Optimized Offspring
Summary
The bioethicist Henry Greely predicted a decade ago that people would start having their children in the lab, choosing among embryos even when they had no trouble conceiving. He told me the most obvious place to regulate is across about 500 IVF clinics where embryos are screened and implanted. He said regulating them “wouldn’t be easy,” especially since the FDA has almost no experience with them. Regulating genetics labs would likely be even harder and would raise serious questions about FDA jurisdiction. If the FDA lacks it, he said, no one else has it under current U.S. structures. In the U.K., the Human Fertilisation and Embryology Authority can approve or ban specific procedures. “It seems to do a pretty good job,” Greely said, though he noted it wields far more power than anything the U.S. has or is politically likely to get. Even so, a national regulator wouldn’t stop an intended parent or rogue scientist from going overseas. “I think international regulation with teeth is almost impossible,” Greely said.
The law is new, and its boundaries are untested. But Preventive has been exploring the jurisdiction, where a path toward eventual clinical use may exist that the FDA rider bars in the U.S. Greely estimated it would take a couple million dollars to set up an adequate facility for a few germline edits. Cheap enough, he said, that it could happen in countries without regulation.
Greely said he sees few tools beyond “soft power condemnation and ostracism” where regulation doesn’t reach. He Jiankui became a global pariah due to a shared sense among scientists that editing a human before birth is unethical if we aren’t sure it’s safe. Much of the taboo rested on the technical dangers of CRISPR. The Columbia team’s base-editing results begin to weaken one of those safety arguments. There’s no consensus on when editing embryos for reproduction becomes safe enough to try.
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