The Quackometer

This Saturday, hundreds of people, in many cities,  will be demonstrating outside Boots the Chemists about their selling of homeopathic remedies. Each volunteer will be taking a homeopathic ‘overdose’ of a Boots homeopathy product to demonstrate that there is nothing in the tablets but sugar.

Out of all the volunteer ‘overdosers’ and their supporters in the 10:23 campaign, there may well be many reasons for taking part. The homeopaths think this is a conspiracy by Big Pharma and that the demonstration proves nothing. They are entirely missing the point. But the main point, and the one I would emphasise, is that this mass overdose is designed to embarrass the pharmacists who sell these pills to the public in the full knowledge that they are useless.

The pharmacy profession has been granted statutory privileges to dispense medicines to the public. They do so under a code of practice that insists they do act with ‘honesty and integrity’, that they do not ‘exploit the vulnerability or lack of knowledge of others’, and that they “provide accurate and impartial information to ensure that [they] you do not mislead others or make claims that cannot be justified”

When pharmacists on the high street accept cash for homeopathic pseudo-medicines that promise to relieve their customers of hay fever symptoms, help insomnia, or sooth a baby’s teething pain, they appear to be ignoring their professional standards in the pursuit of profits.

The pharmacists have evolved from the ancient protected trade of apothecaries. Since the middle ages, the state has afforded certain privileges to apothecaries to formulate and dispense medicines. Historically, these privileges have been seen as a restraint on trade by outsiders wishing to cash in on people’s desires for medicine, and as a necessary state by their supporters against rogues, quacks and charlatans.

Indeed, Samuel Hahnemann, the founder of homeopathy had a very unhappy relationship with apothecaries. He felt he was being persecuted by them for allowing people to dispense their own cures. But deeper than that, his philosophy of homeopathy made it impossible for a person to simply walk into a high street store, select a remedy they required and ask an apothecary to make it up for them. Homeopathy had to be ‘individualised’ to the patient, and this was something only a skilled homeopath could do – and not some mere dispenser of medicines.

Indeed, in an exam paper that Hahnemann set for a doctor who wanted to practice Homeopathy, the tenth question, in leading terms, made this quite clear,

10. Why can the homoeopathic medicines never be dispensed by the apothecary without injury to the public?

Any true homeopathic practitioner should object strongly to the idea of a mere dispensing chemist handing out homeopathic cures.

But his objections also recognised the direct conflict between both the financial needs of the apothecary and the nature of their beliefs and training.

In a letter to a friend, Hahnemann wrote,

I do not wish to go to the town of Altenburg itself, to be in the way of you, dearest friend, and of your colleagues. I only wish to be able to settle in some country town or market village, where the post may facilitate my connexion with distant parts, and where I may not be annoyed by the pretensions of any apothecary, because, as you know, the pure practice of this art can only employ such minute weapons, such small doses of medicine, that no apothecary could supply them profitably, and owing to the mode in which he has learnt and has always carried on his business, he could not help viewing the whole affair as something ludicrous, and consequently turning the public and the patients into ridicule.

For these and other reasons it would be impossible to derive any assistance from an apothecary in the practice of homoeopathy.

As is often the case, Samuel Hahnemann is spectacularly wrong in the most interesting ways.

Firstly, Hahnemann appears to believe that you can only sell a medicinal product in proportion to the amount of substance you are vending. Indeed, as the amount of substance is proportionate to its effects, then this would be a common sense view. However, the absurdity of homeopathy is that it subverts the obvious. Hahnemann postulated that the more dilute a substance, the greater the effects. (A claim never substantiated, of course).

However, Boots the Chemist, and other modern day apothecaries understand that what it is in the pill is irrelevant. What the pharmacists in Boots are selling is not the substance of the pills (as there is quite simply nothing in homeopathic remedies bar the sugar), but a promise based on both the trusted brand of Boots and the professional standing of pharmacists.

And with that trust in the Boots brand and the authority of the pharmacist nearby behind the counter, you can charge quite a lot for worthless sugar pills. Boots homeopathic Teething Pain Relief powders contain less than 1 part in a trillion of active ingredient (and there is not even any evidence that the active ingredient does anything). They sell for nearly £5. This pseudo-medicine will do nothing for a distressed baby apart from make the parent think they are doing something and make Boots shareholders a little richer.

