A Miracle, and a Break

This year has been the most difficult of my life, starting with my Mom’s passing in January. Losing her was just the first in a cascade of bad news, and I made the decision to stop maintaining that laundry list because it just made me feel worse.

But three weeks ago, one of the worst and luckiest things happened to us. My husband had a stroke. Not only did he have a stroke, but he was misdiagnosed in the emergency room with vestibular neuritis. So he did not begin receiving treatment for the stroke until we got the accurate diagnosis last week.

As part of getting that accurate stroke diagnosis, we discovered that the stroke was in his medulla. One doctor told him that he was lucky to be alive, let alone walking around and not permanently disabled. He “dodged a bullet,” this doctor said. To have this type of stroke untreated for two weeks because of misdiagnosis, and to be walking/talking/breathing/swallowing unassisted just three weeks later is . . . . well, it’s a miracle.

My husband is my primary caregiver. Through the unwavering kindness and support of family and friends, we have been transported to every doctor appointment, had meals to eat, and all the emotional support that we need. But I had to become the primary caregiver in many ways, especially in making medical decisions and logistical arrangements. And because of that 2015 laundry list of bad news, I was crashed and depleted long before I had to summon an ambulance to our home three weeks ago, not even realizing that my husband was having a stroke.

The time has come for me to take a break. My use of social media, including this blog, will be extremely limited for a few weeks (at least). I will be monitoring email, but probably not responding to much of it. I am not “retiring” from advocacy, but I need to take care of my husband and of myself. That is my prime directive and top priority.

As I said, this is the worst and luckiest thing to ever happen to us. The only reason my husband is not dead or severely disabled is our good fortune. The stroke was extremely small, and the misdiagnosis did not kill him. Both of us will be ok, but we need some time.

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CFSAC Testimony, Jennie Spotila, August 18, 2015

Unfortunately, I am too sick to offer public comment by telephone for the August 18-19, 2015 meeting of the CFS Advisory Committee. I submitted these written comments for the record. Thank you to all of the advocates who are speaking by phone or in person.

Dollar-on-HookWhen I was a kid, I used to go fishing with my Dad. It was nothing sophisticated: just a borrowed boat on a small lake, live bait and a plastic bobber on the line. But there was a hitch. There was no way I was going to squish a live worm onto a hook. And even though my father is a herpetologist, he did not insist that I learn to bait the hook myself. He baited my hook and we fished. My Dad also did not ask me the obvious question: was my fishing strategy going to consist of waiting in the boat and hoping the fish would come to me on their own?

Yet this is the kind of fishing strategy that seems to be NIH policy as far as ME/CFS is concerned.

For the last ten years, advocates, scientists and this Committee have urged NIH to invest more money in ME/CFS research. Both the IOM and P2P reports reached the obvious conclusion that substantially more research is needed in this area. The IOM committee said, “Remarkably little funding has been made available” to study this disease, and “More research is essential.” (IOM, p. 225) This advisory committee has urged greater investment, and has repeatedly recommended that NIH issue an RFA with dedicated funding in order to stimulate this field.

Last year, NIH’s response to this Committee was that issuing an RFA “would not be an effective strategy”. On August 11, 2014, Dr. Francis Collins wrote to Representative Zoe Lofgren, “The lack of sufficiently trained individuals applying for NIH research funds to conduct ME/CFS research projects contributes to the low number of applications received and subsequently the annual spending on ME/CFS research.” This is in and of itself a remarkable assertion, since researchers like Dr. Ian Lipkin and Dr. Ron Davis have applied for NIH funding and been rejected. Are they not sufficiently trained?

Every time NIH has been urged to issue an RFA to stimulate research in ME/CFS, NIH’s response has been that there are not enough researchers or data to make it worthwhile. In other words, NIH is sitting in the boat and expecting that the fish will catch themselves.

This is not NIH standard operating procedure when it comes to other areas of research:

What these diverse initiatives share is an NIH investment policy designed to stimulate research in an area that needs development. But this policy is not applied to ME/CFS.

Worse, NIH’s current position on ME/CFS is not even consistent with its previous actions. In 2005, NIH issued an RFA on Neuroimmune Mechanisms and CFS. How could there have been enough known about the disease and enough qualified researchers to do the work sufficient to issue an RFA in 2005, but not now in 2015 when we have more data and more scientists than at any time in the history of the field?

