Patients to DHHS: Cancel the IOM Contract!

September 19, 2013

Gabby (Nielk) reviews the shennanigans employed by the DHHS recently to try and blindside us with a new clinical definition for our disease; and explains how you can help stop them…

International Call for Action: Your community needs you!

Everyone: please email HHS today and every day till September 30th – see draft below

US Citizens: please email your Congressional representatives – see instructions below

Secretary Sebelius

Kathleen Sebelius
US Secretary of Health and Human Services

The Department of Health and Human Services (HHS) describes itself as “the United States government’s principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.

The HHS is charged by the US government to serve and protect us, the estimated one million patients in the US suffering from the debilitating and complex disease known as ME/CFS.

Yet the recent action by HHS has been one of deceit.

We deserve and should expect fair representation, transparency and accountability but this is very far from what we have seen exhibited by the HHS in its most recent shenanigans.

The HHS has failed to act in good faith and we need now to take affirmative action in response to its potentially dangerous decision to appoint the Institute of Medicine (IOM) to independently develop recommendations for a new clinical case definition.

We are the victims of a ‘bait and switch’

The bait

In October 2012, the CFS Advisory Committe (CFSAC) advanced the reasonable recommendation that HHS convene a workshop of ME/CFS expert clinicians, researchers and advocates to act in consultation with CFSAC members, and work on a case definition taking the 2003 Canadian Consensus Criteria as a starting point.  

 Nancy Lee, Designated Federal Officer, stated at this meeting:

“In general, the Federal Government isn’t in the position of telling doctors a case definition. I think a recommendation from CFSAC that the Secretary should tell people to use “X” definition will go nowhere because that’s not what we do. This is a clinical decision that has to come from the clinical community…

I’ve been in two or three meetings with the Secretary since I’ve been here. One of them was around this: the idea of a case definition, the need for one, and in addition, the need for a different name for the disease. She basically said that this has to be coming from the medical community.”

The switch

HHS refused to adhere to the recommendation from CFSAC, as was heatedly debated at the May, 2013 meeting. Then, on August 27, without any consultation from ME/CFS stakeholders or CFSAC members, HHS announced a sole solicitation to the Institute of Medicine (IOM) for a Study on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.”

You might ask: “What’s wrong with that? They are working on a case definition, which is what we asked for, isn’t it?” And that is where the “switch” comes in to play.

Instead of complying with the reasonable recommendation from CFSAC, HHS took the “bait” that we thought was reasonable — the proposal to work on a better case definition — and then switched it all around in order to fit their own agenda.

Gone are the expert clinicians, researchers and patient advocates.

Gone is the consultation.

The Department of Health and Human Services in their wisdom have chosen to use non-experts to redefine our disease.

Case history: IOM redefines Gulf War Illness

Gulf War Illness - Report IOMThere has been much concern relating to the stories surrounding the involvement of the Institute Of Medicine in relation to Gulf War Illness (GWI). In January the IOM issued a report, “Gulf War and Health: Treatment for Chronic Multisymptom Illness” which served to redefine the disease. 

This new creation, Chronic Multisymptom Illness, muddied the patient cohort and in the words of Anthony Hardie, Gulf War veteran, GWI patient and member of the VA Gulf War Research Steering Committee, it “defined [the disease] so broadly as to include nearly any human.”

The panel at IOM that worked on this redefinition of GWI had only one member with any experience of the condition and a few members were psychologists. One USA Today article back in June quoted Hardie as asking why the Institute of Medicine panel should include experts in psychosomatic illness. He rightly asked:

“Why are there people on a panel that has nothing to do with their expertise? To me as a veteran, that’s insulting.”

The act of subterfuge

The action taken by HHS to solicit the IOM came as a complete surprise to all ME/CFS stakeholders.  There was no mention that any of this was in the works at the last CFSAC meeting in May of this year. This sudden decision brought a great outcry from advocates, patients, CFSAC members and expert clinicians.

I have consulted with several CFSAC members who expressed no previous knowledge of this action by HHS. Dr Susan Levine, together with other CFSAC members and Dr Nancy Klimas, wrote to HHS entreating them to:

“…only enlist the expert members of our committee and/or other clinicians and researchers well known in the CFS/ME community to provide recommendations towards establishing an ever evolving case definition for this condition.  

For now, however, the CCC [Canadian Consensus Criteria] provides an accurate foundation for the state of the art CFS/ME research as it stands at this moment.  

All of us who currently serve on CFSAC are committed members of the CFS/ME clinician and research community and have spent, in many cases, most of our professional lives treating patients or performing in depth research as to the cause(s) and pathophysiology of this disorder.”

And then, much to the ME/CFS community’s delight, on September 4, HHS announced that due to the groundswell of dissatisfaction, it had cancelled its original decision, stating that:

“Because of all of the concern from the public surrounding this potential sole source requisition, we have decided to discontinue this request.”

But then we were left:

Gobsmacked!

Despite this previous outcry from advocates and patients, and letters from CFSAC members as well as clinicians, and its own declaration not to make the request to the Institute of Medicine, HHS announced on September 12, via email on the CFSAC listserv, that it would indeed continue with plans to contract with IOM to develop clinical criteria for ME/CFS:

“We continue to work on a contract with the Institute of Medicine (IOM) to develop recommendations for clinical diagnostic criteria.

When the contract is finalized, we will provide additional information via the CFSAC listserv and website. 

This topic will be included as an agenda item for the November webinar.”

Reliable sources have told us that, despite what HHS had originally stated, it really is pushing through with its agenda and will finalize and sign a contract with the Institute of Medicine (IOM) ahead of the next scheduled CFSAC meeting, and by September 30.

Patience exhausted…

Mary Schweitzer in her blog Slightly Alive, on 16 September, was clear on who should be constituting any advisory committee:

“Our position remains that it is currently active ME and CFIDS specialists and clinicians who should be drawing up that new definition. Like the ones on CFSAC. Not, well, strangers.

They should put together a committee with John Chia (USC), Jose Montoya (Stanford), Dan Peterson (Simarron Institute), Lucinda Bateman (University of Utah), Alan and Kathleen Light (University of Utah), Nancy Klimas (Nova University), Paul Cheney, Maureen Hanson (Cornell), Gordon Broderick (University of Alberta), Charles Lapp (Duke), Anthony Komaroff (Harvard), Ben Natelson (New Jersey College of Medicine), Susan Levine, Ian Lipkin (Columbia), Derek Enlander (Mount Sinai, NYC) – and Chris Snell or Staci Stevens.  

As a start. Not hired strangers.”

But as Jennie Spotila states so well in a recent blog post, Insult, Meet Injury:

“Join me in mourning the death of my faith in the process.

We have learned that HHS is not only continuing to pursue this contract, but that they have every intention of signing it by the end of the fiscal year on September 30th.

This is not fear mongering or over reaction. We have confirmation that this is true. Furthermore, HHS’s stated intention is to share information with the community only after the contract has been signed.”

Mary Dimmock in her article for ProHealth, 17 September, was adamant:

“The IOM contract is not only a waste of precious time and money. It is a threat to our very lives!

HHS needs to adopt a definition our experts have already created and use that definition to re-educate the medical community.

It needs to drive an aggressive and fully funded research campaign to validate biomarkers, understand the pathophysiology of the disease and identify treatment approaches.”

Immediate actions you can take to try and stop the latest IOM contract:

  • Send an email (from any country) to Secretary Sebelius every day to voice your opposition to this contract,

and,

  • If you are a US Citizen, please contact your representative in Congress.

Instructions on how to do both are below.

Finally,

  • Distribute this action alert to your networks and your family and friends, and urge them to join in.

We can and must stop HHS from redefining our disease!

If you have questions, then please contact MEACTNOW@yahoo.com. 


Instructions for Emailing HHS

A template email is provided below.  The heads of all HHS agencies are copied in, as is MEACTNOW@yahoo.com so that the number of messages sent can be tracked.

  • If you are using the sample email provided below, simply copy it into the body of your email message.
  • If you wish to personalize it, then add a sentence or two at the beginning of the letter.
  • Add your name, city and state (or country if you do not reside in the US) to the end of the letter.
  • Feel free to change the subject line from time to time to avoid spam filters.
  • Another tip: If you have more than one email account, use one on one day and the other on another.

