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League tables, Nits, Feeling the cold, Language - Surrogate marker

Are league tables listing surgical outcomes the best way to assess a surgeon? Plus a look at nits, whether women feel the cold more than men and surrogate markers.

Are league tables listing surgical outcomes the best way to assess your surgeon or are high risk patients being turned away as surgeons keep an eye on their figures? New data published this week list the clinical outcomes for heart surgery - cardiac surgeons are just one speciality from an ever expanding list of doctors whose performance is now published in league tables and subject to public scrutiny. But what impact has their introduction had on patient care? Sam Nashef, a consultant cardiac surgeon at Papworth Hopsital, discusses this issue with Mark Porter.

Recent research in schools in Wales suggest that as many as one in 12 primary school children get them at this time of year - and that compares favourably with Australian research, which suggests the figure's much higher - closer to one in five. Resident sceptic Dr Margaret McCartney explains which treatments are supported by evidence.

Lyn e-mailed Inside Health to understand why she often feels colder than other people. How, she asked, do we regulate our body temperature and are some people better at it than others?
George Havenith is Professor of Environmental Physiology and Ergonomics at Loughborough University, and Mike Tipton, Professor of Human and Applied Physiology at the University of Portsmouth, provide answers.

And in the next of our special series demystifying the language of research and statistics Carl Heneghan, Professor of Evidence Based Medicine at the University of Oxford and Dr Margaret McCartney unpack the concept of surrogate markers. These feature increasingly in medical research and can involve everything from blood test results, to the pattern on your heart trace or ECG.

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28 minutes

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INSIDE HEALTH

Programme 3.

TX:听 15.09.15听 2100-2130

PRESENTER:听 MARK PORTER

PRODUCER:听 ERIKA WRIGHT

Porter

Hello.听 Coming up in today鈥檚 programme:听 Nits - they used to be every parent鈥檚 nightmare, but have new treatments guaranteeing to get rid of the little blood suckers changed all that?

Feeling the cold - autumnal weather has finally arrived and there is a definite chill in the air. But why are some people so much more sensitive to drops in temperature than others?

Tipton

There is a physiological basis for the complaints that we get, particularly going into the autumn where women want to have the central heating switched on and men, thinking of the bank account, want to keep it switched off.听

Porter

And baffling terminology - Margaret McCartney and Carl Heneghan are back to demystify the terms bandied around by researchers, and the journals they publish in.

But first how good is your surgeon?听 New data published this week list the clinical outcomes for heart surgery - cardiac surgeons are just one speciality from an ever expanding list of doctors whose performance is now published in league tables and subject to public scrutiny. But what impact has their introduction had on patient care? Sam Nashef is a consultant cardiac surgeon at Papworth Hopsital, as well as an expert on risk assessment, and he is in our Cambridge studio.

Sam, I think the potential benefits of greater transparency in the NHS will be obvious to most Inside Health listeners, but what about the problems? Have there been unintended consequences?

Nashef

It has had an impact on surgeons.听 Surgeons are human and if their results are going to be in the public domain then they will consciously or unconsciously try to do something to make their results look good.听 I have surveyed the surgeons in the UK and asked them a couple of questions regarding this and for example a question about whether they perhaps avoid operating on high risk patients with an eye over their shoulder to their figures.听 And when I asked them that about 30% said yes they have done that, even though they knew an operation was in the best interest of the patients and perhaps more alarmingly when I asked them if they鈥檙e aware of other surgeons doing this the figure went up to 82% said they were aware of other surgeons doing this.听 So there are some downsides to transparency and we have to say that the results of heart surgery in the UK are excellent overall, they compare extremely well with the best international standards.听 Now some of that has been driven by the transparency and there鈥檚 no doubt about that but not all of it.听 And transparency which is good, nobody wants to deny patients information when they want to make choices, it does have pitfalls which are sometimes not in the best interests of the patients and we really do need to be aware of that.

Porter

But Sam, what happens if I have a serious heart condition, I鈥檓 a high risk but an operation is perhaps my only chance of survival, what you鈥檙e suggesting is that if I go and see a heart surgeon he or she might not operate on me because they鈥檙e worried about their results.

