Wake up and smell the (green) coffee

The media is raving about it. Waif-like celebrities like Demi Moore are swallowing it like there's no tomorrow. Any internet search results in a tidal wave of websites and blogposts screaming that its the new "100% safe and natural!" weight-loss secret. In short, the world seems to be falling over itself to get its soon-to-be-no-longer-chubby hands on a green coffee extract supplement. We'll all be size zeros in a matter of days.

Of course you know where this story is from. But its also being advertised in stories in glossy magazines and other newspapers too.

Green coffee beans are normal, every day coffee beans before they have been roasted. The roasting process decreases the amounts of chlorogenic acid contained in the products. Chlorogenic acid is thought to moderate effects of glucose metabolism and inhibit fat accumulation- sounds brilliant, right? Well, before I go off, burger in hand, to eat lots of cake safe in the knowledge that I'll be shopping in the size 8 section in no time thanks to green coffee, lets have a look at the evidence.   

Coffee beans. Just more green than usual ones.

First things first: does it work? The short answer is it might do, a little bit, but we don't really know yet. There are a couple of little trials here and there, but they're limited by their size and trial design, so the results could just be fluke. There's one systematic review, which found that overall the data from the better quality trials suggested that green coffee extract could lead to modest weight loss differences (about 2.47kg (95% CI -4.23 to -0.072kg) over about 12 weeks. That's hardly enough to transform my size 16 lumpen frame into a lithe size 8 overnight, or indeed over a year, despite what all the before and after pictures on the manufacturer's websites say.

And what of its safety? Well, in short we have no idea. I've done loads of research into this and have been unable to find any good, reliable information on its safety. Green coffee contains a similar amount of caffeine as normal coffee beans, so we can assume that all of the nasty side effects from drinking too much coffee could also happen with a green coffee extract. Palpitations, anxiety, insomnia, diarrhoea, and heart problems may result, and even anaphylaxis in the worst cases. Some products claim to be decaffeinated, but as none of these products are regulated, there is no guarantee.

There is nothing out there on the safety of chlorogenic acid. It seems to have been used in chinese medicine injections, and seemed to be thought to cause allergies. However it seems that there is some debate about this. One study in dogs seems to suggest that it could have an effect on the liver and kidneys, but whether it could damage human kidneys or livers is unknown.

So there we have it. We basically know very little about green coffee extracts, despite what the websites that are selling it will tell you. It might work a bit, but its certainly not a miracle cure, and we don't really know whether or not its safe yet. It may well be safe, but we just can't say for certain yet. Instead of waiting until more evidence is known, however, it seems that manufacturers are gleefully happy to sell it far and wide.

What's particularly uncomfortable is that the sellers of green coffee extracts are taking the more and more common approach of marketing their products. Google "Green coffee extract safety" and instead of finding reliable sites or those actually looking at the safety of the product, the search is flooded with marketing sites masquerading as genuine safety sites. This sort of marketing feels really icky, and I don't like it at all.

Its yet another opportunity for unscrupulous people to make money from our insecurities. I'm overweight myself, and I know that I have to struggle against the urge to throw my skepticism to the wind and throw money at anything that claims it will help. The simple fact is that there wont be a miracle cure, and losing weight takes time, effort, patience and willpower, not to mention the fact that the desperation to be unhealthily skinny is dangerous in itself.

Hxxx

MMR: the blame hot potato

I shouldn't be having to write this blog. We shouldn't still be having to see news stories about measles outbreaks in 2013. We have an effective, relatively safe vaccine which should have massively reduced the incidence of this potentially fatal or life-changing disease. But no, here we are in the midst of an outbreak which is starting to reach scary levels. The first fatality has been reported, in 25 year old man, although it hasn't yet been confirmed that measles is the reason for his death.

So why is it still one of the main topics of conversation at the moment? Well I'm pretty sure you're aware of the truly awful, entirely discredited research by the now-struck-off the register Andrew Wakefield. If anyone is unsure about whether or not its unfair to think of Wakefield as a nasty piece of work, remember that he was struck off because of 4 counts of dishonesty and 12- yes, 12-counts of the abuse of developmentally challenged children. Its been 15 years since the publication of his "elaborately fraudulent" paper which suggested a link between the MMR vaccine and autism- and yet still to this day a dark cloud of fear surrounds the big scary needle that evil big pharma and nasty doctors want to inject into innocent children.

A quick history of events goes thus: Wakefield's paper is published in The Lancet---> Wakefield's paper is picked up by the media---> all hell breaks loose---> Children aren't vaccinated---> Wakefield's paper is discredited---> media continues panic-mongering--->Children still aren't vaccinated--->Other research says MMR isnt associated with autism---> media continues panic mongering---> Children still aren't vaccinated---> Measles outbreak---> media continues panic mongering ---> Wakefield denies responsibility ---> media denies responsibility. And that pretty much brings us back up to date.

