On Friday, August 4, Dr. John Zhang was warned by the U.S. Food and Drug Administration that he must stop marketing an experimental procedure that uses DNA from three people – mother, father, and egg donor – to avoid certain genetic diseases.
The Washington Post reported that Dr. Zhang used the technique last year to help a Jordanian couple have a baby boy.
The Food and Drug Administration said that Dr. Zhang and his companies have agreed not to use the technology in the United States without permission; however, they continue to promote the procedure. This procedure has not been approved in the United States, and the FDA has been barred by Congress from reviewing proposals to conduct such experiments.
Dr. Zhang is head of both the New Hope Fertility Clinic and a related company known as Darwin Life Inc. A receptionist at Zhang’s New Hope Fertility Clinic in New York said late Friday that no one was available to comment.
New Hope’s website advertises that they have achieved the “first live birth” using this technology, in addition to offering other advanced fertility treatments. The FDA’s letter to Zhang cites various marketing claims, including a reference to “the first proven treatment for certain genetic disorders.”
Last September, the clinic disclosed the birth of the baby boy. The mother carried DNA that could potentially have given her child a severe neurological disorder that often kills within a few years of birth, known as Leigh Syndrome.
The technique is still experimental: it involves removing some of the mother’s DNA from an egg, leaving behind the disease-causing DNA. Next, the healthy DNA is inserted into a donor’s egg, which is then fertilized. The result is that the baby inherits DNA from the egg donor as well as both parents, producing what is now being named “three parent babies,” even though the DNA contribution from the egg donor is quite small.
DNA is carried in two places: the nucleus of the cell and in structures called mitochondria, which lie outside the nucleus. The technique is designed to transfer only DNA of the nucleus to the donor egg. The case was reported in a medical journal which stated that the procedure was performed at the New York clinic, however the embryo was taken to Mexico where it was implanted, where the procedure is not illegal.
United States government advisers released a report last year advising that it is ethical to begin testing this approach in pregnancy, provided the first studies follow strict safety steps. The studies must include women at high risk of passing on a severe disease, and only male embryos can be implanted so the alterations won’t pass to future generations.
Even though the law against such experiments remains in force, the FDA had requested this report. Last year, British regulators approved “cautious use” of this technique, and this year the first license was issued to allow its use.
It’s important to note that the child born through Zhang’s clinic last year is not the first to inherit DNA from three people. Some children were born in the 1990s after researchers used a slightly different technique, however federal regulators intervened and the field’s interest has now moved to a new approach.
[Featured Image by golubovystock/Shutterstock]