The final P2P ME/CFS documents are coming out today. I am severely crashed from family obligations, so in-depth analysis will take me a little longer than normal. But here are quick descriptions of the various articles to get you started:
Final P2P Report – As of 8:30 am today, this has not yet been published on the NIH P2P website. As of 9:15 am, the final report is available on the NIH site.
P2P Panel’s article in the Annals of Internal Medicine – This reads very much like the Panel’s draft report, and I won’t be surprised if it matches whatever final version ends up on the NIH site.
Overview by Dr. Anthony Komaroff in Annals – If you can only read one document today, start with this one. Dr. Komaroff gives an excellent overview of the intersection between the IOM and P2P reports. This is important because the Panel does not even mention the IOM report in its Annals article.
ME/CFS Treatment article in Annals – This is a summary version of the treatment section of the AHRQ evidence review (prepared for the P2P Panel and presented in December 2014). If you recall, that evidence review found that CBT and GET were the most effective treatments, and made much of the very poor number and design of trials.
ME/CFS Diagnosis article in Annals – This is the summary version of the diagnosis section of the AHRQ evidence review (prepared for the P2P Panel and presented in December 2014). Two things stand out. First, this version has been updated to include references to the IOM report. The P2P Panel did not bother to do so. Second, Dr. Komaroff’s article, in discussing biological abnormalities, largely references the IOM report. Why? Because the evidence review excluded most of this literature.
A playback of the June 16th telebriefing will be available for four weeks afterwards. Use: 888-640-7743 (U.S. and Canada) | 754-333-7735 (Other International Callers)
Enter replay code 118646, followed by the # sign.
Update June 16, 2015 11:37 am: The one hour telebriefing concluded after 30 minutes. Only one report, Miriam Tucker, asked a question. Deborah Langer of the Office of Disease Prevention repeatedly stated that there were no other question. However, I want to be VERY CLEAR: I identified myself as a writer for Occupy CFS when I joined the call. I made SIX ATTEMPTS to ask a question. My place in the queue was never recognized and I was never given the opportunity to ask a question. If any other members of the media attended the briefing, they did not ask questions. This was an appalling way to end the P2P process.
Thank you, Jennie.
Yikes–Kamaroff has an unfortunate typo. He writes: “The IOM committee also proposes a new name for ME/CFS: systemic exertional intolerance SYNDROME” under “What Should the Illness Be Named?” Whatever we think of SEID, at least it contains the upgrade to DISEASE. Can anyone reach him or his people to correct it?
Nice and important catch, Carollynn. I suggest you write to Dr. Komaroff and to the editors of Annals. That should be corrected.
Just left messages about this for SMC, though their offices aren’t open yet today. They may be able to get the on-line version corrected.
Yes, good catch. I double-checked, and it seems too to be “exertion” and not “exertional.” / Systemic Exertion Intolerance Disease
http://www.iom.edu/~/media/Files/Report%20Files/2015/MECFS/MECFS_ReportBrief.pdf
The Annals can also be contacted here: http://annals.org/public/contact.aspx
Great job Jenny staying on top of this. Thanks!
This is related to IOM rather than P2P, but hopefully this is all connected enough that it is okay to share it here.
I wrote in the comments section on this Occupy CFS blog post a few months ago that the proposed IOM definition was narrower than ICC, and my assertion was questioned in a response.
http://occupyme.net/2015/03/23/case-definition-bingo/
So I thought I would point out this new paper by Lenny Jason’s group providing evidence of what I stated.
http://www.tandfonline.com/doi/abs/10.1080/21641846.2015.1051291?journalCode=rftg20
Thanks in general for your work, Jennie.
I haven’t been able to read Lenny’s paper yet. But I am planning an in depth look at it.
Please delete if this is a repeat: “Exertional” in the Annals publication should be “Exertion.” / Systemic Exertion Intolerance Disease
That was a really stupid, practically incoherent call-announcement. All about fatigue, and one got the strong impression that those speaking did not know what they were talking about.
Is this EVER going to get better? The HHS departments do not listen to anything the patients, advocates, experts say, including CFSAC. Nothing has changed in 25 years, except maybe things have gotten worse, as is the case with research funding. The one group that seemed to have “gotten” the disease was the IOM panel which is not part of the HHS, and it has no power to take any of its recommended actions.
