Bottom of the Ramp

In aggregate, 2017 turned out to be the biggest year of ME/CFS funding at NIH ever. But when I scratched the surface, I found bad news buried within the superficially good news. We are still at the bottom of the funding ramp that Dr. Collins promised us, and the ramp is too steep for us to climb without help.

Let’s get the big number out of the way. In FY2017, NIH spent $13.3 million on ME/CFS research. If you only care about the total spending number each year, then you might be satisfied that the number was bigger than 2016.

But how the money is spent is a more important to me. I don’t care how much money NIH throws at ME research if the studies are crap. So let’s break the numbers down to understand how this money is being allocated.

NIH spent $5,101,155 in grants continuing from last year (Katz, Williams, Younger, Friedberg, Alaedini, Medow, Nathanson, Baraniuk, Campagne, Fletcher, Jason, Unutmaz, and Riley). Dr. Friedberg got an additional $103,188 for a study with the same description but a different title from his grant from 2016. NIH renewed Dr. Luis Nacul’s UK longitudinal study for $539,153 in 2017. And NIH awarded two new grants: to Dr. Kathleen Light for $329,085 and to Rakib Rayhan for $35,844. Combined, that’s a total of $6,108,425 in non-RFA money for 2017.

At the very end of September, NIH announced the long awaited Research Centers and Data Center:

The total RFA funding for 2017 comes to $7,225,267.

So, the grand total of NIH spending on ME/CFS research in FY2017 totals $13,333,692. Fantastic, right? This is an increase of almost 75% over 2016.

But there are two very troubling data points buried in that number.

First, without the RFAs we would have seen a significant decrease in NIH funding in 2017: from $7.6 million in 2016 to $6.1 million in 2017. This decrease of more than $1.5 million represented a 20% drop in funding. If the fiscal year had closed before the RFA money was awarded, this would have been a very bad news story. Second, there were only two new grants in 2017. And those two combined were worth only $364,929. That is miniscule compared to 2016, when there were five new projects totaling $1.4 million.

These are the seeds of future disaster. NONE of the researchers who submitted applications for the Research Centers were successful in competing for new individual grants in 2017. Those applications were so labor intensive (as I can personally attest) that either researchers did not submit individual applications or those applications weren’t very good. So hurray for Drs. Hanson, Lipkin and Unutmaz, but everyone else was screwed.

This is a huge problem. We need to see many new grants each year because it maintains a consistent pipeline of projects. As the existing grants phase out over time, we need new studies to begin. Otherwise, we will see gaps in the project cycle.

Don’t expect the seven groups who lost out on the RFA money to turn their applications around and resubmit instantaneously. The research center applications were massive (500 pages or more), and interconnected. It’s not as simple as chopping the application apart and sending it in again. It will take time to reorient the applications and incorporate the feedback from reviews, and I suspect that not very many investigators will meet the October deadline for the next round of funding. That means a further delay as applications are prepared and submitted in future rounds, and crawl through the review process. Grants submitted in early 2018 won’t see funding until the summer or fall.

There is another vulnerability. More than half of the 2017 funding went to the Collaborative Research Centers and Data Center. One of the basic principles of investing is diversification. But NIH has concentrated 54% of its ME/CFS research portfolio in Cornell, Columbia, Jackson Labs, and the Research Triangle Institute. A number of people have rightly criticized the geographic concentration in the Northeast, but I am just as concerned about the funding imbalance. These Centers will take time to come up to speed, recruit subjects, etc. The RFA provides five years of funding, and it will take at least that long for the Centers to start publishing results.

And don’t forget how long it took to get here. Dr. Collins said in November 2015 that NIH was going to ramp up funding. We waited until January 2017 for the RFAs to be announced. Then we waited until last week for the award of that money.

So TWO YEARS have bled away between the “ramp up” promise and the award of the RFA money. But at the same time, the non-RFA research funding decreased by 20%!