So, are the media right to deny any responsibility? Are they hell, and there's evidence to prove it. Anecdotally, I found myself a few months ago having a lengthy, in-depth conversation with a customer about whether or not his first child should be vaccinated. "I thought it was all sorted out and was rubbish" he said. "But then I read about it in the Daily Mail and they said it was proven." Luckily it was quiet, and I had a chance to spend some time with him, discussing the problems with the Daily Mail report, the original research, and the risks of not being vaccinated. "Oh", he said: "we hadn't thought of the fact that measles might be dangerous." He left hopefully feeling reassured, but concerned that his girlfriend still wouldn't believe him and wouldn't want to vaccinate their child. One of my best friends isn't vaccinated, because his Mum read the seemingly terrifying stories in the press and refused to allow him to have the vaccine. As a result he caught measles, and german measles, (and whooping cough too), bless him. This got me wondering about whether or not there is good, hard evidence that the media is to blame.

In short, the answer is yes, a bit. In a telephone survey of the parents of 177 children who hadn't had the MMR vaccine, fear of side effects was the most common reason given, and the most common source of information was the media. Another study found that parents were more influenced by the fear of harm from the vaccine than fear of harm from measles itself. In another, parents seem to have thought that the information on vaccines given to them by healthcare professionals was poor. A qualitative study again found that parents did not rate science or evidence as important factors when making a decision about whether or not to vaccinate their child.

All of this leaves us with an unfortunate dichotomy. We healthcare professionals usually deal in science and evidence- and so we should, as this provides us with the safest and most objective method of treating patients. But it seems like this is a currency that the general public not only don't often deal in, but on occasion actively reject.

Yes, vaccines have risks associated with them, but these risks are nowhere near as bad as the risks of the disease itself- its a simple case of harm reduction.  If your teenager is going to have a drink, would you rather that they had one glass of wine at the dinner table, in your house where they are safe, or a bottle of vodka on a street corner in an area surrounded by drug dealers and murderers? Wouldn't you rather give a small, highly controlled dose of a disease in a vaccine than take the risk of your child getting the whole, dirty, nasty disease itself? It does seem that the potential for harm of the disease itself can be forgotten in the decision making process.

So how do we go about changing this? I have no idea, to be honest. Its amazing to me, and quite mystifying, that one utterly rubbish- and rather cruel-piece of research can still- 15 years later- hold so much weight over the safety of children. Is it the misguided fear of a poorly understood condition in autism, or the terror of  big pharma, or an unquestioning faith in what the papers say? It seems to me that all we can do, as health care professionals, is continue to attempt as much as we can to give rational, evidence-based advice to our patients. We can improve our communication skills, but i'm not convinced that we will ever be able to truly "win" the good fight if the media continues on with such atrocious health and science reporting. 15 years on and some of the newspapers still insist on calling him "Dr" Andrew Wakefield, when he is very demonstrably no longer a doctor. They use scary photos of massive needles, and continue to give space to the idea that MMR can cause autism, when all of science and rationality disagrees. They reach for emotional language at any opportunity, pitting devastated parents against the picture of a cold, uncaring healthcare profession that they paint. We can try as much as we like to convince our patients on a one-to-one basis, but its like trying to take a drink from a firehose with such irresponsible reporting reaching millions of people every day.

The short answer here is that the blame for the current measles outbreaks lies in all sorts of places. ITs a comedy of errors, but not a very funny one. But, it seems clear to me that the media in particular needs to sit up and realise the harm that it is reaping on a daily basis.

Hxxx

Prevalin: Pollen & Prevarication

There's yet another shiny new product on the pharmacy shelves this spring. In plenty of time for the hayfever season, Prevalin(TM) (which, as someone has already pointed out sounds like a bad name for HRT, not a hayfever medicine) promises us "Fast allergy relief at the onset of symptoms. Acts 5 times faster than hayfever tablets"

It's being advertised by a real-life Pharmacist, Mr Nick Kaye, who appears, resplendent in a white coat, in the advert, in front of what looks to me like a photo-shopped sign saying "Effective Hayfever Treatments". In the still from the video on the website, Mr Kaye looks less than happy and indeed even a tad embarrassed to be there. Having had a good look at the website for the product, I don't blame him.

First things first: this is not a medicine. It takes quite a bit of digging, but you can just about find on the website where it says in small letters that its a medical device. You can also tell by the trademark, and the "clinically proven" claims splashed liberally all over the website.

So what is it supposed to do? According to the advert, it has a unique thixotropic formula. That sounds science-y and cool, eh? It basically means that when you shake it, it's a liquid (therefore able to be sprayed), and it'll then thicken up at rest- i.e. on the inside of your nostrils. So it's supposed to form a barrier on the inside of your nose to stop the nasty allergens getting through. According to the website, this is a unique approach, the next generation of hayfever treatment. This is totally untrue: for many, many years we've been advising to put vaseline on your nostrils as a barrier. A product called HayMax which has been around for years claims to be a "natural balm that acts as a barrier to pollen, dust and dander.". This is, in no way, shape or form, a new concept or breakthrough.

