ME Association Calls for Earlier Rituximab Trial in UK

[Cort]

Judging from this statement from Charles Shepherd the ME Association is not content with waiting until the Norwegian study is completed in 2018 to fund a Rituximab trial in the UK. If they did that the results of their trial would not be finished until 2020/21 or so....The MEAssociation has put aside 60,000 pounds for a trial some time ago. They are keeping that funding intact.

• http://www.meassociation.org.uk/201...lable-for-a-clinical-trial-12-september-2015/

“We also believe that serious consideration must now be given towards setting up a phase-3 clinical trial here in the UK before we have the results from the phase-3 clinical trial that is now taking place in Norway. The Norwegian trial is planned to finish in 2017 but it may not be till 2018 that the results are available and published.

“To wait until 2018 before setting this process in motion here in the UK would mean that it would then be 2020 or 2021 before we had the necessary information from a UK trial phase 3 trial that might then persuade the NHS funders to make this drug available here in the UK for at least a sub-group of people with ME/CFS (assuming that the results confirmed safety and efficacy). That is a very long time to wait.”

Why is it taking so long to get these trials up and started? They cited three reasons in July of 2013

1. Rituximab is a very expensive drug. So with the cost of carrying out a high quality clinical trial involving a good number of patients, we could be looking at costs of up to £400,000 or more – unless there is help with the cost of supplying the drug from a pharmaceutical company.
2. Rituximab has the potential to cause very serious side-effects, even fatalities. So the NHS research ethical committees that approve and oversee clinical trials here in the UK are going to take a very cautious view. They are likely to want to ensure that the research group includes people with good practical experience of using Rituximab.
3. Finding a multidisciplinary group of NHS doctors here in the UK with the necessary expertise in immunology, pharmacology and clinical trials, as well as ME/CFS, along with ready access to good quality ME/CFS patients, who want to carry out a proper clinical trial has not been easy.

• http://www.meassociation.org.uk/201...ssociation-doing-about-rituximab-8-july-2013/

 

[Seanko]

Hi @Cort , I've just seen this now. I would like to provide some of the political background in the UK.

A few years ago the ME Association (MEA) offered the £60 000 (about $90 000) to kick start a UK Rituximab trial in the hope that it would encourage other funding to become available to make a decent sized trial viable.

Separately Invest in ME (IiME) started fund raising for a Rituximab trial of their own. IimE have now had £500 000 pledged (not necessarily donated) for the project.

Scroll forward to 2015 & news of the trial at University College London (UCL) has been slow to emerge with IiME issuing statements about the fund raising but not about the trial itself. Talking to people involved in the main UK ME/CFS charities off the record suggests the announcement is partly designed to get IiME & UCL to get a move on with their study. There was animated debate on the Facebook page of the MEA between representatives of the MEA & IiME upon Dr Shepherd's announcement

At times, there is something of a turf war amongst the UK ME/CFS charities which patients would like to see an end to. We would much rather see money, talent & other resources pooled with egos put aside.