On October 26, an Associated Press story broke with the headline, “The Kids are All Right: Children with 3-Way DNA are Healthy.” Riding the wave of recent controversies surrounding 3-person in-vitro fertilization (IVF) in Mexico and the Ukraine, the widely syndicated article plainly misrepresents the source study, which as we shall see, is not at all certain of the reliability of its results.
On October 24, Reproductive BioMedicine Online published the first follow-up study of children born in the late 1990s and early 2000s using a precursor to 3-person IVF known as cytoplasmic transfer. Developed for age-related infertility, this technique, also known as ooplasmic transfer or transplantation, involves injecting mitochondria-rich cytoplasm from donor eggs into the eggs of intending mothers prior to fertilization. Fertility doctors used this experimental technique in human subjects without clinical trials, with at least two dozen babies born as a result. In 2001, researchers from St. Barnabas Medical Center in New Jersey published a study announcing live births resulting from this procedure, and claiming the world’s “first case of human germline modification.”
Scientists, medical professionals, and public interest advocates raised a number of serious concerns at the time, ranging from the children’s increased risk of severe mitochondrial disease resulting from mitochondrial heteroplasmy to ethical concerns about human inheritable genetic engineering. Shortly after the study was published, the U.S. FDA halted the procedure, citing lack of evidence of safety and efficacy and requiring clinics to seek the agency’s approval to continue. No such request was made at the time, and no formal studies to track the effects of this technique upon the resulting children were conducted.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.