Last month’s news that Chinese scientist He Jiankui had gone rogue and conducted an (as-yet-unverified) experiment to modify the genes of two twin girls to make them resistant to HIV has left the scientific world scrambling to discourage creation of other genetically edited babies.
The World Health Organization’s director general, Tedros Adhanom Ghebreyesus, acknowledged that we had jumped into “uncharted waters” and announced the formation of an expert panel to set guidelines and standards. The Chinese government has condemned He’s work and vowed serious consequences to discourage others from pursuing similar lines of research, but it has not offered any specifics.
In the United States, National Institutes of Health Director Francis Collins has called the experiment “a drastic, regrettable step” and an “epic scientific misadventure.” In an interview on Wednesday, Collins spoke of the need for strict and independent oversight of such technologies and outlined some possible ways forward.
Human embryo research has long been a challenging area for the government. In 1996, the Dickey-Wicker Amendment banned federal funding for research in which human embryos are destroyed, even though the research itself wasn’t explicitly prohibited and has continued in the private sector. Germline gene editing in humans — the type that involves reproductive cells such as egg and sperm and leads to heritable changes — is effectively barred because of a law forbidding the Food and Drug Administration from reviewing applications proposing this type of research.
Collins said an important step toward creating a responsible moral and scientific framework for such work is public debate, and he has been working on ways to make that happen.
One model may be an advisory group similar to one NIH set up in 1975 to focus on genetic engineering involving bacteria and viruses. Over time, it evolved to oversee gene therapy trials in humans — a task that in recent years has largely transitioned to the FDA as the science has matured. NIH this year solicited comments on the future of this group, the Recombinant DNA Advisory Committee — nicknamed “RAC” — and is studying the responses.
Collins said a new or modified RAC may provide “an opportunity to have a broader U.S. debate about topics that seem to need attention.” Plans are still in flux, he said, but the group would probably begin in 2019 and include scientists, bioethicists and members of the public. One topic that is likely to be addressed is how to assess the unintended consequences of tweaking certain genes. The group may also want to discuss how to better educate the public about the more complex aspects of gene editing, DNA and medicine.
“One of my concerns is that in some people’s minds, the whole concept of gene editing has been cast into doubt,” he said, emphasizing that although He’s work has been widely condemned, there are very promising and ethically sound clinical trials for people suffering from the blood disorder beta thalassemia and sickle cell disease.
Internationally, Collins said, “I wish there was a clear pathway forward.”
He said the WHO process is likely to take a long time, and even if the 194 member states can reach a consensus on guidelines, it’s uncertain what can be done to stop violators.