Public discussions on human gene editing

On August 3, the National Academies of Science, Engineering, and Medicine posted online the slides and talks from its July 12 meeting to discuss public implications of the Human Gene-Editing Initiative.  A total of four meetings plus a related workshop were held: an introductory discussion in December 2015, followed by three more substantial meetings plus the related workshop in February, April, and now July of 2016. 

I’m still working through the materials, notably Francis Collins’ slide set from the July 12, 2016 meeting, addressing regulatory processes, in utero gene editing, and other topics.  But what first caught my eye was a brief written statement from the same meeting, from Ron Cole-Turner of Pittsburgh Theological Seminary.  In it, he states that Christian opinions on human gene editing are not monolithic; that, far from being reflexively in opposition, those opinions are quite open to editing even of the human germline as long as safety concerns are addressed, embryos are not sacrificed in the process of research, and therapy rather than enhancement are in view.

I must say the statement disappointed me.  The “safety argument” is the most prominent ethical concern raised in discussions of whether editing human genes in heritable ways is ethically permissible.  We certainly want assurances that we would not put the “edited” individuals at risk, and we really would want some level of certainty that the downstream effects would not be disastrous.  But of course, the latter may be impossible to assess, since adverse consequences could be subtle and might become apparent over many generations.

Beyond that, I thought Cole-Turner’s statement was too limited, with no mention of questions of informed consent, and with no deeper reflection on how human germline editing might (I would say, would) alter the way we look at ourselves, each other, our children, and the human race in general.  The push would be further toward seeing humans as plastic, alterable entities without limit, and, beyond questions of “simple” justice (how would we keep from making benefits available only to the rich?), would create a class of, as C.S. Lewis suggested, “conditioners,” or as contemporary European thinkers have put it, a class of engineering humans who work on other, engineered humans.  Finally, Cole-Turner did not really engage the concern that there is a constant eugenic temptation in humanity that would likely re-assert itself with force.

Cole-Turner’s statement was not proud; he opened by admitting that no one person could speak for all Christians.  And maybe brevity was necessary on the occasion of the committee meeting.  But I still would hope for more robust “religious” inputs at sessions like this.  Otherwise, one gets the feeling that all that is sought is a token religious imprimatur on the most cutting-edge biotechnologies of the “brave new world.”

Follow the link in the first sentence of this post, and the statement by Cole-Turner, as well as other materials from all the meetings, may be reviewed in detail.  It is good that these are posted, because, although it’s easy to say that a thorough public discussion of transformative biotechnology should be held with all stakeholder groups, only so much is generally done to achieve that.  Even interested parties, like your humble correspondent, have limited time to devote to the details.  But more of us in the general public should labor to make time to dig in deeper.

ADDENDUM: After posting the above I went back to the link (top of this post) and read through the slides from Dr. Collins.  Readers of this blog should by all means do so as well.  At the end, he muses about the level of acceptability of 28 current or possibly future interventions, placing them on a grid of when they will be in practice vs. level of ethical concern they prompt.  The slides are self explanatory and worth musing over.–JTH

How can we make the “brave new world” a campaign issue?

Wesley Smith, who, based on his writing, I consider a kindred soul in bioethics, has published an essay in First Things dated August 5, 2016, and entitled, “Brave New World Should be an Election Issue.”  In it, he quickly runs down the revolutionary changes in the very nature of humanity that appear in the offing based on biotechnological developments since the publication of Aldous Huxley’s novel.   Noting that Huxley initially thought the “horrors” described in Brave New World would take 600 years to materialize, only to revise that estimate to a century or less, Smith concludes, “It doesn’t have to be that way. We need not helplessly, passively, watch biotechnology’s power and influence surge. We can shape biotechnological advances to achieve moral ends. But that will require far more consideration of these issues than we have yet given them.”

Hear, hear.  But how to get people to listen?

