quackery

Vicks, Feet, and a whole load of nonsense.

Vicks Vaporub. It's a staple of our medicine cabinet, and we all reach for it at the first sign of sniffles. You may have seen (usually on a poorly made image posted on Facebook) or heard (from a friend who heard from their friend who heard from their aunt's sister's niece's dogsitter) that actually we've all be using it all wrong. 

It's logical to use Vaporub on your chest, pillow, in a steam inhalation. It makes sense, because the vapours will end up in or around your nostrils, which is where it acts. But no- according to this particular internet fraud, it is only by smearing our tootsies with it that we will get the full benefit. 

I'm going to pick apart the standard Facebook post, piece by piece, so you can see my thought processes and logical reasons why I don't believe a word. Even if you do think this works, stick with me and see whether or not you agree with any of my individual points, or if you can come up with a more robust argument for using it on your feet. 

"Some of us have used Vicks Vaporub for years for everything from chapped lips to sore toes and many body parts in between."

 Wait, What? Who uses Vicks Vaporub for chapped lips? I've never heard of anyone do this, ever. Firstly, it would sting lots, and secondly it could be highly toxic, given its essential oil content, and aspiration risk when swallowed due to petroleum. I wouldn't put the stuff anywhere near my mouth.

But I’ve never heard of this. And don’t laugh, it works 100% of the time

100% of the time? Nothing in medicine works 100% of the time, so alarm bells are ringing loudly, unless this is the single most important medical discovery that's ever happened. If a medicine had been truly found to be 100% effective for anything, it would have been ground-breaking, world-changing news- probably not something that's just shared by your cousin on FB. 

 In the interests of research, I actually tried this when I had a troublesome post-infective cough. Needless to say, it did nothing to the frequency of my cough, so we've already disproved that number straight away. Whether or not it works, it most certainly does not work 100% of the time, and if that number isn't true, then why on earth should we believe anything else in this post?

...although the scientists who discovered it aren’t sure why.

 What scientists? What were their names? Where were they working? Where did they receive their funding from? Why aren't their details given? If they aren't sure, do they have any working theories? 

The lack of detail here is really telling. It really suggests that this is a whole load of hokum, especially given that a search (see below) shows no formal records of any "scientists" or research.

To stop night time coughing in a child (or adult as we found out personally), put Vicks Vaporub generously on the bottom of the feet at bedtime, then cover with socks.

Ahh, feet. Feet really are a favourite for peddlers of quackery. I'm not sure why, but from reflexology to detox foot patches, the alt med world seems to be obsessed with them. Any time feet are suggested as therapy for anything going on elsewhere in the body, loud alarm bells start going off. 

The ironic thing is that feet are probably the worst place to apply any medicine. The skin on your feet is miles thicker that elsewhere. Absorption through the skin tends to be low and erratic at the best of times, but if you apply something onto your feet, the chances of absorbing anything useful from it are very low indeed. 

Additionally, your feet, when lying down, are very far away from your airways. The post requests that you put socks on over it. Therefore there is certainly no way that vapour could get to your airways in any clinically relevant amounts.

Even persistent, heavy, deep coughing will stop in about 5 minutes and stay stopped for many, many hours of relief. 

Coughing fits are just that- fits. They're acute- you cough a lot for a little while, then stop, then it all starts again. A more chronic cough will still follow this pattern or stopping and starting. So yes, persistent, heavy deep coughing will usually stop- albeit temporarily- in probably much less than 5 minutes. If you're coughing for longer than that, it's likely you're going to be having severe problems breathing, and you'll need urgent medical care- you wouldn't really be thinking about smearing goo on your feet. You may find that you put Vicks on your feet and your coughing stops shortly after, but the likelihood is that the coughing would have stopped even if you hadn't. This is called regression to the mean, and its one reason why we can't rely on anecdotes for deciding whether a medicine works. We need to scale up and look at robust clinical trials instead.

Works 100% of the time and is more effective in children than even very strong prescription cough medicines. 

That 100% claim raises its improbable head again. To claim that something is more effective than other medicines would suggest the existence of comparative trials, which-spoiler alert- don't actually exist. This is rather a strawman anyway, as there are very few prescription cough medicines on the whole. Even conventional cough medicines don't really work to any great degree, and are based on very shakey evidence. It would be a very, very rare occasion indeed that a doctor would prescribe a cough medicine on prescription for a child. 

 In addition it is extremely soothing and comforting and they will sleep soundly.

I can see how that tingly, cold sort of feeling you get from menthol could be pleasant, though I don't think I'd go as far as to call it soothing. To be honest, you'd have to have perfectly soft skin on your feet to feel anything at all- when I tried it I didn't even feel a tiny tingle, especially since it was covered over with socks. 

Just happened to tune in A.M. Radio and picked up this guy talking about why cough medicines in kids often do more harm than good, due to the chemical makeup of these strong drugs so, I listened.

What guy, and on which radio station? What qualifications does this guy have for making medical recommendations?  Who is even meant to be narrating this post? The only medicines now available for coughs in children in the UK are glycerol and simple linctus paediatric. Both of these essentially work on the basis of being sugary, slightly gloopy water. There's no "strong drugs" here, just some soothing "demulcents" that taste nice and are supposed to leave a soothing lining on the throat, making a cough feel less raw. They're mainly placebos. 

It was a surprise finding and found to be more effective than prescribed medicines for children at bedtime, in addition to have a soothing and calming effect on sick children who then went on to sleep soundly.

 Where is this finding published? What sort of a study was it and how was it designed? How many participants were there? Was there a control group, or a comparator group and if so, what was the comparator? As it happens, all of this is irrelevant really, as no studies exist. These statements come from the head of an internet fraudster, rather than actually being grounded in reality. 

My wife tried it on herself when she had a very deep constant and persistent cough a few weeks ago and it worked 100%! She said that it felt like a warm blanket had enveloped her, coughing stopped in a few minutes and believe me, this was a deep, (incredibly annoying!) every few seconds uncontrollable cough, and she slept cough-free for hours every night that she used it.

 We don't even know who is narrating this thing in the first place, let alone their wife. As I've explained above, this is an anecdote, and we can't derive anything from it. A person, who may or may not be mythical, had a cough, and it went away after they did a thing. It might have gone away anyway, we just can't tell. 

A warm blanket?  far from it. It actually just feels like you have some oily gunk on your feet. At best it might feel a little cold, but for most of us, it'll feel no different at all thanks to our thick skin. 

If you have grandchildren, pass this on. If you end up sick, try it yourself and you will be absolutely amazed at how it works!

Well that's just bizarre. Presumably you don't need to bother if you're simply a parent, only if you're a grandparent? What a load of nonsense. I wasn't left amazed, I was just left feeling a little silly. And I had minty-smelling feet.

So of course I have done a search for the evidence and claims included in the post and have found a grand total of Nothing At All. I will say this though: If I was the manufacturer of Vicks, and someone had done some studies which found my product to be 100% effective, I would sing it loudly from every rooftop I could find. I would be the manufacturer of The Number One Most Effective Medical Product In The World Ever, and I would make sure that I made my millions on the back of that fact, as well as collecting my Nobel prize for Medicine and probably world peace as well. What I probably wouldn't do is ignore the claims, and continue on selling my product and advising that its used in a way which has a less than 100% chance of it working. 

Direct harms from following this advice could include dermatitis and skin reactions. Indirect harms? Well, you've slathered some slippery, oily unguent onto the bottom of your feet. When you take your socks off, you may be slip-sliding all over the place.

The moral of the story is: Very rarely should you believe anything posted on Facebook. Unless its me, posting a link to my blog, of course ;)

Hxxx
 

Allergy relievers: red light nonsense

Its just about coming into allergy season again, so today I am turning my attention to a product I’ve seen for sale in a few pharmacies I’ve locumed at of late: The Allergy Reliever Device. These things are sold under some pharmacy chain’s own names, or under brand names like Kinetik.

An allergy reliever display spotted on a Tesco pharmacy counter by @TheWholeT00th. 

An allergy reliever display spotted on a Tesco pharmacy counter by @TheWholeT00th. 

It’s yet another medical device. These things seem to be hitting the pharmacy shelves more and more often these days, giving them a level of respectability which personally I don’t think they deserve. At least this device makes it clear that it is a device though, unlike things like Prevalin which pretend to be real medicine.

According to Kinetik, it uses “red light therapy to suppress the cells that release histamine, thereby relieving the symptoms of hayfever and allergic rhinitis.”

So, essentially shoving some Christmas tree lights up your nose then. Well I must admit that’s a new one on me. It’s pretty hard to sniff out (geddit?) the theory behind this one too.  The manufacturers of these things don’t give any explanation as to why red light would suppress mast cells, and several Google searches later I’m none the wiser. I have managed to dig out one published paper in rats, where the authors seem to be suggesting that red light changes the redox state of cells, which might cause some changes within the cell. Even these others say that they’re not quite sure what’s happening though, and that further investigation is required.

Armed with a few unsuccessful Google Searches, I delved into the medical literature. I tried every which way I could think of to search for evidence that this thing works, but ended up drawing a total blank. I think this may well be the least successful search for evidence I’ve done so far, and that’s saying something. Even the manufacturers can’t be bothered with listing any sources instead they go wild with the clipart, giving us a Generic Smiley White Coated Person and Happy Photostock Chef alongside some very random recipes and general lifestyle advice.

And it looks like this thing really isn't very pleasant or practical to use. You're supposed to shove the probes up your schnozz as far as you comfortably can, then keep them there for three minutes. Not the most dignified of poses. And you're supposed to do this three or four times a day. That's a lot of inconvenience. Seems like prime Use Once Then Put In A Dark Cupboard territory for me, especially since taking a one a day antihistamine tablet is no hassle at all. 

In short, I wouldn’t waste your money. There’s no basis to these things, and it saddens me that they are not only being sold in pharmacies, but are being sold under pharmacy brand names. The more we associated our profession with such nonsense, the less trustworthy we become to other healthcare professionals and patients alike.

Hxxx

"I do my own research"

Something that I see a lot in on-line debates about alternative medicine is phrases like “I did my own research” or “people should be allowed to do their own research and make their own decisions”

However, I don’t think that the vast majority of people are able to do their own research. Now, that’s probably a pretty unpopular opinion. It’s patronising, paternalistic, and it flies in the face of patient choice. Who am I to question the intelligence and abilities of other people? Why do I think I'm so clever compared to anyone else out there? Allow me to explain myself.

I've been a pharmacist for a very long time now. From uni, through pre-reg, to my own revision at work, I've been taught critical appraisal skills. Yet to this day, it’s something that I actually find really hard work. It’s a skill that requires continual honing, and every time I use it I feel like I am fighting with my brain. 

Even in the last two weeks, I've been revisiting my critical appraisal skills to make sure they are up to date. I've done some in-house work, three on-line courses, and a one to one training session. Yet I still find myself sat here at my desk for several hours, if not days, looking over the same study with a furrowed brow, desperately trying to make the numbers and statistics tell me their story.  If I find it so hard, then how on earth is someone without any medical background or critical appraisal training supposed to do any of it? 

There’s hazard ratios, odds ratios, confidence intervals, numbers needed to treat, event rates, absolute risks and other confuddling terms to deal with. I naturally struggle with numbers at the best of times; like most people, I much prefer narratives. That means that I have to constantly argue with myself to keep looking at the results page, rather than just flicking to the discussion. Because if I did that, I'd be relying on what the authors, with all of their possible biases and agendas, say their numbers say. Then, when I eventually manage to squeeze the swimming mass of figures into some sort of order in my head, I find out that these numbers aren't the full story, and I need to dig even deeper into other analyses of the same figures to find out what’s really going on.* 

A quick and very simplistic visualisation of all the layers of interpretation that might lead to information found on your common or garden health information website. That's a whole lot of bias.

