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Chinese scientist Huang Xingxu has established himself as a pioneer in the field of gene editing research. Using a technique known as Crispr, his team was the first in the world to modify a mutation causing disease in a viable human embryo.
But last week, the new Chinese scientist He Jiankui should be prosecuted for creating the first babies in the world to be modified by a gene – a world first illegal in many countries – raised fears that legitimate research are now undergoing further examination by Beijing.
Since Mr. He's revelation last November about the creation of a pair of twins, the Chinese authorities have asked Mr. Huang and others working on the Crispr experiments to provide detailed information on their research. Huang said. "The controls will become stricter," said Yang Hui, a genetic researcher at the Chinese Academy of Sciences.
President Xi Jinping this week called for new legislation on gene editing, without providing details. According to badysts, the introduction of punishment for the implantation of modified embryos on genes in humans and the closer monitoring of committees that approve medical research are necessary to prevent the repetition of security risks and violations of ethics observed in Mr. He's research.
China has established itself as an innovator in this field.
Chinese researchers conducted the first edition of Crispr on monkeys in 2014, used this technique to create the first gene-modified human embryos in 2015 and were the first to use it in 2017 on viable human embryos, capable of develop into babies.
China ranks second after the United States and ahead of Japan in the ranking of the most cited articles in gene editing, accounting for more than 22% of world citations from 2014 to 2016, according to a ranking Nikkei, parent company of the financial group. Times and the Dutch publisher Elsevier.
"China is without a doubt one of the world's leading technology companies," said Robin Lovell-Badge of the British Francis Crick Institute, adding, "Chinese scientists are trying to do it with caution. . . feel that [He] gave a bad name to Chinese science.
In 2003, a regulation of the Chinese Ministry of Science prohibited the implantation of modified human embryos for reproductive purposes and stipulated that modified embryos should not be developed beyond 14 days. But there is no punishment attached to regulation.
To conduct Crispr research in China, scientists must seek the approval of the ethics committee of a hospital – or an IVF clinic in the case of research on the embryo – to ensure that patients have given their consent knowingly and do not run unnecessary risks. Beijing regards Crispr as a medical technology rather than a medicine; the authorization of the central government is therefore not required.
The research resulted. China has 12 registered medical trials involving Crispr, more than the rest of the world combined. In contrast to Dr. He's research, these trials use the technique of modifying genes in adult patients to help them fight chronic diseases.
But the ethics committee process may be lax, especially in for-profit private hospitals, badysts said. Participants sometimes report rushed decisions made with limited information
Fan Zhen, a lawyer at the Beijing People's Liberation Army General Hospital Committee, which hosts five Crispr trials, said his committee had approved up to eight medical trials when 39, a session of three to four hours, with a rate of approval greater than 80 percent
"At a meeting, the researcher will explain for five or six minutes, then committee members will ask questions," he said. Several committee members would review the documents describing the tests only during the meeting, he said, adding, "Time is running out".
Officials from the Ministry of Health of Guangdong Province, where Mr. He worked, accused him this week of "counterfeiting" of documents showing that his research had been subjected to an ethical examination. Mr. He could not be reached for comment.
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In many Chinese hospitals, "the committee itself becomes a formality. The case of He Jiankui shows that there are many loopholes, "said Yanzhong Huang, a Chinese expert in the field of health.
Even with stricter regulation on testing, China has other advantages in researching Crispr, Yang said, citing relatively loose rules for experiments on animals such as monkeys. "There are many people who do IVF in China and many IVF centers, so there are a lot of embryos rejected," he said.
According to official reports, Beijing, which has spent more than 100 million rands ($ 14.7 million) on dozens of Crispr research projects since 2015, should not give up its support for this area because it has designated biotechnology as a key strategic sector.
Scientists, who believe this technique is promising for the treatment of genetic diseases such as blood disorders and cystic fibrosis, also call for caution. "It is essential that these events do not cause a total rejection of genome modification technology as a basis for clinical tools," said Lydia Teboul, head of molecular biology at the Harwell Institute of Medical Research Council of the United Kingdom. "With the right application and the appropriate controls, [Crispr] still holds many opportunities in the clinic. "
Other reports by Nicole Liu in Hong Kong and Clive Cookson in London
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