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.

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

Advert Annoyances Vol 1: Senokot

Welcome to the first installment in what is likely to be a very sporadic series. As you've probably guessed by now, I have a tendency to be irrationally annoyed by small things, especially when it comes to medicines. Adverts for OTC meds can be a prolific  source of cringes. Even leaving aside the requests for "you know, that one on the telly, where there is a guy and a dog and its a blue box", there will occasionally be a little phrase or image used in these adverts that makes me stop and seethe a little.

The current one at the moment, is Senokot. I can't find a link to the new advert, but when I do, I shall pop it in here so you can see for yourself.

There's all sorts of naturalistic fallacies going on, but that's not what annoys me the most. It's the phrase " works in harmony with your body" that i'm finding hard to stomach (geddit?)

Put simply, senna works by irritating your bowel. Your bowel notices that it is being hurt by something, therefore starts contracting and producing secretions to hastily get rid of the thing hurting it.  This then might make you poo, but from your bowel's point of view that's a side issue- its just trying to protect itself from harm.

That doesn't really sound to me like "working in harmony". You might as well say that fire works in harmony with human skin to make you walk faster- in actual fact, one is just out to hurt the other, meaning something else happens as an unintended- but sometimes useful- consequence.

Hxxx

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 websitewww.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

Coldzyme: a result of real science being left out in the cold

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. 

Image source: http://www.sourcewire.com/news/84612/by-cod-now-your-plate-of-fish-chips-could-stop

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

Stick a label on this...

Since before I began my career in pharmacy, there has been a drive to get pharmacists "out of the dispensary", in a bid to better utilise their medicines expertise with patients. This sounds great- we have unique clinical knowledge and skills that we have always wanted to use more to make sure medicines are used effectively, safely and efficiently.

For a patient to use a medicine effectively, they need to actually have it in their possession. There is no getting away from the fact that dispensing prescriptions remains a large part of the community pharmacy business model (leaving aside concerns about the contract and reimbursement etc for now). However, dispensing remains the frumpy friend of the drop dead gorgeous, charismatic clinical side of pharmacy. It seems that these days it is seen as repetitive drudgery: the smartie counting and label sticking that we hear so much about. It is, in short, a waste of pharmacists' time, and is something the profession as a whole seems to unquestioningly want to leave behind.

I believe, however, that it is pharmacy's unique selling point. Its only through dispensing that a prescriber's directions are translated into reality. We can prescribe and advise on the most efficient use of medicines imaginable, but if the patient doesn't physically have the right medicines and know how to use them, all of that is pointless.

Yes, there are ways to reduce the pharmacist's input in the dispensing process. There are robots, accredited checking technicians etc. But a prescription still needs to be clinically checked- and that requires the unique skills, knowledge, and abilities that only pharmacists have.

But lets say we step away from dispensing and move in a purely clinical direction. We sit in a room and do reviews of patient's medicines, answer queries, prescribe medicines, monitor and screen patients. Does this sound familiar to you? It sounds to me like the sort of thing a GP does. So, why do pharmacists exist? What do they add to the healthcare picture? Doubtless such pharmacists would be useful, but the profession would become more nebulous, the edges of our role more diluted and less defined.

In my eyes it is our practicality, our ability to supply essential medicines in a safe and effective way to patients that defines us as a separate profession. That, to me, doesn't have to just mean sticking labels on boxes, and doesn't mean that the profession has to be at a standstill. I just think that we need to stop putting ourselves down and accept and be proud of our role in supply. For years we have been declaring ourselves as able to provide new and more clinical services- and we can. But we need to make sure that we define and build on our niche to give us the solid foundations we need to start branching out.

We pharmacists are an interface. Our role is as go-between, and a bloody important role it is. We are go-between a patient and their GP or their consultant, or whoever. Or, we are a go-between the patient and complex medicines information- we can, crucially, convert difficult to understand evidence into patient friendly terms. We can explain what they read in the paper or on the internet, what the directions of a reducing dose are, help them to navigate through the overwhelming choice of medicines over the counter. We are a go-between the drug manufacturing plants and the patient's bathroom cabinet. And the thing that underpins this role is our accessibility. And the reason we are so accessible is because- wait for it- we dispense prescriptions.

If you ask me (not that anyone will), we need to stop thinking of dispensing as the poor relation and see it for just how useful it is.

Hxxx

Is XLS-Medical Fat Binder worth its weight?

