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

View the Post on the Blog

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/

Support Phoenix Rising​

Phoenix Rising is a registered 501 c.(3) non profit. We support ME/CFS and NEID patients through rigorous reporting, reliable information, effective advocacy and the provision of online services which empower patients and help them to cope with their isolation.

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.

​

View the Post on the Blog

 

Perhaps she (rightly?) views 'CFS' as a non-specific umbrella diagnosis, that includes many 'fatiguing' illnesses, conditions and subsets?
Perhaps she thinks that 'ME' might be a discrete disease, but that there's no evidence for it, or maybe she's paying lip-service to the ME community?
She has repeatedly said that being able to define subsets is essential.
Her current research is attempting to define CFS subsets, using the data acquired from the expert physician clinics.

Can anyone tell me what the current situation re: ME and CFS is in the US? When I first became ill, the doctors and insurance companies had no code for ME, therefore it did not officially exist in the US. CFS was the only official designation for our illness. I was told that that has changed, but the following info is not helping me understand whether we can be officially diagnosed with ME. Or what the correct code for CFS is, for that matter -- is it G93.3 or R53.82?

Subsets, my azz. This looks like the opposite of subsetting.

2013 ICD-10-CM Diagnosis Code G93.3

Postviral fatigue syndrome

• distinctive syndrome characterized by chronic fatigue, mild fever, lymphadenopathy, headache, myalgia, arthralgia, depression, and memory loss; candidate etiologic agents include Epstein-Barr and other herpesviruses.
• Syndrome thought to be caused by a viral organism resulting in chronic fatigue, fever, pain, sore throat, and, in some cases, depression.
• A syndrome of unknown etiology. Chronic fatigue syndrome (CFS) is a clinical diagnosis characterized by an unexplained persistent or relapsing chronic fatigue that is of at least six months' duration, is not the result of ongoing exertion, is not substantially alleviated by rest, and results in substantial reduction of previous levels of occupational, educational, social, or personal activities. Common concurrent symptoms of at least six months duration include impairment of memory or concentration, diffuse pain, sore throat, tender lymph nodes, headaches of a new type, pattern, or severity, and nonrestorative sleep. The etiology of CFS may be viral or immunologic. Neurasthenia and fibromyalgia may represent related disorders. Also known as myalgic encephalomyelitis.
• G93.3 is a specific ICD-10-CM code that can be used to specify a diagnosis.
• ICD-10-CM officially replaces ICD-9-CM on October 1, 2014, therefore, G93.3 and all ICD-10-CM diagnosis codes should only be used for training or planning purposes until then.

Applicable To

• Benign myalgic encephalomyelitis

Type 1 Excludes

• chronic fatigue syndrome NOS (R53.82
  
  )

 

Why not establish a partnership with ME experts now and ask for the adoption of the ICC? Asking DHHS to adopt a decade-old case definition is also unproductive and harmful to patients.

This campaign is so misleading! The “web of confusion” line comes from the ME Primer, as does the quotation in Mary's message to patients, caregivers and advocates: “Research on other fatiguing illnesses, such as cancer and multiple sclerosis, is done on patients who have those diseases. There is current, urgent need for ME research using patients who actually have ME.” Incorrectly attributed to Dr. Carruthers and used without his permission, that statement by the International Consensus Panel was written in support of the ICC.

The problem with ME/CFS advocacy is that there is very little agreement on anything. When a group comes together with many different voices and they reach a consensus on something that is what they go with. A consensus was reached re: the CCC vs ICC. Constantly complaining about this will do nothing except cause further division.

There are still problems with the ICC and there are problems with the CCC too. Of course not everybody will agree that it's best to go with the CCC as a starting point until the ICC is further entrenched. What I find unproductive and harmful to patients is that we never get anywhere because every time a group of advocates come together to try to do something positive, it's criticized and complained about largely based on one's own personal biases related to what they think must be done . I have seen some good work essentially torpedoed by this kind of thing before it can even get off the ground.

 

Can anyone tell me what the current situation re: ME and CFS is in the US?

