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Infertility & Reproduction Health Center

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FDA Explores '3-Person' Embryo Fertilization

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

WebMD News from HealthDay

By Dennis Thompson

HealthDay Reporter

TUESDAY, Feb. 25, 2014 (HealthDay News) -- U.S. Food and Drug Administration hearings opened Tuesday on a controversial fertilization technique that uses the DNA from three people -- two women and one man -- with the goal of preventing inherited genetic diseases.

The technique involves the unfertilized eggs, or "oocytes," from two females. Parts of each egg are combined to weed out inherited genetic disorders contained in one woman's DNA, and the resulting healthy egg is then fertilized using a male's sperm.

The FDA's two-day hearing is meant to provide a forum for discussing how this technique might be tested in human clinical trials.

But the discussion is expected to veer into the ethics of manipulating human genetics to produce "perfect" babies.

"The potential benefits are huge, but the potential harms are also huge," said Dr. Michelle Huckaby Lewis, a faculty member at the Johns Hopkins Berman Institute of Bioethics and the Genetics and Public Policy Center, in Washington, D.C.

The procedure could have unintended health consequences both for newborns and for future generations, as the genetic tinkering reverberates through time, Lewis said.

In addition, she said, the technique raises troubling questions of parental rights and family structure.

"When you use a technology in a new way like this, it really challenges our notions of what it means to be a parent and what it means to be a family," Lewis said.

The hearing was prompted by the work of Shoukhrat Mitalipov, an associate scientist at Oregon Health & Science University (OHSU).

Mitalipov has used the fertilization technique to produce five healthy monkeys, and is seeking FDA approval to begin human trials involving women who carry defective genes that could pass on severe illnesses to their children.

He is on hand at the hearing to explain the process, which he described Monday to the Associated Press as "gene correction" rather than "gene modification."

"We want to replace these mutated genes, which by nature have become pathogenic to humans," Mitalipov told the AP. "We're reversing them back to normal, so I don't understand why you would be opposing that."

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