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Dangerous advice

On Monday 5 Feb 2007, the BBC ran a piece entirled Alternative therapy put on trial. It started

“An experiment in allowing NHS patients easier access to alternative and complementary therapies has been launched by NI Secretary Peter Hain.”

But it is NOT a trial, and NOT an experiment. Journalists seem incapable
of understanding the meaning of these words, and the result is irresponsible
reports (though one might detect a hint of irony in the picture that the
BBC used to illustrate acupuncture; right).

There is nothing new in the failure of journalists to distinguish good science from junk. We saw this very clearly in the case of the phoney fish oil “trials” going on in Durham (see Ben Goldacre’s account of these).

In the case of Durham the effect is to use public money to produce bad evidencethat can be used to promote the dubious claims of a private company, in the case “Eye Q” pills made by Equazen.
In the case of Northern Ireland, £200,000 of taxpayers’ money will be paid to a private company, GetwellUK, GPs in two areas will be able to refer patients for therapies like acupuncture, homeopathy and massage. Nothing there about seeing whether the treatments work! But Peter Hain seems to think he knows the answer already. He said

“I am certain, as a user of complementary medicine myself, that this has the potential to improve health substantially,”

He was “delighted that Northern Ireland is leading the way in integrating complementary and alternative therapies into the National Health Service”

Peter Hain used to be something of a hero to me. In the 70s his work for the Anti-apartheid movement was an inspiration (see his autobiographical notes). Now he has sunk to promoting junk science. Very sad.So what is Hain’s attitude to alternative medicine, and how did he come to ally himself with the batty medical opinions of the Prince of Wales? On his web site he had a section on this topic. For some reason it has now been deleted, but thanks (again) to Google’s cache, here is a quotation from a speech he made to The Prince of Wales Foundation for Integrated Health (12th October 2005).

“Our first baby, Sam, was born with eczema. Later, he developed asthma too. At first, we relied on conventional treatments. Various creams were prescribed, and a steroidal spray. But they didn’t work. In fact, the spray seemed to make him more dependent.


Peter Hain now
Peter Hain in 1970

So instead, we turned to complementary medicine. And with the help of homeopathy and tight restrictions on the sort of food that our son could eat – avoiding in particular wheat and milk products- both ailments went away.”

Hang on! You changed diet and gave homeopathic sugar pills. And that is a reason for the taxpayer to fund homeopathy? Any fool can see that this anecdote means that either (a) change in diet helped, (b) homeopathy helped, or (c) the eczema would have got better anyway. According to the National Eczema Society, “60-70% of children are virtually clear of the condition by the time they reach their mid-teens”. They “grow out” of it. Evidently a First Class Honours Degree in Economics and Political Science is not enough to teach Peter Hain what constitutes evidence and what does not.

On the other hand, the in the same speech Peter Hain also said

“I would certainly never advocate the squandering of public money on so called treatments that have no proven benefits and which take money away from existing therapies that are shown to work.”

But they have “no proven benefits”. Just how inconsistent can you get?

Who are GetwellUK?

GetwellUK is a private company financed largely by taxpayers’ money. And guess who supports it? The Prince of Quacks, once again exerting his unconstitutional influence on public policy. This is done partly through yet another of the Prince’s lobby groups, “GP Associates” (report in BMJ). It seems that “GP Associates” was the forerunner of the recently-launched “Integrated Health Associates”. The inaugural meeting of Integrated Health Associates” was sponsored by a drug company, Solgar Vitamins, a purveyor of unnecessary ‘supplements’ that is a trading arm of Boots Herbal Stores (no connection with that other well-known purveyor of misleading information, Boots the Chemists).

The Company says Support came from the government in February 2005 when the Parliamentary Under-Secretary for the Department of Health, Melanie Johnson, said in the House of Commons, “I thank the hon. Gentleman for notice of the question in relation to Get Well UK. We understand the benefit that many people get from complementary therapies. Local commissioning is a matter for local discretion, but we can see the benefits to local practices of an intermediary pulling together a range of services in the area for alternative medical treatments.” [Hansard].

“We were delighted to be selected as one of the first investees of Futurebuilders – a Treasury fund established to assist capacity building in community organisations who deliver public sector services. The investment will help Get Well UK to serve more NHS patients.”


Prince of Wales with Boo Armstrong (Managing director of Getwell UK)

GetWellUK publish an evaluation of a “pilot project” in London, “Does it Work?”, by Nicola Robinson (Head of the Centre for Complementary Healthcare & Integrated Medicine,Thames Valley University).
The report tells us nothing whatsoever about the effectiveness of the treatments, because the “pilot” study was not designed to do so. It is 40 pages of waffle.

The report also says “Get Well UK is a not for profit organisation established in response to a recommendation by the House of Lords in 2000 that complementary therapies should be made available through the NHS. This is a gross misrepresentation of the House of Lords report which said this should be done ONLY if the treatments worked better than placebo. And, with very few exceptions, that still remains to be shown.

For their efforts in setting back medicine to the 19th century, they have had money from UnLtd Ventures (“provides consultancy support to a number of outstanding social entrepreneurs” and taxpayers’ money from Futurebuilders. And they are getting £200 000 of taxpayers’ money from Paul Goggins, the Northern Ireland Health Secretary

At the end of the “pilot scheme” there will have been no proper assessment of the effectiveness of the treatments. We shall be none the wiser.

