Posts Tagged 'DHHS'

#Millions Missing

Millions of people are missing from everyday life because of Millions Missing from research and Millions Missing of appropriately educated healthcare professionals to care for patients

The #Millions Missing demonstration will take place on 25 May 2016 in select locations across the globe.

#MillionsMissing ME/CFS Protest Demands

  1. Increased Funding and Program Investments

Funding and program investments commensurate with the disease burden

  1. Clinical Trials

Clinical trials to secure medical treatments for ME/CFS

  1. Accurate Medical Education

Replacement of misinformation with accurate medical education and clinical guidelines

  1. A Serious Commitment

HHS leadership, oversight and a serious commitment to urgently address ME/CFS

#MEAction has posted the rationale for the demands.

NOTE –

There is an open community meeting hosted by MEAction on

Wed. May 11th, 2-3:30 pm EDT

to discuss the demands and

hear any questions or concerns you have about them.

More info and call sign-up here:

 https://my.meaction.net/events/millionsmissing-national-call

MEAction says “We are thinking of these demands as a living document. We plan that after the protests (May 25) it will evolve as we get input from the community. MEAction.net will set up a mechanism for receiving that community input. This task, and the evolution of the demands document, will happen after the protests, simply because we lack the capacity to do it while we are organizing the protests.”

MillionsMissing graphic 1

 

 

 

 

 

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CFSAC – to be or not to be

ME community members were caught off guard when the proposed 2016 Senate appropriations bill zeroed out CDC funding for CFS research. Several advocates scrambled to address this and their efforts to be heard appear to have paid off.

But scrambling is not something ME advocates can, or should do. Health- and resource- wise we can’t afford to scramble because it damages our health. Strategic, coordinated and planned approaches would enable less intensive expenditure of resources and allow us to take a measured approach to concerns.

To avoid last minute scrambling, here are a few CFSAC-related things advocates might want to work on.

CFSAC VOTING MEMBERS

In 2016 the terms of 4 CFSAC voting members (Casillas, Collier, Corbin and Fletcher) will expire. FOUR (!) new members out of a total of 11 voting members, means that more than one-third of the committee members will be replaced. That’s a large portion of the voting membership.

The HHS vetting and approval process for advisory committee members is quite lengthy, which means that the request for nominations will probably appear soon. Typically there’s about a 30 day window from the published announcement to the submission deadline, so giving thought to this right away, allows time for recruiting highly qualified nominees and allows for the development and submission of nomination packets. (For reference, the most recent notice was September 2013. The process may be different this time.)

Required expertise (stipulated in the CFSAC charter)

Of the eleven members, seven shall be biomedical research scientists with demonstrated expertise in biomedical research applicable to ME/CFS; four shall be individuals with expertise in health care delivery, private health care services or insurers, or voluntary organizations concerned with the problems of individuals with ME/CFS.”

Of the CFSAC members whose terms end in 2016 –

Mary Ann Fletcher is a biomedical researcher,

Adrian Casillas and Lisa Corbin are healthcare professionals,

Rebecca Collier is a nurse associated with insurance (I believe).

Additional considerations

The CFSAC has a lot of work to do and the learning curve for advisory committee members is steep under the best of circumstances.

In order to best serve the community, all committee members should be highly qualified and knowledgeable individuals who are fully engaged with the work of the CFSAC.

Because of the steep learning curve and the important work that the CFSAC needs to do, ALL CFSAC nominees/members should be well versed in the science, history and politics surrounding this neuroimmune disease, so that from their first day on the committee they all work effectively.

Think about which category of charter-stipulated-expertise the nominees meet. (The categories are – biomedical research related to ME/cfs, expertise in healthcare, insurance, voluntary organizations serving people with ME/cfs.)

It might also be worth examining the current roster to see if there are additional gaps in charter-required expertise.

Which qualifications make for the most effective CFSAC members?

Before initiating the nomination process for anyone, remember to verify their willingness to serve. (In past years, nominees have had to submit letters stating their willingness to serve.)

We have no way of knowing which nominees HHS will appoint to the CFSAC, but ensuring that HHS receives nominations of numerous highly qualified individuals, increases the chances that voting members of the CFSAC will be appropriately qualified individuals who, from the start, can work diligently and effectively on matters related to ME.