The professional code of ethics of a pharmacists would suggest that they are required to provide the customer with all the “necessary and relevant information”. It is surely necessary to inform someone that they are buying a worthless product that cannot work as described and there is no reason to suppose it does. Pharmacists must fall into two camps here: those that believe that homeopathic preparations do work as described, in which case they are simply incompetent, and those that shut up for fear of their jobs and for an easy life.

As David Colquhoun noted some time ago, the real villains here are the regulators of the pharmacy trade, the Royal Pharmaceutical Society of Great Britain. They issue advice to their members about how to interpret their code of ethics when selling homeopathic quackery (under the ironic heading ‘Pharmacists - the scientists in the high street’), and what advice to give to the public. Nowhere does it suggest that you ought to tell the customer that they are buying magic pseudo-medicine.

To add to the rogues’ gallery we must also add the Medicines and Healthcare Products Regulatory Agency (the MHRA) who grant licenses to homeopathic sellers to make claims for their products that cannot be justified by any form of evidence or rationale. They preside over a regime that has allowed the pseudo-apothecaries, such as Neal’s Yard Remedies to sell homeopathic pills for the prevention of malaria. Their light touch on the issue appears to almost offer a wink to the sellers that they can get away with anything.

The 10:23 campaign will almost certainly not stop Boots selling this quackery. There is too much money in it. Perhaps the biggest effect of the demonstration will be to raise some awareness of what your local ‘scientist on the high street’ is prepared to sell you. This should make you angry that your trust is being abused. If you cannot trust them to tell the simple truth about such obvious nonsense as homeopathy, why should you trust them on more important matters, such as the side effects of real medicines?

I shall leave my last words to repeat those Samuel Hahnemann, who showed some unusual insight when he said that,

he [the pharmacist] could not help viewing the whole affair [homeopathy] as something ludicrous, and consequently turning the public and the patients into ridicule.

And that is the pharmacists’ shame: using their trusted position to make fools of the public.

Labels: 10:23 campaign, homeopathy, MHRA

 

Further documents have been published after the House of Commons held its enquiry into the evidence base for government policy on homeopathy. There are some real treats in there, but I am most concerned about new evidence from the Medicines and Healthcare Products Regulatory Agency (the MHRA) on how they test the public’s understanding of the labeling of homeopathic products.

The new document was submitted to the enquiry after Professor Kent Woods (pictured) was challenged over how the regulator allows homeopathic products to make claims on their labels when it is known that these claims are false. The concern is that a customer could walk into Boots the Chemist and see two products for, say, hayfever and be unaware that the homeopathic product has no active ingredient, is just a sugar pill and will not help the relief of any symptoms. Clearly, this is a very unsatisfactory situation, where the medicines regulator is charged with ensuring medicines are safe and do what they claim but appears to wave homeopathic products through without regard to these principles. The public are being badly misled by the people charged with protecting them.

In the enquiry, Evan Harris MP asked a very pertinent question of Professor Woods,

Do you think that people reading that will think that it works for symptomatic relief of those minor conditions, or do you think that label that you have read out - and please feel free to read it out again - would make the average person think, which is the truth, as far as you are concerned, that there is no evidence of efficacy backing it up. Which of those two do you think is most likely, for the average person?

At is issue is the question of how far the MHRA go to ensure that the public are not being misled by the labeling they authorize on homeopathic products.

Professor Woods response was,

Well, fortunately, by law all packaging and patient information leaflets are subjected to user testing to ensure that they are comprehensible to the man in the street, and indeed that seems to be a very straightforward statement of the reality. This is a homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of sprains, muscular aches and bruising or swelling after contusions. That is what it says and the user testing is part of the approval of that leaflet, has the labeling been tested on the average man in the street.

This did not satisfy the MP, Dr Harris,

Sadly my question was not "What does it say? Has it been tested?" My question is, and maybe it is the result of this testing and you need to tell me, does the average person think that that label suggests that it is going to be useful for the symptomatic relief of those indications?

This is an important question. Does the MHRA care if the public are misled by homeopathic labeling or not? What do people make of the labels?

The new documents posted on the House of Commons web site shed light on this question.

