It was a project birthed in hope. Pal Schaathun, a Norwegian filmmaker would document what he hoped might be the end of chronic fatigue syndrome (ME/CFS). That, unfortunately, turned out not to be but Schaathun ended up documenting – in strikingly beautiful fashion – the next best thing. He managed to vividly portray the needs, hopes and desires of a community desperately yearning for health as it embarked on its first real shot for success.
Left Out follows the ME/CFS community in Norway as they participate in and await the results of the Rituximab trial
Schaathun followed a Norwegian oncologist, Oystein Fluge as Fluge and his colleague, Olav Mella, embarked on a major clinical trial. The two doctors found, to their surprise, that a chemotherapeutic and autoimmune drug called Rituximab had produced duo remissions for a few ME/CFS patients with cancer.
As several positive preliminary trials rolled out, the small ME/CFS research community jumped into action as well, producing 11 studies focused on Rituximab or the part of the immune system it was believed to be impacting.
In the film, we get to watch Fluge in action, as he hurries from lab to lab and patient to patient, as he gets lost on the road, watching the news of the trial on the TV with his family and friends, as he meets with colleagues, etc. It’s a touching and personal portrayal of the man behind the Rituximab effort.
Schaathun uses patients in the trial and those awaiting the results of the trial – to vividly demonstrate just the impact this disease has. From teens stuck in their homes, to adults unable to walk down the street without crashing – the awful strangeness and the devastation this disease leaves in its wake is clearly portrayed. So is the courage and sheer stick-to-itiveness of those who have it. They’re coming to terms with their limitations, getting out when they can, thrashing their bodies on exercise studies: they’re a determined bunch.
The trial failed, but even in its failure it produced some interesting results. Some patients on Rituximab did dramatically improve – just not enough of them (not nearly enough) for the drug to be approved. Even more patients on the placebo significantly, but temporarily, improved, demonstrating once again how powerful that response can be. A significant subset received no benefits at all.
Above all, the film is a reminder of the remarkable thing Fluge and Mella did – and how remarkable the Rituximab trial itself was. Two oncologists with no connection to ME/CFS, in a small Scandanavian country without a history of ME/CFS research, somehow managed to birth the largest drug trial in ME/CFS’s history. Twenty-four Norwegian researchers and five hospitals ended up participating. The Norwegian advocacy community turned out in spades and many patients from around the world and the Norwegian government contributed.
The failure of the trial dashed the hopes of many – including the bedridden teen who’s reaction was wrenching – but the Rituximab effort was not. It remains a shining example of what we as a community can accomplish. Another Rituximab will show up at some point, and when it does, my guess is that we will similarly discover resources within ourselves we didn’t know we had, allies we didn’t know existed, and support from places that had been closed to us.
Thank you to Norway for showing us that and thanks, to Oystein Fluge and Olav Mella for your courage and determination and to Pål Schaathun for producing the most visually striking portrayal of ME/CFS yet.
Left Out: Directed and filmed by Pål Schaathun, Producer: Jonathan Borge Lie, UpNorth Film Film editor: Morten Øvreås Composer: Kato Ådland
It is an excellent film, both beautifully shot and very well edited. Cort makes a brief cameo appearance about half way through the film.
I was disappointed that the researchers seemed to have no interest in following up on the patients that improved and trying figure out what happened (unless you know differently Cort). I mean the woman who recovered enough to run the 10k race clearly improved significantly after being ill for nearly a decade and there has to be a reason. A reason that might help other patients if researchers were more curious.
Hi James, Fluge and Mella stated before the trial was completed that even if it was not a success that one thing they hoped to do was identify why the trial worked in those whom it did work for; i.e. try to identify who it worked for.
I haven’t heard that they’ve able to do that or if they tried and it didn’t work or if they’re still trying or what happened but they very much wanted to do that.
LEFT OUT is the perfect feeling this illness brings.
