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,