On Tuesday, the U.S. Food and Drug Administration (FDA) began proceedings on Tuesday to determine whether or not they would allow testing of a contentious fertilization process, where babies could be created from the embryos of three people. However, authorities on the subject recommend great caution with the decision, saying it could take decades to verify the safety - not to mention the ethical standing - of the procedure.
The process, called mitochondrial replacement, ostensibly designed to reduce the risk of genetically-embedded diseases from being passed on, has been criticized for its potential to promote the notion of 'designer babies.' Nonetheless, supporters claim that several hereditary diseases could be sidestepped, should mitochondrial replacement become commonplace.
The technique pertains directly to mothers with defective or mutated mitochondrial DNA, taking DNA from both parents as well as a healthy female donor. Nucleus DNA - or the DNA that inherited traits (i.e. eye color, hair color, height) are defined by - is then removed from the donor's eggs and replaced with the mother's own nucleus DNA. Upon fertilization, the child receives the mother's healthy nucleus DNA, while her defective mitochondrial DNA is superseded by the donor's mitochondrial DNA, dramatically reducing the risk for contracting hereditary conditions. The resulting fetus will have just residual traces of the donor's DNA.
Dr. Shoukhrat Mitalipov of the Oregon University of Health and Science will be one of the speakers presenting a case in favor of permitting the development. In a 2009 study titled Mitochondrial gene replacement in primate offspring and embryonic stem cells, Mitalipov and fellow researchers tested the process on primates, with positive outcomes. A later study resulted in the birth of a healthy infant monkey, called Chrysta. The study was published in scientific journal Nature. In 2010, a British study observing human zygotes had similar findings, further suggesting that mitochondrial replacement could viably thwart the inheritance of faulty mitochondrial DNA.
Executive Director of the Center for Genetics and Society, Marcy Darnovsky, PhD, noted the gravity of the hearing and its bearing on future decisions. "It could well be the first time any jurisdiction in the world had authorized intentional genetic modification of children and their descendants. And it would be making this decision with little or no input from the public or elected officials," she said to the Associated Press. Darnovsky has also questioned whether or not the FDA should have the authority to make and enforce such a decision, as the federal body primarily decides on issues relating to drug authorization and medical devices, as opposed to reproductive matters. Darnovsky has also noted in the past that several lower-risk options are available, "including using third-party eggs, pre-implantation genetic diagnosis, or adoption."
The hearing continues today, with the FDA observing further testimonials from industry experts. While not bound to their recommendations, the FDA typically defers to authorities on complex matters such as this one. However, the FDA has been advised that the decision may take several years before enough information comes to light around the health of any resulting offspring of mitochondrial replacement - and that's just if the process is initially vetted. "The end of the experiment will come decades later," said Michigan State University's Keith Latham on Tuesday. "It's going to take us that long to figure out the health of the progeny produced from these procedures."