And life goes on around us…..as we get…….LEFT OUT…..but, we continue to endure! We don’t give up our HOPE as tomorrow may bring the better “purple bandaid”. Yet we are tired and few understand.
I sure hope we find the puzzle pieces to this complex illness and with those pieces find solutions.
Keep enduring…….
Issie
I love the message to keep enduring, keep the hope for a better future alive. Rituximab presented a pretty exciting possible future. That future still exists and we will get there – and we will get faster if we keep our eyes on the ball.
In the meantime what a great job Fluge and Mella and the ME community of Norway did. The fact that they were able to get this huge trial together is inspiring. Think how much energy was unleashed there and then think how much energy could be and will be unleashed in the US when the breakthroughs occur.
One of the first symptoms I noticed was Lactic Build up.
I kept telling doctors early on in my diagnosis ( 9 years ago ) that my fatigue, muscle & joint pain felt like a build up of Lactic Acid ….. similar to after pains after a intense workout ( done b4 I got sick ) .
I kept saying it to them, but I never got heard ?
Trish, I also noticed my body feels like it did when I really exerted myself by using my muscles in Gym classes, and also when raking blueberries, which demands that one use their muscles over and above a strenuous workout.
I have also mentioned this to many Dr’s and no one seemed to find it of particular interest. I want to stress I believe it’s similar to when one has a build up of lactic acid throughout ones muscles. Sincerely,
Same
This 2016 review on Rituximab may of interest to you James. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4993704/
I think it only works in a subset of people because it’s such a complex illness with different and multiple root causes. If someone has a parasite, virus, gut dysbiosis, Lyme etc., or a combination of these infections, different branches of the immune system will be activated. I think this is one of the reasons it doesn’t work in everyone.
I agree that this illness is complex and that comorbid infections, gut dysbiosis/SIBO, tick borne illness and other parasites must be diagnosed and treated to give the patient any chance for improvement. ME seems to be a defect in oxygen use/metabolism. Fluge also mention sugar metabolism issues. Getting improvement in quality of life will be a multi prong approach as it appears to cause multisystem failures. The answers will come from more than one doctor with more than one treatment option so I do not see the rituximab study as a failure.. Great film, I hope the Norwegians are able to get funding for continued studies.
I agree. I suffer with this disease now for 14 years. I’m alone trying to find something to help with insomnia, lethargy, brain fog, muscle pain, gut issues. I’m now working on killing anything in my gut that should not be there with garlic, oregano oil, and other natural antibiotics. I’m at my wits end. Honestly I pray to God to take me home in my sleep. This has gone on too long and I’ve spent a fortune trying new things. I even worked with a holistic doctor because mainstream doctors have failed me.
Thank you – I look forward to watching this!
Well, I have a question about the saline solution used as placebo, because saline solution definitely helps many of those who suffer from pots and it is not due to placebo effect. it is due to expanding blood volume.
If you’ve ever had a saline solution you know that the effects of saline solution diminish rapidly – a day or two and it’s over. The participants only got a few infusions and then were assessed 12 months later – long, long after the effects of saline would have been gone.
I had the exact same thought. Especially those with ME and POTS. Saline solution is life changing for many POTS patients.
This comes up again and again but for this to be true somehow you’re going to explain saline solution one day is still effecting patients months later. Lots of people have had saline solutions to help them get over a crash and they do really help but have you ever heard of a person getting one and voila! their disease has permanently changed?
The unfortunate thing is that Rituximab has helped many patients. I’ve been on it for 9 months, and it has helped me – I’ve been able to get off of two of the drugs I was on, and overall, my symptoms are better. But, it is only a piece of what I’ve been doing to get better, the other elements of the treatment plan are helping other pieces of my illness.
I have spoken directly with Fluge, and he was honest about not promising anything. However, I think that for the carefully selected patient, who does not have active infections, Rituximab can be a game changer. I also wonder if some may have benefited more with other treatments at the same time, that helped other facets of their disease.