Everyone – patients, advocates, researchers, members of Congress, the IACFS/ME, this Committee, the IOM and the P2P – EVERYONE has told NIH that more research is desperately needed in ME/CFS. EVERYONE has said that this is an under-researched area that needs an immediate infusion of money and personnel if patients are to have any hope at all for effective treatments. Everyone has said this, and NIH refuses to do what is necessary. Instead, NIH is sitting in the boat, waiting for the fish to come and fling themselves out of the water and into the boat on their own.

NIH knows how to encourage interest in under-researched fields. It declares an interest in the field, backed up with dedicated funding. In other words, simply bait the hook, and the fish will swarm the boat.

I say to NIH: Bait the hook. Go fishing. I know you will catch some keepers.

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CDC: Speculations and Consequences

cdclogoControversy continues over the Senate appropriations committee report’s recommendation that the CDC’s CFS program funding be eliminated for FY 2016. We have certainly debated the merits and faults of the program from just about every angle on this blog.

But the real question is: Why did the Senate committee recommend the elimination of funding? I can offer only speculation.

Hypothesis #1: Budget cuts were needed and ME/CFS was an easy target. This is the explanation most likely to be offered by the committee staff. It doesn’t really make sense though, at least not on a Division level. If you look at the chart on page 59 of the report, you will see that CFS was the only category in the Zoonotic Division to see a decrease from FY2015 funding. Every other category was kept stable or increased. I certainly agree that we are an easy target for cutting, given the void in our collective efforts on the Hill. But the overall Senate recommendation for CDC funding exceeds the budget for 2015, and $5 million is almost invisible when compared to the overall budget. Why were we singled out?

Hypothesis #2: Someone wanted to cut it because ME/CFS is unimportant. We are certainly well-acquainted with the misconceptions about ME/CFS. And it is entirely possible that someone on the Senate subcommittee ascribes to those misconceptions. But ME/CFS has been in the news more in 2014-2015 than at any time since the XMRV controversy. If no one working on the subcommittee (including staff) has heard of the IOM report, then we have great cause for concern, and our short-term prospects of increasing our visibility seem low.

Hypothesis #3: Someone wanted to cut it because the CDC CFS program is not producing the right results. This would be interesting. Perhaps there is a staff member who knows more about ME/CFS than we expect, and recommended cutting the funding because the program is doing more harm than good. If this is the case, this person could be a potential ally in a powerful place.

Hypothesis #4: CDC didn’t bother to fight for the program. I don’t have facts to back this up, but it seems like a foregone conclusion doesn’t it? At the highest levels, CDC has paid little attention to (and expressed little love for) the CFS program. There are two exceptions to this: when CDC got caught misappropriating funds from the program and when the early XMRV findings suggested it was a blood borne human pathogen. Other than those two occasions, CDC leadership has not been particularly interested. But even if CDC failed to fight for the funding, that doesn’t explain why it was cut.

Regardless of the reason(s) for the committee recommendation to cut the funding, the ME/CFS advocacy community is responding at full volume. There are multiple email and petition campaigns underway, as well as meetings in the works. We won’t know until September if these efforts are successful. But there would be some interesting consequences to success.

Consequence #1: Community seal of approval. To put it bluntly, the CDC’s CFS program has NEVER had the full force of the ME/CFS community on its side. Never. I am sure that CDC leadership is surprised, and Dr. Beth Unger must be gratified to be receiving such vocal support. This campaign in support of program funding opens a new chapter in CDC/community relations.

Consequence #2: Imprimatur. How will CDC interpret the ME/CFS community’s sudden turn around? I think it is unlikely that anyone at CDC will look at the complexity of the community’s discussion. Most people who are supporting the program funding are doing so because of the multi-site study, or just the basic principle of “don’t cut our funding.” Very very few advocates are endorsing the CDC’s education campaign. But this distinction will not be acknowledged by CDC.

Instead, I predict that CDC will use the advocacy support as an imprimatur on all their ME/CFS efforts. They will be able to say that the program has the vocal support of ME/CFS patients and advocates. When they roll out the latest education materials, when they discuss the multi-site study, or when they make presentations about the program as a whole, CDC will say that the ME/CFS community supports it.

