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.

Is personhood a biased term?

In ethics it is very important to communicate with clearly defined terms. This becomes especially important when dealing with a very divisive topic such as abortion. Fifty years ago, in the ethical debates about abortion, some expressed concern about how the term human being was used by those who claimed that abortion was wrong. The basic argument for the position that abortion was wrong went like this: It is wrong to kill an innocent human being. A human fetus is an innocent human being. Abortion involves killing a human fetus. Therefore, abortion is wrong. It was claimed that this was not a proper argument because the term human being meant different things in two of the premises. In the first premise human being means an individual with full moral status, but in the second premise human being is used in its biological sense. The claim was made that not everyone believes that every member of the human species has full moral status, so we should not use the term human being in this argument. It was proposed that everyone involved in the discussion abortion use the term person to represent those individuals who have full moral status. Since this discussion in the 1970s the term person has been used in the ethics literature as a technical term which is defined as those individuals who have full moral status.

However, it seems to me that the term person has the same problem as the term human being. In common usage it means other things than individuals with full moral status. It is commonly used to refer to adult human beings although children are sometimes included in who we think of as persons. It many times means those with whom we communicate and have a relationship. In legal terms it means something different. It refers to those who have certain rights and responsibilities under the law. It involves those who can be held accountable for their actions and those who can do such things as owning property and entering into contracts. The legal definition a person can include entities that are not human beings such as corporations. This becomes a problem when we look at how we define who is a person. Instead of looking at how we should understand who has full moral status, we tend to look at who fits with how we commonly use the term person. The Supreme Court in Roe v. Wade stated that “the unborn have never been recognized in the law as persons in the whole sense,” but that does not necessarily mean that the unborn do not have full moral status. Mary Ann Warren asserted that it is those who we consider to be persons rather than those who are genetic human beings who make up the “set of beings with full and equal moral rights.” However, she defined personhood based on cognitive capacities that are characteristic of fully healthy adult human beings who are moral agents and leaves out many, such as infants and those with cognitive disabilities, who we would commonly consider to have full moral status.

Using the terms human or human being to represent those who have full moral status assumes that all biological human beings have full moral status. Using the term person to represent those who have full moral status assumes that having full moral status is based on something other than being a biological human being. But that is the question. What we are trying to decide is whether it is correct to decide who has full moral status based on being a member of the biological category of beings we call human beings or based on having certain cognitive attributes or capacities. Since both terms essentially beg the question, it would be better to use neither. In discussing whether a fetus or some other individual has full moral status we need to focus on how we decide who has full moral status and recognize that using the terms human being or person in a moral sense represent positions on that issue.

Chastening and enthusiasm about genome editing

A writer in Nature says that China sent a “strong signal” by punishing He Jiankui and two colleagues with fines, jail times, and bans against working again in human reproductive technology or applying for research funding.  (They lost their jobs as well and may not be able to do research work, presumably in any field, in a Chinese institution again.)  It is encouraging, this writer says, that China took this action demonstrating a commitment to human research ethics.  He and other researchers doing gene-editing work that is not ethically objectionable worry that there may be collateral damage, so to speak, against ANY gene-editing research in China.

Another writer in Nature says cites progress under “appropriate caution” for using gene editing techniques for so-called “somatic” gene editing; that is, editing disease genes in an existing person with that disease, to treat it.  This is, in essence, a form of gene therapy and is ethically permissible under proper research ethical guidelines.  Some clinical trials in progress involve injecting the gene-editing apparatus into a person, while most such trials remove the person’s blood cells, edit them in the laboratory, then re-introduce them into the bloodstream, after which the edited cells are left to mature normally.  The latter approach is particularly attractive to treat genetic blood diseases such as sickle cell anemia.

Both perspectives seem correct, as far as they go—never mind whether Dr. He’s jail sentence fits the crime, as Joy Riley asked on this blog last weekend.  Never mind also whether Dr. He’s research should be published; as Mark McQuain commented, it’s a bit incongruous to want to assess the technical merits of work that should not have been done in the first place.  He linked an opinion in Technology Review that argued, briefly, that because the ethics of editing genes in human embryos is under societal debate, people trying to decide on the ethical merits should be able to assess for themselves whether Dr. He succeeded, technically at what he set out to do.  (The consensus to date seems to be, no, he did not.)   But the role of technical success in assessing the ethical merits of a medical intervention—or, better, an intervention made in the name of medicine—depends on the degree to which the ethical judgment is a matter of making a reasonably reliable of risk and benefit, and the degree to which risk-benefit is a criterion for judging the ethical merits.  And therein, as they say, lies the rub—which I hope to revisit in coming posts.

2020, or 20/20?

