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FDA considers controversial three-person embryo technique to create healthier humans

Kathleen Blanchard's picture
Should the FDA allow clinical trials for three-people embryos?

The US Food and Drug Administration (FDA) is considering allowing clinical trials for the creation of embryos from DNA of three people. The impetus behind the consideration is to create healthier humans.

The new procedure could help quell the incidence of diseases that are inherited according to researchers who have been doing just that in monkeys.Others who oppose the move contend using three embryos to create humans could lead to "designer babies", is unethical and more.

The technique involves removing defective DNA from mitochondria and then swapping it for healthy genetic material. The procedure has been successfully performed on five monkeys by Shoukhrat Mitalipov from the Oregon Health and Science University but has a long way to go before it could be used to produce humans vulnerable to genetic diseases.

DNA swapping could mean the end of genetic diseases

If scientists can produce humans without genetic defects it could mean an end to inheritable maternal diseases like blindness and organ failure. DNA from three embryos would include two from the parents and one from an additional female donor.

Artificially creating healthy babies is intriguing but experts agree the long-term health effects are unknown and would take decades to manifest.

"The end of the experiment will come decades later," said Keith Latham, in a technical discussion presented to the FDA and its advisory panel last week.

"It's going to take us that long to figure out the health of the progeny produced from these procedures." Latham's research focus has been on understanding how what happens during embryogenesis and early in life can contribute to diseases later on.

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"There are so many aspects of mitochondrial disease that change over time and that we don't understand," said Dr. Katharine Wenstrom of Brown University. "We have to be very careful that we develop techniques to test these animals throughout the course of their entire lifespan."

Wenstrom is an award winning genetic researcher who focuses on maternal-fetal medicine, high risk pregnancies and is a professor of obstetrics and gynecology at the Warren Alpert Medical School of Brown University.

Public concerns over "designer babies"

Public speakers urged the FDA to block the procedure, saying there are too many unknowns. Allowing the artificial creation of embryos from three people could also lead to parents who desire to choose their children's eye color and other physical characteristics; thus the notion of "designer babies". More than half a dozen public speakers also voiced concern about ethical considerations.

Marcy Darnovsky of the Center for Genetics and Society pointed out 40 countries have banned gene altering procedures, including France and Germany. Should the FDA allow intentional genetic modification to create healthy babies it would be the first time for any jurisdiction in the world Darnovsky said, adding '...it would be making this decision with little or no input from the public or elected officials." The group is calling for signatures from the public asking the FDA disallow the three-embryo "radical" procedure.

They have also written a letter to the FDA voicing their opinions. One major concern is that babies can't consent to the procedure that could put them at unknown risks that could also be passed to their own offspring, making the procedure "unethical".

Darnovsky also states in her letter that allowing such a technique with "significant risks to the child" could have "profoundly disturbing implications for the future of the human community."

There are also questions about whether the FDA that regulates medical devices and drugs has the authority to make a decision about the artificial fertilization technique.

Other experts wonder if swapping DNA to produce healthy monkeys, cows or other animals could even translate to the same outcome for humans. Mitalipov's experiment would mean children still inherit their parent's traits such as hair and eye color but they would also obtain healthy instead of defective mitochondrial DNA from the third donor.

Image credit: Wikimedia Commons