A Chinese scientist who engineered the first gene-edited babies may now face serious charges for fraudulent practices.
China and the United States have been the leading nations in the research and application of CRISPR-Cas9, a tool used to edit the genes of living organisms. Using this technique, scientists can remove, add, or alter a DNA sequence. The implications of CRISPR are far-reaching, with potential benefits, like making people resistant to fatal diseases like HIV/AIDS, and potential risks, like wiping out an entire population if placed in the wrong hands.
Internationally, there are no strict regulations governing the use of gene editing techniques. In the U.S., any CRISPR trials must be approved and regulated by the Food and Drug Administration's Center for Biologics Evaluation and Research. Some countries, like China, have looser laws governing the use of gene-editing on humans.
CRISPR has been successfully used on people with terminal illnesses, but its use on human embryos has been more limited and much more controversial due to its capacity to pass on traits to future generations. In September, Chinese scientist He Jiankui announced the birth of the first gene-edited babies, twin girls Lulu and Nana. Their father carries HIV, but He edited the twins' DNA to be resistant to HIV.
Chinese officials announced Monday that He's research violated federal laws and was done "in pursuit of personal fame and fortune." He claimed his experiment was approved by a local ethics committee, but the investigation found that He evaded supervision by forging ethical review documents, financing his own study, and using unsafe and ineffective methods, according to the New York Times.
He was also criticized for using CRISPR in this case when there are safer ways to prevent HIV. An HIV-infected man He tried to recruit told Chinese news magazine Sanlian Life Weekly that he was not informed of the ethical concerns of using CRISPR to edit human embryos. Stat reported that the opportunity appealed to Chinese citizens with HIV who felt the need to carry on their family duty of reproduction.
In the fall, after He announced the birth of Lulu and Nana, CRISPR inventor Feng Zhang called for a moratorium on its use in human embryos, saying the risks outweighed the benefits. Following this case, China may take another look at its gene editing regulations.
"Even though the Ministry of Health has issued ethical rules, the legal responsibility is unclear and the penalties are very light," Wang Yue, a professor at Peking University who researches health law in China, told the New York Times, saying this example served as a warning for China to enact stricter regulations.