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Researcher Disinterest Still Hampering Chronic Fatigue Syndrome (ME/CFS) Field

A Freedom of Information Act (FOIA) reveals that during the three grant review panels from July 2017 to April 2018, chronic fatigue syndrome (ME/CFS) researchers applied for a total of 12 grants.  It was the lowest number of grant applications to the panel dating back at least 12 years. Despite the increased interest in ME/CFS, the last five years have shown a more or less steady decline in individual grant applications from ME/CFS researchers.

  • 2011  – 20
  • 2012  – 30
  • 2013  – 16
  • 2015  – 26
  • 2016  – 13
  • 2017/18 – 12
next level ME-CFS

In order to get to the next level, researchers will need to apply for more grants – lots more grants.

The explanation for the low number of grant applications used to be that the grant review panels were packed with pain researchers who would not score ME/CFS grants well. That explanation was demolished when the pain researcher panels vanished with no uptick in ME/CFS grant application rates. Another idea has been that the NIH funds a lower percentage of ME/CFS grant applications than in other diseases.  An analysis suggested that wasn’t true either – ME/CFS studies appear to be being approved at normal and at times higher than normal rates.

On a positive note, the ME/CFS research community showed up in spades with ten applications for the NIH research centers grant. That was an unexpectedly strong showing; at the just-concluded Montreal Conference, Vicky Whittemore said the proposals were strong and if enough funding had been provided, the NIH could have funded several more centers.

The pattern of ME/CFS researchers responding well to NIH grants which have funding attached (the 2006 RFA, the recent NIH Research Centers Grant), but applying in small numbers for individual grants, goes back years. The problem is that NIH grants with funding already attached are rare. If this field is going to move forward with alacrity, ME/CFS researchers need to apply for individual NIH grants in large numbers. The vast majority of the NIH’s funding goes to individual grant applications.

Next Rounds Critical

The next rounds of grant review panels will tell us much. We know that the seven losers of the NIH research centers contest are sitting on about 20 potential grant applications. We know that Ron Davis got one application in early. The big question is how many of those researchers are going to transform their research center applications into individual study applications.

If most of them do, then we could add 4-6 or more big studies over the next year, boosting funding by several million dollars.  If, on the other hand, those applications don’t show up in large numbers, it’s hard to know what will move our researchers to take a stab at this vital source of funds.

Advocacy Thoughts

Avoid Burnout by Keeping Focus on Year-to-Year Results in ME/CFS

I recently came across a book which suggested that we compare ourselves to others less, and focus more on comparing how each of us does over time.  In ME/CFS we regularly, almost reflexively, compare our funding to what other diseases are getting. That’s completely understandable. On a needs basis, we deserve the $75 or $100 million that a disease like MS or lupus is getting.

step by step ME-CFS

Rome wasn’t built in a day – and neither will a successful research field – but steady progress will win out.

I believe that we should set benchmarks for funding compared to other diseases, but most of our focus should be on how we’re doing from year to year. To have the discrepancy between the funding for MS and ME/CFS gnaw at one, day after day after day is: a) physically and emotionally draining; and b) unproductive.

Comparing ME/CFS to MS is like comparing apples to oranges in some important ways. MS and similar diseases benefit from large and powerful research foundations, effective advocacy efforts, a huge cadre of researchers who regularly apply for grants, homes in NIH Institutes, and long term recognition of the diseases in medical textbooks. Funding for them at this point is almost a self-fulfilling prophecy.

Consider that in order to get the $100 million in NIH funding (20% grant success rate, average grant funding $500K/year) MS researchers must be pumping in somewhere around 1,000 grant applications every year. If each study contains from 50-100 participants, about 10-20,000 MS patients are participating in MS studies every year.

ME/CFS, on the other hand, a very small research community, finally got one full-time advocate about a year ago, has small research foundations, its researchers typically submit 10-15 grant applications a year, and it’s not taught in most medical schools. It simply cannot at this point compete with diseases like MS. Better comparisons might be to diseases which are in a similar place – which are trying to gain their way in the medical field.

ME/CFS can, however, move forward and move forward rapidly enough that within a relatively brief period we could have a robust and sustainable research effort going.

