FDA Examines Fertility Method that Raises Ethics Questions

A fertility treatment in which the genetic material of three different people are combined to create an embryo that is free of certain genetic defects is under scrutiny by the Food and Drug Administration amid claims that the therapy could amount to creating “designer babies.”  More on the ethically complex method from The New York Times:

The agency has asked a panel of experts to summarize current science to determine whether the approach — which has been performed successfully in monkeys by researchers in Oregon and in people more than a decade ago — is safe enough to be used again in people.

The F.D.A. meeting, on Tuesday and Wednesday, is meant to address the scientific issues around the procedure, not the ethics. Regulators are asking scientists to discuss the risks to the mother and the potential child and how future studies should be structured, among other issues. The meeting is being closely watched. The science of such therapies has advanced significantly in recent years, and many scientists are urging federal regulators to ease requirements for study in humans.

The procedure in question involves mitochondria, the power producers in cells that convert energy into a form that cells can use. Mitochondria with defects that could be passed to a fetus are replaced with healthy mitochondria from another woman. This is done either before or after an egg is fertilized.

Scientists have already experimented with combining genetic material from cells of three people. In 2001, researchers in New Jersey did so using material from the cytoplasm, the material that surrounds the nucleus of the egg and directs its development after fertilization, from fertile women into the eggs of infertile women. More than 17 babies have been born this way in the United States.

The practice raised questions and eventually led the F.D.A. to tell researchers that they could not perform such procedures in humans without getting special permission from the agency. Since then, studies have been confined to animals.

But a researcher in Oregon, Shoukhrat Mitalipov, has performed the mitochondrial procedure in monkeys and has said that it is ready to be tried in people.

Such genetic methods have been controversial in the United States, where critics and some elected officials wonder how far scientists plan to go in their efforts to engineer humans, and question whether these methods might create other problems.

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