"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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There are many ways you can help Phoenix Rising to continue its work. If you're able to offer your time, we could really use some more writers, proof-readers, fundraisers, technicians...and we'd love to expand the board of directors. You can even donate significant sums, at no cost to yourself, as you shop online! To find out more, visit Phoenix Rising’s Donate page by clicking the button below.

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Comments

I've been asked in the past to get expert opinion for the advocates, Nielk, only to have it roundly rejected. The advocates don't respect the experts or their expertise. Unfortunately, their attitude may be of more benefit to Dr. Unger than to the patients.
Of course, there are a variety of experts with a variety of perspectives and it's impossible to please everyone all of the time. You don't state which people you consider to be "the experts", but I suppose Simon Wessely and Peter White might consider that as "experts" in the subject they should have been consulted. Good luck getting a consensus which includes them. If you think you can achieve a broad consensus of organizations, advocates and experts who support a different position, you're welcome to try, but there is of course an enormous amount of work involved in doing so.
 
The letter to DHHS demands that the “key stakeholders ME patients and ME experts must be engaged in a full and open partnership to plan for and ensure implementation of this change.” Why weren't any ME or policy experts consulted about the change or implementation plan?
 
Can we sign the petition from anywhere in the world or do you have to be a US citizen for the signature to count?
As I write this, there are currently 899 signatures on this petition. I have kept track of the countries from which these signers come: USA, UK, Norway, Canada, Israel, New Zealand, Netherlands, Italy, South Africa, Ireland, Sweden, Puerto Rico, Spain, Belgium, Finland, Germany, Japan, US Virgin Islands, Denmark, Greece, France, Croatia, and Malta. So, Emma, as well as others, please sign the petition if you feel so moved, as this disease, ME, knows no boundaries. We need international support and cooperation on all levels in order to tackle this horrendous problem.
 
You don't state which people you consider to be "the experts"
Dr. Carruthers' opinion concerning the relationship between ME and CFS has been roundly rejected by advocates in the past. Now it pleases Mary to use his name in support of this initiative. Taking a quotation out of context and using it to a different purpose without the author's permission is generally seen as intellectually dishonest behaviour. In Mary's message, even the attribution itself is incorrect. Yet you have refused to make any correction. If an ME expert's opinion isn't valued, why then make use of his name?
 
The letter to DHHS demands that the “key stakeholders ME patients and ME experts must be engaged in a full and open partnership to plan for and ensure implementation of this change.” Why weren't any ME or policy experts consulted about the change or implementation plan?
As explained above. The partnership and consultation referred to there would come from the DHHS if and when they respond. No doubt details would be subject to change at that stage, and there would be opportunity for people to express their views.
 
The partnership and consultation referred to there would come from the DHHS if and when they respond. No doubt details would be subject to change at that stage, and there would be opportunity for people to express their views.
I hope that it's as apparent to DHHS as it is to me that what's at issue here is more than a matter of “details.”
 
Dr. Carruthers' opinion concerning the relationship between ME and CFS has been roundly rejected by advocates in the past. Now it pleases Mary to use his name in support of this initiative. Taking a quotation out of context and using it to a different purpose without the author's permission is generally seen as intellectually dishonest behaviour. In Mary's message, even the attribution itself is incorrect. Yet you have refused to make any correction. If an ME expert's opinion isn't valued, why then make use of his name?
I've answered that question on the other thread already. I think I've answered all your questions, some of them several times, and if you don't like the answers then we'll just have to agree to differ. But I'll answer that question one more time...

The letter has already been sent, and I don't see any meaning or purpose to asking for a correction on a very minor point (which, assuming you're correct, would presumably be to add "et al" after his name, even though the paper from which the quote comes is referenced in relation to the quote?). Quoting something that somebody said on public record does not require their permission, and it doesn't constitute "using their name" in support of the initiative. It's simply using words they said in support of an argument. I think it's pretty standard practice: I was never taught at school when writing essays that I had to contact everybody I quoted to get their permission in case they might disagree with the argument I was making.

And if you think that 'taking a quote out of context' (in fact, the one you are referring to is referenced to the source) and using it to support a position that the author of that quote would not support (which is conjecture on your part and Dr Carruthers is quite able to object himself if he has a problem with this) is "intellectually dishonest behaviour", then I disagree: it would be dishonest if one said or implied that the author of the quote agreed with everything else you were saying, but that is not what has been done here. But supposing that were intellectually dishonest, then that criticism can most definitely be applied to your use on the other thread of a quote (unreferenced), which you attributed to Invest in ME, as an argument against this initiative, despite the fact that Invest in ME themselves state in their latest conference journal, under Guidelines: "Invest in ME support the use of either the so called Canadian Consensus Criteria (CCC) or the later version of these guidelines the International Consensus Criteria (ICC)."
 
