An international group of experts engaged with the ethical and regulatory problems facing gene editing and came to a surprising conclusion.
Gene editing for the purpose of preventing disease is cool, but not for the purpose of creating enhanced humans, according to a new, groundbreaking report from the National Academies released Tuesday.
For the first time, an interdisciplinary, international expert panel has advised that research of clinical applications of germline editing, or traits that can be inherited, using gene editing technology such as CRISPR-Cas9, could go ahead—if a number of criteria are met—paving the way for "designer babies," or at least, babies that have been engineered as embryos to not carry certain debilitating genetic diseases.
The report, a massive, 250-plus-page work in the making since the December 2015 Gene Editing Summit, an international meeting hosted by the National Academies and well as members of both the Royal Society of the United Kingdom (where germline editing has been approved in the form of mitochondrial donation therapy) and the Chinese Academy (where human embryos have been experimented on with CRISPR).
The report aims to develop international norms on gene editing and begin to solidify global policy about using this technology between leading countries. The consensus report is essentially a gentlemen's agreement, for lack of a better term.
Besides looking at the ethical and legal frameworks for therapeutic gene editing, the report also pointedly engages with the concept of enhancement, a tricky issue that is a distinct goal of the transhumanist movement, and which was a huge point of debate at the summit that inspired the report.
However, the report's authors have made it abundantly clear that genome editing is not to be used for the purposes of "enhancement" at all, under any circumstances, and that if using gene editing for anything beyond treatment of diseases were to creep in behind clinical, therapeutic uses of technology like CRISPR, it would not even be worth using.
R. Alta Charo, a leading American bioethicist and the co-chair of the report, insisted during the report's release panel today that genome editing, both somatic (non-heritable changes to genes) and germline (changes that are heritable) should be used for the treatment and prevention of disease and disability only.
The general public has shown a continued concern about the idea of "designer babies," and although germline editing could absolutely produce children that were cured of certain genetic diseases, like sickle-cell anemia, for example, designing babies based on height, hair, or eye color, is still unethical, according to the report.
"We are not talking about germline editing for so-called enhancements," said Charo, reiterating that the technology is to be used for "serious disease and conditions, not for enhancement" and that if conditions cannot be met, "it is not permissible to begin these trials despite the fact that some families would benefit."
Charo noted that the report lists a series of "very strict, very stringent criteria and conditions that must be met before any clinical trial could be considered" for germline or heritable changes. She pointed out that we are "not even close to the amount of research we need for to move forward with this technique."
In fact, even in the US, clinical research of germline editing cannot yet go ahead, because an FDA statute prohibits research that produces heritable changes in an embryo. Until that law is allowed to expire, the report notes, germline editing will still be off the table in the US.
However, it's clear that the enhancement debate won't go away anytime soon.
The report does mention the emergence of "academic transhumanism" in the gene editing debate, and in the enhancement chapter reiterates a number of the traditional arguments against the biolibertatian, and transhumanist positions, including: the slippery slope into an "unnatural" society where some members of the species are edited and others aren't, the issue of eugenics, and the philosophical debate that the parent-child relationship would be altered.
It also points out that the arguments in favor of enhancement for one's own children, based on either morality or personal liberty, are not at present supported by the US justice system, which the report states "would need a reproductive rights framework to be stretched to its limits in order to encompass the right to enhance or diminish traits."
While the report's authors do briefly consider the DIY bio movement, a member of the panel today almost rejected out of hand that biohackers might take enhancements into their own garage "clinics," as it were.
"One has to distinguish DIY science going on particularly as a hobby that can be applied to bacteria or simple organisms. It cannot be applied to clinical applications, that's a long way off," said Richard Hynes, a cancer researcher at MIT and co-chair of the report. "The delivery of any genome editing product into a patient is a much more challenging issue… And would require more than just DIY activities. It would require sophisticated clinics."
That said, Stat makes the excellent point that stem cell clinics provide a similar, unregulated clinical experience. The report's authors do urge clarity on these matters, but until there is a clear and concise ban on enhancing oneself in one's own garage, the biohackers are on their own.
It would not be difficult to imagine a self-edited transhumanist happily living in this legal and ethical grey area.