Oh Omega Pharma. Once again you provide me with some juicy blog fodder.

XLS-Medical Fat Binder has been on my radar for some time, but I haven't really gotten round to writing a blog post on it or taking a proper look at the evidence. However, prompted by a bit of real-life work I've just been doing, I've been doing some digging.

So what is it? Well, it contains something called litramine, which appears to be a cactus extract. It supposedly binds onto dietary fat and stops it being absorbed. Sounds suspiciously similar in action to orlistat, a licensed medicine. However, XLS- Medical Fat Binder is instead marketed as a medical device.

Here's what the company have to say on the matter:
  
"What is a medical device and how does it differ from traditional medicine? 

• A medical device is designed to work on or inside the body - either temporarily or permanently. Its main aim is to prevent, diagnose, monitor or treat diseases. 

• The key difference compared to traditional medicines is that medical devices work mechanically as opposed to pharmacologically. So it works alongside or with your body rather than affecting the chemistry of the human cells."

I think what they've missed out here is this: "If we sell this product as a medical device we just need to fill in a form and send it to the MHRA rather than actually having to bother proving that it works so YAY LETS JUST DO THAT!!." It would seem pretty bizarre that orlistat, which is also not absorbed from the GI tract and which also prevents absorption of fat from the diet is regulated as a medicine whereas this product isn't.

What of the evidence? Well, Omega Pharma once again provide us with a list of the most vague references ever seen, making it virtually impossible to find anything to back up the results they are shouting about. As references go, just writing: "In vivo, 2-armed, randomised, placebo-controlled, double-blind study, conducted in Germany, 2009" is, as someone so succinctly put it on Twitter, the equivalent of saying "This one time, at Band Camp...". These studies don't appear to be published in any peer-reviewed medical journals, so there is no way to verify the results from them. Oh dear.

Well, two can play that game.

Of course, not one to rely on the manufacturers alone, I performed a literature review to see if there was anything else out there. And there is: all of one study. And to be honest, the results are promising. Whilst there is a link to this bit of evidence on the XLS Medical website, its hidden away in the tiniest of tiny footnotes, which seems a bit odd really, given it seems to show that Litramine actually works. The trial appears well desgined (double-blind, randomized, placebo-controlled), and whilst not massive (n=123), it isn't as tiny as the usual sort of guff that can be purported as evidence. Patients who used Litramine lost an average of 3.8kg (+/- 1.8) compared to 1.4kg (+/- 2.6) in the placebo group (p<0.001), which actually seems rather encouraging.

Hang on though, let's not all jump for joy and throw away the salad leaves just yet. Patients in the trial had a hypocaloric diet plan and exercise regimes. The trial only lasted for 12 weeks, so is pretty short- term. and of course its still quite small, and the results would need to be replicated in further, larger, well-designed trials before we could know for sure.

And here's the big problem with it. the study medication is described as:

"Litramine IQP G-002AS is a natural fiber complex derived from Opuntia ficus-indica, enriched with additional soluble fiber from Acacia spp.IQPG-002AS is standardized for its lipophilic activity and has been shown to reduce the dietary fat absorption through GI fat binding." 

- Grube B, Chong P, Lau K, and Orzechoski H. A Natural fiber complex reduces body weight in the overwieght and obese: A double blind, randomised placebo controlled study. Obesity 2013. 21: 58-64

 

The study participants were given 500mg tablets three times a day. However I can't see anywhere on the XLS-Medical website that actually tells me how much litramine is in the tablets- it could be 5mg or 500mg. . So whether or not we can apply these promising results to XLS-Medical, we simply can't say.  

 

And wahoosa are these things are expensive. £39.99 for a months supply? That's six and a half hour's work at minimum wage.

Hxxx

Common Community Pharmacy Annoyances

It's funny how variable working in a community pharmacy can be. Nowadays, I locum here and there, and I tend to really enjoy it. I usually do evening shifts, so you have an hour or two of bedlam, followed by several hours of blissful calm and quiet, where you get to sort out all the outstanding things, do lots of other bits and pieces like checking owings, controlled drug stock levels, and cleaning. I usually also end up having bizarrely deep and meaningful conversations about life, love and philosophy with whoever I am working with. Usually when I leave a pharmacy it is as clean and tidy as possible, I've sorted out what I can, and have left notes for anything that I haven't been able to deal with fully.

