Combined Oral Contraceptives: Old Scare, New Data

I vaguely remember the pill scare of 1995; acres of media coverage, scary headlines and confused messages – I recall thousands of women stopping their contraception overnight for fear of a clot forming by morning, and scores of unplanned pregnancies as a result – but then maybe the way the statistics from the fallout were reported was as unreliable as the reporting of the science behind the original story. I was working as a junior doctor on a medical ward at the time; I didn’t need to think that much about contraception which might account for why my memory is hazy.

There was another pill scare this weekend, and I’m glad to say that there wasn’t too much media hysteria this time, but the story is still important and it will have caused many women to double-check their pill against the list in the newspaper – some will have been relieved to find their chosen brand to be in the clear, and other will be wondering what it means for them. The Mail, of course, couldn’t resist using the word Deadly’ in its headline, and relished the idea of ‘Every GP in Britain’ being told to do something, but the print of the article was reasonably measured, perhaps reflecting the fact that this is not a new story; far from it, there was no new research here, just an updated review of what we learned back in 1995 and some slightly adjusted figures.

It’s not bad to be reminded, though, that the contraceptive pill, like every other medicine we ever prescribe, is not entirely risk-free, and that both the risks and benefits of the pill do vary slightly with the brand. The review, by the European Medicines Agency, looked at the risk of blood clots, both in veins (Deep Vein Thrombosis or DVT and Pulmonary Embolism or PE) and arteries (stroke), which are two of the biggest safety concerns associated with the combined pill.

The first thing to say is that the risk of a clot is only increased with combined pills that contain oestrogen and progesterone (usually taken for 21 days followed by a 7 day gap), and that there is no risk of clots associated with the mini-pill, which contains progesterone only (eg Micronor, Cerazette or Cerelle) and are usually taken daily without a break.

We have known for a long time that the combined pills increased the risk of DVT, but what was new information in 1995, and caused the scare, was that the risk was different with different pills. At that time evidence emerged that older pills, like Microgynon, were safer than the newer pills, like Marvelon. Most women found that the older versions suited them just fine, but some women felt better on the newer pills – perhaps their skin was in better condition, or they had less PMT – and so these had become quite popular. What ensued nearly 20 years ago was a rather panicked move away from these pills, before the pendulum reset itself as people realised that the increased risk was not that great, and having good skin or not turning into a growling  bear on a monthly basis was actually quite important.

More recently there have been newer pills still – Yasmin being the most notable example – that promised to suit women even better than the older ‘new’ pills. There is no doubt that doctors and patients have been swayed a little by the idea that these pills are somehow ‘more feminine’, when actually most women feel no inhibition to their sense of womanhood on the tried and tested varieties, and the newest pills also seem to carry the slightly higher risk of DVT.

So what are the risks? Well the important thing here is to pay most attention to the absolute risk linked with each pill, and for each woman to ask if that is a risk she is prepared to take in order to find a reliable contraception that suits her. The headlines often quote the relative risk – ‘They are believed to double the risk compared to older varieties’  is more eye-catching than ‘About 1 in a 1000 women will develop a DVT’. While comparing the risk between different pills is important in deciding which pill to try, once you have decided which pill to use the fact that there might be a less risky pill out there becomes an irrelevance – what matters is whether you are comfortable with the level of risk attached to the pill you are taking.

The EMA review, therefore, is a useful reminder that no woman should start the combined pill without a discussion with her doctor about the risk of DVT, and that we should always start with the lowest risk pill unless there is a very good reason not to. It is also instructive to look at the estimates of risk given in this new review, as they are higher across the board (even for women who are not on the pill) than the estimates currently provided in the British National Formulary that most GPs in the UK will be using. I have tabulated the figures below for comparison – and I shall now be converting to the EMA figures, since I would always rather over-estimate a risk like this than under-estimate it.


The worst risk, therefore, is 120 per 100,000 – which is not insignificant, although it is worth remembering that this still means that 99,880 women out of every 100,000 on the highest risk pills will not get a DVT. The risk will also be lower if you have no risk factors – such as a family history of DVT/PE, smoking or being significantly overweight. When a DVT does occur it is usually in the first year – which supports the fact that if you are already well established on one of these pills there is no need to panic, and certainly no reason to stop the pill without first speaking to your doctor.

