Second DSM-5 public comment period closes 15 June: Final Call for Action

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

29 May 2011

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.

Thank you.

Suzy Chapman
http://dxrevisionwatch.wordpress.com

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Chronic Fatigue Syndrome Advisory Committee (CFSAC) Presentations 10-11 May 2011

Chronic Fatigue Syndrome Advisory Committee (CFSAC) Presentations May Meeting 10-11 May, Public and Written Testimony

Shortink: http://wp.me/p5foE-3iw

The next meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) takes place on Tuesday and Wednesday, 10 and 11 May 2011.  A copy of the Agenda for this meeting will be posted as soon as it becomes available.

Chronic Fatigue Syndrome Advisory Committee (CFSAC)

The Chronic Fatigue Syndrome Advisory Committee (CFSAC) provides advice and recommendations to the Secretary of Health and Human Services via the Assistant Secretary for Health of the U.S. Department of Health and Human Services on issues related to chronic fatigue syndrome (CFS).

The meeting agenda is not yet available but a list of those who have registered to give Public Testimony and who have submitted Written Testimony has been posted on the CFSAC website on this page:

http://www.hhs.gov/advcomcfs/meetings/presentations/05102011.html

It is hoped that the issue of proposed codings for the forthcoming US specific Clinical Modification of ICD-10, which will be known as “ICD-10-CM” and which is scheduled for implementation in October 2013, will have been tabled for further discussion. The CFSAC Recommendation adopted at the May 2010 meeting is problematic and requires further discussion and revision.

See: Dx Revision Watch posts:  

“CFS orphaned in the “R” codes in US specific ICD-10-CM”: http://wp.me/pKrrB-V4

“The clock is ticking for CFS: Partial Code Freeze for ICD-9-CM and ICD-10-CM/PCS Finalized (US)”: http://wp.me/pKrrB-Un

 

Chronic Fatigue Syndrome Advisory Committee (CFSAC) Presentations
May 10-11, 2011
Room 800, Hubert H. Humphrey Building
200 Independence Ave, S.W.
Washington, D.C. 20201

Meeting Materials
Recommendations Chart

Public Testimony

Tuesday, May 10, 2011

Baker, Keith [PDF, 12 kb] PDF available from CFSAC site
Landson, Joseph D.
Manganaro, Kathleen

Wednesday, May 11, 2011

Smith, Rachel [PDF, 15 kb] PDF available from CFSAC site
Chapo-Kroger, Lori

Written Testimony Received Prior to the Meeting Date

Anonymous 1
Anonymous 2
Anonymous 3
Chu, Lily
Danek, Peg
DiPasquale, Ben
Drasner Haban, Johanna I.
Fairman, Matthew
Farrell, Tracy [PDF, 11 kb] PDF available from CFSAC site
Jackson, Ken
Jackson, Suzan
Kitei, Mindy
McDermott, Lolly
McGrory Richardson, Nancy
McNamara, Mary E.
Paivanas, Sue A.
Pratt, Danielle
Pressner, Erin
Rachel
Reilly, Esq. Justin
Rogalla, Kathleen
Spinhirne, Jerrold
V. Katie
Vokal, Toby
Wiley, Janelle

Related material

Previous ME agenda post: Heads up: Next meeting of Chronic Fatigue Syndrome Advisory Committee (CFSAC) : http://wp.me/p5foE-3ih

CFSAC Notices

http://www.hhs.gov/advcomcfs/notices/index.html

CFSAC Roster

http://www.hhs.gov/advcomcfs/roster/index.html

CFSAC Meetings

Agenda; Minutes; Presentations; Recommendations

http://www.hhs.gov/advcomcfs/meetings/index.html

Recommendations to the Secretary of Health and Human Services

http://www.hhs.gov/advcomcfs/recommendations/index.html

Previous two meetings:

May 10, 2010 Meeting

Agenda

Minutes

Presentations

Recommendations

Videocast    [RealPlayer is required to view]

CFSAC Recommendations – May 10, 2010

http://www.hhs.gov/advcomcfs/recommendations/05102010.html

October 12, 2010 Science Day
October 13-14, 2010

Agenda

Minutes

Presentations

Recommendations

Videocast    [RealPlayer is required to view]

CFSAC Recommendations – October 13-14, 2010

http://www.hhs.gov/advcomcfs/recommendations/1012-142010.html

Heads up: Next meeting of Chronic Fatigue Syndrome Advisory Committee (CFSAC) (US)

Heads up: Next meeting of Chronic Fatigue Syndrome Advisory Committee (CFSAC) (US)

Shortlink: http://wp.me/p5foE-3ih

The next meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) takes place on Tuesday and Wednesday, 10 and 11 May 2011.  A copy of the Agenda for this meeting will be posted as soon as it becomes available.

