The FDA is considering if there is scientific justification for allowing human studies on a very controversial procedure: three-parent in vitro fertilization (IVF) that supporters believe could prevent horrific genetic defects. Those opposed to the procedure believe that it's a wrong step toward creating designer babies.
In public hearings that began last week, scientists presented research to outside advisors to the U.S. Food and Drug Administration and the agency will decide if clinical trials can start. The big question is whether trials would be safe for women and any children born via the procedure. Trials done with animals may not have provided enough data for a clear decision. The panel hasn't been asked to make a ruling on the legal and ethical issues involved, however, that’s been the focus for many in the public, as speakers warned that the use of 3-parent embryos could "alter the human species" and open the door to "modified children."
For this procedure, one man would donate sperm for use in IVF. The would-be biological mother would then contribute the egg and most of its DNA. But if the mother carries harmful genetic mutations in cellular structures — called mitochondria — those would be removed in the lab and substituted for with the DNA of another woman, so the baby would not inherit a potentially devastating mitochondrial disease. Mitochondrial diseases cannot be diagnosed prenatally, and are incurable.
The director of the Berkeley-based Center for Genetics and Society is Marcy Darnovsky, who warns not only against the "production" of genetically-modified humans, but believes that if the FDA allows human clinical trials it will "introduce a regime of high-tech consumer eugenics and represent the first time a government body has approved genetic changes for humans and their descendants." The Center for Genetics and Society is a non-profit organization that focuses on genetic and reproductive technology.