Near the end of 2018, He Jiankui was on the world’s stage announcing that he had edited the genome of twin girls, in the hope of making them resistant to HIV. On Tuesday, December 31, 2019, the Wall Street Journal (WSJ) printed a report that Dr. He and two others have been convicted of “illegally practicing medicine related to carrying out human-embryo gene-editing intended for reproduction.” (online version here).

A court in Shenzhen concluded that the defendants had acted for “fame and profit,” when they “deliberately violated the relevant national regulations, and crossed the bottom lines of scientific and medical ethics.” For the crime committed, He received the most severe sentence. In addition to the three-year prison sentence, He is banned for life from “working in the field of reproductive life sciences and from applying for related research grants, “ according to the WSJ.

The Xinhua News Agency also noted that a third genome-edited baby had been born, and that this child, along with the previously born twins, “would be monitored by government health departments.” The WSJ did not state for how long the monitoring would continue. Not only were the children experimental subjects as embryos, but they continue to be subjects as well. Further, these genome effects will affect their progeny, potentially into perpetuity. Additionally, the Smithsonian Magazine reports that in the summer of 2019, He met with “investors to discuss a potential commercial genetic modification clinic in Hainan, which aims to become a ‘world-class medical tourism hub’.”  One might reasonably call this “a crime against humanity,” even if it does not include genocide of humans already born. (For further reading, see David Luban, “A Theory of Crimes Against Humanity”)

In the print edition of the WSJ, alongside the article on He is an article about Pastor Wang Yi of the Early Rain Covenant Church. Pastor Wang was sentenced on 30 December to nine years in prison. His crime was “incitement of subversion of state power and illegal business operations” (online article here).

Consider that a pastor receives a nine-year sentence for an offense against the State; and a scientist, a sentence of three years for a crime against multiple generations, and indeed, humanity. In the year 2020, we could use a check of our understanding of what is important in the life of the world. Would that our vision were 20/20 also.

Good news

The angel who surprised some shepherds outside of Bethlehem brought them good news. They were told that a baby had been born who would be a savior and that they were being invited to go and see him. I suspect the shepherds thought they deserved some good news. Things were not going very well. They were living in a nation that had been conquered by Rome and the recent requirement that everyone be registered in their hometown was for the good of Rome, not for them. It is likely that the kind of savior they were looking for was one who would save them from their Roman oppressors.

The shepherds answered the invitation and went to see this baby who was going to be a savior and told Mary what the angel had told them. Mary pondered this in her heart. She knew something the shepherds did not. She knew that this baby, who the angel said would be the Messiah and Savior, was not an ordinary child. He had been conceived miraculously by the Holy Spirit. She also knew that an angel had told Joseph that they should name the baby Jesus because he would save his people from their sins. That was a deeper good news than the shepherds probably understood.

When we think of good news in medicine it commonly means that a new more effective treatment has been developed or possibly that a disease that previously had no effective treatment can now be cured. Those things are good news, but however many new treatments are developed, we still all die.

The good news of Christmas gets at something deeper. The Bible helps us understand that the reason that the diseases and death that medicine battles exist in this world is because we and the world we live in are broken by sin. No matter how many new treatments we develop, medicine cannot address the underlying problem. The angel told the shepherds about the ultimate cure. A savior had been born who could reverse the effects of sin and death and save us from our sin. He could bring us eternal life. He did that by going to the cross and showed his victory over sin and death by his resurrection. That is good news.

Merry Christmas!

Determining Fairness in Healthcare

The New England Journal of Medicine (NEJM) had a recent Perspective on proposed bill H.R. 3 aimed at reducing federal spending on prescription drugs. A main component in the bill authorizes the Secretary of Health and Human Services to establish a “Fair Price Negotiation Program” that, beginning in 2023, would permit the secretary to negotiate with pharmaceutical companies the price paid by the federal government on 25 drugs each year. The article provides a broad overview of the bill as it discusses some of the economic pros and cons as well as the political back and forth that would be required to allow this bill to become law. The link is behind a subscription firewall but provides an option for free access to a limited number of articles with registration.

Call me cynical but anytime I see the word “fair” associated with a bill in Congress, I immediately wonder “for whom?” The article is quick to point out that the “negotiation” effectively means “price regulation and severe penalty for noncompliance” by the drug manufacturers. The article describes in general the method that will be used to set the maximum price of a given drug. How or why did Congress determine that method as the best for determining the Fair Price? Also, not all drugs will be included in the group subjected to negotiation. If it is good or fair (as determined by Congress) for drug prices to be determined/set/negotiated by our government, should not all drugs be negotiated similarly so they are fairly priced?

