Furthermore, limited knowledge, insufficient research funding, and a lack of diagnostic tools diminish a clinician’s ability to provide optimal care. P2P Report Press Release
Simply the fact that the report got done indicated that the NH recognizes ME/CFS is major disorder with unmet needs.
Funded by the NIH’S Pathways to Prevention (P2P) program to identify research gaps and methodological and scientific weaknesses in “topics that have incomplete or underdeveloped research”, the report did just that. In order to meet the criteria for having a report done a disorder must meet:
- Have a primary or secondary disease prevention focus.
- Have broad public health importance—key considerations are the severity of the problem and the feasibility of interventions.
- Have limited published data or incomplete or underdeveloped research.
- Have difficulty completing a systematic review and producing a report synthesizing published literature due to lack of randomized controlled trials.
- Have two or more NIH ICs or Offices committed to addressing the topic by participating in workshop activities (i.e., sponsor, steering committee, post-workshop meetings).
The second criteria means that the NIH recognizes chronic fatigue syndrome is a real problem; i.e. that it has “broad public health importance”.
No researchers, advocates or ME/CFS experts were involved. The Pathways to Prevention “Advancing the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome” was done entirely from outside the field. The five-member panel with its experts in the fields of biostatistics, epidemiology, clinical care, and clinical trial research came to ME/CFS freshly – they looked at it with open eyes – and they came down strongly on the need for more research.
The Institute of Medicine (IOM) report got much more press, but this report should, in some ways, cheer the ME/CFS community more. It suggested, as the IOM report did – but more so – that given a good look at the data, outsiders are going to roll up on the side of the ME/CFS community.
The report wasn’t perfect – some real opportunities were missed – but in its entirety the report was a major step forward for the chronic fatigue syndrome community. Powerful statements in the introductory section underscored the fact that the authors recognized the need present.
- “ME/CFS is an unmet public health need with an economic burden estimated to be between $2 billion and $7 billion in the United States.”
- “ME/CFS results in major disability for a large proportion of the people affected.”
- “Limited knowledge and research funding creates an additional burden for patients and health care providers.”
- “ME/CFS is an area where the research and health care community has frustrated its constituents, by failing to appropriately assess and treat the disease and by allowing patients to be stigmatized.”
ME/CFS Exists!
The P2P panel started off the body of the document in similar fashion to the IOM by hammering home the key message that ME/CFS exists! It’s a real disease.
If ME/CFS is a waste-basket disorder – if it’s a bunch of disconnected disorders thrown together – then it’s easier to justify not spending much money on it. The idea that chronic fatigue syndrome is not real, may, in fact, be one of the key issues that’s stopping the NIH from funding it properly.
If ME/CFS, on the other hand, is a real disease which costs the U.S. around $5 billion a year, and results in major disability, etc. then the NIH has been mostly ignoring a real problem for many years.
If it’s true that ME/CFS has “a tremendous impact at the individual, family, and societal level” but that “clinicians have a “poor understanding of the condition” and “patients are typically underserved” then the NIH needs to step up.
Basic Needs Unmet
“Innovative biomedical research is urgently needed to develop a clear definition and diagnostic tools that will serve as a launch for bench to beside program that produce treatments.”
The report provided a long laundry list of unmet needs. It asserted that the most basic questions – what ME/CFS is and how it should be diagnosed – prevent the field from moving forward and patients are bearing the brunt of that.
It reported patients often have to make “extraordinary efforts at extreme personal and physical costs” simply to find a physician”. It stated that the scientific community has a “responsibility” to address the issues that ME/CFS bring, but that “limited” public and private research dollars have been available.
The report asserted that basic issues prevent the ME/CFS field from moving forward.
Treatments are unproven and have not been produced. Patients are often inappropriately labeled as having a primary psychological disorder. Work is” urgently needed” to develop a clear case definition and validated diagnostic tools and endpoints. The small clinical trials done have been fraught with methodological problems, lack power and are unable to produce insights into the disorder. Psychological therapies (which have dominated clinical trials) are not the way out. Long-term studies are needed. Few doctors understand appropriate management strategies (let alone treatment strategies). Little understanding exists of how the disease starts or manifests itself on a molecular level.
