U.K. Rituximab ME/CFS Trial Hits Roadblocks
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[/fright]Considerable funding has been gathered for studying B-cells in ME/CFS patients and hopefully for creating a Rituximab trial in the U.K. Late late year the ME Association called for a UK Rituximab trial to begin soon.
Dr. Cambridge, a UK researcher at the Invest in M.E. conference involved in studying B-cells in ME/CFS patients, suggested, however, that the outlook for a U.K. Rituximab trial is bleak. That was a bit of a shock; Invest in ME has been working on a trial for over three years. They studied the possibility of a trial for a year, queried Universities about it, and then chose a site in Norwich. After their concerns were apparently met, they began fundraising in 2013 and since have gathered over $650,000.
The ME Association's summary of the Conference, however, reported that significant roadblocks to producing Rituximab trials exist in the U.K.
The key problems appear to be cost (at least $600,000), the difficulty finding immunologists and physicians experienced with the drug and clinical trials who are willing participate, and getting approval from a possibly skeptical review panel that a potentially fatal drug could be tested in ME/CFS.
United States in the Hotseat Now?
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[/fright]It's not clear that the proposed U.K. trial is over but it clearly faces some obstacles. If the U.K. does not proceed the onus is even more on U.S. to produce on. The roadblocks cited could be more easily surmounted here. The U.S. potentially has the money (through the NIH), it has ME/CFS physicians experienced in clinical trials and the drug company that makes the drug is based here.
In fact, according to Clinical Trials database the NIH is currently funding no less than 55 Rituximab studies into such diseases as Anti-cytokine Autoantibody-Associated Diseases, B-cell Lymphoma, Lupus Nephritis, Hairy Cell Leukemia, Pulmonary Fibrosis. One cautionary note; despite the fact that Rituximab is often used to treat autoimmune diseases, most of the studies are on lymphoma's.
Rumors have been wafting around that NIH Director Francis Collins is committed to a Rituximab ME/CFS trial - in a couple of years. In Jan. 2016, Collin said regarding the NIH's new stance towards ME/CFS:
Collins has reportedly been more forthcoming in private, suggesting that a trial will get done. If that's true that's good news because if Dr. Cambridge is correct, the U.S. may be the only real possibility for a trial. Not for the first time one wonders little Norway has been able to do what the U.S. and U.K. have not until now. .
The other disappointing point in the overview involved Dr. Shepherd's note that the U.S. results with Rituximab haven't been as positive as the Norwegian results.
[Charles Shepherd note: I was going to ask Dr Cambridge over lunch what she thought about the less positive patient evidence from people with ME/CFS who have been treated with rituximab in America outside the Norwegian clinical trial (an important point that was raised during the clinical and research meeting in Sussex with Dr Amolak Bansal and myself three weeks ago) but wasn’t able to do so.
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Dr. Cambridge, a UK researcher at the Invest in M.E. conference involved in studying B-cells in ME/CFS patients, suggested, however, that the outlook for a U.K. Rituximab trial is bleak. That was a bit of a shock; Invest in ME has been working on a trial for over three years. They studied the possibility of a trial for a year, queried Universities about it, and then chose a site in Norwich. After their concerns were apparently met, they began fundraising in 2013 and since have gathered over $650,000.
The ME Association's summary of the Conference, however, reported that significant roadblocks to producing Rituximab trials exist in the U.K.
The key problems appear to be cost (at least $600,000), the difficulty finding immunologists and physicians experienced with the drug and clinical trials who are willing participate, and getting approval from a possibly skeptical review panel that a potentially fatal drug could be tested in ME/CFS.
United States in the Hotseat Now?
[fright]
In fact, according to Clinical Trials database the NIH is currently funding no less than 55 Rituximab studies into such diseases as Anti-cytokine Autoantibody-Associated Diseases, B-cell Lymphoma, Lupus Nephritis, Hairy Cell Leukemia, Pulmonary Fibrosis. One cautionary note; despite the fact that Rituximab is often used to treat autoimmune diseases, most of the studies are on lymphoma's.
Rumors have been wafting around that NIH Director Francis Collins is committed to a Rituximab ME/CFS trial - in a couple of years. In Jan. 2016, Collin said regarding the NIH's new stance towards ME/CFS:
Collins has reportedly been more forthcoming in private, suggesting that a trial will get done. If that's true that's good news because if Dr. Cambridge is correct, the U.S. may be the only real possibility for a trial. Not for the first time one wonders little Norway has been able to do what the U.S. and U.K. have not until now. .
The other disappointing point in the overview involved Dr. Shepherd's note that the U.S. results with Rituximab haven't been as positive as the Norwegian results.
[Charles Shepherd note: I was going to ask Dr Cambridge over lunch what she thought about the less positive patient evidence from people with ME/CFS who have been treated with rituximab in America outside the Norwegian clinical trial (an important point that was raised during the clinical and research meeting in Sussex with Dr Amolak Bansal and myself three weeks ago) but wasn’t able to do so.
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