Download Lectures on Biostatistics (1971). Corrected and searchable version of Google books edition
Download review of Lectures on Biostatistics (THES, 1973).
Multiple sclerosis
This post is about a product called Esperanza Homeopathic Neuropeptide which is marketed for the treatment of multiple sclerosis.
The case is still under investigation by the Medicines & Health Regulatory Authority (MHRA) but so little has been done in the last six months, I thought it was time to bring this heartless scam to public attention.
On 19th September 2009, I got a heartbreaking letter from the mother of a woman who was suffering from multiple sclerosis.
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I would like to draw your attention to Homoeopathic product advertised in one of the Multiple Sclerosis Magazines called” New Pathways” , A copy is enclosed. We have purchased this product for my daughter who is suffering from MS and paid £3,750.00 for seven months’ supply to what is look like clear water in vials to be sprayed sublingually every day. After six months of regular use, no improvements was noticed in my daughter’s condition, if anything her condition is deteriorating. |
The writer also enclosed a pamphlet that advertised Esperanza neuropeptide (the term homeopathic does not occur in this particular pamphlet). Even by the standards of alternative medicine, it was truly jaw-dropping [download the pamphlet].
The good news is that the pamphlet brought news of a special offer. The price of 12 months’ supply has been reduced from £6,759 to £5,000.
Yes you read that correctly. They want £6,750 (US $12,500) for 12 vials, or £575 for a single vial.
What’s in Esperanza Homeopathic Neuropeptide?
For a start it doesn’t seem to be homeopathic at all. I wrote to Esperanza to ask what the homeopathic dilution was, but got no reply at all. I do hope that the word ‘homeopathic’ has not been added merely to circumvent medicines regulations, (we all know that loopholes in the law can allow homeopaths to get away with murder).
The Esperanza web site states
The Sublingual Homeopathic spray (Esperanza Homeopathic NeuroPeptide) contains a peptide (71 amino acid chain) at a concentration of 10 µg/ml. The daily dose is 6 µg.
The dose mentioned above suggests a vial contains about 20 ml (they don’t say), So at the single vial price that comes to an astounding
£28,670 per litre
(at their rate of exchange that would be over US $53,000 per litre)
I also signed up to get the Esperanza newsletter. The newsletter they sent on 11 November 2009 (see it here) describes the product as Esperanza NeuroPeptide Homeopathic Sublingual Spray. In fairness, it does say it isn’t a "cure" (so you conveniently have to keep on taking it every day). But it does quote Esperanza’s Scientific Director as saying
"This is the only drug that gives back function in MS. It affects ability to walk, motor function, pain, fatigue, speech, co-ordination and balance."
You have to read their web site quite carefully to realise that there are no proper trials whatsoever to back up these claims. It is one of those sciencey-sounding sites that might well be convincing to people not accustomed to reading such stuff.
I guess that pretending that a treatment contains something when it doesn’t (homeopathy) is reversed in this case. They are pretending it contains nothing when it does.
The newsletter quotes Gerry Gallagher, Esperanza’s Chief Executive Officer, as saying
Esperanza NeuroPeptide is derived from a protein called alpha-cobratoxin. This recognizes and attaches to the nicotinic receptor in the brain. In a specific patent-protected chemical process unique to Esperanza NeuroPeptide [sic]. This alpha-cobratoxin is systmatically[sic] changed to create a totally harmless amino acid end-product protein. It lacks measurable toxicity but is still capable of attaching to (and affecting) the nicotine receptors. This means patients cannot overdose and that the end-product is 100% safe and toxin-free.
This alpha-cobratoxin is well known to anyone who works on neuromuscular transmission. It binds very tightly indeed to the nicotinic acetylcholine receptors on muscle fibres and so blocks chemical neurotransmission. This paralyses voluntary movement (including breathing) and so kills you (like curare, but more powerful). There are other sorts of nicotinic receptors in the brain, though only one of them (alpha7) is blocked by things like cobra toxin. This preparation is not cobra toxin (luckily) and its properties are unknown. The claim that it still attaches to receptors but has no obvious effects seems absurd.
What matters is that there is no research that shows any beneficial effect whatsoever in multiple sclerosis.
The case seemed so horrifying that I referred it immediately to Trading Standards on 1 October 2009. Despite the fact that the TS officer concerned had an interest in the medical area, the outcome was zero. No action was taken. After some time arguing with Trading Standards, I eventually I referred the case to the MHRA (on 10 November 2009), In fact they had already been asked about it by the Multiple Sclerosis Society, The MHRA is quite clear that it is not homeopathic and action is likely to follow.
