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"Fatigue is not a disease" - Unger Responds, Advocates Launch Petition

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On May 12th, 9 ME patient organizations (including Phoenix Rising) and 26 advocates sent a letter to Secretary Sibelius, Dr. Howard Koh, Dr. Thomas Frieden and Dr. Francis Collins at the Department of Health and Human Services (DHHS). In that letter, we expressed our strong concerns about the department's current definition activities related to "CFS" and called on them to start using the Canadian Consensus Criteria for ME, which requires the hallmark symptom of post-exertional malaise. A summary and FAQ about the letter is here, and the Phoenix Rising article about it is here.


Tell DHHS: Fatigue is not a disease

For those of you who wish to become part of this important initiative, a petition has now been created calling on the DHHS to stop using the term "chronic fatigue syndrome" and the vague "CFS" definitions and start using the Canadian Consensus Criteria. We urge all our members and readers to please sign the petition and spread the word to everyone you know.

If we get 25,000 signatures in 30 days, we will try to take the petition to the White House. It's a huge goal, but even if we don't reach it, we will use the response as further evidence of patient interest in addressing this critical issue. The more signatures we can get, the more pressure we can apply to the DHHS to stop perpetuating the "web of confusion" that has confounded ME research, made drug development all but impossible, and led to the inappropriate and sometimes harmful guidelines currently applied to "CFS" patients. To join that effort and sign the petition, please use the following link:

http://www.thepetitionsite.com/255/349/958/fatigue-is-not-a-disease/


Elizabeth Unger's Reply

Elizabeth Unger (Chief of the Chronic Viral Diseases Branch at the CDC) has now replied to the letter as follows:

Sent: Wednesday, June 5, 2013 5:58 PM
Subject: Response to signatories of May 12 letter c/o Marry Dimmock

Dear Patient Organizations and Independent Patient Advocates:

Thank you for your letter to Dr. Thomas Frieden, Director of the Centers for Disease Control and Prevention (CDC), stating your concerns about the Department of Health and Human Services (DHHS) activities related to the definition of Chronic Fatigue Syndrome (CFS), as well as your suggested steps to improve research and treatment. Your email was forwarded to me as Chief of the Chronic Viral Diseases Branch that studies CFS at CDC.

I can assure you that CDC is aware of the issues you have described and recognizes that patient advocates are essential partners in moving forward. CDC is fully committed to working with the CFS Advisory Committee (CFSAC) and DHHS to develop consensus about the case definition and name of this devastating illness. The need is not only for a case definition but also for reproducible standardized approaches to applying it, as well as for biomarkers to refine subgroups within the overall CFS patient population.

We are encouraged by the increasing engagement of NIH, FDA, HRSA, and AHRQ through the forum provided by CFSAC. The NIH’s State of the Knowledge Workshop on Myalgic Encephalomyelitis (ME)/CFS Research and AHRQ’s Systematic Review of the Current Literature Related to Disability and CFS are essential steps towards our shared goal of improving care for CFS patients. Likewise, the FDA’s Workshop on Drug Development for CFS and ME has provided new opportunities to capitalize on the energy and collaborative spirit of federal partners and stakeholders. CDC remains dedicated to conducting public health research, developing educational initiatives, and validating CFS phenotypes by utilizing the clinical expertise of physicians experienced in the care and treatment of CFS patients. CDC will continue to engage CFSAC, public health partners, and patient advocates in the development of control and prevention strategies to reduce the morbidity associated with CFS and to improve the quality of life of persons with CFS and other similar medically unexplained chronically fatiguing illnesses such as ME, fibromyalgia syndrome, neurasthenia, multiple chemical sensitivities, and chronic mononucleosis.

Sincerely,

Beth Unger


Satisfied?

At the recent Invest in ME conference, Dr. Andreas Kogelnik began his keynote address with a cartoon highlighting what we don't want: "We're ready to begin the next phase of keeping things exactly the way they are". Workshops and systematic reviews are all very well, and perhaps the department's belated efforts will bear fruit one day, but the patient community is demanding real change now.

In October 2012, CFSAC called for an urgent stakeholders' workshop on a case definition, using the Canadian Consensus definition as a starting point. On May 12, 2013, 9 patient organizations and 26 independent advocates called for DHHS to adopt the Canadian Consensus definition for ME and dismantle "CFS". In response, we have been told that preparations for a systematic review of the current literature are under way, the agencies are demonstrating 'increasing engagement' and as advocates we are 'essential partners in moving forward'.

