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The bulletin of the British Pharmacological Society, Pharmacology Matters, declined to publish the following article. Sadly the Society seems to be more interested in "reputation management" than in truth. Luckily, it is not easy to suppress criticism these days. A version of the article has appeared in Research Fortnight where it will be seen by far more people than it would have been in Pharmacology Matters. This is the original version that I submitted to them. They would not allow me to quote Lewis’s comment (apropos of the sale of homeopathic meningitis vaccine)

“Children will be harmed by this inaction. Children will die. And the fault must lie with Professor Sir Kent Woods, chairman of the regulator [MHRA].”

If a child were to die of whooping cough or meningitis as a result of buying the fraudulent "vaccines", that would be true. It’s a sad reflection on the state of defamation law that journals are not willing to say so. Blogs are fast becoming the best source of reliable information.

BPS logo
mhra1

Stop press. The BPS has now signed up to Alltrials (too late for the printed version)


Pharmacology society does little to defend its subject

David Colquhoun

Over the past few years a courageous group of writers, researchers and activists has worked to expose the truth about the medicines we are sold, be they conventional or alternative.

Thanks, above all, to Ben Goldacre (1), more people than ever know that the big pharma companies have been concealing evidence of the harm that their products do, or the good they fail to do. Thanks to a small army of bloggers the preposterous claims made by peddlers of homeopathic remedies and other quackery are less likely to go unchallenged.

And yet, the organization charged with safeguarding the good name of pharmacology in this country, the British Pharmacological Society (BPS), has remained silent throughout.

The pharmaceutical industry

The BPS, rather than helping, became actively complicit when, along with much of the medical establishment, it signed an agreement with the ABPI (2). This document, developed under the aegis of the Ethical Standards in Health & Life Sciences Group (ESHLSG), contained two objectionable clauses:

“Industry plays a valid and important role in the provision of medical education”

And

“Medical representatives can be a useful resource for healthcare professionals”

Given that clinical “education” has long been part of Pharma’s marketing strategy, this seems disgraceful.  And most of the doctors I know and respect refuse to see reps altogether.  It is hopelessly optimistic to think that can an industry person can teach clinical pharmacology without bias in favour of his own company’s products. The BPS has many members who teach pharmacology.  Can they really cope so badly that we need to have industry to educate clinicians?   

It’s fine, and sometimes desirable, for academics and industry to work together on drug development.  But only as long as the industry partner has no say in how, or whether, the results are published.  Without that proviso we can expect more corruption of the sort that’s been seen at the University of Sheffield (3).

This is very sad, because I have great reason to like the drug industry.  I’ve benefitted from several of their products myself.  But the industry is in trouble.  Many of its products provide only marginal benefits.  Furthermore, some of the things that seemed to be useful, like SSRI antidepressants, have turned out to be next to useless once hidden trials were revealed (4).  The MHRA’s learning module on SSRIs doesn’t seem to have caught up with this yet.

Sadly, the reaction of industry has been to resort to dishonesty, to hide unfavourable data and to increase yet more what it spends on marketing.  Between 2009 and 2012, fines of at least 10 billion dollars (5) have been imposed on some of the most eminent companies.  They include Lilly, Pfizer, AstraZeneca, Merck, Abbott and GlaxoSmithKline (GSK). The biggest fine of all ($3 bn, in July 2012) went to a British company, GSK.  This succession of large fines seems to be regarded by the companies as mere marketing expenses. 

All these fines were levied in the USA.  Where, one might ask, are the regulators in the UK?  Why have there been no fines here? Why, indeed, are some of the senior managers of these companies not in jail?  Why has the BPS remained silent about the prostitution of its subject?  And why have the MHRA done so little to stop it?

I suggest that you support the petition for release of the results of all trials (6). It’s been supported by many individuals and a lot of organisations, including the BMJ and the Royal Statistical Society.  But, disgracefully, not by the BPS.

Quackery

At least in the case of the pharmaceutical industry some of its products work.  But pharmacologists should also be concerned about the quackery industry, worth about 60 billion dollars per year (as opposed to $600 bn for the pharmaceutical industry).  Virtually none of their products work (7). Why has the BPS said so little about it?  It has, along with most of the medical and university establishment, shrugged its shoulders about the fact that students at Westminster University have been shown dowsing with a pendulum as a method for selection of herbal “remedies”, as part of a Bachelor or “Science” degree.  It is an area in which every regulatory agency has failed to ensure even minimal levels of honesty (8).  And the BPS has just shrugged.

The MHRA has been worse than useless in this area: it has been actively unhelpful (9).  The senior staff of the MHRA are members of the BPS which has, as usual, said next to nothing.  The MHRA’s herbal medicine committee has allowed misleading labels that give indications to be put on herbal potions, and these labels fail to make it clear that no evidence whatsoever of efficacy is required to get the MHRA kitemark.  The wording was suggested (not required) by European law, but that law does not prevent the MHRA from saying, as it should, “there is no reason to think that this product is effective for any of the indications on the label” (10).  Arguably, the MHRA is in breach of Consumer Protection law (11, 12).

At the time, the BPS did make some objection to the labelling (13), but only under great pressure from me (indeed I wrote it) .  That has not been followed up, and I can no longer find it on the BPS web site.  Indeed Philip Routledge, one of the people who is responsible for the misinformation in his capacity as chair of the MHRA Herbal Medicines Advisory Committee, is, at present the president of the BPS.

The MHRA has also been responsible for misleading labelling of the products of the most obviously fraudulent products of the lot: homeopathic pills, the medicines that contain no medicine.  Most of the pills (anything beyond 12x dilution) contain not a single molecule of the substance on the label.  Yet they have been given a get-out clause that enables them to evade prosecution by Trading Standards (an organisation that consistently fails to apply consumer protection laws.  Rose et al (2011) (12) concluded

"EU directive 200s5/29/EC is largely ineffective in preventing misleading health claims for consumer products in the UK".  

It is simply bizarre that the people at the MHRA, many of who are BPS members, have sat round a table and approved the following label. This example is for Arnica 30C pills, which, of course, contain no trace of arnica (14, 8). The outcome of their deliberations is simply surreal (see the actual labels here).

"Used within the homeopathic tradition for the symptomatic relief of sprains, muscular ache; and bruising or swelling after contusions."

This will deceive the naïve into thinking that it will have some effect on sprains etc. It won’t. And the MHRA have declined to test how the label is perceived by the public, though it took some effort to get them to admit it.

"If you are allergic to any of the ingredients in this medicine, consult your doctor before taking this medicine."

The ingredients aren’t stated apart from “contains lactose and sucrose”. That’s all they contain. No arnica.

"If pregnant or breastfeeding consult your doctor before use."

Why should a few mg of lactose and sucrose have the slightest effect on a pregnant or breast-feeding mother. This is pure make-believe

"If you forget to take this product, continue to take your usual dose at the usual time, it does not matter if you have missed a dose. Do not take a double dose to make up for a missed dose."

This statement is even more bizarre. There is nothing in the pills.

"If you take too much of this product (overdose) speak to a doctor or pharmacist and take this label with you."

And this is the ultimate in nonsense. The 1023 campaign regularly swallows whole bottles, and of course nothing happens. You can’t overdose on nothing. The fact that the MHRA can insist on this label, with a straight face, is the ultimate betrayal of science and reason.

"When asked to comment, as part of the consultation on these rules, this was the response from the BPS."

no comment

This is extracted from page 16 of the “selected response” provided by the MHRA under a Freedom of Information Act request [download all]

Things have changed little since A.J. Clark wrote his book on Patent Medicines in 1938 (15).  And the BPS has done next to nothing to help. Neither has the MHRA. In fact both have colluded in the failures of both honesty and reason. 

A BBC South West program recently revealed that a pharmacist was selling “homeopathic vaccines” for whooping cough and meningitis (16).  The MHRA have know about his homicidal practice for years, but have done nothing.  The General Pharmaceutical Council let him off with a rap on the knuckles.  It has been left to bloggers and TV reporters to focus attention on these scoundrels. The well-respected blogger, Andy Lewis, wrote (17)

“Children will be harmed by this inaction. Children will die. And the fault must lie with Professor Sir Kent Woods, chairman of the regulator [MHRA].”

And the full clinical data for Tamiflu are still being concealed by Roche (18).

I think that is rather shameful.

I have been a member of the BPS for all my working life. I was happy when they made me an honorary fellow. But I now find myself asking if I can remain a member of an organisation that has done so little to defend honest scientific behaviour.

References

(1) Ben Goldacre’s Bad Pharma. Buy it now. Then do something. http://www.dcscience.net/?p=5538

(2)  ABPI 2012 Guidance on collaboration between healthcare professionals and the pharmaceutical industry.   http://www.abpi.org.uk/our-work/library/guidelines/Pages/collaboration-guidance.aspx

(3) Colquhoun, D. (2007)  The Corporate Corruption of Higher Education: part 2 http://www.dcscience.net/?p=193

(4) Kirsch,I., B.J.Deacon, T.B.Huedo-Medina, A.Scoboria, T.J.Moore, and B.T.Johnson. 2008. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS. Med. 5:e45.  http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050045

(5) Groeger, L. (2012) Big Pharma’s Big Fines http://www.propublica.org/special/big-pharmas-big-fines

(6) All trials registered. All results reported, http://www.alltrials.net/supporters/

(7) Singh,S. and E.Ernst. 2009. Trick or Treatment. Corgi. http://en.wikipedia.org/wiki/Trick_or_Treatment

(8) Colquhoun, D. (2012) Regulation of alternative medicine: why it doesn’t work, and never can. http://www.dcscience.net/?p=5562

(9)  Colquhoun, D, (2006) The MHRA breaks its founding principle: it is an intellectual disgrace.  http://www.dcscience.net/?p=32

(10)  Colquhoun, D. (2011). Why does the MHRA refuse to label herbal products honestly? Kent Woods and Richard Woodfield tell me. http://www.dcscience.net/?p=4269

(11) Colquhoun, D. (2009) Most alternative medicine is illegal. http://www.dcscience.net/?p=30

(12) Rose,L.B., P.Posadzki, and E.Ernst. 2012. Spurious claims for health-care products: an experimental approach to evaluating current UK legislation and its implementation. Med. Leg. J. 80:13-18. http://www.dcscience.net/Rose-medico-legal-2012.pdf

(13) Colquhoun, D. (2006) Learned Societies speak out against CAM, and the MHRA. http://www.dcscience.net/?p=30

(14) MHRA Arnicare Arnica 30c pillules NR 01175/0181 http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con049307.pdf

(15)  Colquhoun, D. (2008) Patent medicines in 1938 and now: A.J.Clark’s book. http://www.dcscience.net/?p=257

(16) BBC South West on the evils of homeopathic "vaccines"  http://www.youtube.com/watch?v=TZf9mUzI4RI

(17) Why Does the MHRA Not Close Down these Homeopaths? The regulators have known of serious problems for years, Nothing is done. http://www.quackometer.net/blog/2013/01/why-does-the-mhra-not-close-down-these-homeopaths.html

(18)  Payne, D. (2012). Tamiflu: the battle for secret drug data http://www.bmj.com/content/345/bmj.e7303

Follow-up

25 February 2013 This post has some follow-up even before it appeared on Research Research. I noticed on the BPS web site a press release “BPS announces intention to sign All Trials Petition“. It was dated 20th February, but I didn’t notice it until after the printed edition went to press. It was expressed as a future intention to sign, though in fact they signed almost straight away (though over 100 organisations had already done so). That’s good. I suspect that when my old friend, Humphrey Rang, who is president elect of the BPS, takes charge, the Society may start to take its responsibilities to the public more seriously than it has in the past.