Nashef

I think that could happen and if you suspect that this is happening my advice to you would be to ask someone else and then ask further someone else and keep on trying until you get a very good idea that you鈥檙e being turned down because it鈥檚 in your own interests rather than you鈥檙e being turned down because it鈥檚 in the interests of the surgeons who are turning you down.

Porter

But are there surgeons and are there units in the UK where these patients tend to end up?听 So these are, if you like, the people working on the hardest cases.

Nashef

Yes I think there are definitely some hospitals and some surgeons who are more prepared to accept patients who are higher risk than others.听 And I know for a fact that my own hospital 鈥 Papworth 鈥 is one of them because we even have a programme for running a service for patients who are turned down elsewhere.

Porter

But does that have an impact on Papworth鈥檚 and your results?听 I mean if you鈥檙e taking on more difficult cases do you on paper look to be worse?

Nashef

At the moment we don鈥檛, in fact we actually look better, we鈥檙e very pleased with our results, we鈥檙e statistically significantly better than expected and the difference between the statistical difference between our results and our expected results is the highest in the country.听 So we鈥檙e very happy with these results but we are obviously at risk of looking a little bit less good if we continue operating on the very high risk patients.听 But we believe our 鈥 we鈥檙e much more interested in serving the patients correctly than we are in the figures.

Porter

Margaret McCartney鈥檚 listening in our Glasgow studio.听 And Margaret we鈥檝e talked here about heart surgery but of course these league tables apply to lots of other specialities and we鈥檝e also been quite negative about them but they do have plus points too.

McCartney

Well I think that it鈥檚 really good though to be as open and transparent about all data that doesn鈥檛 need to be kept confidential for individual patient purposes, so I think we should put as much as possible in the public domain.听 The problem comes when we start to draw unsafe conclusions from it and that鈥檚 where I think it becomes quite difficult.听 And I really think we鈥檙e moving into an age of anxiety where surgeons become anxious for reasons other than simply operating on the patients but how they look about operating on patients.听 And I think as well as that patients will often come and speak to their GPs saying am I choosing the right surgeon, can you look at this data for me and tell me whether this surgeon is a good one or not.听 And it鈥檚 really, really hard to know from the data in the public domain.听 So if you take, for example, bowel cancer surgery, let鈥檚 say that on average one in 20 people die from that, so if you do 20 operations in a year by one surgeon one patient on average will die but you get random variation, it鈥檚 not always going to be one patient per year.听 So if a surgeon had two deaths in a year, that鈥檚 double what you would expect, but in actual fact that will happen on average 25% of the years.听 So it鈥檚 really hard to know what small variations actually mean for that individual patient making a decision at that time.

Nashef

I have some doubts about a number of the features of this publication, even though I still support transparency in general.听 I think the first one is that even if we adjust for risk there are problems, there is room for error, because no risk model is perfect and I make risk models, so I should know, so there is no risk model that will adjust for every possible risk.听 In addition if you find that there is an outlier, somebody whose performance is not as good as you鈥檇 expect, there is always a small probability that this finding is due to chance alone, as you鈥檝e just heard.听 And even if there is one true outlier there is a possibility that the system would not pick the outlier but pick another one.听 So all that means that there is always an element of doubt whenever outlier, be it possible or negative, is identified by the exercise.听 And then finally there is the problem of no matter how good the risk model is and no matter how robust the data surgeons know that the best way to have a better survival figure is to operate only on very low risk patients and that is not in the interests of patients.听 So all of this stuff about transparency is very good and it鈥檚 very helpful but it鈥檚 important for people to know about the pitfalls and to treat the data as intelligently as possible.

Porter

But Margaret while these might be quite a blunt tool for selecting an individual surgeon or an individual hospital in an individual patient鈥檚 case the pressure that this transparency exerts on the system is good, it tunes the system, it makes it work better.

McCartney

Well it might be but it also might not be.听 I suppose one of my concerns is that we鈥檙e focusing so heavily on an individual named surgeon when that surgeon is just one person in a very big team, so what about the anaesthetist, the perfusionist, the nurses, the number of ITU beds, the cleaning staff, the social work support, the general practitioner who鈥檚 perhaps looking after a patient in the community afterwards?听 All of those things are going to have an impact on the eventual outcome for that patient.听 And I suppose I worry that we鈥檙e targeting all of our attention on the surgeon whereas any differences in outcomes might actually be to do with far more complex environmental factors.