TO: Kathleen.Sebelius@hhs.gov 

CC: howard.koh@hhs.gov,  txf2@cdc.gov,  Tomfrieden@cdc.gov,  Marilyn.Tavenner@cms.hhs.gov,  

margaret.hamburg@fda.hhs.gov, Mary.Wakefield@hrsa.hhs.gov,  collinsf@mail.nih.gov, 

richard.kronick@hhs.gov, MEACTNOW@yahoo.com

Subject: Stop the IOM Contract to Redefine ME

Dear Secretary Sebelius,

I strongly urge HHS to abandon its plan to employ the Institute of Medicine (IOM) to define its own clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). 

Researchers and clinicians with years of experience in studying and treating this disease have already created peer-reviewed case definitions – the 2003 Canadian Consensus Criteria (CCC) and the 2011 ME International Consensus Criteria (ME-ICC), which used the CCC as its baseline. These definitions are supported by clinical guidelines for medical practitioners, guidelines also created by experts. These definitions are well regarded by patients, ME/CFS doctors, and ME/CFS researchers. The CCC has been successfully used both clinically and in research for years. 

But rather than adopt these expertly defined disease criteria and their associated medical guidelines, HHS has promoted its own overly broad and inaccurate view of ME/CFS. HHS has questioned the hallmark symptoms of ME/CFS (e.g. Post-Exertional Malaise) and misrepresented the disease in its medical education literature. HHS has even unilaterally reclassified ME/CFS to be a subtype of chronic fatigue, in complete opposition to the standards set by the World Health Organization and all other countries that classify this illness as a neurological disease. 

Now, HHS is intent on creating new criteria for ME/CFS using the IOM, an organization whose single effort to define a disease has been harshly criticized for redefining the disease too broadly and for using non-experts to define the disease. Repeating the error made in defining Gulf War Illness, HHS has stated its intent to use non-experts to define ME/CFS. This is a very serious concern for patients who face widespread disregard from the general medical and research community. Adding to these concerns, the description of ME/CFS in the January 2013 IOM report failed to accurately represent the illness, listing CBT and GET as treatments, treatments that experts have said can be harmful to ME/CFS patients.

HHS is going ahead with the IOM contract unilaterally, ignoring overwhelming opposition from the ME/CFS community. HHS is undermining the work of our experts while patients are suffering and dying. HHS must stop wasting precious time and dollars. HHS must stop wasting our precious lives.

I strongly urge HHS to abandon its plans to employ the IOM to define clinical diagnostic criteria for ME/CFS. It is time for HHS to adopt the Canadian or International Consensus Criteria and use that definition to drive an aggressive campaign of fully funded research and to reeducate the medical community.

Sincerely, 

(Your name)

(Your city and state – or country)


US Citizens: How to contact Congress

Advocate Liz Willow has provided precise instructions and a message template for US citizens to contact their representative in Congress here.

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100 comments

{ 100 comments… read them below or add one }

readyforlife September 19, 2013 at 8:56 am

My new morning routine, coffee and emailing out this letter. Once again thank you for writing a letter that I can copy and paste.

Readyforlife

Keela Too September 19, 2013 at 9:24 am

Done and will repeat ;)

Ema September 19, 2013 at 9:52 am

I sent it too.

Sasha September 19, 2013 at 10:40 am

Great article, Gabby!

Jennie Spotila has produced a template email for our friends to send HHS:

http://www.occupycfs.com/2013/09/19/to-the-healthies/

Clever idea!

Sasha September 19, 2013 at 10:42 am

Just sent today's email (remember it's a daily email, folks!).

Sparrowhawk September 19, 2013 at 10:58 am

Sent again.

snowathlete September 19, 2013 at 11:08 am

Thanks Gabby, very readable and clear about what's happened. So important to show these kinds of actions are not ok – could set us back years again if we don't take this threat seriously!

Ember September 19, 2013 at 12:55 pm

Thanks, Gabby. I notice that the second time you use the IOM name for Gulf War Illness, you call it Chronic Multisystem Illness. It's hard to believe that they've called it Chronic Multisymptom Illness!

Denise September 19, 2013 at 1:40 pm
Ember

Thanks, Gabby. I notice that the second time you use the IOM name for Gulf War Illness, you call it Chronic Multisystem Illness. It's hard to believe that they've called it Chronic Multisymptom Illness!

In the January 2013 IOM report, they recharacterized GWI as Chronic Multisymptom Illness. (insert eye roll here)

Others know ME(cfs) history, I hope you will provide additional info, but I seem to remember hearing that some years ago Reeves (?) referred to ME(cfs) as Chronic Multisymptom Illness.

Denise September 19, 2013 at 1:41 pm

Very nice work Gabby! Thanks very much!

taniaaust1 September 19, 2013 at 5:20 pm

Ive only managed to read half the article but all I can say (appologise to those on the committee for this as I know you have good intent but its truely what is currently going throu my brain) is How on earth can the CFSAC be so stupid to have set up a situation to even allow this to occur!! I predicted this would happen and expressed my views against this previously before this latest thing has occurred as it was the VERY THING I'd feared would happen.

"In October 2012, the CFS Advisory Committe (CFSAC) advanced the reasonable recommendation that HHS convene a workshop of ME/CFS expert clinicians, researchers and advocates to act in consultation with CFSAC members, and work on a case definition taking the 2003 Canadian Consensus Criteria as a starting point. "

Why do that in the first place, it just allowed one heck of a scary door to be opened (which was completely foreseeable to many of us) which may not just affect America but as many of us know it, whatever is done there also ends up affecting us others in the rest of the world.

Why ask for this when there are ALREADY some good consensus definitions out there to use which have been put out by experts in this illness eg push for the CCC one or to use the International ME one. Why keep reinventing the wheel over and over, all that does is make the whole ME/CFS thing more and more confusing as more and more definitions are added out there.

The WHOLE world needs to go to using one good definition, what on earth is wrong with the two current reasonable ones out there and does America truely have to try to invent another new one!! Each country shouldnt have their own definition of it anyway, its not far of us as patients and screws up all the studies. There has to be consensus international agreement of medical experts and we already do have that.

I hope to come back when Im more up to it and be able to read this whole articl.

Snow Leopard September 20, 2013 at 1:18 am

Perhaps this will be a catalyst for those who really care (such as the physicians in that list) to come up with an entirely new definition and name? So that we can finally leave this whole ME/CFS nonsense behind?

Firestormm September 20, 2013 at 2:02 am
Snow Leopard

Perhaps this will be a catalyst for those who really care (such as the physicians in that list) to come up with an entirely new definition and name? So that we can finally leave this whole ME/CFS nonsense behind?

Oh I think we may well be hearing from some (all) of them in due course. And we have not yet heard from e.g. CAA I don't believe.

I am left wondering (having only really digested all of this debacle by 'helping' publish the article above), if anyone has contacted the IOM? By 'anyone' I mean our advocates.

I mean is it wholly outside of the realms of possibility, that the IOM will not gather about itself our expert clinicians, and patient representatives and initiate a period of consultation?

Do we know, yet, what the aims of the contract – the purpose of the presumed 'new' diagnostic criteria – might be i.e. how it was all defined by HHS? The answer could well be in one of Gabby's links, and I probably didn't read it well enough of course.

I must confess that I do seem to recall some mention of who might be on such a consultation panel should it come into existence – which I feel it surely must: but I can't remember now where I saw the conversation! Though I might be confused with the panel for GWI.

Sasha September 20, 2013 at 2:23 am
Firestormm

I mean is it wholly outside of the realms of possibility, that the IOM will not gather about itself our expert clinicians, and patient representatives and initiate a period of consultation?

The canary in the mine on this has been GWI. Of the 16 panel members chosen by the IOM to draw up new diagnostic criteria for GWI, Anthony Hardie (a prominent GWI activist) identifies only Dr Suzanne Vernon as an expert in GWI without a bias towards psychological explanations for the illness; the other members have either no experience with GWI at all or have previously expressed their preference for psychological explanations.

Here's his (very impressive) testimony, including criticism of the IOM project at 5:00 minutes.

He writes: ‘The most striking characteristic of the group selected to be on this committee is how few qualify as experts in the disease. Case definitions are typically developed by committees of experts in the disease in question, using detailed data sources to ascertain objectively which elements best characterize the disease. The VA Gulf War Strategic Research Plan just released called for a case definition to be developed in this well-accepted fashion: “The case definition should be developed by a consensus panel of experts in the field, using analytical results from a comprehensive evaluation of available data resources.”’

That's the issue. This isn't the kind of approach – a panel mostly non-expert in ME but biased towards the psychosocial model in charge of redefining ME – that I think any of us want to see. It's a recipe for disaster and if the HHS want to give this contract to the IOM they need to be explaining right now their safeguards against making the same mistake twice. But unless they stop that GWI committee dead in its tracks and admit that mistake, that's not going to happen. They appear to be locked into a very destructive course of action.