The MHRA, on the other hand, is still evading its self-declared job of ensuring the public that drugs work.

mhra2

13 March 2013. A reply to this piece appeared in red on Research Research, The British Pharmacological Society champions its science. It was written by Humphrey Rang who, as president elect of the BPS naturally felt obliged to defend its record. He defends the BPS membership of ESHLSG, but fails to mention that first the Lancet and then the BMA withdrew their support. Nor does he mention that medical students and doctors launched a campaign, BadGuidelines.org, against the agreement. The Medical Schools Council, which also signed the agreement, said "the scrutiny of the guidance has ‘identified deficiencies in the current statement". Didn’t they read it before signing? Rang says that the BPS is also working to improve the joint statement with the ABPI. That’s good, but one must wonder why the BPS signed up to the original form.

On the points about quackery, Rang sites the BPS statement on homeopathy (now vanished) but fails to mention that that statement was written by me in an attempt to wake the BPS from it’s slumbers on the matter of medicines that don’t work. But he doesn’t mention at all the matter of mislabelling of both homeopathic and herbal preparations.

Of course, the BPS does many good things. But like most organisations, it is too reluctant to speak out when it sees wrongdoing, and too reluctant to say "sorry we made a cock-up that time".

Jump to follow-up

Which? Magazine (the UK equivalent of Consumer Reports in the USA) has done it again. They published an excellent article, Health products you don’t need. It’s a worthy successor to their recent debunking of “nutritional therapists”. Most of the products in question, apart from Bach Rescue Remedy Spray, were not outright quackery like homeopathy or "detox" products. Rather they were old-fashioned pharmaceutical products that were quite respectable in the 1950s but which have subsequently been found not to work.

which

These are the things that were looked at.

  • Benylin Chesty Coughs (Non-Drowsy)
  • Benylin Tickly Coughs (Non-Drowsy)
  • Covonia Herbal Mucus
    Cough Syrup
  • Boots Cold and Flu Relief
    Tablets
  • Adios Slimming Tablets
  • Bio-Oil
  • Seven Seas Jointcare Be Active
  • Bach Rescue Remedy
    Spray

It’s an interesting and large category, and its one that I grew up with. My first job, in the 1950s was as an apprentice in Timothy Whites & Taylors Homeopathic Chemists in Grange Road, Birkenhead (you can’t have a much humbler start than that). Don’t worry about he homeopathic bit. We had one homeopathic prescription in two years, which was made up with great hilarity. These were the days before the endarkenment.

We did, however, sell a lot of "tonics" and "cough medicines". Two popular brands were Metatone Tonic and Minadex Tonic. I was quite surprised to discover that they are still on sale. Even in the 1950s I was a bit sceptical about what a "tonic" was supposed to achieve. The term soon became extinct as it was slowly realised that no examples existed.

Here is the bad news. It is scarcely an exaggeration to assert the following.

  • Nothing is known that alters the time course of a cold.
  • There is nothing that you can buy that will suppress a cough*.
  • There is no such thing as a "demulcent" or an "expectorant"
  • There is no such thing as a "tonic".
  • It would be nice if these things existed, but they are figments of the imagination. Nonetheless they sell by the truckload and vast amounts of money are made by selling them.

[*morphine may have a modest effect, but you can’t buy it]

How can this happen? We have the Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.

Demulcents

In the 1950s this was a more or less respectable term. If you google it now, almost all the references come from herbalists, It is, almost entirely, part of the world of quackery. Apart, that is, from the MHRA. And NHS Evidence. It was surprising to find, in a 2009 document from the MHRA

"Simple cough mixtures containing a demulcent, for example glycerin, and syrup can have a soothing effect by coating the throat and relieving the irritation which causes the cough"

No reference is given, and I’m not aware of the slightest reason to think that there is any such effect. Syrup in your respiratory tract is a bit of a disaster.

But the same document says

There are severe limitations to the efficacy studies given that many of the products were first introduced decades ago. There has been no co-ordinated development program to establish efficacy. What trials there are have not been carried out to current standards.

There isn’t much detail about these old ‘remedies’ on the MHRA site. I did find a Publiic Assessment Report for Benylin Mucus Cough Menthol Flavour Oral Solution. The main ingredient is Guaifenesin

The assessment says this.

benylin PL

And the approved label says this.

benylin label

The Public Assessment Report also says

Efficacy

Guaifenesin . . . is a well-established medicinal product with well-known efficacy and safety profiles

This appears to be pure make-believe. There is no credible evidence for any such effect. The report may be dated 2012, but it is a carry-over from a previous age.

In 1976, it was pointed out that none of these things worked (Ziment, 1976), and the situation hasn’t changed. Ziment’s review concludes

"Perhaps this is the one disease that could truly benefit from that oft-touted panacea of therapeutics, the overworked nostrum of materia medica—namely, chicken soup"

A 2012 Cochrane review agrees: "Over-the-counter (OTC) medications for acute cough". This review concludes

"We found no good evidence for or against the effectiveness of over-the-counter (OTC) medications in acute cough, which confirms the findings of two previous reviews (Anonymous 1999; Smith 1993)."

What the MHRA tell me

I was puzzled by the apparently unjustified statements on the MHRA site so I asked them about the eight products that were investigated by Which? magazine (see above). I asked them also about Metatone and Minadex "tonics"

The questions, and the responses can be downloaded here. (I merely asked some reasonable questions, but the MHRA chose to treat them as a request under the Freedom of Information Act).

The first five items all have full marketing authorisation, as do Metatone and Minadex "tonics".

"Metatone (PL-02855/0017), Covonia Herbal Mucus Cough Syrup, Cold and Flu Relief Tablets and Adios Tablets originally held Product Licences of Right. These products were on the market before the Medicines Act 1968 came into force in 1971. These licences were reviewed in the 1980s to ensure that the products were safe, of suitable quality and have evidence of efficacy. Because of the length of time that the products had been on the market they were considered to have well established use and original clinical data to today’s standards was not necessarily available."

The MHRA tell me that they have no copies of the reviews conducted in the 1980s, apart from one. They sent a scanned copy of the August 1988 expert review of Covania syrup (the ingredients have changed since than).

covania 1988

The document is like an antique. It simply repeats the old myths. The names of the "expert reviewers" have been hidden. Given the quality of the review, perhaps that isn’t surprising, but the MHRA should not be so secretive.

There is no such thing as a "tonic", so I asked the MHRA about that too.

Q.5 Can you tell me what criteria the MHRA uses when allowing a product to be advertised as a "tonic"?
R.5 The MHRA assesses proposed product names on a case by case basis. On the basis of the well established use of Minadex Tonic it was decided that the use of the word tonic in the product name was acceptable. For the same reason, it was accepted that Metatone could be referred to as a tonic in the Product Information Leaflet and product labels

In other words, we let them get away with it because it’s old.

I had always understood that when the MHRA grants "Marketing authorisation", that meant there was some guarantee that the product worked. You’d infer that from the MHRA’s own definition.(my emphasis)

"Medicines which meet the standards of safety, quality and efficacy are granted a marketing authorisation (previously a product licence),"

Sadly, it seems that this isn’t true, at least for old-established products, those that were on the market before the Medicines Act (1968) came into force in 1971.

Conclusion

Although old products which were on the market before 1971 were supposed to be reviewed for efficacy and safety. This hasn’t been done efficiently. The make-believe has simply been perpetuated. I have no objection to people buying benylin etc, but they should not have full marketing authorisation and they should be labelled accurately so that it is clear that there is very little evidence that they’ll do you much good. The MHRA has let down the public, just as it did when it allowed misleading labels on homeopathic and herbal potions.

Postscript

After writing this, I discovered a very recent paper about guaifenesin (Seagrave et al, 2012), This paper shows some effects on mucus secretion in cultured human cells (not in humans) with prolonged exposure to concentrations of 30 and 100 µM. This is an order of magnitude greater than the peak blood concentration (7 µM. = 1.4 µg/ml) that is achieved (transiently) in man (Maynard & Bruce, 1970). This is not mentioned in the paper. I’m sure that has nothing to do with what we read at the end of the paper.

Competing interest
JS has received research funds from Reckitt Benckiser. HHA is a consultant to Reckitt Benckiser and is the co-author of a Mucinex sustained-release guaifenesin) patent. DBH has received research funds and consultancy payments from Reckitt Benckiser. DFR has received consultancy payments from Reckitt Benckiser. GS is an employee of Reckitt Benckiser and is also a co-author of a Mucinex (sustained-release guaifenfesin) patent.

Acknowledgements
This study was funded by Reckitt Benckiser Healthcare International Ltd. Assistance with manuscript submission was provided by Elements Communications Ltd, supported by Reckitt Benckiser Healthcare International Ltd.

On 15 October 2010, Reckitt Benckiser was fined £10.2 m by the Office of Fair Trading after the company admitted anti-competitive behaviour.

Follow-up

Shortly after this post went up. I was attacked on twitter by @iHealthP. That’s a company, http://www.ihealthpartnership.com (the tweeter declined to reveal their identity). It started thus.

Your article asserts that “There is nothing that will suppress a cough.” This is bollocks, pure & simple.

The interchange was one of those less pleasant Twitter moments (I’ve Storifed some of it in case anyone is interested). The discussion did throw up a few useful references though. @LeCanardNoir pointed out a 2007 paper which concludes

"Clearly the widespread notion that codeine is an effective cough suppressant is not supported by the available evidence."

One of the papers cited by @iHealthP in support of his/her contention that pholcodine and codeine work was Recommendations for the management of cough in adults (from the British Thoracic Society Cough Guideline Group). This paper actually concludes

“There are no effective treatments controlling the cough response per se with an acceptable therapeutic ratio.”

That, of course, is exactly what I said.

There was, however, one reference produced by @iHealthP for which I’m grateful. It doesn’t concern over-the-counter cough treatments (which is what this post is about), but morphine. It does, though, produce some evidence that morphine does work to some extent as a cough suppressant. Amazingly this "well-known truth" was not demonstrated until 2006. The paper, Opiate Therapy in Chronic Cough, by Morice et al., 2006. shows a convincing effect of morphine (5 or 10 mg twice a day) on chronic cough. The main caveat lies in the reported side effects: constipation (40%) and drowsiness (25%). Obvious side-effects can make the trial non-blind. In any case, none of this is relevant to the present post (though I altered the blog to refer to it).

Jump to follow-up

The absurdness of allowing statutory regulation of herbal medicines, both Western and Chinese has already been pointed out here, in Government lends credibility to quacks and charlatans, and by Andrew Lewis in  “How to Spot Bad Regulation of Alternative Medicine

The harm done by the government’s endorsement of herbal products could be ameliorated if they were labelled honestly. The labelling is a matter for the Medicines and Healthcare products Regulatory Authority (MHRA), and for a while I have been writing to the head of the MRH, Kent Woods, and to Richard Woodfield (head of MHRA herbal medicine policy), in an attempt to work out their reasons for not telling the consumer the simple truth.

