NIH took two steps down the road that leads to more ME/CFS research funding last week, but it’s important to understand what those steps actually mean at this point in time.
First, NIH issued a Request for Information: Soliciting Input for New Research Strategies for ME/CFS. A Request for Information (or RFI) is used by federal agencies to gather public comment on a particular topic. A few things stand out about this RFI:
- The RFI was issued by the Trans-NIH ME/CFS Working Group and sixteen Institutes.
- The Working Group wants input on: emerging needs and opportunities; challenges or barriers to progress; and gaps and opportunities across the continuum from basic to clinical studies.
- “[T]he Trans-NIH ME/CFS Working Group will review and consider the comments received under this RFI with regard to current and future needs and direction for ME/CFS research and research training.”
- The deadline for response is June 24, 2016.
I can’t emphasize enough how important it is for us to respond to this RFI. To my knowledge, it is the first time our opinions have been solicited as part of a planning process. There is no reason that I can see for us not to offer our best input in response to the request.
Second, Dr. Vicky Whittemore presented a “funding concept” for an ME/CFS RFA to the Council of the National Institute for Neurological Diseases and Stroke on May 26th. But what does that actually mean?
A funding concept “describes the basic purpose, scope, and objectives of a potential solicitation of grants or contracts.” “According to law, experts in the field, usually Council members, must approve a concept before we can announce an initiative.” Approval of a concept by Council does not guarantee that it will become an RFA. In other words, Council approval of a funding concept is a bureaucratic hurdle that must be cleared before detailed work on the potential RFA can proceed.
So what did Dr. Whittemore present to the NINDS Council? Fundamentally, “our concept is that we would put in place a consortium with multiple sites utilizing common protocols across the clinical projects who can also then develop studies across the sites that would address etiology, potentially imaging, potentially biomarkers studies, genetics, that would all work together.” These sites will be at academic centers, and will also include a data-management coordinating center. Another goal of the consortia is to gather a large subject cohort who could eventually participate in clinical trials. Participating NIH Institutes will jointly fund the consortia and data center. After only two questions, the concept was approved by the NINDS Council with no objections or abstentions.
There are several critical things to understand about where we are in the process, now that Council has approved the concept:
- Dr. Whittemore is now able to proceed with drafting the RFA itself. However, there is no guarantee that an RFA will actually be approved and issued.
- We have no information on how many sites will be funded in this consortia.
- We have no information on the amount of money that will be allocated to this RFA.
- We have no information about whether the RFA will fund research directly. It’s possible that it will provide funding for the costs of getting a site up and running, not covering the cost of research projects.
- We have no information about the timeline. Dr. Whittemore said at CFSAC that she hoped to issue the RFA in June or July and make awards next year. But at least one Institute describes the process as taking six months after concept clearance.
- We don’t know if these sites will provide clinical care, so we should not assume that these will be Centers of Excellence as CFSAC recently recommended.
- We don’t know if NIH will wait for the responses to its RFI before issuing this RFA.
- We don’t know if there will be any other RFAs for research grants.
In other words, there are a lot of blanks that still need to be filled in. This RFA could be spectacular, it could be dreadful, or it could be somewhere in between. We simply do not know. Interestingly, one of the RFAs NIH issued this week was for Diabetes Research Centers. That RFA specifically requires participating Centers to already have at least $3,000,000 in peer-reviewed research underway, and the RFA does not fund research projects; only administrative and core activities are supported. This RFA for Diabetes Research Centers will provide a total of $13,500,000 for up to nine sites in 2018, approximately $1,500,000 per site.
It remains to be seen whether the steps taken by NIH last week will ultimately get ME/CFS research where we need it to go. In the meantime, the RFAs for other research areas keep rolling upwards.
