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/

Response from Joan Kirkbride, NRES (SMILE pilot study in children)

Response from Joan Kirkbride, National Research Ethics Service (complaint in response to ethical approval of SMILE Lighting Process pilot study in children)

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

On Thursday, 4 November, I wrote to Joan Kirkbride, Head of Operations, National Research Ethics Service (NRES).

Re: Concerns in response to the favourable opinion handed down by South West 2 REC in September 2010 to the application from Dr Esther Crawley, Principal Investigator for the SMILE (Specialist Medical Intervention and Lightning Evaluation) pilot study

Study Refs: 10/H0206/32, ASH106264, LIN1750

My letter expanded on some of the concerns I had raised, in August, with the Director of Legal Services, University of Bristol, in a formal request for an Internal Review of the Information Rights Officer’s decision (17 June) to decline to provide certain information on the basis that this information was exempt from disclosure under section 22(1)(a) of the Freedom of Information Act 2000 (information intended for future publication). I also included other concerns.

I gave Ms Kirkbride permission for my concerns to be forwarded, in full, to any individuals charged with the scrutiny of complaints in response to the decision to grant the Lightning Process pilot study ethics approval, within the NRES, within South West 2 REC and including the sponsors, Chief Investigator, co-applicants and study funders.

I requested confirmation that my communication had been received and my concerns noted.

Today, I received an acknowledgement from Ms Kirkbride which she has CCd to a colleague who is understood to be involved with the scrutiny of complaints.

I am advised by Ms Kirkbride that:

She has appended a copy of the standard response which NRES is sending to all respondents on this matter.

That she advises that NRES “do feel that they now have sufficient information available to [them] and that no new issues are being raised in correspondence which is being sent to [them] for consideration”.

That she has copied my email to the Chief Investigator and Sponsor as I had given permission to do so.

That I “had raised a number of specific questions outside the remit of NRES where [they] cannot provide a response and the answer to my questions would need to come from either the CI [Chief Investigator] or the sponsor”.

The standard response being issued by NRES is:

“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 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.”

 

I am given to understand that at least two others who wrote to Ms Kirkbride, last week, have received similar responses.

AYME welcomes ethical approval of Bath/Bristol Lightning Process pilot study in children (SMILE)

AYME welcomes ethical approval of Bath/Bristol Lightning Process pilot study in children (SMILE)

November 1, 2010 by Suzy Chapman

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

In the November edition of LINK Newsletter (Issue 40), the Association of Young People with M.E. (AYME) has welcomed the decision by South West 2 Research Ethics Committee to grant ethical approval for the controversial pilot study around the application of the Lightning Process in children as young as 12.

Lead researcher for the SMILE study (Specialist Medical Intervention and Lightning Evaluation), Dr Esther Crawley,  is AYME’s Medical Consultant.

To date, no rigorous RCTs have been undertaken into the safety, acceptability, short and long-term efficacy of the Lightning Process in adults.

In a joint press release issued in August, two national ME patient organisations – The ME Association and The Young ME Sufferers Trust –  condemned the study as “unethical” and called for the project to be abandoned.

In a position statement issued in March, Action for M.E. had said it saw “no reason to oppose this pilot study”.

But in August, Sir Peter Spencer, CEO of Bristol based Action for M.E., disclosed that “Action for M.E. has not seen the research protocol for this proposal and has no detailed knowledge of the way in which this trial would be conducted if approved.”

Sir Peter Spencer is a non-executive director of the Royal National Hospital for Rheumatic Diseases, NHS Foundation Trust – Dr Esther Crawley’s employer and the hospital where this research study is being undertaken.

The study hopes to recruit around 90 children aged between 12 to 18 and is expected to start this month. Half the patient cohort will undergo a three day course of the Lightning Process.

According to the NHS REC IRAS application form, the SMILE study Protocol and other SMILE study documents published on the University of Bristol website in September:

Ethical issues   The Lightning Process is popular with over 250 children with CFS/ME attending courses each year. There is therefore an urgent need to study this intervention properly.”

“There are currently no reported studies investigating the effectiveness or side effects of the Lightning Process in children. As with all interventions, proper evaluation is necessary if it is to be brought into mainstream practice.”

“CFS/ME is different in children and adults with different risk factors [15-17], course and outcome [18]. It is therefore not possible to complete a study in adults and extrapolate the results to children.”

“The need for doing a study properly evaluating the Lightning Process came from patients and service users. Representatives from the Association of Young people with ME (AYME) have read, and suggested changes to the protocol and methodology. Service users publicized the research project and are keen to disseminate the findings.”

