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INSIDE HEALTH

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Programme 6.

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TX:Ìý 08.08.17Ìý 1530-1600

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PRESENTER:Ìý MARK PORTER

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PRODUCER:Ìý ERIKA WRIGHT

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Porter

Coming up today:Ìý A pioneering new initiative in schools, hoping to change the next generation’s attitudes to health and illness by encouraging them to be less dependent on doctors and pills.

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Clip

I’m seeing a society which is becoming increasingly medicalised, there is, at the moment, an easy contract between the population, as it were, and the health professionals that whatever’s wrong with people we will deliver a solution.Ìý And this is a long term investment, it’s a punt, it’s a gamble in a way to address a moral, practical and philosophical issue upstream in the hope that in 10, 20, 30 years’ time we’ll have people who are more mindful, robust, resilient, intelligent around their health.

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Porter

And Margaret McCartney and Carl Heneghan are back for another insider’s view of the world of clinical research.Ìý This time examining why so few trials translate into real world benefits for patients.

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But first breast cancer and a major risk factor that you have probably never heard of – breast density. Women who have more glandular and supportive tissue tend to have denser breasts, while those with less dense breasts tend to have a higher proportion of fat.Ìý So it’s not about the look or feel but what they’re made up of, something that can only be picked up on X-ray, mammography, where dense breasts appear whiter and less dense ones darker.

Up until recently it is a characteristic that has been largely ignored here in the UK but that looks set to change in light of research that tissue density isn’t only a major risk factor for breast cancer, for many women it is THE most important one.

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Karla Kerlikowske is Professor of Medicine, Epidemiology and Biostatistics at University California San Francisco.

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Kerlikowske

So we did the largest study that’s ever been done with over 18,000 breast cancer cases and over 200,000 women.Ìý By and large breast density was the most important risk factor, whether you were pre-menopausal or post-menopausal.Ìý Breast density accounted for over a third of breast cancers in pre-menopausal women and in post-menopausal women it was 26%.Ìý Other risk factors, such as family history of breast cancer, less than 10% of breast cancer develops because of having those risk factors.Ìý And I always give the analogy is if you get rid of smoking you would basically eliminate 70% of lung cancers.Ìý And you can think of this in a similar way.Ìý If all these women who had high breast density, if we could reduce them to have average breast density, in pre-menopausal women we’d eliminate the development of 39% of breast cancers and in post-menopausal women 26%.

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Porter

And would the woman herself have any idea, assuming she’s not been told by the doctor, that she has dense breasts, is it related to size, to the nature of the breast, how they feel – can you tell externally?

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Kerlikowske

You cannot tell externally, it really is a radiographic term.Ìý So in the United States on every mammogram report we assign the assessment of breast density.Ìý And in qualitative terms we put it in one of four categories.Ìý Least dense, then there’s scattered fibro glandular densities, that’s – there’s a little bit of density but not much.Ìý So those are both considered non-dense.Ìý And then there’s the two dense categories, which is heterogeneously dense or extremely dense.Ìý Because of that there’s now laws in 32 of our 50 states saying you have to tell the woman what her breast density is because we feel it is an important risk factor.

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Porter

What determines breast density?

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Kerlikowske

Breast density is primarily determined by genetics.Ìý It’s estimated 45-60% of breast density is heritable and then that other 45% of breast density can be modified.Ìý And one of the things that modifies it the most is ageing – after menopause there’s a slow decline in breast density.Ìý Breast feeding is thought to reduce breast density.Ìý Tamoxifen or drugs that prevent breast cancer can reduce breast density.

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Porter

What proportion of women have dense breasts?Ìý I mean this grade three or four, the ones that you’d be more likely to worry about?

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Kerlikowske

If you look at the population that generally gets screening mammography, which is between age 40 and 74, it’s about half of all women.

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Cuzik

It’s actually very common and really not known at all.

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Porter

Professor Jack Cuzik is Head of the Centre for Cancer Prevention at Queen Mary, University of London.

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Cuzik

In terms of the more common factors it dominates things like weight or like alcohol consumption.Ìý It’s more important than things like hormone replacement therapy.Ìý So it really is an important factor.Ìý The problem with dense breasts is that it essentially makes, in some cases, the breasts completely white.Ìý Now the way you would detect a cancer with standard mammography is to look for white spots on the breasts, so they’re completely hidden and you just can’t see them.

