The recently developed genome editing technique CRISPR enables researchers to make very precise modifications in the genes of nearly any organism. Researchers are racing to use the technique to create drought-resistant corn, reduced-gluten wheat, and tastier tomatoes. Research on CRISPR-based treatments for maladies such as cancers, heart disease, and Duchenne muscular dystophy is advancing rapidly.
It looks like the current wave of new genetic engineering techniques will largely escape the bans, moratoria, and overregulation that greeted the first wave in the 1970s. More than 40 years ago, the announcement that researchers were able to splice together genes taken from different organisms provoked handwringing over scary scenarios in which infectious cancers break out from biotech labs and activist screeds railing against "unbridled scientific and technological progress" and creeping "corporate hegemony." No epidemics of biotech-generated infectious cancers have occurred, and the global biotech industry now consists of an estimated 77,000 companies with $400 billion in annual sales.
Regulators seem to be learning from that earlier overreaction. This month the U.S. Department of Agriculture announced that it would for the most part not regulate new crops created with CRISPR. That decision opens the way for development of a vibrant new biotech crop and seed industry.
University of Pennsylvania bioethicist Jonathan Moreno and Amy Gutman, former head of President Obama's Commission for the Study of Bioethical Issues, make the case for regulatory restraint in a recent Foreign Affairs article. Gutman and Moreno avoid the usual fatuous call for "democratic" decisions about whether and how to deploy new technologies, instead offering sensible proposals for how to proceed safely with CRISPR-based research. They conclude that regulators should stay out of the way for now.
One example Gutman and Moreno consider is gene drives, CRISPR-assisted interventions than can, say, make a population of mosquitoes immune to the malaria parasite or cause the extinction of a noxious rat species by favoring the birth of males. Gutman and Moreno reject the demand by some activists for a total ban on gene drives:
In lieu of formal regulations on gene drives, scientists could agree to build safety measures into gene-drive systems, such as alterations that would cancel out previous drives or gene modifications designed to grow less frequent over time, so that successive generations would express the gene less and less once the original problem has been sufficiently ameliorated. Researchers will also need to be transparent about their work and consult local communities to gain consent before introducing gene drives into the wild.
Gutman and Moreno say existing regulations for biomedical research should be adequate to address CRISPR-based treatments. (Let's set aside for now the question of whether even that much is needed for current therapeutic compounds and techniques.) But lots of folks worry that CRISPR might be used to correct genetic flaws in human embryos. The supposed bioethical horror of using CRISPR to fix genetic mutations is that it would interfere with the "human germline"; that is, children who are born with corrected genes will no longer be able to pass along to their own progeny the genetic disease that had previously afflicted their family.
Gutman and Moreno observe that "in 2017, the U.S. National Academies of Sciences, Engineering, and Medicine recommended that researchers exercise caution when it comes to efforts to prevent disease transmission through gene editing but said that such work should be allowed to go forward, albeit under 'stringent oversight.'" In other words, no ban. "At some point," Gutman and Moreno write, "governments may have to pass laws to prevent unscrupulous researchers from abusing gene editing. For now, however, the science is nowhere near advanced enough for policymakers to know what kinds of measures would work."
Gutman and Moreno suggest that "governments should follow the principle of regulatory parsimony." Ultimately, they argue, "the most effective standards for gene-editing research will come from the scientific community itself," creating a process that is "most likely to enable CRISPR and the next generation of research breakthroughs to reach their full potential." Happily, many modern biotech researchers recognize that even voluntarily adopted rules can unnecessarily stifle the development of vital new technologies and treatments.