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 )

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

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

Call to Action – petition to sign and share widely

In May, we told you about this letter (https://dl.dropboxusercontent.com/u/89158245/DHHS%20Definition%20Initiatives%20May%2012%202013.pdf) to Secretary Sebelius, Dr. Koh, Dr. Friedan and Dr. Collins about the need for an appropriate definition for patients with ME.

More details about the letter and FAQs can be found here (https://speakupaboutme.wordpress.com/2013/05/15/the-time-is-now/ “Of all the issues that we face today, the one issue that has created the most problems are the diverse case definitions associated with our disease. This single issue has severely impacted research, drug development and clinical care and misled the medical community on the very nature of this devastating disease, causing many doctors to not believe that their patients are really sick. Until this issue is addressed, patients will continue to pay the price. This must stop now.”…..)

CALL TO ACTION – A petition (http://www.thepetitionsite.com/255/349/958/fatigue-is-not-a-disease/ ) is now available for signing.

 

Anyone from anywhere can sign.

Please share the petition widely and encourage others to sign also.

 

Many thanks to Mary Dimmock, Donna Pearson and Erica Verillo for generating the petition.

PLEASE Encourage attendance! SPREAD THE WORD! SPREAD THE WORD! SPREAD THE WORD!

 

(Per Robert Miller)
ME/CFS Patients – Let the FDA Know you Exist!!!
SPREAD THE WORD! SPREAD THE WORD! SPREAD THE WORD!
PLEASE Encourage attendance!

This is one of the most important meetings for CFS/ME Patients – Thursday December 20th, is a public meeting for the FDA review for approval (hoped for) of the first ever treatment for Chronic Fatigue Syndrome.

It is important to be seen – FDA is used to seeing people attend these meetings. Other disease organizations/patients make sure the FDA knows they exist by getting patients and loved ones in front of FDA every chance they get.

If patients do not attend, FDA will think we are not interested. Please attend!

For yourself and all those suffering, we need you and your loved ones to come! You do not need to be there all day, but please attend the Public Comment Session that is from (about) Noon to 2:30 pm. Please keep in mind that this meeting could be a driving force to change the course of this illness.

We know it’s a struggle, as patients, we also know it is hard physically & mentally. We have patients coming from across the U.S. at great cost to themselves. (Giving up time with family & friends during this Holiday Season) We know the timing is BAD, but since when have our disabilities to attend meetings been taken into account?

An approved treatment for CFS will legitimize our illness in the medical community and other drug companies will see a new opportunity, which means Research.

Here’s where to go and when:

December 20, 2012

8AM-5PM (with patients giving public comment around 1:00 pm based on meeting progress, Enter by Noon)

FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room, (room 1503)
(Sign in at Building 1, BRING PHOTO ID )
Silver Spring, MD 20993-0002

No need to register; just bring ID. Enter the meeting by Noon. There is parking at FDA. You can bring food or there is a food stand there. For more information go to:
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm324972.htm

Meeting Room Details:
http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm

 

 

 

 

Your vote is needed! Claim your seat on the bus! Send your public comment!

Item #1:

VOTE!! Everyone can help by voting in this contest!  (from M.S.)

Vote for the Complex Chronic Diseases Clinic, Vancouver, Canada, a contestant in the Aviva contest going on right now through the 12th of December, for a chance for $150,000 to purchase biobank equipment.         Instructions for voting:          http://phoenixrising.me/archives/14810                Spread the word and encourage others to vote and spread the word!            Your help is much appreciated!

AND

Item # 2:

To ME/CFS Patients Living in NJ, NY, PA and surrounding area

 

 

A bus is being sponsored by Simmaron (http://simmaronresearch.com/ ) to take patients, family and friends to the FDA Advisory Meeting on Dec. 20^th on Ampligen.

 

 

This will be the first drug ever reviewed by an advisory committee for the treatment of ME/CFS. Your presence at this meeting is invaluable. Show the committee and the FDA that we need treatments and that this disease is serious.

 

 

The bus (free ride) will be leaving from 783 Jersey Avenue, New Brunswick, NJ (parking is safe and available for the full day – no cost). There are 28 seats available. Drinks & snacks, comfortable seating and restroom facilities on board.

