Written by Judit Sándor, Professor at the Central European University, Budapest, Director of the Center for Ethics and Law in Biomedicine
The Chinese medical researcher, He Jian-kui reported in late November that the first babies had been born with edited genomes. The scientific world seems less than enthusiastic1. The proud scientist announced that Lulu and Nana, the twin girls developed from gene edited embryos, are to be followed by a third baby soon, while the Chinese authorities responded that this experimental research aiming to modify the human genome is against Chinese law and violates international consensus .
There are some who doubt that this experiment was in fact successful. We may recall that at the end of 2002, the American organization Clonaid announced the first successful human reproductive cloning, a baby named Eve, born on December 26, 2002. Despite the claims that further clone babies have been produced by the company since then, there is no evidence that Clonaid has ever managed to clone a human being. Nevertheless, many commentaries and analyses discussed the possibility of human cloning over the next couple years, some denouncing the news, others responding to it with resignation. We may also remember that in 2005, the Korean researcher Hwang Woo-Suk announced the creation of the first embryonic stem cells prematurely. As it turned out, Hwang falsified research data and committed other ethical violations, and this resulted in his shameful downfall. Since others have managed to create embryonic stem cells in the meantime, we now have to face the clinical possibility of interventions into the human genome, even if He Jian-kui’s claim proves to be false. When the genome editing procedure becomes safe and absolutely precise, then there will be cases in which the intervention of genome editing can be justified by preempting the development of a life-threatening disease in a baby. But we have not yet reached this point. Moreover, He’s research made not one, but two long steps ahead: his intervention into the human genome aimed not only to modify the gene of a serious disease, but also to create resistance to that disease, with prophylactic purposes.
It is also astonishing to learn the reason for the intervention in the case of these twin girls. One would think that the Chinese research team sought to find a solution for curing a serious disease incompatible with human life—but this was not the case. It is rather strange that the aim was to produce resistance against the HIV virus in the newborn babies; this can be justified only if the mother of the twins herself is already infected with HIV. The complexity of genome editing makes it an intervention which is excessively risky. One of the basic conditions of engaging in a scientific experiment is that the anticipated results will likely surpass the risks involved in the intervention. This is not the case here. Moreover, it remains a problematic issue to prove HIV resistance. The intention to expose the genome edited twins to HIV infection would be ethically unacceptable. Therefore, the success of this particular genetic intervention could be proven only in case the HIV virus is contracted by chance, at a later phase of life. Otherwise the only option would be laboratory testing, conducted in vitro, outside the bodies of the baby girls. Either way, the procedure presented by He is ethically unjustified.
Moreover, we do not know if any local, national, or international ethical board, or any professional body, has overseen the process of designing the intervention and approved the research protocol. This is not only a serious violence of ethical norms, but it also makes it nearly impossible to reconstruct how the procedure did actually happen. The lack of transparency is highly problematic for the international scientific community that wants to verify the results of the intervention. In other words, the lack of ethical transparency in this case opens up space for serious professional objections.
On November 30, 2018, the Council of Europe issued a statement in which it confirmed that the only binding international legal norm in this field is Article 13 of the Oviedo Convention on Interventions on the human genome which states that “An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants.”
He Jian-kui’s announcement was so unexpected that the Nuffield Council’s report titled Genome Editing and Human Reproduction: Social and Ethical Issues2, published this summer, discussed the application of genome editing to the field of human reproduction only theoretically and in a futuristic way. It analyzed the, as yet, hypothetical situation when genome editing becomes routine and safe, and can be used among the assisted reproductive technologies available to women and men. This would mean that certain disadvantageous human characteristics, mutations, or susceptibility factors can be knocked out before the embryo is inserted into the womb. As a result, even those fetuses can be brought to life that previously did not have a chance to survive or to develop into a healthy child. In certain cases, even infertility, or other obstacles that make reproduction impossible, can be treated through genome editing. If genome editing works safely, it might lead to the possibility of altering or modifying genes in the gametes or embryos in order to ensure that a healthy child or one with specifically tailored characteristics can be born.
The Nuffield Council’s 205-page-long document faces the social and ethical issues related to genome editing in a more venturous way than any previously published ethical or legal statements. To understand the novelty and ethical significance of this Report, it is important to state the ethical consensus that has defined the legal and ethical framework for interventions into human genes over the past two decades. For a long time, modification of the human gene was considered ’manipulation’ and faced strong ethical and moral reservations. Although the relatively new technique of genome editing raises similar concerns as ‘gene therapy’, it modifies the human genome in a different way than the earlier ’gene therapy’ or genetic modification procedures. Genetic modification inserts new, foreign genes or knocks out existing ones in the DNA artificially and as a result, the genetic material changes in a way that would not be possible through natural recombination or fertilization. Gene editing (or genome editing when more than one gene is edited), on the other hand, treats genes by repairing sections in the genetic structure of the DNA with the help of molecular scissors—and the outcome is ‘natural’ or naturally healthy without the disease.
It is not likely that we can reach agreement in the near future on a number of ethical concerns related to gene and genome editing, as we need more information about the consequences of these interventions, more time for further research, and more intensive and widespread debates on ethics. What we can do now, without hesitation, is to designate such interventions into the human genome as exceptional research procedures that can be conducted only after independent, multidisciplinary professional and ethical bodies form a grounded opinion on them, approve, and follow them.
1 https://www.technologyreview.com/s/612458/exclusive-chinese-scientists-are-creating-crispr-babies/ accessed December 3, 2018
2 http://nuffieldbioethics.org/wp-content/uploads/Genome-editing-and-human-reproduction-short-guide-website.pdf accessed December 3, 2018
Please note that blog posts are not peer-reviewed and do not necessarily reflect the views of RHM as an organisation.