MHRA cause Boots to remove homeopathic product and update website

Back in July, Boots had been promoting Nelson's Sulphur 30c homeopathic remedies, alongside a pdf to download to help you choose which homeopathic product you thought you needed, complete with therapeutic indications. (I hate it when I forget to cache a website that's being complained about. Never mind...)

After a complaint from this site, the MHRA contacted Boots and instructed them to change their website, using only the phrase

Nelsons Sulphur 30c Pillules is a homeopathic medicinal product without approved therapeutic indications

according to the current legislation. Boots have since removed the product completely, however the Patient Guide to Homeopathy is still on the website. MHRA are now aware of this and so hopefully it too will disappear soon.

Not that it matters really, because Holland & Barrett are selling Nelson's Sulphur 30c pillules, complete with therapeutic indications, and completely contravening the law. The MHRA are now aware, and the offending site can be seen here.
Indeed, even Nelson's own site deems itself above the law by claiming that the product is "known by homeopaths for its many skin benefits" which is woolly wording in my book, but we'll see what the MHRA do.


Fastest.Blogpost.Ever.

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Totally Hypothetical Remedy? - MHRA introduce certification mark for herbal remedies.

This is the new Traditional Herbal Registration certification mark. Well, it is apart from the 'Warning', which is what I think it is lacking.

According to the MHRA, this

indicates that the herbal medicine has been registered with the MHRA under the Traditional Herbal Registration (THR) scheme and meets the required standards relating to its quality, safety, evidence of traditional use and other criteria as set out under the Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC.

There have been 92 applications since the scheme began in March 06.

The most important line is this one:

Under this scheme, the permitted indications for the medicine are based on traditional usage and not on evidence of effectiveness of the product.

My bold. So, as I wrote before with homeopathy, as long as the seller can demonstrate safety of the product and a history of use for the particular therapeutic indication, then it can receive the THR stamp and be sold legitimately, despite there being no investigation into whether it works or not.

[The MHRA guidance states:

European Directive 2004/24/EC on traditional herbal medicinal products was brought forward specifically in recognition of the position that for many herbal medicines it was difficult for companies to meet the full requirements for a marketing authorisation, particularly in relation to efficacy.

So, because it was difficult to prove they had any efficacy, it was deemed best to create a class of 'pseudo-medicines' that could pretend to be effective, but didn't have to prove it.]

On a positive note, any product with this mark on it will single it out clearly and obviously to me as snakeoil - if it were a *real* medicine that, you know, actually had some effect, then it would be marketed as such and would have some evidence to back it up.

So, perhaps we should look at this stamp as a victory for evidence-based medicine, as it singles out products without any provable efficacy for all to see.

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"We are all individuals!" - The Comedy of Homeopathy

Poking fun at homeopaths and those that follow the religion of homeopathy is an easy game: it's an 18th century quack medicine that requires laws of physics and chemistry to be binned in favour of a belief system based on anecdotes and a denial of evidence.

There is plenty to go at: the pills are nothing more than sugar and water, diluted to near infinity, the followers have an unwavering belief in the power of the magic pill and the theory of homeopathy is so topsy-turvy it requires a huge amount of hand-waving and circle-squaring to make any sense out of it.

Time and time again it has been shown to be no better than placebo, despite the homeopathic high priests trying to cure AIDS, malaria and other diseases, sometimes at the expense of proven medicines.

One of the huge paradoxes in the homeopathic theory is the need to offer the patient an individualised medicine - remember the Homepathic Mantra:

Homeopathy heals the person, not the dis-ease

and on the other hand, sell bottles of homepathic medicine for specific ailments.

The idea that the sugar pills need to be indivualised, but also can sold in a popular dilution for a specific ailment is one that I have yet to hear any homeopath explain coherently.

Take a look at the Alliance of Registered Homeopaths' website for instance:

Homeopathic medicines are chosen to treat the whole person, because homeopaths believe the mind and body operate as one, and you cannot treat one part of the body without affecting the whole

which is followed in the next paragraph by, and seemingly without a hint of cognitive dissonance,:

The onion - Allium cepa - can be used homeopathically to treat colds and hayfever where the main symptoms include runny eyes and nose.

Similarly, the Society of Homepaths' website gives the following mangled idea:

What can homeopathy treat?

Homeopathy treats the person, there is some evidence to suggest it can help a person manage the symptoms of acute fevers, sore throats and toothache, to chronic illnesses such as arthritis, eczema, asthma, anxiety and insomnia.

Note the modifiers "some evidence", "suggest", "help", "manage" and "symptoms" - even with these language modifiers in place, it's still stretching the truth.

