psoriasis

Making Clinical Trials Sexy

If you're buying a new TV, how do you go about it? My guess is that you probably have a look around the shops or internet, find a model you like, then get online to find some reviews of it and decide whether or not to buy based on what you've read. You may well scroll down to the reviews if you're buying something on Amazon, before you click the "Buy" button. If you book a holiday, you're probably straight on Trip Advisor to see what other people- humans just like yourself- have got to say about the hotel.

It is perfectly reasonable behaviour. We understand and respond to the personal experiences of other people- its part of our nature, stitched into our being. Each review is a little story, and humans love stories, especially when they are about other humans.

Its therefore a hugely unfortunate problem that, when it comes to healthcare, stories just aren't good enough. When peoples' lives are hanging in the balance, reviews and testimonials just aren't up to scratch. Here's why:

I have guttate psoriasis. Imagine I go on holiday (alas this is merely a pipedream this year, thanks to what feels like millions of large unexpected bills that seem to keep turning up in my life) and lo and behold, when I return, my psoriasis has cleared up. I conclude that it is definitely the sunshine that has cured it, and proceed to proclaim that I have found the ultimate 100% effective cure for psoriasis.

Is it reasonable that I have come to that conclusion, based only on my own experience? No, not at all. Why have I focused on the sunshine aspect alone? Maybe a week spent relaxing is what has actually cured it. Maybe its because I've changed my diet on holiday and have been eating lots of lovely fresh fruit and vegetables and fish?  Maybe it is because there is a magic ingredient in Sangria which miraculously beats rogue skin cells into submission. What if chlorine in swimming pool water is my skin superhero? Maybe-just maybe- its because guttate psoriasis can be self-limiting, and it has just faded away of its own accord. With just my experience to go on, there is no way I will ever be able to know what it is that has made my condition improve.

What I would need to do to be able to decide is to scale things up. Get as many people as possible with guttate psoriasis, and divide them into at least two groups- one exposed to sunlight, one not. I'd have to try to control the peoples' behaviour as best as I could for the other factors like diet, chlorine exposure, sangria intake, stress etc. Whilst I could never completely control for everything, if the group exposed to sunshine experience a significantly better improvement in their psoriasis, then I could say with more certainty that it is the sunshine that did it rather than anything else.

This is the beauty and elegance of a clinical trial. They are simply the best, slickest, most reliable way we have of teasing out whether a treatment actually does make a difference. They're like an anthology of stories, carefully selected and analysed by researchers in a bid to start finding an answer to a treatment question. Whilst they're not 100% perfect, they're certainly the best sort of information we have at the moment on which to base any decisions about which treatment to choose for which disease, and for which patient.

This is, however, very easy to forget when you actually have to read one. I do not have a mathematically inclined brain, and when faced with tables full of numbers, p values, confidence intervals, hazard ratios, relative and absolute risks etc, my grey matter is usually to be found quivering and wimpering in the corner of my skull. I have to really try hard to focus on the stats and results when reading a clinical trial- its a constant fight to wrench my thoughts back onto the page, when they keep merrily skipping away to think about kittens or bunnies or *that* picture of a minipig wearing red wellies. And I say this as a geeky pharmacist who has undertaken a decent amount of training in how to read a clinical trial. What hope then, does an individual patient or regular joe have of understanding trial data?

A quick glance at pretty much any website selling an 'alternative medicine' and you'll notice there is usually a "Testimonials" page on there. Many other types of healthcare sites also use testimonials to prove their treatment works. They're easy to read, often full of personality, and can really seem to speak to you as a reader. They may seem convincing, but as you've (hopefully) seen from my example above, they simply can't be used to decide if a product works or not. A glossy celebrity story endorsing a product in a magazine is infinitely more sexy than ten pages full of stats and graphs in a medical journal.

