Globally, drug regulators have approved statins for the prevention of cardiovascular disease (CVD), although their use in primary prevention has been controversial. A highly publicised debate has ensued over whether the benefits outweigh the harms. Drug regulators, which are legally required to make independent judgements on drug approvals, have remained silent during the debate. Our aim was to navigate the decision-making processes of European drug regulators and ultimately request the data upon which statins were approved. Our findings revealed a system of fragmented regulation in which many countries licensed statins but did not analyse the data themselves. There is no easily accessible archive containing information about the licensing approval of statins or a central location for holding the trial data. This is an unsustainable model and serves neither the general public, nor researchers.
- coronary heart disease
- ischaemic heart disease
- health policy
- clinical trials
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Contributors The authors have been assessing the debate on statins since 2015. Each author became involved because of their interest and in the case of TJ and MD the interest of their funder, Nordic Cochrane Centre. TJ and PD are systematic reviewers experienced in the identification, retrieval and indexing of regulatory data. MD is a scientific journalist and researcher. TJ is guarantor of the article.
Funding Nordic Cochrane Centre and NIHR (project 'stage 1 review of the benefits and harms of cholesterol lowering drugs to prevent CVD based on clinical study reports and summary of regulatory comments'). Neither funder had input in the design and execution of the study.
Competing interests TJ’s full disclosure is online (https://restoringtrials.org/competing-interests-tom-jefferson/). PD was the recipient of an award from the American Association of Colleges of Pharmacy for studying harms information on statin prescribing information (2015). He is also an editor at The BMJ and unpaid member of the Reagan-Udall Foundation for the FDA, which focuses on drug safety. MD has written about statins in scientific and lay articles and her work on this project is funded by the Nordic Cochrane Centre.
Provenance and peer review Not commissioned; externally peer reviewed.