P2P workshops are designed for topics that “are generally not controversial” – P2P website
Mary Dimmock and Jennie Spotila have collaborated on a call to request Director Francis Collins to cancel the P2P Workshop. Mary’s background is in the pharmaceutical industry, Jennie was a lawyer. Throw an ex-pharma professional and a ex-lawyer together and you get an impressive thirty plus page document and call to action (see below).
Here are some of the factors behind the request to cancel the Workshop.
Redundancy, Inefficiency and Confusion
After years of the feds ignoring the definition problem there are now two federal efforts (IOM, P2P) examining it. That’s a recipe for confusion. What if these two groups, one of which contains ME/CFS experts and one which does not, comes to different conclusions – as they very well may given their different backgrounds? What then? A third effort?
Lack of Collaboration with the ME/CFS community
What if one groups conclusion does not fit with the other ones?
Enough changes have been made to P2P to question whether those leading it are up to the task. Hopefully the NIH will at some point get that the ME/CFS community is there to provide knowledge that NIH officials, none of which are tasked with working on ME/CFS full-time, simply don’t have.
Narrowing the Emphasis and then Broadening It
The entire thrust of ME/CFS advocacy regarding the definition has been to make it more precise. Those efforts were seemingly overturned when the draft agenda obtained by Jennie suggested the Workshop was taking two steps and several decades back with it’s focus on “Overwhelming fatigue and malaise as a public health problem”.
The P2P’s focus does explicitly include contrasting different ME/CFS definitions but the wording of the draft document is at the least disturbing and it’s too broad for the panel to grapple with. Doing so would require extending it’s reach into disorders like multiple sclerosis, primary biliary cirrhosis, hepatitis (under treatment), neurological disorders.
This group had enough work to do without broadening their focus.
Research Gaps Already Identified – Recreating the Wheel Again
The NIH’s ‘State of the Knowledge Workshop’ was produced to identify gaps in research – and it did, yet it’s not been used. The NIH produced the Workshop – now they should use it.
The changing emphases of the P2P project suggests that from the beginning it needed some expert help
ME/CFS Experts Needed …. For Now
Jennie and Mary make a strong argument that given the controversial nature of ME/CFS that ME/CFS experts should always be heavily involved in efforts like this.
The P2P’s own website suggests the P2P – which by design contains no ME/CFS experts – should not be involved. It states that the workshops are designed for topics that “are generally not controversial” yet here they are taking on a controversial topic in a controversial disease (???).
Disagreements
It’s an impressive document but there are some things in the document I don’t agree with or don’t understand.
Objection to the Change from Determining How CFS and ME are Different to Comparing the Different Definitions for ME/CFS
Jennie and Mary believe the change from the original P2P emphasis determining how CFS and ME are different to examining how the different ME/CFS diagnoses differ from each other is detrimental. I believe that that original emphasis displayed an effort that was bound to go sideways.
Explicitly comparing CFS and ME seems intuitively attractive until the weak basis for the comparison is examined. Since almost no research on ME has been done the only comparisons between ME and CFS that can be made at this point, that I can see, involve comparing two definitions. It’s almost impossible at this point to say anything about the pathophysiology of ME that’s based any other than anecdotal reports – and those don’t go far in the medical community.
Any discussion about the differences between the two disorders is going to be a short one.
Central Theses
Core problems suggest the P2P Workshop has not been carried out in a thoughtful manner
This disagreement is small compared to core problems with the P2P:
- the project is redundant, not needed, and could lead to considerable confusion
- More participation from the ME/CFS community and more transparency is vitally needed to keep federal agencies on track.
- The P2P processes own guidelines indicate it is not an appropriate vehicle for this type of project
- The projects jumbled history does not provide confidence it was conceived and carried out in a thoughtful manner
Keeping Officials on Alert
My guess is that canceling the Workshop is not any more possible than canceling the IOM contract was. I also believe that the NIH should know that we’re watching and a case should be built should the panel’s findings be detrimental.
Reports and calls to action like this continue also to sensitize NIH officials to the decades long problems ME/CFS has encountered. It’s about building up a ‘listening’ that something has gone awry.