A final note about arterial clots (stroke); this was also reviewed in the EMA report, and although they did not report on the absolute risk other than it being low, it was reassuring that there was no difference in the rate of arterial problems between the different pills.

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)

The Polypill – Holy Grail or Fool’s Alchemy?

The Daily Express headline of an all-conquering Polypill waiting in the wings, ready to save thousands of lives and rescue the NHS finances, has become almost an annual event. This year’s offering is no disappointment, and its particularly misleading headline –Ten pence pill could help you live 8 years longer was rewarded with a front page spread.

The study that provided this exciting headline was based in India, and compared the use of a single combination pill with usual care for patients with established heart disease, or felt to be at risk of heart disease. The combination pill contained aspirin, simvastatin for lowering cholesterol, and two blood pressure drugs – lisinopril and either atenolol (a beta-blocker) or hydrochlorothiazide (a diuretic). Far from showing any reduction in heart problems, however, the study actually only demonstrated  increased adherence to medication in the treatment group, and a modest reduction in systolic blood pressure and LDL cholesterol compared with the control group. There was also the slightly awkward bias in the study whereby the treatment group received their medication for free, while the control group had to pay for any medication they received – a factor which could surely account for all the study findings at a stroke.

Whenever I hear of yet another study involving the Polypill, I find myself wondering why on earth they bother. Even if they finally break the mould and actually demonstrate benefit that means something to patients – rather than just improving the numbers that doctors measure – are GPs and their patients really going to want to start taking the 4 in 1 pill?

If you needed to be on that exact combination of tablets then there is no doubt that to swallow one pill rather than 4 would make life easier, but does this outweigh the downsides of coupling together 4 very different drugs into one preparation? None of these tablets will make a patient feel any better – they are only used to reduce the risk of something happening in the future, such as a heart attack or a stroke. The biggest issue when starting them, therefore, is side effects. No side effects is the goal, but what are the chances of someone having no side effects if they start 4 drugs all at once? And if they do get a side effect, how are they to know which tablet is causing it?

Some side effects are typical for a type of drug, an irritating cough can occur with lisinopril for instance, and so the doctor may well be able to guess the culprit – but a side effect with even one component in the Polypill will mean having to divide it into its constituent parts and start again. The prospect of having to unpick this magic medicine on a regular basis does not fill me with enthusiasm.

Then there is the need to respond to the ever-changing face of medicine. Aspirin, for instance, was used extensively in patients who were thought to be at risk of heart disease, but more recently the advice has changed to only use it in those with established disease. In fact the twists and turns of advice for this particular drug has an extensive history which caused me to write an early post in this blog. All it would take would be for the advice to change once more, and patients on the Polypill would need to be recalled, with their medicines changed, resulting in all the attendant uncertainty, anxiety and confusion that inevitably accompanies changes in medication.

The current direction of travel in healthcare is towards personalised medicine, with an emphasis on tailoring a drug cocktail to match the exact physiological needs of an individual’s biology. While I would prefer that there was an equal focus on tailoring medications to an individual person’s informed choice and preference, it can only be a good thing to try to personalise treatment in this way. The Polypill seeks to take us in the opposite direction and I remain deeply sceptical about any benefit it may have for our society.

The researchers behind this work are boundless in their enthusiasm, however, and so future studies will no doubt pop up from time to time  – well, at least it keeps a journalist employed at The Daily Express!

10 Minutes for the Patient

Mr Jones comes to see me. He is only 62, but has high blood pressure, had a stroke two years ago and still has a noticeable limp as he walks down the corridor to my room. Like most patients, Mr Jones knows that he has 10 minutes for the appointment and has spent the time in the waiting room wondering how best to use it. His knee has been bothering him for a while and he has decided it is time to bring this to my attention, but he also knows that his review is due and he won’t be able to leave my room without having had his blood pressure taken.

What Mr Jones really wants to talk to me about, though, is that he’s been having trouble maintaining an erection. He’s not quite sure how to broach that subject, so he plays safe, taps his knee as he sits down and opens with ‘It’s this, doctor. Giving me some trouble, that’s the main thing.’

Like any good GP I clock that if the knee is the main thing then there must be something else as well, and make a mental note to come back to that later – but his blood pressure check is flashing on my computer screen, vying for my attention.