I must confess that I do seem to recall some mention of who might be on such a consultation panel should it come into existence – which I feel it surely must: but I can't remember now where I saw the conversation! Though I might be confused with the panel for GWI.

I've seen no such mention. The IOM hasn't even been appointed so there'll have been no such preliminary list of committee members.

Snow Leopard September 20, 2013 at 2:38 am

Firestormm

It took me a little while to realise the problem too, but the lack of consultation and transparency indicates the complete unwillingness to empower the ME and CFS community and this precisely is the problem.

beaker September 20, 2013 at 3:05 am

I also CC'd "Presiden Barack Obama"<president@whitehouse.gov>

I am tired of the forms at my Senator and Congressperson's pages. I want to email directly. Even the White house wants you to use the form.
I want to cc them. I did some hunting around and found this.
If you have different information, re the email I found, please advise.
Thank you !

beaker September 20, 2013 at 3:11 am
beaker

I also CC'd "Presiden Barack Obama"<president@whitehouse.gov>

I am tired of the forms at my Senator and Congressperson's pages. I want to email directly. Even the White house wants you to use the form.
I want to cc them. I did some hunting around and found this.
If you have different information, re the email I found, please advise.
Thank you !

I got a reply back from the white house asking me to use the dang form. ahhhhhhhhhhhhhhhhhhhhhhhhhhhhhh.
What a pain.
More energy. That will have to wait.

Does anyone remember the name of the special liaison for ME/CFS to the President ?
I think that would be an excellent person to include.

medfeb September 20, 2013 at 4:31 am

It took me a little while to realise the problem too, but the lack of consultation and transparency indicates the complete unwillingness to empower the ME and CFS community and this precisely is the problem.

Snow Leopard – you are absolutely correct! HHS is unwilling to even engage, never mind empower the ME community. They are showing complete disregard both patients and experts. THe real question is why are they insisting on doing this when experts have already created consensus criteria, one of which has been in use clinically and in research for years.

Regarding the composition of the IOM panel…
In addition to what has happened with the GWI panel, we also have the repeated statements by HHS that non-experts need to be involved in defining the disease.

But the concerns are broader than just the use of non-experts as panel members.

In January, the IOM report on treatment of Gulf War Illness recharacterized GWI to be chronic multisymptom Illness (CMI), defined “as the presence of a spectrum of chronic symptoms in at least two of six categories—fatigue, mood and cognition, musculoskeletal, gastrointestinal, respiratory, and neurologic—experienced for at least six months.” Hardie said that they defined the disease so broadly as to include nearly any human healh condition.

The current IOM initiative to create a definition is charged to “develop a consensus case definition for chronic multisymptom illness (CMI) as it pertains to the 1990-91 Gulf War Veteran population.”As it pertains' indicating that CMI could be found in other populations? I understand the original IOM report says that CMI is also in the civilian population.

As a clinical entity, CMI is even more nonsensical than Fukuda. But unfortunately, its a clinical entity that ME would fit in. Given Unger's public questioning of PEM as a hallmark criteria at the last CFSAC, its unlikely that this process would result in a more narrowly defined criteria and is unlikely to endorse one of the criteria that our experts have created.

medfeb September 20, 2013 at 4:39 am

Does anyone remember the name of the special liaison for ME/CFS to the President ?
I think that would be an excellent person to include.

Beaker
It was Nancy DeParle but she is gone.

I hear you on the forms. They do take more energy and are a pain. But the advantage is that the forms can make sure the comments get to the specific staffer who deals with health care issues since we dont know all of their email addresses. I spoke to a staffer last week in one of the senator's offices and she said that the use of the form makes it easier for her to see the issues that people are raising and puts her in a better position to help us.

beaker September 20, 2013 at 4:53 am
medfeb

Does anyone remember the name of the special liaison for ME/CFS to the President ?
I think that would be an excellent person to include.

Beaker
It was Nancy DeParle but she is gone.

I hear you on the forms. They do take more energy and are a pain. But the advantage is that the forms can make sure the comments get to the specific staffer who deals with health care issues since we dont know all of their email addresses. I spoke to a staffer last week in one of the senator's offices and she said that the use of the form makes it easier for her to see the issues that people are raising and puts her in a better position to help us.

Didn't anyone take DeParle's place ? If not, shouldn't we ask for someone to do so ?
Crud. Advocacy on top of advocacy.

Snow Leopard September 20, 2013 at 4:58 am
beaker September 20, 2013 at 5:02 am

I shudder to think of how much they are spending on this project. I would much have them just use the CCC or ICC and put the money toward research. Bureaucrats.

Sasha September 20, 2013 at 8:51 am

Just sent today's email – remember it's a daily action, folks!

New post from Jennie on this:

http://www.occupycfs.com/2013/09/20/pedal-to-the-metal/

Bob September 20, 2013 at 9:41 am
Snow Leopard

http://www.publichealth.va.gov/exposures/gulfwar/medically-unexplained-illness.asp

Re the Dept of Veteran Affairs website (see the above link), it states:

A prominent condition affecting Gulf War Veterans is a cluster of medically unexplained chronic symptoms that can include fatigue, headaches, joint pain, indigestion, insomnia, dizziness, respiratory disorders, and memory problems.

VA refers to these illnesses as "chronic multisymptom illness" and "undiagnosed illnesses." We prefer not to use the term “Gulf War Syndrome” when referring to medically unexplained symptoms reported by Gulf War Veterans. Why? Because symptoms vary widely.

In the last paragraph, if we replace 'Gulf War Syndrome' with 'CFS/ME', then perhaps that indicates what we could expect from a similar consultation for CFS/ME. For example:

We refer to these illnesses as "chronic multisymptom illness" and "undiagnosed illnesses." We prefer not to use the term “CFS/ME” when referring to medically unexplained symptoms reported by patients. Why? Because symptoms vary widely.

A panel of non-experts will consider the vast amount of psychological research literature, and may well conclude that there is no agreement about the nature of CFS/ME; that there is a wide range of symptoms; and 'functional' (i.e. cognitive-behavioural) issues may play a role in perpetuating the illness for at least a subset of patients.

readyforlife September 20, 2013 at 9:46 am

Just sent my emails out. This illness is just mind blowing, the last few days I sent out these emails with out any problems. Today it took me forever, my brain couldn't focus and my fingers were useless.

energyoverload September 20, 2013 at 10:10 am

I've just sent the email out too. Will do everyday! :-)

Firestormm September 20, 2013 at 10:49 am

Shame you can't automate the sending really….

medfeb September 20, 2013 at 11:02 am

Snow Leopard

http://www.publichealth.va.gov/exposures/gulfwar/medically-unexplained-illness.asp

Hmmm indeed. The focus on grouping everything together as medically unexplained illness is too reminiscent of the approach HHS is taking. In a response to the May 2013 advocate request to adopt the CCC, Dr. Unger stated

"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."

A panel of non-experts will consider the vast amount of psychological research, and may well conclude that there is no agreement about the nature of CFS/ME; that there is a wide range of symptoms; and 'functional' (i.e. cognitive-behavioural) issues may play a role in perpetuating the illness for at least a subset of patients.

Agree – especially if they focus on a literature review as in the CMI definition initiative.

Keep writing those letters. And if you are U.S. residents, please consider sending an email to your senators and congressional representative. Simple directions and a sample letter can be found here on Liz WIllow's blog and also here

Roy S September 20, 2013 at 2:01 pm

Does the Wessely School conduct formal classes in how to do this sort of thing?

Firestormm September 20, 2013 at 2:23 pm

What was the DSM ruling on this sort of thing out of interest i.e. MUS? Might that be the reason behind this 'push'?

Esther12 September 20, 2013 at 5:55 pm
medfeb

Snow Leopard

Hmmm indeed. The focus on grouping everything together as medically unexplained illness is too reminiscent of the approach HHS is taking. In a response to the May 2013 advocate request to adopt the CCC, Dr. Unger stated

"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."

Doesn't look great.

taniaaust1 September 20, 2013 at 9:16 pm

"the Dept of Veteran Affairs website (see the above link), it states:

A prominent condition affecting Gulf War Veterans is a cluster of medically unexplained chronic symptoms that can include fatigue, headaches, joint pain, indigestion, insomnia, dizziness, respiratory disorders, and memory problems.

VA refers to these illnesses as "chronic multisymptom illness" and "undiagnosed illnesses." We prefer not to use the term “Gulf War Syndrome” when referring to medically unexplained symptoms reported by Gulf War Veterans. Why? Because symptoms vary widely."

