Statins for primary prevention of cardiovascular disease
BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g3491 (Published 27 May 2014) Cite this as: BMJ 2014;348:g3491All rapid responses
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"Clearly, much work needs to be done by general practices" ... "to convince people who think they are healthy to start long term statin treatment."
As a GP, I don't feel any particular urge to "convince" anybody to take statins for primary prevention; only to inform them of relevant facts, which includes informing them what the official NHS guidance says.
If patients opt for informed dissent, that's fine by me.
Competing interests: I work at a practice which is paid to prescribe statins to those deemed at risk of cardiovascular disease.
Starting statins
I would like to agree with and extend the points that Azeem Majeed has made on starting statins (BMJ 2014;348:g3491).
New American guidance proposes consideration of statin therapy at 5% 10 year CVD risk, recommending statin treatment at 7.5% and the NICE consultation recommends treatment at a 10% risk level.
About 60% of the UK population are at 10 year CVD risk of 5% or more, 33% at or above 10% CVD risk and 10% at 20% CVD risk or more.
There are a number of reasons why it may not be advisable to radically reduce the current UK 20% 10 year risk threshold for recommending statins.
BENEFIT TO RISK RATIO:
There is reasonable evidence that statins reduce CVD events down to a 7.5% risk threshold. However, the benefit to risk ratio is smaller at these lower risk thresholds and doubt remains about the net benefit at thresholds below 20%.
IMPLEMENTATION
To have a new recommendation requires an effective and equitable means of delivering such a programme. There are several reasons why this may not be possible. The previous programme which attempted to do this in the UK abjectly failed. In 2004 the DOH recommended statins over the counter at pharmacies to people at 10% CVD risk. Anecdotal information from Roger Boyle, national CVD lead at the time, said that only a handful of people ever accessed this and it has sunk without trace.
The NHS Health Check programme based upon the 2008 NICE lipid/risk estimation guidance adopted the recommended 20% CVD risk threshold. Uptake has been variable and below 50%. Treatment with statins in people at the 20% CVD risk threshold is reported as 20% nationally[1]. In Tower Hamlets where we have promoted the programme we have achieved 60% statin treatment in this group. It should be clear that the NHS Health Check programme, recommending statin treatment for 1 in 10 of the population at high CVD risk, and newly transferred to local authorities, remains in an early and somewhat fragile state despite new and enthusiastic support from NHS England.
Given the above difficulties, it seems inconceivable that a policy that will recommend systematic treatment for at least three times as many people has a hope of succeeding. In fact it is likely that this will undermine the credibility of the existing programme both because of the workload implications and also because most GPs will rightly doubt that this is an effective or proper use of scarce resources because there are other better ways of achieving the desired result.
THE POLITICS OF IMPROVEMENT
The real issue here is the politics of improvement. The choice is not simply whether or not people are treated with statins at 5, 10 or 20%. Exactly the same case could be made for lowering the threshold for antihypertensive treatment (and no doubt these calls will follow).
Geoffrey Rose and Julian Tudor Hart among others, correctly identified that a high risk strategy was complementary to population strategies – envisaging that primary care could deliver simple, safe and effective drug treatments to the top 10-15% of the risk distribution. But there is a tipping point and once we are talking about 30% of the population, most people would agree that we are talking about a population wide strategy and the question then is not whether or not statins or antihypertensives are effective, but what is the best way of preventing premature CVD events in the general population.
When we have to consider risk factor change in 30% of a population for which we have known and effective cures, then treatment after the damage has been done does not seem the best way to proceed – indeed it might appear as an abrogation of responsibility for not insisting on upstream change (JBS3 with their use of lifetime risk are also grappling with this population issue and coming up with medical solutions to ever younger people in ever greater numbers) - music Im afraid only for the pharmaceutical industry.
CVD morbidity remains on the scale of a war zone – let's end the war, we really do know how to do it. We have strategies without adverse effects, that are highly cost-effective and can be rapidly and equitably applied across the entire population.
1. Reducing salt in the diet through food industry legislation and effective labelling
2. Banning transfats
3. Further reduction of total and in particular saturated fats
4. Legislation and labelling on the addition of sugars to food and drink.
5. Alcohol reduction legislation and policies
6. Further legislation on smoking cessation
7. Safer cycling and walking environments
8. A rethink and investment in ways improvement in physical activity during normal daily activities and leisure.
We even have a NICE CVD prevention guideline that says all that and the public health response has been toothless (apart perhaps from smoking).
OLDER AGE
The other issue is one of age. The current NHS Health Check is quite openly ageist ending at 74 years when most people are above a 20% threshold and all are above 15%. As this group are collectively at such high risk there is a case to be made for extending treatment with low or standard dose statins to everyone 75 years and older without contraindications. Given resources, this could probably be accommodated in general practice as many are already being seen for treatment of one kind or another. Extending the existing threshold upwards in age, would be far more effective at reducing events than lowering the threshold that just treats more and more people for longer periods at younger ages. Has this been considered by NICE?