How to fix these problems? Much larger rigorously designed studies employing validated endpoints and an acceptable definition are needed. (Simply fixing the methodological problems cited and then produce studies of the size and the scope needed to properly research this disease, would require a major influx of dollars.)
Besides the methodological shortcomings the field is also simply dogged by a lack of research. The panel stated that research into many of the biological factors associated with ME/CFS has been neglected. Overall “minimal progress over the past twenty years to improve the state of science regarding ME/CFS” has been made.
“Strong evidence” nevertheless exists, of “immunologic and inflammatory pathologies, neurotransmitter signaling disruption, micorobiome perturbation, and metabolic or mitochondrial abnormalities exists”. The panel highlighted the need to better understand the role herpesviruses and other pathogens, infectious mononucleosis and genetics play.
The panel proposed the following actions take place:
Creating the Foundation
- A team of stakeholders (e.g., patients, clinicians, researchers, federal agencies) be assembled to reach consensus on the definition and parameters of ME/CFS. Among others diagnostic biomakers and clearly defined end points need to be produced.
- A national and international research network should be developed to clarify the case definition and to advance the field.
- A network of collaborative centers, focused on producing biomarkers and a variety of other factors should be established.
- A Working Group should be established to produce valid methodological approaches to ME/CFS.
Research
- Genetic, epigenomic and protein expression, neuroimaging and metobolomics studies should be used to identify biomarkers. Epidemiological studies are needed to identify people at risk and understand prognosis and co-morbidity. Diagnostic and prognostic algorithms should be developed to identify who will develop ME/CFS following infection or other triggers. Drug repurposing efforts should be made to identify new ways of treating ME/CFS. Immunologic mechanisms of ME/CFS and pathways associated with disease progression must be defined and characterized. Identical twin studies should be done.
- More investigator-initiated studies, a career development pathway and small grant mechanisms, to assist minority entry into the field are needed.
- Partnerships across institutions to advance the research and develop new scientists should occur.
- Longitudinal studies (e.g., the Health and Retirement Study, the Nurses’ Health Study) should be leveraged.
- A national repository and central archive of de-identified data and tissue samples should be created.
- NIH Institutes and Centers not presently represented in the Trans-NIH ME/CFS Working Group should collaborate to capitalize on the tremendous opportunities to learn from other disciplines and diseases (e.g., Gulf War Syndrome, Lyme disease, fibromyalgia, multiple sclerosis, and Parkinson’s disease).
- The Oxford Definition should be retired.
Treatment
- A curriculum should be produced to facilitate ME/CFS knowledge acquisition in physicians.
- The Health Resources and Services Administration (HRSA) should facilitate practitioner training.
- The NIH Clinical Center for clinical trials should be used and fast-track testing of new therapies be explored.
- A meeting on the state of ME/CFS treatment should be convened by the FDA and NIH.
- Telemedicine or home visits should be used to assist the severely ill and those unable to reach practitioners.
- Demonstration projects of patient-centered medical homes for people with ME/CFS should be developed.
- How people recover from ME/CFS should be identified.
The Future
- Another ME/CFS Expert Panel should be convened in five years to monitor progress.
Some Missed Opportunities
The report could have been stronger. Despite calls from several quarters the report never requested specific dollar amounts. While the body of the document clearly indicated ME/CFS was not receiving the funding necessary an explicit statement that ME/CFS receive funding commensurate with its size and needs would have been helpful. (On the other hand, the panel was asked to identify gaps in research not recommend dollar amounts.)
The panelists appeared to pull their punches linguistically at times, in the recommendations half of the document. After stating that biomedical research is urgently needed they “recommended” investing in it. Instead of stating that creating opportunities for new researchers are “needed” to energize the field they stated new researchers “could” energize the field. Their characterization of the number of researchers in the field as “relatively” small was inaccurate. With ME/CFS receiving ten to forty times less funding that other chronic disorders the number of researchers working in the field is positively tiny.
Time To Step Forward
Is the NIH finally going to get to work in this disease?
Anyone reading the report could only draw one conclusion: the chronic fatigue syndrome field has many fundamental needs that need to be taken care of for the field to move forward. Centers of Excellence need to be produced. Research needs to be expanded. Studies need to be larger and more rigorously composed. New investigators need to be encouraged. Curriculums need to be developed. Physicians need to be trained.
