On the Rebound

My Twitter feed has recently been subject to a series of promoted tweets from a company that sells decongestant nasal sprays. The brand behind these advertisements shall remain nameless (other decongestant nasal sprays are available), but I have been compelled to take to the keyboard because the spray is being recommended for the relief of symptoms of hay fever – which is just bad medicine.

I must make it clear that the company is doing nothing wrong – the spray is licensed for the treatment of hay fever and it is available without prescription, so they are well within their rights to advertise it in this way. That doesn’t mean I have to agree with them, though.

 

On the face of it, it seems reasonable to use a decongestant for hay fever – one of the symptoms is nasal congestion, after all. The problem lies in the issue of rebound congestion – sometimes known as rhinitis medicamentosa (medical speak for your medicines made your nose run). The decongestants might make you feel dramatically better in the short-term – as they reduce the blood flow, and hence the swelling, in your nasal passages within minutes – but they don’t do anything about the underlying cause. Worse than that, within a few days your nose can start getting ‘addicted’ to these sprays so that the congestion returns with a vengeance, requiring more of the spray to relieve the symptoms, leading to further rebound congestion and so on.

For this reason all decongestants have strict warnings on them that they are not to be used for more than 7 days. They are mostly used for treating colds, and since these last only a week or so that is not too problematic. For treating acute sinus pain, or relieving earache on a flight, they are fantastic, since these are short-term problems. Hay fever, on the other hand, will last as long as the pollen you are allergic to – April and March for tree pollens, May, June and half of July for grasses. So the adverts promote something that should never be used for more than a week, to treat a condition that will usually last at least 2 months. Even for those patients who have only very intermittent symptoms on high pollen days there are more effective treatments out there, in the form of antihistamines and steroid nasal sprays.

While the ‘S’ word can cause people concern, I sometimes describe steroid nasal sprays as being the polar opposite of decongestants. The latter make you feel better straight away, but do nothing for the underlying condition and will make it worse in the long-term, while steroid sprays do absolutely nothing straight away, but treat the underlying inflammation that is the problem in hay fever and will usually solve the problem in the longer term. The steroid dose is extremely low so that there are no side effects due to absorption into the blood stream. It’s better not to use them all year round if you can help it, due to thinning of the lining of the nose and nose bleeds, but then hay fever is seasonal so most people can have prolonged breaks from treatment.

As a doctor I feel especially powerless to stop people becoming dependent on decongestant nasal sprays; and some do become truly hooked – I have had some patients rely on them for decades. I know that my pharmacy colleagues are very good at warning patients not to take them for more than 7 days, and I can’t imagine any pharmacist recommending them for hay fever, but patients don’t have to speak to any health care professional to buy these products. They are categorised under General Sales Licence, which means that you can just drop them in your basket from the shelves of a supermarket and take them to the checkout – no-one will notice that you buy them every week, or advise you that it might be causing you such a problem.

How such a product was ever made so readily available, or achieved a licence for hay fever, I shall never know. There is no prospect of changing this, but perhaps by writing about it I can steer one or two people away from turning their seasonal allergy into a year-round problem of rebound congestion.

The Polypill – Holy Grail or Fool’s Alchemy?

The Daily Express headline of an all-conquering Polypill waiting in the wings, ready to save thousands of lives and rescue the NHS finances, has become almost an annual event. This year’s offering is no disappointment, and its particularly misleading headline –Ten pence pill could help you live 8 years longer was rewarded with a front page spread.

The study that provided this exciting headline was based in India, and compared the use of a single combination pill with usual care for patients with established heart disease, or felt to be at risk of heart disease. The combination pill contained aspirin, simvastatin for lowering cholesterol, and two blood pressure drugs – lisinopril and either atenolol (a beta-blocker) or hydrochlorothiazide (a diuretic). Far from showing any reduction in heart problems, however, the study actually only demonstrated  increased adherence to medication in the treatment group, and a modest reduction in systolic blood pressure and LDL cholesterol compared with the control group. There was also the slightly awkward bias in the study whereby the treatment group received their medication for free, while the control group had to pay for any medication they received – a factor which could surely account for all the study findings at a stroke.

