Well not really. It's semantics but Fluge and Mella clearly stated that the very severe should not receive RTX outside of a clinical trial and that they themselves were excluding the very severe from any of their additional trials.
They didn't specifically say "contraindicated" but your comment was close enough and in my opinion well warranted.
http://simmaronresearch.com/2015/01/chronic-fatigue-syndrome-rituximab-fluge-mella/
Thanks for referencing the source for this idea that Rituximab is 'contraindicated' in the severely ill. The full quote (from Fluge and Mella) where this seems to come from is:
Only four very severely ill ME/CFS patients have been at our hospital, and it is very difficult to give them the care they need in a very busy oncology ward. For these for patients, although rituximab has influenced their disease in a slightly positive manner for two, none of the four could be characterized as responders. We do not encourage treatment of patients with very severe ME/CFS with rituximab outside clinical trials!
In fact, until further scientific data and evidence are available, all patients receiving rituximab for ME/CFS should be treated within clinical trials.
Cort has a graphic next that quote, with a caption which reads:
Caution! Rituximab use in severely ill patients is not recommended…
Cort's quote is very much a shorthand for what was said, of course, and I can easily see how that bit of info got filed in the vault in the way it was; I'm sure I file similar shorthand interpretations myself all the time. However, there seem to be two very important nuances here.
First, they are not saying that Rituximab is 'contraindicated' in the severely ill, which would imply that there was some kind of negative effect they suspected. In fact, they say here that Rituximab was 'slightly positive' for 2 of the 4 they treated with (in the context of this quote), and they don't seem to have mentioned specific harms from Rituximab that are potentially associated with the severely ill. They just seem to be saying that so far their experience suggests that severely ill patients may be more treatment-resistant. That's consistent with everything I've heard them say: they are actively looking for alternative treatment protocols that work more effectively for the more severely ill, who are more difficult to treat.
Second, while they do say in this quote that they don't recommend use of Rituximab for the severely ill outside of clinical trials, they also emphasise that they don't recommend use of Rituximab for
anyone with ME/CFS outside of clinical trials. They've said this since the beginning. I think I recall them saying that they don't particularly expect that Rituximab will
ever be a mainstream treatment for ME/CFS: they see its main use as being for research purposes. My interpretation of that is that they think that by the time Rituximab has achieved what's needed for regulatory approval, there will be a similar but more effective treatment available - like cyclophosphamide for example.
Jonathan Edwards has made the point on this forum that there's a particular risk of getting Rituximab treatment right now, which I think is an important point worth emphasising: while we're at the stage where researchers are refining the protocol, we don't really know what the most effective treatment regime is and what the long-term effects may be. But as I recall it, Jonathan noted that in RA, to some extent you may be 'using up your bullets' every time you try Rituximab treatment. Somebody getting treatment now might find they don't respond, and 3 years from now we might all know that a different dosage and schedule would have had a much better chance, but now it's too late because patients develop something equivalent to 'tolerance' to the treatment and next time round it will be less effective.
We just don't know how it all works yet, so this is all speculation of course, but in any case, treatment outside of the context of a clinical trial benefits nobody but the individual patient and doesn't advance the scientific knowledge base at all. Harriet Hall's article is just vile; I've heard Dr Kogelnik spoke twice at Invest in ME and spoke with him briefly once, and he seems to me a very decent and smart researcher and physician. But personally, I do think treating patients with Rituximab outside of a clinical trial is questionable and probably not very helpful; I just hope that where this is being done it is being done in a way that might at least provide some data and insight to the people who are researching this.
