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Meningitis B vaccine came too late for 22 month Harmonie who contracted it a year ago

We are looking for volunteers with a past history of postnatal depression that started for the first time within 6 weeks of having a baby. We are also recruiting mothers who have suffered from a depression in the past, but NOT after having a baby.ÌýThis is not a treatment trial and participation in this project won’t help you directly. However, we hope that this project will help us better understand why some mothers suffer from depression after having babies. The project includes taking pictures of your brain with a brain MRI scan, some questionnaires, and a blood test.

If you have any questions, please contact:Ìý

Vladi Stoencheva at the Institute of Psychiatry, London:Ìý

Vladimira.stoencheva@kcl.ac.uk

Tel:Ìý0207 848 0942

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INSIDE HEALTH

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Programme 1. -Meningitis B, Hormones and depression, Statins, Unexpected heart attacks

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TX:Ìý 01.09.15Ìý 2100-2130

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PRESENTER:Ìý MARK PORTER

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PRODUCER:Ìý FIONA HILL

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Porter

Hormones and mental health - we examine the evidence behind claims that HRT and other hormone treatments should be used more often to help women with depression.

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To take a statin, or not to take to take a statin? That is the question. But is it right to pay GPs to put millions more otherwise healthy people on the cholesterol lowering drugs? ÌýNICE thinks so - or at least it did - it now seems to have changed its mind.

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Clip

What we’re doing, it’s not a U-turn, what we’re doing is listening to some of the concerns that we had from GPs and going to pilot it in practices to see if it really is that challenging to attain.

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Porter

And heart attacks in middle age - a recognised hazard if you smoke, are sedentary or you’re overweight. But quite a shock if you are a clean-living cyclist? And a doctor to boot.

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Miller

Heart attacks only happen to patients, they don’t happen to doctors.Ìý

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Porter

Not clean living sporty doctors like you, no.

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Miller

It was not on my agenda, so this was a bit of a surprise.

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Porter

I will be discovering why heart attacks don’t always follow the rules a bit later, but before that - a world first.

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As of this week the UK has become the first place to incorporate the new vaccine against the most feared strain of meningitis - Men B - into its routine immunisation programme. Albeit after a lengthy delay due to protracted negotiations between the Department of Health and the vaccine manufacturers GSK.

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A delay that meant its introduction has come too late for 22 month old Harmonie who contracted Men B a year ago. Her parents Freya and Ross first noticed something was wrong in the middle of the night, but doctors at the local hospital couldn’t find anything serious and sent her home twice over the weekend before finally admitting her for observation. Only then did the gravity of her condition become apparent.

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Freya

I picked her up and she was sick everywhere, so I called a nurse in and the next minute we looked up on her nose and the nurse noticed it straightaway and she had a purple mark, it was like a bruise, on her nose.Ìý The nurse didn’t even say anything, she just ran and then it’s all a bit of blur then, it just was an emergency.

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Porter

And that purple patch was the start of the serious rash.

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Freya

Every time I looked at her the rash was just growing and growing everywhere, like it was just covering her whole body.Ìý They told us that it could be meningitis but they didn’t know what type yet.Ìý

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Porter

So they took her to intensive care and how was she by the time she arrived there?

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Ross

When we saw her she was just a totally different child.

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Freya

I’ve never seen anything like that before, so I’d thought they were going to tell me that she’d already gone but obviously they just said she’s fighting and we’ve got all these machines like helping her stay alive.

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Porter

Other than the fact that she was obviously unconscious had there been any change in her appearance?

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Ross

Her kidneys – her kidneys failed, all her face was bloated, her whole body was bloated where all the fluid was building up in her body and not releasing it.

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Freya

And then she was just literally purple from head to toe.Ìý And then as the days went on she started going black.Ìý The fingers went first and her feet and then her legs, the whole of her legs went black.

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Porter

So where the rash had clustered together – I mean the tip of her nose, her arms and legs – I mean they basically turned gangrenous in front of you?

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Freya

Yeah.

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Porter

It must have been awful for you.

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Freya

I don’t even know how we got through it now but…

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Porter

But you did get through it and so did Harmonie, as we can hear in the background there.Ìý She responded to the antibiotic treatment, that got rid of the meningitis but she’d been left with some terrible injuries as a result of the septicaemia.Ìý What happened to her afterwards?

