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He Jiankui claims that he and a team of researchers have helped make the world’s first genetically edited babies: twin girls whose DNA he said he altered. Photo: AP

‘We’re in the dark’: Chinese health officials unaware of research on ‘world’s first gene-edited babies’

  • Authorities say they were not told about the controversial experiment that researchers claim to have carried out in China
  • Research to switch off HIV-related gene not independently verified
Science

A Chinese scientist’s claim that he has created the world’s first gene-edited children has caught health regulators flat-footed and triggered a flood of condemnation from research bodies.

He Jiankui, from Southern University of Science and Technology in Shenzhen, said in a YouTube video posted online on Monday that healthy twin sisters were born in China this month from embryos he and a team of researchers modified to switch off an HIV-related gene.

Chinese health officials said they were unaware of the controversial experiment.

“We just saw it on internet. We are equally shocked as everybody else,” an official in charge of medical ethics evaluation at the National Health Commission said. “We are completely in the dark.”

The commission is the highest authority on health-related issues in the country and can stop any experiment deemed unsafe or unethical.

The research is controversial because of the risk that children born using it could die from unknown side effects and the technology could be abused.

China is developing a wide range of controversial technology from using children to develop AI-powered killer robots, to deadly artificial viruses to modify human genes.

He Jiankui claims that he and other researchers disabled a gene called CCR5 which produced a type of protein that acted like a receptor for HIV and was key to the virus spreading throughout the body. Pictured is a microplate containing embryos that have been edited in a laboratory in Shenzhen in southern China's Guangdong province. Photo: AP

The announcement by He comes just days before he is expected to speak about human embryo editing at the Second International Summit on Human Genome Editing at the University of Hong Kong, which starts on Tuesday. He has not published any research paper on the project so the work has yet to be peer-reviewed or independently verified.

David Baltimore, president emeritus of the California Institute of Technology and chairman of the summit organising committee, said He had not informed the organising committee about the research.

“What he will say I have no idea and I don’t know what he will cover, but he has been quoted in the press as having done experiments that would involve the changing of human genes and he may well talk about that,” Baltimore said.

He Jiankui said the father of the newborns, identified only as Lulu and Nana, was HIV-positive and the gene was edited to prevent the children from contracting the virus.

Any private or public hospital can approve such an experiment if they want to
Senior Chinese government researcher

He said the scientists, including collaborators from the United States, disabled a gene called CCR5 that produced a type of protein that acted like a receptor for HIV and was key to the virus spreading throughout the body.

“The CCR5 gene surgery, maybe not applicable for the general public, may be valuable to help a few affected and very high-risk families,” He said in the video, adding that the method was safe.

“As a scientist and a father of two girls, safety is my number one concern above all else.

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“The gene we choose, CCR5, is one of the best-studied genes. In fact, about 100 million people naturally have a genetic variation that disables CCR5, protecting them against HIV.”

But in a statement on Monday, Southern University of Science and Technology said it had no knowledge of the research, adding that it “severely violated academic ethics and code of conduct”.

Chen Yonglong, associate professor and deputy director of the experimental ethics committee in the university’s department of biology, also said the experiment was conducted without approval from the school.

The university is only authorised to approve trials involving animals
Chen Yonglong, of the university’s experimental ethics committee

“The university is only authorised to approve trials involving animals. He had come to us and we have had a discussion. The conclusion is that he would need to get approval from an organisation outside that deals with humans, such as a hospital,” Chen told the South China Morning Post.

The trial was approved and conducted by Shenzhen HarMoniCare Women and Children’s Hospital, according to documents submitted by the research team to the Chinese Clinical Trial Registry, a database affiliated with the World Health Organisation.

Members of an ethics review committee signed the approval paper, but Qin Suji, the hospital’s former director of medical affairs who left the facility last month, denied he was one of them.

Qin told Guangzhou-based Southern Metropolis Daily that he also asked several other colleagues whose names appeared on the document about the matter and they all denied seeing the form before.

The WHO did not immediately respond to requests for comment.

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Cheng Zhen, the hospital’s general manager, said the experiment was not conducted at the hospital and the children were not born there either, according to the Southern Metropolis Daily report.

The hospital did not respond to requests for comment.

A senior Chinese government researcher specialising in medical ethics said the case showed that the authorities were losing control of some controversial studies in some of the laboratories they funded.

“Any private or public hospital can approve such an experiment if they want to,” the researcher said, requesting not to be identified.

The researcher also said there were no laws or regulations in China forbidding the creation of genome-edited children.

“The last and only line of defence is the moral standard of the researchers involved in these experiments,” the researcher said.

China’s brightest children are being recruited to develop AI ‘killer bots’

While scientists agree that CCR5 plays a key role in HIV infection, some expressed their concerns about the side effects of disabling the gene.

Immunologist Zhang Linqi, head of Tsinghua University’s Aids research centre in Beijing, warned that gene editing should not be used on humans until scientists could make sure the technique was safe.

“The gene, CCR5, is critical to cells in the immune system,” Zhang said. “We have not found such cases where a person’s CCR5 is completely disabled. An HIV-infected father and healthy mother could have a healthy baby without gene editing.”

A researcher adjusts a monitor showing a video feed of another scientist moving a fine glass pipette containing Cas9 protein and PCSK9 sgRNA to an embryo under a microscope at a laboratory in Shenzhen in southern China's Guangdong province. Photo: AP

He Jiankui used a gene editing tool called CRISPR-cas9, which can supply a needed gene or disable a defective one in DNA.

The technique was co-developed by scientists at the Broad Institute, MIT, Harvard University and the University of California, Berkeley in 2013.

Curing the incurable? US scientists unveil powerful new tools to fix genetic faults

Using the tool, scientists are able to introduce DNA sequences from external sources into a host, either in the form of gene therapy or gene editing. Gene therapy refers to the treatment that delivers certain genes as a drug into the patient’s cells, which usually will not change the host’s genome.

Gene editing, on the other hand, changes the host’s DNA at specific site that will continue for life and could pass on to future generations, according to Shaw Pang-chui, a biologist with the Chinese University of Hong Kong.

This article appeared in the South China Morning Post print edition as: Mainland scientist claims world’s first gene-edited babies
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