What CRISPR ‘Designer’ Babies Could Mean for the Future of Society
Why A Dangerous Precedent in Designer Babies Must Spur a Call to Action
About 24 hours ago, He Jiankui, an Associate Professor at the South University of Science and Technology of China, uploaded five videos to his YouTube page. In them, he describes the birth of twin girls, Lulu and Nana. The twins are part of a trial involving seven Chinese couples. In all of these couples, the father is HIV-positive and the mother is not. Dr. He claims that, at the embryonic stage, the genomes of both Lulu and Nana were modified using CRISPR-Cas9. In particular, the CCR5 gene, which encodes a receptor that is implicated in the uptake of the human immunodeficiency virus (HIV) into host cells, was removed. The study was carried out in apparent secrecy and numerous medical experts have questioned whether it was necessary or safe, particularly considering that there are well-established methods to prevent the transmission of HIV from parent to child.
This claim follows a 2015 report of genome-edited human embryos, published in the journal Protein & Cell, led by Chinese researcher Junjiu Huang. This previous report was conducted in non-viable human embryos obtained from fertility clinics. Huang injected 86 embryos with the CRISPR-Cas9 system, of which 71 embryos survived, 54 were genetically tested, and only 28 were modified as expected. The team stopped the research project because they felt that the method was still “too immature”.
Now, Dr. He has self-reported a highly unethical practice. The research was not conducted in accordance with academic protocols, in solidarity with international scientific agreements, or with any oversight from an academic institution. Instead, the work was conducted in partnership with a private fertility clinic.
In a hollow effort to convey a sense of ethical morality, Dr. He published a list of “Ethical Principles of Therapeutic Assisted Reproductive Technology” on his laboratory website, which includes “mercy for families in need” and “only for serious disease, never vanity”.
Of the ‘principles’ listed, none of them counteract the serious ethical leaps which have been made. The gene deleted in this example, CCR5, is likely not the safest method for mitigating the spread of HIV from parent to child, and so the risks to Lulu and Nana likely outweigh the benefits of other medical practices that could have been utilized.
After releasing the YouTube videos, the story was picked up by MIT Technology Review and the Associated Press News. In the hours that followed the initial release, other news outlets scrambled into the fray, offering, at times, prescient words of dismay and concern. In a The Guardian article, Dr. Sarah Chan, a bioethicist at Edinburgh University in Scotland, called Dr. He’s claims “of grave ethical concern.”
Dr. He is now under investigation by the South University of Science and Technology of China. The university claims that “it had been unaware of the research project and that the academic, He Jiankui, had been on leave without pay since February.”
In a statement released today by the University of California — Berkeley, Jennifer Doudna, co-inventor of CRISPR-Cas9, called on Dr. He to “fully explain their break from the global consensus that application of CRISPR-Cas9 for human germline editing should not proceed at the present time”. Feng Zhang, whose lab was the first to edit the DNA of human cells using CRISPR-Cas9, expressed similar concerns, urging a moratorium on gene-edited embryos.
Whether or not the claims made by He are true, they mark a serious ethical violation of international scientific agreements set forth during the first International Summit on Human Genome Editing, which occurred in 2015.
The timing of He’s announcement is not an accident, either. Today, the Second International Summit on Human Genome Editing kicked off in Hong Kong, with many notable speakers, including Jennifer Doudna, Feng Zhang, David Liu and Nobel Laureate David Baltimore, in attendance. Dr. He is scheduled to speak at the summit tomorrow.
Already at the Summit in Hong Kong, Chinese scientists have condemned Dr. He’s actions, stating that “what Dr. He did is not just somatic nor germline genome modification, but germline genome modification for enhancement. This is a practice with the least degree of ethical justifiability and acceptability”. They further state that there already exist practical methods to prevent HIV infection, and that the use of genome editing for this purpose is akin to shooting a bird with a cannon.
It is clear at this time that the independent, unregulated, unverified claims made by Dr. He present a serious concern for scientists and patients alike. At this juncture, it may be prescient to consider what happens next. The decisions enacted by the scientific community today may have drastic implications for the future of germline editing.
At the First International Summit on Human Genome Editing, researchers agreed to not proceed with genome editing of human embryos due to the uncertainties in the scientific methods. In 2017, Dr. He spoke at Cold Spring Harbor Laboratory and mentioned, at that time, that the use of CRISPR-Cas9 with in vitro fertilization methods resulted in few “off-target effects”, but only some of the cells within an embryo are successfully edited. Additionally, scientists have not studied the long-term effects of CRISPR editing in humans.
While ethical guidelines are necessary to enact meaningful policies regulating the use of CRISPR on human patients, there is clearly now a dire need for real political, international legislation punishing its unauthorized use until scientific agencies have carefully studied and approved its use in specific contexts.
The use of CRISPR-Cas9 to edit germline cells without deleterious effects, if true, marks a substantial advancement in CRISPR as applied to precision medicine. While the use of genome editing technologies to correct inherited genetic diseases safely will hopefully, some day, be a reality for all, it should nevertheless be regulated in the interim. Much like any pharmaceutical pushed by a drug company for government approval is highly vetted, so too should CRISPR medicine be heavily scrutinized. Indeed, this is the case, as human CRISPR trials were set to begin in the United States, but were preemptively halted by the FDA.
Improper or heavy-handed regulation in response to this recent development could stifle further developments in this area, but a thorough investigation by international experts should be conducted to ensure that lone actors do not repeat the actions of Dr. He.
Now that Dr. He has ‘taken the blame’, so to speak, how should other scientists respond? Well, they should condemn the actions of Dr. He for a start, assuage the concerns of an anxious public, and work towards a future in which the scientific process and regulations are thoroughly followed before putting the health of humans at risk.
International governments should enact policies to regulate the propagation of the unlawful use of CRISPR technologies before lone actors provide irreparable harm to scientific credibility. In all aspects of the political process, ethicists and academics should work together to ensure that the regulations enacted are warranted, but not restraining.
CRISPR has the potential to help humans live longer, healthier lives. We must continue in our research aims, holding ever high our commitment to the public that provides the opportunity to uncover the secrets of the natural world.
Tell me your opinion on Twitter @NikoMcCarty
What CRISPR ‘Designer’ Babies Could Mean for the Future of Society
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