Thursday, 28 June 2018

Asyra machine

The Asyra machine has been mentioned in a number of posts. The Advertising Standards Authority (ASA), at the time of writing, have just issued a ruling about a practitioner.

Carolyn Stevens
Stevens is a member of the Alliance of Registered Homeopaths (ARH). Stevens offers CEASE therapy - it is worth discussing what she says about before looking at the ASA ruling. She makes the usual claims, spells out the acronym in full and links to the CEASE therapy website but this -
The majority of the children I see who have ASD labels were born healthy and attentive, but started to display behaviour leading to the ASD diagnosis at a later stage. Generally we can see exposure to toxins and pharmaceutical drugs in childhood, and it seems as if the body just at some point just can’t take any more. There are many theories regarding autism but one thing is for sure, the jump from 1 child in 80 to 1 in 6 over the last few years means that something very wrong is happening to our children, and something needs to change.
1 in 6? Unless the majority of these children are being hidden somewhere, this is obviously not the case. Tracking down the source of these kinds of claim can be difficult. Experience of reserching sources of anti-vaccination misinformation is that a figure can be inflated with retelling or that its scope can grow. The most likely source of the 1 in 6 figure is the Centers for Disease Control and Prevention (CDC) report Key Findings: Trends in the Prevalence of Developmental Disabilities in U. S. Children, 1997–2008. The report puts the prevalence of all development disabilities at 1 in 6. Autism? 0.47% which is less than 1 in 200. Either Stevens naively swallows misinformation, has language comprehension issues or is scaremongering. None of these are positive trait in a "healthcare professional".

Steven claims for Asyra can be found here and they do not make for good reading. Ignoring the list of symptoms -
The Asyra unit emits a low voltage output to check for the body’s response to a variety of issues and imbalances. The software can then run through a database of literally thousands of items (homeopathics, herbs, vitamins) to see which ones the body responds positively to. All consultations will result in a remedy (drops or pillules) to help adjust any imbalances. The testing is painless and results are available instantly.
In essence, Steven is implying the Asyra can diagnose disease and select medicines via a  combination of hardware and software. That's quite a claim, even by implication.

ASA Ruling
Stevens did not respond to the ASA and so far her website has not been amended. The ARH has compliance with advertising regulation in its Code of Ethics and thus is a contractual obligation on members.
The ASA was concerned by Carolyn Stevens’ lack of response and apparent disregard for the Code, which was a breach of CAP Code (Edition 12) rules 1.7 (Unreasonable delay). We reminded them of their responsibility to provide a substantive response to our enquiries and told them to do so in future.
The antipathy of some homeopaths towards the ASA is well known. This post includes a statement by Karin Mont who is the chair of the ARH in which she clearly implies that compliance with ASA rulings is of no concern.
The ASA noted that the ad included a number of claims, such as “The Asyra can be used for screening for a multitude of issues and imbalances in your system” and “The Asyra will identify issues and help with the start of a balancing, desensitisation or detoxification protocol”, and listed a number of health conditions, including allergies, nutrition levels, infections, alcohol addiction and others. We considered those claims were medical claims for the Asyra Pro device used by Carolyn Stevens that it was effective in screening and diagnosing the various health conditions listed in the ad.
It has to be remembered that the ASA are a voluntary regulator and their codes represent an understanding of the law. Stevens' claims would be in breach of consumer protection legislation for one thing.
The CAP Code required that medicinal or medical claims and indications were made only for a medicinal product that was licensed by the MHRA or under the auspices of the European Medicines Agency (EMA) or for a CE-marked medical advice. We had not seen any documentary evidence to demonstrate that the Asyra Pro Bio-Energetic device used by Carolyn Stevens was a CE-marked medical device and because of that, no medical claims could be made for the product. In addition, we had not been provided with any documentary evidence to substantiate the claims that the device could be used to diagnose the conditions listed in the ad. 
Because the ad made medical claims for a product which was not a CE-marked medical device, and because we had not seen evidence to support the efficacy claims made for the device, we concluded that the ad was misleading.
Medical device regulations are very complex.