Bills like H.R. 3 are part of the larger discussion of what I call the ultimate “Rights vs. Obligations” in the delivery of healthcare. If healthcare is a human right, who is obliged to provide that right? In the present case of medication pricing, if the present cost of a drug is too high, who is obliged to offset that cost (read – pay the difference between “too high” and “fair”)? The provision of healthcare, generally, and the creation, testing and production of medications, specifically, have real costs. Are these costs fair? Who will pay these costs? The patient? The doctor? The hospital? The pharmaceutical industry? Should healthcare be for-profit? If so, how much profit? Should healthcare become a utility with strict(er) oversight? Can the market decide a fair cost or price? Can a utility board? Can our elected representatives? How about a group of really (and I mean really) smart, unelected bureaucrats?

Thoughtful answers to any one of these questions should be submitted immediately to your local congressperson. Collectively, they are presently the ones determining fairness (in a real bioethical sense) in healthcare.

The importance of premises

In an interesting article in the Hastings Center Bioethics Forum, titled “Hannah Arendt in St. Peter’s Square,” Joseph Fins and Jenny Reardon write about the importance of deep ethical reflection in dealing with the ethical challenges of biomedical research. They point out that when ethics becomes a matter of simply following a set of rules we can end up in the wrong place. Even such fundamentally good concepts as informed consent and the need to have research proposals reviewed to be sure that they are ethically sound can lead to a mindset of regulatory compliance, essentially following the letter of the law, while leading to poor conclusions about what we ought to do. In the end they suggest that in order to facilitate deeper ethical thinking regarding new areas of biomedical research we need more interdisciplinary conversation between the sciences and engineering on one hand and the humanities and social sciences on the other. I think this is quite true and is a strong argument for a liberal education in its classic sense.

However, I find it particularly interesting how the thinking of Hannah Arendt enters into their discussion. Arendt was a German Jew who fled from Europe to the US in the Nazi era. She wrote about the kind of thinking that allowed the totalitarian regimes of Hitler and Stalin to gain control. Fins and Reardon focus on her idea that logical thinking can lead from a seemingly self-evident statement to a replacement of common sense with thinking that leads in a direction that is very wrong. They see a culture in medicine and science that considers ethics as a matter of regulatory compliance rather than deep reflection an example of this.

What I find most interesting in Arendt’s thinking is the idea that logic will lead to faulty conclusions if the premise is not true. The problem that she saw in the thinking leading to totalitarian regimes was not that the thinking was illogical. The problem was that the seemingly self-evident statements which were used as the premises were false. When we apply that to ethics it means that we will only reach sound ethical conclusions when we begin with moral premises that are true. A liberal education with interplay between the humanities and the sciences is one way to seek true premises for our ethical thinking in the wisdom that can be found in the interplay of academic disciplines. Another is to recognize that the existence of common sense morality suggests a source of moral wisdom that is beyond human wisdom. Christian ethics finds its premises in that higher source of moral wisdom. A Christian liberal education integrates them both.

Different answers to “Why?”

Sometimes when we ask “Why” we are really asking the mechanical or causation question: “How did something come to be?” In a billiards game, one might ask: “Why did the 8 ball go into the side pocket?” A valid answer might be: “It was struck by the 3 ball.” A reasonable follow-up question might be: “Why did the 3 ball strike the 8 ball?” Answer: “It was struck by the cue ball after a billiards player struck the cue ball with her stick.” These are correct mechanical explanations as to how the 8 ball came to go into the side pocket.

Sometimes when we ask “Why?” we are really asking: “For what purpose did something come to be?” In the previous billiards game, the answer to the question: “Why did the 8 ball go into the side pocket?” might be: “The player struck the cue ball which struck 3 ball which struck the 8 ball which went into to the side pocket so she could win the billiards game.” There was a purpose behind or beyond the physical or mechanistic description of the 8 ball falling into the side pocket.

Two opinion pieces asking “Why?” from medical and bioethical aspects were published within a week of one another and provide similar examples. The first was a NEJM Perspective by Anthony Breu entitled “Why is a Cow? Curiosity, Tweetorials, and the Return to Why” (subscription required). The second was by Stephen Phillips in this blog entitled “Why do we do this?”

In the first article, Dr. Breu begins with the classic infinite regression example of his 4-year old daughter asking “Why” to every response he provides to her previous “Why” question.

Daughter: “Why was [so-and-so] sleeping?”
Dr. Breu: “Because it was nighttime.”
Daughter: Why was it nighttime?”
Dr. Breu: “Because the earth rotates.”
Daughter: “Why does the earth rotate?”

