Key points: rtx dosage is halfed in current study if rtx-study is positive, probably need to be replicated in other countries before approved, but probably not in norway last year done metabolic studies (on the study-participants). 200. looking at the amino acids. they have also found a faulty energy metabolism. patients cant make enough atp, especially in women, and especially in white lymphocytes. Mella: this is why patients get lactic acid. when people e.g. run, atp-production increases by 70-80 fold, so even small defects can have big consequences. one patient had 4 times more lactic acid when standing they have found same metabolites as navieaux they dont think its hibernation like navieaux, but that it is a battle in the body to overcome the energy defect. therefore light sensivities etc. pending paper to german journal. They have measured oxygen uptake and lactic acid uptake, and found differences. "the disease is not in the mind". Found two genetic abnormalities in families with ME on the cyclo studies: they see responses, even though cellular mechanisms are different from rtx. peculiar drug, effects vary with dosage and time given. not a new drug, but what is new is that it works on some ME-patients. Could not give numbers: but they were astnonished over the amount having effect. what was negative: many responders get worse for a period. Positive: rtx non-responders may have effect from cyclo. mella emphasizes that not all immunosuppression works (e.g. steroids and etanercept) emphasizes the need to be systematic when investigating potential immunological diseases they have a new biochemical researcher due to the metabolic testing other hospitals are becoming enthusiastic from seeing the cyclo results there is a factual increase in ME-why? vaccines? etc question: what side effects may happen with rtx? "some extremely rare neurological conditions. allergic reactions more frequent (to the animal proteins in rtx). the b-cell depletion does not really cause infections, due to circulating antibodies (igG). But as they fall over time with long treatment, infections may be more frequent. The most frequent side effect: transient worsening of disease. one patient in phase 2 who received infusion was in remission: then relapsed under infusion. very peculiar, what is the mechanism? she later got better again. " question: is there more ME in norway? Mella: "this is not systematically investigated. Current studies have often been done by phone. In norway- use of registers. Pretty certain: more in north europe, than south europe. but it happens all over the world. a lot of patients feel better in warmer climate." Question: is gut flora being researched? Mella: "yes. unsure how important it is. cause gut problems go away with responders. Mella is skeptical of the tabloid notion that its all in the gut" Question: Your talk gives hope. whats the time horizon before treatment? alternative treatments? Mella: "Maybe som supplements might have slight effects. might try such on nonresponders to both cyclo and rtx. not happy about private rtx. but he also understands patients trying it. they know dagfinn øgreid well, but disagrees with trying it outside clinical trials. because effect cant be verified. time horizon? difficult, its up to the politicians. it is a sensation that fluge will have the main talk at the conference in florida. he thinks that if it was done at stanford, the world would explode from excitement. norway is in the outskirts" . question: do you think there is subgroups? Mella: "yes. very common in autoimmune diseases. underlying mechanisms may be different, even though the symptom picture is the same. this is seen in ME. " Question: regarding saltintake. do we need more? Mella: i"t seems me-patients have low blood volume. and some have a smaller heart. thinks it might be benefical, but it dont treat the underlying cause. " Question: what food is best when having PEM?: Mella: "i dont have the recipe, because we dont know about the mechanisms.... when i walk up the stairs i get lactic at the top, but it disappears in 15 seconds. this does ot happen with ME-patients. question: "i hope you apply for the new grant advertised in norway so that the psychobabblers dont get it. just a little tip. Mella: the grants is at least having more specific requirements." Question: Can vaccines give ME? should we take it? Mella: "that seems to be the case. the risk is low, so i cant give a definite answer". question: the kavli-fond gives you much money? Mella: "4 million NOK the last 2 years" Question: What counterarguments against salt water injections? Mella: "not enough studies. so might be hard to get from hospitals. but low risk of side effects. ask your GP (if hes nice). question: when does the cyclo results come? Mella: "in around 6 months. Part B with 20 severely ill ME-patients already approved. the protocol might have to change in a potential phase 2. because of many side effects. maybe dosage must be lower, and the time interval changed. so maybe protocol will change on severely ill. but all in all very positive findings. and some rtx responders with relapse feel better after response on cyclo, but also vica versa" question: why cant we say when treatments may be available, when patients are suffering so much with no life in darkened rooms. they only exist. does this not mean to be ethically discussed? Mella: "one of the problems, even though the rtx is safe for other conditions, not neccesarily ME. But this is a dilemma. And hard for us. even though rtx is approved overnight: we do not have the apparatus to treat 10 000 patients. but we need to be strict to get the research done. we need to treat the placebo-patients first. " question: regarding the private clinic: can they contact u? Mella: "the private clinic should register side effect and responses. question: can you say something about LDN? Mella: "well.. there are some reports of improvement. but its usually slight. we think we might understand why." question: if you get benefit for something, is there a risk of overdoing it and getting worse? Mella: "yes there is a theoretical risk, but patients are often good in pacing accordingly. one rtx-patient in phase 2 startted jogging under remission, and relapsed. so then youre not well."