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Freya

So she had both arms and legs amputated and also her nose.Ìý At the beginning we were told that she was going to be a torso with absolutely no arm or no leg, so we’re quite lucky that she’s actually through knee on both legs and she’s through elbow on one arm and then she’s halfway up the arm – the top arm.

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Porter

And how have you coped since – or how has she coped since, she sounds like she’s doing…?

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Freya

She’s amazing.Ìý She’s full of life, it’s crazy, when I look at photos it just doesn’t look like her and she’s just recovered so well, she’s adapted amazingly.Ìý She’s obsessed with doors.

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Porter

Moving must be a bit tricky for her so how does she get about, she bum shuffles everywhere does she?

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Freya

Yeah she bum shuffles all around and she used to roll but now she’s discovered how to bum shuffle.Ìý It was just a couple of days ago she tried pulling herself up on the sofa, so hopefully soon she’ll be up on leg – on like what’s left of her legs.Ìý Hopefully we’ll be measured up in September for Harmonie’s prosthetic legs, yeah that’s just our next step.

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Porter

This might be a difficult question but how do you feel now that – about the launch of the vaccine, I mean it was too late for Harmonie?

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Freya

Yeah it’s a bit bitter sweet obviously because it could have saved Harmonie – Harmonie was born in 2013 when I think I was reading that the vaccine was meant to be coming in in 2013 but I think they said no.Ìý So obviously if they said yeah Harmonie would not be in this situation now and she’d be running round with all her friends and playing and climbing, just like any other child but obviously it’s amazing that nobody else has to suffer what we did and what Harmonie did anymore.

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Porter

Freya, Ross and a very chirpy sounding Harmonie. Margaret McCartney is in our Glasgow studio. Margaret who’s going to be offered the new vaccine and when?

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McCartney

As of now, as of September 1st England, Scotland, Wales and Northern Ireland are all starting to offer the meningitis B vaccination.Ìý And that’ll be offered for babies at two months, four months and then again at 12 months for booster dose and that’ll part of the routine childhood immunisation schedule as of now.

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Porter

What happens if a baby’s three or four months old already and has missed out on those first jabs?

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McCartney

That’s right they would have missed out on the first dose but there will be a one-off catch up programme for babies who are just now aged three or four months and they will get the catch up doses, so they will be fully protected against the meningitis B, they will get the full doses anyway for the meningitis B vaccination as well.

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Porter

But not so good news for older babies or children who will miss out - and, if experiences at my practice are anything to go by, that has upset some parents. Sue Davie is Chief Executive of Meningitis Now - a charity of which I am a patron and which has been pushing hard for the early introduction of the vaccine.

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Davie

There is a huge amount of concern Mark and obviously with the catch up programme only going up to four months then any child born before that isn’t going to benefit from this vaccine free, it’s still available privately but for many that’s out of reach.Ìý From our perspective we know that the under-ones are most at risk and five months seem to be the most at risk within that, but we would have loved to have seen this programme offered to a wider age group from that perspective.

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Porter

Ideally who – because you’ve got to draw the line somewhere haven’t you with these programmes – where would you have liked the line to have been drawn?

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Davie

I think as ever with these things with under-fives being most at risk we would have loved to have seen it go that far but even under-ones I think we would have been really pleased about.

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Porter

So catch up up to school age effectively but at least up to the age of one is what you would have liked to have seen?

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Davie

That would have been fantastic from our point of view.Ìý And I think the challenge that we had, as a charity campaigning for the introduction of this vaccine, was it was so hard to get it through from a cost effective argument perspective that really trying to argue for more of a catch up what we were being told was but that would put in jeopardy it coming in for anybody.

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Porter

It must be particularly frustrating though because this has been going on a long time.Ìý I’m looking at Harmonie, the vaccine was available, it’s not just children who are five months who are missing out, it’s children who’ve been around for longer than that who’ve seen this vaccine – the discovery’s been announced yet it’s not available.

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Davie

That’s absolutely right because this vaccine was licenced back in January 2013 so that meant that it had been tested, everybody was happy with it, it was safe and it was available to be introduced within the UK and it was only at the end of March this year, so two and a bit years later, that we actually got confirmation from the Department of Health that a price had been agreed.

