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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.

Studies related to COVID-19 increasingly use electronic health records (EHR) to obtain large-scale evidence. However, EHR-based research must be performed with care because it can involve new study design problems that are unfamiliar to much of the medical community. Haimovich et al. (2020) sought to inform COVID-19 practice by evaluating temporal artery thermometers (TATs). They retrospectively searched EHR for temperatures measured twice within 15 minutes, including once with a TAT. The TAT often disagreed with reference measurements, so Haimovich et al. concluded TATs perform poorly. Here, we extended Haimovich et al.’s study design to all other major thermometer types using the eICU Collaborative Research Database. We retrospectively identified 80,065 pairs of quickly retaken temperatures from 24,765 adult U.S. critical care patients treated in 2014-2015. We found that oral, tympanic, and axillary thermometers disagreed with reference measurements as much as TATs did. Moreover, all thermometer types showed unprecedentedly worse agreement than observed in research using other study designs: every thermometer type broke ±0.9°F (±0.5°C) limits of clinically acceptable agreement by >2-fold and no type satisfied basic standards for repeatability. A natural explanation for these findings is that clinicians often retook temperatures within minutes because of user or patient errors during measurement, such as probe misplacement or patient movement. This means that quickly retaken EHR measurements do not reflect device accuracy or precision in correct use and, contrary to Haimovich et al.’s conclusions, should not be used to evaluate thermometer performance or revise COVID-19 fever thresholds. Our study provides an illustrative example of unexpected study design problems that can undermine EHR-based research.