The pinnacle of this confused comedy came last January, when Napiers Herb and Plant Remedies held a workshop called "Homeopathy for Families" workshop. The advert has since vanished but I blogged about it back in the day. The workshop cost £20, but delegates would receive

a complimentary bottle of the homeopathic remedy Arnica.

Imagine if Pfizer ran a similar scheme, giving away a bottle of Viagra to each delegate? It would be popular, sure, but wholly, wholly unethical, immoral, and illegal.

I made the MHRA aware of this - and was faced with another crazy dichotomy in the up-is-down world of homeopathy. MHRA decided that because the product isn't licensed as a medicine,

the restriction on the distribution of free samples therefore did not apply

.

Compare this with the Alliance of Homeopaths Website:

Homeopathy is one of the two most widely used forms of medicine in the world today

So it's a medicine but not registered as a medicine. Black is white.

There is a push from within the Church of Homeopathy to register some of these sugar pills under the EU Homeopathic Registration (MLX312) scheme.

This scheme allows specific homeopathic preparations to be licensed for sale for specific therapeutic indication - to a backdrop of "treat the person, not the disease".

After all, we are all individuals.

BPSDB

Update on Glasgow Chiropractic

Back in July, I blogged on Glasgow Chiropractic's claims to cure asthma, carpal tunnel syndrome, colic and period pains.

Following a complaint to the General Chiropractic council, Glasgow Chiropractic tweaked their website to remove some of their claims and to included a surprisingly truthful statement that "Chiropractic has never cured anyone of anything".

Since then, they have completely revamped their website, bringing in a ChiroMatrix, a "leader in Chiropractic website design" with the strapline "Raising healthier families".

This is quite a subtle but interesting shift happening within chiropractic - Chiropractors are salespeople, and as any sales guru will tell you , integrating your business with your client as much as possible makes repeat business more likely and therefore the business increases profitability. No longer are chiros happy to hand wave and back-crack, if they can peddle a philosophy of constant need, regular checkups, and a long-term 'wellness plan', they are on their way to the bank because:

Every person is unique, therefore everyone requires a customised wellness plan. The purpose of our wellness program is for you to achieve good spinal alignment, have a healthy diet, exercise, and maintain a positive mental state.

Long termism, think more of the model of the dentist, rather than the doctor.

Phase 1 of the Glasgow Chiropractic's "What to expect" is initial intensive care. Here we find the Humpty Dumpty language of what it means to cure:

Chiropractic does not 'cure' anything! If you are looking for a list of symptoms that Chiropractic has been shown to 'cure' then you will just end up more confused than when you started.

No, you'll end up realising that there is no real evidence that chiropractic has any effect over placebo or similarly administered therapy. But they wouldn't say that, now would they? They'd rather call you 'confused'. I can understand how someone would be confused - here they repeat the 'chiropractic has never cured anyone of anything' line then one paragraph later state

There are many 'conditions' that Chiropractic care has shown to provide assistance with.

- there's glory for you!

Phase 2 is Corrective Care. Bearing in mind the push for repeat business, how does this sit with you:

In order to prevent a rapid recurrence of symptoms, it is often necessary to continue receiving care even though your symptoms are gone.

Nice little earner - a therapy which does nothing will continue to do nothing long after whatever it was it was supposed to do is not even needed! Taking a leaf out of the homeopaths book, they have the 'heads-I-win-tails-you-lose' argument -

Do not be discouraged if you have mild flare-ups in your symptoms on occasion. This is normal.

Homeopaths have a similar get-out clause - called aggravation. i.e. if the problem gets better it shows the sugar pill is working, if the problem gets worse, it still shows the sugar-pill is working. Similarly with Chiropractic, if the pain goes, it was due to chiropractic, if it doesn't that in no way means that the therapy is not beneficial - how can you lose! As sugar on top,

this phase of your care may last anywhere from a few months to a couple of years.

Kerr-ching!

Phase 3 is Wellness Care

When you make routine chiropractic care a part of your lifestyle, you avoid many of the aches and pains that so many people suffer through, your joints will last longer and you will be able to engage in more of the activities you love.

A completely unfalsifiable statement, but a slick sales ploy nonetheless.

It turns out that

Some of our offices are equipped with the very latest in technology designed to non-invasively test your nervous system very accurately. This technology uses a number of cutting edge techniques to give you a very detailed report on the integrity of your spine and nerves. These systems are called the 'Discovery Insight' or the 'Neuro-Infiniti' - please ask at reception about what technologies apply to you.

Doesn't that all sound very sciencey and exciting! Here is a bit more information on the Discovery Insight Subluxation Station. (Bear in mind, subluxations are a very undefined woolly concept in chiropractic, with no real agreement about what they are, so how anything can 'detect' them is a mystery). From the ad, it was used by NASA - oooooh.