I hope that it's as apparent to DHHS as it is to me that what's at issue here is more than a matter of “details.”
Since that's made clear in the letter to them, and in any case obvious, I would hope so too.
 
One more time, Mark, I did not take any quotation out of context. The statement by the International Consensus Panel that Mary has used in support of her initiative was written in support of the ICC.
 
Sorry where did the quote 'fatigue is not a disease' come from? Thanks.
Answered by someone else above (thanks!) but as to the title of the article, it's taken from the title of the petition.

I find the point that golden makes - that this might be a risky slogan, because it could be turned around against us - quite interesting and thought-provoking. I've been reflecting on that, and my thought is that in the end this just illustrates what a good issue it is to highlight. What we're really saying here is: This is a disease, not (just) fatigue. It's a starting point for thought about the issue, and yes anybody could take it in either direction, but if somebody were to say "yes, fatigue is not a disease, it's just fatigue, so you shouldn't call it a disease" then the answer is easy: list all your other symptoms and say "exactly, I don't have fatigue, I have a disease with many symptoms, so the name is completely inappropriate for me (and for M.E.)".

I wonder whether any good slogan is open to cynical misinterpretation to mean the opposite of what it says. I think maybe the value of any slogan is that it opens up a sharp and important question and makes it clear what the issue is, but slogans in themselves never prove anything or win arguments.

Having said all that, "This disease is not 'fatigue'" might be better.
 
I think I've answered all your questions, some of them several times, and if you don't like the answers then we'll just have to agree to differ.
You referred my questions to Mary, who has not yet replied.
 
One more time, Mark, I did not take any quotation out of context.
I don't think I said you did. Neither did the letter - it stated the context quite clearly.

I have no idea what the context of your Invest in ME quote was, because there's no reference for me to confirm whether IiME said it or in what context. All I know is that the interpretation you placed on it is contradicted by IiME's quote in their latest conference journal, which clearly states support for both CCC and ICC.

The real point here is that supporting the ICC does not imply opposing the CCC always and everywhere, or opposing anyone campaigning for the CCC in any context. Invest in ME get that, as my quote clearly shows. The signatories of the letter get that, because I'm sure there are some amongst them who would ideally prefer the ICC but think that a united front is more important. I strongly suspect that most of the authors of the ICC also get that. I think most reasonable people get that.

The statement by the International Consensus Panel that Mary has used in support of her initiative was written in support of the ICC.
Correct. So what?
 
You referred my questions to Mary, who has not yet replied.
We've both spent an awful lot of time answering your questions, and we do have other things to do. I think all the questions on which I referred you to Mary have now been answered either by me or by her.
 
Is PR behind this ?- terrible foggy brain today.... A cliff notes version would be appreciated ....
Sorry for the delayed reply golden.

Phoenix Rising has signed the letter and we are supporting this campaign, but we are not 'behind it' in the sense of organizing it. We joined the discussion process part way through.

Our original article might be helpful for a simple summary:
http://phoenixrising.me/archives/16954

In particular, the key points in the letter are summarized part way down under "What are we asking for?", and there's more explanation above and below that.
 
I've been awaiting since last Wednesday a reply from Mary about the concerns that I've raised:
Unfortunately, your answers don't address a number of the concerns that I've raised.
Ember
I am sorry that it took me so long to reply to your questions but I did try to answer your questions as best I could. I still need to reply to your post from yesterday.
 
The real point here is that supporting the ICC does not imply opposing the CCC always and everywhere, or opposing anyone campaigning for the CCC in any context.
This initiative involves adopting the CCC, calling it ME and collapsing CFS as a diagnosis. No experts were consulted, but the campaign suggests that these ends are supported by the authors of the ICC and in particular by Dr. Carruthers.
 
It is very much a non-answer, isn't it. Sometimes it seems that CDC is still 30 years behind the rest of the CFS/ME community. I'm also not encouraged by the systematic review, as there is so much worthless CFS research out there. Reviewing some selective dodgy behavioural literature, one might conclude that CFS is a simple behavioural fatiguing disorder, treatable with CBT. And yet the biomedical literature shows a complex biological disorder with clear immune dysfunction, and biological markers/abnormalities. So I'm not sure how a systematic review will be able to make any sense of such opposing research paradigms.
Very much a non-answer, yes Bob.