Now, when it comes to politics, I’m an opinionated blowhard but no pundit.  (I know, I know, a distinction without a difference?)  Yet from what I read and see it looks like people vote based on their near-term concerns, not longer-term issues or matters that appear more abstract or are hard to understand (these days, > 140 characters).  Hence, the economy, jobs, trade, immigration, terrorism, how we view and empower and deal with the police, and the like are what come to the forefront in political campaigns.  These issues make for more striking video and/or louder shouting matches on TV, and most folks feel close enough to them to form opinions.

Less so with the technically complex issues of the new biotechnology, which we almost by necessity leave to “experts,” expecting that “they” (or maybe I should use Thomas Pynchon’s “They”) will steer these to places that we will find convenient and congenial.  And often times, that boils down to “what will they think of next?” rather than, “do we really think this should be done at all?”

And so, the challenges are to get people’s attention, communicate complex matters in ways they understand, and convince them not to support questionable actions even if they make life more comfortable.  And so, how to get people to understand what’s potentially at stake with human gene editing?  How to get them to stop what they are doing long enough to try to think through how much we should use genetic diagnosis to control the phenotypes of our offspring?  And how to get them to at least question something that could be awfully convenient and career-friendly, like artificial gestation, admittedly still rather further off than the other two examples here—or, than, IVF and gestational surrogacy?

Essays, blogs, the occasional Congressional testimony, and 2-minute spots on cable news may be necessary but hardly seem sufficient.  Expert conferences, open to the public though they may be, are practically limited to the experts who live the issues being discussed, and who have the time, energy, and experience to be able to address the concerns, give them priority, and then, in turn, be listened to coming out of the conference. 

(It’s as if we need a “Reformation-style,” if you will, public availability of the “Bible of science,” with common folk encouraged and empowered to read it on their own and draw their own common-sense conclusions, rather than rely on a learned “clergy” for their hermeneutics.  But that surely is also fraught—common sense can surely go awry, and a certain amount of learning is needed to read at all.)

What to do?  Well, I suppose: focus on education, from a very young age, in normative anthropology—what it is to be human—and on normative views of the family and procreation; keep theology central, as much as the secular world resists that; take individual techniques and issues and try to demonstrate, in simple terms, where they not so much might lead but are likely to lead; create creative works—movies short and long, public service announcements, ad campaigns—trying to illustrate concerns (think about the campaign against texting while driving); talk matters up in normal conversation.

Social media?  You tell me.  I never touch the stuff.

That in turn requires, I think, a group of people with the persistence, wherewithal, and creativity to press the different cutting-edge bioethical concerns in new ways, on an ongoing basis.  It requires a different approach than the advocacy of the last 40 years that attempts to “influence policy,” in an age where the opportunities, much less the efficacy, of that kind of advocacy appear constricted.

I’m not exactly sure how one would do it, or who.  Pray God will raise up a new generation.

And suggestions are welcome.

The need for believers to base moral decision on biblical concepts

The article “I’m a Christian with Stage IV Cancer. I Want Death with Dignity.” by Corinne Johns-Treat on that Neil Skjoldal discussed in his post on Monday illustrates a problem within the church that I have become very concerned about. I have written about this concern before in the context of what I hear from students at the Christian university where I teach, but I think it is a problem within the church as a whole. I am concerned that people who sincerely believe they are followers of Jesus and a part of his church make important decisions about how to live their lives based on underlying concepts that come from the secular culture around us and not based on biblical concepts.

In the article Johns-Treat says, “the more I learned about the safeguards and autonomy in the law, and the more I prayed about it, having seen people suffer so much at the very end of their lives, I came to believe in that it fit into my faith,” and “I think when you look at a personal experience, governing doctrines from a church don’t seem to matter nearly as much.” These two statements provide insight into the thought processes that have led the author to her conclusions. The problem is that these thought processes are grounded in the thinking of the secular culture that surrounds us and not in biblical concepts.

In the first statement she refers to the principle of autonomy which is the primary moral principle used to defend the moral permissibility of assisted suicide or medical aid in dying. From a biblical perspective we have reason to respect the autonomy of others because God does that in allowing us to make our own choice whether we follow him or not. However, if we do choose to be disciples of Jesus, we have chosen to submit ourselves to him and our decisions should be made based on submission to God’s revealed truth in scripture and not based on our own autonomy.

