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INSIDE HEALTH

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Programme 6.

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TX:Ìý 30.07.13Ìý 2100-2130

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PRESENTER:Ìý MARK PORTER

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PRODUCER:Ìý ERIKA WRIGHT

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Porter

Hello. Coming up in today’s programme:Ìý Aortic aneurysms – a problem that kills around 7,000 people every year in the UK. We take a closer look at a new screening programme which hopes to reduce that toll.

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Omega-3 and fish oils – if you were concerned, or confused by recent headlines like these:

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Headline clips

Can fish oil cause prostate cancer?

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Taking Omega-3 fish oil supplements may increase the risk of aggressive prostate cancer by 70%.

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Omega-3 prostate cancer alert.

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Porter

Then you will want to hear Inside Health’s Margaret McCartney’s analysis later in the programme.Ìý And, while we are on the subject of research that makes the news, I will also be asking two insiders about the murky world of the media. How do journals decide what to publish? And why does so much flawed research make the headlines?

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But first - the return of whooping cough or Pertussis. ÌýOnce a major threat to children whooping cough has been largely controlled by routine vaccination given to babies, but despite continuing high uptake rates, the disease seems to be making something of a comeback.Ìý There were nearly 10,000 confirmed cases in England and Wales in 2012 – 10 times the number in 2011 - and next year could be even worse if trends in other countries are anything to go by.

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Kathryn Edwards is Professor of Paediatrics at Vanderbilt University in Nashville where she leads the Vaccine Research Programme.

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Professor Edwards – what has been happening in America?

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Edwards

Well whooping cough has been increasing very remarkably in the United States, in fact last year 2012 the number of reported cases of whooping cough was 41,000 and that was actually the highest since 1955.Ìý And we feel that likely the number of cases are under-reported, so that those that actually get to the public health service are probably just simply a proportion of those that really exist.Ìý So we’ve really been seeing a remarkable increase in whooping cough cases.

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Porter

Do we know what’s behind this rise?

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Edwards

Well there are a number of possibilities and I think that perhaps that each of them contribute somewhat.Ìý One of the changes that has occurred has been that the vaccine has changed and the vaccine that was given about 15 years ago was made of the whole pertussis bacteria that was killed and that was given as a vaccine.Ìý It was associated with a lot of local swelling and tenderness and a lot of fever.Ìý So that vaccine was not well received by parents and children so we worked to make vaccines that consisted of just parts of the whole pertussis called Acellular vaccines.Ìý The data we’re seeing now suggests that those Acelleular vaccines do not have as long a durable immunity so that we’re now beginning to see cases in children seven to 10 years of age, so it suggests that the immunity wanes.Ìý The second factor is that we are getting better at diagnosing whooping cough.

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Porter

There’s been a suggestion that routine vaccination against whooping cough has encouraged the emergence of a more virulent strain of the disease, is there any evidence to support that?

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Edwards

I don’t think in the United States that we have data to say that it’s become more virulent but I think we are having some distressing findings that some of the pertussis strains now that are circulating lack some of the proteins that are present in the Acellular vaccine, so it suggests that well maybe the whooping cough germ is getting smart and trying to find a way to outwit the vaccine.

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Porter

One of the problems of course with pertussis is that it does tend to come in cycles, how do we know that this isn’t just one of those cycles where we get a bad four or five years and then it disappears again?

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Edwards

I think if you look at the cyclical nature of pertussis, even though the cycles persist, the baseline levels are marching up with each year.

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Porter

Who’s most at risk from pertussis?

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Edwards

The very young children are the most at risk, those children less than a year of age and those children less than two months of age are really at the highest risk.Ìý We also know, however, that there are increasing rates in children seven to 10 years of age and they present with persistent cough, cough which may last for as much as a 100 days.Ìý We also know that adolescents and young adults are also at risk with persistent cough and we even now are appreciating that people over 65 as well.Ìý But the really, really target group, the one that has the most difficulty, are those children less than two months of age, less than the time where they received any of their vaccinations.

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Porter

And what are you doing about that in America at the moment?

