Dry January and Nalmefene, PLAC Blood Test for Inflammation, Dental Check-ups

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INSIDE HEALTH

           

Programme 2.

 

TX:  13.01.15  2100-2130

 

PRESENTER:  MARK PORTER

 

PRODUCER:  ERIKA WRIGHT

 

 

Porter

Hello. Coming up in today’s programme:  A new way of assessing the state of your arteries and the risk of succumbing to an early heart attack. But what does it add to the methods we already use?

 

Clip

This is a very personalised, individualised test, this is you, this is what’s going on in you at the moment.

 

Porter

I will be discovering what the blood test says about my circulation a bit later.

 

And looking after your smile – how long should you or your family leave it between dental check-ups?

 

But first if you are one of the thousands of people across the UK trying to abstain from alcohol for a dry January then you might want to listen up. Nalmefene is a new treatment recently approved by NICE to help people with a drinking problem. You may not think that applies to you, but then again you might be surprised.

 

NICE has said that nalmefene should be an option for helping people who regularly drink high amounts of alcohol defined as 7.5 units or more a day for a man, and 5 units a day for a woman - that’s around twice the recommended limits, but a level achieved by lots of so called social drinkers.

 

Nalmefene is a once daily tablet that can be taken on an as needed basis – such as over the weekend - to reduce the urge to drink. But the drug is not supposed to be taken in isolation – it is only licensed to be used alongside psychosocial support. And there’s the rub.

 

To debate the issue - Inside Health’s Dr Margaret McCartney and two experts with a special interest in the field: Emily Finch is an addiction psychiatrist at the South London and Maudsley NHS trust and she treats people with drug and alcohol problems in South London.

 

Finch

My concern is it may give the impression that the medication alone is likely to deal with the problems that the individuals are experiencing.  The medication, quite rightly, recommends that various types of counselling, or as we would call it psychosocial intervention, are given in conjunction with the medication.  But it really assumes that that counselling’s available.

 

Porter

Because NICE is very clear on this, isn’t it, it says this must be used alongside this sort of support?

 

Finch

Yes.

 

Porter

Now is that sort of support available?

 

Finch

Well it is in some areas and it is for some people.  It’s implication really is that it’s available in primary care, actually that’s by no means universally available, some GPs are interested in alcohol, some aren’t, some have additional support and many don’t.  So the idea that an individual patient could get a regular counselling session with a GP to follow up the use of that medication is in many situations not going to happen and it’s going to lull the system into perhaps a false sense of security that they’ve dealt with this issue because they’ve handed someone a tablet.

 

Bellis

My name’s Mark Bellis, I’m the alcohol lead for the UK Faculty of Public Health.  We’re talking about in England just alone of about two million people who drink at the very harmful level, around, if you like, for a male about three quarters of the equivalent of three quarters of a bottle of wine a night or for a woman about half a bottle of wine a night.  Now there are other stipulations around who may receive this sort of treatment but if we take that group that’s equivalent to about two million drinkers in England alone.  If we go down a group, and that would take us up to 10 million that drink over the guidelines.

 

Porter

And this is a group that if you stop in the street and ask them if they thought they had a drink problem they’d almost certainly say no.

 

Bellis

One of the tragedies with alcohol is that one of the points at which people recognise what they’re drinking is really hurting them is when they’ve already – require medical attention.  And the levels we’re talking about here carry significant risks of a whole range of health harms.  Now what we’re saying here is in some way we can medicate our way out of what’s a social problem.  What we’re doing, instead of taking the more difficult political changes, such as increasing the cost of alcohol, putting proper health warnings in place and controlling adverts, we’re pushing the pressures back on to the NHS when it’s already dealing with huge levels of problems and actually moving aside the political and personal solutions which would help everybody and not bring in side effects and more costs.

 

Porter

Margaret, you’re a GP like me, do you welcome the introduction of this drug?

