May 26, 2015

White House Weighs In on Use of CRISPR Gene-Editing Technology for Human Germline Modification

The rapid dissemination of the publication reporting the use of CRISPR/Cas9 gene-editing technology by Chinese scientists in an attempt at human germline modification has generated quick responses from several official quarters. The National Academy of Sciences (NAS) has announced its upcoming involvement in the scientific, ethical, and policy debate over the use of the CRISPR technology in germline applications: 
The National Academy of Sciences and the National Academy of Medicine are launching a major initiative to guide decision making about controversial new research involving human gene editing. Human gene-editing technologies, such as CRISPR-Cas9, may lead to promising new treatments for disease. However, recent experiments to attempt to edit human genes also have raised important questions about the potential risks and ethical concerns of altering the human germline. Future advances are likely to raise new questions. 

Our initiative will include an international summit this fall to convene researchers and other experts to explore the scientific, ethical, and policy issues associated with human gene-editing research. In addition, we will appoint a multidisciplinary, international committee to begin a comprehensive study of the scientific underpinnings and clinical, ethical, legal, and social implications of human gene editing. The committee will consider and recommend standards, guidelines, and practices governing the use of gene-editing technologies in biomedical research and medicine. An advisory group to steer the overall initiative will soon be announced.
The NAS initiative has now generated an official reaction from the Obama administration. It is evident that the administration would like to see the scientific community get out ahead of lawmakers in considering how to responsibly handle the potential of CRISPR in reproductive applications. In the White House statement:
The scientific community has a good record of establishing and adhering to ethical principles in genetic technology. In the 1970s, scientists called for a temporary moratorium on gene-splicing technology until the implications and policies could be sorted out. Similarly, this year scientists called for a moratorium on germline-editing research until the safety and ethical issues could be explored by the community. 
The advances in health technology over the past century - vaccines, antibiotics, early disease diagnostics, and treatment for countless health conditions - have reduced infant mortality, extended life expectancy, and alleviated suffering for millions. But new technology also brings risks and ethical challenges that require careful consideration. For example, researchers in China recently conducted genome-editing experiments in human embryos of a kind not able to develop into a fetus or a person. 

Research along these lines raises serious and urgent questions about the potential implications for clinical applications that could lead to genetically altered humans. The full implications of such a step could not be known until a number of generations had inherited the genetic changes made — and choices made in one country could affect all of us. 

It is important that the NAS’ international summit fully explore the implications of germline editing for the current generation and generations to come across the globe, as well as the potential for alternative technologies that do not require germline alteration to deliver similar medical promise. The Administration looks forward to seeing the results of the scientific community’s discussion.
The quiet alarm that underlies these relatively rapid reponses highlights how the use of CRISPR technology application in human reproduction is not just another clinical application, but it goes right to the heart of human potential and scientific power, as well as not insignificantly raising fears of eugenic intent.
In the U.S., we lack a formal regulatory body devoted to oversight of reproductive technologies (unlike, e.g., the UK Human Fertilization and Embryology Authority) so we see a more ad hoc display of responses. The reminder by the National Institutes of Health that no federal funding would be available for gene-editing experiments on the human germline is a kind of de facto ban, since many U.S. scientists rely on federal support.