Porter

But they鈥檒l all be taken into consideration in the clinical outcomes won鈥檛 they, but it鈥檒l be the surgeon whose name is attached to it.

McCartney

But it may not be the surgeon is to 鈥渂lame鈥 (in quotes) for something 鈥済oing wrong鈥 (in quotes).听 So it may be, for example, that one surgeon has a fantastic anaesthetist who can really help to sort out a lot of problems or issues and it may be that on another day that same service doesn鈥檛 apply or there鈥檚 less ITU beds or someone that鈥檚 waiting a while in a less good ward area or something, I don鈥檛 know but I just worry that when we say that it鈥檚 a surgeon that鈥檚 responsible for these individual figures there鈥檚 a lot more people behind that than one individual person.

Porter

Sam, how do you feel about that?

Nashef

Well there is an aphorism in surgery which says 鈥 heart surgery is a team effort, until the patient dies then it鈥檚 the surgeon鈥檚 fault.

Porter

Rest assured that aphorism doesn鈥檛 just apply to heart surgery, Mr Sam Nashef thank you very much. And there is a link to the new cardiac surgery performance data on the Inside Health page of the Radio 4 website.

Stay with us Margaret because I want to move on from unintended consequences of league tables, to an unintended consequence of going back to school. Nits or, to be more accurate, head lice.

Most children are now in the second week and have been back long for lice to start spreading. Recent research in schools in Wales suggest that as many as one in 12 primary school children get them at this time of year - and that compares favourably with Australian research, which suggests the figure鈥檚 much higher - closer to one in five! Either way they are common.

Getting rid of them used to be easier said than done, but if the ads are to be believed, modern treatments have changed all that by guaranteeing elimination. That is quite a claim for any type of medicine. So Margaret has been doing some digging. Margaret, are they really that effective?

McCartney

Well it鈥檚 all very confusing, so I鈥檝e been looking very hard for definitive evidence and the normal place that I would look for that would be on the medical research database PubMed, which is where randomised control trials are usually filed and stored.听 And it鈥檚 very hard to find definitive evidence from randomised control trials that these new products work and work as well as they say that they do.

Porter

Now the other thing that confused me slightly is that the manufacturers seem to be involved in a bit of a tussle themselves, you look at the Advertising Standards website there鈥檚 some complaints have been going on.

McCartney

That鈥檚 right, there鈥檚 claims, there鈥檚 counter claims.听 One company complained that another company has said that their product鈥檚 really good.听 But what I would really like to have is a proper evidence battle and for everyone to get their trials out there into full public view and let鈥檚 see what happened and where.听 So quite often trials are done of these products in quite closed lab situations, perhaps in test tubes or the equivalent, sometimes they鈥檙e done with volunteers who offer to be infested with lice in order to demonstrate cures.听 But what we really want to know about is real life situations, what actually happens in school, what works, what doesn鈥檛 work.

Porter

So what you鈥檙e saying is that these new treatments may work well but we don鈥檛 have real world hard convincing clinical evidence that you can find to back up the claims that are out there at the moment?

McCartney

Well that鈥檚 true and it鈥檚 also not true.听 There鈥檚 good evidence for a drug called dimethicone, which is available in several head lice treatments, and they do have quite good evidence behind them which show that they do work pretty well and these are physical pesticides, so they鈥檙e not chemical, older fashioned chemical pesticides, but they certainly do work and there is quite good randomised control trial evidence to say that they鈥檙e good and they are recommended by the NHS and also by NICE.

Porter

And looking at dimethicone what sort of cure rate, in inverted commas, would you expect then?

McCartney

Well there鈥檚 鈥 dimethicone鈥檚 one of them, there鈥檚 also Isopropyl myristate, which is similar in many ways.听 And these expect a cure rate of around about 70%.

Porter

So that鈥檚 around three quarters of cases which is a little less than is being claimed by some of the ads that I鈥檝e seen.

