Deadlines and Opportunities

Posted on July 30, 2015 by Jennie Spotila

There are a number of opportunities for ME/CFS advocacy right now – all of which you can do on your own from home! Here are the details:

CFS Advisory Committee Public Comment: The Federal Register notice for the August 18-19th meeting has been published.

  • Registration to attend in person is different this time! You must download a form on the CFSAC website (although it’s not available yet) and email it to CFSACmtg@hhs.gov. Registration for attendance closes August 13th.
  • Public comment registration is required to comment in person or by phone. Request a slot by emailing CFSACmtg@hhs.gov. Comments are limited to three minutes in length, and registration closes August 10th.
  • Written public comment can be submitted, whether you have a speaking slot or not. Comments should be no longer than 5 single spaced pages using 12pt font, and should be in MS Word format. Email your comments to CFSACmtg@hhs.gov by August 13th for inclusion in the public record.

NIH Strategic Plan: Public comment is due August 16th. I‘ve posted details about the plan and my own comments.

Key States Targeted for NIH Funding Petition: MEAction is looking for advocates in twenty-two key states to participate in targeted advocacy with Congress. Even if you don’t live in one of those states, you can still sign the petition.

I expect more advocacy actions will be launched in the near future, so stay tuned.

Posted in Advocacy | Tagged , , , , , , , , , , , , , | 6 Comments

A New Strategic Plan

Posted on July 28, 2015 by Jennie Spotila

The National Institutes of Health is creating its first strategic plan, at the request of Congress. The public now has an opportunity to comment, and this is an important opportunity to reinforce the need for ME/CFS research funding.

Liz Willow was the first in the ME/CFS community to write about the NIH strategic plan. Congress has requested that the NIH create an overarching strategic plan that crosses Institute boundaries. The individual Institutes will still create their own strategic plans, but NIH’s overall plan will address larger issues.

There are not a lot of details available about the plan. The first iteration focused on disease categories that cross Institutes, such as cancer, chronic disease, etc. But the Advisory Council to Director Dr. Francis Collins thought the plan still relied too much on organ based systems. The second version, now open for public comment, takes a more thematic approach. Take a look at the slide presentation to the Advisory Council for more details on the second version.*

So what is in the plan, and how will it affect ME/CFS funding? The three main themes are: the importance of basic science and harnessing technology and data; promoting health and prevention by studying healthy people and advancing early diagnosis; and finding treatments and cures through molecular medicine, breaking down disease boundaries and finding new partnerships.

What I find most interesting is the section on “Setting NIH Priorities”:

Incorporate disease burden as an important, but not the only factor

Foster scientific opportunity; need for nimbleness

Advance research opportunities presented by rare diseases

Consider the value of permanently eradicating a pandemic

Incidentally, that last line – eradicating a pandemic – is actually talking about HIV/AIDS, and it is a way to continue justifying the astronomical NIH investment in HIV/AIDS research.

One of the major weakness of the plan is that it leaves all the disease-specific planning to the Institutes. But for diseases like ME/CFS which have no Institute home, this structure guarantees that we will be left out of all plans. NIH uses a silo structure, and this plan does not sufficiently break down those barriers.

The other major weakness is that there is absolutely no role for the voices of patients at NIH. Clinical trials and outcome measures creation are moving solidly in the direction of increasing patient participation, and this is also the case in treatment choices in healthcare. Yet NIH remains walled off from patients, and is not coming to terms with how to shift. Including burden of disease as a factor in priority setting is a step in the right direction, but NIH is struggling with that as well.

Public comment on the plan framework will be accepted until August 16, 2015. NIH will be holding webinars in August to help explain the strategic plan, although no details are available yet. Although NIH has said that it would prefer for advocacy organizations to submit one comment on behalf of their membership, I do not know if any ME/CFS organization is planning to do so. If you can, I strongly recommend that you submit comments via the comment form. Here are the comments I submitted:

Potential benefits, drawbacks/challenges, and areas of consideration for the current framework

There is a major weakness in the proposed plan structure, in that it assumes that the Institutes cover all diseases in their own strategic plans. However, there are diseases like ME/CFS which have no assigned Institute home. Under the current framework, ME/CFS and other orphan diseases will be left to fall through the cracks.

Instead, NIH must find ways to address diseases that cross Institute boundaries. ME/CFS has immunological and neurological components, yet it is not assigned to NINDS or NIAID. It is not covered by any strategic plan, nor does it benefit from dedicated funding by a responsible Institute. The goal “Breakdown of traditional disease boundaries” does not sufficiently address this problem.

There is, of course, an ongoing role for body system/disease centric approaches. But NIH must grapple with the challenges of diseases which cross boundaries, and must either assign responsibility to existing institutes or create a new structure that can address the diseases that currently fall through the cracks.

Comprehensive trans-NIH research themes that have not been captured in the Areas of Opportunity that Apply Across Biomedicine

This strategic plan has allowed no room for the voices of patients. While FDA has sought to expand the role of patient voices in its decision making, and PCORI’s mission is focused on patient views and preferences, NIH has taken no steps in this direction.

