Patients to DHHS: Cancel the IOM Contract!

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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


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

There 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.


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 feel able to offer your time and talent, we could really use some more authors, proof-readers, fundraisers, technicians etc. and we'd love to expand our Board of Directors. So, if you think you can help then please contact Mark through the Forum.

And don't forget: you can always support our efforts at no cost to yourself as you shop online! To find out more, visit Phoenix Rising’s Donate page by clicking the button below.

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.

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Comments

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!
 
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!
 
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.
 
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.
 
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?
 
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.
 
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.
 
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 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.
 
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.

 
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.