Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases

Type: Consensus Study
Topics: Biomedical and Health Research, Children and Families, Diseases
Board: Board on Health Sciences Policy

Activity Description

Mutations in mitochondrial DNA can cause serious diseases that are in some cases fatal. Researchers have proposed transferring the nuclear genetic material from the eggs or zygotes of a woman affected with mitochondrial disease caused by mutations in mitochondrial DNA to an egg or zygote of a woman with normal mitochondria. As mitochondria are inherited solely from a mother through her eggs, this would in theory prevent maternal transmission of mitochondrial disease from the affected woman to her children. These modifications of eggs and zygotes would allow affected women to have genetically related children without passing on their mutant mitochondrial DNA. However, these children would have nuclear DNA from one man and one woman and mitochondrial DNA from another woman. Thus, any children born to women as a result of these methods would have DNA from three individuals. An FDA Advisory Committee (AC) met on February 25 and 26, 2014, to discuss the science regarding assisted reproductive methods involving genetic modification of eggs and zygotes for the prevention of  mitochondrial disease. FDA has requested that the Institute of Medicine produce a consensus report regarding the ethical and social policy issues related to genetic modification of eggs and zygotes to prevent transmission of mitochondrial disease.

The committee met five times over the course of the study. The first committee meeting was convened in January 2015. The second meeting of the committee was convened in March 2015 and included a 2-day public workshop in addition to a closed committee session. Another public comment session was held in conjunction with the third committee meeting in May 2015. Subsequently, two closed committee meetings were held, during which the committee drafted and finalized the final report.

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