# Professionalism/He Jiankui and Designer Babies
## He Jiankui and Designer Babies
### Background on He Jiankui

He Jiankui is a Chinese biophysics researcher who studied at Rice University for his PhD and taught at Southern University of Science and Technology in China. He founded the company Direct Genomics in 2012, which developed single molecule sequencing devices. In 2018, He Jiankui claimed to have created the first gene-edited twins "Lula and Nina" and a baby named "Amy". He recruited couples in which the father had HIV and through in vitro fertilization, edited the genomes of embryos to be protected from HIV later in life.
Background on CRISPR
CRISPR is highly efficient, relatively easy to use, and has revolutionized the field of genetic engineering. It has the potential to treat and cure a wide range of genetic diseases, improve crop yields, and enhance our understanding of genetics and biology. First, scientists design a guide RNA molecule that matches the target DNA sequence they want to edit. This guide RNA molecule then binds to the Cas9 protein, which acts as scissors, cutting the DNA at the precise location where the guide RNA has bound. Once the DNA has been cut, scientists can then introduce a new DNA sequence into the cell, which the cell uses as a template to repair the break in the DNA. This process can be used to either insert or delete specific genes or to correct genetic mutations that cause diseases.

### Guidelines and Regulations

Starting in 2015, industry groups began releasing statements regarding the ethical implications of genetic modifications of embryos. The U.C. Berkeley Institute for Genome Innovation "strongly discourage[d]…any attempts at germline genome modification" and the International Summit on Human Gene Editing said "it would be irresponsible...until the relevant safety and efficacy issues have been resolved...and there is broad societal consensus". In 2017, the National Academy of Science and the National Academy of Medicine released the official position of the US Academies, stating that genome modification should only occur with a clear regulatory framework. They recommended that genetic editing be restricted to preventing a serious disease or condition, restricted to converting genes to versions that are prevalent in the population, and take place with "ongoing, rigorous oversight" and "maximum transparency".
Beyond industry guidelines, many countries have implemented laws that ban clinical trials of genome editing in embryos. As of 2020, no country allows for the genetic modification of embryos in pregnant women, through either explicit or de facto bans. However, at the time of He's experiment, the regulations surrounding genetic modification research in China were dubious at best, and did not explicitly prohibit clinical studies of this kind. Additionally, the regulatory environment surrounding research in China is relatively new, making it easy for He Jiankui to avoid any oversight from both industry and governmental agencies. Regardless of the lack of robust legislation on genetic modification, He blatantly violated a number of other ethical and legal restrictions in order to carry out his experiment covertly. He forged documents to get medical approval, fabricated a fake ethical review certificate, and misled doctors "misled doctors into unknowingly implanting gene-edited embryos into two women." In the years since He's research, China has passed new regulations restricting genome editing and created a new national medical ethics committee to oversee future genetic experiments.

### Controversy

In China, the government immediately launched an investigation into the experiment, and in January 2019, He Jiankui was fired from his position at the Southern University of Science and Technology in Shenzhen. The Chinese government also issued a statement condemning the experiment, stating that the researchers had "violated China's laws and regulations, breached the morality and ethics of academia, and damaged China's international reputation in the field of science and technology." While the babies' parents were aware of the gene editing, He broke Chinese laws by forging Chinese documents. In December 2019, He Jiankui was sentenced to three years in prison and fined three million yuan (approximately $430,000) by a Chinese court for his involvement in the experiment. Two of his colleagues, Zhang Renli and Qin Jinzhou, were also sentenced to prison and fined.
Media Response
There was immediate outcry from many people in the industry against He's actions. The NIH, Chinese Academy of Medical Science, WHO, and countless other bioethicists, geneticists, and other biomedical researchers all strongly condemned He Jiankui and his experiments. A documentary called "Make People Better" about the activities of He Jiankui and his relations with the Chinese Government was released in 2022. It provided a critical perspective on He yet claims that he is part of a larger trend in China and was thrown under the bus. The National Academy of Sciences, which has been outspoken about the ethical concerns of gene-editing, tweeted in 2019 seemingly in support of using gene-editing to create designer babies with enhanced abilities beyond resistance to diseases. He Jiankui's research has prompted much public discussion on the ethics of genetic modification and "designer babies". While most people disagree with using genome editing to make babies more intelligent, public opinion is more mixed on its use to cure diseases.