We talk about the knee for the first minute of the appointment, and then I reach for the blood pressure cuff. There is a good reason to tackle this first, since getting him up onto the couch to examine his knee might adversely affect the reading. The numbers are the same as last time – 145/85 – which is a bit awkward, as six months ago this was ok, but in the meantime the Government has changed the goal posts. Now the target is to get blood pressure below 140.

2 minutes

We spend a couple of minutes talking about this, discussing his medication and why we might need to increase his treatment. Since he’s not keen on extra medications – and I’m not convinced about the new target – we decide that he will borrow one of the practice machines and check his blood pressure at home. I wonder if I have just put the problem off for another day.

4 minutes

The amended blood pressure target is not the only new directive to be imposed by the Department of Health this April, so there are more boxes to tick before we can get back to the knee. There’s the new activity questionnaire for starters. Making some assessment of exercise has its place, but I am now required to ask the same questions of all patients with hypertension, however appropriate – or not – it might be. It seems wrong when I ask Mr Jones how much vigorous exercise he undertakes, and he becomes defensive when I enquire how many hours per week he spends doing housework, but we battle through. The advice we receive on the administration of the test states that it takes 1-2 minutes to complete; by the time I have added advice to do more exercise, and received the inevitable reply that this is not easy with only one good leg, that’s a fifth of his appointment.

6 minutes

We return to more familiar territory – I need to ask about smoking – we both know we’ve been here before when I ask if he’s still smoking. He shakes his head and replies: ‘Not the right time, doc.’ The expression on his face asks why I keep going on about it, when he’s made it quite clear he has no intention of giving up.

‘Have you any concerns about your memory?’ Mr Jones is a little taken aback, as he’s not heard this one before, but he is in an at risk group for dementia and so this is the question I am required to ask. It could have only taken a moment – a simple ‘no’ and we move on – but who doesn’t sometimes forget things? Mr Jones occasionally goes into a room and forgets what he’s gone there for – is that what I mean? It takes a little while to explore this further before we both decide that he is not showing early signs of dementia. He taps his knee.

8 minutes

There’s a blood test to sort out. He’s on a statin for his cholesterol, and although the guidelines I read tell me not to perform regular cholesterol checks once treatment is stabilised, the GP contract insists that I check it annually. Still, I like to keep an eye on his kidney function so it’s not entirely wasted. The forms take a while to print out.

‘Do I have to fast?’

‘No, that’s ok’

9 minutes

There’s not enough time to get him up on the couch to examine his knee properly, but I know he’ll need an x-ray to look for arthritis so I do a quick examination in the chair and print another form for him.

10 minutes

I have forgotten that the knee was only the main thing and make it clear that the consultation has ended. Mr Jones leaves with the forms. He’s happy with the x-ray, but he’ll have some explaining to do for Mrs Jones when he gets home. He’ll say the doctor was very busy and promise to ask next time.

The 10 minutes belong to the patient.

We need to give them back.

Mr Jones is not a real patient, but I know of many who share some of his frustrations.

A Hiccup for the Health Check-Up

Scientific data can be a real headache for politicians, especially when it has an irritating propensity to directly contradict flagship Government policy.

This is exactly what happened last week, when a Cochrane review published the results of a meta-analysis on the efficacy of Health Check-Ups, which was widely reported by the BBC and others. The review looked at the effects of health screening in over 180 000 patients, and concluded that while those screened were more likely to be diagnosed with high blood pressure or raised cholesterol than those not offered the check-up, there was no difference in mortality, hospital admission or disability between the two groups. The review concludes:

From the evidence we’ve seen, inviting patients to general health checks is unlikely to be beneficial.

The problem for politicians is that this is undermines a key health policy from the Department of Health which involves inviting all people aged 40-73 to a health check to look for the risk of heart disease, stroke, type 2 diabetes and kidney disease. And this includes politicians of all the major parties – the policy was introduced by the Labour Government and has been continued by the Coalition.

What should we make of this? Aren’t we used to contradictory scientific headlines telling us that something is terribly good for us one week and causes cancer the next? Well, how hard we should listen depends on the quality and type of evidence before us. A small observational study is a very different piece of evidence to a large randomised trial, or a systematic review of all the evidence. I have borrowed an illustration from Margaret McCartney’s book The Patient Paradox which illustrates this well. It is a hierarchy of the quality of evidence, with the most reliable being at the top:

Cochrane reviews are not only at the top of this hierarchy as a systematic review, but they are also renowned in medicine as being among the most reliable, unbiased reviews that are conducted. They are important, and we should listen to them. Which is exactly what a Department of Health spokesman did not do in response to this important research. When questioned by the BBC, the response was to say:

By spotting people who are at risk of heart attacks, diabetes, stroke and kidney disease we can help prevent them.

