science

When real science gets left out in the Coldzyme

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

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

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

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

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

Medicine vs. Medical Device

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

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

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

The Evidence

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

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

The practicalities

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

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

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

To Summarise

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

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

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

Hxxx


Blowing a raspberry

Imagine there is a door in front of you. There is a person standing next to the door:

"Hey there, pudgy, do you want to be thin and beautiful without having to do any exercise at all? All you have to do is hand me some cash and step through that door there."

This person goes on to explain that if you step through the magic door, you will step out of the other side with a perfect, slim figure. You won't need to change your diet or do any exercise. You just need to walk through the door. They show you some glossy before and after pictures. There are pictures of beautiful, smiling people holding out the waistbands of their old elasticated tracksuit bottoms, so you can see just how much more skinny they are now.

There is a slight rumble from behind the door. You ask what is behind it.

"Oh, we don't know. But honestly, it'll work." 
"But is it safe?" you ask. 

"Oh yes, its perfectly safe" is the reply. "All you need to do is go through that door, and you will definitely lose all of that stubborn weight and absolutely nothing bad will happen to you whatsoever. Now if you'll just hand me your money there, that'll be great."   

Sounds great, right? You excitedly take a step towards the door.

But before you step through the door, you take a moment to consider what might be behind it.  You don't know, and the person telling you to go through the door doesn't know what's in there either. No one has studied what's behind the door. There are no photos and  no videos of what's in there. All you have is this person's word that it is safe, and it will work. 

Broadly speaking, there are three possibilities of what's behind the door:

  1. Nothing. Its just a room. You go through the door, and nothing happens. You don't lose any weight, but you have lost your money. 
  2.  It works. You step through the door and emerge as a smiling, happy, beautiful, skinnier you. You quickly run home to find some horrible grey tracksuit so you can smugly show everyone how marvellous you are now you're skinny.
  3.  Something harmful is in there. Maybe there is a big pile of dog poo right behind the door, and you are destined to step in it, which will be mildly unpleasant for you. Or the door could be perched on top of a cliff, below which is a mesh of razor blades that will cut you into little pieces. Worse than that, perhaps Piers Morgan is through there.

Do you step through the door? 

Now, I really do want to lose weight. But I also don't like being deceived, and I really don't like being harmed. I also really don't like Piers Morgan. 

All of which brings me nicely on to this season's most fashionable weight- loss aid, Raspberry ketone. Its the chemical contained in raspberries that makes them smell nice. Its widely used as a flavouring and fragrance agent in foods, which begs the question: if its so effective, why don't we already lose weight when we eat food that it is in?

You've probably heard about it already. By which I mean that you've probably seen someone on Twitter tweeting about how they lost 3000 kg using raspberry ketone, along with a handy link to a website where you can buy it. You've also then probably seen the follow up tweets, that go something along the lines of "Urgh, my account has been hacked. I've changed my password now, sorry."

And there's the first warning sign. People who make real medicines which work don't tend to need to resort to hacking people's social media accounts in a desperate bid to get people to buy their wares. You don't see Pfizer or Glaxo, for all their faults, hacking into random peoples' accounts and mass tweeting "My cancer is in remission thanks to Drug X. Buy it here!!!!". Its not a particularly ethical way to sell healthcare products.

Putting all of that aside, is there any evidence that raspberry ketones work as a weight loss aid?

In short: no, except for 18 mice and a difference of about 5 grams at most. Which also means there is no evidence that it is safe. There are no human studies out there at all. All of this hype about it is based on the fact that its chemical structure looks a bit like two other chemicals (capsaicin and synephrine) which might have some effects on weight loss.

That's a bit of a stretch. Human bodies are complicated things, and we can't always predict how they will react to medicines. Even when we theoretically think that something might work for good, plausible reasons, there's no guarantee that it will (COX-2 inhibitors come to mind as an example). Marketing raspberry ketone as a foolproof weight loss aid just because it looks a bit like some other chemicals is like finding a random key on a street and expecting it to work without fail on your front door, just because it looks a bit similar to your front door key. 

If you were to decide to take raspberry ketone, you would essentially be walking through that door. You might lose a bit of weight, or you might not. You might be harmed, or you might not. There's just no way of knowing right now.

Hxxx


Does XLS Medical Fat Binder weigh up?

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.

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

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 theDaily 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

Homeopathic Harms Vol 7: Professional Ethics

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

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

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

  1. Make patients your first concern

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

  3. Show respect for others

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

  5. Develop your professional knowledge and competence

  6. Be honest and trustworthy

  7. Take responsibility for your working practices.

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

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

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

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

We are also advised to:

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

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

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

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

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

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


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

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

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

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

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

 

Homeopathic Harms Vol 5: Interactions

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

In the next instalment of our series on the harms of homeopathy, I want to talk about interactions. I've covered this a bit in the past, but let's have a look at this area in a bit more detail.

We all hopefully know by now that homeopathic medicines pretty much have no trace of active ingredient in them by now. Do we need to worry about drug interactions with homeopathic remedies?
 