### Impact

There is a lot of uncertainty surrounding the effects of the gene editing experiment. He Jiankui attempted to disable the CCR5 gene that is responsible for HIV infection, but this is far from a guarantee. This experiment he conducted is still being monitored with no concrete evidence that this gene is completely disabled. In a video released on his YouTube channel, He Jiankui said that gene editing should only be used for healing rather than enhancing IQ or physical appearances. Interestingly, the CCR5 gene is a suppressant of memory and brain plasticity. Disabling this gene may prevent the contraction of HIV, but it also has implications in creating highly intelligent babies. There are loads of possible consequences these babies can face from higher risk of West Nile Virus and severe flu to cancer. The impact on babies "Lula and Nina" it yet to be seen, but this experiment has launched a heated debate between scientists over the use of CRISPR-Cas9.

### Conclusion

He Jiankui's actions have been almost universally denounced by researchers and governments around the world, and he paid the price when he was sentenced to prison. However, in 2022, He was released from prison and is already attempting to raise money to perform new experiments, this time working to "develop affordable gene therapies for rare diseases." To this day, He has never apologized for his actions or experiments. The only regret He has expressed is that he "did it too quickly." While He's work brought the ethical dilemma to the forefront of public attention, it did not result in any definitive answers. Research on genome modification continues, albeit under stricter oversight than in He's experiment, and ethical debates within the industry are still ongoing. He Jiankui received an array of opinions for his work. In a professional sense, He should have informed others at the institute he was working with due to the fact he was using their resources and the ethical questions associated with his experiment. A question that comes into play is how will He Jiankui be viewed in 100 years? Will he be revered for his trail blazing work or continue to be condemned due to the fact that he violated the regulations and ethical guidelines of the time?

