The Science of Gene Editing Demands Caution and Consensus

(Bloomberg Opinion) -- A Chinese scientist’s claim to have edited the genes of human embryos has provoked condemnation from scientists worldwide, and rightly so. He Jiankui barged ahead without ensuring that the genetic changes he says he made — meant to confer resistance to HIV infection — would not cause unintended harm to the children, twins who have now been born.

His insistence that he fully informed the parents of the risks involved is absurd: The risks are unknown. His experiment was conducted without oversight, and he’s published no report that would allow other scientists to check and verify his assertions.

One good thing can come from this outrageous lapse of judgment, though. It shows that the need for tight restrictions on editing of germline genes — those that can be passed from generation to generation — is urgent.

Countries shouldn’t inflexibly ban all embryonic gene-editing — as, in effect, the U.S. has done. One day this technology might be used to fight heritable diseases and disorders. But research should be carefully restricted and monitored.

The U.K.’s Human Fertilisation and Embryology Authority, which regulates fertility clinics and research centers, is a good model. The agency has approved the use of so-called Crispr gene-editing technology on embryos that will not become pregnancies, to advance research on how genes control early human development. It has allowed in-vitro babies to be conceived using a technique that combines DNA from three people, to prevent mitochondrial diseases. In every case, the authority grants approval only after meticulous review, and oversees the work as it moves ahead.

Any efforts in Britain to embark on germline gene-editing would have to go through the same process. That would preclude the kind of reckless experiment just undertaken in China.

The U.S. has no such special agency, but it does have the Food and Drug Administration, which has authority over human gene editing. In the U.S., it would be illegal to embark on clinical trials  without applying for a license from the FDA. Theoretically, this should allow for a careful process similar to what Britain has. But there’s a complication. In 2015, following previous reports about Crispr being used on embryos in China, Congress barred the FDA from even considering applications for research that would lead to the creation of an embryo with modified heritable genes. 

True, the congressional ban — added as a rider to the omnibus spending bill, and since renewed — blocks irresponsible genetic engineering. But the FDA was in a position to block it anyway. This extra restriction is mistaken because it stops the FDA from engaging in any thoughtful regulation of embryonic gene-editing.

The news from China certainly proves the need for thought — and, ideally, for a set of adequately strict regulations that all countries could adopt.

Three years ago in Washington, an international group of scientists agreed that it would be “irresponsible to proceed” with germline editing until there is “broad societal consensus about the appropriateness of the proposed application,” and until all risks are known and considered. A concerted international push to form that consensus, while enforcing adequate rules in the meantime, can’t come too soon.

Editorials are written by the Bloomberg Opinion editorial board.

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