Whenever I hear of yet another study involving the Polypill, I find myself wondering why on earth they bother. Even if they finally break the mould and actually demonstrate benefit that means something to patients – rather than just improving the numbers that doctors measure – are GPs and their patients really going to want to start taking the 4 in 1 pill?

If you needed to be on that exact combination of tablets then there is no doubt that to swallow one pill rather than 4 would make life easier, but does this outweigh the downsides of coupling together 4 very different drugs into one preparation? None of these tablets will make a patient feel any better – they are only used to reduce the risk of something happening in the future, such as a heart attack or a stroke. The biggest issue when starting them, therefore, is side effects. No side effects is the goal, but what are the chances of someone having no side effects if they start 4 drugs all at once? And if they do get a side effect, how are they to know which tablet is causing it?

Some side effects are typical for a type of drug, an irritating cough can occur with lisinopril for instance, and so the doctor may well be able to guess the culprit – but a side effect with even one component in the Polypill will mean having to divide it into its constituent parts and start again. The prospect of having to unpick this magic medicine on a regular basis does not fill me with enthusiasm.

Then there is the need to respond to the ever-changing face of medicine. Aspirin, for instance, was used extensively in patients who were thought to be at risk of heart disease, but more recently the advice has changed to only use it in those with established disease. In fact the twists and turns of advice for this particular drug has an extensive history which caused me to write an early post in this blog. All it would take would be for the advice to change once more, and patients on the Polypill would need to be recalled, with their medicines changed, resulting in all the attendant uncertainty, anxiety and confusion that inevitably accompanies changes in medication.

The current direction of travel in healthcare is towards personalised medicine, with an emphasis on tailoring a drug cocktail to match the exact physiological needs of an individual’s biology. While I would prefer that there was an equal focus on tailoring medications to an individual person’s informed choice and preference, it can only be a good thing to try to personalise treatment in this way. The Polypill seeks to take us in the opposite direction and I remain deeply sceptical about any benefit it may have for our society.

The researchers behind this work are boundless in their enthusiasm, however, and so future studies will no doubt pop up from time to time  – well, at least it keeps a journalist employed at The Daily Express!

Intrinsa? Intrinsically Wrong

Few of us will have noticed the change in status of the testosterone patch Intrinsa last October. As a GP I have no patients who have been affected by it, and while a treatment for the controversial diagnosis of Female Sexual Dysfunction might be significant for a small number of women, it is hardly a life-threatening condition or a major public health priority. However, we would do well to take note, because it heralds a new low in the behaviour of the pharmaceutical industry as they try to maximise profit, and has implications not only for the resources of the NHS, but also patient safety.

Intrinsa is a testosterone patch, and was one of the few such products licensed for use in women. In October 2012 Warner Chilcott, the company that held the rights to market Intrinsa, took the unusual step of voluntarily withdrawing its product licence ‘for commercial reasons’. Given the high costs involved in obtaining a product licence in the first place, it is hard to see how this could bring commercial benefit – until you follow the story a bit further.

Ben Bryant of The Daily Telegraph has been drawing attention to the activities of the pharmaceutical industry in a series of articles in the last two months, and has highlighted the situation with Intrinsa in his latest article. What Warner Chilcott have done is to maximise profit by exploiting the financial regulations surrounding licensed and unlicensed medicines – with the former having to abide by an agreed price cap while the latter exists in the mysterious world of the unregulated ‘specials’ market, where the drug company can charge whatever they want – frequently at outrageously high prices.

Within a month of the change, the ‘last batch’ of Intrinsa (sufficient for ‘the foreseeable future’) was acquired by another company HFA Healthcare, who were quick to point out their altruistic motive to ‘ensure continuity of medication for patients,’ but rather more reticent about mentioning the price hike – from £26 per pack to £395 per pack.

