Make your voice heard – every day! Action Alert

We remember Nancy Lee saying “Nothing about us without us”…

In Chronic Fatigue Syndrome Advisory Committee (CFSAC) discussions Designated Federal Official (DFO)Nancy C. Lee, M.D. has used the phrase “Nothing about us without us” implying that stakeholders should be involved in all things regarding ME/CFS.

But (on Sept 12^th) HHS says:

“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.”

Yet CFSAC members, ME experts and ME stakeholders have been shut out of the HHS/IOM contract development and process.

Sooooo, how exactly is that “Nothing about us without us”? (Just to be clear — the question is in jest.)

Because the reality is that HHS is moving ahead on the IOM contract unilaterally and with total disregard for the overwhelming opposition from the ME community. HHS is undermining the work of ME experts while patients are suffering and dying.”

Take action today(!) and everyday (if you can).

Share widely and encourage others to act!

Tell HHS ENOUGH IS ENOUGH!

Subject line (variations encouraged): Stop the IOM Contract to Redefine ME/CFS

Send (daily) emails (from many people from any country) to:

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 , cfsac@hhs.gov , MEACTNOW@yahoo.com

Email templates can be found here:   http://www.occupycfs.com/2013/09/17/insult-meet-injury/#comments

and here:   https://www.facebook.com/events/705280782832088/

(MEACTNOW@yahoo.com is used to tabulate emails sent)

Dear Secretary Sebelius,

I strongly urge the Department to abandon its plan to contract with 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 doctors, and ME researchers. The CCC has been used both clinically and in research for years.

But rather than adopt these expertly defined disease criteria and the associated medical guidelines, HHS has promoted its own overly broad view of ME that does not require the hallmark symptoms of ME. HHS has questioned these hallmark criteria and misrepresented our disease in its medical education. HHS has even unilaterally reclassified “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 disease as a neurological disease.

Now, HHS is intent on defining its own new criteria for ME using the IOM, an organization whose only effort to define a disease was harshly criticized by Gulf War Illness Advocates for redefining the disease too broadly and for using non-experts to define the disease. HHS has repeatedly stated their intent to 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. Adding to these concerns, the description of ME/CFS in the January 2013 IOM report on Gulf War treatments failed to accurately represent ME and listed CBT and GET as treatments, treatments that our experts have said can be harmful.

HHS is progressing the IOM contract unilaterally and with disregard for the overwhelming opposition from the ME 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 contract with the IOM to define clinical diagnostic criteria for ME/CFS. It is time for HHS to adopt a definition that our experts have created and use that definition to drive an aggressive campaign of fully funded research and to reeducate the medical community.

(sign your name)

Background info for those sending emails   (do not include with email) —— https://dl.dropboxusercontent.com/u/89158245/Action%20Alert%20Sept%2017%20HHS%20on%20IOM.pdf

Questions —- lots of them

During the development of the proposed DHHS/IOM project, it seems that DHHS did not involve CFSAC members or let them know what was going on. We do not know if ex-officios were involved at all – because the project was progressed without the knowledge of, or input from the ME community.   When advocates contacted some of our clinical and research experts it turns out that they had no idea about the proposed project until the advocates brought it to their attention.

For some time now, DHHS has wanted to use non-experts in the definition process – CFSAC DFO (designated federal officer) Nancy Lee has pushed really hard on that on a number of occasions. Non-experts? –  to define a disease that many non-experts know little if anything about and that many don’t believe is real? Somehow that does not inspire warm and fuzzy feelings of comfort and confidence.

In May 2013, at the CFSAC meeting, Beth Unger of the CDC indicated that she is not certain post-exertional exacerbation (PEM) should be a required symptom of ME. At least one other person on the CFSAC has indicated that they think PEM is optional and should not be a required in a definition of ME.   Yet, ME experts agree that PEM is a cornerstone, a hallmark of this illness. Is a definition that does not include illness hallmarks one that can accurately describe the illness?

DHHS appears to have changed its position on consensus definitions and who they believe to be the most appropriate groups for developing them. The minutes from the CFSAC Oct 2012 meeting indicate that Secretary Sebelius believed that definitions need to come from the medical community:

           “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. CFS Advisory Committee Minutes, October 4, 2012, p. 37, 38.”

Yet now, DHHS wants to develop a consensus clinical diagnostic criteria for ME. (“The Committee will consider the various existing definitions for chronic fatigue syndrome and develop consensus clinical diagnostic criteria for this disorder.” https://www.fbo.gov/index?s=opportunity&mode=form&tab=core&id=7fafc35816ee932dc44d6c319937b366&_cview=1)

We already have the CCC (http://www.cfids-cab.org/cfs-inform/CFS.case.def/carruthers.etal03.pdf) . We already have the ME-ICC (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3427890/) . Creation of another consensus criteria would take significant time. Implementation of the criteria would add time on top of that. Dissemination of educational material would add even more time. And if the creation of another consensus criteria is done by a group that includes lots (or any) non-experts, we will likely be at least five years further on the road to nowhere or backwards.

