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HomeME Association
Second DSM-5 public comment period closes 15 June: Final Call for Action
June 4, 2011 June 10, 2012 meagenda 25% ME Group, AfME, Action for M.E., AYME, CFS Research, CFSAC, DSM revision process, DSM-5, DSM-V, Dx Revision Watch, ICD-11, Invest in ME, ME Association, MUS
Second DSM-5 public comment period closes 15 June: Final Call for Action by UK patient orgs
Shortlink: http://wp.me/p5foE-3iT
This communication has been sent to the following organizations:
Action for M.E.; The ME Association; AYME; The Young ME Sufferers Trust; The 25% ME Group; RiME; Invest in ME; BRAME; ME Research UK; Mrs Sue Waddle
[Update: On June 1, Action for M.E. published a news item on DSM-5 confirming that it does intend to submit a response.]
Final Call for Action by UK patient organizations
Second DSM-5 public comment period closes 15 June
The above organizations were alerted to this second public review period on 5 May, the day after revised criteria were posted on the American Psychiatric Association's DSM-5 Development website.
To date, not one patient organization in the UK has confirmed to me that they intend to submit feedback, this year. Please take some time to review these proposals and prepare a submission or consider submitting a joint response with another UK patient organization.
The American Psychiatric Association (APA) DSM-5 Task Force is again accepting public comment on the latest proposals for the revision of DSM diagnostic criteria for psychiatric disorders.
The deadline for this second stakeholder feedback period is June 15 – less than three weeks away!
Is this a US specific issue?
No. UK and international input is required from patient organizations.
The DSM-5 "Somatic Symptom Disorders" Work Group has responsibility for the revision of the existing DSM-IV "Somatoform Disorders" categories. Two UK Professors of psychological medicine and research, Professor Michael Sharpe and Professor Francis Creed, are members of the Somatic Symptom Disorders Work Group.
The Diagnostic and Statistical Manual of Mental Disorders is the primary diagnostic system in the US for defining mental disorders and is used to varying extent in other countries. The next edition of the manual is scheduled for publication in 2013 and will inform health care providers and policy makers for many years to come. DSM-5 will shape international research, influence literature in the fields of psychiatry and psychosomatics and inform perceptions of patients' medical needs throughout the world.
All UK patient organizations need to submit responses in this second review, even if they submitted last year. The latest key documents that expand on the proposals are attached for ease of reference. (Note: These documents have been revised several times since last year's public review. Yellow highlighting has been applied by the Work Group to indicate edits and revisions between these latest versions and the texts as they had stood, earlier this year.)
What is being proposed?
The DSM-5 "Somatic Symptom Disorders" Work Group is recommending renaming the "Somatoform Disorders" section to "Somatic Symptom Disorders" and combining the existing categories – "Somatoform Disorders", "Psychological Factors Affecting Medical Condition (PFAMC)" and possibly "Factitious Disorders", into one group.
("Somatic" means "bodily" or "of the body".)
The Work Group also proposes combining "Somatization Disorder", "Hypochondriasis", "Undifferentiated Somatoform Disorder" and "Pain Disorder" under a new category entitled "Complex Somatic Symptom Disorder" (CSSD). There is also a "Simple or Abridged Somatic Symptom Disorder" (SSSD) and a proposal to rename "Conversion Disorder" to "Functional Neurological Disorder".
If the various proposals of the Somatic Symptom Disorders Work Group were approved, there are considerable concerns that patients with a diagnosis of CFS, ME or PVFS, or awaiting diagnosis, would be vulnerable to the application of an additional "bolt-on" mental health diagnosis of a Somatic Symptom Disorder like "CSSD", "SSSD" or "PFAMD", or of misdiagnosis with a Somatic Symptom Disorder.
Because the APA and the WHO have a joint commitment to strive for harmonization between category names, glossary descriptions and criteria for DSM-5 and the corresponding categories in Chapter 5 of the forthcoming ICD-11, there could be implications for the revision of the "Somatoform Disorders" section of ICD-10 and therefore implications for UK patients – both adults and children.
Where can I find the full criteria for "CSSD", "PFAMC" and other proposed categories?
Proposed criteria are set out on the DSM-5 Development site here: http://tinyurl.com/Somatic-Symptom-Disorders
The CSSD criteria are here: http://tinyurl.com/DSM-5-CSSD
There are two key PDF documents, "Disorders Descriptions" and "Rationale", which expand on the Work Group's proposals (attached for your convenience)
Disorders Description Key Document One: "Somatic Symptom Disorders"
Rationale Document Key Document Two: "Justification of Criteria — Somatic Symptoms"
Which patient groups might be hurt by these proposals?
The Chronic Fatigue Syndrome Advisory Committee (CFSAC) provides advice and recommendations to the US Secretary of Health and Human Services (HHS). On Day One of the May 10-11 CFSAC meeting, CFSAC Committee discussed the implications of these proposals for CFS, ME and Fibromyalgia patients as part of the agenda item around concerns for the proposed coding of CFS for the forthcoming ICD-10-CM.
If the Work Group's proposals gain DSM Task Force approval, all medical diseases, whether "established general medical conditions or disorders", like diabetes or heart disease, or conditions presenting with "somatic symptoms of unclear etiology" will have the potential for an additional diagnosis of a "somatic symptom disorder" – if the clinician considers that the patient's response to their bodily symptoms and concerns about their health or the perception of their level of disability is "disproportionate", or their coping styles, "maladaptive."
But as discussed by CFSAC Committee members, patients with CFS, ME, Fibromyalgia and IBS (the so-called "Functional somatic syndromes") may be especially vulnerable to the highly subjective criteria and difficult to measure concepts such as "disproportionate distress and disability", "catastrophising", "health-related anxiety" and "[appraising] bodily symptoms as unduly threatening, harmful, or troublesome."
In a 2009 Editorial on the progress of the Work Group, the Work Group Chair wrote that by doing away with the "controversial concept of medically unexplained", their proposed classification might diminish "the dichotomy, inherent in the 'Somatoform' section of DSM-IV, between disorders based on medically unexplained symptoms and patients with organic disease." The conceptual framework the Work Group proposes:
"…will allow a diagnosis of somatic symptom disorder in addition to a general medical condition, whether the latter is a well-recognized organic disease or a functional somatic syndrome such as irritable bowel syndrome or chronic fatigue syndrome."
In its latest proposals, the Work Group writes:
"…Having somatic symptoms of unclear etiology is not in itself sufficient to make this diagnosis. Some patients, for instance with irritable bowel syndrome or fibromyalgia would not necessarily qualify for a somatic symptom disorder diagnosis. Conversely, having somatic symptoms of an established disorder (e.g. diabetes) does not exclude these diagnoses if the criteria are otherwise met."
"…The symptoms may or may not be associated with a known medical condition. Symptoms may be specific (such as localized pain) or relatively non-specific (e.g. fatigue). The symptoms sometimes represent normal bodily sensations (e.g., orthostatic dizziness), or discomfort that does not generally signify serious disease…"
"…Patients with this diagnosis tend to have very high levels of health-related anxiety. They appraise their bodily symptoms as unduly threatening, harmful, or troublesome and often fear the worst about their health. Even when there is evidence to the contrary, they still fear the medical seriousness of their symptoms. Health concerns may assume a central role in the individual's life, becoming a feature of his/her identity and dominating interpersonal relationships."
These proposals could result in misdiagnosis of a mental health disorder or the misapplication of an additional diagnosis of a mental health disorder in patients with CFS and ME. There may be considerable implications for these highly subjective criteria for the diagnoses assigned to patients, the provision of social care, the payment of employment, medical and disability insurance, the types of treatment and testing insurers and health care providers are prepared to fund, and the length of time for which insurers are prepared to pay out.
Dual-diagnosis of a "general medical condition" or a so-called "functional somatic syndrome" plus a "bolt-on" diagnosis of a "Somatic symptom disorder" may bring thousands more patients, potentially, under a mental health banner where they may be subject to inappropriate treatments, psychiatric services, antidepressants and behavioural therapies such as CBT, for the "modification of dysfunctional and maladaptive beliefs about symptoms and disease, and behavioral techniques to alter illness and sick role behaviors and promote more effective coping [with their somatic symptoms]."
Who should submit comment on these proposals?
All stakeholders are permitted to submit comment and the views of patients, carers, families and advocates are important.
But evidence-based submissions from the perspective of informed medical professionals – clinicians, psychiatrists, researchers, allied health professionals, lawyers and other professional end users are likely to have more influence. Patient organizations also need to submit comment.
Where can I read last year's submissions?
Copies of international patient organization submissions for the first DSM-5 public and stakeholder review are collated on this page of my site, together with selected patient and advocate submissions:
DSM-5 Submissions to the 2010 review: http://wp.me/PKrrB-AQ
How to comment:
Register to submit feedback via the DSM-5 Development website: http://tinyurl.com/Somatic-Symptom-Disorders
This is the last alert I shall be sending out. I hope all UK patient organisations will take this opportunity to submit their concerns.
Remember, the deadline is June 15.
Letter issued by NRES following scrutiny of complaints in relation to SMILE Lighting Process pilot study
January 6, 2011 January 6, 2011 meagenda AfME, Action for M.E., AYME, CBT/GET, CFS Clinics, CFS Research, Dr Esther Crawley, Lightning Process, SMILE study, ME Association, ME in children, ME Research, The Young ME Sufferers Trust
Letter issued by NRES (6 January 2011) following scrutiny of complaints in relation to SMILE Lighting Process pilot study
Shortlink: http://wp.me/p5foE-3g5
Letter issued 06.01.11 by National Research Ethics Service
Open PDF here: 05.01.11 Letter SMILE
Received 6 January 2011, by email attachment
Mrs Joan Kirkbride
National Research Ethics Service
Darlington PCT
Dr Piper House, King Street, Darlington DL3 6JL
Direct Line – Mobile 07979 806425
Tel: 01325 746167 (Assistant – Janet Kelly)
Email: joan.kirkbride@nres.npsa.nhs.uk
Website: www.nres.npsa.nhs.uk
Dear Ms Chapman
Assessing the feasibility and acceptability of comparing the Lightning Process with specialist medical care for Chronic Fatigue Syndrome (CFS/ME) – pilot Randomised Controlled Trial
This study, exploring how best we might treat children with Myalgic Enchephalitis [sic] or Chronic Fatigue Syndrome under the guidance of Dr Esther Crawley, Senior Lecturer/Consultant, Child and Adolescent Health sponsored by Bristol university and with the active participation of the association of Young People with ME (AYME) was reviewed on 8 July 2010 by the South West Research Ethics Committee (REC) as part of standard research regulation and ultimately received a favourable opinion on 8 September 2010.
