Overcoming bioethical, legal, and hereditary barriers to mitochondrial replacement therapy in the USA

The purpose of the paper is to explore novel means to overcome the controversial ban in the USA against mitochondrial replacement therapy, a form of IVF, with the added step of replacing a woman’s diseased mutated mitochondria with a donor’s healthy mitochondria to prevent debilitating and often fat...

Full description

Saved in:
Bibliographic Details
Published in:Journal of assisted reproduction and genetics 2019-03, Vol.36 (3), p.383-393
Main Authors: Pompei, Marybeth, Pompei, Francesco
Format: Article
Language:English
Subjects:
Autonomy
Bans
Commentary
Genetic engineering
Genomes
Gynecology
Human Genetics
Medicine
Medicine & Public Health
Mitochondria
Reproductive Medicine
Reproductive technologies
Terminology
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:The purpose of the paper is to explore novel means to overcome the controversial ban in the USA against mitochondrial replacement therapy, a form of IVF, with the added step of replacing a woman’s diseased mutated mitochondria with a donor’s healthy mitochondria to prevent debilitating and often fatal mitochondrial diseases. Long proven effective in non-human species, MRT recently performed in Mexico resulted in the birth of a healthy baby boy. We explore the ethics of the ban, the concerns over hereditability of mitochondrial disease and its mathematical basis, the overlooked role of Mitochondrial Eve, the financial burden of mitochondrial diseases for taxpayers, and a woman’s reproductive rights. We examine applicable court cases, particularly protection of autonomy within the reproductive rights assured by Roe v Wade. We examine the consequences of misinterpreting MRT as genetic engineering in the congressional funding prohibitions causing the MRT ban by the FDA. Allowing MRT to take place in the USA would ensure a high standard of reproductive medicine and safety for afflicted women wishing to have genetically related children, concurrently alleviating the significant financial burden of mitochondrial diseases on its taxpayers. Since MRT does not modify any genome, it falls outside the “heritable genetic modification” terminology of concern to Congress and the FDA. Correcting this terminology, the IOM’s conclusion that MRT is ethical, the continuing normalcy of the first MRT recipient, and increasing public awareness of the promising benefits might be all that is required to modify the FDA’s position on MRT.
ISSN:1058-0468
1573-7330
DOI:10.1007/s10815-018-1370-7