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INSIDE HEALTH – Breast cancer, Alcoholism, CRPS, Generics

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Programme 3.

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TX:Ìý 27.09.16Ìý 2100-2130

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PRESENTER:Ìý MARK PORTER

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PRODUCER:Ìý ERIKA WRIGHT

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Porter

Coming up today:Ìý Costly generics - why have some run-of-the-mill non-branded medicines - like antibiotics and anti-inflammatories - suddenly become so much more expensive?

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Alcoholism and Baclofen - could a muscle relaxant be the latest addition to treatments offered to people with a drink problem?

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And a rare insight into complex regional pain syndrome - the most painful condition you have never heard of.

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I had a sheet in my mouth to stop screaming, I had a scalpel in my bed – I was considering taking my own arm off.

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Porter

More on the latest thinking on the causes and the treatment of pain like Gareth’s later, but first - breast cancer. It’s in the headlines again amid claims that thousands of British women are missing out on potentially life-saving treatment. Recent research suggests that bisphosphonates - normally used to treat the bone-weakening condition osteoporosis - can significantly reduce the risk of breast cancer spreading. But over half of oncologists surveyed are not routinely prescribing the drugs.

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Dr Margaret McCartney is in our Glasgow studio: Margaret, what’s is your take on the story?

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McCartney

Well it is very interesting.Ìý The bisphosphonates are the group of drugs that we’ve been using for years, they’re very ordinary, very plain, drugs that we use to try and prevent or to treat osteoporosis.Ìý So there’s usually a balance in your bone cells between new cells that are being made and bone cells which die, a process called bone remodelling.Ìý And several cancers are particularly prone towards spreading to the bone and breast cancer is one of them.Ìý Now we’ve known for some time that these drugs can be very useful when breast cancer has already spread to the bone but The Lancet study that was published last year is saying actually there’s a different use for these drugs, these can be used to try and prevent breast cancer spreading to the bone before it’s actually done so.

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Porter

So why wouldn’t oncologists use them?

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McCartney

There seems to be an argument about who should pay for it, essentially should it be commissioned by the hospital services or with general practitioner services.Ìý In some cases these drugs will be given by a drip in hospital, in some cases not.Ìý So there is I think a bit of a debate about where it would be done, who would do it and then how much would be paid for it and who would be signing the cheque at the end of the day.

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Porter

I’m just thinking in practice Margaret, if you and I got a letter from an oncologist saying your patient Mrs X has had breast cancer, I’ve started her on a bisphosphonate in light of recent research, would you mind continuing it – I wouldn’t refuse that.

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McCartney

No, I mean these are drugs that we’ve been using for a long time.Ìý The difference is though it’s a new indication, so these drugs don’t have a licence for being used in this way.Ìý Now we’ve discussed on this programme before that there are a lot of drugs out there that we use that don’t have a licence, so in a way it’s a bit like that, it’s an old drug but a new indication for it and some oncologists did say they were waiting for some more clinical guidance to come back.Ìý And I suppose that’s one of the big issues – are doctors not prescribing this because they’re waiting for guidance to come through?Ìý NICE have said they’re reviewing it in 2017, Scotland I understand are reviewing it as part of their cancer strategy and that decision will be made fairly soon.Ìý This will apply to post-menopausal women only for example but the bottom line is I think that women should be thinking about asking their oncologist about this when they next see them and it’s certainly the kind of thing as a GP that I’ll be looking to my local excellent oncology doctors for some advice about prescribing in future.

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Porter

Thank you Margaret.

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And there is more information on the use of bisphosphonates in breast cancer, and indeed other cancers too, on the Inside Health page of the Radio 4 website.

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Now to an update on a story we have been following for a while. The drug Baclofen has been used as a muscle relaxant for years to ease pain, spasm and stiffness in conditions like cerebral palsy and multiple sclerosis. But over the last few years there has been growing interest in its ability to do something very different - to help people with an alcohol problem.

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The use of Baclofen to help people control or stop their drinking is much more widespread in Europe - particularly France - than it is here in the UK, and a number of Inside Health listeners have asked us to revisit the subject to see what is happening elsewhere.

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Well the findings of the latest research into Baclofen have just been revealed at the World Congress on Alcohol and Alcoholism in Germany, and Anne Lingford Hughes, Professor of Addiction Biology at Imperial College, was there.