- Total RFAs Issued by NIH: 231 (October 2015 to date)
- Total Dollars Committed to RFAs: $2,074,240,000 (October 2015 to date)
- Total RFAs for ME/CFS: ZERO (October 2015 to date)
| Week Beginning | RFAs Issued | Total Commitment | RFAs for ME/CFS |
|---|---|---|---|
| 5/23/16 | 8 | $37,400,000 | Zero |
| 5/16/16 | 2 | $7,800,000 | Zero |
| 5/9/16 | 11 | $32,100,000 | Zero |
| 5/2/16 | 8 | $32,485,000 | Zero |
| 4/25/16 | 4 | $7,500,000 | Zero |
| 4/18/16 | 10 | $42,230,000 | Zero |
| 4/18/16 | 10 | $42,230,000 | Zero |
| 4/11/16 | 4 | $6,825,000 | Zero |
| 4/4/16 | 8 | $27,000,000 | Zero |
| 3/28/16 | 13 | $161,000,000 | Zero |
| 3/21/16 | 1 | $2,700,000 | Zero |
| 3/14/16 | 5 | $23,650,000 | Zero |
| 3/7/16 | 9 | $82,710,000 | Zero |
| 2/29/16 | 1 | $1,890,000 | Zero |
| 2/22/16 | 9 | $30,100,000 | Zero |
| 2/15/16 | 4 | $26,500,000 | Zero |
| 2/8/16 | 5 | $9,500,000 | Zero |
| 2/1/16 | 8 | $26,000,000 | Zero |
| 1/25/16 | 4 | $9,300,000 | Zero |
| 1/18/16 | 2 | $4,500,000 | Zero |
| 1/11/16 | 10 | $71,200,000 | Zero |
| 1/4/16 | 0 | $0 | Zero |
| 12/28/15 | 0 | $0 | Zero |
| 12/21/15 | 3 | $10,260,000 | Zero |
| 12/18/15 | 5 | $20,260,000 | Zero |
| 12/11/15 | 27 | $765,090,000 | Zero |
| 12/4/15 | 6 | $26,600,000 | Zero |
| 11/27/15 | 4 | $21,000,000 | Zero |
| 11/20/15 | 15 | $134,400,000 | Zero |
| 11/13/15 | 2 | $16,100,000 | Zero |
| 11/6/15 | 10 | $22,850,000 | Zero |
| 10/30/15 | 7 | $49,800,000 | Zero |
| 10/23/15 | 10 | $33,200,000 | Zero |
| 10/16/15 | 0 | $0 | Zero |
| 10/9/15 | 13 | $332,450,000 | Zero |
If you want more background on the RFA Ticker, read the inaugural post.
All at once, I am encouraged, disgusted, and bemused by the RFI. None of the research groups have exactly made secrets of their research agendas, have they? Has the NIH really not noticed the roadmaps laid out in front of them? The mitochondria. The microbiome. Omics of all kinds, and all beneficial to general science as well as to us.
Nonetheless I hope researchers submit ideas. And I hope resources go to actual research, rather than empire building.
Heck I may submit my own ideas. Teach them for asking, anyway!
Excellent point, Joe. I assume they read the P2P report!? I am definitely going to submit something. We have a lot of very knowledgeable people; I hope they all submit thoughtful responses.
We also have no idea what criteria they will require for subject selection: Fukuda, CCC, ICC or SEID. So we really don’t know what “illness” they plan to fund research for: CF, CFS, ME or SEID. The criteria is the foundation. Without knowing this, it is impossible to judge any of the other developments at the NIH.
You are absolutely right that the case definition is key. But we do have a glimpse of what NIH’s approach might be. Dr. Whittemore was asked if there were well-defined criteria for the disease. This was her opportunity to refer to the IOM report or Canadian Consensus Criteria. Instead, she said:
The criteria project described by Dr. Whittemore is not quite as objective as it may sound. Its success depends very much on how the development of data elements is approached, by whom, with what biases. And how precisely defined will these data elements be? One could argue SEID is based on common data elements. Another set of descriptive criteria does not sound like an improvement of the status quo to me.
Something I have found frustrating all along is that, in general, the recommendations from CFSAC have been good. Yet you would think there does not exist a “CFS” Advisory Committee from everything NIH has said. Of the many recommendations that have been made and ignored, two stand out for me:
1. Use the Canadian definition (there are three now; pick one).
2. We need centers of excellence. Patients need to be diagnosed. Young doctors need to be trained. Medics of all types need to see what this disease really looks like. And there needs to be places where researchers can access patients for scientific studies.
They claim that they don’t want to do any more centers of excellence, yet NIH is supporting 69 cancer treatment (and research) centers. And Jennie notes that one RFA will be involved with creating Diabetes research centers.
So I guess I would ask three things that seem to me to be pretty reasonable:
Look at the recommendations made by the committee created to advise HHS about what to do regarding this disease! They’ve been there all along. Ask CFSAC for the best RESEARCH definition (or look at what they have already suggested. And, as CFSAC has been requesting since formed in 2003, create centers of excellence.