I say all this because I lately did one of *those* locum shifts. The ones where it is constantly busy, no prescription is straightforward, the fax machine isn't working, and you seem to have to deal with every problem under the sun. On this particular locum shift, I think my colleagues and I encountered every single type of category of impolite customer possible in a 4 hour shift.

So, because the only way that we can cope with such things is to laugh about them, and because I fancy a self-indulgent rant, here is my compilation of the things in pharmacy that annoy me and that happened in that locum shift.

The Mythical Taxi
Some people do get a taxi to their local supermarket. I have done it myself. But it would appear that taxi companies must have an amazingly lucrative trade in ferrying people to and from pharmacies if the frequency of use of the phrase "Can you do it quickly please, I've got a taxi waiting" is anything to go by. These are not, as far as I am aware, magic words that will somehow warp the time-space continuum so that I am able to dispense and check a twenty item prescription in a mere matter of seconds. Whether or not you actually have a taxi waiting will simply mean that your prescription gets put in the queue in the same place it would have done anyway, and you will wait the same amount of time as you would have done anyway. Needless to say, I suspect that many of these taxis don't actually exist, but merely a tactic used by some people to attempt to "hurry their prescriptions along".

The Dry Chesty Cough
"What sort of a cough is it?" "Well, its a dry, chesty cough."
No, no it isn't. It's either dry or its chesty, its not both. And either way, there is little point buying anything for it given that there is no evidence that any cough medicines work.

The Evil Eyes
Glaring at me continuously for the entire time that I am dispensing your prescription will not in any way speed up my work, and in fact may have the opposite effect as I am more likely to lumber around in a sloth-like manner just to annoy.

"I Need To Be Somewhere"
At 6:05pm, a woman handed in her prescription of 4 items. At 6:07pm, having spent all of two minutes repeatedly sighing and tapping her feet, she asked to speak to the pharmacist. Off I went, leaving a prescription half-dispensed. She demanded to know how long her prescription was going to be (the one I left to go and speak to her), because she needed to be somewhere. I gave her an estimation, told her I was doing it now, then went off to complete it. She then asked to speak to me a further three times to find out how long it was going to be, each time meaning it would take a little longer. "But I need to be somewhere at 6:15!!" she told me each time. I handed her the prescription at 6:12pm, thanking her for her patience. She then proceeded to rant for several minutes about how long the prescription had taken and how it meant she was going to be late and she had to be somewhere at 6:15. She eventually stopped complaining at exactly 6.15, and I returned to the dispensary, whereupon I noticed out of the corner of my eye that she had taken the time to hang around to complain about how long it had taken her to get her prescription to some of her friends who she just happened to bump into in the shop. Goodness only knows what time she actually left.

Invading Privacy
If you have ever picked up a prescription from a pharmacy, you will have probably been asked to confirm your address. This is so that we can make sure that you actually get the correct prescription. This is not because we are evil assassins or because we want to sit in a bush outside your house and spy on you- we really don't- and you're address is written on the prescription so if we wanted to we could anyway. On this locum shift, however, we were accused of invading someone's privacy for asking for this information. "I don't need to give you that information!" he declared. The counter assistant advised him that this is a routine question to ensure that we give out the correct prescription. But this wasn't good enough, and he wanted to speak to someone in charge. Off I went into the breach. I told him that he could come into the consultation room to give us his address so no one could overhear, but this was "an inconvenience", apparently.

By this time, he was shouting and other people in the queue were staring at him.

Again, I advised that we routinely confirm the address to ensure that the correct prescription is given out.

He decided to prove that the prescription was his instead by giving out his name, date of birth, and by telling me every item that was on the script. Loudly. One of which was sildenafil (Viagra).

Magicking Up Medicine
Me: "I'm sorry, we don't have that item in stock. There is a manufacturing problem on it, so we can't get it from our suppliers"
Patient: "But I need it"
Me (in head): "Oh I see. Well if you can hold on a few minutes, I'll just nip round the back into our large pharmaceutical manufacturing factory, dig out the raw materials, and whip you up a batch right now then"
Me (in real-life): "I understand, but I'm really sorry, we can't get any in at the moment."
Patient: "But I need it."
Me: "Where is the nearest wall please, so that I can bash my head against it repeatedly?"

