Big Pharma and the NHS: a 746% price hike for a disabled person’s vital medication leaves her without it

The one tablet in this article’s main picture used to cost 35p. It now costs £2.66. So, for just five-days worth of medication (eight tablets a day) the cost is now over £112. It was £15. That’s £672 a month – from £90. Welcome to the corrupt world of ‘Big Pharma’ and its extortion of the NHS.

First off, a plea for help

Sadly, this massive price rise means that me and my partner can no longer afford them. As her treatment is not available on the NHS, it is via a private GP – hence we have to pay. I’m a full time carer to my partner, as well as working as much as I can while we have to claim Universal Credit – essentially because I cannot work the hours I need to, to get us off benefits while I have to care for her as well.

We now need help with the cost of finishing this course of treatment – which will be £2,600 at current prices for the next four months.

If you can help, please donate via PayPal at http://www.paypal.me/NicolaCJeffery

The true cost of medication

Valaciclovir is an antiviral drug, most commonly used to treat the herpes family of viruses. It’s what my partner, Nicola Jeffery, is currently taking to treat her myalgic encephalomyelitis, commonly known as ME. It’s for this which the cost has rocketed.

Price rises for medicines under the NHS are not unusual. This is because pharmaceutical companies often increase their prices, which then has a knock on effect on the health service’s costs. As The Lowdown noted:

in 2017/18 the overall drugs cost at list price in the NHS, before any discounts, was £18.2 billion.

 

This is an increase of 4.6% from £17.4 billion in 2016/17 and an increase of 39.6% from in 2010/11.

Branded (patented) medicines are allegedly “protected” by a voluntary code of conduct between big pharma and the NHS. This stipulates that companies cannot put the price of medicines up by more than 2%. If they do, then they have to pay the NHS the difference back. In Nic’s case, the branded version of valaciclovir is Valtrex, of which the cost is already high.

But there’s a catch with this price control: it doesn’t cover generic medication.

What price control?

As The Lowdown also noted:

Generic medicines, those that are not protected by patents, are not covered by any price control scheme. UK governments have relied on market competition to control the prices of these products. This has worked to a large extent, generic versions of best-selling branded products are sometimes 90% cheaper than the original branded products.

In Nic’s case, this is valaciclovir, which has several different manufacturers. The Lowdown continued:

There has been a problem, however, with relying on market competition. Although a product may be old and produced as a generic, it will not necessarily have many or in some cases any competitors on the market. Some manufacturers took advantage of this situation and hiked the price of a generic product year-on-year knowing that there could be no comeback.

 

An article in Pharmaphorum reported that dramatic price increases included the anti-epilepsy drug phenytoin sodium, the price of which was reportedly increased by up to 2,600%.

It is this brazen and nefarious profiteering which has hit valaciclovir.

Rampant profiteering

In short, there is a supply issue at present – most likely due to the coronavirus pandemic and knock-on supply issues from China (along with some political tensions, too) Knowing that, the big pharma manufacturers have forced the price of it up – as I said, by 746%. And it’s the same profiteering which allowed prices of paracetamol to shoot up at the start of the pandemic – along with valaciclovir’s also beginning to head skywards.

What is unusual is that most patients wouldn’t notice, because of the fixed price of an NHS prescription. But because Nic’s treatment is private, we’ve been directly hit by this croniest of corporate capitalist phenomenons. And her valaciclovir is probably the most important medicine she currently takes.

15 conditions

She lives with 15 different illnesses and conditions. You can read more about that here. But sadly the UK’s public health service doesn’t treat many of these. Some of the ones it either doesn’t deal with, or doesn’t treat correctly, are ME and:

Nic during a CSF leak

It’s the ME which we decided to tackle first. Please note that this is not chronic fatigue syndrome (CFS), which in ours and other people’s opinions is a separate illness.

She’s been under the care of the amazing Dr Sarah Myhill for nearly a year and a half. It’s been a long battle: changing diet (from a corporate, glycolysis-based, Western carb and sugar-heavy one to a paleo-keto, fat burning regime); taking a huge amount of tablets and oral solutions (a mixture of vitamins, minerals, hormone replacements, metabolic enhancers, amino acids, enzymes and herbal remedies) and full-time clinical monitoring from me – including a daily medical diary, blood pressure, heart rate, temperature, SpO² levels and perfusion indices.

