Discussion in 'Phoenix Rising Articles' started by Mark, Aug 12, 2013.
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Thanks Sasha for this article. It is real exciting news!
That's wonderful news to end my hectic day. Thanks Sasha I needed that.
Mmm MEA have pledged that money to be ring fenced for *A* Rituxan trial...but as far as I know they haven't offered it to 'THE' trial ie: THE Invest in ME trial.
Thanks for a great summary of what's happening with Rituximab, I've found it all very confusing.
I still don't really understand why the study is so small. I know there is extensive discussion of this on the main thread - which I've only dipped into - and Jonathan Edwards seems to be saying that a small study can be more tightly controlled than a large multi-centre one. I can see the logic that a smaller replication study would have been a better place to start, but given that the large study is already largely funded and plans are well-developed for it, I do wonder how much 'value' a smaller study will add in practice. Any pointers on this appreciated.
Hi lilpink - Charles Shepherd clarified on the MEA Facebook page that this is the same trial, i.e. the one initiated by Invest in ME, for example in this statement:
https://www.facebook.com/permalink....comment_id=5247930&offset=0&total_comments=77Yes, this is the trial that Professor Jo Edwards is advising onYes, this is the trial that Invest in ME are fundraising forYes, this is the trial that the MEA is very happy to help fund (we have around £60,000 raised so far) - provided it passes the peer review procedures referred to in my 10 point statement and the MEA website statement
So, a superb achievement by IiME in initiating the trial, an excellent example set by the MEA early in the game for other UK charities who might donate and speed up this whole process. If the charities work together, we could have very substantial funds for this within a few months. I don't know if there's any scope for work to begin before full funding is obtained as has been the case in the Norwegian trial (it's not yet fully funded) but clearly, the sooner we get big money together, the sooner this is going to happen.
Thanks, Simon - one for Jonathan Edwards there!
Oh, oops - actually that's a good one for the interview, I'll bung that question on the list.
Maybe because there is no trial?
At least at present. Once something has actually been proposed by UCL, and if a Trial recommendation or other form of research (see Prof. Edwards' thread and comments from him), is outlined; then the other charities might - once peer reviewed - invest with IiME or directly with UCL.
You have to remember that the other charities need to do right by their own members - the ones who actually entrusted the money to them. There are rules they need to follow.
Currently, IiME have said they would effectively 'own' all funds donated to their Rituximab Fund and if a Trial did not proceed they would then reinvest within their own organisation's 'biomedical' research programme.
Such a thing is probably not acceptable to the other charities who in such an event might want the money back.
I sincerely hope it can all move forward and become clearer when we hear something concrete from UCL. I suspect we are talking months rather than weeks - but maybe Professor Edwards will reveal more or Dr Cambridge once he returns from Norway.
Great write up Sasha and very accurate - thank you! Just one comment to make. If Action for ME do make a donation, there will be NO collaboration. This is my opinion. Action for ME and a few other charities have already joined A collaboration of which Invest in ME will have nothing to do with since the likes of Simon "I didn't say that" Wessely and Esther "only poor people who have been abused as children get ME" Crawley - are involved. I should think that as with the ME association, a donation will need to be made and then Invest in ME can be left to do what they do best: what many of the patients need, and what many of the patients want.
I agree that no charity is likely to want to donate to another charity - I've never seen research funding work that way and in fact there's no need for it or advantage to it. In joint funding, charities donate via the research team's parent body (some bit of UCL in this case, probably). As you say, if other charities all donated to the IiME Rituximab fund and for some reason the trial doesn't come off (and it's only responsible to have a fallback plan for that), Invest in ME would end up holding tens of thousands of pounds that the original donors had given to the original charities and that would hardly be fair to those donors. The trustees of those charities might be in trouble in such a case.
I don't think we'll see donations at this point - in a sense, even IiME haven't donated their own money to the trial, unless they've already paid money over to UCL. They're quite correctly ringfencing it in their dedicated Rituximab fund - but someone please correct me if I'm wrong. The normal thing to do at this stage, when there's no protocol in place ready for submission to charities' peer grant-giving processes, is to ringfence it, and that ringfencing is very, very welcome indeed. The MEA have made it clear that they're keen to fund this, subject (responsibly) to peer review, and I expect other charities will be too. In the meantime, ringfencing funds gives a big signal to all donors that this is a viable project that they should donate to. It will also give a big signal to the MRC.
Thanks for the kind comments, Heart Face. I think we cross-posted and my comments on the post below yours address this issue of why other charities wouldn't be expected to donate directly to IiME for this project, but rather directly to the trial (i.e. the appropriate bit of UCL).
If AfME or any other charity ringfence funds for this, and donate to the trial (i.e. to the appropriate bit of UCL), that will be money direct to the trial. The only 'collaboration' going on is to collaboratively fund and whatever one thinks of any particular charity, it's all cash and it's going to speed up funding of the trial.
We've got to put the trial first in this. There's some difficult history in the UK, of course, but it would be a terrible shame to let that history delay or destroy our chances of moving forward quickly with the trial. If the results of the trial confirm the Haukeland findings and establish ME firmly in the public and medical mind as an immune condition treatable by an immune drug, everything changes for us and the psychosocial model gets left in the dust. Our disease will be validated as an immune disease, the research funding coffers will open, and our world will change. We've got to fund the trial as quickly as we can.
