The Quackometer

Just a day after I write about Dr James Colthurst and the Fenzian device (see Turning A Pint of Tea Leaves into Pure Gold), The Telegraph publishes a business story about how Dr Colthurst plans to raise a pot of gold in pre-IPO cash to help develop the company.

Dr Colthurst's company, Eumedic, has developed a new treatment called Fenzian that uses painless electrical impulses to encourage the body to heal itself.

Following a successful pilot study on the use of this treatment to alleviate the symptoms of asthma sufferers, Dr Colthurst is seeking around £20m in pre-IPO funding before a possible flotation 18 months to two years down the line.

Now that is a lot of money. My previous analysis suggested that there was scant evidence to suggest that the Fenzian device did anything at all and that it appeared to be very similar to a whole range of suspect devices that have been characterised as pure quackery.

So, should Quackometer Venture Capital be investing in this product? Let's go into the Dragon's Den.

As a potential Dragon Investor, I want to ask some pretty simple questions. I want to know if there is a market for this device that is large enough to accommodate the investment. I want to ensure that the device can be made with sufficient margins to make me a profit. I want to know how this device is innovative and compete against alternatives. I want to know what the risks are associated with my investment. In short, I want to establish how I can get my money back with a sufficient return to justify the risk I am taking.

So what is innovative about this device that claims to cure asthma and a whole host of other things? As I noted on my last post, it looks rather similar to the SCENAR - a dubious device that claims similar things - invented by Secret Russian Cosmonauts and encourages the body to 'heal itself'. Dr Colthurst has previously dabbled with this device.

DeviceWatch notes.

In a recent review of Internet websites touting these devices, the Attorney General's Office was able to find the following numerous examples that are indistinguishable in their ineffectuality from the EPFX: NES, E-Lybra, LSA Biofeedback, QXCI/SCIO, Life System, CoRe, Oberon, Mars, Quantec, Metascan, Etascan, SCENAR, ACUSEN, Interx: VEGA, Prognos, Biomeridian, Rife, Bicom, BioPuslar, Mitosan Therapy, Bodyscan, Zappers, F-Scan, Q2, Syncrometer, Magnagraph, Merid, NES, Acusense, Listen, EQ4, Orion, Explorer, Computron, Elision, Interro, Interactive Query System, MORA, Matrix Physique System, Propylene, Punts III and Vitel.

The Fenzian claims to be different by using 'short wavelength AC' rather than direct current'. Is this the key breakthrough? Now, if the Fenzian works, that would be a real innovation in this market. A government public insurance body in New Zealand looked into the Fenzian and concluded,

There is currently a lack of evidence with which to assess the effectiveness of Fenzian treatment. ACC should await the findings of the ongoing trials, particularly those involving sports injuries, and carefully assess the methodologies used.

The review looked at the same paper we examined in my last Fenzian post (Colthurst J, Giddings P (2007). ) and came to similar conclusions,

The findings of the case note review are described as "highly encouraging", but they do not in themselves constitute strong evidence for the effectiveness of Fenzian treatment; the treatment outcomes were not clearly defined, there was insufficient information about the patients and their complaints to make judgements about generalisability, and the authors were both involved with Eumedic Ltd.

The review does note some trials in progress. And the Telegraph reports that there has been a successful pilot study of asthma sufferers. Except I cannot find any reference to it. I doubt it has been published yet. I have written to the lead researcher, a Dr Cooper who studied medicine at the same place as Dr Colthurst, St Thomas's London, to ask where I may find the results. I have not had a reply so far.

Until this, or any other study is published, Quackometer Venture Capital will not be investing as I can see no other market differentiation for this product. But even if something is published, the trial is only a pilot study which is unlikely to give any sort of definitive answer. Indeed, pilot studies are, by their very nature, weak in statistical power and are more prone to bias. As the New Zealand researchers say, I will have to carefully assess the methodologies used in any trial.

So, is there a market for this device, even if it does work? Time for some back-of-the-envelope calculations. A pre-IPO investment of £20m puts a very high valuation on the company. Assuming Dr Colthurst wants to retain any control, this puts a current post-investment value of over double this amount. As this is pre-IPO investment, I am wanting to see my money double or more in a couple of years. For such a risky venture, I do not want building society rates of returns. Most investments like this do not get a return. When they do, they have to be big. So, My guess is that this puts a target IPO valuation at over £80m. That is a big sale.

Could it be worth it? Again, any potential share holder in the post-IPO company is going to want to see rates of return towards to top end of 10-20%. Let's be pessimistic and we see a 10% profit in the first year - that means we need to see £8m generated in cash.

