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.

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].

I don’t know about you, but I’m bored stiff with homeopathy. There are a lot more important things. Nevertheless, it remains a gross insult to reason, and there has been such enormous success in combating it over the last five years so, this is not the moment to stop.

Hats off to the Merseyside Skeptics Society. I admit that when I first heard about the 10:23 campaign, it seemed to be a bit of a gimmick, but in fact it turned out to be an enormous success., not just in the UK but also in Canada, Australia and New Zealand

The campaign was focussed on Boots, the UK’s biggest pharmacy chain, In particular the fact that Boots sell homeopathic pills. and regularly gives appallingly bad advice about all forms of quackery that they stock.

I’ve been criticising Boots for years now, starting with Mis-education at Boots the Chemist in May 2006. was largely about homeopathy, but Boots’ quackery is not restricted to homeopathy, In November 2007, Don’t Trust Boots described Boots’ promotion of vitamin pills that were
advertised by Boots to increase your energy, and also the appallingly bad advice given by shop staff on this product.

In March 2008, Boots did it again, with a big promotion written up as Boots reaches new level of dishonesty with CoQ10 promotion. The strategy seems clear by now. Launch an enormous publicity effort, and rely on journalists to parrot the press release. Put mendacious advertisements in every newspaper. Eventually the advertisements are found to be inaccurate by the Advertising Standards Authority. Boots are told to stop using the advertisement, but suffer no penalty at all.  By that time the advertising campaign is over anyway, and they can rely now on inaccurate advice from "Boots expert team"; face to face in the store, to continue the promotion in a way that evades all regulation.

Boots is deeply involved too in the great ‘detox’ scam, as recounted, for example, in “Detox”: nonsense for the gullible, along with the Prince of Wales.  And, most recently, Lactium: more rubbish from Boots the Chemists. And a more serious problem.

The nauseating hypocrisy of Boots’ Corporate Social Responsibility statement beggars belief. The same stuff is repeated on the current Alliance Boots site.

“Trust – The essence of the way we do business. We are trusted because we deliver on our promises.”

You must be joking.

Who owns Boots?

Boots started in 1849 as a single shop in Nottingham. Within my lifetime, they were rather ethical pharmacies (my recollection is that they didn’t sell homeopathic pills). They were also an ethical pharmaceutical company.  They developed ibuprofen, which was launched in 1969.   But since then the company was involved in a complicated series of acquisitions. Now it is a supranational conglomerate with presence in 20 countries, and almost beyond the reach of the law. Boots’ executive chairman is Stefano Pessina, who, with private equity firm Kohlberg Kravis Roberts in a £11.1 billion deal last year, took the firm private in 2007.   In 2008 they announced a 20% increase in profits, to £771 million In 2008 they moved their headquarters out of the UK, to Geneva, partly, it seems, so they can be closer to other giants of Big Pharma, and partly, no doubt, to put pressure on the UK government not to tax them too much,   On the other hand, tax may not be a big consideration because, according to The Times, the ultimate owners of Boots are based in Gibralter

The disgraced head of HBOS, Andy Hornby, was appointed as chief executive of Alliance Boots in June 2009. Before playing his part in ruining the UK economy he used to work for grocery chain, Asda. I’d guess that he has limited interest in pharmacology.

The economics of such organisations are beyond most people. a bit like the two cow economics joke perhaps.

"VENTURE CAPITALISM – AN ICELANDIC CORPORATION

You have two cows.

You sell three of them to your publicly listed company, using letters of credit opened by your brother-in-law at the bank, then execute a debt/equity swap with an associated general offer so that you get all four cows back, with a tax exemption for five cows. The milk rights of the six cows are transferred via an intermediary to a Cayman Island Company secretly owned by the majority shareholder who sells the rights to all seven cows back to your listed company. The annual report says the company owns eight cows, with an option on one more. You sell one cow to buy a new president of the United States, leaving you with nine cows. No balance sheet provided with the release. The public then buys your bull."