Some readers may say that CDC would never twist the facts this way. But all’s fair in politics. NIH twisted the facts of the letter signed by 50 ME/CFS experts in support of using the Canadian Consensus Criteria. In his August 11, 2014 letter to Representative Zoe Lofgren, NIH Director Dr. Francis Collins said, “This is a critical, unmet need in the area since there are very few ME/CFS clinician-scientists pursuing this line of research (for example, the advocacy groups identify approximately 50 ME/CFS clinicians and scientists world-wide who are considered experts in this field).” Do you see how skillfully this was done? The fact that 50 experts signed the letter, combined with advocates touting that letter as definitive on the CCC, was twisted and fabricated into the statement that advocates identify only fifty experts worldwide. Masterful politics, and CDC excels at this too.

Consequence #3: Bargaining chip. There is a powerful and positive consequence if the program funding is continued. ME/CFS advocates will be able to claim that we got the funding restored, and that gives us power with CDC. If we can get funding restored, we can just as readily get it taken away. I hope that the leaders of the current advocacy efforts realize this.

The petitions and letter writing and meetings may be successful in securing program funding in 2016. This is being done, as far as I know, with no advance promises from CDC or Dr. Unger to make the changes we want to see (particularly in the education campaign). CDC could take the money and run, using this campaign as a shield for whatever they plan to do next. Or advocates could use the success to get CDC to come to the table and work to improve the program.

If flexing the advocacy muscle succeeds, then we must follow through to ensure the program improves. And if CDC fails to do so, then we should flex the muscle to end that funding in 2017, or at least attach so many strings of Congressional oversight that CDC has to comply.

Because one thing is for certain: if this is the beginning of a new chapter in CDC/community relations, that the chapter must benefit ME/CFS patients. Otherwise, the whole effort will have been a waste.

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No CDC Funding for CFS?

cdclogoME/CFS advocates focus almost exclusively on research funding from the National Institutes of Health, and with good reason. But now it appears that funding for the Centers for Disease Control’s CFS program may be at risk in the 2016 appropriations bill. This is not a done deal, and many people believe we should advocate for continued funding. I do not.

Funding or No Funding?

The first step in the federal appropriations process is at the committee level in the House and the Senate. Each committee approves the text of an appropriations bill, and submits an accompanying report for consideration by Congress.

On the House of Representatives side, the appropriations committee report recommends $5.4 million for the CDC’s CFS program (see page 39 of the report). This is the same amount of funding as in 2015. The House appropriations bill does not specify funding for CFS or any other program within the Emerging Zoonotic and Infectious Diseases branch, but only recommends aggregate funding (see page 44 of the bill).

On the Senate side, the appropriations committee report explicitly declines to include appropriations for the CFS program (see page 59 of the report). It is the only program in the Zoonotic branch that the committee declines to fund in 2016. The Senate appropriations bill, like the House bill, only recommends aggregate funding for the Zoonotic branch (see page 52 of the bill).

So the House and Senate committees have approved the appropriations bills. The House committee report recommends CDC CFS funding, and the Senate committee report does not. The next step in the process is a vote in each house of Congress on the appropriations bills. However, with Congress now in a five week recess, these votes won’t happen until September.

It is very important to understand a couple of things. First, neither of these recommendations is a done deal. The House and Senate have to vote on their versions of the appropriations bills. You can track the status of each bill as it winds through the process in the House and the Senate.

Second, even after these bills pass in the House and Senate, the differences between them have to be reconciled. The House bill allocates $460 million to the Zoonotic branch, while the Senate bill allocates $388 million. The many differences between these bills have to be reconciled in a budget conference, and then the reconciled bill has to go back to the House and Senate for a final vote. All of this has to be completed before September 30th in order to get the bill to the President and avoid a government shut down.

Third, the conference reports are not binding. Just because the Senate recommended killing the CFS funding does not mean CDC has to do it. CDC can spend money on the program even if the conference report does not recommend this. However, if CDC is looking to cut back or kill the CFS program, then the committee report certainly gives them political cover to do so.

Fourth, we don’t know why the Senate committee report declined to recommend funding. Was it because the committee didn’t hear from the public about the importance of the program? Was there a staffer who advocated this? Or was it simply a matter of looking for places to cut, and this was an easy target?

Multiple sources have expressed deep concern to me about the prospect of no funding for the CDC’s CFS program. Among other things, the CDC’s multisite study would be in jeopardy. I certainly respect these concerns, and I also respect the fact that the multisite study is an important epidemiological effort that provides revenue to the seven contracted participating sites. But there are powerful arguments on the other side too.