A quick and very simplistic visualisation of all the layers of interpretation that might lead to information found on your common or garden health information website. That's a whole lot of bias.

It’s not a pleasant task by any stretch of the imagination. It really does feel like a mental marathon. I often question whether I am even up to the task- I can end up feeling stupid, and confused. But in order to really figure out whether or not a drug works I need to strip away all the levels of other peoples’ interpretation and start from scratch, with the cold, hard, impersonal numbers. That way I can build my own narrative, uninfluenced by what the study’s authors or sponsors want me to think, by what newspapers want me to believe, by what campaigners want me to know. The only way to know the truth is to start right at the bottom, in a dark dank pit of statistics, then to slowly start building yourself a ladder until you emerge, blinking, into the pleasant knowledge that you've worked out what on earth is going on.

This sort of raw data is not only extremely hard to deal with once it’s in front of you, but its also pretty difficult to come by. Finding it in the first place includes searching multiple medical databases- and these things aren't just a quick free text search like you would do on Google. Constructing a search can in itself take an hour or so, and then you have to trawl through the results to decide which are relevant to what you are specifically looking for. For me, most of the time, a question is structured like this:

What is the evidence that [drug/ group of drugs] works for [disease] in [patient group

 So, in my poorly drawn Venn diagram below, I need to find those holy grail papers that reside in the pink area:

I am truly terrible at MS paint, but you get the idea.

I am truly terrible at MS paint, but you get the idea.

What a typical EMBASE search looks like. This is for a new drug with few synonyms so its a fairly straightforward one. Others can have forty odd lines of searches.

What a typical EMBASE search looks like. This is for a new drug with few synonyms so its a fairly straightforward one. Others can have forty odd lines of searches.

Some of these papers might be pay-walled, so it’ll take me a week or so to get my hands on them. Some of them might initially look promising, but once you start to dig down into the figures you see that there might actually be problems with how they were undertaken or reported, or they might turn out to not quite fit in some way- perhaps the dose they used in the trial is different to the licensed dose in the UK, or the people enrolled into the trial don’t quite fit the population you want to know about, or perhaps the trial just didn't recruit enough people so any results from it are invalidated.

I've been doing this job for years, and I really do still struggle with all of this stuff. That’s not because I'm poor at my job, or because I'm stupid, or because I haven’t put the effort in to understand it. It’s because, when it comes down to it, this stuff is really bloody hard. It’s time-consuming, boring, and unintuitive.

People might well feel like they've done their own research. They might spend several hours digging about on the internet and feel empowered by any decisions that they make. But what they don’t realise is that what they've been researching isn't just the information- it’s the information with many, many layers of interpretation (and therefore bias) added. For a choice to be truly informed, you need to go right back to the start, to those terrifying tables of numbers and statistics. That’s simply not realistic for the majority of people.

Far better, then, to learn how to decide on whose interpretation you’re going to rely on. Will it be those that take the media reports at face value, or who have an agenda or a product to sell you? Or will you go with those that have years of training in how to pull apart complicated data and disseminate it in understandable ways?

Hxxx

*I thought I’d give you a quick real life example here, but I thought it best to asterisk it because I've probably bored you enough already. I'm currently looking at a drug called edoxaban and its use in reducing the risk of stroke in patients with atrial fibrillation. It’s the newest in a series of novel oral anticoagulant drug- they’re supposedly like warfarin, but less faffy. So I find and look at the main trial, and spend days unpicking the stats. It looks like both strengths used in the trial are no worse than warfarin, and the higher dose might even be a little better. Great, right?

Well, that’s not quite the end of the story. Because it turns out- and this isn't reported in the trial at all, but instead is contained in the FDA’s briefing document- that in people with fully working kidneys, edoxaban is actually worse than plain old warfarin. In people whose kidney’s aren't quite at full capacity though, it might work better than warfarin. So the overall trial results are kind of skewed, and if we didn't dig deeper, we might have been giving a whole group of people a more expensive drug with worse outcomes than warfarin. Even the FDA findings are borderline- some of what they describe doesn't reach statistical significance.

It's thyme to Bronchostop this nonsense

I’m sorry, I just could not resist that headline.

Whilst working a locum shift the other week, I noticed a couple of new products had leapt their way to the pharmacy shelves. “Bronchostop”. Sounds interesting, I thought, until I moved a bit closer and noticed that they are, in actual fact, a herbal cough remedy, and my vague excitement was replaced with a bit of my soul dying. Then I saw the price tag, and the anger kicked in.

Brought to us by our old friends at Omega Pharma, Bronchostop syrup contains thyme extract and marshmallow root, whilst the lozenges just contain thyme extract. Omega claim that it “relieves any type of cough”, and that it “takes the hassle out of choosing a solution”. Well, I must say, I’m pleased to hear that, because I find one of the main stressors in my life is choosing which cough remedy to use. I mean, it’s just so complicated to decide if you have a dry or a chesty cough, then realise that it makes no difference anyway as most cough medicines don't work, so you then just by a cheapo honey and lemon thing to make yourself feel placebo-ey better. 

So, given that the great all-consuming cough medicine dilemma of my life has now been sorted out by Omega, I can spend some quality time looking up the evidence to see if it works.

It turns out that there are some preliminary trials which suggest thyme might improve cough symptoms. However, these all use specific cough syrups with different combinations of ingredients compared to Bronchostop, so they’re not very helpful. Because the product is being sold as a traditional herbal remedy, the manufacturers don’t need to bother collecting any evidence that it works before it goes on sale- their claims are based entirely on “traditional use”, which means nothing at all scientifically.

One attempt at a clinical trial compared thyme syrup with a “real” expectorant, bromhexine, and found no difference over a five day period. There are a number of problems with this though- firstly, bromhexine isn’t commonly used in cough medicines. Secondly, there’s little to no good evidence that expectorants work anyway, so we’re comparing something that may or may not work with something that doesn’t.

Worryingly, the website www.bronchostop.co.uk contains absolutely no safety information whatsoever. It doesn’t tell you who can’t use it, who needs to be careful using it, or what any of the side effects might be.

What side effects could it possibly have, you’re wondering. After all, its just a herb. We eat it, so it can’t be that bad, right? Well, sort of. The amounts used in food tend to be a lot lower than when it is used as a herbal medicine.

On the whole, thyme is well tolerated, but occasional gastrointestinal effects can occur. Uncommonly, and more seriously, people can have allergic reactions to it. It can interact with drugs, including those that thin the blood, those used in Parkinson’s disease, those with anticholinergic or cholinergic effects, oestrogens (research suggests it may decrease the effects of HRT, but theoretically also the contraceptive pill), and non-steroidal anti-inflammatory drugs. It may cause problems in people with bleeding disorders, who are undergoing surgery, or who have hormone sensitive cancers. We have no idea of the effects that medicinal amounts of thyme can have in pregnant or lactating women.

It seems to me, however, that its main adverse effect will be on your bank balance. This stuff is £8.99 for a 200ml bottle or £4.99 for 20 pastilles- that’s a whole lot more than simple linctus, which is about £1.50 and which will probably do just as good a job.

Hxxx

When real science gets left out in the Coldzyme

There’s no getting away from it, folks. Its sniffle season. For the next 6 months or so, the sounds of sneezes, coughs, and millions of noses being blown will echo throughout the nation.

We all know by now that the common cold is a virus. We all know that there is no cure. We also all know that, although you feel like crawling into a small dark warm cave and dying at the time, its usually much better after a few days, and it goes away of its own accord. Cold and flu remedies do nothing to actually get rid of your cold- they are there to make you feel better during it, although many of them are actually irrational combinations of products in shiny boxes with a redonkulously high price.

It is often said that if someone did come up with a cure for the common cold, they would be millionaires. I was, therefore, surprised to read this week in Chemist + Druggist magazine that indeed, the first ever product to not only treat the symptoms but to act on the virus itself was winging its way to pharmacy shelves as we speak. Really? Because blimey charlie, if that's the case, then this product should be Big News. 

The product is ColdZyme, a mouth spray that costs £8.99 for 20mLs. Seems a pretty fair price to pay for a product which claims to cure the most prominent infectious disease in the western hemisphere. It seems odd, though, that instead of this marvellous scientific breakthrough being plastered all over the media and medical literature, the article announcing it is tucked away quietly in a barely read corner of a trade journal.

What is this breakthrough, miracle product that will powerfully break down viruses? Well, an enzyme called trypsin. An enzyme that already merrily and plentifully kicks about in your digestive system, breaking down proteins. An enzyme which, for the purposes of this product, is inexplicable being derived from cod (which has meant that I have had to resist the urge to refer to it as somewhat fishy.) An enzyme which should be stored at temperatures of between -20 and -80 degrees Celsius, to prevent autolysis. Now, I've seen some fancy medicine packaging in my time, but never a simple mouth spray bottle that can manage such cold chain storage feats. So, if trypsin really is present in this product, then it seems fairly likely that its going to be inactive, unless the manufacturers have found a way of warping room temperature. Or you happen to be in Winnipeg in the middle of winter.

Medicine vs. Medical Device

The manufacturers make some really very extraordinary claims on their website, including one textbook example of special pleading. Their product, they state, isn’t a medicine. It’s a medical device, because it has no systemic effect. They then of course go on to helpfully tell us about the systemic effect it has:

“The medicines currently on the market only treat the various symptoms of a cold. ColdZyme treats the cause of the symptoms – the virus itself – and thus works both preventively against the common cold and shortens the duration of illness if you have already been infected.”

Right. So in the same breath, they are claiming that the product only forms a barrier, no more. But then they are also claiming that this barrier affects the ability of the virus to produce illness if you are already infected- viruses which are already through that barrier and inside your body. Come on, Enzymatica, you can’t have it both ways.

The Evidence

All these claims are backed up by evidence, right? Well, there is a tiny trial performed on only 46 people, which isn’t published anywhere. I can’t say whether or not it is a well designed trial, because I can’t see it in full, so to be honest, we pretty much have to just discount it. What we can do, however, if have a look to see if there is any other decent published information looking at the effect of trypsin on the cold virus. So I turned to the medical databases Medline and Embase, to trawl through the published medical literature. 

I did find one experiment which looked at the trypsin sensitivity of several human rhinovirus serotypes(1). And this appears to have found that viruses are only really susceptible to trypsin when there have been exposed to low pH, followed by neutralization- something which wont have happened to your common or garden cold viruses. I couldn’t find much else suggestive of a clinically significant antivirus action of trypsin.

The practicalities

This isn’t a simple, one-off- couple of sprays and away flies your cold sort of product. You have to use it every two hours, as well as after you brush your teeth and before you go to bed, and you have to continue this “until your symptoms are relieved”. That’s one hell of a regime. I have difficulty remembering to use medicines twice daily, never mind every two hours. I’ve never used this product, but I’d imagine that if it really does leave a “barrier” coating in your mouth, its a pretty unpleasant sensation. I can’t imagine many people sticking closely to these dosage instructions, and if the mechanism of action is as the manufacturer’s claim, skipping doses would cause the product to fail (if, indeed, it works in the first place)

We are also directed to “Start using ColdZyme® as soon as possible when you detect symptoms of a cold.”. Now, those of use who suffer with cold sores who have ever used aciclovir cream will know that this is often easier said than done- you probably haven’t got the stuff in the house, or at work, and by the time you’ve managed to get your hands on some, its already too late- your cold sore is out loud and proud, and using the drug will be pointless. Its likely that the very same thing will apply here. And remember that the incubation period for a cold is about 2 days- so the virus will already be cosily settled into your body before you even know about it. Its therefore completely ludicrous that this product claims to be able to reduce the length of a cold simply by forming a barrier.  

