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I believe I’m crazy enough to do that
Written by: Hanna Fleisher

Dear friends, we continue the series of posts dedicated to CRISPR-Cas9 technology. This time we will not talk about patents, but about ethics in scientific research.

Our team could not ignore such a high-profile case related to CRISPR-Cas9 technology as that of He Jiankui, a scientist from the Southern University of Science and Technology (SUSTech) in Shenzhen, China, who dared to create a human child from genetically modified edited embryo.

First, it should be emphasized that one cannot be sure of what is actually known about Jiankui He’s experiment. There is a lot of information, but it does not come from 100% reliable sources. Most of it became known from the words of the scientist himself, something stems from the releases of the Chinese government news agency, and very little got available from the reports of scientists with whom Jiankui He collaborated or contacted.

The story begins in 2017, when the researcher met a couple – an HIV-positive man and his HIV-negative wife, at a conference held at SUSTech. The scientist offered them participation in an experiment on fertilization, which would be accompanied by gene editing of their embryos to develop innate resistance to HIV infection in their children. Subsequently, he managed to attract six more couples to the experiment.

He Jiankui collected sperm and egg samples from the couples, performed in vitro fertilization, and then edited the genomes of the embryos using CRISPR-Cas9. The editing targeted the CCR5 gene, which encodes a protein used by HIV to enter cells. The scientist tried to recreate the phenotype of a specific mutation in the gene, CCR5-Δ32, which few people naturally have and which may confer innate resistance to HIV. However, instead of introducing the known CCR5-Δ32 mutation, He introduced a frameshift mutation designed to render the CCR5 protein completely non-functional. As a result, three babies were born, two of which were twins. Two days after birth, the twins’ DNA was collected. Whole-genome sequencing confirmed the mutations, but the children carried incomplete CCR5 mutations – the mutations were different from the typical CCR5Δ32 mutation, so it is unclear whether the twins are susceptible to the infection or not.

Immediately after the children birth, He Jiankui posted several videos on YouTube boasting of his experiment. It should be noted that at that time, Jiankui’s experiment had not received independent approval and had not yet been peer-reviewed or published in any scientific journal, but the scientist had the opportunity to present the results of the study entitled “Editing the CCR5 gene in mouse, monkey and human embryos using CRISPR–Cas9” as part of the Second International Summit on Human Genome Editing in 2018. The presentation triggered mixed reactions, but the next day Southern University of Science and Technology, and local authorities and the Chinese government launched a series of investigations. As a result of the official investigation, on December 30, 2019, the Shenzhen Nanshan District People’s Court sentenced He Jiankui to three years of imprisonment and a fine of 3 million yuan (US$430,000) for “forging ethical examination documents and misleading doctors who unknowingly implanted two women with edited gene embryos.” In addition, two of He’s co-authors were punished – Renli Zhang of the Guangdong Academy of Medical Sciences and Guangdong General Hospital, who got a two-year prison term and a fine of 1 million yuan, and Jinzhou Qin of the Southern University of Science and Technology, who was sentenced to 18-month prison term and a fine of 500,000 yuan.

Why did this experiment induce such a negative reaction?

First, the laws of many countries specifically prohibit any use of genome editing techniques in human embryos, eggs or sperm intended for reproduction. Secondly, informed consents and documents related to the ethical side of the experiment were forged. Third, the very identity of the scientist raises many questions – He’s career path and scientific work never involved editing human embryos, he was not a doctor, and he had no experience in using CRISPR on embryos, human or non-human, and had absolutely no experience in assisted reproduction. Fourth, CRISPR-Cas9 is a new technology, and the first use of a new technology is always inherently dangerous – the CRISPR machinery can make changes in the wrong places, creating so-called “off-target” effects, or make the wrong changes in the right places, or editing only some cells of the embryos, resulting in “mosaic” organisms, with some edited and some unedited cells, all of which could positively or negatively affect several generations of the “edited” human. Unfortunately, it is not yet possible to predict exactly how.

Fortunately, He definitely would not have been able to patent his achievements, since the patent legislation of most countries of the world clearly does not allow patenting the processes of changing the genetic identity of people through the germ line.

In any case, work with professionals. Our scientific and patent department will not only secure your rights, but also plan and protect your ideas in any country of the world. We launch new products to the market and conduct direct prosecution in the countries of the European Union, Bulgaria, Ukraine, Azerbaijan, Armenia, Uzbekistan, Georgia, Kazakhstan, you can find out more on our website.

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