Friday, 23 August 2013

Conference Talks Online

A number of weeks ago I mentioned a couple of upcoming Christian conferences.  These have now both taken place and the talks from both of them are available online as follows –


Recovery from Spiritual Decline – Proving the Methods of Scripture

MP3 audio files and MP4 video files of all the talks can be downloaded from here  

A timetable of the conference can be found here



MP3 audio files of the talks can be downloaded from here  

Videos of many of the talks can be found on YouTube by clicking here 

A report on the conference is here


Monday, 19 August 2013

From Invest in ME: The UK rituximab trial - Status Update

http://www.ukrituximabtrial.org/Rituximab%20news-Aug13%2002.htm

Another update on the UK Rituximab Trial - I imagine there may be many more in the coming weeks and months!

August 2013

On 6th June Invest in ME announced that we were in discussions to set up a UK trial of rituximab for ME patients and since that announcement things have been progressing well. The charity had been working on trying to get such a trial started since the IIMEC7 conference - click here.       

In updates published through June/July, we have stated that all that is required for the trial to proceed is the funding.

As such, IiME began fundraising for this trial and invited everyone to support us in this project.

Recently we arranged a specific web site which has been set up to inform on all aspects of the UK rituximab trial. This is at - www.ukrituximabtrial.org

and we reiterated the current status - (click here)  

We have the facilities available.

We have the researchers available.

We have the best expertise possible available.

We have the means of fundraising for this trial available (see The MATRIX - click here) and we have a campaign to raise funds   

As we have agreed with our advisor, Professor Jonathan Edwards, the proposed clinical trial will undergo a rigorous peer review process.

We have reached this position thanks to the vision, efforts and help from Professor Edwards, Dr Cambridge, UCL and our supporters.

We have emphasised from when we announced the trial that the only element required is funding.

IiME will continue organising and raising funds for this trial. The IiME BRF Rituximab fund is specifically ring-fenced in a separate account for the UK rituximab trial.

The first part of the trial will be a preliminary study which will be designed to confirm and extend the earlier work of Dr Amolak Bansal (click here) on B-cells but using a different cohort of ME patients. 

Professor Edwards believes this is a useful study in its own right and a pre-requisite for the clinical trial. Meanwhile work is continuing on the design of a protocol which will be finalised after the trip to Bergen that IiME and Professor Edwards have arranged.

Good progress is being made and IiME are committed to expedite this trial as best we can. To achieve this IiME has recently been in discussions with a charitable foundation with a view to help in funding this work.

We are enormously pleased to announce that, thanks to the extraordinary generosity and support of the foundation's representative, our biomedical research fund for the UK rituximab trial has now reached £50,000. This is due to a donation from the charitable foundation which will match our existing BRF rituximab total of £25,000 - click here. The charitable foundation currently wishes to remain anonymous but they have asked us to keep them informed of the progress of plans for the trial and we are sure that the ME community will join us in thanking them for this wonderful support    

This now means that the first part of this project can be initiated by the UCL team without delay.

We thank all those who are supporting this trial and we will continue to provide information on the status of the trial as we progress.

We now resolve to increase our efforts to raise the remaining funds for the trial and ask for your continued support in this project in the knowledge that it will benefit all people with ME and their families.

The fundraising for this trial is being organised and coordinated by IiME so please contact IiME directly if you or your organisation would like to assist or contribute.

If anyone would like to ask any questions about the UK rituximab trial then please use the Contact form on the rituximab web site (click here).    

In summary we feel that the best research team possible to undertake this trial is now able to begin the work - taking a huge leap forward in ME research in the UK.

Thank you.


Saturday, 3 August 2013

The UK Rituximab Trial for ME


Professor Malcolm Hooper        Margaret Williams

2nd August 2013 

The charity Invest in ME has provided a truly remarkable opportunity to address one of the biggest medical scandals in history and to remove what in 2007 Alex Fergusson, Presiding Officer (Speaker) of the Scottish Parliament, referred to as “the cold grip of psychiatry” on myalgic encephalomyelitis (ME), which he said was “still far too deeply rooted in the world of ME”  (http://www.meactionuk.org.uk/Defiance_of_Science.htm).

Now, however, despite the power and control of the psychiatric lobby, thanks to Invest in ME and the invaluable support of Jonathan Edwards, Emeritus Professor of Connective Tissue Medicine at University College, London, (world-renowned for his work in B cell immunology and as lead researcher in the clinical trials of rituximab for rheumatoid arthritis), the neuro-immune disease ME is at last about to enter the realm of mainstream medicine in the UK under the guidance of Professor Edwards himself.

Invest in ME are at the forefront of international biomedical research and have by sheer determination and effort managed to put things in place for a trial of rituximab to begin on ME patients in the UK.  They recognise the urgency of the situation and know that many ME patients do not have the luxury of time. The charity already has the facilities in place, including suitably experienced researchers (Professor Jo Cambridge is now principal researcher at UCL, and the ME trial will involve the same team working under her that carried out the rituximab research in RA).