Clearly there is not the slightest chance of an organisation like this will have any sort of conscience about selling useless pills, The only way that they can be influenced is by public mockery of their outrageous behaviour. If the publicity harms their image enough they may decide to cut their losses, because it pays, not because it is right.

10:23 a great success

The campaign was a success because it got good coverage in the newspapers, radio and TV. Boots, rather like vice-chancellors, seems to be uninterested in reason or morals, but will certainly be sensitive about its public image, There is a partial list of coverage at the 10.23 site.

Laura Donnelly had a good account in the Telegraph, "Homeopathy: medicine that’s hard to swallow?".  And Hadley Freeman in the Guardian showed that fashion journalists can spot nonsense too, in "Me and my homeopathic overdose. How I knocked back a bottle of homeopathic ‘medicine’ and lived to tell the tale"

The spoof published on the NewsArse site (despite the name, it is excellent) hit the nail on the head, because it uses exactly the naive sort of post ho ergo propter hoc argument that homoeopaths love.,

Homeopathy proven to work after overdosing protesters eventually fall asleep

Homeopathic practitioners are today claiming victory for the efficacy of their remedies, after a protest by the 10:23 group who overdosed on homeopathic sleeping pills, left each participant asleep within just 36 hours of taking the remedy.

Funniest of all though, was the bleating by homeopaths themselves. Try, for example, Homeopathy Heals. Like all the others it alleges a conspiracy by big Pharma: “it seems to be driven by those working for Pharma behind the scenes”. It seems to have escaped the attention of these conspiritorialists that the demonstration was aimed at Boots and Boots IS Big Pharma. The two are inextricably linked and both use the same tactics to increase sales.

My small contribution

Apart form contributing to Laura Donnelly’s piece in the Telegraph, "Homeopathy: medicine that’s hard to swallow?"., I had a few more calls.

Mary English, homeopath and astrologer

The most interesting was a talk show on Radio 5 live, where I was was pitted against a homeopath, Mary English [download the mp3 file, 4.4
Mb]. Having come across Mary English before, I was well-prepared to talk about her record not only in homeopathy, but also in astrology. The presenter didn’t give me time to raise these points but he did a pretty good job himself in asking her the relevant questions.

Mary English’s website is a delight. "Homeopathy and Astrology can heal you".

" If you eat a whole bottle of them it wouldn’t make any difference because it’s the dose that you have, not the quantity of the tablets"

"It’s the frequency of dose . . .because it’s vibrational medicine"

The host asked "what’s vibrational medicine?"

"it works with your bodies systems as opposed to against it"

No doubt Mary English is quite sincere, She just, like so many homeopaths, seems to be quite unaware that these words don’t mean anything at all. Just pure gobbeldygook.

Some of her claims are bizarre, even by the standards of homeopaths.  She has researched the birth charts of Indigo Children, and written a book, "How to survive a Pisces"  Her claim to homeopathic fame is that she has done "provings" of "remedies" including thunderstorm, and shipwreck  and Stanton Drew Stone Circle, and Old Wardour Castle. Ahem, suddenly Arnica 30C sounds quite sane.

Less excusably, Mary English went on to claim that there is good evidence that homeopathy works. She just hasn’t read, or hasn’t understood the evidence. But since she earns her living as a homeopath
and astrologer, she hasn’t got much incentive to read the evidence. if she did, her income would dry up.

The presenter put directly to Mary English the recommendation of homeopathy for malaria prevention. "You wouldn’t condone that would you?". Quite disgracefully that question was avoided. She
changed the subject without answering the question.  The quackometer’s classic post on The Gentle Art of Homeopathic Killing came to mind (see also here for links to full text)

Some herbal stuff

Herbal medicine rather than homeopathy was the topic of the other two weekend gigs. That arose from the Pittilo proposals for statutory regulation of herbalists and Chinese medicine.

