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.

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

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

 

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).​

 

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

 

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.

 

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

 

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?

 

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!

 

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.

 

Thanks for the link to the study Ember,

 

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.

 

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--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.

 

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

Good idea Sparrowhawk -

 

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.

 

"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.

 

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.

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.”

 

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.

 

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

 

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

 

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.