US FDA weighs evidence on producing 'three-parent' embryos

NEW YORK - U.S. medical advisors are weighing whether there is scientific justification for allowing human studies of a controversial procedure known as "three-parent in vitro fertilization (IVF)," a technique supporters say could prevent horrific genetic defects, but critics believe could lead to designer babies.

Over two days of public hearings starting on Tuesday, scientists were scheduled to present their research to outside advisors to the U.S. Food and Drug Administration. The agency will decide whether safety concerns raised by three-parent IVF are minimal enough to allow clinical trials to begin.

The committee is focusing only on the science, not the legal or ethical issues, Celia Witten of the FDA's Office of Cellular, Tissue and Gene Therapies said in comments introducing the hearing.

That did not stop members of the public from focusing on ethical issues. Speakers warned the panel that use of three-parent IVF "could alter the human species," represented "an unprecedented level of experimentation on non-consenting human subjects" (meaning any children born via the technique), and "could open the door to genetically-modified children" who would be "manufactured products."

In the three-parent procedure, one man would donate sperm and all its DNA for in vitro fertilization. The would-be biological mother would contribute the egg and most of its DNA. But if the mother carries harmful genetic mutations in cellular structures called mitochondria, scientists would remove her unhealthy mitochondria and substitute those of a second woman so the baby would not inherit a potentially devastating "mitochondrial disease."

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US FDA weighs evidence on producing 'three-parent' embryos