Bioethics @ TIU

Human germline gene editing full report—a bit more

Posted February 16th, 2017 by Jon Holmlund

As Steve Phillips pointed out yesterday, the National Academies of Science, Engineering, and Medicine has published, in book form, its full report on “Human Gene Editing: Science, Ethics, and Governance.”  On Valentine’s day.  (I suppose it’s not so ironic.)  The entire report may be downloaded for free through this link.  Also available at that page are links to a 4-page summary report and to one-pagers on different aspects of the report.  I urge interested readers to follow the link to the National Academies’ website and read at least the executive summaries.  

Steve asks whether heritable gene editing in humans has “compelling” support, and argues not.  Regular readers of this blog will know that I have agreed, arguing this is a road we ought not to travel.  There have been numerous posts on this blog, notably in 2015, including the December 3, 2015 post with embedded links to other 2015 posts on the subject.  Rather than repeat those here I invite the reader to follow the breadcrumbs.

Steve’s take is that, because of unknown risks to an affected unborn child, editing of said child at the embryo stage, or perhaps even at the germ cell stage, prior to fertilization, should not be undertaken.  The argument FOR doing it is that, in very limited cases in which there is a well-known, single-gene defect whose effects are devastating and for which treatment alternatives are absent or inadequate, parents desiring to have an unaffected child could ethically avail themselves of a gene-editing approach.  The most immediate example is Huntington’s disease—genetically dominant, untreatable.  This is what we argued about on this blog back in 2015.  The argument in favor is understandable.  So is Steve’s argument against.  To take Steve’s side, we must admit we would be asking some parents to forego childbearing or accept the genetic risks.  Or, if one accepts in vitro fertilization and pre-implantation genetic diagnosis, go that route and accept creating some genetically diseased embryos that will never be brought to birth.

Again, the 2015 posts traced the ethical arguments, which are complex enough that they are hard to encapsulate in a single blog post.  But apparently we have gone from “it would be irresponsible” in 2015 to, in 2017 (from the 4-page report summary), “Given both the technical and societal concerns, the [National Acadmies’] committee concludes there is a need for caution in any move toward germline editing, but that caution does not mean prohibition.”  Now, the recommendation is that “clinical trials using heritable genome editing” could be allowed “within a robust and effective regulatory framework” that adheres to the following criteria:

·       Absence of reasonable alternatives

·       Restriction to preventing a serious disease or condition

·       Restriction to editing genes that have been convincingly demonstrated to cause or to strongly predispose to the disease or condition

·       Restriction to converting such genes to versions that are prevalent in the population and are known to be associated with ordinary health with little or no evidence of adverse effects

·       Availability of credible pre-clinical and/or clinical data on risks and potential health benefits of the procedures

·       Ongoing, rigorous oversight during clinical trials of the effects of the procedure on the health and safety of the research participants

·       Comprehensive plans for long-term, multigenerational follow-up while still respecting personal autonomy

·       Maximum transparency consistent with patient privacy

·       Continued reassessment of both health and societal benefits and risks, with broad on-going participation and input by the public

·      Reliable oversight mechanisms to prevent extension to uses other than preventing a serious disease or condition


On the surface, these criteria sound reasonable.  I also worry they are overconfident.  The whole effort has the feel of trying to steer a runaway train.


But we have come to this.  We can but guess where it will end.  I confess I think a world in which nobody ever got Huntington’s disease or sickle cell anemia would be better than the current one, everything else being equal.  But there’s the rub: everything else will not be equal.


I remain astounded at how far things have come in 40 years.  The likes of Paul Ramsey and Francis Schaeffer worried about it in the 1970’s.  I would not give back the medical advances of these decades.  But I would have drawn a bright line here.  The proposed “regulatory framework” will not hold.  Just my guess.

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