The IOM report – Tuesday, 10 February 2015

“The Institute of Medicine’s Committee on the Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome will hold a public release event for its consensus report on February 10^th, 2015 from 11:00 am-12:00 pm EST at the Keck Center of the National Academies in Washington, D.C.  (500 Fifth Street NW, Washington, DC).

Interested individuals will be able to attend the public release event in person or virtually via webcast. “

More info:

http://www.iom.edu/Activities/Disease/DiagnosisMyalgicEncephalomyelitisChronicFatigueSyndrome/2015-FEB-10.aspx

EDIT: Link for registration:

http://www.surveygizmo.com/s3/1957594/Public-Release-of-the-Report-by-the-Committee-on-the-Diagnostic-Criteria-for-Myalgic-Encephalomyelitis-Chronic-Fatigue-Syndrome

Many thanks to each of the advocates who searched for this link!

Contacting Congressional Representatives – Call to Action

There is an action to push for $7 to $10 million for an RFA (see below for definition) — This would be NIH money specifically to fund ME(cfs) research. (Yes, we need more than that but this request is in line with CFSAC recommendations and the effort is already underway. We can continue to work on getting more.)

1) This link is to a “Dear Colleague” letter and asks Congressional Members to join Reps. Lofgren (San Jose) and Anna Eshoo (Mountain View, Palo Alto) in raising awareness about ME/CFS among Congress. This is important because such letters signal to other politicians what interests some politicians have and are used for “trading favors” when it comes to voting/ supporting certain things. https://dl.dropboxusercontent.com/u/57025850/Dear%20Colleague%202%20-%20letter%20-%20March%202014.pdf

2) This link is to a letter, signed by 11 Congressional Members, that asks Dr. Collins for $7-$10 million to be earmarked for ME/CFS research. (Currently no funds are specifically set aside for ME/CFS research each year.) https://dl.dropboxusercontent.com/u/57025850/Congressional%20letter%20-%20Dr.%20Collins%20-%20March%202014.pdf

What can you do? 

Start by reading the letters.

1) If your Congressional Rep. has signed the letter, contact them and THANK them for their support. Something as simple as “Thank your for your attention to and support of research into the medical condition myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS).” They get little positive feedback so everything helps. Please thank Dr. Gutman for starting this at ben.gutman@mail.house.gov. It’s extra good if you’re Rep. Lofgren’s constituent but even if you’re not, that counts too.

 

2) If your Congressional Rep. has NOT signed, contact them and ask them to do so. Remember that peer pressure works on them as it does for other people. Seeing their colleagues sign helps. If your relatives or friends who live outside your area can send it to their Congressional members, that helps as well. More signatures = more power.

Congressional contact info can be found via this link http://www.contactingthecongress.org/).

Before you do call or write, plan out what you want to say.

Tell them (write) you are a constituent (i.e. you vote in their district), tell a bit of your story (perhaps 5 minutes), why research is important to you, and ask the Congress person to read and considering signing both letters. Do not be put off by speaking to staff only and not the Congress person; staff are influential. Remember also, they work for you so don’t be shy!

Online forms for many Congressional offices do not provide for attaching documents . Since you need to attach the Dear Colleague letter and the letter to Dr. Collins it probably is best to call and ask for an email address (unless you already have one).

Let them know that you will follow-up in 2-3 weeks to find out if the Congress(wo)man has signed or not.

Ask them to forward a paper copy of the signed letter to you if possible and report to speakupaboutme AT gmail DOT com who signed – name, state, Congressional district. If they did not sign, remember to politely ask why and post the reason along with the Rep.’s name.

Make a note on your calendar to follow-up in 2-3 weeks.

If they sign please be sure to thank them for doing so.

FYI (and in case they ask)
Congressional Reps who have already signed:
Anna Eshoo (Mountain View, Palo Alto, Saratoga, along the coast)
Zoe Lofgren   (most of San Jose)
Mike Honda (Sunnyvale, Cupertino, Santa Clara, Fremont, Newark, North San Jose, and Milpitas)
John Garamendi (Sacramento, Fairfield)
Sheila Jackson Lee (Texas, Houston)
Suzan Delbene (King County, Washington)
Eric Swalwell (Los Gatos, Cupertino, San Jose parts)
Scott Peters (San Diego, Poway)
Daniel Lipinski (Chicago suburbs, Illinois)
John Lewis (this is *the* John Lewis, the Civil Rights leader, from Atlanta, GA)
Eleanor Holmes Norton (Washington, DC)