I'm not completely pessimistic about the systematic review though. I think something useful might come out of that, and from the other initiatives (like the CDC multi-site study). I find it quite understandable that the federal agencies feel the need to proceed in that way, and respond to these requests with the kind of tools they have, and nobody (I think) disagrees with Unger about the importance of finding biomarkers and other evidence to support eventual definitions. The problem as I see it is all the ongoing harm that's caused while they're working through all that, when there is already more than ample evidence of that harm and it's clear that short-term solutions to the problem of the "wastebasket" they've created for us are available now. (And of course we have no real basis for confidence that they'll do a good job of it this time, and plenty of reasons to fear that they're still determined to do it in a way that completely misses the point).

So I'm not blindly optimistic about what the systematic review will throw up, but I found a few of the comments about it at CFSAC fairly promising. One key point that was stressed is that really what it will tend to do is identify the gaps in the research; the key issues, the unknowns, the things that need to be clarified - and that this will then be used to guide what research should be done next. It's quite interesting to think about what that might highlight. If it concludes that the research so far doesn't amount to much, then it has to also conclude that much more research is needed. If it finds issues like NK cells and other immune abnormalities inconclusive, then it pretty much has to say what needs to be done to resolve those questions. And assuming it reviews both of the halves of the literature that you describe, Bob, then it would seem to me that the picture you have sketched is accurate: there are two camps, one researching one broad definition and CBT, and the scientists researching the biology of the disease using a narrower definition. One possible conclusion from that picture that might seem to leap out is that the two should be seen as separate entities, and separated, and that the best candidates for tests that seem to distinguish the disease need to be studied with large multi-site studies.

So I think it's quite possible that some useful conclusions may come out of the review. Oh, and if the review takes a close look at PACE (the study, not the spin), with no axe to grind, asking what it tells us about which subgroups are helped by which treatments (allegedly a key question for the review) then they may well come out of that with some rather scathing conclusions. I'm not blindly optimistic, but I don't assume a pessimistic conclusion either.

My main problem with all this is that this is an incredibly slow process, and while it's fine for them to go down that road, they need to make interim changes now. The letter and petition are aimed at what we think is the most realistic shot for a strong campaign to demand those changes, and I don't personally imagine that anything that happens now could be the final word on the case definition. I think pretty much everybody now recognizes that as soon as there's been proper, thorough investigation of biomarkers and other evidence-based diagnostic metrics, the emphasis around case definition will shift from the existing definitions to new and more 'evidence-based' criteria, so I personally see the CCC (or indeed the ICC) as inevitably short-term solutions while that other work is being done. I think that the emphasis around case definitions will increasingly move towards biomarkers and objective metrics in the coming years, and anything that happens now is bound to evolve as that evidence comes in. But in the meantime, we need recognition of something considerably better than Fukuda, especially to help make that research on metrics more meaningful and to reduce the number of patients with PEM or PENE who are being told to exercise and ending up bedbound as a result.
 
This initiative involves adopting the CCC, calling it ME and collapsing CFS as a diagnosis.
Yes.

No experts were consulted
You keep saying that, but that doesn't make it true. We've listed the people who were consulted, and stated that others were too, and you don't know and won't know who those people are if they don't want to be named.

but the campaign suggests that these ends are supported by the authors of the ICC and in particular by Dr. Carruthers.
No it doesn't.

On the other hand, your own campaign against the initiative suggests that you believe the ICC authors are opposed to the initiative. Do you have any evidence of that? Have you consulted the experts you're referring to, to find out whether they agree with what you're arguing? If you could get some kind of current statement from them on the matter, it might make your case stronger.
 
If Dr. Unger is aware of the issues, then she is aware of the harm that the CDC is causing. Does that make her responsible? Shouldn't it mean she (or delegated people) need to form a group with concerned patients and expert researchers to rapidly change things? A new case definition could be argued for, but its too far off. Harm is being done now.
Wonderfully succinct, thanks Alex. I don't see how she can be 'aware of the issues' and yet unprepared to make any changes in the short term to mitigate the problem. Her perspective as a scientist on what needs to be done long-term to systematically work through investigating the issues is understandable, but the failure (by her and others) to respond in the short term to what a host of patients, researchers and physicians have been telling them for years - decades even - about the harm they're causing and about what can and should be done now to address that, is pretty much impossible to excuse.
 
I'm very foggy at the moment too - there's a lot of it about!

I was starting to fill in my details but thought I had better make sure of what I was asking for, and was concerned that the Canadian criteria might exclude me due to the apparent necessity for significant pain, which I don't have. So I haven't signed it - yet.

I may reconsider when my head is clearer and I have been able to think about it properly.
Pain isnt necessarily for a diagnoses under the Canadian CFS criteria defination if you had an infectious illness type onset.