He Jiankui affair

He Jiankui, working at the Southern University of Science and Technology (SUSTech) in Shenzhen, China, started a project to help people with HIV-related fertility problems, specifically involving HIV-positive fathers and HIV-negative mothers.

[16] On 30 December 2019, a Chinese district court found He Jiankui guilty of illegal practice of medicine, sentencing him to three years in prison with a fine of 3 million yuan.

[30] When the place of the clinical experiment was investigated, SUSTech declared that the university was not involved and that He had been on unpaid leave since February 2018, and his department attested that they were unaware of the research project.

[33][34] He was trying to reproduce the phenotype of a specific mutation in the gene, CCR5-Δ32, that few people naturally have and that possibly confers innate resistance to HIV,[33] as seen in the case of the Berlin Patient.

[33] He used a preimplantation genetic diagnosis process on the embryos that were edited, where three to five single cells were removed, and fully sequenced them to identify chimerism and off-target errors.

[11] He Jiankui was planning to reveal his experiments and the birth of Lulu and Nana at the Second International Summit on Human Genome Editing, which was to be organized at the University of Hong Kong during 27–29 November 2018.

[42] Amidst the furore, He was allowed to present his research at the Hong Kong meeting on 28 November under the title "CCR5 gene editing in mouse, monkey, and human embryos using CRISPR–Cas9".

[10] On the news of Lulu and Nana having been born, the People's Daily announced the experimental result as "a historical breakthrough in the application of gene editing technology for disease prevention.

Robin Lovell-Badge, head of the Laboratory of Stem Cell Biology and Developmental Genetics at the Francis Crick Institute, who moderated the session on 28 November, recalled that He Jiankui did not mention human embryos in the draft summary of the presentation.

[29] There was widespread criticism in the media and scientific community over the conduct of the clinical project and its secrecy,[51][52] and concerns raised for the long term well-being of Lulu and Nana.

[49] The Chinese Academy of Medical Sciences made a condemnation statement on 5 January 2019 saying that: We are opposed to any clinical operation of human embryo genome editing for reproductive purposes in violation of laws, regulations, and ethical norms in the absence of full scientific evaluation.

The Chinese Government prohibits the genetic manipulation of human gametes, zygotes, and embryos for reproductive purposes ... Jiankui He's operations violated these regulations.

Its flaws include an inadequate medical indication, a poorly designed study protocol, a failure to meet ethical standards for protecting the welfare of research subjects, and a lack of transparency in the development, review, and conduct of the clinical procedures.

[69] On 30 December 2019, the Shenzhen Nanshan District People's Court found He Jiankui guilty of illegal practice of medicine, sentencing him to three years in prison with a fine of 3 million yuan.

[78] Stanford University also investigated its faculty of He's confidants including William Hurlbut, Matthew Porteus, and Stephen Quake, his main mentor in gene editing.

"[79] In response to He's work, the World Health Organization, formed a committee comprising "a global, multi-disciplinary expert panel" called the Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing "to examine the scientific, ethical, social and legal challenges associated with human genome editing (both somatic and germline)" in December 2018.

[23] As of 2021, the committee stood by the grounds that while somatic gene therapies have become useful in several disease, germline and heritable human genome editing is still with risks,[85] and should be banned.

[86] In May 2019, the Chinese government prepared gene-editing regulations stressing that anyone found manipulating the human genome by genome-editing techniques would be held responsible for any related adverse consequences.

"[93] As Janet Rossant of the University of Toronto noted in 2018: "It has also raised ethical concerns, particularly with regard to the possibility of generating heritable changes in the human genome – so-called germline gene editing.

[109] According to the Guidelines for Ethical Principles in Human Embryonic Stem Cell Research (2003) of the Ministry of Science and Technology and the National Health Commission of China:Research in human embryonic stem cells shall be in compliance with the following behavioral norms: He Jiankui also attended an important meeting on "The ethics and societal aspects of gene editing" in January 2017 organized by Jennifer Doudna and William Hurlbut of Stanford University.

[110] Upon invitation from Doudna, He presented a topic on "Safety of Human Gene Embryo Editing" and later recalled that "There were very many thorny questions, triggering heated debates, and the smell of gunpowder was in the air.

[49][28] One of the more peculiar statement is that if the participants decide to abort the experiment "in the first cycle of IVF until 28 days post-birth of the baby", they would have to "pay back all the costs that the project team has paid for you.

The researchers criticized He's unethical action by presenting the fact that the prevention of HIV transmission from parents to newborn babies can be safely achieved with existing standard methods, such as sperm washing and caesarian section delivery.

[118] Thus, while genome editing in humans has potential as an effective and cost-efficient method for manipulating genes within living cells, it requires more research and transparent procedures to be ethically justified.

[122] In 2007, Timothy Ray Brown (dubbed the Berlin patient) became the first person to be completely cured of HIV infection following a stem cell transplant from a CCR5Δ32 homozygous donor.

"[126] In February 2019, scientists reported that Lulu and Nana may have inadvertently (or perhaps, intentionally[63]) had their brains altered,[127] since CCR5 is linked to improved memory function in mice,[128] as well as enhanced recovery from strokes in humans.

[131][132] Rasmus Nielsen and Wei Xinzhu, both at the University of California, Berkeley, reported in Nature Medicine of their analysis of the longevity of 409,693 individuals from British death registry (UK BioBank) with the conclusion that two copies of CCR5Δ32 mutations (homozygotes) were about 20% more likely than the rest of the population to die before they were 76 years of age.

[146][147] The next year they reported successful experiment in monkeys involving a removal of two key genes (PPAR-γ and RAG1) that play roles in cell growth and cancer development.

[159][160] The individuals have not complained the symptoms and needed blood transfusion normally required in such disease, but the method is arduous and poses high risk of infection in the bone marrow, to which David Rees at King's College Hospital commented, "Scientifically, these studies are quite exciting.

"[158] In June 2019, Denis Rebrikov at the Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology in Moscow announced through Nature that he was planning to repeat He's experiment once he got official approval from the Russian Ministry of Health and other authorities.