I know it can be used as a cold preventative, but how many people who feel completely fine are going to remember to use the product every two hours, every day, for the entirely of the cold season?

To Summarise

So, do I think there is scientific evidence to back up the extraordinary claims being made by ColdZyme? I might do when hell freezes over. Or at least when some decent trials are published, which might take just as long.  Do I think that this product should be sold through pharmacies? Absolutely not- this isn’t, if you ask me, real medicine. This is pure pseudoscience, trying its best to fool you into buying real medicine. Do I think lots of people will buy this, use it once or twice, then leave it to languish in their bathroom cabinet? Absolutely.

Here’s the problem though: this stuff will appear on the shelves of pharmacies all over. The pharmacists wont have a clue what this stuff is, and because they are really busy and probably quite tired at the end of each day, they wont be able to do the sort of evidence review I have managed to squeeze into a quiet moment. So they’ll get asked about it, and they’ll sell it. Some people will buy it and will feel better after a few days, and will think that the spray has made them better, forgetting that colds are self-limiting anyway. A customer might come back in the pharmacy one day, and say something like “hey, that new-fangled spray got rid of my cold!”, and the pharmacy staff will end up making recommendations on the basis of customer feedback and anecdotes, rather than on the basis of rational, scientific evidence. In my eyes, this really is a shame, and by selling this sort of nonsense, we really are cheapening our profession, and we're causing our customers to waste their money. 

If patients ask me about it, when I’m working behind the counter, I’ll tell them something along the lines of: “there’s no evidence or logical way that it works. It seems to be a bit of an expensive gimmick, with no decent basis to it. You’ll feel horrible with your cold, but it will start to go away of its own accord, I promise. In the meantime, you’d be much better off looking after yourself, having plenty of fluids and rest, and taking paracetamol according to the packet.”

Hxxx


A Miracle Migraine Machine?

Cefaly. No, it's not a village in Wales, nor is it a type of cheese (actually, it might be for all I know, but nevermind.) It is instead a new all singing, all dancing miracle cure for migraines, according to its manufacturers anyway. So, in our usual fashion, let's take a look at the evidence and see what on earth it is, and whether it is worth spending money on.

It's a medical headband device that you wear on your noggin, around your forehead. This means that you can easily pretend to be the Empress from the Never Ending Story. The downside is that you'll have to pay somewhere in the region of £250 to do so, plus electrodes and batteries. So, for that amount of money, you want to know that what you're getting is going to provide you with a bit more than simply cosplaying as a child-like film character.

What I love about pictures like this is that it's always perfectly made-up women in them. As if anyone can be arsed to think about makeup when they're vomiting everywhere and their head feels like its being crushed. 

What I love about pictures like this is that it's always perfectly made-up women in them. As if anyone can be arsed to think about makeup when they're vomiting everywhere and their head feels like its being crushed. 


It is essentially a TENS machine, which applies an electric current to the middle of the forehead via self adhesive electrodes. Anyone who has ever used one of those godawful Slendertone thingies on their stomach is probably right now recoiling in horror at the idea of having to endure such torture right between their eyes- I know I am. But first I suppose we need to see if it works- after all, migraines are horrible things which can massively impact on the quality of life of sufferers. Those who are desperate may be quite happy to have their foreheads electrocuted.

Its been approved by the FDA, which is nice. What isn't quite so nice is the fact that this approval is based on one trial- the one and only trial in existence, despite what the manufacturers would have you believe.

This trial included 67 patients who suffered at least 2 migraine attacks per month. Although small, this trial is well designed, with an identical sham stimulator being used as a comparison to the test product. After three months of daily 20 minute usage, the mean number of migraine days in users of Cefaly was significantly reduced (6.94vs 4.88, p=0.023), but were not significantly changed in the sham group. But here's the thing: the difference between groups was not significant (p=0.054).

There was significantly higher percentage of responders (defined as ≥ 50% reduction in no of migraine days per month) in the Cefaly group compared to the sham group (38.24% vs 12.12%, p=0.023).

There was no significant difference in severity of migraine.

Although some of the results in this trial are encouraging, it is limited by its very small size. It is worth noting that the authors and manufacturers claim that this trial proves that the product is effective at preventing migraine, despite the lack of a significant between-group difference in the primary outcome of migraine days.
Other papers have been published in the literature regarding this product, and the manufacturers try their best on their website to make them look like they are real trials. However, these range from letters, conference abstracts, experiments in healthy adults, and case studies- not robust clinical trials.

An uncontrolled survey of 2313 Cefaly rental users found that roughly just over half of patients were satisfied with the treatment and would be willing to buy the device. The rest of the patients stopped therapy- that's a pretty high number of people. There are a number of methodological and confounding problems with this study, so the conclusions drawn from it should be considered unreliable.

Being a rental user is one thing- at least they were able to try it out before taking the plunge and handing over a rather large wad of cash. In the UK, though, it seems that the rental option isn't readily available. £250 is an awful lot of money to spend on a product, especially when, for roughly half of its purchasers, its going to be used a couple of times then lie in a cupboard, forlorn and forgotten about. 

Let's have a think about compliance. To get the best results, you are supposed to use it for 20 minutes per day. Now, initially that might not sound like too big a deal, but if you work, have a social life, go to the gym, or spend every waking minute building a house in Minecraft, finding 20 minutes a day for something that could be, in most cases, painful, is probably pretty unappealing, and impractical. I can't see too many people who will be able to religiously use this product exactly as intended in the long term. I'm guessing that in most cases its going to go the way of that bit of exercise equipment that you bought 5 years ago and that you've used twice and now only trip over on occasion.

So to summarise: there is a little bit of encouraging data, though it's not as compelling as the manufacturers would like us to think. It's extremely expensive, impractical, and probably pretty unpleasant to use. Its an interesting device, but one that I am placing firmly in the "Yet to be convinced by larger trials" pile.

Hxxx
 

Evidence-Based Ambridge

Ahh. Sunday mornings. They can mean only one thing: bacon.
Okay, two things: bacon and tea
Whoops, no let's make that three things: bacon, tea, and The Archers omnibus. 

So welcome to the first instalment of an occasional series (probably so occasional that this is the only one), in which I critically examine the treatment choices of the fictional residents of Ambridge. 

In today's omnibus, Hell-on's child falls over. There is much hysterical panic, and much bewailing the fact that she wasn't watching him properly. Apparently its hard to look after a child and gaze lovingly off into the distance in the direction of Rob Titchener's house. Who knew. 

But never fear, Hell-on's mother, Pat (who doesn't appear to have noticed that her husband has been kidnapped and replaced by an interloper), is on hand to reassure her that she has done her best with the arnica. 

Arguably, I'd say arnica is one of the most accepted forms of woo in the UK. Arnica cream is a standard item in many pharmacies, and I would say that many people know that it is supposed to be useful for bruises. I wonder just how many first aid boxes have a tube of arnica languishing in them, but I reckon it is quite a few.

Its also a poster boy for the sort of confusion that reigns between the public perception of homeopathy and herbal medicine. herbal arnica cream often sits side by side homeopathic versions with no explanation of the difference. 

Even Nelson's seem rather confused about which modality to use, with both herbal and homeopathic arnica sitting in their "Arnicare" range of products. I can't quite get my head around this to be honest. Imagine going into an off-license and seeing two bottles of Smirnoff, one of which contains vodka and one of which contains water, though the only difference on the label is that one says Smirnoff Vodka 30C. Hmm.

Does the distinction matter? Yes, I think it does. I think its pure, outright deception to sell a homeopathic product to someone expecting a herbal medicine. One has arnica in, one doesn't. 

Anyway, all of this is by the by. Obviously there is no evidence that homeopathic arnica works for bruising. It's homeopathy. It has nothing in it. 

And as for herbal arnica? there's also no evidence that it works, although there is a little bit of prior plausibility, in that some of the chemicals in the arnica plant have an anti-inflammatory and anti-platelet action. There is, however, no information on how clinically significant these actions are, and whether rubbing a bit of cream into an area would get these potentially useful chemicals to the right place in any meaningful amounts.

Let's not forget that bruises are self-limiting. They go away of their own accord (and probably at the same pace), regardless of whether or not you rub some gunk into them. herbal arnica isn't risk free: the cream can cause  contact itchiness, dry skin, and rash. Orally, arnica can be pretty nasty stuff, even causing coma and death in extreme cases. 

So, my evidence-based advice to Helen would be: kiss it better, and leave it be. Henry is a small child, and falling over is pretty common in that age group. Don't apply an ineffective treatment which could rarely lead to side effects, and save your money.  

Nelson's: Suggesting that your kids need mood stabilisers from two years old.

You know of Rescue Remedy, right? You probably had an aunt who would constantly swig a drop for her nerves, or might have even taken some before a driving test or exam.

Rescue Remedy has become a pretty well known brand- so well known, in fact, that most people don't bother finding out whats in it, or what principles its based on. You wouldn't want to know the recipe of Coca-Cola before you take a refreshing swig- you'd just assume that because its a well known brand, its probably going to work.

Rescue Remedy is, however, a whole load of woo nonsense. Sorry, but there's no other way of putting it. Some dude called Edward Bach decided- apropos of nothing- a good few years ago that some flowers, if left out in the sun and dissolved in alcohol,  will be able to balance physical and emotional distress. This is interesting, really, given that its taken the entire fields of neuroscience, psychiatry, and psychology many, many years to get to a point where there are still a vast amount of unknowns regarding mood disorders.

Science is getting there- slowly- when it comes to understanding things like depression. It's a vastly complicated subject. There's no perfect cure-all drug out there for treating such things- mainly because we don't yet understand it that well yet. So forgive me if I am skeptical that some random guy years ago has just randomly (without any basis in science) decided that, for example, mustard flower:

 "is the remedy for deep gloom and depression that descends for no apparent reason out of a clear blue sky. People in this state often list all the reasons they have to feel happy and contented, but still everything looks black and hopeless to them. The remedy helps to dispel the clouds so that we can once again appreciate the joy and peace in our lives."

Rescue Remedy is a blend of some of Dr Bach's made up flower remedies, diluted in brandy. You're supposed to reach for it in times of anxiety, as a soother. Funnily enough, brandy, being alcohol and all, it might make you feel a little bit better, but similarly to homeopathic remedies, they are dilutes such that very little or no levels of active ingredient are likely to remain. So even if Dr Bach were right about the flowers (despite evidence and science suggesting otherwise), there wouldnt be enough flower-stuff in a drop of it anyway to make a difference.

I can't quite get away from the fact that this is a cynical product which Dr Bach made up in an attempt to target wealthy women ("ooh! pretty flowers!") in the days where women were considered "hysterical" and many were labelled as having "problems with their nerves" based entirely on their sex.

Anyway, why am I on about Nelsons, and why am I on about children? Well, because the Bach Rescue Remedy brand- in all of its many, varying, and just-as-cynically money-grabbing-as-Big-Pharma- forms- is sold via Nelson's homeopathic brand. That's Nelson's who the FDA discovered weren't putting magic woo water in all of their magic woo water pills, but were happy enough to put particles of glass in there. That's Nelson's who are all "ooh, we care about you and your healthcare unlike those big meanie pharmaceutical companies who only care about money" all the time.

