Another Non-Answer from HHS

Remember the allegations of intimidation at the May 2013 CFSAC meeting?

Remember the letters sent asking for an investigation of those allegations?

It seems fair to say that HHS (Department of Health and Human Services) is running true to form, because yet again we have a NON-answer from them…

Read more about it at this OccupyCFS post :

http://www.occupycfs.com/2013/11/25/nothing-to-see-here/

“Nothing to See Here

November 25th, 2013 Jennie Spotila Leave a comment Go to comments

After more than four months, Assistant Secretary Dr. Howard Koh has finally responded to our request for an investigation into the allegations that Dr. Nancy Lee attempted to intimidate at least two voting members of the CFS Advisory Committee. His response boils down to something along the lines of, “Ok people, move along, nothing to see here.” In fact, his letter is so dismissive of the allegations and so vague on what he’s done about it, that it barely qualifies as a response at all.”

REMINDER – Public comment for CFSAC is due Friday Nov 29^th(https://www.blsmeetings.net/CFSACdec2013/publicComments.cfm) —  If you are still working on your public comment, consider adding in your take on this much delayed lack of answer (and perhaps other examples of non-communication by HHS)……

Act NOW! Act often! Share widely! Time Critical!

HHS wants to turn Nancy Lee’s use (at CFSAC meetings) of the phrase “Nothing about us, without us” into “Everything about you, without you” particularly when it comes to defining ME and keeping ME stakeholders and experts out of the equation.

The Federal fiscal year ends Sept. 30^th, so the contract would need to be signed by then.

“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.”

HHS is moving ahead on the IOM contract unilaterally – 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.

Tell HHS to Stop the IOM Contract to Redefine ME(cfs)!

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

Send emails 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

Sample email (feel free to adapt)

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)

 

 

 

 

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

We encourage you to take action and to share widely

We direct your attention to these posts on Occupy CFS and Twenty Years and Counting

http://www.occupycfs.com/2013/09/16/cut-back-or-cut-out/

http://twenty-years-and-counting.blogspot.com/2013/09/tell-dhhs-to-stop-all-attempts-to.html

http://twenty-years-and-counting.blogspot.com/2013/09/tell-congress-president-no-to-iom.html

Take action.

Share widely.

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

No way to guess how this will turn out…..

You probably remember that one of the October 2012 CFSAC recommendations was

“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

We know that CDC has a definition initiative as part of its multi-site study, and we know that NIH and AHRQ have said they were conducting a research case definition process.

In his letter to the CFSAC on May 1, 2013 Dr. Howard Koh (Assistant Secretary of Health at the Department of Health and Human Services - DHHS) wrote:

“The National Institutes of Health (NIH) is convening an Evidence-based Methodology Workshop process  . . . to address the issue of case definitions appropriate for ME/CFS research. However, it will not cover in detail a clinical case definition. The Office of the Assistant Secretary for Health, Department of Health and Human Services, is actively pursuing options for a separate effort that would work in coordination with the NIH process, but result in a case definition useful for clinicians who see patients with symptoms that may be ME/CFS. . . . .” (http://www.occupycfs.com/2013/06/03/perplexed/ )

There was no indication at that time what the options were that were being actively pursued but now we learn that the Office of the Assistant Secretary of Health (Dr. Koh's office) is going to have the Board on the Health of Select Populations at the Institute of Medicine (IOM) set up a committee “of thought leaders and stakeholders to comprehensively evaluate the current status of criteria for the diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).” (https://www.fbo.gov/index?s=opportunity&mode=form&id=fb67835096d2486592952c90cd3acee7&tab=core&_cview=0)

The impact of the clinical diagnostic criteria they develop will be on the ME(cfs) community is a big question.

Earlier this year the IOM Board on the Health of Select Populations produced a report on Gulf War Illness (which they refer to as Chronic Multisymptom Illness or CMI – which is almost as board a categorization as the term chronic fatigue syndrome). (http://www.iom.edu/Reports/2013/Gulf-War-and-HealthTreatment-for-Chronic-Multisymptom-Illness.aspx)

That report seemed heavily focused on psychological concerns, and CBT and GET were included in their clinical practice guidelines for treatment of GWI.

