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.

Cancer Diagnosis – Woeful Performance, or the Reality of General Practice?

As GPs we get used to being beaten up in the press; hauled over the coals for this lamentable failing or that shocking inadequacy. It is still a bitter pill to swallow, however, when you are lambasted for failing to achieve a target that belongs to someone else.

The BBC reported recently that

Under NHS targets, 95% of people with suspected cancer should be seen by a specialist within two weeks. But the data indicates that this target was missed in more than half of the 4,000 GP surgeries sampled.

The article goes on to report how woeful our figures really are – 59% of GP practices achieve less than 50% and some practices less than 10%. A cancer target of 95% where only 10% is achieved? My goodness we are bad, aren’t we? Before we all decide to give up and let someone else have a go, however, let’s just have another look at that target, and what the figures from NHS England actually mean.

There is indeed a 95% target around cancer referrals, and it is this: 95% of those patients referred by their GPs under something called the Two Week Rule (TWR) should be seen within those 2 weeks. It is a target for hospitals to make sure they really do see patients within the 2 week period, with 5% wriggle room for those few inevitable cases where the system breaks down. The NHS England league tables, on the other hand, are not based on a target at all. They have simply looked at all those who have been diagnosed with cancer, and then the percentage of those cases that were referred under the TWR, as opposed to any other route. The BBC report mystifies me – is this just rank ignorance and inadequate research, or do they really know what they are talking about, but find that a little judicious muddying of the waters makes for a better story?

So what of the NHS England data? Does it make sense to rank practices on the basis of how many cancer patients are seen under the TWR, and does the implication that the highest percentages indicate the best practice hold water? There are many routes a patient might take on their journey to a cancer diagnosis, and surely what really matters is not how they got there, but whether or not there were unnecessary delays along the way. Many of my patients, for example, are diagnosed through the breast and bowel cancer screening programmes. Now these patients could be referred back to me with their abnormal mammograms and bowel tests for a TWR referral – it would do my figures no end of good if they did – but that would hardly improve patient care. Then there are those patients I see where a TWR referral is far too long – acute leukaemia, for instance – and emergency hospital admission is required. Am I to regret getting on the phone to the on-call team because I might slip a place or two in the league table?

Other patients, quite rightly, will take themselves to accident and emergency when they first present with symptoms – a first seizure from a brain cancer, for instance, or a sudden bleed from a stomach cancer; still others will be diagnosed with cancer after an appropriate period of watchful waiting in the hospital – a slowly rising PSA for instance. All of these patients appropriately referred and diagnosed without delay and without mention of the TWR. What is the ideal percent of patients who should be referred under the TWR, I wonder? Even NHS England states that the figures are ‘not a clear measure of performance’.

Then comes the harder part, those patients who do present to their GP, who have cancer and may have typical red flag symptoms or may have an illness which is far more vague and challenging. We have to be careful here, because there are too many real life stories of patients who see their GP and are not listened to, or are fobbed off; patients who attend again and again, knowing there is something seriously wrong with them, but not feeling sufficiently empowered to insist on action being taken. We must not dismiss these stories, and there is always the need for doctors to improve the care they give, but neither should we be so afraid of missing cancer that we become defensive. The only way that I could guarantee that I never miss a case of bowel cancer would be to refer every patient with bowel symptoms for a colonoscopy under the TWR. My TWR percentage would be magnificent, but my local bowel consultants would be tearing their hair out and, more importantly, I would be putting my patients through unnecessary anxiety and investigations.

General practice is about dealing with uncertainty, knowing when to refer and when to spare the patient from a referral. We have learnt to tolerate this, and so do most of our patients when we talk to them one to one, but our society is becoming increasingly intolerant of any uncertainty. Politicians and the charitable sector are too quick to issue sound bites about their patient care without seeing the bigger picture. Indeed, Stuart Barber, from Beating Bowel Cancer, said it was ‘intolerable’ that patients were having to wait. I don’t want any individual patient with cancer to have to wait either, but we have to realise that the more sensitive we make our TWR criteria, the less specific they will become – and the more patients we have to put through the trauma of a TWR referral, with all its attendant worries and the risks of investigation.

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)

Can You Walk off the Risk of Breast Cancer?