BBC’s You and Yours programme (a lunchtime consumer programme) ran a good piece on “Helps Stop Snoring”, a dubious herbal “remedy” for snoring. They picked up the story from my site. Listen to the programme [mp3 file]

“Helps stop snoring” claims to work on the basis of a clinical trial. But the trial is flawed in many ways. In addition the author, Dr Andrew Prichard, seems to have quite forgotten to mention that a Helen Prichard who lives at the same address holds 2000 shares in the company that makes this wonder cure. [transferred from old improbable science page].


My pharmacological curiosity was stirred by a TV advertisement for a spray that, it was claimed, could stop you snoring. It’s hardly a life threatening condition, but it can be marriage-threatening. But what’s in it, and does it work?

A visit to the web site of Essential Health Products Limited looks promising. Their claim is this.

“CLINICAL TRIALS
Many products claim to have undergone tests, but Helps Stop Snoring is the only natural snoring remedy in the UK have undergone to a full, double blind clinical trial, conducted by a practicing Ear,Nose and Throat Consultant Surgeon.
Lasting over 18 months, the trial involved 140 snorers and their partners, and the results showed a headline success rate of 82%. The trial was conducted by Andrew Pritchard FRCS, Ear Nose and Throat Consultant at the Royal Shrewsbury Hospital and one of the UK`s leading specialists in the field of snoring and sleep disorders.
In a further first for a snore remedy the results of the trial were published in Phytology Research, an international journal, in October 2004.”

This claim was not so easy to check because the manufacturer mis-spells both the name of the author and the name of the journal. The paper in question seems to be this. Prichard AJ., The use of essential oils to prevent snoring Phytother Res. 2004 18(9), 696-9 [get the pdf].

Sadly this paper is not very convincing. The paper does describe the work as “preliminary”, but the manufacturer’s web site does not. There’s a surprise.   For those who are interested, here are a few details.

140 adult snorers were recruited to the study via a snoring clinic. Snorers were randomly allocated to receive a metered dose of “Stop snoring “gargle, “Stop snoring ” spray or placebo gargle (there was no placebo spray at all). It isn’t obvious what placebo could mimic the peppermint, lemon, clove, thyme, eucalyptus and pine oils that the “remedy” contains (among other things). Their concentrations aren’t stated. The paper makes no mention of what was used as placebo, but Dr Prichard tells me “The content of the placebo could not be an essential oil. I have been told by the manufacturer that we used a sugar type mix”. Actually it contained water, sodium saccharin, polysorbate 20, potassium sorbate and citric acid. It would be have been obvious tor the patient whether they got the placebo or not.

“A simple comparison was made between the 14-day control period and the 14-day period of ‘treatment’ either with product or placebo. Statistical analysis was performed using the Wilcoxon non-parametric test.”


Figure 4. Placebo gargle



Figure 2. “Stop snoring” spray

The comparison that is made is before and after in each treatment group, rather than comparing the groups. The eminent statistician, Stephen Senn, has some trenchant criticisms of this sort of experimental design.

Senn points out that “Having made the mistake of using the within treatment group to baseline comparison he ought to then use the Wilcoxon signed ranks test rather than the rank sum but he doesn’t say which”. The results are pretty odd too. In the placebo group, 4 out of 11 patients show a big reduction in snoring severity (Fig. 4). In the spray group, a smaller proportion, 5 out of 28 show a big improvement (Fig 2). The changes in the rest of the patients are mostly very small, but there are more slight improvements in the spray group than in the placebo group. The percent of patients that “improve” (by any amount, however small, is therefore bigger in the spray group than control, but the difference in mean snoring severity was much smaller

Financial interests in the snoring study

Sadly, it is essential to consider vested interests in drug assessment, as I have noted below (and here, and here). Prichard’s paper states openly that it was “Sponsored by Essential Health Products Ltd, 4 Top Farm Barns, Pitchford, Shropshire, SY5 7DW, UK.”  That doesn’t mean it’s wrong, though the bias associated with sponsorship is well known,

But there is no mention of shareholdings

Companies House will, only £1, sell you company reports. The records show that Helen Jane Prichard, holds 2000 shares in Essential Health Products Ltd.

Is this just a coincidence of names? I think not. If you look up. Dr Andrew Prichard in the phone book, you see that his address is exactly the same as that of Helen Jane Prichard.

Oh dear: looks like yet another undisclosed financial interest in a clinical study.

Many thanks to the inimitable Ben Goldacre fot the totally over-the-top link to this item: it has done wonders for my hit rate.

Boots the Chemists is selling the same stuff

True to their philosophy of making money and never mind the evidence, the “Boots Alternatives” range of snake oil products has, for £14.99, exactly the same stuff. They claim the Boots
Alternatives Snoring Remedy
is “effective in reducing snoring for 4 out of 5 users”. The “4 out of 5” was what Essential Health Products told Boots, so it must be based on Figure 2, above.

Enquiries to Boots about this product have not been answered or have been answered inaccurately. See also below for Boots miseducation pages.
And here’s the ironical bit. Boots web site makes a big point about CSR (Corporate Social Responsibility).  (Thanks to Sean
Kehoe
for spotting this.)

“TRUST BOOTS

As you may have noticed, that’s the tagline which in 2005 we adopted as the sign-off to all our advertising. But it’s much more than just a slogan. It’s a concise statement of our entire corporate strategy. Our aim is to make Boots the world’s best health and beauty retailer, and we’re 100% clear that the unique trust in which we are held provides the key to achieving this. Which means, of course, that those two words are also the rationale for all our CSR activities. Everything we do that builds trust is good for our business; anything which could compromise it, a risk we can’t afford to take.”

