Why CRISPR baby production (if it happened) was unethical & dangerous

Reports are out that a scientist in China has been working to make a CRISPR baby for some time and supposedly has made twin genetically modified babies. I see this work as unethical and dangerous.

Just a couple years ago when I published my book GMO Sapiens on potential use of CRISPR in a heritable manner in humans, some people said it would only happen decades down the road if at all due to technological issues.

I was too worried, they said.

Others said no one would try it any time soon because it would be way too risky.

However, if these new reports last night (here from Antonio Regalado on the ongoing work with reproductive intent and from Marilynn Marchione of the AP on the purported actual production of CRISPR’d babies) are generally accurate, then it has already happened.

A scientist named Jiankui He of Shenzhen, China claims he has made genetic changes via CRISPR of human embryos then used for pregnancies. The supposed end result? Genetic changes in the CCR5 genes in twin baby girls (he refers to them as Lulu and Nana). Apparently one is heterozygous and the other homozygous, possibly at least one of them with mosaicism.

He vaguely claims there were no off-target effects, but I’m not sure I believe that at this point. Importantly, we are hearing today that He has been suspended and is under investigation by Chinese authorities.

From the AP last night:

“The researcher, He Jiankui of Shenzhen, said he altered embryos for seven couples during fertility treatments, with one pregnancy resulting thus far. He said his goal was not to cure or prevent an inherited disease, but to try to bestow a trait that few people naturally have — an ability to resist possible future infection with HIV, the AIDS virus.”

I see this as a reckless human experiment focused on traits rather than genetic disease. There are many problems with it. Also, there are established, low-risk ways to prevent HIV transmission during pregnancy.

Back in 2015 I felt like the human gene editing summit in DC hosted by the NAS missed an opportunity for a stronger stand against human germline CRISPR because the statement coming out of that meeting was relatively weak.  I also did a TEDx talk that year on an envisioned world with potential designer babies via CRISPR within 15 years (see above), which a few people said they thought was unrealistic as it would never happen so soon.

Such a hypothetical future world with designer babies is potentially a huge step closer to reality if He’s self-reported (unpublished) claim about the babies is at least in part accurate.

You can see an aspirational video of He promoting his work and the birth of the CRISPR’d babies on YouTube below.

Here is a simple bullet point list of problems and red flags I see with this human genetic modification “research.”

1. While some kind of consent apparently happened, it’s unclear if proper consent was conducted with the participants.
2. It’s also unclear if the work received a proper ethics review or consultation with experts in bioethics in advance.
3. The rationale for targeting CCR5 for mutation in this way is not very solid or convincing.
4. There may be more of a commercial or ambition-driven rationale for this research rather than a benefit to human health rationale.
5. There is likely no benefit at all to the twin girls themselves.
6. There seems no logical reason to have proceeded with a pregnancy with a heterozygous gene edited embryo.
7. Unfortunately, the girls face a lifetime of potential health risks from the gene editing, particularly if they are mosaic. Mutation of CCR5 also definitely confers increased risk related to other illnesses even if it may be protective against HIV infection.
8. I also just want to reiterate I’m not going to just believe this guy that no off-target effects happened, which would raise risks to the girls substantially further.
9. These girls may face social risks or other unanticipated problems as well if they are ultimately identified, which seems likely.
10. The project and/or elements of it were reportedly kept secret. There was a lack of transparency here.
11. The researchers involved appear to be improperly pushing an “AIDS vaccine” analogy for this work including on consent forms according to the AP. Was that part of an attempt to mislead about what was really going on?
12. According to Marchione’s piece, “Both men are physics experts with no experience running human clinical trials.” This raises risks to participants.
13. According to Regalado, CRISPR use in human reproduction wouldn’t be permitted according to regulations in China, but it’s unclear if He got permission. Again, now he seems in trouble with authorities in China so he probably did not.
14. It’s also unclear if some other pregnancies in this human genetics experiment were terminated due to problems with the fetuses or if some other babies could have been born with problems or stillborn. The lack of transparency in how this research was done makes it hard to just implicitly trust the researchers if they do say nothing has gone wrong with other pregnancies and fetuses.

The story is developing so hopefully we’ll all learn more in coming weeks and it’s possible some things may change.