A similar (but even worse) problem arises in the labels that have been allowed by the MHRA for homeopathic pills. That has been discussed in Pseudo-regulation: another chance to save the MHRA from looking idiotic . The matter is not yet decided, but on past performance, I’m pessimistic about whether the MHRA will listen to scientists.

The Traditional Herbal Registration (THR) scheme allows herbal medicines that are registered on this scheme to be sold if they are safe, and have been in use for 30 years. There is need to supply any information whatsoever about whether they work or not. That itself is very odd, given that the MHRA’s strap line says

"We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe."

In the case of herbals, the bit about ensuring that medicines work has been brushed under the carpet.

A typical dishonest label

Take "Echina Cold Relief". The Traditional Herbal Regulation document specifies the label.

Note, first of all, the therapeutic claim in the brand name itself. This is blatant practice for most herbals and appears to be unregulated. The label says

echina label


It is my contention that most people would interpret this label as a claim that the tablets would have a beneficial effect on the symptoms of "common cold and influenza type infections". The impression is reinforced by the government stamp of approval on the package.

The MHRA tell me that no tests have been done to discover how shoppers interpret these words. They should have been done.

 

kite mark

Why is there nothing on the label that tells the plain, unvarnished truth? Perhaps something like this

 "There is no evidence that this product works for the indications mentioned". 

Or

"Clinical trials have shown this product to be ineffective for xxx "

or, at a minimum

"The MHRA kite mark does not imply that this product is effective"

Some Evidence

Echinacea is a generous choice of example because, unlike most herbs, there is a bit of evidence about its effectiveness. A Cochrane review says

Sixteen trials including a total of 22 comparisons of Echinacea preparations and a control group (19 placebo, 2 no treatment, 1 another herbal preparation) met the inclusion criteria. All trials except one were double-blinded. The majority had reasonable to good methodological quality. Three comparisons investigated prevention; 19 comparisons investigated treatment of colds. A variety of different Echinacea preparations were used. None of the prevention trials showed an effect over placebo. Comparing an Echinacea preparation with placebo as treatment, a significant effect was reported in nine comparisons, a trend in one, and no difference in six. Evidence from more than one trial was available only for preparations based on the aerial parts of Echinacea purpurea (E. purpurea). 

“It seems that some preparations based on the herb of Echinacea purpurea might be effective for this purpose in adults, while there is no clear evidence that other preparations are effective or that children benefit. Side effects were infrequent but rashes were reported in one trial in children.”

The US agency NCCAM has spent over a billion dollars on testing various sorts of alternative treatment, and has failed to find a single useful treatment, They say

"Two NCCAM-funded studies did not find a benefit from echinacea, either as Echinacea purpurea fresh-pressed juice for treating colds in children, or as an unrefined mixture of Echinacea angustifolia root and Echinacea purpurea root and herb in adults."

So the evidence is a mess. There is no evidence that Echinacea can prevent colds, and, at the very best, it might shorten slightly the time for which cold symptoms last. The most likely interpretation of the mixture of contradictory results, many negative trials with a handful of small positive effects, is that for practical purposes, echinacea is useless. There is NO treatment known that affects the duration of a cold to any useful extent.

I wrote to Kent Woods in February 2011

Hello

Sorry to bother you again, but recent events have caused me to think about a rather fundamental question, and I have never seen it discussed in any official documents.  I suspect it needs to be answered at the highest level.

Question,  Do you make any distinction between (a) herbs that have unknown efficacy (most of them). and (b) herbs that have been shown in good trials to have no useful effect (like echinacea)?

It is one thing to say “traditionally used for …” when you don’t know whether it is true or not.

It is quite another thing to say “traditionally used for. . . ” when you know it is untrue

No such distinction seems to be made at the moment.

Is that because the distinction has never been considered by the MHRA?

Or is it because it has been considered, but dismissed as unimportant?

Or is it considered important but you are prevented from doing anything about it (and, if this is the case, what prevents you?)

Best wishes

David

His reply was, essentially, that herbs come in so many different forms that they can’t all be tested so it is never possible to say that a herb “does not work to any useful extent”

. . .

Based on our experience of regulating herbal medicines, we think it unlikely for the foreseeable future that there would be available for particular herbs a comprehensive body of published studies that meet medicines regulatory standards and cover systematically the numerous possible permutations as to type of extract, plant species and part of plant. Consequently, it is unlikely that evidence would be available for MHRA to know that a traditional herbal product did not have efficacy.

In summary, you suggest an interesting scenario the handling of which would be worthy of further consideration in the event of major advances in the range and quality of clinical trials of herbal medicines – but for the foreseeable future we would see the dilemma as largely a theoretical one.

Regards

Kent Woods

This strikes me as a cop-out. It amounts to saying that it’s impossible ever to say that a treatment us useless. If NICE took the same view, no medicine would ever be ruled out as having no useful effect.

Then I asked about a press release from the MHRA, dated 18 March 2011.

Hello
I really must object to the wording of today’s press release
http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON111687

It says (my emphasis)

"The growth of the THR scheme means that consumers will have access to a wide choice of over-the-counter herbal medicines made to assured standards.

"The current signs are that the market will be lively and competitive. The key difference for consumers is that in future they will be in the driving seat and able to make an informed choice when they wish to use these medicines.
"

Since the main sort of information that people want about a medicine is whether it works, and you have explicitly ruled out any information about that, the description "informed choice" seems to me to be exaggerated to the point of dishonesty.

This raises another question.  Many people think that the wording that you approve is deceptive.  can you tell me whether you have yet done tests to discover whether or not the average consumer interprets your wording as suggesting effectiveness?  This was raised (apropos oh homeopathics) with Kent Woods at the SciTech enquiry and they were assured such tests had been done.  Still nobody has seen the result of such tests.  Please will you let me know if they have been done, and, if they have, what the results were?  if they have not been done, why not?

Best regards
David Colquhoun

The legal requirement

In response to my letter, Richard Woodfield said

"Specifically on the question of wording affecting efficacy, we have to comply with the requirements of the herbals Directive which specifies the required product information about the traditional basis of the registration. We have not user tested the required statement in the Directive.
"

The European Herbals directive 2004/24/EC [download it] does make it mandatory to include the words used by the MHRA

“In addition to the requirements of Articles 86 to 99, any advertisement for a medicinal product registered under this chapter shall contain the following statement: Traditional herbal medicinal product for use in specified indication( s) exclusively based upon long-standing use.”  

Telling the truth on the label

I asked the MHRA whether there was any legal reason why they could not add the following notice to the wording required by the European Directive. I had to ask the question several times before I got a straight answer, but the answer eventually turned out to be that there is no legal reason that bars honest labels. Eventually Richard Woodfield told me there was no legal reason.

Dear Prof Colquhoun

There is no specific bar in the European Directive that would definitely preclude requiring additional statements that were consistent with the Directive. Obviously one would have to look at the specifics of what was proposed.

The main bar is that of Government policy.  Under the previous Administration when the scheme was set up there was a strong policy of avoiding gold plating of European legislation – and this would clearly be a case of gold plating.  Under the new Government that policy of avoiding gold plating has been strengthened further.  And added to that there is now a presumption that wherever possible Directives should be transposed by “copy out” of the text rather than elaborating upon the requirements of the Directive.

The onus would be on those seeking gold plating to demonstrate that it was necessary.  In the present absence of evidence of significant detriment under the THR scheme to consumers who for example choose to take a THR to help with a condition such as mild indigestion we have no present plans to propose the introduction of a form of retrospective gold plating of this legislation.

As recognised in your last email, I think that is about as far as we can usefully comment on the issue for the time being.

Regards

Richard Woodfield

So, at last we have the answer. And pretty pathetic it is. “Gold-plating” is a term that is used by the anti-European lobby to describe the process of not simply implementing European law but making it more strict that is essential. In this case, I would claim that making the label honest was the opposite of gold-plating, The European law is obviously designed to encourage the herbal industry by disguising the lack of evidence for the herbs. The MHRA should correct that deficiency but has declined to do so.

Safety

The herbal medicine business, especially the Chinese Traditional medicine, is riddled with impure, contaminated and sometimes lethally toxic rubbish. Of course it is right that the public should be protected from this. Probably it is a job that should be done by Trading Standards officers, but sadly they have shown themselves time and time again to be incompetent and unwilling to enforce the law when it comes to false health claims. The MHRA make a reasonably good job on this front, but that is no reason for them to endorse misleading labels. Statutory regulation by the HPC will do nothing to help: on the contrary it will endorse courses that teach dangerous nonsense.

The Herbal Medicines Advisory Committee

The MHRA’s Herbal Medicines Advisory Committee should have resisted this misleading labelling, but they do not seem to have not done so (it’s hard to tell because the published minutes are totally free of any useful information). The chairman of that committee is Professor Philip A Routledge OBE MB BS MD FRCP FRCPE. If I had been in his position, I would have resigned. I believe that he has let down honest science, and potentially endangered patients by not insisting on honest labels. I do hope that this was not a result of pressure from the Prince of Wales. We know he has lobbied Kent Woods and Philip Routledge. Incidentally, Routledge is president elect of the British Pharmacological Society. Quackery has crept in even there.

What can be done

There us no reason why, even now, the MHRA could not change the labels to something honest. I expect the government is pressing them to support the herbal industry, and big business usually wins over regulators (as with banks).

Freedom of choice by consumers was mentioned several times by the MHRA. That’s fine. Nobody wants to ban echinacea. The whole point of labels is to ensure that it is informed choice. Labels that mislead do not help anyone. They hurt the consumer and they are disastrous for the reputation for integrity of the MHRA.

We should keep up the pressure on the MHRA. Here are a couple of my recent efforts, on BBC Breakfast TV.

The second interview was joint with Dick Middleton. It should have been made clear that Middleton is a pharmacist who is technical director of Schwabe Pharma, a company that sells expensive herbal pills, so has a vested financial interest in disguising the lack of evidence for efficacy,

Follow-up

1 May 2011. The new herbal regulations have come into effect. Radio 5 put me up against the herbal industry representative, Michael McIntyre (chair of the European Herbal & Traditional Medicine Practitioners Association). I was pleased to get the chance to debate directly with him, because he has been misrpresenting the evidence for years. See, for example, Some truly appalling reporting of science by the BBC. and Government lends credibility to quacks and charlatans. I was able, at last, to ask him directly, which herb had the best evidence for its efficacy. He repeatedly refused to answer: “I’m not going to get into detail”. Eventually he resorted to the argument that herbalists treat people not diseases. I pointed out that the MHRA-approved labels list all sorts of diseases. No response. He then misquotes Sackett, who did NOT say that experience was as good as RCTs.

McIntyre goes on to misrepresent the BMJ Clinical Evidence paper which, he says, shows that 46% of all treatments are not proven to be effective. It is hard to be believe that McIntyre is really unaware that a large proportion of those that were not shown to be effective are CAM treatments, herbal medicine and the like. Professor John Garrow has pointed this out (see, also Healthwatch). Either he doesn’t read the literature or he deliberately misrepresents it.

