He Jiankui affair

Lulu and Nana are allegedly twin girls born to parents Mark and Grace^[1][2], which according to the researcher He Jiankui are the world's first germline genetically edited babies.^{[3][1][4][5][6][2][7]} Using CRISPR-Cas9, a technology that can modify DNA, He claims to have edited the CCR5 gene to confer genetic resistance to the HIV virus that causes AIDS.^[1] According to Dr He's slides, one of the twins has both CCR5 genes disabled (conferring an immunity), while the other has only one allele disabled (suggesting she is still vulnerable).^[8][9]

His claim was reported in November 2018 during a public conference but has received no independent confirmation^{[10][11][12][13][2][6][4][7][1]} and has not been peer reviewed or published in a scientific journal.^{[12][13][4][7][5][2]} The reaction to the project has been widespread scepticism and criticism.^{[13][12][3][5][6][2][4][1][7][11][10][14]}

The main researcher, He Jiankui of Shenzhen, said he modified about 70% of 31 embryos from seven couples during fertility treatments, with one pregnancy giving rise to two live twins, with another pregnancy in progress.^[15][16][9] Dr. He said he was trying to provide a trait (CCR5 Δ32) that few people naturally have — that possibly confers innate resistance to HIV, seen in the case of the Berlin Patient.^[4] In this instance, the CCR5 gene was targeted. Based on a mechanism described in Quartz, the CCR5 gene "is responsible for producing a protein that HIV uses to latch on, enter, and infect a human immune cell. If the CCR5 gene were mutated, ... the HIV virus would not be able to infect—and thus the mutation would confer resistance to the disease."^[2]

Dr He recruited serodiscordant couples (where the father is HIV positive and the mother is HIV negative) though an HIV/AIDS support group on social media. He argues that human germline modification of the CCR5 gene prevents mother-to-child transmission of HIV if the mother were to become HIV positive. The father's sperm goes though sperm washing during the IVF process. Dr He alleges that serodiscordant couples are at a higher risk of mother-to-child transmission of HIV during the first 18 months of life, and that changing the CCR5 gene may confer genetic resistance. He also argues that the gene editing technology is justifiable in a rural Chinese "AIDS village" where more than 30% of the population has AIDS.^[15]

Dr He says he used CRISPR on a knockout mouse, before moving onto a monkey embryo model (to study chimerism and off-target modifications) before using the technique in human 3PN embryos deemed unfit for implantation, and implantable embryos.^[8]

Reaction to the project has been widespread criticism.^{[13][12][3][5][6][2][4][1][7][11][10][14]} Just some examples: geneticist Eric Topol stated, "This is far too premature .. We're dealing with the operating instructions of a human being. It's a big deal."^[4][12] According to geneticist Kiran Musunuru of the University of Pennsylvania, the gene editing technique was "unconscionable ... an experiment on human beings that is not morally or ethically defensible."^[4] Developmental biologist Kathy Niakan of the Francis Crick Institute said, "If true...this would be a highly irresponsible, unethical and dangerous use of genome editing technology."^[1] Medical ethicist Julian Savulescu of the University of Oxford noted, "If true, this experiment is monstrous".^[1] Bioethicist Hank Greely of Stanford Law School declared, "I unequivocally condemn the experiment".^[7] Biochemist Jennifer Doudna, of the University of California at Berkeley, a pioneer of the CRISPR–Cas9 technology, condemned the research.^[17][11] 122 Chinese scientists issued a statement to condemn Dr. He's action on human gene editing.^[18] George Church, a geneticist at Harvard University, said gene editing for HIV resistance was "justifiable" since HIV is "a major and growing public health threat" but questioned the decision of this project to allow one of the embryos to be used in a pregnancy attempt as the use of that embryo suggests that the researchers’ “main emphasis was on testing editing rather than avoiding this disease,”.^[4][7] That said, no all reactions were negative. For example Arthur Caplan, bioethicist at the New York University School of Medicine, said that engineering human genes is inevitable and, although there are concerns of creating "designer babies", medical researchers are more interested in using the technology to prevent and treat diseases, much like the type of experiments performed by Dr. He.^[10]

Critics of He say that the English version of the informed consent form he used had a vague phrase "AIDS vaccine development project" that did not describe fully the risks of using Cas9 on embryos.^[8]

Investigation

The Southern University of Science and Technology (SUSTech) claims that Dr. He had been on non-paid leave from February 2018. SUSTech, and the Department of Biology, were unaware of the research project and its nature, and will call for international experts to form an independent committee to investigate this incident, and to release the results to the public.^[19]

Another researcher, Micheal Deem, an associate of Dr. He, and a bioengineering professor at Rice University in Houston, Texas, may also have been involved in the gene editing studies, and may also be investigated, according to news reports.^[14]

• Official WebSite/Jiankui He
• The He Lab's channel on YouTube
• Video (04:43) Lulu and Nana details (The He Lab; 25 November 2018)
• Video (02:51) Lulu and Nana news (AP News; 26 November 2018)