One of this week’s health stories is typical of how rather unexciting research can reach the headlines by virtue of its association with a condition like breast cancer, but it also serves as a good example of two of the most common sources of sloppy reporting that plague health stories – which makes me think it a subject worthy of a blog.

The research relates to the possible effect of exercise on the risk of developing breast cancer, and the headline is Walking ‘cuts breast cancer risk’. If true, this is hardly an earth-shattering discovery. Perhaps it will add in some small way to our understanding of the mechanisms involved in the development of cancer, but this is for the journals to worry about. When it appears in mainstream media, the point is surely whether it means anything to an individual concerned about her breast cancer risk – in other words, if you want to reduce your risk of developing breast cancer, should you take up walking? Unfortunately, the way the results are reported makes it very difficult to answer this question.

 

Problem 1: associations are not the same as cause and effect

The first problem is that the study has made an observation, which has been presented as a cause. The researchers did quite a simple thing: they arranged for a group of over 73 000 post-menopausal women to complete a questionnaire at intervals over a 17 year period from 1992 to 2009, asking questions about how many hours walking the women did, and any diagnosis of breast cancer. They found that those who walked for 7 or more hours per week were less likely to have been diagnosed with breast cancer than those who walked for 3 hours or less. This does not mean that the walking caused the reduction in risk, however. It may well have done, but it could have been some other factor. There could have been a different cause that was linked to both breast cancer risk and the amount women walk. For instance, walking less could be linked to obesity, which could explain the extra breast cancer risk.

The researchers were aware of this problem, and tried to exclude some factors – for instance, it was not due to those who developed breast cancer being more overweight than those who did not – but they can never exclude all of the possible confounding influences. For instance, it may be that those who walked less were more likely to have other health problems, and the increased risk of breast cancer was in some way linked to this.

In my experience, observational health studies are very frequently reported as cause and effect. I can understand why – Walking ‘cuts breast cancer risk’ Has more of a ring to it than Walking is associated with a reduced risk of breast cancer. The problem is that the more catchy headline is misleading, and it is left to the reader to spot the error.

Problem 2: what do we mean by a reduction in risk?

The second pitfall when it comes to knowing what to make of a study like this is more serious – and more troubling, because the fault lies not with mainstream journalists trying to enhance their stories, but researchers and journal editors being guilty of the same. The problem is this: as is so often the case, the results have been presented in terms of a reduction in relative rather than absolute risk.

The trial demonstrated a 14% Relative Risk Reduction (RRR) – but is that a 14% reduction of a big number or a small number? If the Dragons in Dragons’ Den are offered a 14% share in company profit, they are very quick to ask how big that profit will be before they part with their money. The same should apply to us before we invest our energies in a health intervention. If the Dragons want to know the absolute amount of money they can expect to receive then we should expect to know the Absolute Risk Reduction (ARR) of any intervention.

The problem is that ARRs are always a lot smaller than RRRs, and so they make research look far less impressive, and researchers are reluctant to give them the attention they deserve. From the BBC article it is impossible to find the ARR, and so you have to go to the original research – and even here only the abstract is available without paying a fee and so you have to work the numbers out for yourself. It turns out that the risk of developing breast cancer over the 17 years of the study was 6.4 percent, making a 14% RRR equate to a 0.9% ARR.

Let us assume for the moment that the reduction in risk really is due to walking. Then if you are a woman after the menopause, and you walk for 7 hours a week rather than 3, then over a 17 year period you would reduce your risk of getting breast cancer by 0.9%. Put another way, if 1000 women walked the extra 4 hours a week for 17 years that would be 3 560 000 hours of walking to save 9 cases of breast cancer, or 393 000 hours of walking per case. At 3 miles per hour, it’s the equivalent of walking more than 47 times round the world! Now I do know that this statistic is probably as meaningless as being given a 14% relative risk reduction – but it was fun to work out!

That’s not to say that walking is a bad idea – there are clearly very good reasons for walking more. However, whatever the associated health benefits might be, the two most compelling reasons to walk will always be these: it’s a very useful way of getting from A to B, and most people find they rather enjoy it!

