The Invisible Graveyard: Quantifying the Mortality Cost of FDA Efficacy Lag, 1962-2024

The 1962 efficacy requirement adds 8.2 years (95% CI: 4.85 years-11.5 years) to drug approval after safety is proven. This study quantifies two distinct mortality costs: (1) 102M deaths (95% CI: 36.9M deaths-214M deaths) historical deaths during actual drug approval delays (1962-2024), and (2) 416M deaths (95% CI: 225M deaths-630M deaths) future deaths from pushing the disease eradication timeline back. Type II errors exceed Type I benefits by 3.07k:1 (95% CI: 2.88k:1-3.12k:1).