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
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The core scientific issue in the row over what we should do about statins revolves around the interpretation of the results from a number of clinical trials. But we could resolve the debate tomorrow if we could access existing data from the NHS.
The key problem with the clinical trials is that they are all too small to provide the levels of statistical certainty required to reach a definitive conclusion. And, perhaps, not all the results have been released (I'll leave that to other experts to judge).
But the NHS has been prescribing statins to millions for years (in 2013 the English NHS issued just over 58 million prescriptions for the two major generic statins, simvastatin and atorvatstsin). GP records for those patients contain, potentially, huge amounts of information relevant to judging both side effects and mortality and on a scale that is large enough to eliminate the statistical uncertainties that plague the clinical trials.
The data exist but it are not accessible. The intent of care.data was to make this sort of information readily accessible for the purpose of answering exactly this sort of question. But hysterically overblown concerns about potential risks to patient confidentiality (the risks of breaches are very low and the potential harms very small) have held back and may completely stop progress on making this information accessible.
The real scandal here is that we have already collected all the data we need to resolve the question of whether statins are good or bad in low risk patients but we can't access it or use it. In the meantime millions of patients will be taking the drugs while the statisticians dispute the error bars on much less informative datasets that can never give us definitive answers.
Competing interests: No competing interests
Do epidemiologists actually speak to patients? It is very easy to encounter people who have suffered from the harmful actions of statins but epidemiologists tend to think that more epidemiology is needed.
Nigel Hawkes writes that Iain Chalmers has called for statins to be reassessed in a withdrawal trial, where people who complain of side effects are randomly allocated to receive either placebo or to continue the active drug and the outcomes measured.1
Would anyone with the onset of severe fatigue, muscle pains and weakness, diabetes, liver damage, cataracts, thyroid disease, dementia, mental confusion, breathing difficulties or cheat pains while taking statins, be willing to have a 50% chance of taking statins again?
I think not – especially if they have read the 2012 book written by John Yoseph and Dr Hannah Joseph which details the scientific evidence of how statin drugs, developed from mycotoxins, damage cells by blocking the mevalonate pathway of life.
1 Hawkes N. Risks and balance: the statin row. BMJ 2014;349:g5007
2 James B Yosepn, Hannah Yoseph MD. How statin drugs really lower cholesterol and kill you one cell at a time. James and Hannah Yoseph, 2012 jandhyaseph@yahoo.com USA.
Competing interests: No competing interests
The discussion in the bmj of 9th August regarding the use of statins evokes memories. The inflexibility of the protagonists and the heat engendered in the discussion about statins is reminiscent of similar heated discussions in a former era about duodenal ulceration and gastric acid secretion.
If one substitutes duodenal ulcer for coronary heart disease and acid secretion for cholesterol then the two literatures are very similar. The similarity extends even to the variability in prevalence in populations which cannot be explained readily in terms of acid and cholesterol metabolism. A huge therapeutic industry developed around reducing gastric acid secretion. The preoccupation was to reduce acid production to a minimum. No acid, no ulcer. Then fortuitously the Helicobacter was discovered and duodenal ulceration therapy became very simple and effective. Problem resolved.
It is conceivable that one day coronary heart disease will be shown to have a transmissible aetiology, and that cholesterol is the secondary effector. And like duodenal ulceration a truly effective therapy will appear.
In the meantime humility and thoughtfulness are are important
Martin Eastwood
Competing interests: No competing interests
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