Except it wasn't, as they've distanced themselves from it. Indeed, the Chiropractic Journal has launched an investigation regarding the sales practices of the companies behind such machines. Without a hint of irony they state:

The Chiropractic Journal has 23- year history of representing doctors of chiropractic and watching their backs. We will not sit by and see doctors taken advantage of by charismatic salesmen concerned and motivated purely by profit.

Spoing!

One last bit on Glasgow Chiropractic, in case you had thought they had launched the "cure nothing/heal the person" Chiropractic 2.0 free of therapeutic indications, here is a photo of the Glasgow Chiropractic stand in an East Kilbride shopping centre, complete with old school (and removed from their website) claims of colic.

I'll be sure to let the Advertising Standards Authority know.



So either their stand or the website is talking rubbish. I reckon it's both.

H/t to Blue Wode and Zeno

BPSDB

Magic Smokescreen - homeopathy & cigarettes

Smoking is big business.

According to the Tobacco Manufacturers Association consumer spending on tobacco products in 2007 amounted to £12.6 billion. This led to tax revenue amounting to £9.9 billion - £8.0 billion in excise duty plus £1.9 billion in VAT.

Then there's the aftermath - according to Medical News Today, the global smoking cessation aids market is to reach $2.6 billion By 2010.

Quite the lucrative industry all in all.

There are all manner of products to try and wean the addict from the evil weed, with varying degrees of success, but surprise surprise, they all require will power and rely on the person concerned having a genuine desire to give up.

It shouldn't really come as a surprise for this to be a booming industry. It is notoriously hard to give up, compounded by the fact that people know it is notoriously hard to give up and that provides its own psychological barriers. To be cynical for one second, a product which relies on will-power (regardless of whether it is Big Pharma or Big Quacka), will help to ensure repeat sales from people who won't give up giving up, and keep the tills ringing for many a moon.

This is happy home turf for homeopathy - a placebo remedy that depends largely on the psychology of the person, and not at all on the sugar pill. Failure is due to lack of will-power, success is due to homeopathy. FTW!

Despite it being illegal to sell homeopathic products in the UK with therapeutic indications (unless licenced by the Medicine and Healthcare product Regulatory Agency), it is possible to buy homeopathic products marketed at the smoker.

How about a homeopathic anti-smoking spray from Smoker Stop Shop?

Spray away your cravings (for tobacco smoke or chewing tobacco) with Smoke Control homeopathic oral spray. It helps with nervousness, anxiety and irritability when quitting. It can also help with cough or shortness of breath, difficult breathing and the sensation of weight on your chest from smoking.

Or what about those homeopathic detox tablets and anti-craving lozenges further down the page

Drug Facts
Active Ingredients (per lozenge) Purpose
Caladium seguinum 4x, 12x, 30x Reduces tobacco cravings
Plantago major 4x Reduces tobacco cravings
Cinchona officinalis 6x, 12x, 30x Reduces tobacco cravings
Lobelia inflata 6x Reduces ill effects of nicotine
Nux vomica 6x, 12x, 30x Reduces tobacco cravings
Staphysagria 6x Reduces ill effects due to tobacco
Calcarea Phosphorica 12x Reduces tobacco cravings
Ignatia amara 12x Reduces nervous tension

Seems like pretty straightforward indications for homepathic products to me.

For the interested few, I'm led to believe that 4x dilution is equivalent to a 2c concentration. This means that 1 drop of the mother tincture has been diluted in 99 drops, hit against a magic board (succussed) and then a drop of that taken and diluted in another 99 drops and succussed again. This means that although the product is dilute, there is still some 'active' in the sugar pill. i.e it's not a homeopathic remedy in reality, it's only labelled that to pass US Food and Drug authority regulations. This crazy loophole which means that products containing 'actives' can be called homeopathic and thereby politely excuse themselves from the rigours of normal drug testing. This can mean that the untested pseudo-homeopathic products have massive unknown negative side effects and cause problems in the users - ZiCam is the most recent example. A pseudo-pseudoscience, if you will.

This can lead to all sorts of wacky products like homeopathic nicotine water being sold (I'm sure I can get hold of some bong-water and sell that?) - but only in US, right? Our strict laws wouldn't allow such quackery to be sold in UK?

As ever there are loopholes. Just because a site has got a '.co.uk' domain name doesn't mean it comes under UK law. As I found when I contacted my MP about a quack arthritis product called Artrosilium and put a written question to the Department of Health, the UK's position is that

The importation of medicines by individuals for their own personal use or for use by a family member is exempt from regulatory controls, and this includes purchases from the internet.