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Edwards

What we’re doing in the United States is that we are recommending that all pregnant women be vaccinated with pertussis vaccines with each pregnancy.Ìý We have done a lot of studies looking at the ability of the antibody or the protective substance that’s able to be passed from mother to baby through the placenta and when we measure antibody levels in the baby we find that they are as high, if not higher, than in the mother.Ìý So the babies are really good at getting that antibody from the mother.Ìý But we also know that babies have to get pertussis from someone else, someone bigger and often we find as much as 30% of the time that babies will get the whooping cough either from their mother or their parents or their other siblings.Ìý So by vaccinating mother not only do we protect baby by getting antibody but we protect mother from getting pertussis and then presumably exposing her baby.

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Porter

Professor Kathryn Edwards, thank you very much.

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Here in the UK 13 young babies died from whooping cough in the outbreak last year, and there is currently a major push to vaccinate pregnant women before the next whooping cough season gets underway in the autumn. But safety is likely to be a major concern shared by most pregnant women offered the jab. Professor David Salisbury is Director of Immunisation at the Department of Health.

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Salisbury

Of course it’s a concern to them and that concern is entirely understandable and that’s why it’s so important that we have done everything we can to ensure the safety of this vaccine.Ìý And what we’ve seen from a large study – 18,000 pregnant women have been followed – and we’ve seen that there has been no adverse effects that can happen in pregnancy, premature labour, even stillbirth of the baby, we’ve looked carefully and those have not increased.

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Porter

Because this is a vaccine that wasn’t formally tested or licensed to be used in pregnant women, so I mean I suppose the first people to have it during pregnancy – I mean they are guinea pigs effectively – but you’re saying there’s already been 18,000 of those?

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Salisbury

I don’t believe they’re guinea pigs, I think that women are indeed vaccinated in pregnancy with these sorts of vaccines and there’s a long history of vaccinating women in pregnancy against tetanus, for instance, and indeed against polio.Ìý So I think it’s unfair to say that they are guinea pigs.Ìý But safety to us was really important, just as it was important to be able to demonstrate how effective the vaccine was.Ìý We can give good answers on both of those questions.

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Porter

Of course one of the other ways to protect very young baby would be to bring forward to time at which you give the routine whooping cough immunisations, is that something you’d consider, is there a reason why you didn’t do that?

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Salisbury

Yes we looked very carefully at the age at which the cases of whooping cough were occurring in young babies and it was clear that even bringing the age of immunisation, for example, down to six weeks rather than eight would not have protected those most serious cases where the babies did in fact die.

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Porter

Professor David Salisbury.Ìý And for more information on the immunisation programme go to bbc.co.uk/radio4 and click on I for Inside Health.

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Now, do fish oils cause cancer? We have had a number of e-mails from concerned listeners about a possible link between Omega-3 rich fish oils and cancer of the prostate.Ìý Concerns prompted by the publication of a study in the Journal of the National Cancer Institute that led the Daily Mail, amongst many others, to warn readers that taking Omega-3 supplements may increase the risk of aggressive prostate cancer. But is that what the research really found?

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Inside Health’s Margaret McCartney has been examining the evidence

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McCartney

Oh dear, my take on the data is not impressed – bottom line.Ìý So lots of headlines – Taking Omega-3 fish oil supplements may increase the risk of aggressive prostate cancer by 70% - lots of people saying oh if you take Omega-3 fish oils you’ll end up dead from prostate cancer.Ìý So that was the bottom line from the press coverage.Ìý Unfortunately not borne out by the paper but very much, I think, overegged in the press release that the researchers sent out.

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Porter

Well let’s start with the paper – what did the researchers actually find?

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McCartney

Okay, so they basically found that the higher your fat levels in your blood, part of which is Omega-3, the higher your risk for being diagnosed with prostate cancer.Ìý But in actual fact the numbers of this trial were fairly small because they were taken from a much bigger trial looking at other factors that could be related to prostate cancer, so it was a small trial overall.Ìý And they basically found that the higher your blood fat levels were, which included Omega-3s, the higher your risk of developing prostate cancer.

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Porter

So the assumption from that might be that if you eat a lot of Omega-3s, either as supplements or in oily or naturally in oily fish, that it might increase your risk of prostate cancer?

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McCartney

Well that’s what the researchers tried to say in their press release and sort of said you know this is another reason to avoid supplements.Ìý But I think that they didn’t actually ask men, as part of the trial, whether or not they took any supplements for example, so I think it’s really overstepping the mark to say that therefore this is a harmful supplement to take.