Implied in the first statement and stated more clearly in the second statement is the author’s underlying concept that moral decisions are based on our personal feelings and experience rather than on biblical truths. As long as a person feels that assisted suicide or aid in dying is not wrong then it is permissible and it is not necessary to base that decision on biblical concepts. When I think about why I would think it would be wrong for me to turn to assisted suicide if I had terminal cancer it is because of the concept of the sanctity of human life due to being made in the image of God and the idea that my life belongs to God and not to myself. We live in a society that says that our moral choices are based on how we feel, but by choosing to follow Jesus I have chosen to live based on God’s understanding of what is right and wrong rather than based on how I feel.

In his post Neil expresses a desire that people would see good palliative care as the better way to relieve suffering at the end of life rather than turning to assisted suicide. For those who are followers of Jesus there are biblical reasons based on the sanctity of human life and our submission to God as the Lord to whom we belong to choose palliative care over assisted suicide.

Toward human-animal hybrids

To be published tomorrow in the Federal Register, the massive, Byzantine thousands-upon-thousands of pages repository for all of the rules and regulations that constitute so much of de facto law in the contemporary United States: a Request for Public Comment on the Proposed Changes to the NIH Guidelines for Human Stem Cell Research and the Proposed Scope of an NIH Steering Committee’s Consideration of Certain Human-Animal Chimera Research.  

As always, the technical issues are complex.  But, briefly, some scientists are working on putting human “pluripotent” stem cells—like embryonic stem cells, the kind that can produce many different organs or tissues or even a full human being—into early embryos of other mammals, such as mice or pigs.  Why?  To try to understand a disease better, or, in the case of some of the pig work, event to “grow” a human organ in an animal for future transplantation.

The National Institutes of Health (NIH) limits the scope of what it will pay for, because, frankly, we don’t know what we will get.  Concerns include having an animal with a more “human-like” brain, or one that can make human sperm and egg cells, or one that could breed to “spawn,” if you will, a part-animal, part human or even a human baby in a female animal.  More generally, what percentage of human cells does it take for a living being to be considered human, and how far might we experiment with adding human cells to animal embryos and animal cells to humans?

Farfetched?  Some scientists have reportedly looked at human stem cells in mice to see if brain function is affected in a way that can help understand psychiatric conditions.  See this discussion from the New York Times.

The proposed revisions to the NIH rules purport to make restrictions tighter by prohibiting government funding of experiments in which any pluripotent cells, not just the specific ones in the current guidelines, are inserted into early embryos from non-human primates (monkeys, apes) or breeding animals when the work may have contributed to human sperm or egg cells having been produced. 

But they would open introduction of human cells into other mammals’ embryos, or in non-breeding situations, as long as a committee determines that there could not be “a substantial contribution or a substantial functional modification to the animal brain by the human cells.”  Even here, they exclude rodents, presumably to permit such work in mice or rats to proceed.

The NIH wants to claim that this work can be carefully monitored and regulated to keep it from getting out of hand.  But non-government funded research would not be affected, and intrepid actors will invariably try to stretch the boundaries.  And some are concerned that even in the specific case, much less the “field” as a whole, we can’t predict where it will all lead.

If the society could, it should slow much more of this work down, if not call a halt entirely.  But legal bans are likely to be circumvented, and appeals to potential benefits generate continual pressure to move ethical boundaries further.   I think that ultimately it will not do to argue that eventual risks outweigh benefits.  Rather, we would have to convince our fellow humans that ethics require that we just forego some opportunities.  And that’s a hard sell.

