Archive for September, 2012

TV screening of Voices From The Shadows (Brisbane Australia)

Voices From the Shadows is a documentary about ME/CFS.

It is very powerful, it is very moving*.

TV Screening in Australia – Brisbane

“Posted by Admin on September 20, 2012 in News

We are delighted to announce the first TV screening of Voices from the Shadows this year. It is being broadcast by 31Digital Community Television Station in Brisbane on Sunday 7th of October 2012. We would like to thank Lesley McLeod, as this has come about entirely as a result of her determined efforts to use the film for educating people in her region.”


Please spread the word about this TV screening!


*May be too emotionally wrenching for young people with ME/CFS.


FDA, CFSAC, and Voting

FDA comment deadline

Remember that your comments, questions, etc. about the FDA teleconference held Sept 13th, 2012 (transcript must be submitted by Sept 30th.

(These suggestions might help )

Then go to:!home;tab=search Search for Docket # FDA-2012-N-0962 And follow the instructions for providing your input. (Your comments provided to the FDA Docket are part of the public record.)

CFSAC October 2012

The CFSAC meeting will be LiveStreamed again on October 3rd and 4th, 2012.

Details will be posted (hopefully soon) here:

The CFSAC agenda has now been posted here:

Some of the presentations include:


a presentation by Dr. Kweder from the FDA about drug development,

and a presentation by the Social Security Administration.


If you are a U.S citizen, remember to (register if you need to) vote in the November election.

Find voting information for your state:

(Thank you for the link L)

To find out about absentee ballots, you might search for absentee, absentee ballot, advance ballot (not an exhaustive list).

Very interesting…..

Another link to the OccupyCFS blog by Ms. Spotila.

This time her post is full of interesting information about who nominated CFSAC members.

The composition of the committee is likely to be indicative of what they focus on and their degree of responsiveness to the ME/CFS community.

We urge you to read the post, think about it and share your thoughts, comments, ideas.





And where are the CFSAC bylaws?



Transcript of FDA teleconference now posted

The transcript of the teleconference call (Sept 13th) is here

Please remember that FDA is accepting questions and comments in the docket!searchResults;rpp=25;po=0;s=FDA-2012-N-0962

Questions and comment for this docket must be submitted before Sept 30th, 2012.




FDA ME/CFS page:

FDA teleconference of Sept 13, 2012


Please read this excellent summary by Ms. Spotila of the teleconference call:

Here is additional information about the FDA and NIH designations of serious or life-threatening condition:


[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2012]
[CITE: 21CFR312.81]









Subpart E–Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses

Sec. 312.81 Scope.
This section applies to new drug and biological products that are being studied for their safety and effectiveness in treating life-threatening or severely-debilitating diseases.

(a) For purposes of this section, the term “life-threatening” means:

(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; and

(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival.

(b) For purposes of this section, the term “severely debilitating” means diseases or conditions that cause major irreversible morbidity.

(c) Sponsors are encouraged to consult with FDA on the applicability of these procedures to specific products.

[53 FR 41523, Oct. 21, 1988, as amended at 64 FR 401, Jan. 5, 1999]





Serious or life threatening disease or condition

Consistent with current FDA and guidance, the NIH interprets “serious and life-threatening disease or condition” to mean: (1) diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and (2) diseases or conditions with potentially fatal outcomes, where the endpoint of clinical trial analysis is survival.

Any investigational drug that has received fast track designation by the FDA is considered a drug to treat a serious disease or condition.

The seriousness of a disease is a matter of judgment, but generally is based on such factors as survival, day-to-day functioning, and the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.  For further elaboration of the NIH’s interpretation of “serious or life threatening disease or condition”, please access the “Fact Sheet: Registration at”.

A transcript of the call should be available by Sept 21st…    




Announcement: Position Paper in Support of the CFSAC Recommendations on the CDC CFS Toolkit and the IACFS/ME Primer (updated 12 Sept 2012)

On September 10, 2012, an alliance of ME/CFS patient organizations and independent advocates submitted a position paper to the CDC in support of the June 2012 CFSAC recommendation to remove the CFS Toolkit and make the IACFS/ME Primer widely available.  Our goal in submitting this joint position paper is to improve patient care by significantly improving the clinical guidance material available to medical providers, insurance companies, health clinics, secondary medical educators and patients.

For years, patients have expressed serious concerns regarding the content of the CDC CFS Toolkit because it fails to convey the seriousness of the disease, offers inadequate diagnostic guidance and it even fails to acknowledge PEM as a hallmark symptom while focusing on CBT and GET for treatment. The Toolkit also states that the same clinical guidance is appropriate for both ME/CFS and “CFS-like illness” (chronic fatigue but without the 4 symptoms), which only blurs the line with other causes of fatigue such as depression. As a result, the CDC CFS Toolkit has mis-educated medical providers and led to inadequate patient care, harmful clinical recommendations and stigmatizing of patients. 

By comparison, the IACFS/ME Primer provides much more accurate and complete information about the pathology of ME/CFS and also provides extensive diagnostic and treatment information. As Steve Krafchick, CFSAC member, stated, the IACFS/ME Primer is “a good, basic document that gives a primary care physician a real road map, whether it is to consider a differential diagnosis or different treatment options. There’s nothing like it anywhere else”.

Is it perfect? No. There are opportunities to improve it and the IACFS/ME has undertaken an effort to do just that. But as it is, the content of the Primer is far superior to the content of the Toolkit, providing both immediate benefits to medical providers and patients and also a significantly better baseline from which to make improvements over time.

It is for that reason that the alliance of ME/CFS patient organizations and independent patient advocates have jointly submitted this position paper to the CDC and requested that the CDC seriously consider this patient perspective as they consider their actions on the CFSAC recommendation. We have asked for a response to our recommendations by Oct 22, 2012.

You can access the position paper, toolkit and primer at the following links:

CDC CFS Toolkit:

IACFS/ME Primer: ME/CFS: A Primer for Clinical Practitioners – IACFSME > Home

The full position paper:

If you have any questions or comments, do not hesitate to contact one of the organizations or individuals who submitted the position paper. These include:

ME/CFS Patient Organizations          (update 12 Sept 2012 – Pro-Health has signed on)

Chronic Fatigue Syndrome, Fibromyalgia and Chemical Sensitivity Coalition of Chicago Phoenix Rising
Coalition 4 ME/CFS Portland Fibromyalgia-ME/CFS
The Connecticut CFIDS & FM Association, Inc. Rocky Mountain CFS/ME and FM Association
Mothers against ME Speak Up About ME
Massachusetts CFIDS Association, Inc. Vermont CFIDS Association, Inc.
New Jersey CFS Association, Inc. Wisconsin ME/CFS Association, Inc.
PANDORA (a.k.a. CFS Solutions of West Michigan)

ME/CFS Patient Advocates              (update 12 Sept 2012 – Rich Carson has signed on)

Lori Chapo-Kroger, R.N. Mike Munoz
Lori Clovis Matina Nicolson
Mary Dimmock Donna Pearson
Pat Fero, MEPD Mary Schweitzer, Ph.D.
Joan Grobstein, M.D. Meghan Shannon
Jean Harrison Rivka Solomon
Cort Johnson Jennifer Spotila, J.D.
Patricia LaRosa, R.N., MSN Tamara Staples
Denise Lopez-Majano Patty Strunk
Billie Moore

Registration for CFSAC is open as is registration for public comment!