Jennie Spotila and Mary Dimmock’s Letter
The P2P Workshop will use a panel of non-ME/CFS experts, selected by NIH, to make recommendations on case definition, research direction and possibly treatments. You can read more about P2P and what I’ve discovered through FOIA requests in the posts gathered here.
If you are worried about what P2P could produce . . . if you think this is bad science . . . if you want to voice your opposition to using non-ME/CFS experts to advise NIH on the direction of ME/CFS research . . . here is your chance.
Fax or email Dr. Francis Collins today and request that he cancel the P2P Workshop.
Use the template I have provided below, or write your own. Fax Dr. Collins at 301-402-2700 or email him at collinsf@mail.nih.gov. It’s simple, but it’s a start.
Please take a few minutes to do this today. If you have questions or comments, post them here or email me at jspotila AT yahoo DOT com.
Dear Dr. Collins:
I am writing to request that you cancel the P2P Workshop on ME/CFS . I believe that the P2P Workshop will not advance us towards the much needed ME/CFS research case definition or strategy, for the following reasons:
- ME/CFS experts have already pointed a way forward on research and case definition.
- The Workshop is examining the wrong disease: the problem of medically unexplained fatigue and not ME/CFS.
- NIH has not engaged or involved stakeholders in a substantive way.
- The Workshop decision makers are non-ME/CFS experts.
- HHS has made numerous contradictory statements about the purpose of the Workshop, so it’s goal is unclear.
I understand that you were recently provided with extensive documentation of these five points. Dr. Collins, I am not objecting to the P2P Workshop simply to criticize federal efforts to address the challenges of ME/CFS. Careful consideration of these issues raises legitimate concerns about whether the P2P Workshop will produce the good science and sound recommendations we need to advance ME/CFS research.
I hope you will give my concerns a fair hearing, and that you will cancel the P2P Workshop.
Sincerely,
[Your name]
I just sent in my letter. I believe that persistent, repetitive clear communication is key. We need to keep it up, to correct the errors in the government system. Be squeaky wheels!
Thank you Mary and Jennie for your analysis and letter!
Cecelia
I just sent my letter in too. Please note that in the last point, the word “it’s” should be “its”, with no apostrophe. Grammatical errors tend to reduce the credibility of the sender in some people’s eyes.
You are absolutely right, Steven. I have corrected the original post. Thanks!
Sent my letter. Thanks for all you do to get the word out! I wish there were a link on your site to simply click and the emails are automatically sent to the correct people. Much simpler with brain fog. Is that possible, Cort?
It’s a great idea Nita. I’m sure that it’s possible and I’ve thought of doing that. It would take some funding, however.
Just sent my letter too. Let’s hope our concerns are heard!
I’ve just sent a letter. I began with the truly helpful template, feeling too weary to do more than copy/send; but passion put some fuel in my tank and I wrote for an hour. [That doesn’t mean a long, erudite email – it’ll take me an hour to write this, lol.]
I think the idea of having a clickable link on-site to make voicing concerns doable for the sooo many who don’t have more than a molecule of fuel in the tank is super, and would be glad to pitch in to help make it fundable. (Cort, back-channel me to discuss, if you wanna.)
Thanks for this and all that you do, and – Sharon – let’s do indeed hope we will be heard. It’s high time!
If ME and CFS are not the same thing, then why do the same researchers show up to present their research findings at both CFS conferences and ME conferences to enlighten us on “this disease”? The latest Invent in ME conference just took place on May 30, 2014. Among the presenters were Mady Hornig, Sonya Marshall Gradisnik, James Baraniuk, Maureen Hanson, and Andreas Kogelnik. In the past Dr. Dan Peterson has given talks in Europe on ME, or is it CFS? He doesn’t change his message about this disease when talking to ME groups. It is the same message when he talks in the States about CFS. Dr. Leonard Jason is featured prominently in the film “Voices from the Shadow” which was made in the UK — about ME, but it is the same message he uses when speaking about CFS in the States. Of course, I use “CFS” here as the disease we have come to refer to as ME/CFS, and not the all-encompassing idiopathic fatigue some would like this disease to be watered down to. I believe they are the same thing and wish this quibbling would end and researchers and governments around the world would finally get on the same page to fight this disease instead of this incessant wrangling.
