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12th May 2010

Dear Sir Liam,

In a letter to you and other European health ministers and chief medical officers from the European ME Alliance (EMEA) of 26th April 2010 (1), a call was made for a Europe-wide ban on people with ME be implemented in order to safeguard the blood supply. The chairman of EMEA has passed on the comments from your reply to Invest in ME, and the other members of EMEA (2).

Your comments reflect those returned to Invest in ME by the UK Secretary of State for Health, Mr. Andy Burnham, in reply to a letter from Invest in ME of 14th March 2010 [3].

As Mr Burnham’s letter, via the Department of Health (DoH), and your reply to EMEA both seem to be using the same text from the same template then we can assume that you and the secretary of state share the same views on ME and blood donation.

Owing to the recent UK general election and the uncertainty surrounding the future government we request that you speak for the health of the citizens of the UK, which is the remit of your position, and we hope you will be able to answer our questions and take forward these issues to the new UK government when that is formed.

May 12th is ME Awareness Day around the world, in a month which has become ME Awareness Month – a necessary feature of the calendar which continues to mark the untold suffering of patients with this neurological illness which neither government nor chief medical officer and certainly not the Medical Research Council seem willing to end.

The reply from the DoH did not challenge the presumption that Mrs Keen’s original comments (4) were representative of the government. We can, therefore, continue to assume that the government and, by implication, the Chief Medical Officer, consider that – people with ME/CFS are in need of proper healthcare provision which treats the disease properly blood supplies may be compromised and contaminated by accepting blood from people with ME as donors due to the organic nature of this disease that an embargo on people with ME donating blood would mean that there is an infectious agent at work which could be passed on via blood

Mr. Burnham nevertheless failed to answer the questions we put and have, in his reply, raised more issues.

It was stated that “Decisions over who can give blood are based on a relationship of trust with each donor, which assumes the information they provide is honest and accurate”.

• What happens in the situation where the donor is not aware that they have ME – either because it has taken so long to diagnose them, or that they have been mis-diagnosed, or that they have not been aware that ME is an infectious illness - which your statements now support?

It was stated in your letter and that of Mr Burnham that “People with CFS/ME are temporarily excluded from donating blood on the basis that the condition has been diagnosed by an appropriately qualified clinician.”

• Please can you specify what is meant by temporary – is this for one month, one year or more?

It was stated in your letter and that of Mr Burnham that “If a donor has any doubts about whether they have been diagnosed with CFS/ME, with their permission the National Blood Service (NBS) would contact their GP or specialist for further information.”

• What happens if the GP does not believe that ME exists (which, from the number of supporters contacting us would seem to be a majority in the UK)?

• What if the donor in question has not seen a GP for years due to their being no services available for people with ME?

Mr Burnham’s letter stated that ”Health professionals are free to use their clinical judgement, and whatever guidelines they choose, for the diagnosis and treatment of CFS/ME.” We are aware that NICE has produced a document which purports to contain guidelines to aid diagnosis and treatment. You will no doubt be aware that ME patients took NICE to a judicial review so appalled were they that these guidelines lacked any analysis of the biomedical research into ME.

• Does the answer from DoH thus mean that doctors really can use any criteria that they so choose to diagnose ME?

• Does this carte-blanche for doctors to use their own criteria apply to other illnesses?

• If this is so then how is it possible to diagnose ME effectively?

• Should not each diagnosis be objective rather than this very subjective view?

• When using the Oxford criteria (which the MRC allow to be used for the psychiatric PACE trials which they fund in favour of biomedical research) which exclude patients with a neurological illness how can accurate diagnosis be made?

• As the government and the WHO recognize ME as a neurological illness (under WHO code ICD-10 G93.3) then how is it possible to use any criteria such as is deemed appropriate by the individual doctor who may not believe that ME exists?

• Does this not show a gaping hole in government, CMO and MRC policy in not using a standard clinical guideline for diagnosis of ME, such as the Canadian Consensus – which Invest in ME have been promoting as the standard to use for many years?

• If doctors can use any guidelines they wish then does this not pose a huge risk that ME patients may be missed and therefore the blood supply could become contaminated?

You have written that “UK donor selection guidelines state that people who have previously been diagnosed with CFS/ME are able to donate blood once they have recovered and are feeling well. There is no set timescale for this, and no additional diagnostic tests are carried out before they can donate blood. “

• Where in the UK donor selection guidelines does it specifically state that people previously diagnosed with “CFS/ME” are able to donate once they have recovered?

• Please can you answer our original question posed to Mr Burnham of how one is to be defined as “recovered”?

• How is it possible to determine if a person with ME has recovered when, in your own admission, there is no diagnostic test to be carried out?

• You state that no diagnostic tests are carried out before people with ME can donate blood. How can you guarantee the blood supply has not been contaminated if no diagnostic test is performed?

• What does “feeling well” mean and how does “feeling well” affect the contents of one’s blood?

• If a person with HIV “feels well” are they then able to donate blood?

• Is this a universal description of the qualifications to donate blood which can be applied to all health conditions?

• Is it the responsibility of the person with ME to determine if they are “recovered” or “feeling well” in order to offer their blood?

• Is it really true that there is no timescale that exists for a person with ME to “feel well” before they can donate? If so how do you cater for the possibility of relapse with ME – something that is a common feature with ME?