Trust Boots to provide straight answers.

They must be joking.

BBC’s Panorama programme broadcast the content of secret emails. They show that GSK was aware of evidence the Seroxat increased risk of suicide in young patients, and suppressed it. They also showed that Prof Martin Keller’s paper on the topic was ghost-written by a PR firm working for GSK.

Moved to this blog from the old IMPROBABLE SCIENCE page: see Universities Inc

In the course of a long correspondence with the MHRA about their endorsement of a dishonest label for a herbal preparation, arnica gel, I eventually got an admission from them that the stuff doesn’t work.

For earlier episodes in this saga, see part 1, part 2, part 3 and part 4.

“As you have clearly identified the Directive is far from perfect. The vast majority of herbal products currently on the UK market without claims are of unproven benefit.”
Dr Linda Anderson, B.Pharm., PhD,
Pharmaceutical assessor at the MHRA.

They didn’t explain why, in that case, they approved a label that says “it helps to relieve symptoms . . .”The MHRA has on its web site (Jan 2007) a document “Using herbal medicines: Advice to consumers“. It includes the following passage.

Which herbal medicines have been assessed by the Regulator?

  • Look for PL or THR on the product labels. Herbal medicines licensed in the UK have a PL (product licence) number on the label.
  • Traditional herbal medicines registered in the UK have a THR (traditional herbal registration) number on the label. The first registered products under this new scheme are expected to reach the UK market in the coming months.
  • Both these kinds of medicines are regulated by the MHRA and meet assured standards.
  • Other herbal medicines on the UK market have not been assessed by the MHRA.

“Both these kinds of medicines are regulated by the MHRA and meet assured standards.” would, by most people, be interpreted to mean that the MHRA was providing some sort of asssurance that the stuff worked. It doesn’t. This wording is, to my mind, misleading and disgraceful.

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health). It is roughly the UK equivalent of the Food and Drugs Administration (FDA) in the USA.

The MHRA has just betrayed the trust placed in it by the public by allowing untrue claims to be put on the labels of homeopathis and herbal treatments, apparently under pressure from the government and the Prince of Wales, as described below, and here. The cause such outrage that the MHRA was censured by an annulment debate in the House of Lords, It also caused condemnations to be issued by the many learned societies, most of which you can read at the links here. For example, Royal Society, the Medical Research Council, the Academy of Medical Sciences, the Royal College of Pathologists, the Biosciences Federation (which represents 40 affiliated societies), the Physiological Society and the British Pharmacological Society.

In contrast, the main medical organisations have kept disgracefully silent. Nothing has been heard from the British Medical Association (I hear that a move to say something was heavily defeated). Nothing either from the Royal College of General Practitioners or from the Royal Society of Medicine.

The Physiological Society ‘s Newsletter for December 2006 published and excellent leading article ‘Homeopathic mumbo-jumbo], by Austin Elliott [read it here].

The Physiological Society“The Physiological Society is concerned with the scientific investigation of how the body works “It is our view that “alternative medicine” has, with very few exceptions, no scientific foundation, either empirical or theoretical. As an extreme example, many homeopathic medicines contain no molecules of their ingredient, so they can have no effect (beyond that of a placebo). To claim otherwise it would be necessary to abandon the entire molecular basis of chemistry. The Society believes that any claim made for a medicine must be based on evidence, and that it is a duty of the regulatory authorities to ensure that this is done.”

Austin Elliott comments thus.




“And as the web site of the European Council for Classical Homeopathy (6) puts it: ˜To make such a claim, the manufacturers need only show that the product has been used to treat those particular conditions within the homeopathic industry. No scientific basis. No clinical trials. No evidence of effectiveness.

The homeopaths, and the companies that produce over-the-counter homeopathic remedies, are understandably delighted.

Well, you might say, so what? The placebo effect is not new, and a fool and his/her money are soon parted. Most scientists would agree that the labelling is a joke, but in a world awash with ridiculous claims, why get worked up?

Well, firstly, perhaps, because the MHRA, acting on our behalf, is supposed to care -their web site states they ‘enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe’.

Secondly, . . . there is a principle at stake, namely that decisions of this kind should b made on the basis of scientific and medical evidence and understanding.”

A debate was held at the Natural History Museum on “Does Homeopathy Work?”. You can see it on streaming video. Peter Fisher gave a talk which, after shameless cherry-picking of the evidence, went on to explain that if a memory stick can hold a lot of information, so can water (I’m not kidding).

Read full entry on the original IMPROBABLE SCIENCE page.

The MHRA’s new policy towards CAM has already received a well-deserved drubbing in the House of Lords. Now have the first example of the MHRA allowing totally misleading labels to be put on over-the-counter treatements.

A press release dated November 8th 2006 gives the shocking news.

MHRA grants landmark registration for Traditional Herbal Medicine

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted the first UK product registration under the European Directive on traditional herbal medicinal products.

.

Professor Kent Woods, Chief Executive of the MHRA said:“This first product registration is an important landmark. We hope that Atrogel Arnica Gel will be the first of many products to receive a traditional herbal registration. Our aim is to enable those consumers who wish to take herbal medicines to make an informed choice from a wide range of products which have been made to assured standards of safety, quality and patient information.”

What is the evidence that Arnica Gel does the slightest good for the conditions that will appear on the label? The answer is essentially none. There are only two papers in Medline. The first shows no detectable effect of arnica gel (compared with vehicle alone) (Alonso D, Lazarus MC, Baumann L., Effects of topical arnica gel on post-laser treatment bruises. Dermatol Surg. 2002 Aug;28(8):686-8.)