“Members of the public will have the opportunity to provide oral testimony at the May 10-11, 2011, meeting if pre- registered.”

Chronic Fatigue Syndrome Advisory Committee (CFSAC)

The Chronic Fatigue Syndrome Advisory Committee (CFSAC) provides advice and recommendations to the Secretary of Health and Human Services via the Assistant Secretary for Health of the U.S. Department of Health and Human Services on issues related to chronic fatigue syndrome (CFS). These include:

factors affecting access and care for persons with CFS;

the science and definition of CFS; and

broader public health, clinical, research and educational issues related to CFS.

Administrative and management support for CFSAC activities is provided by the Office of the Assistant Secretary for Health (OASH). However, staffing will continue to be provided primarily from the Office on Women’s Health, which is part of OASH.

Dr. Wanda K. Jones, Principal Deputy Assistant Secretary for Health in OASH, will continue in her role as the Designated Federal Officer for CFSAC.

CFSAC Notices

http://www.hhs.gov/advcomcfs/notices/index.html

CFSAC Roster

http://www.hhs.gov/advcomcfs/roster/index.html

CFSAC Meetings

Agenda; Minutes; Presentations; Recommendations

http://www.hhs.gov/advcomcfs/meetings/index.html

Recommendations to the Secretary of Health and Human Services

http://www.hhs.gov/advcomcfs/recommendations/index.html

 

May 10-11, 2011 CFSAC Meeting

PDF: http://edocket.access.gpo.gov/2011/pdf/2011-6702.pdf

Html: http://edocket.access.gpo.gov/2011/2011-6702.htm

[Federal Register: March 22, 2011 (Volume 76, Number 55)]
[Notices]
[Page 15982]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr11-88]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Meeting of the Chronic Fatigue Syndrome Advisory Committee
———————————————————-

AGENCY: Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health.

ACTION: Notice.

SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.

DATES: The meeting will be held on Tuesday and Wednesday, May 10 and 11, 2011. The meeting will be held from 9 a.m. until 5 p.m. on May 10, 2011, and 9 a.m. until 4:30 p.m. on May 11, 2011.

ADDRESSES: Department of Health and Human Services; Room 800, Hubert H. Humphrey Building; 200 Independence Avenue, SW., Washington, DC 20201. For a map and directions to the Hubert H. Humphrey building, please visit http://www.hhs.gov/about/hhhmap.html .

FOR FURTHER INFORMATION CONTACT: Wanda K. Jones, DrPH; Executive Secretary, Chronic Fatigue Syndrome Advisory Committee, Department of Health and Human Services; 200 Independence Avenue, SW., Hubert Humphrey Building, Room 712E; Washington, DC 20201. Please direct all inquiries to cfsac@hhs.gov .

SUPPLEMENTARY INFORMATION: CFSAC was established on September 5, 2002.
The Committee shall advise and make recommendations to the Secretary, through the Assistant Secretary for Health, on a broad range of topics including (1) the current state of knowledge and research and the relevant gaps in knowledge and research about the epidemiology, etiologies, biomarkers and risk factors relating to CFS, and identifying potential opportunities in these areas; (2) impact and implications of current and proposed diagnosis and treatment methods for CFS; (3) development and implementation of programs to inform the public, health care professionals, and the biomedical academic and research communities about CFS advances; and (4) partnering to improve the quality of life of CFS patients.

The agenda for this meeting is being developed. The agenda will be posted on the CFSAC Web site,
http://www.hhs.gov/advcomcfs  when it is finalized. The meeting will be broadcast over the Internet as a real-time streaming video. It also will be recorded and archived for on demand viewing through the CFSAC Web site.

[Ed: the real-time streaming also has real-time auto transcription.]

Public attendance at the meeting is limited to space available.

Individuals must provide a government-issued photo ID for entry into the building where the meeting is scheduled to be held. Those attending the meeting will need to sign-in prior to entering the meeting room.

Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated contact person at cfsac@hhs.gov in advance.

Members of the public will have the opportunity to provide oral testimony at the May 10-11, 2011, meeting if pre- registered.

Individuals who wish to address the Committee during the public comment session must pre-register by Monday, April 18, 2011, via e-mail to cfsac@hhs.gov . Time slots for public comment will be available on a first-come, first- served basis and will be limited to five minutes per speaker; no exceptions will be made. Individuals registering for public comment should submit a copy of their oral testimony in advance to cfsac@hhs.gov  prior to the close of business on Monday, April 18, 2011.

If you do not submit your written testimony by the close of business Monday, April 18, 2011, you may bring a copy to the meeting and present it to a CFSAC Support Team staff member. Your testimony will be included in a notebook available for viewing by the public on a table at the back of the meeting room.

Members of the public not providing public comment at the meeting who wish to have printed material distributed to CFSAC members for review should submit, at a minimum, one copy of the material to the Executive Secretary, at cfsac@hhs.gov  prior to close of business on Monday, April 18, 2011. Submissions are limited to five typewritten pages. If you wish to remain anonymous, please notify the CFSAC support team upon submission of your materials to cfsac@hhs.gov

All testimony and printed material submitted for the meeting are part of the official meeting record and will be uploaded to the CFSAC Web site and made available for public inspection. Testimony and materials submitted should not include any sensitive personal information, such as a person’s social security number; date of birth; driver’s license number, State identification number or foreign country equivalent; passport number; financial account number; or credit or debit card number. Sensitive health information, such as medical records or other individually identifiable health information, or any non-public corporate or trade association information, such as trade secrets or other proprietary information also should be excluded from any materials submitted.

Dated: March 18, 2011.
Wanda K. Jones,
Executive Secretary, Chronic Fatigue Syndrome Advisory Committee.
[FR Doc. 2011-6702 Filed 3-21-11; 8:45 am]
BILLING CODE 4150-42-P

Previous two meetings:

 

May 10, 2010 Meeting

Agenda

Minutes

Presentations

Recommendations

Videocast    [RealPlayer is required to view]

CFSAC Recommendations – May 10, 2010

http://www.hhs.gov/advcomcfs/recommendations/05102010.html

The Secretary should ask the blood community to defer indefinitely from donating any blood components, any person with a history of chronic fatigue syndrome.

The Secretary should recognize the special challenges of ensuring that CFS is part of any efforts to train or educate health care providers under health reform.

The Secretary should direct CMS, AHRQ, and HRSA to collaborate on developing a demonstration project focused on better value and more efficient and effective care for persons with CFS. This can be a public-private effort, and monitoring outcomes and costs should be part of the overall evaluation.

The Secretary should ask the Designated Federal Officer to explore adding a web-based meeting to conduct CFSAC business.

CFSAC rejects proposals to classify CFS as a psychiatric condition in U.S. disease classification systems. CFS is a multi-system disease and should be retained in its current classification structure, which is within the “Signs and Symptoms” chapter of the International Classification of Diseases 9-Clinical Modification (ICD 9-CM).*

*DFO Note: The ICD 10-CM is scheduled for implementation on October 1, 2013. In that classification, two mutually exclusive codes exist for chronic fatigue [sic]:

post-viral fatigue syndrome (in the nervous system chapter), and
chronic fatigue syndrome, unspecified (in the signs and symptoms chapter).

HHS has no plans at this time to change this classification in the ICD 10-CM.

October 12, 2010 Science Day
October 13-14, 2010

Agenda

Minutes

Presentations

Recommendations

Videocast    [RealPlayer is required to view]

CFSAC Recommendations – October 13-14, 2010

http://www.hhs.gov/advcomcfs/recommendations/1012-142010.html

The specific recommendations articulated by the Committee are:

Develop a national research and clinical network for ME/CFS (myalgic encephalomyelitis/CFS) using regional hubs to link multidisciplinary resources in expert patient care, disability assessment, educational initiatives, research and clinical trials. The network would be a resource for experts for health care policy related to ME/CFS.

Engage the expertise of CFSAC as HHS moves forward to advance policy and agency responses to the health crisis that is ME/CFS.

Adopt the term “ME/CFS” across HHS programs.

