About this fundraising:
Support The Norwegian ME Associations fundraising for biomedical research into Myalgic Encephalomyelitis!
In October 2011, a very exciting medical paper was published in PLOS ONE – an international peer-reviewed, open access, online publication.
Two Norwegian oncologists, who gave immune modulating medicine to 15 ME-patients, saw a remarkable improvement in two thirds of the patients in the study.
Could this be a breakthrough in treating the devastating disease known as ME? Was this the beginning of an actual medical treatment?
Maybe for the first time in history we are getting closer.
But before any conclusions can be made, larger studies are desperately needed!
Eager and hopeful patients all over the world are waiting for answers, and hoping that more research will bring us closer to a treatment.
The two Norwegian oncologists, together with Haukeland University Hospital in Bergen Norway, are sadly lacking in funds for follow-up studies.
They are now doing a pilot project with a few patients, but this is not a double blind study – the medical standard needed to confirm their initial results.
The Norwegian Research Council recently turned down the oncologist’s application for funding a larger double blind study.
The Norwegian ME Association has therefore taken the matter into its own hands, and started a fundraising appeal, called ME-research.
When this goal has been achieved, ME-research would like to continue fundraising so that we can support other biomedical research projects into ME.
We would very much appreciate your help!
Donations can be a made to our Bank Account:
IBAN NO67 1503 3204 334
Contact us at: email@example.com
A presentation of the Rituximab-study by Haukeland University Hospital where the research is taking place: “Cancer medication proves beneficial to ME patients”
Article from BBC from about the study (Oct. 2011): “Immune system defect may cause ME”
Further information on the Rituximab trial by RESEARCH 1ST + more relevant links in English: “Rituximab Trial Shows Promise”
The publication in PLoS ONE from 2011 by the Norwegian oncologists and their team:
What is Happening with the Research into ME and Rituximab?
by Anette Gilje
The cancer doctors Øystein Fluge and Olav Mella, Haukeland University Hospital, published their study on ME and rituximab last autumn. Following their sensational and promising findings that some people with ME had benefitted from the immune modulator rituximab, the Government allocated two million Norwegian Kroners (approx. 220 000 £) to the Western Norway Regional Health Authority to help funding a larger follow-up study.
– This is far from enough to fund a larger, double-blinded multi- center study which is necessary to determine the scientific research question: Does rituximab have an effect on this patient group, or not, says Professor Mella.
– We do believe it has, but this has to be confirmed in a larger study to gain scientific credibility internationally. To be reasonably certain to answer the question, the study has to include between 120 and 140 carefully selected patients that meet the Canadian Consensus criteria. The patient-sample will be divided into two groups, one of which will receive active treatment with rituximab, the other placebo (i.e. inactive substance). Both groups will be closely observed for potential effects and adverse reactions.
Providing the study can confirm a significant effect in the group that was given rituximab and the adverse reactions are acceptable, the placebo group will be offered treatment with rituximab.
A scientific study of this scale cannot be initiated before the whole project is fully funded. So far Drs Fluge and Mella have worked out a draft protocol for a larger study and are now awaiting comments from the ME/CFS-Centre, Oslo University Hospital (Aker). When the preliminary protocol is completed, it is time to establish collaborations with other research communities that want to take part in the study. After that the research protocol will be submitted to the Committee for Medical and Health Research Ethics and the Norwegian Medicines Agency.
Professor Mella says it is extremely important that the research centers included in the study are dedicated to the task. They need people who are very good at diagnostics and that can administer the rituximab treatment in a safe manner for the patients. – If you can’t accommodate this, it’s probably better for the study to be carried out in fewer institutions.
There are some serious, but very rare adverse reactions. – Our experiences in working with cancer patients show that this is a drug that do not trigger a lot of adverse reactions, Mella says. – What you do, is to deplete the B-cell lymphocytes which are normally responsible for production of antibodies. Because this is done only for a short period of time, many of the cells are still circulating in the blood stream. The increase in infections in most patients receiving this treatment is small. There is, however, a theoretical risk for serious infections. That is why it is necessary to be alert when looking for emerging signs of infection.
Dr Mella explains that rituximab is a protein substance that is partly produced from human material and partly from mouse material. The tendency for allergic reactions is increased compared with some other drugs. That is why it is important that the patients receive the drug under observation, preferably at a rheumatological-, neurological- or a cancer ward.
– If you are used to administer rituximab and know what to do if allergic reactions occur, we see this as an easy treatment, Dr Mella reassures.
– The patients must be under observation for some hours when they receive the treatment in the ward, and they are admitted for 24 hours to make it possible to deal with potential adverse reactions.
Drs Fluge and Mella have worked for almost three years in their search for biomarkers for ME, thanks to the funding from Western Norway Regional Health Authority. In their search, biological samples from the study participants are investigated in the laboratory. The patients’ clinical picture is the researchers’ starting point in their search for biomarkers. From there they can reflect where the problem might be located and search for abnormalities. Dr Mella admits that there is always a need for money for research, more can be done and things can move forward a little quicker.
Ellen V. Piro and Eva Stormorken Norwegian ME Association
16th March 2012
The translation has been approved by Professor Olav Mella and is published with his permission.