Medical Device Regulations
Not only are medical device regulations complex and difficult to read, they are in a period of transition and major changes are pending. Whether or not these changes will apply to the UK post-Brexit (if it happens) is moot - they will certainly apply to any devices that are intended for export.

The Medical Devices Directive (MDD) is the most important part of EU regulation but it is very hard to read. It is implemented in UK law by the Medical Devices Regulations 2002 (Regulations 2002). The Medicines and Healthcare Product Regulatory Agency (MHRA) has copious guidance but there is so much that is hard to follow. However, this is a good place to start. A medical device is -
... described as any instrument, apparatus, appliance, software, material or other article used alone or combined for humans to:
  • diagnose, prevent, monitor, treat or alleviate disease
  • diagnose, monitor, treat, alleviate or compensate for an injury or handicap
  • investigate, replace or modify the anatomy or a physiological process
  • control conception
The claims made by Stevens certainly place Asyra as a medical device. The article then goes onto describe a number of different types of medical device - Asyra is not implantable or for in vitro use so the MDD applies.

One important concept is whether a device is "active". The MDD contain the following definition -
Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices. Stand alone software is considered to be an active medical device. 
The Asyra device whateve the claims made for it, measures skin conductance which requires passing an electric current between two electrodes through the skin. It might be very low current, but MDD isn't concerned with that. The Asyra device connects to a PC and its "results" are analysed by software. So, it is an active device.

Medical devices are divided into classes, which are 
  • Class I - generally regarded as low risk
  • Class IIa - generally regarded as medium risk
  • Class IIb - generally regarded as medium risk
  • Class III - generally regarded as high risk
All medical devices must be registered with the MHRA. All devices require confirmity assessment and bear a CE mark and in the case of Class IIa and above, plus Class I devices that are diagnostic in function or sterile, that assessment must be carried out by a Notified Body. In the case of non-diagnostic, non-sterile Class I devices, self-assessment is sufficient. There is a database which is extremely difficult to navigate but the Asyra device does not seem to appear there.

The rules for determining which class a device belongs to are quite long so only those that may apply to the Asyra device are considered -
Rule 1 - All non-invasive devices are in Class I, unless one of the rules set out hereinafter applies.
Asyra certainly is non-invasive.

But -
Rule 10  - Active devices intended for diagnosis are in Class IIa: 
  • if they are intended to supply energy which will be absorbed by the human body, except for devices used to illuminate the patient's body, in the visible spectrum, 
  • if they are intended to image in vivo distribution of radiopharmaceuticals, 
  • if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of CNS in which case they are in Class IIb.
 Active devices intended to emit ionizing radiation and intended for diagnostic and therapeutic interventional radiology including devices which control or monitor such devices, or which directly influence their performance, are in Class IIb.
The Asyra website states here that -
The Asyra is not a diagnostic device. All bioenergetic testing devices (as with manual techniques such as kinesiology) work by sending signals of some form to the body and getting a response – balanced or unbalanced, and reporting the response back to the practitioner. 
Diagnosis is the process of dividing people into groups according to the set of signs and symptoms they show, whilst bioenergetic testing reflects back a unique pattern of information that can be used to treat on a like-cures-like basis and to gain insight for the practitioner and client. 
The information you obtain from the system may of course assist you in arriving at a diagnosis, if this is what you are licensed to do.
But it still would appear to be a Class IIa device so it require assessment by a Notified Body. But what form would that assessment take? Most of is concerned with quality management systems (QMS) and compliance with various QMS standards. QMS is a very dull subject. The assessment will involve consideration of whether the device actually does what it claims to do in its specification - which isn't always the same as marketing claims. Those are dealt with by the Consumer Protection Act 1987 etc as explained in the Regulations 2002 . Device regulation is different from medicines regulation in this regard.

The MHRA do have the powers to seek the removal of products from the market as well as prosecute.