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Lingford

So I’ve just come back from Berlin where the latest three trials were all presented for the first time.Ìý So we’re very excited about this.Ìý So two of the trials have not shown that Baclofen is superior to placebo, so what they’re saying is that Baclofen didn’t seem to help people with alcohol dependence, or alcoholics, trying to remain sober.Ìý But there’s a couple of things that are quite important.Ìý One of the studies there was a very comprehensive psychological package alongside and they had been inpatients as well.

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Porter

So these are people in hospital?

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Lingford

Yeah, so that maybe quite different to a lot of the situations that occur in the UK, where many people don’t get access to inpatient treatment and the majority of people get some psychological help but it may not be very comprehensive.Ìý So it may be that all that psychological help – and this is what the authors think – minimised any impact that Baclofen could have on top.

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Porter

So Baclofen was an additional tier to quite a lot of care already, so that’s why it might have made any difference?

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Lingford

Absolutely.Ìý I mean it’s important to say that nobody’s ever advocating that you prescribe Baclofen, or any drug, to help alcoholism without the psychological help.Ìý But the majority of people maybe not be able to engage, maybe they have some cognitive impairments and difficulties with thinking and memory that they can’t actually access some of this help or it may not be available.Ìý So in that particular study I think what it’s telling us that a very comprehensive package that people can engage well with is very effective treatment for alcoholism, we knew that already, and in that circumstance adding in Baclofen may not help particularly.Ìý The other study was done in the community and again showed no superiority.Ìý But this study was actually done in France where there is quite a lot of debate going on on Baclofen at the moment about how much to prescribe and who to prescribe it to.Ìý So there was quite a lot of media coverage and there’s been quite a lot of discussion about this drug and that may have impacted then on the study.Ìý But neither study was fully presented – I mean it was a conference – so we need to understand about adverse effects, we need to understand maybe more about the patients that went into the study in order to get a real ideal of what happened.

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Porter

But this is in contrast with what the message that we get – I mean we get emails from our listeners telling us this is a wonder drug, that British doctors are in denial and why aren’t we using it more and more.Ìý And what you’re saying is that the latest trials that you looked at they showed it didn’t work, there might be lots of different reasons why that is but it certainly doesn’t appear to be a wonder drug.

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Lingford

I don’t think there is a single wonder drug to treat alcoholism because we know there are different routes into the disorder.Ìý So you wouldn’t expect one drug to be a miracle drug.Ìý What I will say is having used Baclofen myself to treat patients it has substantially helped a number of people, particularly those that are more severely dependent and have an anxiety or an anxious sort of predisposition.Ìý In those particular people it has seemed to be very helpful in addition to the psychological help we’ve given them.

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Porter

And that’s one of the reasons why trials might not work isn’t it, that we’re not giving the drugs or the intervention to the right people, that it only works for a sub-set of them.Ìý So what positive evidence is there out there to show that this drug may be helpful?

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Lingford

So the earliest trial, which was published in 2007, was done in patients with liver cirrhosis who are wanting to be abstinent…

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Porter

Give up alcohol…

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Lingford

Give up alcohol completely.Ìý And in that trial, at quite a low dose, at 30 milligrams per day, it was shown to double the rate of abstinence to about 40%.Ìý Subsequent trials at that dose have not been overwhelmingly supportive of that result.Ìý And a lot of the trials are done in people who haven’t got such a severity of alcohol dependence, so they may not have damage, they may not have liver cirrhosis or whatever.Ìý Another trial where they looked at those that were very anxious those did seem to benefit from Baclofen, but if you looked at the group as a whole there was not superiority.Ìý So a lot of these trials are quite small in number and that may impact on our ability to really find out which patients are going to do best.

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Porter

Tell me about the mechanism of Baclofen – how it’s working.

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Lingford

So we know it’s targeting the brain, it’s a particular receptor.Ìý And what we understand by it’s targeting the brain is that it’s controlling the reward system, so that when we do something pleasurable or something nice happens this system fires in the brain.Ìý And we believe that if you give Baclofen it calms this system down, so if somebody drinks alcohol or sees something that cues them or craves them, thinking about alcohol, this will calm that pleasure system down so it won’t trigger their desire.

