Preface —
I continue to be incensed at the manner in which DHHS arranged for this project and the lack of engagement by DHHS with this community.
I have serious reservations about this project, its end result and its impact.
The question posed by IOM was “What is the most important aspect or information that this committee should consider throughout the course of the study?” and each person providing public comment was limited to three minutes.
This was not an easy task as there is so much this panel needs to know, and needs to be cognizant of as this project goes forward. This project is a consensus study and I sincerely hope that any/all panel members who disagree with the findings of the panel feel free to produce written dissenting opinions.
I chose to talk about some of the hallmarks of ME and the process the panel will use. Here is my public comment:
“Good afternoon.
Many thanks to all advocates for their presentations and comments as well as all participants near and far.
I especially want to thank Mary Schweitzer (Wisconsin ME/CFS(1)) and Charmian Proskauer (Mass CFIDS (2)) for highlighting concerns about young people.
I want to address 2 hallmark symptoms of this illness and then highlight five points about the process you will use.
Number 1 Post-Exertional Collapse(unfortunately known also as Post-Exertional Malaise (PEM))
Post-Exertional Collapse can result from minimal physical or cognitive exertion, is unpredictable and lasts for days or weeks. The pervasiveness of Post-Exertional Collapse often has no correlation with the minimal exertion of the triggering event.
Number 2 Impairment of Executive Function
Impairment of executive function is evident in areas such as processing speed, reaction time, working memory, and concentration. These impairments have been reported as significant concerns both in research and in reports such as FDA’s Voice of the Patient (3).
As of today (27 January 2014) you have just 371 days until your deadline for the clinical diagnostic criteria of this illness (4).
IMPORTANT THINGS FOR YOU TO THINK ABOUT
ONE – This illness may require different diagnostic criteria — such as pediatric (3) and adult – depending on the age at presentation.
TWO – The definition(s) used to select patients for studies greatly impacts the study results. Therefore – assessment of literature about this illness must include careful evaluation of the definition(s) used and the symptoms covered therein. The clinical diagnostic criteria that you have agreed to develop will have far reaching effects on diagnosis, health insurance, and treatment, and will likely have very important effects on school accommodations for young people with this illness.
THREE – Clinical diagnostic criteria for this illness should include detailed assessment of symptom severity and frequency (5) and should reliably assess post-exertional collapse and cognitive impairment.
FOUR – The clinical diagnostic criteria must include clearly defined criteria and appropriate assessment tools. It must be as accurate as is possible at this point in time.
As you develop the diagnostic criteria, think about how this criteria will best serve patients and practitioners.
The outreach strategy you develop to operationalize and disseminate this criteria must provide for widespread education about this illness so that patients are appropriately diagnosed — including all those who are currently undiagnosed or misdiagnosed (6).
FIVE – This afternoon is a very limited time to spend with those who know this illness best. FDA spent months pouring over input to develop The Voice of the Patient. Your work will be most successful if you engage experts and patients throughout the process.
Thank you.
References
- http://www.wicfs-me.org/ http://www.masscfids.org/
- http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM368806.pdfhttp://hhs.granicus.com/MediaPlayer.php?view_id=5&clip_id=99 (see Cognitive Functioning in CFS)http://www.iacfsme.org/Portals/0/pdf/Lange%20Multitasking%20vol17%20n1.pdf
http://www.cfids-cab.org/cfs-inform/Testcognitive/brimacombe.etal05.pdf
http://www.cfids.org/special/brain.pdf
http://www.hhs.gov/advcomcfs/meetings/presentations/presentation_10132010_gudrunlannge.pdf
http://www.youtube.com/watch?v=ErcJCI-sm_A&list=UUzrFQHNiCc_6AMpw_GpWZOA&feature=plcp
- https://dl.dropboxusercontent.com/u/57025850/MECFS%20IOM%20SOW.pdf
- http://www.hhs.gov/advcomcfs/meetings/presentations/diagnose_me_cfs_200905.pdfhttp://www.name-us.org/DefintionsPages/DefinitionsArticles/JasonBell2006Pediatric.pdf
- http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3170036/http://dsq-sds.org/article/view/1375/1540
http://www.tandfonline.com/doi/abs/10.1080/21641846.2013.862993#preview
- http://www.cdc.gov/cfs/programs/cdc_research/program_update_2002-2003.html (accessed 18 Jan. 2014),http://link.springer.com/article/10.1007%2FBF02506968#page-1
http://www.rcpe.ac.uk/journal/issue/journal_40_4/newton.pdf
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3269106/”
Reminder “At any point during the study, you may submit written comments to mecfs@nas.edu.”
