Request for internal review: FOI responses Lightning Process pilot using ME and CFS children

Request to Director of Legal Services for internal review: FOI responses on Bath/Bristol Lightning Process pilot using ME and CFS children

Shortlink: http://wp.me/p5foE-2Yy

For background to this issue see ME agenda 5 July report:

Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)

 

This formal request for an internal review of the Freedom of Information responses to my request for information was submitted on 22 July. The complaint has been referred to the University of Bristol’s Director of Legal Services who will respond within 20 working days (by 19th August 2010).

The University has confirmed that the research study, for which funding was secured last November, is still going through the ethics approval procedure.  The study is due to start in September.

 

To: Director of Legal Services, Secretary’s Office, University of Bristol, Senate House, Tyndall Avenue, Bristol BS8 1TH Email: freedom-information@bristol.ac.uk

Re: Request for a review of responses to my request for information under the Freedom of Information Act

Request for information submitted on: 16 May 2010
Fulfilled: 17 June 2010

University of Bristol’s Response of 17 June 2010 in PDF attachment in response to:

Royal National Hospital for Rheumatic Diseases NHS Foundation Trust/University of Bristol:

Pilot project to investigate how to recruit to a randomised controlled trial looking at the Phil Parker Lightning Process and specialist medical care in CFS/ME in children. Project to incorporate study on health economic cost of CFS/ME in children.

22 July 2010

Dear Sir or Madam,

I write to request a review of the decision to withhold almost entirely the information and documents requested on 16 May 2010, under Clause 22(1)(a) and on the stated grounds:

“This information is intended for future publication when the study protocol and other related documents are published online. It is therefore exempt from disclosure under section 22(1)(a) of the Freedom of Information Act.”

“The study is currently going through the ethics approval procedure and this information is expected to be published around August / September 2010. We cannot see that there is any public interest in disclosing this information before that time.”

My complaint is based upon, but not restricted to the following areas of concern:

1] The “Lightning Process” is controversial, unregulated and untrialled. It is said by its creator to be developed from Neuro-linguistic Programming (NLP) and Life Coaching. It is marketed by the Phil Parker organisation not as a therapy or a treatment but as a “training program” delivered by “instructors” or “practitioners” or “coaches”.

Instructors are trained and licensed by the Phil Parker organisation and are not accountable to any regulatory professional body. If individuals have complaints about a practitioner or about the Lightning Process, itself, which cannot be resolved directly with the practitioner or through the Phil Parker complaints procedure, the client’s only recourse is Trading Standards.

To date, no rigorous RCTs into the application of the Lightning Process have been undertaken in adults with CFS and ME.

It is a matter of public interest that an NHS paediatric CFS unit should be planning to undertake a study in relation to the Lightning Process involving children as young as eight when no rigorous controlled trials have first been undertaken using an adult patient cohort into the safety, acceptability, long and short-term effects of the application of a previously untrialled research area.

No rationale has been provided by the research team for piloting first with children and there is very little information currently available about the study design, methods, objectives, recruitment process etc. for public scrutiny.

 

2] Children are considered a vulnerable research group. The Medical Research Council (MRC) and other institutions, for example, the Royal College of Paediatric Child Health (RCPCH), publish specific ethical guidelines for research using children.

All extracts from document MRC Ethics Guide: MRC Medical Research Involving Children (Nov 2004, revised Aug 2007)

http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430

“(1.3) Research should only include children where the relevant knowledge cannot be obtained by research in adults.”

“(4.1) Does the research need to be carried out with children? Research involving children should only be carried out if it cannot feasibly be carried out on adults.”

“(4.3.2) Have previous laboratory studies, animal research, studies with adults, or other data provided a sufficient basis for proceeding with research involving children?”

“(4.3.2) Is inclusion of children necessary to answer the scientific question posed by the research?”

Since no RCTs have been carried out in adults, there is no reliable data on the safety of the application of the Lightning Process in patients with CFS and ME.

There are concerns that with no access to robust data, the research team and the Research Ethics Committee(s) considering the application will have no basis on which to assess the safety, acceptability, short and long-term effects of the Lightning Process and are not in a position to determine that overall the likely benefits of the research outweigh any risks to child participants and that undergoing the training program would not be detrimental to a child’s current health status and psychological well-being, as a patient diagnosed with CFS or ME.