Intrinsa? Intrinsically Wrong

Few of us will have noticed the change in status of the testosterone patch Intrinsa last October. As a GP I have no patients who have been affected by it, and while a treatment for the controversial diagnosis of Female Sexual Dysfunction might be significant for a small number of women, it is hardly a life-threatening condition or a major public health priority. However, we would do well to take note, because it heralds a new low in the behaviour of the pharmaceutical industry as they try to maximise profit, and has implications not only for the resources of the NHS, but also patient safety.

Intrinsa is a testosterone patch, and was one of the few such products licensed for use in women. In October 2012 Warner Chilcott, the company that held the rights to market Intrinsa, took the unusual step of voluntarily withdrawing its product licence ‘for commercial reasons’. Given the high costs involved in obtaining a product licence in the first place, it is hard to see how this could bring commercial benefit – until you follow the story a bit further.

Ben Bryant of The Daily Telegraph has been drawing attention to the activities of the pharmaceutical industry in a series of articles in the last two months, and has highlighted the situation with Intrinsa in his latest article. What Warner Chilcott have done is to maximise profit by exploiting the financial regulations surrounding licensed and unlicensed medicines – with the former having to abide by an agreed price cap while the latter exists in the mysterious world of the unregulated ‘specials’ market, where the drug company can charge whatever they want – frequently at outrageously high prices.

Within a month of the change, the ‘last batch’ of Intrinsa (sufficient for ‘the foreseeable future’) was acquired by another company HFA Healthcare, who were quick to point out their altruistic motive to ‘ensure continuity of medication for patients,’ but rather more reticent about mentioning the price hike – from £26 per pack to £395 per pack.

We have been here before with far more significant drugs – Epanutin was acquired by Flynn Pharma last year, with a 23-fold rise in the price and a great deal of worry for patients. What is new about is scenario, however, is the loss of the licence. A Licence is not just a mechanism to allow the pharmaceutical company to promote its product; it is a source of protection for both the doctor and patient. It provides security that a medicine has been properly tested, has safety data approved by an independent body (in this case the European Medicines Agency), and has been deemed to be effective in treating the condition in question. It is the medical equivalent of a Kite Mark.

The absence of a licence means prescribing a drug off-label. Doctors are used to doing this where treatment is required and no licensed product exists – the patient cannot always wait for the time-consuming processes involved – but this is because a licence has never existed, not because it has been withdrawn for purely commercial reasons. When a doctor does prescribe off-label in this way a doctor has to take extra responsibilities, or, to quote the MHRA:

The responsibility that falls on healthcare professionals when prescribing an unlicensed medicine or a medicine off-label may be greater than when prescribing a licensed medicine within the terms of its licence.

Put crudely, if something goes wrong you can’t sue the drug company as the medicine was used in a way that they did not recommend. The patient is more likely to sue the doctor, or not be able to get compensation at all if there is a problem; the drug company is able to wash its hands, and say ‘nothing to do with us.’ It is the equivalent of selling an electrical appliance, but withholding its 1 year warranty ‘on commercial grounds’, only the patient isn’t able to shop elsewhere, since there is no other licensed product to turn to.

Withdrawing a licence is not just a matter of finances, a way of a company balancing its books or a headache for the NHS drug budget – it is a patient safety issue first and foremost and this practice needs to be investigated and stopped in its tracks before the industry tries it out again – this time with a drug that really matters.

The Real Cost of the Epanutin Scandal

Last year I published two posts on the scandalous price rise in the cost of Epanutin (phenytoin), an important treatment for epilepsy. You can read the posts here and here, but in short, here is the gist of what happened: Pfizer, the manufacturers of Epanutin, struck a deal with Flynn Pharma, a far smaller pharmaceutical company. Pfizer would continue to make the drug in the same way as before, but Flynn would now re-brand it, and in the process they would increase the price over 23-fold. The NHS would be held to ransom on the matter because the danger of switching a patient with epilepsy to a competitor brand was far too dangerous for the patient – and anyway there are no competitor brands.

At the time I was incensed by the huge unnecessary extra cost to the NHS of £44m per annum – and I still am – but over the last 6 months I have been deeply humbled by comment after comment posted on the blog by those who are bearing the real cost of this outrage – patients. 