“The PIS [Participant Information Sheet] follows the NRES recommended layout and has adopted the NRES recommendations for children. We have also tested the PIS on healthy teenagers who reported that it was clear to read. Members of the patient charity AYME have scrutinised the PIS and also felt it was clear to read.”

“Healthy teenagers have scrutinized the patient information sheets and consent forms. The Chief Executive of AYME will be on the External Advisory Group.”

“As this is only a feasibility study, participants will not be individually informed of the outcome. However, the results from the feasibility study will be disseminated through patient charities.”

In a response to the ME Association, published on 28 October, Joan Kirkbride, Head of Operations, NRES (National Research Ethics Service), has written:

“Given that this treatment is currently available, 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.”

I have submitted a FOI request, due for fulfilment on or before 25 November, for the provision of:

1] The names of all patient organisations who have been involved in the planning/development of the SMILE pilot study.

2] The names of all members of the External Advisory Group and the organisations with which they are associated, where applicable.

AYME LINK Issue 40

www.aymelink.org

November 2010

Association of Young People with M.E.

Research study to investigate a chronic childhood condition

A favourable Ethical opinion has been given to a feasibility study which will see if it is possible to look at two different approaches to the intervention and treatment of chronic fatigue syndrome/ME (CFS/ME) in children.

The project called SMILE (Specialist Medical Intervention and Lightning Evaluation) aims to find out if it is feasible to recruit young people into a study to compare specialist medical treatment with specialist medical treatment plus the Lightning Process for young people with chronic fatigue syndrome or ME (CFS/ME).

The research team will be led by AYME’s medical advisor, Dr Esther Crawley, Consultant Senior Lecturer in the University of Bristol’s Centre for Child and Adolescent Health and Consultant Paediatrician at the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust and is funded by the Linbury Trust and the Ashden Trust.

AYME is aware that there are concerns from families about The Phil Parker Lightning Process®.

However, around 250 children a year are already receiving the treatment, and it seems clear that large numbers will continue to do so. Many of the families that AYME supports have asked us about LP and it has been frustrating for us to be able to give them only limited information.

We therefore, welcome this feasibility study to see whether a future study is possible. In addition, AYME is pleased to see the study group are looking at how much health resources young people with ME use and are also investigating the measures clinicians use to look at outcome. If the study is successful, not only will the team be able to apply for funding for a larger study to look at effectiveness, but they will also have a lot of data on the cost of CFS/ME as well as what we need to measure in future research.

It is important to realise that only a larger study in the future will be able to investigate whether LP is effective or not which will enable children and young people and their parents and carers and to make an informed choice about LP. The study is using a mixture of interview techniques to understand what young people think about both interventions, including actually observing and comparing both interventions in order to understand more about them. The fact that all young people will be closely monitored by both the clinical and research team is reassuring.

Esther Crawley said: “We are doing this study because so many young people with ME and their families asked us for this. We are very grateful we can now go ahead and start to answer some of the questions they have been asking”.

The Phil Parker Lightning Process® is an intervention that is used for a variety of conditions including CFS/ME and has been developed from osteopathy, coaching and neuro-linguistic programming. It is a three-day training programme run by registered practitioners and designed to teach individuals a new set of techniques for improving life and health.

Phil Parker, designer of the Lightning Process said: “It is vitally important that all interventions that could assist children with CFS/ME to return to school and improve their health are explored”.

What ethical review has SMILE received?

The study has been scrutinised by the South West 2 Research Ethics Committee whose role it is to ensure that research is safe and ethically sound. The ethics committee has looked in detail at the study design, and all associated documentation and suggested improvements to the readability and accessibility of the patient information leaflets and consent forms which have been adopted.

The SMILE study is compliant with Good Clinical Practice Guidelines, Research Governance Framework, Medical Research Council guidelines, Royal College of Paediatrics and Child Health guidelines for the conduct of trials and has been approved by an ethics committee.

Further information about this research project, including frequently asked questions can be found at the URL:

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smile.html

 

Key SMILE documents

SMILE Research Protocol

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/smprotv6final.pdf

Open here: smprotv6final

Research Ethics  Application Form

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/recfrmrfs.pdf

Open here: recfrmrfs

All published SMILE documents here:

Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME)

Countess of Mar Written Question on ethical approval of Lightning Process study: Response from Earl Howe

Countess of Mar Written Question on ethical approval of Lightning Process pilot study in children aged 12 to 18: Response from Earl Howe, Parliamentary Under Secretary of State (Quality)

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

House of Lords Business
Questions for Written Answer [House of Lords]

Tabled on 21 October and due for answer by 4 November.