This quotation is taken from the National Alliance for Myalgic Encephalomyelitis:

At present, the U.S. still uses its modification of WHO's ICD 9th revision, the ICD-9-CM. Chronic fatigue syndrome is classified under "Symptoms, Signs and Ill-Defined Conditions," code 780.71, under the sub-heading of "General Symptoms." As the Definitions and Research pages of this website demonstrate, M.E. is a clearly defined clinical entity that was coded in the ICD-9 as 323.9 under "6. Diseases of the Nervous System and Sense Organs(320-389); Inflammatory Diseases of the Central Nervous System(320-326)." However, the U.S. modification of the ICD-9 (ICD-9-CM) tabular document revised 323.9 to "Unspecified cause of encephalitis, myelitis, and encephalomyelitis" but still lists in the ICD-9-CM Index: "Encephalomyelitis (chronic) (granulomatous) (hemorrhagic necrotizing, acute) (myalgic, benign) (see also Encephalitis) 323.9." This is the diagnostic code we recommend doctors use when a patient fits the distinct M.E. definitions, according the the Consensus Document, Ramsay, Dowsett et al definitions, and Hyde descripton. According to a CDC ICD coding representative (July 2006), "M.E. has always been indexed to code 323.9. That is the code number that patients should be assigned." Correctly diagnosing this disease benefits patients and health care providers by acknowledging the true prevalence of ME in the U.S.

 

“We’re ready to begin the next phase of keeping things exactly the way they are”.

That about sums up Unger and the CDC. They'll acknowledge they're feeling the heat and try to cool things off with cheap talk and no action of any real import. Everything they've proposed or done has already been done, most of it decades ago. Regurgitating the past is their way of jogging in place while claiming to be running as fast as they can.

There is no place in modern scientific discourse for "neurasthenia." They might as well claim that it's witchcraft or bad air. That's Unger's way of extending the middle finger of her hand to patients and their supporters.

The only improvement I can see is that they are no longer claiming that those who know the disease, like Dan Peterson, are "contaminated", as Reeves once did. But wait...Peterson didn't get invited to any of the recent government shindigs, did he? As for physician instruction, the video Peterson did for doctors in Sweden (or some other Scandinavian country) a year or so ago on how to diagnose and treat would be a huge step forward if the CDC would just put that out there. But no, they insist they must reinvent the wheel and the one they always invent has four flat sides to it. No wonder it never goes anywhere.

 

The problem with ME/CFS advocacy is that there is very little agreement on anything. When a group comes together with many different voices and they reach a consensus on something that is what they go with.

It would help if the advocates were well-informed. AIDS activists succeeded when they started doing their homework.

 

It would help if the advocates were well-informed. AIDS activists succeeded when they started doing their homework.

Non-productive and harmful comments will get us nowhere. Were you privy to how decisions were made? Are you well-informed of how the consensus was reached? I was actually given some good descriptions of how the decisions were reached and it doesn't seem to go to anybody be ill-informed.

Groups working together will get us somewhere.

From what I have personally heard, the advocates involved are not ill-informed and have done their homework.

I think it's best to move on and look at Unger's response than posting digs at advocates.

If we were to wait for all the advocates to agree, then hell would likely freeze over.

I signed the petition for many reasons. I could have held back because I disagree with a few things but I would rather have something being worked on over nothing at all. Progress takes time but it doesn't happen when advocates are bogged down with constant criticism.

I really have nothing else to say. This of course is only my personal opinion. I actually don't believe that even if the ICC were being suggested that Unger's non-response would have changed one iota.

 

Were you privy to how decisions were made? Are you well-informed of how the consensus was reached? I was actually given some good descriptions of how the decisions were reached and it doesn't seem to go to anybody be ill-informed.

No medical or policy experts were consulted, and basic questions about the initiative go unanswered.

 

Sorry where did the quote 'fatigue is not a disease' come from? Thanks.

Hello Firestorm,

The phrase "fatigue is not a disease" came from Erica Verrillo. See ProHealth post: http://www.prohealth.com/me-cfs/library/showarticle.cfm?libid=18131

 

No medical or policy experts were consulted, and basic questions about the initiative go unanswered.

What medical or policy experts have you consulted to come to your conclusions regarding the CCC vs ICC? Nevermind, don't bother answering because it doesn't get us anywhere. Maybe people stopped answering questions because of the constant criticism. I really don't know. I just have a different mindset I guess. I appreciate the work many advocates are doing on our behalf and even if I have questions and think things could be done differently, I still believe that something over nothing, and consensus over constant squabbling is preferable. Just because you believe something is wrong, doesn't make it wrong.

We have a long road ahead of us and there is a lot to be done.

I am actually more interested in this thread regarding Unger's response and how it should be responded to.The letter has been sent after a consensus was reached, the petition can be signed or not. I am not interested in repeated criticism regarding a group of advocates who have come together to work on our behalf. The problem isn't with the advocates, it's with people like Unger.

