Concern about the cost of carelessly pursuing genome modification is well-founded, but we should be equally wary of the cost of being too cautious. (Madelene Cronje)
COMMENT
Much of the attention garnered by the novel gene-editing technology CRISPR-Cas9 is due to the prospect of unprecedented therapeutic applications becoming a reality within the foreseeable future; much of the debate about gene editing has centred on the similarly unprecedented risks that accompany this technology.
Donrich Thaldar and Beverley Townsend (“Gene editing is risky, but it is worth it”, Mail & Guardian, September 13) address the possibility of adverse consequences of using CRISPR-Cas9. They argue that, although unforeseen risks are a factor, all therapeutic interventions carry similar risks. Accordingly, we ought to treat gene editing as we do all other therapeutic interventions. They point out that we can never be sure about all the effects that any drug or therapy will have; all we can do is try to ascertain that it is safe and efficacious through testing and nonhuman trials.
Some would define this approach to using CRISPR-Cas9 in humans as “cautious”, in that it entails using established criteria to determine safety. For others, this is not enough. In her response to Thaldar and Townsend, Sheetal Soni (“Yes, edit our genes — but do it cautiously”, Mail & Guardian, September 27), calls for a more cautious approach. For Soni, caution in the context of gene editing requires a global moratorium to be adopted.
Both of these articles suggest CRISPR-Cas9 be regulated in ways that could be described as “cautious”, but the point of contention appears to be about what being cautious means when it comes to gene editing. Does caution necessarily require adopting a moratorium? To respond to this, we must consider the reasons Soni provides for why a moratorium is necessary.
Soni refers to recent research that indicates how the modification of one gene, (with the intention of producing a beneficial effect) can have unanticipated outcomes that adversely affect the health and well-being of the edited person. Although this is undoubtedly a serious concern, it is not a problem that a moratorium can fix. No matter how long we wait, the danger of unpredictable risks will remain. It is for this reason, Townsend and Thaldar argue, that the best we can do is to subject CRISPR-Cas9 to the same rigours we do all therapeutic interventions.
Moratorium or not, the basic research necessary to reach a point at which we can say using CRISPR-Cas9 is safe and efficacious must be undertaken. But adopting a moratorium will serve as a hindrance to scientific progress if we expect basic research to elucidate what all the possible outcomes will be. If this were practically possible, one wonders why we would ever do human trials for new drugs or therapies before putting them on the market.
Soni also argues that a moratorium is necessary to deter rogue actors, such as the Chinese scientist who in 2018 announced the alleged birth of the world’s first gene-edited twins. This experiment was conducted in secret, and there is evidence he lacked the requisite skills or knowledge to do it safely. It is unclear how a moratorium would solve this problem, because making rules to bar research or clinical applications of CRISPR-Cas9 will do nothing to impede people who refuse to follow the rules.
Regardless of where we set the bar, “cowboy” scientists will endeavour to ride around it. Reports in Nature indicate that there were protocols and oversight mechanisms in place that ought to have prevented this experiment from taking place, but it appears that the Chinese scientist failed to adhere to regulations, and that the relevant authorities failed to exercise proper oversight.
Although a moratorium is unlikely to deter those rogues who are willing to contravene rules, what it will likely do is impede the progress of responsible scientists who do adhere to laws and ethical guidelines that regulate their work. As such, what we ought to campaign for — if we aim to deter rogue actors — is proper oversight on research and clinical applications of novel technologies, and the promotion of responsible science.
Lastly, Soni opines that a moratorium on gene editing is necessary to allow input from various communities, including the general public, on the ethical implications of using CRISPR-Cas9. This input would certainly be valuable, but it is important to consider whether widespread approval of gene editing is a necessary precondition for its use.
In a constitutional democracy such as our own, general policies for regulating science are formulated with opportunity being made for input from various stakeholders. This includes the mechanisms for the approval of therapeutic interventions. But it is not the case that we think widespread approval is necessary before we can approve each new drug, and how it will be used. If we intend to adopt a different standard for CRISPR-Cas9, we have to question why this departure from established mechanisms is justified.
Furthermore, when considering the ethics of particular interventions, it is important to remember that in a legal system that values individual liberty, such as our own, public approval of any particular action is not a necessary precondition to that act being permissible. Even if it were, the idea that we could ever reach agreement on whether any instance of gene editing is permissible is unlikely.
Although CRISPR-Cas9 is a new technology, debate about the ethics of gene editing is not. Since at least the 1970s, scientists and philosophers have intensely debated whether genome modification is ethically permissible at all, and that debate still rages today. To illustrate: although Soni regards the modification of the CCR5 gene to create children immune to HIV to be ethically acceptable because it amounts to a therapeutic use of CRISPR-Cas9, the Association for Responsible Research and Innovation in Genome Editing in 2018 claimed that genetic modification of the CCR5 gene to prevent children from contracting HIV is a genetic enhancement and, therefore, unnecessary and unethical.
In cases such as these, if we take our commitment to the liberty of the individual seriously, we must err on the side of freedom and accept that people should be allowed to use this technology to genetically modify their future offspring — if it is reasonably safe to do so — if we have no other reason to prohibit it except that the idea of gene editing makes us uncomfortable.
Concern about the cost of carelessly pursuing genome modification is well-founded, but we should be equally wary of the cost of being too cautious. Moratoriums carry a danger of delaying good science, and the longer that delay, the more people who suffer and die without benefiting from a therapeutic intervention that could have had a beneficial effect on their lives.
A moratorium, it seems, does not resolve the issues raised by those with reservations to creating genetically edited children. In my opinion, if we are going to deny even one future child a life without a debilitating genetic disease, or a life free of a disease such as HIV because of an intentional delay, we better have a very good reason for doing so. I do not think we do.
Bonginkosi Shozi is with the School of Law and the African Health Research Flagship at the University of KwaZulu-Natal