The second paper claims a positive effect, but it is worthless because it was an open trial with no proper controls. (Knuesel O, Weber M, Suter A. Arnica montana gel in osteoarthritis of the knee: an open, multicenter clinical trial. Adv Ther. 2002 Sep-Oct;19(5):209-18.). The last author on this paper, incidentally, gives his address as Bioforce AG.

So yes, the MHRA’s press release is indeed a landmark. It is the first time that they have allowed a medicine to be labelled with a therapeutic claim when there is no reason to believe it to be true.

The bottom of the press release says (my emphasis) “The MHRA is the government agency that is responsible for ensuring that medicines and medical devices work, . . .”.

Uhm, surely some inconsistency there.

But no, Kent Woods tells me “The strap-line you refer to is a highly simplified statement of our role in making regulatory judgements based on risk/benefit analysis in the real world. ”

The bizarre behaviour of the MHRA is based on European Directive 2004/24/EC.This contains (para 6) the following prime example of pre-enlightenment thought.

“The long tradition of the medicinal product makes it possible to reduce the need for clinical trials, in so far as the efficacy of the medicinal product is plausible on the basis of long-standing use and experience. Pre-clinical tests do not seem necessary, where the medicinal product on the basis of the information on its traditional use proves not to be harmful in specified conditions of use.”

Evidently the MHRA have decided to go along with the licence for snake-oil salesman that this provides. It isn’t clear that they were compelled to do so (MHRA’s response here).

This is what the packet looks like. On the right, one panel is enlarged. The claim “It helps relieve symptoms including:” is quite outrageous. There isn’t the slightest reason to believe anything of the sort. I know the bit above that says “based exclusively on long-standing use”, but it certainly won’t be obvious to most shoppers that this is meant to imply that the clear claim that “it helps to relieve symptoms” may be so much nonsense.

The regulations that allow unjustified claims to be made for homeopathic pills were the subject of an annulment debate in the House of Lords on 26 October 2006. The regulations were introduced as a statutory instrument.

“Statutory Instruments (SIs) are a form of
legislation which allow the provisions of an Act of
Parliament to be subsequently brought into force
or altered without Parliament having to pass a
new Act.”

In other words a minister just decides to do it without any debate or parliamentary approval

“The instrument is laid after making, subject to annulment if a motion to annul (known
as a ‘prayer’) is passed within 40 days.”

The BBC Today programme covered the event before the debate. Lord (Dick) Taverne put the view of reason and common sense superbly, against some totally evasive fantasies from Imogen Spencer of the Society of Homeopaths. He is the author of “The March of Unreason: Science, Democracy, and the New Fundamentalism“).

[Listen to the interview: mp3 file, 5.6 Mb]

Read the debate

The debate can be read in Hansard. In the archaic language of the House.

“Lord Taverne rose to move, That an humble Address be presented to Her Majesty praying that the regulations, laid before the House on 21 July, be annulled (S.I. 2006/1952). [44th Report from the Merits Committee].”. Here are a few quotations.

Lord Taverne

“There is one very important, absolutely fundamental objection to this regulation. For the first time in the history of the regulation of medical products, it allows claims of efficacy to be made without scientific evidence. It is an abandonment of science and the evidence-based approach. Under this new regulation, the sole basis on which claims of efficacy can be made for homeopathic products quite legally is “homeopathic provings”. There is no need for clinical or scientific tests.
Homeopathy is not based on science and is not a science in any sense whatever.”
.

Let me read just three of the comments, the first from the British Pharmacological Society. I quote it first because two members of the MHRA, including the chairman, have pharmacological qualifications. The society says:

“The British Pharmacological Society believes that any claim for a medicine must be based on evidence, and that it is the duty of the regulatory authorities, in particular the MHRA, to ensure that no claims can be made for the efficacy of any form of medicine unless there is good evidence that the claim is true. Despite many years of investigation, we have no convincing scientific evidence that homeopathic remedies work any better than placebo”.

.

“What it has done is to promote what is in effect the selling of snake oil. This statutory instrument should be withdrawn—it is a disgrace. I beg to move.”

Lord Rees of Ludlow (Martin Rees, President of the Royal Society)

“ My Lords, the Royal Society, of which I have the honour to be president, believes that all complementary and alternative medicines should be subject to careful evaluation of their efficacy and their safety. All treatments so labelled should be properly tested and patients should not receive misleading information.

There are no great concerns about the safety of homeopathic treatments. What is at issue is their effectiveness. Obviously placebo effects can be powerful, nobody denies that. It is, however, quite different to assert that homeopathic treatments offer benefits beyond a placebo. Indeed, if medicines can really work even when so diluted that barely a single molecule is left, this would entail some fundamentally new scientific principle with amazingly broad ramifications. It would mean that materials like water carry imprints of their past and can remember their history, as it were, in some quite novel and mysterious way. If that were the case, it would have fundamental implications for precise experiments over the whole of science.

So it seems to me that the burden of proof on homeopathic remedies should actually be higher, not lower, than for conventional ones. Extraordinary claims demand extraordinary evidence. To put it mildly, so-called “homeopathic provings” seem to fall far short of that. That is why I wholeheartedly support what the noble Lord, Lord Taverne, is saying on this issue.

Excellent speeches were made on the side of reason by Lord Turnberg (ex-professor of medicine and ex-president of the Royal College of Physicians) and Lord Jenkin of Roding . (who, as Patrick Jenkin, was a member of Margaret Thatcher’s government).