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Porter

You get a sort of white out of the picture effectively.

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Cuzik

You get essentially a white out, so you can’t actually always see cancers, they’re hidden by this whiteness, that’s called masking.

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Porter

So not only are they at increased risk but actually if they do have an early cancer that it’s harder for a radiologist to spot, so it might be missed.

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Cuzik

That’s correct, it might be missed yes.Ìý And it’s very clear that it is being missed in many cases.Ìý So there’s a lot of discussion about women who have dense breasts probably don’t get as much protection from a mammogram so they need additional screening – ultrasound screening, in some cases MRI screening.

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Porter

And does MRI get round this sort of snowflake in a snowball problem of the cancer being whited out by the density?

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Cuzik

Yes it does.Ìý MRI uses a completely different mode of detection, it’s not x-rays, it’s magnetic changes in the breast.Ìý And they don’t see the white, they can actually see through it.

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Porter

What are we likely to see change in the UK as a result of this latest research?Ìý I mean are women going to start being told whether they’ve got dense breasts or not?

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Cuzik

There’s ongoing work that’s actually really very much been developed in Manchester really trying to report this back to women and it should really be part of an overall risk assessment.Ìý We have a risk tool that integrates all of the other factors, like family history and weight and hormone replacement therapy use, and breast density’s a very major part of that.

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Porter

We heard there about the four gradings of density and three and four being potentially the problem groups but obviously there are some women out there who are grade one, who’ve got less dense breasts than normal, does that mean that they’re at considerably lower risk than the average woman?

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Cuzik

You’re right, they’re really are two aspects to this.Ìý Some women have got dense breasts, they need more screening, more attention, some have fatty replaced breasts, it’s either fat or dense tissue, they need less screening and I think that will be a sort of political issue as whether or not we can tell women that they don’t need to be screened quite so often in some cases.

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Porter

But if we’ve known that women with denser breasts are at higher risk I mean has there not been a case for looking at screening these women more often, more aggressively?

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Cuzik

I think there is a case for that and that’s only now being recognised because the screening programme has been very much unless you’re at very high risk, based on family history, they’ve always been one size fits all and that’s something we hope to change.

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Porter

What about the way that we screen these women, what does the research tell us so far, I mean you say that mammograms are difficult to interpret, should we be doing more tests routinely on women with breast density?

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Cuzik

There’s a lot of interest, there’s a so-called new development called fast MRI in which you can do an MRI in about three minutes rather than a typical half an hour.Ìý And this of course will bring the cost down.Ìý One of the challenges of MRI is that it’s very expensive.Ìý So bringing the cost down will make this much more attractive and I think quite a good option.Ìý One of the interesting discoveries is that for women at high risk, where we offer preventive therapy, the benefits of preventive therapy can be measured immediately in terms of a reduction in breast density and that’s quite exciting because some women get big reductions in breast density and they’re the ones that seem to get the best response to these treatments.

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Porter

And that’s using medications like tamoxifen is it – giving these high risk women – and you can actually see their breast density shrink along with their risk?

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Cuzik

Absolutely.Ìý It takes about six to 12 months for this to happen but rather than wait five years and hope for the best, which is what we do with these treatments now, we are beginning to get a signal at about six months as to whether the treatment is actually working.

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Porter

But how is the realisation that density is such an important factor impacting on current screening practice? ÌýInside Health’s Dr Margaret McCartney.

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McCartney

Well in the UK there is a programme for women who are at higher risk of breast cancer but that’s mainly about genetic risk or women who’ve previously had radiotherapy to their chest for treatment for a previous cancer, something like that.Ìý Breast density isn’t seen as a separate issue that would increase the need for different or more screening.Ìý In Australia they have looked at the issue and they’ve decided that there is not enough evidence to say that women with dense breasts should be screened differently.Ìý However, in Austria they set up a screening programme in 2014 to basically replace a haphazard system of screening that was already happening and they are identifying women with more dense breasts and they’re offering them extra screening as part of that programme.

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Porter

Are you aware of any changes likely to happen here in the UK because at the moment these women are getting mammography like everybody else, might they get additional ultrasound do we know that?

