#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.”

 

 

 

 

 

link to Miriam Tucker’s article Chronic Fatigue Syndrome: Wrong Name, Real Illness

 

http://www.medscape.com/viewarticle/837577_2
“Chronic Fatigue Syndrome: Wrong Name, Real Illness
Miriam E. Tucker
January 08, 2015

Introduction

Sufferers of what has been called chronic fatigue syndrome (CFS) are challenging patients, presenting with complaints of postexertional
malaise, persistent flulike symptoms, unrefreshing sleep, “brain fog,” and often a long list of other symptoms that don’t seem to fit any
recognizable pattern. Some appear ill, but many don’t. And the routine laboratory tests typically come back negative. ….”

http://www.medscape.com/viewarticle/837577_2

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

Connections, study contact info

One of the highlights of (most) meetings is the opportunity for connecting with people. Such was the case with the IACFS/ME conference held last week in San Francisco.

(There have been some excellent summaries of the IACFS/ME conference — among them: http://phoenixrising.me/archives/24323 , http://phoenixrising.me/archives/24390 , http://phoenixrising.me/archives/24452 , http://phoenixrising.me/archives/24522 , http://phoenixrising.me/archives/24553 , and http://quixoticmeblog.blogspot.com/2014/03/detailed-notes-from-all-4-days-of.html .)

Over and over people talked about how they had exchanged emails with this person or that person for years but had never met in person until this meeting.
ME is such a horribly isolating illness. Even caregivers are often isolated.

Therefore being able to meet other advocates in person, being able to exchange ideas with clinicians/researchers, etc. is exciting and invigorating (and exhausting).

Among the people I spoke with was Dr. Jim Baraniuk who has a study that will start soon (he did not say when). He provided the following contact info for it:

Exercise and Brain Scan Study
Purpose: to understand Chronic Fatigue Syndrome (CFS)
Who: Adults (over 18 years old) with and without CFS are invited to participate.

What: Subjects will have magnetic resonance imaging (MRI) brain scans then bicycle exercise tests.
They will stay overnight, then have a 2nd exercise test and MRI the next day.

Where: Clinical Research Unit, Georgetown University, Washington D.C.
Compensation for time and travel will be paid.

Contacts: Telephone 202-687-8231, FAX 202-687-9886

E-mail:cfsresearch@georgetown.edu or baraniuklab@gmail.com
Georgetown University Medical Center (edit *)

When you contact the lab you might ask (among other things) for clarification about the extent of the bicycle exercise testing, the criteria for patient selection, whether or not any cognitive testing will be done as well (if so, at which points during the study). Please share the responses you get and help us make them widely available.

Many of us came away from the IACFS/ME conference with information on numerous studies and avenues of exploration, getting lots of ideas, hearing hints about soon-to-be-published studies and great connections (some new ones, some long-standing ones but first time in-person meetings)…..

This was a real treat and I am deeply grateful to everyone who helped facilitate attendance at the meeting.

 

(*edited  – disclaimer – I have no connection to and accept no responsibility for the study or participation in it. Thanks for the reminder TK.)

Questions —- lots of them

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

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

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

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

           “In general, the Federal Government isn’t in the position of telling doctors a case definition. I think a recommendation from CFSAC that the Secretary should tell people to use “X”                   definition will go nowhere because that’s not what we do. This is a clinical decision that has to come from the clinical community. . .

I’ve been in two or three meetings with the Secretary since I’ve been here. One of them was around this: the idea of a case definition, the need for one, and in addition, the need for a different name for the disease. She basically said that this has to be coming from the medical community. CFS Advisory Committee Minutes, October 4, 2012, p. 37, 38.”

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

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

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

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

“CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS)experts, patients, advocates) workshop  in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus  Definition for discussion purposes.” http://www.hhs.gov/advcomcfs/recommendations/10032012.html

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

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

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

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

Have we seen evidence of this transparency?

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

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

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

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

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

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

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

Lots of questions…..

Just say NO to tapioca!

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

 

Subject: MECFS definitions

Secretary Sebelius,

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

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

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

Thank you for your consideration. Go Jayhawks. 

Joe Landson

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

NIH and funding priorities

Hint, ME(cfs) isn’t one of them.

 

Ms. Spotila at Occupy CFS has another post that deserves to be read, discussed and shared widely:

http://www.occupycfs.com/2013/05/15/2012-nih-spending-on-cfs-studies/

“….The 2012 numbers are now available, and the news is not good at all: funding has fallen off a cliff to its lowest level since 2008.

First, recall that NIH had projected to spend $6 million on CFS research in 2012, the same as the amount spent in 2011. Unfortunately, NIH now says that it spent $5 million in 2012, and projects the same amount for 2013 and 2014. Even worse, when I dug into the actual grants, I found that NIH had spent far less than $5 million.

There are 16 grants listed for 2012 spending (several grants appear twice on the list because they received funding from more than one Institute) for a total of $4,518,182. This is a decrease of $1,827,966 or 28.8% from the 2011 funding. In 2011, ME/CFS was 218th out of 235 disease categories funded by NIH. In 2012, we dropped to 224th place. ….”

http://www.occupycfs.com/2013/05/15/2012-nih-spending-on-cfs-studies/

 

 

Register for CFSAC May 2013 attendance and for public comment

The Spring 2013 CFSAC meeting will be held May 22–23, 2013

Registration is open:

http://www.blsmeetings.net/CFSACMay2013/

To register for public comment:

http://www.blsmeetings.net/CFSACPublicCommentMay2013/

 

The Federal Register notice for the May 2013 CFSAC meeting:

http://www.gpo.gov/fdsys/pkg/FR-2013-04-30/pdf/2013-10083.pdf

The meeting will be held at the Department of Health and Human Services; Hubert H. Humphrey Building; 200 Independence Avenue SW., Room 800; Washington, DC 2020

Video of FDA meeting (April 25/26 2013) now available

The FDA public workshop on Drug Development for CFS and ME ended on Friday at 5pm and the video is already available. (Pretty good turnaround time!)

Video of the April 25/26 2013 FDA meeting is now archived and available for viewing.

http://www.tvworldwide.com/events/fda/130425/

(Scroll down on the right side under webcast archives.)

 

Thanks for eagle-eyed Nielk for spotting it! 🙂