Sunday, 28 October 2012

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 They have also withdrawn it from off-label use for MS pending approval, on the grounds that "any adverse event outside a clinical trial … may complicate the regulatory process".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.

Thursday, 25 October 2012

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!