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INSIDE HEALTH Care.data, Asthma, Acne rosacea, Pacemakers

TX:Ìý 12.07.16Ìý 2100-2130

PRESENTER:Ìý MARK PORTER

PRODUCER:Ìý FIONA HILL

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Porter

Coming up today - a new treatment for an unsightly skin condition that affects millions of people in the UK - acne rosacea.

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Clip

My classic patient is usually someone in their 30s, most commonly female and they report that they were blushing and flushing when they were children and that now the redness seems to be permanent and they’re also getting spots, which they can’t account for because they thought that they’ve got over their teenage acne.

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Porter

And I’ll be investigating how two simple tests for asthma could change how we care for those most at risk from the disease.

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Clip

Okay, so it’s a breath in first. ÌýLight up all the green or the dots into the orange, that’s it, and now breathe out for me.Ìý That’s it, just a bit harder, just a bit harder, that’s it and keep it in that green bit, perfect.Ìý Just a few more seconds.Ìý Three, two, one – first time.Ìý Excellent.

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You should be a trumpet player.

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Oh well no, my music teacher wouldn’t agree with that.

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Porter

More on diagnosing and treating asthma, including that special breath test, a bit later.Ìý But first care.data - the NHS England initiative to collate and share data from our medical records.

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Given recent events - Brexit, the fight over the leadership of the Labour party, the fight over the leadership of the Conservative party, the football in France and Wimbledon -Ìý you may have missed NHS England’s announcement. ÌýThree years - and millions of pounds in - the controversial initiative has been pulled. ÌýWe invited both NHS England and Life Sciences Minister, George Freeman, to come on to the programme to explain the U-turn, but no one was available. Fortunately Inside Health’s Dr Margaret McCartney is on hand to provide a bit of background. Margaret, could you outline what the care.data initiative was, and what it was supposed to achieve?

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McCartney

This was an enormous scheme that was based in NHS England – and that’s important, it was only happening in NHS England, so an English only system.Ìý And it was designed to link all general practice and hospital records, all the medical records of all the patients in a big organisation called The Health and Social Care Information Centre or the Centre, as it’s sometimes called.Ìý And the idea was that by linking all these records lots and lots of data could be drawn out to understand what was happening to patients, where they were in the system, and got all sorts of information about illness, disease, drugs, medication, hospital use, all kinds of things, a really enormous scheme.

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Porter

And the aim of this scheme was?

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McCartney

Some aims were academic aims, to study disease patterns or courses; some was about prescribing, who was being prescribed what and when; a lot was about data needed for commissioning, use of hospitals, use of nursing homes, use of care services.Ìý All kinds of data, really interactions with the health service covering the entire English population.

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Porter

But care.data got off to a bumpy start.Ìý Geoff Schrecker is chair of the National EMIS user group, EMIS being one of the leading providers of clinical software to GPs in England.Ìý And he had concerns from the outset.

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Schrecker

Obviously each practice has a duty to make sure that its patients are aware of exactly what is happening to the information we store and it wasn’t at all clear to us what was going to happen to this information and for what purposes it was going to be used.

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Porter

And because of that uncertainty in the early stages I mean a lot of practices erred on the side of caution didn’t they.

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Schrecker

Yes, I mean a lot of practices once we were given the option for patients to opt out felt that they should opt all their patients out until they had consulted them.

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Porter

And at what stage did you get that reassurance or did you ever get it?

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Schrecker

We didn’t get it, no, I think this was one of the fundamental problems with the programme.Ìý If anyone in the programme was exactly clear what they were trying to achieve they weren’t managing to communicate that either to patients or to the GP surgeries.Ìý And I suspect it was that they weren’t entirely clear from the outset what they wanted the data for.Ìý There was a sense that somebody had the idea that there’s all this data, which must be very useful, so what we need to do is get it and then think what we can do with it.Ìý And as anyone who works with data knows that’s not a very sound basis on which to proceed especially when you’ve got patients’ identifiable data.

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Porter

What sort of concerns were raised by your patients?

