GAITHERSBURG, Md. — The Food and Drug Administration is weighing a controversial fertility procedure that involves combining the genetic material of three people to make a baby free of certain defects, a therapy that critics say is an ethical minefield and could lead to the creation of designer babies.
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.
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 healthy women into the eggs of infertile women. More than 17 babies have been born this way in the United States.
The practice sparked controversy 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 successfully and has said it is ready to try in people.
“Every time we get a little closer to genetic tinkering to promote health — that’s exciting and scary,” said Dr. Alan Copperman, director of the division of reproductive endocrinology and infertility at Mount Sinai Medical Center in New York. “People are afraid it will turn into a dystopian brave new world.”
He added that the current meeting and discussion was an attempt at “putting together a framework for us to prepare for this genetic revolution.”
“The most exciting part, scientifically,” he said, “is to be able to prevent or fix an error in the genetic machinery.”
SOURCE: The New York Times
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