That isn't an answer, it is not what we called for, and it simply isn't good enough. If CDC is "aware of the issues" we described in our letter, then it is aware that its continued failure to adopt a disease appropriate case definition is unproductive and harmful to patients. It should make the appropriate changes now to mitigate that continuing damage. We can't afford to wait for the various agencies to gather evidence in a process which by their own admission has - so far at least - excluded those patients who are bed-bound.

We do not claim that the CCC is a perfect case definition, and many of us would ideally wish for the DHHS to leap ahead to the ICC, but the adoption of the CCC would be a huge step forward. As we said in the rationale for our recommendations, we believe that "it provides the best option to establish a disease appropriate baseline definition in the short term that can readily be further evolved in partnership with ME experts as additional data, knowledge and experience is gained, and as the definition is further operationalized and biomarkers are validated."

So if you're not prepared to wait - until 2014...or 2015...or 2016 - for the DHHS to eventually come up with its own consensus case definition for ME, then we urge you to join us in calling on the DHHS to enter the 21st century and adopt the 2003 Canadian Consensus definition. Please sign the petition - and don't forget to ask your friends...

http://www.thepetitionsite.com/255/349/958/fatigue-is-not-a-disease/





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Comments

Hi Mark, RE

The letter calls for the CCC case definition to be used and called "ME", and CFS to be disbanded. Which is pretty much the opposite of what you describe there.
I've never understood the mentality of people who have no medical training whatsoever who think that they can redefine a definition like the CCC and say that they have decided that it should be called a ME definition, when it is not a ME definition it is a definition of ME/CFS, it very clearly states that ME and CFS are the same disease.

Do you think that you are better qualified then Dr B. Carruthers?? Maybe you would like to explain to him why you are so much more knowledgeable than him and have the right to redefine what disease is defined by the CCC.

And as for your extended waffle trying to make out that you and the US CFS orgs are the victims and making personal attacks against people and comparing them to

the traditional tactics of the security forces
This is highly offensive and abusive and I have reported it

It seems to me that it is you who is using “traditional tactics of the security forces” to try and stop anyone from expressing decent against this US CFS orgs plan. By trying to imply that anyone who doesn’t like this plan is against trying to achieve something good for ME patients.

Do not bother to reply I have better things to do with my time!
 
I can understand ME patients in the UK not wanting to be contaminated with the "CFS" fiasco because I am an ME patient in the US that does not want to be contaminated with the "CFS" fiasco. But thanks to our infamous CDC, I have been caught up in that web with no place to go. ME patients in the US have been obliterated and ignored since day one of the 1984 Incline Village ME outbreak, which was totally mishandled by the CDC. This outbreak eventually was given the name "Chronic Fatigue Syndrome," which in turn was subsequently expanded to include who knows what kind of "fatiguing illnesses." ME virtually does not exist in the US, even though many of us are ill with ME. Along the way, efforts were made by some our ME doctors and researchers to get that name changed. As an interim step, the term ME/CFS was proposed with the thought that as future research revealed more of the neurological, immunological, etc. nature of this disease, the CFS would be dropped and we would be back to ME. That was the plan, and US patients began using ME/CFS. Now, we could at least distinguish ourselves from "chronic fatigue," depression, etc. Just as we didn't want to be contaminated with the "CFS" fiasco, we also don't want to be contaminated with the psychiatric fiasco taking place in the UK and other European countries. There was a very unfortunate time when Dr. Reeves of the CDC shared the same views of the psychiatric proponents in the UK, and they fed off each other. We both have had these traumas and injustices to work through. We both want the same thing: ME recognized for what it truly is -- a complex, severely debilitating neurological disease with multi-system involvement as described in Ramsay or CCC or ICC. I believe that is the goal of the letter to DHHS and this petition. It is my hope that these actions will put pressure on the US DHHS to open up this dialogue so that the process of getting an accurate and appropriate case definition for ME in the US will begin, so that fruitful research and appropriate treatments can follow. This is not just a US or UK problem. ME knows no boundaries. Signatories on the petition come from many different countries: Norway, New Zealand, Netherlands, Italy, South Africa, Ireland, Spain, Germany, Korea, Japan, Greece, Croatia, to name a few. ME is a global problem and it will take international cooperation and support on all levels to tackle it.
 
rlc

I'm not at all stifling anybody from expressing their views on the matter or expressing dissent. I could moderate, delete, or ban if I wanted to do that, and I haven't done so: I value open and productive discussion and a range of views. I'm also able to respond and express my views as well and that's all I've done.

