Archive for May, 2012

Registration and Public Comment Sign up Instructions for 2012 CFSAC Spring Meeting

New procedure and registration format!  

As with most new procedures there seem to be a few glitches and questions about the procedures. As we get answers, we will do our best to update this information.

PLEASE NOTE – there are TWO registration forms.

One is for attendance (this is new and there is no option – at present – to indicate if one is attending both days or one day only).

The other registration form is for public comment. There is an option here for stating the preferred date one wants to give public comment, but no guarantees of it.

“CFSAC Registration

Public attendance is welcome, but due to limited space advance registration is required. Individuals who plan to attend should register at the following link by Friday, June 8, 2012http://www.blsmeetings.net/CFSACJune2012.  Members of the media will also need to register.

All attendees will be required to show government-issued picture identification for entry into the federal building.  Attendees will receive a wrist band that must be worn the entire time. Security requires all non-federal employees to be escorted the entire time they are in the building. Upon leaving the building for any reason all persons will be required to follow the security steps mentioned above and receive a new wrist band. Members of the public will have the opportunity to provide public comments at the meeting or via telephone. International calls cannot be accommodated.

Public Comment Sign Up

A separate sign-up process for requesting time for public comment must be completed by Wednesday, June 6, 2012 at the following link: http://www.blsmeetings.net/CFSACPublicComment.

Individuals wishing to provide public comment must also submit an electronic copy of their testimony in advance to: CFSACJUNE2012@seamoncorporation.com by Wednesday, June 6, 2012.  We require that you email a document (5 pages or less) in MS WORD format that is single-spaced, 12-point font.

Note:  PDF files, hand-written notes and photographs will not be accepted.  Requests for public comment and written testimony will not be accepted through the CFSAC mailbox. Also, the CFSAC mailbox will not respond to questions about specific public comment requests.

All public comment becomes part of the public record, available for viewing and posted on the CFSAC website.  All testimony and printed material submitted for the meeting are part of the official meeting record and will be uploaded to the CFSAC website and made available for public inspection. Testimony and materials submitted should not include sensitive personal information, such as social security number, birthdates, driver’s license number, state identification or foreign country equivalent, passport number, financial account number, or credit or debit card number.  Sensitive health information, or non-public corporate or trade association information, such as trade secrets or other proprietary information should be excluded from any materials submitted. If you wish to remain anonymous the document must specify this.

We will confirm your time for public comment via email by Monday, June 11, 2012. Each speaker will be limited to five minutes per speaker; no exceptions will be made.  We will give priority to individuals who have not provided public comment within the previous year.

 Persons who wish to distribute printed materials to CFSAC members should submit one copy to Designated Federal Officer at cfsac@hhs.gov, prior to Wednesday, June 6, 2012.  Submissions are limited to 5 typewritten pages. ”                          http://www.hhs.gov/advcomcfs/2012spring_mtng_signup_instr.html

 
 

 

Reminder – The Empty Chair Project* for June 2012 CFSAC meeting

Photos, reasons and release forms are needed by May 29th !!!

Submit:

Photo(s) (jpeg format) suitable for 8×10 inch print (photos can be current, prior to illness, both, silhouette, etc.)

Reason(s) the individual cannot be at the CFSAC

Signed release form *

to SpeakUpAboutME at gmail dot com

Family members/friends, etc. can also be part of The Empty Chair Project, if they would like to participate in the CFSAC, but cannot be there and the reasons they can’t be there. (for example – can’t afford to take additional time off from work, can’t afford the expenses and so on.)

Are you providing public comment remotely (via DVD/phone)? – send your photo. Someone will sit at the table and hold up your photo during your public comment. (Connecting a face with the public comment provides huge visual impact.)

If your name cannot/should not be used, please provide a nickname.

Each participant must submit a completed and signed release form (in part, so that the CFSAC will allow us to display the photo).

* Request release form from SpeakUpAboutME at gmail dot com.

(We need photos, reasons and forms by May 29th in order to get photos printed and assembled.)

*PANDORA originated The Empty Chair Project. We thank them for letting us revive it.