It’s unfortunate that Rituximab has so LOUDLY been said to be unsuccessful, as I fear many patients who would benefit will not be given the chance to try it, which would be tragic. Part of the problem lies in the subsets of patients with ME/CFS – not every subset will benefit. But some will.
I think this is a great point and I don’t think your experience is actually that uncommon. A drug fails a trial but doctors still find it useful for some patients. For instance Florinef failed in an ME/CFS treatment trial but Rowe and other doctors still find it quite helpful for some patients.
We clearly need more precision medicine! I remember that Nancy Klimas has talked about infectious vs autoimmune subsets and the need for dramatically different treatments for each group.
Just over 25% of the people in the trial did respond to Rituximab. This drug does appear to really help some people – as the film showed.
Cort I am sending this out on Sinc I know but I have just finished reading the book Primal Pancreas. It is wonderful and I am taking to my new Auto Immune Dr here in Ga in March. It is written from a Patient point of view. Hope it helps.
Pls also comment, everyone, who has heard the Nova SE NID team in Florida mention MOLD affected people as a subset, or something even remotely like this. This may not be an accurate paraphrase, but I think I heard a mention of 80%? of Nova NID patients testing high on the Real Time Labs mycotoxin panel and / or the Great Plains Labs mycotoxin panel.
RTL is covered by Medicare; GPL is not but may be reimbursable if the paperwork ugh is followed through to success.
I don’t remember the exact number but it was something like that. I was pretty shocked. I don’t know how long Dr. Klimas has been doing that test and I actually don’t know what test was used but the prevalence was REALLY high.
Yes Learner1 I agree with you in relation to the subsets. Maybe in the future these subsets will actually be regarded as different illnesses?
Also, like you, I do a whole range of things to improve my health and I believe they’re all interconnected – I see them like cornerstones – each playing a major role – (diet, sleep, stress reduction and supplements).
Also Dr Oystein Fluge said something simple on the TV interview – ‘Patients seem to struggle with transforming sugar to energy.’
I would absolutely agree with him. I’ve had terrible trouble trying to keep my brain fuelled. However with all of what I’m doing and regularly eating the proteins, fats and vegetables I’m managing at long last, to keep my brain functioning.
I think that maybe because my brain was running low on fuel, lactate was building up, like Jarred Younger believes. Now that I’m regularly getting fuel to it, in a usable form, my brain is working much better, I have more clarity of thought and my memory is improving.
Dr Fluge also said ‘It’s some sort of functional disability. It’s not structural damage. I think it’s a struggle for energy. It’s like they use all available resources to survive.’
Over the years, I’ve been worried that I was being damaged by the illness. However as I feel better my level of functioning is improving, especially my brain, which is a huge relief.
In the film Laila’s functioning improved dramatically, enabling her to complete the 10k run in under an hour. I think that even though the Rituximab trial wasn’t a success for everyone, for the individuals it did help, it would have made an enormous difference. Like my improvement has made to me. Hopefully people in other subsets will be helped by specific treatments that suit them.
“It’s like they use all available resources to survive”, that’s it we do, just survive. Our lives are simply, Just Surviving. I love the example using the battery. I’ve long wanted an easy way to describe what happens and this is perfect. The “spoon” one never worked for me. In my humble opinion, a holistic approach is needed when looking at ME/CFS/FMS as there are many variables, but one connection is – an inability regenerate after physical activity. It doesn’t damage our bodies, they still function normally if we find something that helps, it just depletes our energy and effects our energy systems. It is interesting to me, and not surprising, that no one has investigated the mouth ie teeth and jaws and hidden infections. I am currently seeing a holistic dentist and am amazed at what he has found under a microscope, in my mouth, including spirochetes, parasites etc. I have not been diagnosed with Lyme Disease, yet the Spirochetes are in my mouth. My teeth and jaws are misaligned which is causing massive problems, including brain fog. The saying goes “our health begins in our mouth and ends in our gut, if these are both healthy, we are well”. Why has no one investigated the mouth.