We have been here before with far more significant drugs – Epanutin was acquired by Flynn Pharma last year, with a 23-fold rise in the price and a great deal of worry for patients. What is new about is scenario, however, is the loss of the licence. A Licence is not just a mechanism to allow the pharmaceutical company to promote its product; it is a source of protection for both the doctor and patient. It provides security that a medicine has been properly tested, has safety data approved by an independent body (in this case the European Medicines Agency), and has been deemed to be effective in treating the condition in question. It is the medical equivalent of a Kite Mark.

The absence of a licence means prescribing a drug off-label. Doctors are used to doing this where treatment is required and no licensed product exists – the patient cannot always wait for the time-consuming processes involved – but this is because a licence has never existed, not because it has been withdrawn for purely commercial reasons. When a doctor does prescribe off-label in this way a doctor has to take extra responsibilities, or, to quote the MHRA:

The responsibility that falls on healthcare professionals when prescribing an unlicensed medicine or a medicine off-label may be greater than when prescribing a licensed medicine within the terms of its licence.

Put crudely, if something goes wrong you can’t sue the drug company as the medicine was used in a way that they did not recommend. The patient is more likely to sue the doctor, or not be able to get compensation at all if there is a problem; the drug company is able to wash its hands, and say ‘nothing to do with us.’ It is the equivalent of selling an electrical appliance, but withholding its 1 year warranty ‘on commercial grounds’, only the patient isn’t able to shop elsewhere, since there is no other licensed product to turn to.

Withdrawing a licence is not just a matter of finances, a way of a company balancing its books or a headache for the NHS drug budget – it is a patient safety issue first and foremost and this practice needs to be investigated and stopped in its tracks before the industry tries it out again – this time with a drug that really matters.

The Bizarre, Unpredictable and Shameful World of Drug Pricing

In recent months I have become so used to being bashed over the head by press releases from the Department of Health, that I have developed an almost Pavlovian response – the head bows, the shoulders go down, I duck for cover.

So it was only while peering carefully from a place of safety that I was pleasantly surprised by one of their latest pronouncements – to give NICE new responsibilities to look at fair pricing for pharmaceuticals.  For all its imperfections, NICE has been one of the best developments in the NHS in recent years. It has brought some much-needed clarity to prescribing guidelines and a degree of protection from the seemingly irresistible lure of the latest best thing to be marketed by the pharmaceutical industry. It can only be a good thing for NICE to be more involved in helping to bring common sense, and the needs of the NHS, to bear upon drug pricing.

In fact, I think it is such a good idea, that I would like to make some suggestions for how they could take things even further – by looking at some of the bizarre, irrational and often downright scandalous anomalies that exist within the drug tariff.

Take nebivolol, for instance, an important beta-blocker for some cardiac patients. It comes in both 2.5mg and 5mg tablets – how can it possibly make sense that the half-strength tablet costs the NHS over 30 times as much as its stronger counterpart? The anti-depressant paroxetine is similar – the multiplication factor is less extreme, with the 10mg tablet being only 6 times more expensive than its 20mg cousin, but the illogicality and blatant unfairness is the same.

Lest any doctor get wise to the fact that lower strength tablets might be more expensive, we have the opposite situation with omeprazole. For most drugs it is more expensive to prescribe two low dose tablets than a single tablet of a higher dose, but 40mg omeprazole is twice as expensive as the equivalent dose in 20mg tablets. I have to ask my patients to swallow their pills twice as often, but most are more than willing once they realise it is the scarce resources of the NHS which are at stake.

