Archive for February, 2013

FDA Stakeholder Meeting for ME and CFS April 25 and 26 2013


Last year the FDA committed to holding a Stakeholder Meeting about drug development and treatment for ME(cfs).

Originally planned for one day, the meeting will now be 1.5 days long and will begin on the afternoon of Thursday April 25th and go all day Friday April 26th.

Here is what is available on the FDA website (

FDA Workshop on Drug Development for Chronic Fatigue Syndrome (CFS)
and Myalgic Encephalomyelitis (ME) – Update

The public workshop will be held on the afternoon of April 25 and all day, April 26, at the Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814, Phone 301-897-9400.  

Beginning at 1:00 pm on April 25, FDA will gather patients’ perspectives on CFS and ME through a facilitated group discussion focusing on two main topics:  (1) disease symptoms and daily impacts that matter most to patients; and (2) patients’ perspectives on current approaches to treating CFS and ME.

The second day will include a scientific discussion with patients, clinicians, researchers and government experts focusing on how to identify quantitative outcome measures to determine if disease symptoms improve with specific drug interventions.  

Additional information will be posted soon (see link below), including the Federal Register Notice that will describe the meeting format and provide details about how to register to attend the meeting.”



Reposted from OccupyCFS

Thank you Ms. Spotila for drawing attention to this!

A Public Citizen

February 18th, 2013 Jennie Spotila Leave a comment Go to comments

When I wrote about the CFS Advisory Committee’s creation of a High Priority Recommendations document and how their process violated their own charter, many people asked me “What can we do about it?” Today, I can finally tell you what I did.

I contacted Public Citizen, a non-profit organization with the mission of serving “as the people’s voice in the nation’s capital.” Public Citizen has litigated cases under the Federal Advisory Committee Act, and has a Health Research Group that advocates for safer drugs and medical devices, equitable access to health care, and other issues.

On February 14th, Public Citizen sent a letter on my behalf to William B. Schulz, Acting General Counsel of the Department of Health and Human Services (you can read the full letter here). The letter details what I uncovered about the High Priority document, and asks the General Counsel to do two things:

We ask that you act to ensure that CFSAC complies with FACA and with its own charter going forward. We also ask that you return the January 2012 “High Priority Recommendations” document to the full committee for review, so that whatever action CFSAC chooses to take regarding those recommendations or any other transmission to HHS be debated and approved by the full committee, in public, as required by FACA.

It remains to be seen whether the General Counsel will act, and what he will do. There has been no official response as of today. However, upon checking the CFSAC website, I found that the High Priority document has been removed from the website. Perhaps this is a first step in correcting the Committee’s error.

I extend my sincere thanks to the people at Public Citizen who moved so quickly to assist me in this way. Sometimes, I feel like no one outside the CFS world cares about what we’re dealing with, and that requests for help will be met with disinterest or active disbelief. But Public Citizen did not dismiss my concerns or our disease. They recognized the public interest in the proper operation of advisory committees, and moved to help us. I am grateful for their assistance and support.

So what can you do? Help me boost the signal!!! Share my blog post, circulate it on Facebook and Twitter, and write about the Public Citizen letter on your own blogs. Tell your support groups and share it with all your contacts in the CFS world. Let’s ensure the community is informed about this action, and let’s monitor the progress together.

The full text of the letter from Public Citizen is pasted below:

Letter to Department of Health and Human Services Regarding the Chronic Fatigue Syndrome Advisory Committee

February 14, 2013

View as PDF.

By postal and electronic mail

William B. Schultz
Acting General Counsel
Department of Health & Human Services
200 Independence Avenue SW
Room 713-F
Washington, DC 20201

Dear Mr. Schultz,

On behalf of Jennifer Spotila and Public Citizen’s Health Research Group, we are writing to call to your attention to and ask you to halt violations of the Federal Advisory Committee Act (FACA) by a Department of Health and Human Services (HHS) advisory committee, the Chronic Fatigue Syndrome Advisory Committee (CFSAC), which is housed within the Office on Women’s Health. Ms. Spotila is a chronic fatigue syndrome (CFS) patient and activist who has a keen and personal interest in federal policy regarding CFS. Public Citizen’s concern for the proper functioning of advisory committees stems from its long history of advocacy, in both legislative and judicial fora, for openness in government proceedings and the regular participation of Public Citizen’s Health Research Group in the meetings of HHS advisory committees.

