But no one wants to research that; they can’t make any money from it…

A couple of my recent posts have focused on potentially dangerous ‘alternative’ treatments for medical conditions. Invariably, such posts generate comments along the lines of “I’ve been using it for years and I’m FINE” and the other favourite “ahhh but They don’t want to research it because it’s cheap and They can’t make any money from it!” (‘They’ is usually the eponymous ‘Big Pharma’).

It’s hard to argue with the first one. The friend of a friend of your uncle’s dishwasher repair main who’s smoked 40 a day for years without ever even getting a case of the sniffles doesn’t believe all that stuff about smoking being bad for you either. No one ever believes the thing they’re doing will turn out to be bad for them. Until, that is, they start getting nasty shooting pains in their left arm.

olaparib

Olaparib costs £49,000 per patient.

The other one though, well, let’s have a look at that. It’s a really common argument, especially from Americans who tend to be much more aware of the cost of medication than Brits. We on this side of the pond are somewhat shielded from the realities of specific costs by the way the National Health Service works. However, some recent decisions by NICE (The National Institute for Health and Care Excellence) have raised the issue of the price of medication in the minds of people over here as well. For example, just a few days ago it was widely reported in the press that NICE had turned down a drug called olaparib (Lynparza) – a targeted treatment for ovarian cancer – because its price tag of more than £49,000 per patient per year was considerably higher than NICE’s upper limit of of £20,000 to £30,000.

£49,000 is a lot of money, no question about it. In some places you could buy a house for that kind of money. At the very least, you could buy a big chunk of a house. For the average household it’s almost double a year’s salary. How could a year’s worth of a drug possibly be worth so much money? Surely the pharmaceutical company (AstraZeneca in this case) are having a bit of a laugh with this price tag? All the way to the bank?

Why ARE medicines so expensive?

Why ARE medicines so expensive?

Well, how much does it cost to develop a drug? A study by the Centre for the Study of Drug Development at Tufts University in Massachusetts reported that the average cost for drugs developed between 1995 and 2007 was $2.6 billion (*see update below) which, based on 2007 exchange rates, is very roughly £1.3 billion. Of course, these figures are from a few years ago – it will be more in today’s market.

Why so much? Well, it takes on average about 12 years to get a drug from the laboratory to the market (and many potential drugs fall by the wayside during the various testing processes). There are a lot of people involved, from researchers in the lab to people running clinical trials to chemical engineers who have work out how to get a small-scale lab production up to something much larger to the people who design and produce the packaging. Even if you just start adding up 12 years worth of salaries (the average salary of a chemical engineer is something like £35,000, for example), you quickly get into big numbers, and that doesn’t take the cost of offices, factories, equipment, raw materials and so on into account.

Back to olaparib and its £49,000 a year price tag. There are about 7000 ovarian cancer diagnoses in the UK each year, but it’s a very specific treatment that would probably only apply to about 450 women each year and it’s estimated to extend life by about a year so, sadly, each patient would probably only be taking it for one year. It’s difficult to get specific figures about development costs, but let’s estimate it took about £1.5 billion to develop it (probably a conservative estimate), and let’s give it 20 years to break even, since after 20 years drugs go off-patent (which means other companies can produce them), and profits immediately drop).

Are pharmaceutical companies really ripping us off?

Are pharmaceutical companies really ripping us off?

Based on those rough numbers, each year the pharmaceutical company would need to make about £75 million. Divide by 450 patients and you get (rounding up a bit) £170 thousand per patient per year – more than three times the price tag NICE was working with. To stress: this is just to cover development costs. I’m not adding any profit on here. Even if you allow for the fact that AstraZeneca are selling the drug in other countries (in the US and Europe in particular), it’s hard to see how their profit margins can be anything more than pretty small.

You might say, so what? This is someone’s life we’re talking about here. Life is priceless. Yes, of course. But unless they can break even, and in fact make some kind of profit, no pharmaceutical company is ever going to invest time in drug development. No one runs a business to deliberately make a loss. Not for long, in any case.

turpentine

Don’t let anyone convince you to swallow this stuff.

There are plenty of people out there claiming that some cheap, every-day substance can cure cancer (could be anything from a type of bleach to turpentine to baking soda, depending on the day of the week), but that ‘Big Pharma’ deliberately suppress these treatments, and/or refuse to research them, because they can’t make thousands selling them, and they would rather push their expensive (but, you know, tested) drugs.