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Schrecker

I think very similar to the concerns that we were raising which was well what are they going to do with it, what do they want to use it for.Ìý There was a lot of concern about whether it would be passed on or used by commercial concerns because for the most part our patients are very happy for the NHS to use their data and to a slightly lesser degree for charities to use their data but they do feel uncomfortable about commercial concerns using their data without them actually knowing about it and giving consent.

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Porter

Margaret McCartney, NHS England went to great lengths, including sending everybody leaflets, to try and reassure people but in the end it didn’t work.Ìý But we should point out that in general collating and sharing this sort of clinical data can be a very, very good thing and it’s something we should strive to achieve.

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McCartney

Yeah, I mean Geoff is completely right that there are just so many purposes that this data can be put to and that’s the big problem because NHS England really didn’t make it clear in the care.data programme what data was going to be used for whom and when and whether different restrictions would be placed on to that or not.Ìý And I have to say I think that people were treated pretty badly during it, so they did indeed – NHS England did organise a leaflet drop to try and explain care.data but it went into most people’s junk mail, so I think we need a little bit more information before we can make proper choices about where our information goes and why.

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Porter

Well the care.data initiative may be dead in the water but the idea’s definitely not gone away.Ìý So what happens next?Ìý Geoff Schrecker.

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Schrecker

Well I hope that what will happen next is that the Centre clarify what it is that they’re actually trying to achieve and sit down with those people who have been using this sort of data for years.Ìý So if the Centre were to sit down with them and talk about how they do it and how they do it safely and with good patient information and obtaining patient consent properly I think this would be really helpful to the progress of the health service.Ìý But it’s got to be open, it’s got to be very clear and patients and practices must know exactly where they stand in terms of who’s having access to what data.

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Porter

Margaret, what would you like to see change about the next attempt to do this and can we learn anything from what’s been going on in the rest of the UK?

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McCartney

Yes, so there’s now a public consultation in NHS England and I would urge people who are interested to go and have a look on their website and respond to it, you’ve got until the 7th September.Ìý I think it’s really useful to think what kind of information do we want to share and what do we not want to share.Ìý And I think there’s a great deal we could learn about what’s happening in the rest of the devolved United Kingdom.Ìý So what’s really interesting is that in Scotland, Wales and Northern Ireland there are already schemes that are being rolled out or are already in process doing very similar things with this kind of big data management but it’s been very uncontroversial.Ìý And I think the reason is that they’ve done it in a very different way, they’ve been really clear about what the data is for, they’ve said it’s limited to bona fide researchers, they are very careful about identifiable data, most places are pseudo-anonymising the data which means that it loses lots of links to the individual person, so it’s extremely difficult to identify that person.Ìý And there’s been patients involved at a much higher level in decision making in most of the organisations here.Ìý And part of the difference for me is the way that the devolved nations have made it very clear, I think, that the purpose of this data is for the NHS and the NHS population, rather than for the commercial sector.Ìý And I think because they’ve drawn this line between them it’s been better accepted in general and it’s been much less controversial because of that.

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Porter

Thank you Margaret and thanks to GP Dr Geoff Schrecker who was talking to me down the line from his surgery in Sheffield. As ever, there is more information on the Inside Health page of the Radio 4 website.

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There are over five million people in the UK - children and adults - with asthma. In its mildest form it is little more than a minor inconvenience, easily managed by taking the odd puff on an inhaler. But at least 250,000 people are at the other end of the spectrum and have severe asthma, and their breathlessness can be both life altering and life threatening.

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Wendy Lovegrove was diagnosed when she was seven years old.

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Lovegrove

It’s just the constant trips into hospital.Ìý From one week to fortnightly for quite a long time.

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Porter

And this is because you were having severe attacks?

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Lovegrove

Yes, and I don’t know why they were happening but I would step up to get off the sofa to go to the bathroom, I would have an asthma attack.

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Porter

Describe what that feels like to someone who’s not had an asthma attack.

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Lovegrove

It’s kind of scary really because you can’t breathe, you can’t control the sensations that are actually going through your chest.Ìý You’re just fighting all the time, you panic, it felt like I was being suffocated.

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Porter

If you’re going into hospital that often, potentially life threatening attacks, I’m assuming you were taking lots of medicines?

