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FDA Explores '3-Person' Embryo Fertilization

Meant to prevent genetic diseases in children, the procedure raises ethical issues

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The result: a child who inherits the mother's nucleus DNA, which contains most of a person's inherited traits, but the donor's healthy mitochondrial DNA. The child could have the mother's eye color or height, but would not run the risk of inheriting a genetic disease from the mitochondria.

Such genetic tinkering raises concerns among many bioethicists. In a letter to the FDA, the nonprofit Center for Genetics and Society noted that "more than 40 countries, including those with the most highly developed biomedical sectors, have adopted policies on human germ-line modification, and all of these have prohibited it."

"This emerging global policy consensus has been supported by the major international biomedical and bioethical organizations and councils," the letter continued. "We believe that it would be unconscionable for the United States to unilaterally cross this bright technical and policy line that has been observed internationally for decades."

The center's letter also questioned how useful the new procedure would be.

"We sympathize with women who place a high importance on having children genetically related to them. But we note that the number of women who would be candidates for the techniques in question is quite small," the letter stated. "While about one in 5,000 to 10,000 people suffer from mitochondrial diseases, only about 15 percent of mitochondrial disease is caused solely by mitochondrial DNA mutations," the letter said.

For her part, Lewis said the FDA first must determine how safe these procedures are, and how to ensure safety during human trials.

Beyond that, the agency will need to weigh how to track children born from this process, so any unintended consequences -- for example, new birth defects that crop up from genetic manipulation -- can be detected, she said.

"There has not been a registry to follow these children who were created through the use of in vitro fertilization and other artificial techniques, so maybe that is something to think of going forward," Lewis said.

The process also raises a number of societal concerns regarding parental rights and consent.

"It will be important to emphasize what the consent form looks like so it's very clear what the potential future rights of all the different people are," she said. "As experience has shown, these sort of problems arose that weren't contemplated when IVF was first discovered."

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