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McCartney

The breast cancer screening programme is constantly being reviewed and updated, according to the evidence.Ìý I think the big problem is that there is no evidence just now that doing additional screening for these women will extend their lives or improve the quality of their lives, the trials have not been done and that’s the really big issue.

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Porter

What’s your take on breast density being talked about as being for most women the biggest risk factor for breast cancer?

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McCartney

Well when I was a junior doctor I was always taught that breast density was a problem because it made more difficult to read the mammogram.Ìý There could be a breast cancer in there that was hidden…

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Porter

You could miss a cancer.

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McCartney

Exactly, so that was always what I was taught.Ìý And I think what’s coming out now with some of the research is they’re saying that it’s breast density itself that is the risk factor.Ìý And I think it’s quite confusing.Ìý Statistically it’s difficult to untangle and I think there’s still a bit of a debate out there as to whether it’s the breast density itself that’s the problem or whether it’s whatever’s caused the breast density that might be the problem.

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Porter

So there might be some other characteristic that the woman has that makes her breasts dense but also increases the breast cancer but they could be separate pathways.

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McCartney

Yeah there is lots of research that’s really at logger heads with each other.Ìý I don’t think the picture is crystal clear yet.

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Porter

But you’re not disputing that women with dense breasts are more at increased risk?

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McCartney

No, I think that’s well established, there is a clear association between increased breast density and an increased risk of breast cancer.Ìý What we don’t know is what best to do about that.Ìý So we really have to know whether a different type, more frequent or different kinds of screening, would help these women either have a longer life or a healthier life.Ìý So my feeling is that anything we do from now should be in a really high quality trial.Ìý We know that breast screening in general has so much controversy attached, why don’t we try and reduce the uncertainty here by entering women into really high quality trials so we can find out what, if anything, helps?

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Porter

Margaret McCartney.Ìý And there is more information on breast density on the Inside Health page of the Radio 4 website.

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Now to a something that really struck a chord here at Inside Health – an education initiative that tackles over-medicalisation. ÌýRather than just encouraging healthy lifestyles, Facts 4 Life – a new programme currently being piloted in schools in Gloucestershire – teaches young children about illness too. ÌýAnd, perhaps most importantly, that most illnesses are not that worrying and don’t need special treatment by teachers, parents or doctors.

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Intrigued, we went to Park Junior School in Stonehouse to learn more.

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The project is the brainchild of local GP Dr Hugh van't Hoff who had concerns both as a doctor and as a parent.

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van’t Hoff

I think it’s because I’m seeing a society which is becoming increasingly medicalised.Ìý I think we’re medicalising normality, I think we’re treating minor symptoms with major drugs and sometimes people are looking for instant solutions to problems which will settle in time with reassurance.Ìý You have to remember that 90% of the contact between patients and the NHS is done in general practice and most of the people we see in general practice we see for reassurance and we listen to their symptoms and we come up with helpful ideas, hopefully, about why they might get better in time.

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Porter

So it’s your belief that if we’re going to change those attitudes in adults, the medicalisation of society, that we need to start young?

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van’t Hoff

Of course yeah, it’s a punt, it’s a gamble in a way to address a moral, practical and philosophical issue upstream in the hope that in 10, 20, 30 years’ time we’ll have a population of people who are more mindful, robust, resilient, intelligent around their health.

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Carmen

My name is Carmen and I’m year six.Ìý I remember when I had quite a bad earache and I had to stay at home.

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Porter

Do you worry about your health?

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Carmen

No not really because I know that it’s just part of life and most people get better by it.

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Green

My name is Kelly Green.Ìý Part of the Facts 4 Life team.Ìý My role is around the development of the curriculum, so that teachers don’t feel that oh this is another new initiative that we’ve got to add to our workload because they just don’t have the time to do it.Ìý And so it enhances, it’s very much looking at a topic but looking at it through a Facts 4 Life lens.

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Porter

And what’s different about looking at a subject through the Facts 4 Life lens, what are you bringing that wasn’t there before?

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Green

Where traditionally health education has been around all the things that you should do to be fit and well this acknowledges that sometimes you’re not and that’s okay.Ìý So being unwell is a normal part of human experience and how that might look.Ìý So what does illness look like, how might it track on your body, what might you want to do to help your body recover.Ìý And that’s a real central theme to the resources that most of the time for most people they will get better from most illnesses on their own and understanding that the body is remarkably efficient in restoring balance.Ìý What we mean by that is homeostasis – how the body naturally returns to a balance.

