COMMENTS ON THE MINUTES OF SW2 REC REVIEW

COMMENTS ON THE MINUTES OF SW2 REC

7. Mr Parker has used the study to increase sales

No evidence has been provided that Mr Parker has specifically used this study to increase sales. [snip] The protocol and application clearly state that practitioners had been informed that they must make NO therapeutic claims on the basis of this study.

*On May 14th 2010, Phil Parker’s website – lightningprocess.com; carried this advertisement: “Breaking News. NHS and LP research collaboration. A new pilot study involving the LP and the NHS has been awarded £164,000 for research into the treatment of CFS/ME in children and adolescents.” (Link 1)

Phil Parker’s website currently states: (Links 2, 3)

“Phil Parker, designer of the Lightning Process said: “We are thrilled to have the opportunity to collaborate on this exciting and groundbreaking research with Dr Crawley and her team. It is vitally important that all interventions that could assist children with CFS/ME to return to school and improve their health are explored. We hope that this study is successful and leads to further research collaborations between the Lightning Process and specialist teams like Esther’s.”

On March 29th, 2010, (Link 4) and September 1st, 2010, (Link 5) the following statement was documented on Mr Alastair Gibson’s website:

“Breaking News – NHS and Lightning Process research collaboration.

“A new pilot study involving the Lightning Process and the NHS has been awarded £164,000 for research into the treatment of CFS/ME in children and adolescents. Alastair Gibson is one of the two practitioners working with the NHS and the young people in this exciting research study. Find out more.”

Mr Gibson also makes these unproven therapeutic claims: “If you are currently suffering from ME / CFS Chronic Fatigue Syndrome, and you are ready to make a big difference in your life, and take the step to recovery, then the Phil Parker Lightning Process ™ is here for you. The Lightning Process ™ is a training programme to enable you to take control of your life, it will give you the skills that you need to live a normal, healthy and positive life”, and under; “Lightning Process Courses for Children and Young People”; “Alastair Gibson has a proven track record of working with Children and Young People, [snip] (How do I know it works? Well, I suffered from ME for over 7 years and in only three days I got my life back!)” (Link 6)

As these are business websites promoting and selling LP, these announcements appear intended to exploit the NHS research in order to lend credence to their therapeutic claims for LP. This exploits not only the NHS but also the child participants and their guardians.

8. The complainants claim it is not appropriate to research children before work has been conducted in an adult population that can give consent

It was felt that respondents had selectively quoted from guidance about the acceptability to undertake research on children. The Committee accepted the researcher’s view that CFS/ME is different in children and adults and therefore results from research on adults cannot be extrapolated to children.

*“The complainants claim it is not appropriate to research children before work has been conducted in an adult population that can give consent”. This is not a ‘claim’ made by the ‘complainants’. This is a requirement embodied in Guidelines for Ethical Research by the MRC, GMC and others.

Dr Crawley’s ‘view’ is insufficient grounds to disregard Ethical Guidelines established for the protection of child participants.

Child participants and their guardians are entitled to their human rights and the protection of the law. The guidelines are unequivocal – adult research should precede child research whenever possible. Dr Crawley’s ‘view’ that adult and child CFS/ME are different is unsubstantiated and self-serving. It is not for ‘complainants’ to prove that adult and child ME are the same, it is for Dr Crawley to prove that they are not. If there were any substantial evidence to support Dr Crawley’s ‘view’, then neither the REC nor Dr Crawley would have had to rely on a ‘view’.

9. Risk

The Committee noted that the intervention was in addition to standard care. The ME association survey data seemed to suggest it is as effective, ineffective or harmful as many other current treatments. Evidence of the risk provided to NRES was anecdotal and of low evidential value, reinforcing the need for such a trial as this one. The Committee felt that there may be a slight risk of a child being worse after therapy (but equally a chance of improvement) and considered that they could withdraw at any time from the study if they wanted to. Supervision of the process was in place

* The ME Association survey data shows that 35% had no change with LP, 21% were made worse including 13% made ‘much worse’.

The minutes observe rather glibly that, “they could withdraw at any time from the study if they wanted to.” This observation demonstrates a disturbing lack of knowledge about CFS which indicates that the risks associated with the SMILE research have not been evaluated.

Simply withdrawing from either mental or physical activity does not protect people with CFS from suffering injury; and that injury can be severe and long lasting. This is due to the ‘hallmark symptom’ of CFS – Post-exertional Malaise. The Chief Medical Officer’s Working Group Report on CFS/ME (CMO 2002) states:

“Perhaps the prime indicator of the condition is the way in which symptoms behave after activity is increased beyond what the patient can tolerate. Such activity, whether physical or mental, has a characteristically delayed impact, which may be felt later the same day, the next day, or even later. This is followed by a recovery period, which again may last for days or even weeks. In some instances, the patient can sustain a level of activity for some time, but a cumulative impact is seen, with a setback after several weeks or more. The amount of activity that provokes increased symptoms is related to the severity of the disorder, and in some individuals is very modest. Delayed fatigue, postexertional malaise, or increase in other symptoms after activity can be helpful to make a diagnosis. However, the consequent variability in functional disability can make adaptation to the illness very difficult for the patient, and can be confusing to those around the patient or who assess them.”

The CMO report confirms that even minor exertion can lead to exacerbation of CFS symptoms, yet this may not be felt until later or much later making it difficult for the patient or ‘those around the patient’ to know when they need to stop an activity. The National Institute for Clinical Excellence (NICE 2007) Guidelines for CFS/ME requires the presence of Post-exertional malaise for a diagnosis of CFS/ME; “1.2.1.2 Healthcare professionals should consider the possibility of CFS/ME if a person has:- fatigue with all of the following features:- …characterised by post-exertional malaise and/or fatigue (typically delayed, for example by at least 24 hours, with slow recovery over several days)”

Assessment of the risks that accompany activity in people with CFS is not possible without understanding it’s ‘hallmark symptom’. If these factors specified in the CMO Report and NICE Guidelines have not been given due consideration then the risks of participation in the SMILE research have not been assessed.

