The side effects of statins would be clearer with more data. This was illustrated very recently by the report of an independent panel which looked at two papers published by The BMJ that contained errors. Click here to read the background on the panel. The panel called for data from clinical trials on statins to be made available for independent scrutiny. From the panel’s report:
It became very clear to the panel that the fact that the trial data upon which this controversy is based are held by the investigators and not available for independent assessment by others may contribute to some of the uncertainty about risks and benefits. Different investigators may come to different conclusions with the same data. In fact, a particularly germane example occurred recently in which two experienced Cochrane groups were charged with evaluating a particular intervention and, despite being given the same instructions, data and resources, did not arrive at identical results or conclusions. The panel strongly believes that the current debates on the appropriate use of statins would be elevated and usefully informed by making available the individual patient-level data that underpin the relevant studies.
Dr Fiona Godlee, Editor in Chief, The BMJ and co-founder of AllTrials:
I echo the panel’s call for the individual patient data from the statins trials be made available for independent scrutiny. Patients and their doctors need access to all relevant information to make informed decisions about their health.
Dr Ben Goldacre, author and co-founder of AllTrials:
Sharing individual patients’ data from clinical trials poses modest privacy challenges, because participants can sometimes be identified from that data, if someone accessing it chooses to be malicious. But this risk can be managed, and it should never be used to prevent legitimate work by serious academics. Doctors and patients need to know the risks and benefits of treatments to make informed decisions: that is how we save lives in medicine. This can only happen when we have good data, from fair tests, analysed transparently, and communicated clearly.