Journal of IiME Volume 6 Issue 1 (June 2012) most exciting things he had followed in his professional career. Professor Carmen Scheibenbogen, Deputy Director of the Institute of Medical Immunology at the Charité University Hospital in Berlin, described the results of the study as a possible 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 told bto.no. In Norway, a country where ME/CFS has generated a lot of media attention the last few years, the Rituximab study led to a media blitz. For several days the media reported on the study, the lack of good care for the patients and all the broken promises about better services for ME/CFS patients from the government and the responsible health care providers. It was like Rituximab was a tipping point for not longer being able to give the impression that this disease was not real, or that it was mainly a psychosomatic problem. Because how do you argue against a big gun cancer drug? In a way, Rituximab did not just heal some of the study participants, it also healed the self-respect of thousands of Norwegian ME/CFS patients who finally experienced something else than suspicion and disbelief. In a rare public statement the National Institutes of Health in Norway even apologized to the patients for the lack of services and years of mismanagement. Before the Rituximab study hit the news, I called Sheba Medical Center in Tel Aviv to talk to the Israeli scientist and world renowned expert on autoimmunity, Yehuda Shoenfeld. He is editor in chief of Autoimmunity Reviews and has written several books and published hundreds of scientific articles on autoimmunity. In a review article in 2009 he wrote that recent findings in ME/CFS “points toward an ongoing autoimmune phenomenon in such patients that, although not fully understood, is likely to be enhanced by the presence of certain infectious agents and other adjuvants”. Invest in ME (Charity Nr. 1114035) “I cannot say for sure that this is an autoimmune disease, but CFS has a lot in common with this group of diseases”, a busy Shoenfeld told me over the phone. At this time he had only seen Mella and Fluge's pilot study on three patients, but he said that what they reported there looks much the same as what you see when you use Rituximab in diseases like rheumatoid arthritis and SLE (lupus). Then he said that if they got positive results in a controlled study, it would indicate that a central mechanism in ME/CFS will be found in the immune system. I asked him if that would be surprising to him. “No, not to me, but it depends who you ask. I have the idea that CFS belongs in this group of autoimmune patients”, said Shoenfeld. I have since talked to several international ME/CFS experts, all of them enthusiastic about the Rituximab results. At last year’s Invest in ME conference I sat down with one of the most respected ME/CFS-clinicians, Daniel Peterson, and asked him his thoughts. - I think it is a crucial step forward, he told me. And then he went on to say that he had seen effects of Rituximab himself. Several of his ME/CFS patients had developed lymphoma and therefore got treated with Rituximab, one of them for several years. - And after starting treatment his ME/CFS symptoms disappeared, said Peterson. The future: Persistence Of course, like everything in ME/CFS, no promising study without controversy. So the study in PLoS ONE also met criticism right away. This is science after all. Controversy is the rule, and more so in ME/CFS than anything else. A group of prominent ME/CFS researchers commented the study at the PLoS ONE pages, implying the results were oversold and with methodological flaws, and they challenged the conclusions. Then one of the world leading authorities on Rituximab quickly commented on a lot of flaws in the critics own criticism. Professor Jonathan Edwards from University College London said their criticism “contains several errors”, and went on to say that the “trial’s authors give the account that is by far the most consistent with the data”. www.investinme.org Page 16 of 108
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