Memo from Secretary Sebelius to Christopher Snell, CFSAC Chair, on the October 2010 Meeting

http://www.hhs.gov/advcomcfs/sebelius_memo.pdf

Ian Swales, MP amends his understanding of government policy on CFS and ME

Ian Swales, MP amends his understanding of government policy on CFS and ME terminology (Three Parliamentary errors)

Shortlink Post: http://wp.me/p5foE-3hH

On 2 February 2011, Ian Swales (Lib Dem, Redcar) addressed a Parliamentary Adjournment Debate on ME. During that debate, the Health Minister, Paul Burstow, had stated that the World Health Organisation (WHO) uses the composite term CFS/ME for this condition.

This was incorrect. The WHO does not use the composite terms “CFS/ME” or “ME/CFS”.

In a Parliamentary Written Answer to Mr Swales, dated 16 February, the Health Minister corrected his error [1].

Mr Burstow had clarified:

“…During the Westminster Hall debate, on 4 February 2011, I said that the World Health Organisation uses the composite term CFS/ME for this condition. This was incorrect.

“The World Health Organisation classes benign myalgic encephalomyelitis and post viral fatigue syndrome under the same classification G93.3 ‘diseases of the nervous system’; subheading ‘other disorders of the brain’.

“The report of the CFS/ME Working Group to the Chief Medical Officer, in January in 2002, suggested that the composite term CFS/ME be used as an umbrella term for this condition, or spectrum of disease. This term is also used by the National Institute for Health and Clinical Excellence for their clinical guidelines.

“We do, however, intend to seek further advice on our classification and will update the hon. Member in due course.”

[Note that although Health Minister, Paul Burstow, gave the date of Ian Swales’ Adjournment Debate as “4 February” in his Written Answer of 16 February, the Debate took place on 2 February 2011.]

On 17 February, Mr Swales published a report on his website which went out under the title “Swales wins battle with Government on ME”. This report had claimed:

“Ian Swales MP’s fight for better treatment of myalgic encephalomyelitis (ME) continues as he succeeds in getting the Government to recognise ME and Chronic Fatigue Syndrome (CFS) as different illnesses.”

But Mr Swales had misinterpreted the content of the Written Answer he had received from the Health Minister.

This has caused much confusion amongst ME and CFS patients.

Advocates have raised this misunderstanding with Mr Swales and with his Parliamentary Researcher.

Today, an amended report has been published on Mr Swales’ website under the same URL and date, but with a new title – this time it is called:

“Swales corrects Minister on World Health Organisation definition of ME”

I am appending both versions.

To recap, because this is important, and because there is a further error:

Paul Burstow, Health Minister, incorrectly stated on 2 February, during an Adjournment Debate, that the WHO uses the composite term CFS/ME for this condition. That error was corrected by Mr Burstow in his Written Answer of 17 February.

Ian Swales, MP, then claimed in a website report that he had succeeded in getting the government to recognise ME and Chronic Fatigue Syndrome (CFS) as different illnesses. This was a misinterpretation of Mr Burstow’s own correction and clarification. Mr Swales’ Parliamentary Office has now amended his report.

The Countess of Mar, meanwhile, tabled a Written Question of her own for which a response was provided on 1 March, by Earl Howe [3].

The Countess of Mar had tabled:

“To ask Her Majesty’s Government, further to the statement by the Minister of State for Health, Paul Burstow, on 2 February (Official Report, Commons, col. 327) that the World Health Organisation (WHO) described myalgic encephalomyelitis (ME) as Chronic Fatigue Syndrome/myalgic encephalomyelitis (CFS/ME) and that this was the convention followed by the Department, in light of the fact that the WHO International Classification of Diseases 10 lists ME as a neurological disease with post viral fatigue syndrome (PVFS) under G93.3 and CFS as a mental health condition under F48.0 and that the latter specifically excludes PVFS, whether they will adhere to that classification.”

The response received on 1 March, was:

Earl Howe (Parliamentary Under Secretary of State (Quality), Health; Conservative)

“The department will continue to use the composite term chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) for this condition, or spectrum of disease, as suggested by the Chief Medical Officer in his 2002 report. We recognise the condition as neurological in nature.”

But the Countess of Mar’s Written Question also contains an error.

In the International version of ICD-10 (the version used in the UK and over 110 other countries, but not in the US which uses a “Clinical Modification” of ICD-9), CFS is not classified as a mental health condition under F48.0.