ME/CFS/FMS are multifaceted, the thyroid can also play a huge part. The problem I see is that ME/CFS especially and at times FMS are used as an umbrella for several ills that the doctor cannot or is not interested in diagnosing ie too hard basket. Therefore a whole plethora of different diagnoses need to be made, to rule out other causes and find the connecting link causing low energy. Most medicos’ won’t do this and if you are on public health, forget it. I do think lactic acid build up is certainly a problem, especially with FMS and am going to look into that for myself.
Thanks for posting this Cort. It should be aired on the television network so we get real recognition of our illness by the general public and hopefully the medical profession at large.
You do a wonderful job Cort, much appreciated.
Also it needs mentioned some patients worsen with Rituximab. (I think for some they permanently worsened) So there’s a risk to this stab in the dark approach. Hence I’ll be waiting to find out if they discover a way to identify the subset of patients where it does work
I think the issue of “active infections” brought up by Learner1 is really important. Especially when the active infections are apparently due to our ineffective immune systems (e.g. MAI).
Thanks for letting us now about this , Cort!
I was remiss for not sending a message to Drs Fluge and Mella after the results first came out — to thank them profusely for what they did.
I was so caught up in the disappointment that it was a negative study. Yes, the results are a disappointment but these researchers are the opposite!
Despite the outcome, the point is that these 2 wonderful specialists – in oncology medicine – undertook this rigorously scientific study to follow this Rituximab lead. For that, I am forever grateful. They, not even previously in the ME field, took ME patients seriously and believed that we are indeed ill. This is a LOT.
Also, the ME field seems to have a lot of small studies that were never properly followed up on, leaving only questions behind. It is essential we follow these leads, even if they result in negative studies. We learn valuable information from them.
And some of the other comments here mention the possibility of subsets perhaps being responders — it would be useful to know what the researchers think about that.
I’m sorry I didn’t say it sooner — but if you’re reading this, thank you, Drs. Fluge & Mella!
I felt the same way! They told us the trial didn’t work out and I kind of lathered myself in my disappointment and went on my way -forgetting how grateful I really was that these two oncologists and their research group devoted so much time and enery to this study. You could see during the film how bitterly disappointing the results were for the group.
Anyway – yah for Drs. Fluge and Mella and thanks for exciting us, for believing in us and giving us hope…and thanks to Pat for taking all the to embed himself in the team…
Indeed.
Are they still working in our space I thought they were following an autoimmune lead?
Thank you Cort for this article and being able to view the documentary about the study. While heart breaking for them, its interesting that some improved although not enough did. I would like to know if there is a plan to follow those patients that did improve. I haven’t watched the entire documentary – just skimmed and then some of the end. I can’t sit at the computer long enough but I’ll eventually watch half of it at a time. Again, thank you so much Cort.
Thanks for this. I thought it was an excellent film. You write that even more patients on the placebo significantly temporarily improved. Is it in the study write up that those on the placebo only temporarily improved whilst those on rituxamab had a sustained improvement?
Ha! Great question. Unfortunately I haven’t been able to get the paper and don’t know how many people continued to benefit from the Rituximab 24 months later. We know from the film that at least one did.
I just watched this film and found it really beautiful and extremely well done. One of the things I especially like about it is that it captures the experience of people, young and middle aged (though the older folks are left out, alas) while also documenting a universal story about the vetting of a possible treatment through a scientific drug trial which could apply to any disease. I think that is enormously important, and should make this little film much more acceptable to a wide audience than previous ME/CFS centered films.
Also, and I probably won’t say this delicately enough but so be it, this film is effective because the subjects are dignified while clearly suffering. Too many ME/CFS films produced in the US (including Jen Brea’s) have been so self-pitying and maudlin as to make the patients unsympathetic subjects. The Norwegians here did a much, much, better job!
I have never forwarded on any of the Brea-type CFS films, but this one I am sending around to both family and friends.
