Statins for all
BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g1899 (Published 03 March 2014) Cite this as: BMJ 2014;348:g1899All rapid responses
Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles or when it is brought to our attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not including references and author details. We will no longer post responses that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
It's a pity that drugs so useful for a subset of patients have been over-generalised in their recommendations to groups with a far larger NNT and higher risk of side-effects. The US bodies have changed their tune on this somewhat.
Mr Matheson, above, may have an autoimmune myosotis triggered by statin use. Uncommon.
C.
Competing interests: No competing interests
Another salvo from Dr Spence to rattle a few cages.
I can't say that as a layman or as an allied professional that I have always agreed with Dr Spence, but his forthcoming retirement from writing for the BMJ is going to leave a gaping hole.
Dr Spence's legacy will be one of challenging the status quo and perceived wisdom of others; to inspire and to encourage debate and promote critical thinking.
A real mentor who will be sadly missed. I wish Dr Spence all the best for the future.
Competing interests: No competing interests
Having read Spence, Chand and the rapid responders so far:
I am happy that I decided a long time ago, to NOT bother about the level of my blood pressure, the level of my cholesterol. I am 82. I would prefer to die of a heart attack than of other alternatives. A cancer death is more painful. Senile dementia too is not to my liking.
Do I blame the drug firms for the Statin Fashion? No. It is the Department of Health and the promoters of preventive medicine who want the GPs to prevent this and that. I hope they won't ask GPs to start screening for "early" Alzheimer's which cannot be treated at present but will leave thousands worried about their future mental capacity.
Perhaps the BMA's Ethics Committee could pay attention to this issue?
Competing interests: Please see the text
I would like to thank Dr Chand, the deputy chairman of the BMA, for drawing attention to the possible serious and debilitating side effects about which users of statins are not informed by the drug companies manufacturing them.
I was prescribed Simvastain 40g tablets in the 1990s following a transient ischemic attack when I was in my fifties. I then began to suffer breathing problems and a degree of muscle weakness and slowness which I attributed to the aging process. However I was able to carry on with normal life, albeit at a slower pace than before. However in recent years I have developed severe pain in the muscles of both legs and a feeling of extreme fatigue and weakness to the point that I can now only stand for a minute or so and need a wheelchair to move more than a few yards. Although I have suffered other health problems since 2006, none of these appear to be related to my current level of disability, and my GP is unable to provide me with an explanation of my physical condition.
My quality of life has been dramatically affected because of the constant pain in my legs and the impact upon my mobility of my muscle weakness and exhaustion. Every day is a struggle. When I read about Dr Chand's personal experience of statin use, it immediately struck a chord. I have ceased to take statins but my fear is that my long-term use of statins has resulted in permanent muscle damage.
I am therefore alarmed to hear the news that under NICE recommendations millions more adults could be routinely prescribed statins. The effect of statin use over a long period, particularly in the case of people with pre-existing health problems and in the older age group, should be the subject of independent research, not restricted to trials undertaken by the drug companies who will reap considerable profits from their increased use.
Yours sincerely
Campbell Matheson
Competing interests: No competing interests
Characteristically, Des goes to the heart of the matter !
I know from the many RCTs that Statins reduce cardiovascular events in people at risk (at least down to 10% ten-year CVD risk). But ipso facto the numbers needed to treat climb reciprocally as the targeted patient's absolute risk falls.
Des rightly asks "wouldn’t it be meaningful and useful to advise patients of numbers needed to treat for deaths and heart attacks and strokes prevented?".
NICE does not furnish this important information, but anticipating Des's cri-de-couer my colleague and I calculated the benefit rates and GP workload, together with "Numbers expected to be treated" (1)
Reference
http://www.pccj.eu/images/stories/CurrentIssuePdf/March_13_p32_Treatment...
The numbers expected to be
treated (NETT): a way forward in
CVD prescribing? Lewis, LS and Gollop ND. Prim Care Cardiovasc J 2013;6:32-36.