CFSAC CHARTER

The CFSAC is supposed to be our venue for getting things on the public record.

The CFSAC charter is up for renewal every two years which means that in 2016 the CFSAC charter is up for renewal.

Renewal is not automatic/guaranteed, so it is worth devoting time to the who, what, when, why and where of charters and working towards getting it renewed.

Since ensuring renewal is likely to be a protracted process, it could be helpful for a team of people to share this work.

Additional considerations

Are there charter changes that would be beneficial?

Would it be appropriate to examine the charters of other HHS advisory committees to see if they include language/provisions that would strengthen the CFSAC charter?

Charter designation

Would it be more appropriate if the CFSAC were a Presidential, or statutorily mandated advisory committee as opposed to being a discretionary advisory committee?

If so, who will follow through to make it happen?

Using unified talking points when working on charter-related issues will help ensure that TPTB aren’t confused by differing messages.

ENGAGEMENT

CFSAC meetings take place (at most) twice a year. Is that sufficient to adequately address material from the working groups, other related concerns within HHS and SSA, etc.?

The current DFO has said she does not have sufficient time to act as DFO and do “her other job”. Will the new DFO be wholly devoted to ME matters?

Is the engagement model we have with the CFSAC and HHS satisfactory? Is the level of openness and transparency in communications and actions satisfactory?

Does HHS take this neuroimmune disease into consideration when developing strategies, policies and/or disseminating information?

Do we need someone at HHS (at a prominent level) who can provide continuity between meetings and outside of working group activities and who can ensure that ME concerns are taken into consideration across all HHS activities?

Would it be useful to have someone more engaged with the community and the activities of HHS to progress matters related to ME?

The IOM report used the model of the HIV Czar and recommended a Czar for this disease. Would this improve HHS’ level of engagement regarding this disease?

If the community is not satisfied with our current engagement model with the CFSAC and HHS, what changes would best serve us and how will we ensure that they come about?

Talk is Cheap

For decades, stakeholders have advocated for funding commensurate with the severity of ME/CFS. The government’s response has been to hold an occasional meeting, commission a report from time to time, and little if anything has changed. More words are spoken, with clinicians and researchers saying things that have been said before. But officials haven’t followed through with the necessary funding increases or with the sustained attention required to address this severely disabling disease whose economic impact wildly exceeds the paltry dollars allotted to research.

For example, NIH hosted a State of the Knowledge Workshop in April 2011. The report from that meeting bears a great deal of resemblance to the NIH’s Pathways to Prevention (P2P) Workshop report published in June 2015. Four years have passed, but the situation remains the same.

Both reports acknowledged patients’ suffering.

2011: Individuals with ME/CFS, their families, and their caregivers have gone through untold suffering and difficulties from a disease that is poorly understood and for which there is relatively little to offer in the way of specific treatments. (p.5)

2015: Unfortunately, ME/CFS is an area where the research and health care community has frustrated its constituents, by failing to appropriately assess and treat the disease and by allowing patients to be stigmatized. (p.2)

Both reports recommended research on biomarkers and epidemiology.

2011: Continued research on biomarkers for ME/CFS, including biomarkers that are mediators of the illness, has the potential to aid in diagnosis, and treatment and prevention. (p.15)

2011: There is a lack of longitudinal, natural history, early detection, pediatric-versus-adult-onset, and animal model studies. . . . In addition, few studies look at comorbid conditions, biomarkers, or genetics.  (p.18)

2015: Research priorities should be shifted to include basic science and mechanistic work that will contribute to the development of tools and measures such as biomarker or therapeutics discovery. (p.8)

2015: Epidemiological studies of ME/CFS, including incidence and prevalence, who is at high risk, risk factors, geographical distribution, and the identification of potential health care disparities are critical.   (p.11)

Both reports recommended a network of collaborative centers.

2011: Creating coordinated and collaborative systems for sharing research was an important topic that included creating standard operating procedures for the field, within and across labs, as well as common data elements. (p.18)

2015: Create a network of collaborative centers working across institutions and disciplines, including clinical, biological, and social sciences. These centers will be charged with determining the biomarkers associated with diagnosis and prognosis, epidemiology (e.g., health care utilization), functional status and disability, patient-centered QOL outcomes, cost-effectiveness of treatment studies, the role of comorbidities in clinical and real-life settings, and providing a complete characterization of control populations, as well as those who recover from ME/CFS. (p.15)

Both reports recommended central repositories.