Even if I prescribe the drug perfectly, price inflation can still happen in the most unpredictable way before the medicine leaves the pharmacy. The breast cancer drug letrozole is a prime example. It is only given as a 2.5mg dose, so what could possibly go wrong? Well, it turns out that pack sizes can make all the difference. If the drug is issued in packs of 14 the price is £1.89, while packs of 28 cost a staggering £73.24. What is going on here? A pharmacist who is on the ball and gives 2 packs of 14 will be saving the NHS nearly £70 a time – but if they all did that then how come the packs of 28 would manage to sell?

How am I meant to know all of this? Can I remember it all, each and every time I prescribe? Even if I could – do we want doctors to have to learn the prices of drugs? Wouldn’t we rather they spent their time keeping up to date with real medicine instead?

There can only be one reason why these pricing anomalies occur – bombard and bamboozle doctors enough with confusing prices and some of them won’t notice, leading to vast sums of money bleeding its way into the coffers of big pharma. It is a marketing strategy that is not unfamiliar to anyone who pays a utility bill; price plans are so bewildering that the companies rely on many of us making the wrong choice and paying over the odds. The Government has become wise to this and is trying its best to limit the number of price plans companies can offer.  If the Government can protect the voting public in this way then it should do the same for the NHS and start limiting the marketing opportunities of the pharmaceutical industry.

NICE should be involved in changing this. I have a simple formula to suggest to them, and it goes like this: Every drug should have an agreed, fair price for its lowest dose, and as you double the dose, you double the price. What could be simpler? There would be no more bizarre pricing arrangements, nor could a drug rep boast that their product has a fixed pricing regime whilst their rival’s does not – nor could the tariff be changed at the whim of the company once my patients are established on their treatment.

Everyone would know where they were, every drug would be fair. Simples.

I am very grateful to our pharmacist at Binscombe, Rebecca Huish, for helping me research this post, which was originally published in Pulse magazine (access through free registration).

We Need to Talk About Conflicts of Interest

When I penned my previous post on the possible role of antibiotics in the treatment of back pain, I was unaware of one vital piece of information which, for me, changes everything: The doctors behind the research had a significant conflict of interest, which they had not declared when they submitted the article for publication.

This was first brought to my attention by Ben Riley, who keeps the Ferret Fancier blog, and the issue has also been covered by Margaret McCartney in the British Medical Journal. To summarise, three of the four authors are part of an organisation called MAST Medical, which states:

The latest research shows that back pain from Modic changes can be successfully treated with a prolonged course of antibiotic treatment.

To ensure that treatment is successful patients should consult a MAST certified doctor and/or therapist.

It is no surprise that to become ‘MAST certified’ requires attendance on a course run by MAST Medical, and payment of an inevitable fee. Apparently the authors did not think that this was a conflict of interest, because the website was launched three months after the article was published – a defence of their position which stretches the concept of conflicts of interest beyond breaking point.

The current system with regards to competing interests relies on self-declaration – this is a problem, since the editor of a journal cannot police every article that is submitted to them, or challenge authors concerning conflicts about which they are unaware.

Scientific method should make self-declaration a reliable system. A true scientist is more concerned about elucidating the truth than promoting their own interests; they will always be keen to see if their results can be reproduced by other researchers before declaring them to be proven; a true scientist may still have a conflict of interest – but they will positively want to declare it as they know that it could bias their interpretation.

Unfortunately, not everyone in the medical world behaves as a true scientist. This group, far from being concerned that they could be biased, have chosen to defend what is an obvious financial interest in the results of their trial. A cynic might guess that they delayed the launch of their website precisely so that they could get away without declaring it. As a medic I am very concerned that they are promoting antibiotics for the treatment of back pain before their results have been replicated elsewhere.

Sometimes declarations may fail to be made for very obvious reasons of personal gain – we only need to remember Andrew Wakefield and the MMR scandal to realise just how serious this can be – while at other times it may be due to laziness or thoughtlessness on behalf of the authors. An example of this more innocuous, but nevertheless important, neglect to make a proper declaration occurred when I wrote to the British Medical Journal, as part of a diverse group of people involved in healthcare, to raise concerns about the prospect of screening for dementia.