McCartney

And I think one of the problems is that we haven鈥檛 seen in full sight of the evidence going along with these.听 I would like to see much bigger trials being done, published in full and also in real life situations.

Porter

So Margaret what happens if listeners want to avoid using chemicals altogether and want to use a more natural method, I mean the other thing is the wet combing technique, is there any evidence to support that?

McCartney

Yes, so wet combing has a lot going for it but it does contain chemicals, shampoo and conditioner of course are all chemicals, but basically you have wet hair which you detangle and then you use a very special fine toothed comb and it takes forever.听 It needs to be done twice a week for two weeks and longer if lice are found after that.听 And if you don鈥檛 have any lice over three sessions then you can think of yourself as having a successful intervention.听 And if you鈥檙e dedicated 鈥 and you do need a bit of dedication to do this 鈥 you can get cure rates of up to about 57-58% or so, so it certainly does work but you have to be committed to do it and I鈥檓 afraid to say that this is one of my many failings as a parent, I don鈥檛 think I鈥檓 quite as good at this as I should be.

Porter

You鈥檙e not alone.听 Thank you very much. And, as usual, links to any research mentioned will be on Margaret鈥檚 blog. Head to our website for more details.

Now to Inside Health listener Lynn, who has been struggling with her piano lessons.

Actuality

That鈥檚 it, so what鈥檚 happening is there鈥檚 a little place where you keep stopping 鈥 da, da, da 鈥 you鈥檙e holding it on for too long.

But my fingers are always so cold, so I鈥檝e got my mittens.

Are you going to just try the left hand from that little bit and see if the mittens have helped?

Lynn e-mailed Inside Health for help, not with her piano playing but to understand why she often feels colder than other people.听 How, asked Lynn, do we regulate our body temperature and are some people better at it than others?听

George Havenith is Professor of Environmental Physiology and Ergonomics at Loughborough University.

Havenith

The control system is thought to be in the hypothalamus and the hypothalamus is at the bottom of your brain, it鈥檚 quite deep in skull.听 And the idea is then that in that region all the signals from a lot of different body parts, temperature signals, are integrated to tell the brain what temperature you are.听 So to give you an example that area is sensitive to temperature itself, so if your brain temperature changes it will respond.听 But there is also temperature sensors along your spine, for example, and there鈥檚 temperature sensors in different areas in your trunk, you intestines and very important you have a lot of sensors on your skin which very quickly can sense changes in temperature.

Porter

What鈥檚 the main challenge for the average body for someone living in a country like the UK, is it one of heat conservation or are we trying constantly to get rid of heat?

Havenith

People are very well designed to get rid of heat really so it鈥檚 often said that man is a tropical animal, if you think evolutionarily where we came from, so our heat defence mechanism, the sweating system, is one of our best developed systems.听 In the cold people struggle more and if I would put you in a cold room or you go outside you add clothing but then if you can鈥檛 manage to control your temperature well enough you would start to shiver, you get goose bumps and in the area in between those a really important reaction is a change in your blood flow to the skin.听 So when you get warm more blood goes to the skin, so the skin gets warmer and releases more heat, but if you go into the cold the opposite happens and the skin blood flow is reduced and that鈥檚 often the cause why people get such cold hands and feet because the skin blood flow to the hands and feet is reduced dramatically, really dramatically and that means you鈥檙e more or less sacrificing your hands and feet in terms of temperature and comfort to maintain that body heat in your body core 鈥 so in your trunk and in your brain.听 And that response tends to be a lot stronger in females which means their skin cools down more than the skin of males and once your skin gets cold that causes you discomfort.

Actuality

Well are you as cold as usual today 鈥 let鈥檚 feel?

奥别濒濒鈥

Oh fairly, not as icy as they can be.

Well they鈥檙e pretty grim.听 This is my excuse 鈥 my cold hands 鈥 for all the mistakes that I make.