Subsequently the National Research Ethics Service (NRES) received a number of emails and letters about this study and, despite being satisfied with the ethical review, felt it fair to give consideration to the issues raised.
It was clear that the application had received a considered and extensive review of the ethical issues of the project prior to the issue of the favourable opinion. This met all required procedures and processes, however, in view of the weight of correspondence received, much of which raised very similar issues, NRES asked the REC to consider the application, taking into account the issues that had been raised in the subsequent correspondence. Dr Hugh Davies, NRES Ethics Advisor provided a summary to the REC on the issues which had been raised and the opportunity was offered to Dr Crawley and the research sponsor to respond to the issues raised.
In December 2010, the South West REC met again to consider the application and associated documentation. Dr Davies and Mrs Kirkbride attended the meeting to provide advice and support to the REC in relation to ethical matters and operational processes. Dr Crawley was also invited to attend the meeting and was accompanied by sponsor representative Professor David Gunnell. The Chief Executive of the Association of Young People with ME (AYME) had been due to attend to offer support but as a result of illness was unable to do so and sent in a letter of support. The REC considered all the information available to it and discussed the application and agreed a number of questions which they then put to Dr Crawley. After this interview and further consideration the REC agreed that they would uphold their initial decision to grant a favourable opinion to the research with one minor change to the patient information documentation and one suggestion for the future should the research progress beyond a feasibility study.
Given the uncertainties of treatment of this condition and the need to resolve these, in line with professional guidance and duties, the REC felt this project would be a valuable start. A copy of the minutes of the meeting are attached and provide full detail of the discussions and agreements reached. I would like to thank you for your time in raising with NRES your concerns about the study. NRES believes that the initial application received a thorough review and an extensive reconsideration of the application at the December meeting and that it has fulfilled all its duties in the ethical review of the application.
JOAN KIRKBRIDE
Head of Operations, England
Encs Minute of the application discussion
National Research Ethics Service, National Patient Safety Agency, 4-8 Maple Street London W1T 5HD
Extract of Minutes from South West 2 REC meeting held on 2 December 2010.
5.1 10/H0206/32
Assessing the feasibility and acceptability of comparing the Lightning Process with specialist medical care for Chronic Fatigue Syndrome or Myalgic Encephalopathy (CFS/ME) – pilot Randomized Controlled Trial.
Chief Investigator: Dr Esther Crawley
Type of review: Other
Sponsor: Royal National Hospital for Rheumatic Diseases NHS Foundation Trust
Joan Kirkbride, NRES Head of Operations advised that the REC had previously given this study a favourable opinion to this study. Following this, NRES had dealt with a number of requests under the Freedom of Information Act from people and organisations who had raised a number of objections about the study. In view of this correspondence NRES asked the REC to debate these representations. Her attendance and that of Dr Hugh Davies, NRES Ethics Advisor at today's meeting was to provide the REC with any guidance they may require in relation to process and ethical considerations.
To facilitate this review, Dr Davies, had put together a paper which included a collection of representations made on this study. The points raised by the representations were distilled into 15 issues that the Committee discussed in turn.
Permission had been sought from people who had sent correspondence to NRES to forward this information to Dr Crawley. Dr Crawley had provided a detailed response, which included letters from Mary-Jane Willows, CEO of Association for Young people with ME (AYME) and Colin Barton, Chairmen [sic] of the Sussex and Kent ME/CFS Society which the REC had available for consideration.
1. The study is misnamed and should be seen as more than a pilot study.
The Committee felt that 96 participants may be quite a lot to recruit for a feasibility study and queried if a 30% drop out rate was expected. In discussion with the researchers the REC were happy with the title of the study
The Committee reviewed what data was available comparing the effectiveness of different treatments. This data seems to indicate that the Lightning Process is as effective/ineffective as many other current treatments and that more research is needed to resolve these uncertainties for the benefit of ME patients.
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
4 Mr Parker is shortly to attend court for making false claims about his product
The Committee noted the correspondence submitted by Dr Crawley from Mr Parker and the refutation of this. The Committee considered this but had no further comments to make on this point
5 Conflict of interest
The REC considered this and felt they were similar to much other research and that they were adequately handled in the application
6. Mr Parker has a history of past failed businesses
The Committee noted the correspondence submitted by Dr Crawley from Mr Parker refuting this. The Committee considered this.
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. It was noted that the adjudication by the Advertising Standards Authority (ASA) had stated that "The ad [16 June 2010 Internet sponsored search] must not appear again in its current form. We [the ASA] told Withinspiration to ensure they held substantiation before making similar efficacy claims for the lightning process" and that all Lightning Practitioners had been advised of this. The protocol and application clearly state that practitioners had been informed that they must make NO therapeutic claims on the basis of this study.
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.
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
10. Service user involvement
The Committee were reassured by the fact that AYME had been consulted during the planning of this study.
11. The role of the External Advisory group
The Committee considered that AYME has been consulted during the planning of this study.
12. The claims that the LP is coercive and bullying
The Committee considered this but were satisfied by the processes and precautions in place in the study..
13. Concern about the "primary endpoint"
The Committee clarified that this is only a feasibility study and that the primary endpoint is to see if it a full study is possible. The Committee also suggested that the secondary endpoint could be altered to assess the return to the education that children were in prior to their treatment rather than attendance at school.
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.
15. Participant Information
The Committee was unsure if the ME groups have enough information in the PIS to join.
The Committee felt that the PIS should include statistics on the risks of getting worse, whether there was no change, or whether the treatment was helpful.
The Committee debated whether, in order to address a possible perceived lack of training of those that might be conducting the Lightning therapy that a practitioner who is subject to a professional code of conduct could be used to deliver the therapy. This was also considered in discussion with the researcher.
The Committee also wanted to know if the research has begun recruitment.
Dr Esther Crawley and Professor Gunnell were invited to join the meeting and were asked by the Vice-Chair to clarify the following issues:
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.
Q2: You stated that the study has started recruiting,
Dr Crawley stated there has been a high recruitment rate so far. Participants have not started receiving treatment yet.
Q3: Please explain your recruitment figures and what dropout rate are you expecting?
Dr Crawley replied that 96 participants may seem high for a feasibility study this number is smaller than that for some other feasibility studies and reflects both the expectation of up to 50% dropout in one of the arms and a moderate treatment effect (participant numbers reflect the need to ensure there is sufficient data to reliably estimate sample size requirements for the full trial) .Therefore they need high numbers to keep the numbers up to judge across the arms and see why people are dropping out.
Q4: Are there differences in the way children and adults are treated?
Dr Crawley replied that the treatment approaches are very different in the two groups. There are lots of points of difference but given the outcome is so different between adults and children, adult services tended to focus on symptom management whilst paediatric services aimed for recovery. In addition, paediatric services involved families and dealt with education not work. She added that children are already receiving this treatment and that we need to evaluate it to see if it works.
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.
The Committee requested that the fact that the practitioner is not clinically qualified be added to the PIS.
The Committee suggested that consideration should be given to using "clinically qualified" Lightning Practitioners should the feasibility study proceed to a full study in the future.
Q6: The risk balance of the study is not included in the PIS.
Dr Crawley and Professor Gunnell replied that they would be happy to add this to the PIS. They added that according to the figures in the Parliamentary Inquiry into NHS Service provision for ME/CFS*, Lightning therapy fares better than the standard NHS therapies of Graded Exercise Therapy (GET) and Cognitive Behavioural Therapy (CBT).
It was noted that this information related to treatment in adults. Data for children was not available. They also added that when patients get better they also don"t tend to take part in surveys.
The Committee asked for these figures to be added to the PIS and to reference them so they are available but to note that they are relative to adults.
Q7: The Committee discussed the secondary endpoint regarding returning to school and suggested that it could be altered to assess the return to the education that they were in prior to their treatment rather than attendance at school.
Dr Crawley replied that recruitment and retention is the primary endpoint of the study as it is a feasibility study. She added that the inventory used to measure school attendance also measures home tuition. Those children that are house bound are excluded from the study as they have to be able to get to the clinic.
Dr Esther Crawley and Professor Gunnell left the meeting.
The committee felt that given current treatment uncertainty research was vital in this area and the proposal is a standard way to assess this. Currently survey data were limited and it was unwise to base health policy on individual case reports. It is vital to see if the lightening process is or is not helpful as children are already receiving this therapy.
The committee voted unanimously to confirm the favourable opinion of the application with the following additional conditions:
1. PIS for Teenagers and PIS for Parents: Please add the fact that the Lightning Practitioner is not clinically (medically) qualified (trained).
2. PIS for Teenagers and PIS for Parents: Please include the following text in the "Are there any disadvantages to taking part" section:
"Teenagers with CFS/ME can get worse with any intervention offered. There is no data in teenagers, see tables 1 and 2 for data in adults."
3. PIS for Teenagers and PIS for Parents: Add the figures for GET, CBT and the LP from the Parliamentary Inquiry into NHS Service provision for ME/CFS include Data taken from Action for ME (AfME) and Association of Young people with ME (AYME) joint report "M.E. 2008: What progress" and reference it.
4. PIS for Teenagers and PIS for Parents: Add the figures for GET, CBT and the LP from the 2008 MEA survey and reference this.
The Committee suggested that for the future Dr Crawley might consider using Lightening [sic] Practitioners who were additionally clinically qualified.
