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

In which the title of "Pharmacist" makes a real difference.

Here is a little story of something that made me proud to be a pharmacist. It works as a sort of counterpoint to all the talk of pharmacy as a quack profession, the sort of bad experiences I have recently had as a customer in a pharmacy, and the Which? Report.

It happened now behind a pharmacy counter, or in my office, but instead at one of my last phototherapy sessions. Because they were three times a week for 10 weeks, you sort of start to get to know the other folk who go there, and of course I got chatting with a few. I had mentioned offhand to one of them during a bout of small talk that I was a pharmacist.

The next time I saw her, she was eager to talk to me "I've been thinking, and I have a question for you, although I hope you don't mind me asking." She had had very severe psoriasis for many years, and it was having a real, tangible impact on her life. It had been suggested to her that she could try methotrexate, but she had been resistant to this treatment strategy "Because I'm just so terrified of all the side effects"

Her question to me was simple: Would I, as a pharmacist myself, take methotrexate if I was in her position? What a great question. And how amazing that someone I don't know at all thinks enough about my opinion, simply because of my job description, to ask me it.  And so, shivering slightly in our hospital gowns in the clinical white of the dermatology changing rooms, we had a really good chat about the benefits and risks of all drug treatments, about how methotrexate works ("someone told me its like chemotherapy!"), about her fears of the medicine ("I've had a look on the internet and the side effects are terrifying") and her fears of the psoriasis ("I sometimes think other people think psoriasis is something that isn't serious enough to warrant a drug like methotrexate, when it's also used to treat cancer and things. But it really is ruining my life."), about the sort of monitoring she could expect. and some of the things to look out for if she did decide to take it.

My bottom line answer was that yes, I would take it if my psoriasis was as severe as hers, and having the impacts on her life that she was experiencing. I explained that I too would be scared of the side effects, but not everyone gets them, and because you're quite closely monitored whilst you're on it, the most serious side effects should be pretty easily picked up and with some careful dosing, along with folic acid, could hopefully be minimized.

"Eeee, well thank you. You've really put my mind at rest." she said, and off she padded to receive her few minutes on the NHS sunbed whilst I attempted to put my clothes on the right way round for the second time that day- no mean feat when you're me and you haven't yet had your first cup of tea or coffee yet. I don't know whether or not she was definitely going to start taking the methotrexate, but I get the feeling that I had given her a few things to consider that she hadn't thought about, and that I had provided some reassurance that the horror stories on the internet are not the full story.

This just goes to show the sort of esteem we pharmacists have the privilege of in the eyes of some. Its a privilege we should honour by doing all we can to ensure our advice is good quality and evidence-based. Being a Good Pharmacist doesn't stop the moment we extract ourselves from behind the counter, or out of our office or wards. Our words are more trusted, more weighted than many of us probably realise, because to some (but not enough) people "Pharmacist" really does mean "expert in medicine", and we need to ensure that we don't take advantage of that to sell products that don't have a good evidence-base just for profit. Our integrity as medicines experts can and should shine through, even when you're standing in a cubicle failing to rock the hospital chic look, bleary eyed and in need of caffeine.

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.

Vicks, feet, and a whole load of nonsense.

And so it was that I ventured onto Facebook last night, for the first time in a while. And what I discovered there was an intriguing post about putting Vicks Vaporub on your feet to cure a cough.

A very quick google search suggests this is a long-standing bit of nonsense that's been doing the rounds with pretty much exactly the same wording for years. I thought it might be worth revisiting. so, here it is in its entirety, with my skeptical, critical thinking thoughts inserted in blue. I guess its a bit of an example about how to think about claims that appear at first glance to be too good to be true:

"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 potentially 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 happenee, ever.>, although the scientists who discovered it aren’t sure why. <what scientists?>

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. <Feet seem to be a favourite of the quackery world, what with detox patches, reflexology and all that sort of thing. Alarm bells are a lot louder already. Why would Vicks be particularly effective on your feet? Is this as compared to any other parts of your body, or compared to nothing at all? Wouldn't it sting, and could it have potential to cause sensitisation in the area? Where is the prior plausibility here?>  Even persistent, heavy, deep coughing will stop in about 5 minutes and stay stopped for many, many hours of relief. <A coughing fit usually does stop after a few minutes of its own accord regardless of treatment. If it doesn't, and you're coughing constantly for more than 5 minutes, you probably need to be checked out by a doctor.> Works 100% of the time and is more effective in children than even very strong prescription cough medicines. <There are very few prescription cough medicines, on account of the fact that most preparations for cough don't really work anyway.Again, this 100% of the time claim is quite extraordinary and would require major clinical evidence to back it up.> In addition it is extremely soothing and comforting and they will sleep soundly. <Is the stinging, cold sensation you get with menthol really soothing?>