This same report talks about chronic fatigue syndrome (that's how they refer to I) as being among co-morbid conditions with GWI, includes the 1994 Fukuda definition (http://www.cfids-me.org/cdcdefine.html) and the “2007 NICE Guidelines for CFS” (http://publications.nice.org.uk/chronic-fatigue-syndromemyalgic-encephalomyelitis-or-encephalopathy-cg53) and has the following pharmacologic and non-pharmacologic treatment recommendations for chronic fatigue syndrome:

“Chronic fatigue syndrome

Pharmacologic:

• NSAIDs for pain symptoms

• Melatonin for problems in sleeping

• Antidepressants for depression and to improve sleep quality

Non-pharmacologic:

• CBT (cognitive behavioral therapy)

• Graded exercise therapy

• Lifestyle changes (for example, regular sleeping schedule; avoidance of caffeine, alcohol, and tobacco; and dietary changes)

• Alternative therapies (for example, yoga, Tai Chi, acupuncture, and massage)

• CPAP for problems in sleeping”

This OccupyCFS post http://www.occupycfs.com/2013/08/29/iom-on-the-case/ poses a few of the many questions that come to mind about the IOM initiative on ME(cfs) clinical diagnostic criteria.

Many view the GWI report as heavy on inadequate and inappropriate treatment approaches (for GWI and ME(cfs) among other things) with emphasis on psychological rather than biological processes.

The suggestion in the GWI report that CBT, GET, and a massage or two - or perhaps yoga, will treat our illness(es), and that in chronic fatigue syndrome (again, this is THEIR term, not ours), cognitive dysfunction tends to be mild, and that the report makes no mention of PEM/PENE, one wonders what sort of materials the IOM will be accessing to develop their clinical criteria.

Will the IOM produce clinical diagnostic criteria that accurately captures the complexity of ME(cfs)?

(By the way, it is estimated that an IOM initiative typically costs one million US dollars.)

 

Update 31 Aug 2013:

Thanks to those responsible for getting the response date extended to Sept. 11, 2013 (4pm Eastern time)

and

Hat Tip and MANY thanks to Leela Play for finding the notice.

 

CFSAC May 2013 videos have all been posted now

Twenty-six days elapsed between the end of the meeting and the posting of these videos. (Typically the time frame has been 4-6 weeks….)

Day 1 May 22, 2013

Welcome & Call to Order – Day 1 (CFSAC Spring 2013)

May 22, 2013, 9:00 – 10:30 AM.    http://www.youtube.com/watch?v=PBYumSQZxC4

Public Comment on Day 1 (CFSAC Spring 2013)

Chronic Fatigue Syndrome Advisory Committee (CFSAC) Meeting, Day 1, May 22, 2013, 11:45 AM – 1:00 PM. (I think the time is incorrect here. I think the start time should be 10:45AM)    http://www.youtube.com/watch?v=85EFDQ2UPVw

Approve Prioritized Recommendations List – Day 1 (CFSAC Spring 2013)

May 22, 2013, 1:00 – 1:30 PM.   http://www.youtube.com/watch?v=3U9VOgTNxBc

Determination of Medicare Coverage of Test and Treatments – Day 1 (CFSAC Spring 2013)

May 22, 2013, 1:30 – 2:30 PM. http://www.youtube.com/watch?v=1BvZ6YQ2YFM

Public Question & Answer on Day 1 (CFSAC Spring 2013)

2:45 – 3:15 PM. Public Q&A.   http://www.youtube.com/watch?v=M7jKA8uuK-8

Committee Discussion and Plans for Day 2 (CFSAC Spring 2013)

3:15 — 5 PM.  http://www.youtube.com/watch?v=VJ7VqYJTsWI

Day 2 May 23, 2013

Opening Remarks on Day 2 (CFSAC Spring 2013)

9:00 – 10:15 AM. http://www.youtube.com/watch?v=cfGa7_kU1bg

Health Insurance Marketplace – Day 2 (CFSAC Spring 2013)

10:15 – 11:00 AM http://www.youtube.com/watch?v=daJejV7B_XE

Public Comment on Day 2 (CFSAC Spring 2013)

11:15 AM – 12:15 PM http://www.youtube.com/watch?v=PHP4BzItyF0

Public Question and Answer on Day 2 (CFSAC Spring 2013)

1:30 – 3:00 PM.  http://www.youtube.com/watch?v=D-wAHh3KC0w

Committee Discussion on Day 2 (CFSAC Spring 2013)

3:00 – 3:30 PM. http://www.youtube.com/watch?v=JVeavAWmHsI

 

 

 

Committee Discussion (Part #2) on Day 2 (CFSAC Spring 2013)

3:30 – 5:00 PM

http://www.youtube.com/watch?v=GEAqwVmPpBE

The spring 2013 CFSAC Meeting will be held Wednesday May 22 and Thursday May 23, 2013 at HHS

 

The spring 2013 CFSAC Meeting will be held Wednesday May 22 and Thursday May 23, 2013

at the Hubert H. Humphrey Building, Room 800, 200 Independence Avenue, S.W., Washington, D.C. 20201

(sorry, no other information on the meeting yet….)