The Committee restated the favourable opinion of the application.
The Committee nominated Tom Lucas to be the point of contact should further clarification be sought from the applicant.
[Ends]
*Ed: Note: The Inquiry into NHS Service provision for ME/CFS was not a "Parliamentary Inquiry". This was an unofficial inquiry instigated and undertaken by the APPG on ME. The interim report published by the APPG on ME, last year, does not have the authority of either House nor any government agency or department.
Update on NRES scrutiny of complaints received in relation to ethics approval of SMILE LP pilot study
January 6, 2011 January 6, 2011 meagenda AfME, Action for M.E., AYME, CBT/GET, CFS Clinics, CFS Research, Dr Esther Crawley, Lightning Process, SMILE study, ME Association, ME in children, ME Research, NHS, The Young ME Sufferers Trust
Update on NRES (National Research Ethics Service) scrutiny of complaints received in response to the granting of ethics approval for the Dr Esther Crawley led Bath/Bristol SMILE Lightning Process pilot study using children and young people with ME and CFS
Shortlink: http://wp.me/p5foE-3fO
Update: Letter issued today by National Research Ethics Service:
Yesterday, I wrote to Joan Kirkbride (Head of Operations, England National Research Ethics Service (NRES), National Patient Safety Agency) to ask whether there is a date by which she anticipates contacting those who have written to her in connection with the SMILE Pilot study with an update on the progress of the scrutiny of complaints and concerns.
Ms Kirkbride has confirmed to me, today, that she plans to issue a letter this week. I will update when this letter has been received.
Because there is no formal procedure through which decisions of Research Ethics Committees can be challenged, this exercise undertaken by the NRES in response to the considerable number of complaints received is not a process open to public scrutiny.
The "standard response" being issued by Ms Kirkbride in October and November in response to the receipt of complaints had been:
"NRES has received the submissions from the ME society [The ME Association] and others concerning the SMILE study, a children's study investigating treatment of ME in this age group.
"Following our Standard Operating Procedures we have collated the information we've received and will work with the REC to consider it.
"Given that this treatment is currently available, ME society [The ME Association] survey data suggests it has a similar profile to other therapies and the split opinions in the ME community (this study has the support of particular ME charities who have also been involved in its planning) we feel that a fair way forward is to seek the responses of the researchers, sponsor and the ME charities involved in the development of the study before asking the REC to review its favourable opinion. We also note that in this project, subjects will not be deprived of what is current care in this clinic. Research participants will receive this intervention in addition to their standard treatment.
"We will also be seeking the views of our National Research Ethics Panel."
Complaints were being passed by Ms Kirkbride to am NRES colleague and to Dr Esther Crawley where permission had been given for communications to be forwarded.
The study, which was granted ethics approval by South West 2 REC in September, last year, was expected to start recruiting last September. According to documents obtained under the FOIA, the study funders, The Linbury Trust and The Ashden Trust, had stipulated that the study must begin by October latest.
A meeting of the SMILE Pilot External Advisory Group, for which the patient organisation AYME has a seat, was held on 2 November. A copy of the Minutes of that meeting is posted on the website of the University of Bristol website, on the dedicated page for the SMILE Pilot study or open a PDF here on ME agenda: Minutes SMILE Pilot External Advisory Group 02.11.10
Under AOB (Any Other Business):
"1. SL asked how the study was going to date. EC replied that recruitment was going well, parents and teenagers appeared to be enthusiastic and there was a higher recruitment rate then envisioned.
"2. EC informed the group that she needed to respond to complaints made to NRES about the study. She suggested that she drafted a response, discussed this with co-applicants and sent the response to the External Advisory Group before submission. This was agreed.*
"[Action] EC to draft response for NRES, show co-applicants and then send to External Advisory Group before submission."
SMILE Protocol Flowchart and Time plan
Source: Protocol document
1] SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME): http://wp.me/p5foE-37x
2] Background to this issue: http://wp.me/p5foE-2Vt
3] All posts on Lightning Process pilot study in children issue:
https://meagenda.wordpress.com/category/lightning-process-smile-study/
4] Minutes, meeting of the SMILE Pilot External Advisory Group: 2 November 2010: http://wp.me/p5foE-3er
BMJ takes two months to publish letter on Lightning Process and SMILE pilot study in children
December 21, 2010 December 22, 2010 meagenda CFS Clinics, CFS in the media, CFS Research, Dr Esther Crawley, Lightning Process, SMILE study, ME Association, ME in children, ME in journals, ME Research, NHS, The Young ME Sufferers Trust
A not very rapid Response: BMJ takes two months to publish letter on Lightning Process and SMILE pilot study in children
Shortlink: http://wp.me/p5foE-3fj
On 14 July, I submitted a Rapid Response to the BMJ in reply to a response published on 8 March by a Dr Munglani, Consultant in Pain Medicine, West Suffolk Hospital. Dr Munglani had recommended the Lightning Process and given a link to the Lightning Process website in the references at the end of his own Rapid Response to an article about pain management, published in the BMJ in January.
BMJ Rapid Responses usually appear within two or three days following submission and when mine failed to appear on the site, I assumed it had been rejected for publication by the Rapid Response Letters Editor.
In fact, my letter was published by the BMJ but not until 14 September. Why this letter had been held back over two months isn't known and an enquiry to the Letters Editor has met with no response.
My Rapid Response can be read here on the BMJ site:
http://www.bmj.com/content/340/bmj.b5683.extract/reply#bmj_el_238859
BMJ Original article:
Views & Reviews: From the Frontline: Bad medicine: pain
Des Spence (Published 6 January 2010)
BMJ 340:doi:10.1136/bmj.b5683:
http://www.bmj.com/content/340/bmj.b5683.extract
Rapid Response Re: Failure to appreciate pain is a symptom not a diagnosis is what leads to bad medicine
Suzy Chapman, BMJ (Published 14 September 2010):
in reply to Rapid Response to article: "From the Frontline: Bad medicine: pain":
Failure to appreciate pain is a symptom not a diagnosis is what leads to bad medicine, Rajesh Munglani, BMJ (Published 8 March 2010):
Between late July and early August, the testimonials by Dr Munglani to which I had referred in my response were taken down from the website of the Rowan Centre. Dr Munglani's testimonials had read:
"I have been very impressed with the results of the LP. I have seen the lives of some of my patients transformed by this self empowering technique. Everyone who has battled with chronic illness and wants to win should have an opportunity to do the Lightning Process. Professor Rajesh Munglani. MB BS DCH DA FRCA FFPMRCA. Consultant in pain medicine. West Suffolk Hospital and Nuffield Health Cambridge Hospital."
Between late July and early August, the Rowan Centre ceased offering the Lightning Process and all references to the Lightning Process and Lightning Process logos have been removed from their webpage. They now offer their own flavour of the "process", known as the "BodyMind Programme".
See their rationale for distancing themselves from the Lightning Process here:
http://www.simpsonandfawdry.com/about-simpson-and-fawdry.htm
Text on the Rowan Centre website was changed from:
"People using the Lightning ProcessTM have recovered from, or experienced significant improvement with the following issues and conditions…"
http://www.simpsonandfawdry.com/lightning-process.html#lp1
"We have helped people with the following illnesses and conditions…"
Text on their "Introduction" page reads:
http://www.simpsonandfawdry.com/lightning-process.html
"There are now NHS and private consultants, GPs and occupational therapists referring their patients to us at the Rowan Centre. Clinicians in the NHS have observed the work we do. To find out more, you can speak to Gael Postle, Occupational Therapist at the James Paget University Hospital pain clinic on 01493 453307 or the O.T.s at the Norfolk and Suffolk ME/CFS service on 01502 527579."
The Rowan Centre also offer their programme for MS patients.
Another Lightning Process site which has changed its text since late July is this one:
http://www.x-eed.com/page/services
which has changed:
"What does it work for?
People using the Lightning Process® have also recovered from, or experienced significant improvement with the following conditions:-
Post Viral Fatigue
Anxiety And Panic Attacks
Parkinsons Tremors
Motor Neurone Disease
Hyper And Hypo Thyroidism
Chronic Aches And Pains
Anger Issues
Noise And Light Sensitivity
Using the Lightning Process® has proven effective for clearing ALL the debilitating physical and mind based symptoms of ME, chronic fatigue syndrome, and post viral syndrome.
Some of the symptoms that people have cleared are listed here…"
[long list of conditions]
to "What do we work with?"
[shorter list of conditions]
Here's a site that hasn't changed its text:
A Manchester and Cumbria practitioner
http://www.helenjames.com/
"The Phil Parker Lightning ProcessTM is a hugely successful training programme which has transformed the lives of thousands of people whose problems had previously seemed impossible to resolve such as Myalgic Encephalomyelitis (ME), Chronic Fatigue Syndrome (CFS), Post-Viral Fatigue Syndrome (PVFS), Fibromyalgia, Multiple Sclerosis (MS), Obsessive Compulsive Disorder (OCD), Anxiety, Depression and many other debilitating issues.
Helen James is a fully qualified Lightning Process Advanced Practitioner, with many years experience in helping people to recover from numerous conditions. For more information about Helen see the About Helen page.
Many people that have already used the Lightning Process to recover from the above conditions had previously tried all sorts of alternative healthcare treatments and complementary therapies, but the only treatment that is consistently helping 1500 suffers a year to recover is the Lightning Process. 85% of people that have the attended a Lightning Process training make a full recovery, and the recovery is permanent.
http://www.helenjames.com/lightningProcess/more
Further applications for the Lightning Process
The Lightning Process can help you to recover from/resolve any of the following…
.Myalgic Encephalomyelitis (ME)
.Chronic Fatigue Syndrome (CFS)
.Post-Viral Fatigue Syndrome (PVFS)
.Fibromyalgia
.Depression
.Obsessive Compulsive Disorder (OCD)
.Overwhelmedness
.Feeling stuck
.Guilt
.Asthma
.Allergies including Hay Fever
.Bipolar Disorder
.Irritable Bowel Syndrome (IBS)
.Food intolerances
.Hyper and Hypo Thyroidism
.Migraines
.Multiple Sclerosis
.Post Traumatic Stress Disorder (PTSD)
.Anger Issues
.Rheumatoid Arthritis
.Anxiety and Panic Attacks
.Perfectionism
.Coeliac Disease
.Dyspraxia
.Focal Dystonia (undesirable muscular contraction or twisting)
.Insomnia
.Low self esteem
.Lyme Disease also known as Borrelia or Borreliosis.
