Challenges Raised by Gene Editing
A DISCUSSION OFWhy We Need a Summit on Human Gene Editing
Read Responses From
In “Why We Need a Summit on Human Gene Editing” (Issues, Spring 2016), David Baltimore describes how the planning committee chose the main theme and diverse topics of presentations for the International Summit on Human Gene Editing, held in December 2015. I appreciate the committee’s dedication and effort to make the global forum a memorable and significant event. Dr. Baltimore also expressed hope that the discussions would “serve as a foundation for a meaningful and ongoing global dialogue,” and with that in mind, I would like to share what has been happening in Japan and offer some thoughts for the future.
In Japan, the Expert Panel on Bioethics of the Council for Science, Technology, and Innovation in the national government’s Cabinet Office has been considering the issue since June 2015. The panel decided to take action because of the publication of the first research paper about gene editing on human embryos, and was also prompted by statements by the US government and the International Society for Stem Cell Research in spring 2015. The panel held four hearings with experts in medicine and ethics, and delivered an interim report in April 2016.
The panel concluded that clinical usage of gene editing techniques on human embryos that would lead to heritable genetic changes in future generations should not be allowed at this time, owing to safety concerns, as well as other ethical, social, and philosophical issues. The panel’s report also refers to the technical, ethical, and social issues described in the Statement of the International Summit. Regarding basic research on human embryos, the panel judged that it might be possible to justify some areas of research, such as research into the function of genes during the development of human embryos. All such research, however, would need to undergo strict ethical reviews and—whatever the case—gene-edited embryos should never be implanted in the uterus.
The Japan Society of Gene and Cell Therapy (JSGCT) issued a joint statement with the American Society of Gene and Cell Therapy in August 2015 (Molecular Therapy, 23:1282). Furthermore, in April 2016, the JSGCT, in collaboration with three other academic societies in Japan, issued a proposal for the prohibition of clinical application of germline editing and urged the government to establish appropriate national guidelines for basic research.
As a participant in both international and national activities, I can confidently say that the international summit has had a positive influence on the discussion of gene editing in Japan. Two of the members of the Expert Panel on Bioethics who participated in the summit—including myself—presented reports at one of the panel’s meetings, as well as at several academic societies. The challenge now is how to make the dialogue truly global. As a result of the summit, there are surely many discussions taking place all around the world. I hope that those local discussions—particularly those in non-English speaking countries and regions such as Asia, Africa, and Latin America—will be welcomed into these global discussions, since the challenge of how to handle gene editing technology is one that concerns all of humanity.
I had the privilege of attending the International Summit on Human Gene Editing, and the take-home message for me was that from an experimental perspective, human somatic and germline gene editing are acceptable within local (and global) regulatory and ethical/moral frameworks. In addition, from a therapeutic perspective, somatic gene editing provides a very exciting and globally acceptable opportunity. In contrast, editing the human germline for therapeutic (or preventative) purposes raises many important questions for which there are currently no answers. These questions are complex and touch on issues such as altering the course of natural evolution (with unpredictable consequences) and eugenics, among many others. All present at the summit shared a strong commitment that the scientific community should not proceed in the direction of therapeutic/preventative human germline gene editing.
Having studied and worked in the “North” and now located in the “South,” I have often been asked whether technological advances such as gene editing are indeed relevant to emerging economies, given the need to focus on more pressing priorities such as basic education, health, and food security. I live in a country—South Africa—that has one of the highest levels of HIV positivity, most of the affected individuals being in the economically active segment of the population. My own research would see the implementation of advanced technologies in the genomics field (including gene therapy) in a country in which the number of HIV-positive individuals on antiretroviral therapy is far below 100%. Can one justify advanced technologies in the face of an inability to meet basic needs?
The answer does not appear to lie exclusively in the notion of distributive justice, but perhaps in the principles of health economics: if it makes sense from an economic perspective, then everyone stands to benefit. Too little has been done, in my opinion, to accurately estimate the benefits that would be derived from implementing the fruits of the genomics era (including gene therapy and gene editing) on a large scale in the developing world. This approach would require a calculation of the costs, for instance, of lifelong therapy for communicable diseases such as HIV, genetic disorders such as cystic fibrosis, sickle cell disease, and familial hypercholesterolemia, and then contrasting this to the cost of a one-off diagnostic test or therapeutic procedure. In practice, this would include, for example, the institution of newborn screening programs in the public sector (currently available only to the privileged minority in the private sector) and the application of gene therapy and gene editing for diseases including those mentioned above, bearing in mind the significant cost reduction that would occur with economies of scale.
I would welcome an opportunity to work with like-minded individuals on the health economics of the large-scale implementation in the South of the fruits of the genomics era (including gene therapy and gene editing), where the need paradoxically is as great, if not greater, than in the North, where most of the attention appears currently to be focused. The hope is that armed with an objective appraisal, it will be possible to approach leaders in government and business to convince them of the urgency to act.
Michael S. Pepper
The emerging power of biotechnology is promising an unprecedented ability to alter human structure and function. To foster global dialogue on those powerful possibilities, members of the international community gathered in Atlanta in May 2015 for Biotechnology and the Ethical Imagination: A Global Summit (BEINGS). Leaders from science, business, philosophy, ethics, law, social science, religious disciplines, and the arts and humanities convened to propose a set of ethical principles and policy standards for biotechnologies that impact the human species. The results will be published in the coming months.
The potential of biotechnological advances demands many such conversations as BEINGS, and so I applaud the sponsors of the International Summit on Human Gene Editing. But the key question for such conversations is: who should be at the table?
Human gene editing challenges our definitions of what it means to be human, as well as the proper limits of scientific interventions. But it also demands an examination of how our desire to define and heal disease is conflated with aesthetic definitions and desires, and strongly challenges us to examine our socially and culturally situated definitions of concepts such as “normal functioning” and “disability.”
How we approach such questions is historically and socially contingent. The impact of human gene editing will be felt beyond the biotechnologically advanced countries, and, as participants in the collective human experience, the world community deserves a voice. In the past, technologically advanced societies made decisions that had tremendous impact on the social progress and physical environments of other societies. We must learn from that history and solicit the combined wisdom of different cultures with different experiences and perspectives to thoroughly and transparently debate the implications of this technology. Different kinds of insights lie in the collective experience, the science and philosophy and art and literature of our species, including that of tribal and indigenous populations.
We must invest in those conversations now. It is not only the power of these technologies that challenge us, but their simplicity. It is challenging enough to determine how the scientists represented at the summit should handle human gene editing; it will become nearly impossible when the tools can be mastered by anyone with basic competence in genetic technical skills. The do-it-yourself, garage genetics lab may not be quite ready for human gene editing, but the ability to alter the genomes of plants and microorganisms is becoming routine. As these technologies become increasingly accessible, so will the potential for creating accidental (or, unfortunately, intentional) pathogens or environmentally destructive species.
How do we confront such challenges as a world community? I am not sure of all the solutions, but I am sure of the process: we need collective innovative thought from as many different fields, cultures, philosophies, and perspectives as possible. And that is going to happen only if we also invite critics, opponents to the technologies, and those whose disciplines or fields may at first seem irrelevant to the conversation, as we tried to do in BEINGS. Time is not on our side.