This afternoon, we received a further letter from the NHS National Research Ethics Service about the pilot study which aims to compare the Lightning Process with specialist medical care for children with ME/CFS. It contains an apology to Mr Phil Parker for any embarrassment or difficulties caused by previous publication of inaccurate information about his business.
Here is the text of the letter:
Dear Dr Shepherd
Assessing the feasibility and acceptability of comparing the Lightning Process with specialist medical care for Chronic Fatigue Syndrome (CFS/ME) – pilot Randomised Controlled Trial
Further to my letter of 6 January 2011. I would advise you that following the publication of the South West 2 REC Minutes, Mr Phil Parker has contacted NRES to point out an error in the documentation. Whilst it is accepted that the Minutes are an accurate reflection of the discussions held, the consideration of one issue was not accurately presented to the REC for its consideration. The Minutes state that
“3. The Lightning Process (LP) is subject to trading standard and Advertising Standards Authority (ASA) enquiries. Complaints that Mr Parker made unsubstantiated claims of effectiveness have been upheld by the ASA and this is in line with data from the ME society indicating it is effective (or ineffective) or harmful as other therapies. It was noted that the judgement of the ASA was made after the submission of the application to the ethics committee. And corrective action had been taken.”
Mr Parker has confirmed that the complaint that was investigated by the Advertising Standards Authority (ASA) did not concern him but rather an entity called “WithInspiration” with whom he has no financial, employment or other interest. It is a private business managed by a registered Lightning Process Practitioner and he had no ability to influence the day to day management or marketing of this business. The complaint made and subsequent adjudication was not related to Mr Parker and he has never been the subject of any complaint investigated by the ASA or by trading standards.
NRES has verified this information at http://www.asa.org.uk/Asa-Action/Adjudications/2010/6/Withinspiration/TF_ADJ_48612.aspx
NRES would wish to apologise to Mr Parker for any embarrassment or difficulties which may have been caused by this incorrect information. NRES is organising for the SW2 REC to formally process an addendum to their minutes to correct this inaccuracy.
If you have organised any publication of the minutes of the SW 2 REC meeting, NRES would be grateful if you could publish this information, together with the NRES apology, to reflect the correct position.
Yours sincerely
JOAN KIRKBRIDE
Head of Operations, England
Quite right to – can’t have any incorrect facts messing up the legitimacy of the Ethics Committees approval for such trials can we?
I mean let’s be under no illusions here – first he gets approval and then he gets an apology!
Just who the heck said that about him in the first place?
But wait – has the Committee just taken his word for it?
Yes, you would never want a fact like the difference between children and adults with ME to be ignored. Oh wait it was! How are they different again??? Crawley never said, but the NRES just push on with child experiments.
I would assume that this mistake was made NRES, after all they are accepting responsibilty for it. It is an understandable mistake, as both Phil Parker and Alastair Gibson are named as involved with the SMILE study.
Withinspiration is the business name that the LP practitioner, Alastair Gibson, is trading under for his sale of The Phil Parker Lightning Process.
The ASA ruling applied to Gibson’s false claims of cure of disease including ME/CFS by application of the Phil Parker Lightning Process.
The fact that the ASA were not dealing with Parker personally is, merely a technicalilty and this error does not, therefore, in any way, affect the validity of the concerns raised with NRES about this pilot study.
I am not so sure JMBE.
When the MEA posted the minutes and the rest of it was debated elsewhere I do believe it was one of the petitioners that mentioned the ASA ruling was pending.
Maybe I am wrong though – usually am 🙂
I cannot speak for other complainants, Firestormm, but I can confirm that in my own letter to the SW REC, I not only specified that the ASA ruling applied to Withinspiration, but gave the link to the ASA website page.
The relevance of the ASA ruling is that Withinspiration is the name under which Alastair Gibson sells The Phil Parker Lightning Process. Alastair Gibson is the LP trainer involved with SMILE. Both he and Parker are listed in the study proposal documentation. Gibson’s address in the list of contacts is an hotel in Bournemouth. This is one of the venues he uses for his training programme.
