He Jiankui, the Chinese scientist who is the first and only to genetically engineer babies, was sentenced to three years in prison and a $430,000 fine on Monday for “illegal medical practice.” Two of his colleagues were also sentenced to time in prison for practicing medicine without a license, crossing an ethical line, and violating Chinese regulations.
At the time of the research as well as currently, it is illegal in much of the world to use a genetically engineered embryo to establish a pregnancy. In China, it is prohibited under a 2003 ministerial guidance to IVF clinics.
Regardless, He announced on Nov. 26, 2018 via a YouTube video and interview with the Associated Press that he used CRISPR/Cas9 to help make the world’s first genetically edited babies—twin girls born earlier in the month. A third baby, carried by a second woman, was reportedly born in Summer 2019.
In the announcement video, He explained the mother of the twins, Grace, got pregnant through “regular” IVF—with one significant difference. After Grace’s egg was implanted with her husband, Mark’s, sperm, He and his team also implanted protein and instructions for gene surgery to disable a gene called CCR5, which is a protein doorway for HIV to enter a cell. Mark, the twins’ father, is HIV-positive. Before returning the embryo to Grace’s womb, He said whole genome sequencing indicated the surgery worked safely.
Post-birth, He did another deep sequencing of the twin girls’ whole genome. His team compared 80 to 95% of the twins’ genomes to their parents’ and only saw one mistarget in one girl’s DNA, in a section of inactive genes. However, the tests suggest that one twin had both copies of the intended gene altered while the other had just one altered. He said no other genes were altered except CCR5.
Still, scientists worldwide condemned He and the experiment. Most raised concerns about the long-term health of the twin as humans without the normal CCR5 gene have been shown to face higher risks of contracting other viruses, such as West Nile or the flu.
Despite He’s assurance that no other genes were changed, scientists said not enough is understood about mistargeted editing to perform such an experiment on live children. They pointed to the fact that only one twin had both genes altered as proof itself. For the other twin, this means the risk of HIV infection is the same as everyone else. Essentially, her genes were altered—with possible unknown consequences—for no purpose.
Other scientists, including HIV researchers, questioned the ethics of He recruiting parents for his experiment directly (and only) from an HIV advocacy group. While He and his U.S. colleague Michael Deem, former Rice University physics and bioengineering professor, told the AP the study participants were aware of the purpose of the experiment, the paperwork suggests otherwise. Consent forms called the project an “AIDS vaccine development” program.
He did receive approval for his project from Shenzhen Harmonicare Women’s and Children’s Hospital, and he gave official notice of his work to the Chinese registry of clinical trials—but only months after he started. Through the duration of the experiment, 16 of 22 embryos were edited and 11 were used in six implant attempts before the twin pregnancy was achieved, as well as the third baby, He told the AP.
Photo: He in his lab during the November 2018 initial announcement. Credit: YouTube.