Chronic fatigue syndrome is listed in ICD-10 Volume 3: The Alphabetical Index, where it is indexed to G93.3, the same code as Postviral fatigue syndrome.

So in International ICD-10, Postviral fatigue syndrome, Benign myalgic encephalomyelitis and Chronic fatigue syndrome are all three coded or indexed to G93.3 under “G93 Other disorders of brain”, in Chapter VI (6): Diseases of the nervous system.

In International ICD-10, the Mental and behavioural disorders chapter is Chapter V (5).

http://www.who.int/classifications/apps/icd/icd10online/?gf40.htm+f480

Chapter V (5) Mental and behavioural disorders

Neurotic, stress-related and somatoform disorders are coded between (F40-F48)

Neurasthenia
Fatigue syndrome

are classified under (F40-F48) at F48.0, which specifically Excludes

malaise and fatigue ( R53 )

and

postviral fatigue syndrome ( G93.3 )

So now you know what UK government policy is and that Mr Swales had misled himself.

The forthcoming US specific ICD-10-CM

Perhaps the focus can now return to more pressing issues – like the fact that in the US, a Partial Code Freeze is looming for the forthcoming US specific version of ICD-10, known as “ICD-10-CM”.

Under longstanding proposals, the committees developing ICD-10-CM intend to retain Chronic fatigue syndrome in the R codes, and code it under R53 Malaise and fatigue, at R53.82 Chronic fatigue syndrome (NOS), but propose to code for PVFS and ME in Chapter 6, under G93.3.

The R codes chapter (which will be Chapter 18 in ICD-10-CM) is the chapter for

“Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified (R00-R99)”

“This chapter includes symptoms, signs, abnormal results of clinical or other investigative procedures, and ill defined conditions regarding which no diagnosis classifiable elsewhere is recorded.”

Coding CFS patients under R53.82 will consign them to a dustbin diagnosis: there are no guarantees that clinicians will use the unfamiliar ME code or that insurance companies will reimburse for G93.3. It will make patients more vulnerable to the proposals of the DSM-5 Somatic Symptom Disorders Work Group. It will mean that ICD-10-CM will be out of line with at least four versions of ICD-10, including the Canadian “Clinical Modification”, and also out of line with the forthcoming ICD-11, where all three terms are proposed to be coded in Chapter 6 Diseases of the nervous system.

There are only seven months left before the 1 October Code Freeze and the clock is ticking.

 

Here is the first version of Mr Swales’ website report, followed by his amended version.

Version One:

http://ianswales.com/en/article/2011/455560/swales-wins-battle-with-government-on-me

Swales wins battle with Government on ME

February 17, 2011 3:45 PM

Ian Swales MP’s fight for better treatment of myalgic encephalomyelitis (ME) continues as he succeeds in getting the Government to recognise ME and Chronic Fatigue Syndrome (CFS) as different illnesses.

During Ian’s recent parliamentary debate on ME he argued that the Government needs to distinguish between Chronic Fatigue Syndrome and ME to provide better treatment for the different illnesses.

However, Health Minister Paul Burstow MP responded by saying that the World Health Organisation classifies Chronic Fatigue Syndrome and ME as the same illness.

Following an outcry from the ME community about this statement, Ian challenged the Minister on his definition of CFS/ME. The Minister admitted that the definition he used in the debate was “incorrect”.

Commenting, Ian Swales MP said:

“I am pleased that the Government has now recognised that ME and Chronic Fatigue Syndrome are two different illnesses.

“After the debate I received a lot of correspondence from the ME community about the Government’s definition of CFS/ME, so after doing some more research on the matter I decided it was right to clarify this point with the Minister. I know they will be reassured by this news.

“I hope that approaching ME as a distinct condition will help lead to better, more effective treatment for sufferers through better analysis of their possible different causes and symptoms.”

[Ends]

Version Two:

http://ianswales.com/en/article/2011/455560/swales-wins-battle-with-government-on-me

Swales corrects Minister on World Health Organisation definition of ME

February 17, 2011 3:45 PM

Ian Swales MP’s fight for better treatment of myalgic encephalomyelitis (ME) continues as he succeeds in getting the Government to acknowledge that the World Health Organisation does not use the composite term CFS/ME for the condition.