Can homeopathic medicines interact with conventional medicines?

The obvious answer is no. Magic Sugar Water Pills are highly unlikely to affect any conventional medicines. There's a lack of actual evidence to prove this, but I think it's pretty safe to rely on a theoretical basis here. So that's great, right, blog post over and see you later. If only it were that simple. 
 

Can homeopathic practitioners interact with conventional medicines?

Unfortunately, yes. very much so. It's pretty well known that homeopathic practitioners step over (and in some cases stomp over, then jump up and down repeatedly on) the boundaries between conventional and homeopathic medicines, just by the advice they give. One example would be vaccines- many homeopathic practitioners are against vaccines and therefore advise their patients to avoid them- Just look at the emails sent by pharmacist (and embarrassment to the profession) Tony Pinkus to an undercover BBC reporter. Little offhand remarks about the toxicity of conventional medicines, or big pharma conspiracies, or how conventional medicines might not work, all add up to the effect of harming the patient's relationship with their actual doctor. And how about the spectacular example of inappropriate advice in my previous post? 

Can conventional medicines interact with homeopathic medicines?


I'd like to say no here, because of course homeopathic medicines are inert and don't actually contain any medicine. It is the case, however, that homeopathic practitioners unfortunately think otherwise, which can lead to a huge amount of harm as patients discontinue their conventional medicine in favour of homeopathy.

I have in front of me a book called "Homeopathic Pharmacy", by Stephen Kayne. This is a book aimed at healthcare professionals, and indeed is a  recommended resource for medicines information pharmacists in the UK. (EDIT: This book no longer appears as a recommended source.) And yet, even this source, which we could consider to be one of the more balanced tomes (despite the ominous mention of Dana Ullman in the acknowledgements), contains a wealth of dangerous nonsense. This book tells me that, for example, "potent topical steroids are thought to negate the use of  homeopathy in the treatment of eczema and psoriasis" Now I know more than some that skin conditions such as this can be horrifically uncomfortable, not to mention their effects on your self-esteem. Stopping treatment that works in favour of a placebo is not, in my opinion, acceptable in any shape or form, especially given how vulnerable and desperate people can be because of skin conditions- don't forget that in some cases, dermatological conditions are terminal, as they can drive sufferers to suicide.  

There can, apparently, be interactions between oral steroids and homeopathy too. "the patient's symptoms tend to be masked, however, making an accurate choice of remedy much more difficult", we are told on page 205 of Homeopathic Pharmacy. Well, you could call it a masking of symptoms, or you could- as I prefer, refer to it as "working". So what is the average homeopath to do then, when presented with a patient who is taking steroids but seeking their help? It would seem that the obvious (but sadly not the ethical) solution would be to ask them to discontinue their steroids so that that the symptoms are "unmasked". This will obviously lead to an increase in symptoms for the patient, and lead to unnecessary suffering, but it can also precipitate acute adrenocortical insufficiency, which can in the worst case scenario be fatal. Patients should "ideally" discontinue their steroids for 6 weeks prior to initiating a homeopathic remedy- this is more than enough time to result in loss of control in their condition.  

It's not just drugs themselves that can be a problem, but the excipients (inactive ingredients used in the formulation of a medicine) too. Strong flavours used in syrups, for example. This could potentially discourage patients to take- or to give their child- antibiotic syrups, with the potential to worsen or prolong a patient's condition. 
 

Can foodstuffs interact with homeopathic medicines?

  
Yes, apparently so, though again there is no hard study evidence for this- why would there be, when there's no good hard study evidence that homeopathy works in the first place? Coffee, tea, cocoa, chocolate, and spicy foods are all to be avoided. Aside from being unnecessarily restrictive, and potentially causing a patient anxiety, this idea fills me with horror. Imagine a life without tea, chocolate, or spicy foods. I rely on all of these three things to get me through my daily life, and would inevitably become depressed if I had to avoid any of them.
 

Can homeopathy interact with homeopathy? 


I know, right? What a bizarre question, given that homeopathic remedies are sugar with specially shaken water sprinkled on. Can sugar interact with sugar? Well it seems that someone has decided that they can, based on a grand total of no evidence. Aromatic preparations, such as camphor, menthol, and peppermint, are supposed to inactivate other homeopathic medicines. Remember, though, that homeopathic camphor, menthol  or peppermint is highly unlikely to actually contain any molecules of camphor, menthol or peppermint, and we're left in a bit of a ridiculous situation based on nothing at all. 

It would seem that homeopaths utilize certain foods or remedies as "antidotes". Apparently, if a remedy isn't working, and they want to try something else, they might ask a patient to drink a cup of coffee, or take a remedy like camphor to "wash out" the previous remedy so that they can start again. I'll refer you again to "Homopathic Pharmacy"- with a reminder that this is one of the more reasonable texts:

"It is certainly not dangerous in life-threatening terms, but used injudiciously will interfere with the vibrational pattern of the vital force."

Vital force, vibrational energy, sugar as an antidote to sugar, and none of it- not a scrap- based on science, evidence, or even basic logic.