Mmmm but he still hasn't said for sure it's going to the Invest initiative. I think people need to be aware of that and if they want to donate to the Jonathan Edwards/ Invest in ME fund they must do it directly to Invest in ME and not presume that their money will get to this particular research initiative if given to the MEA. The MEA have been curiously unclear about their intentions. (I'm au fait wit the commentaries by CS et al on the MEA FB page etc).
I'm glad you've made it clear Firestormm that the MEA has not actually promised this money to Invest in ME for the Invest in ME trial. It does need to be made clear. I think everyone who wants to move this forward must ensure that Invest in ME are able to reach the total needed to start the process as quickly as possible without interference from outside influences which may slow things down. Thus it would seem reasonable to donate directly to Invest in ME where the mandate is clear and unambiguous.
Here's the link to ensure this trial (with Jonathan Edwards on board) goes ahead. Please donate..it's in all our interests to do so: http://ldifme.org/donate/
Hi lilpink - I honestly don't see any room for confusion there, given that statement from Charles Shepherd. The only circumstances under which money donated to the MEA's Rituximab fund wouldn't go to the Jonathan Edwards study that IiME initiated would be if Prof Edwards's team produced a protocol that failed the MEA's peer review process and, given the MEA's strongly expressed wish to have the trial happen, and the expertise of Prof. Edwards and his willingness to take peer review comments on board, I think the chances of that are extremely remote.
Here's Charles Shepherd again on this topic:
https://www.facebook.com/permalink....comment_id=5250558&offset=0&total_comments=77I can assure you, as I have assured Professor Edwards on the phone this week, that the MEA wants to speed up the process of getting this clinical trial moving at UCLThat is why we have (so far) put together a package of almost £60,000 to help fund a clinical trial of RituximabAs far as I am aware this is the largest contribution from any ME/CFS research funding charity at presentAs Professr Edwards has indicated in the above posting he is very happy to take on board suggestions regarding the protocol - which is now being prepared at UCLHe is also very happy to approach the MRCThis is all part of the scientific process - as is peer review for a potential funder whereby a finalised research proposal is critiqued by other experts in the field Peer review will not hold up the process of getting the Rituximab study moving - the delay will almost certainly come from the time it takes to raise around £400,000And although I'm sure a good ethics committee will have questions to ask (and I'm familiar with ethics at UCL from our work with the ME Biobank) I don't think this will be a factor in the delay eitherYes, it all boils down to funding - which is why I will say yet again that there ought to be a joint charity fundraising effort to get this trial moving
It seems to me that all roads lead to Rome on this.
It's a huge achievement that IiME have pulled off in initiating this trial. I'm extremely grateful to them for all the hard work that must have gone into that - they can be very proud indeed of what they've done. But we're into a new stage now and IiME will need the help of other charities to get this done quickly. It's a huge compliment to IiME that the MEA want to help fund the trial that they've initiated. Whatever IiME can do to encourage more charities to do the same and set up their own funds that their own supporters can donate to, the better.
Hi Simon, Jonathan Edwards addresses these questions here:
Hi Sasha, I think you may be a little naive about Uk ME politics. This is clearly a manoeuvring by MEA to try to take the reins on this project (imo and many others)..hence why they make proviso after proviso. It's worded in such a way to sound reasonable to most folks, but you can't get any sort of firm reply from the MEA to the question 'so are you going to give your ringfenced money to the Invest in ME initiative or not'? If you have have seen a 'yes' or 'no' to this I'd be grateful for the link.
A "joint charity fundraising effort to get this trial moving" would be ideal if it weren't for the concerns over the motives and machinations of the UKRC to which most of the other charities now belong. It would be nice to see the MEA *pledge* the money they have ringfenced (which would not, I believe, preclude them from changing their plans if the trial parameters were not to their liking, but would show true faith in this initiative) ..then, and only then, might many of us who have a better understanding of the social nuances that pervade UK ME interactions accept their affirmations in good faith.
It's fair enough (and probably sensible) to ask and encourage people to donate directly to Invest in ME if they want to contribute to the Rituximab study, but I believe that Charles Shepherd has been crystal clear about the MEA's intentions...
The MEA are enthused by, and are in support of, the UCL Rituximab study, that Invest in ME have organised.
And the MEA have ring-fenced their funding pot, waiting to receive the peer-reviewed protocol for the proposed study from UCL.
Once they've received and assessed the protocol, then they'll release the funding. (Assuming that the protocol is of adequate quality, which it will be because it's being drawn up by the experienced UCL team.)
I don't think it could be any clearer.
That's my interpretation of their position, anyway.
Hi lilpink - after several decades of having ME in the UK I've watched the politics and discussed them with others and have formed my own understanding of them. I see a field in which, as in any contentious issue, people faced with the same facts can (and do) come to different conclusions according to their temperaments, life experience, social circle of contacts, and general assumptions. I don't think we're likely to agree on these issues but we've both set out our arguments and I think we can leave people to make up their own minds.
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