F.D.A WEIGHS FERTILITY METHOD THAT RAISES ETHICAL QUESTIONS
The Food and Drug Administration is weighing a 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.
|A sperm cell is inserted into an egg in the labs at the Mount Sinai Hospital department of reproductive endocrinology|
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.
|Dr. Alan Copperman, director of infertility at Mount Sinai Hospital, in his office in New York on Tuesday|
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.
“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.”
“The most exciting part, scientifically,” he said, “is to be able to prevent or fix an error in the genetic machinery.”
But others have sounded alarm bells. Jeremy Gruber, president of the Council for Responsible Genetics, a bioethics advocacy group, said it was premature to try the procedure in people. He said it could cause new, unforeseen genetic abnormalities and that more animal studies were needed to determine whether that might happen.
“There’s a step missing here,” he said. “The basic research is still unresolved.”
Dr. Mitalipov presented his work at the meeting, and some participants asked whether he had tried to create a real-life environment that would be typical for a pregnant woman.
“What kind of diet did you have these monkeys on?” said Dr. David L. Keefe, a professor in the department of obstetrics and gynecology at New York University School of Medicine. “Did you have them on a McDonald’s super-size stress test?”
Dr. Mitalipov said he had plans for more work with the monkeys.
Dr. Celia Witten, director of the office of Cellular, Tissue and Gene Therapies at the F.D.A., gave few clues to the agency’s thinking.
“We haven’t made any decision about whether clinical trials will be allowed to proceed,” she said.
Correction: February 25, 2014
An earlier version of this article misspelled the surname of the director of an office at the Food and Drug Administration. She is Dr. Celia Witten, not Whitten.