It is worth reporoducing the test questions that are used to establish what people make of the labeling on a homeopathic product:

Three rounds of user testings were carried out with ten participants in each testing. Twelve questions relating to the key safety messages were asked and were designed to assess whether the respondent was able to find the information, understand it and use the information. The questions asked were as follows:

1. Can you tell me the name of this medicine?

2. What does the label say that this medicine is for?

3. If you take too much of this product (overdose) what does the label tell you to do?

4. Is there any advice on the label for women who are pregnant or breast feeding?

5. What does the label say is the active ingredient in this medicine?

6. If you have missed a dose of this medicine, what does the label tell you to do?

7. Once you have opened your medicine, how does the leaflet tell you that you should store it?

8. This medicine contains Arnica Montana 30C. What are the other ingredients in this medicine?

9. How many pillules are there in the Clikpak container?

10. This medicine contains lactose and sucrose which are types of sugar. If you have an intolerance to some sugars, what does the pack tell you to do before taking this product?

11. How many pillules does the pack say that you should take in a dose and how many times a day should you take them?

12. The pillules in this medicine are contained in a plastic Clikpak to help protect them. What instructions does the label give you as to how to dispense the pillules from the Clikpak?

These questions fail to address the central concern that labeling homeopathic products for the relief of specific symptoms is going to mislead patients into thinking that there is reason to believe this is true and that there is evidence to back up the stated claims. In my opinion, the MHRA is complicit in supporting a fraud on the public.

Question 2 is quite insidious in my view. It tests to see if the subject understands the medicine is targeted at specific conditions, when there is no evidence to suggest that the medicine can help. What would the answer to the question mean? Question 5 implies there is an active ingredient in the pill. If the test subject answered ‘Arnica’ would the MHRA conclude that the patient has been deceived by the packaging or has just read the label and concluded that it is telling the truth?

Question 8 explicitly states that the pill contains “Arnica Montana 30C”. Only someone with a good understanding of the nonsensical production methods of homeopathy would appreciate that this means that the pill does not contain any Arnica (it has all been diluted away). What would the average customer on the street conclude? In the original hearing, Professor Woods states that the labeling is designed for people who believe in homeopathy,

To begin with the fact that this is a homeopathic remedy, we are making provision for a group of people who believe in homeopathic remedies and, therefore, the first thing to establish is that this particular remedy is recognised by homeopathic practitioners as a homeopathic remedy. That is the essence of what we are trying to prove.

This is simple nonsense, as the products are likely to end up on the shelves of Boots where people may simply misread ‘homeopathic’ as ‘natural’ rather than ‘batshit magic pseudo-medicine’, the wording that ought to be on the label.

The MHRA appear to completely miss the point over homeopathy. As I have written before, they fail twice over. Firstly, they endorse misleading labels on homeopathic products and fail in their primary mission to “ensure that medicines and medical devices work.” Secondly, they appear to be blind to the blatant abuses that do go on in the creation of homeopathic medicines where claims are made explicitly and implicitly without even seeking MHRA approval.

The mistake that all regulatory efforts from this government has made is to attempt to regulate alternative medicines as if they were medicines. They are not: they are pseudo-medicines and need a different style of thinking. Trading Standards should take a more leading role in prosecuting misleading claims as they would with any other consumer product. The MHRA need to stop feeling they need to treat homeopathy as if it were medicine and give special dispensations in the claims that they can make. As with any other medicine, homeopathy should only be allowed to make claims if they can back them up with sound evidence.

I understand that there are some efforts within the MHRA to look into the issues I have raised with them. It has been several months since I last heard from the investigating officer involved. My first enquiry took 17 months for a response. In the meantime, I hope the the upcoming publication of the House of Commons Evidence Check report into homeopathy will be severely critical of them for presiding over a regulatory regime that endorses the homeopathic trade in misleading the public.

Labels: 10:23 campaign, homeopathy, MHRA, regulation

 

The Medicines and Healthcare products Regulatory Agency (MHRA) have been heavily criticised in recent years for abandoning their core mission by allowing homeopathic sugar pills to contain statements about what symptoms and illnesses they can be used for without having to provide evidence that this is true.

The MHRA mission and values:

Mission
The MHRA’s mission is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe.

Values
In pursuing our mission we will strive to act with:

• integrity;
• openness;
• courtesy;
• responsiveness;
• timeliness;
• professionalism;
• impartiality; and
• consistency.