House of Lords Written Question

http://www.theyworkforyou.com/wrans/?id=2010-10-28a.311.3&s=speaker%3A12904

The Countess of Mar (Crossbench)

To ask Her Majesty’s Government what assessment they have made of whether the decision by the South-West Research Ethics Committee to approve a pilot research study into the effects of the Lightning Process on children is consistent with the ethical guidance issued by the Medical Research Council to the effect that clinical trials should only include children where the relevant knowledge cannot be obtained by research on adults, and that research involving adults cannot provide the same benefits.

House of Lords Written Answer

Hansard source (Citation: HL Deb, 28 October 2010, c311W)

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

Research ethics committees’ decisions are expected to be impartial and independent of ministerial and other influences. The Government do not interfere with their deliberations, either while they are in progress or by reviewing the outcome. The practice of research ethics committees is subject to training, accreditation and other quality assurance by the arm’s-length National Research Ethics Service to ensure the competence and consistency of their decision-making.

It would be unethical if scientists did not seek to determine the safety and efficacy of treatments and care for all intended beneficiaries, male and female, young and old. When considering whether the particular sample of people proposed as research participants is appropriate, research ethics committees have regard to the established ethical principles reflected in the medicines for Human Use (Clinical Trials) Regulations 2004, international and professional codes of practice and guidelines from funding bodies such as the Medical Research Council (MRC), although the research project in question is neither a drug trial nor funded by the MRC.

Countess of Mar: Questions for Written Answer: Lightning Process pilot study ethical approval

Countess of Mar: Parliamentary Questions for Written Answer: Lightning Process pilot study ethical approval

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

http://www.publications.parliament.uk/pa/ld201011/minutes/101022/ldordpap.htm

House of Lords Business

Questions for Written Answer [House of Lords]

Tabled on 21 October and due for answer by 4 November.

[…]

The Countess of Mar to ask Her Majesty’s Government what assessment they have made of whether the decision by the South-West Research Ethics Committee to approve a pilot research study into the effects of the Lightning Process on children is consistent with the ethical guidance issued by the Medical Research Council to the effect that clinical trials should only include children where the relevant knowledge cannot be obtained by research on adults, and that research involving adults cannot provide the same benefits. HL3014

 

Related material

Children should not be used as guinea pigs: Prof Robin Gill, Church Times (Lightning Process Pilot study): http://wp.me/p5foE-3ak

House of Commons: Written answers and statements: Phil Parker Lightning Process: http://wp.me/p5foE-39J

Hansard Citation: HC Deb, 11 October 2010, c87W

11 Oct 2010 : Column 87W

Health
Phil Parker Lightning Process

Written answers and statements, 11 October 2010

Annette Brooke [Mid Dorset and North Poole, Liberal Democrat]: To ask the Secretary of State for Health what representations he has received on the research and development of the Phil Parker Lightning Process.[15725]

Paul Burstow [Minister of State (Care Services), Health; Sutton and Cheam, Liberal Democrat]: The Department has received representations, from individual members of the public and on behalf of chronic fatigue syndrome/myalgic encephalomylitis stakeholder groups, on research proposals associated with the Lightning Process.

————–

Annette Brooke, MP, is Vice-chair of the newly reformed APPG on ME and has been active in a number of Parliamentary Public Bill Committees (formerly known as “Standing Committees”) representing the rights of children and families:

http://www.theyworkforyou.com/mp/annette_brooke/mid_dorset_and_north_poole

ME in Parliament: Written Questions: ME and UK blood ban; Retrovirals and ME research

ME in Parliament: Written Questions: ME and UK blood donor ban; Screening stored blood; Retrovirals and myalgic encephalomyelitis (ME) research

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

From the News pages of the ME Association

Parliamentary Questions: the UK blood ban on people with ME/CFS

by Tony Britton  |  19 October 2010

Caroline Lucas, leader of Green Party and MP for Brighton Pavilion, tabled two written questions on the blood ban which is to be imposed on everyone in the UK who has ME/CFS from November 1.

In the first, she asked the Secretary of State for Health on what date his Department’s decision that people with myalgic encephalomyelitis should not give blood was (a) made and (b) implemented.