Our letter was initially published as a rapid response, where it triggered a reply from an eminent group of doctors who declared that they had no competing interests. The letter was subsequently published as an Observation article, and a further reply came from many of the same authors, several of whom decided on this occasion to declare interests, including financial support from pharmaceutical companies and appointments related to the field of dementia. These conflicts are not wrong in themselves, and do not invalidate their comments, but neither are they unimportant, nor did they arise in the intervening three-month period between the letters. What changed? A prick of the conscience? A word from the editor? Or perhaps the fact that the BMJ tightened its wording about conflicts of interests in January 2013 – between the two submissions.

Even a robust policy on this matter is insufficient, however. The BMJ has very clear guidance on what should be declared, but there is very little the editors can do when proper declarations are not made – with retraction of the article being their most draconian punishment. Retraction may have repercussions in the scientific community, but it is rarely reported on in mainstream media. The furore and excitement on the front pages of our national newspapers that surrounded the news that back pain could be treated with antibiotics is hardly likely to be repeated were the paper to be retracted by the journal at a later date, and so patients with back pain – and even their GPs – may never get to hear the full story.

The BMJ, along with many other leading journals, has encouraged the use of a uniform reporting system for competing interests, but this is by no means universal, and still lacks teeth. There needs to be a national debate on this important issue, and serious consequences for failing to declare significant competing interests. I don’t know what these should be – a ban on publication for a period of time, rather like a football player being suspended? A published apology? Even fines?

If this seems heavy-handed then we should remind ourselves of the consequences of misleading reasearch. Andrew Wakefield published his discredited research in The Lancet in 1998. It took 6 years before his financial conflicts of interests were unearthed by Brian Deer of The Sunday Times, but it was only in 2010, when he was struck off the medical register by the GMC, that the journal finally retracted the article. How much damage was done in the field of public health in the meantime – and is still being felt today as the outbreak of measles in Swansea is a stark reminder?

The danger with Wakefield is that we write him off as a dishonest maverick and fail to learn the lessons of a system that is broken and in need of a major rethink. We don’t need to wait for the next scandal before we talk about conflicts of interest – we need to do it now.

The Real Cost of the Epanutin Scandal

Last year I published two posts on the scandalous price rise in the cost of Epanutin (phenytoin), an important treatment for epilepsy. You can read the posts here and here, but in short, here is the gist of what happened: Pfizer, the manufacturers of Epanutin, struck a deal with Flynn Pharma, a far smaller pharmaceutical company. Pfizer would continue to make the drug in the same way as before, but Flynn would now re-brand it, and in the process they would increase the price over 23-fold. The NHS would be held to ransom on the matter because the danger of switching a patient with epilepsy to a competitor brand was far too dangerous for the patient – and anyway there are no competitor brands.

At the time I was incensed by the huge unnecessary extra cost to the NHS of £44m per annum – and I still am – but over the last 6 months I have been deeply humbled by comment after comment posted on the blog by those who are bearing the real cost of this outrage – patients. 

I felt that these patient stories deserved a post of their own. We need to listen to them. Pharmaceutical companies need to hear these voices when they make business decisions in boardrooms, far away from the lives of the patients they tell us they care about. Politicians need to hear these voices when they consider the rights of big business against the care of the patient. The media need to listen too – perhaps pausing in their current obsession for exposing every possible fault in the NHS, and considering how patient care can be affected just as much by private companies and political policy as by frontline workers struggling to cope. Here are some of these voices:

Jeremy Whitehead had a fit when his brand was changed (this may not have been the Flynn Pharma change, but shows the danger of changing brands), and has decided to give up driving as a result:

I have had very little trouble until recently when the 100mg capsules of which I took 3 were presented in a different packaging labelled Epanutin but with a Malta licence. I started taking these and had a very bad fit shortly afterwards. Thank God I was at home and not driving my car.

