A DISCUSSION OFHuman Genome Editing: Our Future Belongs to All of Us
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As the debate about heritable genome editing unfolds, divergent perspectives are coming more clearly into view. Those who see it as offering little or no benefit while posing unacceptable societal risks support either the currently prevailing policies that ban it outright, or a moratorium that leaves the option of prohibition on the table. Enthusiasts, in contrast, speak of a “responsible path forward.” They dismiss the need for anything called a moratorium, and backpedal on the commitment to broad societal consensus made at the first International Summit on Human Gene Editing, in 2015.
There is one point of agreement: nearly everyone says they favor public engagement in the decision. But as suggested by the contributions to the Spring 2019 edition of Issues, there are important differences over just what kind of public engagement and deliberative process each has in mind.
The Center for Genetics and Society, a public interest and social justice organization, has long pressed the case for prohibiting human germline modification. We are confident that a meaningful deliberative process will conclude that this use of powerful genetic tools has no place in a just and fair future. We suggest that such deliberations will require first, an expansive model of public engagement; second, a significant reframing that puts social context and consequences rather than physical risks at the forefront; third, a concerted effort to clear up confusions that currently distort public understanding; and finally, the time, financial support, and human resources to make these criteria feasible. Some thoughts on each follow.
Broad and inclusive participation. Genuine public debate must involve a far wider range of voices and concerns than those included so far. Among the all-but-missing are scholars in the social sciences and humanities, and public interest advocates for reproductive, racial, disability, and LGBTQ rights and justice. The small number of these representatives presenting or participating at the two international scientific summits on human genome editing falls dramatically short of meaningful public participation.
Center the social. Most considerations of heritable genome editing focus on technical and scientific matters. Concerns grounded in recognition of systemic patterns of social discrimination and stratification, powerful commercial dynamics, and historical contexts including widespread eugenic abuses are seldom investigated. Although these issues are ill suited for laboratory experiments, they bear importantly on the likely consequences of heritable genome editing and require careful collective consideration.
Confront misunderstandings. Meaningful deliberations will require clearing away a number of confusions that have become widespread. Among these is the frequent characterization of heritable genome editing as a medical intervention, when it is much better understood as a way to satisfy parental preferences for genetically related children. Most people haven’t considered this point, in part because media accounts downplay or ignore the existing methods by which at-risk parents can avoid passing on serious genetic diseases. In our review of articles and commentaries on heritable genome editing in three prestigious newspapers over an 18-month period, fully 85% failed to mention this.
Support meaningful public deliberations. The international summits on human genome editing were multiday events with hundreds of participants and voluminous media coverage. Nothing close to the resources expended on those meetings has been available to convenings—or to any other deliberative process—with majority participation by nonscientists. Democratic governance requires adequate time, hard work, and human and financial resources.
The coming policy decision about altering the genes of future generations carries huge stakes, including the prospect of dividing future societies into genetic “haves” and “have-nots.” This is one we have to get right.
Center for Genetics and Society
In the workplace, people work better, harder, smarter, and have more job satisfaction when they are paid fairly, where transparency of governance is the norm, and where all workers feel they have a voice and perhaps even a stake in how the company is run. When policy and management create an adversarial, disrespectful, authoritarian environment, workers are more likely to be surly, apathetic, resentful, pissed-off. Governance needn’t be a popularity contest; expertise needn’t be devalued. Decision-making simply needs to be open, fair, just. It’s about the process, and it’s not hard to spot.
Such a process is what I understand Françoise Baylis to be calling for in “Human Genome Editing: Our Future Belongs to All of Us” with respect to citizenship and germline gene-editing policy. As she has noted elsewhere, when scientists control ethics discussions, the conversation tends to focus on only two issues: safety and efficacy. In considering germline gene therapy, safety and efficacy are necessary but not sufficient. Baylis insists that germline engineering raises significant questions of risk, equity, and justice that need to be at least heard and seriously discussed if we are to proceed ethically.
Consensus-building will slow down the science a bit. This frustrates scientists who believe that maximum speed must be sustained in the march toward new therapies. Some scientists have essentially told ethicists and other nonscientists, “Get out of the way.”
Arrogance, hubris, and unintended consequences are all-too-common themes in the history of human genetic manipulation. Perhaps science with high moral and ethical stakes should be slowed down a bit. I wish bioethicists and other critics had been in the way when Harry Laughlin, of the Eugenics Record Office in Cold Spring Harbor, New York, lobbied a century ago for eugenic sterilization laws. I wish they had been in the way when Stanfield Rogers in 1970 and Martin Cline in 1980 performed rogue gene therapy experiments on people. I wish they had been in the way when unforeseen consequences of gene therapy caused the death of the American teenager Jesse Gelsinger in 1999 or the two French girls who in 2002 successfully incorporated a gene to repair their severe immunodeficiency but succumbed to iatrogenic leukemia. Bioethicists and other concerned citizens: get in the way!