Progress

As small as it is, ME/CFS is making substantial progress. Over the last couple of years, NIH funding for ME/CFS almost tripled, 3 research centers have been funded, and a large intramural NIH study is underway.  With the Pineapple Fund kicking in $5 million for the Open Medicine Foundation and the $1 million or so the NIH’s Intramural study costs, plus CDC funding, we’re looking at $25 million plus in research funding for ME/CFS this year from the U.S. A couple of years ago (with the CDC funding), we were at about $10 million.  It’s not nearly enough, but it is progress – something we haven’t seen for decades.

We have a long, long way to go to achieve parity. Consider that with the NIH’s grant approval rate at about 20%, getting $50 million in NIH funding (or about 100 studies) would require the ME/CFS field pumping in about 500 individual grant applications a year — or 40-50 times what the field is currently producing.  (ME/CFS researchers produced 12 grant applications last year.)

It’s questionable whether this field could successfully handle $50 million in funding if given it tomorrow. The sudden appearance of that much easy money would cause all sorts of researchers to enter this field – many of whom we might not want to enter this field – doing studies on who knows what kind of ME/CFS patient. The backlash that ensued at the wasted money could be horrific.

This field could grow much faster than it is, however, and in a sustainable manner. The research insights gained during that process will draw in good researchers. The NIH has started this process but is not doing nearly what it could.

The $15 million the NIH is now spending is not a lot, but it is a start. Consistently boosting our funding levels by, say, $5 million a year over five years, would have NIH spending $40 million/year on ME/CFS or funding 60-80 studies a year.  It’s rare that funding grows so rapidly in a disease but it has happened. Behind a very strong advocacy movement, autism funding, for instance, grew spectacularly.

The Next Big Step for ME/CFS? Growing the Field

That’s not going to happen without help. The NIH has been saying for decades that, ‘if you give us grant applications, we will fund them’. I suspect, the occasional weird rejections aside (e.g. Ron Davis’s grant – which did not go to the CFS SEP), that the NIH will, in fact, provide funding if the grant applications come, but years of the NIH stating, ‘just give us more grant applications’, has made no difference. As a purely practical matter, it just isn’t working.

NIH research centers

Research Centers were a step forward. Now the NIH needs to grow the field for individual researchers.

It particularly needs to find a way to entice individual researchers to apply for ME/CFS grants. Several decades of evidence indicate that the ME/CFS research community has trouble responding to unfunded grant opportunities (program announcements) but the response to the Research Centers grant opportunity gave the NIH notice that the ME/CFS research community will respond to funded grant opportunities. It now needs to jump on that insight. 

The 2006 ME/CFS RFA was very successful, and one done now would undoubtedly be far more successful. (Maureen Hanson talks about the need for this kind of grant in the recent issue of the Solve ME/CFS Chronicle (not online yet. Sign up for the SMCI’s newsletters here.)  This field could handle a $10 million five-year RFA which provided for 20 or so very large studies.

Because of the hypercompetitive nature of the NIH grant funding these days, many new researchers would be attracted into the field were RFA’s for ME/CFS proposals available. Maureen Hanson – Spring 2018 SMCI Chronicle

The NIH is not inclined to fund RFA’s for individual diseases – they rarely do that – but ME/CFS is a special case and the NIH acknowledges that it’s neglected this disease and has a lot of catch up to do. In the SMCI interview, Dr. Hanson noted that funding opportunities are often needed to help fields grow and those provided for HIV/AIDS early on helped that field quickly grow.  Plus, because individual grants for RFA’s take place in a less competitive environment, simply the fact that an RFA for ME/CFS is available will tend to draw other researchers into the field.

While funding obviously helps enormously, it’s important to notice that progress can be made at times without huge funding increases. POTS hasn’t even had a dedicated funding option at the NIH, but the field is moving forward rapidly because of some key discoveries. Those POTS findings, in turn, prompted Carmen Scheibenbogen to look for autoantibodies in ME/CFS — successfully. She recently published an impressive review of autoimmunity in ME/CFS.  A possible new drug for ME/CFS – Cortene – popped up out of seemingly nowhere, and the recent discovery of how Epstein-Barr Virus triggers autoimmunity could easily reap major dividends in ME/CFS.

Interact with the NIH that is – not the NIH that isn’t.

For years I railed against the NIH.  I thought about the NIH in terms of what I thought it should be and wanted it to be, not what it actually was. Decades of busting my head against the wall, expecting the NIH to finally respond to this disease’s unmet needs, have met, at least until recently, with the same frustrating, heartrending result.