The first baby steps

As I previously wrote:

We are confident this regime will resolve Nic’s ME. We’re loathed to go into detail until the course is over, but suffice to say the signs so far have been good.

 

What we can say is that she was living with polycystic ovary syndrome, first diagnosed in 2009. But since starting Dr Myhill’s regime, this has been completely cured. Effectively, the regime for ME has also cured this other illness.

 

The NHS, meanwhile, says polycystic ovary syndrome “cannot be cured”. We think we know why it has with Nic, and it is absolutely unbelievable when compared to what the NHS offers for those living with it.

We can also now say that Dr Myhill has already resolved some of Nic’s underlying problems. For example, much of her dysautonomia has gone.

Making progress

Her core temperature, which used to fluctuate by up to 1.7°c a day, has now stabilised to a 0.3-0.5°c variation. Bowel function is now regulated – before she could go at least three days without movement; now, she’s almost regular as clockwork every morning. The seizures which plague her have reduced in frequency. Her blood pressure, which used to be constantly hypotensive, is rising. She now sweats normally (before, barely sweating at all). Muscle cramps have gone, and lingering pain from physical exertion (for example, lumbar pain after being upright all day or walking) no longer lasts into the following day. And her bouts of insomnia and disregulation of the wake/sleep cycle have all but vanished.

Central to all this has been Dr Myhill’s vast treatment plan. But crucially, so has the valaciclovir.

Studies into valaciclovir

Several studies (one spanning six years) have shown it to be effective in treating ME. But the criteria was fairly strict: there had to be a proven history of infection with Epstein Barr virus (EBV, more commonly known as glandular fever), cytomegalovirus (CMV) or one of the herpes viruses. This was done by showing antibodies in a person’s blood. But we went further than that.

Nic has had a bone marrow aspirate and a trephine biopsy, which showed EBV and CMV immunoglobulins present (EBV in the highest concentration). We also know she has had either HHV6 or HHV7 (as she had pityriasis rosea as a child).

Further to this, she had advanced flow cytometry testing (one of only a handful of people with ME in the world to have this done), which showed her body was on a three times higher immune response than the general population; specifically reacting to a virus. But crucially, there was no viral pathology present in her blood stream. In other words, her body was trying to fight a virus that seemingly wasn’t there.

There’s no clear reason why valaciclovir works in ME. But I have a theory: I think the EDS caused her ME.

My theory? EDS causes ME

All cells have a protective surrounding environment. This is called the extracellular matrix. It is made up of a lot of collagen. Because Nicola’s collagen is faulty, this has made her extracellular matrix weak.

When she has had viral infections, the viral genomes (the part of viruses which are their genetic coding bit) don’t just attack the major parts of her body. Because of the weak collagen, they have been able to get right into her cells and into their nuclei more easily than in most people. Here, they reproduce their genome constantly.

When a cell is infected with a virus, it warns the body by producing specific molecules (called class I major histocompatibility complex proteins, or MHC class 1). Cells release these onto their surface. The immune system knows there’s a problem because these MCH’s have viral material in them. So, the body can fight the virus.

It’s all about the collagen

But with Nicola, because of her weak collagen the MCH’s cells’ release is faulty (it’s all about peptides, which are amino acids made up of collagen). The immune system is not sure if there’s a virus present in her cells. So, it fights the virus in the obvious places like the bloodstream. But it doesn’t kill it in the nuclei of her cells. Here, it keeps replicating and therefore never leaves – hence the body’s constant immune response, and hence the symptoms of ME like post-exertional malaise (PEM). A similar theory is already being recognised in coronavirus patients, who still haven’t recovered from the virus months later.

Studies have already shown [pdf] or questioned the high prevalence of ME in EDS/connective tissue disorder patients. Anecdotally, speak to people in both communities and the dual diagnosis appears to be common. And I think my hypothesis above would go some way to explaining it. I’m more than happy to discuss this with anyone: I’m not a virologist, immunologist or microbiologist. I am a deeply concerned partner first, and a nosy journalist second.

