Following the ME Awareness Week research and clinical meeting in Sussex where Dr Amolak Bansal provided an update on the current situation regarding the proposal to carry out a clinical trial of rituximab here in the UK, I have received several queries regarding the availability of this drug, the current MEA position, and the UK clinic trial.
1 The current MEA position regarding our offer to help co-fund a UK clinical trial with around £60,000 of funding from the MEA Ramsay Research Fund remains exactly the same – despite the current uncertainties. This is set out below as part of the Sussex meeting report
2 I am not aware of any more people from the UK currently travelling to the USA to receive treatment with rituximab outside a clinical trial – possibly because of the generally negative feedback on treatment results that have been emerging from people who have been treated in America outside a clinical trial. My personal view is that rituximab is a form of treatment that should not be used outside a clinical trial in our current state of knowledge – unless there are very good reasons for doing so
3 I cannot add anything further to the information on the proposed UK clinical trial that was provided by Dr Bansal last week – apart from a recent comment from Professor Jonathan Edwards during a discussion on the Phoenix Rising discussion forum on March 27th 2016:
Q: When do you think a UK rituximab study is likely to happen? I am currently a patient of Dr Berkovitz in London. I'm desperate to get on a trial! @Marky90 How much is your rituximab treatment in Norway? Good luck with it! Do you think it would be possible for a non-Norwegian speaker to go and get treatment?
A: I am afraid I cannot give any information about when a trial might occur in the UK. As you know I am retired and can only advise. There needs to be a clinical team in place with the time and resources to take care of the patients and that is not easy to organise in the present system.
Source: http://forums.phoenixrising.me/index.php?threads/is-there-any-way-i-can-be-treated-with-rituximab-privately.39972/page-13
Summary of information provided by Dr Bansal that was given to the Sussex Research and Management meeting on Saturday May 14:
RITUXIMAB
During the Question and Answer session Dr Bansal provided a comprehensive update on the current situation regarding the proposal to carry out a clinical trial of rituximab here in the UK to see if this could replicate the benefits that have been reported from the Norwegian trial.
However, feedback relating to people in the UK who have been treated with rituximab in America, as well as US citizens who have been treated with rituximab, has been nowhere near as positive as the results that have been reported from Norway. Consequently, questions are now being asked as to how a UK trial could/should proceed and whether this is the right time to commence a UK trial.
Dr Bansal noted that it is possible that the failure of these people to respond to rituximab could be explained by different trigger factors being involved in the Norwegian population, and/or that there is something different about the patient selection process in Norway.
These concerns and uncertainties about the UK trial are due to be discussed with US colleagues shortly.
Dr Shepherd pointed out that the MEA Ramsay Research Fund still has around £60,000 of ring-fenced money to help fund a UK clinical trial of rituximab – if a suitable protocol can be developed by the group concerned (which includes Dr Bansal) and there is a definite intention to move forward with a clinical trial, and a formal application is received.
However, if a UK trial of rituximab is not going to take place, or it is going to be delayed until the results from the phase 3 clinical trial in Norway are published, the MEA Ramsay Research Fund will have to reconsider our position. This is because we have other requests for funding, including a commitment to keep the ME Biobank going for the next two years (at a cost of around £40,000 per year), which will need to be taken into consideration.
Most recent MEA statement on Rituximab:
www.meassociation.org.uk/2015/09/our-60000-rituximab-fund-is-still-available-for-a-clinical-trial-12-september-2015/
Full MEA report on the Sussex Research (Dr Amolak Bansal) and Management (Dr Charles Shepherd) meeting:
www.meassociation.org.uk/2016/05/remember-shine-the-spotlight-on-mecfs-research-and-management-dr-shepherd-recalls-highlights-of-burgess-hill-meeting-14-may-2016/
Dr Charles Shepherd
Hon Medical Adviser, ME Association
May 23 2016
Thanks for the update MEA. Patients might be interested to know that a page is being maintained on MEpedia about Rituximab and what we know about its risks, availability and the mixed picture from the studies done so far. Professor Edwards has contributed to the page. MEpedia is a wiki so anyone can click Edit improve the page (just like Wikipedia), adding new articles, studies etc and I encourage patients and professionals to consider doing that so we have a single place to collate what is known. http://me-pedia.org/wiki/Rituximab It’s vital patients have a full picture of what is happening, especially with a drug with known risks and where efficacy is muddy and we do not have any way to identify any subgroup for treatment with it.