On February 3, 2016, a panel consisting of elite scientists and bioethicists gave its approval to “go forward with caution” with a form of genetic engineering called Mitochondrial Replacement Therapy (“MRT”) as long as the process is carefully monitored and closely regulated.
The purpose of MRT is to prevent the passage or development of congenital diseases by using DNA from three parents. It would use a third party’s DNA to cut out the risk of certain disorders being passed on from parent to child by replacing the mother’s damaged mitochondrial DNA with healthy mitochondrial DNA of a donor. The ultimate goal is that parents can have healthy children that are genetically their own.
Although the panel did urge that the use of MRT be limited to male embryos because “the implications of a child growing up with donor mitochondrial DNA are not yet clear.” The panel argues that it is important to limit MRT’s use to males only, because males do not pass down mitochondrial DNA to their children. Since males do not pass mitochondrial DNA to their children it would prevent modified DNA from being passed down to multiple generations, which is incredibly important since the long term impact of modified DNA is still unknown. The Panel cautioned that the procedure should only be extended to female embryos once the long term effects are better understood. However, this decision differs from the United Kingdom’s approval of the technique in 2015 and its decision not to place any sex-based restrictions on the use of MRT.
The decision came from a committee that was created at the request of the Food and Drug Administration (“FDA”) to investigate the ethical implications of three-parent babies. First, there is a serious amount of concern that babies born as a result of MRT could have germline changes, which could be passed down for multiple generations. It also magnifies the slightest lab mistake into a problem that could be faced by people for decades to come. There is also a major concern about this technology being a tool to “play god,” which strengthens the argument for significant restrictions and regulations. Additionally, the technology poses several safety and regulation concerns.
However, this approval has hit the ultimate roadblock- the Congressional wall. The omnibus fiscal 2016 budget bill passed last year contained language that prohibits the government from using any federal funds to handle applications for experiments “in which a human embryo is intentionally created or modified to include a heritable genetic modification.” Therefore, the FDA is paralyzed and unable to move forward with MRT. As a result of this restriction families that could seriously benefit from MRT will not be able to take advantage of the technology anytime soon.