Françoise Baylis wonders how it is that in 14 months (from December 2015 to February 2017), the U.S. National Academy of Sciences and the U.S. National Academy of Medicine have moved human germline genome editing out of the category ‘irresponsible’ and into the category ‘permissible.’
In December 2015, the U.S. National Academy of Sciences, the U.S. National Academy of Medicine, the Chinese Academy of Sciences and the U.K.’s Royal Society co-hosted an International Summit on Human Gene Editing. At the close of the meeting, members of the Summit Organizing Committee issued a Statement that included four discrete conclusions. In response to the Statement, the Presidents of the four co-sponsoring organizations confirmed that: “Together with academies around the world, and in coordination with other international scientific and medical institutions, we stand ready to establish a continuing forum for assessment of the many scientific, medical, and ethical questions surrounding the pursuit of human gene-editing applications.”
One of the pivotal conclusions in the 2015 Statement was that “it would be irresponsible to proceed with any clinical use of germline editing unless and until (i) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives, and (ii) there is broad societal consensus about the appropriateness of the proposed application.”
This conclusion has since been usefully characterized as a helpful ethics framework for decision-making about heritable germline modification. The framework is both beautifully simple and exquisitely complex. It is simple in that there are only two conditions to be satisfied. It is complex in that the scope of these conditions has yet to be determined. Currently, there is no agreement on what the safety and efficacy parameters should be, and the meaning of “broad societal consensus” remains unclear. To my way of thinking these facts of the matter are not limitations, but opportunities.
Now, after a little more than a year, it appears that the U.S. National Academy of Sciences and U.S. National Academy of Medicine have decided to ‘go it alone’ insofar as their ‘Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations’ has decided to move things along without working towards broad societal consensus.
The February 2017 report Human Genome Editing: Science, Ethics and Governance concludes that “clinical trials using heritable germline genome editing should be permitted” provided the research is only for compelling reasons and under strict oversight limiting uses of the technology to specified criteria. For the committee, a compelling reason is the desire of some prospective parents who are at risk of having children with a “devastating genetic disease like Huntington’s disease” to have children who are both ‘healthy’ and genetically related to both parents. And, the criteria to be satisfied have mostly to do with safety and efficacy. In this way, with nary a word, the second element of the 2015 proposed ethics framework – broad societal consensus – has been jettisoned.
Interestingly, I doubt there would be broad societal consensus on the merits of the identified ‘compelling reason’ for proceeding with germline editing. Indeed, from a global perspective, I can more easily imagine a broad societal consensus on the use of germline editing to enhance or modify traits to help ensure the survival of the species, than I can imagine agreement on the benefits of pandering to the desires of a very few for genetically-related children. This is especially so as there are alternative family-making options for people who know they are at risk of transmitting an inherited disease.
To be clear, I am not endorsing germline genetic enhancement. I am just making the point that different people have different ideas about what objectives, values, and priorities should drive decision-making about the ethics of heritable germline editing and these different ideas are worthy of discussion and debate. While the authors of the 2017 Report are moved by the desire of some to have genetically-related children, others are not similarly convinced that this should be an important consideration in decision-making about the permissibility of germline editing.
This brings me to another important conclusion in the 2015 Statement that also appears to have been set aside in the 2017 Report. The 2015 Statement insisted on the need for ongoing meaningful discussion and debate including “biomedical scientists, social scientists, ethicists, health care providers, patients and their families, people with disabilities, policymakers, regulators, research funders, faith leaders, public interest advocates, industry representatives, and members of the general public.” The 2017 Report repeatedly mentions the need for broad public input, but nowhere is the ‘public’ described or defined. Moreover, it appears that public input is to focus narrowly on matters “that go beyond treatment or prevention of disease or disability (e.g., for enhancement)” – it having already been decided by the Committee that both somatic and germline modification for therapeutic purposes are permissible.
So it is that by legerdemain, the U.S. National Academy of Sciences and the U.S. National Academy of Medicine have sought to redirect public engagement so that it is no longer about somatic versus germline genome editing, but rather is about gene editing for therapy or enhancement.
Conflict of Interest: Françoise Baylis was a member of the Organizing Committee for the 2015 International Summit on Human Gene Editing.