ME/CFS Funding Worsens As NIH Maintains Status Quo

by Cort Johnson | Dec 20, 2019 | Advocacy, Homepage | 41 comments

A FOIA and Jennie Spotila’s analyses indicate the NIH funding for ME/CFS is heading in the wrong direction.

Into the Dark Side

Researchers abandoning the NIH? Significant drops in funding? Who could have imagined it would have gone this way four years ago when Francis Collins, the director of the NIH, no less, asked the ME/CFS community to “Give us a chance to prove that we’re serious because we are”. ME/CFS, he said, was a priority.

Increasing Individual Research Grant Applications (NIH – Grade F)

“To increase funding in this field, there must be an increase in the number of investigators doing research on ME/CFS and the number of meritorious research applications submitted to NIH.” Walter Koroshetz– Director National Institute of Neurological Disorders and Stroke (NINDS).

Research grant applications are getting worse – not better – since the NIH launched its “reinvigoration” effort.

The most important objective of the “reinvigoration” and our most important need is to increase researcher-initiated grant applications. Seventy-five percent of NIH funding goes to individual research grants. Koroshetz has made the point many times that you can’t be successful at the NIH without them.

A Freedom Of Information Act (FOIA) request revealed, though, that, as of Nov 12th, the NIH Special Emphasis grant review panel for ME/CFS had received a total of 9 applications. That’s not for November. That’s for the entire year. With the grant review panels presumably finished, 2019 ended as 2018 and 2017 did – with the lowest number of grant applications for ME/CFS on record.

To be clear, NIH grants are essential because the big NIH grants – the RO1’s – are multimillion dollar, multi-year grants, the likes of which can be found nowhere else. As the NIH is far and away the largest medical research funder in the world, they also provide a devastatingly simple way to assess the productivity of a field. For one, the dauntingly complex applications require a major effort and a degree of sophistication on the part of a researcher. You have to have your “you know what” together to get one.

Somehow, though, despite all the interest, all the private funding, all the NIH’s promises, researcher interest in ME/CFS hasn’t gotten stronger in the four years since Francis Collins promised to make ME/CFS “a priority” – it’s actually gotten weaker.

Grant Applications Received at the ME/CFS Special Emphasis Panel

2011 – 20
2012 – 30
2013 – 16
2014 – 18
2015 – 26
2016 – 13
2017 – 8
2018 – 8
2019 – 9

Bootstrapping Not Working

The ME/CFS community is doing the best it can – it’s pouring more and more money every year into our research, but while private research efforts are keeping the research alive, they haven’t boosted the crucial grant application rates. In other words, this field is not showing any evidence that it can bootstrap itself to success.

In fact, everything that’s been tried has failed to entice researchers to put on their big boy pants and try and go get a major NIH award.

NIH Efforts Not Working

The 7 failed NIH Research Center applicants presumably had 21 near shovel-ready applications to throw into the mix – but didn’t. The 3 NIH research centers that were supposed to spawn a bunch of applications – haven’t. That poorly attended NIH Conference on ME/CFS that was intended to boost interest in ME/CFS – had no impact. The NIH’s attempt to get young investigators interested in this disease – apparently failed. Francis Collins’s and Director Koroshetz’s blogs on the need for ME/CFS research – completely ineffectual.

The “cross your fingers” and “click your heels”, and hope that 3 small research centers are somehow going to jump-start this field was dead from the get-go.

“We hope the Centers and other NIH efforts will attract researchers from other fields to propose research on ME/CFS…We believe the steps NIH has taken over the past two years will lead to a significant increase in the number of high-quality grant applications in the future.” Koroshetz – reply to Laurie Jones

Koroshetz is right that eventually the Centers probably will at some point result in a “significant” increase in grant applications but, at this point, 12 applications would be a significant increase from 9 applications a year.

Despite the fact that Koroshetz has repeatedly said that increasing individual research applications is the key to this field’s success, neither he nor Collins have done anything to move the needle on it. We all know what needs to happen – the NIH needs to put its money where its mouth is and produce an RFA.

Right now, the NIH appears to be on the same 10 year plan it’s been on for decades. Do something significant once a decade, close your eyes and wish for a miracle, and then do it again 10 years later.

Increasing Funding (NIH Grade – F)

Warning: funding may get worse next year.

Certainly we could have expected funding to grow but not surprisingly, it too, is declining – rapidly. Jennie Spotila’s recent overview, “NIH Funding for ME Needs Life Support“, showed that funding for investigator-initiated grants has declined by 25% since 2017.

Hold on tight, though, that number is likely to get worse – significantly worse – before it gets better. Jennie pointed out that three major five-year grants are in their last year of funding. If they’re not replaced next year – and replacing three major grants in one year is a very tall order for this field – funding will drop substantially.

Bringing New Faces To the Field (NIH – Grade F)

Another major goal was to bring new faces into the field but Jennie’s analysis indicated that over 80% of NIH funding is going to 7 individuals/groups – almost all of whom were involved in ME/CFS research before the “reinvigoration” began. (The sole new entry to the field is RTI – a data coordinating center for the research centers.)