That makes me wonder if they want to get the "Gulf War Syndrome" name out of the picture as it envokes too much public sympathy. So give it a crappy name and help to try to make the illness vanish some by also washing down the definition.

Wonder if they have lessons on "how to make an illness disappear" cause those doing these things seem to be experts at what they do and unfortunately the patient group still has to catch up with the sly tactics that is played with us by those high up.

Ember September 21, 2013 at 12:48 am
Denise

I hope you will provide additional info, but I seem to remember hearing that some years ago Reeves (?) referred to ME(cfs) as Chronic Multisymptom Illness.

This CDC definition for Chronic Multisymptom Illness, with significant CFS overlap, was developed in 1998 to classify cases of Gulf War Illness:

One or more chronic (more than 6 months) symptoms from two of the following categories:

  • Fatigue
  • Mood and cognition (depression, difficulty concentrating, moodiness, anxiety, word-finding
    difficulties, sleep disturbance)
  • Musculoskeletal (joint pain, joint stiffness, muscle pain)

The CDC further classified patients by severity of illness (mild-moderate or severe). Compared to military personnel who were not deployed to the Persian Gulf, veterans who served in the Gulf War were 8.6 times more likely to have "severe" illness and 2.8 times more likely to have "mild-moderate" illness. Most of those who met the definition for "severe" illness also met the case definition for chronic fatigue syndrome (CFS). Although women were a minority of the Gulf force, females were statistically more likely than males to have GWI.

Overlap with CFS
Rates of chronic multi-symptom illness and CFS are very similar in the general public and non-Gulf War military personnel. However in Gulf War veterans the rates are considerably higher, especially those for "severe" illness, which the CDC has found overlaps with CFS. CDC has called the Persian Gulf War the first documented cluster outbreak of chronic fatigue syndrome.

medfeb September 21, 2013 at 3:52 am

Thanks for that link, Ember. Was this 1998 definition ever published in the literature?

Ember September 21, 2013 at 5:31 am
medfeb

Was this 1998 definition ever published in the literature?

"Chronic Multisymptom Illness Affecting Air Force Veterans of the Gulf War" by Fukuda et al.:

ABSTRACT

ABSTRACT | METHODS | RESULTS | COMMENT | REFERENCES

Context.— Gulf War (GW) veterans report nonspecific symptoms significantly more often than their nondeployed peers. However, no specific disorder has been identified, and the etiologic basis and clinical significance of their symptoms remain unclear.

Objectives.— To organize symptoms reported by US Air Force GW veterans into a case definition, to characterize clinical features, and to evaluate risk factors.

Design.— Cross-sectional population survey of individual characteristics and symptoms and clinical evaluation (including a structured interview, the Medical Outcomes Study Short Form 36, psychiatric screening, physical examination, clinical laboratory tests, and serologic assays for antibodies against viruses, rickettsia, parasites, and bacteria) conducted in 1995.

Participants and Setting.— The cross-sectional questionnaire survey included 3723 currently active volunteers, irrespective of health status or GW participation, from 4 air force populations.The cross-sectional clinical evaluation included 158 GW veterans from one unit, irrespective of health status.

Main Outcome Measures.— Symptom-based case definition; case prevalence rate for GW veterans and nondeployed personnel; clinical and laboratory findings among veterans who met the case definition.

Results.— We defined a case as having 1 or more chronic symptoms from at least 2 of 3 categories (fatigue, mood-cognition, and musculoskeletal). The prevalence of mild-to-moderate and severe cases was 39% and 6%, respectively, among 1155 GW veterans compared with 14% and 0.7% among 2520 nondeployed personnel. Illness was not associated with time or place of deployment or with duties during the war. Fifty-nine clinically evaluated GW veterans (37%) were noncases, 86 (54%) mild-to-moderate cases, and 13 (8%) severe cases. Although no physical examination, laboratory, or serologic findings identified cases, veterans who met the case definition had significantly diminished functioning and well-being.

Conclusions.— Among currently active members of 4 Air Force populations, a chronic multisymptom condition was significantly associated with deployment to the GW. The condition was not associated with specific GW exposures and also affected nondeployed personnel.

Denise September 21, 2013 at 7:51 am
Ember

"Chronic Multisymptom Illness Affecting Air Force Veterans of the Gulf War" by Fukuda et al.:

:)
Thank you Ember.

Sparrowhawk September 21, 2013 at 11:39 am

This part, "The condition was not associated with specific GW exposures and also affected nondeployed personnel." is troubling and intriguing. Did nondeployed personnel get the same immunizations? What other common factor could there be? I admit that until I read that sentence I had assumed it was all from exposure to depleted uranium dust, and only confined to deployed personnel.

readyforlife September 21, 2013 at 11:51 am

Just finished sending my Saturday emails out. Everyone needs to keep sending out emails.

Sasha September 21, 2013 at 12:26 pm

Just sent today's email.

Keep sending them in, folks!

alex3619 September 21, 2013 at 12:40 pm
Roy S

Does the Wessely School conduct formal classes in how to do this sort of thing?

[Satire] Yes, its right next door to Clown School.

Ember September 21, 2013 at 12:49 pm
Sparrowhawk

This part, "The condition was not associated with specific GW exposures and also affected nondeployed personnel." is troubling and intriguing. Did nondeployed personnel get the same immunizations? What other common factor could there be?

Professors Simon Wessely and Christopher Dandeker have suggested following the streetlight effect:

We conclude that it is difficult to see how further direct research on Gulf veterans will provide much more in the way of relevant information concerning what happened in 1991. Likewise, after 20 years we don’t expect to learn much more about the direct causes of ill health. Much relevant information wasn’t collected, and is not going to be found now. However, researching other populations may shed some light, and animal studies will continue to provide controlled data in a way that human studies cannot.

But does that mean that we should abandon research into Gulf veterans? Not at all. There is still a need to try and understand the causes of disability and disadvantage in Gulf veterans. We have suggested looking at Gulf War illness in a similar fashion to the way we think about illnesses such as CFS, irritable bowel syndrome and other unexplained syndromes, and to think more about why veterans are either staying ill or not getting better, putting to one side the vexed question of what started the problem in the first place (emphasis added).​

Tally September 21, 2013 at 12:58 pm
readyforlife

Just sent my emails out. This illness is just mind blowing, the last few days I sent out these emails with out any problems. Today it took me forever, my brain couldn't focus and my fingers were useless.

I was doing fine as well and today after I clicked send I realized I have completely forgotten to sign it. Damn you brain fog

Sparrowhawk September 21, 2013 at 2:02 pm
Tally

I was doing fine as well and today after I clicked send I realized I have completely forgotten to sign it. Damn you brain fog

I send a copy to myself, and then copy that the next day, resend, repeat.

Firestormm September 21, 2013 at 6:31 pm

22 September 2013
Note: Please be advised we have added clearer details on how to contact your Congressional representative to the above article with a link to the blog from Liz Willow.

Fire :cool:

Nielk September 21, 2013 at 6:39 pm
Ember

Thanks, Gabby. I notice that the second time you use the IOM name for Gulf War Illness, you call it Chronic Multisystem Illness. It's hard to believe that they've called it Chronic Multisymptom Illness!

Yes – the Institute of Medicine renamed Gulf War Illness, Chronic Multisystem Illness (CMI). Can you imagine what they would do to us?

Nielk September 21, 2013 at 6:58 pm
Snow Leopard

Firestormm

It took me a little while to realise the problem too, but the lack of consultation and transparency indicates the complete unwillingness to empower the ME and CFS community and this precisely is the problem.

This is exactly the problem. It makes you think why are they so evasive, deceitful and underhanded? Why, when they have chartered an advisory committee such as CFSAC, are they not consulting with them as to how they are working for our benefit?

Not only do they leave us patients, advocates, experts, clinicians in the dark but they go behind the backs of their own CFSAC members which they have chosen as advisers???

The window for action is getting shorter and shorter each day. I am really begging for each and everyone to get involved in this action. I would also urge you to get family and friends involved. If they have been asking you what they can do to help you, this would be a great start.

They are due to sign this agreement with IOM on September 30th. – only 9 days away!

Nielk September 21, 2013 at 7:04 pm

Thank you to everyone for taking part in this e-mail action.
We have added a new link to simplify contacting you US representatives:

US Citizens: How to contact Congress

Advocate Liz Willow has provided precise instructions and a message template for US citizens to contact their representative in Congress here.

medfeb September 21, 2013 at 7:10 pm

Thanks for the link to the study Ember,

medfeb September 21, 2013 at 7:16 pm

The window for action is getting shorter and shorter each day. I am really begging for each and everyone to get involved in this action. I would also urge you to get family and friends involved. If they have been asking you what they can do to help you, this would be a great start.