This is NIH’s loss. Patients and caregivers have valuable information that can inform research design and priority setting. Even basic research can be improved and informed by including patients’ views.

Creating large cohorts of healthy and sick individuals, such as in the Precision Medicine Initiative is valuable, but it is not sufficient. Patients can contribute to hypothesis generation, selection of outcomes measures, and identification of treatment targets.

NIH must come to terms with the role patients can play in biomedical research. Incorporating these views in a systematic way would strengthen NIH and its research, regardless of the disease or Institute involved.

Future opportunities or emerging research needs

While I agree that burden of disease should not be the only factor in priority setting, it must play a more central role. NIH must do more than select 69 categories from the Global Burden of Disease study. It’s a start, but in no way is it sufficient.

For example, ME/CFS is a disabling disease that costs the US economy more than $20 billion per year, but it was not included in the GBD study. No one has calculated a DALY figure for ME/CFS in the United States. And so, left to fall through the cracks, the burden of this disease is not considered in decision making.

Furthermore, NIH must create more transparency in its funding decisions. Regardless of whether the 21st Century Cures act passes and mandates such transparency, NIH owes it to the ultimate source of its funding – the American people – to justify the enormous gap between the burden of a disease like ME/CFS and the paltry funding allocated to solving it.

A disease like ME/CFS, which crosses multiple body systems, represents a tremendous opportunity for discovery. Unlocking the pathophysiology of this disease could have implications far beyond just ME/CFS. This is an area that could and should be prioritized, but instead it languishes without any focused attention.

There are institutional obstacles to progress for diseases like ME/CFS, yet if those could be solved the opportunity to advance science and find treatments is enormous. If the strategic plan includes “Research Spotlights” as proposed, then I submit that ME/CFS is a case study in opportunity and trans-NIH priorities.

*My thanks to Denise Lopez-Majano for digging up information on the strategic plan.

Posted in Advocacy | Tagged , , , , , , , , , , , , , | 2 Comments

The Return of CFSAC

Posted on July 22, 2015 by Jennie Spotila

Publicly, the CFS Advisory Committee has been MIA this year. There were some comings and goings, and general silence, but now there is finally movement to report.

UPDATE July 28, 2015: The Federal Register notice for the meeting has been published. Registration is attend in person closes August 13th. You must request public comment time by August 10th. Written public comment is due by August 13th. Details for all these deadlines is in the Federal Register notice.

We Meet Again

The big news is that CFSAC will hold a two day in-person meeting on August 18th and 19th. There is no agenda yet, and instructions for submitting testimony will presumably be included in the August 3rd Federal Register notice.

My suggestion is that you don’t wait for the Federal Register notice. The deadline for submitting public testimony will be probably be about three weeks from now. Start working on your comments, because that deadline will be upon us very quickly.

Roster Changes

I previously reported that Dr. Gary Kaplan‘s term expired on May 15, 2015. Without fanfare or announcement (or a public call for nominations), Dr. Kaplan’s term has been renewed for another two years, through 2017. Four members’ terms will expire next year.

You may recall the public call for nominations to the non-voting liaison positions. The Solve ME/CFS Initiative and IACFS/ME have been reappointed to two year terms. However, the charter specifies “there will be three non-voting liaison representative positions.” No explanation has been offered for why only two liaisons were appointed.

There have been interesting developments in the ex officio roster. First, Dr. Nancy Lee has officially been reappointed to the Designated Federal Officer position, to replace Dr. Ledia Martinez who resigned after about a month. Second, as I previously noted, Dr. Suchitra Iyer is the new ex officio from the Agency for Healthcare Research and Quality. She was the contract officer on the AHRQ systematic review for the P2P meeting.

Third, Dr. Deborah Willis-Fillinger has been replaced as ex officio for the Health Resources and Services Administration. Erin Fowler will now serve in that capacity. Fowler works in the newly created Bureau of Health Workforce, which focuses on encouraging and training health care workers for underserved populations.

Fourth, the new NIH ex officio is Dr. Vicky Whittemore from the National Institute of Neurological Diseases and Stroke. This is huge news. For the first time that I can remember, the NIH ex officio is from an Institute, rather than the Office of Research on Women’s Health. Furthermore, Dr. Whittemore has acted as the Program Official on ME/CFS grants to Dr. James Baraniuk, Dr. Mary Ann Fletcher and others. Whether this signals changes at NIH remains to be seen.

And You?

As I said, the agenda has not been posted yet. But presumably, there will be discussion about the IOM and P2P reports – perhaps even recommendations? This is hugely important, given HHS’s perfect silence about IOM and what they are going to do next.

Will SEID be adopted as the official name? With the IOM criteria replace Fukuda? What will CDC do with its website and Toolkit? Will there be NIH funding? Will anybody in the government be doing anything different?

So do you have something to say to CFSAC or to NIH or to CDC? Then start writing those comments and block off August 18th and 19th. This is our chance to speak publicly about the IOM, P2P, and the current state of inaction and silence. Get ready.

