Big Pharma and price hikes: not NICE

Having a long-term illness affects your life, and your concerns, in lots of ways. For once, I'm not talking about the symptoms, about pain, fatigue, or whatever characterises your particular flavour of poorliness. I want to write about the medications many of us need, and how we, and our doctors, are held to ransom by the pharmaceutical companies - "Big Pharma" - that manufacture them.

Epanutin is one brand name of a drug called phenytoin, which reduces the risk of seizures for people with epilepsy. It's used less than it used to be, but it's still taken by around 100,000 people in the UK. The cost of this was around £2 million a year.

The rights to manufacture Epanutin have recently been sold by Pfizer, to UK firm Flynn Pharma. They've repackaged it and increased the bill by a staggering 2330% to £46.6 million. All that has changed is the packaging: the capsules themselves are identical.

Because phenytoin is a relatively old drug, it's out of patent and any drug company can make it. So the NHS can just switch to another supplier, right? Sadly, wrong. Pfizer, and now Flynn, are virtually the only manufacturers of the capsules. Phenytoin is also available as a syrup and as tablets, but there's a problem. People with epilepsy tend to be extremely sensitive to levels of their medication in their blood, so they and their doctors are reluctant to switch from the Epanutin capsules. As a result, there's virtually no competition to make another version of phenytoin, and Flynn pretty much have a monopoly.

Result: Flynn basically have the NHS over a barrel. Because Epanutin is a standard treatment for epilepsy, it's more or less 100% sure that the NHS will go on funding it.

That's a standard treatment. What's the situation with newer medications?

Alemtuzumab, or Campath, is currently licensed for use in leukaemia. Neurologists have also been prescribing it off label for aggressive multiple sclerosis since a large, encouraging trial in 1998 and subsequent published trials showing it as superior to other MS treatments.

It's also considerably cheaper than other MS treatments, at around £2,500 a year per person. Or it was. The manufacturers, Genzyme, have applied for a license for Campath for the treatment of MS, and are expected to relaunch it at up to 20 times its current price. They have also withdrawn it from off-label use for MS pending approval, on the grounds that "any adverse event outside a clinical trial … may complicate the regulatory process".

When a medication is licensed for use in the UK, it then has to be reviewed by the National Institute of Health and Clinical Excellence (NICE). NICE has the difficult task of deciding which treatments should be funded by the NHS, to share out the limited amount of cash available. Should it approve the use of an operation that costs, say, £20,000 per person, or a medication for a completely different condition that can treat 50 people for the same amount? What if the operation saves lives, while the medication is for something far less serious?

So, assuming Campath is licensed for use with MS, NICE will have to decide whether the NHS should fund it. If it was still cheaper than existing treatments, with better results, it would be a no-brainer (though of course the risk of side-effects also comes into the equation). But it looks like it's going to cost far more than that.

We've all seen stories in the newspapers about people denied treatments by NICE, often for cancer. Is Campath going to be another such? MS is progressive: people denied Campath would be at risk of severe disability as a result. And if Campath is approved, what else will be denied?

These are two examples of big hikes in price. I have no doubt there are others. What these pharmaceutical companies are doing is certainly not illegal, but is it moral? These are existing drugs. There are no additional research and development costs to recoup.

Big Pharma. Getting bigger every day, and at the expense of sick and disabled people.

Too clean to be healthy? Maybe not.

Have you ever had food poisoning? Maybe from a dodgy kebab, or a suspicious curry? We might think that we're only going to get food poisoning in the kind of restaurants that turn up on Grimefighters, but according to the World Health Organisation, around 40% of outbreaks happen in the home.

For more than 20 years, the hygiene hypothesis has been a dominant theory in immunology. The idea goes that our homes are basically too clean: a lack of early childhood exposure to infectious organisms and parasites increases susceptibility to allergic diseases (and possibly some auto-immune conditions) by suppressing the natural development of the immune system.

This has been seen to explain both the rise in allergic diseases since industrialisation, and the higher rate of allergic diseases in more developed countries.

Now a new study has challenged this theory. The researchers found that changing exposure to microbes could indeed be a factor in the rise of allergies, but there was no evidence that current cleaning habits are to blame. The authors denied that we are living in super-clean, germ-free homes.

Recently disinfectant company Zoflora commissioned a study of 2000 adults from across the UK, looking at their attitudes to home hygiene. 66% of us say our homes are not as clean as they should be, and 19% say they are not clean at all. Just under a third of us are so worried about the cleanliness of our homes that it can keep us awake at night. Many felt anxious, stressed or depressed about having an unclean house.

