When does being careful become its own kind of reckless?: Action bias
The rate
Between December 11, 2020, and August 23, 2021: 340,000 Americans dead of COVID. 1,300 per day. 44 per hour. One every 82 seconds.
The agency’s review division had every piece of clinical data it would ever need by February 2021 — tens of millions of real-world doses, a safety profile more thoroughly documented than any vaccine in history. Full approval took six more months. The paperwork was killing people, and the paperwork could not be reasoned with because it was following the process.
A QALY is one year of perfect health. The three weeks between data submission and EUA: 5,000 to 10,000 lives. The gap to full approval: tens of thousands more, because institutions worldwide that required full FDA approval held back mandates that had nothing to do with the drug’s safety and everything to do with the agency’s internal workflow.
The precautionary principle invokes thalidomide. Thalidomide was approved in an era with no controlled trials, no reproductive toxicity requirements, no independent data monitoring boards. Comparing the 2020 FDA to the 1960 Contergan process is a ghost story told to frighten people out of looking at the data.
The precautionary framework assumes the cost of delay is always lower than the cost of error. During a pandemic, that assumption inverts. The practitioners saw this from the floor. The framework has no variable for the people who die while waiting.
The context weighers want dynamic assessment. We are not opposed. Every dynamic framework we have seen proposed takes three years to implement and operates at the same speed as the old one with better slides.
Where we concede ground: Vioxx is ours. Accelerated review, 80 million patients, 60,000 cardiovascular deaths. The safety net has holes.
What would change our mind: A pre-registered comparison where standard timelines catch a signal the accelerated timeline missed, causing more harm than the delay.
Read the full synthesis: When does being careful become its own kind of reckless?