I didn’t get the message because I didn’t want to get it, but I do now. It’s clear to me that the NIH as an institution just doesn’t respond well to disease needs. It’s not that the organization is bad, it’s just not structured that way. I believe that the NIH is primarily structured to respond to researcher interests — not disease needs.

ignoring disease needs

The NIH may not have a way to incorporate a disease’s unmet needs into its funding decisions.

Because everything is scored at the NIH, taking unmet disease needs into account would require a scoring mechanism which incorporates that statistic into funding decisions.  My strong guess is that there is no such thing, and until there is, our unmet needs are going to have little sway in the most important area –  funding.

Discrepancies in funding, after all, abound. ME/CFS is just one of several diseases that the NIH vastly underfunds. Chronic obstructive pulmonary disorder (COPD), for instance, kills 30 times as many people as HIV/AIDS and gets about 30x less funding ($3 billion vs $100 million/year.)  HIV/AIDS’s success is an amazing story of how a maligned group (gay people) managed to capture an out-sized portion of the NIH’s budget. It’s story should give us – another maligned group – hope.)

Controversy over the NIH’s poor response to disease burden lead it to produce a 2015 report. The report showed that migraine and headache cause major illness burdens (they are by themselves on the bottom right) but get few resources, while HIV gets far more resources than its disease burden suggests it should. What was the NIH’s response to this visually obvious and public demonstration of its neglect? Three years later, both migraine and HIV are getting about the same amount of funding they did in 2015.

My guess is that the pull at the NIH is to always respond to researcher interest and the next new hot item. The NIH probably assumes that researchers will naturally incline to diseases with unmet needs, and for the most part, they probably do. They just don’t incline to controversial newer diseases that have large unmet needs.

This is not to say that the NIH cannot respond to unmet disease needs. It can and does at times do that – it just did it with us – but it tends to do so feebly; it’s clearly not its forte.

Newcomers Not Very Welcome

The NIH  also appears to be structured in a way that rewards “older” diseases and makes it difficult for “new” diseases such as ME/CFS to make headway. Grant applications from “new” diseases have to be reviewed by people outside the field. New diseases don’t typically have homes at top academic institutions – which lowers their grant scores. They may not have an institutional home at the NIH.

That very same structure, though, provides a very consistent source of funding once a disease does get in. If you’re outside of the traditional power structures, it takes a lot of work to get in, but once you’re in – you’re probably in. Our job is to get in.

The NIH That Is…..

If the NIH usually doesn’t give disease needs much priority, then the burning question becomes what does it respond to? I’m a novice at the interworkings of the NIH, but from what I can tell, it responds strongly to at least three things:

  • Researcher interest
  • Highly visible public health needs
  • Congressional prodding.

Researcher Interest – More than anything else, the NIH appears to respond to researcher interest. Seventy-five percent of the NIH’s budget, after all, goes to individual grants. The vast majority of research funding decisions come from its hundreds of review panels which review individual grants. This strong response to researcher interest allows a field, once it has been built and attracted a strong stable of researchers, to keep up its momentum year after year after year, but the overwhelming focus on researcher interest makes it difficult to get a field started.

Highly Visible Public Needs – The NIH also responds at times to highly politicized major public health needs.  The NIH, for instance, recently put together a large funding program to fight the opioid epidemic which includes, by the way, understanding pain better. (It took a Presidential campaign to get it to do that.)  A couple of years ago, it boosted Alzheimer’s and dementia funding by over $300 million. These are major, well recognized health issues that have gotten a lot of publicity. (ME/CFS does not fit in this category: it’s simply not prevalent enough.)

Congressional Prompting – Because Congress holds the NIH’s purse strings, it can sometimes force the NIH to move.  Since 2013, Alzheimer’s advocates working through Congress have tripled funding for Alzheimer’s and dementia (from $500 million to $1.8 billion).  The effort began slowly with just 9 Senators signing on in 2016 and 12 in 2017. This year, 38 Senators signed a letter to get the NIH to spend even more on Alzheimer’s.

Although the NIH responds poorly to disease needs, Congressmen and women can and do understand and respond to our needs. They can then put pressure on the NIH and that can make a difference. This is probably our best avenue for a breakthrough.

Staying Homeless at the NIH?

The general idea is that having a real home at an NIH Institute would give us protection and access to its resources.  The NIH is not a fiefdom, though, and it’s questionable whether forcing ME/CFS on an Institute that doesn’t particularly want it would benefit us much. Waiting for the right Institute to show up, on the other hand, could benefit us greatly.