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Porter

To be fair though – and this is a fantastic vaccine – we are the first country in the world to have it, so although there has been delay and maybe the catch up programme’s not ideal, we are very lucky to have it.

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Davie

We are extremely lucky and I think we always say that but recognise that it is too late for many.Ìý We are pleased, this is a fantastic step forward, there’s just a lot more work to be done.

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Porter

Sue Davie from Meningitis Now. And you will find more details on the new Men B vaccine on the Inside Health page of the Radio 4 website.

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Now, if you are a regular Radio 4 listener you may have heard an item on Woman’s Hour over the summer in which gynaecologist Professor John Studd spoke about the importance of considering hormones when helping women with mental health problems like depression.

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Clip – Woman’s Hour

Interviewer

What percentage of women really need this sort of help?

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Studd

I don’t know the answer to that but I see five patients – new patients – a day who have this sort of history.Ìý They all should have transdermal oestrogens and they nearly all will be better within about two months.

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Interviewer

Better – how do you define better?

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Studd

Oh better – no longer depressed.Ìý They can sleep at night, they don’t have arguments all the time.

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Porter

A small excerpt from what was quite a lengthy debate, but it was obvious that Professor Studd feels strongly that many women are missing out because hormone fluctuations are not being given due consideration. There is too much focus on medicines like antidepressants, and not enough on hormone based therapies.

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Which got us thinking here at Inside Health, so we decided to dig a little deeper. Dr Michael Craig is a consultant psychiatrist at the Maudsley Hospital in London where he runs the Female Hormone Clinic which specialises in helping women with mental health problems at times of hormonal flux.

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Craig

There’s a small minority of women out there who seem to have mental health problems that are exacerbated at times of hormonal change.Ìý This is classically women who have problems premenstrually, after pregnancy and around the time of menopause.

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Porter

You say a small number, I mean the inference from the interview that we were listening to earlier on suggests that this is an extremely common problem but you suggest that it’s only for a minority of women?

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Craig

Well if one takes the different phases of the reproductive lifespan premenstrually at the extreme end there is a condition called premenstrual dysphoric disorder – about 5-8% of women would probably fulfil the full diagnostic criteria.Ìý With regards to postnatal depression about 10% of women are believed to suffer from postnatal depression and amongst that group there will be a subset who are probably being triggered off by changes in the hormonal constitution we see at around that time.Ìý And then around the time of the peri-menopause there is figures to suggest a doubling of the incidence of women developing depression.

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Porter

Given how common depression is, just looking at the menopause figures, I mean we’re talking quite a lot of women then, this is a minority but a significant minority of women who may have hormone related mental health issues.

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Craig

Yes, I think it’s important though that although we describe these particular times in the reproductive lifespan what we’re not saying is that all of these women are having mental health problems specifically triggered by hormones.Ìý We know from a social perspective there are all sorts of reasons why, for example, postnatally and around the time of menopause women may also be vulnerable to developing mental health problems.Ìý But there does seem to also be a subgroup of women who are particularly vulnerable to these sudden changes in hormonal concentrations.

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Porter

So do you think we might be underestimating the impact of hormonal flux in these groups, people – pregnancy, menstruation and the menopause?

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Craig

I believe that we are and I believe that it is something that general practitioners, psychiatrists and gynaecologists need to be more aware of and in fact next week is National Premenstrual Syndrome Week where we’re trying to raise awareness of these particular conditions amongst the general population.

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Porter

What sort of evidence is there that taking into consideration hormonal flux and trying to do something about it, for instance with the menopause by giving oestrogen supplementation, is it beneficial, have we shown it to be beneficial in any trials?

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Craig

At the moment the studies are limited but what we do know from the studies that are out there is that women in the peri-menopause who suffer from depression may actually benefit from taking HRT around that time.Ìý And it seems to be because they’re in this period of time where there’s a fluctuation in hormones and it seems to be this fluctuation that’s important in terms of a trigger.Ìý But there are a group of women who may benefit during that time.Ìý I say may because at the moment the number of studies that are out there are limited and the main study that we based this information on was a study made up of 50 women of whom about 26 had what we would call a major depressive disorder.Ìý And although that study found a significant difference between women who were given the hormonal supplementation and those that weren’t we couldn’t really base the results of that to a whole population.