 

Neurasthenia is also a neurotic disorder according to the ICD-10.

that isn't even in the ICD-CM. We refused to have it because it's sexist in how it's used. Some decades ago. CDC bringing this up is a complete mystery.

 

Officially I think the CDC has considered ME to be a separate disease for a long time, but this is not reflected in treatment advice I think.

this is sort of complicated. If you ask them what to do with an ME patient, they will refer you to the diagnostic and treatment protocols for CFS (or this is what they have done in the past). If you ask them why they are not treating CFS as a neurological disease, they will tell you CFS has a case definition distinct from the case definition for ME.

 

The problem isn't with the advocates, it's with people like Unger.

Challenging Dr. Unger requires effective advocacy.

 

this is sort of complicated. If you ask them what to do with an ME patient, they will refer you to the diagnostic and treatment protocols for CFS (or this is what they have done in the past). If you ask them why they are not treating CFS as a neurological disease, they will tell you CFS has a case definition distinct from the case definition for ME.

Yes Willow. Its called a double standard, a.k.a. hypocrisy.

 

Challenging Dr. Unger requires effective advocacy.

That again is an unproductive and harmful comment and just outright rude. I think we have people working hard on our behalf. Constant negativity does nothing. In the face of all the crap that our advocates constantly have to face, it's a wonder anybody ever steps up at all. I appreciate those people, most who are sick themselves actually trying to go forward and get things done to make some kind of a difference. Kudo's to them. If you believe that you have something better to offer, why don't you get to it rather than just criticizing the hard work of others.

If you don't like the fact that they chose by consensus to use CCC over ICC, it doesn't translate into ineffective advocacy.

Anyways, it's obvious anything I say is going to met with terse one-liners. That's okay, but I guess it's pointless to have any kind of conversation because I believe the advocacy efforts are fine, I don't have a problem with using the CCC until the ICC is refined a bit, I like that we have people advocating on our behalf. I suspect if you had written the letter to Unger from your point of view, the response would have been the same.

 

Can anyone tell me what the current situation re: ME and CFS is in the US? When I first became ill, the doctors and insurance companies had no code for ME, therefore it did not officially exist in the US. CFS was the only official designation for our illness. I was told that that has changed, but the following info is not helping me understand whether we can be officially diagnosed with ME. Or what the correct code for CFS is, for that matter -- is it G93.3 or R53.82?

Subsets, my azz. This looks like the opposite of subsetting.

R53.82 is designed by DHHS for people who fit case definition for CFS (and ME? would certainly include ME patients at any rate) with no proven viral onset. Since CDC has been specifically telling doctors NOT to test for any viruses in ME/CFS patients for many years, that would be most everyone.

However, I don't know for sure what CDC has decided or will do in the final version of ICD-10-CM or if it's out yet. Donna Pickett hasn't answered any inquiries about this, as far as I have heard. Current version can be obtained directly from CDC, but I've been extra ill and lost track of whether it was finalized.

The code helpers on can find online in html use a variety of sources to and are not based solely on DHHS sources, so they might not be the same as the official one. They do include official sources as one of their inputs, though, so it is worrying that they are using the CFS NOS. (NOS = not otherwise specified)

 

Challenging Dr. Unger requires effective advocacy.

Ember,

Are you involved with advocacy? It's easy to criticize from the stands. What's hard is doing something about the status quo and trying to affect change. You seem to have a lot of knowledge about the issue. Why not get involved and help?

 

If you believe that you have something better to offer, why don't you get to it rather than just criticizing the hard work of others.

Input from members of Phoenix Rising wasn't invited, and experts weren't consulted.

 

You seem to have a lot of knowledge about the issue. Why not get involved and help?

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, that attitude may be of more benefit to Dr. Unger than to the patients.

 

Personally, I can see both sides of the argument here.

I like that people are trying to do something, and I believe that collaboration and getting several groups/people supporting an effort is a good way to go. Essential, actually.
Change takes time, and you never ever win from the beginning, but arguments you make now set the sometimes un-acknowledged foundations for change to occur next time (or more likely, next year, couple of years...) so in this respect there is an opportunity, often, to refine what you actually want to happen as things progress, because when you ask for change, your first request never gets implemented in cases like these. In this respect I think it’s important that people don’t get disheartened by the reply and future replies like this. Its normal, and totally what I expected to happen. Change takes time.

But I can see some of Ember's arguments and questions are valid, and I think it's right to ask them, and for this advocacy group to improve in the way they work, because it’s all a learning process and no one expects anyone to get everything right first time, and what is 'right' is often a matter of opinion in some of these things, but getting it close (something that will progress things) is still a worthy effort and I support it.