It should be noted that we did have a home at one time – the NIAID –  which was funding three research centers which were pumping out quite a few studies. After NIAID decided almost 20 years ago that ME/CFS was probably not at its core an immunological disorder, it dumped us.

homeless ME-CFS

Being homeless might be the best option for ME/CFS right now.

That breakup left us wandering in the NIH wilderness for almost 20 years.  Our three research centers shut down and funding levels declined and declined. By the time funding levels reached their nadir – shortly before the recent expansion – ME/CFS funding levels in real terms were lower than they had been in about thirty years. That was particularly galling given that most other diseases had ridden a doubling in total NIH funding to new heights of funding.

Finding the right home, then, is clearly important. The two most likely homes right now are NINDS and NIAID. Given our history with NIAID, I would quite frankly rather be homeless than be housed with them again. NINDS is a safer bet, given Dr. Koroshetz’s public support for this disease, but if ME/CFS turns out to be a metabolic disease or a disease of the cardiovascular system, then the NDDK and NHLBI, not NINDS, would be better homes.

As more Institutes provide funding for ME/CFS, the case for a single home loses some of its power because while putting ME/CFS in one Institute might increase funding from that Institute, it could also lose funding from the other Institutes.  A better strategy might be to leave ME/CFS where it is and have its true home reveal itself as the research proceeds.

Staying Active, Getting Really Creative

As a smaller disease with low resources which is trying to break into the medical mainstream, we have to be creative. Recently Dr. Bateman told the Brain Science Conference that she believes we know 80% of what we need to know in ME/CFS – we just need to get other specialties involved, but we should acknowledge that, as a disease, we’re lousy at networking. Our researchers hardly interact with fibromyalgia researchers and almost completely ignore POTS, dysautonomia, cancer and multiple sclerosis fatigue research. By doing so, we’re missing major opportunities. It should be noted that Dr. Klimas has moved mountains in ME/CFS by getting it included in GWS funding.

Check out what a recent review of the biological mechanisms of fatigue found. No mention of ME/CFS is made – remarkably enough they didn’t even assess the work being done in our disease (talk about a lack of networking) –  but they did come to this conclusion:

Cancer researchers have been in the forefront in investigating the possible biological mechanisms of fatigue, identifying inflammation, dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis, and activation of the autonomic nervous system.

Fatigue Conference? The review missed out on metabolism – a huge area of interest in ME/CFS – but aside from that, it could have described ME/CFS. Carmen Scheibenbogen, who is not just full of ideas but is actually putting them into action, is holding the first Fatigue conference I’ve ever heard of in order to get ME/CFS researchers talking with other fatigue researchers in Germany – the land of no ME/CFS funding – of all places.

If she can do that there, we can do that here. The IACFS/ME did include fibromyalgia in its last conference. It could take that one step further by having special sessions on the connections between dysautonomia and POTS research and cancer fatigue researchers in its next conference. It’s not just that these fields can help us. If we can get them interested in metabolic issues or in Dr. Klimas’s modeling techniques – two areas where we are way ahead of the curve – we could propel their fields forward along with ours.

A Fatigue Conference idea apparently made the rounds at the NIH, but was rejected. This is one area where the NIH could bring likeminded researchers from other fields together and thereby boost ME/CFS research. Or perhaps a philanthropist could produce one.

Dr. Klimas asserts that getting a single line inserted into the Gulf War Syndrome funding opportunity at the Department of Defense could clear the way for clinical trials for ME/CFS. Dr. Klimas is ready to begin clinical trials – she just doesn’t have the money. Likewise, the NIH program announcement (PA) for ME/CFS does not allow funding for clinical trials. That’s something that Dr. Koroshetz said would change, but it hasn’t. Getting that PA to specifically allow grant proposals for clinical trials could clear the way for Nancy Klimas, Ampligen, Cortene and others to apply for funding.

Advocacy Ramping Up

Thankfully, advocacy efforts – so important to success – have ramped dramatically up with The Solve ME/CFS Initiative’s rededication to advocacy, the success of Unrest and the very active ME Action Network. The ME Action network recently scored $50,000 from the Pineapple Fund to support its advocacy work.

The SMCI and the ME Action network teamed up to get 10% of the members of the House of Representatives to support funding for ME/CFS and to request our greatest need – that the NIH develop a strategic plan to increase funding for ME/CFS. The SMCI is attempting to get ME/CFS access to the Congressionally Directed Medical Research funds, and on May 15th will hit Capital Hill in its second annual Advocacy day.

 




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