Please do contact your congressional leaders and HHS. Especially the congressional leaders since HHS has demonstrated that it is not listening to anyone.

Chris September 21, 2013 at 7:41 pm

Hi–as a Canadian I know that this will affect me and those in the same boat up here too, and have sent my own letter to the list to be copied to. I have a couple of questions–one about the need to keep sending daily–is it clear that these letters will never be read ,and that the only thing that counts is sheer gross number received?

And I wonder a bit too about the choice of the OIM; here in Canada, Health Canada sets the safety standard for RF and EMF emissions (much, much too high of course) and after 10 years has to review them. They gave the job to an institute called the Royal Society of Canada, of which I had never heard, with the claim that they had a "strong conflict of interest" policy. When investigated, it turned out that several of the committee members chosen by the RSC had actually appeared on the Health Canada website reassuring viewers that there was no danger, and no or virtually no research showing that there was. That of course is not true–and when quite a few of us kicked up a fuss, the man chosen to chair the committee (who was the most obviously conflicted) stepped down. But further investigation revealed that Health Canada in fact was intent on controlling the purportedly "independent" committee in every way, including providing the choice of research material to be looked at, holding the right to "approve" (and therefore disapprove) members chosen, etc.etc.
In other words, the RSC was just a public front for Health Canada reviewing its own standards, and it seems pretty clear that behind that is a desire to keep the cell phone and "smart" meter companies happy.

I just wonder if something like that is going on here…?
Chris

Nielk September 21, 2013 at 7:57 pm
Chris

Hi–as a Canadian I know that this will affect me and those in the same boat up here too, and have sent my own letter to the list to be copied to. I have a couple of questions–one about the need to keep sending daily–is it clear that these letters will never be read ,and that the only thing that counts is sheer gross number received?

And I wonder a bit too about the choice of the OIM; here in Canada, Health Canada sets the safety standard for RF and EMF emissions (much, much too high of course) and after 10 years has to review them. They gave the job to an institute called the Royal Society of Canada, of which I had never heard, with the claim that they had a "strong conflict of interest" policy. When investigated, it turned out that several of the committee members chosen by the RSC had actually appeared on the Health Canada website reassuring viewers that there was no danger, and no or virtually no research showing that there was. That of course is not true–and when quite a few of us kicked up a fuss, the man chosen to chair the committee (who was the most obviously conflicted) stepped down. But further investigation revealed that Health Canada in fact was intent on controlling the purportedly "independent" committee in every way, including providing the choice of research material to be looked at, holding the right to "approve" (and therefore disapprove) members chosen, etc.etc.
In other words, the RSC was just a public front for Health Canada reviewing its own standards, and it seems pretty clear that behind that is a desire to keep the cell phone and "smart" meter companies happy.

I just wonder if something like that is going on here…?
Chris

Hi Chris,

You are right to think that this action by HHS will probably affect all ME patients around the world.

I am just a patient and not an expert in politics. I have read about the history of the "politics" of this illness in the US and it seems that this is just an extension of more of the same. It seems to me that this action is aimed at keeping the formulation of this illness in the "control" of DHHS. They have made it clear from day one what their agenda is and they are forging ahead with speed.

Nielk September 21, 2013 at 7:57 pm
Sparrowhawk

I send a copy to myself, and then copy that the next day, resend, repeat.

Good idea Sparrowhawk -

Nielk September 21, 2013 at 8:01 pm
beaker

I shudder to think of how much they are spending on this project. I would much have them just use the CCC or ICC and put the money toward research. Bureaucrats.

Yes, very interesting that they mysteriously have the money to fund this, yet they don't have the funds for a regular "live' CFSAC meeting this November! They will have a truncated webinar.:confused:

Nielk September 21, 2013 at 8:07 pm
taniaaust1

"the Dept of Veteran Affairs website (see the above link), it states:

A prominent condition affecting Gulf War Veterans is a cluster of medically unexplained chronic symptoms that can include fatigue, headaches, joint pain, indigestion, insomnia, dizziness, respiratory disorders, and memory problems.

VA refers to these illnesses as "chronic multisymptom illness" and "undiagnosed illnesses." We prefer not to use the term “Gulf War Syndrome” when referring to medically unexplained symptoms reported by Gulf War Veterans. Why? Because symptoms vary widely."

That makes me wonder if they want to get the "Gulf War Syndrome" name out of the picture as it envokes too much public sympathy. So give it a crappy name and help to try to make the illness vanish some by also washing down the definition.

Wonder if they have lessons on "how to make an illness disappear" cause those doing these things seem to be experts at what they do and unfortunately the patient group still has to catch up with the sly tactics that is played with us by those high up.

Yes. Give it a crappy name….sounds familiar? Washing doewn the definition?…sounds familiar.

"those doing these things seem to be experts….the patient group still has to catch up."

You have to realize that this is not a fair game. They are the ones who have the power. They have the money. They set the rules. What do we have? A group of very ill patients.:ill::ill::ill:

Ember September 21, 2013 at 9:29 pm
Nielk

You have to realize that this is not a fair game. They are the ones who have the power. They have the money. They set the rules. What do we have? A group of very ill patients.:ill::ill::ill:

All these maneuvers were set in play two years ago in Ottawa when an international panel of experts had the dedication, the vision and the audacity to publish an ME definition free of any form of sponsorship. Their work is being deliberately ignored. With IACFS/ME and patient support, CFSAC chose an alternate route:

In October 2012, the CFS Advisory Committee (CFSAC) advanced the reasonable recommendation that HHS convene a workshop of ME/CFS expert clinicians, researchers and advocates to act in consultation with CFSAC members, and work on a case definition taking the 2003 Canadian Consensus Criteria as a starting point.

Cort recently posted, “Honestly, if Lenny Jason gives his OK to anything I would just go with that.”

Ember September 21, 2013 at 9:32 pm
Nielk

Yes – the Institute of Medicine renamed Gulf War Illness, Chronic Multisystem Illness (CMI). Can you imagine what they would do to us?

Make that Chronic Multisymptom Illness (CMI), Nielk. Even worse.:(

Tally September 21, 2013 at 10:17 pm
Sparrowhawk

I send a copy to myself, and then copy that the next day, resend, repeat.

That's a good idea. I was just intent on changing the subject of the e-mail and it seems that drained all the concentration I had :P

Valentijn September 22, 2013 at 11:31 am
alex3619

Roy S said:

Does the Wessely School conduct formal classes in how to do this sort of thing?​

[Satire] Yes, its right next door to Clown School.

I'm pretty sure both of those doors lead to the same place :D

alex3619 September 22, 2013 at 1:33 pm

If they go ahead, if they ignore the patient community and continue to bypass CFSAC, if this results in a definition which ignores the science, then we have every right to boycott this, to demand an investigation for deliberately producing a bogus outcome, and to insist that nobody uses this definition. Its a lose all round.

Sasha September 22, 2013 at 1:46 pm

Just sent today's email.

Hope everyone has sent theirs! :)

Ember September 22, 2013 at 2:18 pm
alex3619

If they go ahead, if they ignore the patient community and continue to bypass CFSAC, if this results in a definition which ignores the science, then we have every right to boycott this, to demand an investigation for deliberately producing a bogus outcome, and to insist that nobody uses this definition.

Just don't hold your breath. “Whatever happened to that investigation we requested after the last CFS Advisory Committee meeting?” — from Lips Are Sealed

Nielk September 22, 2013 at 2:36 pm
Ember

Just don't hold your breath. “Whatever happened to that investigation we requested after the last CFS Advisory Committee meeting?” — from Lips Are Sealed

Exactly! As Jennie Spotila states in her blog:

"The importance of this really can’t be overstated. Two members are on record saying that they have been intimidated for expressing their views. The public can have no confidence in any deliberations or recommendations made by a federal advisory committee where members are being intimidated by the Designated Federal Officer."

They seem to have no problems with ignoring us. These allegations are very serious. How can we even be assured that this is being looked at and in estivated when the repeated letters by advocates are ignored?

Parismountain September 22, 2013 at 2:48 pm

I'm utterly disheartened. I don't vote for the party Sebelius is a cohort of but it's ironic the party which normally would be accused of plotting our doom doesn't have its hands on this one.

I don't agree with the Affordable Care Act, heard a reminder the other day of how a central database of all our medical info is nothing to fear, it's secure. cough cough Bradley Manning and Edward Snowden type secure (and the security clearance vendor type secure, Aaron Alexis passed clearance). The cost of those 64gig flash drives is down to about $40.