 

McCartney

I think what’s really important is that we understand what this drug can and can’t do.  And I’m really afraid that the effects of it are being overhyped.  We know, for example, that it can cut down the number of heavy drinking days someone has but only by about 1.7 days per month, which isn’t overall a huge effect.  And if you look at the graphs of where the alcohol reduction occurs it occurs almost as much in the placebo group of patients, who are just given counselling.  So what we have to conclude is that counselling is the effective thing here, it’s a psychosocial intervention that Emily was talking about.  The drug is really of very minimal effect overall.  And the question for the patient and for the NHS, more broadly, is is that where we want to put our money?  Do we want to put the money into the drug or do we want to put the money into the psychosocial intervention that really does make the difference?  And I know where I would put it.

 

Finch

My reading of the research evidence is that they’re helpful but they’re by no means the whole answer and for many people they sort of almost block the process of understanding the level of behaviour change and the level of social change that the individual needs to do to stop their drinking.

 

Porter

Emily, the resources may not be in place but does it matter if the pill is prescribed without the proper support by people like me, for instance?

 

Finch

I think it’s likely that it will matter quite a lot if it’s used without the proper counselling support.  I think the truth is we’re not entirely sure, we haven’t seen it happen but our experience with these sorts of pills is it is unlikely to make much difference unless people get the right support and they know the message that you’re trying to give and they’re given the psychological tools to help themselves.

 

Porter

So it could be a waste of resources and false reassurance really?

 

Finch

Yes it could be.

 

Porter

This country has been criticised in the past for being relatively slow to adopt treatments like this and this isn’t the only pill, if you like, that you can take to help people who’ve got a drinking problem.  How do we sit with that then, are we under-using these medicines by international standards?

 

Finch

We do underuse them by international standards.  They’re not particularly acceptable to patients, many of them have quite unpleasant side effects.  In my experience patients don’t like taking them and by this I really mean people who’ve got more serious issues than the group that nalmefene is directed at.  I have some patients who are happy to take them, who find them useful.  Many of them, once you start giving them to people who have severe alcohol dependence, they conflict with many of the evidence based treatments that we know do work.  So the idea that you’re using a tablet long term is quite alien to many people who struggle with recovery from alcohol.

 

Bellis

Whether we are or not behind other countries in terms of that prescribing, we’re also behind in so many other social things, such as the regulations in France which are tightening up the pressures for people to consume alcohol at heavy levels in the first place.

 

Porter

I think we’re all agreed that this would need to be used as part of a better public health policy but do you not welcome, Mark, that actually this moves this problem up the agenda, that people look more willing to do something about it?

 

Bellis

I think that the problem is that you’re sending out a message, if you like, that you can wait until people reach this particular stage and then the NHS will pick up the pieces.  And whereas that needs to be there for a certain number of individuals, it is still a very dangerous message.  Let’s just think about these people who are on nalmefene, at what point do they come off?  And they are then being returned to an environment with exactly the same pressures which caused their problems in the first place.  There may be individuals who need this treatment but we really need to turn down, if you like, the constant supply of people who are falling into these problems in the first place.

 

Finch

I think we’ve got to look at the environment that we are putting our population in, which is encouraging them to drink and this group are going to be the group who are particularly susceptible, will respond particularly well to issues like minimum alcohol pricing.  And I think the problem is nalmefene is an easy option, it’s an easy one for people to push, it’s not focusing on the things that really matter and on the social change that is likely to stop people becoming severely alcohol dependent.

 

Porter

Dr Emily Finch.

 

Well NICE’s Health Technology Evaluation Director is Professor Carole Longson.  Does nalmefene really add that much to good counselling, if you look at the data submitted to NICE it was the counselling that seemed to confer the vast majority of the benefit?

 

Longson

It’s a very good question and yes the evidence does show that our psychological support, so interventions, psychological interventions, do have quite a big impact in some individuals.  But the evidence suggests that nalmefene, so this new medicine, as an adjunct, as an addition, to that psychological support does have some benefit.  Now you’re right the benefit is modest but yes I do have to stress that this is part of a package of both psychological support and if necessary the adding on of a medicine.

 

Porter

And herein lies another problem is that it’s important that nalmefene’s used as part of that package but it’s very difficult to get access to counselling across the UK at the moment.