Dawn Primarolo signed the letter. Trading Standards have recently been warning people about false confidence in '.co.uk' websites with consumer goods - surely untested imported medicines with their uncontrolled, unregulated ingredients should be given higher priority than a few knocked-off hair-straighteners?

So who runs the Smoker Stop Shop (www.smokerstopshop.co.uk)? That is one Penelope Walford, who runs a private clinic in Harley Street and refers to herself as a 'smoking cessation specialist' using hypnotherapy as her main tool.

[A Cochrane Review asking "Does hypnotherapy help people who are trying to stop smoking" concluded that

We have not shown that hypnotherapy has a greater effect on six month quit rates than other interventions or no treatment.

So much for that, then. No doubt she has many positive testamonials - most placebo treatments do, and present them in place of real evidence]

So how can Penelope Walford sell homeopathic products in the UK with therapeutic indications, which is against the law? I've asked MHRA the same question - I'll let you know the response.

The idea that homeopathy can do something for smokers to help them kick the habit is quite widespread. Other UK-based companies that seem to be up against the law are The Body and Mind shop and i-Quit, with the media, helpful as ever, to give a hand to evidence-free nonsense. Yet surprisingly, few of them seem to require the major magic ingredient that known to give results - willpower.


H/t to Blue Wode

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Beware The Spinal Trap - Lawyer-friendly reprint

Just in case you haven't been to your chiropractor in the last little while due to the recession, there has been a maelstrom.

Science writer Simon Singh wrote an article for the Guardian which the British Chiropractic Association claimed libelled them and so went the way of the courts. Justice Eady decided there were words used which conveyed a meaning which Singh had not intended, but that the case should go to trial nonetheless. Singh is appealing the decision.

In the meantime, the searchlight of skepticism was directed towards chiropractic. Hundreds of complaints were sent to the General Chiropractic Council meaning the GCC were unable to cope with the volume of complaints and causing some chiropractors to rapidly remove or rehash their websites, with some of them throwing in the towel and admitting that Chiropractic has never cured anyone of anything.

Sense about Science has been working with Singh to campaign to keep libel laws out of science.

As part of that, they have arranged for Singh's original article to be scanned by lawyers, have the few words removed that were called into question, so that the article can be reprinted without fear of libel. The important point of this article is that, the whole feel, meaning and impetus is unchanged by the removal of a few contentious words. The thrust of the article is the statement of fact that there is little/no evidence for most (all?) of the claims of chiropractic.

I am pleased to reprint the lawyer-friendly article below - it should also be noted that the BCA have no issue (and therefore tacitly agree with?) everything in the article below.

Beware the spinal trap

Some practitioners claim it is a cure-all, but the research suggests chiropractic therapy has mixed results – and can even be lethal, says Simon Singh.

You might be surprised to know that the founder of chiropractic therapy, Daniel David Palmer, wrote that “99% of all diseases are caused by displaced vertebrae”. In the 1860s, Palmer began to develop his theory that the spine was involved in almost every illness because the spinal cord connects the brain to the rest of the body. Therefore any misalignment could cause a problem in distant parts of the body.
In fact, Palmer’s first chiropractic intervention supposedly cured a man who had been profoundly deaf for 17 years. His second treatment was equally strange, because he claimed that he treated a patient with heart trouble by correcting a displaced vertebra.
You might think that modern chiropractors restrict themselves to treating back problems, but in fact some still possess quite wacky ideas. The fundamentalists argue that they can cure anything, including helping treat children with colic, sleeping and feeding problems, frequent ear infections, asthma and prolonged crying – even though there is not a jot of evidence.
I can confidently label these assertions as utter nonsense because I have co-authored a book about alternative medicine with the world’s first professor of complementary medicine, Edzard Ernst. He learned chiropractic techniques himself and used them as a doctor. This is when he began to see the need for some critical evaluation. Among other projects, he examined the evidence from 70 trials exploring the benefits of chiropractic therapy in conditions unrelated to the back. He found no evidence to suggest that chiropractors could treat any such conditions.
But what about chiropractic in the context of treating back problems? Manipulating the spine can cure some problems, but results are mixed. To be fair, conventional approaches, such as physiotherapy, also struggle to treat back problems with any consistency. Nevertheless, conventional therapy is still preferable because of the serious dangers associated with chiropractic.
In 2001, a systematic review of five studies revealed that roughly half of all chiropractic patients experience temporary adverse effects, such as pain, numbness, stiffness, dizziness and headaches. These are relatively minor effects, but the frequency is very high, and this has to be weighed against the limited benefit offered by chiropractors.
More worryingly, the hallmark technique of the chiropractor, known as high-velocity, low-amplitude thrust, carries much more significant risks. This involves pushing joints beyond their natural range of motion by applying a short, sharp force. Although this is a safe procedure for most patients, others can suffer dislocations and fractures.
Worse still, manipulation of the neck can damage the vertebral arteries, which supply blood to the brain. So-called vertebral dissection can ultimately cut off the blood supply, which in turn can lead to a stroke and even death. Because there is usually a delay between the vertebral dissection and the blockage of blood to the brain, the link between chiropractic and strokes went unnoticed for many years. Recently, however, it has been possible to identify cases where spinal manipulation has certainly been the cause of vertebral dissection.
Laurie Mathiason was a 20-year-old Canadian waitress who visited a chiropractor 21 times between 1997 and 1998 to relieve her low-back pain. On her penultimate visit she complained of stiffness in her neck. That evening she began dropping plates at the restaurant, so she returned to the chiropractor. As the chiropractor manipulated her neck, Mathiason began to cry, her eyes started to roll, she foamed at the mouth and her body began to convulse. She was rushed to hospital, slipped into a coma and died three days later. At the inquest, the coroner declared: “Laurie died of a ruptured vertebral artery, which occurred in association with a chiropractic manipulation of the neck.”
This case is not unique. In Canada alone there have been several other women who have died after receiving chiropractic therapy, and Edzard Ernst has identified about 700 cases of serious complications among the medical literature. This should be a major concern for health officials, particularly as under-reporting will mean that the actual number of cases is much higher.
If spinal manipulation were a drug with such serious adverse effects and so little demonstrable benefit, then it would almost certainly have been taken off the market.