The Clinical Trials Unit at UCL is already working on the protocol, and Invest in ME have agreed with Professor Edwards that the protocol will be externally reviewed even though the UCL team will make sure it is cast-iron by their own internal reviewers.

Invest in ME have been told this trial could start relatively quickly if the charity had funds available. Such an opportunity must not be lost.  However, this will not happen without substantial funding.

We therefore ask everyone who is able to do so to donate whatever they can afford, in order that the UK rituximab trial can get under way as quickly as possible whilst the excellent facilities and committed staff at UCL and the active support of Professor Edwards remain available, so that ME can finally be recognised as the devastating multi-system neuro-immune disease that it is and – most importantly -- so that sufferers may at last have some hope of alleviation of their suffering.

Invest in ME have assured us that all donations to the rituximab fund will sit in a separate account which is totally ring-fenced, and should the trial not proceed, the following statement on the IiME website will be honoured –

What Happens With These Funds If The Project Does Not Go Ahead:
If the rituximab project does not go ahead for some reason then the funds raised will be transferred to the IiME Biomedical Research Fund to fund other biomedical research projects which are attached to our proposal for an examination and research facility based in Norwich Research park in Norfolk, UK. These funds will only be used for biomedical research into ME.

A UK trial of rituximab is essential to move ME out of the realm of psychiatric dogma and into the realm of medical reality.

Information on how to donate can be found on the Invest in ME website:  www.investinme.org 


In order to make it easier for ME patients, ME support Groups, charities, organisations, researchers and the media to find more easily and bookmark the central point for the UK Rituximab Trial, Invest in ME have set up a special micro-site to collate all of the relevant information - www.ukrituximabtrial.org


On a separate issue – but still ME related – the following is a new document that gives a detailed analysis of the “6 Minute Walking Test” which was used in the PACE Trial. 

‘Recovery’ in PACE, the 6 Minute Walking Test and Other Issues:
How Well Can ‘Recovered’ Patients Walk? (August 2013)
Susanna Agardy  (Australia)

For further info about the PACE Trial, please see –

Magical Medicine: How to make a disease disappear (February 2010)
Background to, consideration of, and quotations from the Manuals for the Medical Research Council’s PACE Trial of behavioural interventions for Chronic Fatigue Syndrome / Myalgic Encephalomyelitis, together with evidence that such interventions are unlikely to be effective and may even be contraindicated
Professor Malcolm Hooper



Thursday, 1 August 2013

UK Rituximab Trial


Statements By Professor Jonathan Edwards and Invest in ME - July 2013

Professor Jo Edwards

My interest in ME/CFS was sparked when I was invited, unexpectedly, by IiME to the IiMEC8 Conference in May.

The meeting was impressive: not just professional science, but at a high level. I was particularly impressed that negative findings were given adequate weight.

It became clear to me that there was a community committed to identifying and encouraging the very best research in a difficult and neglected field.

I was aware of the study by Fluge and Mella, using rituximab. I had not been surprised to see some patients respond, but the type of response, which was similar to what we had found in rheumatoid arthritis fifteen years ago, caught my attention. In fact, the situation seemed very reminiscent of the time when we first started to get results with targeted therapy in rheumatoid arthritis. We had the benefit of more immunological clues then, but on the other hand, the experience we have gained over the last decade now makes things easier in other ways.

My limited understanding of ME/CFS is that, like arthritis, it is probably several diseases with similar symptoms. Most colleagues who specialise in ME/CFS seem to agree. What the Fluge/Mella study suggests is that perhaps half of those suffering from these symptoms may have a B cell-dependent autoimmune disease.

A recent study by Dr Amolak Bansal and colleagues also suggests that B cells may be functioning abnormally in a significant proportion of people with ME/CFS.

To me, a key feature of this approach, unlike chasing one particular virus or gene, is that, if confirmed, it will provide a broad base for understanding disease mechanisms.

Even if rituximab is a cumbersome treatment in the short term its use may not only help a good proportion of patients directly but also begin to show us how to divide ME/CFS into different groups. So it may be useful even for those whose disease does not respond because once separated out from B cell-dependent disease the role of other factors such as NK cell function or cerebral blood flow may become clear.

Looking at the research directions currently being pursued in ME/CFS, I am in no doubt that the usage of rituximab is one of the most promising. There is clearly enthusiasm for further trials. However, rituximab is not an easy drug to use and many doctors do not feel confident with using it. This may explain why studies have been slow to gain momentum outside Norway.

Safe and effective usage requires understanding of B cell life history and function. Each condition has to be considered differently, especially in terms of when treatment is repeated. But with experience its use is very effective and probably as safe as most drugs.

