ME/CFS doctors respond

ME/CFS Doctors Respond

Dr. Lapp, Dr. Klimas and Dr. Bateman all responded to emails asking their thoughts on the study and the use of Rituximab at the present time in ME/CFS and all responded similarly; they were excited by the results, they were concerned about the ability of many patients to pay for the drug and they all wanted more data, in particular, more studies.
Dr. Bateman hoped to help enroll patients in a clinical trial of the drug:
"In short, I think the news is very exciting. I have personally observed the phenomenon of CFS patients improving after chemotherapy. I look forward to and anticipate speedy progress toward a US clinical trial designed specifically to facilitate an FDA indication, should the findings be replicated. My primary goal will be to help enroll well defined patients in such a clinical trial of rituximab, if possible, rather than to start using it for treatment right away. I don't have enough information yet to know what my position will be on off label use. It will be important to identify our best available biomarkers with which to identify appropriate patients and to assess treatment outcomes."
The biggest concerns are cost, appropriate patient selection and understanding the risks in the CFS population.

In a statement to the Norwegian Press, Dr. Klimas emphasized the different ways Rituximab may be working and called for more study into the infections that may be occurring in ME/CFS:
"The recent study of Drs. Øystein Fluge and Olav Mella demonstrating significant improvement in ME/CFS patients treated with the B cell depleting agent Rituximab is a key study for our field. By showing that depleting B cells can cause dramatic improvement, the investigators point the field in the direction of autoimmunity, and autoimmunity caused by an autoantibody. [.....]
However, there is one other plausible explanation: that the B cells were acting as a reservoir of infection and by depleting the B cell line the viral load can be brought down to the point of suppression by the immune system. Because EBV infection is harbored by B cells, as are several other putative latent viruses that could contribute to illness persistence, I believe both of these theories deserve vigorous scientific pursuit."

The Early Studies Syndrome : A Cautionary Note - in an email, Dr. Bateman noted that we will need more studies to determine the true extent of Rituximab’s usefulness in the ME/CFS Community. It’s not uncommon for early studies to demonstrate higher rates of efficacy than later studies. Why? The Fukuda definition is so broad that different researchers often look at different types of patients. Researchers also tend to pick patients they think may make their case. When a wider mix of patients are added to the mix in later studies efficacy rates sometimes go down.

Dr. Maes, who has investigated autoimmune processes in ME/CFS, stated he believed there was a significant autoimmune subset in ME/CFS and he has more data to show that, but the percentage may be lower. The word, then, is caution. The study's strong point was that it was rigorous enough that it seems inconceivable that a good chunk of ME/CFS patients will not benefit, but more studies are needed to figure out how many.

Widespread use of Rituximab is a long ways off as well. In a statement from the Research1st website, Dr. Shepherd cautioned that "We're still a long way from making this drug more widely available, but if someone wants to mount a UK trial, we'd look at that," he said.
Prof. Carmen Scheibenbogen from the Institute of Medical Immunology at Berlin Charité has had many years of experience with ME/CFS condition, and is convinced that the Norwegian study is a decisive step forward. “This is important news, especially for patients in Germany, as the situation that CFS patients encounter here is particularly bad”, she says.[...] Professor Carmen Scheibenbogen, Deputy Director of the Institute of Medical Immunology at the Charité University Hospital in Berlin, describes the results of the CFS study as a “breakthrough”: “This is a very important first step. For the first time, a therapeutic study has been conducted with medication that was originally applied to the immune system, and which proved effective for a majority of the patients”, she says.
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