The MHRA allow sellers to submit evidence from homeopathic ‘provings’ as evidence. A proving is where a homeopath takes a new type of homeopathic pill to see what symptoms it generates. Homeopaths believe ‘like cures like’, so an onion, which makes your eyes stream, can cure hayfever – allegedly. However, homeopathic pills have been so diluted that no ingredients actually remain. What homeopaths ‘prove’ is plain sugar pills – any symptoms they note are either coincidental or imaginary. This is the first failure of the MHRA to allow such nonsense methods to act as a guide to efficacy.

In order for a homeopathic pharmacy to make claims, they must submit the evidence from their provings. So, far few submissions have been made. And yet, homeopathic pharmacists continue to sell many sugar pills, with indications, with no license and apparently with impunity. Is the MHRA even failing to uphold its own rules?

I tested this out.

Over a year ago I was invited to speak at London’s Skeptics in the Pub. I chose to speak about the dilemmas of regulating quackery. As part of my preparation, I visited London’s Nelson’s Homeopathic Pharmacy just off Oxford Street. I went in and said I needed something for an upset stomach and that I had diarrhoea. “Do you have anything like Imodium?” I was told that the stuff they has would not just ‘suppress my symptoms’ but get to the bottom of my problem – so to speak.

I was handed a little green container of white sugar pills labelled ‘Traveller’s Diarrhoea’. The full label read:

TRAVELLER'S DIARRHOEA

RELIEVES SYMPTOMS OF DIARRHOEA & VOMITING DUE TO

CONSUMPTION OF UNWASHED FRUITS, VEGETABLES, BAD MEAT

OR FISH. DOSAGE. TAKE 2 TABLETS EVERY HOUR UNTIL BETTER

ARSENICUM 30/PODOPHYLUM 30/PYROGEN 6/CARBO VEG 30/NUX

VOMICA 30

EXP 12/12 KEEP OUT OF CHILDRENS REACH

NELSON'S HOMEOPATHIC PHARMACY

73 DUKE STREET, LONDON W1K 5BY 020 7629 3118 P

The number 30 is significant because it means the ingredients have been diluted to 1 part in 10 to the power of 60. (that is 30 sequential dilutions of 1 part in 100). In other words – the pills I got were just plain sugar pills with no active ingredients.

Now, remember – like cures like. So being actually healthy at the time, if I had taken one of these pills I would have ‘proved’ the pill and developed the symptoms. Not wanting to do a crude experiment of n=1, during my talk at Skeptics in the Pub I handed them out to the crowd so that dozens of brave and selfless sceptics had the chance to develop a rather uncomfortable journey home.

We downed our pills, and thankfully, due to science, we all remained rather intact and the pub landlord did not have to clear up a rather horrible mess.

On the 28th of March 2008, I submitted an enquiry to the MHRA suggesting that this might be an illegal product as it had no marketing authorisation. On the 14th of April 2008 I was told that the case had been passed onto the MHRA's Enforcement and Intelligence Group.

Now you may have noticed that the MHRA’s listed values include

• responsiveness;
• timeliness;
• professionalism;

25th August 2009

I have been informed by our Enforcement Unit that an investigation has taken place in response to your complaint below. The outcome of the investigation is that following advice from the Enforcement Unit, Nelson's have removed the product you mentioned from their display shelves.

Regards,

Yes, timeliness in this case means 17 months.

It may also come as a bit of a shock to find this product still for sale on Nelson’s website. It may have been ‘removed from the shelves’ but is still advertised on the web. You can also see other similar products that are intended to cure constipation, accident & injury, allergic reactions, bites & stings, hangover & indigestion, heat exhaustion, jet lag, and sun exposure. All the same sugar pill.

In fact, the Nelson’s web site is riddled with products that make specific claims and that do not appear to have any marketing authorisation.