We have become aware of the following problem: CFSAC subcommittees have been transmitting recommendations directly to HHS officials without public debate and approval of the full committee, as required by both CFSAC’s charter and FACA. Specifically, at its November 2011 public meeting, the CFSAC decided to create a distilled list of its most important recommendations for the Secretary. But the process of creating the list of key recommendations for the Secretary did not occur in the full committee or in public. Instead, various subcommittees met in private to identify the recommendations to prioritize, which Dr. Nancy Lee, the Designated Federal Officer for CFSAC, then compiled into a single list that was discussed with Assistant Secretary for Health Dr. Howard Koh. The final document, dated January 2012 and titled “High Priority Recommendations from CFSAC,” was never discussed or approved by the full committee or in a public session. Additionally, the document was not posted on the committee’s public website for an entire year (the document is dated January 2012, but it was posted just last month).

CFSAC’s statutorily-mandated charter provides the following regarding subcommittees: “The established subcommittees shall provide advice and/or make recommendations to the parent Committee. The subcommittees may not report its [sic] findings directly to any Federal official unless there is specific statutory authority for such reporting.” The transmission to Assistant Secretary Koh of recommendations developed by subcommittees and never approved by the full committee constitutes “subcommittees . . . report[ing] [their] findings directly to any Federal official” in violation of this provision. Additionally, FACA § 10(b) requires that the minutes of advisory committee meetings be made public. By acting through subcommittees closed to the public to develop the January 2012 “High Priority Recommendations from CFSAC,” CFSAC circumvented the public openness requirement of FACA.

The FACA violations deprived Ms. Spotila and the public generally of important rights to observe and participate in the advisory committee process, which can have significant influence over federal policy. Making advisory committee recommendations through a public process allows interested members of the public such as Ms. Spotila to comment, enables all members of the full committee to contribute to the decision, and allows the public at large to review the work of advisory committees. Public oversight of the work of advisory committees is one of the central goals of FACA. See Cummock v. Gore, 180 F.3d 282, 285 (D.C. Cir. 1999).

We ask that you act to ensure that CFSAC complies with FACA and with its own charter going forward. We also ask that you return the January 2012 “High Priority Recommendations” document to the full committee for review, so that whatever action CFSAC chooses to take regarding those recommendations or any other transmission to HHS be debated and approved by the full committee, in public, as required by FACA.

Thank you for your attention to this matter.


Michael A. Carome, M.D.
Public Citizen’s Health Research Group

Howard K. Koh, Assistant Secretary for Health
Nancy C. Lee, Director, Office on Women’s Health

re The PACE trials

First watch these videos.

The PACE trials

Then read about this report – be sure to read the initial reaction from the MEA.

Recovery from chronic fatigue syndrome after treatments given in the PACE trial
P. D. White1*, K. Goldsmith2, A. L. Johnson3,4, T. Chalder5 and M. Sharpe6 ; PACE Trial Management Group#
pdf format:

MEA initial reaction to latest PACE Trial results on recovery | 31 January 2013

by Tony Britton on January 31, 2013

Initial reaction from Dr Charles Shepherd, Medical Adviser, The ME Association:

It is really quite bizarre to find that there is absolutely no data whatsoever in this paper on what most people would regard as three objective markers of recovery:

1 a return (or ability to return) to full time meaningful employment or education

2 no longer claiming any DWP sickness or disability benefits

3 an estimation of how far someone can walk

Just as surprising is the absence of any discussion on the use of benefits as a marker of recovery along with the very unsatisfactory reasoning given in the paper (on page 6) for not using employment status or an objective measure of activity levels:

The main limitation of this analysis is the absence of a generally agreed measure of recovery. We addressed this by using multiple domains of health and disability. The domains chosen and the criteria for recovery on each were defined before we undertook the analysis. Alternative domains could have been used, such as return to work or objective measures of physical activity. Return to work is not, however, an appropriate measure of recovery if the participant was not working before their illness and is influenced by other factors such as the job market. Objective measures of physical activity have been found previously to correlate poorly with self-reported outcomes (Wiborg et al. 2010), which may be related to the finding that activity patterns in CFS patients are heterogeneous, with only a minority being pervasively passive (van der Werf et al 2001).