### References

* ↑ "The untold story of the 'circle of trust' behind the world's first gene-edited babies". www.science.org. Retrieved 2023-05-09.
* ↑ "The businesses behind the doctor who manipulated baby DNA". Nikkei Asia. Retrieved 2023-05-09.
* ↑ Kolata, Gina; Wee, Sui-Lee; Belluck, Pam (2018-11-26). "Chinese Scientist Claims to Use Crispr to Make First Genetically Edited Babies" (in en-US). The New York Times. ISSN 0362-4331. https://www.nytimes.com/2018/11/26/health/gene-editing-babies-china.html.
* 1 2 Horodecka, Katarzyna; Düchler, Markus (2021-06-04). "CRISPR/Cas9: Principle, Applications, and Delivery through Extracellular Vesicles". International Journal of Molecular Sciences. 22 (11): 6072. doi:10.3390/ijms22116072. ISSN 1422-0067. PMC 8200053. PMID 34199901.{{cite journal}}: CS1 maint: PMC format (link)
* ↑ Baltimore, David; Berg, Paul; Botchan, Michael; Carroll, Dana; Charo, R. Alta; Church, George; Corn, Jacob E.; Daley, George Q.; Doudna, Jennifer A.; Fenner, Marsha; Greely, Henry T.; Jinek, Martin; Martin, G. Steven; Penhoet, Edward; Puck, Jennifer (2015-04-03). "A prudent path forward for genomic engineering and germline gene modification". Science. 348 (6230): 36–38. doi:10.1126/science.aab1028. ISSN 0036-8075. PMC 4394183. PMID 25791083.{{cite journal}}: CS1 maint: PMC format (link)
* ↑ Organizing Committee for the International Summit on Human Gene Editing. (2015). On Human Gene Editing: International Summit Statement. https://www.nationalacademies.org/news/2015/12/on-human-gene-editing-international-summit-statement
* 1 2 Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations. (2017). Human Genome Editing: Science, Ethics, and Governance. https://www.ncbi.nlm.nih.gov/books/NBK447260/
* ↑ Baylis, Françoise; Darnovsky, Marcy; Hasson, Katie; Krahn, Timothy M. (2020-10-01). "Human Germline and Heritable Genome Editing: The Global Policy Landscape". The CRISPR Journal. 3 (5): 365–377. doi:10.1089/crispr.2020.0082. ISSN 2573-1599.
* 1 2 Greely, Henry T (2019-10-25). "CRISPR'd babies: human germline genome editing in the 'He Jiankui affair'*". Journal of Law and the Biosciences. 6 (1): 111–183. doi:10.1093/jlb/lsz010. ISSN 2053-9711. PMC 6813942. PMID 31666967.{{cite journal}}: CS1 maint: PMC format (link)
* 1 2 3 "Chinese scientist who produced genetically altered babies sentenced to 3 years in jail". www.science.org. Retrieved 2023-05-08.
* ↑ "China tightens its regulation of some human gene editing, labeling it 'high-risk'". www.science.org. Retrieved 2023-05-08.
* ↑ Qiu, Jane (2019-03-05). "China creating national medical ethics committee to oversee high-risk clinical trials". STAT. Retrieved 2023-05-08.
* ↑ "Statement on Claim of First Gene-Edited Babies by Chinese Researcher". National Institutes of Health (NIH). 2018-11-28. Retrieved 2023-05-09.
* ↑ Wang, Chen; Zhai, Xiaomei; Zhang, Xinqing; Li, Limin; Wang, Jianwei; Liu, De-pei (December 3, 2018). "Gene-edited babies: Chinese Academy of Medical Sciences' response and action". The Lancet. 393 (10166): 25–26. doi:10.1016/S0140-6736(18)33080-0.
* ↑ Molteni, Megan. "The World Health Organization Says No More Gene-Edited Babies" (in en-US). Wired. ISSN 1059-1028. https://www.wired.com/story/the-world-health-organization-says-no-more-gene-edited-babies/.
* ↑ Conversation, The (2022-12-21). "'Make People Better': Documentary Spurs New Look at Case of First Gene-Edited Babies". Heavy.com. Retrieved 2023-05-09.
* ↑ "More Than a Misstep: The NAS Twitter Debacle Represents an Abuse of Authority". Center for Genetics and Society. Retrieved 2023-05-09.
* ↑ Funk, Cary (2018-07-26). "Public Views of Gene Editing for Babies Depend on How It Would Be Used". Pew Research Center Science & Society. Retrieved 2023-05-09.
* ↑ About Lulu and Nana: Twin Girls Born Healthy After Gene Surgery As Single-Cell Embryos, retrieved 2023-05-09
* ↑ "China's CRISPR twins might have had their brains inadvertently enhanced". MIT Technology Review. Retrieved 2023-05-09.
* ↑ Stein, Rob (June 3, 2019). "2 Chinese Babies With Edited Genes May Face Higher Risk Of Premature Death". NPR.
* ↑ "The creator of the CRISPR babies has been released from a Chinese prison". MIT Technology Review. Retrieved 2023-05-08.
* ↑ "The man who claimed he genetically engineered babies just got out of a Chinese prison for practicing without a license and he's eyeing a comeback". Fortune Well. Retrieved 2023-05-08.
* ↑ Devlin, Hannah; correspondent, Hannah Devlin Science (2023-02-04). "Scientist who edited babies’ genes says he acted ‘too quickly’" (in en-GB). The Guardian. ISSN 0261-3077. https://www.theguardian.com/science/2023/feb/04/scientist-edited-babies-genes-acted-too-quickly-he-jiankui.
* ↑ Stein, Rob (March 6, 2023). "Experts weigh medical advances in gene-editing with ethical dilemmas". NPR.