I felt that these patient stories deserved a post of their own. We need to listen to them. Pharmaceutical companies need to hear these voices when they make business decisions in boardrooms, far away from the lives of the patients they tell us they care about. Politicians need to hear these voices when they consider the rights of big business against the care of the patient. The media need to listen too – perhaps pausing in their current obsession for exposing every possible fault in the NHS, and considering how patient care can be affected just as much by private companies and political policy as by frontline workers struggling to cope. Here are some of these voices:

Jeremy Whitehead had a fit when his brand was changed (this may not have been the Flynn Pharma change, but shows the danger of changing brands), and has decided to give up driving as a result:

I have had very little trouble until recently when the 100mg capsules of which I took 3 were presented in a different packaging labelled Epanutin but with a Malta licence. I started taking these and had a very bad fit shortly afterwards. Thank God I was at home and not driving my car.

I am within a couple of months of my 70th birthday and can’t put up with much of that sort of thing any more. I assume that it was the variation in brand which triggered my attack, but my main concern is that there will be other people in my situation who might not be so lucky, they could be driving around and have a horrible accident. I have returned my licence to the DVLA.

Tom McLaughlan expressed the anxiety that many patients on this drug are feeling:

What if the outcry against their pricing strategy were to result in Flynn pulling the drug?

I’ve been taking it for 31 years. Fifteen or so years ago my GP tried to take me off it but within hours of the transfer process being completed and me being on the new drug alone I had two seizures. So I went straight back on to the Epanutin and have stayed with it ever since. I do not want to face the likelihood of seizures again…

It is hard to underestimate the consequences of having a seizure in epilepsy that has otherwise been well controlled, and therefore the anxiety that can be created even by the possibility of this happening – Ian Bates knows this all too well:

There has been two times that my Neurologist has tried to remove/change this medication but each time it has led to me being hospitalised and nearly causing my death. Therefore I understand the consequences of removing or even altering the drug slightly.

Dawn Stocks describes the effect of a lack of communication about the change (as a GP I am especially humbled here as I am sure we could have done this better with our own patients):

I have stuck to Pfizer epanutin from the early 1980s up until last week when I received my prescription and noticed the Flynn Pharma label. I have had no warning from the pharmacy or my GP about the change and, like most epileptics, have severe consequences of not receiving the same brand medication. Panic set in which makes seizures worse .

Richard had a similar experience and laments the lack of communication from the company to the patient:

There should be a duty of care on the supplier to explain all of this via the GP and pharmacist. I have received absolutely no communication over this matter from my GP. The pharmacist (Boots) had a copy of a letter from the manufacturer which I requested a copy of, but was informed that I could not have a copy as this was the pharmacist’s only copy.

There have been supply problems, and it is hard to see that this is unrelated to the change since this has never been a problem before with Epanutin. Sean Loftus explains:

Went to a large high street chemist earlier this month & they were unable to supply the full prescription…I’m now low on epanutin, less than a weeks supply.

He is not alone – here’s a comment from Ginger:

I am quite happy to accept either Epanutin or Phenytoin Sodium Flynn Pharma, but a bigger problem has arisen – both are in short supply!

Just before Christmas I could not get my prescription made up by my usual pharmacy, and had to phone around until I found one with half the amount I needed. This was the 2nd time in 18 months.

Rosie has had similar problems, with real reasons to doubt the reliability of her medication:

I have taken these since 1974 and my GP is not happy about prescribing them because of the cost.I found my local branch of Boots would not supply the Flynn brand against the prescription that my GP gave me with Pfizer on. I have had a permanent struggle with the change of name. Now that the prescription has been updated on the computer to Flynn I am getting left overs of Epanutin from various chemists still made by Goedecke, Germany supplied by Parke Davis with a Pfizer label over that. They must be old as the use by date is January 2014.

When we listen to these stories we must remind ourselves that we are not talking about uncertainties over a drug that you could take or leave – this is epilepsy – serious medicine. I want to thank all those who have taken the time to comment, and to readers for listening.

Choices, Choices , Choices

Choice has become a mantra within the public sector, a sine qua non, an indisputably good thing. Politicians are so entranced by its allure that they are blind to both the inherent paradoxes and blatant inequities that are frequently the close companions of choice. The result is that we are often left feeling let down and oddly disempowered.

