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Three Parents? FDA Mulls Safety of Embryo Technique

<p>FDA advisers are discussing whether it's safe to try making babies that would have three genetic parents.</p>
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Is it designer babies or a way for parents to have healthy children?

A panel of Food and Drug Administration officials is finishing up a meeting on Wednesday asking whether an experimental technique using eggs and sperm from three adults is safe to try in humans.

The FDA advisers are not looking at the ethical implications, but whether the science is solid enough to justify trying the process in people. The goal would be to allow people to have babies free of horrific and untreatable mitochondrial diseases, and perhaps also to help some older women have babies if their own eggs are no longer fully healthy.

“Safety issues and how to get data to address them is really the issue,” said John Gearhart, an expert in embryo development at the University of Pennsylvania who is serving on the panel of experts. “Somehow, the designer babies slant is always there.”

For most scientists watching the meeting, the question is all about whether researchers know enough to try the technique safely in people.

“In my mind, it’s not eugenics,” said Phil Yeske, chief science officer for the United Mitochondrial Disease Foundation. “It’s affording potential for women affected by mitochondrial disease to have a healthy child.”

Scientists have been tinkering for years with the approach, which uses parts of the egg cells of two females, and the sperm from a male to create an embryo. It’s been done a few times in monkeys to create healthy offspring and now some researchers would like permission to try with humans.

“In my mind, it’s not eugenics. It’s affording potential for women affected by mitochondrial disease to have a healthy child.”

Fertility specialist Dr. Jamie Grifo of New York University tried one technique in the 1990s to help older women conceive healthy children using IVF techniques and the healthy eggs donated by younger women, but the FDA asked him to stop.

About two dozen children were born using various approaches, the FDA says, and at least three of them had developmental disorders including Turner syndrome, a genetic conditon in which a female doesn't have the usual pair of two X chromosomes. But FDA says it’s hard to tell whether the IVF technique is what caused the problems.

Taiwanese scientists tried another method, using a woman’s own healthy mitochondria, and reported 20 babies were born in 2004. But they haven’t reported on how healthy those children are today, FDA says.

It’s an important question, said Michigan State University's Keith Latham. "The end of the experiment will come decades later," Latham told the committee hearing. "It's going to take us that long to figure out the health of the progeny produced from these procedures."

The committee will not come to a decision this week, and the FDA isn’t due to decide any time soon, either. Hearings like this are designed to gather information and to get people thinking and asking questions.

“There’s overall great concern for the well-being of these kids,” said Dr. Evan Snyder of the Burnham Institute for Medical Research in La Jolla, Calif., the panel’s chairman.

Mitochondria help provide energy in a cell. They also carry a special type of DNA, called mitochondrial DNA, and this DNA is passed down virtually unchanged from mothers to their children.

It probably accounts for less than 1 percent of a person’s genetic traits, but they are important to health. Damaged mitochondria are responsible for more than 200 different diseases, Yeske said.

They include Alpers disease, which causes seizures, dementia and blindness; carnitine deficiency, which can damage the heart and sometimes sends babies into coma; and Leigh’s disease, a progressive disorder in which brain cells gradually die off, causing a range of symptoms.

There’s no cure for any of these conditions. “So this is a group of patients that really has no hope,” Yeske said.

His organization hasn’t taken a stand on the research yet. “Watching the science is the best way to describe our position,” he said. “Obviously, we wouldn’t advocate for something that isn’t safe. Let’s face it, the ethical considerations are significant here, too.”

But Art Caplan, a bioethicist at New York University, said in an NBC opinion piece that it’s worthwhile.

“In my view, trying the technique to fix a terrible disease even with risks of failure makes ethical sense,” he said. “Given the severity of mitochondrial diseases, it is worth trying the technique."

An estimated 1 in 4,000 children born in the U.S. is affected by some version of mitochondrial disease, according to the Mitochondrial Disease Foundation.

And in the end, there's this: “All of us deal with mitochondrial dysfunction,” said Yeske. “It’s called aging.”