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China confirms the birth of gene-edited babies and vows to punish scientist He Jiankui who 'violated rules to carry out the unethical study for personal fame'

Investigations reveal He Jiankui had acted on his own and forged review papers.

Kelsey Cheng, The Daily Mail, Jan 21, 2019

A Chinese investigation says the scientist behind the birth of two babies whose genes had been edited in hopes of making them resistant to the AIDS virus acted on his own 'for personal fame and profit' and will be punished for violating regulations.

Confirming the births, the official Xinhua News Agency said Monday that investigators in the southern province of Guangdong determined Dr He Jiankui organised and handled funding for the experiment without outside assistance in violation of national guidelines. The university He worked for said he had been fired.

The scientist sparked global controversy in November when he announced in a YouTube video that he had successfully used a gene-editing technology known as CRISPR-Cas9 to alter the embryonic genes of twin girls born that month.

One of the mothers gave birth to twins nicknamed 'Lulu' and 'Nana', the investigators said. Another woman is still carrying a gene-edited fetus. The Xinhua report said all three would remain under observation.

His university disavowed his work and fellow academics condemned his unethical actions and slammed his procedure, intentions and whimsical approach to morality.

The government halted work at his lab and is carrying out an investigation, saying it would take a 'zero tolerance attitude in dealing with dishonourable behaviour' in research.

The investigation by the Health Commission of China concluded that He had 'organised a project team that included foreign staff, which intentionally avoided surveillance and used technology of uncertain safety and effectiveness to perform human embryo gene-editing activity with the purpose of reproduction, which is officially banned in the country'.

Between March 2017 and November 2018, He forged ethical review papers and recruited eight couples to participate in his experiment, resulting in two pregnancies. Five others did not result in fertilisation while one opted to leave the experiment.

The report didn't say which regulations He might have violated but added that his staff and organisations related to his project would be punished according to laws and regulations.

'This behavior seriously violates ethics and the integrity of scientific research, is in serious violation of relevant national regulations and creates a pernicious influence at home and abroad,' the report said.

The Southern University of Science and Technology (SUSTech) in the city of Shenzhen, said in a statement on its website that He had been fired.

'Effective immediately, SUSTech will rescind the work contract with Dr. Jiankui He and terminate any of his teaching and research activities at SUSTech,' the statement said, adding that the decision came after a preliminary investigation by the Guangdong Province Investigation Task Force.

Dr He was trained as a physicist, not a biologist, and was therefore unqualified and likely unable to carry out the research himself.

It is believed he used his own £40 million fortune to fund the project and privately recruited highly-trained scientific professionals to carry out the research.

Little is known about the research which staggered scientists for its brazen flaunting of every rule and guideline on ethics and legality in genetics.

The whereabouts of the Chinese researcher have been a mystery since November. Reports claimed He was placed under effective house arrest in Shenzhen after making an appearance at the Second International Summit on Human Genome Editing in Hong Kong in late November.

He and his family are living in university housing on the grounds of Southern University of Science and Technology in Shenzhen, with guards stationed outside his apartment, according to a recent Bloomberg report citing Dr William Hurlbut, an adjunct professor at Stanford Medical School who has been in touch with the Chinese scientist.

'He told me that in both his living situation and in the process of the investigation, he's being treated respectfully,' Dr Hurlbut, a neurobiologist whom Dr He had consulted over the past two years on his genetics research, told reporters.

Gene editing for reproductive purposes is effectively banned in the US and most of Europe. In China, ministerial guidelines prohibit embryo research that 'violates ethical or moral principles.'

The chief of the World Health Organization said last year his agency is assembling experts to consider the health impact of gene editing.

WHO Director-General Tedros Adhanom Ghebreyesus said gene editing 'cannot be just done without clear guidelines' and experts should 'start from a clean sheet and check everything.'

'We have a big part of our population who say, 'Don't touch,'' Tedros told reporters. 'We have to be very, very careful, and the working group will do that.'

What Are Some Of The Doubts Surrounding Dr He's Claims?

Several scientists reviewed materials that Dr He provided to the AP and said tests so far are insufficient to say the editing worked or to rule out harm.

They also noted evidence that the editing was incomplete and that at least one twin appears to be a patchwork of cells with various changes.

'It's almost like not editing at all' if only some of certain cells were altered, because HIV infection can still occur, famed Harvard University geneticist Professor George Church said.

Church and Dr Kiran Musunuru, a University of Pennsylvania gene editing expert, questioned the decision to allow one of the embryos to be used in a pregnancy attempt, because the Chinese researchers said they knew in advance that both copies of the intended gene had not been altered.

'In that child, there really was almost nothing to be gained in terms of protection against HIV and yet you're exposing that child to all the unknown safety risks,' Dr Musunuru said.

The use of that embryo suggests that the researchers' 'main emphasis was on testing editing rather than avoiding this disease,' Church said.

Even if editing worked perfectly, people without normal CCR5 genes face higher risks of getting certain other viruses, such as West Nile, and of dying from the flu.

Since there are many ways to prevent HIV infection and it's very treatable if it occurs, those other medical risks are a concern, Dr Musunuru said.

There also are questions about the way Dr He said he proceeded.

He gave official notice of his work long after he said he started it - on November 8, on a Chinese registry of clinical trials.

It's unclear whether participants fully understood the purpose and potential risks and benefits.

For example, consent forms called the project an 'AIDS vaccine development' program.

The hospital linked to the controversial project denied approving the procedure and accused Dr He of forgery.

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