I am within a couple of months of my 70th birthday and can’t put up with much of that sort of thing any more. I assume that it was the variation in brand which triggered my attack, but my main concern is that there will be other people in my situation who might not be so lucky, they could be driving around and have a horrible accident. I have returned my licence to the DVLA.

Tom McLaughlan expressed the anxiety that many patients on this drug are feeling:

What if the outcry against their pricing strategy were to result in Flynn pulling the drug?

I’ve been taking it for 31 years. Fifteen or so years ago my GP tried to take me off it but within hours of the transfer process being completed and me being on the new drug alone I had two seizures. So I went straight back on to the Epanutin and have stayed with it ever since. I do not want to face the likelihood of seizures again…

It is hard to underestimate the consequences of having a seizure in epilepsy that has otherwise been well controlled, and therefore the anxiety that can be created even by the possibility of this happening – Ian Bates knows this all too well:

There has been two times that my Neurologist has tried to remove/change this medication but each time it has led to me being hospitalised and nearly causing my death. Therefore I understand the consequences of removing or even altering the drug slightly.

Dawn Stocks describes the effect of a lack of communication about the change (as a GP I am especially humbled here as I am sure we could have done this better with our own patients):

I have stuck to Pfizer epanutin from the early 1980s up until last week when I received my prescription and noticed the Flynn Pharma label. I have had no warning from the pharmacy or my GP about the change and, like most epileptics, have severe consequences of not receiving the same brand medication. Panic set in which makes seizures worse .

Richard had a similar experience and laments the lack of communication from the company to the patient:

There should be a duty of care on the supplier to explain all of this via the GP and pharmacist. I have received absolutely no communication over this matter from my GP. The pharmacist (Boots) had a copy of a letter from the manufacturer which I requested a copy of, but was informed that I could not have a copy as this was the pharmacist’s only copy.

There have been supply problems, and it is hard to see that this is unrelated to the change since this has never been a problem before with Epanutin. Sean Loftus explains:

Went to a large high street chemist earlier this month & they were unable to supply the full prescription…I’m now low on epanutin, less than a weeks supply.

He is not alone – here’s a comment from Ginger:

I am quite happy to accept either Epanutin or Phenytoin Sodium Flynn Pharma, but a bigger problem has arisen – both are in short supply!

Just before Christmas I could not get my prescription made up by my usual pharmacy, and had to phone around until I found one with half the amount I needed. This was the 2nd time in 18 months.

Rosie has had similar problems, with real reasons to doubt the reliability of her medication:

I have taken these since 1974 and my GP is not happy about prescribing them because of the cost.I found my local branch of Boots would not supply the Flynn brand against the prescription that my GP gave me with Pfizer on. I have had a permanent struggle with the change of name. Now that the prescription has been updated on the computer to Flynn I am getting left overs of Epanutin from various chemists still made by Goedecke, Germany supplied by Parke Davis with a Pfizer label over that. They must be old as the use by date is January 2014.

When we listen to these stories we must remind ourselves that we are not talking about uncertainties over a drug that you could take or leave – this is epilepsy – serious medicine. I want to thank all those who have taken the time to comment, and to readers for listening.

Epanutin Scandal Picked up by The Daily Telegraph – Now MPs Need to Know

I am delighted to say that my previous post concerning the scandalous increase in the price of Epanutin, an important epilepsy drug, has been picked up by the mainstream media and was reported in The Daily Telegraph today. The increased exposure that the story will now receive is greatly welcome, as it is vital that the pharmaceutical industry realise that when they try to manipulate the price of important medical treatments in this way it will not go unnoticed. What we now need is for MPs to become aware of this misuse of a monopoly position, in order to try to put real pressure on the companies involved.

I have written a draft letter below which I will be sending to my MP, and to Jeremy Hunt, and it would be fantastic if as many people as possible could join me and do the same. Please do copy and paste the letter below if it is helpful.

