In November 2015 NIH Director Francis Coillins said that NIH was going to “ramp up” funding for ME/CFS and that it would be “substantially greater” than the current five or six million dollars a year the disease was getting. “Just watch us” he said. With the recent announcement of two RFA’s for ME/CFS we found out if Collins kept his word.
The RFA Game
Requests for Applications or RFA’s don’t come around often for ME/CFS. The last RFA for chronic fatigue syndrome (ME/CFS) on Neuroimmune Mechanisms, published in July 2005, was for $4 million. It was backed by five Institutes.
Despite the fact that Vivian Pinn said it was the smallest RFA possible, the Institutes so dragged their feet funding it that it took Senate Majority Leader Harry Reid to intervene to get it funded.
Skip forward 11 1/2 years. The director of the NIH himself has publicly promised significantly increased funding. Two federally funded reports have made it clear that urgent funding increases are warranted. A champion for ME/CFS at NINDS, Vicky Whittemore, has appeared, and the head of NINDS, Dr. Koroshetz has publicly stated that he’s on board. The Trans-NIH Working Work – dead in the water for years – is reinvigorated, and the long funding drought for the NIH appears to be over. It looks like the ME/CFS field is set to rumble!
- Eleven years after its last major funding opportunity for ME/CFS the NIH almost doubled funding for ME/CFS. Since 2014 funding has increased 250%.
- Several research centers will be funded for a period of five years
- Funding levels, however, remain very low relative to other diseases
- Doubling funding for a disease over one year and getting an RFA for a disease like ME/CFS is rare, and in itself constitutes a considerable achievement.
- The few grants applied for indicates that lack of interest from researchers constitutes a considerable drag on this field that must be overcome
But the late arrival of the RFA’s, first expected in summer, and then in December, sparked worries that the NIH, once again, is balking at funding chronic fatigue syndrome (ME/CFS).
Finally at the January, 2017 CFSAC meeting, the full funding was announced: $29,750,000 – over five years or about $6,000,000 a year. Add on the NIH Intramural study which will surely cost $1-2 million over the next couple of years and we’re at over $30 million over five years.
The 2005 RFA was a one-off event; $4 million paid off over several years. The $30 million from this RFA is clearly a significant improvement.
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In year to year dollar totals, though, not so much. In 2005, Vivian Pinn said the $4 million RFA was the smallest RFA possible. Accounting for inflation that $4 million RFA is now worth $4.25 million and we’re still hovering around the smallest RFA possible. Six million more is going to help but I don’t think anyone is going to be doing cartwheels over it.
It probably means two research centers. Two and a half million dollars a year for each center is not peanuts, but I was told that a significant portion of that immediately gets taken off the top by the university the research center is based in. So let’s cut that down to somewhere around $1,750,000 a year per center.
With typical large NIH studies costing about $4-500,000 a year we’re looking at about eight new studies for both centers. If each study takes three years, that’s about 12 or so large new studies over a five year period. That’s a significant increase over what we have but make no mistake, it’s still a small number of studies and a very small amount of money for a very complex disease.
That’s disappointing but not entirely surprising given our history with the NIH. Vicky Whittemore herself characterized obtaining funding from the Institutes as “challenging” which could probably translate into something like “pulling teeth”.
Moderate Increase – Major Accomplishment?
It’s not nearly as much money as we want or warrant, but let’s note that by almost doubling funding for a controversial disease, Vicky Whittemore did something rather remarkable. I found only one instance of a disease’s funding (Valley fever) being doubled at the NIH in the last five years. (Valley fever’s funding almost quadrupled from $3 million to $11 million. Prior to 2014 it received no funding; Valley fever clearly has a friend somewhere.)
Most increases in disease funding are from 5-10% a year, and a significant number of diseases have seen declines (see multiple sclerosis, below) over the past four years. Last year – a year of largesse for the NIH after years of decline – just a few diseases increased their funding by over 10%. Proportionally ME/CFS is easily going to lead the field.
Plus a search of RFA’s produced by the NIH over approximately a six month period this year found that the kind of RFA issued – for a single disease – was relatively rare. All the diseases (e,g. diabetes, asthma and Parkinson’s disease) getting this type of RFA already enjoyed high levels of funding.
Plus the diseases ME/CFS has traditionally been aligned with have done terribly over the past four years (see below). Looked at in that light, Vicky Whittemore’s ability to about double funding using an RFA for a single, neglected disease is pretty remarkable.