I'm sorry if you interpreted my comments about infiltration of extreme political groups as applying to you personally, or to any other people on this thread in particular, that was certainly not my intention. As I said, I think it is something that very likely happens, since it is a known tactic (I provided an example and there's more evidence of it available), and I think it's important to be aware of it, but I also wanted to make clear (and I'll re-iterate now if I didn't) that I don't at all think that's a full explanation of the pattern I see, which is that in any political scenario there is a temptation for people on the extremes to spend more time attacking the people closest to them for being (in their eyes) too moderate, rather than building an alternative or attacking the 'enemy' or the 'other side'.

I want to stress that what I'm trying to say here is not that you should not argue for the points you have raised, particularly the points about engagement. What I'm trying to say is that it is more productive, in terms of achieving the changes you want to see, to be constructive rather than destructive, positive rather than negative, in the way that you go about making those arguments. And I'm also not leveling this as a general criticism of you personally, rlc, because I haven't really seen that from you in general - I'm saying it in reaction to what you said a few posts ago suggesting that people should be getting 'mad as hell' with the advocacy groups, because what you are advocating for there is basically civil war. This is a highly unproductive suggestion for all of us and achieves precisely the opposite of the results you say you want to see. Because the more that kind of thing happens, the more defensive the groups attacked become, and the more likely they are to exclude people who attack them...so it makes open engagement and transparency less likely, not more likely - and there you see the vicious cycle that so often happens in those situations. And it works this way always and everywhere, on an individual level and on a group level, and this is something I've learned myself, and changed in myself, and it's been a revelation in terms of understanding how to achieve my goals and get listened to, so I offer it to you and you can take it or leave it as you choose.

If people want to change things about how the advocacy groups operate, the best way by far in my opinion is to volunteer, work for them, and do the work of implementing the changes you want to see. Alternatively, if you can't stomach that, then set up your own non-profit and run things the way you want to see them run. Then, at least, you will understand all the realities of how simple, or difficult, it is to achieve the things you are arguing for. In other words, frame your response to the problems you observe in a positive and constructive way. "Be the change you want to see in the world".

I'll keep on saying that to everyone, because I see a lot of this reality from the inside of some of these situations, and I'm telling you that the reality is that many and perhaps most of us - certainly all of the leadership of PR - want to change the engagement model in exactly the ways you have described, and what we need in order to do that is more people getting their hands dirty and sharing the workload of working through the difficult practical, technical and political problems to achieve that, and less people using up resources by shouting from the sidelines about what they want other people to do for them.

It's all offered as genuine advice on what, in my experience, achieves results, and what doesn't, but if you want to see it as intimidation then I guess that's up to you. It is certainly not intended that way.
 
This is our own version of "I'm mad as hell and I'm not going to take it any more!" It's our line in the sand. This is about standing together and making ourselves heard. It's political, not scientific. The details are irrelevant. Does anyone really expect the DHHS to say, "Oh yes, you're exactly right, nail on the head. We'll do exactly as you say."? Of course not. The details are going to be argued and debated to death after the petition is read however we write it. What is important is that we are seen and heard as a community to contend with. For that we need to forget our differences and get ourselves heard. This petition can do that for us if all of us unite and sign this petition as a message to DHHS that we are here and we intend to be heard.
Eloquently said, SOC. I get that "we're mad as hell feeling and not going to take it anymore" every time I see a new signature go up on the petition.
 
If Rituximab pans out then most theories of ME are dead or dying, at least with respect to the responding subset. Every theory will have to take into account why depletion of B cells results in a cure or substantive remission.

Alex.
Anyone want to lay odds that the psychoquacks will start claiming that we are making/keeping our own B cells overactive/dysfunctional by thinking the wrong way and/or being too inactive...?
 
