Statins, Statins Everywhere

The health of America is in trouble. Life expectancy is noticeably lower than in other developed nations, 15% of the country lives precariously without health insurance, and the launch of Obamacare was so badly botched that this much-needed health reform is in serious jeopardy. Not to worry, though, the American Heart Association and the American College of Cardiology have a plan that will rescue the health of the nation: put a third of US citizens on statins – that ought to do it!

The new guidelines, released last month was widely reported in the UK press. The Mail misleadingly called the publication a new study rather than a set of guidelines, while the BBC gave a more measured view, including a revealing statistic that roughly half the expert panel had financial ties to the makers of cardiovascular drugs. What is worse, while the panel’s conflicts of interest appear to be clearly presented, with neither the chair nor co-chairs having conflicts, the superb investigative journalist Jeanne Lenzer has discovered that the chair in particular has been rather misleading with declaring his own interests. The protestation from the AHA spokesperson Dr George Mensah that ‘It is practically impossible to find a large group of outside experts in the field who have no relationships to industry’ is hard to swallow. In a country with as many specialists as the US? There were only 15 members on the panel – is it really that hard to find experts without financial ties? Or is it harder to tell some Key Opinion Leaders that their much vaunted opinions are not welcome since they are too close to industry?

The major change to the guidelines is that there is less emphasis on absolute levels of cholesterol, and a new category for treatment in those aged 40-75 with an estimated 10 year cardiovascular risk of 7.5%. Current UK guidelines recommend treatment at 20% risk, but NICE say they are looking at the same evidence as the US, before publishing new guidance next year. Despite the important debate in the medical press about overmedicalisation – spearheaded by the BMJ’s excellent Too Much Medicine series – we can expect a lowering of treatment thresholds when NICE issues its verdict.

The problem with the way we present guidelines, though, is that they are far too black and white, when the world of medicine we inhabit with our patients is generally full of grey. The question we should be asking is not what the threshold should be for treatment, but how to empower patients to make their own, informed decisions – because ultimately, the level of risk a patient is prepared to accept before they take a tablet is a personal decision, and a panel of experts has no authority to tell patients what risk they should, or should not take.

If we use the 7.5% cut-off, for instance, and assume that taking a statin for 10 years would lead to a 50% reduction in significant cardiovascular events (which is likely to be a gross over-estimate). This means that 3.75% of patients would avoid an event by taking the drug – call it 4% for ease of maths – and 96% would not benefit. The number needed to treat (nnt) is therefore 25 to avoid one event. What will our patients think about this? Surely that is entirely subjective and not for experts to dictate? One patient may have seen a close family member affected by a devastating stroke and might think any ability to reduce the risk of stroke is an opportunity to be grasped, another might consider the 3650 tablets they would have to swallow over 10 years and wonder if a 1 in 25 risk is really worth trying to avoid. In reality, the benefits of statins are much smaller than a 50% reduction, and so the nnt for low risk patients is likely to be 50, 100 or even higher.

We need a different approach to guidelines, one based on nnt, and the corresponding number needed to harm (nnh) (like this excellent calculator from ClinRisk Ltd. There should be a lower level below which the NHS says treatment is not justified on the grounds of either harm or rationing, and then a range of nnt and nnh based on individual risk. Expert panels should analyse the evidence to provide these figures, not to tell people what to do, and doctors and their patients can be given the freedom and flexibility of a large area of grey,  in which they can personalise treatment and truly empower patient choice. The experts and policy-makers won’t like it though – because it involves trusting patients, and we’ve never quite mastered how to do that.

This article was originally published in Pulse magazine (free registration required)

Quick Post: Best not wash your pills down with grapefruit juice

Food-related health scares usually involve a tenuous link with either cancer or heart disease, and the associated headlines warning us to avoid the offending substance, or eat it by the bucket-load, are usually best ignored. The recent news reports concerning grapefruit juice, however, are worth heeding.

Grapefruit juice is good for our health, being low in fat and high in both fibre and Vitamin C. It does, however, contain a chemical which can affect the way our bodies handle certain medications – in particular some statin drugs used for cholesterol, and blood pressure tablets called calcium channel blockers. The result of this is that the tablet stays in the system much longer than it should, and to wash your pills down with a glass of grapefruit juice could have the same effect as taking an over-dose. While doctors do know about this problem, it probably needs to show up on the radar more often both for doctors and their patients.

The list of medications affected can be found here, and a pharmacist would be the best source of information for anyone who wants to check if their own tablets are affected.

Finally, I do feel obliged to make a declaration of interests here: I really do not like grapefruit – I wonder how I’d feel if it were orange juice?