Denham and Nelson (2002) explain why ‘Self Determination’ – the basis of Informed Consent, is not an applicable concept in child research because; “the purpose of parental permission is not self-determination but protection.”

Denham and Nelson conclude: “The burden of parental permission is to protect a child from assuming unreasonable and unjustified risks given his or her immaturity. The burden of independent committee review is to be sure those research risks occur within the limits established by the special protections for research involving children.” [emphasis added]

Therefore the fact that participants can withdraw from the research at any time does not provide any safeguard against injury to participants. This is especially so in view of the hopes and motivation that can be expected from participants, and the way that LP encourages trainees to ignore their symptoms and engage in normal activities. There is no data or criteria to discern which participants might benefit and which might be harmed by the LP; such as might be ethically derived from research involving consenting adults with the power of Self-Determination.

14. A lack of generalisability

The Committee considered that the researchers accepted that they would not be able to generalise from this to children who had severe ME that kept them at home. It would still provide data on other children with this condition.

*What criteria have the researchers and the Committee used to differentiate participants from those excluded from participation – other than whether they can leave home or not? If the research results are to be generalisable based on whether a ‘child with ME can leave their home’ or not, the results will be useless to patients and professionals because this measure has no scientific or medical meaning.

What steps have Dr Crawley’s team taken to prevent housebound children and their parents from attempting to participate. Some might undertake a desperate and possibly dangerous effort to participate; particularly those vulnerable families that could never afford around £700 to purchase the LP. Or is one to assume that any child that can be dragged, carried or wheeled to the venue is eligible for participation?

Q1: Is there anything you would like to say regarding your study?

Dr Crawley said that this research had the full support of children and families, indeed the impetus for starting it came from children and families and had the support of AYME. They started recruiting in September and this is well up to schedule. Dr Crawley said that it was a feasibility study and the Committee were content with this.

*Where did this “impetus for starting” come from; were the Committee even curious about this? If it did not originate from the SMILE research, then it is likely that it originated from either support group newsletters or lightning process advertising and the hard-sell typical of LP websites. In the prior case it is likely that those that are interested then investigated the latter. These generally follow a tried and tested formula for flogging unproven alternative remedies:

1. tell potential customers about their condition so that the seller appears knowledgeable

2. provide a plausible-sounding theory of how the remedy works

3. support the theory with scientific-sounding information

4. provide testimonials from delighted customers – raise hopes and play on potential customer’s vulnerability and desperation for help.

This format can be seen on the webpage of many alternative remedy seller on the internet.

The first contact with a potential research participant is considered to be the start of the Informed Consent process; therefore all information is required to meet the ethical standards of research. Coercion is prohibited. In the case of those providing the “impetus for starting”, if said impetus originated from exposure to LP websites then their Informed Consent is invalid because they are clearly coerced and have been subjected to claims and information that does not meet the requirements of ethical research conduct. All the information on the websites they have seen is positive and many of the claims unproven. No researcher is permitted to expose potential participants to such unbalanced and coercive information. For potential participants that have seen LP websites and/or been influenced by newsletter articles about ‘recovery’, their raised hopes must be redressed – not exploited.

Q5: The practitioner of the lightning therapy has no other allied professional qualifications. The Committee suggested that it might be beneficial to the research if the practitioner had external qualifications other than in Lightning therapy and was covered by a code of conduct?

Dr Crawley replied there is a geographical limitation to who can be chosen and that she has worked before with the Bath practitioner who is good. In addition, the children will remain under her care. Prof Gunnell pointed out that children will continue to be under the specialist service in both arms. As the Chief Investigator for the study Dr Crawley accepted responsibility for the activities of the research team and pointed out that in this feasibility study, all Lightning intervention sessions will be recorded and some observed.

*Are you sure that Dr Crawley can adopt legal responsibility for NHS research? I would have thought it was for Dr Crawley’s employers to choose whether or not they accept responsibility for unqualified people treating children that are NHS patients. Kindly confirm that the REC lawyer has checked this and/or that the NHS have consented to accept this responsibility.

REFERENCES

CMO. 2002. Report of the Chief Medical Officer’s, CFS/ME Working Group. [Online]. Available at: http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4064945.pdf. Accessed March 2, 2011.

Denham E, Nelson R. 2002. Self-determination is not an appropriate model for understanding parental permission and child assent. Anesth Analg 2002;94:1049

NICE. 2007. National Institute of Clinical Excellence. CFS/ME Full Guideline. [Online]. Available at: http://www.nice.org.uk/nicemedia/live/11824/36191/36191.pdf. Accessed March 14, 2011.

LINKS (All accessed March 25th 2010)

1.http://replay.waybackmachine.org/20100514074048/http://lightningprocess.com

2.http://philparker.org/data/uploads/FINAL%20NHS%20CFS_ME_funding.pdf

3.http://www.philparker.org/data/uploads/Press%20pack%20for%20journalists.pdf

4.http://www.theoneclickgroup.co.uk/news.phpstart=3680&end=3700&view=yes&id=4954#newspost

5.http://meagenda.wordpress.com/2010/09/01/landmark-agreement-extends-asas-digital-remit-lightning-process-pilot-study-in-children/

6.http://replay.waybackmachine.org/20090228161254/http://www.withinspiration.co.uk/lightning_process_courses_children_young_people.php

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