Roadblocks at the NIH
Still putting the cold, hard statistics up (1-4 million afflicted, $7 billion economic losses/year for one of the most functionally debilitating diseases found) against the NIH’s still feeble commitment is painful. We have to ask ourselves why eeking out $6 million dollars a year more from the mighty NIH was such a challenge? ME/CFS is now getting about $13 million a year in funding – a 250% increase over a couple of years ago.
That’s a nice increase but $13 million is still very low relative to our needs. The question has to be asked “Why, even after the IOM and P2P reports, is it still so hard for the Institutes to give us money?”
(1) NIH is Very Poor at Funding Diseases Like Chronic Fatigue Syndrome (ME/CFS)
For one, the NIH has historically been very reluctant to fund diseases like chronic fatigue syndrome (ME/CFS) which mostly affect women, are mostly invisible, which rarely kill but which cause widespread pain or fatigue.
From migraine to fibromyalgia to interstitial cystitis all these diseases get very low funding per patient year. This suggests that the funding problem is not some special antipathy towards ME/CFS but that it reflects a historical trend at the NIH to downplay the importance of certain types of diseases.
Even more than ME/CFS, migraine is a case study in the NIH’s ability to year after year turn its head away from a great deal of suffering. Christopher Murray’s work at the IHME indicates that migraine produces the sixth greatest illness burden of any disease in North America yet the NIH provides less than $1 in funding per migraine patient per year.
|Disease||# Effected in U.S. (millions)||Funding Per Patient Per Year||Economic Costs Per Year (billions)||Current NIH Funding (millions)||Funding +/- Since 2013|
|Chronic Fatigue Syndrome||1||$15||$17-24||$15 (including NIH intramural Study||+ 250%|
|Multiple Sclerosis (for comparison purposes)||.4||$245||$16||$98||-13%|
ME/CFS Still in State of Limbo at the NIH
Not being in an Institute probably doesn’t help. Not putting ME/CFS in an Institute until a cause is found makes sense, but having every Institute – which means having no Institutes – responsible for ME/CFS does not inspire confidence. Until the buck ends somewhere this program is going to exist in a kind of limbo.
That being noted, being ensconced in an Institute is not magic. Fibromyalgia is in NIAMS and its funding has declined over time to the point where it’s now both getting less funding than ME/CFS and much, much less funding per patient.
It should be noted that with ten Institutes contributing to the RFA the numbers do start adding up. Whether NINDS would be willing to pony up $13 million if ME/CFS was is a good question that we might not like the answer to. For now the Working Group may actually be an asset.
Note that if the rest of the Institutes had just contributed the minimum $250,000 we would have been seen nearly a $10 million increase with a total budget around $17 or $18 million a year. (If an Institute can’t pony up even $250,000, what is it doing on the Trans-NIH Working Group?).
Low Interest From the Research Community
Lack of interest from the research community may be the single biggest factor impeding our growth. The NIH is probably reluctant to throw a lot of money at a disease that its own researchers are not supporting.
The Chronic Fatigue Syndrome Special Emphasis Panel (CFS SEP), which reviews grant applications, was a convenient scapegoat for many years, but no more. For at least three years ME/CFS experts have dominated the CFS SEP’s roster yet grant applications have remained at pitifully low levels. In fact, 2016 may have seen the fewest grant applications for ME/CFS since 2013, with the last two CFS SEP meetings reportedly receiving just two and four grant applications. With the NIH grant approval rates around 15-20%, that’s just 3-4 new studies funded a year.
It may be that researchers have been waiting for the RFA’s to appear. There’s little reason I can think of for them to do so and some good reasons for them no. No one knew if the NIH was going to keep its word, plus few research centers funded aren’t going to help most researchers get grant anyway.
NIH grants are no small matter. Typically running $4-500,000/year for several years, they’re one of our few sources of large, complex studies. Perhaps we haven’t attracted researchers experienced in going through the NIH grant process or the kind of researchers willing to gather the data and go through the work. (The Solve ME/CFS Initiative grants to researchers are so valuable because they provide the funds needed to get the preliminary data the NIH wants for its large NIH grants). Perhaps ME/CFS researchers don’t know about the shift in the SEP makeup? (If not, perhaps the IACFS/ME should make an effort to inform them?)
Whatever the reason, ME/CFS is actually one of the few diseases with its own grant review program and it’s a shame that it’s hardly being used. (It’s a small miracle that the NIH has kept the CFS SEP going at all.) Thus far the evidence suggests that if ME/CFS researchers turn out, the NIH will fund their grants. There’s no indication that the NIH is approving grant applications at a lower rate than for other diseases. In fact what evidence is available suggests that grant approval rates for ME/CFS could be slightly higher than normal.
