Abstract

Over the past year media outlets and scientific and bioethics journals have reported about several medical and scientific innovations touted as having the potential to fundamentally change not only how diseases and disorders are diagnosed and treated but even how to alter the genomes of future generations. The purported “miracle” blood-testing technology of Theranos and the potential use of the genome editing technology CRISPR-Cas9 to modify human and nonhuman organisms reflect dramatic advances in scientific understanding about the biological mechanisms of humans and other living organisms. Yet evidence about whether these and other innovative biomedical technologies are safe and effective and lead to improved health outcomes for patients young and old is often in dispute. How to assess the safety and effectiveness of innovative biomedical technologies, who should be involved in that effort, and how to define risks and benefits of those technologies are questions at the intersection of values, interests, and politics.