The BBC TV interview, together with a herbalist, Rhona Edmonds, is now in YouTube. A Welsh member of the European parliament, Jill Evans (Plaid Cymru) , has been backing herbalists on the grounds that they are a “well-respected profession”. Oh yes?  The Prince of Wales has also had support from another MEP. Mike Nattrass (UKIP).  It seems that our fringe parties have even more trouble with science than the Labour and Conservative parties (and, tragically, that includes the Green party too).

There was also an early morning talk show interview on Sunday 31 January, against the same herbalist [download mp3 file] She claims "we treat all sorts of conditions",. Yes indeed, that’s the problem. "If we were recognised it would give the public even more confidence". And that is the problem too. They don’t deserve that confidence.

The analogy between alternative medicine and religion is often striking. Both involve blind faith, and both are characterised by tendency to split into sects that war with each other even more viciously than they war with unbelievers. All the discussions of herbalism ignore the fact that an enormous number of herbalists (2536 as of 4th February) have signed a petition opposing the idea of statutory regulation, even in the ineffective form that is being proposed.

The Prince of Wales declares war on . . . the Enlightenment

That was the headline of an article in The Times (February 4th, 2010).  There can be no more high profile propagandist for every form of magic medicine than the Prince of Wales. Nothing seems to stretch his credulity.  But even I was taken aback by his latest pronouncement.  It seems he’s been called an enemy of the enlightenment (yes, by me among many others).

“I was accused once of being the enemy of the Enlightenment,” “I felt proud of that.”

“We cannot go on like this, just imagining that the principles of the Enlightenment still apply now. I don’t believe they do. But if you challenge people who hold the Enlightenment as the ultimate answer to everything, you do really upset them.”

So it seems he wants to return medicine not just to 1800, but to 1500, the dark ages. Can he really think that life in 1500 was some sort of utopia?  Of course one suspects that his disapproval of the enlightenment is restricted to medical matters.  He hasn’t been seen to reject other products of the enlightenment, like cars, aircraft, telephones, radio, TV and the internet.

I suspect that the Prince of Wales needs a history lesson.

Follow-up

Thanks to a colleague for pointing out an excellent sketch from the Newsjack show on BBC Radio 7, broadcast on 4th February 2009. [download mp3 file, 2.4 Mb]. I quote.

“Last weekend, people up and down rhe country engaged in a mass anti-homeopathy protest, swallowing whole bottles of remedies outside Boots.”

“It’s very easy to sneer at homeopathy but we at Newsjack believe it’s important to listen to both sides of the debate. So to put the case for homeopathy we have invited on a ridiculous charlatan who extorts money from innocent people while providing no services of any actual value.”

“Will you please welcome His Royal Highness, the Prince of Wales”

Lindy contributes acute comments regularly here.  She is also an accomplished musician.  She has kindly allowed me to post here four of her re-written carols.

Adam lay ybounden  |  Hark the Herald  |  Holly and the Ivy  |  Merry Gentlemen

Adam lay ybounden

The Middle English dialect is not easy to follow. In fact Wikipedia reveals that it is oit even standard Middle English, but Macaronic English. The original words are reproduced in the right hand column.  The original, sung by choir of King’s College Chapel, is on YouTube.

Hark the Herald Angels sing.

This version is for Simon Singh. If you haven’t yet signed the new peition, please do it here.

Mark this very dang’rous thing,

Story is of Simon Singh.

He got chiropractors riled,

“Sod it! We have been defiled!

Ployful all ye woosters rise,

Join us to defend our lies,

With us loudly please proclaim,

Subluxations are our game”



Christ, they all with one accord

Took young Simon off to court.

“We’ll put you before a judge,

Since we always bear a grudge

‘Gainst all those who say our modus

Operandi is all bogus;

Mark the words of justice Eady,

Gave his ruling oh so speedy.



Mark the case of Simon Singh

With support the web does ring.

Ditch draconian libel laws,

Without which they’d have no cause

To sue those who would speak freely,

Truth, opinion-and reason really

Should prevail o’er all such things,

Surely he his case must win.

The Holly and the Ivy

Dedicated to the Prince of Wales, certain vice-chancellors and other champions of the endarkenment.