The web site for Esperanza is no better. All sorts of wild claims are made. You can download a powerpoint show, but it won’t tell you anything useful.
The MHRA investigation
Although I submitted a complaint to the MHRA on 10 November 2009, the fist sign of action was on 26 May 2010. I got a brief letter from an assessor in the MHRA’s Advertising Standards Unit
“You may wish to know that the advertisement published in the MSRC magazine has been withdrawn. Esperanza Peptide Ltd has stated that the advertisement will not be repeated and they are not planning to run any more campaigns in the UK for 2010. “
“The Enforcement Group are continuing to investigate this Company and will keep you updated. “
That’s a start but a pretty modest start. Let’s hope that the MHRA will decide to prosecute. The enforcement group tell me that, six months on, they are still investigating. No idea when they’ll finish. One thing, though, emerged early on.
On 11th December 2009, the MHRA told me they agreed that the description as ‘homeopathic’ was inaccurate.
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The MHRA considers Esperanza a conventional medicinal product and under no circumstances would it ever be acceptable to regulate it under any of the UK homeopathic schemes. Esperanza would require a full Marketing Authorisation and if such an application was made, it would have to be supported by full efficacy data based on the results of clinical trials. |
There exists no such efficacy data, so the company is surely in trouble.
The state of the law
It seems that there is a real problem. Laws that already exist are flouted regularly, with impunity. Those who break the law, get, at most, a mild rap on the knuckles.
The Consumer Protection Regulations (May 2008) make it illegal to claim that a product will benefit your health if you can’t produce evidence to justify the claim. That should be quite enough to regulate quacks (though it would put many of them out of business). The problem is that these admirable laws are barely enforced. Enforcement is the duty of Trading Standards Officers, and they just don’t do the job. This is the response that I got from Trading Standards.
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. . . we were very sympathetic to the complainant, both of us sharing your own aversion to quack medicine. We looked at the options for action under sch 1 CPRs 17. Falsely claiming that a product is able to cure illnesses, dysfunction or malformations. I am prepared to accept that it is in principle possible to prove such a thing by, most likely, a succession of expert witnesses. However, there is little doubt that the company would provide a vigorous (and well funded) defence. As well as their own ‘experts’ there would likely be a long procession of people into the witness box telling their tale of how they were cured by the drops. Bear in mind the likely scenario for this: a magistrates court with a lay bench. Questions that must properly be addressed by ****shire Council include: what is the likelihood of success? What are the financial risks (with ****shire resident’s money)? What are the benefits to ****shire residents? Has any ****shire resident complained. We concluded that there is in this particular case no proper grounds for us to intervene. |
This response, to such a flagrant case, seems to me pathetic. They decline to enforce the law because no MS sufferer in the local area has been harmed. The law does not require that they should have, but that’s the way Trading Standards works (or, rather, fails to work).
One reason for their ineffectiveness is that the organisation of Trading Standards is desperately out of date. They have not kept up with the internet age. They still work almost entirely via local offices, just as they did when their main job was to check the accuracy of weights on scales used to sell groceries. It is a modus operandi that simply doesn’t work now that they are meant to deal with health frauds that are largely internet-based. One problem is that any particular office is unlikely to have anyone with the specialist knowledge to judge the truth or falsehood of claims that are made for ‘health’ products.
A search of Companies House for “Esperanza” shows the usual trail of dissolved companies but two are still in business, Esperanza London Ltd, (ground floor 25 Balham High Rd.) and Esperanza Peptide Ltd (Largs, Ayrshire). They have moved HQ to Grand Bahama (there’s a surprise) but since they appear on Companies House this should not prevent prosecution .
It is also quite unsatisfactory that the duties of Trading Standards offices overlap heavily with those of the MHRA. In this instance, only the MHRA did anything, and that very slowly.
Follow-up
The MHRA published the following judgement on 4 August 2010.
A healthcare professional complained to the MHRA about an advertisement produced by Esperanza Peptide Ltd for consumers, which was published in the MSRC magazine. The complainant was concerned that the advertisement promoted an unlicensed homeopathic medicine.
The MHRA upheld the complaint. The company agreed to not use the advertisement again in the UK. It stated that it would be making changes to its global website and it would not be promoting it in the UK. The MSRC also withdrew the advertisement from the online version of its magazine.