Posted in Advocacy | Tagged , , , , , , , , , , , , | 7 Comments

Brian Vastag to Dr. Francis Collins

Posted on July 15, 2015 by Jennie Spotila

Yesterday, an open letter from science writer Brian Vastag to Dr. Francis Collins (Director, NIH) flashed around the ME/CFS social media-sphere like lightning. Then it spread among Brian’s high profile colleagues, like Martin Enserink and Carl Zimmer. Brian’s letter is both personal and scientific, and he makes a very reasonable suggestion for how to increase ME/CFS funding. I’ve reprinted excerpts of the letter here with Brian’s permission, but please go read the entire original on The Last Word on Nothing.

Dear Dr. Collins,

You might recall the last time we spoke. It was January 2013, and I was working as a science reporter at The Washington Post. Your people arranged an early call for you to announce that the N.I.H. had decided to retire most of its research chimpanzees. We spoke for about 20 minutes, and I typed up a 600-word story. It wasn’t very good.

I was working from home that gray day because I had little choice. I was mostly bedbound then, seven months after a sudden fever had knocked me prostrate. My legs were so weak that climbing the stairs to my home office required pulling myself up the railing hand-over-hand. My brain was so sluggish I asked few questions of you. The ones I managed to croak out were poor, no doubt.

Too sick to work, I did anyway. I loved my job at the Post – not an easy gig to come by – and I was desperate to keep it. I had been following the research chimp story for a while, and I liked that the N.I.H. chose me to break your news.

I’ve long appreciated how the N.I.H. helps the world. My career began there in 1998, when Paul van Nevel hired me for a science writing fellowship at the National Cancer Institute. I count your communications director John Burklow among my mentors, and I was honored to write Paul’s obituary. That first boost of professional success propelled me to an exciting career.

Lately, though, my love for your august institution has been strained. You see, I’ve been felled by the most forlorn of orphan illnesses. The most accurate name for it is myalgic encephalomyelitis, which means “painful inflammation of the brain and spine.” (Yes, it is painful, and yes, there’s strong evidence of neuroinflammation.) At the N.I.H. and elsewhere, it is instead called chronic fatigue syndrome. That’s a terribly vague and dismissive moniker for so serious an illness, and one that needs to be retired. Fatigue is not the primary or most troubling symptom for most people with M.E.

. . .

On the list of illnesses the N.I.H. studies, M.E. (listed as “M.E./C.F.S.”) is near the bottom in funding, ranked 231 out of 244. It received $5 million in 2014, less than hay fever, which cripples no one. That’s not enough money to equip a laboratory and run it for a year. This abject neglect – or sustained prejudice, or maybe both – stretches back a full three decades at the N.I.H. (For a detailed history of how this sad state came to be, read Hillary Johnson’s deeply-reported book Osler’s Web.)

. . .

But M.E. is finally emerging from the basement. Brand name institutions and big-time researchers now recognize the huge burden M.E. places on society – tens of billions in medical expenses, lost productivity, and missing tax revenue each year. Columbia University’s Ian Lipkin is searching for infectious triggers, and has reported severe immune problems in patients. Columbia received $150 million in N.I.H. grants in 2015; Lipkin’s operation gets a big chunk of that. But when the famous virus hunter applied for a trifling $1 million for M.E. research, the N.I.H. turned him down, twice. So spurned, Lipkin and colleague Mady Hornig recently resorted to eating habanero peppers to raise money.

. . .

At Stanford University, prominent geneticist Ron Davis is searching for genetic risk factors. His investment is deeply personal, as his adult son – formerly a world-traveling photographer – is severely ill with M.E., and can no longer walk or talk.

When you peruse the recent M.E. literature, you’ll see a mix of young researchers and experienced lab leaders producing a string of insights into how the illness damages the immune system and the brain. Mutations in the gene MTHFR have been identified by the Open Medicine Foundation as a risk factor. Diagnostic biomarkers await validation. Promising treatments need to be tested in patients. And all of this has happened with little support from the N.I.H.

Patient advocates have called for $250 million in M.E. research funding, a figure commensurate with the burden of disease. This is a huge ask, and in all likelihood politically infeasible, so let me make a smaller one. A new N.I.H. program funded with as little as $10 million to $20 million per year would be absolutely transformative for the field – and for patients. Such a program would affirm the N.I.H.’s commitment to understanding the illness. It would draw more young researchers to studying M.E., and it would encourage further private funding. Such a commitment would also give patients – many housebound or bedbound for decades – hope that they’ll be healthy again. I challenge you to find another illness where such a small investment could make such a huge difference.

You now have broad support from the medical community to make this happen. Earlier this year, the Institute of Medicine made a strong call for a robust M.E. research program. And just last month, an N.I.H.-appointed panel urgently made the same recommendation. With the bipartisan 21st Century Cures Act poised to pass Congress – giving N.I.H. an extra $8.75 billion over five years – you could do so without pulling money from existing programs. At the same time, you could help things along by moving responsibility for M.E. from its long-term parking spot at the Office of Research on Women’s Health to one of the institutes that, you know, funds disease research.

. . .