 

Longson

Well we do know that that access is a little bit patchy but it is improving and we think about 55% of adults that perhaps could benefit from this type of intervention might be able to access it at the moment, so we do need to see those improvements.  But I would suggest that in primary care GPs would really benefit from being able to deliver that, it’s good for patients and it’s good for society.

 

Porter

Yet we live in a world where half the population can’t access the counselling they need. Professor Carole Longson thank you very much.

 

And there is a link to the NICE guidance on nalmefene on the Inside Health page of the Radio 4 website.

 

Now time for me to turn patient … again.

 

Clip

Porter

So how much blood do you take?

 

Doctor

Well about like 15-20 mils altogether.

 

Porter

Good.

 

Me having blood taken for a new test that has just been approved by the US regulatory authority – the FDA – as a screening tool for predicting a person’s risk of future heart attacks.

 

Clip

Doctor

It’s a sting, there you go, great.

 

And it has now arrived in the UK and is being offered by a number of private clinics.

 

The PLAC test measures levels of the enzyme Lp-PLA2 – a marker for inflammation of the blood vessels associated with the build-up of dangerous plaque in the lining of the arteries supplying the heart.

 

But what does it add to the risk calculators GPs are already using to pick up their patients at highest risk of an early heart attack based on criteria like age, blood pressure, body mass index and smoking habits?

 

Clip

Doctor

And that’s it.

 

Porter

Thank you very much.

 

Doctor

No problem at all, thank you.

 

Thanks to a high cholesterol level and a poor family history my desktop calculator tells me that I am at increased risk and that I have a 13% chance of having a stroke or heart attack over the next decade. That is around twice as high as what an equivalent 52 year old with a normal lipid or cholesterol profile and no family history might expect.

 

Indeed it’s a high enough risk to put me over the recently lowered threshold for being offered statins. Something I have been advised to do in the past but have been reluctant to pursue. Might the PLAC test help me make up my mind?

 

Dr Cliff Bucknall is a consultant cardiologist at the London Bridge Hospital.

 

Bucknall

Mark, with a 13% risk you’re just the sort of person that this test is really targeted for because you’re not in the low risk, in other where it would have been inappropriate, in a sense, to even consider the test because we know that you don’t need it, you’re not in the very high risk where – over 20% or so – where quite frankly we all know, or at least we think we know, that you’re better off to be on not only risk modification in terms of diet and exercise but you’re also better off to be on medicines like statins.

 

Porter

It’s what you might call a no-brainer?

 

Bucknall

Correct.

 

Porter

I’m at high risk, I need to do something about it anyway.

 

Bucknall

Correct.  Now you’re not in that group and until very recently we would have been saying to you look you’re between 10 and 20% risk, quite frankly let’s do the lifestyle modifications, let’s really see what we can do, let’s see if there’s something that we can do to bring you under 10%, that’s exactly the pattern we would have taken.  But the world is changing, we’ve now reached the situation where if it’s above 10% you’re in this intermediate section and that is the whole thing, that you’re in the 10-20% risk mark and now the question is should you go on to a statin?

 

Porter

That’s exactly the question that I’m thinking about at the moment.  Now I am quite reluctant to take medicines, I’m a clean living – I regard myself outwardly as being pretty healthy and that is just a risk calculation.  Will the PLAC test tell me what’s going on inside me?

 

Bucknall

This really helps the patient to grapple with that big question which is I’ve been advised to take a statin, I don’t really want to take a pill for the rest of my life.  This is a very personalised, individualised test, so this can’t be, in a sense, fobbed off as some – this is just a routine test that we’re doing on everybody and it may not apply to me, this definitely applies to you, this result is your test.

 

Porter

And are you seeing lots of people a bit like me, who are reluctant to take statins based on some sort of guestimate from a calculator?