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Porter

Dr Michael Craig who is currently recruiting women to take part in a clinical trial to study the effect of hormones on mood and the brain, details are on our website if you are interested.

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Statins are seemingly never out of the news these days with the latest headlines suggesting that the health advisory body, NICE, may be rowing back on its apparent enthusiasm for offering the cholesterol lowering drugs to millions more people in the UK.

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Margaret McCartney’s here to explain more. ÌýMargaret this all centres around rewarding GPs for using a new lower threshold for prescribing the drugs to otherwise healthy people, doesn’t it?

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McCartney

It does, this is all the dirty truth about how GPs are paid.Ìý So part of the money we get is a kind of lump sum for how many people we have on our list and for certain services but other stuff is target based, target based practice.Ìý And one of the big issues has been cardiovascular risk management, that is trying to predict who’s going to have a heart attack or a stroke in the next 10 years and then offering them interventions for that.Ìý And that can be blood pressure management but also in a lot of cases statin management to try and get cholesterol down.Ìý And the idea is that will then reduce your risk of having a future heart attack or stroke.Ìý And it’s important to note that this is for people who have never had a heart attack or stroke or a mini stroke before, these are for people who are completely well.

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Porter

Now up until recently that threshold was set at 20%, a one in five chance of having a stroke or heart attack over the next decade.Ìý NICE then dropped that to 10%, which caused a little bit of a hoo-ha but then caused even more of a hoo-ha by saying if you GPs want to get your financial incentives you’ve got to be treating people over 10%, that’s what they’ve changed their mind on?

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McCartney

That’s exactly right and this is an economic calculation.Ìý So Atorvastatin statin, one of the statins that’s been recommended just now, that used to cost 30 pence a month, now it costs £2.50.Ìý So when an intervention becomes cheaper it becomes more cost effective to do things at a lower threshold and that’s really what’s driving this, this is a cost effectiveness economic calculation that you can get bang for your buck, according to NICE, out of prescribing more statins to more lower risk people.Ìý But that’s not the whole story.

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Porter

But GPs weren’t that keen on this threshold being lowered, they felt there’s a little bit of over-treatment going on in some quarters and the fact that their pay effectively was going to be linked to this lower threshold upset a lot of them.

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McCartney

Absolutely and I have to say I’m one of those GPs that raised objections and lots of doctors I think were saying hang on a minute are we really going in the right direction here and there’s lots of issues.Ìý So NICE estimated that another 4.5 million people would go on to statins as a result of reducing their risk threshold down to 10% and that means an awful lot more people would be coming to their doctors for this risk assessment, this risk calculation.Ìý And I think what really upsets me more than anything is the fact that payment is linked to prescribing, for me payment should be linked to how well I make a good decision with that patient that is for that patient, it’s around that patient, what they value, what they don’t want to do, what kind of risk the patient is willing to accept either for or against statins, it should not be to do with how many pills I end up prescribing at the end of the day because that’s a conflict of interest.

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Porter

Thank you Margaret. Well, NICE’s Deputy Chief Executive is Professor Gillian Leng, so what is NICE suggesting?

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Leng

Well the new threshold that NICE is recommending is there’s a 10% risk of having some sort of cardiovascular disease event such as a heart attack over the next 10 years, previously in the UK we were working to a 20% risk.Ìý So you might think quite a big drop there but in fact we are in many ways playing catch up in the UK because across Europe they are already largely working to a 10% risk.Ìý And in the United States it’s more like seven and a half percent, although they have a slightly different way of calculating risk.Ìý But just to give you a sense that we are in fact not ahead of the game, we’re playing catch up.

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Porter

But that said, lowering the threshold has been met with some resistance, both amongst the public who aren’t obviously very keen, these are otherwise generally pretty healthy people who are not that keen on taking medicines but it’s also been met by quite a lot of scepticism from within the healthcare profession as well, particularly GPs.Ìý Is that why you’re revisiting this issue?Ìý I mean there’s been talk about NICE doing a U-turn, can you explain what’s actually happening?