2011: To capture the extensive information from such studies, a centralized interactive database, using common data elements and accessible to everyone, is sorely needed to collect, aggregate, store, and analyze results.   (p.18)

2015: Biologic samples (e.g., serum and saliva, RNA, DNA, whole blood or peripheral blood mononuclear cells, and tissues) and de-identified survey data should be linked in a registry/repository to understand pathogenesis and prognosis, and facilitate biomarker discovery. (p.11)

Both reports highlighted the urgent need for consensus on case definition.

2011: Throughout the Workshop, participants identified opportunities for advancement in the current research paradigm for ME/CFS, beginning with a need to define and standardize the terminology and case definitions.   (p.6)

2015: Define disease parameters. Assemble a team of stakeholders (e.g., patients, clinicians, researchers, federal agencies) to reach consensus on the definition and parameters of ME/CFS.   (p.9)

2015: Thus for progress to occur, we recommend (1) that the Oxford definition be retired, (2) that the ME/CFS community agree on a single case definition (even if it is not perfect), and (3) that patients, clinicians, and researchers agree on a definition for meaningful recovery.   (p.16)

Both reports highlighted the need for collaboration and new scientists.

2011: The study of ME/CFS can benefit from an interdisciplinary collaborative approach using well-connected clinical and research networks. . . . Moreover, additional highly qualified investigators must be attracted to study ME/CFS.   (p.18)

2015: [T]here is a need for partnerships across institutions to advance the research and develop new scientists.   (p.14)

Both reports noted the need for educated clinicians.

2011: However, the biggest barrier to treating patients, according to Workshop participants, is lack of informed clinicians… (2011, p.6)

2015: Thus, a properly trained workforce is critical…   (p.14)

***************

If I just listed the quotes without telling you which report they came from, I bet you would not be able to tell which were from 2011 and which were from 2015. That the same points are repeated without substantive differences illustrates how little has changed, other than the year the report was issued.

Perhaps time moves at a different pace for those in charge of allocation of funds and they don’t feel the urgency we feel. However, for more than thirty years patients have grown up, lived and died, all the while being subjected to disdain and neglect. Failed policies mean there are no treatments, and this horrid disease is so disabling that patients usually live isolated, impoverished lives.

We NEED better and we DESERVE far better than occasional federal lip-service and occasional meetings.

  • We (patients/caregivers, healthcare professionals, policy makers, HHS) need to be very clear about the disease being addressed.
  • We need a total overhaul of federal policy regarding this disease with stakeholders as active participants.
  • We need a sustained and meaningful increase in biomedical research funding and we need it now!
  • We need an awareness campaign like the one outlined here.
  • We need to be meaningfully involved at every step of the way in all of this.
  • We want and deserve to have our productive lives back! NOW!
  • We need to work together in a sustained manner to push for these changes.

And HHS ABSOLUTELY must do its part. The IOM report has been out for months and the P2P report is out now, yet there is no indication from HHS as to what they are going to do with these reports. So HHS – tell us – what you are going to do and when you are going to do it?

Talk is cheap. It’s relatively easy and cheap to hold a meeting and write a report. Investing the requisite resources in research and building the infrastructure needed to sustain progress is hard work. It’s expensive. But this is what is needed. Not more meetings. Not more spin.

Talk is cheap. It’s time to show ME the money.

READING THIS Exit Stage Right

(http://www.occupycfs.com/2014/03/13/exit-stage-right/) MAKES Ms. LOPEZ-MAJANO’s PUBLIC COMMENT on 11 March 2014 seem even more significant:

“Even before arriving at their first meeting, CFSAC members need to be well versed in the history, politics, science, breadth of illness, and issues of concern to the community, as well as what has transpired since the committee’s current inception in 2003.

They also need to be ready to work. Right away!

During the December 2013 meeting Dr. Kaplan said “The Center of Excellence idea I think is extremely important and one that I think we should be recommending…”

It is disconcerting that Dr. Kaplan seemed quite unaware that Centers of Excellence have been mentioned more than 130 times in 10 years of CFSAC meetings. It seems to me that he is not familiar with the past work of the CFSAC.