So here’s a DISEASE that affects millions of Americans leaving many severely disabled, with ample evidence of immune dysfunction and many other systems involved, with direct and indirect costs between 17 and 24 billion dollars annually, BUT with NO known cause, with not ONE single FDA approved treatment, no representation of severely ill in research, NO mortality data, NO universally accepted prevalence numbers, not ONE single universally accepted case definition, not ONE single universally agreed upon clinical diagnostic criteria, not ONE single agreed upon name, not ONE single agreed upon diagnostic code, virtually NO (NIH) research funding, not ONE single funded institute within the NIH that will oversee it, has NO mention on the National Medical Boards, NO sense of urgency within the government agencies, NO national or international leadership, yet it undergoes the “Pathways to Prevention” process, which then dies in the water. With so many unanswered question why start with a prevention workshop?
From the P2P website, “P2P workshops are designed for topics that have incomplete or underdeveloped research, difficulty producing a report synthesizing published literature, and are generally not controversial. ”
Well, the incomplete or underdeveloped research efforts would be solved if NIH appropriated funding commensurate with the severity of disease and initiated a national database, IoM (a costly endeavor) did a very thorough job of a literature review, and, excuse me, but isn’t controversy the only thing THIS DISEASE DOES HAVE?
Extremely well said, Claudia. And said more calmly than what I’ve been thinking all day.
Very well said Claudia!
Thank you.
Claudia,
Brillian!
I would add to this that all HHS seems to be able to do for us is meetings.( like in CFSAC) workshops (P2P) and processes with systemic reviews (AHRQ, IOM) followed by NO action. Just recommendations for more meetings and workshops. Just to give the appearance as if something is being done while in effect we are stagnating and worse, the sick are getting more severe and new people are getting sick every day. Yet, the neglect and abuse just continues.
Amazingly well said, Claudia!
Thanks, Jennie, for this round-up of links.
Get some rest though.
This is a long haul; we have to build up energy reserves.
This is beyond frustrating. It’s the Theatre of the Absurd, which just
gets more so.
The government agencies really don’t want to do anything, increase
funding, take us seriously, find treatments other than the two ridiculous
ones they keep repeating.
We all have to figure out a strategy, a list of demands, Congresspeople
to reach out to, publicity for our points, etc.
I listened to the press briefing. It was stunningly useless. After a very brief introduction of the panelists, someone basically read the first page or two of the report. After the intros were done, I realized one important reason the report is so bland: they are all academics! Although presented as volunteers and “independent”, obviously they are not going to go very far in criticizing a primary funder of their institutions, Duh!
Near the end of the briefing one panelist revealed her profound ignorance of the history of this illness. She insisted that “CFS” is the original name and that “ME” was a Johnny-Come-Lately. Apparently they never bothered to find out about Dr Ramsey’s work, the Royal Free outbreak, or any of the early epidemics. Pitiful.
The panelists did strike me as being sincere and appalled at the stories they heard regarding our treatment. But that’s far from sufficient. They should be MORALLY OUTRAGED – and the report should reflect that. After all, they are supposed to be independent, right? As volunteers, theoretically NIH can not retaliate by withholding payment, right?
Well, maybe in some imaginary world. But not in this one.
Sincere, probably; but alas, still clueless. Even after their own suggestion (and the IoM’s, to which they – still didn’t have access?) that the Oxford definition be retired, they took their only suggestions for possible treatment (GET & CBT) from studies and trials that had used this very definition and had included patients who might only have been depressed, some of whom may have experienced mild to moderate improvement. At this moment one of the three (‘medical professionals’ – we can’t comment there) comments on the Medscape report on the P2P publication today was (comment in full) “Nearly everyone has some form of this.” The CDC still lists both, though warns that CBT isn’t curative, but may help us adapt and learn tricks for pacing but CBT practitioners still see referrals to them as proof that we need to adjust the way we think about our ourselves and our illness. As soon as CBT is suggested, we’re back under the thumbs of (sincere) people who have no idea what we’re dealing with and how much harm they can do. I’m still shaking. Today was extremely upsetting. I was deeply disappointed to hear from Jennie that they weren’t taking calls from any but one reporter.
I also find it amazing that at the onset they would state the Oxford definition was so broad as to be virtually useless – but then when they compared PUBLISHED results of treatments, they failed to note that the CBT at/GET literature was published, in the main, using Oxford.
I made this point at the Workshop and was dismissed.
I saw that, Jennie. I applauded your question but my jaw dropped at the non-answer. Some evasion about scientific iteration? ‘Science’ can serve as a great cover for rubbish answers.
Sorry you have again been mistreated in the conference call of P2P.
Thanks for your hard work.
First, I see very little difference in Komaroff’s current “summary” and the one Komaroff provided in the 1999 special issue of the American Journal of Medicine devoted to “CFS.” 16 years ago. That’s very sad.
Second, I’d like to correct a misapprehension by Lisa Petrison with regards to Jason et al. Lisa wrote: “the proposed IOM definition was narrower than ICC.”