 

Bucknall

Yes, this is part of the difficulty with saying to a patient, look here’s the risk calculator, looks as if you’re just above the 10%, according to the guidelines you really do need to be on the pills, here are the pills.  And the whole idea of this is that what we’re measuring is enzyme activity, this is an enzyme that we’re measuring, so we’re measuring enzyme activity going on in plaque that’s laid down in your arteries, specifically your coronary arteries or your brain arteries.  So if you have a high score then what has been found from the studies is that this doubles your chance of getting an unwanted event.  In other words if you’re sitting there with your score, as you have, of 13% and you’re trying to decide should I do something about this other than lifestyle and diet and you found that your PLAC test score is high then quite frankly that would trigger me to want to take a statin.

 

Porter

And what’s actually happening at arterial wall level then?  This enzyme is doing what?  Why is it a marker of my future risk of stroke and heart attack?

 

Bucknall

Right, so this all comes down to the whole question of vulnerable plaque versus non-vulnerable plaque.  So a vulnerable plaque in your heart artery is one in which there is lipid rich pool inside the artery wall and you can either have a thin wall to that pool or a thick wall.  If you have a thick wall to that pool then that plaque’s reasonably safe.  If you’ve got a thin wall to that plaque then that implies that that plaque could rupture.  Now you may say well surely we all know that we could look at the coronary arteries, if you’ve got a tight narrowing you’re the one at risk.  Unfortunately it’s not that simple.  And now we understand it far better, it’s all to do with vulnerable plaque.  It’s likely that about 70% of heart attacks are due to plaque rupture, not because it was a tight narrowing itself.

 

Porter

I mean it’s a simple analogy but it’s a bit like a spot popping on the side of the wall of the artery and that then creates a reaction that leads to the artery being blocked and gives you your stroke or heart attack?

 

Bucknall

Correct. 

 

Porter

So how does the enzyme test, that we’re doing, differentiate between stable and unstable plaque?

 

Bucknall

Right, so the belief is this: the thin walled plaque is thin walled in part because of what’s going on inside the lipid pool.  And what’s going on inside the lipid pool is macrophages, white cells, chewing up bits of LDL and because it’s doing that releasing all this enzyme that’s going on.

 

Porter

The immune system is attacking the cholesterol pool effectively?

 

Bucknall

Correct, but it’s doing it in a way that’s leading to an inflammatory response.  So that inflammatory response is the thing that you’re then, in a sense, measuring.

 

Porter

So where there’s this inflammation going on that’s where you get higher than normal levels of this plaque enzyme?

 

Bucknall

Quite right.  So what you’re dealing with then is a potential risk in the artery wall that is making this plaque liable to rupture.

 

Porter

How reliable is the result that you’re going to give me?

 

Bucknall

The data that we’ve got is that it is reproducible, the European Society of Cardiology at the FDA in America are quite comfortable with promoting it, this is a very good test at being able to identify those who are at more risk.  This is you, this is what’s going on in you at the moment.

 

Porter

Dr Cliff Bucknall. And let’s face it the new lower threshold for starting statins has left many people facing a similar dilemma. But what does our resident sceptic Dr Margaret McCartney make of the new test?

 

McCartney

This is all about the search for the holy grail of cardiology which ultimately is a discriminatory test that can predict who is going to get a heart attack or a stroke and who isn’t.  And this is all part of the same ideal that we can somehow work out what’s going to happen to people in the future.  And we’re not there yet, we’re not there yet by a very, very long shot.  And if you look through the cardiological literature there are hundreds and hundreds of inflammatory markers in little test results out there that people are trying to work out whether this could be the one that will work out whether you in the future are going to have a heart attack or stroke or whether you’re not.  And this is just one of the very many tests that seems to be slightly better than many of the other ones when it comes to making your prediction.  So as you know, Mark, we’ve already got lots of risk calculators out there and this is just another thing that you can go and try and add in to that equation and try and make it more accurate.

 

Porter

So Margaret you say this test might be a little bit better.  What does the evidence show?