The Expert Customer
I'm advising a patient about how to manage their child's teething problems. Another customer waiting in the queue decides to chip in with "Those Nelsons Teetha sachets are really good." (Nelsons Teetha sachets are homeopathic, therefore contain nothing of use and have no pharmacological effect). From then on, I (and my many years of training and experience) might as well not exist, as nothing I say can steer the patient away from believing that Nelsons Teetha are simply THE best thing since sliced bread, and in her eyes I'm obviously a terrible pharmacist for not recommending them immediately.

Impatient Patient Questioning
You ask the patient all the usual questions. They're all answered with a loud sigh, vacant eyes, and a disinterested "yes" or "no" at all the bits that they think are right. I could be asking anything, and I'd get the same response. So sometimes, I like to mix it up a bit and throw in a question they're not expecting. If its something like Nytol or a codeine containing medicine, I'll ask "Do you take it regularly?" to which the response is usually a bored yes. In which case, I advise them that I can't sell them any, then swiftly duck for cover when they inevitably throw things at me.

A variant You ask the patient if they are taking any other medications, to which they sigh and say "no". It's only when they're about to hand over their money that they a) ask what would happen if they were taking medicines, then confess, or b) whip out an inhaler and proceed to take a couple of puffs right in front of you after they have just told you that they don't have asthma or COPD.

Specifics
The patient can inexplicably only take one or two brands of generics for a product. You are, of course, expected to telepathically know this and dispense the right one, and woe betide anyone who doesn't. Now, I am entirely understanding of cases where a patient has specific requirements for one type of product- maybe an allergy to an excipient, say. But when there is not reason for it, and the patient is shouting at you for not giving them "the right medicine" despite them at no point telling you what "the right" one is, then I tend to feel a bit put out.

Mobile Misery
Now I am known for being attached to my mobile phone. However, one of the most annoying things when working in retail is having to deal with customers who refuse to hang up theirs whilst you are trying to have a conversation with them. Over a pharmacy counter, we often need to give detailed counselling, and of course we need to ask a lot of questions. I can't really do that if you are also listening to so-and-so discussing who was drunkest down the pub the other night. At this particular locum shift, I had to attempt to explain that there was an item owing on a prescription to a chap who was having just such a conversation. The icing on the cake was when he said to his phone-based friend "Hang on, I can't hear you, this stupid woman keeps talking about something and wont give me my prescription". Needless to say, despite me explaining the owing and handing him an owing slip, he returned a few minutes later demanding to know where the missing item was. This "stupid woman" then had to patiently and politely re-explain everything I had already told him.

How do I deal with situations like this? Politely, professionally, and with a smile on my face. I might have a bit of a rant and a laugh about it later in the back of the pharmacy, but outwardly in these situations I remain as calm as possible and attempt to be as helpful as I can. I've had many years of practice. The worst thing about this shift was that I was working with a new counter assistant and a newly qualified pharmacist, and I could see their morale slipping minute by minute. Their shoulders slumped, their smiles became more forced, and I found myself desperately trying to reassure them that this is just how some days go. Of course, we pharmacy types do make mistakes on occasion, and inconveniences do happen. I can understand that, when it comes to health, people can be scared and anxious, and that can come across as aggression. It is my firm belief, however, that a little bit of kindness and manners get you everywhere, and I am always much more likely to respond positively to calm and polite customers than those who default to outright rudeness, although I will do what I can to ensure that I help them all.

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

Customer walks into a pharmacy...

...and chooses what medicine they want to buy, before taking it to the pharmacy counter. Yes, that's right folks, instead of telling a daft joke, I'm going to witter on yet again about the self-selection of P-meds. This time I want to think about it from a patient's perspective. Some of these considerations may seem small and petty, but i just want to put my thoughts down on virtual paper and you can see what you think.

When I walk into a shop, I can be pretty easily intimidated. I'm shy, and I don't like to bother people. I also hate that uncomfortable feeling when you walk into a shop and you feel like you're being watched by someone and then you feel terrible about not buying something. I can get anxious about the smallest of things, in particular not quite knowing what you're supposed to do in a shop- if I can't find the til, or there's an empty box and i don't know who to ask, or if I can't find something, for example.Of course this is worse when I am feeling a bit poorly and I can be particularly skittish- im likely to go home without buying anything, even if i need it, because i can't be bothered to have to work out what I'm supposed to do. This brings me onto my first point about self selection

1. It could be different everywhere. Not all pharmacies will take up the self-selection option, so I'll need to ask at the counter as i am used to. But in some pharmacies, the packs may be out on the shelves, whilst in others, they might be in security packs or might be empty packs that I need to take to the counter, like an early nineties video rental shop. It sounds daft, but this sort of thing could be quite off-putting.

