Posts Tagged 'clinical diagnostic criteria'

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”.

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Our ME/CFS Experts Have Spoken on the Case Definition

On September 23, 2013, HHS announced that it has entered into a contract with the Institute of Medicine to begin work to develop “clinical diagnostic criteria” for ME/CFS.

But there’s more.

On the same day, 35 of the leading researchers and clinicians in the field of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) have written an open letter to Health and Human Services Secretary Kathleen Sebelius to announce that they have reached a consensus on adopting the Canadian Consensus Criteria (CCC) as the research and clinical case definition for ME/CFS. They called for HHS to follow their lead by using the CCC as the sole case definition for ME/CFS in all of HHS’s activities related to the disease and strongly urged HHS to abandon its plans to reach out to groups like the Institute of Medicine to develop clinical diagnostic criteria.

Acknowledging that the case definition will be refined as science advances, the authors unambiguously endorsed the Canadian Consensus Criteria as the baseline criteria, stating:

The expert biomedical community will continue to refine and update the case definition as scientific knowledge advances, for example, this may include consideration of the 2011 ME International Consensus Criteria … As leading researchers and clinicians in the field, however, we are in agreement that there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and that failure to do so will significantly impede research and harm patient care.”

Just as directly, the authors stated their strong opposition to the IOM initiative, stating:

We strongly urge [HHS] to abandon efforts to reach out to groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for ME/CFS. Since the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.”

Wow! Could our experts have spoken any more clearly, loudly and collectively?

More than any other issue, HHS’ decades long failure to adopt a definition that actually reflects our disease has confounded research and forestalled drug development. It has caused doctors to dismiss their patients’ illness or attribute it to depression. It has bred the widespread stigma and misunderstanding that ME/CFS patients face every day. By its actions, HHS has abandoned ME patients to lives of terrible debility and suffering with no treatments, no care and no hope that anything will ever change. In the face of such suffering, some patients have chosen suicide.

Compounding its mistakes, HHS unilaterally entered into a contract with the Institute of Medicine (IOM) to develop clinical diagnostic criteria and has repeatedly stated its intent to use non-experts to define our disease. We need only look to the Gulf War Illness experience with IOM and chronic multisymptom illness to know that this would be disastrous.

But today, thanks to our experts, the time for pretending ME/CFS doesn’t exist is OVER! The time for burying this devastating disease inside of an illegitimate collection of unexplained fatiguing illnesses is OVER! To quote advocate Tom Hennessey, NO MAS!

HHS can no longer claim that there is a lack of consensus amongst disease experts. As with every other disease, it is time for HHS to follow the lead of our disease experts and adopt the CCC for research and clinical purposes. In particular, HHS must now stop wasting taxpayer dollars on misguided efforts that, in the words of the letter authors, “threaten to move ME/CFS science backwards.”

For patients who have suffered through years of studies into ‘false illness beliefs” and maladaptive coping styles, this is finally a way out of the morass, an escape route from all those wasted years. As the authors stated, adopting the CCC will “jump start progress and lead to much more rapid advancement in research and care for ME/CFS patients.” It gives hope that our disease will be treated as the terrible disease that it is and that progress will now come quickly. It gives hope that we will soon rise up from our beds!

This letter is remarkable and historic for the ME/CFS community.

But what does this letter mean in terms of the IOM contract that HHS has just signed? Typically, like most contracts, government contracts have mechanisms built into them to allow the contract to be cancelled when the contract no longer makes sense.

Now that the ME/CFS experts have spoken, the path forward is clear. It does not make sense to waste money and time redefining the disease when the experts have now agreed upon the immediate adoption of the CCC.

We need to send two strong messages to HHS. First, HHS needs to immediately adopt the CCC as the sole definition for ME/CFS as the experts have called for. Second, HHS needs to cancel the IOM contract, which is completely unnecessary, wasteful and a step backwards scientifically.

We need to forcefully engage our congressional leaders on this issue. Further information along with the actions to take with congressional leaders will be provided as soon as possible.

The Sept 23, 2013 open letter from ME/CFS researchers and clinicians to Secretary Sebelius can be found here – http://bit.ly/15npS9B

The Sept 23, 2013 CFSAC announcement on the IOM can be found here – http://bit.ly/18m7XlJ

Thanks to Mary D for this information!