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ME/CFS on Verge of Being Defined Out of Existence

Posted Sep 03 2013 1:19pm
Picture On August 27, the Department of Health and Human Services (HHS) announced a proposal to award a contract to the Institute of Medicine  (IOM) on a sole source basis to recommend consensus “clinical diagnostic criteria for myalgic encephalomyelitis/ chronic fatigue syndrome.” Due to federal contracting rules, HHS has given other potential contractors until September 11, 2013 to inform HHS of their interest and capabilities before HHS moves forward with signing the contract with IOM.  It is likely that HHS will sign a contract with IOM immediately after the September 11 deadline.

We have good reason to be extremely concerned that this IOM initiative will produce a definition that is as bad or even worse than Fukuda. The VA contracted the IOM to study Gulf War Illness (GWI). In January of 2013, the IOM issued a report, “Gulf War and Health: Treatment for Chronic Multisymptom Illness”. This report recharacterized GWI as 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.” The creation of CMI muddied the patient cohort and in the words of Anthony Hardie, Gulf War vet, GWI patient and member of the VA Gulf War Research Steering Committee “defined [the disease] so broadly as to include nearly any human health condition.”

Not surprisingly, the IOM report recommended treatment guidelines that focused on anti-depressants, CBT and exercise. The IOM report even included a section on “CFS”, which included erroneous and outdated information and also listed CBT, exercise and anti-depressants as treatments.

Reading about the IOM initiative for GWI is like reading a prequel to the planned IOM initiative for “ME/CFS”. It is not a leap to surmise that if the proposed IOM project goes forward, ME will be completely obliterated and be replaced with CFS as a subtype of chronic multisymptom illness.

Why is HHS spending the time and money to come up with a new clinical criteria for ME when expertly developed consensus criteria and medical education already exist and are in use? Why is HHS using IOM, an organization whose single effort to define a disease has generated so much controversy with GWI advocates? What is the specific statement of work for this initiative? Will the panel be composed primarily of non-experts as was done with GWI? Why is HHS being so secretive? It appears that discussions with IOM regarding development of a case definition have been going on for months, yet HHS has not discussed the IOM initiative with ME clinicians and researchers, the members of CFSAC or the patient advocates.

This initiative is dangerous and will hurt ME patients.

HHS’s proposal to contract with the IOM to “develop clinical diagnostic criteria for ME/CFS” is extremely dangerous and must be stopped.

If the current IOM initiative to define Gulf War Illness is any indication, the “ME/CFS” IOM initiative will use non-ME experts to “define” our disease and will likely result in a definition that is even worse than Fukuda – a vague, non-science based case definition that will set ME science and treatment back for decades.

Immediate Actions You Can Take to Stop This Contract
1.     Send an email every day to HHS voicing your strong opposition to this initiative as soon as possible but no later than by 5pm on Monday, September 9th. The email should go to HHS Secretary Kathleen Sebelius, Assistant Secretary Howard Koh, and the heads of all the CFSAC ex officio agencies.  The email addresses are provided below along with detailed instructions and a sample email that you can use if you wish.

2.     Distribute this action alert to your advocacy networks and your family and friends, and urge them to send an email every day as well.

The above actions are initial steps to send a strong message to HHS that the ME advocacy community opposes this effort.  But we will not stop there - more actions are planned, including Congressional intervention.  Stay tuned for updates and additional actions you can take.  We can and must stop this destructive initiative!

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

Instructions for Emailing HHS:

1.     If you are using the sample email provided below, copy the sample email into the body of an email message.

2.     Add your name to the end of the letter.

3.     Add the Subject Line “Stop the IOM Contract on “ME/CFS” Clinical Criteria”

4.     Copy the following addresses into the ‘TO” and “CC” boxes

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

The CC includes the following individuals:

HHS Assistant Secretary Howard Koh

AHRQ Director Richard Kronick

CDC Director Thomas Frieden

CMS Administrator Marilyn Tavenner

FDA Director Margaret Hamburg

HRSA Director Mary K. Wakefield

NIH Director Francis Collins

The Social Security administration is not included because the agency head’s email is not available yet. The email address MEACTNOW@yahoo.com is used to track the numbers of messages sent.

 [email]

Dear Secretary Sebelius,

I am writing to voice my strong opposition to the HHS proposal to contract with the Institute of Medicine (IOM) to develop “clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome.” I am a member of the ME community and have witnessed firsthand the devastation of this disease. I am extremely concerned that this planned IOM initiative will gravely harm ME patients. Note that I am purposely using the term “ME” to distinguish the disease that has affected me from the overly broad “CFS”.

I oppose this proposal for the following reasons
·       Two peer-reviewed consensus case definitions, developed by experts in this disease, already exist – the 2003 Canadian Consensus Criteria (CCC) and the 2011 ME International Consensus Criteria (ME-ICC), which used the CCC as its baseline. The CCC has been used both clinically and in research. Both are accompanied by clinical guidelines for medical practitioners, and are well regarded by patients, ME doctors, and ME researchers. Given that expertly defined and accepted consensus clinical criteria already exist, the proposed IOM contract wastes scarce taxpayer dollars and is unnecessary.

·       HHS has inexplicably refused to accept the CCC or the ME-ICC and even questions the hallmark symptoms of ME. Instead, it has promoted an overly broad view of the disease called “CFS”, which does not require the hallmark symptoms. This has confounded ME with depression, deconditioning and non-specific chronic fatigue, has severely impeded research, and is the direct cause of the medical skepticism and inappropriate or harmful treatment recommendations to which patients are subjected.

·       IOM has only been involved in one other study to define a disease, the current effort for Gulf War Illness (GWI). Advocates and the Research Advisory Committee for GWI (RAC) have criticized the IOM report that redefined GWI as the overly broad chronic multisymptom illness (CMI). They further criticized the misguided focus on psychiatric issues and the failure to staff the IOM panel with GWI experts. Given this and IOM’s inaccurate characterization of CFS in the January 2013 IOM report on treatments for Gulf War Illness patients, we have no confidence that IOM is capable of producing a clinical consensus criteria that defines ME as described by CCC, ME-ICC and most importantly, the patients themselves.

·       Ironically, the claimed intent of the HHS-IOM initiative is to develop a consensus definition but this effort has been progressed in secret, apparently for many months and without consultation with key ME stakeholders. The timing of the announcement before a holiday weekend and the short response time indicate that HHS was not looking for input from the ME experts and ME community.

·       This IOM initiative does not reflect the October 2012 CFSAC recommendation on the development of a case definition for this disease and in fact is in direct contradiction to that recommendation.  CFSAC recommended that a clinical and research case definition be developed in unison, that the effort begin with the Canadian Consensus Criteria and, most importantly, that it be developed by disease experts only.

I strongly urge HHS to abandon its plan for this ill-advised, wasteful, and unscientific initiative.

Sincerely,



 [Your Name]

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