International commission: go slow with heritable human genome editing

The international commission on heritable human genome editing (HHGE), formed by the US National Academies of Medicine and Science and the Royal Society of Great Britain, has issued it report.  The 224-page report is freely available for reading here, and a summary news report can be accessed here.

The upshot:  not too fast.  The commission’s 11 major recommendations, briefly reworded and rearranged in order, are:

  • Before attempting any pregnancy with a gene-edited human embryo, “a significant cohort” of edited human embryos should be studied in the laboratory to ensure that the desired gene edit(s) “can be performed with sufficiently high efficiency and precision to be clinically useful.”  (No attempt would be made to bring these embryos to birth, and they would exist solely for research purposes, after which they would be destroyed.)
  • This efficiency and precision have not been demonstrated yet, and “no attempt to establish a pregnancy” with an edited human embryo should be made until they have.
  • Even then, the attempt should come only after “extensive societal dialogue” within any country whose leaders are considering endorsing the attempt.  This dialogue would include medical and scientific concerns, which the report addresses, and also “societal and ethical issues that were beyond the Commission’s charge.”  (Your correspondent has just begun reading the report, so cannot say yet whether the Commission considered how to proceed if one country green-lights edited human pregnancies while others do not.)
  • The only conditions that should be considered for editing are those of a serious disease caused by a single gene abnormality, for which the prospective parents have a less than 25% chance of having an unaffected child using current preimplantation genetic diagnosis (PGD).  Further, the resulting edited gene would be common and non-disease causing in the general population, and no embryos without the diseased gene would be edited. (This would seriously limit the use of HHGE—not permitting it for genes that increase the risk of cancer, for example—but, like the first point, would also raise concerns for conservative ethicists who consider all human embryos, from conception, to be human beings with the right to life.  If you’re troubled by PGD in general, this recommendation won’t satisfy you.)
  • The above would need to be followed for every proposed “treatment” of genetic disease—there is no “one-size-fits-all” approach to setting up a regime for heritable gene editing in general.  (This would have the effect of limiting the “industrialization” of HHGE, it appears.)
  • The actual transfer of an edited embryo to a woman’s uterus should be subject to (future) “rigorous” regulatory review and approval—that is, the edited embryo would be checked, in the laboratory, before transfer, to be sure that the edit had succeeded.   After transfer and through pregnancy, birth, and the life of the individual, close medical monitoring would be mandatory to learn what medical problems may have arisen.
  • A potential work-around should be studied in the laboratory: making human eggs and sperm from stem cells, with the intent of being able to use them for in vitro fertilization to give rise to an embryo without the abnormal gene.  However, the Commission recognizes that there are other canned worms, so to speak, to be dealt with here—such as whether this approach to begetting children is ethical at all, apart from any use of gene editing.
  • Any country embarking on HHGE in actual pregnancies should first put in place “mechanisms and competent regulatory bodies” to oversee standards and adherence to them, publication of results, and oversight in general.
  • An International Scientific Advisory Panel should be established in advance to oversee the progress of the science overall, before pregnancies are attempted—essentially, a single point of review to prevent intrepid scientists from “going rogue,” as it were.
  • An international body (presumably a different one from the above) with appropriate expertise should review every new proposed medical application of HHGE before pregnancies with the relevantly-edited embryos are established.  So, presumably, attempts to edit the gene for Huntington’s disease would be assessed separately from attempts to edit the gene for sickle cell anemia, for example.
  • An international mechanism should be established to adjudicate cases of alleged deviation from received guidelines or standards, and its’ results should be transmitted to individual governments and publicly released.

It looks like a careful report, welcome in its caution, although, as noted, those who hold that human life begins at conception will still likely object to the endorsement to continue with laboratory-based research.  “Just say no” to the prospect of HHGE—a position your current correspondent has consistently advocated on this topic—does not appear to be in view.  One might also be forgiven for skepticism over the effectiveness of any international body, given the controversies that arise from our existing international bodies for medicine and health, not to mention other endeavors.  Some such efforts, such as the regulatory harmonization of human clinical trials and drug development that governs the US, the EU, and Japan, work pretty well, but arguably are limited.