This is not a pretty picture. We are magnitudes short of funding commensurate with disease burden. We are magnitudes short of what NIH admits – actually admits – is needed in this field. We’ve spent the last two years waiting at the bottom of the funding ramp, and even losing ground, before getting the RFA money. And because of the timing and allocation of the funding, I expect to see gaps in the project cycle as current grants wrap up and future grants have not started.

Time = Lives.

Time. Is. Wasting.

Here is my proposed solution: NIH should work with the seven Centers that did not get funded and help improve the quality of those proposals. Then NIH should fund another three Centers in FY 2018. That would significantly increase funding and put three more Centers in the pipeline behind the current group. That would be a good start to build this field.

The worst possible thing NIH could do right now would be to wait a few years before funding more centers.

Think about it. When you are in a wheelchair at the bottom of a steep ramp, do you need a nudge or do you need a sustained push?

Obviously, you need a sustained push. But what people with ME are getting from NIH right now is a nudge, and we are in danger of rolling back down the ramp.

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22 Responses to Bottom of the Ramp

  1. Cindy Downey says:

    Thank you once again, Jennie for your deep analysis of NIH funding. At first glance, this supposed funding increase was disappointing; much less than expected given the hoopla – but when you let us know about the more specific aspects of this funding it is indeed very grim.

    Here in Canada, last November, the Canadian Institutes of Health Research (CIHR) declared that ME “is a chronic, complex, multisystem illness. Preliminary research has linked it with disturbances in energy metabolism, immunology, brain and nervous system functioning, epigenetics, and the microbiome. More research is needed to determine the underlying pathology of ME/CFS, and advance understandings of its relationship with overlapping conditions such as Fibromyalgia, and establish effective treatments. An estimated 800,000 Canadians are affected by ME/CFS, Fibromyalgia, or both.”

    The CIHR statement goes on to say that two Catalyst Grants for ME/CFS were launched (for 2016 fiscal year). These were for $100,000 each; only one was awarded. The CIHR said:”These grants are intended to serve as seed money to support research activities that represent a first step towards the pursuit of more comprehensive funding opportunities. We are also seeking to engage in partnerships with other funding agencies to advance the ME/CFS research agenda.” The NIH, and Stafford Research Foundation in Australia were two institutions noted, ramping up investment in biomedical research.

    Current fiscal CIHR ME research funding is $70,000. That’s 12 cents per Canadian with ME, at 561,500 Canadians diagnosed as of 2015 – government statistic. Very concerning, and disappointing to see the real impact of the NIH ME funds, and even more concerning as a Canadian to think that our government may be pinning its hopes on NIH coming up with the answers, without having to invest much.

    I wish to add that our government has spent over 800 million on 3 diseases affecting developing countries; 650 million on reproductive health, likewise in developing countries, and more. Laudable. I understand that these large amounts are tied to industry. At this point, ME research, treatment etc. doesn’t have strong ties to industry. Clearly, the ravages of ME that has felled over a half million of its citizens is of little consequence to our government decision makers.

  2. You echo the deep gut distress I felt when I saw the awards. It’s as if they were DESIGNED to bypass existing researchers.

    Surely something is salvageable from some of the previous research!

    Starting at zero is how school districts keep from being held accountable for the dismal results in the American educational system. Every three years they find ‘something new and better’ – and start at zero. Again. And again. Result: no politician (read School Board) or teachers (they keep getting jerked around, and the bad ones are NEVER removed) ever had to be accountable. And they all keep piling the paper higher and higher.

    • Jennie Spotila says:

      Just to be clear, I don’t think Hanson/Lipkin/Unutmaz are undeserving of funding. And while they are all relatively new to the field (compared to others who have been doing it for decades), they all have experience in ME research personally and on their teams.

  3. billie moore says:

    And then there’s this, just announced via CO-CURE: “The CureME team at The London School of Hygiene & Tropical Medicine is delighted to announce the award of $2.1m (£1.57m) of grant funding from the United States National Institutes of Health.

    “The grant will fund a longitudinal study that will measure changes in the immune system and genetic profile of individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.”

    As if our researchers could not do the same research. I think this is a second funding of this study. So let’s guess that the NIH has given something like $4 million to researchers in the UK. (Jennie? correct?) It’s disgusting.