The folly and the lies, see

How they’ve become full-blown;

The braying of th’quackti’tioner Roy-

Al, th’enlightenment has flown.



Refrain: For deriding all the data

(Such stunning stuff we hear)!

The displaying of such cherry pick-

-Ing, beats bringing in Chi square.



The folly hears no critics

It makes you quite struck dumb,

Just put a poison substance in,

And dilute to kingdom come.



For deriding all the data etc.



The folly so does blossom,

Beguiles you with its charm,

Just make some movements with your wrist

And it will do no harm.



For deriding all the data etc.



The folly’s given credence

If you are qualified

With a BSc in pseudosci-

-Ence, th’endarkenment is nigh!



For deriding all the data etc.



The folly bears a burden

Now it has fallen down;

F.O.I requests and publicity

Have giv’n D.C. the crown.



For deriding all the data etc.



The folly is so fickle,

How did they have the gall

To tell us how their remedies

Were here to treat us all?



For deriding all the data etc.



The folly and the lies, see

How they must surely fail

We’ll drink a toast to good evidence

And let real science prevail!



Alternative refrain:



Oh the rising of the Reiki,

Of acupuncture too,

All Rolfering* and Tuina-ish,

They all amount to woo.



*The names Rolf and Roger seem remarkably similar in some circumstances so I get a little confused.

Merry gentlemen. 

Here is Lindy’s version of "god rest ye merry gentleman", composed in the wake of the admission by the Professional Standards director of Boots the Chemists that they sell homeopathic pills despite being aware of the fact that there is no reason to think they work.

I arrest you merry gentlemen,

Please kindly step this way.

For you are selling sugar pills

For which the people pay;

We’re from the Trading Standards and through courts we’ll find a way

To stop your profit-making ploy, Profiting ploy,

We’ll stop your profiteering ploy”!



The chemists calmly did defend

Themselves though they were riled;

“The people do demand these pills

Because they’re not defiled

With molecules (nor ‘owt at all), despite the claims so wild;

We’ll continue our profiteering ploy, Profiting ploy,

We’ll continue our profiteering ploy”.



So Trading Standards did respond

“We understand your aim

To make more money, though if you

Persist with bogus claim

To cure disease with sugar pills,

We’ll put you all to shame!

We are stopping your profiteering ploy, Profiting ploy,

We are stopping your profiteering ploy”.





“You breach the regulations by selling pills, you see,

Which claim to contain ‘aqua’ (dilute to 30C),

Or ‘dolphin song’ or ‘canine testes’ – even ‘ATP’!

So you’ll stop all this profiteering ploy, profiting ploy,

So you’ll stop all this profiteering ploy”.



The Dept of Health bangs on and on

About a patient’s choice,

But all good people must condemn

These lies with one great voice.

We dream of days when fibs are gone and we can all rejoice

‘Cos they’ve stopped all their profiteering ploy, Profiting ploy,

‘Cos they’ve stopped all their profiteering ploy

We have listed many reasons hear why you should never trust Boots.  Here are the previous ones.

Can you trust Boots?
Don’t Trust Boots
Boots reaches new level of dishonesty with CoQ10 promotion

This post is about a "functional food".  That is about something a bit more serious than homeopathy, though I’ll return to that standing joke in the follow-up, because of Boots’ latest shocking admission..

Alternative medicine advocates love to blame Big Pharma for every criticism of magic medicine.  In contrast, people like me, Ben Goldacre and a host of others have often pointed out that the differences seem to get ever smaller between the huge Alternative industry (about $60 billion per year), and the even huger regular pharmaceutical industry (around $600 billion per year),

Boots are as good an example as any.  While representing themselves as ethical pharmacists, they seem to have no compunction at all in highly deceptive advertising of medicines and supplements which are utterly useless rip-offs.

The easiest way to make money is to sell something that is alleged to cure a common, but ill-defined problem, that has a lot of spontaneous variability.. Like stress, for example.

