Monday, September 16, 2013


Totally disregarding the strong outpouring of patient opposition to HHS’ August 27 announcement to contract with the Institute of Medicine (IOM) to “develop clinical diagnostic criteria for ME/CFS”, HHS announced on September 12 that it intends to go forward with its contract with IOM! This is after telling the ME community it was withdrawing from this solicitation.  What a blatant lie!  And HHS has said that it will provide additional information only after the contract is completed -- which it expects will be September 30!


HHS is speaking loudly and clearly. The Department does not want to hear what we have to say about our disease. It has every intention of pursuing its plans to redefine ME, unilaterally and in secret. 

It’s time to change our tactics.  Rather than emailing HHS, let’s bring this to the attention of our Congressional delegations.   They  need to know about HHS’ outrageous actions . Let’s ask THEM to go to bat for us!  And while we’re at it, let’s send the same message to the President’s Council of Advisors on Science and Technology (PCAST).  And let's do this DAILY.


1. Copy the sample message provided below.
3. This will bring up contact forms for your Representative and your two Senators.
4. If you have to choose a subject area from a scroll-down menu, look for "federal agency" or "health".
5. Paste the sample message into the body of the contact form. If you wish to personalize it, add a sentence or two at the beginning of the text. 
6. Add your name to the end of the message.


1.Go to
2. Scroll down to “PCAST” on the menu and fill out the rest of the required information.
3. Copy and paste the sample message for the body of the content form.
4. Add your name to the end of the message.

SAMPLE MESSAGE  (to be copied into the contact form)

Dear _________,

HHS has stated it intends to sign a contract with IOM to redefine my disease by September 30!  Please tell the Department not to do this -- as soon as possible.

I have been personally touched by the devastating disease, Myalgic Encephalomyelitis (ME).  ME has been classified as a neurological disease by the World Health Organization (WHO) since 1969 (WHO ICD code 93.3).  However, in the US, the Department of Health and Human Services (HHS) promotes an excessively broad view of the disease and conflates it with “Chronic Fatigue Syndrome” (“CFS”).   “CFS” is a social construct created by a government committee in 1988 based on a cursory investigation of an outbreak of ME in Lake Tahoe, Nevada, by the Centers for Disease Control and Prevention (CDC).  According to the physicians and patients who were affected by this outbreak, patients were not examined and abnormal test results were ignored.  This has confounded ME with depression, deconditioning and nonspecific 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.

Now HHS is intent on redefining ME again using the Institute of Medicine (IOM), an organization whose former President, Dr. Kenneth Shine, has stated it is highly unusual for  the IOM to be asked to  define a disease.  The first time IOM was contracted to do this was earlier this year -- to define Gulf War Illness (GWI).  The GWI IOM study group includes people with well-known biases as well as members unfamiliar with the disease. (IOM's study procedures are aimed at including non-experts.) It is harshly criticized by GWI advocates as a previous IOM report referred to GWI as “Chronic Multi-Symptom Illness”, a symptom based syndrome defined so broadly that half the US population could be diagnosed with it.  

HHS has repeatedly stated its intent to similarly use non-experts to define ME. This is a very serious concern for patients who face widespread disbelief every day from the general medical and research community.   It is also inexplicable given that researchers and clinicians with years of experience in studying and treating this disease have already created two peer-reviewed case definitions, the 2011 ME International Consensus Criteria (ME-ICC)and the 2003 Canadian Consensus Criteria (CCC). Both are accompanied by clinical guidelines for medical practitioners, and are well regarded by patients, ME doctors, and ME researchers. 

In defiance of President Obama’s Open Government Initiative, HHS is pursuing the IOM contract unilaterally and with disregard for the overwhelming opposition to it from the ME community and advice from its own “Chronic Fatigue Syndrome” Advisory Committee (CFSAC). I have been emailing HHS daily ever since I found out about the IOM contract solicitation to ask the Department to stop it.  

I thought I was heard when, at one point, the contract solicitation was modified to read, “Because of all of the concern from the public surrounding this potential sole source requisition, we have decided to discontinue this request”, followed shortly thereafter by the statement, “This request has been cancelled. However, HHS will continue to explore mechanisms to accomplish this work.”  But on September 12, the ME community was informed (via a listserv) that HHS will “continue to work on a contract with the Institute of Medicine (IOM) to develop recommendations for clinical diagnostic criteria.  When the contract is completed, we will provide additional information via the CFSAC listserv and website.  This topic will be included as an agenda item for the November (CFSAC) webinar." Since then, HHS has informed the ME community it expects to finalize the IOM contract by September 30.

I beg you to intervene and stop HHS from pursuing the IOM contract to redefine my disease.  Ask HHS to use this money instead to set aside funds for research based on the criteria ME experts have already created.  This would drive the sorely-needed aggressive campaign to validate biomarkers, understand the pathophysiology of the disease, and identify treatment approaches.

<Your Name>


For those who want to email HHS again, I suggest a brief message:

Stop your work on the IOM contract to “develop consensus clinical diagnostic criteria for ME/CFS." IOM's study group selection procedures work against limiting such a panel to disease experts.  If you don't abandon this contract, you will  be putting my fate in the hands of a "diverse" group of people, including some who know nothing about my disease or may have preconceived biases. Faulty criteria will affect diagnosis and treatment for years. Instead, accept and follow the criteria created by ME experts.