Then a caller came in to swear that Chinese Medicine had cured his prostate problem and his wife’s hair. Of course he hadn’t any idea of how is prostate would have progressed if he hadn’t taken the Chinese medicine. Luckily for him, he didn’t have prostate cancer (the people who take Chinese medicine for cancer are probably dead so they can’t appear on the radio). These people are difficult to deal with without appearing rude, by saying they are gullible and deceived. I tried. Interestingly McIntyre did not leap to the defence of Chinese herbs.

Listen to Radio 5 Live

Jump to follow-up

I hate to be forced to return to the world’s most boring delusion, homeopathy. It is boring because the battle to inform people how daft it is has been almost won. Now not a single Bachelors degree in homeopathy appears in UCAS, compared with at least five in 2007. But the battle is not quite won with the UK Government. This post is not so much about homeopathy as about the failures of the Government and the MHRA.

The Medicines and Health Regulatory Authority (MHRA), has just launched yet another consultation and I have felt obliged to waste an entire Sunday writing a response to it, I can’t imagine that any scientist would disagree much with what I have written, but most of them have far better ways to spend their time than bothering about the lunatic fringes of medicine. No doubt most of the responses will come from people who make money from homeopathy, Not just the homeopaths on the High Street, but also the very rich companies like Boiron and Weleda who make enormous profits from selling pills that contain nothing but a bit of sugar.

The documents

The consultation concerns what should be done, about homeopathy in the wake of the scarifying report of the House of Commons Select Committee [get pdf], and the governments response to that report [get pdf].

The MHRA’s request for consultation is here. Download the consultation document. You can download my full response [get pdf], Please write your own response and send it to andreafarmer@mhra.gsi.gov.uk before February 17th. Feel free to plagiarise anything you find here.

Another good response is from Healthwatch, [download pdf]

And an excellent response  by Prof John C. McLachlan [download pdf].

Now I’ll filll in some of the background and outline why I think the MHRA still hasn’t understood.

The Medicines Act 1968 and PLRs

The Medicines Act (1968) was passed in the wake of the thalidomide disaster. It required evidence that medicines work and that they are safe. It was not possible to check all existing medicines by the time the Act was implemented in 1971, so, as a temporary measure, many medicines, including homeopathic stuff, were give a "public licence of right" (PLR). Forty years later they have mostly vanished. But not for homeopathy. The PLR is the licence that allows homeopaths to break all the rules. They still exist.

MHRA cocked it up in 2006

The story starts with the National Regulation Scheme for homeopathic junk that was introduced by the MHRA in 2006. This allowed, for the first time, indications to be put on the labels of the bottles of sugar pills. There were howls of outrage from just about every scientific organisation (the medical establishment was, as usual, more pusillanimous, with some honourable exceptions). The history is related here in the following posts.

The MHRA breaks its founding principle: it is an intellectual disgrace 

The Royal Society speaks out on CAM

Learned Societies speak out against CAM, and the MHRA

The MHRA loses the plot: it allows mislabelling of Arnica gel

House of Lords slams homeopathy and the MHRA

MHRA admits herbal medicines unproven

The Science and Technology Select Committee report

This was an admirable effort, It extracted, with some difficulty, admissions from Boots’ professional standards director that the sold pills while knowing that they didn’t work. It also squeezed out of the then Health Minister, Mike O’Brien an admission that they don’t work, Less surprisingly, the head of the MHRA agreed that they don’t work. So it is unanimous (apart, of course, from those who make money from selling things that don’t work).

If you want to know more about Boots’ Professional standards, take a look at Mis-education at Boots the Chemist, or The Vitamin B scam. Don’t trust Boots, or Boots reaches new level of dishonesty with CoQ10 promotion, to name but a few. The oral sessions of the committee were notable for the squirming evasiveness of most of the answers to simple questions. An account can be found in Comedy gold in parliament and tragedy from Prince of Wales: editorial in British Medical Journal

The Government’s response to the report was mostly as truly pathetic bit of official waffle, like those letters you get when you write to your Member of Parliament. But it did contain one good thing."In order for the public to make informed choices, it is therefore vitally important that the scientific evidence base for homeopathy is clearly explained and available." (though even that statement is attributed to John Beddington, the Government’s Chief Scientific advisor, rather than something the Government thinks essential).

"“The MHRA will review the labelling requirements under the NRS to ensure that these deliver clarity as to the status of products and their composition."

The proposals in the MHRA Consultation document’

There are a couple of good things in the proposals. The MHRA proposes to end PLRs (decades overdue, but nonetheless welcome).

The MHRA proposes to stop ‘regulating’ (ho ho) “Bach Flower Remedies” as medicines (but seems happy to classify them as food Supplements, another weasel description to evade sensible regulation). That’s sensible because they aren’t medicines. Homeopathic pills most certainly aren’t medicines either but the MHRA seems to have difficulty grasping that, and wants to treat them quite differently from “Flower remedies”

More honest labelling was about the only sensible thing recommended by the Government’s response. On this topic the MHRA proposals verge on the laughable

At present the labelling allowed under the NRS includes

“A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of ….”

It is proposed to change this to

“A homeopathic medicinal product licensed only on the basis of safety, quality and use within the homeopathic tradition”

“A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of……”

Spot the difference!

The is utterly inadequate. In fact it verges on the pathetic (and on the dishonest). Here is an extract from my full response.

"Sad to say these proposals to remedy the labelling problem are wholly inadequate. They are almost as deceptive as the originals. These labels don‘t come anywhere near to fulfilling the requirement in the government‘s response which said

In order for the public to make informed choices, it is therefore vitally important that the scientific evidence base for homeopathy is clearly explained and available

Why, oh why, cannot the MHRA bring itself to simply tell the truth? It seems to be so stifled by some perversion of political correctness that it is unable to do what it must know is right.

Nothing indicates more clearly the ludicrous state of the NRS than the label approved for Arnica 30C pills.

The approved label says

"ACTIVE INGREDIENT
Each pill contains 30C Arnica Montana
Also contains: lactose and sucrose"

The MHRA must decide whether or not it believes Avogadro‘s number or not.

How many people in the general public realise the ―Each pill contains 30C Arnica Montana‖ means that the ―pills contain no Arnica whatsoever‖? The very mention of the words ―active ingredient‖ will suggest to most people that there is an active ingredient when there is not. This wording alone is both dishonest and deceptive.

The rest of the approved label consists largely of make-believe too.

"If you are pregnant or breastfeeding consult your doctor before use"

What is your doctor meant to advise you about the dangers of taking a few mg of sugar when you are pregnant?

"If you take too much of the product (overdose) speak to a doctor / pharmacist and take this label with you,."

Unless the MHRA has disavowed Avogadro‘s number, an overdose is impossible. To allow a label like this makes the MHRA a laughing stock

http://www.dcscience.net/wp-admin/edit-tags.php?taxonomy=category

Labels should tell the truth in plain language. For example they should say

This product contains no Arnica

There is no evidence that it works for any condition, other than as a placebo

Some comments on regulation of magic medicine

Governments like to regulate things. They should have regulated the banks a bit more. The problem arises when you try to regulate things that are myths. Like homeopathy.

Andy Lewis has recently written a superb account of the problems on his Quackometer blog, When the Regulator Believes in Fairies, Who Protects the Public?

The government appears to believe that "training" will solve all the problems. Training people to believe things that aren’t true can never solve problems. On the contrary, it creates problems. Organisations like the Complementary and Natural Health Care Council (CNHC)do nothing to protect the public, They endanger the public (see Why the CNHC can’t succeed). Their excuse for rejecting complaints that members were making false claims was not to deny that the claims were false, but to say that it didn’t matter because that is what they had been trained to say. That is make-believe regulation.

Follow-up

.This is Andy Lewis’s version of an honest label. It looks quite accurate to me.

quackometer

27 January 2011

News today makes one despair of the morality of governments. Remember those obviously fraudulent bomb detectors, no more than a dowsing rod? Although they are now the subject of a fraud investigation, they are still being sold. The government has banned their export to Iraq and Afghanistan, but NOT to anywhere else, This suggests not only that the government is (or at least was) quite happy to believe in dowsing. It also implies that even when they realise that it’s fraud they take the view that that business is far more important than even the most basic morality. No doubt they will allow fraudulent labelling of medicines in order to protect the homeopathic industry

Does politics have to be quite so disgusting?

28 January 2011. An excellent post on a similar topic is that referred to in a comment below. The MHRA and the non-regulation of homeopathy explains the European background better that I have done.

11 February 2011. Here is a characteristically beautiful response to the consultation by Prof John C. McLachlan, who has allowed me to post it here [download pdf].

Jump to follow-up

The Yuletide edition of the BMJ carries a lovely article by Jeffrey Aronson, Patent medicines and secret remedies. (BMJ 2009;339:b5415).

I was delighted to be asked to write an editorial about it, In fact it proved quite hard work, because the BMJ thought it improper to be too rude about the royal family, or about the possibility of Knight Starvation among senior medics. The compromise version that appeared in the BMJ is on line (full text link).

The changes were sufficient that it seems worth posting the original version (with links embedded for convenience).

The cuts are a bit ironic, since the whole point of the article is to point out the stifling political correctness that has gripped the BMA, the royal colleges, and the Department of Health when it comes to dealing with evidence-free medicine. It has become commonplace for people to worry about the future of the print media, The fact of the matter is you can often find a quicker. smarter amd blunter response to the news on blogs than you can find in the dead tree media. I doubt that the BMJ is in any danger of course. It has a good reputation for its attitude to improper drug company influence (a perpetual problem for clinical journals) as well as for clinical and science articles.  It’s great to see its editor, Fiona Godlee, supporting the national campaign for reform of the libel laws (please sign it yourself). 

The fact remains that when it comes to the particular problem of magic medicine, the action has not come from the BMA, the royal colleges, and certainly not from the Department of Health, It has come from what Goldacre called the “intrepid, ragged band of bloggers”. They are the ones who’ve done the investigative journalism, sent complaints and called baloney wherever they saw it. This article was meant to celebrate their collective efforts and to celebrate the fact that those efforts are beginning to percolate upwards to influence the powers that be.

It seems invidious to pick on one example, but if you want an example of beautiful and trenchant writing on one of the topics dealt with here, you’d be better off reading Andrew Lewis’s piece "Meddling Princes, Medical Regulation and Licenses to Kill” than anything in a print journal.

I was a bit disappointed by removal of the comment about the Prince of Wales.  In fact I’m not particularly republican compared with many of my friends.  The royal family is clearly good for the tourist industry and that’s important.  Since Mrs Thatcher (and her successors) destroyed large swathes of manufacturing and put trust in the vapourware produced by dishonest and/or incompetent bankers, it isn’t obvious how the UK can stay afloat.  If tourists will pay to see people driving in golden coaches, that’s fine.  We need the money.  What is absolutely NOT acceptable is for royals to interfere in the democratic political process.  That is what the Prince of Wales does incessantly.  No doubt he is well-meaning, but that is not sufficient.  If I wanted to know the winner of the 2.30 at Newmarket, it might make sense to ask a royal.  In medicine it makes no sense at all.  But the quality of the advice is irrelevant anyway.  The royal web site itself says “As a constitutional monarch, the Sovereign must remain politically neutral.”. Why does she not apply that rule to her son? Time to put him over your knee Ma’am?

