny: Humanity in the image of God [Eerdmans, 2015] carefully explains both the Bible’s teaching on the image of God, as well as the horrific things that happen when it is ignored.)

Justice is one of the foundational principles of bioethics. It is also one of the foundational principles of both the Hebrew Bible and the New Testament. Justice for George Floyd will not be reached simply by trying those responsible for his death. It will be reached when all humans are treated with dignity and respect.  Until that day, let us faithfully work towards that end.  (For a passionate and theological treatment of this issue, please listen to Rev Dr Charlie Date’s sermon from May 31 [sermon begins at minute 43:17].)

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.

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.