Now let鈥檚 go over to the tricky bit over here and do that hand separately.听 Bah da da鈥

Tipton

I鈥檓 Mike Tipton, I am Professor of Human and Applied Physiology at the University of Portsmouth.听 And we鈥檝e done a fair number of studies looking at the differences between the control of skin blood flow and its effect on temperature in men and women.听 And if you take a man and a woman, you put them into a warm environment, and then you cool that environment what you鈥檒l find is that the female will shut down her blood flow to the extremities sooner and shut it down tighter than the man and then if you warm that environment up the female will stay shut down for longer.听 There鈥檚 several reasons for that.听 One of the important ones is that females are just more sensitive to that peripheral cold stimulus.听 Also oestrogen, a female hormone, makes the blood vessels more sensitive to cold, so they shut down sooner and more tightly and stay shut down longer.听 Now the consequence of that is that females tend to have colder hands and feet.听

Now an important factor in your overall determinant of how hot or cold you feel, how comfortable you feel, is the temperature of your hands and feet, they鈥檙e very dominant, particularly in a cold environment or cool environment in determining you overall thermal sensation.听 So there is a physiological basis for the complaints that we get, particularly going into the autumn where women want to have the central heating switched on and men, thinking of the bank account, want to keep it switched off.听 It is actually a physiological basis.听 It makes women more susceptible, one, to lower temperatures but also to sudden changes in temperature 鈥 draughts 鈥 they鈥檒l shut down more quickly.

Actuality

Just a bit sluggish today with that rhythm.听 Okay.听 So let鈥檚 just go from there again, sticking to the beat.听 Da, da, dum鈥

Havenith

In general it is so that females tend to respond stronger to heat and cold physiologically than males, so females indeed are more sensitive, as soon as you go out of the comfort range where we鈥檙e virtually the same, males and females, females will have a stronger response to the environment.

Porter

How quickly can the body react 鈥 it has to be on the ball, doesn鈥檛 it, it has to react quickly?

Havenith

Yes that鈥檚 true.听 As soon as you start to exercise, for example, the idea is that your body temperature goes up and the brain then reacts to that by making you sweat or change your behaviour 鈥 taking off clothing.听 The body reacts really very quickly, so within a few minutes and sometimes even quicker, you can get your sweat system going if you鈥檙e hot and especially if you鈥檙e going into a cold room, for example, and you sense the temperature through your skin you will initiate very quickly first behavioural responses.听 So to give you an example if you think me giving a lecture to a room full of students and let鈥檚 say that鈥檚 a room in the middle of winter and the heating may not be perfect yet, it鈥檚 the first lecture in the morning, what you will find if you look through the room is that most people are sitting with their arms crossed or their hands in their armpits, so they鈥檙e preserving heat in a very subtle way.听 Well then because the number of people in the lecture room the temperature starts to rise you slowly see people spreading out more, so the arms disappear, they鈥檙e not crossed anymore, they鈥檙e on the table and that鈥檚 the first subtle signs of a little bit of regulation of your body temperature by just changing the surface area of your body that鈥檚 exposed to the environment.

Tipton

If you match a male and a female in terms of their height, weight, amount of subcutaneous fat, amount of muscle, then actually lots of the differences in terms of your ability to thermoregulate disappear between men and women.听 But of course that鈥檚 not the real world.听 In the real world women are smaller, they have more subcutaneous fat, sweat less, so the old saying that men sweat and women glow is probably true because women don鈥檛 have such an effective sweating mechanism or such an effective shivering mechanism because of their physiological anthropometric differences.听 The one difference that remains when you match them is this difference in the control and sensitivity of peripheral blood flow.听 And the best way of maintaining warm extremities is to maintain a deep body temperature that keeps the blood flowing to them.听 So after sitting down and doing something like 15 minutes of playing the piano it wouldn鈥檛 be a bad idea just to get up and move about to generate some metabolic heat, which will help reperfuse those extremities.

Actuality

Ba da 鈥 then don鈥檛 hang on too long.听 I don鈥檛 think the mittens are working very well today.

They鈥檙e not, I鈥檓 just cold.

Porter

Any excuse hey Lynn? But hopefully Professors Mike Tipton and George Havenith have given you some insight into your problem. I just add one other thing, intolerance of the cold - particularly if it is a recent problem - can sometimes be a sign of an underactive thyroid. Something that is also more common in women. More details on our website.

