FDA takes a firm stance on three-parent fertilizations

Aug. 22, 2017

The idea that whatever science is capable of doing, it eventually will do, is a staple of dystopian science fiction, but in fact history has not proven that idea to be accurate. For instance, yes, science has produced nuclear bombs with power far greater than those that exploded over Hiroshima and Nagasaki, but they have never been used.

With that in mind, I don’t have much fear that the technology of human germline modification will eventually give rise to a society in which people with the means to pay for them will be able to have three-parent “designer babies.” I don’t think that you or I will live to see that, and neither will our grandchildren, who probably will themselves be conceived and born the old-fashioned way.

But just in case things ever threaten to get out of hand, I believe that the U.S. Food and Drug Administration (FDA) will apply the brakes—as it did last month. In case you didn’t hear:
Last year, John Zhang, MD, PhD, MSc, founder of the New Hope Fertility Center, based in New York City, developed a new in-vitro fertilization method that transfers DNA from a mother’s ovum into a hollowed-out egg that had been donated by a younger woman. U.S. federal law forbids the implantation of a genetically modified embryo, so, after fertilizing the egg cell with the father’s sperm, Zhang and the mother went to Mexico. He implanted the fertilized egg in the mother’s womb there.

The FDA got wind of this and, reportedly, the agency notified Zhang that he must not market the technique in the Unites States. The letter also asserted that Zhang had not received permission to export the embryo to Mexico. The agency also denied a request from Zhang for a meeting, in which he planned to ask for permission to begin a clinical trial to test the technique (which is called spindle nuclear transfer) in the United States.
U.S. law does not prohibit the modification of embryos in the lab. It does, however, prohibit the implantation of a modified embryo in a woman’s womb. In the 1990s, the FDA decided to regulate the procedure, and since then it has not approved the treatment. Since December 2015, the U.S.Congress has required that the FDA not allow research involving a human embryo “intentionally created or modified to include a heritable genetic modification.” Apparently, the FDA under its new commissioner, Dr. Scott Gottleib, plans to adhere to the letter of the law.

The couple who engaged Dr. Zhang’s help had previously conceived two children who had (and died from) the neurological disease Leigh’s syndrome, caused by faulty mitochondria. The child who was born with the help of Zhang’s technique reportedly is free of the disease.

There is no denying the value of the service that Dr. Zhang provided to a couple who sought only to have a healthy child. At the same time, scientific questions remain about the long-term health of a child born by this method, which means that ethical questions remain, and that government regulation is a must. The FDA’s actions were appropriate.

Questions also remain about Dr. Zhang’s efforts to monetize his research. He has been marketing his procedure to older women who have trouble conceiving and to women with specific genetic diseases via a new company, with the somewhat provocative name Darwin Life. When you go to its website, by the way, you get an error message.

I think we can all admire Dr. Zhang for his valuable work. But, I am also glad that the government is watching it carefully.