Two of the major bits that were cut out are shown in bold, The many other changes are small.

BMJ editorial December 2009

Secret remedies: 100 years on

Time to look again at the efficacy of remedies

Jeffrey Aronson in his article [1] gives a fascinating insight into how the BMA, BMJ and politicians tried, a century ago, to put an end to the marketing of secret remedies.  They didn’t have much success. 

The problems had not improved 40 years later when A.J. Clark published his book on patent medicines [2]. It is astounding to see how little has changed since then.  He wrote, for example, “On the other hand the quack medicine vendor can pursue his advertising campaigns in the happy assurance that, whatever lies he tells, he need fear nothing from the interference of British law. The law does much to protect the quack medicine vendor because the laws of slander and libel are so severe.”>  Clark himself was sued for libel after he’d written in a pamphlet “ ‘Cures’ for consumption, cancer and diabetes may fairly be classed as murderous”. Although he initially tried to fight the case, impending destitution eventually forced him to apologise [3].  If that happened today, the accusation would have been repeated on hundreds of web sites round the world within 24 hours, and the quack would, with luck, lose [4].

As early as 1927, Clark had written “Today some travesty of physical science appears to be the most popular form of incantation” [5].  That is even more true today.  Homeopaths regularly talk utter nonsense about quantum theory [6] and ‘nutritional therapists’ claim to cure AIDS with vitamin pills or even with downloaded music files.  Some of their writing is plain delusional, but much of it is a parody of scientific writing. The style, which Goldacre [7] calls ‘sciencey’, often looks quite plausible until you start to check the references.

A 100 years on from the BMA’s efforts, we need once again to look at the efficacy of remedies.  Indeed the effort is already well under way, but this time it takes a rather different form.  The initiative has come largely from an “intrepid, ragged band of bloggers” and some good journalists, helped by many scientific societies, but substantially hindered by the BMA, the Royal Colleges, the Department of Health and a few vice-chancellors.  Even NICE and the MHRA have not helped much.  The response of the royal colleges to the resurgence in magic medicine that started in the 1970s seems to have been a sort of embarrassment.  They pushed the questions under the carpet by setting up committees (often populated with known sympathizers) so as to avoid having to say ‘baloney’.  The Department of Health, equally embarrassed, tends to refer the questions to that well-known medical authority, the Prince of Wales (it is his Foundation for Integrated Health that was charged with drafting National Occupational Standards in make-believe subjects like naturopathy [8].

Two recent examples suffice to illustrate the problems.

The first example is the argument about the desirability of statutory regulation of acupuncture, herbal and traditional Chinese medicine (the Pittilo recommendations) [9].

Let’s start with a definition, taken from ‘A patients’ guide to magic medicine’ [10]. “Herbal medicine: giving patients an unknown dose of an ill-defined drug, of unknown effectiveness and unknown safety”.

It seems to me to be self-evident that you cannot start to think about a sensible form of regulation unless you first decide whether what you are trying to regulate is nonsense, though this idea does not seem to have penetrated the thinking of the Department of Health or the authors of the Pittilo report.  The consultation on statutory regulation has had many submissions [11] that point out the danger to patients of appearing to give official endorsement of treatments that don’t work.  The good news is that there seems to have been a major change of heart at the Royal College of Physicians.  Their submission points out with admirable clarity that the statutory regulation of things that don’t work is a danger to patients (though they still have a blank spot about the evidence for acupuncture, partly as a result of the recent uncharacteristically bad assessment of the evidence by NICE [12]).  Things are looking up.  Nevertheless, after the public consultation on the report ended on November 16th, the Prince of Wales abused his position to make a well-publicised intervention on behalf of herbalists [13]Sometimes I think his mother should give him a firm lesson in the meaning of the term ‘constitutional monarchy’, before he destroys it.

The other example concerns the recent ‘evidence check: homeopathy’ conducted by the House of Commons Science and Technology Select Committee (SCITECH). First the definition [10]: “Homeopathy: giving patients medicines that contain no medicine whatsoever”.  When homeopathy was dreamt up, at the end of the 18th century, regular physicians were lethal blood-letters, and it’s quite likely that giving nothing saved people from them.  By the mid-19th century, discoveries about the real causes of disease had started, but homeopaths remain to this day stuck in their 18th century time warp. 

In 1842 Oliver Wendell Holmes said all that needed to be said about medicine-free medicine [14].  It is nothing short of surreal that the UK parliament is still discussing it in 2009.  Nevertheless it is worth watching the SCITECH proceedings [15].  The first two sessions are fun, if only for the statement by the Professional Standards Director of Boots that they sell homeopathic pills while being quite aware that they don’t work.  I thought that was rather admirable honesty.  Peter Fisher, clinical director of the Royal Homeopathic Hospital, went through his familiar cherry-picking of evidence, but at least repeated his condemnation of the sale of sugar pills for the prevention of malaria. 

But for pure comedy gold, there is nothing to beat the final session.  The health minister, Michael O’Brien, was eventually cajoled into admitting that there was no good evidence that homeopathy worked but defended the idea that the taxpayer should pay for it anyway.  It was much harder to understand the position of the chief scientific advisor in the Department of Health, David Harper.  He was evasive and ill-informed.  Eventually the chairman, Phil Willis, said “No, that is not what I am asking you. You are the Department’s Chief Scientist. Can you give me one specific reference which supports the use of homeopathy in terms of Government policy on health?”.  But answer came there none (well, there were words, but they made no sense). 

Then at the end of the session Harper said “homeopathic practitioners would argue that the way randomised clinical trials are set up they do not lend themselves necessarily to the evaluation and demonstration of efficacy of homeopathic remedies, so to go down the track of having more randomised clinical trials, for the time being at least, does not seem to be a sensible way forward.”  Earlier, Kent Woods (CEO of the MHRA) had said “the underlying theory does not really give rise to many testable hypotheses”.  These two eminent people seemed to have been fooled by the limp excuses offered by homeopaths.  The hypotheses are testable and homeopathy, because it involves pills, is particularly well suited to being tested by proper RCTs (they have been, and when done properly, they fail).  If you want to know how to do it, all you have to do is read Goldacre in the Guardian [16].

It really isn’t vert complicated.   “Imagine going to an NHS hospital for treatment and being sent away with nothing but a bottle of water and some vague promises.”  “And no, it’s not a fruitcake fantasy. This is homeopathy and the NHS currently spends around £10million on it.”

That was written by health journalist Jane Symons, in The Sun [17].  A Murdoch tabloid has produced a better account of homeopathy than anything that could be managed by the chief scientific advisor to the Department of Health.  And it isn’t often that one can say that.

These examples serve to show that the medical establishment is slowly being dragged, from the bottom up, into realising that matters of truth and falsehood are more important than their knighthoods.  It is all very heartening, both for medicine and for democracy itself.

David Colquhoun.

Declaration of interests. I was A.J. Clark chair of pharmacology at UCL, 1985 – 2004.

1.  Aronson, JK BMJ 2009;339:b5415

2.  Clark, A,J, (1938) Patent Medicines FACT series 14, London.  See also Patent medicines in 1938 and now  http://www.dcscience.net/?p=257
(A.J. Clark FRS was professor of Pharmacology at UCL from 1919 to 1926, and subsequently in Edinburgh).

3.  David Clark “Alfred Joseph Clark, A Memoir” (C. & J. Clark Ltd 1985 ISBN 0-9510401-0-3)

4.  Lewis, A. (2007) The Gentle Art of Homeopathic Killing

5.  A.J. Clark (1927) The historical aspect of quackery, BMJ October 1st 1927

6.  Chrastina, D  (2007) Quantum theory isn’t that weak,  (response to Lionel Milgrom).

7  Goldacre, B. (2008) Bad Science. HarperCollins

8. Skills for Health web site
   The ‘competences’ have been revised since the account at http://www.dcscience.net/?p=215#sfh, but are still preposterous make believe.

9. A very bad report: gamma minus for the vice-chancellor

10. A Patients’ Guide to Magic Medicine,  and also in the Financial Times.

11.  An excellent submission to the consultation on statutory regulation of alternative medicine (Pittilo report)

12.  NICE fiasco, part 2. Rawlins should withdraw guidance and start again

13. BBC news 1 December 2009 Prince Charles: ‘Herbal medicine must be regulated’.

14.  Oliver Wendell Holmes (1842) Homeopathy and Its Kindred Delusions.

15.  House of Commons Science and technology committee. Evidence check: homeopathy. Videos and transcripts available at  http://www.viewista.com/s/fywlp2/ez/1

16.  Goldacre, B.  A Kind of Magic  Guardian  16 November 2007.

17.   Homeopathy is resources drain says
Jane Symons.  The Sun 2 December 2009. 

Follow-up

There is a good account of the third SCITECH session by clinical science consultant, Majikthyse, at The Three Amigos.

16 December 2009.. Recorded an interview for BBC Radio 5 Live. It was supposed to go out early on 17th.

17 December 2009.  The editorial is mentioned in Editor’s Choice, by deputy editor Tony Delamothe. I love his way of putting the problem "too many at the top of British medicine seem frozen in the headlights of the complementary medicine bandwagon".  He sounds remarkably kind given that I was awarded (by the editor, Fiona Godlee, no less) a sort of booby prize at the BMJ party for having generated a record number of emails during the editing of a single editorial (was it really 24?). Hey ho.

17 December 2009.  More information on very direct political meddling by the Prince of Wales in today’s Guardian, and in Press Association report.

17 December 2009Daily Telegraph reports on the editorial, under the heading “ ‘Nonsense’ alternative medicines should not be regulated“. Not a bad account for a non-health journalist.

17 December 2009. Good coverage in the excellent US blog, Neurologica, by the superb Steven Novella.’ “Intrepid, Ragged Band of Bloggers” take on CAM‘ provides a chance to compare and contrast the problems in the UK and the USA.’

18 December 2009.  Article in The Times by former special advisor, Paul Richards. “The influence of Prince Charles the lobbyist is out of hand. Our deference stops us asking questions.”

“A good starting point might be publication of all correspondence over the past 30 years. Then we will know the extent, and influence, of Prince Charles the lobbyist.”

Comments in the BMJ Quite a lot of comments had appeared by January 8th, though sadly they were mostly from the usual suspects who appear every time one suggests evidence matters. A reply was called for, so I sent this (the version below has links).

After a long delay, this response eventually appeared in the BMJ on January 15 2010.

It’s good to see so many responses, though somewhat alarming to see that several of them seem to expect an editorial to provide a complete review of the literature.  I ‘ll be happy to provide references for any assertion that I made.