Simon Singh is a science writer in London and the co-author, with Edzard Ernst, of Trick or Treatment? Alternative Medicine on Trial. This is an edited version of an article published in The Guardian for which Singh is being personally sued for libel by the British Chiropractic Association.

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Acupuncture needles no good as toothpicks...

...yet funny enough toothpicks are just as good as acupuncture needles for providing relief of lower back pain.

The reference is

DC Cherkin et al. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Archives of Internal Medicine 2009 169: 858-866

but evidence-based healthcare knowledge collater, Bandolier has written a plain, easy-to-digest synopsis of the paper here.

The study looked at four therapies; individualised acupuncture, standardised acupuncture, simulated acupuncture with toothpicks and lastly, usual care. From Bandolier:

This large trial involved 638 adults, with follow up of 90% or above up to 52 weeks. Participants had an average age of about 47 years, with about 60% being women. About 70% had back pain for at least a year. The average initial RMDQ score was about 10.5 on a 0-24 scale, and average initial bothersomeness score 5 on a 0-10 scale.

The main results were these:

* There was no difference between individualised acupuncture, standardised acupuncture, or sham acupuncture.
* RMDQ scores fell from 11 to 6 for acupuncture of any sort by 52 weeks, compared with 7.9 for usual care. Any form of acupuncture was better than usual care.
* Bothersomeness scores fell from 5 to 3-5 to 4 for all four groups, with no difference between them.
* Use of medications (about 65% at baseline) fell to 47% with acupuncture, but remained at 59% with usual care.
* There was no difference in SF-36 mental and physical component scores.
* Cutting down on usual activities for more than seven days in the last month at 52 weeks was more common with usual care (18%) than with acupuncture.
* More participants with usual care missed work or school for more than a day (16%) than with acupuncture (5%-10%).
* There was no difference in total costs of back related health services between groups ($160-$221), though costs of acupuncture were not included.
* Adverse events occurred in 12/315 with real acupuncture, compared with 0/162 for simulated acupuncture, with one serious adverse event for real acupuncture.
* One patient in the usual care group went on to have back surgery.

There are a few interesting things that came out of the study.

The difference between standard care and intervention is significant, and confirms previous discussions suggesting the more theatrical the intervention the larger the placebo effect.

Secondy, the cost comparison is interesting - no real cost difference, and indeed acupuncture costs weren't included. So even the 'cost effective' argument is unfounded.

Thirdly, adverse effects - one serious adverse effect and 12 lesser, compared with zero for the toothpicks. This means about 4% of the patients had an adverse effect from a treatment which had absolutely no demonstrable benefit compared to toothpickery.

So let's see: there's no patient benefit, no cost benefit and increased risk of adverse effects. So why are NICE approving it for lower backpain?

Perhaps I'll drop them a line.

(How long do you reckon it'll be before a quackupuncturist declares that this proves acupuncture works, and the toothpicks were "accidently" letting the Qi energy move as it should?)

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