Dr. Jason’s work has shown that Fukuda CFS and ME-ICC or ME/CFS CCC are not the same thing. The patient populations do not overlap perfectly. This means that research done on Fukuda CFS patients (most of the research that’s been done) may or may not be perfectly applicable to patients who meet the ICC or CCC.
We’ve been treating the terms as synonymous. Researchers do not always make a distinction between ME and CFS (although some certainly do). But as I’ve examined the research, I’ve realized that treating them as the same thing is an assumption, sometimes an assumption of convenience. I would love to see studies on biomarkers that examine a Fukuda cohort and a CCC cohort side by side. Maybe they match, maybe they don’t. But if we never question the assumption, we will never know.
Bravo!
I would never suggest that they are the same. Nor would I suggest that they’re completely different. Nor would I suggest, give the very limited research on this – that we know much about them at all. Only in the last year or so have a few studies come out.
What we need is more research to flesh out the differences between the two.
But who is treating Fukuda and ME-ICC or ME-CCC as synonymous? Since the definitions are different by definition (:)) they almost can’t be synonymous…I think the problem is not that the terms are being treated as being synonymous but that not enough interest has been shown in determining what they mean.
One positive outcome of the P2P workgroup could be to call for research studies into the meaning of the different definitions (how different are the populations they call up?). Those recommendations could form the basis for a grant effort.
With Jason’s algorhythms it’s not that hard to contrast the definitions in a study. Researchers can readily identify who fits what criteria and then do their analyses from there – if they have enough patients. All they have to do is do it. I hope the CDC is doing that in their multi-site study.
Thanks for the input and clarification, Jennie. It helped me to think more deeply about all the problems and confusion resulting from the multiple definitions of CFS. When I am talking about “CFS” in my post above I am really taking about the ME outbreaks here in the United States that eventually and unfortunately were given the name CFS by the CDC with the influence of Stephen Straus of NIH. I am talking about the disease I have which is thoroughly reflected in the CCC and the ME-ICC. I believe I have ME, but in the 1980’s we didn’t call it that in the US. Who anywhere in the US was given the diagnosis of myalgic encephalomyelitis? Many health professionals even to this day have never heard of myalgic encephalomyelitis. It was watered down to CFS, and tragically that’s what many ME patients have had to live with, including me. In time we began using the term ME/CFS to distinguish ourselves from the continual watering down of CFS (Fakuda) with its overtones of psychogenic origin. In my post above, I used “CFS” because that is what this disease was called in the US from the 1980’s on. However, I am talking about the former (ME/CFS or the CCC or ME-ICC if you will), not the latter (Fakuda and its water-downed variations). I don’t know if that makes any difference. This discourse, however, does highlight the quagmire ME patients have been caught up in for decades.
I absolutely get what you are saying. Many people say CFS, because that’s what is used in the US, when they actually mean CCC or ICC.
In my opinion, the question is whether people who meet Fukuda but do not meet CCC or ICC have a disease we can call CFS or whether they have other diagnosable conditions, like depression, hypothyroid, etc. That’s why I question whether ME and CFS are separate distinct diseases. If you take the ME population out of the Fukuda cohort (as I believe MUST happen), who is left and what are they sick with? In other words, is Fukuda CFS an actual entity, or is it a name slapped on a mixed group of patients?
I think Fukuda must be a name slapped on a group of patients; I think even Fukuda understood that as they noted their must be subsets in the group – and I think they meant patients with different disorders. I don’t think we’ll really know until we know about all the designations for ME. If you look at the ME outbreaks I think you would conclude there are subsets to ME!
For those who may not know, this Invest in ME conference was held in London, England.
Sent Dr. Collins my request to cancel the P2P workshop based on the misinformation that I
(and, unmentioned, that probably you) have had to correct to be heard, that surrounds this illness.
