Your questions answered about the ME/CFS Biobank

August 10, 2011

Three charities – Action for M.E., the ME Association and ME Research UK – and a private donor have joined forces to fund the UK’s first biobank of human blood samples for research into the causes of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (M.E./CFS).

The biobank will be situated at London’s Royal Free Hospital where it will be able to link in with the extensive research facilities at University College London.

The principal researchers are Dr Eliana Lacerda and Dr Luis Nacul, of the London School of Hygiene and Tropical Medicine.

What is the biobank?

The aim of the project, starting in August 2011 and lasting for 15 months, is to set up a biobank consisting initially of blood samples from clinically well- characterised cases of M.E./CFS and healthy controls.

With the creation of the fundamental infra-structure required to underpin a disease-specific biobank for M.E./CFS in the long term, the research community would have access to a well-characterised cohort of patients with biological, clinical and laboratory data attached.

Can I donate blood to the biobank?

Not yet. But by Christmas you will be able to register your interest (see below). Initially, blood samples will only be collected from a group of patients currently enrolled in the M.E./CFS Disease Register*, including the Case History Research on M.E. (CHROME) database of severely affected patients.

*The M.E./CFS Disease Register is one of six subprojects within the National M.E./CFS Observatory, a research programme funded by the Big Lottery Fund and sponsored by Action for M.E. It established a pilot for a national disease register of confirmed cases of people with the illness. The study recruited 29 general practices in East Yorkshire, East Anglia and London which recorded all cases of M.E./CFS they had under their care.

If I can’t donate now, when can I?

The earliest time that we expect to be able to accept blood from other donors is late 2012.

Why can’t I donate blood sooner?

The timing is determined by the availability of funding. Initially the biobank has been funded to run until November 2012.

After this time, we hope that one of the major medical research funding organisations (eg. the Medical Research Council, the National Institute for Health Research, or the Wellcome Trust) will decide to provide funding for this vital piece of research infrastructure on a long-term basis.

If such core support does not materialize, then the three charities funding the biobank (Action for M.E., the ME Association and ME Research UK) will work together to maintain the biobank at whatever level of activity can be achieved with available charitable funds until a major source of long term finance can be found.

The availability of funding may determine the geographical areas in which assessments and blood donations can take place.

How can I register my interest in donating blood to the biobank?

The precise arrangements are still being worked out by the three charities with the research team at London School of Hygiene and Tropical Medicine and we hope to be able to announce them before Christmas.

We have to ensure that the procedure we adopt is legal under the Data Protection Act. As soon as we have a system that has been independently confirmed as being compliant, we will advertise details in our publications (ie. InterAction, ME Essential and Breakthrough) and on the websites of all three charities and of LSHTM. We hope to be able to announce these arrangements before Christmas.

How will samples from severely affected patients be collected?

A research health professional will visit these patients in their homes and immediately dispatch samples via authorised courier or in person to arrive at the biobank within six hours.

Is it safe for M.E. patients to give blood?

Blood donation in this case means “blood samples of 50 – 60 ml (which is approximately 10 – 12 teaspoons), including the amount for lab tests and for long term storage.

There is no evidence that giving this amount of blood exacerbates patients’ symptoms, but adverse effects will be monitored by asking all participants to complete a specific form in the days following blood-sample drawing.

What criteria will be used to select donors?

All selected donors must have received a diagnosis of M.E./CFS at some time in the past. However, as there are inconsistencies in how the diagnosis is made in primary, secondary or tertiary care, it is essential that all cases are newly assessed by a health professional trained in the diagnosis of M.E./CFS. Patients will be assessed on whether they fulfill the CDC-1994 (Fukuda) criteria and the Canadian 2003 criteria.

Since cases meeting the Canadian criteria have been shown in most cases to also meet the Fukuda criteria, this will enable the sub-grouping of cases into those meeting and not meeting the Canadian criteria, throwing light on the appropriateness of the different classifications. In due course comprehensive phenotyping (Phenotyping =.categorizing patients based on their clinical information) of patients may enable categorisation of individuals according to other clinical criteria.

Patients will be excluded from donating samples if they have
• recently used (in the preceding three months) drugs known to alter immune function, eg. anti-viral medications and vaccinations
• acute and chronic infectious diseases such as hepatitis B and C, tuberculosis, HIV (but not herpes virus or other retrovirus infection)
• other severe illness and mood disorders.

What information will be collected about each donor?

Subjects will be assessed using standard forms that enable the confirmation of an M.E./CFS diagnosis according to study criteria. This will be complemented by a number of tests and the completion of study forms (self-completed or completed with the aid of a next of kin, in cases of very severe M.E./CFS).

These will enable further characterisation of cases according to clinical data (phenotype), disease severity and, for cases and controls, in relation to a range of demographic (i.e. age, gender etc), socio-economic and other exposure variables, which were chosen based on our previous experience at the M.E./CFS Observatory and the practices at the existing UK Biobank.

The following additional instruments will be used to characterise participants: Medical Outcomes Survey Short Form-36 (SF-36), for assessment of functional capacity and quality of life; the pain analogue scale, for the assessment of pain severity; the fatigue severity scale and energy fatigue scale; the Mini International Neuropsychiatric Interview (MINI); and the Epworth sleepiness score.