The 30th Countess of Mar

All of this counted for little with the Countess of Mar, a heriditary peer and organic farmer who opposed the annulment. She was, I fear, rather selective with the evidence. She quotes, for example,

“Professor Madeleine Ennis of Queen’s University, Belfast, with a large pan-European research team led by Professor Roberfroid of the Catholic University, Louvain, set out to show that homeopathy and water memory were utter nonsense. This was an exercise conducted with extreme scientific rigour.” . . . “In the end, she had to concede that high dilutions of the active ingredients in homeopathic solutions worked, whether or not the active ingredient was present in the water”

Bits of Lady Mar’s speech bear an extraordinary resemblence to an article written in the Guardian in 2001, by Lionel Milgrom (maverick chemist and apologist for homeopathy). I wonder who wrote it for her?

The Noble Countess appears not to have noticed that the first author on both of Ennis’s papers was Philippe Belon. who is a director of the huge French homeopathic company, Boiron. In fact the address on the papers is not the University of Belfast (or Louvain), but it is “Boiron, 20 rue de la Liberation, 69110 Sainte-Foy-Les-Lyon, France.”

Boiron makes profits from homeopathy of about 20 miilion euros a year, on net operating revenues of about 300 million euros. It is big business. Philippe Belon has an interesting record.

He was one of the authors of the notorious Benveniste paper(see also below), which lead to Beneveniste’s dismissal form INSERM in disgrace. The Countess also seems to have missed the careful refutation of Benveniste’s results by Hirst, Hayes, Burridge, Pearce and Foreman (1993, Nature.366, 525-7.

Belon was also senior author in Fisher, P., Greenwood, A., Huskisson, E. C., Turner, P., & Belon, P. (1989). (Effect of homoeopathic treatment on fibrositis (primary fibromyalgia) British Medical Journal 299, 365-366.). That is the paper which I was asked to check (by a TV programme).
After Peter Fisher gave me the raw data I found that a naive mistake had been made in the statistical analyis. There was NO evidence for the effect of the treament at all, as described below.
This correction was published (Colquhoun, D. (1990). Reanalysis of a clinical trial of a homoeopathic treatment of fibrositis. Lancet 336, 441-442.), though the correction is usually ignored by homeopaths (see below). [Get pdf].

How odd that all Belon’s papers seem to favour homeopathy.

Lord Colwyn

(The Rt Hon Lord Colwyn, CBE, a Conservative peer) also supported mumbo jumbo. Don’t you love this bit?

“I went on a course about 15 years ago on the relationship between quantum physics and homeopathy. I probably did not understand a word I was told at the time, but at least there was evidence that the two were linked.”

But he shouldn’t worry if he didn’t understand a word: it was just gobbledygook.

Lord Colwyn finished his speech thus.

“It is interesting to consider why homeopathy, which of all complementary therapies is probably at most variance with orthodox medicine, should have received sufficient support from the Government to be able to maintain a number of specialised hospitals.”

Well, agreed again, it is interesting -in fact it’s quite incredible.

What a pity, though, that Lord Colwyn quite forgot to declare his interests. He is vice-president of the Blackie Foundation Trust. This trust was “founded by Dr Margery Blackie in 1971, at that time homoeopathic physician to Her Majesty, the Queen. Dr Blackie saw the need to promote homoeopathic remedies to the wider community and to educate the public about the success of homoeopathy in treating illness.”.
He also forgot to mention that he is a patron of the National Federation of Spiritual Healers.

Lord Warner

(Lord Warner of Brockley, Minister of State at the Department of Health) defended quackery on behalf of the government. He says the legislation

“will, for the first time since the PLR scheme in 1971, allow homeopathic products to be marketed with information to the consumer about what they can be used for. This will provide better information to the consumer and reduce the risk of confusion. “

Lord Warner makes no comments about how claims made for efficacy
in the absence of evidence can be called “better information” for the consumer

“We have done much as a Government to support science and research,
and will continue to do so. Homeopathic products are, however, in a different
category. Provided that such products are safe, properly manufactured and
clearly labelled without making false claims, which they will be under the
new national rules scheme, patients should not be denied access to them for
the conditions to which they relate. “

What, one wonders, does “a different category” mean? The magic category? And
since the manufacturers have just been excused from producing any evidence of
efficacy, who is to judge what are “false claims”.

Some reports

The BBC report before the debate

The Daily Mail -pretty good stuff.

A correspondent has passed on to me a letter from Caroline Flint, Minister of State at the Department of Health. She describes herself as “New Labour [sic] Member of Parliament for the Don Valley constituency in South Yorkshire.”

My correspondent describes himself as “a non-scientist member of the general public who has nevertheless become very concerned about the continuing rise of pseudoscience and quackery, particularly its penetration of the government and some institutions who ought to know better.”. Join the club! His reaction to this reply was “I am speechless”.

The minister offers the opinion that homeopathy works and refers him to the Faculty of Homeopathy, “which has a network of advisors around the country who are pleased to offer advice to members of the public about homeopathic issues”. They, of course, will tell him the usual lies. What are Ms Flint’s qualifications for offering this appalling advice?. BA Hons in American Literature & History, University of East Anglia, Former local government officer, and Senior researcher/political officer GMB 1991-7.

Ill-informed views like these are certainly consistent with the view that the recent bizarre decision by the MHRA, to allow dishonest labelling of homeopathic products, was taken under instructions from the Department of Health.