I also find it a bit odd that some people think that an editorial is not the place to express an opinion robustly.  That view seems to me to be a manifestation of the very sort of political correctness that I was deploring.  It’s a bit like the case when the then health minister, Lord Hunt, referred to psychic surgery as a “profession” when he should have called it a fraudulent conjuring trick.  Anything I write is very mild compared with what Thomas Wakley wrote in the Lancet, a journal which he founded around the time UCL came into existence. For example (I quote)

“[We deplore the] “state of society which allows various sets of mercenary, goose-brained monopolists and charlatans to usurp the highest privileges…. This is the canker-worm which eats into the heart of the medical body.” Wakley, T. The Lancet 1838-9, 1 

I don’t think it is worth replying to people who cite Jacques Benveniste or Andrew Wakefield as authorities.  Neither is it worth replying to people who raise the straw man argument about wicked pharmaceutical companies (about which I am on record as being as angry as anyone).  But I would like to reply directly to some of the more coherent comments.

Sam Lewis and Robert Watson. [comment] Thank you for putting so succinctly what I was trying to say.

Peter Fisher [comment].  I have a lot of sympathy for Peter Fisher.  He has attempted to do some good trials of homeopathy (they mostly had negative outcomes).  He said he was "very angry" when the non-medical homeopaths  were caught out recommending their sugar pills for malaria prevention (not that this as stopped such dangerous claims which are still commonplace).  He agreed with me that there was not sufficient scientific basis for BSc degrees in homeopathy.  I suppose that it isn’t really surprising that he continues to cherry pick the evidence.  As clinical director of the Royal London Homeopathic Hospital and Homeopathic physician to the Queen,  just imagine the cognitive dissonance that would result if he were to admit publicly that is all placebo after all.  He has come close though. His (negative) trial for homeopathic treatment of rheumatoid arthritis included the words "It seems more important to define if homeopathists can genuinely control patients’ symptoms and less relevant to have concerns about whether this is due to a ‘genuine’ effect or to influencing the placebo response” [2]. [download
the paper
].  When it comes to malaria, it matters a lot.

Adrian White [comment] seems to be cross because I cited my own blog.   I did that simply because if he follows the links there he will find the evidence.  In the case of acupuncture it has been shown time after time that "real" acupuncture does not differ perceptibly from sham.  That is true whether the sham consists of retractable needles or real needles in the "wrong" places.  A non-blind comparison between acupuncture and no acupuncture usually shows some advantage for the former but it is, on average, too small to be of much clinical significance [3]. I agree that there is no way to be sure that this advantage is purely placebo effect but since it is small and transient it really doesn’t matter much.  Nobody has put it more clearly than Barker Bausell in his book, Snake Oil Science [4]

White also seems to have great faith in peer review.  I agree that in real science it is probably the best system we have.  But in alternative medicine journals the "peers" are usually other true believers in whatever hocus pocus is being promoted and peer reveiw breaks down altogether.

R. M. Pittilo [comment] I’m glad that Professor Pittilo has replied in person because I did single out his report for particular criticism.  I agree that his report said that NHS funding should be available to CAM only where there is evidence of efficacy.  That was not my criticism.  My point was that in his report, the evidence for efficacy was assessed by representatives of Herbal Medicine, Chinese Medicine and Acupuncture (four from each).  Every one of them would have been out of work if they had found their subjects were nonsense and that, no doubt, explains why the assessment was so bad.  To be fair, they did admit that the evidence was not all that it might be and recommended (as always) more research   I’d like to ask Professor Pittilo how much money should be spent on more research in the light of the fact that over a billion dollars has been spent in the USA on CAM research without producing a single useful treatment.  Pittilo says "My own view is that both statutory regulation and the quest for evidence should proceed together" but he seems to neglect the possibility that the quest for evidence might fail. Experience in the USA suggests that is exactly what has, to a large extent, already happened.

I also find it quite absurd that the Pittilo report should recommend, despite a half-hearted admission that the evidence is poor, that entry to these subjects should be via BSc Honours degrees.  In any case he is already thwarted in that ambition because universities are closing down degrees in these subjects  having realised that the time to run a degree is after, not before, you have some evidence that the subject is not nonsense.  I hope that in due course Professor Pittilo may take the same action about the courses in things like homeopathy that are run by the university of which he is vice-chancellor.  That could only enhance the academic reputation of Robert Gordon’s University.

George Lewith [comment]  You must be aware that the proposed regulatory body, the Health Professions Council, has already broken its own rules about "evidence-based practice" by agreeing to take on, if asked, practitioners of Herbal Medicine, Chinese Medicine and Acupuncture.  They have (shamefully) excluded the idea that claims of efficacy would be regulated.  In other word they propose to provide exactly the sort of pseudo-regulation which would endanger patients   They are accustomed to the idea that regulation is to do only with censoring practitioners who are caught in bed with patients.  However meritorious that may be, it is not the main problem with pseudo-medicine, an area in which they have no experience.  I’m equally surprised that Lewith should recommend that Chinese evaluation of Traditional Chinese medicine should be included in meta-analyses, in view of the well-known fact that 99% of evaluations from China are positive: “No trial published in China or Russia/USSR found a test treatment to be ineffective” [5]. He must surely realise that medicine in China is a branch of politics.  In fact the whole resurgence in Chinese medicine and acupuncture in post-war times has less to do with ancient traditions than with Chinese nationalism, in particular the wish of Mao Tse-Tung to provide the appearance of health care for the masses (though it is reported that he himself preferred Western Medicine).

1. Lord Hunt thinks “psychic surgery” is a “profession”. http://www.dcscience.net/?p=258

2. Fisher, P. Scott, DL. 2001 Rheumatology 40, 1052 – 1055.   [pdf file]

3. Madsen et al, BMJ 2009;338:a3115  [pdf file]

4. R, Barker Bausell, Snake Oil Science, Oxford University Press, 2007

5. Vickers, Niraj, Goyal, Harland and Rees (1998, Controlled Clinical Trials, 19, 159-166) “Do Certain Countries Produce Only Positive Results? A Systematic Review of Controlled Trials”. [pdf file]

15 January 2010. During the SciTech hearings, Kent Woods (CEO of the MHRA) made a very feeble attempt to defend the MHRA’s decision to allow misleading labelling of homeopathic products. Now they have published their justification for this claim. It is truly pathetic, as explained by Martin at LayScience: New Evidence Reveals the MHRA’s Farcical Approach to Homeopathy. This mis-labelling cause a great outcry in 2006, as documented in The MHRA breaks its founding principle: it is an intellectual disgrace, and Learned Societies speak out against CAM, and the MHRA.

22 January 2010 Very glad to see that the minister himself has chosen to respond in the BMJ to the editorial

Rt Hon. Mike O’Brien QC MP, Minister of State for Health Services

I am glad that David Colquhoun was entertained by my appearance before the Health Select Committee on Homeopathy. But he is mistaken when he says, “you cannot start to think about a sensible form of regulation unless you first decide whether or not the thing you are trying to regulate is nonsense.”

Regulation is about patient safety. Acupuncture, herbal and traditional Chinese medicine involve piercing the skin and/or the ingestion of potentially harmful substances and present a possible risk to patients.

The Pittilo Report recommends statutory regulation and we have recently held a public consultation on whether this is a sensible way forward.

Further research into the efficacy of therapies such as Homeopathy is unlikely to settle the debate, such is the controversy surrounding the subject. That is why the Department of Health’s policy towards complementary and alternative medicines is neutral.

Whether I personally think Homeopathy is nonsense or not is besides the point. As a Minister, I do not decide the correct treatment for patients. Doctors do that. I do not propose on this occasion to interfere in the doctor-patient relationship.

Here is my response to the minister

I am very glad that the minister himself has replied. I think he is wrong in two ways, one relatively trivial but one very important.

First, he is wrong to refer to homeopathy as controversial. It is not. It is quite the daftest for the common forms of magic medicine and essentially no informed person believes a word of it. Of course, as minister, he is free to ignore scientific advice, just as the Home Secretary did recently. But he should admit that that is what he is doing, and not hide behind the (imagined) controversy.

Second, and far more importantly, he is wrong, dangerously wrong, to say it I was mistaken to claim that “you cannot start to think about a sensible form of regulation unless you first decide whether or not the thing you are trying to regulate is nonsense". According to that view it would make sense to grant statutory regulation to voodoo and astrology. The Pittilo proposals would involve giving honours degrees in nonsense if one took the minister’s view that it doesn’t matter whether the subjects are nonsense or not. Surely he isn’t advocating that?

The minister is also wrong to suppose that regulation, in the form proposed by Pittilo, would do anything to help patient safety. Indeed there is a good case to be made that it would endanger patients (not to mention endangering tigers and bears). The reason for that is that the main danger to patients arises from patients being given “remedies” that don’t work. The proposed regulatory body, the Health Professions Council, has already declared that it is not interested in whether the treatments work or not. That in itself endangers patients. In the case of Traditional Chinese Medicine, there is also a danger to patients from contaminated medicines. The HPC is not competent to deal with that either. It is the job of the MHRA and/or Trading Standards. There are much better methods of ensuring patient safety that those proposed by Pittilo.

In order to see the harm that can result from statutory regulation, it is necessary only to look at the General Chiropractic Council. Attention was focussed on chiropractic when the British Chiropractic Association decided, foolishly, to sue Simon Singh for defamation. That led to close inspection of the strength of the evidence for their claims to benefit conditions like infant colic and asthma. The evidence turned out to be pathetic, and the result was that something like 600 complaints were made to the GCC about the making of false health claims (including two against practices run by the chair of the GCC himself). The processing of these complaints is still in progress, but what is absolutely clear is that the statutory regulatory body, the GCC, had done nothing to discourage these false claims. On the contrary it had perpetrated them itself. No doubt the HPC would be similarly engulfed in complaints if the Pittilo proposals went ahead.

It is one thing to say that the government chooses to pay for things like homeopathy, despite it being known that they are only placebos, because some patients like them. It is quite another thing to endanger patient safety by advocating government endorsement in the form of statutory regulation, of treatments that don’t work.

I would be very happy to meet the minister to discuss the problems involved in ensuring patient safety. He has seen herbalists and other with vested interests. He has been lobbied by the Prince of Wales. Perhaps it is time he listened to the views of scientists too.

Both the minister’s response, and my reply, were reformatted to appear as letters in the print edition of the BMJ, as well as comments on the web..

Jump to follow-up

This is another short interruption in the epic self-destruction of chiropractors.  In a sense it is more serious.  One expects quacks to advocate quackery.  What you don’t expect is that the National Institute of Clinical Excellence (NICE) will endorse it.  Neither do you expect the Medicines and Healthcare products Regulatory Agency (MHRA) to betray its mandate to make sure that medicines work.

The saga of the NICE low back pain guidance has been the subject of a deluge of criticism, It seems doubtful that the guidance can survive, not least because of its absurd endorsement of chiropractic, at a time when chiropractic is undergoing self-immolation as a consequence of the persecution of Simon Singh by the British Chiropractic Association (see here, and here, and here, and here and thousands of other sites).

The other betrayal has come to the for after the MHRA approved highly misleading labelling of a homeopathic preparation.  At the time,
in 2006
, when the principle was approved by the MHRA, just about every scientific organisation, even the Royal Society, condemned the action.  What was discouraging that the clinical organisations all stayed silent.  It is still a mystery why the MHRA made this enormous mistake,  Some said that European regulations required it, but that is quite untrue, as Les Rose has shown.  It appears to have been the result of a pusillanimous MHRA bowing to pressure from a deeply unscientific Department of Health (a letter from Caroline Flint at the time borders on the surreal).