.Noise and Light Sensitivity
.Torticollis
.Chronic Aches and Pains
And it's also effective for enhancing:
.Business success
.Peak Sports Performance
http://www.helenjames.com/lightningProcess/multipleSclerosis
Over the last few years we have started to see number of people getting impressive results when using the Lightning Process with other neurological conditions such as CFS, Parkinsonian type tremors, cerebral palsy and strokes. As a consequence we were asked whether the Lightning Process could be used for improvement and recovery with any other types of neurological illness, particularly Multiple Sclerosis…"
Landmark agreement extends ASA's digital remit
In March 2011, the Advertising Standards Authority (ASA) broadens its remit to include website content:
Landmark agreement extends ASA's digital remit, News release, 1 September 2010
Summary MEA Board of Trustees meeting 15-16 November 2010: Lightning Process
November 30, 2010 meagenda CFS Clinics, CFS Research, Dr Esther Crawley, Freedom of Information, Lightning Process, SMILE study, ME Association, ME in children, ME in Parliament, ME Research, NHS, The Young ME Sufferers Trust
Extract from Summary of the ME Association meeting of the Board of Trustees which was held on 15 and 16 November and at which the issue of the controversial Bath/Bristol Lightning Process pilot study in children was discussed.
Shortlink: http://wp.me/p5foE-3eX
http://www.meassociation.org.uk/?p=3059
Summary of the MEA Board of Trustees meeting, November 2010
by tonybritton on November 20, 2010
This is a summary of key points to emerge from two routine meetings of The ME Association Board of Trustees.
These meetings took place at our Head Office in Buckingham on Monday afternoon, November 15th and on Tuesday morning, November 16th.
Informal discussion on some of the topics also occurred on the Monday morning.
This is a summary of the two Board meetings – not the official minutes.
The order of subjects below is not necessarily in the order that they were discussed.
Where appropriate, there is background information relating to the issue being discussed.
Lightning Process:
Trustees held a further discussion on a controversial new research study that has been announced into the use of the Lightning Process. Costing £164,000, the feasibility study will investigate how children and adolescents could be involved in a randomised controlled trial that will assess the Lightning Process and compare it to specialist medical care. Not surprisingly, a number of concerns and objections have been raised about the possible use of children and adolescents in this type of study and we are discussing these concerns with our colleagues in other ME/CFS charities. As a result of these discussion The MEA and the Young ME Sufferers Trust (Tymes Trust) issued a joint statement of concern: http://www.meassociation.org.uk/?page_id=1341
This statement was sent to the Department of Health with a request that it should be forwarded to the ethics committee that is dealing with the application but the DoH refused to do so. Following a Freedom of Information request we obtained the identify the ethics committee that was dealing with the application and our statement was then forwarded to the Chairman. Unfortunately, due to initial secrecy surrounding the identity of the ethics committee, the information did not reach them till after the application had been approved.
We have also passed our concerns to the National Research Ethics Service, who are considering whether the local ethics committee should review their decision. More information can be found on the MEA website: http://www.meassociation.org.uk/?p=2720
A BBC radio discussion from Thursday 11 November about the Lightning Process – which included contributions from Professor Leslie Findley, Dr Charles Shepherd and Phil Parker and was chaired by Anne Diamond – can be heard on YouTube: http://www.meassociation.org.uk/?p=2921. A transcript is also available on the MEA website.
[Extract ends]
The Bath/Bristol press release announcing the pilot study was published on 2 March 2010.
The ME Association and The Young ME Sufferers Trust did not issue a joint statement and press release condemning the pilot study until five months later, on 4 August.
Under FOI (in a response dated 27 August) I established that the REC responsible for reviewing the application was the South West 2 Research Ethics Committee. This information was provided by Jonathan Cramp, FOI Manager, NHS South West.
This information had been requested by me of the University of Bristol on 15 May but was denied in a response of 17 June.
It was denied a second time following a request for an Internal Review of the University's decision to withhold almost all information that had been requested by me under the FOIA. The Internal Review was handled by Sue Paterson, Director of Legal Services and Deputy Secretary, Office of the University Secretary, from whom a response was received on 17 August.
Within the response of Jonathan Cramp, FOI Manager, NHS South West, was the information that the application for ethics approval had been received on 14 June 2010 and that South West 2 RE committee had met to consider the application on 08 July 2010.
As soon as I had received confirmation of the name of the REC which had (already) reviewed the application, this was passed to the ME Association, who had also been passed all previous communications I had been having with various FOI offices, with various parliamentarians, with the Department of Health and with the South West Regional Manager, National Research Ethics Service.
As recorded in the MEA's meeting summary, above, it was the case that by the time it had been established which RE committee had reviewed the application for ethics approval, the committee had already met six or seven weeks previously (although a favourable opinion was not handed down until mid September since the CI had been asked to revise some content of the patient literature and also address other areas of concern which delayed a decision).
When the MEA and TYMES Trust did issue a statement on 4 August, condemning the pilot and calling for the study to be abandoned, this was widely welcomed, as has been the ME Association's initiative in contacting Trading Standards offices, as is their continued interest in this issue.
It remains unclear, though, and of concern to me, why these two patient groups took five months to issue position statements and a joint press release.
RNHRD NHS FT Bath/University of Bristol Lightning Process pilot study in children 12 to 18 (SMILE study): Minutes of meeting of External Advisory Group held on 02.11.10: http://wp.me/p5foE-3er
Transcript BBC Radio Berkshire Anne Diamond Show, broadcast 11 November 2010: http://wp.me/p5foE-3dG
3] All posts on Lightning Process pilot study in children issue: https://meagenda.wordpress.com/category/lightning-process-smile-study/
Minutes Forward-ME meeting, 26 October 2010: Lightning Process trial involving children
November 30, 2010 meagenda AfME, Action for M.E., AYME, CBT/GET, CFS Clinics, CFS Research, Countess of Mar, Dr Esther Crawley, Lightning Process, SMILE study, ME Association, ME in children, ME in Parliament, ME Research, The Young ME Sufferers Trust
Shortlink: http://wp.me/p5foE-3eO
Forward-ME is a caucus group to the All Party Parliamentary Group on ME (APPG on ME) convened and chaired by the Countess of Mar.
The most recent meeting of the group was held in October in a meeting room within the House of Lords and the issue of the SMILE Lighting Process pilot trial was tabled on the Agenda at Item 6.2. The following is an extract from the Minutes of that meeting:
http://www.forward-me.org.uk/26th%20October%202010.htm
Minutes of the meeting held on
HOUSE OF LORDS.
1. Present:
Jane Colby – TYMES Trust
Christine Harrison – BRAME
Bill and Janice Kent – ReMEmber
Peter Spencer – AfME
Charles Shepherd – MEA
Sue Waddle – MERUK
Margaret Mar – Chairman
Mary-Jane Willows – AYME
2. Apologies:
Tanya Harrison – BRAME
6.2 Lightning Process trial involving children
The Group were informed that MEA and Tymes Trust had provided a joint statement on the SMILE Trial to Richard Ashby, Chair of the South West ethics Committee, saying that they felt the trial was unethical and that the ethics committee had probably not been made aware that the Advertising Standards Agency had ruled against a claim made by a Lightning Process Practitioner and that trading standards departments had been taking action in relation to misleading therapeutic claims. Concerns about the trial were being assessed by the National Research Ethics Service, headed by Joan Kirkbride.
It was said that an increasing number of individuals were contacting ethics bodies to express concerns about the trial.
The Group was told of a commentary in the Church Times by Prof Robin Gill, Chair of the BMA Ethics Committee, in which he criticised the research, and that Prof Gill planned to take this up with the BMA.
The Chairman had tabled a question asking what the Government's opinion is on this matter.
(Hansard text)
Christine Harrison asked whether a complaint had been made to the NSPCC regarding the SMILE Trial. Charles Shepherd replied that it had and the content of this could be viewed on the internet.
A discussion followed. Concern was expressed regarding the fact that the study involves research being conducted on children before it was tested on adults. It was recognised that the MRC guidelines stated circumstances under which it would be acceptable to perform a study on children in the first instance. The feasibility study would need to prove that these conditions were satisfied in order to achieve ethical clearance of the actual trial. The Principal Investigator would also have to prove that a robust risk management strategy had been developed to minimise any harm to participants.
Another concern was that the ethics committee seemed not to have been made aware of the ruling made by the Advertising Standards Agency in relation to claims made by a practitioner of the Lightning Process.
The point was made that 250 children a year undergo this treatment and a paediatrician had been approached and asked whether the treatment was safe. However there was a concern that parents who believed they must try everything that might be of benefit to their child could feel pressurised to try the treatment. Children could be very vulnerable to inappropriate pressure to say they felt better.
The Group was told that Dr Esther Crawley, the lead for the LP research, had received a large volume of malicious correspondence about her proposals. The Group agreed that this was not an appropriate or acceptable manner in which to demonstrate opposition and confirmed that none of them had been involved. It was suggested that it was activities such as this that drove young researchers from the field.
The Group was told that the research ethics papers submitted for the feasibility study were on the Bristol University website. Some of these papers made the case that M.E. in children was a different illness from M.E. in adults. It was drawn to the Group's attention that Dundee University (in a biomedical study co-funded by Tymes Trust and Meruk) had discovered the same abnormalities in the blood of children that they had previously found in adults, so in this respect, ME in children was not a different illness from ME in adults. (See item 11)
The Chairman suggested that it was important to look at the recovery period covered by the study because M.E. was a relapsing condition.