Here in Hawaii, there’s a smaller mountain behind my yard. It’s called Sleeping Giant, and the giant’s forehead juts less than 500 feet above my back patio. A well-trod trail carries people up there for sweeping views down the volcanic slope and across the endless Pacific. Oh how I would love to drink in that view. But I may as well be gazing up at K2; a summit attempt would be supremely unwise, as a sophisticated exercise test found that I suffer from severe metabolic, cardiac, and pulmonary dysfunction. Exercise for M.E. patients is more damaging than sugar is to a person with diabetes.

At 43, my productive life may well be over. There’s a good chance I have hiked my last trail. The nation’s coffers lose some $25,000 in tax revenue each year I remain disabled, and I will soon know if Social Security Disability Insurance will start coming my way. I don’t enjoy being a drain on society, and neither do any of the other M.E. patients I know. And yet, with the ever-growing research interest in M.E., I have hope that someday I’ll be able to stand for more than a few minutes, walk for more than a block or two, maybe even resume my career. (It took me four days, with frequent breaks, to write this letter…that’s a bit slow for newspaper work.)

The causes of M.E. will eventually be discovered, treatments will be found, and patients will enjoy long-term remissions. As the leader of our nation’s medical research enterprise, you have a decision to make – do you want the N.I.H. to be part of these solutions, or will the nation’s medical research agency continue to be part of the problem? At the very least, you could ensure Dr. Lipkin doesn’t have to scorch his intestinal tract again just to drum up a few research dollars.

Sincerely,

Brian Vastag

Posted in Advocacy | Tagged , , , , , , , , , , , , , , , , | 13 Comments

Talk Is Cheap

Posted on July 13, 2015 by Jennie Spotila

In today’s guest post, Denise Lopez-Majano makes the case that the time for talk is over and the time for action is now.

moneyFor 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.

Posted in Commentary | Tagged , , , , , , , , , , , , , | 12 Comments

Wheelchair – HELP!

Posted on July 6, 2015 by Jennie Spotila

I need a new wheelchair, and I need your help!

I have used a manual chair for many years, relying on friends and family to push me around. But the chair gets caught in pavement cracks, has trouble going over small bumps and curbs, and is generally rickety.

I need a chair that can handle bumps, rises, cracks, and rough terrain. I need a chair that can fold up and go in the car. And I would love an electric chair to give me some independence.

I’ve got a couple models in mind, but I need your help! Do you have any experience with one or more of these wheelchairs? Do you have another model that might fit my requirements? Help me out and drop a comment!

KD SmartChair

EZ Lite Cruiser

Whirlwind Rough Rider

TravelScoot

 

Posted in Occupying | Tagged , , , , , | 19 Comments

P2P: Where Next?

Posted on June 29, 2015 by Jennie Spotila

people-marchingThere is one official final step in the P2P process: a federal partners meeting supposed to be held six to eight months after the workshop. But there are other marching orders, too. For us.

Federals Only

As described on the P2P website, there is a federal partners meeting six to eight months after each workshop. The purpose of the partners meeting is to review the panel’s report and identify possible opportunities for collaboration. The key here is that it is federal partners only – no other stakeholders are invited as far as I can tell.

Only one P2P workshop has progressed to the partners meeting. The Polycycstic Ovary Syndrome (PCOS) federal partners meeting was held in May 2014, almost 18 months after the PCOS workshop. There is no list of attendees posted online, but a basic summary of the meeting is available. A number of ideas seem to have been tossed around, but no specific action items or commitments were made by the federal partners.

The takeaway is that the final P2P step is a meeting for federals only, without a track record of producing actions or commitments. For all the fuss and promotion around P2P, NIH seems rather uninterested in applying anything that comes out of the process.

The To Do List

But WE don’t have to take the same attitude. As I said in my post about the P2P report’s failures, there are good things in the report too. I have compiled a list of all the action items suggested by the Panel, and I think we should use it to check NIH’s progress at every opportunity.

You can see the full list here. I’ve included citations to the pages where these recommendations appear. The only changes I made were to make the phrasing active, rather than passive. The recommendations are listed in the order with which they appear in the document. I had hoped the Panel would explicitly prioritize their recommendations, but the order remained unchanged from the draft report. It is a very long list of action items: sixty-five in total. What it boils down to is this:

  1. Reach consensus among the stakeholders on a case definition.
  2. Prioritize biomedical research for biomarkers, pathogenesis, diagnostics, prognostics, and therapeutics, including -omics and imaging studies.
  3. Create a central repository/registry for biological samples and clinical data.
  4. Increase patient involvement in creating research priorities, patient-reported outcomes, and the case definition.
  5. Disseminate best practices and training to primary and specialty physicians.
  6. Create a network of centers to determine: biomarkers for diagnosis and prognosis; epidemiology; outcomes; cost-effectiveness; co-morbidities; recovery; and control populations.
  7. Convene an ME/CFS expert panel in five years to monitor progress.

Many of these items have been recommended by the CFS Advisory Committee and advocates many times before. This is a list that cannot be completed in five years, and which will never be completed without a very substantial increase in investment.

