Last month, an FDA Advisory Committee held a hearing examining mitochondrial disease prevention with the creation of three-parent embryos.

Mitochondria are organelles in every cell of the body that are responsible for creating energy. These mitochondria contain their own DNA genes, but mutations in mitochondrial DNA can result in serious diseases and genetic disorders. There have been various proposals to attempt to treat these disorders by mitochondrial replacement therapy, and one proposal that the FDA Advisory Committee recently discussed was the creation of three parent-embryos.

Three-parent embryos are created by various techniques with the intent that the new embryos be healthy and without a genetic disorder. One technique uses an egg from a mother with the genetic disorder and removes the nucleus of that egg, placing the nucleus into the cytoplasm of a healthy egg that has had its own nucleus removed. Then using that recombined new healthy egg it is fertilized with a father’s sperm resulting in the creation of an embryo with genetics from three parents.

There are numerous scientific uncertainties surrounding three parent embryos. There is sparse scientific evidence to support the effectiveness of these techniques. Additionally, there is virtually no evidence to support safety or health results for three-parent children born from these techniques. Plus, one wonders about the impact of this procedure on future offspring, including the unintended side effects of genetic engineering of human beings.

There are also serious ethical questions that need to be answered first, and which were raised to the Advisory Committee during their hearing. These techniques would destroy human embryos for the purpose of science. Additionally, the annual Dickey Wicker Amendment prohibits federal funding for human embryo harm or destruction. Although many presenters who gave oral testimony at the FDA Advisory Committee, including FRC’s Dr. David Prentice, focused on the ethical questions surrounding three parent embryos, the Committee said that they were not focusing on whether the FDA should approve this technique, but rather how they would go about creating three parent embryos.

Senator Roy Blunt (R-Mo.) and Rep. Alan Nunnelee (R-Miss.) both raised concerns recently about three parent embryos to FDA Commissioner Margaret Hamburg during Congressional hearings.

Commissioner Hamburg admitted that she knows there are ethical concerns regarding this issue, yet the FDA is not the appropriate agency to address those concerns. If the FDA is not the appropriate agency to consider the ethical concerns with this technique, about which they held a public Advisory Committee hearing, who is responsible to address these concerns?

Commissioner Hamburg’s response regarding the ethical controversy surrounding three-parent embryos raises more concerns that the FDA may actually continue to proceed forward with this human experiment, and even produce guidance for scientists who wish to proceed with the creation and gestation of genetically-designed babies.