Even conscientiously inclusive scientific projects can go awry when they lack broad consensus among stakeholders. Case in point: the Human Genome Diversity Project of the 1990s. Politically progressive scientists seeking to broaden ethnic representation in DNA databases were shocked to learn that the indigenous peoples whose DNA they wanted to “rescue” didn’t want scientists taking parts of their bodies to use for their own purposes. Similarly, health care workers in developing countries have learned that medical aid is received much more favorably when they take care to enroll the affected communities. When researchers and health care workers do otherwise, it feels like biomedical colonialism.
In short, it is perfectly possible to know “broad international consensus” when we see it, and the historical record is rife with cautionary tales of science gone askew when such consensus fails to be reached.
Institute of the History of Medicine
Johns Hopkins University
I read with the interest the thoughtful article by Mohammed Ghaly on “Islamic Ethical Perspectives on Human Genome Editing.” It should be noted that this discussion is timely given the recent events that reminded us once again how science tends to move ahead of ethics, and the consequences of such gaps as exemplified by the announcement of the birth of two genetically edited babies in China. The latter development has created an outcry not only from the public but from the very scientific community that developed the enabling tools for such editing.
As with many contemporary ethical questions, the religious establishment often has one or more stances that can influence public opinion, and these positions should not be ignored since public engagement in the ensuing debate is key to addressing these questions. Ghaly was careful in listing the different opinions among Muslim scholars with respect to genome editing and the basis of such opinions. In general, he painted a favorable picture in which approval is the rule rather than the exception, which is an encouraging start.
Unfortunately, it is unclear what the relative distribution is among Muslim scholars of the contrasting opinions. This is key because Ghaly seems to suggest the presence of a liberal school of thought that supports even the most hotly contested application of genome editing—that is, germline editing for the purpose of enhancement. But the article provides little with regard to how this camp favors permissibility of such drastic actions to alter the human race in the face of unpredictable risks, to say nothing of the issue of inequality between those who can afford this technology and those who cannot, or even the very basic issue of fairness of resource allocations, all of which are fundamental principles in the Islamic Law.
Ghaly correctly pointed out the seeming obliviousness to the issue of consent among future descendants, but it should be clearly stated that even the apparent dismissal of the issue of consent among one’s own children on the basis of guardianship laws seems out of context. Indeed, it is hard to see the analogy between the power of guardianship granted by Islam to the parents to act in the best of interest of their children when making decisions about their treatment, and the power to override the children’s consent about what will be a permanent and transgenerational change.
The danger of curious, unilateral, and uninformed religious opinions about such an extremely complicated and multifaceted issue of societal importance as genome editing cannot be overemphasized. It is precisely for this reason that the institutions of religious rulings on contemporary issues that Ghaly mentioned must take up the issue of genome editing and analyze it systematically with input from subject matter experts. For now, however, the sense of optimism conveyed by Ghaly is a reason to believe that the discourse around genome editing among Muslim scholars will at the very least not stifle the adoption of this disruptive technology and may very well embrace it in positive ways to improve human well-being.
Fowzan S. Alkuraya
Head, Developmental Genetics Unit
King Faisal Specialist Hospital and Research Center
Riyadh, Saudi Arabia
The authors of the articles on the reality and future prospects of genetically engineered babies offer reflections on the appropriation of human biology by technology so as to improve the outcomes—a bioengineering strategy much like our species has done with plants and animals over past millennia. As Peter Mills points out in “Three Venues for Discussing Human Gene Editing,” these are not therapeutic interventions, since there are not yet any existing persons to be treated. Says Mills: “What is at stake in the use of genome editing is bringing about the birth of a human being with one set of genetically conditioned features rather than another set.”
Is this a path that would be destructive for the human species to go down? Many deliberative bodies have concluded that it is. In her article, Françoise Baylis acknowledges that “the [global] political consensus on heritable human genome editing … inclines toward an outright ban.” The Council of Europe’s Convention on Human Rights and Biomedicine, for example, which is legally binding on 29 countries, prohibits any gene alteration to a human embryo that would affect the genomes of the modified person’s descendants.
But with the advent of purportedly precise CRISPR-based techniques, neither Baylis nor the other commentators are having this. Baylis asserts that “we should be asking the world’s citizens to identify their interests and ideas about how heritable human genome editing technology might make their lives go better, or not.” Henry T. Greely in his article, “How Should Science Respond to CRISPR’d Babies?” avers that “demanding social acceptance before using it to make babies is both legally and politically right,” though he derides calls for even a limited-duration moratorium. Mohammed Ghaly, consulting the Islamic religious literature, concludes in his article that “there is no one-size-fits-all moral judgment that views genome editing as a single block or indivisible whole,” and that it depends on “a number of circumstances.”