Well, I happened to stumble across this product of theirs today. Rescue Remedy Gummy Stars- aimed at children from 2 years and onwards. According to Nelsons:


"The first day back at school is a big day so parents should have a secret weapon against tiny tears on standby in the school run bag. RESCUE® Gummy stars - The latest addition to the RESCUE brand come in fun star shapes to help turn a frown upside down at the school gates and each Gummy Star contains four drops of RESCUE, the famous soothing combination of five flower essences."

What's wrong with that? The fact the Nelsons are attempting to medicalise a perfectly normal part of childhood purely for their profit, that's what. Being nervous on your first day of school is entirely normal, especially for a little one. What they need to do is to develop normal coping mechanisms to deal with their anxiety. What they don't need to feel is that their anxiety is abnormal and something which only a medicine can fix.

When encountering the world of complementary or alternative medicine, I often like to stop for a moment and replace the names of the companies with those of Big Pharma. It gives a good indication of whether or not there really is a difference in practices between the two camps, and whether people's reactions would be different

"The first day back at school is a big day so parents should have a secret weapon against tiny tears on standby in the school run bag. PROZAC® Gummy stars - The latest addition to the PROZAC brand come in fun star shapes to help turn a frown upside down at the school gates and each Gummy Star contains 10mg of PROZAC, the famous soothing antidepressant fluoxetine."

Icky, right?

Hxxx

Water in a can now available on prescription. No, really.

No, its not a homeopathic sort of magic water this time, but instead Magicool.

Yep, remember when there were cheesy adverts on the TV all the time advertising this breakthrough, world's first spray? The website for Magicool even goes so far as to call it "heaven-sent". What in it? Well, water it would seem. I can't find any of the other ingredients listed on the website, save for a rambling explanation of how they still manage to get away with putting fragrance into it whilst claiming that it is an "unscented" product. Presumably it will have some sort of propellant in it too.


The theory is simple, and to be honest pretty good. When its warm, water on your skin evaporates, drawing out the heat. You feel cooler. So that's good. But its fairly impractical to keep having a cold shower every two seconds if you're at work or out and about, so Magicool is a nice portable option. Fine so far. 

However, Magicool have decided to go one step further, and start making medical claims with their Magicool Plus range. They're classed as medical devices (sound familiar?) so don't need to go through the rigorous clinical trials that licensed medical lotions or potions have to. But they're now apparently available on prescription, so there must be some evidence that they work, right?

The Magicool website is frankly appalling. But what I'm looking for is a plausible mechanism of action for why their products work, and some good evidence that they do work. Let's have a lookie, shall we?

Kinetic pulses? anaesthetizing? Vital deep cell hydration? adjusting pH? Despite its claims to be unscented, I am smelling pseudoscience at work. And what is with the text speak?! I've had emails from Nigerian princes asking for my bank details so that they can send me millions of pounds that are better written than this supposedly medical resource.

The evidence section appears to be a badly scraped together list of links from places like Trip Advisor and Yahoo Answers, where people have vaguely mentioned in passing that the product worked. But, dear readers, as we know by now, testimonials and reviews certainly do not constitute robust medical evidence, especially when lots of them are merely spam adverts posted on forums etc, as they are here. Again, there's no indication of what the ingredients actually are, so I have no idea whether or not there is even any plausibility in the claims above and beyond the fact that it might make you feel a little bit cooler.

So, if the manufacturer's aren't being forthcoming with any evidence, let's turn to the medical literature. This is made difficult, of course, by fact that I have no idea what is in it, other than water. Searching for the brand name brings up nothing at all, so it would appear that there is a grand total of no evidence whatsoever that this stuff actually works more than ordinary Magicool, or a shower, or standing next to a fan. The manufacturers are claiming that the product has "maximum therapeutic efficacy" on the basis of thin air. 


According to Chemist and Druggist, the availability on prescription is coinciding with a large advertising campaign. This means two things:We'll have to sit through more daft adverts filled with smug thin people on holiday cooling themselves down despite not even looking remotely hot (where's the red face and frizzy hair, eh?!) and that some patients will inevitably rock up to their doctors and demand it on prescription. 

The cost price to the NHS is £5.77. That doesn't seem like its going to break the bank, but I don't care how small an amount it is, frankly. There is a finite pot of money in the NHS, and we need to use every single penny of it wisely. If £5.77 is being spent on water in a can, that £5.77 can no longer be used to pay for something life saving.

Hxxx 

Dermalex: a superficial skin miracle?

I've written before about the guttate psoriasis which suddenly appeared at the start of this year and the impact it has had on my life.

I'm pleased to report that, after 9 weeks of phototherapy, it is much better. It has virtually gone on my top half, but the plaques on my legs are still stubbornly visible, although much better. The fact that it hasn't gone away entirely yet means its probably not going to clear up. Without wanting to sound over-dramatic, it actually feels like quite a bit to deal with- I've never had any long-term health conditions before, and although I've become slightly more confident, I'm still really conscious and nervous of having to expose any affected skin.

A while ago, my Mum rang me. "There's this new product out that says its for psoriasis, shall I buy you it so you can try it and see if it works?". To be honest, it was tempting, but when she told me the price £29.99 for just 150g, I declined. Skin diseases really can have an enormous impact on your life, and leave you desperate to try anything to find that one miracle that will get rid of it once and for all. Since then, I've seen it prominently displayed in quite a few pharmacies, hailed on shelf-edges as a 'breakthrough in psoriasis treatment'. So the big question is, is there any evidence that it works?

This poor chap obviously has some practical joker friends who like to write words of skin conditions in his sun tan lotion when he is sleeping in the sun.

This poor chap obviously has some practical joker friends who like to write words of skin conditions in his sun tan lotion when he is sleeping in the sun.

The product is Dermalex, and it is made by Omega Pharma. If their name sounds familiar to you, that may be because they also produce Prevalin, the overpriced, overcomplicated, under-evidenced Vaseline substitute for hayfever. This leaves me with a slight prickling of my skepticism, but lets keep an open mind for now.

How is it supposed to work? Well, the fact that the website itself titles this section "How its works?" (sic) begins to worry me slightly. I know this blog is liberally sprinkled with typos and spelling errors, but at least I have the courtesy of being shameful about it. In a professional website selling a quality medicinal product, I don't think spelling errors are acceptable, and there are a few dotted around the whole website. Nowhere on the website does it actually tell you what is in the product. Its said to: 

  • "Reduce Psoriasis symptoms by: Normalising skin cell production and Acceleration of the recovery of the skin barrier"
  • "Fortify the skin barrier through: The creation of a protective shield on the skin by means of Alumino silicates against outside to inside insults (bacterial superantigens & toxins) through the non-intact skin barrier."
  • "Providing a barrier to water loss"

This is helpfully illustrated by a diagram of the skin, which has labels that don't correspond to any numbers at all- either they're deliberately trying to make it look all science-like and confusing, to make the patient think "this is too complicated for me, so it must work", or its just sloppy oversight. Either way is bad enough.

Some labels on those numbers would be nice. Unless there really are little blue circles with random number in them floating about in the layers of our skin.

Some labels on those numbers would be nice. Unless there really are little blue circles with random number in them floating about in the layers of our skin.

We can pretty much entirely discount the claims for "fortifying the skin barrier". All this means is moisturising the skin, and a plain old (cheaper) emollient will do just as good a job at that. Once again, this seems to be Omega Pharma reinventing the Vaseline-greased wheel. As for the former claims, well, I need to see some evidence to corroborate them and decide if they are reasonable or not. So let's have a little lookie, shall we?

Having had a bit of a dig about on the website, I could see no clinical evidence. So of course I emailled the manufacturers, and got back a curt response after several days telling me to look at this page for references. So, here it is, the grand total of the evidence that Dermalex Psoriasis works:


"PASI based clinical efficacy study of Dermalex Psoriasis cream for the treatment of Psoriasis Vulgaris symptoms in a mono application therapy, Józsefváros Health Center, Budapest, Hungary; Open Label Clinical Study into the overall efficacy of Dermalex Psoriasis Cream, 2008, Dermatology and Psoriasis Clinics Laudau and Kandel, Germany"

For some reason, Omega Pharma seem to want to throw away the usual format of referencing- the one that is accepted and good enough for use in the rest of the medical profession. These references do not give me enough information to find the original studies, so what use are they? I've emailled them back to ask for standard reference formats, including where the studies are published, and have been greeted with a loud silence. I've tried googling the titles, and this brings up nothing, suggesting that they haven't even been published.

Why isn't the evidence published anywhere? How many patients were involved? What are the study designs? What were the results, and the statistical analysis of the results? Without answers to any of these questions, all I can do is discount this as evidence at the moment. 

Of course I didn't just leave my research there, in the hands of the manufacturers. I've also had a look myself at the medical literature. And could I find anything at all for whether Dermalex works for psoriasis? Not a sausage. 

You're supposed to apply this stuff  three times a day. 150 grams will not last you long at that rate. That makes this a whoppingly expensive product. The national minimum wage in the UK is £6.31, meaning one pack would be equivalent to just under 5 hours work. Isimply don't think that a couple of unpublished trials that may or may not say it works is a good enough reason to justify the expense. They're either being deliberately evasive about the evidence, or remarkably blase with people's hard earned cash.   

They say beauty is only skin deep. It would seem that the evidence that Dermalex is even more shallow than that. 

Hxxx

Update: I was contacted by the manufacturers of Dermalex, who promised to provide me with the references I asked for above. Here is the response I've gotten, with my response to the points they have raised below. . 

Thank you for your enquiry regarding Dermalex.
As you may be aware, the Dermalex range contains a number of different products to treat the following conditions; atopic eczema, contact eczema, psoriasis, rosacea, atopic eczema for babies and children. Please rest assured that all Omega Pharma products have been produced under strict guidelines and regulations.
range of proprietary studies have been conducted across the Dermalex product portfolio and as medical devices, these products have undergone statutory trials to ensure they meet the safety and efficacy standards required by regulatory bodies to demonstrate an impact on skin pathologies.
Medical devices are designed, engineered and formulated, in compliance with the UNI EN ISO 14971:2009 and 13485 guidelines. This means that each step of development and marketing has been strictly regulated to ensure the safety and efficacy of the products.  All testing is carried out by medical device status certified organizations, which include leading dermatology research centres. In addition, all studies were conducted by practicing clinicians. Please note that these studies include varying number of participants and study designs.
The research behind the Dermalex range is ongoing - we are working towards publishing data on the product range this year to ensure we are able to communicate the efficacy and safety of these products to healthcare professionals. We are working closely with the University of Amsterdam and are looking to publish the first set of results in theInternational Journal of Contact Eczema. We will also be presenting this data at the upcoming conference on ‘impaired skin barrier in the pathogenesis of atopic and contact dermatitis’ in Amsterdam in June.
To date, we have conducted six trials across the product portfolio involving nearly 200 patients. The products have also been used in in Belgium, France, The Netherlands, UK, Italy, Portugal, Austria, Switzerland, Ukraine, Czech Republic, Slovakia, Turkey and Australia, among nearly 3 million sufferers.
All Dermalex products are well tolerated and have been clinically proven to work. In summary, the trials showed:
  •  Dermalex Contact Eczema produces symptom improvement comparable to prescription drug treatments
  •  Dermalex Atopic Eczema (Babies & Children and Adult formulations) effectively relieves both objective and subjective symptoms of contact or atopic eczema
  •  Dermalex Psoriasis is effective against objective and subjective symptoms of psoriasis
  • Dermalex Rosacea & Couperose is effective against objective and subjective symptoms of rosacea
We hope that this information is useful and thank you for taking the time to contact us."

