The New York doctor who made headlines last year for helping a couple have a child with DNA from three people has been warned by the Food and Drug Administration to stop performing the controversial procedure in the US.
John Zhang, founder and CEO of the New Hope Fertility Center in New York City, was the first doctor to perform an experimental procedure that allowed a mother with a genetic mutation to avoid passing it on to her son. It involves extracting maternal chromosomes from an egg, and injecting them into the egg cell of a woman who doesn't carry that mutation.
Zhang set up a company, Darwin Life, to commercialize the procedure. There, and at New Hope clinic, the procedure is marketed as a fertility treatment. Zhang performed his first procedure in Mexico in the summer of 2015.
According to the FDA letter, Zhang applied for permission to conduct the procedure in people in April 2016.
But Congress has banned the agency from reviewing any proposal that involves making heritable genetic modifications in an embryo. That stipulation, included most recently in the Consolidated Appropriations Act of 2017 — the big annual spending bill — has stalled such research in the US.
So far, the UK is the first country to greenlight the procedure. A university in Newcastle became the first to receive a permit to do so earlier this year.
In the letter to Zhang, Mary Malarkey, director at the Office of Compliance and Biologics Quality, told Zhang that he would need to obtain approval from the FDA for the procedure — which the FDA cannot give.
Yet, Malarkey noted, Zhang's clinic and company advertised the procedure on multiple web pages as a "treatment for certain genetic disorders" that would "prevent maternally transmitted diseases, like Mitochondrial Disease, in an unprecedented way." The letter requested that Zhang address this and other violations immediately.
"The letter to me is like a shot across the bow," Leigh Turner, associate professor of bioethics at the University of Minnesota, told BuzzFeed News. “This seems like an area where you’d want to do careful cautious incremental research and not race into the clinic making strong marketing claims."
As a way to avoid the US rules, Zhang's performed his first procedure in Mexico. The mother carried a mutation for Leigh syndrome. In April of this year, Zhang published a scientific article reporting that her son was born healthy.
The letter also addressed Zhang's attempts to skirt the rules by performing the implantations outside of the US, saying that he could not modify the embryos and then ship them overseas.
"It does seem like they’re pretty serious about this," Paul Knoepfler, professor of cell biology at the University of California at Davis, told BuzzFeed News.
Nidhi Subbaraman is a Science Reporter for BuzzFeed News and is based in Washington, DC.
Contact Nidhi Subbaraman at email@example.com.
Got a confidential tip? Submit it here.