A Chinese researcher who claims to have created the first gene-edited babies, He Jiankui of the Southern University of Science and Technology (SUST), in Shenzhen, is now facing investigation over whether the experiment broke Chinese laws or regulations.
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On Sunday, MIT Technology Review was first to disclose a secretive project in China to produce children whose genomes had been modified to make them resistant to HIV.
He, who led that effort, later released a video statement in which he said that healthy twin girls, Lulu and Nana, had been born “a few weeks ago.”
He said the girls had been conceived using IVF but that his team had added “a little protein and some information” to the fertilized eggs. That was a reference to the ingredients of CRISPR, the gene-editing technology he apparently employed to delete a gene called CCR5.
The claim set off a wave of criticism in China and abroad from experts who said the experiment created unacceptable risks for a questionable medical purpose. Feng Zhang, one of the inventors of CRISPR, called for a moratorium on its use in editing embryos for IVF procedures.
Documents connected to the trial named the study’s sponsors as He along with Jinzhou Qin and said it was approved by the ethics committee of HarMoniCare Shenzhen Women and Children’s Hospital.
On Sunday, the Shenzhen City Medical Ethics Expert Board said it would begin an investigation of He’s research and released a statement saying that HarMoniCare “according to our findings … never conducted the appropriate reporting according to requirements.” The former medical director of the private hospital, Jiang Su-Qi, told Southern Capital News he had no recollection of approving He’s research while he was on its ethics committee.
“These two children are the guinea pigs. They will go through their whole maturing process having not understood the risks ahead of time,” said Liu Ying of Peking University’s Institute of Molecular Medicine.
The president of He’s university called an emergency gathering of researchers connected to the project. “This has nothing to do with SUST, the research wasn’t conducted at SUST,” said SUST president Chen Shiyi, according to Chinese media reports. According to the school’s biology department, the research “seriously violates ethical and academic standards and regulations.”
A 2003 guidance to Chinese IVF clinics prohibits the transfer of genetically modified embryos to start a pregnancy. He’s American media spokesman, Ryan Ferrell, did not respond to questions about the legality of the project.
It remains unclear where He carried out his research and who paid for it. “He has explained to me that he electively went on leave years ago to focus full time on research and not teach,” Farrell said.
The news of the children’s birth comes on the eve of global gene-editing summit occurring in Hong Kong to debate governance of the powerful technology. The website Stat reports that the Chinese Academy of Sciences declined to sponsor the meeting and that it won’t officially be playing a role.
Eric Topol, a doctor and scientist at the Scripps Research Institute, in La Jolla, California, said he had previously been provided information about the trial, but not enough to determine whether the gene editing had worked. “That is not good medicine,” he said. Topol criticized the absence of a scientific report describing the research.
The report of the babies was just as big a surprise in China as elsewhere. “The consequences are impossible to predict,” said the vice-director of the Tsinghua University Comprehensive AIDS Research Center, Zhang Lin-Qi. “Most people are completely at a loss, including me.”
Separately, a group of 122 Chinese academics and scientists put out a statement condemning He’s research and calling on authorities to establish legal governance over gene editing. “This presents a major blow to the image and development of Chinese life sciences on the global stage,” they said. “It is extremely unfair for the many honest and sincere scholars working to adhere to moral practices in the sciences.”
In his video, He presented himself as a willing martyr to some higher cause. “I understand my work should be controversial, but families need this technology, and I am willing to take the criticism,” he said.
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