This theory is where the valaciclovir would come in, and why it would work. But probably only in Nic’s and other EDS patient’s cases with Dr Myhill’s regime in full play.

A complex solution

The active ingredient of valaciclovir is aciclovir. As ScienceDirect noted:

The mechanism of antiviral activity consists of its [aciclovir’s] transformation to triphosphate and subsequent inhibition of viral DNA synthesis. Its action is highly selective. Acyclovir diffuses into the cell infected by a virus and phosphorylates thymidine kinase of herpes simplex to a monophosphate. Uninfected cells do not use acyclovir as a substrate. The monophosphate is subsequently transformed to a diphosphate, and then a triphosphate, which inhibits viral DNA polymerase, as well as viral DNA, where it acts in the process of breaking the chain, thus preventing further elongation of the DNA chains and correspondingly, replication of the DNA virus.

In short, acicilovir stops viruses replicating. On the face of it, this shouldn’t work in Nic – because it doesn’t solve the problem of her body not knowing that the virus is deep in her cells in the first place. But it will work, for several reasons: not least because of Dr Myhill’s full regime putting Nic’s body and immune system in the best health possible, and also because the dose is so high (4g a day is getting towards the dose used in post-operative patients at risk of CMV) that her body is being flooded with aciclovir. Standard doses are one to two grams, but only for a matter of days. Nic has been on valaciclovir for eight months, now.

When most ME patients try and fail with antivirals, their bodies are already on a weak footing: diet is probably Western, carb and sugar heavy and poor; energy delivery mechanisms are weak; deficiencies high; other illnesses (like mycotoxicosis) have probably been left undiagnosed, and overall their bodies are under strain. Dr Myhill’s regime (yes, of 82 tablets and nine oral solutions a day at one point) is torturous. But it’s already yielded results – and we believe it is what will make the valaciclovir work.

MEDS 1

Unlike most ME patients, whose illness and severity of symptoms is based around clinical presentation, we’ll be able to prove whether Dr Myhill and the valaciclovir have worked at the end of the process – as Nic will repeat the advanced flow cytometry testing.

So, we need to finish the course of it. And unfortunately, there is no substitute.

No other option

The other available treatment is straight aciclovir. This is infinitely less expensive, currently listed on the NHS British National Formulary (BNF) page as being around £4.50 a box. But it’s not as straightforward as that.

Valaciclovir has a mean bioavailability of around 54.2%. This means that for every tablet taken, the body absorbs 54.2%. So, on Nic’s current dose of 4g a day, she gets 2.1g of aciclovir. But the straight tablet form of aciclovir has a mean bioavailability of 17.5%. This means, by my calculations, she’d need to take around 12g a day to get the some dose as valaciclovir.

That is impossible to administer; not least because her kidneys would not cope with having to process that level of chemical. Moreover with aciclovir, as the dose increases the bioavailability decreases. So, she’d have to spread a minimum 15 tablets (based on 800mg per tablet) out across the day; one every hour.

In May, we got her down to 56 tablets a day, after she was on 82 for six months. Having to add another 7 into the mix (8 of her current tablets are valaciclovir) and spread them out hourly is not fair on her. But overall, switching to aciclovir would be pointless – and ultimately jeopardise her treatment; a clinical plan that’s been in place for nearly a year and a half.

Please help

I refuse to let Nic falter at that point. It’s has been the hardest one and a half years of both our lives, in many respects. And to have got this far only to be forced to give up – not through fault of our own, but because of a system that would happily see us fail in the first place – is not happening.

So please – if you can help towards the cost of Nic finishing her treatment, then donate if you can via http://www.paypal.me/NicolaCJeffery

Thank you for reading and for the anticipated support.

ECLg55oX4AAOsUM

 

One comment

  1. Annette · July 3

    Please let the ME community know how this all goes . My daughter also has Severe ME and many of the same diagnoses . Take care & best wishes xx

    Like

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