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Porter

So the assumption was that if you had high Omega-3 levels in your blood you were probably on a supplement but that might not be true.

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McCartney

It might not be true.

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Porter

So fish oil supplements and Omega-3 supplements are among the most common supplements taken in the UK, there may be people out there who have been concerned about this link with prostate cancer, what would you say to them?

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McCartney

Well I wouldn’t be stopping them on the basis of this particular study.Ìý However, I think it would question whether or not they do any good in the first place because of lots of really good quality evidence that says actually Omega-3 taken as a supplement don’t do us any good.Ìý So there’s been big studies looking at the risk of cardiovascular disease, heart attacks, strokes, sudden death, all-cause mortality – all types of death – not showing a reduction, we’ve had a big Cochrane review looking at Omega-3s and dementia – no evidence that it prevented dementia.Ìý Big study again looking at cancer risk – no evidence of reducing risk with Omega-3s.Ìý So if you’re going to take Omega-3s I have to say there’s no evidence for doing so.

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Porter

So your advice would be not to worry too much about stopping them but to give serious consideration as to whether you should be on them in the first place?

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McCartney

Absolutely.

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Porter

Margaret McCartney. So, once again, coverage in the news doesn’t accurately reflect the original research - or indeed question its veracity.

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There were similar issues recently with claims that antibiotics could revolutionise the treatment of back pain – a subject we covered on Inside Health.

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But how do studies like these get such prominent coverage – and why aren’t the media more critical? Trish Groves is Deputy Editor of the British Medical Journal, and Jeremy Laurance is a freelance journalist and former health editor at The Independent – and he joins us on the line.

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Jeremy, would it be fair to say that most journalists are more interested in news worthiness rather than the quality of the research?

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Laurance

Well absolutely, you know 400 aeroplanes took off safely from Heathrow this morning is not a story, one plane that skidded off the runway is.Ìý It’s the exception to the rule that makes the story.Ìý Editors are always interested in that water cooler moment – they want their stories to be discussed around the water cooler by readers.Ìý Whereas a drug, let’s call it Knee Bend, for arthritis that a new study has found, well actually it’s not quite as good as we thought it was, well it may be very important but it’s unlikely to be of interest to those - other than those who are actually taking it.Ìý So what I’m saying essentially is that there’s a difference between what is worthy and what is newsworthy.Ìý And that’s the judgement that journalists are always having to make.

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Porter

Trish Groves, can you give us some idea of the number of papers that you might consider to publish just one?

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Groves

Yeah we get about three and a half thousand submitted a year and we reject 93 or 4% of them, that was the rate last year.Ìý So we’re a big rejection machine and most of our customers are dissatisfied.Ìý But what we’re looking for is a great research question, so the actual aim of the study needs to be important and relevant and new enough and then we’re looking for the right study design to answer that question properly and scientifically and we shouldn’t care whether the answer is yes or no.

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Porter

Does the point that Jeremy was making about worthiness versus newsworthiness, do you consider that?

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Groves

We do but you know it can be just as important, if not more important, to know that drug A doesn’t work because people are actually prescribing it madly and it’s costing the health service a fortune or that there isn’t actually a link between A and B when everybody thought there was.

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Laurance

The fact is that medical journals operate in the same way with the same constraints that newspapers operate – they depend on their audiences, they need a reaction from their readership.Ìý And there was a study some years ago that showed that papers in the New England Journal that were reported in the New York Times were cited far more often in scientific articles than those that didn’t make the New York Times.ÌýÌý Actually getting a medical paper into the lay press does increase the scientific traffic.Ìý And so they are under pressure to sell their stories in exactly the way that we are.

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Porter

And Trish would you know if a paper that’s been submitted to the BMJ has been submitted to other journals?

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Groves

Well the peer review process, as it called, at journals is confidential, so when somebody sends us a paper we have to keep quiet about the fact that we’ve got it and if we end up rejecting it it’s like we never had it, we haven’t – we can’t tell anybody.Ìý Having said that we do ask authors to say has this been rejected from somewhere else and have you fixed the problems that peer reviewers – experts – at other journals noticed and a lot of authors do say that, they do tell us that it’s been somewhere else and they’ve got good feedback and they’ve improved the article and we’re really pleased when they do that.

