Preventing Mitochondrial DNA Diseases: One Step Forward, Two Steps Back
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On February 3, 2016, the Institute of Medicine (IOM) released its Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases report. Commissioned by the US Food and Drug Administration (FDA), the report provides important information for the agency, which is considering the approval of mitochondrial replacement therapy for the prevention of mitochondrial DNA diseases. Expansive in its purview and thorough in its scrutiny, the report concludes that it is “ethically permissible” to embark on clinical trials involving human beings, subject to rigorous safety and efficacy imperatives. The report further recommends that initial clinical trials be limited to male embryos whose mitochondria cannot be transmitted to their progeny. In so doing, the IOM is seeking to preclude transmission of unintended outcomes to the progeny. In an unforeseen turn of events, the release of the IOM report was preceded by the enactment of a federal statute that prohibits the FDA from considering research applications for the conduct of this therapy. This Viewpoint seeks to contextualize the IOM report by describing the drive to bring mitochondrial replacement therapy to the clinic and the statutory constraints blocking its adoption. [...]
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bioethics fda genetics health law policy human subjects research i. glenn cohen regulation