Post-Hong Kong: Human Genome Editing’s Brave New World [VIDEO; 1:33:17]
Wednesday, March 27, 2019 2:00 pm – 3:30 pm; CSIS Headquarters, 2nd Floor
A firestorm followed Professor He Jiankui’s disturbing announcement last fall in Hong Kong that he had made heritable genetic changes in human embryos that resulted in the birth of twin girls. Critics pointed to the lack of oversight and transparency, the inadequacy of the informed consent process, the lack of a compelling medical rationale, potential unknown future harms to the edited babies, and the lack of a clear consensus about the actual use of new, powerful gene editing technologies. This historic incident has stirred an intense debate over both the promise of these technologies to cure devastating diseases, such as Huntington’s Disease, and alarm over the idea that these same technologies might be used to create “designer babies.” The U.S. National Academy of Sciences and National Academy of Medicine, together with other international academies, have led vital international discussions over next steps.
On Wednesday, March 27, 2:00-3:30 pm, the National Academy of Medicine and the CSIS Commission on Strengthening America’s Health Security [hosted] a conversation on the unfolding debate as to whether human germline genome editing should be permitted, the types of applications which might be appropriate, the standards and criteria that should be followed, and what regulatory or governance framework is needed.
Editor’s Note: In the context of the hour long broadcast by CSIS an audience question related to informed consent and relating to this digest was posed. It was answered by Jeffrey Kahn; Andreas C. Dracopoulos Director, Johns Hopkins Berman Institute of Bioethics, an excerpt of which has been transcribed below. Readers can find this exchange at around 1:20:45 in the broadcast.
Q – audience member:
Can you talk about some of the therapies that [Editas Medicine] is developing and walk through the informed consent process that would happen in, say for example, childhood blindness? How does that work?
A – Jeffrey Kahn; Andreas C. Dracopoulos Director, Johns Hopkins Berman Institute of Bioethics:
I served on the recombinant DNA advisory committee, the so called RAC as Victor mentioned, when the drug that became the Spark Therapeutics drug for treatment of genetic inherited forms of blindness was being considered in its early phase. So that’s the body that reviews gene transfer, so called gene therapy, research in humans. You must get approval from that body advisory to the NIH before you can go forward.
What was really interesting about that particular story which was and is for children, was that the parents of those children, first of all there are no other treatments, there are no alternatives, it was very promising in animal studies and so this is the first time in humans it is being offered. They showed a video I remember very clearly of a child walking through a maze, which was how they set up and assess levels of vision before and after one eye being treated. It was remarkable to watch this child stumble into the obstacles in the before film and then navigate it very easily after.
The question wasn’t so much about whether it should go forward as a clinical trial but whether parents should be permitted to give consent to having both eyes of their children injected at the same time. So the question was, do we know enough about this very novel first in human use of a therapy to say we’re willing to let you risk your child’s vision, because we don’t know the long term effects of this and whether the child’s restored vision would last or plummet and go away after a few weeks.
And the parents said let us make the decision about preserving whatever vision our child may have. The sooner you treat these kids the more vision you preserve it turns out.
What I learned from that was that is not consent in the sense that we really wish for. There aren’t good alternatives and these parents are willing to do anything for their children to preserve or restore their vision, understandably.
Consent doesn’t work in the way that I think we hope it will in some of these first in human devastating diseases, no other therapy, contexts. People will do anything effectively, so it’s an insufficient tool for doing the ethics work that I think your question implies. I don’t have a good alternative but in lived experience it’s really challenging.