Some California Physicians are trying to fight back against Doctor-Assisted Suicide

The Wall Street Journal op-ed page this week carried an offering (subscription required) from one Dr. Philip Driesbach, a cancer doctor in California who is one of six plaintiffs on a lawsuit attempting to block California’s new “End of Life Options Act,” which went into effect July 9.  Dr. Driesbach’s article covers several key points:

  • ·       By allowing such individuals as potential heirs and the owners of caregiving facilities to be formal witnesses to a request for aid in dying—something the law prohibits them from doing if the document in question is a will—the law removes protections from vulnerable people.
  • ·       The law does not require psychological referral—and hence screening for coercion or easily treatable conditions—unless there are clear signs of mental illness. 
  • ·       “Killing is never medical care,” and doctor-assisted suicide is “fundamentally incompatible with the physician’s role as healer,” a position still affirmed by the American Medical Association.
  • ·       There is no compelling reason to compel doctors, as opposed to others, to take on the role of “agent of death.”
  • ·       There is something contradictory about asking the medical community, which has objected to participating in capital punishment, to become the agents of hastening peoples’ deaths.  (Dr. Driesbach actually said, “killing the innocent” here—I’m sanitizing, perhaps unnecessarily.)
  • ·       He cited the 2015 testimony of Dr. William Toffler of Oregon, who stated that doctor-assisted suicide in Oregon operates under “a shroud of secrecy” under which getting accurate data about the practice is “impossible” unless one works for the Oregon Health Division.

Rather, Dr. Driesbach charges that the push for doctor-assisted suicide is part of a social campaign, a “necro-political” movement, funded by rich donors who are quick to invoke equal protection under the law in other contexts but ignore it here.  I think he’s right.

A similar lawsuit has been filed in Vermont against that state’s law. Not everyone in the medical profession is supine before the doctor-assisted suicide juggernaut.

The Strange (Future) Case of Doctors & Mr. Hyde

On 28 June 2016, the Supreme Court declined to hear an appeal of a Ninth Circuit decision that forced a small pharmacy in Washington to dispense Plan B (a “morning after pill” that terminates a pregnancy via abortion) despite the religious objections of the pharmacist owners. In other words, the lower court ruled that the pharmacists must violate their conscience by prescribing Plan B or terminate their pharmacy business. Only three Supreme Court Justices agreed to hear the case; four are required. It can be argued that if Justice Scalia were still on the Court, The Court would have heard the case. As such, the Ninth Circuit’s ruling stands but is limited to the Ninth Circuit. Justice Alito’s dissent is worth the 15 page read. Doctors of Pharmacy no longer have religious/conscience protections in the United States within the Ninth Circuit.

Read that last sentence again.

Conscience protection for other health care providers may be more tenuous than is generally granted. Previously, multiple federal amendments provided health care workers conscience protections (Church Amendment, Public Health Service Act 245 & Weldon Amendment) A separate rider to annual omnibus bills called the Hyde Amendment actually prohibited federal Medicare and Medicaid funding of abortion specifically. The PPACA (Obamacare) changed the funding rules and arguably some of the previous conscience protections to the point where President Obama had to issue Executive Order 13535 specifically guaranteeing continuation of those protections in order to secure passage of the PPACA. The alleged tenuousness of current conscience protections mentioned above is the fact that an Executive Order can be easily be rescinded by this or any future president while overturning, even in part, the PPACA is no easy task. Additionally, efforts by those pro-abortion to eliminate amendments like the Hyde Amendment in its current form are vigorous and ongoing. (The link is presented as evidence not endorsement)

Regarding the title, the late Congressman Mr. Henry Hyde, author of the Hyde Amendment, is the antithetical homonym of the fictional Mr. Edward Hyde, the evil sociopathic alter ego of the philanthropic Dr. Henry Jekyll. Ironically, the present day Hyde (along with the other amendments listed) may be one of health care’s last protections against future violations of moral integrity by continuing to allow the unobstructed practice of medicine with one’s conscience intact.

On the “Moral Era” of Medicine

A colleague shared a recent JAMA article titled “Era 3 for Medicine and Health Care.” The author, Dr. Don Berwick, quickly surveys Era 1 — the “era of professional dominance”– and Era 2 — the “era of accountability and market theory”– before introducing what he hopes to see in “Era 3,” the “moral era.”