So, regardless of whether one of the petitioners you mention mistook whether it was Parker himself or the other trainer involved in the study and selling The Phil Parker Lightning Process, who was the subject of this ruling, the fact is that they were given the correct information by at least one complainant and it was incumbent upon them to check the facts.
Surely, it was not beyond the intelligence of someone in the SW REC or NRS to follow the link and check the details. Gibson is not named as the trader on that page, but a quick call or email to the ASA could have confirmed that this Withinspiration is indeed the same as that involved with SMILE.
But then they didn’t bother to check any of the facts in the study proposal either did they? What on earth are they being paid for? For an Ethics Service this is grossly negligent and would be risible if the subject were not so serious.
I didn’t make any comments to the NRES.
However, I have heard multiple times that each LP practitioner gives a percentage of each appointment to the overseeing LP company. I’m not sure what this business model is called – franchise? Is this incorrect?
Like McDonald’s then. Do you think the kids get a toy at the end?
Nah, but I bet they are conditioned to want more!
Dear Joan,
I refer to your letter of 4th February regarding the pilot study known as SMILE and the NRES’ apology to Phil Parker for associating him with the ASA judgement that was made against Withinspiration. Given that you consider it such a serious matter to have associated him with that adverse judgement, it is amazing that the NRES has seen fit to uphold SW REC’s decision to grant ethical permission to a study to be carried out by someone who actually was the subject of it.
1. The association of Alastair Gibson and Withinspiration with the SMILE study
Alastair Gibson sells The Phil Parker Lighting Process under the trading name of Withinspiration. Were you aware of this when you issued your apology and why did you not make this clear?
Alastair Gibson is the LP practitioner named, along with Phil Parker, in the SMILE study proposal documentation. I believe that Alastair Gibson is the LP practitioner who will be carrying out the training programme with the children in the study. If this is not correct, please would you name all of the LP practitioners who will be training the children in the SMILE study and explain the relevance of Gibson being named in the proposal.
I would like to point out that Gibson’s address in the list of contacts is an hotel (The Suncliff) in Bournemouth. This is one of the venues he uses for his training programme, as shown on the Withinspiration website. Does this indicate that this hotel will be one of the venues for the training of the children in the study? All other participants have listed their address as their home or business premises.
Title: Forename/Initials Surname: Mr Alastair Gibson
Post: Lightning Process Practitioner
Qualifications: ABNLP,BMHRD,EFT
Employer: Self Employed
Work Address: The Suncliff
East Overcliff Drive
Bournemouth
NHS REC Form Reference:
10/H0206/32
IRAS Version 2.5
Date: 24/05/2010 17 51434/123204/1/666
2. The links between Withinspiration and Phil Parker
Your letter states, “Mr Parker has confirmed that the complaint that was investigated by the Advertising Standards Authority (ASA) did not concern him but rather an entity called “WithInspiration”with whom he has no financial, employment or other interest. It is a private business managed by a registered Lightning Process Practitioner and he had no ability to influence the day to day management or marketing of this business.”
The ASA adjudication applied to Alastair Gibson’s claims about the Phil Parker Lightning Process.
If Alastair Gibson is the practitioner who will be delivering the training to children under the SMILE study, then it is quite extraordinary that Phil Parker chooses to so vehemently disassociate himself from Withinspiration, and hence Alastair Gibson, by saying that he has, “no financial, employment or interest” in his business.
Not only is Gibson selling The Phil Parker Lightning Process via Withinspiration, but at the time that approval had been granted for the SMILE study, the Withinspiration website included recommendations of Alastair Gibson by Phil Parker himself. Does Phil Parker endorse Alastair Gibson’s practice of selling his LP or not? Were the endorsements by Parker of Gibson used by Gibson on his Withinspiration website false and/or used without Parker’s knowledge and permission?