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Laurance

It would be extremely useful if journals such as your own could inform us journalists when a paper had been rejected by other outlets.

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Groves

So you mean it’s popped up in a journal that you’re thinking of covering it and we previously rejected it – unfortunately we look at papers in confidence so our promise to the authors is that if we see it and reject it then we don’t tell anyone.Ìý Effectively it’s a leak and you can’t do that.Ìý So you have to trust the journal where it does end up to have done a great job with it.

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Porter

But it would sometimes be helpful to know that’s something’s been rejected by 20 or 30 journals ahead of – and it gets published somewhere, it probably says something about the trial does it not?

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Groves

It does tend to and there’s a big clue in how obscure the journal is and how long the gap is between finishing the study and getting it published somewhere.

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Porter

Alright, so three years ago in a small journal – be sceptical?

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Groves

Mmm.

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Porter

Jeremy, so far we’ve been talking about results that the researchers want published but what happens when the study doesn’t quite work out as planned in the eyes of either the researchers or indeed their sponsors, which may be a pharmaceutical company, do you believe that scientists have an ethical responsibility to publish everything, even if the results aren’t good?

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Laurance

Absolutely I do and there is currently a campaign – the all trials campaign – led by Ben Goldacre to achieve precisely that.Ìý Even now not all trials are in the public domain available for researchers to check and that’s most important.Ìý We saw that, just to give one example, there was a drug produced in the 1970s to correct abnormal heart rhythm, by 1990 it was estimated that that drug was killing more Americans than died each year in the Vietnam War.Ìý And there had been data that had appeared earlier suggesting that there was a problem with the drug but it had not been published, so that illustrates the damage that can be done by failure to publish negative results.

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Porter

But Trish in practice how could we police this thing of making sure that everybody publishes their research, how do you know what research is being done?

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Groves

Well certainly for clinical trials, which is where you’re testing a drug or a medical device or some other thing that you’re actually actively doing to patients, there’s a big campaign to get people to register the study at the beginning before it starts…

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Porter

Is that mandatory at the moment?

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Groves

It’s mandatory in the US if you’ve got a drug you want to market there.Ìý It’s going to be mandatory in the EU from next year.Ìý And the big journals say we’re not going to consider your paper of a randomised controlled trial unless the study was pre-registered.Ìý So that means that even if papers never get published you know that the study was done and you can contact the researchers and say what happened.

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Porter

Trish Groves and Jeremy Laurance we must leave it there, thank you both very much.

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Now the team at Inside Health has a particular interest in screening programmes - and weighing up the benefits and risks associated with them. The latest national programme to be launched in the UK screens men aged 65 or over for aortic aneurysms – swelling of the blood vessel that takes blood to the lower half of the body. And it only includes men because aneurysms are much less common in women.

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Screening has been rolled out across England over the last four years, and similar programmes are now underway in Wales and Scotland.Ìý

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To find out what is involved I went to have the diameter of my aorta checked at Addenbrooke’s Hospital in Cambridge.

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Rankin

My name’s Patrick Rankin, I’m the abdominal aortic aneurysm screening coordinator for the Cambridgeshire area.Ìý And what I would like you to do if possible is just to lie yourself on the couch, just lift your shift up, just above your abdomen here and just lie back on the couch.Ìý So what I’m going to do is I’m just going to do a quick scan on your abdomen, in this area here, so it’s just a quick ultrasound scan.Ìý So there’s going to be some cold jelly on your abdomen, like when you see pregnant ladies having an ultrasound scan.Ìý And if you have a look on the screen here what you can see is your aorta, it’s this circular structure here, that’s your spine.Ìý So I’m just in the very proximal at the very top of the aorta here and I’m just coming down the aorta, just looking how big it is.

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Porter

It’s roughly the size of a small hose pipe is it – a normal one?

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Rankin

Yeah between 1.2 centimetres and 2.5 centimetres is pretty much normal.

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Porter

It’s a big blood vessel.

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Rankin

It is, it’s the biggest one in the body.