It is also worth mention that the California Institute of Regenerative Medicine (CIRM), established with Proposition 71 in 2004, ostensibly to translate embryonic stem cell research into cures (with creation and destruction of human embryos for the purpose), is proposed for renewed public funding in California with Proposition 14 in this November’s election.  Nothing approaching a cure was achieved under the CIRM, and even proponents of human embryonic stem cell research argue a renewal is unnecessary, because there is plenty of private money supporting related work already.  Further, the CIRM came under charges of insider dealing, because it needed to draw its leaders from the small pool of experts who tended to have career or monetary interests in the field to begin with, raising repeated concerns about a conflict of interest.  Would such potential conflicts plague the national and international bodies proposed by the HHGE Commission?  (Full disclosure: your correspondent will eagerly vote “no on 14” on his mail-in ballot this fall.)

Finally, so-called “somatic” gene editing—a fundamentally ethical undertaking by which a person’s cells may be altered to make them into a treatment for disease—is here to stay, as are certain forms of gene therapy that don’t involve heritable changes.  Expect to hear about those more in the future; they are subject to standard human subject research concerns, and to justice concerns like the eventual costs of the treatment.  Those topics for another day.

The NFL is back!

As we observe another Labor Day, our annual transition from the heat of summer to the cool breezes of autumn, it is refreshing to know that the National Football League is planning to start its 2020 season in just a few days.  As you are probably aware, team officials throughout the league have factored COVID-19 into their planning this year and have made adjustments accordingly.  For example, my hometown team, the Miami Dolphins, will be limiting their home attendance to just 13,000 fans per game (which is 20% capacity of their home field, Hard Rock Stadium).  

What caught my interest in the run-up to the new football season was a recent article in The Washington Post describing a former player’s concern about chronic traumatic encephalopathy (CTE), the concussion-related disease that has profoundly affected many players.   

In the past few years, the NFL has acknowledged the negative impact of traumatic head injury associated with football-related concussions and reached a financial settlement with players.  This settlement, according to the Post, “already has awarded nearly $790 million to retirees with cognitive impairment or conditions such as Parkinson’s or Alzheimer’s.”  

The Post reported last week that neurologists are working on experimental scans that would identify the presence of CTE while players are still alive.  It tells the story of Sean Morey who was Pro Bowl player for the Arizona Cardinals: “Morey estimates that he suffered more than 20 concussions over his career, most of them undiagnosed, and countless other blows to the head.  Following the 2009 season, he began having blind spots in his vision and excruciating headaches that would leave him immobilized for hours at a time.”

The tests are still in development and more work must be done, but the goal is a worthy one.  The ability to have a diagnostic test that would clearly show whether or not a player has CTE (or the extent to which they have it) would be a major step forward for the many who wonder if their current mental impairment is a result of their playing days.  Eventually, it could lead to the development of a treatment that could help affected players live happily past their playing days.

Not that long ago, the NFL was in denial about these issues (hence the book, League of Denial by Mark Fainaru-Wada and Steve Fainaru), creating a major ethical (and legal) problem.  I hope as research continues that the league will continue to help those who have helped make football so successful.

A Tale of Two Elders

Concern for elderly relatives and friends has been heightened during the coronavirus pandemic.   In the last month, I have visited two nonagenarians:  one was in the assisted living portion of a large multi-level care facility; the other, in her own home.  In both, frequent hand washing or sanitizing by visitors was done.  The assisted living facility visit required a mask and at least six feet of distance between us at all times.  The second nonagenarian refused to wear a mask, and we ate several meals together, maintaining some interpersonal distance.  Both visits were incredibly special, and I am grateful that we all continue to be well.

Thanks to Andrew Cockburn’s “Elder Abuse” article in Harper’s Magazine, I have formulated some important questions to ask about the care facilities for elderly that abound in our nation.  These should be helpful for relatives and friends who are either in long-term care facilities, or contemplating moving into one:

  1. Are you/will you be close to concerned relatives or friends, or far from any potential visitors?
  2. How often are visitors allowed?  What are the rules, including during a pandemic?
  3. Who owns the facility?  Have there been any fines levied for substandard care/other problems?
  4. Is the facility in a state that has legislation holding harmless the facility during this pandemic?
  5. Does the state where the facility is located have an ombudsman for senior care?  Is that office functioning now?
  6. Is there a local newspaper/reporter who publishes on senior issues?  Read their articles, and consider sending an email to interact with the writer of any article on elder concerns.  Building bridges in the community is important.
  7. Not to put too fine a point on it, but who will be paying for the care?  The “Elder Abuse” article points out that nursing homes strive to obtain the “right mix” of Medicaid and Medicare patients.  A COVID-19 diagnosis can benefit facilities monetarily; but then, so can discharging Medicaid patients in an effort to open beds for patients with higher-paying Medicare benefits.

