What Stands In for Health ยท four essays
At a Glance
A number a drug moves stands in for health only when trials show that moving it moves the patient.
- 1The Plaque Was GoneHow did one yes and one no become a yes?
- 2No Row for AgingWhy does aging have no row on the FDA's table?
- 3The Arrow Nobody Has DrawnWhat would it take to draw the arrow from marker to years?
- 4How a Stand-In Earns Its RowOut March 9, 2027.
| Idea | 1 | 2 | 3 | 4 |
|---|---|---|---|---|
| Did it move the person? | ||||
| Count the trials | ||||
| Whatever way the drug works | ||||
| The lower yes | ||||
| Rules before the data |
Did it move the person?
A drug can move a number while the patient gets no better.
- Part 1Each patient's plaque change explained nothing of the drug's effect (p = 0.884).
- Part 2Predicting who gets sick and moving when a treatment changes are two different jobs.
- Part 3A negative-control trial checks whether the marker can move without the patient.
Count the trials
One trial, or one person, cannot show a number stands in for health.
- Part 1Two trials built the same way: one yes (p=0.01), one no (p=0.83).
- Part 2Blood pressure earned its trust as strokes fell in trial after trial.
- Part 3Make each dot one randomized trial, not one patient.
Whatever way the drug works
A stand-in for aging must hold for every kind of drug.
- Part 2An aging stand-in would need the word on blood pressure's row: mechanism agnostic.
- Part 3Hold back every trial of one mechanism and test whether the line still predicts them.
The lower yes
Approving on a stand-in only "reasonably likely" to work raises doubt about the next one.
- Part 1The plaque fell in both trials, and the rule let the plaque stand in.
- Part 2The plaque's row says Accelerated: the lower yes.
- Part 3Doubt raises the bar for any stand-in, and a higher bar means fewer approvals.
Rules before the data
The test that counts is the one named before the numbers came in.
- Part 1A new reading of the rules put the chance of a false win as high as .0975.
- Part 3Part one's tests ran on the plaque after the fact; here they are set before any data.