The problem is which ICC are you referring to?
In the paper cited by Lisa, Jason et al wrote:
“Conclusion: The recently developed SEID criteria appears to identify a group comparable in size to the Fukuda et al. criteria, but a larger group of patients than the Canadian ME/CFS and ME criteria, and selects more patients who have less impairment and fewer symptoms than a four-item empiric criteria.”
That means the IOM criteria are BROADER than either the Canadian-ICC (2003) or the Canadian ME-ICC (2011). There is a third, Wessely-like “ICC” definition that came out of the secret CDC workshops in the early 20-oughts, which is sometimes called the Reeves definition. The IOM criteria are, of course, more narrow than the Reeves ICC, but then, most everything is.
With three “ICC”s [International Consensus Criteria] floating around, it gets confusing.
Most people use CCC (2003), Reeves (2006), and M.E. (2011), to avoid confusion. Lenny wrote Canadian ME/CFS (the 2003 CCC used ME/CFS throughout because Canada had just adopted ICD-10-CA, which placed CFS with ME at G93.3 in the tabularversion) and Canadian ME, which would reference the Alberta conference resulting in the 2011 research criteria for M.E.
Finally, my criteria for substantive change remains unfulfilled: we still get about 1% of the funding we should from NIH, and CDC’s entire website needs to be thrown out, along with the physical pamphlet and toolkit which they seem to still be sending out. I thought that briefly we might see a change in the CDC website, but it was the bare minimum.
For those of us who remember when CDC and NIH would start talks with a slide of a woman in Edwardian dress lying back in a fainting couch, her forearm delicately draped across her forehead, when they talked about “CFS” as a condition caused by Yuppie women trying to have it all, when later they said it was due to stress at an early age, include sexual abuse …
These are an improvement. But until my substantive criteria are met [CONSIDERABLE increase in NIH spending commensurate with the prevalence and severity of “ME/CFS” coupled with either the total abandonment of CDC’s website and their CFS shop, or a complete turnover in personnel and total revision of the website and mailings] … I fear it is all window dressing.
My hope rests in the large number of peer-reviewed studies being published – and on the probability that neither Stanford nor Columbia Universities are amused at being denied funding by NIH …
“neither Stanford nor Columbia Universities are amused at being denied funding by NIH”
This is an excellent point. These are important institutions with the right connections. Perhaps the entrenched NIH “leadership” is finally getting too big for its britches. Are the disability insurers more influential that the Ivy League?
At any rate, I propose a retirement party for Dr Fauci.
All of you make good points. I am now furious that this group wouldn’t listen
to Jennie speak.
And then to hear about CBT and GET once more is ridiculous and infurating. There is no science here. The science propounded by Drs. Montoya, Honig, Lipkin, and every other researcher who is tackling this disease looking for causes, biomarkers, etc. is being overlooked, once again.
We have to have a coordinated strategy with media and congressmembers, including those who represent our districts.
This elephant is in the room, but it’s being ignored and minimized.
It’s astounding that the IOM report is not being read either by these people.
It’s with this kind of event that the lack of a national, patient-led US advocacy organisation strikes me so clearly, of the kind that Dr Alan Gurwitz wrote about in the previous Occupy CFS post:
http://occupyme.net/2015/06/13/stuck-four-months-of-almost-nothing/
There’s a big vacuum there waiting to be filled, and one that individual advocates can’t fill. It’s too easy to dismiss individual advocates (look at what just happened to Jennie and the disgraceful way in which she was disregarded). I’m still very surprised at what a quiet response Dr Gurwitz’s post received (and I’m aware of the history of the former CAA). I’d have thought that PWME would have been piling on and applauding that call.
I hope a load of stuff is going on behind the scenes that I don’t know about.
I agree completely with Sasha. We will not progress without a well funded, strongly supported national organization.
Just read the most recent disturbing reporter’s take on the P2P final: http://www.empr.com/medical-news/more-evidence-needed-chronic-fatigue-diagnosis-treatments/article/421071 . This is exactly what we assumed (and feared) would be gleaned from a light skimming of the report and not ‘getting’ or reporting on the limitations of any ‘success’ based on the Oxford definition. I’m not familiar with this website or publication, and there was no link for comments, so this will remain recent ‘news’ instead of inadequately researched reporting. There’s a lot of that going around. It hurts.