Some examples:

• Migraine Headaches (Helps with migraine symptoms.) http://www.nelsonshomeopathy.com/shop-online/Migraine-Headaches_prod1628.aspx
• Morning Sickness Relief (To help relieve symptoms of morning sickness....) http://www.nelsonshomeopathy.com/shop-online/Morning-Sickness-Relief_prod1629.aspx
• PMT (To help relieve symptoms of premenstrual tension.) http://www.nelsonshomeopathy.com/shop-online/P.M.T._prod1634.aspx
• Sore Throat (To help relieve symptoms of sore throat) http://www.nelsonshomeopathy.com/shop-online/Sore-Throat_prod1639.aspx
• The Nelsons Quit Smoking Kit http://www.nelsonshomeopathy.com/shop-online/The-Nelsons-Quit-Smoking-Kit_prod1664.aspx

So, what’s the harm? On the face of it, all the consumer will be getting is some sugar pill placebos and so there can be no more harm than any other homeopathic remedy. But the harm comes when the purchaser may well be relying on specific effects.

We saw recently how Neal’s Yard Remedies were selling sugar pills to customers and telling them that these could prevent malaria. The BBC undertook an investigation and interviewed their ‘Medicines’ Director, who stormed out of the meeting after being asked if this was ethical and legal.

After the BBC forwarded on their evidence, the MHRA investigated and slapped their wrists. That was it. Despite the appallingly irresponsible nature of Neal’s Yard behaviour the MHRA saw fit not to prosecute. I for one, was quite shocked.

The MHRA appear to be quite tolerant of homeopathic pharmacies sales processes. Why should this be? Could the MHRA think it not worth the effort to better police this sector? Are they under other influences to tread softly here?

I do not know. But the problem is deeper and more entrenched than even these problems suggest. Homeopaths are a group explicitly opposed to real medicine. They define their product in terms of direct opposition to medicine. From its first invention, homeopathy made grand claims to universality and having found the true philosophy of curing illness. All other approaches were heresy and to be opposed. This is what makes the vipers nest of homeopathy so insidious as a source of anti-scientific thinking about disease which leads to more widespread problems such the stubbornly unreasonable anti-vaccine movement.

We can see this foundation of anti-vaccine thinking in many homeopathic products. A large fraction of the Ainsworths medicine cabinet consists of homeopathic versions of vaccines. These are often in the form of what homeopaths call nosodes where some diseases tissue or some other ‘infectious’ agent is taken and serially diluted and shaken and probably banged against a leather bible many times to create the homeopathic witchcraft pill. Look at the remedy lists of Ainsworths and you will see a product for each Influenza strain going back 20 years. You will find homeopathic replacements for Measles vaccine, Parotitis vaccine (mumps) and Rubella. You find homeopathic sugar pills for all forms of Hepatitis, strains of TB, and Typhoid, as well as the usual comedy remedies such as shipwreck, trout and Ayres rock.

These products are making implicit claims to be alternatives to real vaccines. All of them are the same useless sugar pill pulled from the same large tub at Ainsworths, some hocus pocus spouted over them, bottled, labelled and shipped.

Why the MHRA do not prosecute for straightforward fraudulent trading I just do not know.

***********************************************************************************

Update

18th September 2009

Simon Perry from the excellent Adventures in Nonsense blog wrote to the MHRA to see what their response to this criticism would be. I have also written, but not received a reply.

Dear Mr Perry,

Thank you for your recent enquiry to the MHRA and please accept our apologies for the wait you have experienced. We have liaised with our enforcement team and the investigator involved and we can confirm that our response to this blog post is as follows:

"This referral was allocated to an investigator and concluded by way of a compliance visit when the product was removed from the shelves. The matter of the product being available via the company internet site has been referred to our enforcement group to take the appropriate action."

Please contact us again if you need further assistance with this, or any other queries.

Kind Regards,

Ben, on behalf of the

Central Enquiry Point

Information Centre

Medicines and Healthcare products Regulatory Agency

At the time of writting, Nelsons are still selling the product online.

Labels: homeopathy, MHRA

 

If you haven’t managed to escape the winter sniffles, look no further than our new Echina-Relief Tincture, which offers natural relief from cold and flu symptoms.

 

This week were celebrating the launch of our brand new Herbal Tinctures range. Our Echinacea, Hypericum and Detox Tinctures provide alternative and natural ways of treating common ailments such as colds, low moods and digestive discomfort.

From the time I received the email to the time it was in the hands of the ASA was probably less than 120 seconds (a record I hope) thanks to their online complaint submission form. Investigating the claim took a little longer but now we can see the results of that investigation. I had complained that the company would not be able to substantiate the claims that these tinctures were  effective.

