We must strictly regulate gene-editing now, before it becomes the norm

Science magazine, not known for sensationalism, highlighted the first human germline gene-editing endeavor in their recent publication with this headline: &#8220;CRISPR bombshell: Chinese researcher claims to have created gene-edited twins.&#8221;Dr. He Jiankui conducted the research, in which the genes of twins were edited to resist HIV infections; it has created a scientific uproar. The genomic alteration occurred at the embryonic stage &#8212; known as germline editing &#8212; which means the edited genes will be inherited by future generations. Previous human gene research has been on somatic cells, which only affect an individual&#8217;s cells.Early statements from many scientists in China, around the world and especially in the U.S., condemned this newest foray into gene research. Dr. He Jiankui was fired from his university, Southern University of Science and Technology of China in Shenzhen (SUSTech), and could face charges of disobeying regulations regarding ethics and research integrity. Even though germline engineering (not by gene editing) has been prevalent for both plants, animals and agricultural purposes, its use in humans had been considered an ethical breach because of potential unknown risks and consequences for future generations.The National Academies of Science, Engineering and Medicine issued a report in February 2017 recognizing the serious ethical risks of heritable genome editing. Unforeseen biological complications are a concern; but societal factors &#8212; including the dividing line between those with the means to accomplish enhancements for their children and successive generations &#8212; are a grave concern.Yet, in spite of ethical recommendations to refrain from such research, the push for such gene editing is on, with a recent report of research underway at Columbia University in New York into germline editing of human embryos.Such genetic tampering is thought to have potential to cure known diseases, such as Sickle Cell, a devastating single gene mutation genetic disorder affecting many sub-Saharan Africans and at least 100,000 Americans, which is the focus of a half-dozen clinical trials using gene therapy. But it could also be used to gain better physical capabilities, change one&#8217;s appearance and create a better brain &#8212; just to name few possibilities. The wealth of parents will play a major role in opening such pathways for enhancements especially when medical tourism is becoming an accepted practice.The United States has the highest health care cost per capita in the world. Despite the U.S. having the highest health expenditure, twice that of other rich countries, our health outcome is lower, including a lower life-expectancy compared to other developed nations. Currently, somatic gene therapy could cost nearly a million dollars or more per patient treatment. Lifetime treatment with drugs could require that amount as well. Germline therapy, while expensive, could be favorable to eliminate such diseases by treatment with one expensive process.With cost-cutting pressures on one side and wealthy patients desiring enhancements on another, risk/benefit analyses may not be able to hold back the advancement of scientific discovery, especially considering this: Gene editing may soon become a risk-free or low-risk procedure for individual patients. Ethical arguments may not be able to withstand the pressures of the public health need coupled with attaining advantages that money can buy.Successful enhancement procedures could put us on the road to having a master class of wealthy and more intelligent individuals. It could also pave the way to a service class of individuals that are sicker, less intelligent and less strong. Francis Fukuyama, conservative economist and philosopher, in his 2002 book, &#8220;Our Posthuman Future&#8221; predicted that such issues would result in social unrest and would eviscerate the Enlightenment ideals of fairness to which current developed countries have subscribed.We stand in a moment in which the risks of such research must be strictly regulated. The gene editing &#8220;machine&#8221; should become as restrictive as possible, integrated into an international law ratified by governments around the world and augmented by international treaties. With such regulations in place, we can move forward in gene editing research and treatment, carefully considering the consequences of each to protect our ethics, our moral code and fairness to each of us.Adil E. Shamoois a professor at University of Maryland School of Medicine. He is the founder and editor-in-chief of the 30-year-old journal: Accountability in Research. He teaches bioethics.

We must strictly regulate gene-editing now, before it becomes the norm

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