Church Times: Dr Esther Crawley responds to Prof Robin Gill (SMILE Lightning Process pilot study)
November 30, 2010 November 30, 2010 meagenda CBT/GET, CFS Clinics, CFS in the media, CFS Research, Dr Esther Crawley, Lightning Process, SMILE study, ME Association, ME in children, ME in the media, ME Research, MRC, NHS
Dr Esther Crawley responds to Prof Robin Gill's letter of concern (Church Times, 8 October 2010) about the ethics of the Bath/Bristol SMILE Lightning Process pilot study
Shortlink: http://wp.me/p5foE-3eB
On 8 October, Professor Robin Gill had a letter published in the Church Times. A full copy of Prof Gill's concerns about this pilot study can be read in this posting:
Children should not be used as guinea pigs: Prof Robin Gill, Church Times (Lightning Process Pilot study)
Children should not be used as guinea pigs
Church Times, 8 October 2010
BY: ROBIN GILL
Clinical trials of a training programme for ME, MS, and other conditions raise serious ethical questions, argues Robin Gill.
Canon, Prof Robin Gill is a member of the BMA Medical Ethics Committee, has been a member of the Medical Research Council's Stem Cell Steering Committee, is President of the Society for the Study of Christian Ethics and Chairs the British Sociological Association's Study Group of Religion.
In the current issue of Church Times (Page 19, 26 November 2010) the Editor has published this response from Dr Esther Crawley, SMILE pilot study Chief Investigator to Prof Gill's letter:
Professor Gill's article on the SMILE study
From Dr Esther Crawley
Sir, — On 8 October, you published an article about a feasibility randomised controlled trial investigating interventions for CFS/ME in teenagers — the SMILE study. This article appeared two weeks after all study documentation was made publicly available, and we are disappointed that the author, Professor Robin Gill, made no attempt to contact the study team to verify his assertions before publication, particularly given the nature and strength of the assertions made.
We agree with Professor Gill that there is limited evidence on the effectiveness of the Lightning Process in treating CFS/ME. Despite this, approximately 250 children a year pay for and attend Lightning Process interventions. It is precisely for this reason that we listened to children and their families who have asked for improved evidence, and are conducting research that will enable them to make informed decisions about their care.
The SMILE project is not "comparing the effectiveness of the Lightning Process with that of conventional medical care". Participants in this study will receive either specialist medical care or specialist medical care plus the Lightning Process. The purpose of the study is to assess the feasibility of recruitment to a full trial — it is not designed to compare outcomes of care.
In this article, Professor Gill argues that children or non-competent adults should be involved only when competent and consenting adults have been fully tested first or where this is impossible, and he quotes from the guidance issued by the Medical Research Council (MRC) and the General Medical Council (GMC). There are, however, other quotations he could have selected, such as the MRC's lengthy advice about when research into medical care for children is important (pages 7-8) and ethical (page 13), and similar statements from the GMC.
Our protocol makes it clear that CFS/ME in children is not sufficiently close to CFS/ME in adults to mean that research in adults could be extrapolated to children. The Royal College of Paediatrics and Child Health states: "Research involving children is important for the benefit of all children and should be supported, encouraged and conducted in an ethical manner."
Professor Gill ends by stating: "The coercion of children is not an ethically acceptable option." We absolutely agree with this, and deeply resent the implication that our study involves such coercion. This view was encouraged by the cartoon used to illustrate the article, which we find abhorrent and unacceptable.
All the children and families participating in the SMILE study provide fully informed consent/assent by means of a rigorous, recorded procedure that has been reviewed and given a favourable opinion by a research ethics committee. No child is coerced to join the study, and participants can withdraw at any time.
ESTHER CRAWLEY
on behalf of the SMILE Study Group
School of Social and Community Medicine
Cotham Hill
Bristol BS6 6JS
The Editor apologises for any offence caused by the cartoon, and for any misrepresentation of the research it might have suggested.
1] SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME):http://wp.me/p5foE-37x
2] Background to this issue:http://wp.me/p5foE-2Vt
4] Children should not be used as guinea pigs, Church Times, 8 October 2010: http://wp.me/p5foE-3ak
Bath/Bristol Lightning Process pilot study: Minutes of meeting of External Advisory Group 02.11.10
November 24, 2010 meagenda AYME, CFS Clinics, Dr Esther Crawley, Freedom of Information, Lightning Process, SMILE study, ME Association, ME in children, ME Research, NHS
RNHRD NHS FT Bath/University of Bristol Lightning Process pilot study in children 12 to 18 (SMILE study): Minutes of meeting of External Advisory Group held on 02.11.10
Shortlink: http://wp.me/p5foE-3er
On 28 October, I submitted a requested for the following information under the FOI Act, from the University of Bristol:
1] The names of all patient organisations who have been involved in the planning/development of the SMILE pilot study.
2] The SMILE protocol document states on Page 7, under "Study management" that:
The study will be monitored by a Trial Monitoring Group which will meet every 4 to 6 weeks. The trial Monitoring Group will consist of: Dr Esther Crawley (PI), a member of the BRTC as well as applicants on the grant.
An External Advisory Group will also meet: prior to the study starting, by phone conference 6 monthly and at the end of the study. This will be an independent group and will include experts in CFS/ME, including a representative from the Association of Young people with ME (AYME) and the Lightning Process.
Please provide the names of all members of the External Advisory Group and the organisations with which they are associated, where applicable.
Today, I have received the following responses from the University's Information Officer:
That:
Details of collaborators/sponsors are included at sections A63 and A64 of the research ethics application, available online at:
http://www.bris.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/recfrmrfs.pdf
from which I conclude that the only patient organisation involved in the planning/development of the SMILE pilot study has been the Association of Young people with ME (AYME).
There was a meeting of the External Advisory Group on 2nd November, the minutes of which are online at:
http://www.bris.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/smileminutesoctober.pdf
The membership of the group is included in these minutes.
Text of Minutes, appended, or open on ME agenda site here: SMILE Minutes 02.11.10
Agenda External Advisory Group: November 2nd 5pm – 6pm.
Stuart Logan (Chair) (SL), Exeter University
Jane Coad (JC), Coventry University
Jenny Ingram (JI), University of Bristol.
Kamal Patel (KP), Paediatrician, Brighton
Alison Wearden (AW), University of Manchester*
Mary-Jane Willows (MJ W), CEO AYME
Also Present: Esther Crawley (PI) (EC)
(*Ed: Dr Alison Wearden was PI for the FINE Trial. No representative of the Lightning Process appears to have been present.)
Everybody introduced themselves. EC outlined the study.
Review of study documentation
SL invited comments on the study documentation. SL said the aims and objectives were clear and it was good to see documentation on the web. This comment was endorsed by other members of the meeting.
1. There was a general discussion about what would happen if either the Lightning Practitioner or the child/family felt that a LP course was not appropriate after discussion. It was agreed that understanding about drop outs was part of the study.
2. There was a discussion that the PIS wasn't clear on the qualifications or registration of the practitioners. EC agreed and suggested that an amendment was put forward to ethics to add further information on the PIS about this.
[Action] EC to draft amendment for PIS
3. AW asked whether groups would be feasible given the wide geographical area. EC replied that there were concerns about this but that was why a feasibility study was so important.
4. AW asked why the Chalder trial was not included in the reference list. EC replied that it was published after initial submission to Ethics.
5. JC suggested that the teenager PIS was clearer to read then the adult PIS and could be used for both.
EC informed the External Advisory Group that it was likely that FOI requests would be received
EC suggested that the minutes were put on to the website. This was agreed.
[Action] EC: Minutes to go on web
Date of Next meeting – due in 6 months time
[Action] EC to doodle date
[Minutes end]
*Ed: See:
Response from Joan Kirkbride, National Research Ethics Service (complaint in response to ethical approval of SMILE Lighting Process pilot study in children), 8 November 2010
Shortlink: http://wp.me/p5foE-3da
Progress on complaints to NRES (ethics approval of SMILE Lightning Process pilot study in children), 16 November 2010
Shortlink: http://wp.me/p5foE-3dY
Transcript: BBC Radio Berkshire, Anne Diamond, ME/CFS: Shepherd, Findley, Parker
November 12, 2010 November 16, 2010 meagenda Blood Donation, CBT/GET, CFS Clinics, CFS in the media, CFS Research, Lightning Process, SMILE study, ME Association, ME in the media, MRC, NICE CFS/ME guideline, Professor Findley, WHO (World Health Organization)
Transcript of BBC Radio Berkshire Anne Diamond Show, broadcast 11 November 2010
Shortlink: http://wp.me/p5foE-3dG
On 11 November, Radio Berkshire presenter, Anne Diamond, interviewed Dr Charles Shepherd, Medical Adviser for the ME Association and Professor Leslie Findley, Clinical Director of the National ME Centre and Centre for Fatigue Syndromes. Towards the end of the item, Duncan McLarty spoke to Phil Parker, founder of the Lightning Process.
See also previous post: http://wp.me/p5foE-3dk
Within the UK, until 18 November, you can "Listen again" to the Radio Berkshire broadcast here on BBC iPlayer. The item starts 2 hours 3 mins in from the start of programme and is around 12 minutes long.
Or listen on YouTube here: http://www.youtube.com/watch?v=9YX3wFkDlhI
This transcript has been prepared by Suzy Chapman for ME agenda. Care has been taken in the preparation and proofreading of this transcript; some errors and omissions may remain.
The Anne Diamond Show, Thursday, 11 November 2010:
Anne Diamond: Last week on the show while Esther Rantzen was standing in, we looked at the subject of ME because people diagnosed with the condition are no longer able to give blood. Now we've had a huge response from people with experience of the condition and because this is such a controversial area we thought it might be a good idea to get some experts on to the show to deal with some of the points that have been raised.