In her written reply on 19 October 2010, Anne Milton (Parliamentary Under Secretary of State for Public Health) wrote:

The UK Blood Services decision to permanently exclude from blood donation anyone who reports that they have had Myalgic Encephalopathy/Chronic Fatigue Syndrome (ME/CFS) was made on 8 July 2010. The change to the donor selection guidelines will come into force on 1 November 2010.

This change is being made on the grounds of donor safety, as ME/CFS is a relapsing condition. It brings practice for ME/CFS into line with other relapsing conditions or neurological conditions of unknown origin.

The change is being made on the grounds of donor selection criteria by the UK Blood Services Standing Advisory Committee on the Care and Selection of Donors, and Joint Professional Advisory Committee.

In her second question, Caroline Lucas asked the Health Secretary whether – with reference to an answer given to the MP for Stroud on 27 January* whether (a) the UK Blood Services and Health Protection Agency study of the prevalence of a rodent virus linked to ME and (B) his Department’s risk assessment in respect of the study had been completed; and if he will make a statement.

Anne Milton replied:

There has been a consistent failure of independent European and American studies to confirm the original American study that described the detection of xenotropic murine leukemia virus-related virus (XMRV), a virus related to rodent viruses, in patients with chronic fatigue syndrome, sometimes referred to as myalgic encephomyelitis.

An expert subgroup of National Expert Panel for New and Emerging Infections (NEPNEI) met in May 2010, to consider all available evidence about XMRV and conduct a risk assessment. The subgroup concluded that XMRV can infect humans but there is currently no evidence that it causes human disease and that on the evidence before the group, no public health action is required at this time. Since the subgroup meeting in May there has been no new scientific evidence that would change the conclusions of the subgroup but they are keeping it under review.

The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO), on the basis of current evidence does not recommend further measures at present but wishes to continue to monitor the situation. The NHS Blood and Transplant and Health Protection Agency study group concur with the views expressed both by NEPNEI and SaBTO but also recognise the need for further research on the prevalence of XMRV in the United Kingdom.

In a recent unpublished pilot study conducted by the group a series of 540 randomly selected English blood donors were screened for XMRV and none were found to be infected.

ME Association questions the rationale behind the blood ban – BBC News Report (8 October)

MEA medical adviser, Dr Charles Shepherd, discusses the subject on the BBC R4 ‘Today’ programme

* The 27 January Parliamentary Question

 

From the News pages of the ME Association

Parliamentary Questions: UK blood banks and XMRV

by Tony Britton  |  21 October 2010

The Minister for Public Health, Anne Milton, has responded to related questions from two MPs about what the Department of Health plans to do with blood from people with ME that is held in storage or whether he has any plans to screen blood already held in storage for the XMRV virus.

David Anderson (Labour MP for Blaydon) asked if the Department of Health would be screening blood held in blood banks for the XMRV virus. And Sharon Hodgson (Labour, Washington and Sunderland West) asked whether the Department would be removing from storage blood donated by people with ME.

In her written answer on 20 October 2010, the Minister replied:

There are no plans to screen blood already stored in blood banks for the xenotropic murine leukemia virus-related virus (XMRV) or to remove from storage blood donated by persons diagnosed with myalgic encephalomyelitis.

A recent study in the United States (of America) reported that XMRV has been detected in a number of chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) sufferers. CFS/ME sufferers can currently give blood when they are well. These data have not been replicated in Europe.

An expert subgroup of National Expert Panel for New and Emerging Infections (NEPNEI) met in May 2010, to consider all available evidence about XMRV and conduct a risk assessment. The subgroup concluded that XMRV can infect humans but there is currently no evidence that it causes human disease and that on the evidence before the group, no public health action is required at this time. Since the subgroup meeting in May there has been no new scientific evidence that would change the conclusions of the subgroup. In July 2010, the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO), similarly did not recommend further measures at present. Both groups will continue to monitor the situation.

However, from 1 November 2010, CFS/ME sufferers will no longer be able to donate blood. The UK Blood Services recognised that exclusion from donation by people with ME/CFS needed to be brought in line with that from other relapsing conditions for the protection of the donor, and not because of potential infection risks.

Parliamentary Written answers and statements, 21 October 2010

David Anderson (Blaydon, Labour)
David Willetts (Minister of State (Universities and Science), Business, Innovation and Skills; Havant, Conservative)

Hansard source (Citation: HC Deb, 21 October 2010, c867W)

Chronic Fatigue Syndrome

Mr Anderson: To ask the Secretary of State for Business, Innovation and Skills if he will provide funding for research on the relationship between retrovirals and myalgic encephalomyelitis. [18037]

Mr Willetts: The Medical Research Council (MRC) is one of the main agencies through which the Government support medical and clinical research. In keeping with the Haldane Principle, prioritisation of an individual Research Council’s spending within its allocation is not a decision for Ministers. Such decisions are rightly left to those best placed to evaluate the scientific efficacy of proposed research.

