Letter on “Assessment of adverse effects attributed to statin therapy in product labels: a meta-analysis of double-blind randomised controlled trials”.

This letter discusses the Lancet CTT Collaboration meta-analysis of statin-labeled adverse effects. It argues that the study combines multiple, compounding sources of bias that can systematically favor false-negative conclusions in safety assessment: stringent multiplicity control, threshold-based interpretation of statistically "non-significant" results, dichotomous reading of interval estimates, and reliance on randomized trial settings with limited real-world transportability together with intention-to-treat dilution under non-adherence. The letter clarifies that "non-significant" does not mean "no causal effect" and calls for effect-size-centered interpretation, explicit uncertainty reporting, and sensitivity analyses across alternative error trade-offs, risk strata, and dosages.