Hank Greely over at The Center for Law and Biosciences at Stanford Law School was one of the participants in the recent Napa meeting on approaches to human germline genetic modification. Hank was also one of the authors on the resulting position paper in Science with David Baltimore as first author (here).
Now Hank, pictured below, has written an intriguing blog post that kind of gives a behind the scenes look at what has gone on in this area in the last few months and in addition he articulates his personal views on this situation.
I’m not a bioethicist or legal scholar myself, being rather a basic and translational lab scientist, so I enjoy and value reading the work of scholars such as Hank who are more focused in these areas and have that specific training. I really enjoy Hank’s work and his style of directness. In this case of human germline modification I mainly agree with him, but we differ on some key points.
I agree with Hank’s notion and that of the group represented in the Baltimore paper that we should draw a distinction between (A) in vitro research on human germline modification and (B) in vivo work and/or clinical applications, which should not be done for the foreseeable future and possibly never unless safety and efficacy issues can be resolved. My own views (ABCD plan) just already dive more into the specifics and practical issues.
Where Hank and I differ is that he does not see heritable human germline modification as particularly concerning at this time. He writes, “I don’t expect engineered human germline modification to be a big issue – as a practical matter – for a long time, if ever, for several reasons.”
Why?
Hank argues this is in large part due to the fact that it would be so unsafe:
“You’d have to be criminally reckless, or insane, to try to make a baby this way unless and until we’ve had a decade or more of preliminary research, with human tissues and with non-human animals (including certainly primates and maybe even some of the non-human apes), showing that it is safe.”
Ironically, for the same reason, I come to the exact opposite conclusion: human germline modification is a major issue right now.
I believe that there are numerous people who would go ahead and try to make genetically modified people in the coming years despite the safety risks. Factoring in hubris and a desire for fame, I just don’t see that this kind of safety or legal risk would be a broad deterrent to certain folks.
The technology is simple and available as well, which is an enabling factor.
I predict that unfortunately that someone and probably more than one group will try it with the intent to make modified people in the coming years. It could well be catastrophic, but again I don’t see that stopping some folks from trying it. We may also never know about certain attempts to make designer babies, particularly if it fails badly, but that doesn’t mean people won’t try and do serious harm in that way.
Hank goes on to say, “If the moral risk isn’t enough of a deterrent, the potential legal liability should be.”
As to legal risk it is not clear to me that there would be one.
In the US, for example, at the federal level and in many states I’m not aware of specific laws that would confer a clear legal risk to someone recklessly trying to either do human germline therapeutic editing prematurely or even outright attempting to make designer babies.
The FDA has indicated it has regulatory oversight in this area, but the situation is rather vague in terms of real world consequences should someone take the “ask for forgiveness later rather than permission now” kind of approach to making designer babies.
The other two reasons that Hank gives are that the medical and non-medical demand would be small for this kind of technology.
I’m not so sure about that.
It is very difficult to make that kind of prediction about what could be such a powerful technology.
Aside from patient or “customer” demand, also again what about the potential quest of a few wildly misguided doctors or scientists involved for a place in history? I don’t think that can be ignored as a possible motivation for some and it could prove relatively easy for them to get the tools they need to try.
Further, Transhumanism needs to be part of the equation and discussion as well. Already the transhumanist movement seems to be embracing CRISPR-Cas9 technology as a tool for improving humanity and not just minor tweaks here or there. They appear to want humans to become more than human with transcendent changes. There are a lot of very smart and rich folks who are at the very least toying with the idea of Transhumanism.
In the end, Hank and I agree on far more than we disagree upon.
Perhaps I just have a lot less faith in human nature and wisdom, particularly when a new technology arises that is so transformative and exciting. If you think about the case of nuclear physics in the 20th century, for example, it is a striking lesson in how complicated and thorny the real world emergence of a powerful, new technology can be and how difficult it usually turns out to be to control.
Paul, thanks for your thoughtful comments on my post – and on the general issue. I want to reply on just two points.
First, in terms of legal liability (and sticking to the US for now, where I’m most knowledgeable), I think there are several venues for action against someone who tries, in our present state of ignorance, to make babies with germline genome editing. One is the FDA, where the jurisdiction isn’t clear but a sympathetic case like this is likely to make it clearer, at least to the courts that review it. Another is civil liability, particularly if something goes wrong – either to the parents or to a damaged baby. Only a few states recognize wrongful life suits by babies for their prebirth damages, but, again, a sympathetic case like this (where the parents might not sue because they were foolish enough to try this) might make other state courts sympathetic. Third, consider miscellaneous criminal charges – the lack of a specific statute doesn’t necessarily constrain a creative prosecutor. Child endangerment? Manslaughter (reckless or negligent killing) if a baby dies? Wire fraud if there are some misrepresentations made to the parents or to authorities? Fourth, professional sanctions, like losing your medical license for attempting something so wild. (Again, the likely strong lack of sympathy for those who try this will make possibly weak claims stronger.) Fifth, institutional issues. The clinic where this is tried might find its license at risk. The research institution that tried this might find its human subjects research rights pulled. Public revulsion or political pressure can bring forth lots of creative sanctions.
Second, in spite of the long list above, I don’t doubt that someone might try to do this. I think Zavos and Antinori probably did try to do human productive cloning, though I doubt they got anywhere close to as far as they claimed. (Not sure whether Clonaid/the Raelians ever actually tried, though they claimed to have succeeded.) It might even work – though in reproductive matters, it is hard to predict across species. Cloning in mice easy, in rats hard; in cats easy, in dogs hard; in primates (until recently) hard to impossible. But I don’t think the world will end if a handful of children are born, healthy or not, after germline modification. One, or one thousand, cars didn’t transform California; it took millions.
I don’t see a few babies as a “big issue,” though big enough in our current state of knowledge that I’d encourage authorities to go after the reckless experimenters with everything they could think of. Part of that is the numbers, part of it is the low impact of the plausible changes. Show me 100 super-babies and maybe that would be a big deal; show me 100 babies with engineered HIV resistance (for example) and I say “meh.” Show me a million with the latter and I’m impressed.
Fundamentally, though, I agree with you that we agree far more than we disagree.
Hank
I think you are right on the money. There probably are people who would rush to create designer babies given half a chance. I only arrive at this conclusion from the general observation that people do a heck of a lot of other crazy things for no good reason.
There are other technologies that might also end up posing similar issues. Consider, cyber enhancement, for example. It is conceivable that such technologies could become so integrated with bodies that they eventually become an inseparable part. I can imagine many ways this might happen — starting with enhancement, progressing to dependence. Perhaps, one day, mitochondria will be replaced by a nano engine.
OK, I’m being far out there. The point is, that regardless of the technology (biologic or non-biologic) there is a more general issue.
One of the things that intrigued me about the article by Hank Greely was the notion that different states might have different regulations about changing the germline. There is a corollary to this:
Different regulations might be imposed upon people with modified germlines. For example, one state/nation/culture may find this technology abhorrent and regulate against the reproductive rights of someone who has arrived from another state/nation/culture in which he was legally created with a modified germline…
You may think that this is strange, but consider that we already have cultural and religious groups in some parts of the world that impose extreme sanctions upon those who only differ by ideology (or natural variation of biological characteristics).
Paul- as you know, the genie’s been out of the bottle for some time. Cell, 13 February 2014: Generation of Gene-Modified Cynomolgus Monkey via Cas9/RNA-Mediated Gene Targeting in One-Cell Embryos Yuyu Niu et al (Nanjing, China)
These manipulations are easier to do in humans than in non-human primates.