The NHS Health Check programme is based on expert guidance. Everyone having a health check is offered tailored advice and support to manage or reduce their risk of developing serious health conditions.

So the power of a Cochrane review has been dismissed on the basis of expert evidence. When you look at the above hierarchy it is easy to see how ridiculous this is – it is like pretending that a pair of Jacks can beat a Royal Flush, it just does not work.

So where does this leave us? Well for the Government the situation is clear: Inviting large numbers of healthy people for routine health check-ups has no discernible benefit and the Department of Health programme should be reviewed. The main reason for this is that since it is of no discernible benefit, it is poor use of NHS funds. The checks themselves still need to be better evaluated, but they are not unreasonable – if you are going to have a check-up then to look at the 4 disease areas in question once every 5 years is probably the thing to do.

The organisations that really need to take note of this study (but they are unlikely to do so as they make too much money from health screening) are the private health providers like BUPA, which offer annual health checks that are far more wide-ranging than the NHS scheme – including many tests which are of zero value (such as measuring urate, the waste product implicated in gout which is uninterpretable in a person who does not suffer from gout) and others which are extremely controversial (such as prostate screening).

For individuals, however, we need an individual approach. When the Government first announced the proposal to invite people for check-ups most GPs felt mildly bemused – hadn’t we been doing this for years? You can always see your GP for a blood pressure or cholesterol check and the only thing that was different in the new policy was the invitations. There may be good reasons to assess your risk of conditions such as heart disease or diabetes, especially if there are particular concerns, such as a strong family history.

We must remember, however, that health check-ups are, by definition, performed on people with no symptoms. When we engage in health screening of any sort we cross a line that transforms us, temporarily, into a patient. We hope that this will be the briefest of forays into this alien world and we will soon return to our lives, unscathed, stamped with a clean bill of health and medical approval. We must always accept, however, that we may just remain a patient for longer than we have envisaged if a problem is picked up. This may have real benefits – such as avoiding a heart attack – but will also incur personal costs, including anxiety, more tests and the possibility of unnecessary treatment.

There is still a place for individual health check-ups, but these need to be tailored to individual risk, and also our personal views on how we like to deal with risk. We need to get away from the concept that every upright citizen “ought to have a health MOT”. We are not cars in need of a certificate of roadworthiness, and health screening is a complex issue: Its benefits are often far smaller than we first realise, and its potential for harm far greater than we like to admit.

Healthscans: A Lifeline for Patients, or a Cashline for Private Medicine?

One of the questions I am most frequently asked by patients and friends alike (and I am sure most other GPs would say the same), is what I think about Lifeline Health Screening, and so it is high time I gave the matter some attention. I am not the first to write on this subject (Margaret McCartney has been one of the most effective voices on this issue, and the UK National Screening Committee has produced excellent advice leaflets on private screening), and I hope I will be far from the last. Given the effectiveness of the leafleting and advertising campaign of the company involved, the majority of us will have come across their products several times over, and we need to balance such effective marketing with regular comment from as wide a range of doctors as possible.

I try to retain a sense of balance on this blog, but having come at Lifeline with an open mind, I find it increasingly difficult to find anything in favour of the tests they offer, and am extremely concerned about their approach with regard to how they advertise themselves, and the (complete lack of) support if the test results are abnormal. Their website claims that an “easy and painless package of screenings at £139 can help put your mind at ease.” Well the tests are easy to perform, and painless (they state these facts again and again on the site, and there is no doubting these facts), but the statement is highly misleading. The most significant pain associated with any screening test is related to what you might do if the test is abnormal – for instance, they screen for abdominal aortic aneurysm (an enlargement of the main artery to the legs), and the main treatment for this is major abdominal surgery – not exactly a painless event. The assertion that the £139 will “put your mind at ease” also assumes that the tests are going to be normal. Most of us don’t have sleepless nights worrying that we might have a stroke – but if we are told that the artery to our neck is partly furred up, “at ease” is probably the last thing we will feel.

