The Problem of Transparency and Human Genome Editing

Posted on Jun 4, 2016


In the past several weeks, human genetic modification has been dominating headlines.  This time, the controversy surrounded the closed door meeting between 130 scientists, attorneys, entrepreneurs, and government officials to discuss the creation of a synthetic human genome.  The project, called “Human Genome Project-Write Testing Large Synthetic Genomes in Cells” aims to synthesize a complete human genome in a cell line within ten years, with the future goal of translating such basic science into clinical applications.  Rather the modifying the human genome through editing technology such as CRISPR, synthetic creation would allow scientists to make extensive and radical changes throughout the genome.


According to one of the co-organizers, Harvard Geneticist George Church, the meeting merely constituted a “thought experiment” and the organizers made an executive decision to close the meeting to the public, asserting they would subsequently publish the discussion from the meeting in a prominent scientific journal that required a pre-publication embargo on publicly sharing the content of the meeting.


Stanford’s Drew Endy not only declined to attend based on the meeting’s intentional secrecy, but posted to his Twitter a copy of the meeting invitation, which stated the organizers instituted the media ban as a mechanism avoid media scrutiny and “to permit attendees to speak freely and candidly.”  Endy, along with Northwestern’s Laurie Zoloth published a response in Cosmos Magazine noting that “when the first people at the table mostly have significant and direct material interests in the proceeding, everyone, not just those in the room, risk out-of-control competition between public and private interests, ethical conflicts of interest, and temptations to manipulate human subject consent.”


Endy advocated for “pluralistic, public, and deliberative discussions” to encourage transparency of purpose and content.  Marcy Darnovsky  from The Center for Genetics and Society posited the meeting served as a step to privatize efforts toward genetic modification.  According to the Center for Genetics and Society, billionaire attorney and entrepreneur Randal Kirk plans to expand his empire of life sciences corporations focused on genetic modification (projects that currently include genetically modified salmon, genetically modified mosquitoes, and human gene therapy research) to include research projects designed to synthetically create human ova and alter the human germline.


We have seen the impact of closed meetings and the power by which interested stakeholders with deep pockets and a vested interest in promoting a technology can direct public opinion like a puppet master through strategic media campaigns, assert “conclusions” professing basis in scientific evidence, proclaim consensus despite the existence of divisive questions within the scientific community, and strong arm regulation and policy without public transparency.  Perhaps most problematically, few members of the public are even aware of this complex history behind the curtain of genetically modified food so eloquently and meticulously presented by attorney Steven Druker in Altered Genes, Twisted Truth In his book, Druker raises several notable points, each of which are pertinent to the discussion relating to human genetic modification: we must analytically examine the current state of science rather than accepting inflated promises, comprehend the danger of failing to consider unintended effects within the organism and its ecosystem, and scrutinize the implication of inherent unpredictability when altering genetic structures.


Indeed, the Committee on Science Technology, and Law Policy and Global Affairs at the International Summit on Human Gene Editing noted that the current gene editing technology CRISPR is highly unpredictable: it can alter DNA at other unintended locations other than its target, which would impact genetic structure and function at other locations on the genome.  This process could activate other genes including cancer causing genes,  inactivate essential genes, or cause chromosomal rearrangements.  One team from Guangzhou Medical University China who conducted gene editing on non-implantable embryos using CRISPR reported dismal preliminary results: only 4 of the 26 embryos the team used produced the desired mutation that scientists believe confers HIV resistance and the embryos demonstrated signs of mosaicism.  Furthermore, Geneticist Eric Lander observed inducing this particular mutation simultaneously confers an increased risk of West Nile virus and aptly summarized: “We are terrible predictors of the consequences of the changes we make…we don’t understand the genome enough to make changes in the long run.”


Despite a United Nations prohibition on the modification of the human genome and other nations that legally prohibit human genetic modification, the US does not have federal regulations prohibiting human genetic modification, whether achieved through genome editing or synthetic human genome creation.  It is also foreseeable that any obstacles arising out of federal funding limitations could be easily circumvented though private funding or successful lobbying to ease or even erase such restrictions.


This weekend at the American Society of Law, Medicine and Ethics Annual Heath Law Professors Conference Law Professor John Robertson repeated Church’s label, asserting that we are likely to see “exciting” efforts to “correct disease” fairly soon but efforts for enhancement are a distant “thought experiment.”  I disagree.   Corporations need not offer perfectly accurate technology, but instead appeal to a market by advertising a product’s technological promise.  As we’ve seen in current genomic technologies, this translates into technology premised upon manufacturer advertisements of accuracy and validity which may or may not produce the desired advertised outcome.


The community of interested stakeholders must rise as a leader to promote thoughtful governance, particularly given the transnational and global nature of this research.  Public transparency of the scientific community’s goals and agendas are imperative given our current juncture-  private corporations are poised to create synthetic ova, presently occurring experiments create chimeras integrating human DNA into animals, and Bill Skarnes of the Wellcome Trust Sanger Institute predicts the utilization of human genetic modification for clinical use in humans within the next five years.  Failing to intervene with prudent regulation at this juncture will have unimaginable and irreversible consequences.