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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.

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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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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
 
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?
 
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.
 
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.
 
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.
 
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.”
 
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.
 
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.)
 
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.
 
"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"