On 20 May 2009, the British Medical Journal printed an article Drugs agency grants its first licence to homoeopathic product by Deborah Cohen (available free). The comments were mostly highly critical of the MHRA. The BMJ asked, as it does from time to time, for my comment to be converted to a letter
for the print edition
. That isn’t freely available, so here it is.

Published 9 June 2009, doi:10.1136/bmj.b2333
Cite this as: BMJ 2009;338:b2333

Letters

Homoeopathic product licence

MHRA label seems to be illegal

The strap line for the Medicines and Healthcare products Regulatory Agency (MHRA) is “We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe.”

Yet the MHRA has made mockery of its own aims by ignoring the bit about “ensuring that medicines work” and allowing Arnica 30C pills to be labelled: “a homoeopathic medicinal product used within the homoeopathic tradition for the symptomatic relief of sprains, muscular aches, and bruising or swelling after contusions.”1

This label should be illegal anyway because the pills contain no trace of the ingredient on the label, but this deceit has been allowed through a legal loophole for a long time now. If you sold strawberry jam that contained not a trace of strawberry you’d be in trouble.

But I can see no legal loophole that allows the manufacturers of Arnica 30C to evade the provisions of the Consumer Protection from Unfair Trading Regulations 2008. One of the 31 commercial practices which are in all circumstances considered unfair is “falsely claiming that a product is able to cure illnesses, dysfunction, or malformations.”

The consumer protection laws apply to the way that “the average consumer” will interpret the label. The average consumer is unlikely to know that “used within the homoeopathic tradition” is a form of weasel words that actually means “there isn’t a jot of evidence that the medicine works.”

Since there is not the slightest evidence that Arnica 30C pills provide symptomatic relief of sprains, etc, the labelling that the MHRA has approved seems to be illegal. The MHRA is not selling anything itself, so I presume that it won’t find itself in court, but anyone who follows its advice could well do so.

Cite this as: BMJ 2009;338:b2333

David Colquhoun, research professor1

University College London, London WC1E 6BT


Competing interests: None declared.

References

  1. Cohen D. Drugs agency grants its first licence to homoeopathic product. BMJ 2009;338:b2055. (20 May.)

    [Free Full Text]

It is, I suppose, just a sign of the chaos that reigns in the multiple agencies and quangos responsible for ‘regulation’  that one arm of government proposes action that a different branch would consider illegal.  That is an inevitable consequence of trying to regulate something without first deciding whether it is nonsense or not.  The Department of Health appears to be quite incapable of grasping this simple and obvious fact.

Follow-up

Health: best treatments. The Guardian seems to the be picking up BMJ stories and ran this one.

Jump to follow-up

Alfred Joseph Clark FRS held the established chair of Pharmacology at UCL from 1919 to 1926, when he left for Edinburgh.  In the 1920s and 30s, Clark was a great pioneer in the application of quantitative physical ideas to pharmacology.   As well as his classic scientific works, like The Mode of Action of Drugs on Cells (1933) he wrote, and felt strongly, about the fraud perpetrated on the public by patent medicine salesmen.  In 1938 (while in Edinburgh) he published a slim volume called Patent Medicines.  The parallels with today are astonishing.


Alfred Joseph Clark FRS (1885 – 1941)

I was lucky to be given a copy of this book by David Clark, A.J. Clark’s eldest son, who is now 88. I visited him in Cambridge on 17 September 2008, because he thought that, as holder of the A.J. Clark chair at UCL from 1985 to 2004, I’d be a good person to look after this and several other books from his father’s library. They would have gone to the Department of Pharmacology if we still had one, but that has been swept away by mindless administrators with little understanding of how to get good science.

Quotations from the book are in italic, and are interspersed with comments from me.

The book starts with a quotation from the House of Commons Select Committee report on Patent Medicines. The report was submitted to the House on 4 August 1914, so there is no need to explain why it had little effect. The report differs from recent ones in that it is not stifled by the sort of political correctness that makes politicians refer to fraudsters as “professions”.


The problem

“2.2 The situation, therefore, as regards the sale and advertisement of proprietary medicines and articles may be summarised as follows:

For all practical purposes British law is powerless to prevent any person from procuring any drug, or making any mixture, whether patent or without any therapeutical activity whatever (as long as it does not contain a scheduled poison), advertising it in any decent terms as a cure for any disease or ailment, recommending it by bogus testimonials and the invented opinions and facsimile signatures of fictitious physicians, and selling it under any name he chooses, on payment of a small stamp duty. For any price he can persuade a credulous public to pay.”

Select Committee on Patent Medicines. 1914

“The writer has endeavoured in the present article to analyse the reasons for the amazing immunity of patent medicines form all attempts to curb their activity, to estimate the results and to suggest the obvious measures of reform that are needed.”

Clark, writing in 1938, was surprised that so little had changed since 1914.  What would he have thought if he had known that now, almost 100 years after the 1914 report, the fraudsters are still getting away with it?


Chapter 2 starts thus.

THE LAW

The Select Committee appointed by the House of Commons in 1914 ‘to consider and inquire into the question of the sale of Patent and Proprietary Medicines’ stated its opinion in 28 pages of terse and uncompromising invective. Its general conclusions were as follows:

That the trade in secret remedies constituted a grave and widespread public evil.

That the existing law was chaotic and had proved inoperative and that consequently the traffic in secret remedies was practically uncontrolled.

In particular it concluded ‘”that this is an intolerable state of things and that new legislation to deal with it, rather than merely the amendment of existing laws, is urgently needed in the public interest.”

The “widespread public evil”continues almost unabated, and rather than introduce sensible legislation to cope with it, the government has instead given a stamp of approval for quackery by introducing utterly ineffective voluntary “self-regulation”.

Another Bill to deal with patent medicines was introduced in 1931, without success, and finally in 1936, a Medical and Surgical Appliances (Advertisement) Bill was introduced. This Bill had a very limited scope. Its purpose was to alleviate some of the worst abuses of the quack medicine trade by prohibiting the advertisement of cures for certain diseases such as blindness, Bright’s disease [nephritis] , cancer, consumption [tuberculosis], epilepsy, fits, locomotor ataxy, fits, lupus or paralysis.

The agreement of many interests was secured for this measure. The president of the Advertising Association stated that the proposed Bill would not affect adversely any legitimate trade interest. Opposition to the Bill was, however, whipped up amongst psychic healers, anti-vivisectionists and other opponents of medicine and at the second reading in March 1936, the Bill was opposed and the House was counted out during the ensuing debate. The immediate reason for this fate was that the Bill came up for second reading on the day of the Grand National! This is only one example of the remarkable luck that has attended the patent medicine vendors.
(Page 14).

The “remarkable luck” of patent medicine vendors continues to this day, Although, in principle, advertisement of cures for venereal diseases was banned in 1917, and for cancer in 1939, it takes only a few minutes with Google to find that these laws are regularly flouted by quacks,  In practice quacks get away with selling vitamin pills for AIDS, sugar pills for malaria and homeopathic pills for rabies, polio anthrax and just about anything else you can think of.  Most of these advertisements are contrary to the published codes of ethics of the organisations to which the quack in question belongs but nothing ever happens.
Self-regulation simply does not work, and there is still no effective enforcement even of existing laws..

“It has already been stated that British law allows the advertiser of a secret remedy to tell any lie or make any claim that he fancies will sell his goods and the completeness of this licence is best illustrated by the consideration of a few specific points.

Advertisements for secret remedies very frequently contain a list of testimonials from medical men, which usually are in an anonymous form, stating that ………….. M.D., F.R.C.S., has found the remedy infallible. Occasionally, however, the name and address of a doctor is given and anyone unaware of the vagaries of English law would imagine that such use of a doctor’s name and professional reputation could not be made with impunity without his consent. In 1899, however, the Sallyco Mineral Water Company advertised that ‘Dr. Morgan Dochrill, physician to St. John’s Hospital, London and many of the leading physicians are presenting ‘Sallyco’ as an habitual drink. Dr. Dochrill says nothing has done his gout so much good.
Dr. Dochrill, whose name and title were correctly stated above, sued the company but failed in his case. ”

“The statement that the law does not prevent the recommending of a secret remedy by the use of bogus testimonials and facsimile signatures of fictitious physicians is obviously an understatement since it is doubtful how far it interferes with the use of bogus testimonials from real physicians.”

Dodgy testimonials are still a mainstay of dodgy salesman.  One is reminded of the unauthorised citation of testimonials from Dr John Marks and Professor Jonathan Waxman by Patrick Holford to aid his sales of unnecessary vitamin supplements. There is more on this at Holfordwatch.

The man in the street knows that the merits of any article are usually exaggerated in advertisements and is in the habit of discounting a large proportion of such claims, but, outside the realm of secret remedies, the law is fairly strict as regards definite misstatements concerning goods offered for sale and hence the everyday experience of the man in the street does not prepare him for dealing with advertisements which are not merely exaggerations but plain straightforward lies from beginning to end.

Scientific training is undoubtedly a handicap in estimating popular gullibility as regards nostrums. One imagines that no one today would be willing to spend money on pills guaranteed to prevent earthquakes but yet the claims of many of the remedies offered appear equally absurd to anyone with an elementary
knowledge of physiology or even of chemistry. A study of the successes and failures suggests that success depends chiefly on not over-rating the public intelligence. (Page 34)

This may have changed a bit since A.J. Clark was writing in 1938. Now the main clients of quacks seem to be the well-off “worried-well”. But it remains as true as ever that “Scientific training is undoubtedly a handicap in estimating popular gullibility as regards nostrums.” In 2008, it is perhaps more a problem of Ben Goldacre’s dictum ““My basic hypothesis is this: the people who run the media are humanities graduates with little understanding of science, who wear their ignorance as a badge of honour.”

Clark refers (page 36) to a successful conviction for fraud in the USA in 1917.  The subject was a widely advertised ‘get fat quick’ pill that contained lecithin, proteins and sugar.  The BMA analysis (in 1912)
suggested that the cost of the ingredients in a box of 30 tablets sold for 4/6 was 1 1/4 d. [4/6 meant 4 shillings and six pence, or 22.5 pence since 1971, and 1 1/4 old pence, a penny farthing, is 0.52 new pence]. He comments thus.

The trial revealed many interesting facts. The formula was devised after a short consultation with the expert of one of the largest drug manufacturers in the U.S.A. This firm manufactured the tablets and sold them to the proprietary medicine company at about 3/- per 1000, whilst they were retailed to the public at the rate of £7 10s. per 1000. The firm is estimated to have made a profit of about $3,000,000.

These trials in the U.S.A. revealed the fact that in a considerable proportion of cases the ‘private formula’ department of the large and well known drug firm already mentioned had first provided the formula for the nostrum and subsequently had prepared it wholesale.

