In November 2018, Chinese biophysicist Jiankui He garnered global attention with his controversial claim of creating the world’s first gene-edited babies. He announced that twin girls, Lulu and Nana, had been born with their DNA modified to resist HIV infection. This revelation immediately sent shockwaves through the international scientific community, igniting intense debate and widespread condemnation regarding the ethics and safety of human genome editing.
The Science Behind the Experiment
He employed CRISPR-Cas9, a powerful gene-editing technology that allows for precise DNA modifications. This technique functions like molecular scissors, capable of cutting DNA at specific points. He’s team targeted the CCR5 gene, which produces a protein on immune cells that HIV uses to enter and infect.
The intended purpose was to introduce a mutation, known as CCR5-delta 32, which is naturally present in some individuals and confers resistance to HIV infection. He aimed to replicate this natural immunity by disabling the gene in human embryos. The modifications were made in embryos created through in vitro fertilization (IVF) from couples where the father was HIV-positive. The embryos were then transferred to the mother’s uterus.
The Ethical Breach and Global Condemnation
Jiankui He’s experiment involved profound ethical violations that drew widespread condemnation from the global scientific and bioethical communities. A central concern was the use of germline editing, which involves making heritable changes to DNA that can be passed down to future generations. Such modifications carry unknown long-term health risks for the individuals and their descendants, as changes introduced could have unforeseen effects across generations.
The medical necessity for the procedure was also questioned, as established methods like sperm washing already exist to prevent HIV transmission in couples where one partner is HIV-positive. Furthermore, there were significant issues with the informed consent process. Critics argued that the parents may not have fully understood the experimental nature, potential risks, and lack of medical necessity for the gene editing.
The experiment also lacked proper ethical review and oversight, with He reportedly forging ethical review documents. Leading scientific organizations and individual researchers worldwide quickly denounced his actions, emphasizing that his work breached widely accepted ethical norms and guidelines for human genome editing. They highlighted the premature and unjustified nature of the intervention, exposing the babies to risks without clear benefit.
Legal Consequences and Regulatory Responses
Following his announcement, Jiankui He faced immediate legal repercussions in China. Chinese authorities suspended all his research activities, describing his work as a violation of Chinese law. He was found guilty of “illegal medical practices” for forging ethical review documents and misleading doctors. A Chinese court sentenced him to three years in prison and imposed a fine of 3 million yuan.
His collaborators, Zhang Renli and Qin Jinzhou, also received lesser sentences and fines. The incident prompted global calls for stricter regulation and moratoriums on human germline editing. China subsequently tightened its regulations on human genome editing, with new guidelines emphasizing that clinical research involving germline genome editing is not permitted. Regulatory bodies worldwide initiated efforts to establish clear international guidelines for gene editing research in humans, underscoring the need for robust ethical governance.
The Unfolding Aftermath
Jiankui He was released from prison in April 2022 after serving his three-year sentence. Since his release, he has indicated a shift in his research focus towards gene therapy for rare genetic diseases, opening a new laboratory in Beijing. He has stated his intention to work on conditions like Duchenne muscular dystrophy and familial Alzheimer’s disease, emphasizing the use of discarded human embryos and adherence to regulations.
Information regarding the health and well-being of the gene-edited children, Lulu, Nana, and a third child named Amy, remains limited due to privacy concerns. He has claimed that the children are “perfectly healthy and have no problems with their growth,” with the twins reportedly attending kindergarten. However, some experts express ongoing concerns about potential long-term health consequences, including off-target effects and mosaicism. This event has reshaped the scientific community’s approach to human germline editing, leading to increased caution and stricter global oversight.