Reposted from OccupyCFS

Thank you Ms. Spotila for drawing attention to this!

A Public Citizen

February 18th, 2013 Jennie Spotila Leave a comment Go to comments

When I wrote about the CFS Advisory Committee’s creation of a High Priority Recommendations document and how their process violated their own charter, many people asked me “What can we do about it?” Today, I can finally tell you what I did.

I contacted Public Citizen, a non-profit organization with the mission of serving “as the people’s voice in the nation’s capital.” Public Citizen has litigated cases under the Federal Advisory Committee Act, and has a Health Research Group that advocates for safer drugs and medical devices, equitable access to health care, and other issues.

On February 14th, Public Citizen sent a letter on my behalf to William B. Schulz, Acting General Counsel of the Department of Health and Human Services (you can read the full letter here). The letter details what I uncovered about the High Priority document, and asks the General Counsel to do two things:

We ask that you act to ensure that CFSAC complies with FACA and with its own charter going forward. We also ask that you return the January 2012 “High Priority Recommendations” document to the full committee for review, so that whatever action CFSAC chooses to take regarding those recommendations or any other transmission to HHS be debated and approved by the full committee, in public, as required by FACA.

It remains to be seen whether the General Counsel will act, and what he will do. There has been no official response as of today. However, upon checking the CFSAC website, I found that the High Priority document has been removed from the website. Perhaps this is a first step in correcting the Committee’s error.

I extend my sincere thanks to the people at Public Citizen who moved so quickly to assist me in this way. Sometimes, I feel like no one outside the CFS world cares about what we’re dealing with, and that requests for help will be met with disinterest or active disbelief. But Public Citizen did not dismiss my concerns or our disease. They recognized the public interest in the proper operation of advisory committees, and moved to help us. I am grateful for their assistance and support.

So what can you do? Help me boost the signal!!! Share my blog post, circulate it on Facebook and Twitter, and write about the Public Citizen letter on your own blogs. Tell your support groups and share it with all your contacts in the CFS world. Let’s ensure the community is informed about this action, and let’s monitor the progress together.

http://www.occupycfs.com/2013/02/18/a-public-citizen/

The full text of the letter from Public Citizen is pasted below:

Letter to Department of Health and Human Services Regarding the Chronic Fatigue Syndrome Advisory Committee

February 14, 2013

View as PDF. http://www.citizen.org/documents/2095.pdf

By postal and electronic mail

William B. Schultz
Acting General Counsel
Department of Health & Human Services
200 Independence Avenue SW
Room 713-F
Washington, DC 20201
William.Schultz@hhs.gov

Dear Mr. Schultz,

On behalf of Jennifer Spotila and Public Citizen’s Health Research Group, we are writing to call to your attention to and ask you to halt violations of the Federal Advisory Committee Act (FACA) by a Department of Health and Human Services (HHS) advisory committee, the Chronic Fatigue Syndrome Advisory Committee (CFSAC), which is housed within the Office on Women’s Health. Ms. Spotila is a chronic fatigue syndrome (CFS) patient and activist who has a keen and personal interest in federal policy regarding CFS. Public Citizen’s concern for the proper functioning of advisory committees stems from its long history of advocacy, in both legislative and judicial fora, for openness in government proceedings and the regular participation of Public Citizen’s Health Research Group in the meetings of HHS advisory committees.

We have become aware of the following problem: CFSAC subcommittees have been transmitting recommendations directly to HHS officials without public debate and approval of the full committee, as required by both CFSAC’s charter and FACA. Specifically, at its November 2011 public meeting, the CFSAC decided to create a distilled list of its most important recommendations for the Secretary. But the process of creating the list of key recommendations for the Secretary did not occur in the full committee or in public. Instead, various subcommittees met in private to identify the recommendations to prioritize, which Dr. Nancy Lee, the Designated Federal Officer for CFSAC, then compiled into a single list that was discussed with Assistant Secretary for Health Dr. Howard Koh. The final document, dated January 2012 and titled “High Priority Recommendations from CFSAC,” was never discussed or approved by the full committee or in a public session. Additionally, the document was not posted on the committee’s public website for an entire year (the document is dated January 2012, but it was posted just last month).