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Lovegrove

I was taking steroids, I was taking my purple and my blue inhalers…

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Porter

Your preventer and your relieving inhalers.

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Lovegrove

Yeah and I was montelukast tablets as well.Ìý I was also on aminophylline and also I was on the [indistinct word] trial as well for three years.

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Porter

So you were on pretty well everything that’s…

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Lovegrove

Everything going.Ìý

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Porter

On a typical day in the UK three people will die and nearly 200 people will be admitted to hospital because of asthma attacks and despite the NHS spending almost a billion pounds a year on asthma, these statistics have remained stubbornly consistent over the last decade. We are not making the sort of progress we should be. But why?

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One reason could be that we have seen asthma as a single condition and apply a one size fits all approach to treating it - typically something to open up the airways (a reliever) and something to reduce the inflammation (a so-called preventer).

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But now there’s a dawning realisation that asthma is anything but one disease. Which explains why the one size fits all approach to therapy has been failing to control symptoms in some of those most at risk.

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Using a combination of two markers of airway inflammation - a breath test known as FENO and a readily available blood test – doctors can now stratify patients with asthma into different sub groups and tailor their treatment accordingly. It is personalised medicine which could soon be available at a GP surgery near you.

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To learn more I went to the Churchill Hospital in Oxford, to meet Professor Ian Pavord.

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Pavord

A big advance has been that we’ve discovered simple measures that can tell us about the activity of the inflammation in a patient’s lungs.Ìý And these are measures that could be done in primary care, so they’re not highly complex technical measurements, so simple breath tests rather like a roadside breathalyser test can give us a very good insight into whether the airways are inflamed and whether the patient is at risk of asthma attacks.

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Porter

Now this isn’t the conventional breath test that we’ve been doing for years in general practice, the peak flow, spirometer, etc., it’s something different, can you explain how it’s different?

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Pavord

Yes, this is a test that measures the amount of nitric oxide in your breath.Ìý Nitric oxide is produced by the lining of the airway when it’s inflamed.Ìý And luckily for us it’s only the sort of inflammation that we see in asthma that causes increased nitric oxide in the breath.Ìý So the finding of increased nitric oxide in the breath is a very specific indicator of asthmatic type inflammation, we call it Type 2 inflammation in fact, that’s the correct term.

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Porter

And that’s irrespective of the patient’s symptoms, it’s an independent marker of whether there’s inflammation going on in the lungs, whether or not they’re noticing that they’ve got an issue?

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Pavord

That’s right.Ìý So symptoms and traditionally lung function tests like the peak flow meter, that you mentioned, give us a very poor perspective on the likelihood of there being inflammation.Ìý So what we firmly believe, and there is already evidence that this is the case, is that we need to extend the assessments we do in people with asthma and other airways disease to include measurements of how inflamed their airways are.Ìý And in doing that we’re able to make much better, much more precise treatment decisions.

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Porter

So if you have a patient who has difficult symptoms but a low reading on this it suggests that there’s not conventional inflammation going on, so there’s little point in you or I increasing the dose of their inhaled steroids for instance.

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Pavord

That’s absolutely the case but unfortunately that is often what happens.Ìý Many of these patients are taking treatment which has the potential to cause side effects with perhaps little gain.Ìý So we need to realign their treatment and focus perhaps on other aspects of the disease where intervention might be more fruitful.

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Porter

Like nearly every GP I don’t have ready access to the nitric oxide test – even though NICE is keen to see it used in primary care – so I was interested to see the small machine on Ian’s desk. I have had mild asthma in the past but haven’t needed to use an inhaler for years. Time to find out if my chest is as good as I think.

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FENO test

Porter

You’ve got one in front of you here, just talk me through how it works then, I mean it’s about the size of a paperback.

