Posts Tagged 'canadian consensus'

Our ME/CFS Experts Have Spoken on the Case Definition

On September 23, 2013, HHS announced that it has entered into a contract with the Institute of Medicine to begin work to develop “clinical diagnostic criteria” for ME/CFS.

But there’s more.

On the same day, 35 of the leading researchers and clinicians in the field of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) have written an open letter to Health and Human Services Secretary Kathleen Sebelius to announce that they have reached a consensus on adopting the Canadian Consensus Criteria (CCC) as the research and clinical case definition for ME/CFS. They called for HHS to follow their lead by using the CCC as the sole case definition for ME/CFS in all of HHS’s activities related to the disease and strongly urged HHS to abandon its plans to reach out to groups like the Institute of Medicine to develop clinical diagnostic criteria.

Acknowledging that the case definition will be refined as science advances, the authors unambiguously endorsed the Canadian Consensus Criteria as the baseline criteria, stating:

The expert biomedical community will continue to refine and update the case definition as scientific knowledge advances, for example, this may include consideration of the 2011 ME International Consensus Criteria … As leading researchers and clinicians in the field, however, we are in agreement that there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and that failure to do so will significantly impede research and harm patient care.”

Just as directly, the authors stated their strong opposition to the IOM initiative, stating:

We strongly urge [HHS] to abandon efforts to reach out to groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for ME/CFS. Since the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.”

Wow! Could our experts have spoken any more clearly, loudly and collectively?

More than any other issue, HHS’ decades long failure to adopt a definition that actually reflects our disease has confounded research and forestalled drug development. It has caused doctors to dismiss their patients’ illness or attribute it to depression. It has bred the widespread stigma and misunderstanding that ME/CFS patients face every day. By its actions, HHS has abandoned ME patients to lives of terrible debility and suffering with no treatments, no care and no hope that anything will ever change. In the face of such suffering, some patients have chosen suicide.

Compounding its mistakes, HHS unilaterally entered into a contract with the Institute of Medicine (IOM) to develop clinical diagnostic criteria and has repeatedly stated its intent to use non-experts to define our disease. We need only look to the Gulf War Illness experience with IOM and chronic multisymptom illness to know that this would be disastrous.

But today, thanks to our experts, the time for pretending ME/CFS doesn’t exist is OVER! The time for burying this devastating disease inside of an illegitimate collection of unexplained fatiguing illnesses is OVER! To quote advocate Tom Hennessey, NO MAS!

HHS can no longer claim that there is a lack of consensus amongst disease experts. As with every other disease, it is time for HHS to follow the lead of our disease experts and adopt the CCC for research and clinical purposes. In particular, HHS must now stop wasting taxpayer dollars on misguided efforts that, in the words of the letter authors, “threaten to move ME/CFS science backwards.”

For patients who have suffered through years of studies into ‘false illness beliefs” and maladaptive coping styles, this is finally a way out of the morass, an escape route from all those wasted years. As the authors stated, adopting the CCC will “jump start progress and lead to much more rapid advancement in research and care for ME/CFS patients.” It gives hope that our disease will be treated as the terrible disease that it is and that progress will now come quickly. It gives hope that we will soon rise up from our beds!

This letter is remarkable and historic for the ME/CFS community.

But what does this letter mean in terms of the IOM contract that HHS has just signed? Typically, like most contracts, government contracts have mechanisms built into them to allow the contract to be cancelled when the contract no longer makes sense.

Now that the ME/CFS experts have spoken, the path forward is clear. It does not make sense to waste money and time redefining the disease when the experts have now agreed upon the immediate adoption of the CCC.

We need to send two strong messages to HHS. First, HHS needs to immediately adopt the CCC as the sole definition for ME/CFS as the experts have called for. Second, HHS needs to cancel the IOM contract, which is completely unnecessary, wasteful and a step backwards scientifically.

We need to forcefully engage our congressional leaders on this issue. Further information along with the actions to take with congressional leaders will be provided as soon as possible.

The Sept 23, 2013 open letter from ME/CFS researchers and clinicians to Secretary Sebelius can be found here –

The Sept 23, 2013 CFSAC announcement on the IOM can be found here –

Thanks to Mary D for this information!

Tell DHHS to stop attempting to redefine ME (revised first paragraph 7 Sept 2013 2:27pm)

Please continue sending letters to DHHS

There is a Facebook event page that has sample letters that can be used/adapted….

A slightly different sample letter (feel free to adapt) is posted below.

Each of these letters reflects the cancellation of the proposed solicitation and urges DHHS to stop attempting to redefine ME.

Dear Secretary Sebelius,

I understand that HHS has canceled the IOM contract but will “continue to explore mechanisms to accomplish this work”  While I appreciate that the Department has responded to the public by cancelling this contract, I object to the Department continuing to explore other mechanisms to define criteria for myalgic encephalomyelitis/chronic fatigue syndrome”. The experts have already defined this disease.