Statins – Time to Change the One Size Fits All Approach

Let us assume for a moment that you have a spare £10 000 that you wish to invest. This is unlikely in these times of austerity, I grant you, but it would help if you could suspend your disbelief for just long enough to follow through the analogy. You decide to seek the advice of an esteemed independent financial advisor and present your happy situation to her. I suggest you would be somewhat startled if she took note of your age, gender and postcode, considered the size of your investment and then wordlessly consulted a set of tables compiled by the National Invest your Cash Emporium (NICE for short), nodded wisely and declared: “The guidelines recommend the Futures Market – copper in fact – sign here and it’s all done.”

Startled enough to take your money elsewhere, I suspect. Of course a good financial advisor would do no such thing. She would ask how you feel about investment and risk; is this really spare money and you could cope without if stocks went ‘down as well as up’; or is it your life savings that you just need to keep safe for a year or two before you splash it all on the holiday of a lifetime when you retire? In short, you would be at the centre of things, saying what is important to you, relying on the specialist knowledge of the expert, but taking charge of the decisions you make.

What happens, then, when you take the somewhat less desirable burden of cholesterol readings, blood pressure records and family history to the doctor, seeking to invest in your own future health? Well, the doctor will take note of your age, gender and postcode, consider the size of your cholesterol, blood pressure and cigarette packet, and then wordlessly consult a set of tables compiled by the National Institute for Clinical Evidence (NICE for short), nod wisely and declare: “The guidelines recommend a statin, here’s a prescription, you can pick it up next door.”

At least that’s the essence of what the NICE guidelines tell us to do. In reality a good GP will add a much more human touch than this, and try their hardest to incorporate the patient’s perspective, but this is more in spite of rather than because of the guidelines, and patients can all too easily feel like they are being railroaded into taking treatment they are not sure about.

The guidelines state that: “Statins are recommended…for adults who have a 20% or greater 10-year risk of developing cardiovascular disease.” Recommended is a strong word for both doctors and patients. For doctors it makes us feel we are negligent if we don’t prescribe, while patients are left to feel that in going against guidance they might be taking foolhardy risks with their health. There is some leeway in the NICE report – it states that the decision whether to prescribe or not should be taken: “After an informed discussion between the responsible clinician and the individual about the risks and benefits of statin treatment, and taking into account additional factors such as comorbidities and life expectancy.” – so there is some room to discuss risks and benefits, but the factors we should take into account are comorbidities (other health problems) and life expectancy – no mention of the patients feelings or preferences.

We are all wonderfully different with a richly diverse range of feelings and preferences. When it comes to financial investment some of us are happy to take big risks if there is a chance of real gain, taking a nothing ventured… approach to life. Others are more cautious and will always play safe, still others trust no-one and would rather invest in a burglar alarm and better locks while hiding their savings under the mattress. So too with health. For some, the risk of stroke is paramount and even a 10% risk over the next 10 years seems too high. If a tablet might reduce that risk then they’ll want to give it a try. Others are more cautious with tablets and hate the idea of being on them, they’ll take them if they have to, but would really rather not, while still others have a fatalistic view of life – if a stroke will happen then it will happen, just don’t bother me with pills. None of this is wrong, and is something to be celebrated rather than ignored and hidden away.

A study published in The Lancet hit the news last week with the suggestion that more healthy people should be prescribed statins for cholesterol, and there were calls for NICE to lower the guidance threshold from 20% down to 10%, but this misses the point – who are NICE to decide what sort of risk you are willing to take? There may be a risk below which the NHS is not willing to fund treatment, but other than this NICE should present the evidence in a way that enables doctors to help patients make informed choices about their treatment without pressure to conform or be a good citizen for the sake of population statistics.

Importantly, for an informed decision to be made, the statistics need to be meaningful – which means absolute risk reduction, not relative risk reduction. Newspaper headlines and enthusiasts love relative risk measurements – they are far more exciting – but sadly they are often highly misleading. For The Lancet study the relative risk reduction is the same whatever your actual risk of heart disease – for every 1.0mmol/l fall in cholesterol there was a reduction in the risk of heart disease of just over 20% for all categories of patient. Hence the headlines excitedly stating that healthy, low risk people stand to gain as much as those at high risk. The trouble is that a 20% reduction in a small risk does not amount to much. If your risk of heart disease in the next 10 years is 30% then a 20% reduction is 6% absolute risk reduction – so 6 people in every 100 treated will not have a heart attack or stroke who would otherwise have had one. However, if your risk to start with is only 10% then to take the same statin for the same period of time will only give a 2% absolute risk reduction – or 2 people in 100 benefitting. The question is, what is the risk that works for you?