A Contagion of Lunacy

My mother always warned me about mixing with the wrong people. “They will lead you off the straight and narrow”, she would intone. That could not be more true in the case of our august drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). That body has access to a wide range of advisers, among which is the Advisory Board on the Registration of Homeopathic Products. The MHRA recently advertised for new members of this committee, via the Appointments Commission. My good friend and fellow HealthWatch committee member Professor Susan Bewley wrote to the Appointments Commission, to ask what possible use the committee was. Here is the reply she received. Each section is headed by her question in blue, with the reply, and my comments in red.

Dear Dr Bewley (sic – she is Professor)

Thank you for your letter of 2 September 2011.

I am sorry you have had to wait so long for our response. The delay was caused by the fact we have only just received feedback on your queries from the Medicines and Healthcare products Regulatory Agency (MHRA), the body with responsibility for the Advisory Board on the Registration of Homeopathic Products (ABRHP).

I can imagine it would have taken some time to work out how to answer such searching questions.

The MHRA has provided the following information in response to your request that we explain the following:

a) What possible service this Board serves?

The Advisory Board on the Registration of Homeopathic Products (ABRHP) was established in 1994 by the Medicines (Advisory Board on the Registration of Homeopathic Products) Order 1994 (SI 1994/102) as amended by the Medicines (Advisory Board on the Registration of Homeopathic Products) Order 1995 (SI 1995/309) and Medicines (Advisory Board on the Registration of Homeopathic Products) Amendment Order 2006 (SI 2006/2386) pursuant to the powers contained in section 4 of the Medicines Act 1968.

The service that this Board offers is encapsulated in its terms of reference which are:

a. to give advice on safety and quality in relation to any homeopathic medicinal product for human use, in respect of which a certificate of registration has been granted or applied for;

b. to give advice on safety, quality and efficacy in relation to any homeopathic medicinal product for human use:

i) in respect of which a homeopathic marketing authorisation has been granted or has been applied for

ii) in respect of which a licence of right has been granted.

Note: efficacy means acceptability within the UK homeopathic tradition.

I suspect the MHRA is deliberately missing the point here. Susan was really asking what value the ABRHP was providing, not the work it was doing – they are different. But just look at that staggeringly revealing tailpiece. The MHRA unilaterally redefines efficacy. No longer does it have anything to do with evidence, it is based entirely on faith.

b) More specifically, what is the ‘complex scientific expertise’ that is required to understand homeopathy (that has no effect beyond that of a placebo)?

The remit of the ABRHP is to provide advice on homeopathic medicinal products and not homeopathy per se. It gives advice on all aspects of homeopathic medicinal products, including consumer information.

The MHRA is learning from its political masters. When asked a difficult question, just ignore it and answer something else, that hasn’t been asked. The MHRA has asked for `complex scientific expertise’, but on what remains a mystery.

c) How can experts advise about the safety and quality of safety and homeopathic medicines that contain negligible, if any, ingredients?

Applicants submitting an application for a certificate of registration are required to submit dossiers to demonstrate the pharmaceutical quality and safety of the products concerned. Quality and safety dossiers are also required when submitting an application for a homeopathic marketing authorisation in addition to a dossier supporting the use of the product by UK homeopathic practitioners within the indications sought.

The Directive lays down requirements that are the same as for conventional medicinal products. Homeopathic medicinal products are made from starting materials that may be of animal, vegetable, herbal or mineral origin and other chemicals. The quality dossier submitted must provide data on the production and control of the homeopathic stock or starting material, since the nature of homeopathic products is such that tests on the finished product are of limited value with regard to quality control. The quality and control of stocks is therefore of considerable importance in assuring the consistent quality of the finished product.