Firstly: I was aware that Dermalex is being sold as a medical device, but only because of those tell-tale words "Clinically proven!" and based on knowledge of Omega Pharma's other product, Prevalin. the fact it is classed as a medical device (and therefore not subject to the rigorous clinical testing of a real medicine) is even less prominent on the Dermalex website than it is on the Prevalin website.  

The rest of the e-mail appears to be a lengthy way of saying "We don't have any trials published yet, and no, you can't have any results in order to make up your own mind whether or not it works, you'll just have to take our word for it.". 

What's particularly interesting is that the International Journal of Contact Eczema doesn't appear to actually exist, as nothing at all is coming up for it on a Google search.

They say they have conducted six trials, which initially sounds reasonable. But this is across the product range, which includes at least four products and also children's versions. 200 people over six trials is not a lot- if shared equally that is only 33 patients per trial, and assuming they're placebo controlled, that would only mean that 16 patients per trial are actually exposed to the product- nowhere near enough to claim clinical significance of any results. Stating that the product has been used in other countries is meaningless, unless it is backed up by good, robust clinical trials. Its a logical fallacy- an appeal to popularity. Just being used doesn't mean it works- people might just try it once, or use it on the basis of advertising alone, but the product could still be ineffective.

So here's my main problem. How do Dermalex justify charging such an enormous price for a product before they have proven its efficacy. If good quality research had been undertaken prior to marketing, and robust results said that it worked, then that's one thing. But charging people £29.99 for "We think it might work, but we don't know yet because we're still doing research now, and the trials we've done so far that haven't been published yet in a non-existent journal are too small to decide" is, to my mind, entirely unjustified. 

The Magic Blankie

When its cold and dark outside, I like nothing more than snuggling on the sofa under my blanket with a good book or a film. Some would even say its medicinal. No, really, they would. They'd go on to claim that its excellent for treating chronic diseases and that everyone should have a Magic Blankie of their very own at home.

Enter the healing blanket TMB-01, which stands for Treatment Multilayer Blanket. I prefer The Magic Blankie, though to be honest. Or Truly Mad Bollocks, that would also work. I love how they think also assigning it a number will make it more scientific sounding. Mind you, coming from SCENAR (Self-Controlled Energo Neuro Adaptive Regulation), we can be fairly confident that they have a robust, experienced Department Of Shoehorning Random And Sceince-y Words Into Acronyms (DoSRASWIA) on the case.

NO Kermit! Don't you know that by saying bye bye blankie you are denying yourself the health benefits of Magic Russian Technology?!

NO Kermit! Don't you know that by saying bye bye blankie you are denying yourself the health benefits of Magic Russian Technology?!

They're all the rage in Russia apparently. And I suppose, given how cold their winters are, it's only natural that every household would have a cosy blanket lying around. At only $325 a pop, why wouldn't you?

So what can the healing blanket actually heal? Lets see what Scenar have to say about it:

"The healing blanket TMB-01 can be combined with other therapies for a treatment of a wide range of diseases as well as stand alone independent treatment for psycho-emotional regulation, insomnia, stress and reduction of muscular spasm. The TMB blanket also helps to regulate psychosomatic conditions, relieves constant tiredness, and improves feelings of well being."

Insomnia, stress, tiredness, psycho-emotional stuff. Well we all have problems with those, don't we. Lets have a look at how we should use the blanket: 

"Maximum effects are achieved when the patient is wrapped completely and sleeps... One procedure takes around 40 minutes and could be repeated 2 – 3 times a day. The course of treatment is between 15 – 20 days 9 up to 1 – 3 procedures a day)".

Right, so to make yourself feel less sleepy, or to stop insomnia, what you should do is get cosy in your Blankie and sleep. Yep, seems perfectly plausible to me that the effects on conditions caused by lack of sleep are purely down to the blanket itself and nothing to do with sleeping, or just having a bit of a relax. Although frankly, having a 40 minute nap three times a day for 20 days is unlikely to help my stress levels as I'd have time to get sod all done in the rest of the day. 

How is The Magic Blankie supposed to work? Similarly to a tin foil hat, it would seem. It's made of layers of metal, which apparently shields the body from all external electromagnetic fields and radiation. Except, presumably, your head, which you'd probably not be covering with the blanket to avoid the minor inconvenience of suffocating. Its a reverse tin foil hat, I suppose.

"No, no its fine. We don't care if any electromagnetic evil rays of death  get into their angelic little heads,. It's not like there's any useful organs in there that might need protection. What's a brain ever done for us?"- SCENAR Department of Making Excuses (DoME) Spokesperson. Probably.

"No, no its fine. We don't care if any electromagnetic evil rays of death  get into their angelic little heads,. It's not like there's any useful organs in there that might need protection. What's a brain ever done for us?"- SCENAR Department of Making Excuses (DoME) Spokesperson. Probably.

Physicists, forgive me if I'm wrong here, but aren't there some forms of electromagnetic radiation that even several feet of lead won't stop? But those clever Russians have found a way to stop all of it. Makes you wonder why X-ray departments aren't simply tents made of these blankets held up with curtain poles. They could be renamed X-ray dens.  

Anyway, what about evidence? There is some, of course. It's just been blown away by the electromagnetic fields of reality.

Hxxx

P.S.I hope the sarcasm is clear enough in this post. Don't want to end up with quotes being used as testimonials or anything. "AT $325 A POP, WHY WOULDN'T YOU?"- Sparkle Wildfire, Skeptic Pharmacist 

Nose gunk strikes again: Nasalguard AllergieBLOCK

What is it with people trying to produce "Revolutionary" new versions of rubbing vaseline on your nose whilst charging vastly over the odds for the privilege? Someone, somewhere has obviously decided that our noses just aren't greasy enough. Thanks to my friend Paul for bringing this to my attention.

Enter the new kid on the over-the-counter hayfever market block (see what I did there?): Nasalguard AllergieBLOCK. Firstly, how am I supposed to trust a product that can't even manage to spell allergy properly? Secondly, is that Comic Sans font that I spy on the packaging?! Okay, so it seems like the UK packaging is different, but that doesn't matter. The damage is done, and the use of Comic Sans is an unforgivable crime.

Font against humanity. 

Font against humanity. 


Thirdly, on trying to find the UK site, it seems that this is yet another company who has taken to giving free stuff to people so that they will say on their personal blogs how very marvellous it is. This sort of publicity just doesn't wash with me. It feels grimy and seedy and smells faintly of desperation. I therefore imagine this is also what Allergieblock gel smells of.

Let's have a look at what the manufacturer's say:

"NasalGuard AllergieBLOCK® Regular is a revolutionary topical gel based upon patented technology containing cosmetic grade ingredients. The FDA-approved gel creates a positive charge which blocks negatively charged allergens on contact before they enter the nasal passages."

Right, it's really not revolutionary, is it? It's hardly going to free the downtrodden masses from the grips of the evil dictatorship of pollen. It's exactly the same principle as Prevalin and Haymax, and of course good old Vaseline. I've said it before in the Prevalin post, but the idea of putting vaseline on your nostrils to reduce hayfever symptoms is as old as the hills. There's nothing revolutionary about this. This positive charge thing is new, however. It sounds like something that a bunch of marketers sat in an office having a "thinkstorm" session would come up with as being suitably science-y to wow the masses. 

But surely this can't possibly be the case, not when there is a heart-warming "Inventor's Story" on the website:


"About 20 years ago, New Jersey Professional Engineer Ashok Wahi's daughter Aikta frequently suffered from allergies after exposure to her friend's cat. He wanted her to be relieved from the constant sneezing, runny nose and congestion without taking drugs.  The conventional over-the-counter remedies made her sleepy at school, he got motivated to create a drug-free solution for his daughter that wouldn’t cause drowsiness, dry mouth and similar side effects.

The project's goal was to prevent the inhalation of allergens rather than treating the allergy symptoms after the fact.

With this in mind, Wahi put his engineering skills to work and developed a unique gel that blocks allergens on contact, therefore alleviating allergy symptoms. Hence the birth of NasalGuard® technology."


So its taken this dude 20 years to reinvent the wheel and come up with a fancy version of Vaseline. Shame really, he could have saved himself the effort if he had only spoken to a decent pharmacist or GP. Whilst I'm sure being a "Professional Engineer" is awesome and all, I'd really rather like it if people who are trying to improve my health have some sort of background or training in healthcare, thank you very much. 

Anyway, all of this is by-the-by, because of course there is going to be a wealth of good quality clinical trial evidence to say that it works, right? Dear readers, you probably know the drill by now. There's some testimonial videos on the website, a grand total of 4 of them. With Prevalin, the manufacturers tried to pass off two methodologically poor trials about products that bore no relation to Prevalin at all off as clinical proof that it works. These guys don't even bother going to that amount of effort. There is no mention anywhere on the website about any trials at all. They don't even bother cursorily referencing the Principles and Technology bit:

 "NasalGuard AllergieBLOCK® uses patented technology that works on a simple principle of electrostatic charges: opposite charges attract each other.
AllergieBLOCK gel has a slight positive charge which attracts negatively charged allergens. Allergens like pollen, ragwort/ragweed, hay, dust mites, pet dander and house dust all carry a slightly negative charge. The allergens are blocked on contact. You do not inhale allergens, which means you don’t suffer from allergic reactions"

Now, it does seem to be the case from this PLoS One study that allergens are negatively charged whereas non-allergens are more likely to be postively charged. But until there's some evidence that a mixture of "Dl Water, Polyquats, Propylene Glycol, Octoxynol-9, Glycerin, other cosmetic grade ingredients and preservatives" can definitely produce some sort of nasal forcefield against the nasty pollen, and the manufatcurers can demonstrate an ability to spell properly, I'm not interested.

I'd also rather not apply something to my face which is going to actually attract the very things I am expressly trying to keep away it, thank you very much. Without evidence to the contrary, there is nothing to say that all of those positively-charged allergens which are supposedly now attracted to the gunk on your nose will get stuck on the gunk. A few allergens with probably make it through, given that nostrils are relatively big holes in comparison to how small the allergens are. So if anything, there is a potential that you end up with more allergens than you would have done had you not bothered applying it in the first place. Imagine Justin Bieber in a young girl's school, with only one or two bouncers for protection. a fair proportion of the screaming pre-pubescent youngsters are likely to get through the bouncers to plant a kiss or two on the fresh-faced child-adonis. (If I'm honest, I have only a vague knowledge of who Justin Bieber is, but I understand he's the Jason Donovan of modern time)

How much does it cost? oh, only the princely sum of £11.99 for 3g at Boots. ELEVEN POUNDS AND NINETY NINE PENCE for THREE GRAMS!!! Think of all the other things you could buy for £11.99.

Save your money, people.

Homeopathic Harms Vol 7: Professional Ethics

In February 2013, my friend @EBMScientist and I delivered a Newcastle Skeptics in the Pub talk entitled Homeopathy: Where's The Harm? As a follow up to this, we decided to write a series of blog posts expanding on a number of points we covered in the talk:

"Ethics is the science of morals, or moral philosophy. The principles, written or unwritten, that are accepted in any profession as the basis for proper behaviour are the ethics of the profession" -Dale and Appelbe's Pharmacy Law and Ethics

As you'll know by now, I'm a pharmacist. And as such, I have to be registered with the General Pharmaceutical Council (GPhC) to practice in the UK. I'm therefore governed by the GPhC, and in particular their code of conduct, ethics and performance, which has seven main points:

  1. Make patients your first concern

  2. Use your professional judgement in the interests of patients and the public

  3. Show respect for others

  4. Encourage patients and the public to participate in decisions about their care

  5. Develop your professional knowledge and competence

  6. Be honest and trustworthy

  7. Take responsibility for your working practices.

If I-or any of my colleagues- were to act against this code of ethics, we could be held to account by our regulator and reprimanded accordingly. Other healthcare professionals- Doctors, nurses etc- all have similar codes of conduct produced by their regulatory bodies. They all have one thing in common- that the patient is central to everything you do, and if a member steps outside this code of conduct, there is a clear and organized route through which complaints or concerns can be raised. This is as it should be: healthcare professionals have the lives of patients in their hands, and need to be held to account if anything goes wrong. As I've written before in this series, homeopaths don't have to register with a regulatory body and anyone can set themselves up as a homeopath with no training whatsoever. Whilst some 'professional' bodies exist in the UK, they have no regulatory powers so are unable to reprimand anyone if they receive a complaint.