Request for Application (RFA)

An RFA is a formal statement that solicits grant or cooperative agreement applications in a well-defined scientific area to accomplish specific program objectives. An RFA indicates the estimated amount of funds set aside for the competition, the estimated number of awards to be made, whether cost sharing is required, and the application submission date(s). For cooperative agreements, the RFA will describe the responsibilities and obligations of NIH and awardees as well as joint responsibilities and obligations. Applications submitted in response to an RFA are usually reviewed by a Scientific Review Group (SRG) specially convened by the awarding component that issued the RFA.

http://grants.nih.gov/grants/glossary.htm#R11

To contact your member of Congress: http://www.contactingthecongress.org/

https://dl.dropboxusercontent.com/u/57025850/Dear%20Colleague%202%20-%20letter%20-%20March%202014.pdf

https://dl.dropboxusercontent.com/u/57025850/Congressional%20letter%20-%20Dr.%20Collins%20-%20March%202014.pdf

You might consider attaching this for your Congress(wo)man and staff to read:

http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM368806.p

May 5th 2014 Public Meeting of the Institute of Medicine committee on Diagnostic Criteria for ME/CFS

FROM THE IOM LISTSERV

“The third meeting of the Institute of Medicine committee on Diagnostic Criteria for ME/CFS will be held May 5-6, 2014 in Washington, D.C. On the afternoon of May 5, the committee will hold an information-gathering session that will be open to the public. Interested individuals will be able to attend the open session in person at the National Academies of Science building or virtually via webcast.

This open session is one of the many processes that the committee will use to gather information and assemble evidence that it will examine and discuss in the course of making its findings, conclusions, and recommendations. The objectives for the committee during this open session are to learn more about the cognitive, sleep, and diagnostic issues related to ME/CFS; and to seek input from patients and caregivers regarding their interaction with health care professionals.

If you would like to provide written comments to the committee for this meeting, please focus your comments on responses to the following questions:

1) In your opinion, what are the most important issues that healthcare providers should be educated about when it comes to diagnosis of ME/CFS?
2) What are your thoughts on the current terminology used to describe this disease: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome? If you could suggest new terminology, what would you suggest and why?

Please use the email mecfsopensession@nas.edu to submit your written comments. Written comments received by April 23, 2014, will be distributed to the committee before the meeting on May 5. After April 23, written comments should be sent to the project email address (mecfs@nas.edu). All comments will be considered by the committee, but those received after the April 23 deadline may be distributed after the meeting is adjourned. As with any information sent to inform the committee, all written comments will be placed in a Public Access File in compliance with Section 15 of the Federal Advisory Committee Act.

Registration for the open meeting will open shortly and more information, including a tentative agenda, will be posted on this website as it is available.”

PLEASE NOTE THAT THIS MEETING IS BEING HELD IN A DIFFERENT LOCATION (NOT WHERE THE JANUARY MEETING WAS HELD)

The National Academy of Sciences Building

Room 120  NAS Floor Plan

2101 Constitution Ave, NW
Washington, DC

 

DIRECTIONS CAN BE FOUND HERE: http://www.iom.edu/About-IOM/Visit-IOM/Directions-NAS.aspx

FAQs http://www.iom.edu/Activities/Disease/DiagnosisMyalgicEncephalomyelitisChronicFatigueSyndrome/2014-MAY-05.aspx

OTHER INFO http://www.iom.edu/Activities/Disease/DiagnosisMyalgicEncephalomyelitisChronicFatigueSyndrome.aspx

 

 

Public comment provided to IOM meeting

Preface —

I continue to be incensed at the manner in which DHHS arranged for this project and the lack of engagement by DHHS with this community.

I have serious reservations about this project, its end result and its impact.

The question posed by IOM was “What is the most important aspect or information that this committee should consider throughout the course of the study?” and each person providing public comment was limited to three minutes.

This was not an easy task as there is so much this panel needs to know, and needs to be cognizant of as this project goes forward. This project is a consensus study and I sincerely hope that any/all panel members who disagree with the findings of the panel feel free to produce written dissenting opinions.

I chose to talk about some of the hallmarks of ME and the process the panel will use. Here is my public comment:

“Good afternoon.

Many thanks to all advocates for their presentations and comments as well as all participants near and far.

