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Gene-edited babies, if true, opens floodgate

TOKYO/BEIJING -- It has been nearly two months since a Chinese researcher made the announcement that he helped make the world's first genetically edited babies -- twin girls born in November last year.

While it has yet to be proven that the DNA-altered babies actually exist, the researcher's claim has sent shockwaves through the scientific community.

He Jiankui, an associate professor at the Southern University of Science and Technology of China in Shenzhen, in the southern province of Guangdong, claims to have altered the DNA of embryos to prevent them from being infected with HIV.

Chinese government guidelines ban the implantation of genome-edited embryos into the uterus. The Chinese Ministry of Science and Technology ordered He to halt his research; he is now under investigation by the ministry and other government bodies, and the Southern University of Science and Technology of China has shut down his lab. He has not been seen in public since an international conference in Hong Kong at the end of November, and he is believed to be under house arrest at a university guest house.

Meanwhile, the head of Baihualin (BHL) China League, a Beijing-based HIV support group that cooperated with He's research, emphasized, "He never told us the full extent of his research." According to Chinese media outlet Hongxing Xinwen, in spring 2017 He requested BHL's chief refer 20 married couples to volunteer for a clinical trial. He explained that the husbands would have to be HIV-positive and the wife HIV-negative.

BHL introduced about 50 couples, and was told that seven couples took part in the trial. The cost to remove HIV from sperm is approximately 100,000 yuan (around 1.6 million yen) even in relatively inexpensive Thailand. BHL's head said he felt like he was "introducing couples to free fertility treatment."

He Jiankui, however, is neither a doctor nor a genome editing expert. He obtained his doctorate in biophysics from Rice University in the U.S. in 2010, with a focus on calculating trends in infectious diseases and the economy. The venture firm He set up in 2012 following his return to China was also unrelated to gene editing.

According to U.S.-based health news website STAT, He began trying to enter the genome-editing field in around 2016, emailing and visiting eminent American researchers. In 2017, he presented basic research that included the alteration of human embryos at two U.S. conferences. The work did not attract attention, but He continued talking to people in the field. Apparently, multiple researchers who had heard about He's clinical trial plans had tried to dissuade him.

Feng Zhang of the Broad Institute of MIT and Harvard, who developed the CRISPR-Cas9 gene editing technique, was one of those researchers. Zhang told the Mainichi Shimbun that He visited him in summer 2018, and showed him test data on CRISPR-Cas9-edited mice. Zhang recalled that the data quality was not good, and that he told He that it was premature to apply gene editing to human embryos to be carried to term. He apparently did not tell Zhang about the clinical trial.

The focus now is on the Chinese investigation, which is set to announce its findings before the start of the National People's Congress on March 5, according to Hong Kong media reports. Remaining questions include whether the gene-edited twins actually exist, and if so, why did He go through with his experiment in violation of government guidelines?

Gene editing human embryos means rewriting the "blueprint of life," and many countries prohibit implanting such embryos in women from a safety and ethical standpoint. Germany, France and Australia have clear legal bans on implantation and childbirth using embryos, sperm or eggs that have been genetically edited. In Britain, with the exception of some technology, artificially altered embryos cannot be implanted into the womb. The U.S. has a law banning government funding of all research that entails the genetic editing of embryos.

Japan, meanwhile, has no such laws. Government guidelines set to go into effect in April approve of basic research involving gene editing for the purpose of contributing to future fertility treatments. A separate guideline bans the implantation of genome-edited embryos into the uterus, but there are no punitive clauses.

"If He's announcement is true, then it's shown everyone that (human genome editing) can easily be done," said Hidenori Akutsu, head of the reproductive biology research department at the National Center for Child Health and Development. "The same thing could happen in Japan."

Meanwhile, Tetsuya Ishii, a professor of bioethics at Hokkaido University, pointed out, "If such gene alterations are carried out as 'medical procedures' at fertility clinics, there's a chance they might not be subject to government guidelines."

Kazuto Kato, an Osaka University medical ethics professor, suggested, "Regardless of whether we think we'll adopt this technology in the future, we need to hold society-wide debates on the pros and cons, as well as rules on this technology in Japan. And as an issue that concerns all of humankind, international discussion that encompasses diverse societies and cultures is also of great importance."

(Japanese original by Momoko Suda and Suzuko Araki, Science & Environment News Department; and Joji Uramatsu, China General Bureau)

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