Thank you so much, Cort, for giving us this.
(But I couldn’t figure out whether you were the tall guy in the backpack, or the professorial guy with the glasses).
No Matter! Many thanks again.
I too was inspired by the grit and determination the patients showed. I loved seeing the woman on the exercise bike – right after I believe the film showed a woman unable to walk to the corner. That juxtaposition showed just how courageous many people are.
Katarina Lien has done some great work on exercise in ME/CFS. She’s another new Norwegian star in the ME/CFS world – and another consequence of Fluge and Mella taking Rituximab and ME/CFS on.
I thought the film was beautifully shot, too.
And at about the 2:10 mark, the animation to explain the ME energy problem was just excellent – one of the best I’ve seen — very effective for the public to understand.
In regard to ‘Waiting”, if what you are referring to was the ‘battery inside the human’, I totally concur. I was thinking that also at the time that it was shown. That puts it in a way that we (who suffer from ME/CFS) have not been able to explain in mere words. If we could use just that ‘diagram’ on posters etc maybe we could explain to other ‘healthy’ people what we deal with every day.
I, myself have been ‘dealing’ with this since November 13, 1992. I attended 2 support groups for 2 years to learn more about it; I finally gave up as I could see more people were interested in changing the name than figuring out how to live with it. I had to work to support myself (having no family or friends), I have made the best I could since it already took me 3.5 years to even get SSI, to live on. It is a hard way to live.
Thank you to Cort for making this possible for us to see.
Hi Diane Crow,
Yes – the ‘battery inside human’ is the animation I was referring to.
I agree – even in the form of a series of diagrams on a poster, it would be great.
Also agreed – having this disease is indeed a hard way to live.
Cort, thank you for highlighting this study and providing the link to the documentary. I have had ME for 29 years (am now age 60) and follow all of the research. I appreciate what doctors Fluge and Mella have done with the study. And I appreciate all that you do for ME patients, Cort.
It is a good documentary. Although it shows a failed trial, it advocates CFS research to say the least. The ambiguity, grayness of this sickness is the reason why NIH doesn’t want to fund the research with significant resource. Anyone knows any progress done at Stanford?
I have a very good idea why Rituximab failed & how it is possible it could be better I need to do some more searches to conclude what I am finding
Wondering what Rituximab was originally designed to treat?? Is it still used for any illness?
Rituximab is a very widely used drug to treat cancer and autoimmune diseases. It’s not a mild drug – almost 21% of the study participants reported a serious adverse event. On the other hand, somewhere around 19% of the placebo group also did – demonstrating that ME/CFS is not a fun disease to have!
Simply having ME/CFS was almost as bad as taking a pretty toxic drug (lol)
Heart wrenching yet wonderful, exciting and hopeful at the same time.
I am so grateful to these two doctors.
Me to….Talk about two people making a difference! They transformed how Norway approaches this illness! I hope they are able to keep working on ME/CFS – they do have a cyclophospamide trial under way.
I know there are other Fluges and Mellas out there.
Rituximab is used to treat certain types of Cancer (such as lymphoma) as well as certain autoimmune diseases. It is used to treat RA (rheumatoid arthritis).
Thank you Fluge and Mella for all your wonderful research. We must keep up the hope!
Thank you, Cort, for this beautiful post, and for sharing the film with a wide audience.
Initially, I decided to make this movie after a friend with ME told me that I didn’t understand the illness. So I tried to show it. And I know for a fact that the documentary had an impact on health workers in Norway. A lot of people have told me after watching this: “I had no idea what ME/CFS actually was, until now”. Most people are totally unaware of the fact that physical activity can and will have a negative effect on patients with ME/CFS.
A small fun fact from the editing process: Even though every second of music was specially composed for this movie, it is the only time I have deliberately kept the music volume lower than industry standards on a production, trying not to make this a nightmare to watch for patients. I know it still takes a lot of energy to watch it. Hopefully, it can be worth it.
