FDA Reprimands Fertility Doctor for Marketing Genetic Modification of Human Embryos
John Zhang has finally been called to account. Last Friday, the US Food and Drug Administration (FDA) sent Zhang a warning letter demanding he cease and desist both the conduct and the marketing of an experimental genetic modification technique known as 3-person in vitro fertilization (IVF). The story was made public the same day by stem cell biologist Paul Knoepfler on his blog. It has subsequently been reported by other media outlets (1, 2, 3).
The US-based fertility doctor openly skirted US regulations last year in order to deliver a child in Mexico that his team created via 3-person IVF. Zhang later began marketing the technique online through his start-up, Darwin Life, as Human Egg Rejuvenation In Vitro Fertilization (HER IVF) – for the unproven purpose of addressing age-related infertility. (See CGS press releases about those incidents here and here).
What is 3-person IVF?
3-person IVF – also known as nuclear genome transfer and mitochondrial transfer – is an experimental procedure that essentially cuts and pastes the genetic material of two individuals’ eggs or embryos together. With sperm from a third individual, it thereby creates an embryo with genetic material from three people. It is a biologically extreme procedure that is unprecedented in human evolution, and carries significant health risks for any resulting children and subsequent generations. The majority of discussion around the technique so far has centered on its potential use for allowing women with severe mitochondrial disease to have unaffected and genetically related children.
The UK is the only country in the world that has approved the clinical use of 3-person IVF, an approval criticized as the result of a process that didn’t fully consider the safety risks of the procedure, skipping clinical trials and going straight to clinical use. While the UK approved the technique’s use to treat severe mitochondrial disease, it recommended against its use being “extended to otherwise healthy individuals with fertility problems, because a strong causal link between infertility and impaired mitochondrial function has not been made; in addition, such clinical use is not legal in the UK.”
FDA Letter to Zhang
As the FDA states in its warning letter, Darwin Life is currently marketing 3-person IVF to treat both mitochondrial disease and fertility, a slippery slope we noted back in October. No clinical trials have been conducted of 3-person IVF for either purpose, and it is not permitted in the US insofar as the FDA is currently prohibited by Congress from reviewing any Investigational New Drug (IND) applications that involve “a human embryo . . . intentionally created or modified to include a heritable genetic modification.”
The FDA takes issue with Zhang’s actions on three main points:
- Zhang sent an April 2016 letter to the FDA stating that “until an effective IND is in place, and a clinical trial is authorized by FDA, Darwin [L]ife will not use its spindle transfer technology again within the United States to support ex-US studies or procedures,” yet Darwin Life is currently marketing the technology through claims they can successfully treat mitochondrial disease and infertility;
- Darwin Life is currently marketing a technique that has not yet undergone clinical trials and has thus been proven neither safe nor effective; and
- As Zhang admitted in a recently published article, he and his team created genetically modified embryos in their New York clinic before exporting them to Mexico for implantation. Both actions – the creation of genetically modified embryos and their exportation – violate current regulation.
Zhang was open about his regulatory violations as well as future aspirations to pair 3-person IVF with gene editing techniques to create “designer babies.” So it is heartening that the FDA is finally holding him accountable for his irresponsible actions and marketing claims.
Some might allege that this action by the FDA will only serve to push 3-person IVF into unregulated territory abroad, but as we saw with the precedent of cytoplasmic transfer in the early 2000s, the involvement of the FDA did not lead to a dangerous, booming market abroad. Fertility doctors in the US simply stopped using it, and for the most part, that was it.