{
  "$type": "site.standard.document",
  "bskyPostRef": {
    "cid": "bafyreibx6v75ksjv6d5bigl5dkg75vowg4f6bqwjmafm6x55bp6tgl6ryy",
    "uri": "at://did:plc:wwyqal4cnqhuwyacdj7rqq3n/app.bsky.feed.post/3mobiztwvmxx2"
  },
  "path": "/t/statin-related-side-effects-the-recent-lancet-publication-is-biased-toward-false-negatives/28635?page=2#post_23",
  "publishedAt": "2026-06-14T13:42:14.000Z",
  "site": "https://discourse.datamethods.org",
  "textContent": "Asking the Oxford authors to word their findings as follows might be a reasonable “middle ground” that would not risk aggravating a serious public health problem (statin denialism):\n\n_“Many of the AEs currently listed in statin product monographs were added to labelling many years ago because of a reported temporal relationship to statin use in individual patients in the postmarket setting. Rigorous evidence for a causal role of the statin in individual cases was not required to include these AEs in the label. Rather, many AEs were added as a precautionary measure, because a causal role for the drug “could not be excluded.” But we have now accrued high numbers of reports of many of these AEs in the context of decades of statin clinical trials. Trial-level evidence allows us to see that many of the AEs reported over the years in the postmarket setting (outside the context of trials) have occurred with**similar** frequency in statin-treated and placebo-treated trial subjects. We can draw the following conclusion from this observation: IF statins are capable of causing these AEs, they would **only** do so at rates **so low that the signal has been undetectable after decades of clinical trials. This fact suggests that that the risk for the labelled AEs in question would have to be so low that it would not be expected to influence clinical decision-making**. AEs that occur at very low rates are often those that occur unpredictably in idiosyncratically-vulnerable patients, for reasons we don’t understand- as such, these AEs can usually not be avoided through pre-treatment patient screening. If no safety signal for an AE has been observed after many accrued AEs of this type in statin clinical trials, we can conclude that IF statins are capable of causing this AE (perhaps in idiosyncratically-vulnerable patients), the risk is likely to be lower than 1 in …”_",
  "title": "Statin-related side effects: the recent Lancet publication is biased toward false-negatives"
}