• Welcome to Phoenix Rising!

    Created in 2008, Phoenix Rising is the largest and oldest forum dedicated to furthering the understanding of and finding treatments for complex chronic illnesses such as chronic fatigue syndrome (ME/CFS), fibromyalgia (FM), long COVID, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and allied diseases.

    To become a member, simply click the Register button at the top right.

Patients to DHHS: Cancel the IOM Contract!

View the Post on the Blog

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.

View the Post on the Blog
 
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?
 
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:
 
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.
 
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."
 
Last edited:
"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.
 
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.​
 
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