Previously, Andrew Baker, the head of Duchy Originals, had said of the detox tincture, “It is not – and has never been described as – a medicine, remedy or cure for any disease”. It was my view that the email advert made explicit claims to be a “medicine, remedy or cure” by saying that it provided, with the other tinctures, “natural ways of treating common ailments such as colds, low moods and digestive discomfort.”

The ASA agreed with me that the advert was misleading and upheld one complaint against each of the three products mentioned. Specifically, the advert breached advertising codes on truthfulness, substantiation  and the advertising of health and beauty products and therapies, and medicines.

This is not the first time that Duchy Originals has been censured over its tincture range. As I reported earlier (Duchy Originals Pork Pies), the Medicines and Healthcare products Regulatory Agency (MHRA) had told Duchy Originals to stop making claims of efficacy for their products that cannot be substantiated after a complaint was made by the science group Voice of Young Science.  The Advertising Standards Authority have told me that the MHRA will also receive a copy of their adjudication. What can we expect  the MHRA to do given these blatant acts of disregard for medicines advertising?

Well, my guess is nothing. For the real villains here, in my opinion, are the MHRA themselves. In their response to the complaint, Duchy Originals stated that two of the three products, Echina-Relief and Hyper-lift tinctures, were licensed by the MHRA under the Traditional Herbal Medicines Directive. This directive allows license holders to make claims about their herbal remedies if the product has been ‘traditionally’ used. The rules are quite daft. In order to get a license, the applicant has to show that the product has been in use for 30 years in the EU, or 15 years in the EU and 15 years elsewhere. So, the product could have been ‘traditional’ in the same sense that ABBA is ‘traditional’ European music. There is no need to show there is any evidence for the product.

This is quite a shocking state of affairs. The MHRA have a mission to “safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe”. By taking on the Traditional Herbal Medicines Directive, the MHRA have undermined their reason for being because traditional use is no substitute for evidence when looking at what medicines work and are safe. In this regulatory regime we are subjugating evidence to the beliefs of any group of cranks (or fraudsters) who have stated that a herb can treat their illnesses.

So, could Duchy Originals have defended their claims with good evidence? The best place to look is to see what Cochrane reviews say about these herbs. The Echina-Relief tincture is probably best reviewed in a study entitled “Echinacea for preventing and treating the common cold”. The author’s conclusions are:

Echinacea preparations tested in clinical trials differ greatly. There is some evidence that preparations based on the aerial parts of E. purpurea might be effective for the early treatment of colds in adults but the results are not fully consistent. Beneficial effects of other Echinacea preparations, and Echinacea used for preventative purposes might exist but have not been shown in independently replicated, rigorous RCTs.

In other words, if there is a positive effect, it will be dependent on the specific preparation and product, and we have no great evidence that even this might be so. As far as I can see, no such evidence exists for the Duchy Originals product. Evidence for effectiveness is pretty slim and unconvincing.

How about the Hyper-lift tincture? The review on “St John's wort for major depression” might give us some clues.  The review of evidence is quite positive, but there is a major complication. Cochrane reports that “trials from German-speaking countries reported findings more favourable to hypericum”. Is it plausible that German speakers get a greater benefit, or are we seeing a greater placebo effect in countries where the treatment is more popular? Whatever, we might conclude, Cochrane is cautious - “St. John's wort products available on the market vary to a great extent. The results of this review apply only to the preparations tested in the studies included”. We cannot use these reviews as evidence that Prince Charles’ products work – even though his family is German.

Looking at the ‘non-medical’ tincture – the detox tincture – this is the most ridiculous of them all. It claims to be a “a food supplement to help eliminate toxins and aid digestion.”. However, the company is unable to name any toxin that is actually removed by this product and what the evidence for this is. It is pure pseudoscientific bullshit.

This inadequacy of evidence is important. The MHRA give themselves a get out clause for licensing these products that they have not used in these cases. They can refuse a license if the claims are not plausible. Given that the best evidence to date on these products is pretty cautious and specifically excludes products that are not explicitly tested, the plausibility that a company can just magic a product up and expect it to work is very low. It is not plausible that a pharmaceutical company could do this. It is not plausible that Prince Charles could either.

