The Food and Drug Administration is taking a closer look at a fertility procedure that uses the genetic material of three people to make a baby free of genetic defects. Critics worry that the process could lead to "designer babies" — or that it could actully produce new defects.
The lead researcher, Shoukhrat Mitalipov of the Oregon Health and Science University, has been performing tests on monkeys and believes it's time to test the procedure on humans. The method involves mitochondria, the "cellular power plants" that generate most of the energy of a cell. The procedure uses mitochondria from a woman with healthy cells to replace defective mitochondria in another woman's egg — material that could cause mitochondrial disease in the child that develops from the egg. This could be done before or after the egg is fertilized.
The New York Times writes, "Roughly 1,000 to 4,000 children born in the United States each year will develop a mitochondrial disease, most by age 10, with symptoms that can range from mild to devastating. These diseases typically prevent mitochondria from converting food into energy and are the result of genetic abnormalities, although some cases can be caused by exposures to toxins."
Though most of the research has involved monkeys, at least 17 human babies were born using a similar process in 2001. Researchers took material from the cytoplasm of fertile women and placed it into the eggs of infertile women. Cytoplasm is the fluid that surrounds the nucleus of the egg and directs its development after fertilization. Because of questions raised, the FDA said researchers could no longer perform the procedures in humans without the agency's permission.
"Every time we get a little closer to genetic tinkering to promote health, that's exciting and scary. People are afraid it will turn into a dystopian brave new world," says Dr. Alan Copperman, director of the Division of Reproductive Endocrinology and Infertility at Mount Sinai Medical Center in New York. "The most exciting part, scientifically, is to be able to prevent or fix an error in the genetic machinery."
Other experts are concerned that there's not enough research to safely move forward with human trials. Jeremy Gruber, president of the Council for Responsible Genetics, worries that the proecure could produce new genetic abnormalities: "There's a step missing here. The basic research is still unresolved."