Jennie, your tireless work is greatly appreciated. You do a wonderful job trying to hold people accountable. I am in total agreement with Dr. Alan Gurwitt (the guest blog you shared from the Massachusetts CFIDS/ME&FM Association). We need research first, then the name and the diagnostic criteria will follow. We need to get it right this time. I know this is what patients want, I do too, but what I want most is better treatment for the cause instead of masking symptoms. With better research we will be able to identify patient subsets. It could be there will be more than one disease identified. Cross over symptoms, like general malaise, can occur due to many factors, chronic low grade fever, influenza, infection, diabetes, SLE, hypothyroidism, POTS, NMH, depression, etc… To create a name that is NOT based on research would just be more of the same in my opinion.
All of the advocates work is important and everyone’s voice is counting, it just isn’t showing up where it should at all times. As an RN, I am a member of Medscape, which is an organization for continuing education for physicians and nurses, I get weekly notification of CME and CEU programs, and article updates. For THE VERY FIRST TIME, I am seeing article after article on ME/CFS, and most importantly, they are publishing the views of important game players, such as Dr. Komaroff. There is a drive to educate physicians and nurses that ME/CFS is a biological illness.
Your work and the work of so many advocates and individual patient are making a difference, and you need to know that. Thank you.
Thank you for these very kind words, Celeste.
I believe that, having read and reread the articles that Jennie listed and more, I can clear up the confusion and emotional reaction a little bit if given a chance to explain what I perceive as the IOM and P2P’s goals as clearly outlined. I didn’t realize this myself, but since 1988 nine various diagnostic criteria, definitions, ways of including or excluding someone from a diagnosis of CFS/ME have been offered up beginning with the Oxford and ending with the IOM’s new SEID definition (which was included in the P2P review and has only 4 criteria). What the P2P discovered by studying these various definitions is, for example, that the Oxford definition would include some patients who do not actually have ME/CFS if compared to the ICC or IOM’s criteria, changing the incidence from 2.5% to 0.3% of the general population. Because, and this is the important part, the reports were convened as “evidence-based methodology workshops”, the only research papers included in these 2 studies were to determine the most accurate DEFINITION for CFIDS/CFS/ME/SEID thru 3 methods which they outlined:
1. Evaluation and comparison of methods used to diagnose.
2. Identification of the limits of current studies.
3. Determination of the needs for future research.
As we all know by now, the only way to diagnose CFS is “clinically”, e.g. subjectively based on the patient’s own reports. Though many physiological abnormalities have been and are being found, none of these is a “gold standard” for the diagnosis of CFS that excludes other disorders. Research findings such as brain inflammation and elevated cytokines and abnormal T-Helper cells are found in other diseases as well so cannot be used as the method of diagnosis.
Hopefully, if the NIH accepts the IOM’s diagnostic criteria and the new name, this will lead to several gains for us patients even though it seems too little too late. One very necessary goal can finally take place and that is to inform all current practitioners of the new diagnostic criteria for CFS so that patients can be appropriately diagnosed although it is still by ruling out other disorders as well. Also, curriculum for medical university students can finally be put into place as currently CFS/ME is not taught at all.
Research methodology will improve as it has been very small groups of people, primarily women, often from the same geographical area or same physician with a particular goal in mind and done rather subjectively. The research methodology in order for a paper to be published and approved by peer review must be improved to meet the standards of medical and research journals. In the articles the P2P reviewed only one study for diagnosing patients with CFS/ME was found to be a good study without errors in methodology. With these improvements in mind, the research can be improved upon and continue to seek out the exact mechanism causing the agreed upon widespread inflammation and neuropathology.
The Harvard Nurses Health Study has recently incorporated CFS/ME into their study which is an excellent start as that covers employed and retired for whatever reason nurses of all ages and with both sexes throughout the US. In other words, they are studying the epidemiology of CFS which means the incidence and prevalence of a disease throughout a large population of people. Their findings alone should significantly add to what is currently an unknown. (It has long been thought that nurses and other healthcare workers have a higher incidence of CFS than other populations for reasons as yet unknown but likely attributed to the stressors inherent in the job.)
I hope this clears up some of the misunderstanding that appears to be going on currently with the IOM and P2P studies. I also believe it’s time for a national CFS organization to be formed but that’s a topic for another time. Thanks, Marcie Myers
many many thanks to jennie for her good work on all this!
Unfortunately the Project Manager at the Harvard Nurses’ Study gave me incorrect information. The question regarding if a nurse has been diagnosed with CFS will not appear until the 2016 questionnaire as the 2015 is already printed and being mailed out. It was last on the Nurses’ I Study in 2010 but he was unable to provide me with any results. So, per the usual, we wait another year but nonetheless it should prove a good study, I hope. I
If anyone has an idea of who will make the decisions regarding all the IOM and P2P recommendations, I’d sure like to know. Who is in charge? We are, apparently, and as was recommended: ACT UP! marcie myers
Marcie Myers.