#Millions Missing

Millions of people are missing from everyday life because of Millions Missing from research and Millions Missing of appropriately educated healthcare professionals to care for patients

The #Millions Missing demonstration will take place on 25 May 2016 in select locations across the globe.

#MillionsMissing ME/CFS Protest Demands

1. Increased Funding and Program Investments

Funding and program investments commensurate with the disease burden

2. Clinical Trials

Clinical trials to secure medical treatments for ME/CFS

3. Accurate Medical Education

Replacement of misinformation with accurate medical education and clinical guidelines

4. A Serious Commitment

HHS leadership, oversight and a serious commitment to urgently address ME/CFS

#MEAction has posted the rationale for the demands.

NOTE –

“There is an open community meeting hosted by MEAction on

Wed. May 11th, 2-3:30 pm EDT

to discuss the demands and

hear any questions or concerns you have about them.

More info and call sign-up here:

 https://my.meaction.net/events/millionsmissing-national-call

MEAction says “We are thinking of these demands as a living document. We plan that after the protests (May 25) it will evolve as we get input from the community. MEAction.net will set up a mechanism for receiving that community input. This task, and the evolution of the demands document, will happen after the protests, simply because we lack the capacity to do it while we are organizing the protests.”

 

 

 

 

 

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!

Comments on Evidence Review due Oct 20th

Evidence Review Comments Preview

This post comes via Mary Dimmock, Claudia Goodell, Denise Lopez-Majano, and myself. You are welcome to publish it on your site with attribution and a link back to this post. You are also welcome to use this (and other material gathered here ) as a framework for your own comments on the draft evidence review – due October 20th.

It’s been a challenging few weeks, digesting and analyzing the AHRQ Draft Systematic Evidence Review on Diagnosis and Treatment of ME/CFS.  We continue to be deeply concerned about the many flaws in the review, in terms of both the approach it took and how it applied the study protocol.

Our comments on the Review will reflect our significant concerns about how the Evidence Review was conducted, the diagnostic, subgroup, and harms treatment conclusions drawn by this report, and the risk of undue harm that this report creates for patients with ME. We believe a final version should not be published until these scientific issues are resolved.

Most fundamentally, the Evidence Review is grounded in the flawed assumption that eight CFS and ME definitions all represent the same group of patients that are appropriately studied and treated as a single entity or group of closely related entities. Guided by that assumption, this Evidence Review draws conclusions on subgroups, diagnostics, treatments and harms for all CFS and ME patients based on studies done in any of these eight definitions. In doing so, the Evidence Review disregards its own concerns, as well as the substantial body of evidence that these definitions do not all represent the same disease and that the ME definitions are associated with distinguishing biological pathologies. It is unscientific, illogical and risky to lump disparate patients together without regard to substantive differences in their underlying conditions.

Compounding this flawed assumption are the a priori choices in the Review Protocol that focused on a more narrow set of questions than originally planned and that applied restrictive inclusion and exclusion criteria. As a result, evidence that would have refuted the flawed starting assumption or that was required to accurately answer the questions was never considered. Some examples of how these assumptions and protocol choices negatively impacted this Evidence Review include:

• Evidence about the significant differences in patient populations and in the unreliability and inaccuracy of some of these definitions was ignored and/or dismissed. This includes: Dr. Leonard Jason’s work undermining the Reeves Empirical definition; a study that shows the instability of the Fukuda definition over time in the same patients; studies demonstrating that Fukuda and Reeves encompass different populations; and differences in inclusion and exclusion criteria, especially regarding PEM and psychological disorders.
• Diagnostic methods were assessed without first establishing a valid reference standard. Since there is no gold reference standard, each definition was allowed to stand as its own reference standard without demonstrating it was a valid reference.
• Critical biomarker and cardiopulmonary studies, some of which are in clinical use today, were ignored because they were judged to be intended to address etiology, regardless of the importance of the data. This included most of Dr. Snell’s and Dr. Keller’s work on two day CPET, Dr. Cook’s functional imaging studies, Dr. Gordon Broderick’s systems networking studies, Dr. Klimas’s and Dr. Fletcher’s work on NK cells and immune function, and all of the autonomic tests. None of it was considered.
• Treatment outcomes associated with all symptoms except fatigue were disregarded, potentially resulting in a slanted view of treatment effectiveness and harm. This decision excluded Dr. Lerner’s antiviral work, as well as entire classes of pain medications, antidepressants, anti-inflammatories, immune modulators, sleep treatments and more. If the treatment study looked at changes in objective measures like cardiac function or viral titers, it was excluded. If the treatment study looked at outcomes for a symptom other than fatigue, it was excluded.
• Treatment trials that were shorter than 12 weeks were excluded, even if the treatment duration was therapeutically appropriate. The big exclusion here was the rituximab trial; despite following patients for 12 months, it was excluded because administration of rituximab was not continuous for 12 weeks (even though rituximab is not approved for 12 weeks continuous administration in ANY disease). Many other medication trials were also excluded for not meeting the 12 week mark.
• Counseling and CBT treatment trials were inappropriately pooled without regard for the vast differences in therapeutic intent across these trials. This meant that CBT treatments aimed at correcting false illness beliefs were lumped together with pacing and supportive counseling studies, and treated as equivalent.
• Conclusions about treatment effects and harms failed to consider what is known about ME and its likely response to the therapies being recommended. This means that the PACE (an Oxford study) results for CBT and GET were not only accepted (despite the many flaws in those data), but were determined to be broadly applicable to people meeting any of the case definitions. Data on the abnormal physiological response to exercise in ME patients were excluded, and so the Review did not conclude that CBT and GET could be harmful to these patients (although it did allow it might be possible).
• The Evidence Review states that its findings are applicable to all patients meeting any CFS or ME definition, regardless of the case definition used in a particular study.

The issues with this Evidence Review are substantial in number, magnitude and extent. At its root is the assumption that any case definition is as good as the rest, and that studies done on one patient population are applicable to every other patient population, despite the significant and objective differences among these patients. The failure to differentiate between patients with the symptom of subjective unexplained fatigue on the one hand, and objective immunological, neurological and metabolic dysfunction on the other, calls into question the entire Evidence Review and all conclusions made about diagnostic methods, the nature of this disease and its subgroups, the benefits and harms of treatment, and the future directions for research.

As the Evidence Review states, the final version of this report may be used in the development of clinical practice guidelines or as a basis for reimbursement and coverage policies. It will also be used in the P2P Workshop and in driving NIH’s research strategy. Given the likelihood of those uses and the Evidence Review’s claim of broad applicability to all CFS and ME patients, the flaws within this report create an undue risk of significant harm to patients with ME and will likely confound research for years to come. These issues must be addressed before this Evidence Review is issued in its final form.

Bits and pieces

Many thanks to all those who have written to Tell Dr. Collins to Stop P2P

If you have not already done so, fax or email Dr. Francis Collins today and request that he cancel the P2P Workshop.

Details here http://www.occupycfs.com/2014/06/02/tell-dr-collins-to-stop-p2p/

Additional information about P2P:

http://www.occupycfs.com/?s=P2P

A parallel action to contact Congressional officials about P2P will be released shortly.

WEGO Health Twitter chat about advocating for oneself while living with a stigmatized chronic disease. Hosted by Jennie Spotila

Date: Tuesday, June 10^th

Time 3-4pm (Eastern time).

Details http://www.occupycfs.com/2014/06/08/twitter-chat/

The next meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC)

Monday afternoon (12-5pm Eastern time) June 16^th and Tuesday June17^th (9am-5pm Eastern time).

The meeting will be live-video streamed at http://www.hhs.gov/live . (Registration to attend in person ends June 12^th. Details https://www.federalregister.gov/articles/2014/05/29/2014-12371/meeting-of-the-chronic-fatigue-syndrome-advisory-committee )

FDA Webinar, chance for Q&A and comments April 23, 2014

FDA is hosting a webinar about the draft guidance document “Guidance for Industry Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: Developing Drug Products for Treatment”.

Note: the webinar will be close-captioned and there questions/comments can be submitted in real-time using a chat window. (It is safe to assume that personal information should not be submitted as this would then be available for all to see onscreen.)

Public comment on the draft guidance should also be submitted to the docket DOCKET NUMBER: FDA–2014–D–0264 http://www.regulations.gov/#!docketDetail;D=FDA-2014-D-0264 – as it then becomes part of the public record.

“FDA’s Guidance Webinar series aims to foster collaboration and transparency in the development of guidance documents through direct outreach to affected stakeholders.” (http://www.fda.gov/Training/GuidanceWebinars/default.htm)

“FDA Webinar: Guidance for Industry Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: Developing Drug Products for Treatment – April 23, 2014

The Office of Medical Policy (OMP) in CDER presents another in a series of webinars on 60-day guidances for industry on Wednesday, April 23, 2014 from 1PM – 2PM EDT. The topic is “CHRONIC FATIGUE SYNDROME”.

Guidance for Industry Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: Developing Drug Products for Treatment

FR NOTICE

PUBLICATION DATE:  03/11/2014

COMMENTS [DUE] DATE:  05/12/2014

DOCKET NUMBER: FDA–2014–D–0264 http://www.regulations.gov/#!docketDetail;D=FDA-2014-D-0264

SPEAKERS:

Janet Maynard, MD and others

Medical Officer

Division of Pulmonary, Allergy, and Rheumatology Products

Office of New Drugs

CDER/FDA

SUMMARY: This guidance is intended to assist sponsors in the development of drug products for the treatment of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). This guidance focuses on specific drug development and trial design issues that are unique to the study of CFS/ME and on the FDA’s current thinking on how effective treatments can be developed for CFS/ME. The points discussed in this guidance may not be applicable to all drug products. The FDA encourages sponsors to design clinical programs that fit their particular needs and to discuss their planned approach with the Division of Pulmonary, Allergy, and Rheumatology Products (DPARP).

For questions concerning the webinar, please contact Marsha Holloman (301-796-0731)

Webinar information on FDA’s Web site: http://www.fda.gov/Training/GuidanceWebinars/default.htm

______________________________________________________________

Guidance Webinar Online-Access Instructions:

To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers.

After following the link, enter as a guest and provide your FULL NAME and organization (i.e. “John Smith – FDA/CBER”). The host will then allow you to enter. If you experience technical difficulties email Jeffery.Rexrode@fda.hhs.gov for assistance. Closed captioning will be provided. Questions/Comments can be submitted live via a Q/A chat window.

Access link: https://collaboration.fda.gov/gfiwebinar”

http://www.fda.gov/Training/GuidanceWebinars/ucm392577.htm

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

 

 

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

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