The Times carried a piece Is Boots’s new Lactium pill the solution to stress?. Needless to say the question wasn’t answered.  It was more like an infomercial than serious journalism.  Here is what Boots say.

What does it do? This product contains Lactium, a unique ingredient which is proven to help with the stresses of every day life, helping you through a stressful day. Also contains B vitamins, magnesium and vitamin C, which help to support a healthy immune system and energy levels. Why is it different? This one a day supplement contains the patented ingredient Lactium. All Boots vitamins and suppliers are checked to ensure they meet our high quality and safety standards.

So what is this "unique ingredient", Lactium?  It is a produced by digestion of cow’s milk with trypsin. It was patented in 1995 by the French company, Ingredia, It is now distributed in the USA and Canada by Pharmachem. which describes itself as “a leader in the nutraceutical industry.”  Drink a glass of milk and your digestive system will make it for you.  Free.  Boots charge you £4.99 for only seven capsules.

What’s the evidence?

The search doesn’t start well. A search of the medical literature with Pubmed for "lactium" produces no results at all. Search for "casein hydrolysate" gives quite a lot, but "casein hydrolysate AND stress" gives only seven, of which only one looks at effects in man, Messaoudi M, Lefranc-Millot C, Desor D, Demagny B, Bourdon L. Eur J Nutr. 2005.

There is a list of nineteen "studies" on the Pharmachem web site That is where Boots sent me when I asked about evidence, so let’s take a look.

Of the nineteen studies, most are just advertising slide shows or unpublished stuff. Two appear to be duplicated. There are only two proper published papers worth looking at, and one of these is in
rats not man.  The human paper first.

Paper 1  Effects of a Bovine Alpha S1-Casein Tryptic Hydrolysate (CTH) on Sleep Disorder in Japanese General Population, Zara de Saint-Hilaire, Michaël Messaoudi, Didier Desor and Toshinori Kobayashi [reprint here]   The authors come from France, Switzerland and Japan.

This paper was published in The Open Sleep Journal, 2009, 2, 26-32, one of 200 or so open access journals published by Bentham Science Publishers. 

It has to be one of the worst clinical trials that I’ve encountered.  It was conducted on 32 subjects, healthy Japanese men and women aged 25-40 and had reported sleeping disorders.  It was double blind and placebo controlled, so apart from the fact that only 12 of the 32 subjects were in the control group, what went wrong?

The results were assessed as subjective sleep quality using the Japanese Pittsburg Sleep Quality Index (PSQI-J).  This gave a total .score and seven component scores: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.

In the results section we read, for total PSQI score

"As shown in Table 2, the Mann-Whitney U-test did not show significant differences between CTH [casein tryptic hydrolysate] and Placebo groups in PSQI-J total scores at D0 (U=85; NS), D14 (U=86.5; NS), D28 (U=98.5; NS) and D35 (U=99.5; NS)."

Then we read exactly similar statements for the seven component scores.  For example,. for Sleep Quality

As shown in Table 3, the Mann-Whitney U-test did not show significant differences between the sleep quality scores of CTH and Placebo groups at D0 (U=110.5; NS), D14 (U=108.5; NS), D28 (U=110; NS) and D35 (U=108.5; NS).

The discussion states

"The comparisons between the two groups with the test of Mann-Whitney did not show significant differences, probably because of the control product’s placebo effect. Despite everything, the paired comparisons with the test of Wilcoxon show interesting effects of CTH on sleep disorders of the treated subjects. "

Aha, so those pesky controls are to blame! But despite this negative result the abstract of the paper says

"CTH significantly improves the PSQI total score of the treated subjects. It particularly improves the sleep quality after two weeks of treatment, decreases the sleep latency and the daytime dysfunction after four weeks of treatment.

Given the antistress properties of CTH, it seems possible to relate the detected improvement of sleep aspects to a reduction of stress following its’ chronic administration."