Jackson Labs/Dr. Unutmaz: $2,770,725
Columbia/Dr. Lipkin: $2,241,807
Cornell/Dr. Hanson: $1,849,848
RTI: $1,176,919 (data coordinating center for research centers)
Stanford/Dr. Davis: $762,949
Ohio State/Dr. Williams: $568,411
London School of Hygiene & Tropical Medicine: $539,019

The NIH has clearly failed to bring new faces to this disease – another top priority – not acted on, and certainly not fulfilled.

Bias Arguments Don’t Hold Up Anymore

There is some good news. The idea that NIH bias against ME/CFS is holding researchers back doesn’t wash anymore – at least at the ME/CFS grant review panel where the vast majority of ME/CFS grants go.

Jennie Spotila’s analysis found that ME/CFS grant application success rates there from 2011-2015 were substantially above the NIH norm. Plus it appears that over half the grant applications submitted last year were approved – a phenomenal success rate. (Note that bias is less likely to show up in the ME/CFS grant review panel than in other parts of the NIH.)

That’s very good news because if we can entice researchers to apply for grants their odds appear to be pretty good. Our biggest problem is not bias: it’s getting researchers to take an interest in this field and apply for grants.

Status Quo to Prevail for Now

Director Koroshetz’s response to ME Action’s letter indicated that, despite the fall in individual grant applications, the status quo will prevail. An RFA that would immediately increase individual grant applications – the only thing it seems that could do that – is not in the works.

The NIH set out its path 4 years ago and it’s not diverting from it. (Note that the NIH stated that it intended to reinvigorate ME/CFS research four years ago but it took almost two years for it to announce the awards for the Research Centers. )

Promises To Keep: NIH Commits to Reinvigorate Effort on Chronic Fatigue Syndrome

The only positive points Koroshetz could point to were an upcoming program announcement (PA) and the strategy document. It’s not clear why the NIH, in the middle of its reinvigoration effort, allowed its PA to fail but since PA’s have never increased grant applications, expect this one to have no effect as well.

ME/CFS’s plight – a million sick people getting crap for funding decade after decade – has illuminated one of the great shortcomings of the NIH. The NIH relies entirely on researcher interest to determine what it funds, and has no mechanism to support underfunded diseases. It’s more of a gatekeeper organization than anything. Its role is simply to ensure that rigorous, well conceived grant applications get funded.

Because the NIH relies so much on researcher initiative, it’s set up to reward researchers associated with large, well-established diseases and punish those studying diseases that haven’t made it yet. Ironically, the poorly funded diseases don’t have the cachet they need to change the system.

That’s where politics comes in.

The Gist

The National Institutes of Health (NIH) is by far the biggest medical research funder in the world.
Private research foundations can’t begin to match the funding that the NIH can provide; i.e. it’s crucial that diseases succeed at the NIH.
Four years ago, NIH Director Francis Collins promised to make ME/CFS a priority and urged us to watch them as they did so.
Collins did dramatically increase research but only to the paltry levels ME/CFS had achieved before.
In the 4 years since Collins’ announcement, the most crucial part of NIH funding – researcher-initiated grants for ME/CFS – have fallen dramatically.
Funding has fallen significantly, as well, and may fall more next year.
The NIH has failed, thus far, to bring new investigators into ME/CFS.
Despite its failures, the NIH has stated it will continue with the status quo.
Some bright spots are present, however. No evidence exists that bias is keeping ME/CFS grants from being approved at the ME/CFS grant review panel. In fact, grant success rates appear higher than normal.
Advocacy – perhaps the crucial ingredient in getting more funding at the NIH – is stronger than ever.
The strategic report initiated by Director Koroshetz could produce major results. Time will tell on that.
Several intensive studies – the likes of which this field has never seen before – are wrapping up or are well underway. Each should provide new insights for this field.
Solve M.E.’s International Patient Registry – an important step forward in building the infrastructure we need to understand this disease – is expected to open soon.

Send Dr. Koroshetz a Holiday Card (and ask him to end the NIH’s scrooge-like behavior)

Please join #MEAction in sending a holiday card to Dr. Koroshetz to let him know his recent plan for ME is not enough, and that our community deserves urgent ACTION after 30 years of neglect. Read ME Actions easy, 3-step instructions for sending Dr. Koroshetz a card, below.

Have your friends, family members and allies to send cards, as well!

Into the Light

That’s all bad news but the weird truth is that, in most ways, we’re actually in better shape than ever before. More is happening now than has ever happened before in this disease, and believe it or not, we are closer to a breakthrough at the NIH than ever before.

Advocacy – Our advocacy efforts are stronger than ever. ME Action is more well-funded and active than ever. We’re in year three of Emily Taylor’s five-year strategic plan to get Congress to push for more ME/CFS funding. The plan seems to be working. We have more support in Congress than ever before and that support is growing. Given the NIH’s intransigence, a political push is vital. (An interview with Emily is coming up.)

Strategic Report – Koroshetz did initiate the strategic report being produced by the Trans-NIH Working group. Because it’s coming from within the NIH, it could have enough oomph to get the NIH to get moving. Time will tell.