2. How the hell am I supposed to know what to buy? I tend to acknowledge people who know more than I do about a subject and listen to their opinion. If I go to the hairdressers, for example I tend to ask them what style they think would best suit my hair type and face. After all, they've done some training in cutting hair whilst I am utterly clueless about it. If I walk into a pharmacy, therefore I don't expect to have to do all the hard work of product selection myself. My product selection process for most things usually goes like this:

Its either that, or I stand around reading every single box of every single product. This would take me bloody ages, and would be pretty inconvenient.

3. What If Its The Wrong Thing? After I have found the shiniest product, I take it to the counter, where I am then told that I've picked up the wrong thing and I'm not allowed to buy it. This, frankly, pisses me off and adds even more inconvenience o the whole affair. I've chosen the product, and now some jobsworth glorified shop assistant is saying that I've chosen the wrong thing? how dare they! (I've lost count of the number of times I've been called a glorified shop assistant by patients-and on occasion non-pharmacist managers over the years, by the way). You know like when you're in a hurry, and you've picked something up in a shop and you take it to the counter, and they tell you that its on buy one get one free, but there is a huge queue behind and you're going to be late for your train so you just say "oh its fine, I'll just take that one". I suspect that would end up happening quite a bit as well.

4. Advice Isn't Quite So Forthcoming. When I ask for a specific product in a pharmacy, the counselling and advice I am given tends to be minimal (if at all), whereas if I ask what they would recommend for a particualr symptom (not that I usually have to bother doing that myself, but you know), I tend to be given fuller, more rounded advice as part of the product selection process- I've written about this before. If I want to know something about a product, I have to ask about it, and I might feel a bit stupid doing that when I'm supposed to have picked the product myself. In addition, I might not actually know that I need to ask for advice unless it is offered. With self-selection, I fear that offering routine advice would become the exception rather than the norm, and instead of being proactive in giving advice, we would instead get into a pattern of waiting to be asked.

5. Medicines Are Commodities And Its My Right To Buy Them. I've written before about the paracetamol problem- its so widely available that people think its safe and innocuous, and they can take extra or dismiss it because they've sort of forgotten that its a medicine. I think this may become a wider problem. If medicines are available on the shop floor for me to handle and choose myself, I assume that they're either not very good medicines, or they are so safe that I can use them how *I* like. If I want to take three times the amount of antihistamines that it says on the pack, then I can do, just like how if I want to eat peanut butter out of  a jar with a tablespoon then I should be allowed to, because its my choice to buy it and who is anyone else to judge me and tell me otherwise? this is going to be particularly problematic with codeine-containing medicines and similar.

Anyway, those are a few thoughts for now. I may add to them as time goes on. What do you think?

Hxxx

When Z-day comes, think pharmacy

A little while ago, it occurred to me that I hadn't watched many zombie films in my life. I therefore made it a bit of a project to watch a whole load of them. I got myself a mentor (my friend Frankie) and together we perfected the art of walking back from the cinema in a zombie fashion whilst giggling hysterically.

I've watched good zombie films, bizarre zombie films, Christmas zombie films, thoughtful zombie films, and absolutely terrible zombie films starring Billy Connelly. So I sort of know the ropes when it comes to the genre. On the advice of Nancy, I started listening to the We're Alive podcast, and now extol the virtues of it to any who will listen. Although I dont recommend listening to The Archers right after it, as you find yourself waiting for zombies to jump out and ruin the Ambridge flower festival.

So I've just gotten back from World War Z. It was better than expected, and it managed to squeeze more entertainment than I thought may be possible out of a lab in Wales and Peter Capaldi wearing a jumper. Although given I have a bit of  a thing for Peter Capaldi and Brad Pitt, I was happy enough as soon as he arrived on screen. All that was missing was Hugh Laurie. And a better ending. And more gore. And less CGI. And less not realising that with a pen and paper and the camera he could easily get the people in the know to tell him which vial to choose. And wouldn't there be an intercom in a WHO lab with infectious diseases in it anyway?!

Anyway, I digress. Aside from all the problems with the film that no one else would probably notice, I did note one shining light in all of the z-day carnage. Brad Pitt, like any good citizen should, Thinks Pharmacy. In need of an emergency supply of a salbutamol inhaler, off he goes to the local, friendly community pharmacy.