Dr Charles Shepherd is Medical Adviser to the ME Association and Professor Leslie Findley is Clinical Director of the National ME Centre and the Centre for Fatigue Syndromes. I spoke to them both, earlier, and I asked Charles Shepherd just what is ME and are we any closer to knowing what causes it?
Dr Charles Shepherd: Well ME stands for "Myalgic Encephalomyelitis" and in very simple terms it's an illness which often starts with a viral infection and people then have a range of symptoms, primarily muscle symptoms, muscle fatigue and also brain symptoms, problems with memory, concentration, balance, just generally feeling unwell. And these systems – I mean these symptoms – persist for a long period of time in many of these patients; it is a very disabling and has been recognised as a neurological illness.
Anne Diamond: Yes. Professor Findley, to be absolutely clear, nowadays there's no longer any suggestion that it's a psychological condition, is there?
Prof Findley: Erm, no, there's no suggestion it's a psychological condition but psychological factors can adversely influence the symptoms and they have to be taken into account when one's planning a total management strategy for an individual patient.
Anne Diamond: Would you agree with that, Dr Shepherd, that nowadays we don't look upon it as a psychological condition?
Dr Charles Shepherd: Well, I thoroughly agree, you know, the Department of Health, the World Health Organisation, classifies this as a neurological illness and you know, like with many chronic disabling illnesses, psychological factors, social factors, can sometimes play a role, that's not disputed. But it is essentially a neurological illness with other factors involved.
Anne Diamond: Now you see, since Esther was talking about this last week we've had an email, for instance, which says that all the research and treatment funding then has inappropriately gone to the psychiatric profession since the 1980s. What do you say to that, both of you?
Dr Charles Shepherd: Well, to a certain extent well that is true. Certainly in the UK, the vast amount of government funded research has gone in to behavioural and psychological therapies and there has been a great deal of criticism about that. Fortunately, what we now have is the Medical Research Council [MRC] setting up an expert group which I am a member of, to look into research in this illness and we have been for the past two years looking at what needs to be done in the way of biomedical research and a list of priorities in biomedical research has now been sent to the board of the MRC – they are looking at these priorities and we are expecting an announcement very shortly on this.
Anne Diamond: Professor Findley, is it true then that we've been wasting money – directing the money towards the psychiatric profession?
Professor Findley: We….ell! Waste is a very, is a very strong word to use. The money, I agree with Charles, could have been used perhaps more wisely, but this is a complex illness and it represents, and the MRC would state this, that it represents a group of disorders, it is not a single entity and we're still having great trouble defining within this large group of patients the individual types of Chronic Fatigue Syndrome/ME that exist and if one takes a group of patients the symptom complex that the individuals complain of vary enormously…
Anne Diamond: And yet…?
Professor Findley: …and the NICE Guidelines recognise complex and severe Chronic Fatigue Syndrome/ME to emphasise the complexity of this, this, this illness, it is not a simple entity it's not like some tuberculosis where you have a defined marker and a defined organism and a defined treatment.
Anne Diamond: So and Dr Shepherd, you would agree that this a range of different conditions?
Dr Charles Shepherd: Yes, and I mean this is another key point, that we have renamed and redefined this illness from ME into what's now called "Chronic Fatigue Syndrome", the term that the medical profession tends to use and unfortunately this has now produced, it's rather like dumping everyone with different types of arthritis, inflammatory arthritis, osteoarthritis, infective arthritis, under one umbrella and saying that they've all got the same cause, the same symptoms and the same treatments and that does not apply to arthritis, it does not apply to everyone who comes under this umbrella of Chronic Fatigue/Chronic Fatigue Syndrome.
This is one of the key points the MRC is addressing the need for sub grouping people under this umbrella, finding the different causative factors that are going on and then applying appropriate different forms of management to the different types of sub groups under this umbrella.
Anne Diamond: Now, I mean, you look at the situation – for instance here in Berkshire – where our Primary Care Trusts [PCTs] are offering Cognitive Behavioural Therapy [CBT]. Is that appropriate any longer?
Dr Charles Shepherd: It's not appropriate as a one size fits all treatment and this is our big problem with the NICE Guideline, it's why patients object to the NICE Guideline because the NICE Guideline recommends CBT and Graded Exercise Therapy [GET] should be offered to everyone with mild to moderate ME and this is not what we feel is appropriate one size fits all treatment. Many patients find these therapies either ineffective, around about 50% with CBT and in the case of Graded Exercise treatment, if you apply this wrongly you make these patients worse. That's why there is terrific concern and anger amongst the patient community with the NICE Guideline.
Anne Diamond: Can I move on to the…this business of the Lightning Therapy, the Lightning Process? Because it was very controversial when Esther was talking about it last week. Her daughter went through it, but some listeners were angry that we even mentioned the Lightning Process. Why is it so controversial? Professor Findley, first…
Professor Findley: Erm, that's a very straightforward question with a very complex answer. I think the Lightning Process has a part to play in the management of some patients. It is not a specific treatment for Chronic Fatigue Syndrome/ME, it's used to treat a whole raft of conditions. But there are some patients that can be recognised who have factors which would lend themselves – factors which are perpetuating the illness – which would lend themselves to the Lightning Process.
Now these are, in my opinion, a very small group of patients overall, but because Lightning Process practitioners are often only experienced in that one technique they apply it to anybody who visits them with an objective of getting treatment, so their patients are treated in an unselected manner and therefore this has led to all sorts of complications and dissatisfaction.
Anne Diamond: Dr Shepherd?
Dr Charles Shepherd: Well, I have this strong objection to the Lightning Process – in particular the way it's marketed to very vulnerable groups of people with adverts which are making unsubstantiated claims about success rates.
Professor Findley: Agreed…agreed.
Anne Diamond: But it clearly is true for some and as you both seem to be agreeing that this is multi-factorial, very complex, no one patient is exactly the same as the other.
Professor Findley: Well I think I absolutely agree with this, but erm… the…and I agree with Charles' comments on the Lightning Process – it's been badly, badly applied, poorly researched and we would use it or recommend it probably in perhaps one in thirty or one in forty of patients, after they have been properly assessed over a long period of time and more standard management programmes have been applied.
Anne Diamond: Before we run out of time, can I finally ask both of you really 'cos a lot of people who contacted us were asking about recovery rates from ME. What can you tell us about the numbers and are indeed there any robust figures on this? Dr Shepherd, first.
Dr Charles Shepherd: Well, I wouldn't say there were really robust figures. I think its, a lot of it is clinical judgement from individuals, you know, that see patients with this and you know, a limited amount of epidemiological research.
Where I come in is I think we probably have three groups. We have a group at one end of the spectrum who are severely effected certainly at some stage in their illness and they probably account for about 25% of the total, I mean these are people who are bed-bound, wheelchair-bound, house-bound.
We have a large group in the middle who make some degree of, I think the word here is improvement, over the course of time but do not recover but they hit a glass ceiling, 50, 60, 70% of what they were normally like and then we have a small group at the other end of the spectrum who make a much more significant degree of improvement or may even finally recover – an example there is Yvette Cooper, a former government minister. I would add that the improvement/prognosis in children/adolescents with this disease does seem to be a lot better than it is in adults.
Anne Diamond: And Professor Findley?
Professor Findley: I would, there aren't robust figures and I think Charles is right, we would normally say that the average duration taken across the group, the average duration of this type of illness is three to five years with at least 40% of patients never getting back to previous levels of functioning and I'd agree with Charles there is the very severe group and their prognosis is appalling and they very rarely get any proper management advice.
Anne Diamond: Well that was Dr Charles Shepherd and Professor Leslie Findley speaking to me a little earlier on. It's a very important subject isn't it?
It's very important that we hear a balanced argument on it. So we put some of those issues to the founder of the Lightning Process, Phil Parker. Phil's website calls the process "A non medical tool that is tailored to help people who are stuck in their life or health". Well BBC Radio Berkshire's Duncan McLarty, first asked him whether he agreed that the process is only appropriate in a small fraction of ME cases.
Phil Parker: You know that sounds like scientific data but it's not science – there's no evidence to say that, that's just their opinion! First thing we do is have a chat with people and we assess them as to whether this is a really useful thing for them because obviously we want to see people who we think are going to get value from this.
Duncan McLarty: But if you're not an ME specialist how would you know if it's appropriate?
Phil Parker: Er, well we are specialists at the Lightning Process. We know more about the Lightning Process than these people because we designed it and trained in it. So what we are looking for is, do we think these people are likely to get benefit from the stuff that we do. What we're really interested in is how can we help these people who, who've got stuck, where there aren't many solutions, is there anything we can do to help them that's really where we're coming from.
Anne Diamond: Well can I just say thank you very much for all your emails on the subject of ME over the last week or so. I think we've certainly shown that it's a complex area with plenty of strong and sometimes conflicting views. We also asked Phil Parker whether he agreed that the process was aggressively marketed as those two experts told me.
Phil Parker: Basically our practitioners, erm, don't make claims. What they say is, that you know our experience is, that when some people use this they can make changes. That doesn't guarantee change. If you…you know you have a business then you want to tell people about it that doesn't make it aggressive marketing, that's the thing I… deny and say that all we're doing is, say look this is something that we've found is very useful, have a look at it and if you want to talk to us more about it then do, if you don't that's fine as well. We really don't market it aggressively at all.
Anne Diamond: Well there you are, you see, that was Phil Parker, who is the founder of the Lightning Process, and earlier on I was talking to Dr Charles Shepherd, Medical Adviser to the ME Association, and Professor Leslie Findley who's Clinical Director of the National ME Centre and the Centre for Fatigue Syndromes.
2] ASA adjudication against "Withinspiration", June 2010
4] All posts on Lightning Process pilot study in children issue on ME agenda: https://meagenda.wordpress.com/category/lightning-process-smile-study/
Dr Charles Shepherd, Prof Leslie Findley and Phil Parker (Lightning Process) on Radio Berkshire
November 11, 2010 November 18, 2010 meagenda 25% ME Group, CBT, CBT/GET, CFS Clinics, CFS Research, Lightning Process, SMILE study, ME Association, ME in children, ME in the media, ME Research, MRC, NICE, Professor Findley, WHO (World Health Organization)
Shortlink: http://wp.me/p5foE-3dk
Note: This is an edited version of content first posted on 11 November.