The bottom line is that Dr. Collins did keep his word (barely) and we still have a long way to go to get the kind of funding this disease deserves. The five year commitment provides a foundation for us to build on but researchers have to apply for and get NIH grants in order for this field to grow.
The NIH's Five Year Funding Increase. What Do You Think?
We do have some real pluses as 2017 begins.
Creative Research Programs
From the Severe ME/CFS Big Data project to Bob Naviaux’s and Fluge and Mella’s work and everything in between, the ME/CFS research field is small but creative. The SMCI just funded some fascinating pilot studies and is expanding its patient registry. The Simmaron Research Foundation and Ian Lipkin are expanding upon and validating important studies.
Dr. Klimas’s center is beginning to model treatment regimens. Jarred Younger’s lab has expanded greatly. Maureen Hanson has created a new ME/CFS lab. Dr. Montoya’s work should get published this year. Dr. Marshall-Gradisnuk believes she’s found an answer to ME/CFS. McGregor and Armstrong are putting out metabolomic studies at a rapid rate.
The NIH’s intramural study could be our ace in the hole. It’s comprehensive enough to uncover abnormalities that aren’t on our radar screens yet. The NIH is bound to trust in and expand on its own results. Getting some good results from that study could reap dividends for years to come.
What we’re really looking for is a finding that galvanizes interest in this field. It could come from any study.
Unrest and TED Talk – Formerly “Canary in a Coal Mine”, the Unrest film will premiere at the Sundance Film Festival shortly. Unrest has the potential to galvanize support across the U.S. and beyond. Plus in just a couple of days Jen Brea’s Ted Talk has gotten major airplay.
Solve ME/CFS Initiative (SMCI) – The SMCI’s expanded commitment to advocacy in the form of hiring probably the first full-time staffer (Emily Taylor) ever to focus entirely on advocacy in the ME/CFS field is a major win for this community. Emily is smart, experienced and totally dedicated. Expect her to make a major difference for ME/CFS. An interview will be up shortly.
ME Action – ME Action has produced a great platform for advocacy; its impact will only grow over time.
In order to be properly funded, ME/CFS reds some large private financial initiatives to get behind this horrible disease. More full on press coverage is neede as well. As has been noted, those who are ill with this disease are too weak to advocates for themselves. It would be so beneficial to put a “well known” name for advocacy.
I agree that a big name would be great. They are always helpful. We shall see!
Politic is what move this country and the world.
Unfortunately press is been controled by the own gov institutions and elite forces that manage to keep this disease in the dark.
We keep asking each other why all this decades no research, why after all, why again, why after Collins promised.
Can some one give me one real convincing explanation .
Obviously the ines we have been saying for last 4 decades doesn’t explain it.
I think it’s more than obvious this is a mayor cover up, the underpaying cause, the underpaying pathogen virus behind cfids, Me, it’s a ticking bomb.
Probably responsable for many other neuro-auto immune disorders, cancer etc.
It’s clear all this illness are coming from the base of low immunity, low Nk cell function , this men’s cancer, virus, intracelullar bacteria over growing uncheck, passing to organs, central nervous system.
But the base it low or no immunity, our mediated cell immunity is destroyed by a virus or retrovirus, far more damaging than HIV, far more contagious, depending of the co infection is the illness that will be developed and severity.
Cfs/ms, ms, als, cancers , even the progression of HIV to AIDS.. is probably the result of HIV+ our unknown undelaying pathogen.
To many people to many millions in the us and around the world with different illnesses and still healthy will test possitive to this pathogen if it was to be found and a test aveilable like HIV , but numbers will tenfold if not x20,30,50 the number compared to HIV..
Of this I’m sure 100%, now why not finding it, preventing, curing , treating ?, in not sure if it’s just that it’s to big, to many people with different illness, or for economic reasons, world population control, biological weapon protection .. not sure on why.
!!! But sure 100% that it’s not normal that me/cfs it have been and continue to be mislead and keep in the shadow when it’s more than obvious all it starts with the immune system everything else is the result of co infections.
100% sure is that it’s no normal that none of this auto-neuro immune illness have a cause.
We are in 2017 thing far more complex have explanation and cause.
So are grants separate to RFAs? We’re not confined to the $30m over the next 5 years?
Sorry, my eyes are tired and I am struggling a bit.
As much as I would never wish this disease on anyone, I can’t help but feel we would benefit enormously from someone who is absolutely stinking rich getting ill. I mean a Bill Gates type of rich. (If Bill Gates gets sick now I will feel really bad).
Right! We’re not limited to $30 million over 5 years at all. The research centers are limited to their $6 million or so a year but if researchers outside the research centers write grant applications that get accepted then funding will increase. The NIH has always said they’re willing to fund more grants; they just need to get more good grant applications.
(Ron Davis’s grant application was turned down by people who were obviously not interested in ME/CFS, but his application went to another grant review body, though.)
We thought that the NIH was not funding good grant applications but there’s no evidence that that’s true. It is true that they’re getting hardly any at all; few grant applications = little funding.
If ME/CFS researchers start applying for grants and getting them accepted we could go well over the $30 expected over the next five years.
Getting funding for grants isn’t easy – only 15-20% get funded – but if you get one you can get a lot of money.
That’s great. In my view that casts this in an entirely different light. The $30mil is a little disappointing, but it can act as seed money to build the evidence basis that is needed to make good quality applications for further grants.
And it isn’t like we have to wait for those RFAs to be fulfilled and published in order to build a decent evidence base. We have a steady stream of donations from the community and research occurring in other countries. The evidence base from which to make good quality applications is already growing substantially.
I am quite optimistic.
The metabolomics research has moved more quickly and with greater agreement than anything I can remember. It is truly exciting…
We already have a Billionaire here in the UK Sick he is only worth 4 Billion dollars or most likely Pounds…His entire Family is Sick over 11 people he owns Phones for u…He also like so many think its Lyme but wait until he finds out it is actually radiation sickness instead he does not fund research he has some small website that is all
As you say Cort, In year to year dollar totals, there is no difference.
So, what should wee see Mr. Collins? Where is that “substantially greater” amount of funds Mr. Collins? Hello? Here the Erth calling to Collins….
Well,another bureaucratic inconsistent promise.
Just my two cents
Sorry if I I missrepresentated that. Funding for ME/CFS will about double. (It’s at 7 million now and will go up to about 13 million plus the funding for the intramural project). We will have individual grant application coming in through what’s called program announcements. These announcements tell researchers what the NIH is interested in. We’ve always had those.
Then we will have at least two research centers. I’m not sure how grants will work with those.
Yes, I was confused also by the “substantially greater” than the current five or six million dollars a year the disease was getting.
Are you then saying it will be about thirteen million+ a year? That sounds better.
Any increase is great from NIH or any other gov funding.
Sancar and Alex are correct in wishing and hoping some billionaire will have somebody dear in their family come down with ME/CFS. Not that I wish this upon anybody, rich or poor. Plus a lot of media attention.
We also need much more money towards education of health care professionals. It’s a sad situation seeing a new doctor and having to “teach” them, and some just don’t want to know or have the time to educate themselves.
My apologies for not making that clear Katie. I will fix that up. Yes it’s $13 million and a 250% increase since 2014 – the year before the IOM and P2P reports were released. Except for Valley Fever that the biggest proportional increase of any disease since then.
Of course we started off from a very low point – so our monetary needs are still great – but we have made substantial progress.
Cort, does this funding provide Lipkin with the $5 Million he said he needed to solve Me/CFS?
It could potentially provide Lipkin with $10 million or so over five years plus any other grants he pulls in. I have heard that Lipkin and Hornig are very interested in becoming a research center. Off the top of my head, the SMCI, Nancy Klimas’s group, the Open Medicine Foundation, Naviaux (and Dr. Montoya?), the new Hanson group and Jarred Younger are the top candidates. (I hope that I’m not leaving out anyone).
(I’t remember exactly what he said but I think he might have said $50 million?)
I still believe that it’s nothing for an illness that’s is more severe than any other, % wise compared to previous years it increased but. % compared to current total amount funded Compared to HIV, MS, CANCER.. its nothing if not the lowest.
This is thesame run around with just a little tiny more to say they are doing something different .
There’s no doubt that it’s not much money…
Thank you for this. Cort. A few comments – according to the IOM and the published papers, the economic impact is $17-24B, not $2-7B. The P2P report apparently only reported direct medical costs and ignored the lost productivity costs.
One note on the recent increase in funding – even with those increases, 2016 was the first year when funding was greater than it had been in 1995.
Thanks Mary, I will fix the economic impact. I was surprised at that lower number but figured it was more accurate.