I especially want to thank Mary Schweitzer (Wisconsin ME/CFS(1)) and Charmian Proskauer (Mass CFIDS (2)) for highlighting concerns about young people.

I want to address 2 hallmark symptoms of this illness and then highlight five points about the process you will use.

Number 1 Post-Exertional Collapse(unfortunately known also as Post-Exertional Malaise (PEM))

Post-Exertional Collapse can result from minimal physical or cognitive exertion, is unpredictable and lasts for days or weeks. The pervasiveness of Post-Exertional Collapse often has no correlation with the minimal exertion of the triggering event.

Number 2 Impairment of Executive Function

Impairment of executive function is evident in areas such as processing speed, reaction time, working memory, and concentration. These impairments have been reported as significant concerns both in research and in reports such as FDA’s Voice of the Patient (3).

As of today (27 January 2014) you have just 371 days until your deadline for the clinical diagnostic criteria of this illness (4).

IMPORTANT THINGS FOR YOU TO THINK ABOUT

ONE – This illness may require different diagnostic criteria — such as pediatric (3) and adult – depending on the age at presentation.

TWO – The definition(s) used to select patients for studies greatly impacts the study results. Therefore – assessment of literature about this illness must include careful evaluation of the definition(s) used and the symptoms covered therein. The clinical diagnostic criteria that you have agreed to develop will have far reaching effects on diagnosis, health insurance, and treatment, and will likely have very important effects on school accommodations for young people with this illness.

THREE – Clinical diagnostic criteria for this illness should include detailed assessment of symptom severity and frequency (5) and should reliably assess post-exertional collapse and cognitive impairment.

FOUR – The clinical diagnostic criteria must include clearly defined criteria and appropriate assessment tools. It must be as accurate as is possible at this point in time.

As you develop the diagnostic criteria, think about how this criteria will best serve patients and practitioners.

The outreach strategy you develop to operationalize and disseminate this criteria must provide for widespread education about this illness so that patients are appropriately diagnosed — including all those who are currently undiagnosed or misdiagnosed (6).

FIVE – This afternoon is a very limited time to spend with those who know this illness best. FDA spent months pouring over input to develop The Voice of the Patient. Your work will be most successful if you engage experts and patients throughout the process.

Thank you.

 References

1. http://www.wicfs-me.org/ http://www.masscfids.org/
2. http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM368806.pdfhttp://hhs.granicus.com/MediaPlayer.php?view_id=5&clip_id=99 (see Cognitive Functioning in CFS)http://www.iacfsme.org/Portals/0/pdf/Lange%20Multitasking%20vol17%20n1.pdf

   http://www.cfids-cab.org/cfs-inform/Testcognitive/brimacombe.etal05.pdf

   http://www.cfids.org/special/brain.pdf

   http://www.hhs.gov/advcomcfs/meetings/presentations/presentation_10132010_gudrunlannge.pdf

   http://www.youtube.com/watch?v=ErcJCI-sm_A&list=UUzrFQHNiCc_6AMpw_GpWZOA&feature=plcp

3. https://dl.dropboxusercontent.com/u/57025850/MECFS%20IOM%20SOW.pdf
4. http://www.hhs.gov/advcomcfs/meetings/presentations/diagnose_me_cfs_200905.pdfhttp://www.name-us.org/DefintionsPages/DefinitionsArticles/JasonBell2006Pediatric.pdf
5. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3170036/http://dsq-sds.org/article/view/1375/1540

   http://www.tandfonline.com/doi/abs/10.1080/21641846.2013.862993#preview

6. http://www.cdc.gov/cfs/programs/cdc_research/program_update_2002-2003.html (accessed 18 Jan. 2014),http://link.springer.com/article/10.1007%2FBF02506968#page-1

   http://www.rcpe.ac.uk/journal/issue/journal_40_4/newton.pdf

   http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3269106/”

Reminder “At any point during the study, you may submit written comments to mecfs@nas.edu.”

According to IOM, they will send an announcement when the video and meeting presentations are posted — estimated time — “a few weeks”.