How many units do we have to sell to achieve this sort of profit? The SCENAR device retails for about $5,000. What is the margin on such products? Difficult. Training is thrown in which may be expensive. The cost of sale is going to be higher than retail sales as devices are mainly sold to 'professionals'. Let's use a typical figure of 50%. That means we have to sell about 6400 units to make our target profit.

As we are in a competitive market and say we go for a market share of 20% - which may be hard given the established brands - that means we have to have a global market of 32000 units per year. Can there be enough chiropractors and sports therapists willing to dish out the dosh?

The product, so far, has no uniqueness in the marketplace, the evidence for efficacy is very poor, it relies on implausible modes of operation, and we are going to have to shift a huge number of units year on year.

For those reasons, I am out.

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So, what has this story been about? The promise of a London IPO does not look good. The amount of money just looks daunting given the nature of the product. In my opinion, we are seeing something else here: a way of getting column inches about a product in a national newspaper. It is marketing. And effective marketing. As always, uncritical pieces in the newspapers give the alternative medicine crowd free advertising.

Labels: fenzian

 

Dr James Colthurst and the Fenzian Machine


No, I haven't gone all Daily Express on you. There is a genuine Lady Di connection here. But first, the Daily Telegraph.

We are told (May 10, 2008) how a man had a bad knee and how 'laser acupuncture' made it better again. Time for the Quackometer to investigate.

So, why do alarm bells ring? The Telegraph reports,

Last year I heard about a new treatment, called Fenzian, and decided to give it a go. Pioneered by Eumedic, a Berkshire-based company, it involves a hand-held electronic device that is passed across the afflicted area imparting low-level electromagnetic impulses into the skin. It has been likened to a non-piercing form of acupuncture.

'Electronic devices' that look really scientific and impart 'electromagnetic' things to the body are readily found in the world of quackery. They usually do nothing but allow practitioners to take hefty fees from customers. Is the Fenzian one of these devices? We must look more.


Apparently, the machine works by,

open[ing] a dialogue between the damaged part and the central nervous system, enabling the body to target its own healing powers more effectively.

Now that could be just flowery journalistic uncomprehending language. But if it is what Eumedic claim, then we could be in a spot of bother. One thing I would like to know is what is being said in the dialogue and what language is being used. Unfortunately, I doubt we will find out.

The next worrying aspect is that Eumedic appear to be relying on testimonials. An over-reliance on testimonials ought to alert us to the possibility that quacks are using anecdotes to convince people that their treatments work. (Check out the All-American Sports Stars.) But things look better when it appears that there is an actual written-up study of the treatment with 600 patients involved. There might be real evidence that the Fenzian works. The Telegraph reports,

[The study] showed that most felt they had been “cured”, though this was less evident among the older ones and those who had had symptoms for more than six months.

And hopes may be dashed. If the Fenzian was useless then we might expect those with new symptoms to get better soon anyway, but those with more drawn out problems to continue to have them. Is this paper for real?

The paper, entitled A retrospective case note review of the Fenzian electrostimulation system: a novel non-invasive, non-pharmacological treatment, is by J. Colthurst and P. Giddings. The study was of 600 case notes from one clinic. It was asking if the patients seen at this self-referred, private clinic felt better after a visit. As such, we cannot tell from the study if the Fenzian had any effect whatsoever. It is perfectly possible that people got better anyway. There is no control group, so we simply do not know what the Fenzian did. The criticisms you could make of this paper are exactly the same as those made of the Bristol Homeopathy Study. Funnily enough, both papers report a 70% satisfaction rate.

The authors themselves note that "conclusions that can be drawn from the findings are limited." However, they go on to rather optimistically conclude, "these preliminary results are highly encouraging". I would add that if all 600 patients had paid the initial £350 as the Telegraph correspondent, followed by 15 follow up visits at £150 a pop, a more justified conclusion of this paper might be, "these preliminary results are highly financially encouraging".

My doubts grow even stronger when we note that the lead author of the paper, J. Colthurst, is the owner of the clinic and inventor of the Fenzian. So, the paper can hardly be looked upon as an independent review of the technique. More troubling aspects arise when I note that a Professor Kim Jobst helped with the paper. Jobst has turned up on the quackometer before as an advocate of the highly dubious qlink magic pendant.

More scary things are in the paper, such as the appeals to NASA/Military/Russian/Secret authority,

Research by the Soviet aerospace and military scientists found that rapid changes in skin electrical properties occurred during acupressure, and that the sites of valuable response often correlated with known acupuncture sites. Regrettably, because of the secretive culture of the Soviet military, none of this research was published.

Such claims are always highly doubtful and impossible to verify - but sound very impressive.