3. The suggestion that you were misled in the presentation of this issue for your consideration
You say that, “the consideration of one issue was not accurately presented to the REC for its consideration.”
This is incorrect. The SW REC certainly was advised that the ASA ruling applied to Withinspiration, and I am forwarding you by separate mail the letter that was sent to SW REC in October and the confirmation of receipt of that letter that was received from Tom Lucas.
I therefore wish you to issue a further public apology for this error, as the SW REC were indeed accurately presented with this information and considering the seriousness of the matter, it was incumbent upon the SW REC to clarify the facts for themselves. This was not difficult to do. The relevant links were provided and the contact details for the ASA are easily available from the website. Here is the relevant extract from that letter to SW REC of 10th October 2010:
(start quote)
“8. THE ADVERTISING STANDARDS AUTHORITY ADJUDICATION ON ALASTAIR
GIBSON’S ADVERTISING OF THE PHIL PARKER LIGHTNING PROCESS
“In addition to the specialist Medical Care detailed above, young
people and their parents will be asked to read the information about
the Lightning Process on the website or using information sheets.”
Children in the study and their parents are advised to read the
Lightning Process website, which means they will be exposed to content
that is misleading through a number of unsubstantiated claims,
significant omissions of fact, and statements that are factually
incorrect, and is thereby inappropriate and offensive to anyone who
genuinely sick and disabled by ME/CFS.
I wonder whether the Ethics Committee was aware that The Advertising
Standards Authority ruled in June 2010 that a sponsored link to
Alastair Gibson’s Withinspiration website should be removed. The ASA
stated:
“We were concerned that Withinspiration did not hold robust evidence
to support their claims that the lightning process was an effective
treatment for CFS or ME. We therefore reminded them of their
obligations under the CAP Code to hold appropriate evidence to
substantiate claims prior to publication. Because we had not seen any
evidence to demonstrate the efficacy of the lightning process for
treating the advertised conditions, we concluded that the claims had
not been proven and were therefore misleading. The ad must not appear again in its
current form. We told Withinspiration to ensure they held
substantiation before making similar efficacy claims for the lightning
process. The ad breached CAP Code clauses 3.1 (Substantiation), and
50.1 (Health and beauty products and
therapies).”
The full ASA Adjudication on Withinspiration:
http://www.asa.org.uk/Complaints-and-ASAaction/
Adjudications/2010/6/Withinspiration/TF_ADJ_48612.aspx”
(end quote)
4. NRES’ reaction to news of the ASA ruling
“NRES would wish to apologise to Mr Parker for any embarrassment or difficulties which may have been caused by this incorrect information.”
If Phil Parker has been caused, “embarrassment or difficulties” by this error, which is simply a matter of the Ethics Committee mistaking that it was Phil Parker himself, rather than the other LP trainer involved with the SMILE study, surely that highlights the ethical problems associated with this study.
Moreover, the false claims made on Withinspiration were no different from those that have been made by Parker himself.
5. The effect of misleading information on the Withinspiration website upon SMILE study participants
Alastair Gibson did not change his Withinspiration website in response to the ASA ruling in June, which applied only to a sponsored advertisement, as the ASA’s remit does not cover website content itself, though I believe that it will do from 1st March.
While the offending false claims and misleading information presenting The Phil Parker Lightning Process as a cure for ME, CFS and Fibromyalgia were still on his website, he included the link to the information about the SMILE study. It is therefore very likely that the children already recruited for SMILE will have been exposed to the false claims and misleading information that littered the Withinspiration website at that time. This alone renders results from this study false from the outset as promises of therapeutic value WERE undeniably made about the product to be trialled.
For the avoidance of doubt, I have carefully dated notes of the content of the Withinspiration website as it was at that time, with the misleading claims clearly visible. These can be sent to you upon request.
