From the CEO’s Desk: November 2011
By K. Kimberly McCleary
A patient receiving her infusion is kept company by a study nurse and Drs. Mella and Fluge (far right)
On Oct. 19, 2011, a team of researchers in Norway, led by Drs. Olav Mella and Øystein Fluge at Haukeland University Hospital, published promising results of a small phase II clinical trial of rituximab (Rituxan) in CFS patients. Although it involved just 30 patients, the study was double-blinded and placebo-controlled, the most rigorous kind of clinical trial designed to reduce the potential bias of the investigators and the subjects involved. After two infusions of rituximab (a monoclonal antibody FDA-approved for two forms of cancer and rheumatoid arthritis), 67 percent of subjects in the treatment arm experienced significant improvement in all CFS symptoms. Just 12 percent of the placebo-treated patients benefitted. (For more details, please read our summary of the study and links to media coverage: http://bit.ly/oPSwTo.)
The researchers are following up these encouraging results with two open-label studies in hopes of improving the protocol for administration and dosing of the agent. There has been tremendous interest from researchers and physicians in the U.S., U.K., Spain and other countries to initiate other studies, although we don’t have any specific news to share yet. Some people were surprised that this type of treatment would be applied to CFS, but there are plausible mechanisms (in at least a subset of patients) for its success found in published studies of immune abnormalities in CFS going back to the early 1990s. The study authors have responded to a letter to the PLoS ONE editor, providing an interesting exchange of ideas about the mechanism of action that might be at work. (See http://bit.ly/sgutnc.) We’ve posted systems biologist Dr. Gordon Broderick’s observations about rituximab’s early success here: http://bit.ly/oQk7dw.
Dr. John Sweetenham
Rituximab is approved to treat five conditions and it has been tested in a wide variety of cancers and inflammatory and autoimmune disorders. Oncologist Dr. John Sweetenham of the Cleveland Clinic answered some of the basic questions about rituximab here: http://bit.ly/sQtJdc. We addressed several additional questions in the comments on that post and the others linked here.
It is “early days,” as they say, and there is much to learn about the use of this novel therapy in CFS. It is very encouraging to hear the stories of patients who have benefited from the trial and to see the response from the authorities in Norway, including an apology from the Norwegian Directorate of Health to ME/CFS patients who have received inadequate care in their national health system. (Our story about TV2 news coverage in Norway: http://bit.ly/ol8JAR.) Drs. Fluge and Mella have also reported that there is now a national effort to conduct a larger, multicenter phase III study, but they caution it will take some time to plan and 
get necessary approvals. We’ll host a Q&A with them later this month (after they’ve had some time to breathe!). The doctors have stated in several interviews that use of rituximab in CFS should, for now, be restricted to research studies.
We see these study results as a new lever in our efforts to mobilize resources that will advance objective diagnosis and effective treatment. It’s important that this lead is followed and that other promising research continues as well. We have 26 grant applications for exciting new research projects now under review for scientific and strategic merit. Our SolveCFS BioBank and the biomarker “hit” list we’re working to develop will be even more valuable resources for the field in light of recent publications. We’ll post updates from our funded investigators and about other aspects of our research program later this month. In the meantime, please consider becoming a catalyst for research with a gift of any amount to the Catalyst Fund. Contributions of up to $10,000 each will be matched through year-end and will support the next round of research grants and other exciting work being led by the Association. In return, you’ll receive access to exclusive Catalyst updates and events. You can make an online donation at our secure page: http://bit.ly/2011fund.
The Saturday Evening Post recently interviewed Suzanne Vernon, our scientific director, and the interview is now posted on the magazine’s website; a second part will run in the November/December print edition’s “Medical Mailbox” feature. Media coverage about other research-focused topics continues almost daily; we regularly update the detailed listing here on Research1st.
There is a tremendous amount of gathering momentum and we’ll do our best to keep you well-informed at Research1st! Thank you for your interest and the great dialogue that takes place here.
K. Kimberly McCleary has been the CFIDS Association of America’s chief staff executive since 1991.
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If anyone knows how to stop the constant pain of CFS. Please let me know.
My wife uses endone in small qtys. Sometimes a 1/4 of a tablet. She has been doing so for 2 years and has not had any problems with addiction etc. It has been a lifesaver for her. Probably the only drug we think actually does something.
There is but the US Govt. says it’s an illegal drug.
Matt:
Don’t be a tease. Tell us the name of the illegal drug that will stop the constant pain of CFS or is it Arthritis?
What are the side effects in case I take antidepressant like Zoloft in order to continue & work!otherwise I cannot continue!?
Hi Sina,
Zoloft is a member of a family of drugs called selective serotonin reuptake inhibitors (SSRIs), of which there are several on the market. Some people with CFS do very well taking these types of medications; for others it may take some trial and error with various medications and dosing to find one that has therapeutic effects and minimal side effects. Others cannot tolerate even small doses. We don’t understand why there is such variable effect, as these medications are used to treat a variety of pain conditions (not just depression) including fibromyalgia and migraine that frequently co-occur with CFS.
