NIH, here’s some of what we need from you

In answer to the recent NIH Request For Information (RFI), several advocates and organizations submitted the attached response. Response to NIH June 2016

The response covers essentials such as:

  • show us the money, (Quickly ramp up committed budget)
  • give us access to research by bringing down the walls, (Address NIH Institute process and policy barriers)
  • nothing about us without us, (Provide for meaningful engagement of experts and patients advocates)
  • do it right, (Establish rigorous research standards)

and

the need for speed. (Speed delivery of treatment)

Dear HealthCare Professional

We have seen all sorts of comments by healthcare professionals about patients with ME (myalgic encephalomyelitis) and what is “really” wrong with them.

These are just a few comments (and what is implied by those comments).

They just don’t want to work (they want to be on disability, they stand to gain from disability),

are bored (so they spend their time imagining symptoms),

can’t cope with everyday stress (they need psychological help),

don’t exercise (and are deconditioned),

are fat (and deconditioned),

don’t want to be responsible for themselves (they want to go on disability and live an easy life),

want stimulants, narcotics, etc (they are drugseekers),

want disabled parking tags (because disability is a perk).

 

Dear Healthcare Professionals,

Comments about patients with ME (myalgic encephalomyelitis) such as those made by healthcare professionals like you are painful. I hope this post helps you understand some of our pain and frustration.

My two young adult sons have ME which is a complex and challenging disease.

Both of my sons meet the IOM criteria (this link is to The Clinician’s Guide and you can access the full report ). They also meet the CCC criteria for ME.

One son suddenly became sick since he was 12 years old. He is in his early 20s now.

My other son gradually sick about 15 months later. He too is in his 20s.

Neither of my sons are/were lazy.

A few specifics about my sons.

One son taught himself to multiply before he went to kindergarten.

The other was reading middle school level books at age 5.

They were lively, curious, and fully engaged with life, family and friends.

At the time they got sick they were competitive swimmers, swimming upwards of 20 miles a week.

The sudden onset of one son’s illness rendered him housebound, unable to do schoolwork, inexplicably unable to do mental math that had been effortless for him at age 5, unable to socialize, unable to leave home for things other than medically related appointments. In other words – no fun.

My other son had a gradual onset and he too is housebound and partially bedbound, unable to retain what he reads, unable to socialize, unable to leave home for anything other than medically related appointments. In other words – no fun.

In the past 10+ years since they got sick my sons have diligently done everything suggested by healthcare professionals (including various specialists) – to little avail. Most medications we have tried have produced no benefit and few produce enough benefit to endure their adverse effects.

My sons have not been able to learn to drive – frequent, unexpected syncopal episodes, impaired decision-making, and slowed reaction times would make their safety and that of those around them a significant concern.

My sons’ limited capacity for (cognitive or physical) exertion is not a result of deconditioning.

For one son, the exertion intolerance (a hallmark of this disease) began quite abruptly with the sudden onset of his illness.

For my other son, the exertion intolerance and the disease revealed themselves more gradually.

And as I mentioned above, when they became ill, they were swimming at least 20 miles a week so they were in great physical shape. Therefore deconditioning is in no way an explanation of their exertion intolerance.

These days cognitive and or physical exertion in excess of the strict limits imposed by this horrible disease, produce a dramatic exacerbation of symptoms (post-exertional malaise or PEM) that can last for weeks and render my sons even more disabled than their baseline (which on a good day is about 30% of normal).

All too often I see comments by healthcare professionals saying these patients want stimulants, narcotics, Xanax, disability and disabled parking tags.

My sons take no stimulants (bad reactions to them), no narcotics, no Xanax, etc.

Neither of my sons want to use the disabled parking tag that we have – they don’t want to feel labeled by doing so. So we use the tag quite sparingly – but then again my sons are out of the house so rarely that any use is sparingly.

My sons don’t get SSDI (Social Security Disability) – they have never been able to work so therefore never accrued work credits to qualify for SSDI and having never worked, they never had the option of long-term disability insurance.

Since my sons’ illness onset and because they are so severely impaired by this disease, I have been their 24/7 unpaid caregiver.

There is NOTHING to gain for us with this disease and we do our best not to think about the significant losses (independence, educational aspirations, making a difference in the world, spontaneity, vacations, and on and on).

So you see, your comments about us are not accurate. Nor are they appropriate. And inaccurate, inappropriate, disparaging, and or demeaning comments such as yours cause significant pain and detract from your job which is to help patients.

We don’t need or deserve additional pain and or hardship in our lives.

In public and in private, we deserve respect, compassion, appropriate diagnoses and appropriate treatment. NOW!

Sincerely,

A parent of two patients with ME

May 12th is ME Awareness Day

#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

 

 

 

 

 

No one should go through what Karina and her family are being put through!

Valerie Eliot Smith has written a thorough overview of the case of Karina Hansen – a young ME patient confined (against her will and that of her family) in Hammel Neurocenter (“The Research Clinic for Functional Disorders”) in Denmark.

Thank you Valerie!

Follow-up to AHRQ from patients and orgs

On February 3, 2016, a group of patient organizations and advocates sent a followup letter to the Agency for Healthcare Research and Quality (AHRQ) further detailing concerns with the 2015 AHRQ Evidence Review and reiterating their request, originally made in November 2015, to reanalyze the conclusions of AHRQ’s Evidence Review in light of the long-known concerns with PACE and with the Oxford definition.

Background

In November 2015, a group of U.S. organizations sent a letter to the U.S. Health and Human Services (HHS) requesting a review of the concerns raised with PACE in a series of articles by journalist David Tuller. Based on these concerns and the call by the National Institute of Health (NIH) Pathways to Prevention report to retire the Oxford definition because it could “impair progress and cause harm”, the letter recommended the following steps as appropriate and necessary to protect patients:

  • The AHRQ revise its evidence review to reflect the issues with PACE and with Oxford studies in general;
  • The Centers for Disease Control and Prevention (CDC) remove findings based on PACE and other Oxford studies from current and planned medical education;
  • HHS use its leadership position to communicate these concerns to other medical education providers;
  • HHS call for The Lancet to seek an independent reanalysis of PACE.

The Agency Responses

In AHRQ’s response, the authors of the evidence review noted that the review had already considered some of the concerns raised by Tuller and that the additional information would not change the review’s conclusions. Yet, the evidence review ranked PACE as a “Good” study with “undetected” reporting bias, a rating that is not consistent with the long-known concerns with PACE but one that could presumably influence conclusions. Further, AHRQ’s response did not address the concerns with using Oxford studies as the basis of recommendations of treatment benefits and harms for ME/CFS patients. The February 4, 2016 letter from patient organizations and advocates details these concerns and reiterates the request to reevaluate the evidence review conclusions.

CDC’s response, further clarified by a followup email, stated that the IOM and P2P “have placed the findings of the PACE trial in an appropriate context for moving the field forward.” They stated the need for research and that CDC would be conducting a collaborative initiative to prepare new medical education materials. However, CDC’s response did not address the question of whether findings and recommendations based on Oxford studies would be allowed in new medical education materials for this disease. The CDC has been asked to specifically respond to this question. That response will be shared when it is available.

HHS did not responded to the request to call on The Lancet to seek an independent review.

—-If you have not done so, please join in with us and sign this petition calling for AHRQ and CDC to act to protect patients.

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.



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