 

McCartney

Well there’s lots and lots of data out there and to be honest with you I find it quite hard to put together in a reliable sense because many of these studies are look back studies.  So what they’re really doing is taking populations of people and then looking to see what blood tests they’ve had done that might indicate a higher level of this particular end plaque test result.  And it seems to be that it does help to distinguish probably by around about a 1% change in your overall risk calculation at the end of the day.  So it might put your numbers up by either one or possibly slightly more than that, possibly a bit less than that, or not at all.  So it doesn’t seem to result in a very big shift with your overall percentage calculation of what your risk is thought to be of a heart attack or a stroke over the next decade.  So it’s not going to make a huge change, is that change in risk say from 13-14% really going to be big enough for you to make a step change in deciding that you’re going to take a statin tablet every day or do exercise every day?  Are these small changes really going to be enough to change something?  Should you be doing it anyway?  How useful is it going to be?  I don’t think we really know because we haven’t used these tests in real life as a preventative tool widely enough.

 

Porter

Thank you Margaret. And Dr Bucknall will be back with the results of my test later in the programme, and just to be clear we are not discussing the pros and cons of taking statins, we’ve already done lots of that and you can hear our debates on our website, including our series on conflict of interest.

 

Now how often do you go to the dentist? More to the point, how often should you go? NICE had a go at producing advice on the subject a decade ago, but it seems confusion still reigns. To provide some clarity, Damian Warmsley, Scientific Advisor to the British Dental Association and Professor Aubrey Sheiham from University College London.

 

Sheiham

The sad thing is there’s no scientific evidence at all.  That’s even what the NICE guidelines came up with.  The six monthly visit goes back to the 1850s.  So there’s been no scientific studies on how often you should go.  How often you should go depends on your risk.

 

Porter

But NICE in 2004 came up with some guidelines and they were based on what then?

 

Sheiham

They were based on opinion of experts.  They said there was no evidence.

 

Porter

But let’s to be clear, that NICE guidelines, which is 10 years old now, said that if you’re an otherwise fit and well adult with no dental problems that every two years seemed to be sensible.  And if you’re under 18 it was 12 months or thereabouts. 

 

Sheiham

But that was also not based on any clinical trials, they’re having a blanket recall.

 

Porter

Damian, if you go to a dentist the chances are, as you leave, you’ll be told I’ll see you again in six months and that seems to be quite common practice, yet NICE are recommending two years for adults, one year for the under-18s.  Why is this disparity?

 

Warmsley

Well interestingly we have more recent evidence from the Cochrane Study and in their statement right at the end they said that there’s no evidence, so therefore there’s no evidence to say it’s correct but there’s no evidence to say it’s not correct.

 

Porter

Well we’re plucking a figure out of the air but when your dentist says I’ll see you in however long what is he basing that on?

 

Warmsley

Well six months is a comfortable figure and it’s based, as we’ve just heard, based on an 18th Century idea and it’s a dogma that’s gone through.  The one thing we have to think of is patients are individuals and so as individuals they have different lifestyle choices and there may be differences that happen to them.  And I think what we’ve got to do is make sure that we look and chat and we have a good health assessment of the patient.  We know that people maybe who are diabetes have a more susceptibility to things like gum disease.

 

Porter

Damian, I’m all for that, that that’s targeting, being sensible.  So if somebody smokes and they’ve got gum disease you want to see them more often perhaps than somebody’s who’s got perfect teeth and is a non-smoker.

 

Sheiham

I agree that we should look at individual risk but then again the majority, they’re not doing what Damian is saying.  All the evidence that I’ve seen is even when a person has been considered to have no treatment need at this visit under the new contract about one-third of them are recalled within six months, less than six months in adults.  Now if you look at all the scientific evidence on assessment of risk, and there have been reviews of the literature on this, there’s no good – the only predictor of future caries is past caries.  We know that caries tracks if you have a certain number of cavities when you are six, you’ll have a certain number of cavities when you’re eight unfortunately.  Now dental caries in the permanent teeth is a very slow disease, so you could go every two, three years, if you are rendered dentally fit today it would take two to three years if you started a new lesion tomorrow before that got to the level where it needed to be filled was two to three years.  And in adults that process of progression of the lesion is even slower than in children.

 

Porter

So Damian, you say that people – dentists – should be applying some common sense, if you like, individually assessing their patients, but what Aubrey’s suggesting is that’s not happening, a significant proportion are defaulting to the six monthly follow up.