We had a great response to our special series demystifying the language of research and statistics during the last run of Inside Health so we asked Carl Heneghan, Professor of Evidence Based Medicine at the University of Oxford and our very own Dr Margaret McCartney to come back and do it again. And we start with surrogacy. Not the type you may be most familiar with, but a more obscure form that features increasingly in medical research and can involve everything from blood test results, to the pattern on your heart trace or ECG.

McCartney

A surrogate marker is the art, supposedly, of counting one thing when you鈥檙e trying to actually count something else for whatever reason and that something else is usually something that鈥檚 hard to measure, so if you choose something that鈥檚 easier to measure that you can get some data on and hopefully that鈥檚 going to predict what you鈥檙e really looking for later on.听 So for an example we measure bone density as a surrogate marker for whether or not you鈥檙e going to have a fractured hip in the future.听 We measure cholesterol as a surrogate marker as to whether you鈥檙e going to have a stroke or heart attack in the future.听 So it鈥檚 hard to measure the heart attack you鈥檙e going to have in 10 years鈥 time, it鈥檚 much easier to measure cholesterol now, the question is how useful is that.

Heneghan

Yes, so Margaret鈥檚 right, it鈥檚 a measure that鈥檚 on a pathway to actual outcome you really want to understand.听 Probably one of the most important examples of this, which has led to the birth of evidence based medicine, was the use of anti-arrhythmics in people with heart attack.听 And what used to happen is people use these anti-arrhythmic drugs, this is to stop heart beats when it鈥檚 going really fast, and what they do is treat the ECG really good, so the electrical activity reduces.听 The problem is it reduces the electrical activity, some doctors went umm, but actually some patient dropped dead.听 And what they realised when you did the clinical trial is actually more people were dying while the ECG was looking great, it was twice as likely to die on the drug, catastrophe, killed more people in America than the whole of the Vietnam War with one single drug.听 However, the reason we鈥檝e had this increase in them is because they do clinical trials where the end points are death or fractures, it requires thousands of people, many years of studying, cost an exorbitant amount.听 So what鈥檚 happened this and this has been an explosion in surrogates is often drug companies will say 鈥 we鈥檒l use a measure that鈥檚 halfway to where we really want to go to.听 And sometimes that鈥檚 okay but the way it鈥檚 been spread about is actually it鈥檚 becoming really dangerous.

Porter

Because Margaret most times I hear the word surrogate used it鈥檚 in a negative sense, it鈥檚 the suggestion is that we are measuring the wrong thing.

McCartney

Yeah, what we鈥檙e really interested in are the things that matter to patients.听 And you can wander round with a cholesterol of whatever number, you鈥檙e not going to know that your cholesterol is high or low or middle or whatever it is, it doesn鈥檛 affect you at all, what does affect you is whether or not you have a heart attack or a stroke and something comes about possibly related to the cholesterol level that you have.听 So what we鈥檙e not interested in is the cholesterol, that鈥檚 the surrogate, we鈥檙e really interested in the thing that happens to you, possibly because of that.

Porter

Well one example 鈥 let鈥檚 pick up on that 鈥 because an example that listeners might 鈥 that I see quite often 鈥 it鈥檚 the adverts for foods and drinks that will lower your cholesterol level and everybody thinks that鈥檚 a really good thing.听 But what you鈥檙e saying there鈥檚 no evidence that that actually reduces your risk of heart attack?

McCartney

It鈥檚 total nonsense, it鈥檚 total nonsense because it鈥檚 just a surrogate, that鈥檚 all that it changes. What you really want to know is does drinking gallons of this yoghurt over my lifetime, spending all this money on it, does that stop me from having a heart attack or a stroke later on and that has not been proven, that鈥檚 a really important thing, all that鈥檚 been proven is a change in a surrogate.

Heneghan

The other area where this has really expanded is in diabetes and pre-diabetes, we even have conditions before diabetes.听 And what you see is measures like lowering blood sugar, lowering your HPA1C, which is a measure of your blood sugar, as opposed to we鈥檙e really interested in the important complications of diabetes like eye damage, amputations, heart disease.听 And I鈥檒l go back about 10 years ago there was a very good example of this drug, a drug called rosiglitazone.听 Rosiglitazone reduced your sugar levels and it clearly did that.听 However, when people put all the evidence together they said 鈥 this actually increases the risk of heart failure and actually quite considerably so and what happened to the rosiglitazone 鈥 it鈥檚 been withdrawn from the market in Europe because people use a surrogate initially but actually when you got the hard end points they went actually this drug is actually more harmful than beneficial.听

Porter

But you鈥檙e saying also that we have to use surrogates otherwise you鈥檙e not going to get the sort of 鈥?