Health care professionals who also practice homeopathy still have a duty to ensure that they abide by their regulatory body's code of ethics. In my opinion, however, it is very difficult to reconcile some of the clear guidance with homeopathic principles. Let's take a look at what I mean, using some selected points from the  the first two standards of the  GPhC's Code of Ethics July 2012 as a guide. (I'll cover the rest of the points in another post)

1. Make Patients Your First Concern
Under this heading, the GPhC states that we must "Make sure the services you provide are safe and of acceptable quality". Given the lack of high quality information that homeopathy works, we are unable to guarantee that such a service is of acceptable quality. You'll also know if you've read the rest of this series of blog posts that there is a lack of evidence regarding the harms- both direct and indirect- of homeopathy- so how could we guarantee that it is safe?

2. Use Your Professional Judgement In the Interests of Patients and The Public
There are a couple of relevant points here. firstly we are told that we need to make sure that professional judgement is not affected by personal or organizational interests or incentives. If you're going to charge for a homeopathic service on the side of your usual practice, then there is already a clear personal incentive to promote homeopathy.  We can minimize the possibility of such things affecting our professional judgement by making sure that we use evidence to guide treatment decisions wherever we can: evidence-based medicine is not perfect, but its the most objective method we have at the moment. And, as you'll know, there is no good evidence at all that homeopathy works. 

We are also advised to:

 "Be prepared to challenge the judgement of your colleagues and other professionals if you have reason to believe that their decisions could affect the safety or care of others"

I myself-and other pharmacists-have done this: I've spoken out about Tony Pinkus, for example, a pharmacist who endangers patients' lives by promoting unlicensed homeopathic vaccines or sugar pills to prevent malaria. In Nancy's latest blog post, she covered some of this, and I know Adam at Dianthus Med has also been discussing this point on twitter and his blog lately. Its clear-from our own professional guidance-that where patient safety is in danger, we do not protect our own- we need to report, speak out, and denounce those amongst our colleagues who let the profession down.

Homeopaths, on the other hand, seem to have no such obligation. We've been struggling to think of one single example of where homeopaths have spoken out against other homeopaths where patient safety has been endangered. In a conversation on twitter, for example, no homeopath would say that it was inappropriate for a homeopath to have said that a homeopathic remedy could have saved someone who died due to injuries sustained in a horrific gang-rape and disembowelment.  I recently asked some homeopaths on Twitter whether they would speak out against a colleague who put patients in danger. The answer I received from one was shocking:

"When its so easy 2 wink at 1's own sins, seems impossible 2 find judge orjury before whom 2arraign the 1st law breaker. KENT" (sic)- @22VenkateshN

Admittedly this particular homeopath that responded (he was the only one) has a reputation for obfuscation, but this reply seems to suggest that no, he wouldn't report, in case someone did similar to him. I tried to clarify : "so to clarify: you wouldn't speak out in case someone else did the same to you? A yes or no would suffice, thank you". The reply:

"some questions can't be replied with a simple 'yes or no'. for example_ 'are you still mad ?'"- @22VenkateshN


I'm not sure what he is trying to imply by asking about being mad, but we'll give him the benefit of the doubt and ignore any insinuations he might have been trying to make. What is staggering is the reluctance to admit that he would put patient care first and report a fellow homeopath in a situation. As a health care professional-and a good person- the code of ethics  becomes deeply ingrained in your being. Its second nature- and pretty obvious- that you would put the needs of a patient first. I persisted further,  trying to make it easy for him to agree that you would report a colleague: "It's very easy, if you work under clear ethical guidance. homeopaths do have that, right?: patient safety comes first: therefore yes, you would report and denounce a colleague who endangered it." Again, the reply astounds:

"Its not that easy, every one accusing everyone else would result. That's why I tweeted the appropriate observations of Kent"- @22VenkateshN

Wow. So it would seem- on the basis of this sort of conversation and the complete radio silence from any other homeopaths- that no, they wouldn't report or denounce a fellow homeopath because some sort of petty slanging match would ensue. Instead of a clear referral process to deal with complaints, accusations would be flying all over the shop- and one very, very important aspect gets forgotten: patient safety. 

I'd love to be proved wrong here. I'd love to think that medical homeopaths or pharmacists who also practice homeopathy would do otherwise, in accordance with their code of ethics. But I'm currently deafened by their silence. If I were one of the more professional, caring homeopaths who really did want to do the best for their patients, I would be utterly horrified and disgusted by some of the claims and actions of others, and I'd want to-nay I'd feel obliged to- speak out against them for the good of my own practice. I'd be embarrassed to be associated with them.

So here's your chance, homeopaths. Speak up against bad practice and drown out the previous deafening silence. Go right ahead: I'm listening intently. And while you're at it, please do take a few minutes out to respond to Adam's Challenge to the Society of Homeopaths too

 

Homeopathic Harms Vol 3: Poor Advice

And so begins the third installment in our Homeopathic Harms series, a collaboration between myself and @EBMScientist of the Evidence Based Skepticism blog. For this post, I have my lovely, wonderful friend @shandymarbles to thank for the idea and the action.

Indirect harms due to homeopathy can, as we're trying to cover in these posts, come in various different guises. In my opinion, there is none more dangerous than this: poor advice from homeopathic practitioners. 

To set yourself up as a homeopath in the UK, you don't need any medical background. You also don't need to register with any regulatory bodies or undergo any standardized training. Medical homeopaths, i.e. doctors who practice it on the side, are of course regulated by the GMC, but your common or garden variety homeopaths could basically be anyone.

And yet, they claim to practice medicine and give advice on your health. Scary stuff, in my eyes. And I can give you a specific example of how harmful this can be, because one of my good friends contacted a UK homeopath recently. This homeopath is, as is proudly declared on his website, an engineer by trade.

Under the pseudonym Stacey Slater (which apparently didn't appear to ring any alarm bells with the homeopath in question), my friend asked for help in treating bipolar disorder. She said she had stopped taking the medication prescribed for it because she was getting horrible side effects, and asked if there was anyway that homeopathic treatments could help her stay stable and avoid psychosis. There are a few things to note here: the question was very specifically asking if homeopathy could be used instead of conventional medicines, and was asking about avoiding psychosis- we're talking about serious symptoms here, not a vague sort of "could it help with me feeling a bit down" sort of question. The description of "horrible side effects" would immediately ring alarm bells to me- what sort of side effects, and how is she feeling at that time.

Here's the response I would have liked to have seen in a dream world filled with responsible homeopaths (actually, in my dream world there would be no homeopaths at all, but you know what I mean):

"Dear Stacey,
Thank you for your enquiry. I'm sorry that you've stopped talking your medication for bipolar disorder, and would like to advise you in the first place to speak to your GP first of all about the side effects you have been experiencing. You should also discuss with them your decision to discontinue your medicines, as stopping them suddenly may cause your symptoms to worsen.
Homeopathy may be a useful option to help treat some of your symptoms. However, I wouldn't recommend that it is used instead of your usual medicines, unless this is done with the agreement of your medical team. Once you have spoken to them, please do contact me again and I will be happy to discuss any homeopathic treatment with you then."

This response covers all bases. It makes sure that the primary outcome of patient safety is covered by referring them to their own healthcare provider, however its also helpful and leaves open the possibility of some homeopathic treatment as an adjunctive, complementary treatment. It does not suggest that homeopathy can be used instead of her usual medication.

Here, however, is the real-life response:

"To,
Dear Stacey Slater,
Yes I am happy to help you for your Bipolar Disorder and will try to restore your previous health. 
Recently, my grandmother has been treated for her 15 years long Bipolar disorder with only two weeks of homeopathic treatment. Now, my father-in law (Himself Medical Practishner) says she is 100% okay with homeopathic remedy and need not take any other medications. 
To help you, I need some more information, like; your physical, mental and spiritual condition.
1. Any skin diseases are you suffering from?
2. Do you have problem of thyroid dysfunction? hyper or hypo?
3. Diabetes?
4.High or low blood pressure?
5. Since how long are you suffering from Bipolar disorder?
6. Your family history, if any one in your blood relation have tuberculosis, diabetes, cancer or high blood pressure?
7. Your liking and disliking? Food,Drink, time and weather 
8. Your family life, etc..
Your detail will help me to prescribe best remedy.
Looking forward to your reply,"

There are a few things to note here, as I'm sure you can tell. This homeopath claims that they will "try to restore to previous health"- in other words, he is offering a cure to bipolar disorder. We've got some anecdotes in there, in lieu of actual clinical evidence, and an extraordinary claim that longstanding bipolar disorder can be cured with only two weeks of magic woo water therapy. Now, given that bipolar is, by its very nature (and name!) a relapsing-remitting disease of two extremes, there is no way that an anecdote could be used as evidence of successful treatment. Who’s to say his grandmother wasn't just going through a good period that just happened to coincide with taking a couple of week’s worth of homeopathic medicines. How do we know she wasn't using effective conventional medicines at the same time? Who's to say she even exists? I can't help but wonder about his grandmother's right to confidentiality as well- has she given consent to be used as an anecdote in his consultations with other patients?

Who is this father-in-law mentioned? If he is so happy with the treatment, why isn't he happy to be named, and why is he even commenting on the grandmother's treatment? What relevance does this have to this homeopath's practice? The advice given that she "need not take any other medications" is a clear indication that this homeopath thinks that the homeopathy he advises can be used to "cure" bipolar disorder on its own, as an alternative to conventional medicine. By trying to make it seem like the advice has come from an actual medical practitioner, the homeopath is clearly trying to give this advice more credibility.

Lets have a think about the consequences of this advice: Our Stacey Slater is reassured that she doesn't have to continue on with her conventional medicines. She responds to the email above, goes on to have a consultation with the homeopath online (which costs £50 by the way- we're not talking pennies here. £50 for an email exchange!) She slips into psychosis, or mania, or a deep, deep depression. Eventually, she can't take anymore and she commits suicide. This homeopath has directly contributed to her death by not advising that she sees her medical team before discontinuing her medicines, and by claiming that she can be cured by inert sugar pills instead of continuing on with effective, evidence-based medication

The problem is, we can't gather robust evidence on this sort of thing, as it would be too unethical to do good, clinical studies. Maybe Stacey hasn't mentioned to anyone that she stopped taking her medicines and she was under the "care" of a homeopath- how would anyone know that the death was caused by him? And even if they did know, they're probably too upset and shocked at that point in time to think about raising a complaint. Who would write up a case report to publish in the medical literature? Certainly not the homeopath in question, he's not going to incriminate himself, and her medical team have probably had little contact with her since she's been advised not to bother with them anymore. And so homeopaths can continue to claim that their treatment is "safe", because we just don't know the scale of these sorts of cases. 