<Your Name>


NOTE:  If you are on Facebook, you can participate in this campaign through this Facebook Event Page.  Get updates, show your support, invite your friends!

BACKGROUND (For your information; not to be included in the letter.)

On August 27, the US Department of Health & Human Services (DHHS) announced their intent to award a sole-source contract with the Institute of Medicine to develop new clinical diagnostic criteria for "ME/CFS". In response to an outpouring of concern from patients, HHS cancelled this announcement on September 4. The cancellation notice stated that HHS “will continue to explore mechanisms to accomplish this work.” 

Despite the demands of the ME patient community that HHS not go forward with the IOM contract, HHS announced, on September 12, that it intends to continue its plans to contract with IOM to develop clinical disease criteria for ME. HHS has said that it will provide additional information after the contract is finalized. We now know that HHS expects to sign the IOM contract by September 30.

Could there possibly be any clearer indications that HHS does not care what the community thinks? 

HHS actions are concerning on so many levels:

HHS has rejected expertly defined ME definitions like the Canadian Consensus Criteria (CCC) and the ME International Consensus Criteria (ME-ICC) that require hallmark symptoms like post-exertional malaise (PEM). CDC has questioned whether PEM should be mandatory for a diagnosis of “CFS” and has declined to incorporate the one test proven to objectively demonstrate PEM, the two day Stevens Protocol, into its multi-site study. Instead of accepting our experts view of the disease, HHS promotes an excessively broad view of the disease that encompasses depression, deconditioning and various nonspecific causes of chronic fatigue. In fact, HHS has even reclassified “CFS” to be a subcategory of “chronic fatigue” in direct opposition to standards set by the World Health Organization, which has classified it as a neurological disease.

HHS has repeatedly stated its intent to use individuals who are not familiar with ME to establish the criteria for ME. For patients who face constant disbelief from the general medical and research community and whose illness is too often assumed to be a psychiatric illness, this is very concerning.

The Institute of Medicine (IOM), the organization selected by HHS to develop the clinical criteria, is a prestigious organization. But unfortunately, IOM’s one effort to define a disease has received harsh criticism from GWI advocates for using non-experts, for too much of a focus on psychiatric issues and for rebranding the disease as chronic multisymptom illness, a redefinition so broad “as to include nearly any human health condition” according to Anthony Hardie, GWI advocate. Doing this in ME could set back research and clinical care for years. Further, the January 2013 IOM report on Gulf War treatments also included a section on “CFS” that did not represent ME accurately and which recommended CBT and GET as treatments, treatments that our experts have said can be harmful. 

HHS is wasting money redefining what our experts have already created. Meanwhile, researchers struggle to get the money to do the studies desperately needed to validate the biomarkers, further understand the pathophysiology or identify promising treatment approaches. At a recent presentation, Dr. Lipkin, world renowned researcher, described the extreme difficulties with getting money for ME/CFS research. Why?

HHS is acting unilaterally and in secret. The IOM proposal, in the works for months, caught patients and experts alike by surprise. It was not discussed at the May CFS Advisory Committee (CFSAC) and HHS staff resisted attempts by CFSAC members to discuss the case definition issue at all. HHS staff also resisted requests by CFSAC members to have input on who would be involved in the NIH Evidence Based Methodology Workshop, which will be used to inform a research definition.

HHS is choking off all input from the ME community. Dr. Koh has stated that CFSAC is our mechanism for input to HHS. But at the May 2013 CFSAC meeting, some members alleged they were threatened with eviction from CFSAC by HHS staff for speaking their minds. Almost 4 months later, we still do not have a response from HHS on the investigation of those allegations. And now, the fall CFSAC meeting, long a face-to-face meeting, is suddenly a webinar!

HHS claims it is responding to the CFSAC recommendation but it is not. The 2012 CFSAC recommendation specifically called for a meeting of experts, for those experts to discuss a case definition useful for research, diagnosis and treatment and for the discussion to start with the 2003 Canadian Consensus Criteria. 

HHS needs to adopt what our experts have already created and use that definition to reeducate the medical community and to drive an aggressive and fully funded ME research campaign to validate biomarkers, understand the pathophysiology and identify treatment approaches.


HHS Original Announcement of the Intent to Sole Source with the Institute of Medicine for the “Study for Diagnostic Criteria for ME/CFS”

IOM on Study Committee selection process

Forbes. “Inside the effort to define Gulf War Illness” 6/28/2013 

USA Today. “Gulf War illness advocates skeptical of institute panel. 6/26/2013  

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, ; Video at

IOM Initiative to define Gulf War Illness: “Development of a Case Definition for Chronic Multisymptom Illness” 

CFSAC May 2013 Meeting Minutes. Discussion of the NIH Evidence Based Metholodolgy and the allegations of intimidation of CFSAC members by HHS staff. Starting at page 48. 


  1. done! thank you! -- rivka

  2. Replies
    1. Sheeze....we knew HHS was headed down the wrong road...this is more then that it is a purposeful lead to put sick people out on the streets, in their rented bedrooms if lucky, or to kill them. Thanks Liz

  3. It is a pretty awful development and one that we really need to stop unless want to end up folded into "Chronic Multi-Symptom Illness". Please continue sending those emails EVERY DAY!