Why is HHS pursuing any “other mechanisms to accomplish this work” (“HHS will continue to explore mechanisms to accomplish this work.” https://www.fbo.gov/indexs=opportunity&mode=form&tab=core&id=dfb4054e6f31df6d3969feea989825b8&_cview=0 ) instead of using the work of ME experts?

All of this seems a long way off from the CFSAC recommendation of Oct 2012:

“CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (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.” http://www.hhs.gov/advcomcfs/recommendations/10032012.html

DHHS still has not given a response about the allegations made at the May meeting.

And with this secretive DHHS/IOM proposal, DHHS has shattered the little remaining trust many people had in them.

The draft strategic plan for DHHS F2014-2018 was released earlier this week and one sentence in it reads:

“Every operating and staff division within the Department is committed to ensuring the efficiency, transparency, accountability, and effectiveness of HHS programs.” http://www.hhs.gov/open/recordsandreports/strategic-plan/goal-4.html

Have we seen evidence of this transparency?

Has DHHS ensured the effectiveness of the CFSAC program by implementing CFSAC recommendations?

Has DHHS demonstrated its accountability to the CFSAC and the ME community by their actions?

Do DHHS actions demonstrate that they care about what we have to say, that they respect and value our input and that of ME experts?

After all, according to the CFSAC charter, the CFSAC is supposed to be made up of experts in ME – experts selected by and appointed by DHHS. (“Of the eleven members, seven shall be biomedical research scientists with demonstrated expertise in biomedical research applicable to CFS; four shall be individuals with expertise in health care delivery, private health care services or insurers, or voluntary organizations concerned with the problems of individuals with CFS.” http://www.hhs.gov/advcomcfs/charter/index.html ) —

To what extent does DHHS engage with the CFSAC and demonstrate that they respect and value the input provided by the CFSAC?

Can we continue to believe that their intentions for us are honorable and truly in our interest?

Or does it seem that nothing that has been said about ME, to DHHS for the past decades has yielded significant positive results for us?

Lots of questions…..

Just say NO to tapioca!

The talking points for the email about the DHHS/IOM proposed contract prompted advocate Joe Landson (thanks for sharing it Joe) to send this letter:

 

Subject: MECFS definitions

Secretary Sebelius,

As a disabled veteran, and an ME/CFS patient, I am writing to protest the Department of Health and Human Services’ proposed sole-source contract (or grant?) to the Institute of Medicine, towards a consensus definition of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, or ME/CFS. I am given to understand that due to ME/CFS community feedback, this sole-source proposal has been shelved. I sincerely hope it has. 

In January of this year, the IOM released a report on Gulf War Illness (GWI), which the IOM terms Chronic Multisystem Illness (CMI), a characterization arguably blander and less substantial than the tapioca pudding provided in many hospital meals. While the pudding can, in theory, be consumed, I am not sure that my fellow patients and I can stomach another attempt to portray our crippling illness as a series of bland generalities and vague complaints, treatable with talk therapy. 

Yes, we need a consensus definition. However I submit that we can best serve patients, clinicians, researchers and policymakers by writing a definition based on actual understanding of the mechanisms and causes of the illness in question. In cases where consensus science does not provide knowledge of illness cause and mechanism, then perhaps the DHHS can fund research that actually produces such knowledge. If DHHS cannot even do that, then perhaps it should avoid the definition-writing process until such consensus science does emerge. First, do no harm. Bad definitions do us harm by misdirecting research, and by exposing us to ridicule and ignorance, from which we suffer daily. 

Thank you for your consideration. Go Jayhawks. 

Joe Landson

Extremely Urgent! Tell HHS that you oppose the IOM contract – stop the proposed IOM Study! Update 4 Sept 2013

Second update 4 Sept 2013

As of Wednesday, 4 Sept 2013 the site that posted the announcement about the DHHS/IOM project has this update:  

“Synopsis:

Added: Sep 04, 2013 4:12 pm

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

The worrying part is that we don’t know what the second sentence really means.

Our own feeling is that everyone’s efforts (pat yourselves on the back folks!) on this have bought us time but that we are “not out of the woods yet”.

Your help on this action is much appreciated.

We hope to have more information on Thursday and let you know what next steps need to be taken.

 

(UPDATE 4 Sept 2013 via http://www.occupycfs.com/2013/09/04/dont-stop/

Cautiously optimistic…. but continue sending the emails)

ME Advocacy Action: Urgent

Tell HHS that you oppose the IOM contract – stop the proposed IOM Study!

Act now and spread the word widely (internationally as well)!

HHS’s proposal to contract with the IOM to “develop clinical diagnostic criteria for ME/CFS” 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:

1. Send an email to HHS voicing your strong opposition to this initiative as soon as possible but no later than by 5pm on Monday, September 9^th. 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 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.

Sincerely,

<Name>

———–

BACKGROUND for you (don’t include this in your email)

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:

1. 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
2. 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/
3. 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/
4. 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

5. 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
6. 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