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Porter

They don’t get such a reward.

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Lingford

Yeah they don’t get such a reward and they don’t trigger the desire and the motivation to go and seek the drug, that’s how we believe it is working.

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Porter

What about dosage as well, I mean you talk about 30 milligrams, that’s a more conventional dose, but I’ve seen it nearly 10 times that being recommended for use in alcohol?

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Lingford

So in France it was being used up to that – 300 milligrams a day and even greater dosesÌý And that has been the worry of patients getting it from a source other than their GP or specialist addiction centre – buying it off the internet.Ìý And it is a bit of a puzzle why patients are saying they need very high doses of Baclofen.Ìý So we’ve been giving a single dose of Baclofen and in a healthy volunteer it would make them very sedated, kind of really floor them.Ìý But often if you give the same dose to an abstinent alcoholic they’re not sure that you’ve given them anything, they think they’ve had a placebo.Ìý So that’s clearly telling us that the receptor or the target in the brain is not responding to the Baclofen in the same way.Ìý We know from taking blood samples that it’s not that the drug has been metabolised differently, we know it’s getting into the brain the same but we’re not sure now why this is, it’s clearly something wrong with the target or something changed with the target.Ìý Whether it’s the alcohol that’s caused that or whether it was pre-existing and it was part of their vulnerability to addiction, that would be the next thing to try and understand.

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Porter

Put simply their brains appear to be less sensitive to the Baclofen.

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Lingford

Yep, which has important implications for dose because if it is less sensitive then it explains why you would need to go towards a 100 milligrams.

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Porter

You say you use Baclofen yourself, what sort of patients and what sort of dose?

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Lingford

So I feel comfortable giving it to those that want to be abstinent, at least for a period of time, I’m not convinced that Baclofen helps people reduce their drinking or control their drinking.Ìý So that’s one key thing.Ìý The more severely dependent patients but I’m in specialist care so it’s very likely those are the group I’m going to see.Ìý And particularly those that when they’re craving makes them feel quite anxious.Ìý In terms of dose I will always start at either five or 10 milligrams three times a day.Ìý And some patients get very sedated and others aren’t sedated at all.Ìý And then I feel comfortable building up to about 60 milligrams a day or maybe to 90, I have gone a little higher in one particular individual who was benefitting and not sedated.Ìý I’m not convinced at the moment by the data that higher doses, going over 100-150, 200, 300 are necessary at the moment.Ìý There is a worry in people who have some liver impairment or some difficulties with liver function that you may get more confused on this drug and I know some people who are concerned about that, so at higher doses the rate of confusions may go up.

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Porter

You feel that this works in particular patients at the sort of dose you’re using and I presume you feel that it benefits them, otherwise you wouldn’t carry on using it but feel isn’t good enough in today’s medicine, we need the evidence.

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Lingford

So what we’re trying to do is study abstinent alcoholics.Ìý Abstinent from alcohol for a minimum of a few weeks and work out through a series of tests and some brain imaging and some challenges of various medications that are used to treat addiction how this may alter brain mechanisms.Ìý Without understanding we’re not going to further treatment, we’re not going to identify which patients are going to respond and which importantly maybe not benefit and therefore we waste time trying a drug in them.Ìý It is absolutely critical to do that.

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Porter

Professor Anne Lingford-Hughes acting as Inside Health correspondent at the 2016 World Congress on Alcohol and Alcoholism. Unpaid - naturally.

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There is more information on our website - where you will also find details of how to get in touch.

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Gareth Elfed Jones emailed with a question about complex regional pain syndrome. A rare, but potentially life changing condition that affects around one in 4,000 adults in the UK - often following injuries such as broken bones and sprains, or even surgery.

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Gareth damaged his elbow.

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Jones

It started when I fell over playing tennis.Ìý I played a beautiful slice backhand and my feet slipped, put my hand down and my distal humerus shattered.Ìý I was in hospital for a few days, part of my ulna was taken off and I had plates and screws and wires.Ìý The first thing I noticed was swelling, particularly my hand and my wrist, it was like a rubber glove had been filled with water with little sticks for fingers.Ìý And it turned a sort of salami appearance, it was very hot and this happened over about seven days.Ìý There was intense pain in my wrist, felt like my hand was being crushed in a vice and hot water was being poured all over it.