Well no, the pharmaceutical companies can’t sell these kinds of ‘alternative’ treatments, because they’re controlled by extremely strict regulations and they can’t claim something works without rock-solid evidence. But don’t be taken in by the argument that it’s impossible to make a lot of money from selling this kind of stuff. Of course it’s possible: buy it in huge bulk, put it in small bottles with expensive-looking packaging, and the markup can be comfortably generous. Hey, if it’s possible to make money selling ‘ghost turds‘, then it’s possible to make money out of anything. And if you don’t want to actually sell it (which might upset the regulatory authorities) there are book sales, public appearances and private consultation fees. Oh yes, don’t let anyone convince you there’s not plenty of money to be made.

Besides which, it’s simply not true that medical researchers aren’t interested in ‘cheap’ substances. To quote the comedian Dara Ó Briain:

“Oh, herbal medicine’s been around for thousands of years!” Indeed it has, and then we tested it all, and the stuff that worked became ‘medicine’.

Except we shouldn’t be using the past tense; scientists continue to research this kind of thing all the time. Despite what the conspiracists might say, the people who work in these fields are genuinely interested in making people better. If they really thought baking soda could somehow cure a particular cancer, they’d be on it like a shot. Even if you don’t believe they’d do it for ‘the public good’, it’d be worth it for the prestige alone. Someone who managed to prove something like that would almost certainly be up for a Nobel Prize. The company they worked for would be using it in their marketing material forever more. You can’t buy publicity that good. (For more about this, check out this excellent article by Steven Novella.)

beetroot juice

Recent research suggests that beetroot juice could help treat high blood pressure.

Just to prove that research into simple, inexpensive stuff truly does happen, here are some examples (public health warning: I’m not advocating you experiment with any of these, I’m merely listing them to make the point. Discuss it with your doctor before you try anything):

Believe it or not, doctors like medicines that work.

Believe it or not, doctors like medicines that work.

These are just five examples. I’m certain there are many more. Researchers do look at well-known, relatively inexpensive substances if they think they might have a genuine therapeutic effect. That’s the sort of thing scientists do. The difference is that real scientists don’t rely on testimonials – the word of people who’ve “been taking it for years and never been healthier!” – they design proper, rigorous trials.

Sometimes these trials are promising, sometimes they’re not, but the substances that do turn out to be promising invariably find their way into medicine sooner or later because, essentially, doctors like medicine that works.

* Update: June 2015
After I wrote this post I came across this article on theconversation.com. It casts some doubt on the US$2.6 billion figure from The Tufts Center for the Study of Drug Development, and makes some interesting points about its calculation. In particular, it points out that more than once source has suggested the figure may be over-inflated. This could well be the case, in which case my rough estimate calculations might be off by some margin, but it’s impossible to be more accurate because pharmaceutical companies are pretty cagy about their actual costs. It is certainly the case that a number of pharmaceutical companies have existing, profitable medicines which are reaching the end of their patent lifetime and, it appears, not enough to replace them, leading to some recent mergers and acquisitions activity. A few have run into trouble: Glaxo Smith Kline issued a profit warning last year, as did the French group Sanofi SA. On the other hand, others have been doing extremely well. So are they genuinely over-charging for drugs? It’s a very difficult question, but I think it’s still safe to say that drug development is a very expensive business

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Tales of asking for evidence: are chia seeds all they’re cracked up to be?

I’ve mentioned it before, but this summer I got involved with Sense About Science’s Ask for Evidence Campaign. This is a brilliant campaign in which Sense About Science (for some reason they never abbreviate their name to initials) encourages people to ask organisations about dubious ‘scientific’ claims. Ever wondered what on earth Boswelox actually is and whether it can really counteract ‘skin microcontractions’? Ask the company for evidence. See what they say. (In that particular case the UK Advertising Watchdog has already weighed in, but you get the idea.)

chia-seeds-photo

Are chia seeds all they’re cracked up to be?

I picked up on a few different claims, the first of which had to do with chia seeds. They are the latest health food craze (well, you know, one of latest – this is an area that moves fast, another health food craze could have gone from magical weight-loss aid to dangerous cancer risk in the time it’s taken me to type this), and come with all manner of interesting claims from stabilising blood sugar levels to having “8 times more Omega 3 than salmon“. The trail led back to AZChia, a company set up by Dr Wayne Coates of the University of Arizona. Although, in Dr Coates defence, many of the more hyperbolic media claims don’t appear to have actually started with him, and his work seems to be rigorous.

