Statin-related side effects: the recent Lancet publication is biased toward false-negatives

As a patient advocate on the CIRB I reviewed consent documents and came away with a favorable view of how possible adverse effects are described to the patient - directed by the NCI template … including those that are rare and severe - life threatening. In it we used simple fractions to describe the risk as in “In 100 persons taking this drug, up to 20 have had …” You get the idea. …To attribute rare effects to a drug is challenging and sometimes impossible with current knowledge if there’s no plausible mechanism that points to cause and effect relationship. So for these effects, rare and without known mechanism, the patient needs to understand that chance is a common and likely explanation. Perhaps with language along these line: - that something happened after X doesn’t mean that X caused it. “The rooster’s crowing doesn’t cause the sun to rise.” Anyhow, my point in commenting is that effort I feel is best directed at the language of possible side effects’ and when attribution is uncertain and mechanism is unknown for the rare effects, that has to be explained in plain language.