    • Jennie Spotila says:

      That grant is the one to Dr. Nacul that I mentioned in the post. To date he has received almost $2.5 million.

      I don’t think it is fair to say this is “disgusting.” It’s only disgusting if a US researcher submitted a grant for this type of study (which includes a biobank) that was just as good or better than Nacul’s study. I don’t know whether that is the case. Furthermore, Nacul has done good work. And finally, most people would like to see Fluge and Mella get funding for their rituximab study in Norway. It’s not fair to support their funding (which certainly US investigators could also try for) and then object to funding for Nacul.

      • billie moore says:

        On this subject, I differ, Jennie. Giving grants to researchers from other countries just emphasizes the NIH’s lack of interest in supporting our own researchers (and yes, we know there are plenty, some of whom would be doing equally good research as the UK people, I am sure). By not supporting our people, it is another way of discouraging U.S. researchers from getting into the ME field. Grants like this have ripple effects.

        • J says:

          It’s often through collaboration and discussion that scientific breakthroughs are made. Quality ME Research should be celebrated wherever it is in the world. The centre of excellence of ME Research in the UK is working with Norway on the rituximab trial for example. The UK is woefully underfunded and the money to do the trial was raised by patients. If we want to stop bad Research like PACE we have to work together. Things changing in Britain helps patients in the US. The more scientists work together the better the outcome for all of us. It’s a complex illness, with so many potential lines of research that to cut ourselves off from collaboration will slow the science. Working together we can do so much more!

  4. Mary D says:

    Excellent post, Jennie.

    You are right. NIH needs to do more to accelerate the pace at which they are ramping up research. The stepwise approach is too slow and too small to make a difference in a time scale that really matters. At this rate, it could be 10-15 years or more before we have treatments.

    • jimells says:

      “it could be 10-15 years or more before we have treatments.”

      That would certainly please the disability insurers. But of course, that is just purely coincidental. After all, “everyone knows” that Regulatory Capture of government agencies only exists in the fevered brains of people wearing tin-foil hats.

      Ever notice how every CDC/NIH initiative includes a giant poison pill, such as the requirement that these grants can not be used for clinical treatment trials? That too is also purely coincidental. No way does NIH intend to wait years to consider financing treatment trials, even though there are public statements to that effect (unfortunately I can’t remember where I read that).

      Skilled bureaucratic warriors such as Collins and his public relations team would never use divide-and-conquer tactics to cause division and rancor within the patient advocate community. Everyone knows how much they admire and respect us, right?

      When it comes to respect, I readily acknowledge that Collins and crew have waged a successful public relations campaign. Over on that patient forum, NIH critics have been mostly drowned out by the rose-colored glasses crowd.

      Personally, I don’t find those glasses to be a useful treatment.

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  6. Kathy D. says:

    Definitely a needed reality check on the NIH grants!

    I hope those who got the grants in the U.S. come up with something that will help us. I know that Hanson and Lipkin have been researching ME/CFS. Don’t know about the third person.

    I am dismayed, of course, that Ron Davis, Nancy Klimas and Jose Montoya did not get funding, and especially aggravated over what NIH said to Ron Davis.

    Thanks for your analysis.

  7. Manfred says:

    I agree with what you are saying, such a tiny amount of funding and a huge volume of “busy work” to apply for grants. It is beyond comprehension that Stanford is classed as a “moderate university” and Ron Davis as having a “conflict of interest”. The Friedberg study is largely a bio pyschological social study with a “token” amount of heart rate data and very disappointing. The study doesn’t scratch the surface of what patients are doing and/or finding effective with heart rate/physiological data. The authors were provided with information on how patients are using physiological data but had zero interest in improving/expanding their study E.g. such as using waking resting heart rate, symptom load, sleep amount and quality, heart rate variability and morning temperature to monitor/guide activity levels. Funding the UK bio-bank is great but it seems a bit odd. Hopefully the UK can use the fact that the USA is funding its bio-bank to pressure the UK to pitch in? As you say Jenny, we are at the bottom of a steep ramp and no sign of anyone helping us to get up it. Each of the ten studies could be funded and we’s still be way below parity with other diseases in terms of funding. It appears that the reasons given for not funding OMF are nothing to do with the quality of the application or proposed centres and are not things that can be addressed for instance the rating of Stanford as a moderate university, the fact that Whitney is severely ill, the focus on real/substantial research at the expense of a publication history are all things that are outside the realm of tweaking the application. I suggest that each and every application of merit is funded and those with substantial issues are given the oppurtunity to address issues and resubmit.