So what of the tests? Well their main package involves five tests, as well as a lipid profile and blood glucose (which are the most useful tests they offer, but your GP will happily do these when needed anyway). I’ll look at them in turn:

Carotid artery screening The test involves a scan of the main artery to the brain to see if it is narrowed by cholesterol deposits. This is useful in patients who have had a temporary stroke (transient ischaemic attack) as they are at high risk of a second, more permanent stroke. If the artery is sufficiently narrowed then sometimes surgery to remove the narrowing can significantly reduce the risk of further strokes. As you can imagine, though, operating on the main artery to the brain is a risky business, and so you would only want to undergo this if your risk of stroke outweighed the risk of surgery. For people without symptoms this is just not going to be the case. There’s a fair chance your GP would feel obliged to refer you to a surgeon, who would advise that you shouldn’t have surgery! What would be more worthwhile would be lifestyle changes – don’t smoke, a healthy diet, possibly attention to blood pressure and cholesterol – but you don’t need a carotid scan to work this out.

Atrial Fibrillation (AF) and stroke risk The test involves a limited ECG to see if your heart rate is irregular, which would put you at risk of stroke. AF is an irregular heart rate, and is generally worth knowing about (although the risk of stroke is only really a problem in the over 75s or those with other health problems which you and your GP will already be aware of). The main issue here is that you don’t need an ECG to screen for AF – the company are hiding behind technology. Your GP can easily exclude AF by simply taking your pulse and seeing if it is regular (and will then arrange an ECG if it is not).

Peripheral Artery Disease The test involves measuring ABPI, which is basically the blood pressure in your legs. It is useful in people with symptoms, but completely meaningless in people without – like the carotid artery screening it would simply be a pointer towards lifestyle measures and you would never want to consider surgery to improve the circulation to the legs without symptoms.

Aortic Aneurysm Screening This scan looks for a weakness of the main artery to the legs, called an aneurysm. The main concern about aneurysms is that they can rupture, which is a sudden and commonly fatal event. Small to moderate aneurysms are usually left alone, but a large aneurysm can be repaired surgically. This is a major operation with significant risks involved, and the evidence in favour of screening being more beneficial than harmful is only for men over the age of 65 – a screening programme which is being rolled out in the NHS anyway.

Osteoporosis Screening This has all the hallmarks of “We’ve got a scanner, what else can we do with it?” It’s the wrong test (a heel scan, which is only a test to see if you might need another test), being performed on the wrong people. This condition relates to how our bones become more brittle as we get older, and so more prone to fracture. If you are at high risk of fracture (eg you have had a fracture already, have coeliac disease or are a post-menopausal woman with a family history of osteoporosis) then you may well want to consider having treatment with medication to reduce your risk – but if this is the case then your GP can arrange the proper test, which is a Dexascan.

Worst of all is the aftercare once you have had your scans. No doubt to cut costs the test results are simply forwarded to your GP, who is left to deal with the interpretation and emotional fallout from abnormal test results. All too often private companies are able to pick up the financial benefit from screening and leave the real cost to the NHS, and Lifeline Screening UK Ltd are far from alone in this practice – Spire Healthcare do the same with their Lifescans, and company medicals have been doing it for years. It is high time that we started seeing screening tests in the same light as any other medical intervention – capable of both benefits and harms – and regulated them accordingly. The onus should be on the company to prove benefits outweigh harms before they are licensed to offer screening tests to the public – but maybe then they would just be left with the tests the NHS already offers, and where would be the profit in that?

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?

On Shrinking or Growing

We doctors like to think that each day brings another stream of contented patients, leaving our rooms with their health bolstered by the edifying power of our erudite and well-considered advice. And maybe each day a few do just that. We know, however, that lives are far more complex, that the doctor only plays a minor role in any individual healing journey – and that the patient may play no small part in the journey of the doctor also.

“Our patients are our greatest asset,” was what my former senior partner, Chris Jagger, said to me when he invited me to join the practice over ten years ago, and the longer I have been in General Practice the more I have understood what he meant – that the people I am meant to be helping will have an important role in teaching me and shaping me as a doctor.

One such lesson, which I come back to again and again, happened a year or so ago when a patient said to me: “When something bad happens to you, you can shrink or you can grow – and you do have a choice.” These wise words are well worth holding on to, storing somewhere safe and retrieving whenever the need arises.