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Pavord

Yes, it’s a rather nice bit of kit.Ìý I’ll switch it on first.Ìý We have a disposable mouthpiece here, which does cost about £10, so there is a running cost, and in essence I breathe in through this mouthpiece, the air that comes into my lung goes through the machine and all the nitric oxide from the environment is removed.Ìý And then I exhale at a standard rate for 10 seconds and then a minute later the machine will tell me what my nitric oxide is.Ìý Now normal nitric oxide concentrations are under 25 parts per billion, a reading over 50 tells me that you’ve definitely got Type 2 high inflammation and you will respond to inhaled steroids.Ìý If you don’t I will suspect you’re not taking them.Ìý The other thing we can say is that a high nitric oxide really identifies you as a patient who’s potentially at risk of asthma attacks unless I give you the appropriate treatment.

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Porter

I’m slightly – 20 years of inhalers, I’ve been well for about 10 years.

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Borg

What you want to do is put your mouth round just the little end bit there, you take a breath in like you’re sucking through a straw – so you go [inhale] – like that.

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Porter

Okay.

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Borg

So it’s a breath in first.Ìý Light up all the green – all the dots into the orange – that’s it and now breathe out for me.Ìý That’s it, just a bit harder, just a bit harder, that’s it and keep it in that green bit.Ìý Perfect, fantastic, that’s really good.Ìý Just a few more seconds.Ìý Three, two, one, first time.Ìý Excellent.

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Pavord

You’ve got very good breath control.

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Porter

Have I?

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Pavord

You should be a trumpet player.

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Porter

No, well no, my music teacher wouldn’t agree with that.

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Pavord

So actually you have an elevated nitric oxide so you probably do have a bit of Type 2 inflammation.Ìý You’re not above the 50 mark, where there would be a very definite indication, but yes if in any doubt get back on your brown inhaler.

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Porter

Well that’s taught me, hasn’t it, physician heal thyself.

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Specialist asthma nurse Katie Borg operating the FENO machine there, but it is not the only way to pick up worrying airways inflammation….

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Pavord

The other is a simple blood count, the sort of test that you have if your doctor thinks you might be anaemic.Ìý And we know that the number of a certain white cell in the bloodstream tells us a lot about the presence of this Type 2 high inflammation.Ìý So there’s a cell type called the eosinophil and patients with Type 2 high inflammation usually have a higher level of those cells in their bloodstream.

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Porter

So let’s say you’ve successfully identified this subset of difficult to manage patients, conventional therapy’s not working well for them, what can you do about it with this new found knowledge?

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Pavord

We can say two things:Ìý firstly, they’re at risk, we know that asthma attacks and particularly severe asthma attacks, occur in this subgroup of people much more commonly than in the Type 2 low group.Ìý So that’s the first thing.Ìý The second thing is we can say on average you will respond well to steroids, so are you taking it – the first question – because many patients are sceptical about the need for regular treatment, you know that as well as I do.

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Porter

Now let’s assume they’re doing that.

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Pavord

Well some are and we do see people with Type 2 high asthma that clearly are taking their inhalers and they’re taking them at high dose.Ìý And here we have a bigger met need for new treatments and the class of treatments called biological agents were trialled in asthma in the 1990s and these are very specific inhibitors of the pattern of inflammation that we’ve been talking about.Ìý And they failed in clinical trials and were put on the back shelf of the drug companies.Ìý And the reason they failed is that a lot of patients who participated in the trials had Type 2 low asthma and they didn’t have the process that the biological treatment inhibited.Ìý When we revisited these drugs 10 years later and gave them very carefully to the people we knew had the right pattern of inflammation we had dramatic clinical benefits.Ìý And so we have, it’s up to NICE, but hopefully within the next few months we will have biological treatments which are very specific and very effective inhibitors of the process.

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Porter

How effective is the drug?

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Pavord

So if your biomarker high, so if your blood eosinophil count’s high and your FENO’s high you can expect between a 50 and 80% reduction in asthma attacks.Ìý In the right patient the impact of these biological treatments is huge.

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Porter

Ian Pavord, Professor of Respiratory Medicine at the University of Oxford. And there is more information on our website.Ìý Where you will also find details of how to get in touch. This listener, who wished to remain anonymous, emailed to ask about a problem with his face.

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Listener

I’m 52, male and I have had acne rosacea on my face for all of my adult life.Ìý It’s an embarrassing and painful condition which gets worse with stress.Ìý Cortisol cream is only sporadically helpful.Ìý Please will you look at this on Inside Health?