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Stannard

The clear picture that emerges is one of persisting pain after whatever the injury was has healed.

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Porter

Dr Cathy Stannard is a Consultant in Pain Medicine at Southmead Hospital in Bristol.

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Stannard

Often the limb will be very swollen, typically it will be discoloured and will change throughout the day, so it might go from red to purple to white.Ìý The nails will often be very unpleasant to look at, sometimes they become very long and hooked or ridged, but they certainly will notice a disparity between the affected limb and the other limb.Ìý Sometimes there will be changes in hair growth, so people can present with a very hairy limb and there can be changes in sweating in the limb, so they might notice that the limb seems to sweat excessively or is very dry.Ìý

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Porter

And how severe is the pain?

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Stannard

Well it’s usually described as very severe and patients are very protective of the limb because it’s so painful and that’s why it’s kind of easy to diagnose in the waiting room – patients may wrap up their arm in a scarf and often people will kind of have an exclusion zone around their limb.

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Jones

Two weeks after the operation the pain got so bad that I was considering taking my own arm off.Ìý I had a scalpel in my bed, I was in two minds whether to take it off.Ìý I had a sheet in my mouth to stop screaming.Ìý It may sound very strange – the fact that I wanted to amputate my own limb – but nothing helps, you’re in a state of absolute desperation.

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Stannard

Patients will wander what’s wrong with their limb.Ìý They develop a strange relationship with their limb.Ìý So they will either think the limb is not there or they will have a false representation of the limb, it will feel much bigger.Ìý But certainly I’ve seen patients who have their limbs amputated because really the limb is in such a poor state of health there’s very little else that can be done.Ìý But of course one has to say to a patient that losing a limb can be very disabling anyway and there is of course the chance that they will have a phantom limb pain as well, so then they would have the same pain and no limb, which is maybe a worst state of affairs.

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Goebel

My name is Andreas Goebel, I’m a senior lecturer in pain medicine in Liverpool at the Walton Centre NHS Foundation Trust.

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Porter

We’ve got guidance for doctors like me already, you’re working on the next set of guidance.Ìý I mean there are a lot of doctors out there who would miss this.

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Goebel

Yes and patients report that it was not recognised at all or certainly recognised quite late, let’s say half a year later or a year later.

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Porter

Do we know what’s going on, I mean why would a simple injury that would normally heal lead to this problem?

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Goebel

We officially don’t know what’s going on.

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Porter

Unofficially?

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Goebel

Well there are some substances, mediators, that are secreted by the nerves in the injured region which are abnormal and we know that the immune system is abnormally activated in probably the majority of these patients at the time of the injury and after the injury.Ìý But we’re not sure about the exact pathways.

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Porter

Would it be fair to say that the result of these inflammatory mediators or the autoimmune system is that it puts the nervous system – makes it hyper-vigilant…

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Goebel

Exactly right.

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Porter

… oversensitive if you like?

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Goebel

The nerves are clearly very much up-regulated – they’re hypersensitive, they’re giving the wrong messages to the brain.Ìý But we don’t know why they do that.Ìý I think there is an interesting change in the ‘60s, ‘70s, ‘80s where there were some doctors saying that this is probably psychological.Ìý If you go back to the publications from that time you’ll find a lot of case reports that say look these people have a special personality, that’s probably what’s causing this pain.Ìý But that has now pretty much disproved.Ìý So recently, over the last 10, 15 years, there’s been another change saying no there’s got to be something biological going on.

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Stannard

I think in the early days it was often thought there may be psychological predictive factors but these have been really, really difficult to elucidate in well conducted trials.Ìý We do know that following the injury pain related fear, distress and anxiety can worsen the picture.Ìý What I would say as a pain clinician is that very, very many of my patients have got not as the cause of their pain but as a background, have got emotional problems, whether it’s depression, anxiety or maybe previous unpleasant emotional experiences.

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Porter

And that’s not surprising, given that pain can have a profound effect on your mental wellbeing and your mental wellbeing can have a profound impact on your perception of pain.

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Stannard

Yes absolutely and they affect each other and then when you put into the mix poor sleep because of pain these things all interrelate.

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Porter

Do we use conventional painkillers, do they work in these people?

