The U.S. Food and Drug Administration (FDA) has told a New York-based doctor that he cannot go ahead with clinical trials meant to test a technique that aims at creating a genetically modified child.
MIT Technology Review is reporting on the letter send by the FDA to John Zhang, founder of New Hope Fertility Center, who developed a type of in-vitro fertilization that involves transferring DNA from a mother’s egg into a hollowed-out egg donated by a younger woman. Called “spindle nuclear transfer,” the technique allowed Zhang to alter the eggs of a Jordanian woman who passed on a serious neurological disease to her children, both of whom died.
Because implanting a modified embryo into a mother’s womb is illegal in the United States, Zhang took his patient to Mexico where she was implanted with the embryo.
“As a result of the procedure, the woman gave birth to a child that technically has three genetic parents, since healthy mitochondria in the hollowed-out donor egg has its own DNA,” MIT reports.
“The baby wasn’t the first to be born with three genetic parents—more than a dozen babies were born with an older three-person IVF technique in the 1990s before the FDA intervened and decided to regulate the procedure like a new drug. The treatment was never approved.”
John Zhang, M.D.
As a result, Zhang received a letter from the FDA on Friday telling him to stop marketing the technique in the U.S. He was also cited for exporting the embryo without permission.
“Modifying embryos in a lab is not illegal under U.S. law as long as federal funds are not used to carry out the work,” MIT explains. “But implanting one in a woman’s womb so that a baby can develop is prohibited.”
The UK approved three-parent embryos last year, but only when a couple is at very high risk of having a child with a life-threatening genetic disease. Any clinic interested in performing the procedure must first procure a license from the government.
“The move is a sign that the federal government is taking a hard line against the development of technologies to make genetically altered babies, even in cases where doing so would prevent severe disease,” MIT reports.
The reason why the FDA is cracking down on the procedure is because it is not yet known what the long-term consequences might be for the child. Even though the child created by Zhang’s experiment remains healthy, without being able to track its health through adulthood makes it impossible to say whether the procedure is safe in the long-term.
The Catholic Church forbids any kind of tampering with human embryos, because it believes that from the moment a human zygote has formed, it “demands the unconditional respect that is morally due to the human being in his bodily and spiritual totality.”
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