Archive for April, 2012

SPEAK UP ABOUT ME June 13th and 14th, 2012


Speak Up About ME especially welcomes early onset patients.

Who:    young people with ME/CFS and ME/CFS advocates

What:   Speak Up About ME

Where: Washington DC Chronic Fatigue Syndrome Advisory Committee (CFSAC) meeting

Why:    to Speak Up About ME –

to raise awareness about ME/CFS because ME/CFS affects people of all ages/genders/etc.,

to provide public comment to the CFSAC committee,

to be Invisible No More!

When: June 13th and 14th 2012

We are going to YANK the nation’s heartstrings again.

Young People with ME/CFS –


Speak Up About ME, to be

Invisible No More!

Why is my participation important?

Physical presence and providing your public comment in person at the CFSAC has great impact and is an empowering experience.

Providing your public comment via DVD is also very powerful.

Public comment can be provided by phone and in writing by those who are unable to attend in person.

(Read more about public comment here: )


We gladly welcome mentors, volunteers, supporters, contributors.


Help defray expenses for Speak Up About ME participants! for information on how to contribute.


Contact Speak Up About ME at gmail dot com  (all one word, no spaces) for more information.


If you are so sick, why are you taking part in Speak Up About ME?

Advocacy and empowerment– we don’t want anyone else to go through what we are going through. By raising awareness, we work to ensure that no one else has to go through this.  This is a personal sacrifice and it takes weeks for us to return to our previous level of functioning.  And yet, participation is empowering, despite the toll it takes on us.


What can I tell my school about the event?

Speak Up About ME participants are part of government in action. Participating in the CFSAC and/or meeting with Congressional representatives on Capitol Hill are integrated learning experiences (advocacy, public speaking, science, geography, social studies).



The next Chronic Fatigue Syndrome Advisory Committee (CFSAC) meeting will take place on Wednesday, June 13th and Thursday, June 14th, 2012

“The Chronic Fatigue Syndrome Advisory Committee (CFSAC), 2012 spring meeting will be held on Wednesday, June 13, 2012 from 9:00 a.m. until 5:00 p.m. EST and Thursday, June 14, 2012 from 9:00 a.m. until 5:00 p.m. EST.

The meeting will be held at the U.S.  Department of Health and Human Services, Hubert Humphrey Building, 200 Independence Avenue, S.W., Room 800,  Washington, D.C. 20201.  For directions please visit

The meeting will be webcast live [YES, THIS IS LIVESTREAM AGAIN!!!] and [option] available by audio (listening-only). Additional information and the CFSAC agenda will be posted to the CFSAC website by June 4, 2012.”

Under federal regulations, notice must be given seven calendar days prior to the meeting.

Many of us have repeatedly stressed to the DHHS and to the CFSAC that because the ME/CFS community is comprised of many people with severe disabilities, we need and deserve much more notice in order to make arrangements to participate.

We have gotten about seven weeks(!) notice.

This will help those of us who can participate in person and everyone who will be participating via public comment.

Have you written your public comment yet?

Please note – registration for attendance and public comment is not yet open.

Call For Action

===============   Call For Action   ===============

To:     All ME/CFS Patients, Loved Ones and Patient Groups                            April 23, 2012

Subject:   Request FDA Stakeholder Meeting for ME/CFS

For decades, ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) has devastated the lives of patients and our loved ones, leaving us with an alarmingly low quality of life. Today, ME/CFS affects the lives of more than 1 million Americans of all genders and all ages at an annual cost of at least $21 billion in direct costs and lost productivity.

As patients and loved ones, we have suffered too long with too little research, a disbelieving medical community and no approved drug treatment specifically for ME/CFS.

This has to change!  We know that we need many things, such as more money for research. But right now, legislation is being put forth by Congress and also via the FDA to accelerate drugs for chronic illnesses. We want to capitalize on this opportunity now to make a change for ME/CFS. We are calling on the FDA to hold a Stakeholder meeting to discuss approval of ME/CFS treatments.

