Posts Tagged 'young people'

Public comment provided to IOM meeting

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

  1. http://www.wicfs-me.org/ http://www.masscfids.org/
  2. 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

  3. https://dl.dropboxusercontent.com/u/57025850/MECFS%20IOM%20SOW.pdf
  4. http://www.hhs.gov/advcomcfs/meetings/presentations/diagnose_me_cfs_200905.pdfhttp://www.name-us.org/DefintionsPages/DefinitionsArticles/JasonBell2006Pediatric.pdf
  5. 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

  6. 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 June 13th and 14th, 2012

JOIN US!

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 –

JOIN US

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: https://speakupaboutme.wordpress.com/public-comment-at-the-cfsac-meetings/ )

 

We gladly welcome mentors, volunteers, supporters, contributors.

 

Help defray expenses for Speak Up About ME participants!

https://speakupaboutme.wordpress.com/support-speak-up-about-me/ 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).