I don't think this is much of a spoiler, given apparently pretty much the whole film is in the trailer, but after barging into the supermarket pharmacy (probably unlikely: in real life he would have just coughed loudly and shouted "shop!") he is greeted by a friendly professional, white coated  pharmacist who offers him an NMS consultation. Okay, maybe not. He's wearing  hoody and carrying a gun, but, ever the professional, still manages to give some health advice when handing over three inhalers. "Children grow out of asthma" he says, helpfully, which may be true, but I think is unlikely to be the case by the time the  3 inhalers are used up.

He even link sales, passing over some bottles of what I presume to be paracetamol liquid too. How very helpful.

Its nice to see a pharmacist in a film or TV show doing something other than serial killing, murdering, nearly killing orphans with poison when drunk, or merrily doling out vicodin to Dr House without a prescription. Its nice to see a pharmacist resolutely doing what he can to help. It reminds me of all those stories you see in Chemist and Druggist, where there has been horrendous floodings but the pharmacy staff still manage to open up and do their deliveries in a makeshift canoe. The ones who, despite broken shutters or six foot deep snow or pandemic Ebola still turn up to make sure all the collections are done and the order is put away.

The pharmacist in question doesn't do any WWHAM questioning though. I'm not convinced Which? Would have been very happy with him.

Hxxx

Self-Selecting P Meds- The evidence

The other week, the lovely folks at The Pharmacy Show Community (they are really lovely, my flattery of them is nothing whatsoever to do with the fact that they are linking to and publishing bits of my blog) held a tweet chat all about the self-selection of P meds, led by the mysterious and always entertaining @MrDispenser.

There are a few concerns that I- and it seems many other pharmacists share about the self-selection of P-meds. I've covered some of my concerns here, but the tweet chat threw up many others too. Other pharmacists have also shared their concerns, and you can find some of them in the links below:
The Pharmacy Show Blog
Dr A R Cox
James Andrews

Right now I want to look at the evidence that self-selection works. The theory is that allowing patients to choose their own medicines leads to greater adherence. As the patient feels they have more ownership over their healthcare decisions, they might use the drugs more effectively for a better outcome. But is there any cold, hard evidence that this is the case when it comes to over the counter medicines?

As a skeptic, the words "Where's the evidence?" are often found escaping from my mouth. Sometimes the need for evidence is countered by the risk averse pharmacist side of me, where the theoretical likelihood of a risk outweighs the need for evidence. As with all things in healthcare, a balance needs to be taken into account: what are the risks vs what are the benefits?  In this case of self selection, I can see there being a real risk of fatalities. Any evidence of benefit to patients needs to be robust in order to outweigh the risks, in my opinion.

So I've made a start by looking at Embase and Medline. I've also had a look at NHS Evidence and have even googled. And I've been able to find very, very little on the subject. I found one Dutch paper about self-selection in the pharmacy, but that has no abstract.

I found this World Self-Medication Industry website which states:

"A study done in the United Kingdom showed that consumers welcome the opportunity to self-select medicines in that country's pharmacy class. Three out of four of the British consumers in the study felt that re-configured pharmacies with easier access to nonprescription medicines was a good idea, half because it would save their own time or that of their doctor, and the remainder because it offered greater choice."

But this doesn't appear to be referenced, so I can't find the study to see how reliable it is.

Have I missed anything? If you're aware of any evidence for the efficacy of self-selection of P-meds, please do let me know by dropping me an e-mail at healthydoseofskepticism@gmail.com. I would be particularly interested in any evidence that could be provided by the GPhC, and might drop them a line to see what they have to say on the matter.

In contrast, I stumbled across a study from New Zealand, which concludes that, when purchasing a pharmacy medicine for the first time, in 62.2% of cases the sale was influence by pharmacy staff. This study has its limitations of course, but if true (and from my personal experience of many years of community pharmacy work it would appear about right), it would seem a shame to eliminate this from the medicines buying experience.

There is also some evidence that patients who approach the pharmacy counter with a specific product in mind are given poorer advice than those who ask for a recommendation based on their symptoms- again something I have experienced both as a pharmacist and a customer.

Of course patients can still ask for the expertise of pharmacy staff, but how many of them will know to ask, and how many will simply pick the nearest thing and hope for the best?