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Porter

Okay, so give me an example of how you explain what’s quite a complex concept and I would imagine most children had no idea what homeostasis is.

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Green

Around year three we’ll say okay homeostasis we can explain it by using a balance ball.Ìý So a balance ball like a yoga ball.Ìý And the ball represents the body and then we talk to the children about how an illness might look.Ìý So say a fluey type virus, what might they notice in a fluey type virus.Ìý So they’ll give us examples like poorly tummy or headache, high temperature, feeling tired.Ìý So each child represents one of those different symptoms.Ìý They put a hand on the ball and hold it in balance, so when they’re all working together the body is in balance but when we’re ill some of those systems are compromised in some way.Ìý So say you’ve got a bit of a poorly tummy so the person who’s representing poorly tummy takes their hand off the ball.Ìý We might have somebody else who’s representing emotions, you say oh I’m feeling a bit sad and grumpy, so their hand might come off.Ìý As each hand comes off whilst the body or the ball wobbles it doesn’t actually fall but as more and more compromises are made, there’s more and more problems to encounter, then it could get to the point where they drop the ball altogether.Ìý And that could be oh perhaps we need a bit of help here, what could we do to help get this body back in balance.Ìý And so we talk about well if we’re feeling tired what is it that we need to do.Ìý Well sleep.Ìý Okay, some time and some rest and having some sleep is going to help us feel better.Ìý So we bring that hand back into play.Ìý Bit by bit we unpick how we can do things to help our body recover.

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Porter

And is it a concept that the children grasp like that?

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Green

Yeah, yeah they seem to take to it really well.

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Porter

Looking at standard health education, in the broadest sense, where do you think it’s gone wrong that this might change?

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Green

Traditionally there’s been a lot of focus around very black and white concepts that you have good drugs and bad drugs.Ìý Adults tend to make things black and white because they think that’s simplifying things and actually children are really good at grappling with big ideas.

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van’t Hoff

We can teach children grey.Ìý We have a grey resource, the cover of the resource is grey, and that’s because we see what we’re trying to deliver as helping the children understand that they live in a world that’s grey, it’s neither black or white.Ìý So most of us are not either going to be gobbled up by a crocodile or be Olympic athletes like Mo Farrah, we actually inhabit the hinterland, the land between black and white, the grey areas, we move in and out of illness, hopefully more well than not, but that’s where we all live and children can grasp these ideas.Ìý I think there was some misgivings that these ideas might be too complex for children to grasp but I think the evidence is we’ve shown that they can understand these complex ideas.

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Porter

Do you think historically that we have been too black and white then, that we’ve sort of had health in one pocket and illness in another and never the twain shall meet?

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van’t Hoff

I do, as a profession yes and as a society there is at the moment an easy contract between the population, as it were, and the health professionals and the contract is that whatever’s wrong with people we will deliver a solution.Ìý

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Jaworski

My name is Nina Jaworski. ÌýI’m a reception teacher here so we do an awful lot of work on communication and language.Ìý A lot of children will often say that they have medicine when they’re poorly, so when that comes out we obviously talk about well what can you do to help yourself, what else can you do.Ìý Are you hot?Ìý Are you cold?Ìý What can you do if you’ve got a headache?Ìý Especially with reception a very young age I think, they don’t know what to do, they don’t know how to communicate, so I think giving them the tools, they’re very independent now when they’re hot, all those basic things.Ìý Knowing what to say and what to do.

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van’t Hoff

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I think we need to be happy blurring the margins, we need to be happy with grey.Ìý Children can handle that and I think us adults, medical professions and possibly government need to accept that that can happen.

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Porter

The aims may well be laudable but one of the problems is in this evidence based world that we live in that you need to be able to prove that your intervention is having the desired effect.Ìý Where are you in that process?

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van’t Hoff

I think we’ve got really robust evidence from our partners at the University of West of England that even with a short intervention we can alter children’s attitudes to whether they need medicines when they’re ill and whether they need to see a doctor.