• In your letter you state that people with ME are temporarily excluded from giving blood. Yet here you say that there is no set timescale. Why?

Referring to details of the current relevant donor selection guidelines Guidelines for Blood Transfusion Services in the UK, published by the Joint United Kingdom Blood Transfusion Services and National Institute of Biological Standards and Control Professional Advisory Committee (JPAC), at www.transfusionguidelines.org.uk - there is no specific mention of ME/CFS necessitating permanent deferral, even though ME/CFS is seen as an infectious disease, probable CNS disease.

• With such a poor, unscientific approach to diagnosis of ME/CFS which you have provided how is it possible to be absolutely certain that no patient with ME/CFS is donating blood, unaware of possible contamination?

• With such an unscientific and risible approach to diagnosing recovery which you and the DoH have shown how is it possible for patients to accurately know if they have ME/CFS still?

The rest of the letter from Mr Burnham concentrated on the spin promulgated by NICE and your government in recommending use of CBT and GET – both approaches almost unanimously rejected by the ME community, save from two charities who receive money from the government to support government policy.

• How is it possible that use of CBT and GET answer the questions relating to the danger of infected blood from people with ME/CFS?

• Will using CBT (to behave better) or GET (to exercise the viruses out of the system) be enough to make a person with ME/CFS recover, or “feel well”?

• Where is the science that proves that CBT and GET will remove a retrovirus from one’s body?

Mr Burnham commented about the lack of information regarding the numbers of people diagnosed with CFS/ME and admitted that this information is not collected nationally.

• Does this not seriously undermine any policy of the government toward ME and blood donations?

• How are you able to make any sensible statement about the threat to blood supply when you have no statistics to inform of the prevalence?

• If no body is collating information on numbers of people with ME/CFS then how is it possible to develop appropriate services for ME/CFS?

• Without effective diagnostic criteria which are standardized for diagnosing ME/CFS then such numbers would mean very little anyway.

Canada and Australia[3] have banned blood donations. Belgium does not allow it. New Zealand's blood banks plan to reject donors with a record of chronic fatigue syndrome [4]. Recently the CFS Advisory Committee in USA, a Federal agency, recommended to the US Secretary of State for Health [5] that donations from ME patients be banned.

Against this background of countries banning blood donation it seems that the citizens of the UK receive this extremely poor, ill thought-out and unscientific advice based on standard DoH templates - which helps neither healthcare staff nor patients and places in jeopardy the integrity of the UK blood supply.

• Does your reply not clearly show that the government, yourself and Medical Research have completely failed patients with ME in this country for a generation when -
• you cannot specify a diagnostic test for ME/CFS
• you cannot accurately define when a patient has recovered
• you cannot provide details of the number of people with ME/CFS
• you cannot provide statistics for the number of people recovered from ME/CFS
• you cannot provide a medical description to describe recovery for a person with ME
• you allow people can continue as if nothing has happened as long as they “feel well”.
• Would it not be sensible in the short term to use the same strategy which the Chief Medical Officer used when the H1N1 influenza virus was occurring in UK, whereby he mounted a publicity offensive to make people aware of the danger of H1N1 and the precautions which needed to be taken?

• Do the people of this country who receive blood transfusions not deserve the same degree of awareness of the potential danger to their health from receiving blood supplies from people with ME/CFS?

Our reply to you is long and reflects the fact that the government failed to answer questions which were put to them and that you have failed to show leadership on a subject as serious as this.

It may well be that a different government, or a different minister may be in place by the time we can expect a reply to this letter.

We therefore request that the civil servants who read this letter ensure that the incoming Secretary of State for health and the new Chief Medical Officer are made aware of this letter and provide a reply to us.

We have also copied this letter to the Conservative, Labour, Liberal Democrat, Scottish Nationalist and Plaid Cymru parties.

We hereby request responses from each of these parties.

To make it easier we have summarised our questions to you [6] and we would appreciate an answer urgently as the health of millions of people in the UK could be affected.

The 5th Invest in ME International ME/CFS Conference 2010 will take place on 24th May in Westminster. With more data and new research being presented at the conference the case for enforcing a ban on blood donations from people with myalgic encephalomyelitis is overwhelming.

The need for a clear strategy of biomedical research into ME in order to provide proper treatments based on proper science is imperative.

We urge you to use your remaining time in office to initiate real change and support Invest in ME in its calls for a new era in ME/CFS research,

Yours Sincerely,

The Chairman and Trustees of Invest in ME

References:

1 EMEA letter http://www.euro-me.org/news-Q22010-005.htm

2 CMO reply to EMEA http://www.euro-me.org/news-Q22010-005%20R-UK.htm

3 Australia's Red Cross Blood Service is reviewing its donation guidelines after Canada halted donations from people who have had chronic fatigue syndrome http://news.smh.com.au/breaking-news-national/cfs-link-prompts-blood-donation-review-20100420-sr25.html

4 New Zealand's blood banks plan to reject donors with a record of chronic fatigue syndrome (CFS) http://www.voxy.co.nz/national/chronic-fatigue-set-disqualify-blood-donors/5/45805

5 USA CFS Advisory Committee click here

6 Invest in ME 40 questions click here

Invest in ME
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Letter from IiME ME to Secretary of State for Health 14th March 2010 click here

Reply from Department of Health 14th April 2010 - click here