The report offers a roadmap which if followed would change how this disorder is funded, researched and treated, profoundly. It provides, as Jenny Spotila, noted in a recent blog, a report card that can be used to assess the governments response.
The federal government has funded two independent reports – the IOM and P2P reports – that say essentially the same thing: it’s time for the NIH to finally get off its duff and engage with this disease like it’s a real disease. It’s time provide some real funding. The federal government commissioned these reports. Will it follow their recommendations? They haven’t yet….
- Check out Is ME/CFS Stuck for more on a doctor’s take of the federal governments lack of response so far – and what the patient community must do to move forward.
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I remember going through the rigorous search for a diagnosis back in the late 1980’s, early 1990’s, when I suddenly became so ill. Never having heard of Chronic Fatigue Syndrome, when one doctor diagnosed me I thought it was a joke, but then a second doctor diagnosed me. I returned to my primary care doctor who had been my physician for 8 years, told him of my diagnosis and had all this information I had gathered for him. He and I were the same age and I had worked for him on some of his special patient programs so we had a good relationship.
I will never forget the pain and humiliation I felt that day when he said he would not treat me for CFS because he was not interested in wasting his time learning about it. If he was going to learn about something new it would be something that could really help people like cardiovascular disease not CFS which people considered the yuppie flu. Then he proceeded to tell me how he highly regarded me as his patient and hoped this wouldn’t change our doctor patient relationship. I walked out of his office that day and never looked back. So I don’t have much confidence in doctors embracing this illness all of a sudden; so few have.
Talk about a destructive belief system and what mixed message. He highly regarded you as a patient and then discounted everything you said. I imagine that he will remember that conversation one point and think what did I say. I imagine many doctors will be having that conversation at some point and as they do they’ll hopefully bend over backwards to redeem themselves.
Cort, I would not bet any money on that. Still today I am disregarded and dismissed by many, probably most doctors. Not proud of my feelings because one day I hope they will struggle with this same disease.
So disgusted with those blank stares and statements like, you just have leaky gut, once that is resolved you will be fine. Almost 20 years now. It’s been an unusually bad couple weeks due to a procedure that would have no adverse effects for most people and I can’t even report it because I will be seen as exagerrating or being an attention seeker. This condition is worse than anyone can imagine.
I had the same issues with my cardiologist/GP of 23 years for several years. He just didn’t understand it and admitted to that. Some of his PA’s were less skeptical, and one was so bad that I nearly jumped off the table and smacked her after I had been diagnosed by several other doctors.
A couple of years ago he was on board and was trying to help me holistically!
I also had a neurologist, a headache specialist (I had and still get severe never ending migraines), I call him Dr. Arrogant, who refused to even listen to me until I one day stood up and shouted at him as I threw the CDC papers stating that one of the conditions was sudden onset of headaches and asked him why he couldn’t open his closed mind! He surrendered. But I never saw him again.
So there is hope, as the medical community discusses it more the better it’ll be accepted.
I’m wondering what you think of this report. I’m not sure how new it is.
http://mentalfloss.com/article/65780/possible-breakthrough-sufferers-chronic-fatigue-syndrome
Kathy, yes, that sounds right to me because my journey began after an extremely bad viral illness with 104 temperature and then an autoimmune condition. My recent visit to an integrative medicine Dr reveals high viral levels still and he told me there is now a drug I can take, perhaps he is referring to this study. I will take the drug, I would do anything to gain some quality of life before I die. I always feel good on prednisone { low dose } but no dr will prescribe it long term, I disagree with that decision… I am also being evaluated for mast cell activation disease because I can check most of those signs, symptoms, cofactors. This disease causes so much stress as does trying to find some answers. It is also very isolating. I have a Masters degree also and never was my intention to live this way.
I am the 77 year old caregiver (mother) for my totally disabled son who has M.E.
