Let the Data Tell the Story
When the clinical narrative outruns the evidence.
We investigate pharmaceutical cases where the public story becomes smoother, stronger, and more settled than the regulatory record and subsequent data can justify. Each report is source-grounded, balanced, and built for decision makers who need to see past consensus confidence.
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The Empagliflozin Narrative
A 38% reduction in cardiovascular mortality. Unprecedented. A standing ovation at a congress in Stockholm. And yet, bizarrely, astonishingly, a 12-11 vote at the FDA advisory committee. The headline looked decisive. The regulatory record told a different story.
The survival curves separated within weeks: biologically implausible for atherosclerosis.
Up to 40% of cardiovascular deaths were non-assessable. Removing them eliminated the statistical signal.
61% of the trial population in Europe and North America showed no mortality benefit.
The 10mg and 25mg doses produced near-identical outcome curves: no dose-response.
Post-trial follow-ups failed to confirm the headline mortality claim.
Narrative Friction Report
Empagliflozin: Cardiovascular Mortality Claim
Full report including regulatory insights, follow-up trial analysis, an authorship conflict-of-interest audit, why this report matters, and implications for the pharmaceutical ecosystem.
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KEY ELEMENTS OF THE REPORT
Built for scrutiny, not comfort.
Every report follows a structured analytical workflow: identifying uneasy approvals, mapping contradictions, preserving both the strongest defense and the strongest critique.
Regulatory Discomfort Analysis
We extract vote closeness, advisory committee ambivalence, narrow or conditional approvals for drugs that later became commercially important or narratively dominant.
FDA vs EMA Divergence
When regulators reach materially different conclusions, that gap is itself evidence. We document the precise reasons and the implications for independent judgment.
Claim / Defense / Critique Matrix
We preserve both the strongest defense and the strongest critique, separating direct facts from synthesis from interpretation.
Authorship & Conflict Audit
A systematic review of sponsor-linked authors, funding disclosures, and the degree of independence within the publication ecosystem.