Hang on a minute, what’s this `Directive’ that has suddenly popped up? Is it  Directive 2001/83/EC as amended by 2004/27/EC? Whatever it is, to say that it ” lays down requirements that are the same as for conventional medicinal products” is demonstrably untrue. All EU and UK legislation excuses homeopathic products from demonstrating any efficacy, as is mandatory for real medicines. The writer’s brain seems to be wired differently from mine – how is the quality of the finished product related in any way to the quality of stocks, when there is no stock in the finished product?

The quality dossier submitted must also provide supporting data on the production and control of the dosage form and due to the low levels of stock present in the dosage form, it is important to ensure that adequate planning and in process controls are applied to the manufacturing process in order to ensure batch to batch homogeneity.

The safety dossier submitted must provide supporting data on the safety of the finished product include (sic) calculations of the concentration of stock in the finished product. Experts advise on the safety of the dosage form and on key safety messages that should be included in the consumer information to ensure the safe use of the product.

Of course, in most cases all they have to show is that they have diluted beyond Avogadro’s number. How hard is that?

d) How the Appointments Commission will handle the fact that professionals with faith based (rather than evidence or science based) beliefs in homeopathy are highly unlikely to be recognised by their peers as eminent members of their profession? Science tells us “that there isn’t anything there”.

Members’ expertise covers a broad range of specialisms in order to enable the ABRH (sic) to fulfill its Terms of Reference as outlined above. The role of each Member is to advise on their own area of expertise. Therefore, Members whose area of expertise is not within homeopathy are not expected to have any knowledge of the theory of homeopathy.

Appendix 1 provides a list of Members and their individual areas of expertise.

The writer has turned the question on its head. Susan was challenging the scientific credentials of homeopaths on the committee. Instead, the writer excuses real scientists from holding bizarre beliefs – how generous!

e) Pharmacognosy has nothing to do with homeopathy. What is the point in requiring an expert in medicines derived from natural sources to advise about products that will no longer be present after multiple dilutions?

Homeopathic medicinal products are not always highly diluted e.g. Euphrasia tincture is traditionally used as eyewash to soothe sore eyes. As discussed above, the quality and control of stocks is of considerable importance in assuring the consistent quality of the finished product. Since many stocks, including Euphrasia, are derived from plants, the expertise of a Pharmacognosist is required.

“Not always..” does not mean “hardly ever..”. The truth is that most homeopathic remedies are diluted beyond Avogadro’s number. This is a classic red herring.

f) What are the benefit and opportunity costs of the taxpayer paying £325 per meeting x 4 members x 11 meetings x 4 years (£57,200) for just part of this committee?

Although 11 meetings are put in the diary only four or five a year are held and this depends very much on the amount of business requiring the Board‘s advice. Board Members are paid a taxable fee of £325 per meeting plus accommodation and travel costs within strict Government guidelines.

And finally, a prime example of evading the question. Susan asked for the benefit and opportunity costs, and quite obviously the writer does not understand the terms, or chooses to ignore them.

I hope this information is helpful and demonstrates the purpose of the ABRHP more clearly. Please let me know if you have any further queries.

Yours sincerely

Andrea Sutcliffe

Chief Executive

Well the letter certainly is helpful, in that it shows how the MHRA regards the public that it serves. It thinks we are idiots. Let me remind you of the MHRA’s mission statement:

We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe. No product is risk free.  Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.

Am I in order to say they are lying to us? By redefining efficacy as they have done here, they are very clearly not using `robust and fact-based judgements’. They have been effectively lying to us since 2006, when the new registration scheme was surreptitiously forced onto the statute book. Well I do think I am allowed to say this, because a lie is something that the speaker knows to be untrue, and is intended to mislead. This has been going on for so long that the MHRA can’t possibly be unaware of the truth. By welcoming anti-scientific people into its fold, the MHRA finds itself forced to defend them and ends up misleading the public.

This scandal has been further aired in the BMJ, with a letter authored by Susan and which I was proud to support. It sparked off the usual vitriolic and sometimes personal attacks by various homeopaths. I am always struck by the courtesy which most sceptics employ, and the gutter language that we usually get from the alternative medicine fraternity. Says it all really.