If committee members haven’t made the effort to find out what CFSAC has discussed, then I wonder if you are sufficiently involved with and knowledgeable about this illness and the issues surrounding it.

Committee members also need to be actively involved in the committee’s work. This includes during meetings, in working groups etc.

I understand that not everyone will have input on every point of discussion. However, when committee members are not active participants, it seems those members are chair-warmers – or worse yet, just there to pad their resumes.

Most of you don’t have this illness. WE however are seriously impacted by it at all times and very few advocates are healthy enough to work on all that needs to be done to improve our situation. So we need an effective CFSAC to help us.

Since this committee is charged with making recommendations to and advising the Secretary of Health and Human Services, you need to do everything you can to ensure that this committee works efficiently and expeditiously.

Additionally, despite assurances from HHS that CFSAC terms would be staggered, five six [updated 13 March 2014 to include resignation of Jordan Dimitrakoff] committee vacancies will occur between May and July (2014). Any committee comprised of only 11 voting members, will be unable to work expeditiously if new members need time to learn about the committee, the illness, etc.

I urge the Secretary to ensure that every voting member of the CFSAC is well aware of the committee’s work, of issues regarding this illness and of the issues of importance to this community.

I also urge the Secretary to require that the DFO provide appropriate orientation to committee members.

These actions will help ensure that the committee can always work at full-speed to help those affected by this illness that plagues my grandchildren and so many other people.”

 

 

Public comment 11 March 2014

It often feels as though we (patient community) speak a different language than Health and Human Services (HHS) agencies and that this results in ongoing communication problems between us. This is complicated by the ongoing lack of openness and transparency by HHS.

At the FDA meeting on April 25th 2013, (http://www.fda.gov/Drugs/NewsEvents/ucm369563.htm), time was spent querying participants and restating things to make sure listeners understood the intent of the speakers. As a result, in its Voice of the Patient report (http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM368806.pdf), FDA was able to characterize the patient experience in a way that no other government agency has done before.

After that meeting, at least one noted clinician/researcher restructured the questions posed to patients and is looking for additional ways to ensure more accurate understanding of patient experiences, symptoms, etc.

It seems that Dr. Unger has begun to understand how threatened patients feel by the term “malaise”. To laypeople the connotation is “feeling out of sorts”. This means that the phrase “post-exertional malaise” gives very little indication of the intensity, severity and extent of the serious problems that post-exertional malaise produces. How did Dr. Unger begin to understand how seriously and negatively the term “malaise” impacts us? It started during a conversation between advocates and Dr. Unger. During that conversation, there were opportunities to clarify points and answer questions.

During public comment we have the opportunity to provide input but there is no way to know if you have understood what we say. And during CFSAC meetings, we have no way of asking clarifying questions to ensure that we understood what you have said. Simply put, as currently structured, there is no opportunity on our part or yours for clarification to ensure that we understand each other. And given that some agencies do not respond to questions submitted by advocates between meetings, or instead respond by reiterating things we are already well aware of, we have no opportunities outside of CFSAC to get answers.

We endure this illness, minute by minute, week by week, decade by decade and as a result, we have a wealth of knowledge and experience.

If you are truly interested in this illness and in helping us, surely there are questions you have, that we can help provide answers to. But we currently have no way of doing so.

We must find ways to ensure substantive discussion and accurate understanding on everyone’s part.

Matthew Lopez-Majano

 

Goal 4: Increase Efficiency, Transparency, and Accountability of HHS Programs

 

HHS’s Open Government efforts will break new ground in enabling the public to give feedback to HHS programs. HHS can help stakeholders contribute knowledge and experience to help it do jobs better, and HHS can support new kinds of collaborative teamwork that will deliver better results for our citizens.  HHS will move forward toward new strategies, new tools, and a new culture of public participation and collaboration in its affairs. “ http://www.hhs.gov/strategic-plan/goal4.html (emphasis added)

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”.

Suggested reading at OccupyCFS

(Lack of) Progress Report

The December 2013 CFS Advisory Committee meeting was controversial before it began, and honestly things only went downhill from there. … Let’s just focus on the lowlights: the tech, the wreck, and the waste.

http://www.occupycfs.com/2013/12/12/lack-of-progress-report/