O2 AUG 2006

Thank you for your letter of 25 July to Patricia Hewitt enclosing correspondence from your constituent *** about homeopathy on the NHS. I am replying as the Minister responsible for this policy area.

I understand Mr *** is concerned that homeopathic therapy has been made available on the NHS. The Department of Health acknowledges that there are now numerous complementary therapies available in the UK. Some of these therapies have been known to alleviate the symptoms of certain illnesses in cases where orthodox medicine does not seem to have offered a complete solution.

However, it is the responsibility of local NHS organisations to commission healthcare packages for NHS patients, be it complementary or orthodox. Complementary and alternative medicine treatments are clearly attractive to a number of people and so in principle could feature in a range of services offered by local NHS organisations. Primary Care trusts (PCTs) often have specific policies on the extent to which their patients can be given access to complementary medicines and within these policies, it is open to GPs to give access to specific therapies where they consider it is in the interests of the individual patient. The cost-effectiveness, availability and evidence in support of specific therapies are all issues that are taken into account when deciding what treatment to provide.

Mr *** may wish to contact his local PCT and find out what their policies are on complementary therapies including homeopathy. The contact details are:

Kennet and North Wiltshire PCT
Southgate House
Pans Lane
Devizes
SN10 5EQ
Tel: 01380 728 899
Website: www.kennetandwiltspct.nhs.uk/

Mr *** may also wish to contact the Faculty of Homeopathy, which has a network of advisors around the country who are pleased to offer advice to members of the public about homeopathic issues:

Faculty of Homeopathy
15 Clerkenwell Close
London
EC1R 0AA

Tel: 020 7566 7810
Website: www.trusthomeopathy.org

I hope this reply is helpful.

Yours

Caroline Flint

Approved by the Minister’s Private Office and signed electronically in her absence.


Jump to the conflict.

The two chiropodists who run the Marigold Homeopathic Podiatry clinic (no, honestly, it’s real) at the Royal London Homeopathic Hospital seem to be spending much of their budget with a company that they themselves own. The UCLH Trust did not receive any notification of this until I told them about it.

This has been re-posted from the story on the old IMPROBABLE SCIENCE page.


It’s about time I dealt with the health fraud on my own doorstep. University College London Hospitals (UCLH) is not part of UCL, but is a National Health Service Foundation Trust. The trust is responsible for eight hospitals: University College Hospital, The Middlesex Hospital, Hospital for Tropical Diseases, National Hospital for Neurology & Neurosurgery, Elizabeth Garrett Anderson & Obstetric Hospital, Eastman Dental Hospital, The Royal London Homoeopathic Hospital and The Heart Hospital.These are all (but one) absolutely first class teaching hospitals, with responsibility for clinical teaching for UCL medical students. The one blot on the landscape is the Royal London Homeopathic Hospital. This hospital was acquired by UCLH in April 2002. Why on earth is a respectable NHS trust promoting quackery? The UCLH web site says

“The merger enables closer collaboration between complementary therapies and conventional medicine to provide better care for NHS patients. The merger co-incides with the government’s commitment to integrate complementary and conventional care within the NHS, where there is evidence of the effectiveness of complementary therapies.” Notice that the crucial proviso in this statement.

“. . . where there is evidence of the effectiveness of complementary therapies.”

That would be fine If there were evidence of effectiveness, but there is next to no such evidence. Why does UCLH brush this inconvenient fact under the carpet?

The Trust actually has an absolutely first class way of assessing the effectiveness of treatments that are used within UCLH. It is called the Use of Medicines Committee. All NHS Trusts are required to have such a committee, and UCLH’s committee was singled out for praise after a visit by the Parliamentary Select Committee on Health, in their 4th report. These committees are required to obtain good evidence that a proposed treatment works, and their evaluations may be more stringent than those of NICE.

Hansard records

“ During the inquiry, we visited University College London hospital to hear about its Use of Medicines Committee. We were incredibly impressed with its drug formulary, which is used not only by the hospital trust but by the nearby primary care trusts. Because members of those trusts are on the committee, it is also well accepted by the GPs in the area.”

So does the UCLH formulary contain homeopathic and herbal products? If so they will have bypassed entirely the high standards of evidence that are required by the Use of Medicines Committee for any other sort of medicine. If these standards were applied to homeopathic and herbal treatments, the Royal London Homeopathic Hospital would have to close down, because few of these alternatives to medicine would pass an evidence-based assessment. Presumably UCLH Management has foreseen this, and would rather adopt a double-standard than deal with the political fall-out that would result from applying rules of evidence to alternative medicine.

A fine example of the abuse of language: Homeopathic podiatry

The UCLH web site says (somewhat ungrammatically): “The Royal London Homoeopathic Hospital is celebrating the first decade of its Marigold Clinic which provides complementary treatment of homeopathic podiatry. ”

“ Dr Peter Fisher, RLHH Clinical Director, said: “It is an honour for the hospital to host the Marigold Clinic which has been tremendously successful. The Royal London Homoeopathic Hospital has a history of acting as a test bed for NHS innovation. The complementary cancer service and acupuncture are just two examples of therapies the RLHH has been the first to introduce on the NHS. I foresee the same thing happening with homoeopathic podiatry. It’s time has come, current reforms and patient choice are working in our favour.” ”

To describe as “innovation” a reversion to a totally discredited 19th century bit of delusional thinking, is a usage that defies belief. See, for example, here and here.

UCLH logo It is embarrassing to a real university like UCL to see a conference, sponsored by RLHH, on ‘Improving the success of homeopathy’ branded with a logo that looks very like UCL’s own (old version) logo. The title carries the assumption that there is something to be ‘improved’. The conference dealt not only with marigold for bunions, but also HIV/AIDS

What does the Royal London Homeopathic Hospital cost you, the taxpayer?