Dr. Breu paused at this point because he did not immediately know why the earth rotated. He jokingly recalled that his own father terminated these inquisitions with: “Why is a cow?”, which Dr. Breu quickly learned meant the “Why Game” was over. The rest (and real emphasis) of the article discussed the benefits of encouraging medical curiosity in his students and the particular benefits of “Tweetorials”, Twitter posts that answer in-depth medical explanations of pathology. “Why does an acute hemorrhage cause anemia?” His Tweetorial provided a mechanistic answer to the question of why (or how) does anemia result from an acute hemorrhage.

Dr. Breu closes his article with the following answer to his daughter’s last question:

…the Earth rotates because of the angular momentum that resulted from asymmetrical gravitational accretion after the Big Bang. And if my daughter asks me “Why was there a Big Bang?,” I’ll be forced to reply, “Why is a cow?”

In the second article, Dr. Phillips answers the question: “Why do we do this?” by succinctly describing the purpose for which we Trinity Bioethics bloggers write the bioethics articles that we write. We believe there is purpose behind or beyond the human biology that we study determined by a loving God in whose image we are made. As such, our bioethical inquiries seek to understand whether the human purpose of a particular medical technology or procedure is complementary or contrary to God’s purpose. Why? As Dr. Phillips explained, because God loves us and has asked us to love our neighbor.

Maybe that is an answer to “Why was there a Big Bang?” (and “Why is a cow?”)

Why do we do this?

Many of the posts on this blog involve cautions that there are things in medicine which we are capable of doing and which some want to do that we should not do. Much of the time those cautions go unheeded by our society. For fifty years we have been saying that we should not perform abortions, but many unborn human beings continue to lose their lives. We give reasons why we should not do euthanasia, but PAS becomes legal in state after state. We write about why we should not alter the genes of human embryos, but the research continues. Is it just that we are anti-medical science and like telling people what they should do?

No. We do it out of love. Sometimes it is love and concern for people who are powerless and cannot speak for themselves. It is because of our love for the person who is aborted as a fetus or comes into being as the result of a genetic manufacturing project rather than being accepted unconditionally as a gift. It is out of love for the Canadian man who chooses euthanasia because he cannot obtain the 24 hour a day care he needs to live life with ALS.

It is also out of love for those who do things that are wrong. Love for the physician who performs abortions or euthanasia. Love for the researcher who uses human embryos as research subjects destined to die. We do it for the sake of the gospel which tells us that we have all done wrong and are destined for judgment unless someone intervenes. The gospel that tells us Jesus did intervene by his death and resurrection and has made forgiveness and restoration available to all who confess their wrongdoing and put our trust in him. We do it for those who will miss out on the amazing grace of the God who died for us if they listen to a culture that says that anything you desire to do is right and there is no need to ask for forgiveness for anything.

What Christian ethics is not

About this time in the semester, after discussing some basic things about the discipline of ethics and looking at some of the main ethical theories in western philosophical ethics, I begin a discussion of Christian ethics with the students in my bioethics class. I intend this to form a foundation on which they can ground their thinking about the issues in bioethics that we will discuss throughout the rest of the class. This year I decided to begin by talking about what Christian ethics is not, because we live in a world that has misunderstandings about many things including Christian ethics.

Here are the things that I have suggested to them that Christina ethics is not.

#1 It is not that we are better than they are (or that I am better than you are.)

Commonly when someone says that something is wrong, those who want to do it say that those who say it should not be done are trying to show that they are morally superior. I think this is a common motivation for making moral statements, but it should never be a part of Christian ethics. It contradicts what we, as Christians, believe. A fundamental part of the gospel is that we are all wrong. We are all sinful and in need of redemption. It is essential to our faith to believe that we are not better than anyone.

#2 It is not about what I think is right.

For those who believe in subjective relativism, ethics is truly about what I think is right. For the cultural relativist it is about what my group thinks is right. Even among many moral philosophers who believe in objective moral truth, whether they are Kantians or Utilitarians, ethics is about what I can determine to be right, based on my intellect and reason. From a biblical Christian viewpoint, it is what God thinks is right that is important. We are just trying to understand what he has revealed to us. None of us understands the mind of God completely. When we disagree, discussing why we think as we do can help us both get a better understanding of what God thinks about it.

#3 It is not about being good enough for heaven (or earning a relationship with God.)

Our society’s cultural religion says that as long as we do more good than bad, we can expect heaven as our reward. The Christian gospel says that our relationship with God and ultimate destiny are entirely dependent on Jesus’ death and resurrection. It is not about being good enough or doing more good than bad. So why do we care about ethics? Genesis says that we were created in the image of God. One of the things that means is that God intended to be a reflection of himself and his glory. Since God is a moral being who is good and we are sinful, we must be transformed to reflect God and bring glory to him.  Living morally upright lives through the transforming power of the Holy Spirit as people who have been reborn through Jesus’ death and resurrection allows us to worship God by living lives that reflect his goodness. That is what Christian ethics is.