Should Policy Makers Tell GPs How Often to Diagnose?

I’m sure NHS England were surprised by the response to their plans to pay GPs £55 every time they diagnosed dementia. What started as a seemingly simple idea to help the Government hit their diagnosis target before the election caused such a furore that Simon Stevens declared the end of the policy before it had really begun, making it clear that it would end at the end of March.

What was striking about the reaction was not the objection among GPs – policy makers are used to that and well accustomed to ignoring it – but the strength of feeling among the public. I’m sure this is what made the difference – no politician wants to lose in the arena of public opinion. It’s not hard to see how this happened. There was something innately wrong about paying GPs to diagnose; no in-depth analysis was needed, no exploration of the evidence – it was just so clearly a bad idea and both doctors and patients were alarmed at want it meant for the doctor-patient relationship.

What continues to concern me, though, is that policy-makers still think they know best when it comes to how many patients GPs should diagnose with a variety of conditions – from heart disease to asthma, diabetes and even depression – and have an even more powerful mechanism for enforcing this, which is to put pressure on practices with low diagnosis rates through naming and shaming, and the threat of inspection. A practice may have the moral courage to resist a financial bribe, but what about if the reputation of your practice is at stake?

I have written in the British Medical Journal about this, published this week, and this is a toll-free link if you are interested. What is crucial is that at the moment of diagnosis there should be nothing in the mind of the GP other than what is best for the patient – it is fundamental to the doctor-patient relationship and something well worth shouting about.

Nagging Never Works

During my time working in hospital I remember seeing a patient in the clinic who came for review after a spell as an in-patient. He had come in with his first episode of chest pain caused by heart disease and he had made a good recovery. What I remember most about him, however, was how emphatically he wanted me to pass on his thanks to the junior doctor who had admitted him:

‘She saved my life, doctor,’ he said. ‘She told me I’d die if I didn’t stop smoking. You know what I did? I handed over my packet of fags and haven’t touched one since; best thing that could’ve happened to me!’

I reassured him that I would certainly pass on his thanks to the doctor, and was glad for his success; what I did not tell him, however, was that my colleague had smoked every one of his cigarettes – ‘shame to waste them,’ she had told me.

What this incident illustrates is the fundamental difference between being in possession of medical knowledge and deciding to act upon it – or in the language of the cycle of change: moving from being pre-contemplative about change to actually contemplating doing something. My medical colleague undoubtedly knew more than most about the risks of smoking, yet she persisted despite the urgent advice she gave to her patient; the presence of crushing chest pain, however, was clearly capable of bringing the same advice into such sharp focus that it motivated radical change.

I often say to my patients that their two best opportunities to stop smoking are to get pregnant or to have a heart attack – a range of options which my male patients find disturbingly limiting. Timely advice from doctors can certainly increase the chance of success, but the studies included in the Cochrane review are of interventions when patients have made an appointment for other reasons. A different question entirely is whether or not we should screen for cardiovascular disease and then provide lifestyle interventions – and the answer to this has appeared in the BMJ recently, and appears to be a resounding ‘no’.

The Inter99 study is a significant piece of work – nearly 60 000 participants with interventions over 5 years and 10 year follow-up, and came to the overwhelming conclusion that screening for risk factors with regular lifestyle counselling had no impact on the incidence of ischaemic heart disease, stroke or mortality. We might be depressed at the poor return for such well-meant efforts, but we should not be surprised: despite the Government’s obsession with ‘making every contact count’, NHS health checks and annual demands in the GP contract to advise our patients again and again about smoking, nagging patients generally does not work.

We know nagging does not work because that is what patients say – receiving health advice when you are not ready for it simply creates resistance and can damage the doctor-patient relationship as this qualitative study in smokers makes clear; it is contrary to all the principles of Motivational Interviewing and against both our training and our experience in the consulting room. The question now is, will policy-makers listen? Will they be bold enough to follow the evidence and stop telling doctors to do things that don’t work, or will they just carry on regardless? Sadly, I think I might know the answer.

This post was first published in Pulse magazine (free subscription required)

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!

Organs by Passport

Some cases stick with you over the years. I remember a young woman who was left fighting for her life as a result of viral myocarditis. That someone previously fit and in the prime of her life could be struck down with such speed was a shock to this (then) fresh-faced young doctor; how her family coped with the awful truth that a heart transplant was the only way to save her, I will never know.

Imagine the same case happening in 2014. Intensive care, a young life, tubes, lines, drugs – 21st century medicine doing its best and running out of options. The difference is that the young woman in question is here on holiday, lives outside the EU, and Jeremy Hunt’s proposal to clamp down on ‘health tourism’ has found its way onto the statute books. The rules have changed for organ transplants – those without a right to remain in the country are excluded. A heart transplant is her only hope – but she is deemed unworthy, a health tourist who came to these shores to exploit our free health service. She should have known that she would develop viral myocarditis while on holiday and stayed in her own country where she had a right to care.

By a strange coincidence the young man who lies in the bed next to her is also here on holiday, and from the same country. Like his fellow country-woman, he had no idea of the tragedy that awaited him – he never saw the car coming, the resident-with-the-right-to-remain who was driving too fast. His family is in a side room, having that conversation – being told the news that his brain is dead and beyond any hope of repair, only his healthy, vibrant organs remain; would they like to consider organ donation?

 

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

Plain Cigarette Packaging – Does the Government Really Care About Health?

So today is the Queen’s Speech, and the promised legislation on plain packaging for cigarettes has been shelved – put on hold, maybe, hopefully, but probably left to flounder in the long grass until it is somebody else’s problem.

I have no doubt that it takes great courage to take on the might of the tobacco industry – but Australia has paved the way for the rest of the world to follow, it has taken the hit of lengthy legal battles and proved victorious. Our own Government just needs to follow in this lead, and that it has refused to do so does not show a lack of political mettle, but a fundamental problem with political ideology: When it comes to the health of the nation or the health of business, business wins every time.

 

This decision makes a mockery of Government rhetoric on health – promises such as:

These are worthy goals, and it is good to hear the Government talking about them – but they have shown no willingness to play their part in tackling these problems. All of these health outcomes are closely linked to smoking. In response to a recent report on international mortality data, Jeremy Hunt derided the UK health service for ‘shocking underperformance.’

Hunt said the UK was a long way behind its global counterparts and called for action by local health commissioners to tackle the five big killers – cancer, heart disease, stroke, respiratory and liver diseases. He will on Tuesday announce a strategy to tackle cardiovascular disease, which he says could save 30,000 lives a year.

I have blogged my views on this report, and Hunt’s response to it, elsewhere, and so won’t repeat them here. It is not good enough, however, to tell local health commissioners to do better if the Government is not willing to play its part. Many of the biggest health benefits in the history of medicine have come in the area of public health – vaccination, health and safety at work, sanitation and the smoking ban to name a few. Plain packaging could have been the next big public health policy to have an impact. I don’t believe anyone thinks it would be bad for the health of our nation to move to plain packaging; undoubtedly most smokers won’t care what the packet looks like, but it is hardly likely to increase smoking rates.

There are arguments being made against, of course – from the ludicrous notion that small shops will implode because of the extra time it might take shop-keepers to find the right packet, to more reasonable concerns about job losses and counterfeit packets. Suzie Gage has looked at the (lack of) evidence for some of these claims – and as for job losses, well wouldn’t that apply to any strategy to reduce smoking? What should really worry us are the conflicts of interest behind the scenes that may be influencing decisions – like ministers enjoying hospitality from tobacco companies and lobbyists failing to declare their links to the industry.

Instead of doing what it can to prevent disease in the first place, the Government prefers that we wait for it to happen, and then catch it in its earliest stages through screening. This is the thinking behind the NHS Health Check (about which I have blogged here), a hugely expensive programme which may have benefits for a few individual, but where the evidence that it will improve the health of a population is very limited indeed.

And the most frustrating aspect of the whole thing is that the Government’s favoured statistic for measuring our health will actually be best improved by encouraging smoking and then screening for disease. Again, I have already blogged about the unhealthy obsession with 5 year survival data. The truth is that you don’t improve 5 year survival by reducing the number of smokers – because you can’t survive something like lung cancer if you don’t get it in the first place. No, far better to keep people smoking, scare them about cancer enough so that they undertake one of our screening programmes and then cure them – that way we can really make a difference to the statistics and give ourselves a lovely congratulatory slap on the back.

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.