IOM webcast link (for live feed) and “Chronic Fatigue Syndrome and the Crisis in Biomedical Research”

(1) Mary Dimmock speaks with Llewelyn King about Chronic Fatigue Syndrome and the Crisis in Biomedical Research on White House Chronicle –

http://www.whchronicle.com/2014/01/chronic-fatigue-syndrome-and-the-crisis-in-biomedical-research/

(also available on these TV stations http://www.whchronicle.com/tv-stations/)

 

 

(2) re. IOM webcast, 27 January 2014

Registration NOT required to view webcast

Link for live webcast (beginning at 1PM EST):

http://www.iom.edu/Activities/Disease/DiagnosisMyalgicEncephalomyelitisChronicFatigueSyndrome/2014-JAN-27.aspx

Reminder (emphasis added – “At any point during the study, you may submit written comments to mecfs@nas.edu.”

(According to IOM, they will send an announcement when the video and meeting presentations are posted — estimated time — “a few weeks”.)

If you want to submit written public comment for the open session of January 27th, 2014 IOM meeting on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

IOM has said:  “It would be most useful if comments are focused on the following question: “What is the most important aspect or information that this committee should consider throughout the course of the study?”

Anyone can submit written comment to the meeting. (No limit on length.) What are you going to tell them?

If you submit by Jan 22nd the committee will get a copy of them before the meeting on Jan 27. Use this email address – mecfsopensession@nas.edu. Comments submitted after Jan 22 will still go to the committee, but possibly not until after the meeting.

All comments go into the public access file.

Additional info: http://iom.edu/Activities/Disease/DiagnosisMyalgicEncephalomyelitisChronicFatigueSyndrome/2014-JAN-27.aspx

After January 27, send written comments to the project email address (mecfs@nas.edu).

Reminder -the Statement of Work for this project – obtained by Ms Spotila – can be seen here: https://dl.dropboxusercontent.com/u/57025850/MECFS%20IOM%20SOW.pdf .

The tentative agenda for the January 27^th, 2014 open session of the meeting on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.

Registration for IOM open session (Jan 27th 1-5:30pm) is now open

http://www.surveygizmo.com/s3/1497040/HSP-Diagnostic-Criteria-for-MECFS-Committee-Meeting-1-1-27-14

IOM provided the following answers to some questions (some questions still unanswered)

Meeting room capacity – after taking committee member’s table into account – 60 (sixty) people

Registration for attending the meeting will automatically close when 60 people have registered.

Webcast viewing – unlimited number of viewers, anyone with an internet connection (any country) should be able to watch.

Valid photo ID needed for security sign in at building entrance

Arrive 20-30 minutes ahead of session to avoid lines at security

Meeting room is on the main floor, close to building entrance

Sign in again at registration table (meeting room entrance)

No security escort required within building

Security guards are available to direct people to wherever they need to go

A room directly across from meeting room is available to people before the open meeting session and for rest during the meeting.

Restrooms are on the main floor (down the elevator hall — not sure where that is in relation to the meeting room)

Food and drink are available on the third floor of the IOM building (Keck). Cafeteria is open from 7:00am to 2:30 pm. Vending machines for food/drink are also on the third floor (near the elevators).

People may eat and drink in the meeting room.

Tentative agenda for open session

http://iom.edu/~/media/Files/Activity%20Files/Disease/MECFS/Agenda27Jan14Website10Jan14.pdf?utm_medium=etmail&utm_source=Institute%20of%20Medicine&utm_campaign=01.10.13+MECFS&utm_content=&utm_term=

With hopes that 2014 will be a year of improved understanding of ME and more appropriate action based on that understanding

In 2014, we hope

your sense of purpose is renewed,

your support network grows larger,

you know that your views are valued,

you learn from others, and they from you,

your days are enhanced with moments of joy,

as you reach out in kindness to others, they reciprocate in turn,

practice makes it easier to say no/not now thank you so as not to exceed your limits.

 

– – – – – – –

The IOM Committee on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome will have its first meeting Monday the 27^th and Tuesday the 28^th of January 2014.

The morning session on the 27^th of January and the session on January 28^th are closed to the public.

 

The afternoon session of January 27^th is open to the public. (Location: Keck Center
500 Fifth St. NW, Washington, DC 20001

 

Information about agenda, registration and (for those who cannot attend in person) viewing via Webcast will hopefully be available soon.

 

http://www.iom.edu/Activities/Disease/DiagnosisMyalgicEncephalomyelitisChronicFatigueSyndrome.aspx

http://www.iom.edu/Activities/Disease/DiagnosisMyalgicEncephalomyelitisChronicFatigueSyndrome/2014-JAN-27.aspx

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