Our Reply to Ethics Service re: NRES Apology to Phil Parker – 8th February 2011

Letter 8th February 2011 – 

To Joan Kirkbride, Head of Operations, England, NRES

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?”

8th February 2011

(End)

The above was in reply to this letter from the National Research Ethics Service of 4th February 2011 – https://frownatsmile.wordpress.com/2011/02/04/apology-by-ethics-service-to-phil-parker-for-error-in-minutes-4th-feb-2011/

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