But a significant value of this list is that it gives us the structure for an NIH report card. We should, at every opportunity and in every possible venue, ask what progress is being made on the list. Print out that NIH report card and share the list with Congress, asking them to monitor NIH’s progress on this advice which, after all, NIH requested itself. Bring the list to every CFSAC and ask the NIH ex officio what progress is being made. Mark your calendar for June 2020, and demand that ODP reconvene an expert panel to monitor progress.

And if no progress is made? If NIH focuses on the cheap and easy recommendations? Then we wave this list and remind them that THEY requisitioned these recommendations, not us. These are not recommendations from the same crowd that has been making the same recommendations for twenty or thirty years.

Funding Funding Funding

Despite the Panel’s reluctance to explicitly recommend an increase in ME/CFS research funding, it is patently obvious that the necessary progress cannot be made on $5 million a year. We must continue our demands for increased NIH funding, especially because it looks like NIH might get a 6% increase in budget in FY2016. Much of those funds will go to “sexier” projects like precision medicine and the BRAIN initiative. But NIH cannot continue to claim there is simply no money.

So how do we go about pressuring NIH to increase its ME/CFS investment? There are several petitions in circulation, and ME Advocacy is running a one-click campaign. ME Action has a petition for more funding. There’s also an email campaign directed at NIH. But as with all advocacy efforts, make sure you read all the details before signing on. Some of these efforts explicitly reject the IOM report, others incorporate quotes from IOM and P2P reports in support of research. Know what you’re signing.

If you can’t find a petition or one-click campaign that fits your views, then consider starting your own. ME Action provides a platform with organizing tools for a variety of actions. And it bears repeating that contacting your own representatives is always a good idea. Congress may especially be interested in whether HHS takes any of the expensive advice they got from IOM and P2P.

Marching Orders

Here’s the bottom line: the P2P Panel recommended research priorities that will cost a lot of money to carry out. Many of the recommendations match what advocates have been saying for years. The only way to make progress is to significantly increase research funding for ME/CFS.

NIH controlled the P2P process. NIH selected the panel members, defined the questions, designed the evidence review and the workshop agenda. This has been NIH’s game, played by their rules. If NIH does not like the advice they got, or if this was all just a show never intended to go anywhere, then that just gives us even more political ammunition.

We must demand the necessary increase in funding. We must hold NIH accountable to the report card of recommendations. We’ve got our work cut out for us.

Let’s get going.

Posted in Advocacy | Tagged , , , , , , , , , , , , , , , , , , , , | 10 Comments

Showing the Back of Their Heads

Posted on June 22, 2015 by Jennie Spotila
image credit: greggilbert.com

image credit: greggilbert.com

The final P2P report is published, and now it’s time to evaluate the quality of the recommendations and how well the process served ME/CFS patients. There are many good things in the P2P report, and I’ll be focusing on those in my next post (now available here). Today, I want to discuss some serious flaws in the report and how, despite all the rhetoric, NIH and the P2P Panel did not engage with the public in a meaningful way. And I also want to discuss a lesson we can apply next time.

All That Input

At the telebriefing on Tuesday, June 16th, Dr. Green said the Panel members individually reviewed each of the public comments and discussed them in a conference call. Unfortunately, the Panel did not take most of our advice. The Panelists may have reviewed each comment, but only minor changes were made to the draft report in response to those comments.

For example, the final report appropriately deleted the sentence, “There is no agreement from the research community on what needs to be studied.” (Draft, lines 34-35) The statement that ME/CFS “overlaps with many other diseases” was also deleted. (Draft, line 33) The need to disseminate diagnostic and treatment recommendations to primary care providers was expanded, as many public comments suggested, to include specialties like neurology, rheumatology and infectious disease. (Draft, line 192) Other minor corrections were made, such as clarifying that Fukuda allows 163 combinations of symptoms, not that there are 163 symptoms of ME/CFS. (Draft, lines 50-51)

But the vast majority of comments were ignored. Even the statement that ME/CFS has an economic impact greater than $1 billion (Draft, lines 6-7) was not fully corrected. I lost count of the number of public comments that provided the correct number of more than $20 billion in direct and indirect costs. However, the final version estimates the burden at $2 to 7 billion, and does not clarify whether those are direct or indirect costs. When journalist Miriam Tucker asked for the reference for this estimate, Dr. Green said they used a number that was “scientifically based,” but she did not provide a reference.

But these are minor points compared to the failure to incorporate the major issues highlighted in multiple public comments. All the input on the critical points that most need attention was ignored.

 The Money Elephant

The issue that receive more attention in public comment than any other was NIH funding. Comment after comment begged the Panel to acknowledge the paucity of funding and to recommend that NIH significantly increase its investment in ME/CFS research.

The IACFS/ME said, “[We] believe that the elephant in the room – research funding . . . needs to be addressed more strongly and specifically. . . . Thus we respectfully ask that the NIH Panel highlight the inadequate research funding of ME/CFS and link this core premise to specific recommendations for new funding initiatives, with dollar amounts, mechanisms, and deadlines, to begin to address the current underfunded status of this illness.”

