Last year, you may have heard of an impressive medical accomplishment, where the gametes of three people were combined to make one healthy baby. The doctor behind that procedure has now been warned by the Food and Drug Administration for advertising the still-unapproved procedure.
The procedure was invented for cases where an aspiring mother may pass on a disease of the mitochondria, the part of each cell that generates energy for the rest of the cell. Using the procedure — known as spindle transfer — scientists remove the nucleus (where most of the genetic information is stored) and transfer it into a donor egg, which has mitochondria without mutations. Then the egg is fertilized with the father’s sperm, as in regular in-vitro fertilization.
In the case of the “three-parent” baby born last year, the scientist, John Zhang, published an article where he detailed creating an embryo in the United States and implanting it in the patient in Mexico, which resulted in the birth of a healthy baby in 2016.
The FDA notices
Here’s the problem, though: The spindle transfer procedure hasn’t been approved, but Zhang continues to advertise it. While the technique was developed for use by women with mitochondrial diseases that they don’t want to pass on to their children, Dr. Zhang has also been advertising it as “a successful solution to age-related infertility,” letting women refresh aging eggs.
As a result of the published article and Zhang’s advertisements, the FDA has sent a letter [PDF] to the doctor and his businesses, warning the clinic to stop advertising the procedure online, since it can’t legally be performed on humans without an official clinical trial or FDA approval.
Last year, Zhang asked for permission from the FDA to begin approved experiments with spindle transfer. The agency was unable to do so, since it isn’t allowed to accept investigational new drug applications that would create a genetically modified human embryo.
Zhang committed to not marketing the procedure or performing spindle transfers in the United States for embryo transfers that would be performed outside of the country. Yet the published article and the clinic website show that he’s doing both, or at least trying to sell the service to interested prospective parents.
“Despite that commitment, you continue to market [spindle transfer] to prevent the transmission of mitochondrial disease and to treat infertility,” the FDA notes in its letter to Zhang and his companies.
The treatment is caught in a regulatory loop: It can’t be approved for testing by the FDA, and can’t be marketed to consumers until it’s approved by the agency, which won’t happen without testing.
Yet, as of publication of this story, the doctor’s website — complete with a New York City office address and phone number — continues to advertise the 3-parent procedure that Zhang can’t legally perform on humans in the U.S.: