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

Suggested reading at OccupyCFS

(Lack of) Progress Report

The December 2013 CFS Advisory Committee meeting was controversial before it began, and honestly things only went downhill from there. … Let’s just focus on the lowlights: the tech, the wreck, and the waste.

……

http://www.occupycfs.com/2013/12/12/lack-of-progress-report/

Public comment by Denise Lopez-Majano

 

 

This is the public comment submitted but Denise Lopez-Majano for the December 2013 CFSAC (webinar only) meeting. Given recent events re. CFSAC, HHS etc this version has minor revisions that do not significantly alter the original message..

 

I want to start by thanking FDA for the report “The Voice of the Patient”(1) which has a very good characterization of ME which FDA produced as a result of active listening by FDA (2) and docket and meeting input. I believe the section “Overview of ME and CFS” would have been strengthened by using information from the Canadian Consensus Definition for ME (3,4). It is noteworthy that the FDA report, that was produced (within 50 days) of the close of the docket (August 2, 2013), was promptly disseminated by FDA to meeting participants and is easily accessible from the FDA website (5).

 

And now, on to the not-so good —-

 

HHS (6), OASH (7) OWH (8) and specifically, those responsible for the management and execution of CFSAC meetings — you have some serious problems.

 

Among them, the way this meeting was planned and managed is a microcosm of the persistent lack of clear communication with and about the ME community.

 

HHS has a Strategic Plan (9) that gets updated every four years.

 

Goal number 4 of the current plan (10) promotes transparency, as well as a culture of public participation and collaboration.

The draft strategic plan for HHS FY2014-2018 builds on that, saying in part:

 

“Every operating and staff division within the Department is committed to ensuring the efficiency, transparency, accountability, and effectiveness of HHS programs.” (11)

 

And yet, HHS does not follow its own strategic plan. With total disregard for transparency, public participation and collaboration, and unbeknownst even to the CFSAC committee members (12), HHS arranged for the Institute of Medicine (IOM) project (13).

 

I have very serious reservations about the IOM project. Among other things I do not think that it is an accurate interpretation of the CFSAC recommendation from Oct 2012 (14). I have reservations about the Statement of Work for the IOM project. It seems vague. Vagueness does not bode well for any project let alone for one costing one million (U.S.) dollars.

 

It states:

“For the purposes of this document, ME/CFS shall be used to refer to Myalgic Encephalomyelitis (ME), Chronic Fatigue Syndrome (CFS), Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS), Neuroendocrine Immune Disorder, and other terminologies in use for this illness.” (15)

 

Yet when Mary Dimmock asked for clarification of the scope of disease the contract deals with, Dr. Nancy Lee (16), Designated Federal Officer (DFO) of the CSFAC and Ms. Kate Meck (17) of the IOM each indicated that the scope would be determined as the project goes forward (18).

 

Spending a million dollars on the IOM project without carefully defining the scope of disease seems as though the project was not thoroughly planned out in advance.

 

An issue as vital as the scope of the disease should not be undecided at this point in time.

 

But if it IS undecided, when will it be decided, by whom and how?

 

There is also the question of how the committee members were selected. We currently have no information about selection criteria.

 

And how will delineating the scope of the disease affect the selection criteria for the committee?

 

Let’s return now to the concepts in HHS’ strategic plans of

public participation and collaboration,

efficiency,

transparency,

accountability and

effectiveness.

 

Are these in any way evident in:

the stunning lack of transparency with which the IOM project was developed?

the vague scope of disease of this project?

the lack of clarity on when the scope will be decided, by whom and how?

the lack of transparency on selection criteria for committee membership?

As part of HHS, NIH is subject to the same HHS strategic plan.

But are the concepts of public participation and collaboration, efficiency, transparency, accountability and

effectiveness evident in the NIH Evidence-based Methodology Workshop (EbMW) on ME/CFS that is being coordinated by the NIH Office of Disease Prevention?

HHS needs to require greater accountability for the accurate implementation of its strategic plan because the Strategic Plan attributes of:

 

public participation and collaboration,

efficiency,

transparency,

accountability,

and effectiveness,

are not in evidence in either project.

Notes and links

1. “The Voice of the Patient Report: Chronic Fatigue Syndrome and Myalgic Encephalomyelitis” http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM368806.pdf

2. April 25^th 2013 PFDD meeting http://www.fda.gov/Drugs/NewsEvents/ucm369563.htm

3. “The Voice of the Patient Report: Chronic Fatigue Syndrome and Myalgic Encephalomyelitis” http://www.fda.gov/Drugs/NewsEvents/ucm369563.htm

4. “Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols” overview: http://www.hhs.gov/advcomcfs/meetings/presentations/canadiandoc.pdf

5. “Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols” full document: http://www.mefmaction.com/images/stories/Medical/ME-CFS-Consensus-Document.pdf (pp.7-115)

6. Department of Health and Human Services http://www.hhs.gov/

7. Office of the Assistant Secretary of Health (ASH) http://www.hhs.gov/ash/

8. Office on Women’s Health (OWH) website not available, contact info listed here: http://www.hhs.gov/ash/contactus/contactus.html

9. Strategic Plan and Priorities Strategic Plan 2010 – 2015 http://www.hhs.gov/strategic-plan/priorities.html

10. “Goal 4: Increase Efficiency, Transparency, and Accountability of HHS Programs” 2010-2014 http://www.hhs.gov/strategic-plan/goal4.html

11. “Goal 4: Ensure Efficiency, Transparency, Accountability, and Effectiveness of HHS Programs” 2014-2018 http://www.hhs.gov/open/recordsandreports/strategic-plan.pdf

12. CFSAC members are appointed by HHS “to provide advice and recommendations to the Secretary of Health and Human Services (HHS), through the Assistant Secretary for Health (ASH), on issues related to chronic fatigue syndrome (CFS)” (6) http://www.hhs.gov/advcomcfs/charter/

13. “Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome”

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

14. The full text of the recommendation states:

“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.” [emphasis added] http://www.hhs.gov/advcomcfs/recommendations/10032012.html

 

15. https://dl.dropboxusercontent.com/u/57025850/MECFS%20IOM%20SOW.pdf

16. Dr. Nancy C. Lee, Deputy Assistant Secretary for Health – Women’s Health, is the Designated Federal Officer for CFSAC http://www.hhs.gov/advcomcfs/

17. Kate Meck, Associate Program Officer, Institute of Medicine http://www.iom.edu/staff/katherine-meck.aspx

18. http://www.occupycfs.com/2013/11/27/which-disease-is-hhs-studying/

As of 29 November 2013, no links (and little information) are readily available for the NIH Evidence-based Methodology Workshop (EbMW) on ME/CFS.

All other links accessed 10 Dec. 2013

11 December 2013 Revised agenda for today’s CFSAC webinar

Received from CFSAC at about 10:45am (Eastern time)

Revised Agenda (Eastern Standard Time)

12:00PM  Call to order, Roll Call (including Introduction of new members, Housekeeping, Welcome, Opening remarks)
12:20PM  IOM Report  – Nancy Lee (including ~20min. for committee questions)
12:50PM Agency Updates
1:10PM Public Comments (please limit to 3 min. each)
1:45PM Break
2:00PM Liaison representatives – reports
2:15PM Education and Patient Care subcommittee and CDC website Committee report
2:30PM ME/CFS Researcher and Clinician-Scientist Recruitment Workgroup Report
3:00PM Education for ME/CFS Working Group Report
3:30PM Committee discussion re: working groups and any recommendations
4:55PM Closing remarks
5:00PM Adjourn

The CFSAC support team hopes to schedule another webinar (either 1-day or 2-day, perhaps in February) before the next scheduled face-to-face CFSAC meeting in May or June 2014 that would specifically focus the committee discussions and recommendations about the workgroup efforts.

Change in CFSAC webinar meeting UPDATE

Because the US government is closed today (weather related) today’s portion of the meeting is postponed.

Hopefully more details will be available soon.

HOWEVER

Indications are that Wednesday 11 Dec. meeting will go ahead as scheduled.

No info yet on how this affects agenda or public comment.

UPDATE from CFSAC ListServ

“Because of a snow storm in the Washington DC area, the Federal Office of Personnel Management has closed all federal govt. offices in DC.  This includes the tech support we need for webinars.

 

Unfortunately, we cannot have the webinar today.  Additionally, we cannot get the CFSAC website updated today. 

 

We will have the webinar tomorrow (Wed. Dec. 11) beginning at noon ET, IF govt. offices are open.   Dr Gailen Marshall, the CFSAC Chair, will work with the committee members at the beginning of the webinar to modify the agenda to accommodate the compressed timeframe. 

 

We will have public comment tomorrow for those who were scheduled to speak on Wed.  Unfortunately, we won’t be able to accommodate the public comments that were scheduled for Tuesday because we cannot confirm with the speakers that they are available for the Wednesday time slot. 

 

So that we have more time for the Committee to deliberate and discuss, we ask those providing public comment tomorrow to limit their speaking time to 3 minutes.

 

If we must cancel the webinar tomorrow (DC doesn’t handle snowy, icy roads well), we will reschedule the CFSAC meeting webinar to occur after the first of the year.

 

More info on government closure in DC at www.OPM.gov

 

We regret that this has happened.  We hope to be on the webinar with you tomorrow!

________________________________________________________

The CFSAC Support Team

http://www.hhs.gov/advcomcfs/index.html

 

Sign up for the CFSAC listserv to receive the latest updates about CFSAC:

   http://www.hhs.gov/advcomcfs/cfsac_email_list.html

 

Learn more about the Health Insurance Marketplace at HealthCare.gov!”

 

 

 

Info on Accessing the CFSAC webinar Dec 10 and 11 2013

There has been a great deal of confusion about the CFSAC webinar meeting and how to access it.

(Contrary to what was previously said by HHS) Registration IS NOT required for viewing it.

HHS’ most recent information on viewing the webinar is:

Webinar Information

The Chronic Fatigue Syndrome Advisory Committee (CFSAC) Webinar will be a “virtual meeting” using Adobe Connect Pro, a web conferencing product that allows users to conduct live meetings and presentations over the internet. In order to view and listen to the proceedings during the CFSAC webinar participants will need to access the webinar using the information below:

Webinar Access:
Adobe Connect URL: http://hhs.adobeconnect.com/owhcfsac/

Access to the Audio Portion of the Webinar:
Conference Call Number: 877-918-6627 | Passcode: 4429527

Using Adobe Connect requires that you have an Internet connection, a Web browser, the latest version of the Adobe Connect Add-in to attend a Web conference. Adobe Connect Pro is supported by many operating systems, including Windows, Macintosh, Linux, and Solaris as well as the most widely used browsers, including Internet Explorer, Firefox, and Safari.

It is recommended that you test your computer prior to attending a meeting. You can do this by going to http://admin.adobeconnect.com/common/help/en/support/meeting_test.htm.

This diagnostic test will ensure your computer and network connections are properly configured to provide you with the best possible Adobe Connect meeting experience. The diagnostic test checks for the following:

1. Clear connection to Adobe Connect

2. Bandwidth availability

3. Latest Adobe Connect Add-in

If the diagnostic check finds that you do not have the latest Adobe Connect Add-in installed on your computer (as seen below) please click on the “Install Add-in” link on your computer as circled in the picture below. Please note that you will not be able to view the webinar if the latest Adobe Connect Add-in is not installed.

Once the Add-in is installed, click on the link http://hhs.adobeconnect.com/owhcfsac/ to join the webinar. You should see the screen below.

Click the button to “Enter as a Guest” and type your name (if you choose to be identified) and click the “Enter Room” button. You will be directed to the CFSAC webinar.

If you have technical difficulty during the webinar, please contact Seamon Corporation at 301-658-3442 or CFSACDec2013@seamoncorporation.com.

The webinar will be archived on the HHS CFSAC Web site at http://www.hhs.gov/advocomcfs.

Additional “How to use” resources for Adobe Connect

If you have never used Adobe Connect, please click on the following link to get a quick overview: http://www.adobe.com/go/connectpro_overview.

The Visual Quick Start Guide provides basic information for participating in an Adobe Connect Webinar. Please click the following link to view the Visual Quick Start Guide: http://www.adobe.com/content/dam/Adobe/en/products/adobeconnect/pdfs/VQS_Guide_for_Participants.pdf

http://blsmeetings.net/CFSACdec2013/webinarinformation.cfm

Info on IOM Panelists

Info on IOM Panelists

As of today we have 16 days (til 23 December 2013) to submit comment on the IOM panelists.

To give everyone info that may help substantiate comment, info on the “unknown” panelists was posted 2 days ago and today info on the “knowns” has been posted on OccupyCFS blog.

http://www.occupycfs.com/2013/12/07/iom-panelists-the-knowns/

“IOM Panelists: The Knowns

December 7th, 2013 Jennie Spotila Leave a comment Go to comments

In this post, we present profiles of the eight members of the Institute of Medicine ME/CFS definition panel who are known to the ME/CFS community in some capacity. Many, but not all, of them are ME/CFS experts in that they work predominantly in that area. You can read about the team who put these profiles together and the methods we used in this previous post.

Important disclaimer: Many of us know one or more of these panelists quite well. They are our doctors, our colleagues, our friends. We strove to be as objective as possible, and applied all the same research methods and questions here as we did for the other panelists.   ….”

Links to previous OccupyCFS posts on this:

http://www.occupycfs.com/2013/12/03/iom-panel-announced/

http://www.occupycfs.com/2013/12/05/iom-panelists-method-to-our-madness/

http://www.occupycfs.com/2013/12/05/iom-panelists-the-unknowns/