Good point on the 1995 funding! Rather painful to hear of course particularly if you add inflation into the mix – which boosts the 1995 figure by about 50%. Why did we lose so much ground? Getting kicked out of the NIAID (or leaving it on our own – whatever the story was) and moving to the ORWH obviously hurt but the cultural biases are probably the key.
Dr. Cheney said he felt a new generation was needed before ME/CFS would really get help. Maybe Dr. Koroshetz – who did not come from the NIH – and Vicky Whittemore are part of that new generation.
On the CDC website it’s even quoted as being a $19-51 billion annual economic burden in the US.
Our body consists of 5 major systems that work together to keep we alive.
Circular, nervous system, digest system, respiration system, Musculoskeletal system.
The 5 major system control by special systems.
If one control system weak or sleep(same like low charge) , a major system related disease are expressed.
If 5 major control system are weak or sleep, Fatigue condition may come…Cure may easy. wake up the sleep control system and remove the sleep source
CFS means 5 of our major control system are not normal.
Our body charged with positive electron and control system work normally.
If our body contact with negative charge, Our body may get negative electron.
If our body charged with negative electron, our control system(gene expression or control)
may changed and abnormal condition.
If negative charged part is partially charged, mental disorder or digest problem or immune problem
etc.. If most of our body charged with negative charged, several disorder occur and CFS.
I can read the positive charge and negative charge from people, material, photo, earth, sound etc..
Gene expression or body control signal may alter or change with negative charge.
The CFS cure may easy and simple.
1. Remove the negative charged source
—water veins above bed or chair, toxic bra, glass, cloth, bedding, phone etc..
2. massage with positive hand or contact with strong positive charged source or cupping.
(body tune up may turn the negative body to positive body)
It need 20-30 minutes
No drug, No acupuncture, No medical treatment.
Cures seems magic and amazing and unbelievable
This is not specific info it is too general. If it truly helps than please explain more.
If you read below article, it may be helpful.. http://www.who.int/peh-emf/about/en/
Always be skeptical when someone promotes a treatment or cure and doesn’t provide any evidence whatsoever.
I am willing to bet $1,000,000 that this treatment will not work in a (double blinded) randomised controlled trial.
Just to be clear – has the NIH officially announced the RFA’s for CFS research or not? I checked their web site but I do not see any formal announcement yet. I assume what was said at the CFSAC was forward guidance not a binding commitment.
No formal announcement yet. I think we can trust what Vicky said – hopefully we can – and we shall see….
It’s a start.
Funding centers is a great idea as it allows us to start building research capacity in the USA.
There seems to be two major limitations in funding –
(1) for innovative (read: risky) hypothetical studies. Funding bodies seem to want to fund sure bets, which means incremental benefit for illnesses that we have a decent understanding of, but little to no progress for those we don’t really understand (including Migraine etc.)
Specifically funding bodies need to be willing to take on more risk when the need for leaps in progress is greater.
Even basic stuff like Nahle studying the PDH complex was turned down by the NIH in 2016 – despite two studies using quite different methods in 2016 finding similar issues with PDH kinases etc. This is an example of “risky” stuff that should be funded.
(2) Replication studies. Seriously, why are so few replications studies funded?
So there still needs to be an increase in funding of the usual grants – and if they claim they aren’t getting enough quality applications (which is bullshit – it’s that they only want to fund “sure bets” that fit with the reviewers a priori hypotheses), then RFAs!!!
Agree with #1. With #2 and the last – when ME/CFS researchers only submit 10-20 grant applications a year to the NIH – then the most we can hope for is 2-5 new studies being funded a year.
Please note that the grant applications to the CFS SEP – the grant review body created for ME/CFS is, and has been for quite a while now, been almost completely composed of ME/CFS experts; i.e. the lack on newly funded studies is not on the NIH.
Why are the likes of Nahle and Davis being turned down then? That’s why I’m saying the problem is too much of a focus on “sure bets”, anything that is too novel (or hypothesis generating rather than confirming) is turned down.
The grant success is still only like 15% so most people do get turned down. According to my back of the envelope calculations the grant success rate in the CFS SEP may be higher – 20% or so – but it’s still really tough.
Ron’s grant didn’t get a fair shake -for sure – but he submitted it to a different grant review which didn’t have ME/CFS experts on it. I don’t know why he choose that panel but it may have been because of the type of grant application that he had.
It’s still hard to get grants! But the review panels are filled with ME/CFS experts. Then the Institutes have to fund the grants. It’s possible there’s a bottleneck there but if only six grants were submitted in the last couple of sessions there’s just no way we’re going to good funding from that. Hopefully the future will be better.