CONCLUSION
It is true that statins reduce CVD events at thresholds below 20% CVD risk and we can inform our patients that that is the case. But that is not the same thing as a requirement for a policy mandating their use. I do hope that NICE will pause for thought and ask – what is it we are trying to achieve? What are the options that are open to us?
Reducing the risk threshold is not the most effective option. It is not feasible to deliver this at a 10% level or below and it would undermine existing effective strategies by plunging GPs into a mire of controversy of which the claims by Krogsboll, the Daily Mail and many in the profession, are likely to be only the beginning.
The NHS Health Checks programme is emerging as a credible, effective and equitable vehicle for CVD prevention. A strategy that saddles it with an unachievable and controversial task may be a sack load too far. For those who would like to see these arguments very eloquently set out by the Americans on both sides of the argument, they should read, ‘The guidelines battle on starting statins’. NEJM 2014;370: April 24.
Politically there comes a point where to (to paraphrase Brecht) to talk of treatment is almost a crime because of the crimes it leaves unsaid. To allow the upstream causes of preventable disease to continue while convincing ourselves and our patients that mass treatment is a solution is unacceptable.
1. van Staa TP, Smeeth L, Ng ES, et al. The efficiency of cardiovascular risk assessment: do the right patients get statin treatment? Heart 2013 doi: 10.1136/heartjnl-2013-303698
Competing interests: John Robson chaired the NICE 2008 Guideline including recommendations to initiate statins at 20% CVD risk and he has promoted the NHS Health Checks programme locally and nationally. He was a co-author of QRisk. He also receives funding from the NIHR to evaluate the NHS Health Check programme
I had to look twice at the date to make sure this wasn’t a historical piece from the BMJ 50 years ago.
And then I shook my head in disbelief..
Thank heavens that the majority of the British public have enough individual common sense, wisdom and sense of autonomy to see through and reject the collective paternalistic coercion being embraced so energetically and so unthinkingly by those charged with caring for them.
Where exactly does "convincing" people who consider themselves to be healthy to take pills for the rest of their lives to show that GPs are complying with new guidelines and performance frameworks fit in the informed, shared decision making model of patient centred care?
Competing interests: reently involved in revising NZ guidance on CV risk assessment
Have doctors become drug pushers? Trying to persuade healthy people to take statins they do not need or want, drugs with serious side-effects, is truly shocking.
Why do doctors want to lower our cholesterol levels? It's a hugely important substance in the body and there is evidence that higher levels are protective (1). We seem to be stuck. Ansel Keys and his Diet-Heart Hypothesis were discredited many years ago when he fudged the results of his research. We need to move on.
We need to move on because some patients are becoming very sick from the side-effects of statins. It's agreed that muscle damage is one side-effect but the heart is the most important muscle in the body. Are patients dying from heart failure as a result of taking statins and how would we know? (2)
We need to move on because this folly is costing the National Health Service a huge amount of money. We all have to die of something and most of us would choose a heart attack over Alzheimer’s or cancer.
I'm a healthy patient who has recently had a health check and after receiving my blood test results said 'no to statins'. If I had a heart attack tomorrow I would still say 'no to statins'. If the bar is lowered so that doctors are required to offer statins to more patients, who really benefits?
References
DVD
'Statin Nation - The Great Cholesterol Cover-up' Rethink Productions Ltd
BLOG
Zoe Harcombe – www.Zoeharcombe.com/blog – Heart Disease 'The Facts'
JOURNAL
British Medical Journal - Adverse Effects of Statins
Dr. John Briffa – BMJ - http://www.bmj.com/content/348/bmj.g3306/rr/698720
Zoe Harcombe – BMJ - http://www.bmj.com/content/348/bmj.g3306/rr/699067
WEBSITES
www.statinnation.net
www.zoeharcombe.com
www.thincs.org
www.second-opinions.co.uk
BOOKS
Dr David Healy - 'Pharmagenddon'
Dr Malcolm Kendrick - 'The Great Cholesterol Con'
Gary Taubes - 'The Diet Delusion'
End Notes
1. Dr Uffe Ravnskov – see his first interview on the DVD 'Statin Nation – The Great Cholesterol Cover-Up'
2. See Dr Peter Langsjoen (cardiologist) & Dr Ragendra Sharma interviewed on the DVD 'Statin Nation – The Great Cholesterol Cover-Up'
Competing interests: No competing interests
Re: Statins for primary prevention of cardiovascular disease
I thank everyone who responded to my article. John Robson makes several important points that policy-makers, clinicians and managers should examine carefully. In response to Dylan Summers and Les Toop, the definition of 'convince' is "to move by argument or evidence to belief, agreement, consent, or a course of action". This implies that patients are given the evidence for and against the use of statins. Whether patients follow a course of treatment after being given this information is entirely their decision.
Competing interests: No competing interests