Dear Members and Friends,
It has been some time since we have updated you on the Association's participation in advocacy work, but a great deal has been happening!
First, a shout-out to Donna Pearson, our vice-president, who was nominated by our Association and selected to serve as a voting member on the Chronic Fatigue Syndrome Advisory Committee (CFSAC). Donna attended her first meeting in Washington, D.C. earlier this month.
As you may know, CFSAC is the official conduit of information from patients to the various agencies of the U.S. Dept. of Health and Human Services. CFSAC meetings also provide an opportunity for designated clinicians, researchers, health policy experts, and patient advocates to come together with representatives of the federal agencies that are supposed to serve us – National Institutes of Health, Agency for Healthcare Research and Quality, Centers for Disease Control and Prevention, Center for Medicare and Medicaid Services, Food and Drug Administration, Health Resources and Services Administration, and the Social Security Administration. The Designated Federal Officer for the Committee is from the Office on Women's Health, Health and Human Services.
While many of us wonder how effective CFSAC actually is (or can be), we are all happy that Donna is there. If anyone of us can bring about some positive change, Donna can! She has already suggested some improvements, such as asking that issues raised by patients during the public comment period be considered for future agendas. Donna will be keeping us in touch with opportunities to participate. If you would like to be notified directly of CFSAC activities, you can sign up for the CFSAC list-serv.
The process continues. So far 3 meetings have been held, and as far as we know they are keeping to the published schedule, so that we expect the final report in the spring of 2015. Written public comments are still being accepted.
Learn more about this study.
This is a program entirely within the National Institutes of Health (NIH). You can read more about it here. It had its first formal meeting in January 2014.
By design this process has limited input from subject matter experts (clinicians and researchers), patients, and the public. The study, which is guided by a Working Group composed of federal officials, a few ME/CFS experts, and one patient representative, is carried out by a panel of professionals who are expert in other fields (not ME/CFS), It is organized around several carefully constructed questions, and is intended to provide objective (that is, unbiased by any previous knowledge of ME/CFS) analysis of gaps in research and suggestions for future research, based on a review of "evidence" (published research literature).
Likewise an outside group is contracted to find and review relevant published research and prepare a summary report. This is called the "systematic review" and you can read more about it here. This summary report is then given to the panel at a 2-day workshop, where they will also hear brief presentations on the topics (from ME/CFS experts??) represented in the questions. A day later, the panel will issue a draft report, which is intended to provide priorities to NIH for future research. The agenda for the final workshop, scheduled for December 9-10, 2014, was published a few days ago, and lists the topics that will be discussed. Who will speak to each point has not yet been announced.
There are a few opportunities for public input: one is happening now, where the public can suggest papers to be considered for the evidence review (but only if they relate directly to the questions). The deadline for submitting suggestions is July 17, 2014. You can get more information here. An informal group of advocates, including several of our Association's board members, is actively engaged in collecting and submitting suggestions.
The Systematic [Evidence] Review is published in draft form a few weeks before the workshop, and there is a 4-week period for the public to comment on the report. The final Systematic Review is then given to the panel in time for the workshop.
The last opportunity for public input is a 2 week comment period following the issuance of the draft workshop report. This happens in the last two weeks of December – according to the current schedule the deadline for public comment on the final report is December 25 – not exactly wonderful timing for patients. The final report is then issued 2 weeks after that (mid January 2015, some months before the IOM issues its report).
Advocates have grave concerns about this process. Many have called for it to be cancelled or at least postponed until the IOM report is issued, so that findings from that study can be considered.
How did these two processes happen at the same time, when they are both considering similar questions? What kind of communication is there going to be between the two groups? Are they even studying the same illness? (Which illness are they studying, by the way? Is there any agreement on this very important point?) Are IOM and P2P the federal response to CFSAC's recommendation to 'convene a workshop of recognized ME/CFS experts to recommend a case definition for research and clinical use, beginning with the Canadian Consensus Criteria'?
Sometimes it feels like we are being kept very busy responding to actions taken by others on our behalf, and doing damage control, rather than helping to move things forward in a positive direction. But we are compelled to keep working to keep this train on the rails, hopefully moving toward more knowledge, faster and more accurate diagnoses, more effective treatments, and eventually a cure.
Many, many thanks to those in our community who are doing this important work. If you are not involved but would like to be put in touch with those who are, please Contact Us.
With warm regards,
Charmian Proskauer, President
Massachusetts CFIDS/ME & FM Association
Ed. note: Changes made on 6/29/2014 correct information about the P2P timeline.