He has NOT seen a doctor in years. His insurance is Medicaid, and there is NO doctor that will make house visits. The last doctor he saw said to him. “I don’t believe there is a disease called M.E., and if I don’t know the disease it doesn’t exist. He told us that it is a psychiatric illness, and gave us a prescription for ZOLOFT. My son has ballooned with water weight, and since we live upstairs the ambulance driver informed us that he is too heavy to be carried down by two people, we would need a second ambulance for the extra 2 people which would cost us over $ 800.-for one trip. My son has not been outside to smell the fresh air in years,
My son has been bedridden for almost 10 years. Hi is in constant pain. I overdid reading to him last week, and he has now an injury again and goes days without talking which at this time causes extra pain. He never listens to music or the TV. He has a masters degree, why would he spend his days in bed? He has now only two visitors. They each come once a week for about 30 minutes to 45 minutes. He is sensitive to noise, and other things. Can anyone help us? He takes supplements, is an almost vegetarian. I cook all meals fresh, with often raw veggies. No restaurant food or chemical additives. We live in Newport News, Virginia. My name is Bruni, and my son’s name is Douglas. Our former church (last 20 years) has NO people who are willing to visit per our priest.— My son is very pleasant and friendly. He hides his pain. HELP!!!
What a difficult situation! I wish I had some answers but I wish you and your son the best in finding some relief.
@ Bruni, Hi, I am so sorry for what you and your son are going through. Is there any soothing music that might help, even 5 minutes to begin. I have started to take FIBROPROTEK supplement from the research by Dr. Theoharides, it seems to help the pain but everyone is different so that is what makes this condition so challenging. Testing for viruses, bacteria, thyroid and adrenal, digestive problems, Mast Cell Disease may give a clue but then treatment is not well understood. Thoughts and prayers to you both. Maintain hope which I understand on some days is just not possible, I have been there too.
Dear Bruni,
I also remember being too sick/weak to even talk. I was 49 years old -1998. There is an book which may give you important tools: The Genie Within by Harry Carpenter. See if a friend can order this over the Internet.
Also, please appreciate that I am a biologist who has completed some original research – not published, but gave oral presentations. Although I believe in the scientific method, I have also stepped into other realms to aid healing.
I have two ideas:
1. Call the Association for Research and Enlightenment in Virginia Beach to see if they may have some recommendation. Number: 800-333-4499 or 757-428-3588
2. Also please check out Cay Randall May in Phoenix. She is authentic.
I hope your son has had the opportunity to work with a doctor to try some of the meds that may help with energy. Wellbutrin helped me get enough energy to get out of bed after one year of severe fatigue.
Don’t give up !
Mrs Bruni,
My heart goes out to you & your son so much! I have been suffering from this dreaded crud since I was 23. I am 40 now. The fine line we must walk between the need for human contact & stimulation (reading, watching, listening) & the inability to withstand stimulation is one of hardest balancing acts this illness thrusts upon us. Hopefully soon these great advances Cort keeps us informed on will reach even into the homes of the most stricken like Douglas. In the meantime this has helped me to have a real hope:
http://www.jw.org/en/jehovahs-witnesses/free-bible-study/video-why-study-the-bible/
Here’s an example of the way it changes lives:
http://download.jw.org/files/media_magazines/7c/wp_E_20151001_06.mp3
I know that it’s been some time since you wrote, I hope this message reaches you, I could not get you & your son off my mind.
Dear Hezza,
Thank you so much for your encouraging email. My son Douglas is the same. At this time he injured himself talking too much, and he is just in bed resting and sleeping, and hoping he will heal soon. He takes many supplements, and I have read many articles on the subject.
Douglas’ whole body is swollen, water, and just going to the bathroom ( the only trip he can take, gets him out of breath.
His brother, and the whole family has forsaken him, they suggest that he has mental problems and he just wants to stay with me and be taken care off.
Douglas is not able to watch TV, or listen to classic music. He says God is not hearing his prayers, and his sadness breaks my heart. He is upbeat with me, but I know he is hurting
inside. Also, he is always in physical pain. Thank you again for your kindness.
We always say” kindness begets kindness,” we even say it in Latin: ” gratia, gratium parit”, hopefully not misspelled. God Bless You. Bruni.
“Innovative biomedical research is urgently needed to develop a clear definition and diagnostic tools that will serve as a launch for bench to beside program that produce treatments.”
“… launch for bench to beside program …” Is this a typo? I can’t make any meaning out of it.
Thanks for once again boiling down the info for us, Cort!
@Bruni, the comments didn’t show up until after I posted mine. I feel so sad for you and your son. I wish I could offer a suggestion or help of any kind. I pray that same miracle will happen for you and that he will finally receive some competent medical help.