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Porter

Around three million people in the UK are thought to have some degree of acne rosacea, many undiagnosed and untreated. Dr Bav Shergill is from the British Association of Dermatologists.

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Shergill

It’s characterised by redness on the cheeks, forehead and chin area and sometimes on the nose.Ìý You can white heads or red blind spots associated with it too.Ìý And it can be very disfiguring and very embarrassing.

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Porter

When does it typically start – who’s most affected?

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Shergill

My classic patient is usually someone in their 30s, most commonly female and they report that they were blushing and flushing when they were children and that now the redness seems to be permanent and they’re also getting spots which they can’t account for because they thought that they’ve got over their teenage acne.

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Porter

Do we know what causes it?

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Shergill

There are quite a few theories about what causes rosacea, which in my experience usually means that we don’t fully understand what’s going on.Ìý We think that there’s an innate immune response, possibly to mites that live on our skin, these are called demodex mites and they cause an irritation in the skin which leads to a lot of inflammation so the body’s trying to clear these mites but it can’t do it successfully.

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Porter

So looking at what our listener’s been doing, he has been using some hydrocortisone cream which is an anti-inflammatory, it dampens down the immune response, is that appropriate in rosacea?

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Shergill

Oh definitely not.Ìý It’ll give you a very short-term relief but all it will do is when you try and stop the cream you’ll have a flare up of your condition.

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Porter

So don’t do it.Ìý

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Shergill

Don’t do it.

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Porter

So what should he be doing, what’s the latest – what’s the latest thinking on treatment?

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Shergill

There’s a few different approaches but you have to remember you’ve got patients who’ve got a lot of flushing and unstable skin, their skin flushes when they go from one environment to another, so we can treat that particular flushing response with low dose beta-blockers, some people use lasers to try and reduce the amount of capillaries that are in the skin, so that background redness goes down.Ìý But I’m more interested in that inflammatory response, the inflamed lumps that come up on the skin and I’ve found recently using cream based anti-parasite medications, there’s some phenomenally good results that are coming through.

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Porter

And these are applied, what, daily and is this a treatment that you have to continue all of the time?

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Shergill

What we’re finding is you need to apply it daily for up to about three months and you seem to get a response within about two weeks or so, which is again very unusual for a cream based treatment.

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Porter

And the active ingredient in that cream is what?

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Shergill

Ivermectin.

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Porter

And that works by killing these demodex mites presumably?

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Shergill

Ivermectin is something that we’ve been using for years to treat scabies and we’ve found, as most things are, serendipity, that if you treated people with scabies their rosacea improved at the same time.Ìý And so the penny dropped and the race was then on to produce a cream based product.

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Porter

That may be one of the newer treatments but there are lots of people out there with rosacea who are being more conventionally treated and I’m thinking of people who are perhaps on antibiotics in either the form of a gel or on long term tablet versions or other gels that we use.Ìý So what’s the evidence behind those now, are they falling out of favour or are they still being used?

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Shergill

They can work very effectively but not in the way that you would think.Ìý There’s no bacteria that they’re killing, they have other properties which dampen down this innate immune system that we have, the kind of first line defence that we have in our skin.Ìý And they work in very clever ways and we’ve learnt a lot about our immunity by looking at how these drugs work in conditions such as rosacea.Ìý So you don’t need to have a bactericidal, so you don’t have to have a dose of antibiotic to actually kill bacteria, you can have actually a low dose of those drugs but still get the benefit on your skin in rosacea.

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Porter

So that’s what happening – antibiotics are effective?

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Shergill

They are effective and if someone wanted to find out what I would recommend for rosacea I think first of all education, look at your triggers, certain things like alcohol, spicy foods and stress, identify what makes things worse before going down the prescription route.

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Porter

What’s the outlook for these people – let’s say the simple case – a woman in her mid-30s who’s got some quite unsightly redness on her nose, cheeks, maybe her chin as well, if she gets treatment early can she look forward to having a normal complexion?