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Leng

Well there’s a number of things, aren’t there, one is that the evidence base behind the use of statins in reducing the risk of cardiovascular disease is really strong.Ìý There are lots of good controlled trials that demonstrate that if you give statins to people pretty much whatever the level of cholesterol that they have their risk of having some sort of heart attack or other event decreases, so there is strong evidence.Ìý But you’re right that there has been resistance to this and that’s because people are otherwise potentially quite well.Ìý But the important point that I think we ought to emphasise is that nobody is going to be taking statins without them having thought about it carefully as individuals, so it has to be individual choice based on what they think the benefits to them might be.

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Porter

But let’s look at this accusation of a U-turn, I mean as of the beginning of this year the plan was GPs were going to be rewarded with something through a system called QOF, points for prizes it is often called, for getting people who come under this new threshold on to statins.Ìý Now the rumour has it that’s been – that’s been dropped, is that the case?

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Leng

Again just to be clear because it’s quite complicated.Ìý We’ve issued a guideline that stands, there’s no change in the 10% threshold in the guideline.Ìý We use the guideline to then identify indicators or measures that GPs might be rewarded for, as you said.Ìý So in the consultation measures for the QOF we did have 20% but the set that’s gone forward doesn’t include that as it is because we did have feedback, we did have resistance that says this is going to be difficult for GPs in practice and of course it’s a financial reward system, it’s not just the same as a recommendation for practice.Ìý So what we’re doing – it’s not a U-turn – what we’re doing is listening to some of the concerns that we had from GPs and going to pilot it in practices to see if it really is that challenging to attain.

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Porter

So to be clear the NICE guidance is still that we should be offering people who come in at this new lower threshold – 10% - we should be offering them statins.Ìý What you’re saying – sorry?

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Leng

It’s not so much – offer implies – here’s your risk, have the statin.Ìý There really does need to be a proper informed conversation at that point and NICE provides, on our website, a really helpful tool that sets out what the risks and benefits might be, what the side effects might be, to properly inform the patient about whether they want to take statins.Ìý So it’s not automatic.

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Porter

So you want that to carry on, that remains unchanged.Ìý What’s changed is that that was going to be incorporated into the way GPs are going to get paid, which is a sort of incentive for GPs to follow the latest NICE guidance, and that’s now not going to happen?

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Leng

Not straightaway because we are piloting it, we’re taking that lower threshold out to some real practices, piloting the impact of that and then we will take it back to our committee and consider whether it should go forward or not.

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Porter

Hindsight’s a wonderful thing but might it not have been better, in retrospect, to have done this piloting work first, rather than raise the hackles of some patients and some doctors?

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Leng

I think that’s a fair point and hindsight is a wonderful thing and perhaps yes that would have been – that would have been wise.

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Porter

Professor Gillian Leng from NICE.

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Now back to that doctor we heard from at the beginning of the programme. Stuart Miller is Clinical Director of Sport and Exercise Medicine at the University of Bath so you won’t be surprised to learn that he is fit and clean living. Or, that despite being in his mid-fifties, he is an unlikely candidate for a heart attack - even using NICE’s recently lowered threshold. But that is exactly what happened to him earlier this year. Much to Dr Miller’s surprise.

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Miller

The weekend before I’d done a two and a half hour cycle ride in the Mendips and I had swum 80 lengths in the pool without any hint of any problems.Ìý So this was a bit of surprise.

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Porter

So take us back – you’re in the middle night.

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Miller

I woke up in the middle of the night with a feeling of indigestion and discomfort down my right arm and into my throat and again I ignored it.Ìý Finally the penny dropped and my wife drove me to the hospital.Ìý They did a heart trace.Ìý I could see the heart trace coming out, I then realised what was going on.

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Porter

And what had gone on – what had happened?

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Miller

One of the arteries of my heart had completely blocked and I’d had a heart attack.

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Porter

So you’re 55, you’re fit and well, you’re clean living, do you have any family history of…?

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Miller

No, no family history.

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Porter

I mean this must have come completely – doesn’t happen to people like you?

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Miller

No, no, this is why I ignored it.

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Porter

So the stent was put in to the area that was blocked, the diseased part of your arteries but the rest of the circulation of the heart was very good.

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Miller

Yes, it was.

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Porter

That was 12 weeks ago.Ìý Are you back to normal now in terms of your activity?

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Miller

I’m swimming perhaps 60 lengths at a time and…

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Porter

Which is more than most people do 12 weeks after a heart attack.