In addition to a full history and clinical examination, all donors will undergo a detailed physical assessment and laboratory tests including full blood count, blood chemistry, liver function tests, erythrocyte sedimentation rate, c-reactive protein, rheumatoid factor, thyroid function tests, tissue transglutaminase antibodies, serum vitamin B12, red cell folate and urine analysis.

Confidentiality is a key element of biobanking. Data will be anonymised and confidentiality will be preserved, with identifiers kept securely in separate files at the LSHTM, and used solely for the purpose of linkage of data with samples. None of the funders of the project will have access to patient data.

What sort of research will the biobank be used for?

The biobank is intended to be a key resource for biomedical research and is expected to be particularly useful for studies investigating phenotypes and biomarkers for diagnosis and prognosis.

How will researchers gain access to samples from the biobank?

Applications to use the biobank for research will be subject to a formal approval process before issuing anonymised blood products together with clinical information about the donors. The approval process will include external ethical approval from a duly constituted ethics committee, either within a university or the NHS. An expert panel will be set up to manage the approval process. Details will be announced in due course.

15 thoughts on “Your questions answered about the ME/CFS Biobank”

  1. A tremendous step forward towards beneficial research, making ME an indisputably medical entity, and silencing the psycho-lobby.
    Congratulations and sincere thanks to everyone involved in the planning and implementation.

  2. Not all those meeting CCC also meet Fukuda. Does that mean those people will be excluded?

    Also, what definition of PEM will be used? Reeves has redefined PEM to be what any sick person gets, or someone who is decondition. How will you ensure it is PEM and not anyone and everyone who is included in the CCC group?

  3. Also, will you be insisting that any studies that use this will have CCC patients and separate Fukuda patients? After all, Fukuda is not actually a diagnosis of anything as it relies on exclusion and is not a discreet disease. So if we only have studies using Fukuda there will be no progress.

  4. •acute and chronic infectious diseases such as hepatitis B and C, tuberculosis, HIV (but not herpes virus or other retrovirus infection)

    Does that include human gamma retroviruses? And are you including people with HTLV?

  5. Thank you so much for the work that has gone into setting up this initiative. And a huge thanks also to the private donor, God bless you.

  6. After the past week’s debacle in the press etc i feel really encouraged by this. We needed something positive this week.
    Well done MEA

  7. May I ask how much in total it has cost for these 3 charities and private donor to fund the first 15 months of this excellent project?

    I ask, not out of mere idle curiosity but as a comparison with the costs of other types of research and management techniques and as a fraction of the MRC £1.5m budget, or from other charitable sources, such as for Dr Esther Crawley’s SMILE project.

    Further, may I ask how much you estimate that you would need, annually, to sustain its work and, if the MRC or other awarding body were not to fund it, what would need to be sacrificed if it had to rely on charity. I can speak only for this organisation but I am fairly confident that other individuals and organisations would rally in support of such a welcome innovation, especially after the body blow of the M.E. “death treats” story. Thank you for some good news at last.

    Best wishes
    Dr John H. Greensmith
    M.E. Community

  8. Dr Charles Shepherd

    John – Thanks for the very kind message of support.

    The cost of setting up the biobank is around £172,000. This is being split amongst the three charities and the very generous private donor, who is a member of the MEA.

    The on-going cost of running the biobank, once this start-up phase is over, is obviously going to be significant and will depend on the way it operates and expands Rather than give you an inaccurate estimate I will go back to the feasibility study paperwork, which looked at costings in detail, and come back to you with an answer.


  9. Thank you for this project, it sounds like it will be a good step forward.

    Since it is likely that those diagnosed with either Fukuda or CCC contain subsets suffering different illnesses, will there be a list of the symptoms suffered by each patient attached to their samples?

  10. Thanks for getting back so quickly with part 1 of the answer, Charles,

    That sounds to me not only excellent value but the best money I have ever heard of being spent of people with M.E.

    That’s why I wanted to see it and future estimates to compare with much larger sums that are being found to fund things we could do without and are not helping, no matter how they try to talk it up.

    (I’ll be a volunteer if there is tea and biscuits afterwards and you promise not to take an armful )

    Best wishes

  11. “Patients will be excluded from donating samples if they have

    • other severe illness and mood disorders”

    So as a depressive who was diagnosed with ME almost seven years ago as a separate condition, I would be excluded? You’re going to exclude anyone with depression?

  12. Dr Charles Shepherd

    The reason why we are excluding people with other illnesses and pathologies at this stage is that we want to be able to provide researchers with blood samples from people who do not have other health problems.

    These sort of exclusions already form part of the various recognised research criteria for ME/CFS.

    And we are not saying that you cannot have ME/CFS and depression.

    In the future it may well be useful for research purposes to have blood samples from people with ME/CFS who also have depression.

  13. I think this is so exciting and I too would like to express my heartfelt thanks to all those people involved in organising this fantastic potential step forward.
    Brilliant……….I’m going to have real difficulty stopping myself getting too excited so that I can sleep! But who cares this is worth it!

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