Here is some information about Zoloft specifically: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001017/. You may wish to consult with your physician about the various medications in this family. If price is a factor, some of the early SSRIs (like fluoxetine/Prozac, paroxetine/Paxil, etc.) are now available in generic form making them more affordable, especially if you have to try more than one before finding something that helps with your symptoms.
Zoloft is also available in a generic. Sertraline HCL
I found out that taking antidepressants like zoloft is the only solution i have to help plus sports and vitamins….waiting for the real treatment hopefully!
I have been dealing with CFS as well as fibromyalgia and degenerative spine disease for quite some time now. (nearly 20 years). I take adderall for the overwhelming fatigue and an immediate release of opana as well as an extended release formula of opana. Although I don’t recommend this unless you have excellent prescription drug insurance. Best of luck to everyone who is in the same position as I am. It’s not an easy road, but keep your chin up. Don’t let these diseases ruin your life. Keep looking for professionals that will both support you and help you search for the right combination of medication that will help you live your life.
I just want to let you know that the article in the german newspaper “Die Welt” is a bit… strange. It starts with the title “never being exhausted again” and then follows: “50% of the cancer-patients suffer from inexplicable and permanent fatigue. Now researchers from norway found a cure for them.” The whole article mixes Fatigue and CFS/ME, what makes it rather chaotic. Some people wrote comments about it but “Die Welt” stopped the comment-function soon. Clever, eh?
Thank you Kim. Very encouraging and I pray this one pans out. I would try anything, anything at all at this point. Jeanie
Am I the only one with CFS that has fatigue so severe that the weight of a 44 oz drink causes you arm to tremble under its weight? When I mention fatigue of this severity, even while taking adderall or vyvanse, to my doctors they look at me like I’m crazy. I am struggling to work part time hours so that I can keep my health insurance, but I am beginning to think that even part time hours will be an impossibility soon.
No, Pam, you’re not the only one with beverage issues. I have given up my favorite sturdy coffee mugs for a smaller china cup, just due to the weight difference. I don’t think doctors took me seriously when I complained that my coffee mug was “getting heavier” or that I had to stop and rest my jaw while chewing food. If you can possibly keep going enough to maintain health insurance, do it! I am now doing without insurance, without healthcare, and without much hope.
That’s crazy………….working PT with this………you need all your time just to work on wellness……..that’s your best shot…….can you file for disability?? I’ve had this for 15 years and I took lots and lots of supplements in my early days and am moving back into that strategy after years on pharmaceuticals now……not good with all the side effects etc……money….with insurances….I found a Naturopath who put me on Mistletoe injections at home several times a week for a year and I found that to be helpful along with many many other supplements to detox and I really recommend green teas and decreased sugar/carbs and to keep joints moving as much as you can do some ROM exercises in bed or sitting……I know how ridiculously difficult that is …..but I didnt’ do it and I am regretting now….I wish you well and hope you can find someone to help you NOW……don’t keep working if there is any other way.
If I’m really exhausted, have been at the computer too long using the keyboard, very bad “fatigue” and muscle pain set in and I can’t lift my arms any longer.
Then I hit my bed and the pain and “fatigue” in my arms is so bad I can’t hold up my newspaper to read it. At that stage, I can’t even walk from room to room.
The word “fatigue” is a mischaracterization. That’s what people get when they work too many hours, or have to stay up with children … healthy people. They sleep and rest and are restored to go on.
But what we get is deep exhaustion to the point where we can’t do anything. For me, I can’t go to the corner mailbox or go the grocery store around the corner or to the basement with laundry or to stand at the kitchen counter and prepare food. Or I can’t take a shower and wash my hair: I can’t raise my arms to wash my hair.
That’s when the newspapers accumulate, the laundry does not get done, the apartment does not get cleaned, I order food delivered and ask friends to take my mail to the mailbox. (Or I eat what’s in the refrigerator like yogurt, fruit). I absolutely cannot wash, cut up and cook food and then wash dirty pots most of the time. I’ve gone through months like this.
People ask me about exercise. If I can’t walk to the corner on many days, even to get a container of milk, or wash my hair, how can I exercise?
I’ve gone through a really bad period in the last several months where on many days I can’t get anything done, just watch tv and read books.
There are people who are totally homebound. I have recently read a blog, “No Poster Girl,” written by a young woman who is in that situation. She can’t prepare meals or go on car trips. She can’t go upstairs and downstairs. Until recently she couldn’t read fiction. She can’t listen to music. She thinks her illness is getting worse.
There are many others in her predicament.
When I read a book about CFIDS years ago, it suggested totally changing one’s view of “productivity.” It said perhaps on one day you can do errands nearby, perhaps on another making a sandwich is your productivity for the day.
A drag … but one has to make constant adjustments to the limitations of this ailment.
If doctors don’t understand it, I don’t get that. If people have bad bouts of the flu or mono (or other diseases) weakness and exhaustion is part of it. The main thing is that they have to listen and hear us and learn and absorb what we’re saying like with any disease.
