Intended for healthcare professionals

Rapid response to:

Editor's Choice

Statins: we need an independent review

BMJ 2016; 354 doi: (Published 15 September 2016) Cite this as: BMJ 2016;354:i4992
Documents relating to a complaint about ​The BMJ ​made to COPE - updated in November 2016

Rapid Response:

Which countries hold the clinical trial data for statins? A letter to 32 national regulators across Europe

Godlee called for an independent review of the statins trial data with special attention paid to the vexed questions about the benefits and harms in primary prevention, i.e. in people at possible risk of cardiovascular disease but with no overt signs or symptoms. This is especially true for low grade musculoskeletal and joint symptoms which some observational studies report as common, and is at odds with reviews of controlled clinical trials.

As a preliminary step to research that addresses this question of the possible harms of statins, we are trying to clarify which governments across Europe have evaluated and currently hold the trial evidence on which the seven statins were approved? The European Medicines Agency did not centrally authorise any of the statins; single nations did.

We have begun this work by sending the following template letter to 32 national regulators across Europe, in the hope of achieving a single unifying overview of the regulatory data holdings for these public health drugs.

12 April 2019

To: [Regulatory Agency of Country X]

Re: Clinical Trial Evidence of Statins

We are writing to you regarding seven statin drugs:

• Atorvastatin (Lipitor, Pfizer)
• Fluvastatin (Lescol, Novartis)
• Lovastatin (Mevacor, Sandoz/Merck
• Simvastatin (Zocor, Merck)
• Pitavastatin (Livazo, Recordati/Kowa Co)
• Pravastatin (Pravachol, Bristol Meyers Squibb)
• Rosuvastatin (Crestor, AstraZeneca)

As a National Competent Authority (NCA) of the Member States of the European Union (EU) responsible for granting a marketing licence to various drugs, we would like you to answer the following questions for the purpose of enabling research to be carried out at the Nordic Cochrane Centre on the harms of statins.

These questions apply to each of the seven statin drugs mentioned above and generic brands in any dosage or format but not in combination with other drugs (e.g. fibrates);

1. Are any of the seven statins authorised in [Country X]? (yes/no for each statin)

2. If yes, what year was each statin authorised?

3. Was each statin first authorised on the basis of [Country X]'s assessment of a marketing authorisation application (MAA)? (yes/no)

4. If Q3 = yes. Does Country X still hold the clinical trial evidence (including clinical study reports) in its archives? (yes/no)

5. If Q3 = no. Which country evaluated the MAA and granted a license that was recognized by [Country X] (for example, on the basis of the mutual recognition or decentralised or national authorisation procedures)?

6. If [Country X] authorised the statin please refer us (via a weblink or URL) to the healthcare professional prescribing information for each statin, in English if possible.

To facilitate your answers please fill in this table (also attached for your convenience).

[Blank table omitted because of formatting difficulties.]

We look forward to your response. Please respond to:

Yours sincerely,

Tom Jefferson MD MSc MRCGP FFPHM
Nordic Cochrane Centre
Rigshospitalet, Dept 7811

Maryanne Demasi PhD
Nordic Cochrane Centre
Rigshospitalet, Dept 7811

Peter Doshi PhD
University of Maryland School of Pharmacy/
Baltimore, MD

Competing interests: TJ is in receipt of funding from the University of Oxford for this work. A complete disclosure is at PD is an associate editor at The BMJ and served on The BMJ’s 2014-15 statins advisory panel. He has conducted research on the possible harms of statins that was financially supported by a New Investigator Award from the American Association of Colleges of Pharmacy. MD: no conflicts of interest.

14 April 2019
Tom Jefferson
Maryanne Demasi, Peter Doshi
Nordic Cochrane Centre
Rigshospitalet, Dept 7811