Furthermore, parents, and children considered competent to give consent, are not in a position to give informed consent because there is no data from adult RCTs.

It is a matter of public interest that the RNHRD NHS FT/University of Bristol research team should be seeking ethics research committee approval for a study using children where this is incongruent with the Medical Research Council (MRC) guidelines for research using children.

 

3] On 16 June, the Advertising Standards Authority (ASA) published an adjudication against a Bournemouth company following its upholding of a complaint about a Lightning Process advertisement. The ASA recorded their concerns that “the company 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 company was advised to ensure “they held substantiation before making similar efficacy claims for the lightning process”.

The Advertising Standards Authority’s remit does not extend to website content but there is considerable concern that there are websites for practitioners offering the Lightning Process to adults and children where claims are being made, for example, in this case, that clients have “recovered from, or experienced significant improvement” from diseases and conditions which, in addition to ME and Chronic Fatigue Syndrome, are claimed to include “…urinary infections, coeliac disease, crohns disease, blood pressure, cardiac arrhythmia, type 2 diabetes, hyper/hypo thyroidism, autistic spectrum disorder, dyspraxia, ADHD, lymes disease, glandular fever, epstein barr virus, multiple sclerosis, cerebral palsy, parkinsonian tremor and motor neurone disease.”

The practitioner associated with the company to whom this ASA ruling was handed down had already identified himself, in March, on the company website, as being one of two Lightning Process practitioners working with the RNHRD NHS FT/University of Bristol research team and the young people, in relation to this Bath/Bristol pilot study.

It is a matter of public interest that the research team has sought to obtain the advice, guidance and involvement of a practitioner who has been subject to an Advertising Standards Authority ruling in relation to claims being made about the efficacy of the Lightning Process for CFS and ME.

It has recently been brought to my attention that therapists at an NHS Bristol CFS service are recommending that CFS and ME patients purchase Lightning Process sessions. If adult NHS patients in the Bristol area are already being recommended outwith the NHS to the Lightning Process – which is costly, unregulated and untrialled, there is public interest in the rationale behind trialling first in children, rather than adults.

No rationale has been provided by the research team for piloting first with children.

 

4] The Lightning Process is marketed by the Phil Parker organisation within a culture of lack of transparency around the process, itself, and what is required of the “trainees” who sign up for the three days of sessions, during the sessions, themselves, and once the sessions have been completed.

First hand accounts of former “trainees” report that the “process” is based on “affirmations” which invalidate the patient’s experience of illness and symptoms; that they are indoctrinated into the belief that they are “doing” illness, rather than suffering from illness, with the implication that they can “stop doing” the illness if they want to; that before undertaking the sessions they are expected to sign up to an agreement which forms part of the application process that they are “ready” to undertake and to benefit from the “process” and that also they hold certain beliefs.

It is also reported that “trainees” who have not benefited at the end of the “process” and who are not willing to declare that their illness is now resolved or substantially improved, are offered the rationale that either they were not “ready” to have signed up for the program; or that they did not properly understand what was being expected of them during the sessions and “homework” tasks; or that they had not carried out the instructions properly or that they had not worked hard enough at putting the “process” into practice.

So the burden of “failure” is placed on the patient and not on the ability of the process, itself, to “cure”, “resolve” or “substantially improve” whatever medical condition, psychological condition or “life-style issue” the “process” has been purchased for.

There are considerable concerns that children and young people are not sufficiently mature to understand what they are being signed up to by parents signing application forms on behalf of under 18s, when applying for Lightning Process sessions.

A significant number of first hand personal accounts in the public domain by patients with CFS and ME have reported negative experiences of undergoing the Lightning Process and the way in which it was delivered. Data from two large UK patient surveys carried out by the registered charities, Action for M.E./Association of Young People with ME (joint survey published 2008) and the ME Association (published May 2010), show similar levels of worsening of symptoms in CFS and ME patients following the three day “training program”, or of no improvement, at all [1].

With regard to the illnesses CFS and ME, there is public concern for the potential dangers of instructing a child or young person to ignore and override sensations of illness and “post exertional malaise”.