Admittedly off topic a bit but sporting some old wounds from this board.

alex3619 September 22, 2013 at 2:59 pm
Ember

Just don't hold your breath. “Whatever happened to that investigation we requested after the last CFS Advisory Committee meeting?” — from Lips Are Sealed

What they do and what we do are two different things. We do not have to accept any definition they come up with, and they are on notice that we may lobby against it in perpetuity.

This is shaping up as something which would make a good sequel to Oslers Web.

Ember September 22, 2013 at 3:10 pm
alex3619

We do not have to accept any definition they come up with, and they are on notice that we may lobby against it in perpetuity.

That isn't a prospect that I relish. An ounce of prevention is worth a pound of cure.

alex3619 September 22, 2013 at 3:37 pm
Ember

That isn't a prospect that I relish. An ounce of prevention is worth a pound of cure.

Which misses my point in part. We need to let them know that, aside from protesting that they are doing this, it will not end if they ignore the patient community, and trust will be broken for yet another generation of patients.

Nielk September 22, 2013 at 3:50 pm
alex3619

Which misses my point in part. We need to let them know that, aside from protesting that they are doing this, it will not end if they ignore the patient community, and trust will be broken for yet another generation of patients.

The problem is, Lex that time for us is in the essence. They have dragged this around for 25 years and I'm sure it wouldn't. Other them to play with this for another 25. We, in the meantime are growing in numbers and getting g sicker.

Ember September 22, 2013 at 3:52 pm
alex3619

We need to let them know that, aside from protesting that they are doing this, it will not end if they ignore the patient community, and trust will be broken for yet another generation of patients.

Are you suggesting that patients should add something specific to their messages? These statements are already being sent:

“HHS is going ahead with the IOM contract unilaterally, ignoring overwhelming opposition from the ME/CFS community. HHS is undermining the work of our experts while patients are suffering and dying. HHS must stop wasting precious time and dollars. HHS must stop wasting our precious lives.”

“Mistakes are being made, and it will only get worse if non-experts are given power to pronounce judgment on ME/CFS.”

“The climate of mistrust and bad dealing that these actions have created will haunt us for years to come, and a case definition that does not reflect the disease will set back research and treatment efforts for decades. None of us can afford for your Department to get this wrong.”

alex3619 September 22, 2013 at 5:40 pm

I am saying that an occasional message that they are losing the trust of the community, and that we will not accept research that is not appropriately conducted, is not unwarranted. Its just some ideas for people to add to their emails.

The climate of mistrust and bad dealing that these actions have created will haunt us for years to come, and a case definition that does not reflect the disease will set back research and treatment efforts for decades.

This is good but I think we need to be more pointed.

For example, as I said in another thread, the terms of the contract are critical. Can they reject using CFS as a label? Can they use ME? Can they create separate labels for idiopathic chronic fatigue, ME etc.? If not then the contract is for a biased construct.

If the terms of research are to take limited data and create a purely CFS diagnostic criteria, using personnel who are not very knowledgeable about CFS or ME, then the outcome will probably be both biased and unfit for purpose. I think we need to be even more clear than we are about this: it could turn out to be a colossal waste of money producing something that will never be used, or if used will be to the detriment of the patient community, and not to the benefit of HHS.

I do understand there are time constraints, I am just saying that there are additional messages that could be sent. I hope to be drafting something myself later today. I don't want them to in any way think we are not addressing issues of potential waste or potential bias.

After this time period has expired, whether we succeed in stopping it or not, questions need to be asked. This is unacceptable behavior.

You get prechosen outcomes by stacking committees, and limiting terms of reference. You can do the same with contracts.

Bob September 22, 2013 at 6:39 pm

I think Alex has raised an important issue here…
I think we need to make it absolutely crystal clear that if they create another fudge, then patients will never accept it.
Let's make sure that they are under absolutely no illusion that we will ever accept something that is foisted upon us without our consent.

I think it's important that we pre-warn them what the consequences will be if they repeat history and create another diagnostic fudge, because they haven't involved patients and experts in the process

I wrote something along these lines in my own letter, but I think I could have been even more explicit in stating that we will absolutely reject a fudge…

I said:
"Just as past projects have failed to satisfy patients, nothing will be achieved by the current proposed approach except a fudged compromise that will not satisfy the patient community. Unless the patient community is able to lead the process, or at least are fully engaged, then the patient community will remain unsatisfied and unhappy, and time and resources will have been wasted. Please do not repeat past mistakes. The patient community must be fully engaged for this project to succeed."

Does anyone think it is worth us starting a petition stating that we will reject any process that has not fully involved the patient community in the process? Even just a few hundred signatures collected over a week could have the potential to make a small difference. (I think I'll leave this for my US friends to consider, as you're more in tune with how your system works.)

Nielk September 23, 2013 at 6:25 am
readyforlife

My new morning routine, coffee and emailing out this letter. Once again thank you for writing a letter that I can copy and paste.

Readyforlife

Have you had your coffee this morning yet?;)

readyforlife September 23, 2013 at 8:13 am
Nielk

Have you had your coffee this morning yet?;)

First cup down. Time to try and focus on emailing, ok maybe one more cup coffee. :)

Nielk September 23, 2013 at 8:28 am
readyforlife

First cup down. Time to try and focus on emailing, ok maybe one more cup coffee. :)

Enjoy!

Sasha September 23, 2013 at 12:30 pm

Just sent my email for today – hope you all have! :)

Bob September 23, 2013 at 3:05 pm

Here's the CAA's take on the IOM issues…
(They seem to be in line with our opinions.)

ME/CFS Clinical Case Definition Debate
http://www.research1st.com/2013/09/23/case-definition-debate/

Bob September 23, 2013 at 3:07 pm

And I've just received this CFSAC email…

IOM Study on Diagnostic Criteria for ME/CFS

We are pleased to announce that the Institute of Medicine (IOM) will begin conducting a study on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome this month. This study grew out of the 2012 CFSAC recommendation to the Secretary to convene a workshop to “reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS.” Because the use of and audience for case definitions for research and clinical care are very different, HHS decided that separate processes were needed to develop them. The NIH is convening an Evidence-based Methodology Workshop process that will consider case definitions appropriate for ME/CFS research and the IOM will address the clinical diagnostic portion of the recommendation.

The Office on Women’s Health/HHS is co-sponsoring the IOM study with several agencies that participate in CFSAC. A group of voting and non-voting members of the committee participated in the development of the Statement of Work.

The IOM has agreed to perform the following tasks over the next 18 months:
· Conduct a study to identify the evidence for various diagnostic clinical criteria of ME/CFS using a process with stakeholder input, including practicing clinicians and patients;
· Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians,using a consensus-building methodology;
· Recommend whether new terminology for ME/CFS should be adopted;
· Develop an outreach strategy to disseminate the definition nationwide to healthprofessionals.

To accomplish these tasks, the IOM has also agreed that:
· the IOM committee will include approximately 15 members with expertise in the following areas: epidemiology; clinical medicine/primary care and other health care fields, particularly with expertise in ME/CFS, including neurology, rheumatology, immunology, pain, infectious disease, behavioral health, cardiology, endocrinology; and scientists and physicians with experience in developing clinical case definitions. The IOM will ask interested parties, including expert clinicians, researchers and patient advocates, to make suggestions for nominees to the committee.
· the IOM, in addition to the committee meetings, will sponsor open meetings to enlist the comments and concerns of patients, family members and other caretakers, health educators, health care professionals, and advocacy groups. During these meetings, an open phone line and email address will be available to those who cannot attend in person.
· as the committee reviews the literature, efforts that have already been completed on this topic area will be considered, including the 2003 ME/CFS Canadian Consensus Definition, the 2007 NICE Clinical Guidelines for CFS/ME, the 2010 Revised Canadian ME/CFS definition, the 2011 ME International Consensus Criteria, and data from the ongoing CDC multi-site clinical study of CFS. In an effort to minimize overlap and maximize synergy, the committee will seek input from the NIH Evidence-based Methodology Workshop for ME/CFS.
· the committee will distinguish between disease subgroups, develop a plan for updating the new criteria, and make recommendations for its implementation. Any recommendations made by the committee will consider unique diagnostic issues facing people with ME/CFS, specifically related to: gender, across the lifespan, and specific subgroups with substantial disability.

HHS is proud to be making this investment in ME/CFS. We have heard the advocates’ concerns and trust that many have been addressed by the information provided in this email. It is our hope that a widely accepted clinical definition and a clear distinction from case definitions for clinical trials and research will aid in advancing clinical care, drug development, and basic translational research for ME/CFS.

