Adumbrations Of Aducanumab

A rebuttal to an Atlantic piece that used aducanumab's approval to argue the FDA is too lax. Scott's counter: the FDA is still far too STRICT -- the AIDS-drug and COVID-vaccine fast-tracks averted hundreds of thousands of deaths, and cost-benefit work (Isakov/Lo/Montazerhodjat) finds it too conservative overall. Marshals the COVID-testing fiasco (banning ready tests, shutting down Helen Chu) and the infant short-bowel-syndrome fish-oil saga (flagged with a later correction) to argue this destructiveness is routine, not COVID-specific. Resolves the too-strict-and-too-lax paradox (like the police) as 'the institution is bad at its job / has a scandal-avoidance mandate', then offers the generative reform: UNBUNDLE FDA approval into separable rights -- legal-to-prescribe vs mandatory-to-cover vs reputation-staking -- via 1-to-5-star approvals with different legal consequences at each tier. Closes with the alternate-universe-global-warming metaphor (the government mandating useless coal plants while letting people freeze).

Quality 78 · Excellent. Excellent floor. A passionate, well-marshalled FDA polemic that rises above a rant via a genuinely constructive proposal (unbundling / star-ratings) and the too-strict-and-not-strict-enough framing. Held at the floor for its rant-y register and a self-flagged factual slip in the short-bowel section.

Claude’s paradigm shift 56 · Moderate. Notable. The 'FDA too strict' thesis is a progress/libertarian staple; the fresh, non-obvious contribution is the unbundling-of-approval design and the star-rating mechanism.

Real-world impact 3 · Moderate. Moderate. A much-cited contribution to the FDA-reform / progress-and-abundance discourse, a real professional sphere, though no specific legal change is verifiably attributable. Niche-professional, aligned with the IRB review.