So there seems to be a direct contradiction between the actual results and the announced outcome of the trial. How could this happen?  The way that the results are presented make it hard to
tell.  As far as I can tell, the answer is that, having failed to find evidence of real differences between CTH and placebo, the authors gave up on the placebo control and looked simply at the change
from the day 0 basleine values within the CTH group and, separately, within the placebo group.  Some of these differences did pass statistical significance but if you analyse it
that way. there is no point in having a control group at all.

How on earth did such a poor paper get published in a peer-reviewed journal?  One answer is that there are now so many peer-reviewed journals, that just about any paper, however poor, can get published
in some journal that describes itself as ‘peer-reviewed’.  At the lower end of the status hierarchy, the system is simply broken.

Bentham Science Publishers are the publishers of the The Open Sleep Journal. (pity they saw fit to hijack the name of UCL’s spiritual founder, Jeremy Bentham). They publish 92 online and print journals, 200 plus open access journals, and related print/online book series. This publsher has a less than perfect reputation.  There can be no scientist of any age or reputation who hasn’t had dozens of emails begging them to become editors of one or other of their journals or to write something for them. They have been described as a "pyramid scheme” for open access.  It seems that every Tom, Dick and Harry has been asked.  They have been described under the heading Black sheep among Open Access Journals and Publishers.  More background can be found at Open Access News..

Most telling of all, a spoof paper was sent to a Bentham journal, The Open Information Science Journal.  . There is a good account of the episode the New Scientist, under the title “CRAP paper accepted by journal”.  It was the initiative if a graduate student at Cornell University. After getting emails from Bentham, he said “”It really painted a picture of vanity publishing”. The spoof paper was computer-generated rubbish, but it was accepted anyway, without comment.  Not only did it appear that is was never reviewed but the editors even failed to notice that the authors said the paper came from the "Center for Research in Applied Phrenology", or CRAP.  .The publication fee was $800, to be sent to a PO Box in the United Arab Emirates. Having made the point, the authors withdrew the paper.

Paper 5 in the list of nineteen stidies is also worth a look.  It’s about rats not humans but it is in a respectable journal The FASEB Journal Express Article doi:10.1096/fj.00-0685fje (Published online June 8, 2001) [reprint here].
Characterization of α-casozepine, a tryptic peptide from bovine αs1-casein with benzodiazepine-like activity. Laurent Miclo et al.

This paper provides the basis for the claim that digested milk has an action like the benzodiazepine class of drugs, which includes diazepam (Valium).  The milk hydrolysate, lactium was tested in rats and found to have some activity in tests that are alleged to measure effects on anxiety (I haven’t looked closely at the data, since the claims relate to humans)..  The milk protein, bovine αS1 casein contains 214 amino acids.  One of the many products of its digestion is a 10-amino-acid fragment (residues 91 -100) known as α-casozepine and this is the only product that was found to have an affinity for the γ-amino-butyric acid (GABA) type A receptors, which is where benzodiazepines are thought to act.  There are a few snags with this idea.

• The affinity of α-casozepine peptide had 10,000-fold lower affinity for the benzodiazepine site of the GABAA than did diazepam, whereas allegedly the peptide was 10-fold more potent than diazepam in one of the rat tests.
• The is no statement anywhere of how much of the α-casozepine peptide is present in the stuff sold my Boots, or whether it can be absorbed
• And if digested milk did act like diazepam, it should clearly be callled a drug not a food.

What’s the conclusion about lactium?

Here is what I make of it.

Does it relieve stress?  The evidence that it works any better than drinking a glass of milk is negligible. Tha advertising is grossly misleading and the price is extortionate.

Corruption of science.  There is a more interesting aspect than that though.  The case of lactium isn’t quite like the regular sort of alternative medicine scam.  It isn’t inherently absurd, like homeopathy.  The science isn’t the sort of ridiculous pseudo-scientific ramblings of magic medicine advocates who pretend it is all quantum theory The papers cited here are real papers, using real instruments and published in real journals,

What is interesting about that is that they show very clearly the corruption of real science that occurs at its fringes,  This is science in the service of the dairy industry and in the service of the vast supplements industry.  These are people who want to sell you a supplement for everything.

