Controversies concerning mitochondrial replacement therapy

Robert Klitzman, M.D., Mark Toynbee, M.B.B.S., Mark V. Sauer, M.D.

Volume 103, Issue 2, Pages 344-346


Research on mitochondrial replacement therapy (MRT) holds the promise of helping women who have, or are at risk of transmitting, mitochondrial disease, but has recently been blocked by the Food and Drug Administration (FDA). Thus, several critical ethical and policy questions arise. Mitochondrial disease can be devastating for those who have it. Yet existing treatments remain supportive rather than curative. Women confronting this disease have a high chance of having an affected child and limited reproductive alternatives.

  • This topic is unfortunately presented in the media in a distorted, oversimplified, and “sensationalized” fashion. Therefore it is refreshing to read a well-written balanced summary regarding the controversies concerning MRT. It is interesting to see how the field of ART evolved over the last decades in a largely unregulated fashion, with often relatively minimal evidence available before new technologies were investigated in humans. Would the FDA ban human trials on IVF now if it wasn’t already invented? How about donor egg IVF? How is human research prioritized and approved? Barriers to MRT may include misinformation and the perception that only a small subgroup of patients would benefit. This article is a good example how the field of ART needs to balance science with ethical principles (“do no harm” / beneficence / justice / respect for persons)- and physicians and scientists need to be trained in both to educate the public.

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