Berwick identifies nine changes that need to take place in order to accommodate this new era which has seen the implementation of ACA, the extensive use of electronic medical records, and the consolidation of hospitals and health plans. Several of the suggested changes are already taking place in health care systems across the country. Others are a bit more idealistic. I would like to use this space to mention two of the more idealistic changes.

Change number 8 is “hear the voices of the people served,” a noble goal indeed. While many health care organizations have moved in the direction of ‘patient-centered care,’ fewer embrace “paying special attention to the needs of the poor, the disadvantaged, and the marginalized, and firmly defending healthcare as a universal human right.” Seeing each patient as a human being, possessing great worth and dignity, is fundamental to all areas of bioethics, from the research lab to the bed of the dying patient. Humans need to be treated with humanity.

Change number 9 is even more idealistic: “Reject greed.” Berwick writes:

“Health care has slipped into tolerance of greed and it has to stop, through volunteerism when possible, through strong regulation when not. Rapacious pharmaceutical pricing, hospitals’ exploiting market leverage to increase prices, profiteering physicians, and billing processes that deteriorate into games with consultants coaching on how to squeeze out more profit all hurt patients and impair trust.”

Idealistic, right? But we know that one devastating medical emergency can bankrupt an insured middle class family and that many others are finding it impossible to make ends meet while undergoing expensive medical treatment. Bioethics should continue to address the staggering financial impact that medicine has on our society. As Berwick suggests, blindly ignoring these factors will lead to even greater regulation.

Bioethics has much to say if “Era 3” is truly to be the “moral era.”

Organ Harvesting in China

On June 13, 2016 the House of Representatives passed HR 343, “Expressing concern regarding persistent and credible reports of systematic, state-sanctioned organ harvesting from non-consenting prisoners of conscience in the People’s Republic of China, including from large numbers of Falun Gong practitioners and members of other religious and ethnic minority groups.” )  In part, the bill “calls on the United States Department of State to conduct a more detailed analysis on state-sanctioned organ harvesting from non-consenting prisoners of conscience in the annual Human Rights Report.”  This is a welcome response to a horrific practice.

Newsweek  reports that according to The Falun Dafa Association, “[I]n China patients aren’t waiting for organs. Rather, organs are waiting for patients.”    This is because executed prisoners provide a constant supply of organs.  The international community must continue to voice its strong disapproval of this practice.  We look forward to the June 22nd report of David Kilgour, former Canadian Secretary of State, investigative journalist Ethan Gutmann, and Canadian human rights attorney David Matas on China’s organ transplantation industry.  It is to their great credit that they are shining a bright light on this troubling issue.

Organ donation is a scientific marvel and a great blessing to those who have received life-saving organs.  Executing  prisoners of conscience and harvesting their organs is beyond the pale of ethical conduct.  It defies human dignity and scandalizes the international community.  It needs to stop.

Gender Indiscrimination

Steve Phillips has recently written in this blog about gender dysphoria and our culture’s struggle to respond consistently to it. Please see here for that discussion. North Carolina recently passed a law requiring individuals to use the bathroom of their biologic sex rather than their self-identified gender. This has resulted in claims of gender discrimination and gender phobia against those who do not wish to be in the same shower or bathroom with someone of the opposite biological sex, regardless of how that someone chooses to self-identify his or her gender.

In early June, a young high school student in Alaska, whose biological sex is male but who identifies as a female, recently placed 5th and 3rd place in the girls 100 meter and 200 meter state high school track meet. Interestingly, the cries of discrimination focused almost exclusively on the claim that this was unfair to the other women running in the same race. Said differently, there have been extremely few claims of gender discrimination or gender phobia against those who do not want to be in the same sporting event with someone of the opposite sex, regardless of how that someone chooses to self-identify his sex.

Why is there a difference?

Notice that in both cases, opposing sides agree that males and females are different, deserving different bathrooms and different sporting competitions, the latter a successful result of Title IX federal regulations beginning in the 1970’s. Both sides seem to agree that the issue is how to discriminate who belongs in which group. In both examples, one side argues that subjective self-identification is a sufficient claim to gender group membership while the other side demands objective biological criteria. So who is right?