According to IOM, they will send an announcement when the video and meeting presentations are posted — estimated time — “a few weeks”.
Speak Up About ME 
Public comment provided to IOM meeting
Published January 29, 2014 Uncategorized 1 CommentTags: advocacy, clinical diagnostic criteria, DHHS, impairment of executive function, IOM, PEC, PEM, Post-Exertional Collapse, post-exertional malaise, public comment, Washington, young people
Preface —
I continue to be incensed at the manner in which DHHS arranged for this project and the lack of engagement by DHHS with this community.
I have serious reservations about this project, its end result and its impact.
The question posed by IOM was “What is the most important aspect or information that this committee should consider throughout the course of the study?” and each person providing public comment was limited to three minutes.
This was not an easy task as there is so much this panel needs to know, and needs to be cognizant of as this project goes forward. This project is a consensus study and I sincerely hope that any/all panel members who disagree with the findings of the panel feel free to produce written dissenting opinions.
I chose to talk about some of the hallmarks of ME and the process the panel will use. Here is my public comment:
“Good afternoon.
Many thanks to all advocates for their presentations and comments as well as all participants near and far.
I especially want to thank Mary Schweitzer (Wisconsin ME/CFS(1)) and Charmian Proskauer (Mass CFIDS (2)) for highlighting concerns about young people.
I want to address 2 hallmark symptoms of this illness and then highlight five points about the process you will use.
Number 1 Post-Exertional Collapse(unfortunately known also as Post-Exertional Malaise (PEM))
Post-Exertional Collapse can result from minimal physical or cognitive exertion, is unpredictable and lasts for days or weeks. The pervasiveness of Post-Exertional Collapse often has no correlation with the minimal exertion of the triggering event.
Number 2 Impairment of Executive Function
Impairment of executive function is evident in areas such as processing speed, reaction time, working memory, and concentration. These impairments have been reported as significant concerns both in research and in reports such as FDA’s Voice of the Patient (3).
As of today (27 January 2014) you have just 371 days until your deadline for the clinical diagnostic criteria of this illness (4).
IMPORTANT THINGS FOR YOU TO THINK ABOUT
ONE – This illness may require different diagnostic criteria — such as pediatric (3) and adult – depending on the age at presentation.
TWO – The definition(s) used to select patients for studies greatly impacts the study results. Therefore – assessment of literature about this illness must include careful evaluation of the definition(s) used and the symptoms covered therein. The clinical diagnostic criteria that you have agreed to develop will have far reaching effects on diagnosis, health insurance, and treatment, and will likely have very important effects on school accommodations for young people with this illness.
THREE – Clinical diagnostic criteria for this illness should include detailed assessment of symptom severity and frequency (5) and should reliably assess post-exertional collapse and cognitive impairment.
FOUR – The clinical diagnostic criteria must include clearly defined criteria and appropriate assessment tools. It must be as accurate as is possible at this point in time.
As you develop the diagnostic criteria, think about how this criteria will best serve patients and practitioners.
The outreach strategy you develop to operationalize and disseminate this criteria must provide for widespread education about this illness so that patients are appropriately diagnosed — including all those who are currently undiagnosed or misdiagnosed (6).
FIVE – This afternoon is a very limited time to spend with those who know this illness best. FDA spent months pouring over input to develop The Voice of the Patient. Your work will be most successful if you engage experts and patients throughout the process.
Thank you.
References
http://www.cfids-cab.org/cfs-inform/Testcognitive/brimacombe.etal05.pdf
http://www.cfids.org/special/brain.pdf
http://www.hhs.gov/advcomcfs/meetings/presentations/presentation_10132010_gudrunlannge.pdf
http://www.youtube.com/watch?v=ErcJCI-sm_A&list=UUzrFQHNiCc_6AMpw_GpWZOA&feature=plcp
http://www.tandfonline.com/doi/abs/10.1080/21641846.2013.862993#preview
http://www.rcpe.ac.uk/journal/issue/journal_40_4/newton.pdf
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3269106/”
Reminder “At any point during the study, you may submit written comments to mecfs@nas.edu.”
According to IOM, they will send an announcement when the video and meeting presentations are posted — estimated time — “a few weeks”.
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