Using data from the World Health Organization, Cockburn reports the differences between, inter alia, the United States and Greece, in terms of elderly casualties from COVID-19.   The United States has 515 nursing home beds per 100,000 population; Greece, 15.  The United States has 39 COVID-19 deaths per 100,000; Greece, with the “largest proportion of elderly people in Europe,” has two deaths per 100,000.  The author suggests, “One might almost conclude that the death toll that has so traumatized and destabilized much of Western society in 2020 was not wrought principally by the coronavirus, but by nursing homes.”

The nonagenarians I recently visited are both Americans.  The masked 93-year-old in an assisted care facility has been restricted from speaking with other residents he meets in the hallway or when he walks outside on the well-manicured grounds.  He has spent months having meals delivered to his room where he eats alone.  He spends thousands of his retirement dollars per month, but cannot be said to be happy with his purchase.  The other nonagenarian I visited lives alone.  She has not seen the inside of a store since March, because other people shop for her, using lists she has provided.  Her budget is significantly smaller than her counterpart described above, but she is rich in relationships.  For her birthday this summer, she received 123 cards. 

The Greek model of elder care seems clearly a better choice. Americans could do this — without importation tariffs.

Pediatric Fertility Preservation for Hormone Suppression in Transgender Youth

Last week, I received an e-mail update on current research and treatment being performed at the institution where I did my residency training. One of the interesting research areas was in the discipline of pediatric fertility preservation. Pediatric patients who undergo cancer treatments often take medications which cause destruction of their testicles or ovaries, not uncommonly resulting in infertility problems when the patient reaches adulthood. Advances in cryopreservation techniques of reproductive tissues are offered as a solution to preserving one’s fertility after pediatric cancer treatment.

The cryopreservation technique in the pediatric population is not limited to cancer treatment. There have been advances in providing fertility to non-cancer medical conditions that previously caused infertility. Two such conditions are Klinefelter syndrome and Turner syndrome which affects sex chromosome anomalies male and female patients, frequently resulting in infertility problems in those patients. By cryopreserving these patient’s testicular or ovarian tissue when they are children, when the number of the reproductive cells are in larger number and/or have the best potential for future reproductive function, in vitro fertilization techniques using these preserved cells when these patients reach adulthood can improve fertility.

The same pediatric fertility preservation treatment is now being offered prior to the hormone medication used to assist pediatric transgender youth transition from their birth sex to the opposite gender. Hormone treatments are used to intentionally suppress the transitioning person’s natural sex hormone production. This causes body habitus transformation to the desired gender. Continuous hormone suppression severely reduces (and can eliminate) baseline anatomic testicular or ovarian function causing permanent infertility in the transitioning patient. There is additional concern that the infertility persists even if that hormone treatment is later discontinued. Limited data exists to make conclusive statements on this subject as studies on long-term physiologic effects of hormone treatment used to transition pediatric patients are lacking; this is true even in the adult population where the number of patients who have transitioned is much larger.

Bioethically, we have moved beyond the question of whether we should be doing hormone suppression to assist in gender transitioning in the pediatric population and begun to discuss whether that child’s fertility ought to be preserved following such hormone administration. A simple Google search for non-hormone treatment of gender dysphoria in the pediatric population shows mostly hormone-based treatments for the first pages of results. With more effort, non-hormone options can be found.

The Mayo Clinic update that I received describes the transgender fertility preservation treatment along with a constellation of other pediatric medical conditions whose treatments potentially cause infertility (i.e. the cancer chemotherapy treatment causing infertility described earlier) as if all of these programs should be considered medically (and ethically) equivalent.

Are they?

If they are not, shouldn’t we be debating the medical and ethical pros and cons of pediatric transgender hormone administration more thoroughly before we consider how (and why) to preserve the very fertility of the pediatric patients we are altering by intentional hormone suppression?

