Intended for healthcare professionals

Feature Publication Ethics

Risks in the balance: the statins row

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5007 (Published 07 August 2014) Cite this as: BMJ 2014;349:g5007

Re: Risks in the balance: the statins row

I am not an academic and my experience of statins is limited to that of working at the coal face as a gp, experience that may be dismissed as only marginally better than anecdote. Yet it is as personally compelling, as must be the experience of researchers who invest their lives in meeting the research requirements of statins as drugs, as opposed to being invested in meeting the needs of patients.

It seems to me that this difference in orientation is important, though very difficult to factor into trial data. It is not necessarily countered by double blinding. And when benefits are of small clinical impact, such subtle factors may loom large.

Another subtle but important cost of treatment that is hard to measure, is the loss of the sense of well-being that some patients may experience in being told they need medication, what I seem to recall Tudor-Hart describing as an ink-stain in the clear waters of the patient's life. This will not show up in the list of side effects unless it triggers measurable morbidity. This does not make this side-effect unimportant.

Nor is drawing a parallel with the MMR fiasco appropriate. Vaccinating children with MMR has, at little cost, the potential to save a large number of healthy life years and to prevent grave misery for the families of children. Even if the failure to treat with statins leads to a shortened life for some, there are substantial differences in the quality of the losses involved.

Surely concerns such as these must mean that statistically significant differences in outcome may not necessarily be sufficient to justify changes in clinical practice. A high margin of safety in proof is essential. It seems to me that extraordinary interventions do require extraordinary evidence.

Competing interests: No competing interests

15 August 2014
Niall Holland
general practitioner (semi-retired)
self-employed
55 Old French Road