 

 

Boarding Location: 783 Jersey Avenue, New Brunswick, NJ

 

 

Time: Thursday, December 20, 7:00 AM BOARDING – 7:30 AM DEPARTURE

 

 

Time: The bus will board at 7 AM; depart by 7:30 AM and head to the meeting in Silver Spring, MD. The bus will re-board at end of meeting at 5:30 PM and head back to NJ.

 

 

If you are interested in going – you must email or phone Nancy by Thursday, Dec. 13^th at 1 PM. Email: nancyimc2@aol.com or call her at 610-952-2595.

 

 

FDA meeting link: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm324972.htm

CDER

December 20, 2012

8:00 a.m. to 5:00 p.m.

 

FDA White Oak Campus Building 31 Great Room (Rm. 1503) White Oak Conference Center 10903 New Hampshire Avenue Silver Spring, Maryland

Item #3:

If you were unable to submit your public comment for the 20 December 2012 FDA meeting about Ampligen, Bob Miller (511bobmiller42@gmail.com)has offered to hand carry your public comment to the meeting.  He cannot guarantee that they will be read but they will be seen!

Tell the advisory committee what it is like to have ME/CFS and tell them that treatment is needed NOW.  

Feel free to use this template:

“Subject line:  Treatment for Chronic Fatigue Syndrome- Ampligen

To The Advisory Committee Reviewing Ampligen:

My name is ___________________…. .

I have had CFS for more than ___ years. 

Before I became ill, I ______________________……. 

My life because of CFS _______________________________________________…….. 

The reality is that CFS is a horribly devastating illness that effects every moment of my life. 

CFS patients need treatments.

We have seen patients do well on Ampligen. We have seen patients’ quality of life improve as a result of Ampligen.

Help us have access to treatments.

Please give the CFS community hope of getting our lives back.

Sincerely,

“

Public Comments due Thursday, December 6th 2012 for FDA Advisory Committee on Ampligen CALL TO ACTION (updated)

Thursday, 6 December, 2012 is the deadline to submit public comment for the 20 Dec 2012 Arthritis Advisory Committee Meeting!

(2 Dec 2012 – CORRECT EMAIL ADDRESS:   AAC@fda.hhs.gov)

Please spread the word about this – there are only a few days until the deadline. Anyone, anywhere can participate!

If anyone has trouble submitting their comments please email us (see below) – we will do our best to help.

Why is it important for you to send your comments?

For the first time ever, ME/CFS has the chance to get a treatment approved.  Whether you have been on Ampligen or not, whether you wanted to try it or not – once one drug gets approved other drugs will come along and so will additional research dollars.  It will also legitimize the disease in the minds of the medical community and the world.

Why is this public comment just about Ampligen?

Because this particular meeting is part of the process to approve a drug. 

Send in your comments to let the advisory committee know what it is like to have ME/CFS and to tell them that treatment is needed NOW.  

Your comments do not need to be lengthy. Feel free to use the template below. (The template uses CFS because that is how the FDA website http://www.fda.gov/AdvisoryCommittees/Calendar/ucm324972.htm refers to this wretched illness. Using CFS will probably make it easier for those on the committee to follow.)

(The advocacy community will continue to update you about additional significant meetings coming up – including the Stakeholder meeting in the spring, as well as about issues dealing with CDC and NIH…) 

Right now we need to let the Advisory Committee hear us on this issue.

Send in your public comment by THURSDAY DECEMBER 6^th, 2012

Send your comments to: AAC@fda.hhs.gov   (this is the correct email address)

Subject line:  Treatment for Chronic Fatigue Syndrome- Ampligen

To The Advisory Committee Reviewing Ampligen:

My name is ___________________…. .

I have had CFS for more than ___ years. 

Before I became ill, I ______________________……. 

My life because of CFS _______________________________________________…….. 

The reality is that CFS is a horribly devastating illness that effects every moment of my life. 

CFS patients need treatments.

We have seen patients do well on Ampligen. We have seen patients’ quality of life improve as a result of Ampligen.

Help us have access to treatments.

Please give the CFS community hope of getting our lives back.

Sincerely,

…………………………

send a copy of your email to:  (SpeakUpAboutMe at gmail dot com)

Remember to send in your public comment by THURSDAY DECEMBER 6^th, 2012