I am hoping greatly that rituximab reveals something about this illness, even if it is not the ultimate cure. For now it says this is an autoimmune dysfuntion. I still beleive though that cfs has a viral component, or at least that it was enacted by a virus. A great many cfsers “cought a cold” right before becoming permanently ill. This could be the virus we contracted, which then permanently altered our immune system. I also believe cfs can be transmitted sexually, though it may only be capable of that in it’s early stages. I wish there was greater knowledge on that issue.
I also hope that the Rituximab studies will provide many more answers as to what CFIDS does, how it works, what systems it attacks, how it affects the immune system — and why this drug worked on 2/3 and not all who received it. The studies may
come up with some answers — even if this drug is not the “miracle cure” being touted in some of the media.
It sounds as if Drs. Malle and Fluge are determined to get to the bottom of this disease, and its affect on the immune system — and to see if this medication is an answer to the many who have it.
Meanwhile, lots of studies are going on in the U.S. on related issues by many dedicated researchers on a host of topics. If their studies are conclusive, that can only help us.
I must whole heartedly agree that “fatigue” is suh a misnomer when it comes to describing how we feel. I have tried so mant times to visually describe this to my doctors; only to get a blank look or a patronizing smile of “understanding”.
In my last summary FAX to my doctors, I bullet pointed my fatigue as follows:
Fatigue for a second time: I had previously described it as if the gravity of Earth was pulling me through the cracks and crevices of our planet. I also described that when walking up a slight incline would cause me to have to mandatorily stop due to exhaustion from the “work-out” of the incline. To further clarify my fatigue, I can secondly describe it in terms of Sg – Specific Gravity. Scientifically, it compares to me living on the planet Jupiter. Mathematically, Jupiter has about 20.87 m/s2 gravity while earth only has 9.766 m/s2. In practical application, if I weighed 180 pounds on planet earth then I would calculation wise, expect to feel as if I weighed 426 pounds.
I have attempted to use descriptive visualizations, metaphores, simily, personification, et al in proper use of english. I have used scientific comparatives for those medical professionals that do not equate to the flowery visual methods.
despite all – I firmly think they dont understand fully. Today I am slightly up; however for the past three weeks, it was like being in a psuedo-coma and catatonic, yet walking.
I have been through every protocol and regiment there is: Endocrine, Thyroid, Adrenal, Hypothalamus; Autoimmune – all biologicals, Methotrexate, Plaquinel, et,,; Narcotics Pain Meds; Antidepressants; Amphetamines; Benzodiazapines…….. nothing works
Despite it all – I do have a few exceptional days where the mind is clear and my energy is almostnormal – only to have it slam me the next day – So HOW CAN THAT BE????
I agree it must be a retro-virus – that is all that really makes sense
G.J. Callen that is a great way to describe it! I’ve also said it’s like coming out from anesthesia after surgery. You WANT to open your eyes but you just can’t.
I think I’ve had ME/CFS for over 20 years but was only dx’d 3 years ago. It has gotten progressively worse since a physical trauma in 1999. That resulted in a surgery in 03. Breast cancer in 05. Several surgeries and with each one my fatigue and joint pain got worse. I am now on Cymbalta and a rx pain med.
The fatigue gets so bad now that I fall asleep while typing and even once when eating! THAT scared me horribly. But it doesn’t stop it from happening. If I am not standing I can fall asleep. I never could fall asleep sitting up before.
My life is not a life. I’m living like a hermit. I rarely go anywhere. Need help to do almost everything around the house. Luckily I can still bathe myself, but it’s getting harder. I am blessed with an incredible husband that works and cares for me and the house. But that doesn’t replace a life, I want my life back!
I do have better days. But each year they get fewer and fewer. I no longer work outside the home and it took over 2 1/2 years and a court hearing to be approved for disability. So if this has any chance of giving me relief from the fatigue I’m ready. The pain I can live with. I’d rather not have to. But at least with the pain I can still get out of the house and have a life. My granddaughter is 2 and I’ve spent very little time with her doing the things grandmothers do. I want to take her to the park, go shopping, bake cookies, keep my eyes open!! (I know, such high ambitions for a 47 year old woman.) Isn’t it sad when that is something you pray for? To be able to stay awake and just do something with your day instead of sleep.
Keep working on it please! It’s hard to think this is all I have to look forward to.
What now?? I’ve had CFDS since 1997, where I slept most of the day and not at night, with stomach/digestive problems and then the pain. Like many of you I have my good days and then I over do and wham.
After several years with my MD, I transferred to “specialist” in the area to get a little better by taking infusions and tons of medications and supplements. Only to not be any better off. Now, I’ve been on a more holistic approach, gotten off most of the meds, and it’s just the same old thing. I only do good as long as I don’t do anything! Plus the stomach problems have come back.
What do I do now?
You mentioned infusions. Have you tried Low Dose Naltrexone (LDN)?