Sandra
That’s exactly what makes the conversation so tricky – the fact that the same term – CFS – has been used in so many different ways.
Of a group of a few hundred medical records specialists at an HHS meeting on ICD 2 years ago, none had ever seen ME used as a diagnostic code in medical records. At that time, the disease characterized by CCC was given the name CFS. At the same time, Oxford, which only requires 6 months of fatigue and allows primary psychiatric illness, also goes by the same name. So from one vantage point, CFS is used as a synonym for ME but from another, its used to refer to a collection of unrelated conditions that share nothing more than the single symptom of medically unexplained fatigue.
Not only is this a babel that impedes effective communication but its also bad science to take such disparate conditions (those that meet any of the CFS definitions) and throw them all together and treat them as the same thing.
I agree that it’s tricky. I’m not a fan of the Oxford definition but it is more than just about having fatigue. The fatigue has to have a definite onset, it should be severe and disabling, it should be present for six months and while the OD does not exclude some psychiatric illnesses (depression, anxiety) it does exclude some others (schizophrenia, manic depressive illness, substance abuse, eating disorder or proven organic brain disease)…It also excludes, as it should, and as other definitions do, people with documented evidence of other disorders known to cause severe fatigue.
The fatigue criteria is important because it is true that while many disorders cause fatigue only a very few cause the kind of fatigue found in ME/CFS; that is, severe and disabling fatigue that effects both mental and physical functioning.
Like I said I’m not a fan of the Oxford definition but sometimes it’s portrayed as all you need is to have fatigue and you’re in! That’s not true. You need to have a particular kind of fatigue – severe and disabling fatigue – to meet the criteria.
Hey Cort,
some thoughts on where definitions are being treated as the same…
I definitely agree that not enough research has been done to sort this mess out. But there are lots of instances where these definitions are treated as synonymous. One of the CDC medical education states that these definitions all represent the same patients who can be treated with the same clinical guidelines. The CDC CFS toolkit extends that to include ‘CFS-like” patients. Then there are evidence reviews that treat all these definitions as a singular collection based on the symptom of fatigue – Cochran for CBT to name one
But even if you just use one definition, Fukuda, Lenny Jason has done some really great work showing that your cohorts can vary dramatically depending on how you apply the definition – the tools and assumptions you make. nor surprising given that it fails to require hallmark criteria. That’s why the prevalence ranges so much even for just Fukuda.
About calling for research studies into the meaning go the definitions… I’d think that the best way to approach it is to start with a clear concept of what disease you are talking about and then evaluate the ability of a definition to describe that disease. Common sense alone tells us that Oxford or Fukuda can not describe patients with the disease seen in Incline Village since they do not require hallmark criteria
I totally agree that ME//CFS is generally thought of as Fukuda. The problem with evaluating the ability of a definition like ME or ME-CCC to describe a disease is that all you have is the definition part. You have almost no information on the disease; ie you don’t information on the exercise capacity or immune functioning or brain functioning of ME patients. You can’t fit the definition to anything physiological.
You can say that this definitions fits what we believe the disease looks like. There’s consensus on that – that’s pretty good. Now that there’s a definition we need to figure out what that definition describes and if it describes a different set of patients than Fukuda and other other definitions; ie we need studies.
I just think the feds and outside researchers are going to feel that a description is enough to say that this (ME/CFS) is a separate disorder and we’re going to devote research funding to that. It would be nice if they would :). I hope, though, that the P2P group will explicitly state that there are significant gaps in our ability to define ME/CFS and studies are needed to determine the correct definition/definitions to describe the set of people currently included in Fukuda.
IMO, the CDC made up the term and the definition of CFS so they wouldn’t have to deal with the more serious sounding neuroimmune disease, ME, as defined by the WHO since 1969.
IMO, the Fukuda and other CDC-produced definitions are just part of the attempt to water down the cohort so that nothing useful can be learned from any research using it. I don’t take Jason’s research to mean that there are two different diseases, ME and CFS, but rather that the Fukuda CFS definition waters down ME, by including patients who don’t have ME, so that not much useful can be learned about it. Instead of researching the disease outbreaks in Incline Villare and New York, the CDC spent $5 million “rebranding” ME to CFS.