Zoflora fragrance and home bacteria expert, Nicola Hobbs says:

Our homes are fertile breeding grounds for bacteria to grow and multiply. Common microbes found in our houses include ‘superbug’ methicillin - resistant Staphylococcus aureus (MRSA) and bacteria like Campylobacter, a common source of food poisoning. A study commissioned by Zoflora found that a shower head had 300,000 times more bacteria than a set of front door keys – bacteria thrive in warm, damp places.

Research has shown that flushing a toilet sends a spray of water droplets into the air which may be contaminated with bacteria and viruses, and that these germs can float around in the bathroom for at least two hours after each flush before landing on surfaces. A study of 60 kitchens where raw chicken was prepared found that bacteria were frequently spread around – and that cleaning with detergent and hot water had little effect compared with the cleaning action of a disinfectant.

Cleaning with disinfectant isn't going to make the home completely sterile. If it did, we'd be dead too. We'll still come into contact with harmless bugs. But we can get rid of real pathogens like MRSA, E.coli, Campylobacter, and the flu virus H1N1.

Using disinfectant as a cleaning product can help you sleep better: you're less likely to stay awake worrying about cleanliness, and you're less likely to be in the loo suffering from food poisoning!

#Helpless: learn first aid!

First aid. It's all about grazed knees and sprained ankles, right?

Wrong.

First aid saves lives. Thousands of lives every year.

New research by St John Ambulance has found that we're over 4 times as likely to think that more people die of cancer than from a lack of first aid, even though there's compelling evidence to take both equally seriously. Up to 140,000 people every year die in situations where first aid could have saved their lives - as many as die of cancer.

People's reasons for not learning first aid are that they think it would be too time-consuming or it's not a priority to them. A worrying 41% say it would take the death of a loved one to make them learn first aid.

St John Ambulance has launched a new awareness campaign, including a hard-hitting TV advert, Helpless. It follows the journey of a man who is treated for cancer and survives, only to choke at a family event because nobody knows the treatment to save his life. You can view the advert below.

St John Ambulance chief executive Sue Killen said:

Cancer is a serious disease, which kills tens of thousands of people each year. When a loved one has cancer, although we do all we can to support them, over three-quarters of people are consumed by a feeling of helplessness.

‘In situations where first aid could help save a life we don't have to feel helpless, because learning life saving skills is so simple. That's why it's so concerning that fewer than 1 in 5 of us knows even basic first aid. This has got to change if we are to stop up to 140,000 lives from being needlessly lost each year.

'Our message is that first aid is simple to learn – just text HELP to 80039 for a free pocket guide so you can be the difference between a life lost and a life saved.

Please, get the pocket guide, read St John Ambulance's first aid advice pages, or (preferably) go on a first aid course. It's vital knowledge. You never know when you might need it!

Strictly Come Dancing 2012 Launch Show

This season Strictly Comes Dancing turns 10. That’s a fair old age for a reality show. In the competitive early Saturday evening slot, can it maintain its viewing figures without constantly reinventing itself and alienating its core audience?

With Moira Ross as its executive producer since 2010, the show became increasingly reliant on props, gimmicks and shock tactics, from sequin-covered wellies for a Countryfile presenter to aggressively heterosexual competitors snogging very camp judges as part of the choreography. It was hard to recognise the dance being performed. The audience share grew considerably, but many diehard fans became disenchanted. The name Strictly Come Dancing appeared less and less appropriate.

Ross moved on at the end of the 2011 competition, to take charge of the BBC’s massive flop The Voice. So what of this year? Will things be any different under new co-executive producers Andrea Hamilton and Glenn Coomber?

Clearly, the show needs a good mix of celebrity contestants. But it’s disappointing to see that all the usual suspects are there yet again: The Ex-Eastender (Sid Owen); The ITV Daytime Presenter (Richard Arnold); The Older Man (Johnny Ball – and be prepared for endless jokes both about his age and about him being the father of Zoe Ball, host of It Takes Two); The Boy Band and Girl Band Members (Nicky Byrne and Kimberley Walsh); The Retired Sportsman (Michael Vaughan); The Fat One (Lisa Riley); The Ringer (Denise van Outen); The Game Old Girls (Jerry Hall and Fern Britton); The Actor You Recognise When You See Him (Colin Salmon); and The Children’s TV Star (Dani Harmer).

The only novelties are two medal-winning 2012 Olympians (Victoria Pendleton and Louis Smith). It’s a shame no Paralympians were included in the cast, but this was probably both impractical given the training timescale, and a mercy given some of the less sensitive jokes and comments they and we might otherwise have been subjected to.