The CFS Advisory Committee said, “We also ask that you take note of the fact that among the 234 disease categories supported by NIH in 2014, chronic fatigue syndrome ranked 228th with an estimated $5 million in funding. In order to move forward, it is vital that this issue be addressed. We ask that the Panel explicitly address the urgent need for government funding in order to advance the research for ME/CFS.”

The Massachussetts CFIDS/ME & FM Association said, “All of these recommendations for future directions in research require significant funding . . . NIH has never funded this illness commensurate with its impact on patients and society. While it may be possible to cobble together small amounts of funding from different agencies for some specific initiatives . . . why not just recognize the inequality here and deal with it? The types of research recommended here cannot be done on nickels and dimes.”

I could go on. Over and over and over, public comments begged the Panel to recommend an increase in NIH funding. If the Panel did indeed read the hundreds of pages of comments we submitted, they could not possibly have missed the blaring consensus on the urgent need to add zeroes to the amount of NIH’s ME/CFS investment. Despite all of this, the Panel made no such recommendation. I have no doubt that some people will conclude that NIH told the Panel they could not make the recommendation.

In fact, Dr. Green told Medscape News, “Money can be reallocated or better targeted.” That’s quite explicitly not an increase in funding, folks.

Eating the Oxford Cake

I blogged about the moment at the P2P Workshop when the Evidence Practice Center suggested retiring the Oxford definition, and the illogical reply to my question about retiring Oxford studies. Chris Heppner made a powerful case for declaring independence from the Oxford definition once and for all. But not only did the Panel’s final report fail to take that logical step, it actually toned down its language on the Oxford definition.

The draft report stated, “The Oxford criteria . . . are flawed and include people with other conditions, confounding the ability to interpret the science.” (Draft, lines 38-40) That sentence is gone from the final version. We are left with the recommendation from the Draft, unchanged in the final version: “Specifically, continuing to use the Oxford definition may impair progress and cause harm. Thus, for needed progress to occur, we recommend (1) that the Oxford definition be retired . . ” (Final, p. 16)

Personally, I am very disturbed by the deletion of the statement that Oxford includes people with other conditions. Why? Because the data establish that this is the case. The Panel should have retained their acknowledgement of the data. For the Panel to step back from acknowledging the facts strikes me as ominous, because obviously it helps ME/CFS advocates to have such an explicit declaration in the report and its removal makes no sense in light of the data. It will certainly raise questions in some minds about whether the Panel was pressured to remove the sentence.

I am also not satisfied with the recommendation to retire the Oxford definition without an accompanying recommendation to retire Oxford studies as applied to the ME/CFS population. Why? Because the largest trial of CBT and GET, the trial that is the basis for the claim that these therapies are effective treatments for ME/CFS, uses the Oxford definition. And that study is continually trotted out, including in the Annals treatment article this week, and no one will acknowledge the very basic logical fact that the study was done on a cohort that included an unknown number of people who did not meet criteria for ME/CFS (not Fukuda, not CCC, not ICC, and not SEID).

Multiple public comments, including mine, made this point to the Panel. The bottom line is, “You cannot take the results of studies done on subjects who do not have ME/CFS and simply apply those results to those that do.”

For some reason, the Panel did not agree with all of the comments making this point. Why? One possible reason is that if the PACE trial and similar Oxford “treatment” studies are discarded, then there is almost nothing left. This is especially true for the systematic evidence review, which excluded studies like the Rituximab trial. It would mean admitting that thirty years of research has not produced an effective treatment for ME/CFS, and that the only promising treatments are extraordinarily expensive. That’s a damning fact and quite an embarrassment for NIH and the research enterprise.

Not Our Wheelhouse

Multiple public comments urged the Panel to consider the IOM report while revising their recommendations. Even Dr. Nancy Lee, newly re-appointed DFO of the CFS Advisory Committee, asked them to discuss it.

Dr. Lee emailed her comments the day after the posting of the Draft Report. I think it’s worth quoting Dr. Lee at length: “To avoid the mistaken perception that NIH and the P2P Panel didn’t know about the IOM study (which NIH helped fund!), I urge you to mention the IOM study in your report. The discussion on lines 201-212 should be modified to acknowledge that the IOM’s report may make substantial progress in fulfilling P2P recommendation. There is a good chance that the IOM report will be released before the Panel’s report so you might even be able to modify your report at the last minute to reflect the content of the IOM’s report. HHS spent $1million on the IOM study to get much of what your panel recommends on line 202. I don’t want it to appear that NIH’s right hand doesn’t know what its left hand is doing!”

Despite the many requests, the Panel wrote that considering and incorporating the IOM’s recommendations was “beyond our scope and charge.” (Final, p. 18)

The charge to the P2P Panel was to provide “guidance to the NIH on research gaps and research priorities for ME/CFS.” (Final, p. 18) The final report notes the critical importance of case definition in ME/CFS research, and urges that a consensus be reached on a single case definition. (Final, pp. 9, 16) So how is the IOM report beyond the scope and charge of the P2P Panel?

I think the Panel members would agree that science requires examining all the data. My personal belief is that the phrase “beyond our scope and charge” is actually code for “we were not given the time and staff support to fully evaluate the IOM report.” Was it a matter of NIH putting its P2P process (evidence review + workshop = report) over the quality of the product? Was there some other reason NIH did not ask the Panel to review and consider the IOM report? I do not know.

