FDA weighs evidence on producing '3-parent' embryos

U.S. medical advisers are considering 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 that critics believe could lead to designer babies.

During two days of public hearings starting on Tuesday, scientists were scheduled to present their research to outside advisers 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, and at the end of Tuesday's hearing some committee members expressed concern that animal research cannot yet show that human studies would be safe for women and any children born via the three-parent technique.

Several panelists felt "there was probably not enough data in animals . . . to move on to human trials without answering a few additional questions" about safety, said committee chairman Dr. Evan Snyder of the Sanford/Burnham Medical Research Institute in La Jolla, California, in summarizing their views at the end of Tuesday's session.

Although the panel has not been asked to consider legal or ethical issues, members of the public focused on those. 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."

Allowing such procedures "would produce genetically modified human beings," Marcy Darnovsky, executive director of the Berkeley, California-based Center for Genetics and Society, a non-profit that focuses on genetic and reproductive technologies, told the committee.

If the FDA allows clinical trials, she warned, it would introduce "a regime of high-tech consumer eugenics" and represent "the first time a government body had okayed genetic changes for humans and their descendants."

Although the FDA committee is considering only scientific issues, such as whether animal research can show mitochondrial manipulation is safe or not, the agency said it is prepared to go beyond that.

"We have heard the concerns expressed at the advisory committee meeting, and will take the information back to consider whether we need to facilitate a public discussion and, if so, how best to do this," spokeswoman Jen Rodriguez told Reuters.

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FDA weighs evidence on producing '3-parent' embryos