Firestormm
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I am rather laid up today - but you might all like to read the statement in full that was posted this morning. Dr Shepherd is taking questions on the MEA Facebook page at the moment if you have any.
It does go into a lot of detail about the regulatory hurdles and likely costings etc. Haven't read all of it myself but will try and come back to it later.
What is the ME Association doing about Rituximab?
by Tony Britton on July 8, 2013
STATEMENT FROM THE ME ASSOCIATION
Unlike the situation with XMRV, where The MEA took a very cautious and sceptical approach from the very beginning, we have consistently maintained that the positive results from the initial case study reports, followed by the results from the phase 2 clinical trial [1] carried out in Norway [2], indicate that Rituximab could form a very significant development in finding a drug aimed at treating the underlying disease process in at least a sub-group of people with ME/CFS – possibly in those with a distinct disease pathway/immune system profile.
However, the fact that some of the anecdotal reports from people who have been prescribed Rituximab, but are not part of a formal clinical trial, have been disappointing (in relation to efficacy) or concerning (in relation to tolerance/side-effects) also has to be taken into account.
What has The MEA done so far?
We have been following all the key developments regarding Rituximab – research-orientated and aneotal – very closely and Dr Shepherd was with the two Norwegian researchers, Drs Øystein Fluge and Olav Mella, at the three day Open Medicine Institute research meeting in New York last year.
Dr Shepherd has also had discussions with a number of UK researchers and clinicians who might be interested in carrying out a clinical trial here in the UK (or peer reviewing the protocols) and has reported back to The MEA Board of Trustees at their regular meetings. His report to the April 2013 meeting can be found at the end of this statement.
We have also produced a comprehensive Question and Answer information sheet on Rituximab.
The MEA website version can be found here: www.meassociation.org.uk/?p=8459
Following the results of the phase 2 clinical trial, which indicate that Rituximab appears to be a safe and effective treatment for at least a sub-group of people with ME/CFS, we very much welcome the news that the Norwegian researchers do now have government funding to proceed with a phase 3 clinical trial [3]...
Read more....
It does go into a lot of detail about the regulatory hurdles and likely costings etc. Haven't read all of it myself but will try and come back to it later.