They say that you can’t tell if a bridge is well made when a cat walks over it – but if a train crosses the same bridge then it has been well and truly tested. The woman who gave me this gem of wisdom has experienced the odd express train over the years, and so I know that this advice is born out of real life rather than the theoretical musings of someone who has never known adversity.

I have just come across a powerful example of someone choosing to grow despite impossible circumstances when I read The Diving-Bell and the Butterfly by Jean-Dominique Bauby – a book that I would recommend to everyone as a remarkable source of inspiration and hope. It is only 135 pages long and consists of short, disjointed chapters with no sense of a plot and so it makes an unusual read, but it is compelling nonetheless.

The book is the account of its author about life with “locked-in” syndrome. This aptly named, profoundly tragic condition occurs when the brainstem is devastatingly destroyed – usually by a stroke. The brainstem is the connection point between the thinking part of the brain and all the body’s functions. A person with locked-in syndrome can think, hear, and see, but cannot speak or move. Conscious yet totally paralysed – this is no ordinary express train to test the structure of your bridge. A stroke was the cruel force behind Jean-Dominique Bauby’s reduction from Editor-in-Chief of the French Elle magazine to locked-in patient at the frighteningly young age of 44. He had only the slightest residual movement – he could blink his left eyelid – and with this he communicated with the outside world, and ultimately dictated this book.

What is remarkable about the book is the author’s lack of bitterness and the strong sense of hope that permeates its pages. Bauby is honest – he does not hide the reader from the pain, frustration and humiliation inherent in his situation – but he has a determination to see the beauty of little things that we don’t normally notice, the ability to dwell in the moment and seize every opportunity to bring a richness to his existence – using his imagination to take him to places that were denied him when he was free to roam. For someone who could apparently do nothing, he was always busy – seeing, thinking, listening, and latterly composing, reworking and memorising the chapters of this beautiful book, ready to laboriously dictate them the next morning.

When someone shows as much courage in diversity as Bauby has shown there is a danger that the inspiration we might receive is tempered by a deep sense of inadequacy by comparison. Here, Bauby helps the reader to stay connected to him by making it clear that he is far from a perfect saint. He is open about his own inadequacies, particularly from before his illness, and you get the impression that he would have been hard to live with at times. He laughs at himself, cracks bad jokes and never gives up hoping for a cure. You feel that you can relate to him – here is a normal guy who has learnt, for the most part, to hold on to that most human of traits – hope – and choose to grow despite it all.

In our success-driven modern world we like to live our lives pretending that adversity won’t happen to us, but if you work in health-care you are reminded daily that it frequently does – and so I commend this book to you, and I will hold on to my patient’s advice. I only hope that, with God’s help and grace, I will always be able to choose to grow when I have the opportunity.

The Life and Times of Aspirin (a drug that just can’t keep out of the News)

If you are going to keep a medical blog, you will need to write about aspirin sooner or later. The medical profession’s love affair with this oldest of pharmaceutical agents has had more twists and turns to it than even Elizabeth Taylor and Richard Burton could achieve. One moment it is a wonder-drug that we should all be taking, the next it is at the centre of the latest health scare to hit the headlines. The last twenty-four months have been no exception.  The Telegraph, for instance,  has published several articles – some of which have eloquently expounded its potential benefits , such as cutting the risk of bowel cancer, and that all people over 45 should be taking it; while others have argued that it is of no benefit at all  in healthy people who are healthy, and – the latest concern published only last week – that it might be linked to blindness.

Aspirin certainly has a long history. It was first purified as acetylsalicylic acid in 1856, and acquired the trade name Aspirin in 1899. Bayer, the company who first marketed it, obviously had a less efficient patent department in the 19th century than they do these days, as they lost the exclusive right to sell the drug under the Aspirin brand – and so it became the widely used name by any manufacturer. Its popularity grew in the Spanish Flu epidemic, as it proved to be one of the few medicines at the time that actually worked, and it remained unopposed in the anti-inflammatory market until the development of paracetamol and ibuprofen in the 1950’s and 60’s. This might have signalled its demise, but by the 1980’s this multi-faceted drug was found to have anti-platelet properties that meant it could work to prevent blood clots from forming – opening up a huge market in the area of prevention of stroke and heart attack.

