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.
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…
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…
So, for thirteen years, research has been confined to a precursor.
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…“The most exciting part, scientifically,” he said, “is to be able to prevent or fix an error in the genetic machinery…”
Then, the TIMES lurches into predictable fears ranging from spooky anti-science to repeating truly incompetent suggestions about diet and stress for test monkeys. RTFA if you think they’re saying something Luther Burbank didn’t hear.
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.
The conference was brought together in the first place to examine methodology and practical results. The kind of discussion science has been limited to since the days of our most recent King George.
No one ever had to wonder whether or not ethics questions would be evaluated in parallel. Most science simply doesn’t operate without such concerns as part of the process. Then, there are sufficient “bio-ethics” experts building anti-science consultancies, ready to turn them into cash cows at the drop of a teabagger’s silly hat. Questions will be raised whether prompted by real concern – or as PR for quasi-religious hustlers.
The arguments are the same as those advanced over stem cell research. We already lost a number of researchers to other nations during the Bush years. Bureaucrats are becoming accustomed to being second-guessed by 14th-Century moralists. They ain’t about to stick their collective necks out over something as “furrin” as genetic science. Especially since the topic scares the Ignorant Left as much as the Ignorant Right.
Let’s move on folks. Try to catch up with the last couple of decades of the 20th Century before we continue to limit 21st Century medicine – in the United states. Just maybe save the lives of a few kids.