Have you read Chronic Fatigue Syndrome Myalgic Encephalomyelitis A Primer for Clinical Practitioners?

Chronic Fatigue Syndrome Myalgic Encephalomyelitis A Primer for Clinical Practitioners  

International Association for Chronic Fatigue Syndrome Myalgic Encephalomyelitis (IACFS/ME) 2012 Edition

 

Highlights of the Primer include:

  • A summary of the pathophysiological effects of ME/CFS to date
  • A user-friendly diagnostic worksheet utilizing the Canadian Consensus Criteria
  • Straightforward treatment suggestions covering an array of ME/CFS symptoms
  • Emphasis on post-exertional malaise and activity management
  • Sections on special populations/ problems (e.g. severely affected, pediatric ME/CFS, pregnancy)

 

(The IACFS/ME requests a contribution of $15.00 (U.S.) for the Primer.    Follow these links to contribute for the Primer:

$15.00 Donation (via Paypal)

Or your own amount (via Paypal)

http://www.iacfsme.org/Home/Primer/tabid/509/Default.aspx)

 

Help the IACFS/ME make this the best Primer yet for ME/CFS! They are collecting comments and suggestions on the Primer and will update it on their website.

 

 

http://www.iacfsme.org/Portals/0/PDF/PrimerFinal3.pdf

Call to Action FOLLOW-UP Letter

If you have sent the second letter,  Thank you! 

If you will be sending it in coming days, please use this updated version.  (The letter is unchanged but two of the recipients requested to be removed from the list.)

Thank you!

CALL FOR THE FDA TO HOLD A STAKEHOLDER MEETING – SECOND LETTER!
May 18, 2012

To All who took ACTION requesting THE FDA TO HOLD A STAKEHOLDERS MEETING for ME/CFS  

THANK YOU!!

We have not yet heard from the FDA re: The ME/CFS Stakeholders Meeting. Therefore, we ask everyone to send in a follow up letter. This letter is directed to Dr. Woodcock and is requesting that the stakeholder meeting be held and that we are responded to by June 1. We are urging Dr. Woodcock to preside over this critical meeting.

PLEASE SEND YOUR LETTER BY MAY 25 and urge your relatives and friends to do the same. (Feel free to send more than one letter, even one per day.) A sample template letter and email addresses are included below. Just Copy, Insert your name at the top (and names and address at the bottom) and Paste.

YOUR LETTERS COUNT. Remember – INTENSE LOBBYING & ADVOCACY is how AIDS/HIV got $3 BILLION a year for research, CFS gets $6 million. AIDS/HIV sufferers now have multiple drugs to fight the disease. We have NONE. 

WE MUST STAND UP FOR OURSELVES, and ask family and friends to do the same, We Must Change Our Situation. We must insist that those who work for our benefit listen to us and Act!

For reference, the original sample letter that was sent in late April can be found at these links on Co-Cure and Phoenix Rising.

Thank you everyone, for taking ACTION!

Copy & Paste email addresses

To:  Kathleen.Sebelius@hhs.gov margaret.hamburg@fda.hhs.govjanet.woodcock@fda.hhs.gov, howard.koh@hhs.gov , brian_ahlberg@harkin.senate.gov, Michael_Barnard@menendez.senate.govAlex_Stern@mikulski.senate.gov jeff.carroll@mail.house.gov monica.volante@mail.house.gov ,   Annie_Walden-Newman@murray.senate.gov ,  Kristen.Molloy@mail.house.gov ,  Call2action.njcfsa@gmail.com

The last email address is merely a counter.  Your emails remain private.  Please note: the mailing is limited to requesting the stakeholders meeting. 