And why is the girl who finished 6th in the 100 meter Alaska High School Track meet less likely to be called bigoted if she complains about having to race against the boy who identifies as a girl as when she complains about having to share the shower with him after the race? If the difference is one of fairness/justice in public sports competition, it is unclear why we should elevate public sports competition above private social interpersonal contact in terms of our bigotry tolerance.

But let’s say we do. Both the IOC and the Women’s Sports Foundation have position statements that effectively argue that the issue comes down to objective biological criteria, namely testosterone levels. At least in competitive sports, subjective self-indentification is not a sufficient claim to gender group membership.

But what about public bathrooms? Curiously, the Justice Department is using Title IX, that landmark federal regulation banning sex discrimination by schools that receive federal funds, to effectively require schools to be rather gender indiscriminate. Effectively, they are requiring schools to allow students to use sex-segregated bathrooms based on their self-identified gender or move away from sex segregated bathrooms altogether. As Jeannie Suk recently stated in The New Yorker: “The discomfort that some people, some sexual-assault survivors, in particular, feel at the idea of being in rest rooms with people with male sex organs, whatever their gender, is not easy to brush aside as bigotry. But having, in the past several years, directed the public toward heightened anxiety about campus sexual assault, the federal government now says that to carry that discomfort into bathrooms is illegitimate because it is discrimination. [emphasis mine]”

It seems that our culture’s response to this issue remains incoherent.

Mitochondrial replacement boosterism

A new Viewpoint article (available for free, without a prescription) from the Journal of the American Medical Association (JAMA) asserts that the United States is acting too slowly to advance mitochondrial replacement techniques (MRTs), the so-called “3-parent baby” approach that would seek to prevent mitochondrial DNA disease, which is transmitted maternally.  The authors approve of the recent recommendations by the afore-named Institute of Medicine (IOM), but are dismayed that, for now, recent federal legislation blocks FDA from further consideration of MRT applications.  This runs counter to the principle of beneficence, they argue, by foreclosing the possibility of reproductive relief for the estimated 800 US women affected each year.  This is their number, not mine, and presumably refers to 800 attempted births per year by women affected with these mitochondrial diseases, which are inherited and so present in an affected individual for life.  Again, the goal would be to allow these women to conceive and, one hopes, give birth to an unaffected offspring. 

In any event, the authors of the article in question find the IOM’s recommendations thoughtful, but the aforementioned legislation thoroughly unreasonable.  Besides blocking the advance of science in the U.S., we are ceding ground to the U.K., where it’s full speed ahead for clinical applications of MRTs.

Now, the IOM recommendations were anything but slapdash, reflecting careful thought leading to conclusions with which one may yet disagree.  What troubles me about the JAMA piece is how cavalier the authors are in embracing MRTs as the camel under the tent for doing anything and everything to the human genome.  They write (emphases are mine, not theirs):

“[The recent] developments [regarding MRTs] are nothing short of historic and their significance multifaceted. First, mitochondrial replacement therapy represents the sole example of state-approved germline gene therapy in the human. Second, it comprises the only known intervention with the potential to reduce the burden of mitochondrial DNA diseases. Third, it constitutes the first case in which organelle and, indeed, whole cytoplasmic cellular replacement are being contemplated. Fourth, it irrevocably alters assisted reproduction by placing it at the center of future genome editing efforts. Fifth, it acts as a test case for the regulatory adjudication of other emerging reproductive innovations. Examples include but are not limited to editing the genome of the human embryo and the prospect of using somatic (eg, skin) cells to generate eggs and sperm in a laboratory dish.”

I encourage readers to let this paragraph sink in.  The thinly-veiled argument is that putting breaks on these technologies is illegitimate not only because it violates the principle of beneficence, but more importantly because it could delay the day when humans are fully engineered.  The authors and their apologists will object that I am putting words into their mouths, but I think their enthusiasms are showing.

Read the whole thing.