Testimonials and reviews are, at first glance, more attractive and more seductive than the more dowdy clinical trial. So what can we do to help the clinical trial apply a bit of lippy, spray some perfume on itself, and don its heels to get out on the town and make people weak at the knees? My short answer is I don't know. Campaigns like International Clinical Trials Day help of course, but at the moment it feels like we're swimming against the tide somewhat. My ultimate dream would be a primetime TV series, fronted by a hunky Brian Cox type. If he can make physics sexy enough to be at the forefront of our entertainment, surely there is some way that we can do the same for one of the best inventions in healthcare? I'd like to get to a place were it's second nature for everyone, whether they be a patients, pharmacist, healthcare professional or general geek, instinctively bypasses testimonials to look for clinical trial evidence instead.

Do you have any ideas? Have you had any really good experiences of explaining clinical trials to patients? Are there any techniques we can use to simplify the stats and make trials more accessible to all? My friend Nancy had a great idea of including a Plain English summary as part of an abstract for every trial. Is there anything else we could do? Let me know, however outlandish your idea, either by commenting, tweeting me (@SparkleWildfire), or dropping me an e-mail at my new shiny sparkly e-mail address healthydoseofskepticism@gmail.com

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?

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

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

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

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

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

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

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

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

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

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


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

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

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

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

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

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

Hxxx

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

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

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

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

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

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

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

A tale of an excellent healthcare system

It seems that everywhere you turn these days there's another horror story about the NHS. In the wake of the Mid-Staffordshire report, press, patients and staff are reeling from what seems like a never- ending list of systematic failures. Some of us in the UK are no doubt left questioning the value of the NHS, wondering whether our taxes are being spent on nurses who are more about painting their nails and chatting than looking after patients and doctors who merrily stand by as scores of patients die while they discuss what they watched on TV last night. 

As with all things, the juicier media stories come out of negative experiences. There are major failings in the NHS for sure, and my goodness we need to address them. But we need to also realise that there are a huge amount of strengths associated with our healthcare system also. Alas, our current health secretary seems hellbent on destroying the good bits once and for all. Unless we start paying attention to the good, positive stories... Well, as the cliche goes, you don't know what you've got til it's gone.

So here is a little story of my recent experience with the NHS.

As you will no doubt know by now, given my incessant whinging on the subject, I currently have guttate psoriasis. You'll probably also know that it's completely freaked me out, and caused a bit of a flare up of anxiety. 

I registered with my local doctors, which I had been meaning to do for ages. I rang at 8am and had a registration appointment by 9:30am that day. The healthcare assistant i saw was warm, friendly, and very empathetic. By 10:15 I was seen by a doctor who was equally friendly, had a good proper look at my rash, and who explored my feelings about it and helped me rationalise my anxiety about it. By 10:30 I was out the door, prescription in hand, and feeling much better. 

Fast forward a few weeks and my rash is still getting worse. I pop back to the doctors and again am seen by a doctor who takes a lot of time and effort to find out how the rash is affecting me in myself. She made me feel totally justified in my feelings and went out of her way to arrange an urgent dermatology referral for me. I had a throat swab for residual strep with the same healthcare assistant who looked after me initially and she was brilliant, chatting with me about how often her mum had to scrub the bath when her sister had eczema as a child. We had a bit of a giggle, and that was exactly what I needed. I get the feeling that had I needed a good cry, she would have been equally happy to spend time listening. 

Some might say this is just them doing their job. Maybe it is, but I think in my case they've done their job brilliantly. I've felt like I've seen people whose primary aim is to help patients like me, and who genuinely care about my emotions and quality of life.

It's little stories like this that have kept the NHS going for all these years. They're also the kind of stories that are so easily forgotten. I know from experience that a little bit of positive feedback from someone you've made a difference to can really make your week, so if you've had a similarly positive experience, no matter how small, I urge you to share it. 

Hxxx

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 at its best,  after vigorous application of topical steroids. I feel like a mutant monster :S

A small section of my thigh at the moment. Imagine this rash, all over. And this is at its best,  after vigorous application of topical steroids. I feel like a mutant monster :S

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.