After the IiME Conference I began thinking about my personal experience of patients and friends with ME/CFS. I was sent a copy of ‘Lost Voices ‘ by IiME, which made me think more. It struck me that, whether or not results are positive, further trials of rituximab for ME/CFS should be encouraged not only because impact on life for those affected can be so severe but also because further trials could give clues to disease mechanism. I am retired and would not be personally involved but have suggested to IiME that I would be happy to advise and to encourage others to set up a trial.

My feeling is that a trial should be carried out somewhere with detailed experience in use of rituximab in autoimmune conditions.

The UCL service set up when we started treating rheumatoid arthritis, lupus and a range of other conditions has the most extensive experience.

There is laboratory expertise in B cell immunology under Dr Jo Cambridge.

UCL also has a new Clinical Trials Research Facility with staff appointed to manage trials of this sort.

Importantly, there is enthusiasm amongst local teams for a rituximab ME/CFS trial.

I have suggested to IiME that this would be the ideal centre for such a trial, to be set up in collaboration with clinicians with expertise in ME/CFS from around London, and in particular Dr Bansal.

IiME have accepted this and this is the planned and preferred research base for this trial.

Clinical trials are costly. The trial planned in Norway to confirm the results from Fluge and Mella’s initial trial will cost something like £1-2M pounds. I think it would be most sensible to set up a smaller scale trial initially in the UK with a focus on trying to identify which patients are most likely to benefit. A trial treating about 30 patients, giving useful scientific information should hopefully be feasible for around £3-400,000. Trial design will require careful thought and some further preliminary laboratory work is likely to be needed before it is clear what design would be optimal.

Nevertheless, I am optimistic that a trial could be set up without major delay if funds can be raised. If the role of B cells in at least some ME/CFS, suggested by Fluge and Mella’s study, can be confirmed I think there is a genuine chance of getting to grips with the mechanism of the disease.

From there on things can only get easier.


Statement from Invest in ME:

The statement above from Professor Edwards is an astonishing opportunity for those patients with ME and their families.

To have somebody of Professor Edwards' standing produce such a statement, after agreeing to advise the charity following the IIMEC8 conference, justifies completely the conference theme of Mainstreaming ME Research.

This is a potential breakthrough for state-of-the-art biomedical research into ME.

We believe this study would add great value to other similar research being performed elsewhere.

It would also put the UK into the forefront of ME research.

There is no greater expert able to advise on a trial of rituximab than Professor Edwards who formally established the validity of B cell depletion in autoimmune disorders via his groundbreaking rituximab trials.

At the Biomedical Researchinto ME Collaborative meeting (BRMEC) organised by Invest in ME and the Alison Hunter Memorial Foundation Dr Jo Cambridge from UCL was invited by the charity to attend and present to the 40 researchers from nine countries gathered in London for the meeting. We felt it important to get the best advice possible to help with this area of ME research. Dr Cambridge added an enormous amount to the meeting – followed by a sincere and positive approach to progressing research.

UCL, as Professor Edwards has explained, has first-class facilities and we believe this opportunity is unique in the UK.

If the UK patient community wish to have a rituximab study then this is as good as it gets.

With the clinical team and Dr Cambridge at UCL performing this work, and with Professor Edwards as advisor, we are sure that a huge leap in understanding ME will be possible.

IiME have managed to work with the experts to set up this possibility. As Professor Edwards states “a trial could be set up without major delay if funds can be raised”.

Our fundraising campaign now must begin in earnest.

We invite everyone to get behind this UK rituximab study and support us.

We welcome contributions from other organisations and companies and individuals. The quality of the researchers and the facilities is beyond doubt.

IiME will contact other organisations to invite them to donate to this cause. One organisation has already indicated it will support a rituximab trial – in fact the MEA chairman has publicly stated on 29th July to an IiME supporter - “Let us know when you find some good quality researchers with a peer reviewed proposal. We have £60,000 in a ring fenced pot awaiting such a development.”.

We now have the researchers willing to perform this trial in the UK.

The quality of the researchers and the facilities at their disposal place the capability of the UCL team to perform this trial beyond doubt.

What Next?

There is enthusiasm for setting up a study at UCL.

UCL can take this forward in collaboration with Dr Bansal and with close liaison, including visits, with Bergen. This has been agreed.

A meeting has been arranged for Professor Edwards to visit Bergen to discuss with Dr Fluge.

Further trips by the UCL team would be a possibility and will be arranged by the charity.

We welcome this as this will undoubtedly help both the Norwegian and the UK studies.

We need to raise funding for this study so we urge all our supporters, and others who wish to have a UK rituximab trial or wish to advance biomedical research into ME, to raise awareness and interest from as many sources as possible and support us in this venture.

This UK rituximab study has been initiated by IiME and the UCL staff who were at our conference and BRMEC research meeting.

The best research team possible to undertake this trial is able to perform this.

We need now simply to fund this.

Please support us in this venture.

Donate to the UK rituximab Trial - click here