A contemporary reprise of theories of justice

This blog’s being sponsored by an evangelical Christian university means, among other things, that at least some contributors, notably the current writer, tend to adopt a set of basic Christian assumptions (monotheism, tenets of historic Christianity, biblicism) in approaching matters of bioethics, including justice.  In that light, a recent summary of a Christian framework for justice, by the Presbyterian pastor Timothy Keller, is worth a careful read.  It is a concise and erudite summary of the different secular approaches to justice in pluralistic American society, contrasting them with a Christian approach.  (It does not attempt to address frameworks specifically grounded in other religious traditions.)

Drawing on the teachings of the Bible, especially the example of Old Testament Israel as embodying universal, enduring principles of justice intended by God, Keller characterizes biblical justice as encompassing concern for community that entails a moral imperative to generosity; equity in treatment of all human beings; corporate responsibility, meaning that sometimes, people bear responsibility for sins of others; but also individual responsibility, meaning “I am finally responsible for my sins, but not all my outcomes”; and an imperative to advocate for poor and marginalized people.  Of these, the contours of corporate vs individual responsibility will certainly spark debate among Christians, but living out these principals is, Keller argues, the responsibility of the Church in a secular world.

The big contrast is with atheistic, secular approaches to justice, which must and do fail because they neglect, avoid, or despise appreciation for human teleology—what are people for, what is their purpose?  Keller invokes Alastair MacIntyre’s Whose Justice?  Which Rationality? and, with MacIntyre, takes the position that “behind every understanding of justice is a set of philosophical beliefs about (a) human nature and purpose (b) morality, and (c) practical rationality—how we know things and justify true beliefs.”  Disagreement about these, particularly about human nature and purpose, leaves the prospect for secular agreement about justice well-nigh hopeless.  The rationality of the Enlightenment failed in this regard, and the popular current secular default that morality springs from common sense begs the question, assuming a common moral intuition that need not and does not pertain.

The current American secular landscape is dominated by four theories, which lie, progressively, on a spectrum of sorts, from individualist to collectivist, in order:

  • libertarianism, the position that justice is the maximization of individual freedom, which fails to appreciate the importance of community and the depths to which sin distorts human affairs, and which is too grounded in individual self-interest;
  • modern liberalism, which focuses on fairness, most recently following John Rawls’s A Theory of Justice, and emphasizes rights or entitlements, often to be guaranteed by the state.  It fails for reasons that have been well-rehearsed many times elsewhere: an enthronement of individual autonomy, a lack of a standard for adjudicating conflicting rights-claims, and an unwarranted faith in reason (notably in cost-benefit analyses), attempting to exclude religious values, but, in America at least, assuming Judaeo-Christian principals and values to support fairness judgments;
  • utilitarianism—justice is what produces the greatest good for the greatest number—which, for all its usefulness in individual judgments, fails as an overarching approach for many well-known reasons, including incommensurability of goods, potential to embrace mistreatment of minorities, insufficient criteria for what is “good” in the first place, and over-reliance on the language of “harm” to ground judgments;
  • postmodernism, the notion that “a just society subverts the power of dominant groups in favor of the oppressed.”  This may be the loudest current voice, and it draws the lion’s share of Keller’s attention.  This approach, Marxist in its foundations, starts from the presupposition that human affairs are the product of impersonal social or historical forces—the old “scientific theory of history.”  Keller provides an excellent, quick digest and explanation of what the current radicals, articulating Critical Theory (or Critical Race Theory when applied to racial relations), are talking about when they invoke “dominant discourses,” “intersectionality,” and “checking one’s privilege.”

Let us be clear—Critical Theory is rubbish, and Keller hits it hard.  Among its defects: deep incoherence—if everyone is blinded by their circumstances, so are the Critical Theorists; it reduces humans to automatons and fails to account for universal sin, moral agency, and the union of soul and body (I suppose if you deny that people have souls, and think they are just bodies, you just might be a  Marxist materialist); it denies human sinfulness and common humanity and makes forgiveness and reconciliation impossible; it invites extreme self-righteousness on the part of its adherents; and it sets the stage for oppression under the disguise of opposing oppression.  (Memo to the young: we just spent a century battling the various demons of totalitarianism, and you get to decide what you think of the second coming of Mao.  Study well.  Read attentively.  Choose carefully.)