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So what happens is it divides just around the level of the belly button, just around here, so the area that we’re scanning is from the aorta just at the very top of the abdomen here, just underneath the diaphragm.Ìý

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Porter

So between my rib – the bottom of my breastbone effectively and tummy button?

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Rankin

Yeah that’s basically all we scan.Ìý If you look here what you can see – this area here – there’s a little bit of bowel gas, so whatever you had for your breakfast or your lunch is just being digested there, so that’s…

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Porter

Does that stop you seeing what you want to see?

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Rankin

Ever so slightly yes, so we just wiggle it out of the way hopefully and it disappears.Ìý I’ve had a look at your aorta and it all looks within normal limits but I’m just going to take a quick measurement and then we input that into our computer system.Ìý So I’ll just freeze the image where I think it’s biggest – here.Ìý About 1.6 centimetres, so it’s pretty much okay.

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Hayes

My name’s Paul Hayes, I’m the director of the Cambridgeshire Aneurysm Screening Programme and we’re based here at Addenbrookes.

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Porter

Paul, I’m hoping that that was a normal measurement at 1.6 centimetres.

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Hayes

Yeah, everything looked just fine there.

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Porter

What sort of measurement would you start to worry at?

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Hayes

Once the aorta gets much over three or three and a bit centimetres then we’ll start – we’d call that an abnormal finding.Ìý At that size the risk of the aneurysm leaking or bursting is really quite tiny and there’s no need for concern when it’s found but there is a need then to go into a long term surveillance programme.Ìý If the blood vessel continues to swell then ultimately when it reaches around five and a half centimetres we’d then start to talk to the patient about potentially having an operation to fix this.

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Porter

What’s actually happening to the pipe to create this ballooning?

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Hayes

The wall of the blood vessel gradually thins out.Ìý The blood vessel expands quite slowly to start with, it’s a bit like blowing into a balloon – when you first start blowing into the balloon it’s really difficult to get it going, once it starts to go though as the blood vessel wall gets thinner and thinner it expands more and more quickly and the danger is that at some point, a bit like a balloon, the wall will give way and at that point a life threatening rupture can occur.

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Porter

Because if the blood vessel – I mean my blood vessel’s 1.6 and supposedly healthy but if there was a hole in that I mean it would produce an awful lot of blood very quickly.

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Hayes

Yeah there’s around two to three pints of blood go through that blood vessel every minute and you’ve only got about eight pints with you, so if it starts to leak it’s life threatening.

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Porter

If an aneurysm’s left to its own devices and it bursts what’s the outcome?

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Hayes

Unfortunately most people don’t survive a ruptured aneurysm.Ìý Around 50% of people don’t make it to hospital and of those people who are lucky enough to make it to hospital again another 50% of those people may not survive.Ìý So around one in four people will survive a ruptured aneurysm.Ìý Obviously it’s not possible to screen every single man who’s aged 65 plus all in one year, physically there aren’t enough screeners around, so we have to be practical and what we’re going to do is we’ll invite every man in their 65th year to come along for a simple ultrasound scan, just like you’ve had, ninety eight and a half percent of those will be completely normal and they’ll be discharged.Ìý One and a half percent of people will have an aneurysm found and the majority of those will just simply need to have an ultrasound scan done in the future over the years.

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Porter

And in terms of evidence if I am one of those people in the one and a half percent what’s the benefit of having that aneurysm picked up, I mean might I never have known I had a problem anyway?

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Hayes

Yeah and that’s true for all screening programmes.Ìý These things don’t cause any symptoms at all until usually the day they rupture and people get a lot of pain.Ìý So people don’t know they have them, it’s a life threatening condition and it’s responsible for around 1% of all mortalities in the age group that we’re looking at, so it’s quite a significant problem.

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Porter

The introduction of the screening programme across the UK was based on what sort of pilot evidence, what evidence do we have that this intervention saves lives?

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Hayes

The evidence here is based on a number of trials, the biggest of which was called the Mass Trial, this was based in and around the South of England and they looked at tens of thousands of men and split them into two groups – half of them had a screening scan and were followed up appropriately and half of them didn’t.Ìý And the number of deaths from aortic aneurysm rupture fell significantly by around 50% in the group who were screened to have aortic aneurysms.

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Porter

And what sort of surgery are you talking about?

