When Will The FDA Approve Paxlovid?
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Follow-up reading
↳ Highlights From The Comments On The FDA And Paxlovid — Highlights (companion) · Nov 2021
Summary
An FDA-urgency argument: Pfizer's Paxlovid trial showed a ~10x reduction in COVID hospitalization/death with no detectable side effects -- so good the FDA agreed it was unethical to continue the placebo arm -- yet the drug remained unapproved and illegal, with prediction markets expecting a ~6-week wait (~50,000 more deaths). Scott walks through the possible justifications (insufficient evidence? side effects? might not work? -> 'just legalize it and un-approve later if it fails') and, pre-empting the obvious challenge, distinguishes this from his ivermectin skepticism (amateur trials of n=25-116 vs a Pfizer trial of n=1,219; and ivermectin is already legally prescribable anyway). Accepts the manufacturing-inspection caveat as the one plausible reason for delay.
Why this score
Quality 67 · Strong. Strong (low): a clear, forceful FDA-urgency argument with a good ivermectin-vs-Paxlovid distinction and honest engagement with the manufacturing caveat, but topical to late-2021 and less deep than his marquee FDA-critique pieces.
Claude’s paradigm shift 45 · Moderate. Moderate (low): applies his standard FDA-delay critique to a specific case; little novel frame.
Real-world impact 2 · Minor. Minor: part of a real drug-approval-speed argument, but a topical commentary without a traceable material change.