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Bird

My name is Emma Bird and I’m a Senior Lecturer in Public Health at the University of the West of England and I’m the project manager for the independent evaluation of Facts 4 Life.

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Porter

So what have you found so far?

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Bird

We have been working with 10 schools in the Gloucestershire area.Ìý Five of those schools have received the Facts 4 Life lessons and five of those schools didn’t receive the Facts 4 Life lessons.Ìý So we’ve been comparing the attitudes and the health.Ìý Now we’ve just had the findings of that work published and we found that for some of the attitudes related to health and illness they have shown significant improvements after they have received the Facts 4 Life lessons and notably the children who have not received the Facts 4 Life lessons have shown no change in their attitudes.

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Porter

And by improvements you mean what?Ìý I mean how are you measuring a change in attitudes good or bad?

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Bird

So this is one of the key issues we have when we’re doing research with children is how do you actually capture and measure changes in attitudes and behaviours.Ìý So what we did is we asked children to complete a questionnaire before they completed the Facts 4 Life lessons and again afterwards.Ìý Questions around their use of medication, around how much they felt they should go to see the GP if they were feeling poorly, around how they perceived their health and illness attitudes.

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Porter

So looking at the two groups – one the intervention group, one the control group – you found some significant differences.Ìý You gave some examples there about depending on medication or wanting to go and see a doctor, were changes in the scores there regarded as improvements?

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Bird

Absolutely yes, so we were able to show that the children perceived they were less reliant on medication and less reliant on visiting the GP if they were feeling poorly.

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Porter

Researcher Emma Bird on the evidence behind the programme, which obviously treads a tricky path between encouraging children to be more resilient and independent, but not putting them off seeking help when then they need it. ÌýMore details, as ever, on our website.

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Time now for another instalment of our mini-series Inside Clinical Trials. This week Dr Margaret McCartney and Carl Heneghan, Professor of Evidence Based Medicine at the University of Oxford, discuss moving the goalposts, one reason why so few clinical trials result in real changes in practice that benefit patients.

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Heneghan

One of the most important things is trying to pick out the research that matters and to be honest over time that’s got much harder.Ìý The reason for that is how much research is done, there are about 42,000 randomised control trials per year that you might want to look at to say does this make a difference to my patient.Ìý Well the thing is if you think about it 42,000 things are not changing in the healthcare each year.Ìý When I ask GPs, like yourself, and so how many times have you changed practice you go well three or four times and most of them seem to be harms not benefits.Ìý So one of the issues that we know is there must be some fundamental problems in 42,000 trials if they’re not translating into real benefits.

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Porter

Okay Carl, well looking at that in the broadest sense I mean what are the main reasons that these trials aren’t percolating through into real changes and benefits?

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Heneghan

Well I think one of the main reasons is because the outcomes are so poor quality.Ìý One of the things we do in a project, which we found really interesting, is a structural problem, it’s called outcome switching.

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Porter

Put that into lay terms, what does that actually mean?

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Heneghan

It means you say I’m going to measure in this trial the most important relevant outcome is, for instance, death and when I publish it and it’s on a register that’s what you get ethical approval for and when you publish it that’s what you should do.Ìý But we found, and many studies – other studies have had – about a third of all trials switch the outcomes, so they may switch something out and replace it with something that they think is a bit better.Ìý And that’s a huge problem because you’re basically trying to pull the wool over people’s eyes.Ìý And when you talk to people and say this is what’s really going on they can’t quite believe that that actually is possible but that is completely possible in the journal world.Ìý Not only that we wrote to the journals trying to correct it and many of them didn’t even want to correct this, impart the project, because they said well it’s goes on, it’s okay and we just accept this sort of ambiguity in clinical research.

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Porter

So that’s a bit like me coming up with a new train that can get to London an hour quicker and I say right we’re going to set off and then I change the destination to Peterborough?

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Heneghan

I think it’s – I see it’s a bit like you’re at the horse races actually and you let the horse race start and just before you get to the last furlong you say I’m now going to place my bet.

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Porter

When you see who’s winning.

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Heneghan

Yeah and that’s exactly what happens, and there’s some very subtle – you wouldn’t know it was happening unless you looked at it.Ìý A good example is they might say we’re going to measure blood glucose at three months and then all of a sudden you’re really checking detail and you see no actually they’ve reported it at six months or at nine months and actually that subtle change means you can cherry pick the positive outcome and then bury the one that’s not positive and pretend that you were going to do that all along.