    • jimells says:

      Friedberg knows how to play the funding game. He’s been publishing sympathetic-but-useless studies for years – just what NIH ordered. I don’t see that changing anytime soon. The same could be said for other well-known US researchers as well.

      How can these researchers devote decades to studying an illness, come up with absolutely nothing clinically useful, and not hang their heads in shame?

  8. Patricia Fero says:

    So next FY, the NIH will be funding the centers + the renewals. I wonder what that total will be. I expect, but I hope I am wrong, that next year we might get one new grant funded. I am happy about the centers, but if the pattern continues as it was the past, funding will actually go down. Have to watch everything about NIH patterns.

    • Jennie Spotila says:

      I almost wish I did not just do this math. Eight existing grants will end in 2018, leaving us with eight non-RFA grants totaling $3.7 million. The RFA funding will drop by $1 million to $6.2 million (this was always the plan).

      So next year’s RFA + non-RFA funding is currently looking like $9.9 million. This represents an overall decrease of $3.4 million, or 25%.

      The non-RFA funding will go from $6.1 million to $3.7 million. This is a decrease of $2.4 million or 40%.

      I am sick to my stomach.

  9. Denise says:

    Jennie, I very much appreciate you and this post.
    What I don’t appreciate (and this has nothing to do with you) is the lack of urgency and resolve on the part of government agencies to truly move things forward.

    I have heard that agencies follow what is said on blogs and forums. I wonder if they come back to posts repeatedly to read the comments also because I sincerely hope they see this” Eight existing grants will end in 2018, leaving us with eight non-RFA grants totaling $3.7 million. The RFA funding will drop by $1 million to $6.2 million (this was always the plan).

    So next year’s RFA + non-RFA funding is currently looking like $9.9 million. This represents an overall decrease of $3.4 million, or 25%.

    The non-RFA funding will go from $6.1 million to $3.7 million. This is a decrease of $2.4 million or 40%.”

    The cold, hard reality is that after all these years and after promises, we only get baby steps and our funding level more than STINKS!

    • billie moore says:

      And as I said, the NIH personnel involved in grant choices and funding choices will be ever so proud of themselves for funding three centers to the total tune, over FIVE years, of $35 million. People like Drs. Nath and Koroshetz will be resentful that we are not down on our knees thanking them for recognizing the “seriousness” of the disease with all that money and attention. But $6 per year per patient barely funds a bottle of aspirin.

  10. Janet says:

    Ron Davis and Raeka Aiyar rewrote parts of their center grant and submitted it yesterday to NIAID. It’s for an R01 grant (highest possible award is $499,000 per year for 5 years). If they get it, they won’t see any funds until at least next July. Meanwhile, Whitney is still lying there, as are millions of others suffering and losing significant parts of their lives.