Competing interests: No competing interests
THankyou Des.
It will be interesting to see what effect the debate that has started has on the final guidelines.
Yesterday I was at the RED WHALE GP-Update Course. This was one of the key areas they covered. They made the point that NICE does not neatly separate Guidelines (evidence based) from Recommendations (Consensus based in the absence of clear cut evidence). This would be a really useful distinction for Drs, journalists, and the public.
Sadly, although they emphasised that the recommendation was to OFFER statins when risk was > 10% (primary prevention) there was nothing said about how an informed discussion with the patient might be had and the DRAFT guidance was very much presented as what we can be expected to need to do from now on.
Although I'm glad statins are available, where given an informed choice patients often choose not to be on a statin for the rest of their lives.
My experience is that patients at around 20% Risk of a CV event (coronary
events, stroke and TIA) presented with Patient decision aids (PDAs) showing that a 25% reduction in relative risk over 10 years means that 100 people like them need to take the statin for 5 to benefit is that they most often choose not to take the statin and focus on life style change instead.
Des asserts that there is not really any new evidence. If others assert differently I'd be interested in whether there is an increase in smiley happy faces on PDAs to go along with this changed recommendation (offer treatment form 10% CV risk upwards).
When using PDAs with patients I’m not swapping from an expensive but no better statin to a cheaper and just as effective statin. And so I don't discuss cost because there is no need to at that point.
And when I say no better this is in terms of Patient orientated outcomes (POOs) – clinically significant, as opposed to Data orientated outcomes (DOOs) where any clinical significance is speculation.
If there is no real new evidence and patients (Using PDAs) tend to prefer not to be on Statins, and cost is not an issue that factors in the decision (at this point) then the use of PDAs needs to be right at the forefront of NICEs final guidance/recommendations, whatever they set the threshold at.
As individuals we are not able to make our views known to nice, they only accept the views of organisations. I will be approaching my CCG to see if they will be submitting a response, though I can't say that at this time of year it is going to be a priority for CCGs to meet the deadlines for NICE Consultations above their other responsibilities.
Competing interests: No competing interests
So NICE are advising that most middle aged people should be taking Statins, even though only a small minority of them stand to benefit, and many will suffer from the side effects. Cardiovascular disease is becoming less common, especially in the non diabetic non smoking population, while cholesterol levels are not changing. Risk scores fail to predict which patients will develop CHD accurately. So putting huge numbers of people on long term medication is wrong.
History will surely judge that Des Spence is right and that NICE are is both biased, and wrong.
Competing interests: No competing interests
Re: Statins for all
Dr Spence points out the basis for the change in guidance is a re-working of existing data by the CTT Collaborators (1) who were allowed access to individual patient data on industry funded trials not otherwise released to the medical community.
Dr David Newman (Icahn School of Medicine at Mount Sinai) does a very interesting dissection of this paper on his (free, non industry sponsored) website: SMART EM via a podcast.(2) After digging into the appendices he eventually gets to the data the carefully worded conclusions are based on. Unsurprisingly the evidence is less than convincing.
I think this should be essential listening to allow us to help patients make an informed decision NOT to take statins for primary prevention.
Dr Spence asks what happened to scepticism and evidence based medicine? It is out there on the 'internet blogosphere' but you have to know where to look for it (3) and it struggles to compete with headline grabbing industry attempts to manipulate prescribing.
Thanks to the BMJ, Drs Spence, Newman and others like them for continuing to raise awareness of this problem. We need them to continue to help us sift through the raw data and not rely on spin doctor abstracts.
1. Cholesterol Treatment Trialists’ (CTT) Collaborators, Mihaylova B, Emberson J, Blackwell L, Keech A, Simes J, et al. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet2012;380:581-90
2. http://www.smartem.org/podcasts/smart-statins
3. http://www.thennt.com/
Competing interests: No competing interests