We are not endorsing any drug/treatment, nor are we asking you to endorse any drug/treatment, but rather, we are asking the FDA for action!

We need the FDA to hear from as many people as possible to ensure that the Stakeholder meeting happens.

Please write and/or call before May 2, 2012 to request the stakeholder meeting.

Please ask your families and friends to send letters on your behalf.

And please use Facebook, Twitter, etc. to get the word out for ACTION NOW!

A Template for the letter along with Email addresses and other details are below.

Thank you for taking part in your recovery!



Instructions for the email

1.  Use the attached template for the letter to Secretary Sebelius/Dr. Hamburg

We ask that you follow this template as closely as possible as that will strengthen our request.

Personalizing the email: The template has space for you to add 2-3 brief sentences about your personal story or information at the end of the second paragraph.

a. Change the items in red text (your name, the date you are sending the email, your story and your contact info).

b. Replace the personal story in the template with your own story, adding details like how long you have been ill and how ME/CFS has affected your life, work, finances, etc.,

If you do add a personal story, please try to keep the overall email length to less than 1 page because it will be more likely to be read. If you want to go more in-depth with personal stories, we ask that you send a separate email as a follow-up after our action is done.

c. If you do not wish to personalize, just remove the personal story from your letter.

Sending the letter:When your letter is ready:

a. Cut and paste your letter directly into the body of your email. Please do not attach as a separate document as it may not get through email systems and is less likely to be read.

b. Add the email addresses by cutting and pasting the following list of emails directly into the “To” box. The one email message will go to all addressees at one time.

2. Email addresses , , ,, , ,    

(The following addresses are included as the contacts for the corresponding legislative leader

Senator Harkin (,  Senator Mikulski (, Congressman Pallone (, Congressman Pitts (, Senator Murray (

The address is included for the sole purpose of allowing us to track the number of letters sent. )

3.  Contact your senator or congressman

You may wish to send a letter (or forward this one) to your senator or congressman as well, especially if they are involved in the Health, Education, Labor and Pension Committee or on the House Appropriations Committee, which has a subcommittee for Health.

If you do not have an email address for your senator or congressman, you can use the following links to access the contact forms for those from your state.

Senators –

Congressmen –



EMAIL TEMPLATE:    One Email sent to those listed below 



From: John Smith                                                                                                      May 2, 2012

To:      Secretary Kathleen Sebelius, Department of Health and Human Services

Dr. Margaret Hamburg, FDA Commissioner

Cc:      Dr. Janet Woodcock, Office of New Drugs, FDA, Dr. Nancy Lee, Director Office of Women’s Health, Dr. Howard Koh, Assistant Secretary of Health, Chairman Tom Harkin, Health, Education, Labor, and Pensions, Senator Barbara Mikulski (D-MD), Senator Patty Murray (D-WA), Congressman Frank Pallone (D-NJ), Congressman Joseph Pitts (R-PA),

Subject: Chronic Fatigue Syndrome: Request for Stakeholder Meeting


I am John Smith and I write to you to request that the FDA hold a Stakeholder meeting to discuss treatment opportunities for Chronic Fatigue Syndrome (also called Myalgic Encephalomyelitis or ME/CFS), a debilitating disease that affects more than one million Americans of both sexes and all ages.


For decades, ME/CFS has obliterated the lives of patients and their families, leaving them with a pitiful quality of life, no hope of treatment and a medical community ill prepared to care for them. Compounding the personal devastation is the effect on our country’s economic well being; ME/CFS drains our workforce and costs our economy more than $21 billion annually. In spite of all this, little has been done to address our situation. My son is one of those millions with ME/CFS who have been left to rot. His life was cut down by ME/CFS at age 22 and if nothing changes, he will be very sick for the rest of his life, never able to work and more likely to die prematurely. 