There are lots of claims out there in the press, but they most seem to boil down to omega-3 fatty acids. Now, there’s a whole other essay to be written on that topic, but essentially (wait for it) these are essential (boom) fatty acids. That means we need them to maintain good health and although there’s some controversy over exactly what they do and don’t affect, there’s no question they’re vital for a healthy metabolism. However they can’t be made in the body (not from scratch, anyway) so we have to eat them. This is potentially tricky for vegetarians because the main source of omega-3 fatty acids is fish oils. But they do turn up in certain plant foodstuffs, and one such foodstuff is chia seeds. In fact, chia seeds biggest claim is that they are the “richest natural plant source of omega-3 fatty acids“.

But before we go any further with this it’s important to realise that there’s more than one type of omega-3 fatty acid. There is a group of molecules that fall into this category, and some of them are tricker to obtain from certain food sources than others. In particular, there’s something called ALA (α-Linolenic acid), another called EPA (eicosapentaenoic acid) and finally DHA (docosahexaenoic acid – these names just get better and better don’t they?).

The main source of these last two, DHA and EPA, is cold-water oceanic fish, like cod and salmon. Both EPA and DHA are converted into prostaglandins which regulate cell activity. DHA is a structural component of such minor essentials as your brain, retina and skin. Make no mistake, you need these molecules.

ALA is slightly different. ALA is available from plants such as, guess what, chia. And also kiwifruit seeds (bizarrely, these have nearly as much as chia seeds), perilla and flax, otherwise known as linseed. Humans cannot make ALA; we have to eat it. However our bodies can make DHA and EPA from ALA.  So, eat your ALA-packed plants and, in theory, you get the complete set.

But it’s not quite that simple (it never is, is it?)  Yes we can synthesise DHA and EPA from ALA, but only poorly. For adults, it might be less than 1% for DHA, and probably less than 5% for EPA (the numbers are slightly higher, although not much, for babies).

Back to that claim that chia seeds have 8 times more omega-3 than salmon (not, I should stress, a claim actually made by Dr Coates). It is true? Well, 100 g of salmon contains roughly 0.4 g of ALA, whereas 100 g of chia seeds contains more like 18 g. So that’s actually a lot more than 8 times. On the other hand, chia seeds contain no DHA or EPA (fish sources, remember) whereas salmon will give you about 1.4 g and 0.4 g respectively. Chia seeds may contain more omega-3 in total than salmon, but it’s not the good stuff. There’s none of the DHA that’s so important for healthy brain, skin and eyes. You might be able to convert a little bit from the ALA that is there, probably enough to get by (particularly if you’re a vegetarian or a vegan and willing to eat a lot of seeds), but oily fish really is the best source.

What about the claim that chia seeds are the richest plant source of omega-3 fatty acids? I pressed Dr Coates for evidence of this, since it’s a statement he makes on his website, and his response was as follows:

“No one paper is going to say that. You are wanting something that does not exist to my knowledge. You would need to compare hundreds of analyses and papers, determine good analyses from bad, etc. Different harvest cycles, growing locations, varieties, all affect the numbers so impossible to really do it. The statement is based on years of work and knowledge.”

So tricky to prove, but probably true. Possibly.

There is a little more to this story. Chia seeds are often promoted as a whole food, packed full of many nutrients over and above omega-3s. A ‘super-food‘, if you will. They do indeed contain a whole range of nutrients. But Dr Loren Cordain, author of the book The Paleo Dietcontends that chia seeds also contain high levels of phytate.  Phytate is the salt of phytic acid, and is a substance that binds minerals such as calcium, iron, zinc, magnesium and copper, making them unavailable for absorption by the body. As a result, chia seeds are actually quite a poor source of these minerals. And, as with all plants, it’s a similar situation with vitamin B6 – it’s something we absorb far more effectively from animal sources. In short, just because something’s in a plant, doesn’t mean we can make use of it.

oily_fish_box

If you’re not a vegetarian, stick to your oily fish.

So, in summary, should you be sprinkling chia on your breakfast cereal? Well, it probably won’t do any harm. If you’re a strict vegetarian or vegan they may be worth considering, although they’re probably not worth paying a lot of money for. If you’re a meat eater, you’re almost certainly better off sticking with oily fish – it’s a much better source of the really essential fatty acids.

….

I also investigated some other claims for Ask for Evidence, one of which was the statement made by Health Journalist Hazel Courteney on national radio that “the average person absorbs into their bloodstream alone about 14 kg of toxins annually through their skin.” There is more to follow on this particular story, and it should appear on the Ask for Evidence page shortly.

There was also something on anti-bac pens which I’ll discuss next time. Watch this space!