The purpose of Saturday night’s 65-minute launch show was for the celebrities to be introduced to their professional dancing partners. This is a slim enough premise, so it was padded out with group dances, training VTs, and a performance by Mika.

The partnership reveals were fairly unspectacular, and in the main uncontroversial. The only one that seemed a little...odd...was the pairing of actor Colin Salmon with professional Kristina Rihanoff. There’s around a foot difference in their heights, so even when Rihanoff is wearing heels the differential will be substantial. It’ll be interesting to watch how she compensates.

There were some very good things in the show. New judge Darcey Bussell performed a beautiful rumba-based American Smooth with Ian Waite, which incidentally showed yet again why Waite should never have been dropped from the programme’s roster of professional dancers. A professional group cha-cha was good on the whole, although some of the lifts went a bit awry. As seems to be traditional in Latin dance, the men were either wearing wifebeater vests or had forgotten the purpose of their shirt buttons.

 But there were also some bad things. Some very, very bad things.

For instance, one thing that had not changed from last season was Bruce Forsyth’s level of presentational skills. It’s really not very professional to have to read the name of the programme’s new judge from a cue card, on camera. Moreover, actor Dani Harmer, wearing one of the show’s typically skimpy costumes, looked thoroughly uncomfortable when he put his hand on her back and asked if it was cold. And I’m not sure the situation was much improved when he moved his hand to the top of her head, as if leaning there (she’s not a tall woman).

Speaking of costumes, the Wardrobe department continue to struggle with dressing anyone over a size 12. They’d put Fern Britton in what can only be described as a pink sack with fringes, while Lisa Riley had been adorned with a stretchy blue wraparound curtain and a brooch. Neither flattered.

The programme finished with a group dance including both professional and celebrity dancers. It’s really too early to say definitely who shows promise, but Louis Smith, Dani Harmer and Colin Salmon all looked good. Nobody obviously had to be pushed into place, which is always a good sign! So much depends on the developing partnerships though, and what happens over the three weeks of training before the first full competitive week of the programme.

It would be wonderful if the new season of Strictly meant we’d be seeing more dancing and fewer pointless VTs, backstories, poorly delivered jokes, autocue and cue card fumbling, inappropriate behaviour, and so on. I’m not hopeful. But I’ll still be watching!

Fighting in the disability movement

So, look. There are a lot of rucks going on inside the disability movement at the moment: arguments breaking out, people blocking other people on Twitter, not-so-subtle digs in articles and blog posts...the list goes on.

I don't know anyone who likes it like this. Most people I've heard from hate it, as I do.

Many things contribute, I think. But in happier times, when we weren't being assailed by the Coalition's attacks on the jobs, incomes and even lives of many disabled people, we wouldn't be trying to pull together in one movement. There are many of us within the anti-Coaltion, anti-WRB movement who would otherwise be fighting and leading our own campaigns. We like to be in charge. We find it difficult to be told we're wrong. (And yes, before you all tell me, I'm fully aware that I'm as guilty of that as anyone else!)

And many of us operate on a hair-trigger anyway: quite aside from the aforementioned Coalition actions, things like pain, fatigue, and other effects of our impairments can have a huge impact. Then there's family issues, again potentially so stressful and painful.

And if you're putting yourself "out there" on social media, you tend to attract trolls: no-marks with nothing better to do than hurl abuse, and who don't care that there's a real person at the other end. The sensible thing to do, of course, is to block them. But people like us don't like not getting the last word....

So what can we do? These are my ideas - grateful for any more (but no obscenities please ;-)

1. Try to remember who the common enemy is! Hopefully this will get a bit easier once the summer recess is over and they're back in session.
2. If you feel yourself losing your temper, take 10 seconds before hitting Enter. Could the person at the other end of the Twitterchute feel just as bad as you? Almost certainly!
3. Remember to disagree with the opinion, not the person.
4. It can be hard to tell somebody's mood in writing. Did they mean that as a joke? Sarcastically? Sod's Law says that inevitably we'll take things the wrong way!
5. Block trolls. Early and resoundingly. Don't let them wind you up.
6. Finally, we have to support each other, and pull together. We need everyone for this battle.

"Alone we can do so little; together we can do so much" ~ Helen Keller 

 Now, if I could only learn to take my own advice...

Edited to add: This excellent post by @markoneinfour looks at these issues from a specifically mental health perspective.

Every breath you take....

My friend got a Brown Envelope from the DWP yesterday (they deserve the capitals).