So, who is the inventor of the Fenzian and author of this paper? Dr James Colthurst MBBS; BSc; MBA; MFHom; FRCS(Ed) is an ex surgeon, educated at Eton and St Thomas’s Hospital Medical School, University of London. He is the second son of Sir Richard la Touche Colthurst, 9th Baronet Colthurst of Blarney Castle, and a capped English rower.

Colthurst is an intriguing character. Having the double misfortune of being second in line to the Baronetcy and loosing a bundle on the Lloyds markets, he found himself studying for a business degree (MBA) and then setting up a private clinic in Berkshire. Beyond his medical career, we find out that he was a close childhood friend of Diana and he turned out to be the paid for 'middle man', supplying the Diana tapes to Andrew Motion for the book that 'blew the lid off' the royal marriage.

Colthurst has a history of investment in alternative medicine. He is proud to claim that he is only the second surgeon to train in homeopathy and join the Faculty of Homeopaths and he only surgeon with an MBA. The Telegraph lists him as one of their Top 20 health gurus, just above Patrick Holford.

He also looks as if he has been dabbling in electronic gizmos for a while now. It is claimed he was one of the fist people to use the SCENAR device in the UK - a box remarkably similar to the Fenzian. The SCENAR was

developed by Russian scientists to ensure that cosmonauts stayed fighting fit as they floated in the stratosphere[sic].

Another user of the SCENAR, claims to be trained by Colthurst and says the device was,

developed in Russia in the 1970s to get wounded Soviet soldiers back on the battlefield as quickly as possible.

Marvelous.

In April this year, the Washington State Attorney General, Rob McKenna, wrote a letter to the US FDA to urge them to curb bogus medical devices such as the SCENAR. He said,

The sale and use of untested medical devices is a national problem. We encourage you to ban the manufacture, distribution and use of these dangerous devices, to step up enforcement against those who are taking consumers' money and risking their health.

Colthurst has other electronic device interests too. He runs a web site called muststopsmoking.com. For this service, you will be charged £250 and plugged into a Bioresonance device that "recognises the echoes of toxins and asks your body to 're-set' itself."

I must let you see the "Medical Description of Bioresonance" that is used to sell the service...

All substances have a resonant frequency. Even cells have resonant frequencies. These vary with different types and state of cells. Healthy cells have 'clear' harmonic waveforms. Unhealthy or damaged cells have disturbed waveforms. Toxic substances will disturb the waveform emanating from cells.

The 'output' signal from a cell can be considered as a resultant of the healthy cell waveform and the frequency of the toxic substance.

Bioresonance aims to measure the waveforms and to be able to separate disharmonic (toxic) waveforms from 'healthy' signals. A process of phase-cancellation is then used to counter the toxic waveforms. In addition, another process is used to amplify the healthy waveforms, thereby re-setting the cellular harmonics.

Gold standard pseudoscience.

Now, we have seen the Blarney-stone-kissing, gift-of-the-gab, silver-spoon-in-the-mouth, side of the family, but on his mother's side there is a more interesting relative. He is the great-grandson of Sir Almroth Wright who is something of a medical hero. Wright was an early pioneer of immunisation, inventing the process of autogenous vaccination preparation and was probably responsible for saving millions of lives through the development of the typhoid vaccine before the First World War. He worked with Alexander Flemming on the treatment and cleaning of wounds to prevent infection and battled fiercely with the 'Harley Street Ethos'. He campaigned to set up a government centralised fund for performing medical research so that it could be taken out of the hands of private practice. This action led Lloyd George to set up the Medical Research Committee (which later beacme the Medical Research Council).

Wright found many detractors, not least in George Bernard Shaw who lamented the passing of the art of medicine to the emerging power of scientific medicine typified by the attitude of Wright. Wright formed the basis of the character of Dr Colenso Ridgeon in George Bernard Shaw's satire The Doctor's Dilemma.

In a biography of Shaw by Hesketh Pearson, it is reported that,

Bernard Shaw called upon Sir Almroth Wright - a noted allopathic physician - to look into homeopathy. Wright expressed complete incredulity. Shaw remonstrated with him. "Look here," exclaimed Wright, "the thing is absurd and impossible; let me put it this way. Would you, Shaw, trouble to get out of your chair if I called from the next room, 'Do come in here and see what I have done - I have turned a pint of tea leaves into pure gold.'?" "Certainly I would," replied Shaw. "

Shaw's credulity stands in stark contrast to Wright's sceptical attitude. Homeopaths see Shaw's response as being more 'open minded'. Sceptics see it as an over willingness to believe in anything in the face of illogical nonsense. Indeed, Wright was supposed to have proposed that logic was formally taught to doctor's as part of their training. His ideas were ahead of their time and rejected.

I wonder what he would make of his descendant? My guess is that science may well have advanced, but society has not.

Labels: electromagnetic quackery, fenzian, qlink