Interesting article, thanks.
“Dr. Whittemore said at CFSAC that she hoped to issue the RFA in June or July and make awards next year. But at least one Institute describes the process as taking six months after concept clearance”
I read this differently. I think the RFAs that ‘might’ happen are those that relate to the concept of centres for mecfs research, not other RFAs. The NIH as already promised RFAs in the next two months, and I assume they know they now how their system works. RFAs relating to ‘the concept’ will presumably take longer.
“We don’t know if these sites will provide clinical care”
Vicky Whittemore highlighted that a big problem was the disconnect between clinical care and academic research, and my assumption was that the sites in the consortium will need to bring the two together.
I agree that the forthcoming RFA will relate to the centers. Dr. Whittemore said at CFSAC that she was presenting the funding concept on May 26th, and that she then hoped to move forward and issue the RFA in June or July. That is the only RFA that is in the works, at least as far as we know. No other funding concept has been presented to a Council for approval. I was simply pointing out that at least one Institute takes six months after clearance to issue an RFA. If Dr. Whittemore can do it in two months, then that’s fabulous.
Here is what Dr. WHittemore said about clinical care:
That does not say that clinical care will be part of the centers. Connecting private practices to academic members of the consortium implies that clinical care will remain with the private practices. The bottom line is that we don’t really know because the concept presentation was vague on details.
[For some reason I’m not getting notifications of replies to my comments (though get them for new posts)]
>Dr. Whittemore said at CFSAC that she was presenting the funding concept on May 26th, and that she then hoped to move forward and issue the RFA in June or July. That is the only RFA that is in the works, at least as far as we know.
Actually, I’d assumed the RFAs were for other stuff, like a pot of cash people such as Ian Lipkin and Ron Davis could apply for to get good work funded. Thanks for the clarifiaction. I’ll be pretty disappointed if the NIH aren’t encouraging the research community beyond setting up these centres.
>No other funding concept has been presented to a Council for approval
So they would need to have Council approval before issuing other RFAs such as I suggested above?
Re clinical/academic hook ups, the presentation was only five minutes long so not surprising some detail is unclear!
Did you sign up specifically to get notifications for the comments on this post, Simon? Let me know so I can track down the problem.
You asked if they will need Council approval before issuing RFAs for research projects like Lipkin’s or Davis’s. As far as I can tell, the answer is yes. I read several Institute pages that state Council approval of the concept is required before it can be fully developed and issued. So an RFA for actual research into biomarkers will require another concept presentation to Council. I’ll try to get confirmation of that.
Wow, council approval even needed eg for biomarker RFAs? Sounds pretty bureaucratic (setting up a network of centres is more obviously a big deal). And thanks for your research on this.
I thought I’d ticked ‘follow-up comments by email’ but not ‘new posts’. However, I DID get a notification to your last comment, so maybe I’ve simply been serially incompetent.
When it comes to NIH, making assumptions is a dangerous business. Words are worth little. As far as actions go, well, the RFA Ticker says it all, doesn’t it?
This RFI business is more busy work that looks like they are doing something while actually doing nothing at all. Like Mary Schweitzer wrote above, NIH could try reading their own Advisory Committee reports. But apparently that is a bridge too far.
If NIH truly wants to help us, they could send a check to Ron Davis, who would put the money to work immediately. But so far, wanting to help us is “a fact not in evidence”.
Question: NIH is soliciting input. Will the NIH be making these submissions public? If not, would you consider offering to create a repository of submissions, as you did for P2P feedback? That repository was extremely useful, even to us outside the US!
I am working on this now and will post when I have more info!
You all have a lot more patience than I have at this point! Why, oh, why is there so much bureaucratic red tape involved in all of this?
We are sick, some for decades. We need research, biomarkers, treatments.
That’s it.
It’s taken 30 years (since I’ve been sick) to get to this point? Meanwhile,
all sorts of research has found biomarkers, changes in genetic expression,
brain changes, cytokines, etc.
Why can’t it all be centralized and studied? And funded?
This is such a rigamarole of red tape when, in fact, we’re sick and
that should be funded and researched. To even understand the levels
of bureaucracy is exhausting and unnecessary.
There’s got to be a better way. Maybe Norway and Australia are doing
better.