During Ian’s recent parliamentary debate on ME he argued that the Government needs to distinguish between Chronic Fatigue Syndrome and ME to provide better treatment for the different illnesses.

However, Health Minister Paul Burstow MP responded by saying that the World Health Organisation “uses the composite term CFS/ME for the condition”.

Following an outcry from the ME community about this statement, Ian challenged the Minister on his definition of CFS/ME. The Minister admitted that his statement was “incorrect”.

Commenting, Ian Swales MP said:

“I am pleased that the Minister has acknowledged the error he made in the debate.

“After the debate I received a lot of correspondence from the ME community about the Government’s definition of CFS/ME, so after doing some more research on the matter I decided it was right to clarify this point with the Minister. I know they will be reassured by this news.

“I will continue my campaign to get more effective treatment for sufferers of ME through better analysis of its causes and symptoms.”

[Ends]

The text of the Adjournment Debate can be read here, on Hansard
2 Feb 2011 : Column 323WH

Myalgic Encephalomyelitis
4.13 pm

Watch video, here, on BBC News:

http://news.bbc.co.uk/democracylive/hi/house_of_commons/newsid_9382000/9382412.stm

 

References:

[1] Written Answer: Paul Burstow to Ian Swales, 16 February 2011, 16 Feb 2011 : Column 864W:
http://www.publications.parliament.uk/pa/cm201011/cmhansrd/cm110216/text/110216w0004.htm

[2] Amended Ian Swales website report:
http://ianswales.com/en/article/2011/455560/swales-wins-battle-with-government-on-me

[3] Written Answer: Earl Howe to The Countess of Mar, 01 March 2011:
http://www.theyworkforyou.com/wrans/?id=2011-03-01a.297.1

Hansard for above:
http://www.publications.parliament.uk/pa/ld201011/ldhansrd/text/110301w0001.htm#11030162000766

[4] Hansard, House of Lords Debate: Myalgic Encephalomyelitis, 22 January 2004:
http://www.publications.parliament.uk/pa/ld200304/ldhansrd/vo040122/text/40122-12.htm

[5] Current codings in ICD-10 for Postviral fatigue syndrome; [Benign] myalgic encephalomyelitis and Chronic fatigue syndrome:
http://dxrevisionwatch.wordpress.com/icd-11-me-cfs/

Letter issued by NRES following scrutiny of complaints in relation to SMILE Lighting Process pilot study

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
Head of Operations
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)
Fax: 01325 746272
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.

Yours sincerely
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
Tel: 020 7927 9898 Fax: 020 7927 9899

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

2. Purpose

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.

Decision

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

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:

Open PDF here: 05.01.11 Letter SMILE

 

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

 

Related information:

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

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):
http://www.bmj.com/content/340/bmj.b5683.extract/reply#bmj_el_238859

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):
http://www.bmj.com/content/340/bmj.b5683.extract/reply#bmj_el_232414

————————–

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…”

to:

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:-

Fibromyalgia
Chronic Fatigue Syndrome
Post Viral Fatigue
Asthma
Rheumatoid Arthritis
Hayfever
Depression
Dyspraxia
Bipolar Disorder
Ocd
Anxiety And Panic Attacks
Insomnia
Cerebral Palsy
Low Self Esteem
Parkinsons Tremors
Motor Neurone Disease
Hyper And Hypo Thyroidism
Chronic Aches And Pains
Ibs
Lyme Disease
Anger Issues
Food Intolerances
Coeliac Disease
Ptsd
Candida
Allergies
Type 2 Diabetes
Interstitial Cystitis
Migraines
Noise And Light Sensitivity
And Many More

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
.Procrastination
.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

Multiple Sclerosis (MS)
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

Related material:

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

Summary MEA Board of Trustees meeting 15-16 November 2010: Lightning Process

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]

 A few points:

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

Related information:

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/

Minutes Forward-ME meeting, 26 October 2010: Lightning Process trial involving children

Minutes Forward-ME meeting, 26 October 2010: Lightning Process trial involving children

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

TUESDAY 26 OCTOBER 2010

1.00 PM

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.

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/

Church Times: Dr Esther Crawley responds to Prof Robin Gill (SMILE Lightning Process pilot study)

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
University of Bristol
Hampton House
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.

Related material:

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] Children should not be used as guinea pigs, Church Times, 8 October 2010: http://wp.me/p5foE-3ak