I'm going to hopefully write another post about my concerns about how the patient experience will be affected. If you have any thoughts on this, again do get in touch. If you're a customer in a pharmacy, I would love to know whether you think self-selection of Over-The-Counter medicines would be good for you.

The Vaper Verdict

I seem to have gotten myself a bit of a reputation as a Vaper-hater. In truth, I'm actually really not.

I even once owned a disposable e-cigar. It was a good few years back now. Although I consider myself a non-smoker, I do smoke the odd cigar, but about one a week and only when the weather is nice (so about 4 days a year then) and only when someone has brought me some back from their holidays probably does not constitute a habit, or would be considered the world's most pathetic addiction. I would never dream of smoking indoors, and somebody thought it would make a nice stocking filler for me one year.

I used it a few times, and it was alright, in the same way that a Pot Noodle is mildly enjoyable in its own right, but bears no resemblance to a steaming hot bowl of freshly cooked spicy Szechuan chicken in udon noodles (no 69. on the menu at Nudo, my favourite restaurant in Newcastle. Its always giggle-worthy ordering it). E-cigarettes are the Smash mashed potato of the smoking world, a Cup-A-Soup to a home-made broth.

I can see how it would be good to have something vaguely resembling a cigarette if you're trying to give up smoking, and I can certainly see how a nicotine delivery method that avoids all the tar, chemicals and other gunk that smoking dumps in your lungs is more healthy.

My reservations are thus:

1. If they're unregulated, you have no idea what's in them. It might say on the pack that it contains x mg of nicotine and chemicals y and z but there is no guarantee of this. Some have been found to contain toxic chemicals like ethylene glycol, for example. Its undoubtedly likely that they still contain less dangerous chemicals that cigarettes, but it would be very nice to have that guaranteed.
2. There's no long term safety data. We literally don't know what the long term effects of these things are. For all we know, the seemingly safe-at-first ingredients could actually prove to be carcinogenic, say, when inhaled in this way in the long term. Admittedly its unlikely the products would be as bad or worse than smoking, but without the studies we just don't know. Theoretically they may seem like they're going to be harmless, but without the data there to back it up we just cannot make that assumption- its that sort of reasoning that lead to the thalidomide disaster, for instance. Unknown does not mean safe.
3. There's evidence that products are often do not contain what it says on the label (if they even have a label at all). A study in the BMJ's Tobacco Control found that products contained variable and potentially dangerous amounts of nicotine- most often the product contained less than was stated. Now, if I'm paying for a product that says it contains 72mg/ml of nicotine, I expect that product to contain 72mg/ml of nicotine, just as I would expect a 500mg paracetamol tablet to contain 500mg paracetamol. If it contains less than this, I'm essentially being ripped off. The other available nicotine replacement products- patches, gums, inhalators etc- all have a license, and I don't really see why these electronic cigarettes should be any different.
4. In smoking cessation, using a product which looks like a cigarette might be helpful in the short term, but it doesn't help to address the habits of smoking rituals, and in my experience of helping people quit, that's half the battle.
5. The risk of serious accidental nicotine poisoning in both adults and children. 
6. There is a risk that the ease of use of the products and ability to use them indoors might actually increase nicotine intake in some people.
7. Even if nicotine itself were entirely safe (which it isn't), its still an addictive substance. Any addiction can lead to harmful effects in a person. For evidence of this, try speaking to me on a day when I have not had any caffeine. If I added up all the time and money I have spent in my life engaging in drug-seeking behaviour to feed my addiction (mainly desperately trying to find the nearest kettle or coffee shop), I suspect it would be very upsetting.

Today there has been, in my opinion, some good news. The MHRA have decided to start regulating nicotine containing products as medicines. This decision essentially eliminates concerns number 1, 3 and 5 and starts us on the road to also ruling out concerns 2,4 and 6. The BMA have responded enthusiastically to the news, stating:

“We can now build on this and press for good research which looks at the efficacy and health implications of e-cigarettes. It’s really important that we find out if the hand to mouth use of e-cigarettes either breaks or reinforces smoking behaviours. We need to know if e-cigarettes actually help smokers quit."

I'm also enthusiastic about this step. Whilst it may lead to decreased availability and choice of these products, it will hopefully lead to a smaller number of better quality products being legitimized and incorporated more formally into smoking cessation or harm reduction schemes- if they are proven to work in robust clinical trials. This is yet another case where, instead of waiting until we have good, robust data that a product works and is safe, it has been widely sold and adopted by users in lieu of risk or efficacy information. There will no doubt be an outcry from users and manufacturers, and wails that the MHRA have banned e-cigarette sales, that its a Big Pharma conspiracy to give everyone cancer so they can sell more drugs, that big evil corporations are trying to trample the little guys down, when all they are trying to do is save some lives. But none of this regulation means that.