I can relate. What would you pick if you got to pick the name for yourself?
I mean, let's just pretend for a second that the CDC phone you up tomorrow, after reading this and say, "You know what Firestorm, you're absolutely right! Sorry for dicking around these past decades and treating you all like dirt. We're serious about this now. It's going to be on every news chanel tonight, and we're increasing funding 10 zquillion percent. But, we arent sure what you call it - what do you reccomend?"
I have said for many a year that 'it' should have been referred to as something like Ramsay's akin to Parkinson's. That leaves a certain ambiguity behind cause and mechanisms.

Even with a label of Ramsay's Disease it might not put these issues behind us - I think 'chronic fatigue' would still be a feature and we'd have to work hard to overcome this association. Changing the label is only part of the issue of course.

There is something else we seldom consider and that is that a person with something like cancer or MS might well be experiencing the same 'ignorance' and poor service from their clinicians as we so often complain about.

And even Ramsay's is historic I suppose. If we had started out with Ramsay's though then things might have been different - but equally they might not.
 
Deliverance or Disaster? The Canadian Consensus Definition Petition Conundrum (Take the Poll)

Cort's latest raises concerns about the petition and the support of CCC and also puts a poll in the field.

This was his conclusion:

The End of Consensus Definitions (?)

Diagnostic criteria should be based on statistical methods rather than consensus declarations. Ongoing discussions about which case definition to employ miss the point that the criteria did not pass appropriate external validation. Maes et al.

The Holmes, Fukuda, Oxford, Empirical, CCC, ICC….. in fact, all the definitions for ME/CFS produced thus far are consensus definitions put together by groups of people who think they know what ME/CFS looks like. It’s questionable whether consensus definitions are going to cut it anymore. My guess is that science is too data driven now for the federal government to put it’s stamp of approval on another consensus definition.. My guess is that attempting to push the federal government to insert something that radically redefines ME/CFS research efforts and other federal programs is going to require statistical evidence.

The best approach at this point might be to press the federal government to have the workshop on producing a new definition and provide a funding set aside for studies that statistically determine the best definition for ME/CFS. Lenny Jason has already done a good deal of work in this area and the feds have shown some interest. We may not be that far from a definition that everybody can support and which the federal government can take action on. I suggest that we wait for more studies from Jason and others before we endorse a definition at this point.
 
I have said for many a year that 'it' should have been referred to as something like Ramsay's akin to Parkinson's. That leaves a certain ambiguity behind cause and mechanisms.

Even with a label of Ramsay's Disease it might not put these issues behind us - I think 'chronic fatigue' would still be a feature and we'd have to work hard to overcome this association. Changing the label is only part of the issue of course.

There is something else we seldom consider and that is that a person with something like cancer or MS might well be experiencing the same 'ignorance' and poor service from their clinicians as we so often complain about.

And even Ramsay's is historic I suppose. If we had started out with Ramsay's though then things might have been different - but equally they might not.
I like the idea of that kind of name, but maybe not that particular one as it could get confused with Ramsay Hunt syndrome, which coincidentally I think I had at age 5, and which I think was due to the chicken pox virus herpes zoster, which coincidentally (again!) may have started off the leaky gut/poor carb digestion problem that eventually contributed to the development of ME.
 
Ric@ it was helpful - thanks for your answer.

@thread - i will have to review all definitions etc before signing my name to the petition , I also have to review corts article stating the .CC .CC & ICC potentially leave us all open to an increased liklihood of a psychiactric diagnoses ...

(I just want to stress here, that I am disgusted by the prejudice the mental health community face. The only purpose for me personally highlighting the fact that M.E. is a physicsl illness is to try to get the physical help and support that I need and deserve and also to avoid being harmed by ignorant psychological treatments- applied to my physical illness ).

This is a thread like no other. I apologise that I think I am completely missing the political points, including PR.

Is there a dead line on this petition? I will try to research properly - but my incling is becoming to not sign it (so far )-

I would be happy to go into a new pile of patients, say called , The Unlabelled :) Providing It does not mean a psychiactric diagnoses by default.

I have been let down by advocates before who are in bed with the agencies they are supposed to be protecting me from - due to their compromised funding situations etc. But I dont think this would be PR. I think Grace Charity for M.E. makes this point about M.E. charities.

We all have to say 'you go your way and I will go my way '...