Bob September 23, 2013 at 3:19 pm

"We have heard the advocates’ concerns and trust that many have been addressed by the information provided in this email."

There seems to be some encouraging info in the CFSAC email, but the devil will be in the exact details.

For example, this is encouraging:
"the committee will distinguish between disease subgroups"
and:
"The IOM will ask interested parties, including expert clinicians, researchers and patient advocates, to make suggestions for nominees to the committee."

Bits I don't like:
"the 2007 NICE Clinical Guidelines for CFS/ME"
"behavioral health"

Nielk September 23, 2013 at 3:23 pm

Thank you Bob. You are fast. I'm just reading the e-mail too. A lot to digest here.

Bob September 23, 2013 at 3:29 pm

A very good idea via Twitter:

"We will need landslide nominations for Lenny Jason and Elinor Stein for the behavioral specialists. :)"
https://twitter.com/janwly/status/382266466277408769

WillowJ September 23, 2013 at 3:30 pm

Does anybody know what an "NIH Evidence-based Methodology Workshop" is?

WillowJ September 23, 2013 at 3:32 pm
Bob

A very good idea via Twitter:

"We will need landslide nominations for Lenny Jason and Elinor Stein for the behavioral specialists. :)"
https://twitter.com/janwly/status/382266466277408769

Good; we should focus on getting people we like into those slots as opposed to grumping that they've included behavioural health.

Not sure what we can do about NICE.

Bob September 23, 2013 at 3:43 pm
WillowJ

Does anybody know what an "NIH Evidence-based Methodology Workshop" is?

This must be what Susan Maier outlined at the most recent CFSAC meeting.

Watch @12:27.

http://www.youtube.com/watch?v=cfGa7_kU1bg

WillowJ September 23, 2013 at 4:05 pm

thanks, Bob. Does that mean they will figure out psychobabble is rubbish? Of course, some of our other research is said to be not well designed, either. But hopefully they'll come up with something good? Is that too much to hope for?

Ember September 23, 2013 at 4:22 pm

So much for the input of Dr. Susan Levine who, together with other CFSAC members and Dr Nancy Klimas, wrote to HHS entreating them to "…only enlist the expert members of our committee and/or other clinicians and researchers well known in the CFS/ME community to provide recommendations towards establishing an ever evolving case definition for this condition.”

The IOM committee will include approximately 15 members with expertise in the following areas: epidemiology; clinical medicine/primary care and other health care fields, particularly with expertise in ME/CFS, including neurology, rheumatology, immunology, pain, infectious disease, behavioral health, cardiology, endocrinology; and scientists and physicians with experience in developing clinical case definitions. The IOM will ask interested parties, including expert clinicians, researchers and patient advocates, to make suggestions for nominees to the committee (emphasis added).

Anyone know any good dirges?:ninja:

Roy S September 23, 2013 at 5:46 pm
Ember

Anyone know any good dirges?:ninja:

Beethoven's Funeral Cantata on the Death of Emperor Joseph II. Beethoven rocks! (IMHO)

This brings to mind observing the beginnings in 1991 of what became the Fukuda definition. This is REALLY important. We need our best experts.

I appreciate everybody's efforts on this.

Roy S September 24, 2013 at 12:00 am
Ember September 24, 2013 at 12:19 am
Roy S

Wow
https://dl.dropboxusercontent.com/u/89158245/Case Definition Letter Sept 23 2013.pdf

Sorry, Roy. I was pasting this up, thinking that it deserved a new thread. I'm slow at that, so I didn't notice your posting it here.

Roy S September 24, 2013 at 12:37 am
Ember

Sorry, Roy. I was pasting this up, thinking that it deserved a new thread. I'm slow at that, I didn't notice your posting it here.

That's fine with me. I think it deserves it's own thread.

Roy S September 24, 2013 at 1:14 am

Here is the new thread:
http://forums.phoenixrising.me/inde…onorable-kathleen-sebelius.25447/#post-389815

Bob September 24, 2013 at 2:10 am

And here's a new Phoenix Rising article about the letter, by Mary Dimmock:
http://forums.phoenixrising.me/inde…determine-clinical-diagnostic-criteria.25448/

Ember September 30, 2013 at 10:09 pm

The Statement of Work

September 30th, 2013
by Jennie Spotila

I have obtained a copy of the Statement of Work (SOW) for the Institute of Medicine study on clinical diagnostic criteria for ME/CFS. I am making that document available to you in its entirety through this link. I am also offering my interpretation of some of the most significant provisions of that SOW in this post….

Pick apart this SOW. Let’s crowd source analysis and action.

Bob October 1, 2013 at 3:56 am

A extract from the 'Statement of Work' (SOW) document (my emphasis):

"For the purposes of this document ME/CFS shall be used to refer to Myalgic Encephalomyelitis (ME), Chronic Fatigue Syndrome (CFS), Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS), Neuroendocrine Immune Disorder, and other terminologies in use for this illness."

Let's be clear that 'chronic fatigue' (I assume they mean of unknown etiology) is not an illness but a symptom.
'Chronic fatigue' is the symptom diagnosed by the most inclusive diagnostic criteria, such as the Oxford criteria.
(The Oxford criteria only requires 'chronic fatigue', and no other symptoms, for a diagnosis of CFS.)
The Oxford Criteria is inclusive of patients who experience chronic fatigue with a psychiatric basis.
'Chronic fatigue' is the symptom that is widely treated with CBT and GET, which are designed to address fear, deconditioning, and behavioural issues.

The SOW does include a requirement to subgroups, but it doesn't give this requirement much emphasis:

"The Committee will also distinguish between disease subgroups, develop a plan for updating the new criteria, and make recommendations for its implementation."

If the new clinical criteria are to be inclusive of all patients, from ME patients to patients with chronic fatigue, then we'll be back to square one, with possibly an even worse set of criteria than Fukuda.

The FDA's recent 'The Voice of the Patient' report (well worth a read) places a great emphasis on post-exertional symptom exacerbation or post-exertional collapse (my specific description, not theirs). So to focus on chronic fatigue, instead of post-exertional collapse, shows a lack of joined up thinking in the government bodies.

Perhaps patients need to clearly state in all our correspondence to HHS:
"I do not suffer from 'chronic fatigue' and it does not define my illness."

Valentijn October 1, 2013 at 8:27 am
Bob

"For the purposes of this document ME/CFS shall be used to refer to Myalgic Encephalomyelitis (ME), Chronic Fatigue Syndrome (CFS), Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS), Neuroendocrine Immune Disorder, and other terminologies in use for this illness."

Let's be clear that 'chronic fatigue' (I assume they mean of unknown etiology) is not an illness but a symptom.

"Chronic Fatigue" is part of the name used by one of the US groups … it's "Chronic Fatigue and Immune Dysfunction Syndrome" (CFIDS). So it's not "chronic fatigue", and the document is repeating the proper name used by that group.

Ember October 9, 2013 at 11:57 am
700 signers. Let's reach 750​
Created by Patricia C. United States of America​
To be delivered to: Kathleen Sebelius, Secretary of Health and Human Services, United States of America​
Posted October 7, 2013​
We, the undersigned people suffering from Myalgic Encephalomyelitis, along with our families, carers and friends hereby ask Secretary Kathleen Sebelius to cancel the contract HHS signed with the Institute of Medicine (IOM) to develop “clinical diagnostic criteria” for ME/CFS. We further urge Secretary Sebelius to respect the consensus reached by a group of experts supporting the adoption of the Canadian Consensus Criteria (CCC) as the research and clinical case definition for ME/CFS.​
Why this is important
Millions of people worldwide suffer from Myalgic Encephalomyelitis (M.E.). For decades, sufferers have been left with no real biomedical research and no effective treatments. Now the HHS is attempting to prolong this time by contracting with the Institute of Medicine (IOM) to redefine the illness. This is unnecessary because experts in the illness, researchers and clinicians alike, have reached a consensus that the Canadian Consensus Criteria (CCC) should be used for both research and clinical purposes. They have sent an Open Letter to Secretary Sebelius expressing their support for the CCC. (See: http://www.mecfsforums.com/wiki/Open_Letter_to_Hon._Kathleen_Sebelius_9/23/2013 ). This HHS contract with IOM would simply be a waste of precious resources.​