I am a member of the ME community and have witnessed firsthand the devastation of this disease.  I purposely use the term “ME” to distinguish the disease that has affected me from the overly broad “CFS”.

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, anything other than officially adopting one of these definitions 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 appropriate research, and is the direct cause of the medical skepticism and inappropriate or harmful treatment recommendations to which patients are subjected. 

While you no longer appear to be seeking a contract with the IOM to develop a consensus definition, the fact that this effort was progressed in secret, apparently for many months and without consultation with key ME stakeholders is extremely disconcerting. In addition, the timing of the announcement before a holiday weekend and the short response time indicates that HHS was not looking for input from the ME experts and ME community. 

I do not see the need for anything but the official adoption of one of the existing, expert consensus criteria.

<Your Name>

CFSAC public comment due May 15th! Speak Up!

Our community usually has common priorities that it would be good for the CFSAC to hear (from as many people as possible).

An obvious one for the May 2013 meeting is thanking the FDA for the recent Drug Development for ME and CFS Public Workshop. FDA modeled engagement and collaboration with us in ways that all of DHHS could emulate.

The agenda (included below) is only an overview of the May 2013 CFSAC agenda.

We do know that the CFSAC will generate a list of high priority recommendations and it would be very helpful for your public comment to include YOUR top 3-5 priorities for the list. Some frequently mentioned priorities (and the recommendations) are as follows:

Holding a stakeholders’ workshop to reach a consensus on case definition. CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (ME/CFS experts, patients, advocates) workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes. (10/12)

Three regarding NIH and funding:

NIH should fund ME/CFS research commensurate with the magnitude of the problem, and issue an RFA specifically for ME/CFS. ME/CFS is an illness with enormous economic and human costs. The April 2011 NIH State of Knowledge Workshop identified a number of gaps in what is known about the illness. To address these gaps warrants an interagency effort comprising, but not limited to, NIH,CDC, and AHRQ. Further, the focus should be on interdisciplinary discovery and translational research involving interacting networks of clinical and basic science researchers. Areas to be examined would include the following: identification of patient subsets for detailed phenotyping and targeted therapeutic interventions, biomarker discovery, systems biology approaches and disability assessment. To facilitate the above goal, CFSAC recommends that ME/CFS research receive funding commensurate with the magnitude of the problem and that the NIH (and/or other appropriate agencies) issue an RFA specifically for ME/CFS. (5/11)

Pool resources to create Centers of Excellence, using physical or virtual locations. CFSAC would like to encourage and support the creation of the DHHS Interagency Working Group on Chronic Fatigue Syndrome and ask this group to work together to pool resources that would put into place the “Centers of Excellence” concept that has been recommended repeatedly by this advisory committee. Specifically, CFSAC encourages utilizing HHS agency programs and demonstration projects, available through the various agencies, to develop and coordinate an effort supporting innovative platforms that facilitate evaluation and treatment, research, and public and provider education. These could take the form of appropriately staffed physical locations, or be virtual networks comprising groups of qualified individuals who interact through a variety of electronic media. Outreach and availability to underserved populations, including people who do not have access to expert care, should be a priority in this effort. (11/11)

NIH should issue a $7-10 million RFA for outcomes measures, and biomarker discovery and validation. CFSAC recommends that you instruct the NIH to issue an RFA (funded at the $7-10 million range) for projects to establish outcomes measures for ME/CFS diagnosis, prognosis and treatment which would include but not be limited to biomarker discovery and validation in patients with ME/CFS. (10/12)


Removal of the CDC Toolkit. CFSAC asks that the Centers for Disease Control and Prevention (CDC) remove the CFS Toolkit (both English and Spanish versions) from the CDC website. (6/12)


Additional background on the CFSAC recommendations can be found here –

If you want to give public comment, you must register ( )

and send public comment to by May 15 if you want it to be on the public record.


CFSAC Spring 2013 Meeting

May 22 – 23, 2013

AGENDA OVERVIEW (note – this is not the full detailed agenda, just an overview)

May 22, 2013

9:00 am – 5:00 pm

·        Call to order CFSAC Chair

·        Welcome – Principal Deputy Assistant Secretary for Health

·        Remarks from the CFSAC Chair

·        Agency Updates – CDC, CMS, HRSA, SSA

·        Public Comment

·        Presentation – Process for CMS determination of coverage for tests and treatments

·        Committee Discussion


May 23, 2013

9:00 am – 5:00 pm

·        Call to order CFSAC Chair

·        Agency Updates – AHRQ, NIH, FDA

·        Presentation – Information about the Affordable Care Act and the Health Insurance Marketplace

·        Public Comment

·        Presentation – How to get more clinicians involved in diagnosing and treating patients with ME/CFS

·        Committee Discussion