DWP envelopes are terrifying: they contain our futures. Another friend spends most of her time in bed, barely able even to sit up. The letter in her envelope demanded that she attend a medical to decide whether she can get ESA. She was given two alternative locations: the nearer is on the third floor with no lift (she uses a wheelchair) and the other is 2 hours journey away, on inaccessible public transport.

The first person I mentioned got good news: following an appeal, she's in the support group for ESA (as she should be). But she's still uneasy. She can't help worrying that the DWP are filming her on "good" (read: less bad) days.

I confessed that I worry I'm being filmed through the windows of my house, if I do something like lift the kettle. She felt the same.

Others joined in the conversation. It began to seem that this was quite common.

Certainly, it's good to know I'm not alone in my paranoia. But isn't it dreadful that so many people are being made to feel this way?

Constant media coverage of benefit scroungers, and misleading use of statistics. Politicians with anecdotes of someone they met once who was really quite fit for work, honest guv. Dob-your-neighbour-in hotlines.

Just because you're paranoid doesn't mean they're not out to get you.

MS research roundup July 2012

Another research roundup, and so soon! But there's just been so much interesting research to tell you about.

We already know that someone's risk of getting MS is linked to where they were brought up: very roughly, the further away from the equator, the higher the risk. Another known risk factor is having antibodies to Epstein-Barr virus (EBV): people with MS are far more likely to have EBV antibodies in their blood than people without.

British researchers investigated the distribution of EBV infection, and found it was the same as for MS: infection was more common further away from the equator. We still have a lot to learn about what causes MS, but this could be a piece in the puzzle.

I've often written before about Vitamin D. Its importance is showing up over and over again in any number of different conditions, including MS. Now an Australian study is under way, to see whether taking Vitamin D can prevent MS. The trial will test 3 dosage levels of Vitamin D against placebo in people who've had a first attack of MS-like symptoms, and will run till 2016. It'll be interesting to see the results.

All of us with MS are different: each of us has different symptoms and a different disease course. We can look at averages, though. American researchers studied over 1000 people with MS. They found that RRMS does not inevitably develop into SPMS, and the onset of progression is more dependent on age than on how long the person has had MS.

As neurons are damaged by MS, cell metabolism is disrupted and there is a buildup of sodium. British and French researchers found that sodium buildup measured by MRI could indicate the degree of MS progression. In those with more advanced disease, sodium buildup in the motor cortex is correlated with greater levels of disability.

This is early-stage research, but could become really useful in monitoring disease progression. With advanced disease, sodium was raised even in apparently normal white matter. 

A group of researchers in Germany have discovered an antibody found in the blood of about half of people with MS that is not found in people without the condition. The antibody's implications aren't fully understood as yet, but in rodents it binds to and damages brain cells known to be important for neurological function.

In time this may lead to a blood test for MS and/or a treatment preventing the antibody from binding to brain cells.

Researchers in America have used monoclonal antibodies to stimulate myelin repair in mice with a condition similar to MS. Similar work had been done before, but using far larger molecules than in this research.

They found the molecules were effective, and quick and cheap to synthesise. They were also stable and unlikely to cause an immune response. Much more work needs to be done, but this could in time be a suitable candidate for human trials.

The nerve damage in MS is caused by T-cells, part of the immune system. American researchers are about to start clinical trials using an extract of sea anemone venom, which they've found is a highly selective suppressant of T-cell activity. They hope it should prevent further damage to the nerves.

It's already known that fingolimod (Gilenya / Novartis) reduces relapse rates and disease progression. Swiss researchers have now shown that it's also associated with a reduction in the number of lesions, and slowing of the rate of brain volume loss. Not everyone is able to have fingolimod, but for those who can, this is just another benefit of another hugely useful treatment.

Modafinil (Provigil) is approved to treat excessive daytime sleepiness in narcolepsy and some similar conditions. It is also used for fatigue and sleepiness in MS. In a small trial, people taking modafinil had no significant change in disability level over 3 years, while those not on modafinil did have significant changes.

A much larger study is needed, and particularly comparisons made between taking modafinil with different disease modifiers. This is a really interesting result though,with a lot of potential.

Taiwanese researchers carried out a meta-analysis of studies on the effect of cranberry juice on UTIs. The results confirmed that cranberries do protect against UTIs. The effect was particularly strong in women with recurrent UTIs. There were,however, concerns about the amount of sugar in cranberry juice.

Finally, some excellent news: Canadian researchers have found that people with MS are less likely to get cancer than the general population, particularly bowel cancer. The risk level varied for different types of cancer.

Further studies are needed to find out why people with MS have these different levels of cancer: it may be because both MS and cancer involve the immune system. Still, good news is good news!