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Stannard

There are no good studies looking at medicines for complex regional pain syndrome specifically.Ìý So what we do is we just use drugs that are used in other nerve pain conditions.Ìý But the reality is that these drugs don’t work for very many people.Ìý In clinical trials they might work for two or three people out of 10 but in real life they’re probably working in one in 10 or fewer.Ìý So patients will have tried a lot of drugs but it’s unusual for those drugs to have been tremendously effective.

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Goebel

So conventional painkillers, over-the-counter drugs, don’t work.Ìý Pain medications that are used for neuropathic pain might have a mild effect and rarely might have a bit stronger effect but generally we need specialised physiotherapy which is very important because if you have a very painful arm you tend to spontaneously not move it and that’s the wrong thing to do.Ìý On the other hand it is not easy because movement is painful.Ìý So we need a specialist who advises you appropriately how to move.

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Jones

The only person that can go near my arm is my physiotherapist because I trust her not to move her hand quickly along my skin which causes a lot of pain.Ìý The most important thing I found was getting the limb movement, so particularly with the wrist and the fingers getting them moving again and also trying to reduce the hypersensitivity as well.

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Goebel

In addition there’s one or two drugs that the pain specialist can try.Ìý At the moment we think that bisphosphonates given once might be helpful in early CRPS only, if you catch it very early.

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Porter

How do we think that’s working then?

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Goebel

Officially again we don’t know.Ìý It’s coming really from trial evidence but if you do an x-ray in people with CRPS a lot of people will have small areas of osteoporosis localised in the affected area, so that’s how it originally came about that people thought oh well there is a bit of osteoporosis how about we give an anti-osteoporotic drug.Ìý Whether it is the anti-inflammatory effect that these agents have or whether there’s something special to the bones we don’t know.

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Jones

The pain was unbearable for about six months.Ìý I was on seven different types of medication, 40 tablets a day, and then after about six months it started to become more tolerable. ÌýBeen no real indication of whether the pain will go.Ìý My GP recommended taking vitamin C, which was rather curious because I’d never heard of vitamin C as a pain reliever before, so I wondered if there’s any evidence to suggest vitamin C has an effect on pain, short term and long term.

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Goebel

There’s some evidence that vitamin C after a special type of fracture of the wrist, if it is given from the beginning, from the fracture onwards, can reduce the chances of developing CRPS.Ìý The effect is probably not very strong.Ìý Vitamin C has a sort of an anti-inflammatory effect.Ìý The evidence is not very strong but if it was my daughter, for example, then I would do it.

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Porter

What do you tell your patients about the outlook, what does the future hold for them?

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Goebel

Most people get better, Mark, they get better themselves.Ìý The body heals itself and after six months or after 12 months 85% of people say I’m a lot better than I was initially.Ìý We are interested in those patients who don’t get better.Ìý So there are 15% of patients – one five – who do not get better and that can go on for life.

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Porter

Andreas Goebel, and there is a link to the existing guidelines on complex regional pain syndrome, which Andreas helped produce and is currently updating, on our website.

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The NHS spends around £200 a year on medicines for every adult and child in the UK so it should come as no surprise that it is keen for doctors to prescribe the cheapest version where differences exist. And that normally means prescribing generically.Ìý

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Once the initial patent on a branded version of a drug expires – that’s typically 10 years or so after it’s first launched - rival drug companies can produce copy-cat generic versions and these generics tend to be much cheaper.

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Or so you would think. ÌýRecently I have noticed that the cost of some generics has risen markedly, and unless doctors, like me, are careful, they can unwittingly end up prescribing versions that cost up to 10 times more than they think they do.

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So what’s going on? To find out I am joined by Warwick Smith, Director General of the British Generic Manufacturer’s Association, and Dr Margaret McCartney is in our Glasgow studio.

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Margaret, let’s be clear, prescribing generically is a good thing.

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McCartney

There was a study last year who basically said that we’re prescribing 84% of our prescriptions in the NHS by generic name rather than by branded name.Ìý And that had saved the NHS £7.1 billion since 1976.Ìý So it really has made a big impact.Ìý For example, Viagra, branded Viagra, costs £23.50 for four tables but if you prescribe it as Sildenafil it’s £1.24.

