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Statins for primary prevention: what is the regulator's role?

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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Vis graf over relationer

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.

OriginalsprogEngelsk
TidsskriftBMJ Evidence-Based Medicine
ISSN1356-5524
DOI
StatusUdgivet - 26 feb. 2020

Bibliografisk note

© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.

ID: 59639439