Drs. Mella and Fluge have become a media sensation in Norway (Photo: TV2)
By K. Kimberly McCleary, President & CEO
The PLoS ONE publication about promising results of a phase II clinical trial of rituximab in CFS, from a team of clinical researchers led by Drs. Øystein Fluge and Olav Mella at Haukeland University Hospital, Bergen, Norway, has generated a blitz of media coverage by TV2, Norway’s second largest television station. TV2 has produced numerous interviews with Drs. Fluge and Mella, several of the patients who participated in the trial, local patients hearing the news, and public health officials who have pledged more responsive support for patients and policy that will advance the research. Dr. David Bell, a widely respected New York physician credited with being one of the first to recognize CFS in the United States, is so far the only person outside of Norway to be interviewed by the station about the research.
The stories are posted to the station’s website in Norweigan, with translations of the written text available using google translate or other tools. The translations are rough, with the usual difficulties associated with medical terms and idiomatic phrases. We’ve listed some of the articles here. A complete list (compiled and updated regularly by TV2) is available here: http://bit.ly/oP6P7q Video clips are also available. Here is a 7-minute video that includes Dr. Bell’s interview: http://www.youtube.com/watch?v=ZBCXKIRBQ-s&feature=youtu.be. (English captions may be available by clicking “cc” on the toolbar below the video, depending on your computer settings.)
Some of the people featured by TV2 in their coverage of the rituximab study
“Norweigan research breakthrough can solve CFS mystery” (Oct. 19, 2011)
“Elene cured of ME” (Oct. 19, 2011)
“American professor applauds research results” (Oct. 19, 2011)
“When can we get the second ME treatment?” (Oct. 19, 2011)
“All about ME breakthrough” (Oct. 20, 2011)
“Anne was sick with ME” (Oct. 20, 2011)
“Will find the world’s first ME test” (Oct. 20, 2011)
“[Health minister] Strøm-Erichsen promises to follow ME breakthrough,” (Oct. 20, 2011)
“[Member of Parliament] Laila Dåvøy about ME breakthrough — on behalf of the severely ill ME patients this provides enormous hope” (Oct. 20, 2011)
“ME sufferer ‘Gunnar’ was not believed, was admitted to psychiatric (ward)” (Oct. 21, 2011)
“Pain being a mom with ME,” (Oct. 21, 2011)
“Anne Kathrine put the cancer doctors on the trail of ME treatment” (Oct. 22, 2011)
“Health directorate: we do not have good (national) health services for sufferers” (Oct. 22, 2011)
For a summary of the study and its results, as well as a list of media coverage by outlets in the U.S. and other countries, please visit http://www.research1st.com/2011/10/19/rituximab-trial/.
K. Kimberly McCleary has served as the Association’s chief staff executive since 1991.
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NOTE: Google Translate has the last headline wrong! The clip is really titled: Health Directorate: We do NOT have good enough health services for ME/CFS sufferers.
Thanks, Anne. We’ll correct that and suggest the correction in the google translate utility too!
Quote from the director at the Norwegian Health Directorate:
“I think it’s correct to say that we have not established proper health care services for these people, and I regret that.”
I keep meaning to read the paper but I’m pretty pooped- did the authors try and determine sudden vs. gradual onset of cases? A lot of the patients in the media articles seem to have ‘classic’ ME, with noise/light sensitivity, etc. Did they do symptom profiles with sore throat, swollen lymph nodes, etc? I had a gradual onset and progressive disease course but no light/noise sensitivity, nor do I have sore throat/swollen lymph nodes. It would be nice to see if the responders/non-responders fit any particular profiles. Thanks.
Hi John,
There were some differences between the treatment group and the placebo group, such as length of illness (shorter in treatment group) and gender (12 women in treatment group vs. 9 in the placebo group), but these occurred randomly in the assignment, not to test any particular hypothesis. Based on the data provided in the PLoS ONE paper, there is nothing reported that helps distinguish the responders within the rituximab group from the non-responders. (I have heard from several researchers who would jump at the chance to dig into that data set to help them look more closely for predictors of response!) When you’re feeling up to it, take a look at Table 1 (http://www.plosone.org/article/showImageLarge.action?uri=info%3Adoi%2F10.1371%2Fjournal.pone.0026358.t001).
Also I’ve read in some of the interviews (at this point, can’t remember exactly which one) that the patients who were younger and ill for less time did better, but that is a pretty generic statement that applies to most treatments for acute and chronic illness. It’s also not clear whether this means they responded more or their response lasted longer, or some other interpretation. There is also the problem with the mechanical translation of the doctors’ statements, so it’s important not to put too much weight on google translate-generated information.
It’s interesting to note that in one of the two follow-up phase II studies listed on clinicaltrials.gov, they have added another step of doing plasma exchange (one plasma volume, up to 5 treatments, during 1-2 weeks), to be performed 2-3 weeks prior to start of rituximab therapy. (See http://clinicaltrials.gov/ct2/show/NCT01156922?term=Rituximab+AND+chronic+fatigue+syndrome&rank=1). This is for the study of very severe CFS, with tighter entry criteria compared to the larger study of 30 patients with the same entry criteria as the study reported in PLoS ONE. So, it’s possible they learned something about severity of symptoms that they are trying to sort out in this follow-up, even though that analysis is not included in the PLoS ONE paper.
Hope that helps.
