Tuesday, September 3, 2013

URGENT: ACT NOW To Stop ME Redefinition!


The US Department of Health & Human Services  is about to contract with the Institute of Medicine (IOM) to "develop clinical diagnostic criteria for ME/CFS”.  This is extremely dangerous and must be stopped.

Why be concerned with this IOM initiative? The January 2013 IOM report on treatments for Gulf War Illness (GWI) redefined GWI as the non-specific chronic multisymptom illness (CMI) and recommended CBT, exercise and anti-depressants as treatments for severely ill and dying veterans with GWI. In addition, IOM is now conducting a study to “define a consensus case definition for chronic multisymptom illness (CMI) as it pertains to the 1990-91 Gulf War Veteran population.” This effort has come under fire by GWI advocates for failing to include sufficient expertise in Gulf War Illness on its panel.

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.

The sample letter to HHS and the background section below provides more information on the dangers of this initiative and on the IOM initiatives on GWI.

Immediate Actions You Can Take to Stop This Contract:

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.

Distribute this action alert to your advocacy networks and your family and friends, and urge them to send an email 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, anti-scientific 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.

Sample Email - To be copied into the body of an email message.

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.



This section is intended to let you know why this is important.  It is not intended to be included in the letter to DHHS.

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.”

Chronic multisymptom illness is even broader than Fukuda and we know how Fukuda has buried ME.

GWI Advocates also charge that the IOM study and report obscured the science. In testimony in front of the House Committee on Veterans Affairs, Hardie further stated:
“The [IOM treatments] panel was charged by VA to conduct a literature review rather than to consult with knowledgeable medical practitioners experienced in treating ill Gulf War veterans.  And nearly all of the first presenters focused on "stress-as-cause", psychological, and psychosomatic issues – all debunked years ago.”
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.

Since then, the VA has contracted with IOM to constitute another IOM panel to “develop a consensus case definition for chronic multisymptom illness (CMI) as it pertains to the 1990-91 Gulf War Veteran population.” GWI advocates have criticized the composition of the panel and its inadequate expertise in Gulf War Illness. Jim Binns, chairman of the federal research advisory committee for GWI stated “the panel includes members that “represent discredited points of view” as well as psychosomatic and mental illness experts.”

Its important to note that Dr. Kenneth Shine, the previous president of IOM, has stated that he does not remember another time when IOM has been involved in defining a disease.

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, money and risk to come up with a new clinical criteria for ME - and the associated medical education material that will be required - 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. We must oppose it.

Additional Resources:

HHS Announcement of the Solicitation for “Study for Diagnostic Criteria for CFS” https://www.fbo.gov/index?s=opportunity&mode=form&tab=core&id=7fafc35816ee932dc44d6c319937b366&_cview=1
Forbes. “Inside the effort to define Gulf War Illness” 6/28/2013 http://www.forbes.com/sites/rebeccaruiz/2013/06/28/inside-the-effort-to-define-gulf-war-illness/
USA Today. “Gulf War illness advocates skeptical of institute panel. 6/26/2013 http://www.usatoday.com/story/nation/2013/06/26/veterans-institute-of-medicine-gulf-war-illness/2458745
March 13, 2013 testimony by Anthony Hardie, Gulf War vet and member of the VA Gulf War Research Steering Committee, before the House Committee on Veterans Affairs, http://veterans.house.gov/witness-testimony/mr-anthony-hardie-0
Video - http://www.youtube.com/watch?v=OuNJbPMfrYo
IOM Initiative to define Gulf War Illness: “Development of a Case Definition for Chronic Multisymptom Illness” http://www8.nationalacademies.org/cp/projectview.aspx?key=49546
91outcomes.Com collection of documents related to the IOM panel to define a consensus criteria for chronic multisymptom illness. Published by Anthony Hardie. http://www.91outcomes.com/2013/06/uploads-iom-gulf-war-chronic.html?q=IOM


  1. I sent a letter of protest within hours of hearing about this proposal.

    If they have not already agreed that "ME" is based on Ramsays evidence and "CFS" consists of the Tahoe outbreak evidence, you can be certain that the new "ME/CFS" definition will be devoid of both.

    In effect, throwing the pieces off the board and starting the game all over again.

  2. It most certainly is a game and one that's aimed at throwing us all under a bus, IMHO. We are politically and financially "inconvenient".

  3. Please make sure to remove the semi colon between the .cc names and replace them with a comma. The semi colons do not work in my email software. Just wanted to let others know.

  4. Thanks for the heads-up, Tink. I edited the post and substituted commas for the semi-colons. Everyone should be able to do a simple cut and paste with the email addresses now.

  5. And just now this little notice from the CFSAC landed in my inbox:

    "This email is to inform you about HHS’ ongoing efforts to address the 2011 CFSAC recommendation “to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS.” In response, NIH will be convening an Evidence-based Methodology Workshop, which would address the issue of case definitions appropriate for ME/CFS research, and that HHS was actively pursuing options for a separate effort that would result in a case definition useful for clinicians. Because the use of and audience for case definitions for research and clinical care are very different, it is important to have separate processes to develop them.

    "HHS is actively pursuing a contract with the Institute of Medicine (IOM) to convene a consensus committee to develop recommendations for clinical diagnostic criteria for ME/CFS as recommended by CFSAC. The IOM is unique in the prestige and authority it possesses among U.S. clinicians, researchers and the public. The reports and recommendations released by the IOM are widely accepted and get extensive coverage in both professional and mainstream media. The IOM has a singular reputation as the gold standard for providing biomedical recommendations on difficult, complex and controversial questions in clinical medicine. As the most respected source for medical consensus, the IOM is in a position to bring together experts, the ME/CFS community, and other stakeholders to develop diagnostic criteria for ME/CFS, so that more clinicians can help patients receive the medical care they need and deserve.

    "Thanks for your support."

    What support? Who the heck is supporting this????

  6. Shifting the goalposts is a well known form of manipulation. Usually this is a con artist's trick, and is not an expected scientific behaviour, only a political one. When the goal posts are shifted by a person purporting to be honest and decent, a con is the most likely reason. Is this what is also going on here?

    1. DHHS' behavior most certainly has and continues to be manipulative. You hit the nail on the head, John.

      As of Wednesday afternoon, the contract solicitation notice was revised to state,

      'This request has been cancelled. However, HHS will continue to explore mechanisms to accomplish this work.”

      Needless to say, one can't help wonder what "mechanisms" are being explored and whether they will be conducted as secretively as this one was.