Guess what? Nobody knows. But with the help of the Freedom of Information Act 2000, I have been able to make some good guesses.

For a start, at least £18 million has been spent on refurbishing the RLHH. The recurrent costs are not so easy to discover. By use of the Freedom of Information Act 200, this is what I discovered.

The direct cost of running the RLHH is £3.379 million per year of which £3.175 million per year are paid by the NHS. Approximately 75% of the direct costs are for salaries.These are the salary cost of staff working at the RLHH. The staff are medical, nursing, pharmacy, administrative and managerial, and ancillary. The balance of cost is for purchase of drugs, laboratory tests, use of patient beds in other Trust hospitals, building and office running costs.

As well as this, the NHS pays also for indirect services, but nobody seems to know the cost of these (and still less, their value). Indirect services are those not charged directly to the RLHH and will include the following. Payroll, payment and income services, accountancy, recruitment , training, personnel, governance and clinical audit, R and D management and governance, medical and nursing education, training and professional support, communications, I.M. and T., estates maintenance management and planning, catering, cleaning, security, insurance, depreciation, payment of public dividend. These sevices are supplied by the Finance Directorate, Workforce Directorate, Chief Nurse Directorate, Capital Investment Directorate, IM and T Directorate, R and D Directorate, Governance Directorate, Directorate of Corporate Sevices, Communications Directorate.

For the UCLH Trust as a whole, indirect costs amount to 39.2 percent of direct costs. If that proportion applies to RLHH, then the total annual cost of RLHH would be £4.7 million.

That sounds to me like a lot of money for a placebo effect.

The RLHH is 97.7 percent homeopathic

Their web site lists eight consultants, all described as “homeopathic consultants” and a ninth has been added recently, Dr H. Roniger. Thus it seems that Lord Winston made an error of fact when he defended the RLHH in the House of Lords by saying “My Lords, perhaps I may be allowed to break with tradition and come to the assistance of my noble friend. Is it not the case that the national homeopathic hospital conducts perfectly normative medicine and is it not justified in doing that, irrespective of the efficacy or otherwise of homeopathy, which I believe is only a small part of its practice?”

This is the breakdown of prescribing at the RLHH (audit taken August 2004, provided under the Freedom of Information Act). It refers to the number of items dispensed, not their value (which I am still trying to discover).

Valid Percent
Valid Homeopathy 53.2
Herbal tinctures and potencies <6x 5.7
Iscador products 2.8
Aromatherapy .2
Marigold products 4.2
Creams/ointments 13.5
Tablets/nutritionals 1.3
Supplements/homeopathic (New Era Products) 7.8
Nutraceuticals 3.4
Anthroposophicals medicine 1.2
Allopathic products 2.3
Weleda 2.0
Flower essence 1.5
other 1.0
Total 100.0

NB: Creams are herbal or homeopathic.

And the cost of CAM in Glasgow

A freedom if Information Act request elicited the following costs. Much of
the information I asked for is not even recorded.

The cost of the Glasgow Homoeopathic Hospital.

The running costs for the Homoeopathic Hospital were:
2004/05 £1,658k
2005/06 £1,881k

The cost of all CAM services at Baillieston Health Centre
There is no record of any specific costs associated with CAM incurred at Baillieston Health Centre.There was many years ago a Baillieston Childrens’ Homoeopathic Clinic but this service was subsumed into the new Glasgow Homoepathic Hospital. That hospital opened in 1999 at a total capital and building cost of £2,780,189.The total cost came from the New Homoeopathic Hospital Endowment Fund.
3) The cost of CAM provided by GPs or any other part of the Trust.
There is no record of specific costs associated with GPs or others employed by the NHS Board providing complementary and alternative medicine. If homoeopathy, hypnosis, acupuncture or any other form of complementary medicine is provided it is not as a costed, discrete service.

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A conflict of interest at RLHH

The table shown above shows the precribing habits at the Royal London Homeopathic Hospital, The 4.2 percent of precriptions labelled ‘Marigold products’ in the Table were for the products of a company called Marifold Footcare Ltd.

The UCLH Trust web site says

“Dr M Taufiq Khan founded the Marigold Clinic in 1981 at St Pancras Hospital, London, and then established it in 1992 at the RLHH. Dr Khan is the Director of Homeopathic Podiatory Sevices at the RLHH and specialises in the treatment. His son Dr Tariq Khan, is the Deputy Director.”

The list above shows that 4.2% of all precriptions at RLHH were for “Marigold Products”. This company is Marigold Footcare Ltd., 134 Montrose Avenue, Edgeware, Middlesex, HA8 0DR.
From left to right: Dr Taufiq Khan, Dr Peter Fisher, Lord Paul of Marylebone and Dr Taufiq Khan open the Sick Feet – Healing Flowers exhibition.

According to a Current Appointments Report obtained from Companies House. Marigold Footcare Ltd has three directors.

  • Dr Mohammed Taufiq Khan, PhD of 134 Montrose Avenue, Edgeware, Middlesex
  • Mr Mohammed Taufiq Khan of Bedford House, 17 New North Street, London
  • Mrs Shamim Fatima Khan of 134 Montrose Avenue, Edgeware, Middlesex

It appears that the director and deputy director of the Marigold Clinic are paying substantial amounts of NHS money to their own company.

Research-based? Which research?

The web site of the Marigold Clinic makes the following claim.