Talking At The Back Of Their Heads

ignoreBy now, we are all familiar with the NIH party line that ME/CFS patients and advocates were fully engaged by P2P. At the telebriefing, Dr. Ronit Elk said that patients and families were “completely a part of the process.” I won’t review all the evidence to the contrary from the last 18 months.

What I will do is point out that the “tremendous number of responses,” as Dr. Elk described it, seems to have had very little impact on the revisions to the draft report. Despite the extra time given the Panel, despite Dr. Green’s statement that each panelist read every single comment, despite the assurances from NIH that patients and advocates were integrated at every step, our comments were not accepted.

Many advocates might think that the dismissal of these comments prove that public comment is a waste of time. We comment, they don’t listen to us, so why bother? I say that’s a response that plays right into the government’s hands. This defeatist reaction has it all backwards.

Over 100 people and organizations submitted comment on the P2P report, and they were ignored. That gives us another link in the Thirty Years of Neglect Chain. We can embarrass them with this fact. We can tell the media, our Congressmen, CFSAC, and others that over 100 people spoke and we were dismissed and ignored. That’s the level of contempt NIH has for our input.

Dialing back our participation is exactly what they want us to do. They want us to go away. They think that if they just keep ignoring us, we will get frustrated and lose interest.

We should do the opposite. We should say, You ignored 100 comments? Let’s see you ignore 200 or 500 or 1,000. The more comments that go in, and the more they ignore them, the more ridiculous the situation becomes. That is a political weapon!

So yes, 100+ comments was not enough to get a stronger recommendation on funding into this report. There is still plenty here we can use. And we have one more incident of Government Ignores Constructive Response From Patient Community to add to the list. They are practically begging us to turn up the volume and intensity.

NIH is showing us the back of their heads. Ok, then we have to be louder. NIH is ignoring us. Then let’s be more forceful. Let’s increase the volume, increase the intensity, and build an ever growing wave of actions that will ultimately overwhelm resistance and swamp them. They ignore us because they can. So let’s make it impossible for them to do so.

Posted in Advocacy, Commentary | Tagged , , , , , , , , , , , , , , , , , , , , , | 42 Comments

P2P Final Chapter

Posted on June 16, 2015 by Jennie Spotila

The final P2P ME/CFS documents are coming out today. I am severely crashed from family obligations, so in-depth analysis will take me a little longer than normal. But here are quick descriptions of the various articles to get you started:

Final P2P Report – As of 8:30 am today, this has not yet been published on the NIH P2P website. As of 9:15 am, the final report is available on the NIH site.

P2P Panel’s article in the Annals of Internal Medicine – This reads very much like the Panel’s draft report, and I won’t be surprised if it matches whatever final version ends up on the NIH site.

Overview by Dr. Anthony Komaroff in Annals – If you can only read one document today, start with this one. Dr. Komaroff gives an excellent overview of the intersection between the IOM and P2P reports. This is important because the Panel does not even mention the IOM report in its Annals article.

ME/CFS Treatment article in Annals – This is a summary version of the treatment section of the AHRQ evidence review (prepared for the P2P Panel and presented in December 2014). If you recall, that evidence review found that CBT and GET were the most effective treatments, and made much of the very poor number and design of trials.

ME/CFS Diagnosis article in Annals – This is the summary version of the diagnosis section of the AHRQ evidence review (prepared for the P2P Panel and presented in December 2014). Two things stand out. First, this version has been updated to include references to the IOM report. The P2P Panel did not bother to do so. Second, Dr. Komaroff’s article, in discussing biological abnormalities, largely references the IOM report. Why? Because the evidence review excluded most of this literature.

A playback of the June 16th telebriefing will be available for four weeks afterwards. Use: 888-640-7743 (U.S. and Canada) | 754-333-7735 (Other International Callers)
Enter replay code 118646, followed by the # sign.

Update June 16, 2015 11:37 am: The one hour telebriefing concluded after 30 minutes. Only one report, Miriam Tucker, asked a question. Deborah Langer of the Office of Disease Prevention repeatedly stated that there were no other question. However, I want to be VERY CLEAR: I identified myself as a writer for Occupy CFS when I joined the call. I made SIX ATTEMPTS to ask a question. My place in the queue was never recognized and I was never given the opportunity to ask a question. If any other members of the media attended the briefing, they did not ask questions. This was an appalling way to end the P2P process.

Posted in Advocacy | Tagged , , , , , , , , , , , , , , , , | 32 Comments

Stuck? Four Months of Almost Nothing

Posted on June 13, 2015 by Jennie Spotila

In this guest post, Dr. Alan Gurwitt argues that it is time for ME/CFS advocacy to move on and move forward. The post first appeared on the website for the Massachusetts CFIDS/ME & FM Association, and is reprinted here with Alan’s permission.