Medical claims are made for supplements, yet loopholes in the law are exploited to maintain that they are foods not drugs.  The law and the companies that exploit it are deeply dishonest.  That’s bad enough. but the real tragedy is when science itself is corrupted in the service of sales.

Big Pharma and the alternative industry. Nowhere is the slose alliance between Big Pharma and the alternative medicine industry more obvious than in the supplement and nutriceutical markets. Often the same companies run both. Their aim is to sell you thinks that you don’t need, for conditions that you may well not have, and to lighten your wallet in the process. Don’t believe for a moment that the dark-suited executives give a bugger about your health. You are a market to be exploited.

If you doubt that, look from time to time at one of the nutraceutical industry web sites, like nutraingredients.com. They even have a bit to say about lactium.  They are particularly amusing at the moment because the European Food Safety Authority (EFSA) has had the temerity to demand that when health claims are made for foods, there is actually some small element of truth in the claims.  The level of righteous indignation caused in the young food industry executives at the thought that they might have to tell the truth is everywhere to see. For example, try Life in a European health claims wasteland.  Or, more relevant to Lactium, Opportunity remains in dairy bioactives despite departures. Here’s
a quotation from that one.

“Tage Affertsholt, managing partner at 3A Business Consulting, told NutraIngredients.com that the feedback from industry is that the very restrictive approach to health claims adopted by the European Food Safety Authority (EFSA) will hamper growth potential.”

“Affertsholt said: “Some companies are giving up and leaving the game to concentrate on more traditional dairy ingredients.”

Science and government policy

It may not have escaped your notice that the sort of low grade, corrupted, fringe science described here, is precisely the sort that is being encouraged by government policies. You are expected to get lots of publications, so never mind the details, just churn ‘em out;  The hundreds of new journals that have been created will allow you to get as meny peer-reviwed publications as you want without too much fuss, and you can very easily put an editorship of one of them on your CV when you fill in that bit about indicators of esteem.  The box tickers in HR will never know that it’s a mickey mouse journal.

Follow-up

Boots own up to selling crap

Although this post was nothing to do with joke subjects like homeopathy, it isn’t possible to write about Boots without mentioning the performance of their  professional standards director, Paul Bennett, when he appeared before the Parliamentary Select Committee for Science and Technology..  This committee was holding an “evidence check” session on homeopathy (it’s nothing short of surreal that this should be happening in 2009, uh?).  The video can be seen here, and an uncorrected transcript.   It is quite fun in places.  You can also read the written evidence that was submitted.

Even the Daily Mail didn’t misss this one. Fioana Macrae wrote Boots boss admits they sell homeopathic remedies ‘because they’re popular, not because they work’

“It could go down as a Boot in Mouth moment.

Yesterday, the company that boasts shelf upon shelf of arnica, St John’s wort, flower remedies and calendula cream admitted that homeopathy doesn’t necessarily work.

But it does sell. Which according to Paul Bennett, the man from Boots, is why the pharmacy chain stocks such products in the first place.

Mr Bennett, professional standards director for Boots, told a committee of MPs that there was no medical evidence that homeopathic pills and potions work. 

‘There is certainly a consumer demand for these products,’ he said. ‘I have no evidence to suggest they are efficacious.

‘It is about consumer choice for us and a large number of our customers believe they are efficacious.’

His declaration recalls Gerald Ratner’s infamous admission in 1991 that one of the gifts sold by his chain of jewellers was ‘total crap’.”

The Times noticed too, with Boots ‘labels homeopathy as effective despite lack of evidence‘.

Now you know that you can’t trust Boots. You heard it from the mouth of their professional standards director.

A commentary on the meeting by a clinical scientist summed up Bennett’s contribution thus

"Paul Bennett from Boots had to admit that there was no evidence, but regaled the committee with the mealy-mouthed flannel about customer choice that we have come to expect from his amoral employer."

Well said

The third session of the Scitech evidence check can be seen here, and the uncorrected transcript is here.  It is, in a grim way, pure comedy gold, More of that later.