6. Recent changes to the Withinspiration website and the effect of the introduction of ‘PER’ on the SMILE study
I notice that Gibson has completely changed his Withinspiration website since the complaints about SMILE made in October were forwarded to him. He has removed most of the blatantly offensive material and false claims that were brought to the attention of the NRES originally.
However, he has replaced all that with something new called Physical Emergency Response (PER) which seems to have been made up to give some sort of medical or scientific credence to the Lightning Process. It seems to be an embellishment of the previous false claim that the underlying cause of ME/CFS is the adrenaline loop.
Given that Mr. Parker has so vehemently denied any link with, or responsibility for, Withinspiration, can you confirm whether he agrees with the current content of Alastair Gibson’s Withinspiration website? If so, can Phil Parker and Alastair Gibson substantiate their claims about PER on the basis of scientific evidence?
If not, should ethics approval be granted for a pilot study of a training programme that is based on a scientifically unproven hypothesis, given that the programme is known to be potentially harmful for children with organic neuro-immune disease, and given that these risks were not disclosed to the children, or their parents, already recruited for the study?
7. Current misleading claims made for the Lightning Process by Alastair Gibson that the NRES ought to be aware of and questioning
Currently, on his website, Gibson states the following:
“How to make this change to your physiology permanent by practising the steps so that they become automatic, leading to health and well being.”
a) The Lightning Process cannot change our physiology – if it can, then this claim should be substantiated by measuring any such changes scientifically. No such scientific measurements have been carried out on subjects of the LP and biomedical assessments are not included in the outcome measures for this study.
Here are a few more examples that show that their approach hasn’t changed, just the website content.
“you will understand how the cycle of ill-health becomes self-perpetuating but most importantly, on day 1 you will discover how to break this cycle and start reducing your symptoms.”
b) This still suggests their true approach, which is that the children are keeping themselves ill by unhelpful thoughts or feelings about illness, and can recover by thinking themselves out of it.
“100% * of people who have completed our training would recommend others attend the Lightning Process with Alastair Gibson. (with asterisk to, “As from 1st Dec 2010 all attendees have agreed this.”
c) How can he predict this percentage will remain at 100%, or will the figure be updated regularly, and what date was that statement added to the website?
“How to make this change to your physiology permanent by practicing the steps so that they become automatic, leading to health and well being.”
d) Claims of changes to physiology by LP cannot be substantiated. These changes would have to be scientifically measured.
From his blog (there’s a link to this from his website). “As you will have read, it is possible to positively change from Chronic Fatigue Syndrome, I know because I have.”
e) You cannot “change” from CFS – this is nonsense. You can arguably recover or else go into remission.
Also from the blog. “I’ve taken time out from detailing my recent journey with the Lightning Process, just to keep you a bit more up to date with what’s happening lately, and to inspire you, so that you can dream of what it will be like for you, when you have done the Lightning Process Training and recovered from your symptoms.”
f) This promises a cure.
I expect that if you alert Alastair Gibson to these further examples, he may well simply remove or change them as he did before. This will not be because his ideas, approach or training programme has changed, but merely to increase the acceptability of his sales literature to the Ethics Service. It seems obvious to many that these people are charlatans and that this is a money-making scam.
The aim of the study is to assess the, “feasibility and acceptability”of comparing the Lightning Process with specialist medical care for ME/CFS. I and the patients, relatives and carers who co-signed our previous letter to you, hope that the NRES can see from both the weight of correspondence received, and the valid and truthful points that have been made, that this study itself is neither feasible nor acceptable from the outset and nor is it ethical.
Please will you put a stop to this study before yet more tax-payers’ money is wasted on it by taking up the valuable time of the NRES and any other publicly-funded organisations involved in dealing with these widespread concerns , but more importantly, before even one child with Myalgic Encephalomyelitis is caused irrevocable psychological and/or physical harm. Finally, a question from the parents of a child with ME, “Is anyone going to apologise to the children they could do serious harm to?”
Your sincerely,
JB
8th February 2011
Pingback: My Homepage