Turtle-Stuck

image credit: The Poised Life

Four months have passed since the release of the report from the Institute of Medicine on February 10th. In spite of much thoughtful review and debate on the part of patient advocates to attempt to arrive at some consensus about an appropriate name and diagnostic criteria for this terrible disease, so far these efforts have changed nothing, nor will they make a difference without major changes in our tactics and attitudes.

The federal DFO’s (designated federal officers) come and go. The Chronic Fatigue Syndrome Advisory Committee (CFSAC) keeps making reasonable recommendations but is often ignored. There is not a peep from HHS and NIH. Indeed, except for some promising responses from the CDC, there is silence. Dr. Francis Collins, the director of NIH, says he is aware of the requests for greater NIH involvement but continues to do nothing. Dr. Anthony Fauci, in office since 1984 as head of the National Institute of Allergy and Infectious Diseases (NIAID), continues to make it clear he wants nothing to do with ME/CFS. While many agree that the work on ME/CFS belongs in one of NIH’s institutes with research funding, not in an unfunded Office of Women’s Health, there is no person or group at NIH and HHS who is leading the charge and no indication so far that the leaders of these huge “health” agencies have paid attention to the findings of the IOM report and the preliminary P2P report and plan to respond promptly and significantly. Some individual lower-level personnel have gotten the message and have done what they can, but overriding indifference has prevailed for thirty years and there are no signs of motivation to change. I believe only strong outside forces will cause HHS and NIH to change.

Under present circumstances, it does us no good to sit and wait another four months for the government’s response. Whether or not HHS and NIH respond we patients, advocates, researchers and allies in the medical professions must review and change our tactics and directions, otherwise we will remain stuck in nowheresville. We have tried for years, with some success to make our illness and cause known but our struggle too often is ignored or seen as unwelcome. At times it seems like war for recognition and survival.

Alone, we are weak, vulnerable, and ineffective. We must supplement and organize our forces and improve our strategies going forward.

So, where should we go from here? I believe that there needs to be a series of coordinated steps to build an effective and constructive force. As I see it, the possible steps are the following:

  • We have been told for years that the federal health agencies will only shift course when Congress demands it. We should establish a group to research and plan how to best educate and recruit Congress people from as many states as possible to act together in Congress. ME/CFS is a bipartisan cause and a very serious national problem. Coordination will be absolutely key.
  • Recruit a coalition of medical professionals, both researchers and clinicians, and institutions outside of the government to map out what are the key areas of needed research, both basic and clinical. This may not be hard to do as there is already much cooperation thanks to the IACFS/ME.
  • Form a planning group to think through the goals of a long overdue national ME/CFS organization, its possible structure, and means of creating and coordinating the above steps. After doing so (six months to no more than a year), implement.
  • Create a group to collaborate with patient groups and clinicians in other countries. ME/CFS doesn’t recognize boundaries. There is much to learn from one another. Australia and New Zealand have succeeded in educating a higher percentage of physicians. Norway is doing key research on whether ME/CFS is an autoimmune illness. In all these cases patient organizations have played a key part.
  • We must stop the pattern of fighting and undercutting among ourselves. Such has been an important reason for limited participation and contributed to our fragmentation. If we don’t all work together in a respectful manner to achieve common goals we defeat ourselves. We have large challenges to overcome but at times we have been our own worst enemies.
  • Time is of the essence otherwise positive components of the IOM report might die. Let us not miss the opportunities opened up by the IOM report and important new research.

I believe the IOM and P2P reports are game changers if we utilize the achievable big findings and recommendations. Of course name and diagnostic criteria are important but it is only with further research that both will become clear. The other big findings which we can propel our work now are:

  1. ME/CFS is a biological, not psychological, disease.
  2. For many years patients with ME/CFS have been undiagnosed, misdiagnosed, mistreated and harmed by uninformed healthcare professionals and shamefully negligent medical educators and medical organizations. We must figure out what are the blocks to learning and how to overcome them, otherwise ignorance will continue.
  3. Children and adolescents present somewhat differently but have a better prognosis IF diagnosed early and well managed. Useful pediatric ME/CFS research is even sparser than for adults. That must change.
  4. There are huge gaps in our scientific understanding of ME/CFS in both children and adults as a result of a biased and indifferent federal government which has almost totally failed for decades to provide the necessary research funds and leadership. In response to the initiatives on the part of HHS and NIH to bring about the P2P and IOM reports, the reports seem DOA (dead on arrival) and the leaders AWOL (absent without leave).

In summary, nothing will change until we change. We must not keep waiting for the federal health agencies nor should we go it alone. We must take a series of steps. One step is to create a multi-pronged coordinated and comprehensive effort to recruit congressional support. We must also build a strong national coalition of patients, advocates, and professionals. We have many wonderfully informed, thoughtful, and active patient advocates among us but our failure to coalesce has created a major obstacle. The challenges are great so our efforts must be greatly smarter, focused, and more effective.

Failure to change our efforts and directions will doom us to remaining stuck. We should utilize our own capacities and wait no more.

Dr. Alan Gurwitt’s opinions here are his own and do not represent the Mass. ME/CFS and FM Association and its Board.

Posted in Advocacy, Commentary | Tagged , , , , , , , , , , , , , , , , , | 9 Comments