Thanks, I agree with the researchers you talked to about trying to tease out responders vs. non-responders as by all accounts it’s looking like patients with a ME/CFS diagnosis might not even have the same disease, or at the very least might be different subtypes. The Lights’ recent research really shows this clearly with the a2a-decrease subgroup that had such different results from the main group (which itself might have more subtypes if the number of patients and/or the number of genes measured were increased), but since Fluge and Mella aren’t ME/CFS researchers they might not be aware of this potential confounding factor. Also I think I’ve read comments attributed to them where they talk about possibly wanting to give more doses to non-responders but this seems like it might be beating a dead horse given the issue of subtypes, IMO.
I think all research studies should at least include a fairly comprehensive symptom profile which patients could fill out at home before taking part in the study, as this seems like it might help tease out subtypes. For instance-
1. Do you suffer from sore throat? Yes/No/Not sure
2. Do you suffer from swollen lympth nodes? Yes/No/Not sure
3. Did you have a sudden or gradual onset to your illness? Sudden/Gradual/Not sure
4. Do you have a progressive or stable (though poor) disease course? Stable/Progressive/Not sure
5. Do you have noise sensitivity? Yes/No/Not sure
6. Do you have sound sensitivity? Yes/No/Not sure
…etc.
It seems like if researchers did this it could possibly be a way to strenghten associations in both treatment and pathophysiology studies. For instance if all (or most) sudden onsets had one result but the graduals had another result then this could possibly be helpful in interpreting the results of the study in question as well as for designing future studies, although an objective way of doing this is what is really needed.
Just give it a little time. I didn’t have light or sound sensitivity at first, but it has slowly come on. It first started with the fact that I couldn’t stand the sun anymore. It weakened and exhausted me. I can’t be out even for 1 hour. It knocks me back down, and I’m weak for sometimes a few days, most of the time, over 1 week.
Thanks to Kim and the CAA for reporting on this in such a great way.
I really wish that there no “miracle cures,” “answers,” “solutions,” “victories,” until all of the studies are done, which answer some of the questions raised above, and all the data is in.
What if this drug only helps younger people, or those with a shorter duration of being ill, or those with certain symptoms but not others, or those who are not as sick as those who are 100$ homebound, etc., etc.
There are a lot of variables and possibilities here, and although the media wants to hype something, doesn’t mean that is scientifically sound or will help everyone with this disease.
Can’t we all wait to find out?
I’ve been ill with this disease for a long time, and I would rather that this be proven to help people with CFIDS as a whole, without jumping on the bandwagon with trumpets blazing.
How about a measured, scientific approach?
I am soooo appreciative for the Research 1st site!!! As I live in Canada, I get BBC World News on TV. This morning the “headline scroll bar” included a reference to CFIDS/ME and I followed up on-line. There is great article! (which should be shared): http://www.bbc.co.uk/news/health-15401746
Thanks, Arne. Here’s another new article from the U.K. Daily Mail: “Cancer drug ‘key to treating chronic fatigue’ as experts say syndrome may be caused by defective immune system,” by Claire Bates. (http://bit.ly/nSg5Vf) We’ve added both to the list on the main story about the trial at http://www.research1st.com/2011/10/19/rituximab-trial/.
Yes, but what happened to the immune system to make it defective? It worked for, in my case, 39 years, and then after a tough flu, I got this. So something went haywire.
I totally agree with you there Kathy d. What did happen? I personally believe that influenza virus is still in the brain, after all that is the Central Nervous System. Maybe a whole new way of treatment could be in the area of radiation or lazer into the brain. I would try it. I wish they would look into this. ever hopeful:)
kathy d.,
Many studies have shown that various infectious agents can trigger an acute illness and that some people (about 10%) do not recover. This has been shown with Epstein-Barr virus, the agent that causes Q fever, the agent that causes Ross River virus, SARS, chickungunya, giardia lamblia and other pathogens. Suzanne Vernon, PhD, our scientific director has written several articles about this, most recently “Acute Infection, Chronic Consequences.” (See http://www.research1st.com/2011/09/13/acute-chronic/) In one study known as the DUBBO study, the researchers found it was the severity of the acute infection that was the biggest risk factor for failure to recovery. So it may be that your immune system was somehow vulnerable at the time you got the tough flu, it was more severe than usual and your body didn’t recover.
Dr. Anthony Komaroff gave a webinar presentation during our 2010 series on “CFS & the Viral Connection.” The recording has been viewed 2,831 times and is available at http://www.youtube.com/solvecfs#p/a/u/1/hyWSNitU-PQ.
Here’s the news clip from Norway Oct 19 with English subtitles.
To activate the closed caption (subtitles), click the play button, then click the CC icon at the bottom right in the video.
http://www.sarasverden.com/2011/10/24/me-breakthrough-with-english-subtitles/
Thanks, Anne. The option to see English captions may depend on viewer’s computer settings. We can’t see them on our system!
To pick up on what Kim says above about long-lasting, bad infections, I was very sick with the flu before I got CFIDS. But, interestingly, for several years before that, I would get the flu around Jan. 1, be home from work for 1 1/2 weeks, then — as a friend said it — drag around until May 1. I always got a bad flu that it took months to get rid of before I even got CFIDS.
As a teen-ager I had a bad case of mononucleosis, kept me home for a long time sick as the proverbial dog.
And at the beginning of the CFIDS, I had high Epstein-Barr titers, an inflamed spleen and liver. For a few years I had liver involvement, which worsened for awhile and then improved.
It may be that my body’s immune system had been battered for 4-5 years when I had bad flu episodes that lasted, and I was always tired.
Thanks for putting together all that great work David.