And look how successful this diversionary tactic has been. 25 years later we are still arguing about just what IS the disease in question.
For me, I would like the name CFS to be abandoned and ME to be used exclusively. Its definition can be refined and adjusted as needed and as more knowledge comes along, but that should be done by the ME/CFS experts (AND has already been done by our experts), not by some committee that doesn’t know anything about either.
Dear Dr. Collins:
I am writing to request that you cancel the P2P Workshop on ME/CFS . I believe that the P2P Workshop will not advance us towards the much needed ME/CFS research case definition or strategy, for the following reasons:
■ME/CFS experts have already pointed a way forward on research and case definition.
■The Workshop is examining the wrong disease: the problem of medically unexplained fatigue and not ME/CFS.
■NIH has not engaged or involved stakeholders in a substantive way.
■The Workshop decision makers are non-ME/CFS experts.
■HHS has made numerous contradictory statements about the purpose of the Workshop, so it’s goal is unclear.
I understand that you were recently provided with extensive documentation of these five points. Dr. Collins, I am not objecting to the P2P Workshop simply to criticize federal efforts to address the challenges of ME/CFS. Careful consideration of these issues raises legitimate concerns about whether the P2P Workshop will produce the good science and sound recommendations we need to advance ME/CFS research.
I hope you will give my concerns a fair hearing, and that you will cancel the P2P Workshop.
Sincerely,
Brigitte Hoctin Boes
Brigitte Hoctin Boes
Done. I only made the following additions to personalize my letter.
ME/CFS experts have already pointed a way forward on research and case definition.
The Workshop is examining the wrong disease: the problem of medically unexplained fatigue and not ME/CFS. (Many disorders are accompanied by unexplained fatigue, and a complete review of the research on CFS suggests that there are reasons I, as a patient, experience fatigue due to the autonomic effects of CFS, blood pressure and heart rate that do not respond normally to activity.) I hardly call that unexplained.
NIH has not engaged or involved stakeholders in a substantive way.
The Workshop decision makers are non-ME/CFS experts. (In my experience as educator, and a past member of the American Society of Hospital Education and Training, we saw this same thing happen with the paradigm shift of healthcare delivery, DRGS, HMOs, etc back in the late 80s by omitting ANY medical personal from the panel, the experts on healthcare delivery, and we know where that has taken us.) Let’s not let history repeat its self.
HHS has made numerous contradictory statements about the purpose of the Workshop, so it’s goal is unclear.
The OD also says some other things about fatigue that are often overlooked. In the “glossary” which forms about half of the short document, fatigue, the “primary symptom,” is defined as a “subjective symptom” and explicitly not as an “inability to maintain activity”–i.e., if we are unable to repeat the results of a one time test on the next day, as is true of most or all who have submitted to that torture (I have not), we should be excluded from the OD–having real, physically demonstrable fatigue, and not simply a “subjective sensation,” is an exclusionary symptom.
TheOD also explicitly allows entry of those who are suffering from depression, and in some of those English CBT andGET trials 20% of those accepted were depressed, and taking “full dose” antidepressants. My personal view is that all studies done under the OD should be excluded from any EBM review…fat chance, but…
I have written to Collins..
Chris
Thanks for writing, Chris. And thank you for bringing up the glossary again. I keep forgetting that particular argument.
ME and CFS are the same thing, obviously with CFS being the watered down definition.
Also no subgroups just one disease.
Whether you use Fakuda, Oxford.e.t.c. they are merely describing phases of the illness.
I’m sure at one point many of us could have read the Fakuda def and said hey that’s me…most likely in our early stages of disease…and then as disease has progression we would fit into another def.
But its all one disease and the definition has to encompass all phases of the illness from early on fatigue and sore throats to more progressed extreme neurological impairment that develops…than onto late stage disease e.t.c.
I like the idea of progression! An immune study does support that I believe.
dear Cort, can you take my brainfoggy letter away please. I thought I was writing to him.