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.

“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].

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.”

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.