The MRC is committed to supporting scientific research into all aspects of ME, including studies into the biological basis of the condition and evaluations of treatments. In 2009/10 the MRC spent £109,000 on research directly relating to ME.

also recorded at:

http://www.theyworkforyou.com/wrans/?id=2010-10-21a.18037.h&s=chronic+fatigue+syndrome

ME and CFS in Parliament: Term dates, APPG on ME and Lightning Process pilot study, Written Question, new EDM

ME and CFS in Parliament: Term dates, APPG on ME and Lightning Process pilot study in children, Written Question, new EDM

Shortlink: http://wp.me/pKrrB-Qf

A compilation of Parliamentary related items

House of Commons Recess dates 2010-11 (Note: All recess dates are provisional)

House of Commons

State Opening: 25 May 2010

Conference Recess: House Rises: 16 September 2010 House Returns: 11 October 2010

Christmas Recess: House Rises: 21 December 2010 House Returns: 10 January 2011

Half term to be confirmed

Easter to be confirmed

APPG on ME

The reconvened APPG on ME had been expected to hold a planning meeting in September. I cannot confirm whether and when a planning meeting took place.

Today, I have written to David Amess MP (Acting Chair, APPG on ME), Annette Brooke MP (Vice-Chair, APPG on ME), APPG on ME ME Association Secretariat and Jane Colby (The Young ME Sufferers Trust).

I have requested that the controversial issue of the Bath/Bristol Lightning Process pilot study in children (which for which ethics approval was obtained in September and for which the study protocol and related documents were published on 16 September) is going to be tabled for discussion at the first meeting of the APPG on ME, on whatever date this takes place. If this is not being tabled for discusion I have requested that it be added to the Agenda.

The following have been advised: Invest in ME; 25% ME Group; RiME, Sue Waddle (rep for ME Research UK) and BRAME.

I took the opportunity of thanking Annette Brooke, again, for raising this issue with Rt Hon Andrew Lansley, MP, Secretary of State for Health and also for tabling the Parliamentary Question for which a response was received from Paul Burstow, MP, Minister of State (Care Services), on 11 October.

I also thanked the ME Association and The Young ME Sufferers Trust for their very strong opposition statements, their joint press release and for their representations to the Department of Health and to the Chair of South West 2 Research Ethics Committee.

I will confirm whether this issue is being tabled for discussion at the next meeting of the APPG on ME, which is expected to be held in November but for which a date has yet to be confirmed.

 

New EDM

An EDM (Early Day Motion) has been tabled by Ian Swales MP (LibDem Redcar). It is understood that this results out of lobbying by Jan Laverick and a family member.

EDM 778

MYALGIC ENCEPHALOMYELITIS
11.10.2010

Swales, Ian

That this House notes that despite the fact that the Department of Health now accepts myalgic encephalomyelitis (ME) as a genuine medical condition, diagnosis can still pose a problem because ME symptoms are similar to those present in a number of other medical conditions; recognises that one of the main obstacles to the adequate treatment of ME is the lack of knowledge and consensus about the disease; believes that funding and research must be focused on the bio-medical factors involved and not just simply managing the psychological symptoms; requests that the Government establishes an independent scientific committee to oversee ME research; and calls on the Government and the Medical Research Council to work with ME sufferers and bio-medical researchers in order to achieve a proper understanding of the condition’s challenges and unjust perceptions of the condition.

At 14 October, 18 MPs had signed up to the EDM. Follow its progres, here, where signatures of supporting MPs are listed:

EDM 778 MYALGIC ENCEPHALOMYELITIS

Ian Swales MP maintains a Facebook page here: Ian Swales (Liberal Democrat) for Redcar on Facebook

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More information on the nature and purpose of EDMs, here, on the Parliament website

 

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Written answers and statements, 13 October 2010 [2]

Written answers and statements
Hansard source (Citation: HC Deb, 13 October 2010, c347W)

Work Capability Assessment: Chronic Fatigue Syndrome

Margaret Curran (Labour, Glasgow West): To ask the Secretary of State for Work and Pensions whether the agency contracted to provide medical examinations as part of the Work Capability Assessment has been issued with specific guidance on the assessment of persons presenting a diagnosis of myalgic encephalomyelitis or chronic fatigue syndrome. [14304]

Chris Grayling (Minister of State for Employment): All health care professionals working for Atos Healthcare are required to read an evidence based protocol on chronic fatigue syndrome as part of their induction training. This was last updated in January 2010. In addition, all health care professionals are required to engage in a programme of continuing medical education which includes two modules on chronic fatigue syndrome. These were last updated in April 2009 and March 2010 respectively.

