Key result
Individual patient adverse event data from statin trials remain largely unavailable for independent scrutiny.
Independent review of the trial data is an essential next step Statins are the UK’s most commonly prescribed drugs and are among the most widely prescribed drugs globally.1 Though their use in people at high risk of stroke and heart disease is uncontroversial, recent recommendations to treat much larger numbers of people at low risk2 3 have caused a storm of controversy.4 Most hotly debated are the nature and frequency of side effects of statins and whether arguably small gains in life expectancy are worth the risk.5 6 In August 2014 an expert panel convened by The BMJ called for the anonymised individual patient data from the statins trials to be made available for independent scrutiny.7 Our subsequent inquiries, guided by an expert advisory group (www.bmj.com/campaign/statins-open-data) have revealed the worrying extent to which these data remain hidden. In reply to a letter from The BMJ , Rory Collins and colleagues of the Cholesterol Treatment Trialists (CTT) collaboration in Oxford confirmed that their meta-analyses have so far been limited to patient level data on cause specific mortality, major vascular events, and site specific cancers. They had not analysed data on other adverse events as these were not part of the original CTT agreement. Collins and colleagues explained, however, that the trialists agreed in 2013 to pool and analyse data on all adverse events. …
No takes yet. Share an insight, caveat, or question.
Parish et al. (2015) conducted an editorial in Low cardiovascular risk. Statins was evaluated. Anonymised individual patient data from statin trials regarding all adverse events currently remain largely unavailable for independent scrutiny.
Synapse has enriched 5 related papers. Consider them for comparative context: