95% Less Harmful – the Story of a Statistic

When Public Health England (PHE) published their recent report on e cigarettes, the statistic to hit the headlines was the claim that the electronic variety were ‘95% less harmful’ than standard cigarettes. It’s a figure that will have entered the collective consciousness of journalists and vaping enthusiasts, and I can guarantee that we will hear it quoted again and again in coming months and years.

The question is: where has it come from, and what does it mean?

The first question is easy to answer: the 95% figure does not come from PHE. Their report simply quotes the estimates made by another group of experts published by Nutt et al in European Addiction Research. Simply put, PHE have said: ‘other experts have guessed that e cigarettes are 95% less harmful than standard cigarettes, and that seems about right to us.’

The over reliance on the findings of another group of experts has received some very public criticism – most notably in an editorial in The Lancet when it emerged that the findings of this group had been funded by an organisation with links to industry, and that three of its authors had significant financial conflicts of interest. These are valid points, although they may have been made better if The Lancet had included the author’s name and declaration of interests alongside the editorial.

The second question is harder to answer, and here is my main concern with how the 95% figure has been presented. What does ‘95% less harmful’ actually mean?

If I were a smoker, wondering whether to switch to vaping, I would primarily be interested in one thing: how harmful are they to me. In other words – am I less likely to die or get ill if I switch to e cigarettes?

Well, the PHE report would seem to answer this question – in the forward to the full report the authors state that e cigarettes are ‘95% less harmful to your health than smoking.’ The trouble is that the report where they obtained the 95% figure looked at far more than just the effects of smoking on the health of an individual.

The piece of work by Nutt and colleagues involved a group of experts being asked to estimate the harm of a range of nicotine products against 12 different criteria – these included the risk to individual health, but also other societal harms such as economic impact, international damage and links with crime. The 95% figure was only achieved after all 12 factors were weighted for importance and then each nicotine containing product was given a composite score.

Now the propensity for a commercial product to be linked with criminal activity may be very important to PHE, but it wouldn’t influence my individual health choice, nor the advice I would want to give to patients.

Moreover, the work by Nutt and colleagues includes this statement: ‘Perhaps not surprisingly, given their massively greater use as compared with other products, cigarettes were ranked the most harmful.’ So the research was greatly influenced by the extent to which products are used. On this basis you could conclude that drinking wine is more harmful than drinking methylated spirits – on a population basis this is true, but it would be a poor basis for individual advice. 

In response to the criticism in The Lancet, PHE produced a subsequent statement in order to try to achieve some clarity over the 95% figure – only to muddy the waters further by claiming that the figure was linked to the fact that there are 95% fewer harmful chemicals in e cigarettes than standard cigarettes. This may well be true – but it is not the reason why they gave the 95% figure in the first place. It also assumes a linear relationship between the amount of chemical and the degree of harm – 5% of the chemical might only cause 1% of the harm, or it could be 50%.

One of the main problems I have with the 95% statistic, therefore, is one of principle – I just don’t like being duped by the misuse of statistics.

My second issue, however, is more pragmatic: the statistic does not help us with some of the key questions we need to answer.

That e cigarettes are safer than standard cigarettes is not much in doubt – mostly on the basis that smoking is so bad for health that it isn’t hard to beat. There is clearly much to be gained by smokers switching to the electronic variety. The next question concerns what smokers should do next.

Much is said about e cigarettes being an aid to quitting, but what is unique about them is that people often stay with them for the longterm, in a way that they would never consider with something like a nicotine patch. This may be their greatest strength – people may be able to quit who could never do so before – but it is also a new phenomenon as longterm nicotine substitution becomes the norm.

Are e cigarettes so safe that once smokers move over to them they can consider the job done? Many vapers talk about it in these terms. For the short term, it seems they are safe. They have been in common use for 5-8 years and there have been no major concerns so far (although acute poisoning is a new problem with liquid nicotine) – but then the same is true for cigarettes where it is use over decades that is the problem. For me, the 95% figure is too questionable to be able to help here.

There are more dilemmas I face as a doctor since I need to know how to interpret the health risks of someone who uses an electronic cigarette. When it comes to cardiovascular risk, should I consider them a smoker, a non-smoker, or something in between? If they have a persistent cough, do I suggest a chest x-ray early on the grounds that they are at increased risk, or can we watch and wait for a while?

We are a long way from being able to answer questions like this, and I would have preferred a little more honesty from PHE about what we don’t yet know, a little less reliance on the opinions of experts, and only to be presented with a figure like 95% if it is based on hard, objective evidence.

I haven’t Been Paid to Write This

There were two items in the news last week that created an interesting juxtaposition on the issue of transparency.

The first concerned the new guidelines for Vloggers – those entrepreneurial YouTubers who have managed to create a following by recording short video clips of their lives, hoping to earn a few pounds along the way.

Some, it seems, have been earning extra money by being paid to recommend products to their viewers – Oreo biscuits being the most high profile example – and such is their influence that new rules have been established to make sure the unsuspecting public know money has changed hands. In short, they can recommend anything they like, but must make a clear declaration if they’ve been paid to do so.

The BBC news cheerfully put together item where three young female Vloggers dutifully explained the new rules, gaining some useful exposure for their own YouTube channel along the way.

You can hardly object to the rules; transparency is important and the consuming public should not be misled.  These young women hardly seemed to be a major threat to society, though, and you couldn’t help thinking that the establishment had come down hard on some enterprising young people who had found a way to start saving for a mortgage.

The second item concerned e cigarettes. Public Health England had produced a report stating that e cigarettes are ‘95% less harmful’ than standard cigarettes and suggesting that they should be prescribed on the NHS in the future.

The report is not a new study, but the opinion of a group of experts who have looked at all the evidence that is out there and given us the benefit of their combined wisdom.

Now, when a Vlogger declares one brand of biscuit to be superior to another, we have a right to know whether or not they have any financial incentive to say so; as Shahriar Coupal, director of the Committee of Advertising Practice says: ‘it’s simply not fair if we’re being advertised to and are not made aware of that fact.’

So what if a scientific expert declares one type of cigarette to be safer than another? Do we not have the same right to know whether the expert has had any financial dealings with the makers of cigarettes? Good medical practice would certainly say so, but the practical reality is often very different.

I have looked at the report in detail. The names of the authors are clear, but nowhere in its 111 pages can I find any declaration of interests; I have no way of knowing whether or not these authors have been paid by the makers of e cigarettes.

Which is more important? The type of biscuit someone may buy after watching a video on YouTube, or the health advice given to the nation by Public Health England on something as topical as e cigarettes?

I’m not stating that the authors do have any conflict of interests – they may well be entirely free from such ties – but the issue is that I cannot tell. If they have no such links, then tell me – I will be far more willing to trust the opinion of these experts if that is the case. If, on the other hand, they have received money from industry, then I have both a right and a need to know – for the sake of my patients and the advice I may pass on to them.

The authors may have made declarations of interests elsewhere, but this is no good to me since I don’t know where to look, and anyway, why should I be required to hunt for them? The Vloggers have to make a declaration on the page where they advertise the product, it should be no different for Public Health England.

Why are these declarations so often absent in reports like this? Is it thoughtlessness, laziness, or something more sinister? I don’t know, but it should be different. We need a culture change until it becomes unthinkable to publish such a report without them. We need a media that will focus the story on the lack of such a declaration rather than on the report itself – which is, after all, meaningless without it.

So what do I think of the report itself? Sadly, until I know if I can trust its authors I just don’t think I can make a judgement.

Addendum

As you will be able to see from the comments below, Public Health England have amended the report to include full DOI on pages 90 and 91 which is great news!

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.

A Message To Our Patients

Last week the Care Quality Commission (CQC) published data on every GP practice, placing each practice in one of 6 bands in order to prioritise them for inspection. The CQC has been very keen to point out that the way it has banded practices is not a judgement on them, as this can only come when the full inspection is completed. Despite this, the newspaper headlines described large numbers of ‘failing practices’ which will have inevitably worried patients; the fact that the CQC used the word ‘risk’ in its reports is a shame, as it has made it more likely that patients will be concerned.

At Binscombe we have been given a band 2 out of 6, which has been hard to take, not because we are worried about an early inspection – we are happy to be inspected at any time – but because the banding does feel like a judgement, and we believe that we give far better care than that. The banding may also have caused anxiety for our patients, and this too is a concern for us.

The CQC reports look at 38 individual pieces of data, from how often the patients at a practice attend A&E, to how our patients rate the practice in the annual GP survey, to how many patients with high blood pressure achieve a certain blood pressure target. There are many other pieces of data they could have chosen, and we had no idea until last week which they would choose, but these are the ones they have picked. Each indicator has an expected value the practice is meant to have achieved, and if the practice is significantly below that value then this will indicate a ‘risk’, with the number of ‘risks’ determining which band the practice ends up in.

There are several indicators that come from the GP annual survey on patient care where we have scored exceptionally well. For instance, when it comes to the percentage of patients who said that the GP they saw was ‘good or very good at treating them with care and concern’ we were expected to achieve 85%, when in fact 97% of our patients felt able to say this. We are incredibly proud of this. We don’t get it right every time, but we always try hard to listen to our patients, to share their concerns and involve them in all decisions about their care.

Where the practice has been criticised in the report mostly relates to indicators that are more about monitoring than listening. These are:

  • The number of patients with diabetes whose blood pressure has achieved a target of 140/80
  • The number of patients with diabetes who have had a routine foot examination in the previous 12 months
  • The number of patients with diabetes who have had their urine tested for protein in the previous 12 months
  • The number of patients with serious mental health problems who have a record in their notes of alcohol consumption in the previous 12 months

And one area to do with the layout of our practice waiting area:

  • The number of respondents in the GP survey who said they could not be overheard in the waiting area.

These are not unimportant, but there is always a tension in a GP consultation between addressing the concerns a patient wants to talk about and the requirements to monitor and treat things like blood pressure. In an ideal world we would always do both, but too much attention to the latter can make the patient feel like they are not being listened to and that the doctor’s agenda is more important than their own.

Last April, Jeremy Hunt said he wanted to end the ‘tick-box’ culture in medicine that too often distracted GPs from spending quality time with their patients, and this is something we have welcomed. While we will address the concerns of the CQC, we will never want the patient to take second stage.

The issue of being overheard in the waiting area is a difficult one. We would certainly like to have an area where patients could talk in the confidence that they cannot be overheard, and we take confidentiality very seriously, but we are constrained by the practical reality of our building and the waiting area. It is not easy to see how we could put up a screen between reception and the waiting area, but we will certainly be looking at any possible solutions to this problem.

We take the CQC report very seriously, and we will be working to address the issues raised within it. We know we are not perfect and we are always looking to improve the care we provide for our patients. When Chris Jagger was at the practice he always used to say that our patients are our greatest asset; this is as true now as it ever was, and we are very grateful for the support we receive from Binscombe patients.

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)

The Saatchi Bill – Innovation or Obscuration?

What’s the difference between a quack and a pioneer? And how do we allow the next William Harvey or Edward Jenner to flourish, whilst protecting the public?

These are the questions at the heart of the Medical Innovations Bill, the basis of which is the belief that true innovation is being stifled by the fear doctors have of being sued, and that legislation is required to remove this barrier.

I found myself trying to answer these questions in the consulting room the other day when a patient asked me directly if she could have a syndrome I had never heard of before. She has a multitude of symptoms that I have been unable to explain, and her internet search had led her to the syndrome as a possible explanation for her situation. She was kind enough to give me time to do my own research, and we agreed to meet again to discuss it.

The syndrome in question (which I won’t name for fear of saying anything that could be misconstrued as libel) was unorthodox, but not implausible. It suggested that there could be a hormonal imbalance at tissue-level which was not reflected in abnormal blood tests, and high-level hormone supplementation was required.

But tissue-level biochemistry is still poorly understood. If bacteria in your gut can cause ulcers and crystals in your ear lead to vertigo, then I don’t see why some hereto unknown enzyme problem couldn’t lead to a hormone imbalance – unlikely, but not impossible.

Here, however, is where the theory started to break down into quackery: the proponent of the syndrome did not engage in the process of scientific enquiry, but named the condition after himself, set up a lucrative clinic offering untested (potentially harmful) therapy to patients outside the bounds of a clinical trial, and continues to offer such treatment despite being disciplined by his professional body.

When I made my conclusions about my patient’s diagnosis, explaining the background, thankfully she agreed with me.

So I am left with a simple distinction between true innovators and quacks. The former will be motivated by a desire to discover truth through rigorous scientific enquiry and external peer scrutiny, while the latter will come up with plausible, attractive theories and hurry on with treatments without stopping to examine the effects in an unbiased way

This is why we do not need Saatchi’s Bill, and we should strongly oppose it. A true innovator will not want to implement the Bill, while a maverick doctor may seek to exploit it. Their motivations for doing so may be benign – a desire to offer hope to the patient in front of them, perhaps, or an inability to admit the truth that really nothing more can be done – but the outcome will be the same.

The Bill is meant to encourage innovation where there is a dearth of clinical trials, but in such circumstances a true innovator will not complain about the lack of trials, they will create one.

The Bill seeks to provide safeguards so that proposed treatments are brought before fellow clinicians before being used. A true innovator knows the value of proper scrutiny as afforded by an ethics committee.

The Bill seeks to encourage treatments for patients who have no time to wait for clinical trials, but a true innovator will see the long line of future patients, and not allow decisions to be dominated by the suffering of those immediately before them.

Maybe our Health Secretary and Lord Saatchi should talk to someone like Barry Marshall, who jointly won the 2005 Nobel Prize for Physiology with Robin Warren for establishing the link between H pylori and peptic ulcer disease, and was so obsessed with finding the truth that he infected himself with the bacterium to study its effects – now that was true innovation. I wonder what he would think about the Bill?

The post was originally published by Pulse (free registration required)

Raising Awareness – Do We Know What We Are Doing?

There was an interesting discussion on Radio 5 Live recently between Glasgow GP Dr Margaret McCartney and Kris Hallenga, the founder of the CoppaFeel breast cancer awareness charity. The interview was arranged in relation to an article Dr McCartney wrote for the BMJ in the first of her new weekly column for the journal, which criticised The Sun newspaper’s rather hypocritical Page 3 campaign to encourage young women to regularly check their breasts for lumps. Whatever you might think of the piece, you have to admire Dr McCartney’s boldness for taking on both a national daily newspaper and the emotive power of the Pink Ribbon for her induction to the column!

The interview exposes how screening for disease and responding to symptoms are so often blurred in the media and by health campaigners – whether this is due to simple ignorance or a deliberate ploy to increase the power of the campaigns is uncertain, but that it is helpful is without doubt. The Sun’s campaign calls for the screening of asymptomatic women through regular breast self-examination, and Dr McCartney’s assertion is that the benefits and harms of this strategy are not sufficiently understood to be able to promote such advice, and what evidence we do have suggests it may do more harm than good. Ms Hallenga, on the other hand says that she ‘ignored her symptoms for so long’; ignoring the symptoms is not the same as failing to remember to check yourself when you don’t have symptoms – there is something more going on here, which brings me to a fundamental problem with ‘awareness raising’ health campaigns.

The logic of raising awareness goes like this: people aren’t seeing their doctor quickly enough about a certain disease – this must be due to a lack of knowledge, understanding and awareness of the condition – there should be a campaign to raise awareness – people will be better informed and see their doctor more quickly – lives and money will be saved. If we were all computer programmes and responded in a predictable way to data input this would work a treat, but people are far more complicated than that.

There are many reasons why someone may choose not to see their doctor when they have significant symptoms. Ignorance may be one of them, but in this day and age of instant health information courtesy of Google, it is surely less of a factor than it used to be – the danger is now the converse, that too much information may be having a detrimental effect. If a woman finds a breast lump – whether by chance or through a belief that she should check herself – she is unlikely to be unaware that breast cancer is a possibility, and yet some will delay seeing their GP despite this knowledge. Other factors must play a part: fear of what might happen next; complex self-denial as we convince ourselves that ‘this can’t be true’; embarrassment; business and the attitude that ‘I haven’t got time to be ill’ are all reasons why someone may not see a doctor – attitudes that might be improved by an awareness-raising health campaign, or might just be hardened by it.

Awareness raising is usually championed by politicians whose motive is to improve a statistic or – for understandable reasons – by those with an emotional connection with the disease in question. The problem with this is that the focus is heavily biased towards those with the disease, with little consideration given to the potential harm to others who may be caught up in the campaign. The justification for this is often that it brings reassurance to those who are checked out and found to be ok – but we should question the merit of a campaign which brings peace of mind to those who have been made anxious by the very same campaign in the first place.

The ‘cough for three weeks could be cancer’ strategy is a good case in point. As with all GPs I have seen more patients with a cough since the adverts appeared – usually non-smokers who are very conscious of their health and would never ignore symptoms for very long – while I am aware of smokers who have been put off seeing their GP by this very campaign because they don’t want to be given bad news. There is rarely any attempt to see how people will respond to these health messages – little consideration given to the fact that the same message might harden the resistance of those who should seek advice while unhelpfully altering the health-seeking behaviour of those who should not. We need to be bolder in challenging this, even if, like Dr McCartney, we end up being accused of acting ‘dangerously’.

Sometimes, though, if you can’t beat them you have to join them, and so I would like to launch my own awareness raising campaign. It’s very simple and it goes like this: ‘Health Awareness Campaigns can do more harm than good – use with caution, apply common sense, and trust your instincts’.

This post was originally posted in Pulse magazine (free subscription required)