See you again soon for the next episode :)

Hxxx

Homeopathic Harms Vol 2. Where's the Evidence?

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

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

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

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

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

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

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

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


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

Firewalk with me: Science, Religion, and some very, very hot coals

Firewalking is, to be honest, great fun. I did it last year and I shall again be strutting over burning embers in a few week's time, to raise money for The Stroke Association, for which I would be very, very grateful if you were to throw your spare pennies in my direction.

I remember from last time that we were told in the pre-firewalk training that you needed the following three things to be able to firewalk successfully:

1. Fire connection- you have to know that it is a real-life fire, not a trick, and that it is going to be really, very hot. We were encouraged to go and hold our hands above the coals so that we knew that it was hot before walking. Apparently, if you tell yourself it's not hot, it just doesn't work.

2. A belief in a theory. You need to have some faith that it works, and that you're not going to end up as barbecue fodder. 

3. Intention to walk. You need to stand at the start of the walk, and know and want to walk across the fire. Supposedly there have been studies done where they blindfolded experienced firewalkers and they were unable to do it unless they knew when they were stepping onto the fire.

"They believe that the power of Saint Constantine—the religious power—allows them to do it and that that is a miracle," Source: National Geographic

Some people believe they're able to firewalk because of their aura and golden light coming from their heart chakras and that sort of thing. The evidence for this appears to be a couple of photos which I'd imagine could easily be explained by the fact that a) you're moving and b) you're walking on fire, usually in the dark so its pretty likely that there's going to be a bit of a glow on photos. 

Other people believe that it's God who allows them to firewalk, and indeed firewalking is an integral part of some religious rituals and is generally considered to be a very spiritual experience.

You'll hopefully know me well enough by now to know that I'm unlikely to go in for this as an explanation. Indeed I'd suspect that if there was a God in control of such matters there'd be even more likelihood of me getting toasted feet, and he's probably see to it that I got hit by lightning or something at the same time, just for good measure, to prove a point and to punish me for all my years of non-belief. Is there any evidence that this option is the truth? In short, no. 

So that leaves us with physics then. Now, it's been many years since I actually did any physics, and admittedly my physics teacher spent more time attempting to give electric shocks to a boy called Alistair than anything else, but I know enough to be pretty damn confident that out of all the options, this is the one that makes sense. It's all about conductivity- because coal and wood are pretty feeble conductors of heat, and because you're walking, there isn't enough time for the heat to transfer to your feet to cause any burning. The evidence for this? Well, lots. Sticking your hand in an oven is an oft-quoted example, and few people declare that to be a spiritual experience overseen by a God, do they? 

Here's the thing: does any of this actually matter? According to the guy who did our training last time, apparently not, as long as you believe that something will get you across safely, it doesn't really matter. If only such attitudes were employed in other aspects of life, one can't help but wonder how many lives would have been saved/made better. 

So does believing in science make firewalking a less impressive experience? Surely if you take out the belief in a protective spiritual presence it would lose its appeal, right? In truth, this couldn't be more wrong. It feels magical, and every bit as much like you are conquering the impossible as it must do for spiritual types. The fact that its caused by the physical characteristics of different types of matter doesn't make it any less transcendent, scary, or beautiful. 

Of course, having said all this it'll be just my luck that I'll end up in a burns unit after my next one. I hereby give you permission to laugh heartily if this is the case. 

I'll just leave this here again, just in case you want to lighten your wallets....
http://www.justgiving.com/Firewalk-WithMe 

Hxxx

A big steaming hot cup of skepticism in practice

The difference between skepticism and cynicism, so we skeptics often say, is that skeptics are willing to accept scientific evidence and adjust behaviour accordingly.

Today, I grudgingly put this principle into practice in one of the most important areas of my life. I have used science to change my behaviour. 

I am a passionate lover of tea. It is my life force, and runs through me, sustaining my body and soul, much in the same way some people would say qi does. And my whole life, I have been making tea in what I considered to be "the right way". Teabag in, pour water over, leave for a few minutes, put milk in. Any suggestion of a variation from this pattern would usually be enough to send to turn me into an angry, spluttering whirlwind of fury. I love tea so much that I even devoted hours of my life to school physics projects investigating the diffusion properties of differently shaped teabags. FYI, pyramid >> round=square

It seems, however, that science disagrees with me, so today I accepted this fact and have been making tea as recommended by science. In 2003, the  produced a press release, which states:

"Milk should be added before the tea, because denaturation (degradation) of milk proteins is liable to occur if milk encounters temperatures above 75°C. If milk is poured into hot tea, individual drops separate from the bulk of the milk and come into contact with the high temperatures of the tea for enough time for significant denaturation to occur. This is much less likely to happen if hot water is added to the milk." 

The office tea run. Doing it right, as per Science.

The office tea run. Doing it right, as per Science.

Now that I am finally aware of this scientific basis, I have realised the error of my ways. 

So this is me accepting the evidence, and accepting that, when it comes to making tea, I am wrong and have been all my life. I hereby follow science, and have joined the Milk In First brigade. 

Hxxx