Heneghan

Yes so I think what we need to do is actually the problem is is now there鈥檚 such a rush to get new treatments to the market they tend to rush them through and the FDA, who regulate drugs in America, and the European Medicines Agency, will just let them through on surrogates.听 What they are is very good markers of actually we鈥檝e got a promising treatment effect and based on that we think this is such a large effect it鈥檚 worth doing the proper clinical trial to say do we get all the benefits that outweigh the potential harms.听 And when you know that then we would expediate and use these treatments really quickly.听 We鈥檙e in a no-man鈥檚 land where often we鈥檙e like should we use this treatment or not, lots of uncertainty, and you see that all the time with this cholesterol lowering at the moment.

McCartney

I completely agree with Carl and I think what we need to see more of is research and recommendations from NICE, so you can say okay this drug looks promising, surrogate markers are going in the right direction, but let鈥檚 use it only in research, so we actually know what the real life effects are of the things that matter to patients, not just these surrogate markers.

Porter

But the problem for listeners is when they鈥檙e reading a news story for instance about some new research, I mean the word surrogate鈥檚 not going to appear in that coverage, they鈥檙e not going to say this is a surrogate marker, so they might not know it鈥檚 a surrogate marker.

Heneghan

Yeah so I think 鈥 let鈥檚 look at what you should look for first.听 I think there are three things you look for.听 One is a very hard clinical outcome like death, like heart attack or like fracture鈥

Porter

Not numbers, not sugar levels or鈥

Heneghan

My second would be quality of life and there are very clear measures for quality of life 鈥 does this improve my鈥μ And the third is actual functioning 鈥 does it do something like actually a clear end point, like you actually can walk more, which is an important point to you.听 They鈥檙e the three things.听 What you shouldn鈥檛 be looking for 鈥 and you see this鈥 some I see it in like even for Ph鈥 the six hour Ph of your acid in your tummy is reduced by this new amazing treatment that will lower your indigestion and you think well how does that help you.

Porter

Is that the clue there Margaret, it鈥檚 about the number 鈥 if you see something 鈥 it reduces your blood pressure by this amount or it reduces your sugar by this or your cholesterol by that or your acid Ph by that, that鈥檚 a clue it鈥檚 a surrogate?

McCartney

Just as would I know this was working for me 鈥 is the question I would ask.听 How would I know this was working for me, would this make a difference to my life?听 And if it鈥檚 a number on a lab form that you would never have known about it had it not been tested for I would just have my antenna up thinking is this a surrogate marker that really isn鈥檛 going to cut the mustard.

Porter

Well the other thing we鈥檙e guilty of, as a profession, is that you鈥檙e doing something to them as well 鈥 your blood pressure鈥檚 come down, your blood sugar鈥檚 come down, your cholesterol level鈥檚 come down 鈥 you can show them the test results.

Heneghan

Yeah and that鈥檚 a really interesting idea isn鈥檛 it, the notion, we haven鈥檛 moved to this society and in fact the quality outcome framework pays you to lower blood pressures.听 And the problem鈥

Porter

Treat surrogates.

Heneghan

鈥eah and the problem is 鈥 and a lot of patients complain about this 鈥 well you鈥檙e just at your computer and walk in and see the doctor, he鈥檚 at the computer, and he鈥檚 treating the computer and the numbers and he鈥檚 not actually treating me and I鈥檓 really worried about the fact I can鈥檛 get to the shops and back.听 My blood pressure鈥檚 okay but I can鈥檛 actually walk 400 yards.听 So we鈥檝e got to find that balance that鈥檚 right.

Porter

Carl Heneghan and Margaret McCartney who will be back next week. When we will also be looking at how difficult it is to access some of the latest cancer drugs on the NHS. And asking whether proposed changes to the current system will help or hinder desperate patients? Join me next week to find out.

ENDS

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