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Shergill

I think a lot of these patients do have a kind of background sort of high colour or redness in the skin prior to getting rosacea itself, you know with the inflammation and the spots and so forth, so you can expect to go back down to the baseline of where they were before.Ìý So if they’ve always had ruddy cheeks, they will have ruddy cheeks once you’ve treated their rosacea.

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Porter

What’s the outlook if they don’t treat it?

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Shergill

Well this is interesting – for women I mean they have a lot of distress trying to cover up acne or what they think is acne on the skin, when actually it’s an inflammation, so they have to use lots of cover up makeups and so forth.Ìý Often, once they reach menopause, it seems to subside, we’re not quite sure why that happens.Ìý For the men they can have persisting rosacea all the way through their adult life and for some of them this can lead to a scarring process, we call it a fibrosis, which leads to unsightly appearances, such as a rhinophyma, which is thickened skin on the nose, very bulbous nose but also within the cheeks and on the forehead too.

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Porter

That change in the nose will be something that everybody will have seen, I mean it looks a bit like a strawberry on the end of the nose doesn’t it?

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Shergill

Yeah it does, very sort of prominent pores and follicles in there, a much larger nose than the patient would have had when they were in their early 20s and 30s and very, very distressing.

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Porter

That’s consultant dermatologist Dr Bav Shergill.

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Now, to the first of a new series dedicated to happy accidents that have altered modern medicine. You know the sort of thing - Fleming and his team leave the lab window open, mould gets in to the bacterial samples they are growing and the antibiotic era is born.Ìý But I bet you never knew that the pacemaker was also an accidental discovery. Here’s Dr Margaret McCartney and Carl Heneghan, Professor of Evidence Based Medicine, with the story.

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Heneghan

Artificial pacemakers are there to provide an electrical pulse to facilitate the normal beating of the heart.Ìý Initial trials of trying to do this resulted in very large unwieldy external machines that delivered painful external shocks, so you can just imagine how gruesome that was.Ìý But in 1958 a chap called Wilson Greatbatch, whilst working in his barn, believe it or not, set out to create an implantable recording device, important is the recording device to be used by the time by the Chronic Disease Research Institute in the US. But happened is apparently, and this is in his obituary in the New York Times, he reached into the box of parts for a resister to complete the circuit and he pulled out one that was actually the wrong size and when he installed it in the circuit instead of recording it produced an emitted intermittent electrical pulse.Ìý And so what happened is instead of having a recorded device he’d suddenly discovered a device that could emit a pulse and he knew it mimicked the heartbeat and suddenly he’d invented the pacemaker.

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Porter

So he was looking initially at a device that would record the electrical signals of the heart, so you could tell what was wrong with it or right with it, and he ended up producing something that overrode it?

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Heneghan

And exactly that because he was working for a research institute, so in research we like to measure things and it was that ridiculous almost mistake that led to the pacemaker.

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McCartney

I read a fantastic oral of this chap describing his career and he describes having monthly meetings in his town of Buffalo where they tried to get equal numbers of doctors and engineers along, up to 50 came along every month, to discuss contemporary problems and how they might fix them.Ìý And if the doctors identified a problem they would send along an engineer for free just to go and see what they could do to try and help.Ìý And when he went to see a Dr Chardack about something else completely, he said he couldn’t help with that but he said look I’ve got a great idea for this internal pacemaker.Ìý And he was very interested and along with a Dr Gage, the three of them end up working together on it.Ìý So it’s a great example of cross working across different specialities, people with great ideas coming together with lots of forums to discuss and chat and work out the best way forward.Ìý I find it a very heartening story.

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Porter

But I love that it all started by putting his hand into this box and pulling out the wrong part, I’m not sure it was quite that simple.

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Heneghan

I can imagine the thought of integrity now of research and thinking you’re in your local barn and it’s like being in your shed, isn’t it, and your toolbox and pulling out.Ìý But there’s obviously something about this chap Greatbatch because he patented more than 325 interventions in his lifetime so he was obviously doing something right.

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Porter

Margaret McCartney and Carl Heneghan - and more on happy accidents later in the series.

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Just time to tell you about next week when, after the enforced retirement of England cricketer, James Taylor, we examine the evidence behind screening those taking part in sports for hidden heart problems that could threaten their lives.