A Letter I Will Probably Send To The FDA

An open advocacy letter to the FDA defending 23andMe against the 2013 order to halt genetic testing. As a physician, Scott argues personal genomics raises useful awareness and gives patients questions to bring to their doctors, then dismantles the FDA's three stated fears: false-positive BRCA (answered by the standard screen-then-confirm model, as with PSA's 30% PPV); a demand that each kit re-validate every gene-trait link ('asking each pharmacy to do independent studies to confirm their own penicillin kills bacteria'); and the patients-might-self-manage worry (which, taken seriously, would require banning medical textbooks and bathroom scales). Frames the choice as ban-all-health-information vs trust-patients-and-doctors; includes his own HSAN3-carrier discovery.

Quality 66 · Strong. 66 — Strong. A persuasive, clearly-reasoned advocacy piece with memorable analogies (the penicillin-validation and ban-the-bathroom-scale arguments land cleanly). Topical and bounded to a specific 2013 regulatory fight, which holds it mid-Strong rather than higher.

Claude’s paradigm shift 44 · Moderate. 44 — Moderate. Sharp application of info-paternalism and validation-logic arguments, but no new frame.

Real-world impact 2 · Minor. 2 — a concrete but individual advocacy act in a real regulatory episode; within-discourse contribution, no demonstrable policy effect.