I’m at the point of utter frustration with all this.
Why aren’t they even using the IOM findings? It’s an NIH-appointed
committee. I am flabbergasted.
I’m with you. It’s taking too long, and there is nothing useful for patients on the horizon.
It didn’t take 30 years to respond to the Ebola crisis last year. It won’t take 30 years to get a Zika program off the ground, either. It only takes 30 years when there is a deliberate policy to *not* research an illness. Until we identify exactly who (and on whose behalf) is controlling the policy, it will not change.
Follow the money. According to the CDC, 85% of 1 million adult Americans with “CFS” [their term] are not diagnosed. So we’re talking about 850,000 people who might be diagnosed if this disease were not kept secret. Gosh, who might benefit from that?
>Follow the money.
Exactly. Unfortunately, it seems like people are so afraid of being labeled a “Conspiracy Theory” nutter that no one even dares to think along these lines.
There is so much smoke, we are coughing and gasping for breath, while still insisting there can’t possibly be a fire. Personally, I don’t give a damn what anybody thinks of me. I just want my life back, or at least some small portion of it.
I find the following in the link: ‘invites input from researchers, health care providers, patient advocates and health advocacy organizations, scientific or professional organizations, Federal agencies, and other interested parties. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and membership as a whole.’
There is NO mention of sick people. Only researchers, etc.
NO mention of patients.
No care – what private care there is is expensive, hard to get to. There is no one in NJ I would see, if I cared to expend my energy in foolish doctor appointments.
I feel, as a PWC, very much left out.
I can’t see commenting – it looks as if they’ve already decided my input (not organized neatly for them into some organization) is not useful.
I don’t know why you’re suggesting we should give them input. They don’t want it. Or I’m missing something.
“Patient advocates” is a term that is used to commonly refer to patients who are advocating for themselves and/or others with a specific disease in scientific and healthcare communications so yes, I believe they are asking for patient (and their supporters’) input as well.
Also, as a patient, my view has always been if you are not specifically given a seat at the table, to elbow or cajole your way in. There is no time and the issue is too urgent/ important to not participate even if one is not handed a letter-pressed invitation. In the annals of social movements, power is rarely handed explicitly or politely to disadvantaged groups; instead, it is often forcibly taken by the disadvantaged groups.
I’ve been involved in ME/CFS advocacy for almost a decade and there were/ are/ will always be naysayers who advocate not participating in efforts but I think that is cutting off your nose to spite your face. The speed of activity is never fast enough for my taste but I do see positive movement taking place. Also, advocacy is like preventive medicine. Without it, the situation might well be much worse than where things are now but we don’t see the alternative situation because someone(s) have always acted.
When I was younger, even without ME/CFS, I was a pessimist but then I realized that got me nowhere.
I do not begrudge the funds used to fight Ebola where over 11,000 people died and thousands more we infected, with the real danger of the disease spreading much further and becoming global pandemic. This government did not do anywhere near enough to help out, but other countries and humanitarian groups, such as Doctors Without Borders did everything — that group lost several staff members to the disease.
And Zika — 1,400 babies in Brazil have been born with microcephaly so far and there are women in Puerto Rico and the U.S. who are pregnant. A woman just gave birth in the U.S. (N.J.) to a baby with microcephaly. The Zika virus also causes Guillain-Barre, a potentially paralyzing disease, and sometimes fatal.
This government did not allocate at all the amount that the administration requested to deal with research, developing a vaccine, prevention. And, the House voted that funds (one-third of amount requested) should come from funds for Ebola and other diseases. The NIH took money from other disease research to try to find a vaccine.
The government has taken money from Ebola and other disease funds so far.
No new money has been allocated in fact.
I’d like to see new funds made available. It is heart-breaking to see babies with microcephaly or to learn that children have died from Guillain-Barre. This could be a real hassle here. What society would have to provide in services and funds to deal with many sick babies if Zika became widespread is phenomenal. Better to prevent it and try to find a vaccine and provide preventive measures than have a full-scale epidemic.
I’d say they should take money from the $1 trillion allocated to develop new nuclear weapons (yes!) or enforce corporate income taxes — now corporations only account for 10% of income tax revenue. I don’t think money should come from other health crises; that makes no sense and then all of us who are sick are fighting over the same pot of money and we’re arguing with each other instead of having empathy for other sick people. I don’t want to live like that.