Why Not Support CDC Funding?

Let’s not forget that the multisite study has design flaws, although it did provide useful data to the IOM committee as they constructed the new SEID criteria. The multisite study is, of course, not the only effort in the CDC’s CFS program. The much maligned ToolKit and Medscape education units are part of the program too. CDC has resisted many recommendations by the CFS Advisory Committee, such as putting a “black box” warning on exercise recommendations. Furthermore, CDC has made no public statement about whether it will adopt the IOM’s SEID diagnostic criteria (or even just post-exertional malaise as a required symptom), and this is inexcusable given that the IOM report was published six months ago.

The potential danger that the CDC education program can pose to ME/CFS patients was underscored last week by a new posting on FedBizOpps. The post is a “Sources Sought” request from CDC for a new education effort, and the details are very troubling.

“Sources Sought” is a specific kind of request for information. Basically, the government needs to establish whether there are sources or contractors who can do the work under consideration. In this request, CDC is looking for contractors who can produce radio segments and interviews to educate the public about CFS.  The idea is expressly modeled on the Memory Loss Initiative, which has collected more than 1,800 personal stories from people living with memory loss.

On the surface, this sounds like a great idea, right? I mean, what advocate does not want the personal stories of people living with ME/CFS to be publicized? But read the posting closely. The CDC uses the name “CFS” with no mention whatsoever of ME. The description of CFS is drawn from the Fukuda definition, not IOM SEID or any other definition that requires post-exertional malaise.

Furthermore, the CDC modified the posting yesterday. The original posting acknowledged that most physicians did not know how to treat and manage the illness, but that has been deleted. Of course, who is responsible for the lack of competency among physicians? CDC and the medical associations. The original version also stated, “CDC will identify subject matter experts to serve as a steering committee or reviewers of the content.” Not surprisingly given the reaction among some advocates online, that statement has also been removed. But don’t let that fool you. This is a Sources Sought request, not the actual contracting opportunity. CDC is unlikely to pay a contractor money and not retain control over the final product in some way.

Not For Me, Thanks

This FedBizOpps posting is just the latest example of how CDC does not understand this disease. CDC refuses to admit that PEM is a distinguishing feature of the disease; refuses to acknowledge that exercise can be harmful to people with ME/CFS; refuses to use any aspect of the IOM report; and refuses to specify an appropriate diagnostic code. And many of CDC’s actions regarding this disease over the last thirty years have been harmful to patients, or just plain wrong.

Personally, I don’t want to pay CDC to persist in its approach to ME/CFS. Why should we? What’s in it for patients? I see no reason to invest my limited capacity in advocating for funding for a CDC program that is largely mistaken and misguided.

I want a CDC program that studies my disease, and that recognizes the central features including PEM. I want CDC to take the lead on educating physicians about my disease, so that all patients can be accurately diagnosed and appropriately treated. This means the end of blanket endorsements of graded exercise therapy and cognitive behavioral therapy as treatments. I want “chronic fatigue” to be excised from the CDC’s approach to ME/CFS once and for all.

Has the multisite study been a step in the right direction? Yes. Does this mean we should support funding for the CFS program? No.

The FedBizOpps notice, the silence on the IOM report, and other CDC initiatives are based on the erroneous view that Fukuda is an adequate definition for the disease and that PEM makes no difference in how one should diagnose and treat patients. If most patients are undiagnosed, it is because CDC and the public health complex have utterly failed to educate physicians about this disease, in part because of the dedication to Fukuda and Reeves’ empirical definition. Every single one of us has been told, early and often, that we need to exercise our way out of this disease. Who is responsible for the pervasiveness of that “treatment” approach? CDC.

I won’t be writing to Congress to ask that the CDC CFS program funding be cut. But I most definitely will not be writing to support the funding, either.

When I weigh the positive things about the CDC’s CFS program against the harmful and negative things, I come up short. When I think about the harm done by CDC’s persistent recommendations for exercise, I come up angry. The program is not 100% bad, and I know that many people in the ME/CFS community believe it should continue. But overall, CDC’s current approach to this disease is not worthy of my support.

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Deadlines and Opportunities

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.

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A New Strategic Plan

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.

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The Return of CFSAC

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.

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Brian Vastag to Dr. Francis Collins

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

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!

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