In a surprise Norway refuses to fund multi-center chronic fatigue syndrome Rituximab treatment trial


Norway Says ‘No Go’ to Further Fluge/Mella Rituximab Funding

It’s kind of inexplicable. Fluge and Mella put Norway on the map of the chronic fatigue syndrome community in a big way, and stimulated interest and efforts from the US to Australia yet the Norwegian Government just announced their proposed  multi-center chronic fatigue syndrome  Rituximab study   didn’t make the cut.
Everyone involved appeared shocked with Secretary General of the ME Association , Anette  Gilje, stating they fully expected, given the feedback they were getting , an easy approval. “The signals we got last year was that this was a breakthrough and that it would be followed up, she said.

Even politicians registered their dismay with one parliament member stating   “I am furious at the government for not initiating this research project to Fluge and Mella. Nine million is nothing in the state budget” and said she would challenge the awards. Two other ME proposals also didn’t make the final cut

Interest in the study was very high with Fluge stating he’d received hundreds of emails. They’d hoped to start a 140 plus multi-center treatment trial.

This was a big loss; no one else appears to be considering a study of this size and rigor (double-blinded, placebo controlled) and it had a chance to pretty much settle the Rituximab question for ME/CFS. A successful Rituximab study would change things radically;  the disorder would be legitimized,  immune and autoimmune researchers would jump on board, funding would surely soar over time.
While no one study is definitive, if  the study was large enough and it was  done right,  it would be a game changer. Contrary to our expectations I think many researchers would love to take a bit out of chronic fatigue syndrome if they had a good way ‘in’. A successful Rituximab trial would have provided that.

Mella was good about the rejection, stating that “When the chance is 10-15 percent it’s no surprise when one does not get the money” but it must have hurt…One might think that the chance to blow open the doors for  such a  mysterious and debilitating condition might have been persuasive…

Patients Punch Back

The flack definitely hit the fan in Norway and it appeared to work.  Norwegian journalist Jorgen Jelstad reported that Norwegian Health Minister Store quickly stated his agencies commitment to ME/CFS  on his Facebook page. Trying to defuse the dismay Store stated that he would send a letter to (translated) “make it clear that research into the causes and treatment of these disease states will be given priority into the research councils program plans…. In addition we will continue to grant to RHA West and other regional health authorities for the implementation of the planned multi-center study on the treatment of ME.”

That was helpful; it sounded like  they were committed to  doing the groundwork for the study but doing the groundwork is not doing the study.  Store’s Facebook post, though, quickly  got around…Five days later it  had almost 400 likes and over 80 comments. Store stated the next round for funding will be in Spring 2013.

The Work Continues

Fluge and Mella will shoulder on and work to start the study and said they would be surprised if one didn’t show up next year. The Kavli Foundation has been helpful in the past and the  Norwegian ME Association has been working on other funding mechanisms since June and has started a fundraising campaign.

The positive Fluge/Mella findings didn’t mean getting a study going was ever going to be easy. This drug is very expensive  and pharmaceutical companies aren’t lining up to spend  money on a disorder  which they have trouble even describing properly while other ‘easier’, more well defined  conditions are available…That’s  why, of course, that  government, non-profit and private funding is so important.

How We Can Help

The Norwegian ME/CFS groups are at ground zero for Rituximab and there are ways we can help them help us; thanks to Anne for providing information how:

Two Norwegian fundraising efforts are running to raise the funds needed (approx. $1.5 million). They are asking ME/CFS patients and their friends and families around the world to contribute.

The multi-center study is set to start as soon as funds are raised, and since public funding may not be available, patients are now aiming to crowdfund the trial. (Should Fluge and Mella be given public funds at a later stage, the money raised in these two Norwegian fundraising efforts will be directed towards other biomedical ME/CFS research studies planned by Fluge and Mella – they have a lot going on)

More on the Norway Situation

Herpesvirus Researchers Embrace Rituximab Results

Two ME/CFS herpesvirus researchers believe the Rituximab results fit their understanding of the disease

Two ME/CFS herpesvirus researchers believe the Rituximab results fit their understanding of the disease

Meanwhile in the conclusions of a small study on EBV persistence in chronic fatigue syndrome, Drs. Lerner and Glazer suggest the success of the Fluge and Mella studies makes sense given their model of an abortive herpesvirus infection in this disorder.  They posit that herpesvirus antivirals  keep viral replication in check while Rituximab removes the infected B-cells that are pumping out herpesvirus proteins).

Several ME/CFS doctors, including Dr. Kogelnik and Dr. Lerner, believe Rituximab’s success in this disorder  is more likely due to antiviral effects instead of the autoimmune suppression ordinarily  associated with this  drug.  Despite searching for three years for biomarkers Fluge and Mella have reportedly  been unable to find evidence of an autoimmune process occurring in ME/CFS.

Analysis Suggests Rituximab is Safe Drug….in Rheumatoid Arthritis patients

Rituximab (Rituxian) – first  developed as a chemotherapy drug and like most chemotherapy drugs it can pack a powerful punch, good and bad. It’s safety information  states it can cause such serious problems as activated hepatitis B and other serious infections, heart problems, progressive multifocal leukoencephalopay, tumor lysis syndrome, low blood counts and more..

Thus far the ME/CS patients taking the drug under Fluge and Mella appear to have escaped serious problems but the spectre of dangerous side effects persists – particularly in such a disabled population. Given Rituximabs immune suppressing properties the prospect of serious infection probably looms largest…

A analysis of over 1,000 Rheumatoid arthritis patients on Rituximab brings some good news.  For one, the risk of serious infection didn’t pan out;  Rituximab didn’t increase the risk of infection  nor were heart attacks or cancer more likely.
At present Rituximab is too expensive and not widely enough available for many people with ME/CFS to get but it will be  going generic in the next year or so…While chronic fatigue syndrome is not rheumatoid arthritis and effects may differ ME/CFS patients on the drug, and those expecting to try it at some point can take heart that serious side effects appeared to minimal in another large population.

Patient Blogs

Several patients on Rituximab are reporting on their experiences…

  • Jacque – at week 18 Jacque has gotten the munchies but is feeling no better but recognizes that 18 weeks may be too little for improvement to show up; five months is common…
  • DSDMon – is on week 13 and has had some trouble with side effects and has seen  no positive results as of yet but again this drug in ME/CFS and other disorders can take quite a while to work
  • Rituximab Tourist – is over 8 months in and is actually getting worse, not necessarily because of the Rituximab , but she’s seen no positive effects  as yet. She has another infusion in January and hopes she may just be a late responder.

The Poll

Would you take Rituximab? With about 110 replies, the results from the  Phoenix Rising Poll has about 53% saying yes, 23% saying no and 24% not sure.





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