I am aware of the FDA’s role in “assessing the benefit-risk of new drugs on a case by case basis” and in “shaping the future of medical breakthroughs by bringing stakeholders together to identify and overcome challenges”.  Yet, ME/CFS patients continue to suffer terribly while ME/CFS as a disease has been moved through six different divisions at the FDA and the only treatment for ME/CFS has been stuck in the FDA process for over a decade.


ME/CFS demands real and significant action today. I request that FDA hold a Stakeholder meeting, including Dr.Woodcock, Dr. Lee, expert ME/CFS clinicians, patients, product sponsor and other key stakeholders, to explore opportunities to accelerate approval of treatments. Approval of a drug is critical to changing the face of this disease.


Robert Miller, a ME/CFS patient/advocate, will contact you in two weeks to confirm scheduling of this meeting.


As patients and family, we cannot allow our lives to be destroyed any longer. This meeting must happen!



John Smith

Waterford, Ct 06385


Have you started writing your public comment?

There is no need to wait for CFSAC dates to be announced before you start writing. Start now.



Contact us if you want to work with a mentor to make your public comment.

Mentors help ensure that your public comment clearly says what you want to convey.

More about public comment at the CFSAC

Patients and advocates have the opportunity to speak at the CFSAC during public comment time IF they register in time.
(Time slots fill up FAST when they become available – they are usually filled the same day registration opens. Don’t despair though, usually a number of people who are wait-listed for public comment, get time slots at the last minute.)

About the Chronic Fatigue Syndrome Advisory Committee (CFSAC)

“The Chronic Fatigue Syndrome Advisory Committee (CFSAC) provides advice and recommendations to the Secretary of Health and Human Services … on issues related to chronic fatigue syndrome (CFS). These include:

  • factors affecting access and care for persons with CFS;
  • the science and definition of CFS; and
  • broader public health, clinical, research and educational issues related to CFS.”

The committee is made up of clinicians and researchers who treat people with ME/CFS and study ME/CFS (and overlapping illnesses), at least one attorney (who deals with disability cases), a patient advocate (the current advocate is a person with ME/CFS). These people serve on the committee in addition to their full-time positions. This is not a paid position (they do receive a per diem).

The committee members have been selected by the Department of Health and Human Services (DHHS) as the DHHS designated experts on ME/CFS. (DHHS oversees the CDC, NIH, FDA, etc.

The committee is also comprised of a number of ex-officio members from the NIH,CDC, FDA and other government agencies. Initially many of the ex-officios have little or no direct experience with ME/CFS.

Meeting announcements are posted in the Federal Register. (Sample:

Announcements are usually made about 4 weeks before the meeting and that is when we find out the dates of the meeting. The meetings (held twice a year – usually spring and fall) are usually two days long.

This is VERY important –

As soon as the notice is posted in the Federal Register, each person who wants to provide public comment has to IMMEDIATELY send an email ( requesting a time slot (for live or remote comment).

There are usually about 35 five-minute time slots.

You will probably receive an automated reply saying that your email was received. (Suggestion – save copies of your emails.) You will not hear back immediately (or even for a few weeks) about whether or not you got a time slot. (Let us know as you soon you do receive a time slot.)

Being at these meetings enables patients to meet and interact with other patients, parents, advocates, researchers, clinicians, etc. The meetings are also an opportunity to make friends.

Public comment:

Anyone can request public comment time. Family members, friends, etc can request time. From time to time only one person from a family gets a time slot because there are so many requests and so few slots.

Public comment can be done in a variety of ways. (Among them – in person, via DVD, via phone, in writing…)

In person – is usually done sitting at the table (with a microphone), reading your presentation (unless you have it memorized).

Creativity is welcome. You can do a skit. You can read a poem, etc.

You are welcome to have other people at the table with you (you do not have to sit there alone).

In some meetings, patients and advocates have stood beside the person presenting as a show of solidarity.

Each person who gets a public comment time slot is limited to five minutes. (The Designated Federal Official uses a timer and will tell you when you have one minute remaining.)

Your public comment can be less than five minutes.