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Hayes

In the past we would make a large incision down the middle of the abdomen to see the aorta, we physically then cut the aorta open and sew a plastic graft inside.Ìý That places a large strain in the heart and lungs and unfortunately was associated with a relatively high mortality of around 4% in good centres and higher in some less experienced centres.

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Porter

So even in good hands there was about a one in 25 chance of not coming through the surgery?

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Hayes

Yes, it’s a significant operation, perhaps more risky than open heart bypass surgery, to put it into context.Ìý Things have moved on though and we now have new technologies available to us and we’re able to re-line these blood vessels now from within.Ìý So we make two small cuts or punctures in the groin and simply place a steel and plastic coated spring up the inside of the blood vessel, a bit like putting a flu liner up a chimney to reinforce the wall.Ìý Those thin walls then the pressure reduces and the risk of the aneurysm rupturing really falls away to almost nothing.

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Porter

And the dangers of that procedure – it’s presumably much safer?

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Hayes

It is much safer, it’s not a procedure that’s without some risks and overall the mortality is around 1% across the UK.

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Porter

So one in a hundred would die as a result of having that surgery?

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Hayes

They would yeah, but overall that’s still four times safer than our old techniques and I think you have to put that into context against what happens if we leave the aneurysms and they rupture.

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Porter

Vascular surgeon Paul Hayes at Addenbrookes Hospital where seven out of 10 men found to have worryingly large aneurysms are now offered the safer less invasive repair.Ìý

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As with all screening programmes, it’s about balancing benefit and risk - and Margaret McCartney thinks men should give it careful consideration.

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McCartney

Yeah, I mean for many people it will be a sensible thing to do – to be screened and to go ahead with prophylactic treatment – the surgery – before the aneurysm ruptures.Ìý So for many people it would be absolutely fine.Ìý However, it’s always a balance of pros and cons when it comes to screening.Ìý Now the major risk really is that of dying as a consequence of a prophylactic operation which you didn’t need because you were never going to die of the aneurysm rupture.Ìý So that’s the really important trade off that has to be made.Ìý Overall there’s still a benefit but the problem is that for some men will have the operation and they will succumb to the operation when they were never actually going to die of the aneurysm rupture in the first place.Ìý So these are pretty big decisions to be making.

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Porter

And I suppose there’s a larger group of men who will be told that they have an aneurysm, albeit not one that needs surgery, that are then going to be worried that they’ve got a ticking time bomb and we don’t quite know what impact that has do we?

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McCartney

Yeah, I mean some men will have it done, they will not be worried or bothered by it, they’ll get on with their life, they’ll be absolutely fine but there is a group of men who will have this done and who will find that they’re personal psychology changes, that they maybe think about it more, they’re more concerned about it than maybe another man would have been and it changes their life in a way that would not have happened if they hadn’t have been screened.Ìý And these are just things to weigh up in your mind before you consider whether or not to have the screening test done in the first place.

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Porter

Do you think people give these factors – these negative factors – enough consideration or is there a sort of gut feeling that all screening is good and therefore I’ll join the programme?

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McCartney

I think what’s really important is the information that people get before they come or not.Ìý Now the AAA screening programme is pretty good for giving quite a lot of balanced fair information with pros and cons on the website but to be honest with you I would set aside a couple of hours to look at it, I don’t think it’s the kind of decision that you can make in five minutes easily on the basis of a bit of paper coming in through the door to invite you.Ìý I think it’s the kind of thing that you really have to sit down and look at.Ìý There will be questions that you have in your mind after reading through it and I think it’s really important to reflect on them and give yourself a bit of space to come to a conclusion.Ìý So I think there is room for a debate around for it but for each man it’s going to be very difficult – if you’ve got a gentleman who’s quite frail and who would really struggle to get through a big operation it might be quite easy for him to decide actually this really wouldn’t benefit me overall maybe compared with someone who’s much more fit and maybe much more able to bounce back after a big operation like that.Ìý So I think it’s a highly individual decision and one that should be taken with great care.

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Porter

Margaret McCartney – and there are links to the various aortic aneurysm screening programmes across the UK on our website at bbc.co.uk/radio4.

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That is it for the current series of Inside Health. But please keep your questions coming for our new series when we come in September. Until then, goodbye.

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ENDS