AMA Policies and Code of Medical Ethics� Opinions Related to Human Genome Editing

Scheper, Abigail

doi:10.1001/amajethics.2019.1056

AMA Journal of Ethics

2019

DOI: 10.1001/amajethics.2019.1056

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AMA Policies and Code of Medical Ethics� Opinions Related to Human Genome Editing

Abigail Scheper¹

Abstract: Recent research using gene editing technologies has made such tools more accessible and easier to use, fueling the promise of their therapeutic capacity. However, development of gene editing tools reminds professionals and the public that these technologies' potential use extends beyond treating somatic disease to germline editing, with consequences yet unknown. This article canvasses AMA Code of Medical Ethics' opinions and policies relevant to gene editing.

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The Dawn of In Vivo Gene Editing Era: A Revolution in the Making

Niazi

2023

Biologics

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Gene or genome editing (GE) revises, removes, or replaces a mutated gene at the DNA level; it is a tool. Gene therapy (GT) offsets mutations by introducing a “normal” version of the gene into the body while the diseased gene remains in the genome; it is a medicine. So far, no in vivo GE product has been approved, as opposed to 22 GT products approved by the FDA, and many more are under development. No GE product has been approved globally; however, critical regulatory agencies are encouraging their entry, as evidenced by the FDA issuing a guideline specific to GE products. The potential of GE in treating diseases far supersedes any other modality conceived in history. Still, it also presents unparalleled risks—from off-target impact, delivery consistency and long-term effects of gene-fixing leading to designer babies and species transformation that will keep the bar high for the approval of these products. These challenges will come to the light of resolution only after the FDA begins approving them and opening the door to a revolution in treating hundreds of untreatable diseases that will be tantamount to a revolution in the making. This article brings a perspective and a future analysis of GE to educate and motivate developers to expand GE products to fulfill the needs of patients.

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The Dawn of In Vivo Gene Editing Era: A Revolution in the Making

Niazi

2023

Biologics

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Somatic Genome Editing: Technical Challenges and Ethical Appraisal

O’Keeffe,

Alphonse,

Mendz

2024

ejmhr

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The ability to modify the DNA sequences with molecular tools that employ nucleases has made it possible to edit genomes. Somatic genome editing is the procedure to alter the genome of somatic cells, making the changes introduced into the nucleotide sequence not inheritable. Powerful tools have been developed for therapeutic purposes to correct monogenic inherited disorders that often cause premature death and for which effective treatment options are not available. To ensure positive impact and minimise potential harms of these techniques, require to understand their limits in addition to apply values and principles that guide their use. This study reviews technical challenges of genome editing and appraises the Ethics of its application.

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AMA Policies and Code of Medical Ethics� Opinions Related to Human Genome Editing

Cited by 2 publications

References 0 publications

The Dawn of In Vivo Gene Editing Era: A Revolution in the Making

The Dawn of In Vivo Gene Editing Era: A Revolution in the Making

Somatic Genome Editing: Technical Challenges and Ethical Appraisal

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