China Declares Genetic Editing of Infants Illegal, Pushes for Bio-Science ‘Central Authority’

The Associated Press
The Associated Press

China’s Vice-Minister for Science and Technology on Thursday declared the gene-editing work of scientist He Jiankui “shocking and unacceptable” and ordered the suspension of his work.

He Jiankui announced this week that he edited the genetic code of two human embryos and produced a pair of twin girls who are allegedly immune to HIV, the virus that causes AIDS, even though their father is HIV-positive.

According to a presentation given by the researcher, one of the girls may not have developed complete immunity because the gene-editing process was not fully effective on her.

He Jiankui, who will henceforth be referred to by his full name for the purposes of clarity, is an associated professor of bioengineering at the Southern University of Science and Technology in Shenzhen, China. His claims, delivered in a series of YouTube videos, have been verified by no one and denounced by nearly everyone.

The experiment reportedly involves a total of seven couples, each including an HIV-positive father and a mother who does not have the virus. He Jiankui claims they are all volunteers who signed a consent form for his “AIDS vaccine development project.”

The New Yorker on Tuesday passed along some of the reaction from He Jiankui’s peers:

Virtually the entire gene-editing community, including Southern University, has condemned He’s claims. S.U.S. Tech issued a statement saying that the “University was deeply shocked,” that its biology department was unaware of the project, and that it believes that He’s conduct “has seriously violated academic ethics and codes of conduct.”

On Monday, a group of more than a hundred Chinese academics and scientists issued a statement calling the research “crazy.”

Since the work is still experimental and can pose serious risks, there has been, since 2015, a voluntary international moratorium on editing live human embryos. But the moratorium was never going to last.

The New Yorker piece also summarized what the professor claims to have accomplished:

In one of the YouTube videos, He says that he used CRISPR to disable a gene, known as CCR5, that makes a protein that permits most variants of H.I.V. to enter human blood cells.

One particular genetic variant of that protein, called the Delta32 mutation, prevents H.I.V. from locking onto a cell. If every person carried that mutation, nobody would get AIDS. In theory, if the father of the baby girls is H.I.V.-positive, disabling the gene would render his children immune to the virus.

But there are many unanswered questions about CCR5’s role in the immune system, and about the efficacy of gene editing itself. Genetic editing, with CRISPR and similar tools, has proved immensely promising in the laboratory, with applications from improving the nutrition of basic crops to eliminating infectious diseases, such as malaria, and many congenital illnesses, too.

CRISPR stands for Clustered Regularly Interspaced Short Palindromic Repeats, a bacterial tool that can be employed to target and modify portions of an organism’s genetic code. CRISPRs exist naturally in all animals, normally functioning very much like a computer’s anti-virus software (or one could say computer anti-virus programs imitate the way CRISPRs detect and repel invading viruses in living creatures).

The idea behind the technology employed in He Jiankui’s research is to reprogram CRISPR bacteria to modify the immense genetic code of an animal or human to induce desirable mutations. There have always been high hopes of using the technology to combat seemingly incurable diseases.

The Chinese doctor shocked biologists around the world by jumping into human experiments and producing what will be remembered as the first genetically engineered human children, if his claims are accurate. He also claims another of his volunteers is pregnant with gene-edited children.

Nature quoted biologists and biochemists outside China who “faulted He for a lack of transparency and the seemingly cavalier nature in which he embarked on such a landmark, and potentially risky, project” when he appeared at a gene-editing summit in Hong Kong on Thursday.

The overall tenor of the response from other genetics experts is a guarded willingness to believe He Jiankui did what he claims to have done, but they want confirmation, they fear the twin girls could suffer terrible side effects, and they are not certain the benefits of the procedure truly include immunity to HIV:

Many scientists faulted He for a lack of transparency and the seemingly cavalier nature in which he embarked on such a landmark, and potentially risky, project.

“I’m happy he came, but I was really horrified and stunned when he described the process he used,” says Jennifer Doudna, a biochemist at the University of California, Berkeley, and a pioneer of the CRISPR–Cas-9 gene-editing technique that He used. “It was so inappropriate on so many levels.”

Alta Charo, a bioethicist at the University of Wisconsin–Madison and a member of the summit’s organizing committee, is also critical. “Having listened to Dr. He, I can only conclude that this was misguided, premature, unnecessary and largely useless,” she says.

The “useless” criticism is based on the availability of other therapies for babies conceived by HIV-positive parents and the list of other diseases that might be better addressed with gene-editing therapy, assuming the technique works as advertised. On that score, the fact that He Jiankui proceeded with implanting the second embryo even though the gene-editing process was not completely successful was strongly criticized by bioethicists. He said the decision to implant the second embryo was made by the parents.

“At the conference, He failed or refused to answer many questions including who paid for his work, how he ensured that participants understood potential risks and benefits, and why he kept his work secret until after it was done,” USA Today reported.

The Chinese government on Thursday suspended the research activities of everyone involved in He Jiankui’s project, calling it “extremely abominable in nature.”

“The gene-edited twins matter reported by the media has brazenly violated Chinese laws and regulations and breached the science ethics bottom line, which is both shocking and unacceptable,” Vice Minister of Science and Technology Xu Nanping said.

China’s state-run Global Times on Wednesday quoted former Vice Minister of Health Huang Jiefu calling for the establishment of a “central authority and complete legal system to supervise bioscience experiments.”

“I strongly condemned the so-called ‘head transplant’ surgery in 2017 and got the support of the scientific community. But that case slowly faded out from the public mind. He Jiankui’s case is more serious because the abuse of gene-editing technology will have an impact on the future of humanity. Scientists all over the world have stood up to oppose it,” said Huang.

The Global Times explained the “head transplant” was the work of Italian surgeon Sergio Canavero, who deemed China “the right place” to perform an ethically dubious (and, according to critics, scientifically useless) procedure that involved transplanting a head from one human corpse to another.

Huang noted that He Jiankui claims to have obtained the necessary ethical review from Shenzhen authorities for his gene-editing experiment, but there is considerable bureaucratic confusion in the process, and there are claims some of the documentation for He Jiankui’s project was forged or improperly approved. Huang derisively observed that some of the hospital administrators who signed off on the experiment probably could not even spell the name of the gene-editing tool correctly.

“Even the law for organ donation and transplantation which has improved a lot in recent years is still imperfect, not to mention one for gene editing,” said Huang. “I hope the country can start to pay attention to the problem after the occurrence of gene-edited babies. There is an urgent need for a national ethics review committee as well as a legal system to regulate bioscience.”


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