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Miller

I suppose so.Ìý And cycling – and admittedly on the flat a bit more, about 20 miles at a time.Ìý And so I have got a reasonable level of fitness back but I do recognise it’s a little bit more difficult going up the hills.

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Porter

Although unusual Stuart’s case is far from exceptional. Seemingly healthy people in their thirties, forties and fifties do have heart attacks - but why? Sanjay Sharma is Professor of Cardiology at St George’s, London.

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Sharma

It is unusual because the vast majority of people that have heart attacks normally have established risk factors in the form of smoking, high blood pressure, high cholesterol, diabetes mellitus or a genetic predisposition.Ìý If you think about the fact that we see about 125,000 heart attacks a year in the UK and the type of heart attacks you’ve just described now in people who’ve got no risk factors and maybe almost normal coronary arteries, the prevalence of those types of heart attacks ranges from about 1% to 12% of all the heart attacks we see.

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Porter

So uncommon but not unheard off, you’re seeing this fairly regularly.

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Sharma

Certainly not unheard of and the sort of person that normally is affected is a young person, a person aged under 50, and usually more common in females.

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Porter

So what’s happening, let’s look at the conventional heart attack.Ìý I mean the majority of patients who are coming in under your care having had a heart attack, what’s happened to them and why?

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Sharma

Well with time of course the coronary arteries, the lining of the vessels of the heart, starts to change and what happens of course with age and certain risk factors such as smoking, high cholesterol and high blood pressure, this lining starts to get damaged.Ìý And once the lining starts to get damaged and inflammatory processes set up, whereby white cells enter the lining, fatty deposits start to develop in the lining and eventually we are left with a vessel wall that’s got accumulation of fatty deposits with time.Ìý Now there’s a healing process going on at the same time whereby these fatty deposits get calcified, they get loaded with calcium, and they become stable but there is a gradual narrowing of the lumen of the vessel and when that hits about 70% - once it’s narrowed by 70% - the patient does start to experience symptoms in the form of angina, which is chest tightness on exerting oneself, going upstairs or getting annoyed or getting upset.

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Porter

And that’s because the blood flow can’t meet the demands of the heart effectively.

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Sharma

You just don’t have the oxygen supplying the heart muscle and the heart muscle complains and this is the way it complains by causing chest tightness.Ìý Now in some people of course as these fatty deposits are developing there is a tendency for them to rupture.Ìý Now we don’t know why they rupture but when they do rupture they set up another inflammatory response whereby some of the sticky cells in our blood vessels, called platelets, start to accumulate around the site and very quickly end up blocking off the whole vessel and therefore suddenly the heart muscle has no oxygen going to it and there is death of the heart muscle and this is conventionally called a heart attack.

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Porter

So the natural story for most people would be you’d have a collection of risk factors, you get some premature ageing of your pipes and one of these plaques would rupture and you’d have a heart attack.Ìý But what’s happening in people like Stuart then?

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Sharma

It’s very interesting, we don’t actually understand fully why people who have very little in the way of risk factors, or even have completely normal coronary arteries, go on to have heart attacks.Ìý And there are several possible explanations for this.Ìý It could be that someone has developed very, very minor plague that we just can’t see through an angiogram.Ìý There are many, many other possible suggestions as to why people may damage the lining of the heart in the absence of risk factors, these include infections, we’ve got to think about drugs of course – cocaine and amphetamine based agents – that may cause spasm of the coronary arteries and cause a sudden blockage.Ìý And then there are of course inflammatory diseases, such as rheumatoid arthritis and other arthritic problems that can cause inflammation of the linings of the vessels.

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Porter

What’s the outlook for people like Stuart, given that his coronary arteries are generally in very good condition?

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Sharma

The outlook’s very good actually.Ìý The fact that he’s got good coronary arteries, only one artery was blocked, what I would certainly tell Stuart is to carry on doing what he’s doing but may be not to push himself as hard because can too much exercise, maybe the shearing and stretching forces of extreme exercise, cause plague rupture in some predisposed individuals, we don’t know that.

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Porter

Just time to tell you about next week when you set the agenda and we will be answering listeners’ queries on a range of topics including carpal tunnel syndrome and vertigo as well as asking why so many doctors still use child-like terms - such as waterworks and front bottom - when talking to adults.

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ENDS