There are three main types of choice within healthcare: Those that are promised to all but only available to some; those we don’t like to talk about, because the reality is that they aren’t available at all; and those we could all have, but that the powers that be prefer not to tell us about – because they don’t trust us to make the right choice.

The first type of choice we might call the big slice of cake choice. When my teenage son and I cut two slices of cake, inevitably one is larger than the other. With equal predictability, since we are rather partial to cake, we both choose the larger piece – but the reality is that only one of us can have it. Similarly in healthcare – the best surgeon cannot operate on everyone, but who would ever choose the second best? Or I might like to choose the beautiful new hospital on the other side of town, but I have no car and the bus only goes to the tired old DGH down the road.

The result of these big slice of cake choices is that only those with the wherewithal to navigate their way through the confusion of options, and are both savvy and mobile enough to take advantage of the range if choices on offer, will actually benefit – which usually equates to the better off and the less unwell, yet another example of the inverse care law in action.

The second type of choice is the one we like to brush under the carpet – the unpalatable lack of choice that we have to face due to the reality of rationing. The NHS can no longer afford to say ‘yes’ to every health choice we would like to make. The latest, most expensive drug may not be available to us, and our varicose veins may not be deemed worthy of treatment. We are getting used to this in the NHS, and should not be embarrassed by a degree of rationing – although the decisions about what we can and cannot choose need to be made ethically and carefully, and not just by a board of panicked managers frantically trying to balance the books.

The third type of choice is the one that really interests me. It could and should be given to us all, and yet it is rarely talked about – because it has little political value, and involves actually trusting patients. If you are going to trust patients, you have to accept that they can be irrational, unpredictable, and sometimes make foolish choices – and here I speak not as a doctor frustrated by his patents, but as a member of the human race celebrating our glorious diversity.

The choices I am talking about here are these: Should I take a tablet for my mildly raised blood pressure? Should I have a mammogram? How do I feel about statins? These are the sort of health choices many of us are faced with when we visit the doctor, or receive a letter in the post inviting us to engage in a health screening programme. And yet it is rarely presented to us as a choice. We are told to take this tablet, made to feel irresponsible if we ignore the invitation letter, and risk being branded as non-compliant if we disagree – as though it is our duty to bend to the will of the medical profession.

This lack of choice is enshrined in the fabric of the GP contract, as GPs are given an ever-increasing number of targets to aim for – including achieving tight blood pressure control, prescribing anti-coagulants or performing cervical smears. Pressure to deny patient choice comes in the form of prescriptive guidelines, which are frequently dictatorial in the manner in which they tell doctors what they should be done in a particular situation. While evidence-based guidance has been an invaluable tool in helping to achieve excellent standards of care, the words ‘depending on patient individual preference’ appear all too rarely in published guidelines, and doctors are in danger of projecting the pressure that they feel to conform onto their patients.

Many treatment decisions are a complex blend of objective medical evidence concerning risk, and need to take account of highly individual, subjective preferences, priorities and health beliefs. Respecting autonomy is one of the principal pillars of ethical practice, but all too often this is reduced to waiting for the patient to raise objections to the proposed treatment plan, or asking them to become an ‘expert’ in their own health, which can equate to expecting the patient to become the doctor.

True respect for autonomy is a highly active process. It involves creating an environment in which autonomy can flourish, and empowering the patient to make the right choices for their individual situation. It requires that the doctor knows and understands their patient, has a thorough grasp of what matters to them, and is able to distil the available medical evidence into an understandable, personalised format. It may involve supporting the patient when they choose to have treatments or investigations which the doctor would not choose for themselves, or giving licence to opt out of guidelines if they wish to, and turn down treatment without being made to feel like a naughty school child,

This respect cannot be confined to the consulting room, but needs to be enshrined in all aspects of health care – and health promotion in particular. Invitation leaflets for health screening should seek to enable informed choice rather than tell us what to do, and health awareness campaigns should avoid emotional manipulation and never, ever, look like this:

cervical-cancer-poster
Cervical Screening Campaign Poster, Kirklees Feb 2012