An advisory committee of the US Food and Drug Administration has just concluded two days of meetings to consider whether to make legal a proposal that scientists be allowed to try to make babies using eggs that have been genetically altered to include DNA from another woman. The committee decided not to vote to determine a recommendation to the FDA after some panellists worried that not enough research has been done to know whether the experiments would be safe. ”I think there was a sense of the committee that at this particular point in time, there was probably not enough data either in animals or in vitro to conclusively move on to human trials . . . without answering a few additional questions,” Dr. Evan Snyder of the Sanford-Burnham Medical Research Institute in La Jolla, Calif., who chaired the 25-member committee, told National Public Radio.
During the hearing, the panel heard from researchers at the New York Stem Cell Foundation, the Oregon Health & Science University and Newcastle University in England who have conducted prelminary research in animals and want to try the procedure in humans.
They argue it would help women with diseases caused by problems with a type of DNA known as mitochondrial DNA to have healthy babies. These conditions can be devastating, even sometimes fatal. The approach could also be used to help treat women suffering from infertility.
“We have developed a technique that would allow a woman to have a child that is not affected by this disease, and yet the child would be related to her genetically,” Dieter Egli of the New York Stem Cell Foundation told NPR in October.
Several critics of the proposal told the panel that they feared the technique could introduce errors into the human gene pool, or even open the door to creating “designer babies” by letting parents to pick the traits of their babies.
At the end of the hearing, the FDA panel outlined what steps researchers might have to go through before they could do a clinical trial. That would include making sure the process was safe, ethical and would produce useful results. The FDA has not said when the agency might make a decision.
In a New York Times report earlier this week the attempt to produce genetically modified human beings was called “a dangerous step.” The techniques would change every cell in the bodies of children born as a result of their use, and these alterations would be passed down to future generations.
The F.D.A. calls them mitochondrial manipulation technologies. The procedures involve removing the nuclear material either from the egg or embryo of a woman with inheritable mitochondrial disease and inserting it into a healthy egg or embryo of a donor whose own nuclear material has been discarded. Any offspring would carry genetic material from three people — the nuclear DNA of the mother and father, and the mitochondrial DNA of the donor.