What is the Asyra Pro exactly?
As mentioned previously, it consists of hardware that connects to a PC running bespoke software. It appears to connect via USB. The wesbite for the product is full of "information" but none of it tells us very much about the hardware. Short of actually obtaining one and opening it up, it's impossible to be certain but there are some clues...
The Asyra software contains digitally-encoded information relating to a wide range of mental, physiological and emotional factors. The signals are output by the Asyra hardware as electromagnetic signals during testing. Using a simple and safe low voltage circuit formed by holding two brass cylinders, the response of the body to those signals is recorded. The response being measured is small changes in the electrical resistance of the skin. This information is relayed back to the software. A report is generated on the computer of any responses that are outside specific limits.
A low voltage current? Well, it connects via USB but the accessories include a "charger" that looks like a laptop power supply. Apparently, it does have batteries but comes with a "charger" that looks like a laptop power supply. "Signals" suggests that what ever electric current that is supplied is modulated in some way - but that can be as simple as on-off as in Morse code. However, as it says, it measures small changes in resitivity and no mention is made of, say, measuring signal degradation. What is meant by "small" is unclear but sensitive ohmmeters are more expensive than cheaper ones but the chipsets are not expensive. The Asyra does obviously contain some microelectronics. The device has a callibration button but what it does is unclear.

So, the device sends resistance data to a laptop over USB. The Asyra software "compares" this to a database
The Asyra database has been refined over many years of development and now contains a huge array of test libraries spanning physiological, emotional, mental and spiritual factors.
Right. And some of these "libraries" are very odd indeed.
Note that energetic testing with the Asyra against any of the included libraries can never be considered diagnostic of any medical condition, or as conclusive of the physical presence of any pathogen. Asyra merely reveals a change in bio-electrical response to informational signatures output by the system, from which you can draw conclusions or otherwise based on your own expertise and experience.
So, it's effectively useless? What "informational signatures" might be conveyed by small changes in skin resistance is not clear. How "informational signatures" can exist for things that don't exist (eg miasms and chakras) is unclear as is how these "signatures" are determined in the first place. Based on these "signatures", the software makes suggestions on homeopathic and/or herbal products to use. 

Something that's not immediately apparent from the descriptions on homeopaths' websites or the ASA ruling is that Asyra is also a radionic remedy maker. These devices "imprint" blank sugar pills with the "electromagnetic signature" (or equally bizarre justification) of (generally) homeopathic remedies. How the "signatures" are obtained is not explained.  Whether homeopaths mentioned in previous posts actually use the machine to "imprint" remedies is unknown. What is known is that the Society of Homeopaths (SoH) do recognise use of remedy makers as potentially problematic. From 305th Board Meeting (July 2016) minutes -
VG reported that it has been brought to the Society’s attention that there are various views/opinions on the use of Remedy machines. 
Discussion took place regarding the use of Remedy machines and whereabouts the Society stands. The Society needs to remain neutral and clarify its position with regards to insurance. It was AGREED that a statement should be prepared and information published to Members.
Oops. 

The Asyra comes with a laser "pen". There's also a Bluetooth version of the Asyra called Qest4.

Implications
From the perspective of the Professional Standards Authority (PSA) this ruling doesn't just apply to a single homeopath who is not a member of an accredited register, it applies to all members of accredited registers. Of course, this does include SoH members but some other registers too like the Federation of Holstic Therapists (FHT) and the Coomplementary and Natural Healthcare Council (CNHC). Because the Qest4 is essentially the same kind of device but with Bluetooth, it's also going to apply to users of that device too. There are a number of similar devices on the market and similar claims are made for them. By extension, the PSA may well expect accredited registers to interpret claims made for those devices in a similar way.

That the ruling doesn't mention the radionic remedy making aspects of the device but the ASA do say advertisers only mention that radionics is available.

There are other classes of device/tests that the ASA has ruled against/issued statements on that are used by SoH, FHT and CNHC members. This guidance on food allergy testing mentions the Vega device, which does roughly the same thing. The Vega device has been the subject of a fair amount of media reporting. The guidance also mentions this ruling on claims made for hair analyis, another thing that crops up on websites of SoH, FHT and CNHC members. The website cited is dead but has been archived.

The Asyra and Qest4 machines (and similar devices) would never make it through the assessment by a Notified Body and thus can not be registered with the MHRA. In theory, they are illegally on the market but the MHRA does not seem particularly concerned by them.

No comments:

Post a Comment