Nothing much has changed here either. The alternative medicine industry (and it is a very big industry) is fond of denouncing the evils of the pharmaceutical industry, and sadly, occasionally they are right.  One of the less honest practices of the pharmaceutical industry (though one never mentioned by quacks) is buying heavily into alternative medicine. Goldacre points out

“there is little difference between the vitamin and pharmaceutical industries. Key players in both include multinationals such as Roche and Aventis; BioCare, the vitamin pill producer that media nutritionist Patrick Holford works for, is part-owned by Elder Pharmaceuticals.”

And then. of course, there is the deeply dishonest promotion by Boots the Chemists of homeopathic miseducation, of vitamins and of CoQ10 supplements.

The manner in which secret remedies can survive repeated exposure is shown by the following summary of the life history of a vendor of a consumption [tuberculosis] cure.

1904, 1906: Convicted of violating the law in South Africa.

1908:            Exposed in British Medical Association report and also attacked by Truth.

1910:            Sued by a widow. The judge stated: ‘I think this is an intentional and well-considered fraud. It is a scandalous thing that poor people should be imposed upon and led to part with their money, and to hope that those dear to them would be cured by those  processes which were nothing but quack remedies and had not the slightest value of any kind.’

1914:             A libel action against the British Medical Association was lost.

1915              The cure was introduced into the United States.

1919               The cure was sold in Canada.

1924                Articles by men with medical qualifications appeared in the Swiss medical journal boosting
the cure.

Secret remedies have a vitality that resembles that of the more noxious weeds and the examples mentioned suggest that nothing can do them any serious harm.

Most of the time, quacks get away with claims every bit as outrageous today.   But Clark does give one example of a successful prosecution.  It resulted from an exposé in the newspapers -wait for it -in the Daily Mail.

There is, however, one example which proves that a proprietary remedy can be squashed by exposure if this is accompanied by adequate publicity.

The preparation Yadil was introduced as an antiseptic and was at first advertised to the medical profession. The proprietor claimed that the remedy was not secret and that the active principle was ‘tri-methenal allylic carbide’. The drug acquired popularity in the influenza epidemic of 1918 and the proprietor became more and more ambitious in his therapeutic claims. The special virtue claimed for Yadil was that it would kill any harmful organism that had invaded the body. A more specific claim was that consumption in the first stage was cured with two or three pints whilst advanced cases might require a little more.  Other advertisements suggested that it was a cure for most known diseases from cancer downwards.

These claims were supported by an extraordinarily intense advertising campaign.  Most papers, and even magazines circulating amongst the wealthier classes,  carried full page and even double page advertisements. The Daily Mail refused these advertisements and in 1924 published a three column article by Sir William Pope, professor of Chemistry in the University of Cambridge. He stated that
the name ‘tri-methenal allylic carbide’ was meaningless gibberish and was not the chemical definition of any known substance. He concluded that Yadil consisted of :

‘About one per cent of the chemical compound formaldehyde.

About four per cent of glycerine.

About ninety-five per cent of water and, lastly, a smell.

He calculated that the materials contained in a gallon cost about 1/6, whilst the mixture was sold at £4 10s. per gallon.

This exposure was completely successful and the matter is of historic interest in that it is the only example of the career of a proprietary medicine being arrested by the action of the Press.

Clark goes on to talk of the law of libel.


“On the other hand the quack medicine vendor can pursue his advertising campaigns in the happy assurance that, whatever lies he tells, he need fear nothing from the interference of British law. The law does much to protect the quack medicine vendor because the laws of slander and libel are so severe.”

The law of libel to this day remains a serious risk to freedom of speech of both individuals and the media. Its use by rogues to suppress fair comment is routine.  My first encounter was when a couple of herbalists
threatened to sue UCL
because I said that the term ‘blood cleanser’ is gobbledygook.  The fact that the statement was obviously true didn’t deter them for a moment.  The herbalists were bluffing no doubt, but they caused enough nuisance that I was asked to take my pages off UCL’s server.  A week later I was invited back but by then I’d set up a much better blog and the publicity resulted in an enormous increase in readership, so the outcome was good for me (but bad for herbalists).

It was also good in the end for Andy Lewis when his immortal page “The gentle art of homoeopathic killing” (about the great malaria scandal) was suppressed.   The Society of Homeopaths’ lawyers didn’t go for him personally but for his ISP who gave in shamefully and removed the page.  As a result the missing page reappeared in dozens of web sites round the world and shot to the top in a Google search.

Chiropractors are perhaps the group most likely to try to suppress contrary opinions by law not argument.  The only lawyers’ letter that has been sent to me personally, alleged defamation in an editorial that I wrote for the New Zealand Medical Journal.  That was a little scary, but the journal stuck up for its right to speak and the threat went away after  chiropractors were allowed right of reply (but we got the last word).

Simon Singh, one of the best science communicators we have, has not been so lucky. He is going to have to defend in court an action brought by the British Chiropractic Association because of innocent opinions expressed in the Guardian.

Chapter 6 is about “The harm done by patent medicines”. It starts thus.

“The trade in secret remedies obviously represents a ridiculous waste of money but some may argue that, since we are a free country and it pleases people to waste their money in this particular way, there is no call for any legislative interference. The trade in quack medicines cannot, however, be regarded as a harmless one. The Poisons Acts fortunately prevent the sale of a large number of dangerous drugs, but there are numerous other ways in which injury can be produced by these remedies.”

The most serious harm, he thought, resulted from self-medication, and he doesn’t mince his words.

“The most serious objection to quack medicines is however that their advertisements encourage self-medication as a substitute for adequate treatment and they probably do more harm in this than in any other manner.

The nature of the problem can best be illustrated by considering a simple example such as diabetes. In this case no actual cure is known to medicine but, on the other hand, if a patient is treated adequately by insulin combined with appropriate diet, he can be maintained in practically normal health, in spite of his disability, for an indefinite period. The expectation of life of the majority of intelligent diabetics, who make no mistakes in their regime, is not much less than that of normal persons. The regime is both irksome and unpleasant, but anyone who persuades diabetics to abandon it, is committing manslaughter as certainly as if he fired a machine gun into a crowded street.

As regards serious chronic disease the influence of secret remedies may be said to range from murderous to merely harmful.

‘Cures’ for consumption, cancer and diabetes may fairly be classed as murderous, since they are likely to cause the death of anyone who is unfortunate enough to believe in their efficacy and thus delay adequate treatment until too late.

The phrase “‘Cures for consumption, cancer and diabetes may fairly be classed as murderous” made Clark himself the victim of suppression of freedom of speech by lawyers. His son, David Clark, wrote of his father in “Alfred Joseph Clark, A Memoir” (C. & J. Clark Ltd 1985 ISBN 0-9510401-0-3)

“Although tolerant of many human foibles, A. J. had always disapproved fiercely of quacks, particularly the charlatans who sold fraudulent medicines.  During his visits to London he met Raymond Postgate, then a crusading left wing journalist, who persuaded A.J. to write a pamphlet which was published in an ephemeral series called ‘Fact‘ in March 1938. It was a lively polemical piece. . To A.J.’s surprise and dismay he was sued for libel by a notorious
rogue who peddled a quack cure for for tuberculosis. This man said that A.J.’s remarks (such as “‘Cures’ for consumption, cancer and diabetes may fairly be classed as murderous”) were libellous and would damage his business.  A.J. was determined to fight, and he and Trixie decided to put their savings at stake if necessary. The B.M.A. and the Medical Defence Union agreed to support him and they all went to lawyers. He was shocked when they advised him that he would be bound to lose for he had damaged the man’s livelihood!   Finally, after much heart searching, he made an apology, saying that he had not meant that particular man’s nostrum”

Talk about déjà vu!

On page 68 there is another very familiar story. It could have been written today.

“The fact that the public is acquiring more knowledge of health matters and is becoming more suspicious of the cruder forms of lies is also helping to weed out the worst types of patent medicine advertisements. For example, in 1751 a bottle of oil was advertised as a cure for scurvy, leprosy and consumption but today such claims would not be effective in promoting the sale of a remedy. The modern advertiser would probably claim that the oil was rich in all the vitamins and the elements essential for life and would confine his claims to a statement that it would alleviate all minor forms of physical or mental ill-health.

The average patent medicine advertised today makes plausible rather than absurd claims and in general the advertisements have changed to conform with a change in the level of the public’s knowledge.

It is somewhat misleading, however, to speak of this as an improvement, since the law has not altered and hence the change only means that the public is being swindled in a somewhat more skilful manner.

The ideal method of obtaining an adequate vitamin supply is to select a diet containing an abundant supply of fresh foods, but unfortunately the populace is accustomed to live very largely on preserved or partially purified food stuffs and such processes usually remove most of the vitamins.”

The first part of the passage above is reminiscent of something that A.J Clark wrote in  the BMJ in 1927.  Nowadays it is almost unquotable and I was told by a journal editor that it was unacceptable even with asterisks.  That seems to me a bit silly. Words had different connotations in 1927.

“The less intelligent revert to the oldest form of belief and seek someone who will make strong magic for them and defeat the evil spirits by some potent charm. This is the feeling to which the quack appeals; he claims to be above the laws of science and to possess some charm for defeating disease of any variety.

The nature of the charm changes with the growth of education. A naked n****r howling to the beat of a tom-tom does not impress a European, and most modern Europeans would be either amused or disgusted by the Black mass that was popular in the seventeenth century. Today some travesty of physical science appears to be the most popular form of incantation.”

A.J. Clark (1927) The historical aspect of quackery, BMJ October 1st 1927

Apart from some of the vocabulary, what better description could one have of the tendency of homeopaths to harp on meaninglessly about quantum theory or the “scienciness” and “referenciness” of
modern books on nutritional therapy?

So has anything changed?

Thus far, the outcome might be thought gloomy. Judging by Clark’s account, remarkably little has changed since 1938, or even since 1914. The libel law in the UK is as bad now as it was then. Recently the United Nations Human Rights Committee said UK laws block matters of public interest and encourage libel tourism (report here, see also here).   It is unfit for a free society and it should be changed.

But there are positive sides too. Firstly the advent of scientific bloggers has begun to have some real influence. People are no longer reliant on journalists to interpret (or, often, misinterpret) results for them. They can now get real experts and links to original sources.  Just one of these, Ben Goldacre’s badscience.net, and his weekly column in the Guardian has worked wonders in educating the public and improving journalism.  Young people can, and do, contribute to the debate because they can blog anonymously if they are frightened that their employer might object.

Perhaps still more important, the law changed this year. Now, at last, it may be possible to prosecute successfully those who make fraudulent health claims. Sad to say, this was not an initiative of the UK government, which remains as devoted as ever to supporting quacks.  Remember that, quite  shamefully, the only reason given by the Medicines and Health Regulatory Authority (MHRA) gave for allowing false labelling of homeopathic pills was to support the “homeopathic industry”. They suggested (falsely) that the EU required them to take this irresponsible step, which was condemned by just about every scientific organisation. But the new unfair trading regulations did come from the EU. After almost 100 years since the 1914 report, we have at last some decent legislation. Let’s hope it’s enforced.

Postcript

The back cover of the series of ‘Fact‘ books in which A.J. Clark’s article appeared is reproduced below, simply because of the historical portrait of the 1930s that it gives.


Follow-up

This post got a lot of hits from Ben Goldacre’s miniblog which read

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