Following Up: Five Months After the Birth of Twins with CRISPR-Edited Genomes

Written by Nascent Transcript writer Allison McCague

It has been five months since the first babies whose genomes were edited using CRISPR were born. What has happened since and where do we go from here?

In November 2018, Chinese scientist He Jiankui shocked the world when he announced the birth of twin girls with CRISPR-edited genomes. His experiments flew in the face of international regulation and scientific consensus, including ASHG’s position statement on human germline genome editing, which states that clinical use of this technique is premature. He’s announcement sparked immediate and widespread backlash amongst the scientific community, including ASHG, which consequently reaffirmed its 2017 position statement. The immediate aftermath of the scandal was like something out of a science fiction film that captivated a global audience, with He briefly going missing and resurfacing living in a heavily guarded university-owned apartment in Shenzhen. While the genetics community continues to question whether, and how, CRISPR technology should be clinically used, this story has faded from mainstream news.

So, what exactly has happened in the five months since He’s announcement?

Southern University of Science and Technology, where He was employed, announced in January that He had been fired. Investigation by the Guangdong health ministry concluded that He’s use of gene-editing intended for reproductive purposes was “explicitly banned by relevant regulations.” However, it did not name specific regulations or how He violated them. Likewise, studies investigating the regulatory framework governing gene editing in China found no laws explicitly prohibiting He’s research, but instead found ambiguous and potentially permissive regulations.

“There’s only a few low-level laws in China that cover gene editing on human embryos, and none of these laws detail the consequences of violating them,” said Lu Yiguang, a medical ethics lawyer based in Shanghai. “This is a big flaw.”

However, He could still face criminal charges. His team agreed to pay research participants’ fertility expenses, which could be a crime if those payments constitute coercion, according to Liu Ye, a lawyer at the Shanghai Haishang Law Firm. Furthermore, He could be in legal jeopardy if the twin girls experience adverse effects from the procedure, including unintended off-target effects.

He also reportedly informed multiple U.S.-based scientists of his experiments before announcing them to the world, including his former postdoctoral advisor, Stephen Quake.  Stanford University recently cleared three faculty members of misconduct, including Quake, with a statement suggesting that Quake expressed serious concerns and urged He to follow proper scientific practices.

However, some believe that more could have been done. “A lot of people wish that those who knew or suspected would have made more noise,” said Alta Charo, a bioethicist at the University of Wisconsin-Madison. But, she said, “If [the research] is happening elsewhere, a scientist may be wholly unfamiliar with the norms and laws in that foreign country.” Given the ambiguous regulatory situation in China, it’s unclear what informed authorities could have done in retrospect.

Thus far, no new laws or regulations have been created as a result of He’s actions. The World Health Organization convened a new advisory committee in March that is working to establish global standards for “governance and oversight of human genome editing.” Part of their plans involve creating a central registry of ongoing human gene editing research to increase transparency and oversight. They will continue to meet over the next two years and promise to “solicit the views of multiple stakeholders including patient groups, civil society, ethicists and social scientists.” Similarly, the National Academies of Sciences, Engineering, and Medicine are working to establish an international commission on germline genome editing. ASHG has been active in assisting with this effort, including planning an event at the 2019 Annual Meeting to engage members on the issue.

While the scientific community agrees that oversight is necessary, some scientists worry about over-regulating preclinical research on human embryos that are never intended to be implanted. Others, including NIH Director Francis Collins, have called for a global moratorium on gene editing research involving human embryos, warning of the naivety of assuming others won’t follow He’s example. Still others have warned of the pitfalls of pushing these advancements forward without asking whether they should move forward at all; they argue that this discussion belongs to all of humanity, not just scientists and bioethicists.

As regulations are developed, and our ability to detect off-target effects induced by CRISPR advances, we must continue to engage in conversations with scientists and the general public about human genome editing long after the name He Jiankui disappears from headlines.

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