Read the whole thing.

The Old Guard

In an effort to disconnect from the craziness of life, I recently watched “The Old Guard,” a popular 2020 Netflix movie.  [Note:  spoiler alerts ahead.]  It tells the story of four “immortals,” led by Andromache of Scythia (also known as “Andy,” portrayed by Charlize Theron), and the ups and downs of their existence.  

As we are introduced to each of the immortals, we find that they were born in different centuries and have been alive for a very long time.  The bulk of their time seems to be participating in battles that have taken place throughout history  (e.g., The Crusades, the Napoleonic era, etc.).  It’s not clear from the movie that they were always immortal, but each one finds out quickly after sustaining a deadly wound and suddenly come back to life.  A fifth immortal, Marine officer Nile Freeman (portrayed by KiKi Layne) is introduced in a graphic scene where her neck is violently slashed and she is basically dead, but remarkably, she heals without explanation and without scars.  Within a few scenes, Andy takes Nile taken from her military camp and has introduced her to the team of immortals.

Obviously, there are some big questions here that we hear the immortals ask throughout the movie:  “Why me, why am I immortal and others are not?”  Or, “What are we supposed to be doing with this ‘immortality’?”   “Are we making any difference in a world that seems like it is getting worse instead of better?”  By the end of the story, the viewer gets an idea about the difference that the immortals have made throughout the years, but the “why” question remains unanswered.  Andy is a confirmed atheist and views Nile’s faith in God as illogical.  

More ethical issues arise when Big Pharma gets involved.   The villain of the movie, Steven Merrick (portrayed by Harry Melling) is the young Zuckerberg-esque head of his own pharmaceutical company.  He enlists help from a former CIA agent, James Copley (portrayed by Chiwetel Ejiofor) to capture the immortals and to run a series of endless tests on them.  As you might expect, the immortals are eventually captured and meet Merrick face to face.  He informs them that it is their duty to submit to his torturous experimentation because in the long run, they will help humanity.  He goes so far as to tell the heroes that it is ethical duty to do this because they could help so many people.

Copley’s ruthlessness clearly tells the viewer that his ethics are problematic.  He is not simply an altruistic scientist, he is an entrepreneur who wants to ensure that the immortals do not fall into the hands of his Big Pharma competitors.  His words about helping humanity ring hollow because of his overall devotion to the bottom line.  Or as he was told at the end of the movie, “It was not your choice to make.”

“The Old Guard” is a cautionary tale cloaked in the garb of a twenty-first century Netflix feature with all the special effects one might hope for.  Humanity never seems to learn their lesson; technology always seems to have a leg up on ethics.  In our fast-paced world, a cautionary tale may be just the thing we need.

Human Fetal Tissue — Considerations

The NIH Human Fetal Tissue Research Ethics Advisory Board met on 31 July 2020 to “make recommendations regarding the ethics of research involving human fetal tissue (HFT) proposed in NIH grant and cooperative agreement applications and R&D contract proposals, as set forth in the NIH Guide Notice NOT-OD-19-128.” The meeting agenda included a brief time set aside for public comment. Additionally, written comment could be submitted within a prescribed time frame prior to the meeting.

It is my hope that the advisory board seriously considered the following comment penned by this writer, on behalf of the educational non-profit Tennessee Center for Bioethics & Culture:

All human beings belong to one another.  Whatever our genetic constitution, our ethnicity, our color, our femaleness or maleness, our geographic location, or stage of life:  we are part of the human family.   That membership is not bounded by a cradle-to-grave timeline.  As human mammals, our beginnings begin before the exodus from our mothers’ wombs.  From the fertilization of the egg by the sperm, a new human being arises (and sometimes, multiples).  How we treat that human zygote, embryo, fetus, newborn, baby, toddler, preschooler, child, adolescent, adult, and elder, has effects on that human being – as well as on ourselves.  How we treat other human beings, especially vulnerable ones, tells future generations and civilizations about what kind of people we are.