On 2 November, the ME Association reported that BBC Radio Berkshire had broadcast an interview with the ME Association's medical adviser, Dr Charles Shepherd, during an item on the UK life ban on blood donation by everyone with the illness ME and CFS which was implemented on 1 November.
During the interview, also broadcast on 1 November, Esther Rantzen, standing in for Anne Diamond, the usual presenter of this mid-morning programme, had sidelined discussion of the implementation of the blood ban to promote the Lightning Process.
The ME Association reported that "Claims were made about the value of Lightning Process approach for people with ME/CFS and recovery rates for the illness which we challenged as soon as we heard they had been made. These will be the subject of a further item on BBC Radio Berkshire on Thursday 11 November…" See next posting
The 1 November broadcast can be heard here, on YouTube, in three parts:
http://www.youtube.com/watch?v=G4MFSRPMOWQ
http://www.youtube.com/watch?v=CS0kHH8NZ0k
http://www.youtube.com/watch?v=vNSgmuMlgXk
There has been considerable concern about the way in which Ms Rantzen conducted herself during the ME strand on this programme which had included contributions from ME patients via phone link. Complaints have been pouring in to the programme producers by email and phone.
One poster on Facebook wrote:
Esther Rantzen to radio caller Will: "..Now I am going to tell you something Will….. I can tell you about my daughter, she found something called the Lightning Process and you can find it on the internet….. it's a method of training your brain to withstand the symptoms….. it's a form of Neuro-linguistic Programming, you know how people use their mindset to withstand symptoms…."
Esther to Will: "…Let me tell you something else, it is an illness that most people recover from spontaneously, most people, 60% of people, get back to normality"
(Surely recovery rates are between 5 and 12%?)
Caller Will to Esther referring to the lifetime ban on giving blood by everyone diagnosed with ME (whether or not any improvement in their health has occurred). Will explains that some people have been wrongly diagnosed with ME and turned out to have completely different diseases:
Will: "…The difficulty is with the diagnostic process with ME, it's an educated guess by specialists so there may be many people diagnosed with ME that may not even have ME in the first place….. now, in line with the blood ban that's been announced to day what happens if you've been misdiagnosed, or undiagnosed…"
Esther: "Well, I mean, obviously the ban cannot apply…"
WRONG. The lifetime blood ban from the 1st November applies to everyone who has been given a diagnosis of ME or CFS in the UK. Esther announced that the ban "cannot apply" to individual cases. That is very irresponsible of her and appears to overrule the Blood Services announcement on the ban.
Esther to Will: "Will listen, don't give up hope..… I tell you what, have a look at what the Lightning Process, it's on the internet…"
Esther has directed the caller to look up Lightning on the internet for the second time in a few minutes. What Will would find on the internet is the commercial Lightning site advertising Lightning.
Will: "…I don't think I have the funds…."
Esther: "I think there may be an equivalent on the NHS"
WRONG. There is no equivalent of Lightning on the NHS.
Today, just after 12 noon, in a pre-recorded interview, Anne Diamond discussed ME and CFS in general, its WHO neurological classification, the need for biomedical research and sub-grouping, the MRC's CFS/ME Expert Group, the Lightning Process, and illness prognosis with Dr Charles Shepherd and Professor Leslie Findley. There was a brief contribution from Phil Parker towards the end of the interviews.
In 2007, Prof Leslie Findley had undertaken an informal, non RCT pilot study of the Lightning Process. No results from this pilot have been published but Prof Findley spoke to the Canadian media in an article here, in 2008, in which he quotes unremarkable results and reports that in small number of cases there can be bad relapses.
CBS News In Depth: Health
Controversial training program comes to Canada
April 18, 2008 | By Zoe Cormier
Prof Findley had also given a presentation around the pilot study at the 2007 Ramsay Society Annual Meeting with a colleague, Gerrie de Vries. There is no English summary or note of this Ramsay Society meeting but photographs and notes were published, in German, by Regina Clos, which can be read in auto translate here:
Gerrie de Vries & Leslie J. Findley: "The Effects of the Lightning Process in the Management of Chronic Fatigue Syndrome – a start." : http://tinyurl.com/sykesgermantoenglish
An personal account here on Bad Science Forum mentions Prof Findley's involvement in "Neuro Behavioural Training" – an approach described as encompassing "Occupational Therapy, Clincal Hypnotherapy, Neuro Linguistic Programming, Cognitive Behaviour Therapy and Life Coaching". Sessions take place over three days.
When asked about the Lightning Process, in today's interview, Prof Findley said "…it's been badly, badly applied, poorly researched and we would use it or recommend it probably in perhaps one in thirty or one in forty of patients, after they have been properly assessed over a long period of time and more standard management programmes have been applied" but he did not mention that he had, himself, undertaken an informal pilot in 2007.
Until 18 November, you can "Listen again" to the Radio Berkshire broadcast on BBC iPlayer at:
Radio Berkshire 11 November Anne Diamond
Starts at 2 hours 3 mins in from beginning of programme.
Broadcast on BBC Berkshire, 10:00am Thu, 11 Nov 2010
Available until 1:02pm Thu, 18 Nov 2010
Or listen on YouTube, here:
http://www.youtube.com/watch?v=9YX3wFkDlhI
On 10 November I sent this letter of complaint to the producers of the Anne Diamond programme. (At 18 November, I have yet to receive a response or acknowledgement.)
Re: Broadcast in which Esther Rantzen discussed ME/CFS and the new UK ban on blood donation by everyone with the illness with ME Association medical adviser, Dr Charles Shepherd, BBC Radio Berkshire: Monday 1 November
I am writing to complain about Ms Rantzen's handling of this broadcast.
I understand that Ms Rantzen was standing in for the usual presenter, Ms Anne Diamond.
I have the following concerns:
1] Ms Rantzen was brought in to present a programme during which the ME/CFS blood ban would be discussed.
Ms Rantzen has a number of COIs in relation to ME/CFS.
Ms Rantzen is President of AYME (The Young People's ME Trust).
She is known to promote the Phil Parker Lightning Process in the media.
The patient organisation of which she is President has for its medical adviser, Dr Esther Crawley.
Dr Esther Crawley is about to commence recruiting participants to a controversial pilot study where the Lightning Process will be applied to children aged 12 to 18 years old, for which Dr Crawley is Chief Investigator.
The patient organisation of which Ms Rantzen is President has been involved in the development and planning of this Lightning Process pilot study.
The patient organisation of which Ms Rantzen is President has a seat on the "Expert Advisory Group" for this Lightning Process pilot study.
2] I have scrutinised a partial transcript and note that during the broadcast, Ms Rantzen, on several occasions, sought to promote the Lightning Process to the public and to a contributor to the programme calling on a phone-link and that she also directed him to look at the internet for more information on the Lightning Process.
Ms Rantzen also made claims for recovery rates of patients with ME/CFS for which she offered no supporting evidence.
3] In my opinion, Ms Rantzen gave misleading information in relation to the blood ban and its application to individuals.
In response to the caller's concerns about the cost of the Lightning Process, Ms Rantzen is reported as having said, "I think there may be an equivalent on the NHS".
This is incorrect, there is no equivalent available on the NHS.
In the light of Ms Rantzen's COIs and given her blatant promotion of the Lightning Process during a BBC broadcast I do not consider that Ms Rantzen could be considered to have been a neutral presenter.
I do not consider that she should have used the issue of the ME/CFS blood ban to promote a commercial "training" programme marketed by Phil Parker and his Lightning Process trainers / coaches / practitioners during a BBC broadcast.
I consider that the BBC was negligent in its failure to take Ms Rantzen's COIs into consideration when selecting a stand-in for Ms Diamond and that Ms Rantzen had taken advantage of her position, as presenter, to introduce and promote the Lightning Process to the public during an item, the focus of which, was the recent UK blood ban for ME/CFS patients.
I would welcome your responses.
I also request a copy of the BBC's policy on the declaration of COIs in its presenters and a copy of the BBC's policy on the promotion of commercial goods and services by BBC presenters during broadcasts.
Sincerely, etc


text:
Events, Restaurants
Washington D.C.'s Top Easter Events
By Correspondent McLean Robbins
Cherry blossoms are blooming, the weather is (slowly, but surely) warming up and Easter is right around the corner, which means springtime has hit in Washington D.C. The city is gearing up for events (both religious and secular) for the whole family to enjoy. From egg hunts to yummy brunches, these are some of my favorite Easter activities in the Washington D.C. area this year.
White House Easter Egg Roll
This annual event takes place on Easter Monday of each year, and this year's 135th edition is scheduled for April 1 from 8 a.m. to 5 p.m. In addition to the "roll" itself, where kids get to race through the grass pushing their egg with a spoon, kids can participate in an Easter egg hunt and enjoy a visit from the Easter Bunny, as well as the President and First Lady. The ticketed event is a highly coveted invite for Washingtonians, and this year is no exception with more than 35,000 guests expected to attend.
Easter Services
Many visitors and locals alike begin Easter celebrations with a Sunday morning church service. Some of Washington's most beautiful chapels and churches are open to the public for Easter programs including the Washington National Cathedral and St. John's Church, an Episcopal church where the President and First Lady attended Easter services in 2012.
National Cherry Blossom Festival
The annual Cherry Blossom Festival may not technically be an Easter event, but it marks Washington's return to warmer weather. More than 3,000 cherry trees throughout the District will bloom during the festivity that takes place between March 20 and April 14, 2013. Nearly 100 special events will take place, but we'd suggest simply strolling around the Jefferson Memorial or taking a paddleboat on the Tidal Basin to see the blooms. Lucky for Easter visitors, the peak bloom time is scheduled for April 3 to April 6.