And if our paths happen to cross through a petition, then so be it - if they dont - thats surely got to be OK too...

What a 'To Do ' :)
 
I have said for many a year that 'it' should have been referred to as something like Ramsay's akin to Parkinson's. That leaves a certain ambiguity behind cause and mechanisms.
...
Of course hindsight is a wonderful (though not always) thing and who could really have forseen that 'ME' would have attracted all of this 'heat'. Nothing to say that Ramsay's wouldn't also of course - but CFS is too specific and I think that's what most people's arguments are about: scientists, clinicians and patients'.

But what to do now if the question were posed? And more importantly where to place the disease - in what category? Could we - should we - 'escape' the syndrome label?

So many interesting philosophical questions coming out of this debate. Good stuff. Bit draining though - ain't it? :)
 
Anyone want to lay odds that the psychoquacks will start claiming that we are making/keeping our own B cells overactive/dysfunctional by thinking the wrong way and/or being too inactive...?
Yes. Odds are 9:1 they will do exactly as you say. There are still some claiming that H. pylori induced ulcers are largely psychosomatic.

As to Ramsay's Disease it wouldn't matter much. The problem is the claims, rhetoric and influence of those who want this to be psychogenic. Who has read Ramsay's book that discusses the mass hysteria crisis in ME? Its next on my wanna buy list.
 
I suppose everyone knows this already !

But i just found this:

http://m.hfme.org/site/mobile?dm_pa...d53a1&fw_sig_premium=1&fb_sig_network=fw#2021

M.E. is a brain virus with onset of 4-7 days of infection. It has similar patterns and bio markers.

t is sudden onset only .

Since I have never been given MR/CT scan......I can not confirm M.E. in myself.

C.F.S. is a collection of Major missed diseases !!!! Since I have never been tested for lupus , lyme etc.etc. If it is not M.E. I have I do not know which major illness I have ...

It is a lose lose situation. Having CFS joined to ME does a disservice to ME people...

And having CFS means the real diagnoses has not been found.

This is very helpful too me as for the first time I feel clearer on the subject .

This is my current new thinking on the subject. I no doubt am wrong .

Going to research more .
 
While you are doing your research, Golden, keep in mind that ME and CFS mean different things depending on which country one lives in.

As far as I know, one cannot get a diagnosis of ME in the US.

I had sudden onset to my illness. I fit the CCC and the ICC criteria, yet I can't get a diagnosis of ME here in the states as of today. That is where this letter to the DHHS would help me, personally.
 
Nielk ,

I think it maybe the US that created the CFS label labeling 1988. (stress, think )

Why would the world health organization not apply in America ?

(i cant seem to find this answer )
 
urbantravels & snowathlete,

dont get it .

if the WORLD health org. applies in Africa - why not America ?
 
The World Health Organization is a toothless tiger. They have no authority in a country unless that country grants them authority. The US uses the ICD, but creates its own version of ICD. I think the UK does too, but I could be wrong.
 
Yes , i see - i found a WHO headquarters in America but its called Panho...

will have to research all this now too. A lot seems to be being made of the WHO classification code of M.E. as a Neurological disease .
 
The WHO classification code essentially means nothing. Its a bureaucratic code, not an endorsement of a particular viewpoint. Oh look, this country has this many people under this code. The science and the experts are what matters. Diagnostic criteria are important, but the name isn't. Misdiagnosis is important. Biomarkers and treatments are important. Funding and medical understanding are important. The name CFS is a bad one, and ME/CFS is not much better, but ME is bad too. Somehow that gets lost in this debate. Most doctors who know anything about ME probably have an opinion biased by the biopsychosocial view, and are unaware of the scientific breakthroughs, expecially in the last decade.

Many experts are going to use the ICC, as will leading ME doctors. The CCC definition is not being proposed as a perfect solution, but as a minimal standard. My guess is that for years the CCC and the ICC will be used side by side, and then researchers will abandon the CCC. This is not up to us though. Its up to our researchers and the CDC.

The letter and petition are about making a political statement, and creating awareness. I see no reason why we cannot put the CCC forward as moderately well established, while at the same time we make it clear that this is an interim measure and the science is evolving rapidly - so the real message to everyone is: watch the science. Things are changing. The ICC is the best definition we have currently. In five years it might be obsolete, in ten it almost certainly will be.