Research-based medicine:
Marigold therapy is an integral part of homoeopathic podiatry. It comprises specially formulated medication applied topically in conjunction with podiatry. It is research based medicine which has been clinically evaluated in double blind placebo controlled trials at British Universities and NHS Trusts.

And Marigold Footcare Ltd claims

“The safety and efficacy of Marigold Therapy have been demonstrated through extensive clinical use in podiatry clinics and numerous studies and in randomised, double blind, placebo controlled trials: (1) at the University of Brighton (Faculty of Health); (2) University of East London (Institute of Health and Rehabilitation, Faculty of Health and Science); (3) University of London (Faculty of Medicine, School of Pharmacy and the Royal London Homeopathic Hospital).”

This sounds impressive, but what exactly is this research? All I can find in Pubmed about marigold treatment in podiatry is two papers. One is in the Journal of Pharmacy and Pharmacology (1996, 48, 768-770) and one is in Phytotherapy Research (1996, 0, 211-214).

And who is the first author on both of these papers? You guessed: M.T. Khan.

The first paper (Khan, 1996) is from the School of Pharmacy, the second (Khan, Potter and Birch, 1996) is from School of Pharmacy and the podiatry department, Leaf Hospital, Brighton. I can find no trace of publications from the University of East London or from RLHH. Repeated requests for references elicited no reply at all for a long time.

Eventually, I had a reply from M. Tariq Khan in response to my request for references to back the claim on their company’s web site. He sent a list of 54 assorted conference communications and student projects, and 28 “papers” published in Journals. Every one of these 82 items bore the names of one or both M. T. Khans. There were no more ‘serious’ papers than Pubmed had revealed. There appears to be no independent verification whatsoever of their claims.

Reaction of the UCLH Trust

The UCLH Trust, when notified about what was going on, referred the matter to Dr Peter Fisher, the homeopath and clinical director at rhe RLHH. Tonia Ramsden, Director of Corporate Services for UCLH told me on July 27 2006

“I can confirm that I have received and registered the declaration of Interest.”

Quite true, It was only later that I was told that the declaration of interest was received by the Trust only after I had told them about what was going on!

Peter Fisher, assured me that he was aware of the Khan’s behaviour. Rather surprisingly, he seemed to think that no conflict of interest was involved. He said

“Thank you for drawing to my attention the potential conflict of interest in relation to podiatry. The management of the RLHH has always been aware of the situation”

That was it. No comment at all was made on the propriety of the Khans’ behaviour. Dr Fisher also assured me that the evidence for the efficacy of marigold products was good, without actually citing what this evidence was. I replied thus.

“I find it quite disturbing that you say below that “the RLHH is committed to evidence-based practice”, but that you seem to regard as evidence two small papers, both from the same people with a financial interest in the outcome, and not replicated elsewhere. Incidentally neither of these papers declared the authors’ financial interest. It is equally disturbing that your letter to me does not seem to give a realistic idea of the strength of the evidence. I had to find that for myself. ”

Declarations of interest shoud be public, but are not,

A declaration of conflict of interest is, I suppose, better than nothing. But these pieces of paper sit in a drawer in the Trust. They are kept secret from both the public and the patients. The patient should know when the prescriber has a financial interest in what he prescribes, but they are kept in the dark. When I wrote to the UCLH clinical governance committee to suggest a bit more openness would be desirable, they did not even bother to reply. That is when I decided to make this information public.

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Gerald Weissmann, editor-in-chief of FASEB journal, talks straight.

It seems that our letter to NHS chiefs has crossed the Atlantic. In a gloriously scholarly and funny editorial, Gerald Weissmann MD, of New York University, puts the knife into homeopathy and its royal advocate. Click here to read the whole thing. Here’s something to whet your appetite.

After publication of our letter . . .

“Prince Charles was unfazed—on the day the Open Letter was published, he stopped at St Tydfil’s Hospital in South Wales to watch alternative medicine at work. He accepted a “spiritual” crystal, as if he were Albus Dumbledore, headmaster of Hogwarts School, accepting the Philosopher’s Stone. Unlike Dumbledore, however, who only professed witchcraft and wizardry, Prince Charles called up every form of “integrative therapy” against Alzheimer’s disease (9). One notes that when Prince Charles and other fans of unproven or disproved medical practices use terms such as “integrated therapy” or “alternative medicine”, they’re following the lead of creationists who hide under the term “intelligent design”—these are all convenient slogans that permit the credulous to con the gullible.”

“Hogwarts is certainly on the move! If the trend persists, perhaps MIT or Cal Tech will march in step with the medical schools and offer prizes for integrative alchemy or alternative engineering. But Dr. Oliver Wendell Holmes, dean of the Harvard Medical School before age of Oprah had the last word on homeopathy:

“Some of you will probably be more or less troubled by that parody of medieval theology which finds its dogma in the doctrine of homeopathy, its miracle of transubstantiation in the mystery of its dilutions, its church in the people who have mistaken their century, and its priests in those who have mistaken their calling.”

[Oliver Wendell Holmes, Medical
Essays. The Young Practitioner
, [A Valedictory Address delivered to the Graduating Class of the Bellevue Hospital College, March 2, 1871.] ”

For more delightful writing by Gerald Weissmann, click here.

Special recommendations
Darwin’s Audubon: Gerald Weissmann on the Art of Science.
Swift-boating Darwin: alternative or complementary science
The facts of evolution: fighting the Endarkenment. . The word ‘endarkenment’ sums up only too well much of what appears here.