Related information

[1] “Unethical” Lightning Process pilot study in children receives ethics approval 

[2] Information on tabling Parliamentary Questions:
http://www.parliament.uk/documents/commons-information-office/p01.pdf

House of Commons: Written answers and statements: Phil Parker Lightning Process

House of Commons: Written answers and statements: Phil Parker Lightning Process

Shortlink: http://wp.me/p5foE-39J

House of Commons Written answers and statements

Hansard Citation: HC Deb, 11 October 2010, c87W

11 Oct 2010 : Column 87W

Health

Phil Parker Lightning Process

Written answers and statements, 11 October 2010

Annette Brooke [Mid Dorset and North Poole, Liberal Democrat]: To ask the Secretary of State for Health what representations he has received on the research and development of the Phil Parker Lightning Process.[15725]

Paul Burstow [Minister of State (Care Services), Health; Sutton and Cheam, Liberal Democrat]: The Department has received representations, from individual members of the public and on behalf of chronic fatigue syndrome/myalgic encephalomylitis stakeholder groups, on research proposals associated with the Lightning Process.

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] ASA adjudication against “Withinspiration”, June 2010:
http://www.asa.org.uk/Complaints-and-ASA-action/Adjudications/2010/6/Withinspiration/TF_ADJ_48612.aspx

3] Background to this issue: http://wp.me/p5foE-2Vt

4] All posts on Lightning Process pilot study in children issue on ME agenda:
https://meagenda.wordpress.com/category/lightning-process-smile-study/

Parliament.uk

http://www.parliament.uk/about/how/business/written-answers/

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New blood donation policy for ME/CFS patients from 1 November 2010

New blood donation policy for ME/CFS patients from 1 November 2010

Shortlink: http://wp.me/p5foE-33U

ME Association

EXCHANGE OF CORRESPONDENCE BETWEEN THE ME ASSOCIATION AND THE CHIEF MEDICAL OFFICER: PROFESSOR DAME SALLY DAVIES

Resulting in the introduction of a new blood donation policy re ME/CFS as from 1 November 2010

August 16 2010

Dear Dame Sally Davies

ME/CFS and blood donation

I wrote to Sir Liam Donaldson on 27 October 2009 following publication of the paper in Science which contained the results of a research study that had found evidence of XMRV infection in people with ME/CFS.

In this letter I referred to The MEA website statement on XMRV, which called for the current UK ban on people with ME/CFS donating blood while being symptomatic to be extended to include anyone who had suffered from the illness in the past but now appeared to be in remission or had recovered. We felt this was necessary given the uncertainty over prevalence, transmission and possible pathogenicity of this infection.

Dr David Harper (Director General of Health Improvement and Protection) replied on 9 November 2009 by stating that this correspondence had been brought to the attention of the Director of the UK Blood Services Joint Professional Advisory Committee and that the situation was to be reviewed by the Standing Advisory Committee on Transfusion Transmitted Infections (SACTTI), who would be producing a risk assessment for the UK Blood Services and the Health Protection Agency. Dr Harper also stated that The MEA concerns had been brought to the attention of  the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) and the National Expert Panel on New and Emerging Infections (NEPNEI).

Relevant part of the 2009 MEA website statement >>

BLOOD DONATION AND XMRV

In relation to blood donation in the UK, current advice is that people with ME/CFS who have symptoms, or are receiving treatment, should not donate blood. It would seem sensible in the short term, until we know more about transmission and pathogenicity of XMRV, to consider extending this restriction to people who have recovered from ME/CFS. It seems strange that many overseas countries have not followed the UK lead on blood donation and ME/CFS.

The MEA has written to Sir Liam Donaldson, Chief Medical Officer at the Department of Health, regarding the possibility of XMRV being transmitted via human blood products and the implications that this has for blood donation.

The CFIDS Association of America has been issued with guidance from the National Cancer Institute regarding blood donation in the US. The guidance can be read on the CFIDS website.