We have a situation where the government is now licensing medicinal products on the flimsiest of evidence. The idea that we can expect a product to work on the basis that someone in Europe in the past few decades have been gullible enough to buy the product is obviously daft. And I would suggest that the MHRA have obviously not been forceful enough on the requirements of their license. They state that the licensee must use very specific wording when making claims – that the product is a “traditional herbal medicine for use on [specific indications] exclusively based upon long standing [sic] use as a traditional remedy”. The stupidity of Duchy Originals is that they did not stick to this wording. The MHRA are supposedly convinced that the public can then interpret the wording as meaning that there is no real evidence for effectiveness. But we know that it is a common quack trick to suggest a treatment has ancient origins in order to sell their product. The MHRA have played right into quack hands.

And so when the MHRA give a license, we then are left with organisations like the impotent ASA to police it. I see little evidence of the MHRA taking a tough stance. I have one complaint against a blatant breach of rules that is now over a year without any action and despite requests for statuses on progress. The MHRA appear unconcerned about quackery claims. This also has to be looked at in the knowledge that we know that Prince Charles has written lots of letters to the MHRA and meetings have been held at Clarence house before these new directives came in. We are not allowed to know the contents of those letters.

The importance of this appears to need to be explicitly stated. We currently have a significant health risk in the form of swine flu. This risk may well not materialise quickly. Flu tends to strike in the winter months. The coming months may well see pockets of infection establishing across the world. Come the winter, we may then see this strain striking out in earnest, maybe even with some more deadly mutations. When our government explicitly licenses companies to make claims that their quack remedies can prevent or treat flu without evidence, they undermine their ability to issue meaningful, evidence-based and life-saving advice.

The MHRA, in taking on this role of licenser and legitimiser of quackery, undermines its ability to be an authority in this most important area.

***********************************************************************************************************

Coverage

Marketing of Prince’s remedies banned  - FT

Prince firm's advert 'misleading' – BBC

Prince of Wales's Duchy Originals herbal remedy claims were 'misleading' - Telegraph

Labels: Duchy Originals, MHRA, Prince Charles

 

The newspapers today were delighting in reporting that a new cold treatment was being made available to us in Britian. Kaloba is an extract of the geranium Pelargonium sidoides, and has been "used by Zulus for hundreds of years".

The Telegraph tells us that "extracts are particularly good at reducing the amount of phlegm." Remarkably, the paper tells us that,

Research by the Cochrane Review showed it to be "effective in resolving all symptoms including headaches and nasal discharge in adults when taken for an extended time period.

The Daily Mail tells us that,

A herbal medicine used by African tribes to counter colds and flu has been given the go-ahead for use in Britain.

For hundreds of years, Zulus have taken extracts from the geranium plant to stop coughs and sneezes.

They say it is particularly effective at cutting phlegm.

To the Daily Mail's credit they do point out that licensing the pills in the UK does not require the manufacturers to produce evidence of efficacy. They say,

However, because it is a herbal remedy the manufacturers, who claim it can activate the body's anti-viral defences, do not have to prove it is effective.

Indeed, the MHRA have issued their own assessment and say that,

This registration is based exclusively upon the longstanding use of the extract from the roots of Pelargonium sidoides as a traditional herbal medicine and not upon data generated from clinical trials. There is no requirement under the Traditional Herbal Registration scheme to prove scientifically that the product works.

There are a number of odd things here that are worth noting. Firstly, the MHRA does not look at the use of this stuff within Zulu tribes to assess whether there has been sufficient 'traditional use' to determine whether it should be granted a license. They actually looked at evidence of usage within the EU - not amongst Zulus, but principally amongst Germans where this herbal remedy has been on sale for some time.

The second is whether there is any evidence at all for the effectiveness of Kalabo. The Telegraph were remarkably selective in quoting the Cochrane review about this plant. Far from being "effective in resolving all symptoms" as reported, the Cochrane review actually concluded that "There is limited evidence for the effectiveness of P. sidoides in the treatment of ARIs. (acute respiratory tract infections)". From the trials reviewed, there was a lot of heterogeneity of outcomes (read 'confusion') and that the 'significant' results came from an unpublished trial. So, it may be effective. But the evidence is too confusing to draw firm conclusions.

But the manufacturers Schwabe Pharmaceuticals and their sales outlet Boots will undoubtedly be welcoming the MHRA's decision to let this stuff loose on us and the misleading and (mainly) uncritical reporting by the nations finest newspapers are undoubtedly providing a good sales launch.

Labels: MHRA