The Lyme folks, it should be noted, were absolutely thrilled to have their NIH-produced strategic report – one which was mandated by Congress, by the way. Rep. Chris Smith, the leader of the Lyme Caucus, was ecstatic to see it:

“After lagging for decades, NIH is all in for researching Lyme and other tick-borne diseases to better diagnose and treat those suffering from this horrific disease. This is great news for patients and Lyme-literate doctors who will now have serious, federal partners working aggressively to improve strategies for the detection, treatment, and one day, prevention of Lyme.”

The Lyme plan includes a number of intriguing focii, including determining the cause of an ME/CFS-like disease (post-treatment Lyme disease syndrome), better understanding the only known food allergy that can be induced by an insect bite (alpha gal syndrome), and developing rapid and direct detection diagnostic tests as well as vaccines and immune-based treatments. All of these will indirectly help us understand ME/CFS as well.

Let’s hope our strategic report will have a similar effect. Due date – sometime next year.

Research

The news at the NIH is not good, but in many ways, ME/CFS is stronger than ever.

The NIH is stuck but the ME/CFS community is coming through. The OMF just blew through its fundraising goal and Solve M.E. funded the largest number of Ramsay grants ever. The OMF-funded Harvard Collaboration is off to a great start with Ron Tompkins.

Four of the largest, most comprehensive studies ever done in ME/CFS have wrapped up or are underway. They will help us in two ways. They will point to beneficial paths to follow and they will block off paths we don’t need to tread down anymore.

The OMF-funded Severe ME/CFS Study by Ron Davis constitutes the most in-depth attempt to get at the molecular foundations of this disease ever done, and it did so in a group – the severely ill – which is rarely assessed. Did the disease shine most brightly in them as was hoped? We should find out next year exactly what this effort achieved as the studies start rolling out.
The NIH Intramural study, led by Avindra Nath, could provide our biggest win. This small, but incredibly in-depth, study is looking at different factors from the Davis study and contained an exercise stressor to boot. We’re on the 3rd year, I believe, of this 3-5 year project. In fact, this study is supposed to set the stage for two more initiatives. The plan was to first identify possibilities for study; second – dig more deeply into those possibilities; third – to attempt treatment interventions.
The CDC’s Multi-site Study – this huge effort by the CDC assessed patients and treatments across eight expert ME/CFS clinics. We’ve been waiting forever, it seems, for the studies to roll out, but the data gathering is over and hopefully the studies are on their way, and will justify the huge amount of time and effort spent on this.
The NIH research Center Collaborative Study – we don’t know how many people this collaborative effort between the three NIH Centers study involves, or what it will contain, but it could contain several hundred people.

The NIH Centers – over the next year or two, the three NIH-Funded research should be publishing a raft of papers. The Centers, themselves, will be up for renewal in three years. My guess is that the Centers will be successful, the NIH will renew them, and we will push hard for and hopefully get an increase in funding.

Solve M.E.’s International Patient Registry should bring new opportunities.

Infrastructure Building

Solve M.E.’s International Patient Registry – another long awaited project and a vital piece of infrastructure for ME/CFS will open soon.

Five NIH Initiatives That Could Help

Francis Collins may be pretty pitiful in moving the needle on ME/CFS but he’s superb at producing major initiatives. The NIH’s initiatives on exercise, pain (HEAL), the brain (the Brain Initiative), and peripheral nervous system stimulation (SPARC) all align well with our needs. As they clarify on a basic level how the brain works, what happens during exercise, how pain is produced, how to tweak the peripheral nervous system, and what’s happening in Lyme disease, they should provide insights into what’s happening in ME/CFS.

Of course, we will need researchers to apply those findings to ME/CFS…

Conclusion

Even as dramatic declines in research grant applications and funding occur, the NIH is standing pat. It has its five year plan and it’s sticking to it.

Inside the NIH, it’s looking pretty dark. Outside the NIH, things are looking brighter. We need to keep fighting….

The good news is that the ME/CFS field, including our vital advocacy efforts, is in many ways stronger than ever. Support for our research foundations is greater than ever before. With some very big studies underway and hopefully wrapping up soon, we should have some new findings to build on.

The NIH has a ton of money but it is not the be all and end all. Much excellent work that’s being done outside of the NIH could provide a breakthrough as well.

We don’t know how much of an impact the strategic report will make but the potential for a major breakthrough is there. That, in concert with political action, is our best chance for a major increase in funding.

An interview with Emily Taylor – our full-time advocate with Solve M.E. – is coming up.

Health Rising Drive Update

Large or small, every bit helps.

Talk about funding needs! Health Rising needs your support to keep providing analyses like this. We’re about midway through our drive. Over 180 people have contributed. Please don’t think your support won’t help. The vast majority of our contributions are small amounts. They add up. Please consider throwing some change our way. Thanks!

GIVE A ONE-TIME DONATION

GIVE MONTHLY

HEALTH RISING IS NOT A 501 (c) 3 NON-PROFIT

41 Comments