The only bright side here is that, of course, my friend will most definitely not be taking this shoddy advice. She's well aware that homeopathy is a whole load of nonsense and just contacted this guy to see what the response would be. However, we have to wonder how many other emails he's getting, from people who are genuinely seeking help. And we have to wonder what's happening to them, and whether they are safe.As an interesting, and rather creepy, aside the homeopath started following my friend on Google plus and Twitter a couple of hours after responding to her. This is at best weird and unprofessional, and at worst, really quite frightening. I can't think of any healthcare professionals who would do such a thing, just randomly looking up a patient on social media and then following them after one consultation- what about confidentiality? 

Hxxx

Homeopathic Harms Vol 2. Where's the Evidence?

Here's the next in our series of blog posts following on from our SITP talk about the harms of homeopathy. This is a guest post written by the marvellous @EBMScientist of Evidence-Based Skepticism fame. Now, I'm going to be a bit bossy here and insist that, if you haven't already bookmarked her blog, you do so right this minute. Future blog posts in this series will just be posted on our respective blogs, but we'll be sure to post links to all of them so you don't miss any instalments. so, without further ado, I shall hand you over to @EBMScientist:

We often harp on about the evidence for homeopathy working or otherwise, and I’m not going to touch on that here, because it’s been covered beautifully by many more eloquent writers than me.  What you don’t often see though, is comment on the evidence for homeopathy doing harm.  In the last post in this series the lovely @SparkleWildfire touched on medicalisation, an indirect harm that’s very real but tough to quantify; but what about direct harms?  I’m glad you asked…

In conventional medicine, randomised controlled trials are the best kind of study we can do of a drug to see if it works and if it it’s safe.  What maybe doesn’t mentioned quite so often is that there’s an even *better* form of evidence – the systematic review.  These are produced when someone sits down to do the very tough but remarkably important job of finding every single scrap of evidence they can on a given topic, and pooling it all together to try and get closer to the definitive answer.  The result is a document that represents the best evidence possible for how well a drug (or anything else, for that matter) works, and how safe it is.

One of the biggest and most respected sources of these systematic reviews is theCochrane Collaboration, who cover all areas of medicine.  Happily, they also have a few reviews related to homeopathy, and that seems as good a place to start as any.  The most recently published is:

Homeopathic Oscillococcinum® for preventing and treating influenza and influenza-like illness

The authors searched multiple databases of medical literature, covering a time period dating back to the mid-60s and all the way up until August 2012.  That’s a lot of literature.  Out of all the results they found six randomised, placebo-controlled trials of Oscillococcinum that were similar enough to be directly compared.  Since we’re not really interested in efficacy in this review, I’ll skip straight to the safety part: out of these six trials, including a total 1,523 people, there was one reported adverse event.  One. It happened to be a headache. Let’s stop and think about that for a moment.

A good quality randomised controlled trial collects every single adverse event that happens to every single patient.  And the use of the term “adverse event” is very deliberate, because it includes absolutely everything unexpected and unwelcome that happens (and here’s the key part) whether or not it’s likely to be related to taking the drug.  That might sound counter-intuitive, but the reason is simple – we want to pick up every possible side effect of drugs, and sometimes side effects are…weird.  So it might sound odd to include as an adverse event that someone got hit by a bus, but what if the drug they were taking made them dizzy, or confused, or clumsy?  It’s not unreasonable to suggest that any one of those things could end up in getting you involved in a traffic accident.  So every single little thing is recorded, and once the trials is over you do some sums to work out the key question – are these things *more likely to happen in the people who took the drug*? If 20 people broke a leg but they were equally spread out among the trial groups then nothing further needs to be said; if 19 of them were on the drug being studied then there might be something to worry about.  The flip side of that of course is that if 19 were in the placebo group, you might want to wonder if the drug is (perhaps unintentionally) promoting better balance and co-ordination, for example (or if everyone in the placebo group was a keen but inept snowboarder).

Is that one single adverse event out of over 1,500 people taking Oscillococcinum starting to look fishy yet?  What about if I drop in the snippet that some of the people involved (327, to be precise) took the remedy every day for four weeks, to see if it stopped them from getting flu in the first place?  How many times in four weeks would an average, healthy person experience something that you could call an adverse event – a headache, a tummy upset, indigestion, a strained ankle, a touch of insomnia?  I’ve had three of those things in the last 24 hours, and I wouldn’t say I’m a particularly remarkable individual.


So hopefully you can see from this that there’s simply a huge, yawning hole in the evidence about safety in homeopathy.  There are ways and means to address this (though they’re far from perfect), and I’ll address one of those in my next post in this series.

Homeopathic Harms Vol 1: Medicalisation

In February 2013, my friend Nancy and I delivered a Newcastle Skeptics in the Pub talk entitled Homeopathy: Where's The Harm? As a follow up to this, we've decided to write a series of blog posts about a number of points we covered in the talk. Here is the first:   

Doctor's appointments: often you feel like you're in and out before you know it, and they can't get you out the door quick enough. They have a target number of minutes to spend with each patient, and sometimes you can feel like they don't have as much time as you'd like to discuss all the things you want to with them.

There is, then, one aspect of homeopathic practice which can be superior to that of conventional medicine: the consultation. A homeopath might spend an hour or more assessing each individual, not just asking about particular symptoms but about their personality as well, how they think and feel about the world. I've never been to see a homeopath, but I'd imagine this is really valuable to a patient, particularly those with minor mental health complaints. I know myself that when I've been to see a good GP who I feel has really listened to me, I leave feeling a bit better already. 

I suspect that the consultation itself may be part of what provides benefit to patients, rather than the sugar pills that are given out at the end of it. I'm not aware of any evidence that compared individualised homeopathic treatment to the OTC stuff though, which would be the only way to tease out and quantify any benefit from the consultation.

So what's the problem here? If a consultation with someone who appears to listen to you and care makes you feel better, where's the harm in that? The sort of subtle, indirect harms that we'll be discussing in this series of posts are often theoretical and would be very, very difficult to assess via hard, clinical evidence, so you'll have to bear with me while I discuss them with you and see if they make sense at the end of it. Consider the following story: 

Imagine I'm quite an anxious person (in actual fact I am, so it doesn't take that much imagining to those who know me). Imagine I'm particularly anxious at the moment because I maybe have a public speaking event (something like Skeptics In The Pub, say!) to deliver in a few week's time. I might be finding it hard to sleep, I find I'm worrying about it quite often, and getting some physical symptoms- my heart is beating quite fast at times, say, and my stomach hurts at times, but it's nothing too serious.

I go to visit a homeopath (admittedly, this would be an unlikely thing to do if I was actually talking about myself) who takes time to discuss with me my problems. I get on well with them, and feel like they are really listening to me. During the discussion, I find that vocalising my anxieties helps me to rationalise them and my fears are allayed somewhat. Just the act of talking about it makes me feel better- in other words, the homeopath is delivering a talking therapy service to me. By the end of the consultation, I'm already feeling more in control of my anxieties, yet I'm still given some tablets to take home, and I dutifully follow the instructions I'm given.

As I've discussed elsewhere, there is a stigma about mental health issues. This also, unfortunately, extends to talking therapies too. Its quite likely that some people would be happier to declare "I'm seeing a homeopath" than "I'm seeing a counsellor" in front of their friends or acquaintances. The handing over of the sugar pills at the end of the consultation will no doubt suggest the talking bit is more "justified", and they can convince themselves that they're not mad, or the sort of weak person who would have to resort to a talking therapy. And thus, the stigma is reinforced. Talking therapies shouldn't be something to be ashamed of. You don't need some inert sugar pills to justify and hide the fact that, now and then, you just need to be able to talk to someone about your problems or feelings.

There are wider issues with this kind of thing too. The visit to the homeopath has made me feel better. I've been to see someone, left with some pills in my hand, and I've improved, reinforcing the fact that I feel better when given something to take. Let's say that in the next few months, I feel a bit rubbish because I've had a bit of a cold and I'm left with a cough that's been there for a couple of weeks. I go to see my Dr, who tells me that my chest is clear, and the cough should clear up of its own accord. However, I've expected to get something out of the visit- I don't want to leave the surgery with no pills in my hand, as I know that last time I left a consultation about my health I was given pills at the end of it and I felt better. It's left to the Dr to explain to me that I don't need antibiotics, and this can be a notoriously difficult thing to do. Some Drs might relent and give me a prescription for an antibiotic, contributing to the catastrophic situation we're in now with antibiotic resistance. If the Dr doesn't give me a prescription, I'm left with a bad taste in my mouth and a bit of mistrust in the conventional health care system. 'Next time I'm feeling ill', I think, 'I'll go back to that homeopath. They take me seriously because they gave me pills'.

And so the cycle goes on.... 

Hxxx

 

The Burzynski Connection

There's an event coming up in Newcastle that I'm really looking forward to. There's a lot of excitement about Street Spice, a street food festival coming up at the end of February, dedicated to celebrating world spices and food. And, to make it even better, its being held to raise money for charity- Brain Tumour UK.

So how does this fantastic event cross over into the murky realms of Dr Burzynski's work? Many others have covered the Burzynski debacle much better than I would ever be able to do. If you do want to know more about it, I recommend starting at Josephine Jones' blog, as she has a pretty extensive list of her own blogposts, along with those written by many others in the skeptical community. 

The event is being held in memory of Kuly Ral, who died of a brain tumour. I know very, very little of this chap, except for the information given on the Street  Spice website:

"Kuly Ral made up one third of super Urban-Bhangra group RDB when his devoted family and Three Records label colleagues discovered that he had a terminal brain tumour. Although Kuly sought to get treatment in America for this, it was not to be:"

It's a very sad fact that my heart sinks every time I read or hear the words "treatment in America" for cancer. I can't help but dread that it means Burzynski's clinic, and with a bit of digging, it seems that in this case it was indeed Burzynski's clinic that Kuly was receiving treatment from when he died. I know nothing of the circumstances of his treatment, or how he died, but given that Burzynski supporters have been known to use the names of dead patients as testimonials for successful cancer treatment, showing no respect whatsoever to the deceased or their loved ones, I'm frankly amazed that Burzynski and his cronies aren't shouting from the rooftops about how they were treating such a high profile Bhangra personality. (In the past I have emailled the Burzynski Patients Group to ask if they were going to take down the name of a patient who had been dead for months. Unsurprisingly, I received no reply.)

I'm making no judgement here on anyone who would choose to go to Burzynski. I'm also still really happy to be going to any supporting the event, as it's raising money for Brain Tumour UK rather than for Burzynski himself. The person who I judge the most in this situation is Burzynski himself, who seems rather happy to be making his millions providing unproven treatments, deceiving patients, making shoddy movies, and claiming an FDA conspiracy, when he could quite easily silence his critics-and the FDA- by simply publishing the results of his "clinical trials". If he spent half the time he spends on shameless self-promotion by sitting at his desk and actually writing up some results, then at least he could back up all of his miraculous claims, and all of us who are critical of him would have to sit down, shut up, and happily accept that there is a cure for cancer on the market.  

So here is my own tiny little memorial to Kuly Ral. It takes the shape of a simple plea, and goes thus:
 

"Dear Dr Burzynski,
Please publish the results of your trials.
Its the least you could do"

Cherry picking the evidence

A good friend of mine is really into running, and has many half-marathons, kilomathons, and marathons under his belt (at least one of which was in a very hungover state). He is taking a sour cherry supplement, which has led to some heated debate about whether or not it works.

He eagerly googled, to bring up some small studies of the effects of sour cherry juice on pain after a marathon. More animated discussion took place. He seemed to think that the very existence of some studies meant that the stuff would definitely work:  So I thought this would be the perfect place to assess what evidence there is for sour cherry.

It would seem that there are several different types of cherry, sweet and sour. It is the sour, tart varieties which appear to be of interest in exercise products such as this. And these things are pretty expensive. 