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? What radio station? What are you on about? The only medicines now available for coughs in children OTC in the UK are glycerol and simple linctus paed- basically, sugary water. No "strong drugs here".> 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, none of these questions really matter given the studies themselves don't actually exist>

My wife tried it on herself when she had a very deep constant and persistent cough a few weeks ago and it worked 100%! <anecdote. It worked 100%, but in one person? This doesn't even make sense.> 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. <I'd imagine it would actually just feel like you had some oily gunk on your feet that would sting a little bit and feel cold. Who is this wife, and why should we believe this anecdote from an anonymous person? There's no way to remove regression to the mean as an explanation to this, but by now I'm suspecting this wife with a cough is mainly mythical>

If you have grandchildren, pass this on. <so presumably you don't need to bother if you're simply a parent, only if you're a grandparent?> If you end up sick, try it yourself and you will be absolutely amazed at how it works! <Actually, I suspect I'll just feel a bit silly. And will have 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

UPDATE: I get a LOT of hits on this blog because of this post. If you've stumbled across it, i would love to know whether it has had any impact on what you thought about whether putting Vicks on your Feet would work, so please do leave a comment or drop me an e-mail.

Skin deep: a lesson on empathy

For the past few weeks, I have been suffering from guttate psoriasis. My poor dear friends and twitter followers will be very aware of this by now, as it has led to much wailing and complaining.

Guttate psoriasis appears a few weeks after a strep throat infection in most cases, as it did with me. It appeared pretty suddenly on my face and chest, then got worse and worse until I basically now resemble a small pox victim with Ebola in the midst of turning into a zombie, with some added bubonic plague thrown in.

The treatment? Well it tends to go away of its own accord after a few week or months. It's not helped by stress, so it's good to chill out. Usually treatment with topical steroids, emollients, and reassurance are all that's required.

A few weeks ago I would have read that sentence with ease, accepting that reassurance and time would be enough for a patient. Slap on a bit of cream, and away you go.

A small section of my thigh at the moment. Imagine this rash, all over. And this is after vigorous application of topical steroids and has gone down slightly.

You learn in university and in various courses that dermatological conditions can have a huge impact on a patient's life. You learn about all the creams an emollients, and how we should advise they're used. You know in the back of your mind that its probably horrible for the sufferer but you don't really give it a second thought. I know I've even been felt vague consternation at having to dispense and check huge, bulky prescriptions for various and many unguents, with my main thought being "how am I going to fit this damn prescription on that shelf?!"

Well, what a lesson in empathy these past few weeks have been. Nothing could have prepared me for the impact a rash would have on my life. Aside from the panic about what it was, the constant feeling that everyone was looking at me and feeling disgusted is utterly wearing. And of course you know deep down that they're not looking at you, but it makes no difference at all. I know I need to be calm about the whole situation because stress makes it worse, and that makes me even more stressed because I'm not destressed enough. I feel like all I want to do is hide in a darkened room, so I don't have to inflict my grotesque features on anyone else.

And my goodness, the treatment. I get in the bath, which is already suffused with an oily emollient bath additive. I then apply some gunk, and wash it off with the oily water. I then get out the bath (which is made more interesting due to the added element of slippery danger) and proceed to apply more oily gunk, in various combinations of layers, then have to wait for it to dry sufficiently to be able to put on my most high-necked, low hemmed, least transparent clothing I can find. I haven't felt clean for weeks. You know on holiday, that awful sticky feeling you get from the sun lotion? That, all the time. In February.

All I've been able to think about is my rash. I'm struggling with conversations because my head is consumed only by thoughts of what bits of skin are visible and to whom. It's crossed my mind that converting to Islam might be an idea because then I could feasibly wear a burkha. Honestly, I have thought this. I've been turned into a hysterical drama queen all because of some spots.

In short, I have a whole newfound empathy for anyone who suffers from a skin condition. I can just about imagine the sort of impacts a longer term condition might have on your life. I can see how desperation can creep in, and how you could be tempted to try anything.

It's no co-incidence that so many quacks target people with skin conditions, nor that so many preparations are so expensive.

Hxxx

P.S. I'd very much like to thank everyone who has been supportive. You're all total darlings.