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Smith

Very interesting product to talk about because originally before there was any generic competition NICE limited the availability of Sildenafil on the NHS.Ìý Now there’s generic competition the price has dropped and it is much more available.Ìý So there’s greater access for patients once that generic competition comes in.

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Porter

But herein lies a concern at Inside Health and that’s that the term generic is associated with great value for money but some generic medicines are incredibly expensive.

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Smith

There’s a very small number, which were never really genericised when the patent expired on the original brand, and they kept going, the price has kept decreasing until they’re no longer viable for the original inventor of the product.Ìý They might then sell that on to a generic company who has to do a lot of work for it to meet modern standards of safety, quality and efficacy.Ìý And they need to recoup that investment.Ìý Now that does lead to the price going up, quite often what that then does is make the product more attractive for other manufacturers to come in, the competition is resumed and the price goes down.Ìý But it’s important to understand that if that doesn’t work properly then there is a fall back for the competition regulator to investigate that and there are a couple of investigations going on at the moment and it’s absolutely right the taxpayers’ money is protected in that way.

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Porter

But there are some concerning exceptions, some of the medicines that we prescribe very frequently – Omeprazole’s an example – there’s one generic version that costs about a pound, there’s another one costs about £7 and it’s very easy for doctors to make mistakes and click on the wrong form.Ìý And I came across an amazing one – Flucloxacillin – it’s a type of antibiotic that’s given for skin infections, the liquid form which we use in children and adults is about £25 a bottle, I mean it seems an absurd amount of money.Ìý And the worry there is that there are some generic manufacturers who are profiteering.

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Smith

So the likelihood is not that, the likelihood is we do have a number of liquid versions of typically solid dose products that some manufacturers specialise in producing for children.Ìý There’s an investment there that has to be recouped.Ìý At the end of the day if the market isn’t working properly then both the Department of Health and the competition authorities can intervene.Ìý I think the other important thing is prescribing the active ingredient in its simplest form will enable the pharmacist to source the least costly product.Ìý I think it’s when people start writing capsules or tablets, which reduces the competition in the market.

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Porter

If I write Sildenafil, for instance, which is Viagra, the generic version of, the chemist can source the cheapest version but do they have to source the cheapest version?

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Smith

It doesn’t matter which version they source, they can dispense Viagra, but they will only be reimbursed at the generic price.Ìý So what successive governments have done is to produce for the vast majority of products almost a perfect market to keep prices low.

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McCartney

Well I’m not sure that we really do.Ìý So one general drug company brought over the ability to make Fusidic acid eye drops which are a standard antibiotic eye drops and they used to cost a couple of pounds and I noticed that actually the price has gone up to almost £30 for a small tube of very basic medicine, I mean this is not, by any means, an exotic prescription.

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Porter

That certainly, I mean that’s something I’ve noticed, that leaves a bad taste in your mouth when you see that.

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Smith

It can be that work has to be done and I don’t know in respect of the particular product that you raise.Ìý I know one other product the regulator is so keen to have a very small therapeutic window is variation has to be very tightly controlled that it’s insisting on signing off itself every batch.Ìý So for products like that the…

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McCartney

The other one was Phenytoin, a tablet used for epilepsy, and the price had increased from 66 pence for 28 tablets up to almost £16.Ìý Now I really find it really difficult to know what the MHRA – or the Medicines and Healthcare Regulatory Authority – what new information they would want that would cost a drug company just that much more money in order to justify their sale.Ìý I mean these are drugs that are longstanding, they’ve been around for decades, why on earth is the NHS being charged just so much money, these are really standard ye olde type medicines?

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Smith

Sure, I take that Phenytoin is an old product.Ìý I’m not quite sure I’d call it a standard product but there is a competition markets authority investigation into one Phenytoin product at the moment and I think that’s evidence of the point I was making that if it looks as if the market isn’t working properly there are powers that the government has to investigate and take action.

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Porter

Both, we must leave it there. Warwick Smith and Margaret McCartney, thank you very much. And if you are listening to this and you’re a prescriber please do check the prices of your favoured generics - if you don’t already - they may not be quite as good value as you remember.

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Just time to tell you about next week when I meet the man whose work has transformed stroke prevention across the world, and reminded me how an aspirin a day can still keep the doctor away.

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ENDS