Let's look at what's actually in it, shall we? This is actually very difficult to find, as it doesn't appear to tell you anywhere at all on their website. At first I thought it was cellulose-based, given that most of the references they cite for it being "Clinically proven" are about cellulose powder.  However, according to Netdoctor, it contains "mixture of inactive ingredients, including bentonite (a form of purified clay), xanthan gum, glycerol stearate and sesame seed oil." So, basically, gunky stuff then. gunky stuff that becomes a bit less gunky so it can be sprayed, but that will dry to be more gunky in your nose (although given the inside of noses are actually fairly moist, it's probably, I should imagine, unlikely to dry completely, which would presumably lessen its ability to form a full barrier). It's basically like PVA glue for your nose and it apparently feels like wallpaper paste when its up there, according to @ianthunderroad. Mmmm, sounds lovely.

The "evidence" they show on their website as proof that it works is frankly laughable. Check out this chart:

'% of patients experience improvement' it reads. Well, how many patients? What do they mean by improvement? Hopefully we'll find the answers in the accompanying text:

"Prevalin™'s efficacy has been proven in 2 clinical studies, where over 9 out of 10 people experienced significant improvement of their allergic symptoms^6,7."

Two studies? that's all? Even if they were pretty big studies, I'd be happier if there were more than two of them. and what is "over 9 out of 10 people"? Surely that would be 10 people then? Given a person is a discrete being, you can hardly have 9.25 people experiencing significant improvements. And what do they mean by significant- statistically? or, what we would be more interested in, clinically?

The referencing on this page is very odd to say the least. I'm expected a reference for two studies, presented in the usual, standard (formerly Vancouver, or similar) format. I'm presented with this:

 6,7. Efficacy of thixotropic nasal spray for seasonal allergic rhinitis assessed by a 4-hour and 3-hour allergen challenge in an environmental exposure unit.

 No authors, no information about date, or where it is published, etc etc. A quick google search finds what I assume to be the paper, although I have no way of confirming that due to the very poor referencing. Even the article itself tells you how to reference it, but the makers of Prevalin have happily ignored this

Luond-Valeskeviciute I, Haenggi B, Gruenwald J. Efficacy Of Three Thixotropic Nasal

Spray Preparations On Seasonal Allergic Rhinitis Assessed By Allergen Challenge In An Environmental

Exposure Unit . WebmedCentral ALLERGY 2010;1(10):WMC00993

So let's have a look at the three nasal sprays being used in this study then, they are referred to as IQM 11, IQM12, and IQM 13. The first study is a pilot, which uses IQM11. The other two are used in the second study.
Here's the ingredients for IQM 11: liquid paraffin, gylcerol, emulsifier (Glucate SS and Glucamate SSE-20), and water.

It's pretty unclear what the ingredients of the other two are, as they're not fully described. However I think the inference is that they have the same ingredients except for the emulsifier.

See any bentonite in there? any xanthan gum? any of the other ingredients that appear in Prevalin at all? No, me neither. There are other methodological problems with the studies too, but to be honest its not worth going into them now because they are unrelated to the product they are supposed to prove efficacy for.

So in summary: the two studies that the manufacturer's quote are actually the same study, poorly conducted and poorly written up, and about completely different products.

Would I buy this product if I had hayfever? Probably yes initially, because the nice trustworthy pharmacist man on the telly said its good and it works. Would I buy it having looked at the appallingly shaky evidence base for it? abso-blummin-lutely not. This is a shoddy effort, if you ask me, and at a cool £9.95 there is absolutely no way that its worth it.

If any patients ask me whether it works on my locum shifts, I will be very clearly telling them to put their money away and use the vaseline they've probably already got in the house instead.

UPDATE: 10/05/13 I'm reliably informed by a friend who is using this product out of desperation (and in spite of my ranting about it) that this product has an inconvenient habit of dripping back out of your nose at inopportune moments without much warning. Doesn't sound great, does it? In fact it reminds me a bit of the 'flatulence with oily seepage' side effect you can get with orlistat, only from your nose. Distinctly unpleasant. 

Homeopathic Harms Vol 7.1: Professional Ethics

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

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

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

1. Make patients your first concern
2. Use your professional judgement in the interests of patients and the public
3. Show respect for others
4. Encourage patients and the public to participate in decisions about their care
5. Develop your professional knowledge and competence
6. Be honest and trustworthy
7. Take responsibility for your working practices.

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

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

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

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

We are also advised to:

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

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

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

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

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

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

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

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

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

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

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

To be continued...