With no robust data from the application of Lightning Process in adults, there are concerns that the research team and Research Ethics Committee(s) considering the application are not in a position to determine that overall the likely benefits of the research outweigh any risks to child participants and that undergoing the training program would not be detrimental to a child’s current health status and psychological well-being, as a patient diagnosed with CFS or ME.

It is feasible to carry out research into the application of the Lightning Process using adults with CFS and ME but the research team has provided no rationale for seeking ethics approval to undertake research using a vulnerable patient group first.

 

5] The process through which research ethics committees review applications for ethics approval appears not to be open to public scrutiny or accountability.

There is public concern that the ethics committee(s) may not be adequately informed around:

a) The nature of Lightning Process techniques and the methods by which it is delivered;

b) the potential for adverse outcomes in patients with CFS and ME, and additionally, in the case of children, the potential for children to feel pressured to get well and to make too early a return to school in order to conform to the beliefs of Lightning Process practitioners, with a potential for subsequent loss to the family of the provision of care packages, benefits and education via LEA home tuition service.

There is significant concern amongst the public and patient organisations that the application of the “process” may be physiologically and psychologically damaging to the child and may impact negatively on the family dynamics if a child were unable to complete the program and withdrew early from the study, or if the child failed to gain benefit from the program, or experienced exacerbation of symptoms during or following the program, or were to experience significant set-back or relapse or if an apparent improvement or resolution of symptoms and disability proved to be short-lived.

Dr Crawley’s clinic sees children and young people with a wide range of fatigue – from fatigue relating to other conditions, for example, following head injury, to chronic fatigue, Chronic Fatigue Syndrome and severe ME, where children may be bedbound and in some cases require tube feeding.

Because information is being withheld, it has not been possible to establish which research criteria are to be used. There are concerns that if improvement were shown in those only mildly affected with fatigue and other symptoms that the process might be applied inappropriately to children with moderate to severe CFS and ME, in the future.

Other than the press release issued by RNHRD NHS FT/University of Bristol on 2 March, there is no information publicly available about the study design, methods, objectives, recruitment process, research criteria, risk management and safeguarding of children recruited to this pilot.

Important questions relating to the safeguarding of children and young people remain unaddressed, for example:

b) During the recruitment process, what information will be given to children and their parents/guardians about the Lightning Process and what is going be required of the children throughout the study, in order that children considered competent to give consent, or to assent with their parents/guardians’ consent, and their parents/guardians, are fully informed of likely benefits and any potential risks?

[…]

f) By what means will it be determined that undergoing the training program would not be detrimental to a child’s current health status, as a patient diagnosed with CFS or ME?

What safeguards will be put in place to avoid the potential for exacerbation of existing symptoms or the development of new symptoms whilst undertaking the sessions, in-between sessions and in the weeks and months following completion of the program?

What support will be given to children and their families if a child were to experience exacerbation of existing symptoms or develop new symptoms as a result of participating in the program or as a result of practicing the instructions in-between sessions or in the weeks and months following completion of the program?

[…]

What safeguards will be put in place in order to protect the child’s psychological well-being?

It is considered a matter of public interest that more information about the research team’s intentions is released at this stage.

 

6] The response to my request for certain documents to be provided under FOIA has been:

“This information is intended for future publication when the study protocol and other related documents are published online. It is therefore exempt from disclosure under section 22(1)(a) of the Freedom of Information Act.”

I question whether copies of specific documents requested, for example,

“copies of applications for research ethics approval for the study, including any accompanying documentation that forms part of the application for example, questionnaires, interview protocol”

“Funding application documents”

will be included when “the study protocol and other related documents are published online”. My experience of published study protocols is that copies of documents such as those requested are not, as a rule, published within, or annexed to a study protocol document.

I therefore query whether copies of the specific documents I have requested would in actuality be made publicly available at some unspecified point in the future, when the protocol is published.

I request that the decision to withhold virtually all information requested under Clause 22(1)(a) is reviewed.

Sincerely,

etc.

Full address supplied

[1] Patient Survey 2008, Action for M.E. and AYME:
http://www.afme.org.uk/res/img/resources/Survey%20Summary%20Report%202008.pdf  

Patient Survey May 2010, ME Association:
http://www.meassociation.org.uk/images/stories/2010_survey_report_lo-res.pdf

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