Ember October 12, 2013 at 9:22 pm

SIGN THIS PETITION

1,300 signers. Let's reach 2,000

Ember October 14, 2013 at 9:38 pm

SIGN THIS PETITION

1,500 signers. Let's reach 2,000

Ember October 19, 2013 at 3:23 pm

SIGN THIS PETITION

1,750 signers. Let's reach 2,000

Ember November 1, 2013 at 9:52 pm

SIGN THIS PETITION

2,500 signers. Let's reach 3,000

Hermes November 13, 2013 at 2:19 pm

5 Reports by IOM mentioning ME/CFS and stating their position on ME/CFS from 2000 – 2013

I have only included a brief synopsis of each report and links to relevant pages from the report

Gulf War and Health (2013)
Reeves paper cited and contains several important flaws, including a prevalence figure of 2.54%. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . Page 22 states that ME/CFS is a somatoform disorder, which is a vague psychiatric illness. Page 97 mentions somatic symptoms. The “primary research” source not included. Primary research should have been included and should have contained findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. The psychiatric based NICE guidelines were included in the definition along with the outdated Fukuda definition which is vague and imprecise, but the Canadian Criteria (2003) and Nightingale Critera (2007) and International Consensus Criteria (2011) were ignored and excluded. Psychiatric treatments such as CBT, GET and psychiatric drugs were recommended for ME/CFS. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored.
http://books.nap.edu/openbook.php?record_id=13539&page=22
http://books.nap.edu/openbook.php?record_id=13539&page=97
http://books.nap.edu/openbook.php?record_id=13539&page=98
http://books.nap.edu/openbook.php?record_id=13539&page=99
http://books.nap.edu/openbook.php?record_id=13539&page=100
http://www.nap.edu/openbook.php?record_id=13539&page=120

Gulf War and Health (2010)
Wessely cited and Straus cited. Wessely’s 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.
http://www.nap.edu/openbook.php?record_id=12835&page=210
http://www.nap.edu/openbook.php?record_id=12835&page=211
http://www.nap.edu/openbook.php?record_id=12835&page=212
http://www.nap.edu/openbook.php?record_id=12835&page=213
http://www.nap.edu/openbook.php?record_id=12835&page=214

Gulf War and Health (2008)
Wessely cited and Straus cited. Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . Telephone and mail shots used as “primary research” source. The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.
http://www.nap.edu/openbook.php?record_id=11922&page=174
http://www.nap.edu/openbook.php?record_id=11922&page=175
http://www.nap.edu/openbook.php?record_id=11922&page=176
http://www.nap.edu/openbook.php?record_id=11922&page=177
http://www.nap.edu/openbook.php?record_id=11922&page=178

Gulf War and Health (2006)
Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.
http://www.nap.edu/openbook.php?record_id=11729&page=161
http://www.nap.edu/openbook.php?record_id=11729&page=1612
http://www.nap.edu/openbook.php?record_id=11729&page=163
http://www.nap.edu/openbook.php?record_id=11729&page=164
http://www.nap.edu/openbook.php?record_id=11729&page=165

Gulf War and Health: Volume 1. Depleted Uranium, Pyridostigmine Bromide, Sarin, and Vaccines (2000)
Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. ME/CFS assumed to be a somatoform disorder.
http://www.nap.edu/openbook.php?record_id=9953&page=343
Quotation from report http://www.nap.edu/openbook.php?record_id=9953&page=343
“ The recognition of a new disease is far from straightforward (Wegman et al., 1997). The simplest statement is that it is a process (Kety, 1974), often taking years. The purpose of the process is to demonstrate that patients are affected by a unique clinical entity distinct from all other established clinical diagnoses. The individual “steps” for gathering and interpreting evidence are not clear-cut. Evidence from biomedical research plays a prominent, but not necessarily exclusive, role in defining and classifying a new disease. Social factors, including culture and economics, influence the recognition, classification, and definition of a new disease (Rosenberg, 1988; Aronowitz, 1998; Wessely et al., 1998).”
This is contradicted by the way that ME/CFS and Fibromyalgia has been recognised and classified by some psychiatrists. Recognising and classifying a new disease is very straightforward for some psychiatrists, they just term it a psychiatric illness and in some cases give it a new definition and classification to suit their own purposes. They even create a competing definition of their own in order to take over an illness. And they conveniently ignore all the biological and biomedical evidence which prove its not a psychiatric illness. Several physical illnesses were wrongly classified as psychiatric in the past, but have since been proved to be physical and biological illnesses not psychiatric.
http://www.nap.edu/openbook.php?record_id=9953&page=350
http://www.nap.edu/openbook.php?record_id=9953&page=354
http://www.nap.edu/openbook.php?record_id=9953&page=355

Hermes November 13, 2013 at 2:23 pm

5 Reports by IOM mentioning ME/CFS and stating their position on ME/CFS from 2000 – 2013

I have only included a brief synopsis of each report and links to relevant pages from the report

Gulf War and Health (2013)

Reeves paper cited and contains several important flaws, including a prevalence figure of 2.54%. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . Page 22 states that ME/CFS is a somatoform disorder, which is a vague psychiatric illness. Page 97 mentions somatic symptoms. The “primary research” source not included. Primary research should have been included and should have contained findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. The psychiatric based NICE guidelines were included in the definition along with the outdated Fukuda definition which is vague and imprecise, but the Canadian Criteria (2003) and Nightingale Critera (2007) and International Consensus Criteria (2011) were ignored and excluded. Psychiatric treatments such as CBT, GET and psychiatric drugs were recommended for ME/CFS. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored.

http://books.nap.edu/openbook.php?record_id=13539&page=22

http://books.nap.edu/openbook.php?record_id=13539&page=97

http://books.nap.edu/openbook.php?record_id=13539&page=98

http://books.nap.edu/openbook.php?record_id=13539&page=99

http://books.nap.edu/openbook.php?record_id=13539&page=100

http://www.nap.edu/openbook.php?record_id=13539&page=120

Gulf War and Health (2010)

Wessely cited and Straus cited. Wessely’s 1998 paper contains several important errors.Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.

http://www.nap.edu/openbook.php?record_id=12835&page=210

http://www.nap.edu/openbook.php?record_id=12835&page=211

http://www.nap.edu/openbook.php?record_id=12835&page=212

http://www.nap.edu/openbook.php?record_id=12835&page=213

http://www.nap.edu/openbook.php?record_id=12835&page=214

Gulf War and Health (2008)

Wessely cited and Straus cited. Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . Telephone and mail shots used as “primary research” source. The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.

http://www.nap.edu/openbook.php?record_id=11922&page=174

http://www.nap.edu/openbook.php?record_id=11922&page=175

http://www.nap.edu/openbook.php?record_id=11922&page=176

http://www.nap.edu/openbook.php?record_id=11922&page=177

http://www.nap.edu/openbook.php?record_id=11922&page=178

Gulf War and Health (2006)

Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.

http://www.nap.edu/openbook.php?record_id=11729&page=161

http://www.nap.edu/openbook.php?record_id=11729&page=1612

http://www.nap.edu/openbook.php?record_id=11729&page=163

http://www.nap.edu/openbook.php?record_id=11729&page=164

http://www.nap.edu/openbook.php?record_id=11729&page=165

Gulf War and Health: Volume 1. Depleted Uranium, Pyridostigmine Bromide, Sarin, and Vaccines (2000)

Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. ME/CFS assumed to be a somatoform disorder.

http://www.nap.edu/openbook.php?record_id=9953&page=343

Quotation from report http://www.nap.edu/openbook.php?record_id=9953&page=343
“ The recognition of a new disease is far from straightforward (Wegman et al., 1997). The simplest statement is that it is a process (Kety, 1974), often taking years. The purpose of the process is to demonstrate that patients are affected by a unique clinical entity distinct from all other established clinical diagnoses. The individual “steps” for gathering and interpreting evidence are not clear-cut. Evidence from biomedical research plays a prominent, but not necessarily exclusive, role in defining and classifying a new disease. Social factors, including culture and economics, influence the recognition, classification, and definition of a new disease (Rosenberg, 1988; Aronowitz, 1998; Wessely et al., 1998).”

This is contradicted by the way that ME/CFS and Fibromyalgia has been recognised and classified by some psychiatrists. Recognising and classifying a new disease is very straightforward for some psychiatrists, they just term it a psychiatric illness and in some cases give it a new definition and classification to suit their own purposes. They even create a competing definition of their own in order to take over an illness. And they conveniently ignore all the biological and biomedical evidence which prove its not a psychiatric illness. Several physical illnesses were wrongly classified as psychiatric in the past, but have since been proved to be physical and biological illnesses not psychiatric.

http://www.nap.edu/openbook.php?record_id=9953&page=350

http://www.nap.edu/openbook.php?record_id=9953&page=354

http://www.nap.edu/openbook.php?record_id=9953&page=355

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