In 1993, President Bill Clinton signed into law the NIH Revitalization Act.  That Act charged the NIH to conduct or support research that reduced the number of animals used in research, and that produced less pain and distress in those animals (https://grants.nih.gov/grants/olaw/pl103-43.pdf). Those are laudable goals.  That same 1993 NIH Revitalization Act authorized the use of human fetuses for research, including fetuses from induced abortion (www.hhs.gov/ohrp/regulations-and-policy/guidance/public-law-103-43/index.html).  The same law that sought to reduce pain and suffering in animals opened the door wider to using nascent human beings as research subjects.  Utilizing tissue that becomes available by virtue of spontaneous abortion (miscarriage) does not actively convert living beings into research subjects/objects.  It is not a planned procedure that can be scheduled around tissue procurement firms.  That is not the case, however, with the use of fetal tissue from induced abortion.  The willful taking of tiny, live human beings from their mothers’ wombs, followed by the use of them in whole or in part, as research subjects/objects, sets up a human market.  Abortionists and abortion facilities are paid to render a living being into products or parts.  Then they are paid again to yield up these beings or parts to research.  Money is exchanged for parts or labor, even if said payment is labeled “handling charges.” This is a market, and it is a market in human flesh:  a stain upon our culture and our civilization.

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.”

A new cautionary tale for heritable genome editing

A fundamental concern about applying gene editing to human embryos is how to limit the risk of errors, or “off-target” effects.  One makes an edit to change a bad gene’s defect, and presumably prevent the disease the defective gene would cause.  But the current methods to do that, although apparently highly selective, might still make other, unwanted changes as well—with possible deleterious, even disastrous, consequences.

Heretofore, the attention to these “off-target” effects has largely been directed to changes in genes that are separated from the target gene.  However, a recent news item in Nature describes three recent experiments with human embryos in the laboratory, in which large defects were induced in the chromosomes bearing the target gene—that is, right next door.  The difference is a bit like the difference between damage by shrapnel (distant effect) and blowing a 6-foot hole instead of a pinhole (near effect).  The latter is now the new concern.  Apparently, and, for one who does not live the scientific details daily, amazingly, prior analytic techniques were missing the possibility of these big, close-in errors.  “CRISPR gene editing in human embryos wreaks chromosomal mayhem,” the headline reads.  Geez Louise…

The technical details are still to be worked out, but one possibility is that, after the targeted gene is cut by the editing mechanism, the way that repair of the genes is done by the human embryo creates the possibility of introducing errors by copying or shuffling of a big chunk of the gene.  These processes are not fully understood in human embryos, and may be different from what pertains in mouse or other animal embryos, or in single human cells such as egg cells or newly-fertilized eggs.

The big technical message is that a lot is poorly understood and will take a ton of work to sort out before one can be confident that a pregnancy carrying a gene-edited to-be-born human will birth a healthy baby, in the immediate outcome, never mind consequences later in life.  It further suggests that no amount of animal work may lay the matter to rest.  From that it’s hard to avoid the conclusion that many embryos will need to be created, altered, and destroyed for research purposes if heritable human genome editing is to proceed with some assurance of safety.  How long would those embryos have to be kept alive to test?  Quite possibly longer than the few days currently possible and accepted by the scientific community.

Absent that, trying to birth gene-edited children would mean, as this blog said some time ago, that “the babies are the experiment.” 

And, even if one does not grant moral status to the human embryo from the point of conception, one is compelled to seek an accounting of the compelling unmet medical need that supports a careful benefit-risk analysis.  Risks to human subjects—embryos, fetuses, eventually-born babies, women donating eggs, perhaps even women carrying partial pregnancies (to allow study of results from a later point in utero?)—seem substantial, overall costs of the effort raise questions of spending the money better elsewhere in the overall health care of society, and alternative approaches to the diseases in question must all be considered.

Geez Louise.

One other point: the Nature article cites preprints posted, prior to peer review of the science, on the website bioRxiv.  Operated by the outstanding Cold Spring Harbor Laboratory, the website offers authors the chance “to make their findings immediately available to the scientific community and receive feedback on draft manuscripts before they are submitted to journals.”  Open access and public feed back are good, but the general press often picks up these preprints, whose quality may not have been fully vetted, and runs with headlines—kind of like I am doing here, following Nature.  So we must watch this space to be sure that the research is being accurately described and interpreted.  For the moment, the topic of this post can be taken as another example of “something to watch out for.”