Founder of Health Rising and Phoenix Rising
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.
Why is it taking so long to get these trials up and started? They cited three reasons in July of 2013“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.”
- 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.
- 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.
- 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.