by Sasha
Photo by fussy onion/Flickr
On June 6, the Norwegian Medical Research Council agreed to give a large enough grant to the Haukeland Rituximab trial for the study to begin. Later that day, the charity Invest in ME announced that they were initiating a UK Rituximab trial. It seemed to come out of nowhere. There were no details – cost, size, location, research team – but there didn’t need to be. The ME community started throwing money at the trial and trusted Invest in ME when it said it could be done.
This trust was surely based on the reputation that Invest in ME has established for itself in its few short years of existence. The newest UK ME charity, run entirely by volunteers, it set up in 2006 an international annual conference on biomedical research into ME – not CFS, but WHO-defined ME – that is now attended by most of the major research groups from all over the world and is a focus for information-sharing and collaboration-building among ME researchers.
At the most recent conference, Drs Fluge and Mella presented their follow-up study of a new Rituximab dosing schedule on the control patients from their Norwegian pilot study. The results are still embargoed until publication but apparently positive. Drs Kogelnik and Scheibenbogen, who are planning US and German Rituximab studies, respectively, were also there. No-one could doubt Invest in ME’s sources of expertise and support in setting up a trial.
The community’s trust quickly paid off as the charity was able to make public a major coup. Jonathan Edwards, Emeritus Professor of Connective Tissue Medicine at University College London (UCL), had agreed to advise Invest in ME on all aspects of running a Rituximab trial (read his statement on the trial here). It was Professor Edwards who proposed in 1999 that self-perpetuating B lymphocytes drive autoimmune disease. He went on in 2004 to conduct the trials of Rituximab for rheumatoid arthritis that established the role of B cell depletion in treating autoimmune disorders, the same mechanism that Drs Fluge and Mella believe is operating in the treatment of ME with Rituximab.
Fresh from that victory, Invest in ME went on to announce their plans to have the trial conducted by an expert team led by Dr Jo Cambridge at UCL, with the intention of including other London sites and other collaborating researchers such as Dr Amalok Bansal, an immunologist with a research interest in B-cell abnormalities in ME.
Further details were announced. To the surprise of many, the proposed trial would not be of the magnitude of the 140-patient Haukeland confirmatory study but, with about 30 patients, would be roughly the same size as the Norwegian pilot trial. Professor Edwards explained that a small trial is appropriate when a large effect is expected, as indicated by the Haukeland pilot trial in which 67% of patients treated with Rituximab improved, compared to 13% of controls. A successful small trial would make a strong case for further studies that themselves may not need to be big. Several independent confirmatory trials will be needed if Rituximab is to be licensed for ME.
The small size of the trial makes for a relatively low-cost project. Details of the study protocol are still being hammered out but the current estimate is £350,000 ($540,000; €410,000). This is potentially a very achievable sum to raise within a short timeframe.
The UK has several advantages here. It has several large ME charities and, in a very welcome move, the ME Association has pledged nearly £60,000 to the trial, subject to its normal independent peer-review procedure. Action for ME have announced that their board of directors will be considering collaboration on the trial; the Irish ME Trust has pledged £1,000, setting a good example for smaller charities; and there are other UK charities that might also be expected to donate. Working together with Invest in ME, who have more support pledged, a very substantial chunk of that £350,000 could be found in short order.
Also, Invest in ME has many supporters and have already racked up about £20,000 in donations even though there has been no big launch or fanfare for the study. The Medical Research Council, thanks to years of pressure, is now finally funding biomedical ME research and might look favourably on this trial, if applied to.
And of course, Maria Gjerpe’s MEandYou Foundation raised something close to the total sum needed for the UK trial in only three months in a country with a tenth of the population of the UK. Her positive, fun, feelgood campaign made people want to join in and expanded the support base well beyond the ME community and into the general public. She raised awareness so effectively that the entire Norwegian football Champions’ League – the healthiest of the healthy – aligned themselves with us, some of the most stigmatised of the sick, and donated signed shirts for auction. We in the UK need to follow her example, work together, be ambassadors for our community, and welcome people in.
Not all elements of the trial are yet in place and Invest in ME, like MEandYou, have sensibly been transparent about what happens if, for some reason, the trial does not go forward. In that case, donations to their Rituximab fund will go into their general Biomedical Research Fund, where there’s no doubt they’ll do some very good things with it. But many – probably most of us – feel the same urgency as Invest in ME to get the money raised and in place, so that things can proceed as soon as possible, and with the £20,000 donated to Invest in ME and the £60,000 pledged by the ME Association, we’re already nearly a quarter of the way there. What can the rest of us do to help?
- Donate! There are now two Rituximab funds raising money for this trial: Invest in ME’s fund and the ME Association’s fund (scroll down for donation instructions), and we can probably expect each collaborating ME charity to set up its own fund for the trial as they join in. UK taxpayers should Gift Aid their donations.
- Join The Matrix (long black coat optional): be one of 100 people to make a pledge to raise £1,000.
- Fundraise: people are doing all sorts of things to fundraise, from selling crafts to sponsored walks. Think about what you can do.
- Raise awareness of the trial. Many people in the UK who have ME don’t belong to any of the charities and won’t know that there’s a trial to donate to or raise money for. Help them find out.
We’re very fortunate that Professor Edwards has joined the forums here on Phoenix Rising. He has already been giving fascinating answers to our many questions (on this thread, starting here) and has generously agreed to answer some more about the trial and how Rituximab might make sense for ME. If you have such a question, please post it in the comments section. I will collate the questions and present them to Professor Edwards for an interview article with him to appear later.
In the meantime, let’s get cracking. We can have a superb trial in the UK, one that will benefit patients all over the world – let’s get on with making it happen!
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Further resources
Invest in ME’s Rituximab trial website
Discover magazine’s April 2013 article on Rituximab, including comments by Professor Edwards
Fluge and Mella’s 2011 PLoSOne pilot trial of Rituximab