CFSAC’s statutorily-mandated charter provides the following regarding subcommittees: “The established subcommittees shall provide advice and/or make recommendations to the parent Committee. The subcommittees may not report its [sic] findings directly to any Federal official unless there is specific statutory authority for such reporting.” The transmission to Assistant Secretary Koh of recommendations developed by subcommittees and never approved by the full committee constitutes “subcommittees . . . report[ing] [their] findings directly to any Federal official” in violation of this provision. Additionally, FACA § 10(b) requires that the minutes of advisory committee meetings be made public. By acting through subcommittees closed to the public to develop the January 2012 “High Priority Recommendations from CFSAC,” CFSAC circumvented the public openness requirement of FACA.

The FACA violations deprived Ms. Spotila and the public generally of important rights to observe and participate in the advisory committee process, which can have significant influence over federal policy. Making advisory committee recommendations through a public process allows interested members of the public such as Ms. Spotila to comment, enables all members of the full committee to contribute to the decision, and allows the public at large to review the work of advisory committees. Public oversight of the work of advisory committees is one of the central goals of FACA. See Cummock v. Gore, 180 F.3d 282, 285 (D.C. Cir. 1999).

We ask that you act to ensure that CFSAC complies with FACA and with its own charter going forward. We also ask that you return the January 2012 “High Priority Recommendations” document to the full committee for review, so that whatever action CFSAC chooses to take regarding those recommendations or any other transmission to HHS be debated and approved by the full committee, in public, as required by FACA.

Thank you for your attention to this matter.

Sincerely,

Michael A. Carome, M.D.
Public Citizen’s Health Research Group

cc:
Howard K. Koh, Assistant Secretary for Health
Nancy C. Lee, Director, Office on Women’s Health

http://www.citizen.org/hrg2095

Message for the ME/CFS community

On June 5, 2012, an alliance of ME/CFS patient organizations and advocates sent a joint request to Secretary Sebelius of DHHS requesting that key deputies meet with us and begin to work with us to formulate a strategic, coordinated and fully-funded response to ME/CFS. We reiterated that request in a letter to Secretary Sebelius on August 8.

To date, we have been unable to secure the meeting with key deputies that we requested.  Four members of the alliance (Joan Grobstein, Jennie Spotila, Mary Dimmock and Charlotte von Salis) did meet with Dr. Nancy Lee, Deputy Assistant Secretary for Health – Women’s Health and Dr. Caira Woods, Advisor for Health and Science Policy, Office on Women’s Health.  The key points discussed in that meeting were:

• The Ad-Hoc Workgroup (described in DHHS letters to the community and at the CFSAC) is formulating a plan focused on budget sharing and coordination across agencies. It is charged to do what it can with no additional funding. It is not charged with developing a formal strategic plan or action plan. Dr. Lee also stressed that the agencies have a great degree of autonomy, although they do collaborate with each other.
• Given that DHHS has not agreed to the requested cross-DHHS meeting and has not committed to a cross-agency strategic, coordinated, fully-funded response, other avenues should be pursued. Dr. Lee suggested approaches that include non-profit or private sector solutions and following up with CDC and NIH separately.
• There are tactical opportunities that could be pursued in parallel and in partnership with CFSAC that include engaging as stakeholders in the case definition process that CFSAC committed to and finding ways to improve engagement and two way dialog within the CFSAC itself.
• We also discussed the CDC CFS Toolkit. The link to the CDC CFS Toolkit has been removed from the CFSAC website which is very good. Note that the Toolkit is still on the CDC CFS website itself. We will have to pursue that separately.

The need for a cross-DHHS strategic, coordinated, fully-funded response, developed with meaningful stakeholder input is as critical now as it ever was. However, it was clear from this meeting that we will need to use alternative approaches to make incremental progress while working toward the full objective. Besides the approaches suggested above, there are also legislative and other non-governmental options. Given our community’s limited resources, we will prioritize those activities that are most critical to both our short and long-term success.

If you have ideas on the areas that you would prioritize that you’d like to share, please share them with your organization or send them to MECFSACTION@Yahoo.com. We’ll summarize the ideas we get in and share them back with the community.

Thank you very much Charlotte, Joan, Jennie and Mary for meeting with Drs. Nancy Lee and Caira Woods.