Stephen Adams, the medical correspondent at The Daily Telegraph discovered some interesting facts during his investigation. The first is the full cost to the NHS of the price increase – a cool £44m each year, or, to put that figure into perspective, enough to employ 1800 extra nurses. The second is the exact nature of the loophole Flynn Pharma have used to be able to get away with it, which relates to changing the drug from a branded formulation to generic.

The price of branded medications such as Epanutin is negotiated between industry and the Department of Health, which means the industry cannot unilaterally determine the price. For generics the market is supposed to keep prices low through competition, so prices are not negotiated. The problem with the market in health care, however, is that is not like other markets, and it sometimes throws up odd quirks where market dynamics cannot work – this is one such case. The fact is that there is no generic market for phenytoin. This is partly because currently there is only one manufacturer – Pfizer, who are now selling their drug to Flynn Pharma – meaning there are no competitors out there. However, even if a new company started manufacture straight away, we would not be able to switch any of our patients to the new brand, because the British National Formulary advises us to prescribe by brand only. We would be able to start new patients on the alternative brand, but this is an old drug and not that many new patients are started on it – it would be impossible for an alternative provider to develop a worthwhile market share.

If, like me, you feel that we should not stand by and watch this improper use of vital NHS resources, please consider using the letter below to send to your MP. And if you do decide to write, it would be great to hear about it in the comments below – and to let us all know of any reply you get too! Thank you for your support.

Dear

At this time when the NHS is trying to make significant efficiency savings, I am writing concerning an abuse of monopoly position by the manufacturer and distributer of a vital epilepsy drug, which is set to cost the NHS an extra £44m per year – the equivalent of employing 1800 extra nurses.

The drug is Epanutin (phenytoin) which helps to prevent epileptic seizures, and the scandal was reported in The Daily Telegraph on 13th October 2012 (http://www.telegraph.co.uk/health/healthnews/9604683/Pharma-firm-hikes-cost-of-epilepsy-drug-24-times.html). On 24th September this year all GPs received a letter  from a company called Flynn Pharma (http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con185674.pdf) detailing their acquisition of the marketing rights for Epanutin. The drug was still to be made by Pfizer, in the same factory and in exactly the same way, but would be packaged and distributed by Flynn Pharma under a new brand ‘Phenytoin Sodium Flynn Hard Capsules’. The letter neglected to advise GPs that the cost of 28 tablets was set to rise from 66p to over £15 – nearly a 24-fold increase.

Flynn Pharma have been able to impose this phenomenal price rise by relaunching the product as a generic medication. The cost of generic medications is not regulated, as the market is supposed to keep prices down through competition. The problem with Epanutin is that there is no generic market, due to the unique situation with epilepsy drugs.

There are two reasons for the lack of market forces for epilepsy medication, and phenytoin in particular. The first is that quite simply there is only one manufacturer of phenytoin capsules in the UK – Pfizer, which means that GPs have no alternative generic product available. However, even if a new company were to start manufacturing an alternative, or supplies could be obtained from abroad, GPs not be able to switch any of their patients to the new brand, because the British National Formulary advises them to prescribe by brand only. This is because even a minor change to the prescription for phenytoin could cause changes in blood levels of the drug, with catastrophic consequences – a seizure is not only hazardous for the patient, but a single seizure would cause an epilepsy sufferer to lose their driving licence for a year.

Flynn Pharma are therefore calling their product generic in order to vastly inflate the price, when in fact such a concept does not exist for this medication. In fact they must recognise this, as they actually direct GPs in their letter to prescribe their own brand.

I am sure you are as concerned about the proper use of NHS resources as I am, and would be grateful if you would consider raising this issue in parliament, in order to try to obtain a review of this situation with the Department of Health. This is important not only for the current situation, but also to prevent the pharmaceutical industry from exploiting this loophole with other epilepsy drugs in the future.

Thank you for considering this matter.

Yours sincerely,