All a manufacturer of e-cigarettes would need to do to continue selling their product is to prove its safety, efficacy and quality. It will take money and time, but if they have been already producing their wares safely and in accordance with Good Manufacturing Practice guidelines, they're already some of the way there. Gaining a license will of course cost time and money, but if these manufacturers are genuinely interested in saving lives- and not just unscrupulously making profit- they would see the value in the licensing process, and the opportunities available for a licensed product in the long run.

So here's to what could be start of a new dawn of smoking cessation or harm reduction. I really hope so, but will reserve judgement until the evidence starts piling in.

Hxxx

My Fantasy Pharmacy

People are allowed fantasy football teams, so why shouldn't I be allowed my own little fantasy pharmacy?

Now people, I want you to contribute to this post. So let me know if I haven't included your desert Island drug and why you think my pharmacy should stock it, and I shall put it on the shelves if I deem it worthy. Tweet me @SparkleWildfire, leave a comment, or drop me an email at inthecityofthefuture@gmail.com. I'm going to start off small with this post, and add to it gradually.

With all this talk of pharmacy as a quack trade, and the lack of evidence base for many OTC products, my pharmacy is going to have the bare minimum. Only the drugs I want to sell, ad that I think are necessary, with none of the extraneous, shiny combination packs that are purely there for profit. 

So, welcome into my emporium of evidence-base, and help yourself to some expert advice, a healthy dose of skepticism, and a pinch of thriftiness.

Shelf One: Pain Relief

Paracetamol: because it is an effective painkiller and antipyretic with few side effects. 

Ibuprofen: again, an effective painkiller and antipyretic. Needs more caution because of side effects, but still useful to have over the counter.
Sumatriptan: a good shout, thanks for your comment, Joanne. This is actually a really useful product to have OTC, in my opinion- its for migraines, so its great for regular sufferers to have easy access to if they don't have their usual meds to hand. But it does needs to be sold very carefully, with good questioning and counselling. 

Shelf Two: Coughs and Colds

Sudafed: just the plain old pseudoephedrine variety. Its the most effective decongestant over the counter (phenylephrine has much less of an effect orally) and can be combined with paracetamol or ibuprofen if there is pain associated with blocked sinuses.

Lemons and Honey: for combining with hot water for soothing throats and coughs. About as effective as any other cough mixture.
Glycerin, Lemon and Honey Mixture: as above, but ready made for when you don't have access to a kettle. Also: its quite delicious. 

I would include a night time product too, but I'm not sure which one yet. I don't want to include Night Nurse because its got far too many ingredients in it, and no one should have to take medicines they don't need. My product would just have diphenhydramine and paracetamol in it, probably, just something to help you sleep when you have that awful achey can't breathe feeling that comes with colds. 

Menthol crystals: for adding to steam inhalations. Inhaling the vapours of a  couple of those bad boys in boiling water will have your mucus cowering and crying in a corner. 

Xylometazoline nasal spray: an option for people with bad congestion who can't take pseudoephedrine.
Pholcodine cough medicine: As voted for by Kev. Its cheap enough, and acts to suppress a dry, tickly cough. Shouldn't be used in chesty coughs though. 

Shelf Three: Ear problems

Olive oil: there is no reason whatsoever for any of the other products to exist. Plain old cheap olive oil will do the job just as well as anything else.

Dropper: for administering the olive oil. 

Shelf Four: Allergies
Generic beclomethasone nasal spray: cheap, works if used in advance of the hayfever season.
Antihistamine tablets (generic): Chlorphenamine, loratadine, and cetirizine. Exactly the same as the hugely expensive branded varieties. chlorphenamine can cause drowsiness, the other two tend to be much of a muchness- some people find one works for them, some the other.
Cheap anti-allergy eye drops: great for people that have predominantly eye symptoms.

That's a little start, and I shall add to it when I think of anything else or get a chance.

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?

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.

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.

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 

and

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.

We can pretty much entirely discount the claims for "fortifying the skin barrier". All this means is moisturing 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. I simply 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.

A 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 the International 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 telltale 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.