Easter Brunch Hot Spots
The capital offers a plethora of Easter brunch options; try out these favorites for a guaranteed great meal:
Dine at one of the Obama's favorites for your Easter brunch. Blue Duck Tavern, located inside the Park Hyatt Washington is offering a three-course menu for $95 per person with exquisite selections such as duck confit hash, rock shrimp scrambled eggs and rhubarb blackberry crumble.
The comfort food choice restaurant, Sou'Wester, located in the Forbes Travel Guide Four-Star Mandarin Oriental, is offering a family-style menu for Easter brunch for $65 per adult and $35 per child. The three-course menu includes bourbon pecan sticky buns, an Ancho chile glazed pork loin entrée, and doughnuts for dessert, among other shareable dishes. Plus, there are two Easter egg hunts on the lawn, one at 11 a.m. and one at 1 p.m.
Zaytinya, a Mediterranean concept by acclaimed chef José Andrés, kicks of "Greek Easter" between March 31 and May 5. The five-week fest will consist of special menu offerings including a $35 prix-fixe brunch menu on Easter Sunday featuring lamb dishes and a contemporary take on vegetable puree soup.
Adour, the Forbes Travel Guide Four-Star restaurant located inside in the Four-Star St. Regis Washington, D.C., is featuring a four-course menu of traditional French dishes and prized Easter picks — expect Maine lobster medallions to start and a roasted baby lamb with a spring vegetable gratin — for $90 per person.
Photos courtesy of iStock/fstockfoto
Adour Blue Duck Tavern D.C. National Cherry Blossom Festival Park Hyatt Washington Sou'Wester St. Regis Washington White House Easter Egg Roll Zaytinya
by McLeanRobbins
About McLeanRobbins
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redpajama_set_name: RedPajamaCommonCrawl


text:
Africa needs free movement
Achille Mbembe
African migrants at a temporary camp of safety in Primrose
MIGRANCY
I am one of those who are actively committed to the idea of a borderless Africa.
I believe in the project of an African nationality as articulated by the best of our thinkers in the continent and in the diaspora since the 19th century.
This project includes the possibility for people of African descent scattered throughout the world to resettle in Africa if so they wish.
This is what the 2000 Ghana Immigration Act calls "the right of abode".
Last weekend, I attended a policy conference on international migration in Sandton at which Home Affairs Minister Malusi Gigaba gave a rousing speech.
Since taking over the department of home affairs, Gigaba has been outspoken about the fact that "South Africa is an African country in Africa".
"Our first focus," he has consistently argued, "is Africa." He has gone as far as calling for an "Afrocentric" international migration policy.
In so doing, he has thrown to all of us who care a challenge that is not only a policy challenge, but also an intellectual one and it is in relation to the intellectual nature of this challenge that what follows makes sense.
An Africa-centered international migration policy requires a radical altering of the South African legal immigration framework.
In spite of consecutive amendments since the advent of democracy, the latter is still in spirit and in soul too reliant on colonial and apartheid-era racial assumptions.
At their core, colonial and apartheid-era immigration policies were explicitly anti-African and anti-black.
It hardly mattered where they came from.
Whites entered South Africa through the front door; blacks from other African countries through the back door, Indians as indentured labour and native black South Africans through the dark tunnel of the pass system.
Gigaba's call for an Africa-centered international migration policy requires a genuine change of paradigm in the management of intra-African migration.
The same change of paradigm is necessary if we are to contribute meaningfully to the unfolding global debate on human mobility in this age of planetary entanglement.
In a world in which arrest, detention, incarceration (including at sea), abandonment and deportation are seen as the most efficient ways of dealing with economic migrants, refugees and asylum seekers, we should draw from our own historical experience as African and diasporic people, and articulate a proposal for ourselves and for the world that is radically different from the anti-humanist norms and practices prevalent on matters concerning the management of human mobility.
At a deep historical level, African and diasporic struggles for freedom and self-determination have always been intertwined with the aspiration to move unchained.
Whether under conditions of slavery (Atlantic and trans-Saharan) or under colonial rule, the loss of our sovereignty automatically resulted in the loss of our right to free movement.
This is the reason the dream of a free, redeemed and mighty African nation — a "bright star among the constellation of nations" as Marcus Garvey, a proponent of black nationalism and pan-Africanism, once put it — was inextricably linked to the recovery of the right to come and go without let or hindrance across this colossal continent.
Our history in modernity has been, to a large extent, one of constant displacement and confinement, forced migrations and coerced labour.
Think of the plantation system in the Americas and the Caribbean.
Think of the "black codes", the "Pig laws" and the vagrancy statutes after the failure of Reconstruction in the United States in 1877.
Think of the chain gangs labouring at tasks such as road construction, ditch digging and farming.
Think, too, of the Code de l'indigénat in French colonial Africa, a set of laws establishing an inferior legal status for local people, of the Bantustans and labour reserves in Southern Africa and of the carceral industrial complex in today's US.
In each instance, to be African and to be black has meant to be consigned to one or the other of the many spaces of confinement modernity invented.
The scramble for Africa in the 19th century and the carving of its boundaries along colonial lines turned the continent into a carceral space and each of us into a potential illegal migrant unable to move except under increasingly punitive conditions.
Entrapment became the precondition for the exploitation of our labour, which is why the struggles for emancipation and racial upliftment were so intertwined with the struggles for the right to move freely.
To complete the project of decolonisation, this is the historical legacy of racial violence we must systematically undo.
Any Africa-centered international migration policy for the 21st century will, of necessity, subscribe to this abolitionist agenda.
It will be a policy that makes it possible for Africans and people of African descent across the globe to move unhindered across our colonial borders and to settle wherever they desire in this colossal continent turned, almost by design, into a mass penitentiary.
Such a policy will protect every single African or person of African descent from the humiliation of being made to feel or be treated as a stranger in Africa.
It will subscribe to a project of openness and circulation rather than of closure and immobilisation.
Anything that, in the name of "national interest", "national security" or any other pretext goes against this goal is by definition anti-African and anti-black.
But this is where the conundrum starts.
South Africa under black majority rule cannot possibly be pro-black and yet anti-African.
Nor can it be anti-black and pro-African.
To be sure, worldwide the nation-state system is still the norm.
In the name of national sovereignty, each national state on Earth has the right to allow in — or to keep out — whoever it deems undesirable.
South Africa cannot be asked to unilaterally share its sovereignty over its borders or to surrender it while other African states keep theirs for themselves.
Opening African borders or abolishing them will be a gradual, mutual and reciprocal endeavour or it simply won't happen.
South Africa cannot legitimately be asked to attend alone to every single economic migrant in Africa.
Nor can it alone shoulder the plight of every single African refugee or asylum seeker.
Furthermore, it cannot be expected to minimise contemporary real and actual threats such as terrorism, the smuggling of drugs and firearms, the illegal export of stolen cars and endangered species, human trafficking and the deleterious activities of criminal syndicates.
These are crude facts we need to acknowledge and relentlessly combat.
And yet under international law, South Africa has the duty to treat in the most humane way each of those who knock at its door, those it chooses to keep out and those it chooses to let in.
Whether this has always been the case should remain an open question, especially when hundreds of thousands of Africans are deported every single year while a few thousands are held at any given time in detention within South African borders.
South Africa has to exercise its sovereignty over its own territory and fulfill its international obligations mindful of the fact that, over the past decade, its companies have aggressively moved into the continent in search of markets, resources and cheap labour.
In most instances, the penetration of South African capital into the rest of the continent has entrenched historical patterns of regional inequality and processes of accumulation based on low wages.
Such has been the case in mining, telecommunications, banking, retail and food.
The country's investment stock in Africa has increased from R14.7-billion in 2001 to R121-billion in 2010.
The rest of Africa is South Africa's fastest-growing export destination after Asia.
If the European Union remains the single most important import source for South Africa, exports from South Africa to the continent have steadily increased since 2009.
In fact, they have been growing at a faster rate than with any other trading partner, China included.
In devising a new immigration policy, a proper appraisal of our "national interests" must take this into account.
In the long run, the future cannot be built on mercantilism on the one hand and resegregation on the other.
Something else must be done.
Opening African borders requires of each African state to put its house in order.
This starts with putting in place efficient mechanisms of civil registration and citizen identification.
As a first step towards the goal of a borderless Africa, South Africa can take the lead in a vast programme aiming at the continental harmonisation of civil registration and citizen identification.
Because of the unparalleled hegemony northern countries enjoy in defining pretty much anything that matters, the global debate on immigration and human mobility has been mostly conducted through categories of thought originating from that part of the world.
As a result, international migrations have been mostly addressed through the prism of those countries' national interests, national sovereignty, national security, the mitigation of risks, the anticipation of threats and eventually their nullification.
Such concepts depend on a Western metaphysics of space, power and movement that is profoundly anti-humanist, tethered as it is to the overwhelming figure of a mortal enemy in a fundamentally hostile world.
No wonder they are mostly mobilised by right-wing political forces in their attempts to bolster racism and Islamophobia.
As far as Africa is concerned, we have to ask whose interests are better served when we import such categories wholesale and frame the question of African mobility in those terms.
To answer Gigaba's call for an Africa-centered international migration policy, a genuine decolonisation of our categories of thought and our conceptions of history, power and space is unavoidable.
In our traditions, space is about flows, networks and circulation.
Crossroads and intersections are more important than borders.
How flows intersect with other flows is what matters the most.
Social and political membership is constantly negotiated. It is never closed. Building alliances through trade, marriages, religion or incorporating latecomers is the norm.
To come up with an entirely different paradigm consonant with the deep spirit of our own history, we explicitly need to embrace our long-held traditions of flexible, networked sovereignty, mutual security, integration through incorporation and of universal right to temporary sojourn (ethics of hospitality).
Coming from a people that has experienced first-hand the violence of history, such a paradigm is not naive about the brutality of our world.
Nor does it espouse the anti-humanist and nihilistic impulses of our times.
Achille Mbembe is a research professor in history and politics at the Wits Institute for Social and Economic Research and a board member of the Ahmed Kathrada Foundation


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