The contributors seek to revisit whatever firm prohibitions are currently in place in order to accommodate interest groups that include innovative scientists and avid entrepreneurs (often the same cohort), and the objective that Mills expresses as “delivering a valued outcome as well as or better than incumbent technologies or having desirable features that those incumbent technologies lack.” The important question for him is “not ‘why do we need it?’ but, once we have it, as we one day very likely will, ‘what might we do with it?’” This (to remind the reader) relates to the civilizationally weighty prospect of bringing human beings into the realm of manufacture.
The permanent bans that have been enacted, however, reflect the reality of modern developmental biology much more faithfully than do the authors’ speculations as to future benefits of embryonic gene modification. The question of whether embryos can be safely or predictably engineered has long been settled: they cannot. This is clear from experiments on animal embryos, where altered genes are often seen to behave in unpredicted ways, and in human population studies, where genetic mutations that had been found to cause disease in some individuals or groups turned out to be perfectly harmless in others. This is entirely independent of how accurately CRISPR can be made to function. Any attempt to edit even a single base-pair in an embryo will be uncontrolled human experimentation of the kind prohibited by international legal conventions that have much broader agreement than those pertaining to germline modification.
Each of the contributors calls for some kind of international, or at least transnational, deliberation leading to accords on circumstances under which human gene modification can appropriately be performed. They all assume that it will happen, but they want it to be with a “broad social consensus,” unlike the recent case in China. Baylis expresses the wish that “We should all have a say in whether to proceed with heritable genome editing.” But the history in the United States of more obviously pressing issues such as climate change or gun control suggests that “we” is a nebulous notion, generally constituted more by money and political power than by philosophical rigor or even scientific probity. (It should be recalled that a broad social consensus for the clinical approval of three-parent embryo construction was reached in the United Kingdom through countless assertions by interested parties, over several years, uncontested by other scientists or bioethicists, that it was “mitochondrial replacement” or “mitochondrial transfer,” when it was actually nuclear transfer.)
We suggest that as with many previous cases, such deliberations will most likely come to a consensus to proceed with caution on a form of human experimentation that should never be undertaken. It is highly irresponsible to entertain the idea of using experimental gene manipulation on prospective human beings.
A call for a permanent ban will not attract universal assent, but affirming that such forms of human experimentation should be beyond the pale is the only ethically sound position.
Stuart A. Newman
Department of Cell Biology and Anatomy
New York Medical College
Department of History, emerita
San Francisco State University
They are the authors of Biotech Juggernaut: Hope, Hype and Hidden Agendas of Entrepreneurial Bioscience (Routledge, 2019)
The term “ethics dumping” was first used by the European Commission to describe the export of research practices that would be considered unethical within the European Union to countries with lower or absent legal or ethical standards or review processes. Many people based in lower- or middle-income countries know that this practice is common and relevant for the genomics era as much as it is for other types of health research. For instance, in a recent study Roger Chennells and Andries Steenkamp trace how the involvement of the San population in southern Africa constitutes a clear example of the export of unethical genomics research practices to African countries.
It should therefore not come as a surprise that we are starting to see the emerging contours of what could be framed as ethics dumping in the context of gene editing experiments. Although not yet considered thus, there are important questions that need to be investigated around the gene editing experiments conducted by He Jiankui, as described in several of the articles on human gene editing. Framed largely as an instance of isolated scientific misconduct by a rogue Chinese scientist, it is also true that He not only trained in the United States but continued to reach out to scientists based in that country, some of whom are now under investigation. What merits investigation is the extent to which He’s actions constituted not just the actions of a rogue scientist working alone, but how the international medical research community could have enabled or empowered him to do what he did and whether this could reasonably be considered a case of ethics dumping.
With the incredible speed of developments in human genome editing, and the presumed absence of regulation for gene editing research in most lower- and middle-income countries, there is a real risk that companies and research institutions from higher-income countries will turn to lower- or middle-income countries to conduct gene editing research on humans. Such research should clearly be permissible if it is in the interests of the populations of those countries and if it is done in a way that is respectful, fair, honest, and based on care for the people who are involved in the research. An example could be gene editing research on sickle cell disease that includes genuine intellectual leadership by scientists from lower- and middle-income countries. Research that does not meet such standards should be discouraged.
Jantina de Vries
Associate Professor of Bioethics
Department of Medicine
University of Cape Town