_____________________________________________________________________________________________________

Sample Letter to Dr. Woodcock 

From: Your Name                                                                                May 18, 2012

To: Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research

cc:       Secretary Kathleen Sebelius, Department of Health and Human Services; Dr. Margaret Hamburg, Commissioner, FDA, Dr. Howard Koh, Assistant Secretary of Health; Chairman Tom Harkin, Health, Education, Labor, and Pensions, Senator Barbara Mikulski (D-MD), Senator Menendez (D-NJ), Senator Patty Murray (D-WA), Congressman Frank Pallone (D-NJ), Congressman Joseph Pitts (R-PA)

Subject: Request for FDA Stakeholder Meeting on Chronic Fatigue Syndrome

Dear Dr. Woodcock:

We urge you to preside over a stakeholder meeting of the clinicians, researchers, manufacturers, advocacy groups, and patients to engage in a rigorous dialogue to accelerate treatment for ME/CFS.  We ask you to set a date for this meeting by June 1st.

As declared by Dr. Hamburg “FDA has an important role to play in shaping the future of medical breakthroughs by bringing stakeholders together to identify and overcome challenges.” It’s time for the FDA to live up to their role.

As you yourself have stated, “It should be noted that FDA assess the benefit-risk of new drugs on case-by-case basis, considering the degree of the unmet medical need and the severity and morbidity of the condition the drug is intended to treat.”

As one of the millions of people suffering from ME/CFS, I cannot even dream about a better quality of life because there is simply no avenue to get there. I live every day with a disease that the CDC has said is as disabling as multiple sclerosis, heart disease, end-stage renal disease and similar chronic conditions; AND YET THERE ARE ZERO TREATMENTS TODAY. As this falls within your responsibility to address this “unmet medical need” please Act Now.

Your Name

Address

City, State  –  Zip code 

A friend pointed us in the direction of this video and we hope that you appreciate it as much as we do.

Sincere thanks to the young person* who made it.

 

 

 

 

 

 

 

(*Please be in touch with us. SpeakUpAboutME at gmail dot com)

Be M.E. Aware


ME/CFS ribbon

(http://meaware.wordpress.com/badges)

Speak Up About ME!

Solve ME/CFS!

ME/CFS

(Myalgic Encephalomyelitis/Chronic Fatigue Syndrome)

Is much more than “fatigue”.

ME/CFS is a chronic, often severely disabling disease that affects the autonomic nervous system, immune system, endocrine system, among others. ME/CFS is unique in that it results in “…marked, rapid physical and/or cognitive fatigability in response to exertion, which may be minimal, such as activities of daily living or simple mental tasks…”* causing relapses that can last for weeks.

ME/CFS affects more than one million Americans of every age, race, ethnicity, and socioeconomic group.

ME/CFS costs the United States over $20 billion/year in medical/disability costs and lost productivity**.

People with ME/CFS need effective treatments so that they are no longer destined to a lifetime of disability.

What must be done:

Provide ongoing research funding on par with equally disabling illnesses such as MS. (e.g.-NIH budgets $6/ME/CFS patient for research vs. $270/MS patient for research ***.)


confirm your participation

Please spread near and far

If necessary, copy and paste into an email, fill in answers (12 questions) and send to Speak Up About ME at gmail dot com

Confirm your participation with Speak Up About ME today!

CFSAC meeting June 13th/14th 2012                      Capitol Hill meetings – arrangements under way.

1. Name(s) and cell phone number(s):

 

2. email(s):

 

3. address:

 

4. phone number:

 

5. t-shirt size for each Speak Up About ME ME/CFS patient*:

 

6. We (# of people __________) will join you for dinner* at the hotel on June 12th (yes or no)

 

We are securing a block of hotel rooms and need to know how many rooms to get.

7. How many hotel rooms do you need for the night of Tuesday, June 12th ?

8. June 13th Speak Up About ME participation (yes or no)

 

9. How many hotel rooms do you need for the night of Wednesday, June 13th?

10. June 14th Speak Up About ME participation (yes or no)

 

Additional opportunity to participate in Capitol Hill meetings on Friday, June 15th.

11. How many hotel rooms do you need for the night of Thursday, June 14th ?

12. We will participate in (Capitol Hill) meetings on (Friday) June 15th (yes or no)

 

* – probably pizza, drinks, fruit… A great opportunity to meet other people, learn more about the meeting on Wednesday/Thursday…

** t-shirts will be oversized, to be worn over other clothes, as the meeting room tends to be cool

 

Ask questions – we will do our best to answer them