Aspirin has had its problems along the way – like any drug that really works, it also has the potential to cause real side effects. In the 1980’s a strong association came to light between a rare, but potentially fatal, condition in children called Reye’s Syndrome. Although we cannot prove that aspirin was the major cause of this condition, there was a stong association and the incidence of this disease fell to a fifth of its previous level within five years of 1986, when it was recommended that aspirin should no longer be given to children under the age of 16.

For adults, the major risk of aspirin has always been bleeding from the stomach and stomach ulcers. This is well established, and the major reason to think twice before taking it. In a healthy individual the risk of bleeding is not great – it approximately doubles if you take aspirin, but if you double a small number then you still get a small number. The reason for considering this risk very carefully, however,  is that the benefits quoted for aspirin are also often very small. For instance, the benefit of taking aspirin in preventing colon cancer (from the article above) is quoted as a reduction of the risk of developing colon cancer by a quarter. The Professor who conducted the research recommended that people should take it in their 40’s and continue until 75. Well, according to Cancer Research UK the lifetime risk of developing colon cancer is 6.9% in a man and 5.4% in a woman, so if I reduce this by a quarter I would have figures of 5.2% and 4.1% respectively, which means that if 100 people took aspirin for 30 years, as recommended, we could expect between 1 and 2 of them to not get colon cancer who otherwise would have developed it – the other 98-99 either will get colon cancer despite the aspirin or would not get it anyway. Well that is a benefit – but it is a small benefit, and so the small extra risk of bleeding from the stomach starts to seem more important.

And what of the latest study showing a link with blindness? Well The Telegraph rightly points out that this is a an observational study, and so does not demonstrate any causal link. The researchers noticed that people who took aspirin regularly were twice as likely to develop an eye condition called wet macular degeneration (a serious eye condition that can cause blindness) than those who did not. There may be several explanations for this, however. For instance, people generally take aspirin for a good reason – such as a history of heart disease or stroke – and it could be that the causal link is more between these conditions and the eye condition, than the aspirin itself. We must always be very wary of drawing conclusions from observational studies – they are mostly useful as a guide for where to do further research.

Observational studies are rather like those ingenious geophysicists in Channel 4’s archeology programme Time Team. Walking up and down the dig site with their high-tech equipment (that looks unnervingly like an upturned television aerial) they produce exquisite pictures of coloured dots that help Tony Robinson and his team to know where to dig their trenches – but that is all they do. Until the trench is dug and they actually see what is under the ground the geophysics is only ever speculation. So with observational studies – they point us in the right direction, but rarely prove anything and so should rarely change our practice.

The main reason to take aspirin remains its effectiveness at reducing the risk of stroke and heart attack. This is well established, with hundreds of studies being conducted over the years, and it seems to reduce the risk both heart attacks and strokes by about 25% (follow this link for a good summary) and so the key question is – are you at risk? If your risk is high enough, then a 25% reduction will outweigh the risk of bleeding and you should take aspirin, but if you are at low risk then any benefit will be outweighed by the risk of side effects. For a person who has had a previous stroke or transient ischaemic attack (TIA, a temporary form of stroke), the risk of developing a new stroke has been calculated as 10.8% over a 29 month period. With aspirin this will come down to 8.3%. So if 100 people, who have had a previous stroke or TIA, take aspirin for 29 months between 2 and 3 of them will avoid having a stroke that would otherwise have happened. This compares with 1 or 2 over 30 years in the above example regarding colon cancer, and now this has clear benefits over the risk of bleeding.The figures are similar for people who have angina or have had a heart attack.

We used to think that the balance would also tip in favour of taking aspirin in people who have not yet developed heart disease or a stroke but who (by virtue of problems such as diabetes, high blood pressure, high cholesterol and so on) are at high risk of developing it. About 18 months ago it became apparent that the benefit of aspirin in these people is much lower than we expected, and probably just out-weighed by the risk of bleeding.This changed my practice and I spent the next few months saying to people: “You know that aspirin I recommended you should take? How do you feel about stopping it?”

So who should take aspirin? Three types of people should consider it: Those who have had a previous stroke or TIA; those who have a history of heart attack or angina; and finally a small group of people who are at risk of stroke because of a heart condition called Atrial Fibrillation who cannot take warfarin (which is usually more effective than aspirin in preventing stroke in this condition). For the rest of us? Well the story of aspirin is certain to have a few more twists and turns before it is finished – keep an eye on the news, but have your large pinch of salt handy!