    I would just like to comment about the idea of NIH working with the 7 who didn’t get grants to help them improve them. I can only speak for Ron’s grant, but there is no way that that idea is even relevant to their grant. It was already a really good grant. And those reviewers added nothing that could improve it. The review was useless, biased, and wrong. What they need to do is get good reviewers, take responsibility for the hole they have dug for ME/CFS, and make wise decisions as to how to move the field forward fast. Ron has done this himself for other fields when he sat on council. They would think about where the field needed to be. They would look at the reviews and discount the wrong, nitpicky stuff. They sometimes awarded grants to applications that were far down on the list because they were good proposals. If someone there who knew about the field thought about the best way to move the field forward faster, they would have funded Ron and team. If they really wanted to get new, good researchers into the field, they would have funded Ron and his team. If they really want progress to be made, they would fund all 10 of the proposals. What they are doing now is just unconscionable. The reviewers aren’t doing a good job, and no one is taking real responsibility for fast progress that aims at finding treatments fast. If people are upset that Ron didn’t get funded, I personally think that NIH should hear about it. I hate to think that they can do this and then get away with it and think the patient community is ok with this. When Ron was on study sections or council, he always had the philosophy of scoring all the good grants high enough to be funded. Then if there wasn’t enough money only a portion of them would get funded, but no one would be saying they didn’t get good grants. Using those ridiculous scores (not just Ron’s) and saying there weren’t enough good grants is just wrong. It’s the effect of a messed up review system and no one taking responsibility to make sure the reviews are reasonable. Ron’s reviews rated Stanford as “mediocre” as a supporting institution, which is nonsense, and had scientific comments that were just plain wrong (among other ridiculous things). No one’s grant should be judged in this way. The system needs fixing. Every scientist involved in ME/CFS research should be volunteering to be on study sections and review grants. And people should be careful not to collaborate with too many people because they then can’t be on a study section for those people’s grants. We don’t want all the good reviewers to have to recuse themselves. This is a very very complex and difficult problem, but it seems to me that it all comes down to there being no one with power at NIH actually taking responsibility for the illness of over 2 million American citizens. That is their job. They are stuck in their bureaucracy.

    I know it may seem like I’m just biased and advocating for my husband, but really, I’ve seen what he has done for 50 years, I know the amazing people he is getting on board to help, and I know that he should be getting whatever funds he needs. He does not think he can do this alone – on the contrary, he is assembling some of the best scientists in the world so that the very best people can be working on the things they do best applying it to ME/CFS. If something doesn’t change, it’s going to take a long time. Ron is going to keep going as fast as he can, with the help of OMF raising funds and all the wonderful support of the patient community donating what they can. I just feel so sad. Ron went to Whitney’s favorite grove of Redwood trees today and cried.

    • Jennie Spotila says:

      I am thrilled that Ron submitted the R01 proposal!

      What they need to do is get good reviewers, take responsibility for the hole they have dug for ME/CFS, and make wise decisions as to how to move the field forward fast.


    • jimells says:

      I recall listening in on some NIH conference call earlier this year. I can’t remember which NIH managers were on the call, but I do remember my jaw hitting the floor when NIH said that researchers needed to submit more proposals so NIH could reject them and maintain their very low grant acceptance rate. They didn’t say why they are required to keep the rate low, or who requires it. Maybe it’s on a stone tablet someplace.

      Perhaps we need to find a way to submit decoy proposals for them to reject so they can meet their bureaucratic goals without rejecting the good proposals, kinda like distracting a child or a pet from engaging in unwanted behavior.

      I know this sounds paranoid, probably it is, but I’m gonna say it anyway. I get this feeling that NIH is rejecting Dr Davis’ funding as a way to retaliate against the patient advocates who keep criticizing NIH. They are well aware that Dr Davis has a lot of support from the patient community. They can do nothing to shut us up, but there is always a way to strike back.

      The phrase “passive-aggressive behavior” comes to mind. Bureaucrats tend to excel at these skills, otherwise they fail to claw their way to the top. (And I have to admit I have had a bit of practice at passive-aggressive behavior in corporate hierarchies myself; maybe that’s why I see it in this situation.)

      As far as the reviewers go, I know nothing about NIH processes, but I know that *somebody* appoints the reviewers – they sure don’t appoint themselves. I see no reason to doubt that the reviewers are reflecting the attitudes of the reviewer appointers.

  11. We need to push NIH via Senators, and Congressional leaders to help push ME up this ramp toward a fairer $200M/yr. Please seek resolutions from 50 states, 100 senators and 435 reps for an end to this decades of gross discrimination against M.E.

    This will also help raise awareness and increase philanthropic donations, that could dwarf the meager Federal efforts if we can find the right donors, who want to have a huge ROI for their donations, such as through OMF.NGO.

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