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.

money for chronic fatigue syndrome

Money for ME/CFS has been in short supply at the NIH

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!

The Gist

  • 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.

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.

breakthrough

Vicky Whittemore said getting money was “challenging” yet she may have done a remarkable thing

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%
Fibromyalgia 5 $1.8 $12-14 $9 -18%
Interstitial Cystitis .7 $16 $11 +10%
Lyme Disease $25 +25%
Migraine 37 <$1 $36 $20 +5%
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.

We do have some real pluses as 2017 begins.

Pluses

Creative Research Programs

Work-in-progress

Getting adequate funding for ME/CFS is a work in progress but studies underway could provide a spark that changes everything.

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.

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