 

Warmsley

And there’s also a patient choice on this as well and so a patient may feel comfortable from just the social side of going to see the dentist and getting – there’s often a wellbeing feeling of feeling good from going – being told that your mouth is well.  But I agree again that we need some trials to look at it and to check, looking whether they do need six months, whether they need 12 months or whether they need 24 months. 

 

Sheiham

You look at – when you say people want reassurance who are the ones who go for reassurance?  The middle class, healthy people.  When we come on to screening for oral cancer, which you say yes, dentists can pick up, who doesn’t go to the dentist is the heavy smoker, the heavy drinker, the ones who are at high risk.  And so if one were to have longer recall intervals for the healthy then you could have more access for the people who really need it.  And – but the healthy well don’t need it and they are the ones who get recalled and comply and go and clutter up dentists’ surgeries.

 

Porter

Professor Aubrey Sheiham and Damian Warmsley, thank you both very much. And there is a link to the NICE guidance on our page of the Radio 4 website.

 

Now back to that blood test and the state of my arteries. What was my Lp-PLA2 result? Dr Cliff Bucknall.

 

Bucknall

Well I’m afraid to say that the result isn’t as good as we would like.  Unfortunately your Lp-PLA2 is elevated and is in the high range.  Now we don’t have to go immediately and start worrying about that, what we have to do is to put it into some perspective.

 

Porter

But has that come as a surprise to you because we already knew from my standardised risk calculator that I was twice as likely as a healthier person of my age to run into trouble?

 

Bucknall

No it really is an independent factor that we’ve got here.  So we have to use it very sensibly.  And the way in which we use it is in folk like yourself who’ve got an intermediate risk, we try to use it to say are you intermediate but in actual fact you’re low or are you intermediate and in actual fact you really are at the 13 and maybe slightly higher percent?

 

Porter

So just to be clear because I’ve scored highly in this one, which doubles my risk of a heart attack, it’s not doubling my 13%, which is already doubled, so I’m not going for 26% risk over the next 10 years?

 

Bucknall

No, what we’re looking at here is this is an independent risk factor.

 

Porter

This is not an additive test in terms of multiplying my risk even further, what it’s doing is validating what we already suspected?

 

Bucknall

Correct.

 

Porter

And that should galvanise my thoughts about what I’m going to do about it.

 

Bucknall

Yes this is really person empowerment, if you like, this is to give you the opportunity to look at your own results, put them in perspective and then say, do you know I really think I should take those pills.

 

Porter

What about going forward, if I make exceptional efforts with exercise and my diet and I take a statin, can I look at this test in the future as a measure of improvement, do we have any evidence to back that up?

 

Bucknall

Yes there is some evidence, there are a couple of papers that suggest that this can be used in this way, but unfortunately they’re not big trials, they’re just reports and therefore I don’t think that we can definitely go wholeheartedly behind them but there is something out there that’s saying that yes we can.

 

Porter

So you could use this potentially as a marker for improvement as well?

 

Bucknall

Yes but you could just as easily use your LDL, and that’s a lot easier for everybody because that’s very much more available.

 

Porter

And in terms of availability here in the UK how available is this test?  Is it only available privately at the moment?

 

Bucknall

At the moment it’s difficult because NICE haven’t declared it to be a good thing, the FDA have and I suspect that NICE will come out fairly quickly and say that yes this is a test to be used in this specific area.

 

Porter

Deciding whether our existing risk calculators have got it right for these people in the intermediate risk like me?

 

Bucknall

Correct.

 

Porter

Because I was hoping for a low result then I could procrastinate still further.

 

Bucknall

Sure, yeah, don’t we all.

 

Porter

Dr Cliff Bucknall thank you very much. And you will find more details on the Lp-PLA2 or PLAC test, which costs around £80, on our website.

 

Just time to tell you about next week’s programme when we will be taking a closer look at plans to increase the number of people offered weight loss surgery. And for those of you taken with the idea of dry January I meet a team of researchers investigating whether a month on the wagon confers any significant benefits. Join me then to find out.

 

ENDS