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FDA Eyes 'Three-Parent' Babies

The US Food and Drug Administration wants to find out if the practice of modifying oocytes for use in in vitro fertilization is safe and scientifically sound, and held a hearing this week to launch a review of the process. Although it is sometimes referred to as three-parent baby-making, the procedure is not as kinky as it sounds, nor is it a likely set-up for a situation comedy, as very little DNA is contributed by the donor, but it has triggered some scientific, safety, and ethical concerns.

Specifically, the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee held a two-day meeting to hear about the use of cytoplasmic transfer, which enables women with inherited forms of mitochondrial disease to have healthy children by combining a healthy donor egg with nuclear genetic material from the mother before the IVF procedure.

The UK is already moving forward with permitting three-person IVF, but the procedure is not allowed in the US.

FDA is leaving the ethical questions and controversies about oocyte modification aside for now and seeking input on future clinical trials and the scientific, technological, and clinical issues involved and how they may affect the health of the mother and child.

In the New York Times, Sabrina Tavernise notes that although the treatments in question here are not what is generally thought of as genetic engineering, research into this area in general spurs fears in the US about how far science will go in human engineering.

“Every time we get a little closer to genetic tinkering to promote health — that’s exciting and scary,” Alan Copperman, director of the division of reproductive endocrinology and infertility at Mount Sinai Medical Center in New York, tells the Times. “People are afraid it will turn into a dystopian brave new world.”

At the FDA meeting this week, Oregon Health Sciences University researcher Shoukrat Mitalipov, who has performed the procedure in monkeys in the US and contends that it is ready to be used in humans, took questions from the panel about the procedures he has used and the specifics of his experiments.

FDA for now plans to consider the science as it is, how it may be used, and whether it may be ready for expanded studies in humans.

“We haven’t made any decision about whether clinical trials will be allowed to proceed,” FDA's Celia Witten tells the Times.

Marcy Darnovsky of the Center for Genetics and Society in a Times op-ed this week says these technologies are not ready, and crystallizes the angst many feel about human genetic tinkering.

She says, though, that they may have value, and that avoiding mitochondrial disease or helping women conceive are worthy goals.

"But these procedures are deeply problematic in terms of their medical risks and societal implications. Will the child be born healthy, or will the cellular disruptions created by this eggs-as-Lego pieces approach lead to problems later on? What about subsequent generations? And how far will we go in our efforts to engineer humans?" Darnovsky adds.