Chapter 20 - Mitochondrial replacement therapy: Ethical, sociocultural, and public policy considerations

Abstract

The National Academies of Science, Engineering and Medicine released a report on whether research efforts to address heritable mitochondrial DNA diseases using mitochondrial replacement techniques (MRT) are ethically justifiable and permissible. Commissioned by the US Food and Drug Administration (FDA), a diverse committee of experts in medicine, ethics, and the law deliberated on issues related to ethics, society, and public policy and arrived at a consensus opinion that endorsed proceeding with research, including clinical trials under the careful scrutiny of the FDA. However, despite this encouraging decision, political opponents of MRT successfully blocked further progress by embedding into an appropriations bill legislation that precludes the FDA from reviewing research applications related to MRT research. This obstacle was gravely disappointing to thousands of patients who hoped to benefit from MRT use and many physicians and research scientists laboring to eradicate these horrific diseases. Scientific progress in MRT research has been impressive, and American investigators have been on the forefront of assisting the international community to move the research bench to human trials. After a similar metric of review and public debate, the United Kingdom passed laws permitting the research efforts that Americans blocked from performing. This unfortunate political move threatens to halt research initiatives in the United States and certainly delays implementing an effective reproductive choice for curing a vast number of mitochondrial mutational diseases. It is our hope that this law will soon be reversed, and we support all efforts to challenge any action that blocks progress with MRT research efforts.