The MEA have pledged £50,000 to support a UK clinical trial into Rituximab – following the news that Norwegian researchers now have government funding for a phase-3 clinical trial.
And our Ramsay Research Fund will ring-fence extra donations for Rituximab research for two years while we wait to find out if such a trial can be organised. This summer, we have already received a donation of £8,000 towards such a study.
“If we are unable to take this forward within the next two years, the money will then be used for other biomedical research funded by the Ramsay Research Fund,” said MEA medical adviser Dr Charles Shepherd.
There is now an urgent need to see if other clinical trials can be arranged outside Norway to see if the Norwegian results can be replicated in another lab.
The Norwegian work has given early indications that the drug has a measurable effect in treating the underlying disease process in at least some people with ME/CFS.
In a statement first put on the MEA website on July 8 – www.meassociation.org.uk/?p=16046 – Dr Shepherd says the efficacy and safety of the drug has to be demonstrated in multi-centre trials in order to get a product licence from the drug regulatory bodies, and then pass muster at NICE and The Scottish Medicines Consortium.
“What is so disappointing at this stage is that these replication trials are still not taking place‚ either here in the UK or elsewhere in the world,” said Dr Shepherd.
“This means that we are still several years away from looking at a product license for Rituximab, if it does turn out to be a safe and effective form of treatment for some people with ME/CFS.”
Anyone can now make a Rituximab research donation to the MEA Ramsay Research Fund, knowing it will be kept for that purpose for the next two years.
To donate to The MEA Ramsay Research Fund, send a cheque made out to The MEA Ramsay Research Fund to:
The ME Association
7 Apollo Office Court
Radclive Road
Gawcott
Buckingham MK18 4DFOr donate by credit/debit card by calling the MEA Buckingham office during office hours on 01280 818964 or 818968 and speaking to Gill or Helen.
When paying by cheque or calling the office to make a card payment, please specify that the donation is for the Rituximab trial.
All donations will be recorded by name (or anonymously if preferred) and the total listed at regular intervals on the MEA website.
All money donated to The MEA RRF is ring-fenced for research purposes. There are no salaries to pay and all the administrative expenses relating to our research projects are paid out of MEA general funds.
It appears that IiME has set the wheels in motion for a trial of Rituximab to take place at UCL; does the MEA have any plans to join forces with IiME, I wonder?
If all ME charities collaborate, the trial could take place in the near future.
Real science – real medicine – real progress – real hope.
This is good news and I hope the MEA can pool funds with IiME so the trial can start sooner.
Comments posted by Dr Shepherd on MEA Facebook on Wednesday, 31 July 2013:
1 The MEA Ramsay Research Fund is very keen to help fund a high quality clinical trial to further assess the safety and efficacy of Rituximab in ME/CFS here in the UK and to see if the results from Norway can be replicated
2 We have made this position very clear in our statements on Rituximab dating back to 2011 when I first approached Professor Edwards (and others) for their advice and input on the way in which a UK clinical trial could/should be set up
3 We have set aside the sum of £50,000 from existing RRF research funds and received ‘ring fenced’ donations amounting to around £8,000 – making a total of around £60,000
4 I have again been discussing the possibility of a UK clinical trial with Professor Edwards (and others, including Professor Stephen Holgate) before going away on holiday and had a further very helpful telephone conversation with Professor Edwards this morning
5 I am very happy with the ideas he is putting forward for a small clinical trial which will hopefully turn into a formal proposal for funding at a later date
6 Provided the proposal meets the high standard of peer review that all research funded by the MEA RRF insists on we will be very happy to help fund a trial at UCL – which is where the ME Biobank is also situated
7 When I first discussed the possibility of a UK clinical trial with other research colleagues it emerged that the likely cost could be in the region of £400,000 – which is why we have suggested that the best way to get this moving would be a joint charity fundraising effort
8 I have already discussed this with most of the UK ME/CFS research funding charities and written to Invest in ME to suggest that it would be helpful to have a meeting of interested charities to see how a joint fundraising effort could be taken forward
9 I also confirmed to Professor Edwards this morning that the MEA RRF would be very happy to consider any funding proposals for preliminary work on immune function etc that may well be required before a clinical trial takes place
10 The MEA RRF is already funding Dr Amolak Bansal to carry out research in another area and is very happy to see that he is involved in this initiative
It’s also worth noting, as in the MEA statement, that the licensing authorities will require strong and consistent evidence of both benefit and safety in relation to a very expensive drug such as Rituximab before it could be made available on the NHS as a possible treatment for ME/CFS here in the UK
Positive results from Norway plus a positive result from a small clinical trial in the UK will definitely help to take this process forward but will not be enough
This is just the start of what is likely to be quite a long process of establishing (or not establishing) a new and important use for Rituximab……..
MEA Facebook: https://www.facebook.com/pages/ME-Association/171411469583186