My last post was a summary of the NAM’s Recommendations on Mitochondrial Replacement Therapy (MRT). Now here is my take on the report. But keep in mind the report was just released and all I could give it was a quick read, so these are really more like initial impressions:
- Overall the report is excellent. It deeply engages with the science, is quite balanced and well written.
- The recommendation that MRT be limited to transfer of male embryos is very clever and interesting. The idea behind it is that it will eliminate the risk of germ-line modifications being transmitted to future generations, which is the real boogy man in the picture and has been a major issue for CRISPR gene-editing. That said it has a couple of negative ramifications
- It will require the discard/freezing of female embryos which may anger some religious conservatives, but I am not sure they are a constituency behind MRT to begin with.
- It creates a gap between what will be permitted in the US v. the UK (where there is no such restriction). I suspect that few individuals will choose one over the other for this reason, i.e., this is not a likely cause of medical tourism. But if the concern is that future generations will have the modification and pass it on, all this does is mean that children born in the US will not, the UK kids will and over time with people moving, marriage, etc, the issue will manifest, though more slowly.
- Some may view this as a problematic form of sex selection. “Some” as in “not me,” but it is interestingly different from, for example, using sex selection to avoid sex linked disorders since the benefit does not really flow to the offspring here but instead future generations.
- I think they give a little too short a shrift to the UK safety data and adjudicatory process I have written about here which is excellent. While every country has to decide for itself, I do think one gets the impression this is more terra icognito from the report than it is. In particular the public engagement in the UK produced some very interesting results/information that I think it useful.
- They have a line about possible use by MRT by older women rather than those with mitochondrial disease but in their recommendations from what I saw (remember just a quick read) seem to assume this will only be used for women with mitochondrial disease not other kinds of users. I think this is an interesting area worth of future study that connects to things I and others have written on infertility vs. dysfertility.
- They have one brief mention (I think one, read it quickly) about contact between offspring and mitochondrial donor but the report really doesn’t spend much time on it. In the UK they explicitly exempted mitochondrial donors from their requirement that all donors register and be contact-able by the offspring at age 18. We don’t have that system in the United States (at least not yet) but the report doesn’t really think more about what the right social relationship/information sharing should be between mitochondrial donor and offspring. This is not a fault of the report, just something more to think about.
- In a similar vein the ancestry issue is teed up but the report doesn’t say much about it. One set of interesting legal questions that will get posed is whether the mitochondrial donor has any legal familial status with the offspring for things like inheritance, social security, parentage, etc. Will the mitochondrial donor be treated in any way as a third parent, a family member, or completely treated as a non-related women for legal purposes? This is largely a matter of state law so we may get some variation. It may be that the existing laws on egg donation (particularly versions of the Uniform Parentage Act) will be held to apply to women who donate mitochondria, but this strikes me as a fertile territory (no pun intended) for more thinking and an avalanche of students notes.
- The Report could do a little more to acknowledge that whatever the US policy in a world where medical tourism is possible and other countries adopt their own systems, so long as not everyone adopts the approach of the US some of these problems will manifest no matter what. So this is about harm reduction not harm avoidance.
- This is a bee in my bonnet but I have serious qualms about the report’s harm to offspring discussion because it fails to acknowledge that in any case where MRT is not allowed to go forward there will be no child that comes into existence. This is related to what philosopher’s call the “Non-Identity Problem” but it raises the question of whether this is really harm to the child if MRT is performed (and indeed to subsequent generations from that child’s lineage). I’ve written a lot on this topic and you can read more if it interests you but for now I’ll just summarize it this way: The Report makes it sound as though this is about best interests of the resulting child. That’s logically incoherent unless you think children born through MRT are better of not existing, since that is their alternative. Instead the underlying regulatory principle has to be something more like non-person-affecting principles (though as philosophers say these are not “same number” cases so we may run into trouble) or reproductive externalities, but those are very explicitly not about the child that results and his or her welfare but instead about our own welfare. This is my only serious qualm about the Report: it recapitulate a big error in reproductive ethics, but of course others may disagree.
- Finally, the report itself is just a report. It makes recommendations but they have no force of law themselves. The next step will likely be consideration by FDA and Congress. FDA it seems to me largely has rule making and administrative adjudicative authority to implement this kind of system if it wanted to, but Congress can always try to implement a different system by legislation. I predict little to no action on this until after the election is over and what happens next may depend on who is elected.
Read Part I of the post here.
Based on Glenn’s useful summary of the NAM report, its claim that they are protecting future children from harm by preventing their birth is clearly erroneous, as Glenn points out, because of the non-identity problem. At this stage in bioethics, I am surprised that they missed it. It would have been a good occasion to confront that issue directly and bring some much needed light to it–that a non-person affectng theory of harm is needed. (see “Procreative Liberty and Harm to Offspring in Assisted Reproduction,” 30 Amer J of Law & Medicine 7-40 (2004) for an analysis).