Hi Pål!
Thank you for making that choice about the music! And for the whole documentary, of course.
And what a beautiful film Pal! I don’t know how you did it but somehow you managed to make one of the most sheerly beautiful films that I’ve seen.
Thank you so much for making this film. It is beautiful and clearly explains the problems we have.
Another thank you to Pål for such a well-done job! It is so very important to have these personal stories told publicly, because human beings respond best to stories. And stories of the researchers as well as of those with the illness! It is so important to make the illness *feel* real even to those who do not have it. Congrats!
HI Pal, all the way from Australia, down under. Thank you for this beautifully made documentary. It is very factual, extremely important for the public to learn, and keeps emotions at a minimum. Also you really do show just how badly we are afflicted and how it affects our lives and how it robs us of our quality of life. Most people are ignorant of this but your movie really brings it home. You’re little example, diagram of the battery is, for me, just the perfect way to describe what happens to us; something I have been looking for, for many years. Thank you for making this documentary, I am going to forward it on to as many people as I can. Congratulations, well done!
Thank you Pål for your devotion and hard work over a long period of time for this excellent documentary. Thank you also for the lowered volume on the music, much appreciated!!!
Yes, I think the saline may be a clue. I know Cort is saying it stops having an effect after a couple of days, but hydration is so important in ME and we all know that most people – never mind those with ME – are under-hydrated. I know that dehydration is a massive part of my illness – not all of it, but a significant part, and I’m unable to hydrate properly just by drinking. So something is going wrong with that process – as it often does with people with autoimmune conditions (one root of my ME is autoimmune thyroid disease). So as another person on this thread says, there are so many routes into ME, so many factors, but perhaps the hydration helped some of those: once hydrated, tissues will start to heal, then another hydration, a bit more healing, somehow they got onto a good path with that and were helped. But it didn’t work for everyone, just like the rituximab. And there will be a placebo effect with the drug as well as with the actual placebo. I am working on my own hydration, trying to find some solutions. I’m sick of being ill. The great thing about your site here is that we can all report back on our own experiments and our own root causes.
Yes, good point. There may be a placebo effect in those taking the drugs. Good luck with your hydration – something I know I could do better at.
Hi Rebecca,
I do have a problem with becoming dehydrated. I do drink a fair amount but generally don’t feel thirsty. If I eat certain things that seem to irritate my kidneys/urinary tract then I feel the constant need to pee, which becomes very concentrated and it’s very uncomfortable.
I don’t ever feel thirsty unless again, I’ve eaten something that sets me off and I will feel the need to drink and drink and I sort of fill up like a balloon!
It’s like getting the energy to my brain, I think some sort of miscommunication is going on or the level that my body is set at is too low.
So many of the issues people have seem very similar to either older people or young babies – like temperature control, dehydration and so on.
I wish Emilie the best! It is heartbraking to see a young person like this. I cried for all ME patiënts. And also for my stolen life, almost 25 years now.
I feel the same way Gijs – I wish Emilie the best too. And all of the others – its no way to live is it?
Thank you for posting this film, Cort.
What an excellent, excellent, brilliant film in that it really shows how people with M.E. suffer with loss of quality of life and that it is a real illness. This doctor, these doctors, are real doctors and thankfully they have taken up the cause and are continuing to search for an answer and how to help M.E. sufferers. It was beautifully shot, but a bit hard to read the subtitles, as they weren’t on the screen for long and my brain is slow. I am so very grateful that I got FM/CFS at the age of 50, unlike that poor young teenager, just tragic for her. Hopefully a treatment will be found soon and a cure would be even better.
Is the battery diagram posted anywhere as a still image? I would sure like to see it but am not up to watching the movie. The graphic doesn’t appear in Google images.
ME CFS South Australia received permission to share the Battery excerpt from the movie. 1 min 42 seconds to watch. It is on Youtube here https://www.youtube.com/watch?v=bXAdsrk0FZw