We now understand, through a letter that is circulating on the internet, that a decision to extend the ban has been made.

Letter in circulation >>

Dear Ms xxxx,

Thank you for your email of 19 July to Andrew Lansley about the xenotropic murine leukemia virus-related virus (XMRV) and chronic fatigue syndrome/myalgic encephalomyelitis (CFS / ME). I have been asked to reply on his behalf.

The issue of XMRV was not specifically raised during the meeting on 20 July with campaigners from Tainted Blood. The National Expert Panel on New and Emerging Infections (NEPNEI) undertook a thorough assessment of the scientific data in June 2010 and concluded that although XMRV can infect humans, there is currently no evidence that it causes disease in humans. NEPNEI’s view is that development of a robust diagnostic tool to detect infection accurately is a priority for further investigation of this infection. Further work is required to investigate which human tissues are susceptible to infection, the epidemiology of infection and whether this infection is of any public health significance.

Both NEPNEI and the Advisory Committee on the Safety of Blood, Tissues and Organs have considered the current evidence and have recommended that no public health action is required at this time. However, the situation will be monitored closely.

In the absence of any infectious cause of CFS, people with this relapsing syndrome are currently excluded from donating blood while they feel unwell, in order to protect their own health. The UK Blood Services will shortly be amending its criteria to exclude such people from blood donation on a lifetime basis, bringing them in line with the practice of not accepting donations from people with other relapsing conditions. Whilst the purpose of this is to protect the donor’s health from any possible harmful effects from donating blood, it will also minimise the likelihood that donations from people who have ever suffered from CFS could enter the blood supply.

I hope this reply is helpful.

Yours sincerely,

Mary Heaton
Customer Service Centre
Department of Health
13 August 2010

We would therefore appreciate some further clarification on this important point and the date when the UK Blood Services will be bringing this extension into effect.

Could I also point out in relation to the opening sentence in the final paragraph of the above letter from Mary Heaton, that whilst it is true that the role for persisting infection in ME/CFS remains uncertain there is very sound evidence, as is referred to in Sir Liam Donaldson’s report into ME/CFS, to show that a variety of infections, predominantly viral, can precipitate this illness. There is also evidence of reactivation of latent viral infection (eg  EBV and HHV-6) in some of these patients.

Finally, you may not be aware that a number of other countries have followed the UK lead in banning blood donations from people with ME/CFS. These countries include Australia, Canada and New Zealand.

However, I find it surprising that no such precautionary action has been announced, at present, by those responsible for blood safety in America.

Yours sincerely

Dr Charles Shepherd

Hon Medical Adviser, ME Association

Member: CMO Working Group on ME/CFS (2002)

Member: MRC Expert Group on ME/CFS Research

ME Association
7 Apollo Office Court
Radclive Road
Gawcott
Bucks MK18 4DF

Website: http://www.meassociation.org.uk

REPLY RECEIVED 27 AUGUST 2010

Dear Dr Shepherd

ME/CFS and Blood Donation

Thank you for your further letter to Professor Dame Sally Davies, Chief Medical Officer (CMO) for the Department of Health, about myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and blood donation. I am responding on her behalf.

As of 1st November 2010, blood donors who report that they have had ME/CFS will be permanently excluded from giving blood in the UK. This change is being made on the grounds of donor safety, as ME/CFS is a relapsing
condition. It brings practice for ME/CFS into line with other relapsing conditions or neurological conditions of unknown origin.

The change to donor selection criteria is being made following a recommendation by the UK Blood Services Standing Advisory Committee on the Care and Selection of Donors, and Joint Professional Advisory Committee (JPAC).

Yours sincerely

Clara Swinson
Director of Health Protection
Department of Health

Wellington House, 133-155 Waterloo Road, London SE1 8UG

ENDS

Lightning Process pilot: Update and response from Research Governance Manager, DoH

Lightning Process pilot for children with CFS and ME aged 8 to 18: Update and a response from Research Governance Manager, Department of Health

Shortlink: http://wp.me/p5foE-30G

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

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

For joint ME charity statement and press release see:

Joint Press Release and statement: ME Association and The Young ME Sufferers Trust

Update

It’s now five and a half months since the RNHRD NHS FT Bath/University of Bristol announced its intention to undertake a pilot study looking into the application of the Lightning Process in children aged 8 to 18. The press release issued 2 March can be read here:  Press Release, a media article here: Media article.

Joint charity press release

On 4 August, the ME Association and The Young ME Sufferers Trust issued a joint statement and press release strongly opposing the pilot study and calling for it to be abandoned. Their joint press release can be read here.

