Forskning
Udskriv Udskriv
Switch language
Rigshospitalet - en del af Københavns Universitetshospital
Udgivet

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  1. Was amorphous aluminium hydroxyphosphate sulfate adequately evaluated before authorisation in Europe?

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Methylphenidate for ADHD rejected from the WHO Essential Medicines List due to uncertainties in benefit-harm profile

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Assessment of assumptions of statistical analysis methods in randomised clinical trials: the what and how

    Publikation: Bidrag til tidsskriftReviewForskningpeer review

  4. Blinding in randomised clinical trials of psychological interventions: a retrospective study of published trial reports

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  5. Considerations on the strengths and limitations of using disease-related mortality as an outcome in clinical research

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Suspicions of possible vaccine harms must be scrutinised openly and independently to ensure confidence

    Publikation: Bidrag til tidsskriftLetterForskningpeer review

  2. Presentation of benefits and harms of antidepressants on websites: A cross-sectional study

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Increased incidence of cervical cancer in Sweden: an unlikely link with human papillomavirus (HPV) vaccination

    Publikation: Bidrag til tidsskriftKommentar/debatForskningpeer review

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