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Porter

So using your, presumably, diabetes example it might have had no effect at the period that they were going to look to have the test, so they’ve left it a bit longer or they’ve gone sooner maybe.

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Heneghan

Yeah and the more measures you take the more by chance you’ll get one that’s positive.Ìý So it’s incredibly important that we are strict on this.

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Porter

Margaret?

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McCartney

The sad truth is that if you have a positive result from your trial, if you find that your drug or your intervention has worked, it has more chance of being published in one of the top rank journals.Ìý It’s absolutely absurd because of course negative trials, when things don’t work, are just as important, if not more important, than things that actually work.Ìý We need to know what we shouldn’t be doing as well as what we should be doing.Ìý So there should be no reason why there’s a disparity but yet there is, and it is wrong.Ìý And of course you can see why people who invested a lot of money, time and resources in taking some drug to market they want to have positive results from it, they don’t want to show that something doesn’t work.Ìý So there’s an inherent bias and that’s why it’s so important that that bias is overcome by making sure we don’t switch outcomes.

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Heneghan

So we looked at the top five medical journals and we checked 67 trials and how many of them were perfect?Ìý Only nine.Ìý And what was interesting out of the ones that were not perfect, the 58 others, we sent letters to them journals and do you know what – they only published 18 corrections.Ìý The rest of them just said we are not interested or we’re not going to publish this correction.

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Porter

So not only are people changing the outcomes, it’s not being picked up.

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Heneghan

One of the editors wrote back to us and said – anybody out there can check the trial register, the protocol and the publication and that should be no problem for them.Ìý It’s practically impossible.Ìý We had to have two medical students and a clinician checking and it took on average two hours to do it for one paper.Ìý So the idea that you can do this, the general public, is nonsense.Ìý And actually this is the problem with a lot of research – it just is not clearly strict enough in terms of its quality criteria and it should stick to these things so that when you look at it you can trust it.Ìý Now interestingly we know there’s a huge trust problem because if you got to the Academy of Medical Science report about the problems that exist in clinical research they said that four out of five GPs do not trust clinical research as it currently is.

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McCartney

I completely agree, this kind of gaming that goes on is notorious and it is something I think that makes GPs distrust the latest research when it comes out and want to look at it more closely.Ìý The other problem I think that we really have to take account of is the fact that the outcome that’s being measured in the trial might not be the most important outcome overall.Ìý So there was a trial a few years ago called the Roadmap Study and that was looking at people with Type 2 diabetes and they gave them either a drug or a placebo to try and prevent protein leakage from the kidney which is a relatively common problem when you have diabetes and what they said was if you took this drug it would reduce the protein that was leaking from your kidneys and they therefore conjectured that that would mean you were at lower risk of developing other vascular problems elsewhere in your body.Ìý But what they didn’t say and what was later found out was that actually that drug gave you an increased risk of heart attacks or strokes.Ìý So they’d focused so heavily on one outcome we’d forgotten about all the other ones that really matter.

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Porter

Just spell that out – it’s possible that it had the desired effect – reduced the protein in the urine – but they didn’t notice that the patients were dying of heart attacks and strokes which rather negated its benefits for the individual.

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McCartney

Totally, so patients didn’t actually get a benefit.

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Heneghan

One of the issues I say to people now is I ask just two questions:Ìý I say does it make a difference and if so by how much.Ìý And if you can’t answer them two things we shouldn’t even be using it, shouldn’t be looking at it and it shouldn’t be published in a journal.

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McCartney

And we should be asking what actually matters to patients in terms of what works.Ìý So the study I mentioned you lose a little bit less protein in your urine, is that an effect that the patients notice, well actually you might notice if you get an increased death rate of taking that drug.Ìý So unless you’re measuring things of value to patients you really may as well not be doing it at all.

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Porter

Margaret McCartney and Carl Heneghan.

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That’s it for this series. ÌýThank you for all your feedback.Ìý We are back in September and we would love to hear from you in the meantime if there’s something you would like us to look into. ÌýYou can email us at insidehealth@bbc.co.uk. ÌýUntil then, goodbye.

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ENDS

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