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Adverse-event forensics


Vioxx was visible from the molecule down

Rofecoxib was withdrawn in 2004 after roughly 80,000 excess cardiovascular events. The mechanism was not occult. Selective COX-2 inhibition suppresses prostacyclin while leaving thromboxane intact, shifting platelet balance toward thrombosis. The signal lived in the coupling between two organ systems, not inside either one.

We have replicated that coupling against the body model. Given the published pharmacology of COX-2 inhibition alone — no access to the eventual withdrawal data — a counterfactual sweep over plausible dose-duration pairs surfaces the cardiovascular signal as a structural prediction.

The methodology is the same one we run on any compound, before or after market.

Two postures

  • Anticipatory: your compound is in development and you want the structural risks surfaced before phase III surfaces them for you.
  • Defensive: your compound carries post-market signals and you need a mechanism-anchored explanation that survives regulatory review.

What this is not

A pharmacovigilance team, a regulatory submission, or a substitute for peer review. We supply the mechanistic counterfactual; what you do with it is your call.

Disclaimer. This note is a methodology and capability description, not medical or clinical advice. Modelled outputs are not substitutes for peer-reviewed evidence, regulatory review, or qualified clinical judgement. Raganele is not a medical practice.
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A trial protocol, a candidate molecule, a withdrawn product with a question attached. If it touches the wired body — and most things do — we can tell you what the counterfactual sweep returns.

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