My first point: the evidence appears to be looking at juice, not tablets. There is nothing to say that any benefits you might get from a juice will also be present in a tablet- think of garlic, for example, where allicin, the active ingredient, is mainly lost during the processing required to make a garlic supplement. 

My search strategy begins with my old friend Embase. eagerly, I find sour cherry in the database and search it, only to get 9 results. When I limit it to humans, I get 1 result, and that is assessing its effects on sleep quality, so is nothing to do with exercising.

And so, I move onto Medline, in which I find a grand total of 2 studies looking at the effects of sour cherry juice in recovery following exercise. 

The first study has 20 recreational marathon runners in it, so its tiny, and far too small to be able to draw any reliable conclusions from. Whilst it seems to show some positive results, with significant reductions in isometric stress, inflammation, and oxidative stress, there is no indication of how relevant this is clinically.1. Would I actually feel better after a marathon as a result of this? Is this increase in recovery of muscle function actually going to make a difference?

The second study has a grand total of 14 male students in it. It's randomised and placebo controlled, but again, to small to be of any interest. This study found that strength loss and pain were reduced in the cherry group, but relaxed elbow angle and muscle tenderness were no different. 2

There are a couple of other little trials dotted here and there are well. But they're all too small to suggest that there is any definite effect. Moreover, there is no information on the safety of such products. Any trials only apply to cherry juice, and can't as yet be extrapolated to cherry supplements such as tablets or capsules.

Whilst the preliminary evidence looks juicy, it's certainly not enticing enough to tempt me to pop my marathon cherry. 
 

I'll stick to my favourite types of cherries, if you don't mind, namely those that are steeped in sugar and  encased in pastry.

Search strategy: Embase:*sour cherry [Limit to: humans] Medline: (sour AND cherry).af OR (tart AND cherry).af [limit to: humans]

References: 1. Howatson G et al. Influence of tart cherry juice on indices of recovery following marathon running. Scandinavian Journal of Medicine & Science in Sports, 12 2010, vol./is. 20/6(843-52), 0905-7188;1600-0838 2. Connolly D et al. Efficacy of a tart cherry juice blend in preventing the symptoms of muscle damage. Br J Sports Med 2006; 40: 679-683

Big Pharma & Big Homeo: Titans will clash, and ducks will die.

There has been much talk of homeopathy in the media in the past few days. I want to pick up on one point that is being brought up by homeopathy believers everywhere at the moment in response to any criticism.
 

"But Big Pharma has many problems! Just read Bad Pharma by Ben Goldacre!"

There are a few reasons why this is an utterly terrible argument.

The Logical Fallacy

This is not a two option scenario, so this is a false dilemma. homeopathic supporters are attempting to suggest that because Big Pharma has its problems, homeopathy is a better alternative. But here's the problem: These are not the only options in the world. Big Pharma does have massive, endemic problems, but that bears no resemblance to whether or not homeopathy works. Even if there were no evidence that any conventional medicine works ever, there still wouldn't be any evidence that homeopathy works either.

There's definitely an element of a "You too!" fallacy here as well. Big Pharma has its problems, but this is no reason to expect anything less than impeccable ethics from any other sector. 

The Misleading Rustic Image

Homeopathic manufacturers would very much like us to have a fluffy, warm, reassuring image in our heads of some nice, compassionate people making a tincture from plants, shaking it in a special way, and making a nice, safe medicine from it. In actual fact, the image is rather more grubby, with diseased body parts, conventional medicines, and limbs being used in the manufacture. Oscillococciinum, supposedly the most popular homeopathic remedy for flu, involves killling a muscovy duck and using its heart and liver to produce a mother tincture. I wonder if folks who are against animal testing and the likes in the pharmaceutical industry are aware of this fact? For the purposes of this blog post, lets call our duck Dave

A Muscovy Duck Named Dave

A Muscovy Duck Named Dave

Homeopathy is not usually made by ethical practitioners in their kitchens. And frankly, if it were, i'd be pretty concerned about hygeine etc and would be wanting inspectors to go round to check it. Its mainly made by large companies who are ultimately concerned with profits. In fact, until very recently, New Era homeopathic products (ooh, sounds all new age-y and nice and hopeful, doesn't it?) were made by Merck (Sounds-and indeed is- a pretty damn large corporate pharmaceutical company).

We also know from the FDA that homeopathic manufacturers can be less than meticulous to say the least in their standards. Broken glass? That's not a problem, just leave it there on the production line, no one will mind. More info on this story can be found at The Quackometer
 

The Massive Mark Up Margins

Pharmaceutical companies spend a HUGE amount on research and development of new drugs. First they have to employ people to find a new chemical entity, whether that be in the rainforest or in the lab. Then they have to find out if it works, which involves a huge amount of lab work. If that seems postive, they then have to do trials, which is hugely expensive. At any of these stages, there is a huge likelihood of failure and it is a very, very small minority of new chemical entities that actually get through to a stage where they can be marketed. At that point, price margins can be pretty damn high, which is in part to cover all of those R&D costs. Yes, there are also huge profits that are made in the pharmaceutical industry, and there are all the associated problems covered in Bad Pharma. This is certainly not an ideal scenario, but at least at the end of the day we are left with some drugs that work.

Big Homeo, on the other hand, puts little-if any- funds into research and development. If it did, we would have a load more trials than we do now. The work in drug discovery has been done for them, by Hahnemann et al who have written Materia Medica and the likes. So not many outgoings there then.

What about the costs of the ingredients? Well sugar is cheap, as is water. And even if your mother tincture comes from a valuable substance, you can make a hell of a lot of homeopathic medicine from it. Here is the recipe for Boiron's Oscillococcinum (according to Wikipedia)

  • Active ingredient: Anas Barbariae Hepatis et Cordis Extractum (extract ofMuscovy Duck liver and heart) 200CK HPUS 1×10−400 g[9]

  • Inactive ingredient: 0.85 g sucrose0.15 g lactose (100% sugar.[10])

So to make 1 gram of oscillococcinum, you only need 1×10−400g of extract of poor Dave's heart and liver. This is a ridiculously tiny amount, and as you will hopefully now know, there will be VERY VERY VERY little chance of any of Dave's molecules remaining in the resulting solution. 

I have no idea how much the heart and liver of Wor Duckie Dave would weigh. I also have no idea how much an extract made from him would cost. I'm guessing, however, that the number of packs of homeopathic pills I could make from his unfortunate organs would mean it is very, very lucrative, and I would be laughing all the way to the bank with my profits were I a company with few scruples about selling nonsense to vulnerable people. 
 

The Pointlessness Of It All

Poor Dave. Dave has been killed to make a medicine. However, none of Dave's molecules actually make it into that medicine in the end, because it has been diluted to such extremes. There's no memory of Dave in the water or sugar left in the medicine, only in the minds of his little duckie friends and his family who miss him dearly. There are huge outcries about bear bile being collected for use in chinese traditional medicines- why is no one speaking out for Dave?

At the end of the day, evidence suggests that after all the sacrificing, succussing, potentization, and all the other fancy words they use for magic rituals, what we are left with is an inert sugar pill.We could have saved ourselves all the bother, and saved Dave's life, if we just made an inert sugar pill in the first place and didn't bother with all the pretending. 

Won't anyone think of the ducks?

Homeopathic Vaccines: An impassioned challenge

Its been a hard week for us pharmacists. To be honest, I'm sort of at a loss as to where to start, but the most obvious place is in London, at a pharmacy called Ainsworths, where a man called Tony Pinkus works.

Ainsworths is a real life, registered pharmacy, and Mr Pinkus is a real life, registered pharmacist. The main problem with this story, however, is that Mr Pinkus is not selling real life medicines to his real-life patients, and in doing so he is putting peoples' lives at risk.

In an expose by BBC News, Mr Pinkus has been caught recommending by email that homeopathic whooping cough "vaccines" are used instead of getting a proper, real-life vaccine. In the email exchange, Mr Pinkus is careful to express his recommendations as personal choice, and this will presumably form his defence. However in my eyes this is absolutely no defence at all. For years, the pharmacy profession has been slowly but surely promoting ourselves as the trusted healthcare professionals that we are, therefore we have a responsibility to be aware of the position of high esteem we may be held in by the public. We have a duty to know that any 'personal recommendations' we make will constitute medical advice in the eyes of many patients.

Mr Pinkus also states that the patients' GP "will undoubtedly throw a lot of fear in your direction". Now, I remember having it very firmly drummed into me that we need to be careful in our role as a pharmacist not to break the trust a patient has in their GP. Obviously, this doesn't mean that we should cover up any mistakes or errors from them, but it does mean some quite careful wording as enquiries arise. Mr Pinkus is clearly and flagrantly attempting to reduce the trust this patient would have had in their GP's advice and showing a shocking lack of respect to the GP in question, despite knowing absolutely nothing about their practice. I wonder if he has ever considered the longer term implications of such wording. "oh, the GP has told me I should be worried about this lump in my breast, but of course they'll just throw a lot of fear in my direction", for example.

Mr Pinkus has also been investigated by pharmacy's governing body before. In 2006 he was caught selling homeopathic travel vaccines. In 2009 he was investigated by the PRSGB for selling homeopathic swine flu vaccines. In 2011 he was investigated for marketing homeopathic travel vaccines again and malaria prophylaxis. In each case the regulator has let the public down by not taking decisive action over a pharmacist who is regularly and routinely endangering lives, all in the name of "free choice". I don't think i actually need to point out the serious indirect harms that could happen if a patient were to use a sugar pills to prevent malaria, or yellow fever etc. 

Free patient choice is not a defence when patient's lives are at risk.

I've been asking for a response to the case from the GPhC on twitter for a few days now and have heard nothing. I'm also wondering why the story hasn't appeared in some of the major pharmacy news publications (Chemist and Druggist, I'm looking at you).  

This story has really angered me, and i can pinpoint exactly why. I've written before about the constant fear I and many other pharmacists feel whilst at work- the fear that one little throwaway mistake could have huge implications for a patient's life. And there's an added, secondary fear that, if something goes wrong, a regulator could step in and your whole livelihood and career could be at stake. This is a fear that all good pharmacists carry to some degree, and it  can weigh heavily on your life. And yet here strides Tony Pinkus, who waves away any notion of patient safety, and flagrantly (I know it's the second time I've used this word, but it seems to fit the situation rather well) ignores the standards of the regulatory body without, apparently, a care in the world.

Well, I'm taking to heart the GPhC standards for conduct, ethics and performance, one of which is:

"Be prepared to challenge the judgement of your colleagues and other professionals if you have reason to believe that their decisions could affect the safety or care of others"

So this, Mr Pinkus (and any other homeopathic pharmacists who would recommend a homeopathic vaccine) is me challenging your decision, because I believe it most definitely could affect the safety and care of others.

UPDATE: Chemist and Druggist have now covered the story (registration required). The comments section is interesting, with a couple of folk showing a staggering lack of knowledge about homeopathic products.
The Pharmaceutical Journal have also covered the story (registration required). This includes some interesting tidbits, like the fact the MHRA have been investigating 20, yes TWENTY unlicensed medicines being sold on the Ainsworth's website. And the post script is particularly interesting:

'Some of you have noticed that the pertussin products highlighted in the BBC investigation are still on sale. We've clarified this with the MHRA - a spokeswoman confirmed that the MHRA asction (sic) was against products labelled as vaccines. 
"Substances and products labelled with the names of serious diseases such as pertussis are part of a wider, ongoing investigation," she said. So it's watch this space for the outcome of that branch of the investigation."'

This wider, ongoing investigation sounds very interesting indeed.