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NIH and FDA Should Allow Gene Editors to Cure Diseases



(p. A15) Should Americans be allowed to edit their DNA to prevent genetic diseases in their children? That question, which once might have sounded like science fiction, is stirring debate as breakthroughs bring the idea closer to reality. Bioethicists and activists, worried about falling down the slippery slope to genetically modified Olympic athletes, are calling for more regulation.

The bigger concern is exactly the opposite--that this kind of excessive introspection will cause patients to suffer and even die needlessly. Anachronistic restrictions at the Food and Drug Administration and the National Institutes of Health effectively ban gene-editing research in human embryos that would lead to implantation and births. These prohibitions are inhibiting critical clinical research and should be lifted immediately.


. . .


What's holding researchers back, at least in America, is outmoded regulations. The FDA is blocked by law from accepting applications for research involving gene editing of the human germ line--meaning eggs, sperm and embryos. The NIH, whose approval also would be needed, is similarly barred from even considering applications to conduct such experiments in humans. These rules date as far back as the 1970s, when the technology was in its infancy. It's easy to invoke hypothetical fears when actual lifesaving interventions are decades away.

Today they aren't--and desperate patients deserve access to whatever cures this technology may be able to provide. The public thinks so, too. A survey this summer found that nearly two-thirds of Americans support therapeutic gene editing--in somatic and germ-line cells alike. Popular opinion is in tune with scientific reality. Legislators and regulators need to catch up.



For the full commentary, see:

Henry I. Miller. "Gene Editing Is Here, and Desperate Patients Want It; Two-thirds of Americans support therapeutic use, but regulators are still stuck in the 1970s." The Wall Street Journal (Fri., OCT. 13, 2017): A15.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date OCT. 12, 2017.)






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