Reading aloud (Most people read their public comment aloud at the meeting) – Practice reading aloud (using a timer) what you have written. If possible, have someone listen to you reading your public comment aloud to make sure that you can be heard and that you are speaking clearly.

Every person presenting public comment should submit the text ahead of time so that it can be printed and put in the binders for each committee member.

DVD – Public comment can be presented via DVD. (The DVDs must be sent in ahead of time. If you use this format, try to make sure that a backup copy is on site with someone attending the CFSAC in DC – just in case.)

Phone – Public comment can be given by phone (for those who are too sick to attend, do not have a travel companion, cannot afford to attend, etc.). The committee calls you, so you don’t incur long-distance charges.

Written submission – Public comment can also be done as a written submission.

ALL public comment text should be submitted as a pdf (there is a date in the Federal Register notice as to when the public comments should be in) and can be NO more than five pages in length. Keep in mind that five written pages, is much more than five minutes of speaking. So, your written comments can be longer than your oral comments.

Some things to think about as you draft your public comment:

Assume the committee members are on our side.

Be assertive and passionate about how the CFSAC can, and why they should, help you/us.

Remember that Speak Up About ME has mentors who can work with you to craft your public comment.

Why it is so difficult to find out when the CFSAC meetings will be?

It seems that much of it has to do with scheduling.

(Not the huge amounts of scheduling that needs to be done by interested parties in order to be at the CFSAC, but the committee members, etc.)

Some of the schedules that have to be taken into account are:

ex-officio members,

CFSAC committee members,

Designated Federal Officer (Dr. Lee),

Assistant Secretary of Health (Dr. Koh),

And a meeting space that must be in a Federal building (per directives issued in Jan. 2012 by the White House and by the Department of Health and Human Services).

All of these have to align for the CFSAC to be scheduled.

Take the ME/CFS Social Security Disability/SSI Survey

Anecdotal reports from physicians and patients suggest that being approved for Social Security disability (SSDI) may be more difficult for ME/CFS patients than for patients with other illnesses. Documentation of success rates is lacking and there is very little hard data on what works best in the disability process.

We look forward to finding out many things with this survey.

Among them:

to see if there are common threads in successful applications.

to see if the application process has been streamlined  – Social Security says that it has.

to find out how things have changed over time for applicants and

what sort of success rates applicants have with SSDI/SSI determinations.

If you are a U.S.* citizen, and have ever filed for SSDI and/or SSI, please complete the survey.

Here is the link for the survey:


The information gathered will be used to provide a report to the CFSAC and the Social Security Administration on the “State of the Social Security Disability Process in the Online (US) CFS Community” and to inform future disability applicants with ME/CFS of factors that might help them be more successful.

You can do the survey in multiple passes by saving and returning.

Feel free to have someone complete the survey for you (if they know you) if you cannot do so yourself.) Only one survey per computer, though –if multiple members of your household have gone through the disability process you’ll need to use more than one computer.

All personal information such as name and email address (if you chose to provide them) will be kept confidential.

Encourage others who have applied for SSDI and or SSI to take the survey also!

* – It is not our intention to exclude citizens of other countries – we just don’t know enough (yet) about social services and disability in other countries to put together similar surveys. Help us all learn about social services and disability in your country by submitting legitimate/valid information about them.

Cooling vests and other cooling products

Some people with OI (orthostatic intolerance), POTS (Postural Orthostatic Tachycardia Syndrome), etc. do better in warm weather and others so better in cold weather.


Increased humidity, poor air quality and heat have very negative effects on the two patients I know best.


In 2011 we found out about cooling vests (and other cooling products) and a friend gave us the following list of links to some cooling products*:


We were pleased to discover that the cooling vests and neck wraps do indeed make a difference for our household (even indoors).


Consider the humidity levels of your area.


If high humidity is frequent in your area, products that use freezer/gel packs (while more expensive) cool much more effectively than evaporative products.




* This list is a sampling of sites that have these products. We will gladly make this list more extensive if legitimate links are sent to us. Legitimate links for such sites in countries outside the US are also hoped for.