The press release was issued too late for inclusion in the ME Association’s Autumn issue of ME Essential. But the magazine does include a write up, on Page 4, of the Advertising Standards Authority (ASA) adjudication against Lightning Process company “Withinspiration”.

ASA adjudication against Lightning Process company

In June, the ASA upheld a complaint against an advertisement in which unsubstantiated claims had been made about the efficacy of the Lightning Process for CFS and ME.

Read the full ASA adjudication against “Withinspiration” here

Alastair Gibson, the Lightning Process practitioner associated with the company, had let it be known in March that he was one of two Lightning Process practitioners involved with this controversial NHS study. This information no longer appears on the “Withinspiration” website and the current status of his involvement in this pilot study is unknown.

25% ME Group position

On 11 August, Simon Lawrence, Chair of the 25% ME Group Management Committee, confirmed that the 25% Group is intending to issue a position statement shortly and that my concerns and documents sent to them have now been passed on to their medical advisors, Dr Byron Hyde, Canada, and Dr Nigel Speight (former NHS paediatrician with a special interest in ME in children).

Requests for information under the Freedom of Information Act

On 22 July, I submitted a formal request to the University of Bristol’s Director of Legal Services for an internal review of their decision to withhold nearly all information around the study under FOIA Clause 22(1)(a). A response is due on or before 19 August. My request for an internal review can be read here.

On 3 August, I submitted a request for information to the National Research Ethics Service (NRES). This is due for fulfilment on or before 31 August. Questions submitted under FOIA around the application for ethics approval and the application timeline can be read here.

Responses from parliamentarians and government departments

In July, I approached my MP, Annette Brooke (Lib Dem, Mid Dorset and North Poole), for her involvement with this issue. (Mrs Brooke is the MP who gave the adjournment debate speech on ME before Parliament dissolved prior to the election and is now Vice-chair of the recently reformed APPG on ME.)

On 31 July, I received a copy of a paper letter from the Parliamentary Office of Annette Brooke to the Rt Hon Andrew Lansley MP, Secretary of State for Health, Department of Health, dated 29 July. Mrs Brooke has requested that the Secretary of State for Health look into this matter. A response is pending.

I also raised my concerns with the Countess of Mar, Lord Clement-Jones and Earl Freddie Howe, all three being Patrons to the Young ME Sufferers Trust. Earl Howe is the Parliamentary Under-Secretary of State for Quality.

My communication was forwarded by Earl Howe to Matthew Harpur, Department of Health.  Mr Harpur forwarded it to Bill Davidson, Research Governance Manager, Department of Health, who has responded on behalf of Earl Howe.

Response from  Bill Davidson, Research Governance Manager, Department of Health on behalf of the Parliamentary Under-Secretary of State for Quality:

30 July 2010

Thank you for your e-mail of 16th July to the Parliamentary Under-Secretary of State for Quality regarding a research project involving the “Lightning Process” in 8- to 18-year-olds with myalgic encephalomyelitis. Earl Howe has asked me to reply.

You are quite right that new treatments should be compared with current standards to see which is better. You are also right that this comparison should be made in appropriate participant groups.

New treatments are not generally tried out first in children before there is evidence of their safety and efficacy in adults, but sometimes it is appropriate to do so. It is a matter for a research ethics committee to be assured that the evidence supports the extension of the new treatment to children.

We require the decisions of research ethics committees to be independent and free from bias and particular stakeholder interests. It would therefore be inappropriate to have a mechanism through which particular stakeholders might seek to affect a research ethics committee’s decision. We require research ethics committees that become aware of a possible breach of good practice in research to inform the relevant authorities so that they can take appropriate action.

Our National Research Ethics Service publishes lay summaries of the research approved by research ethics committees. It is normal practice for researchers also to put details of interventional studies on an open-access register, before the first participant is recruited, unless there is very good reason for delaying disclosure.

I note that the outcome of the research ethics committee review of the proposal for this project has not yet been reached. I expect it will, in accordance with Department of Health policy, come to a decision that takes account of all the ethical issues, including the appropriateness of the proposed participant group.

Yours sincerely,

Bill Davidson
Research Governance Manager
Department of Health
Quarry House
Quarry Hill
Leeds LS2 7UE
Tel: 0113 254 6184 / 07900 164755
Fax: 0113 254 6174
E-mail: bill.davidson@dh.gsi.gov.uk
Web: www.dh.gov.uk