It’s important to engage with people in the community that are asking fair questions (especially difficult ones) because it helps you improve – it’s a positive pressure, in my view...
I think there is a point where it can become counterproductive, but I think it takes both sides to engage on somewhat controversial topics like this. So long as all parties are respectful (which I think they have been on the whole) and the views being discussed aren’t extreme (and I don’t see any of that here) then I think it is beneficial. If one person asks the questions, and the other side doesn’t acknowledge them as fully as perhaps they should, then the first person gets frustrated and is likely to vent and others might be more reticent to support it. Especially in situations where one side has more power. Just like the CDC have more power than advocacy groups, advocacy groups have more power than individuals in the community, so it’s important for everyone to keep an open mind and engage with each other.

Would the advocacy group feel happier if Unger's letter was more engaging, maybe more open to further discussion? Even if it didn’t give any more actual ground? Yes, I think so. Same with advocacy groups when they get feedback from the community they represent. Just as we want the government agencies to listen, groups representing patients need to listen too; else it’s a flawed process and that would be the most damaging thing to efforts like these.
I'm not suggesting that this advocacy group hasn’t done that enough, btw. I think some of the posted answers in other threads on this topic were very helpful, but I favor the greatest engagement that is possible - there is usually room for improvement. From the posts here and in other threads, it looks like some people in the community might feel that they didn’t get any chance for input (even if their input was then ignored) and so that seems like a key are where improvement could be made, in my opinion.
I see this effort as progressive, so I support it, but I'd like to think that engagement in the future would improve and appear to be more open than it might have been this time. I’m not saying we should involve everyone, and have a show of hands, it can’t work that way, but again, more engagement, learning as we go along, taking feedback on board when the community raises it...that’s the way that advocacy groups will be most effective and have the most support from the community, which is important for the success of efforts like these.

As with all this stuff, especially in our community with lots of conflicting views, it is important for everyone to acknowledge, and accept, that things aren't ever black and white. The world is composed of gray! Gray is progress, and we might need to compromise on the shade.

 

Input from members of Phoenix Rising wasn't invited. Experts weren't consulted.

As medfeb has explained on another thread:

As I think we've all seen in PR threads that have tackled the definition before, it is not an easy issue to discuss because of how convoluted all the definitions have become and because the term "CFS" means so many different things to people. As a result, the letter was in the works for about 6 months with numerous discussions across a number of organizations and individuals that included a few doctors and a number of long term advocates on how to frame the discussion and on what recommendations to make. All of the signatories were given the opportunity to provide input as did others. The final product was a result of that iterative process.

As medfeb suggests, public discussion threads (which the recipients of any letter can also read while position statements are being developed) aren't always the most productive way to produce consensus and work productively on drafting an effective document so be submitted to federal authorities. Sometimes such threads can be disrupted and dragged off track by people who don't really want to work constructively in order to achieve a consensus and move forward.

The groups and individuals listed below put their name to the letter. The phrase "...as did others..." in the above quote means that there are other people who were also consulted, but it would be wrong to give the names of those people without their permission. Any experts who agree or disagree with the letter and/or the petition are free to state their position on it publicly, and unless/until they do so, any assumptions about their involvement in its drafting or their stance towards it are just speculation.


Signatories of the letter:

Chronic Fatigue Syndrome,
Fibromyalgia and Chemical Sensitivity Coalition of Chicago,
CFS/Fibromyalgia Organization of Georgia, Inc.,
MAME (Mothers Against Myalgic Encephalomyelitis),
PANDORA (a.k.a. CFS Solutions of West Michigan),
Phoenix Rising,
The Fibromyalgia-ME/CFS Support Center, Inc.,
Rocky Mountain CFS/ME and FM Association,
Speak Up About ME,
Wisconsin ME/CFS Association, Inc.,

Bobbi Ausubel,
Rich Carson,
Lori Chapo-Kroger,R.N.,
Kati Debelic, R.N.,
Mary Dimmock,
Pat Fero, MEPD,
Joan Grobstein, M.D.,
Jean Harrison,
Eileen Holderman,
Suzan Jackson,
Jill Justiss,
Mindy Kitei,
Michele Krisko,
Denise Lopez-Majano,
Mike Munoz,
Matina Nicolson,
Donna Pearson,
Leela Play,
Justin Reilly, J.D.,
Mary Schweitzer, Ph.D.,
Meghan Shannon MS MFT,
Marly Silverman,
Rivka Solomon,
Tamara Staples,
Charlotte von Salis, J.D.,
Michael Walzer