Occupy M.E.

Update: This post was revised on March 12, 2018 to reflect the addition of intramural research to the total.

When I analyzed NIH’s spending on ME/CFS studies in Fiscal Year 2015, I concluded:

The bottom line is that NIH is going to have to do a lot more than say that they are serious about focusing on ME/CFS. NIH has to prove it. Now.

FY 2016 has come to a close, and so this is a good time to make an interim assessment. Has NIH proven that they will do more than talk about getting serious about ME? It depends on how high your expectations were.

NIH spent $7,885,030 on ME/CFS research in FY2016, an increase of 15% over 2015. This brings us up to 261st place out of 282 disease categories. But ME/CFS funding still lags far behind other diseases of similar significance, and very far away from where we need to be. For example, Lyme disease research received more than 3 times as much funding. Multiple sclerosis research received almost 13 times as much. Dystonia research received twice as much funding as ME/CFS, despite the fact that it affects only a quarter as many people in the United States. Interestingly, there is an NIH-funded Dystonia Coalition for research, something that ME/CFS is still waiting for.

Category Breakdown

What kinds of studies did NIH fund? And how much “new” money was spent?

• After a one year absence, psychological research is back. Dr. Fred Friedberg received $395,000 in the first year of a new grant to study correlations between patient activity, stress, autonomic symptoms, and non-improvement. At first glance, this grant may appear to be focused on orthostatic intolerance, but that is only a secondary aim of the study, to see if “autonomic dysregulation (reduced heart rate variability) will be characteristic of both non-improvers and patients with a limiting activity pattern.” And the long range goal of this work is “to develop a new self-management protocol that more clearly identifies non-improvement activities and how they can be changed.” Sounds like a psychological and behavioral study to me.
• Dr. Friedberg also received a $26,500 grant on behalf of the IACFS/ME to support early investigators’ attendance at the IACFS/ME conference.
• Two orthostatic intolerance studies continue from last year. Dr. Shungu received $494,315 to examine oxidative stress as a way to distinguish ME/CFS patients from controls. Dr. Leonard Jason received $396,536 to examine whether orthostatic intolerance is related to neurocognitive function in pediatric ME/CFS patients.
• Dr. Ben Katz received $753,377 for his prospective study of patients who develop ME/CFS after mononucleosis in college. That figure includes an administrative supplement award that I will discuss in more detail below.
• Dr. Fabien Campagne received $728,786 (including an administrative supplement) to investigate gene expression profiles as possible diagnostic biomarkers. Dr. Mary Ann Fletcher received a total of $587,064 (including an administrative supplement) for her study of gender differences in ME/CFS patients.
• Six additional grants continued from last year with no additional administrative supplement awards. Dr. Roland Staud received $362,500 for his study on peripheral and central mechanisms of fatigue and pain. Dr. Jarred Younger received $433,689 to continue his daily immune monitoring in ME/CFS, healthy, and sick subjects. Dr. James Baraniuk received $340,156 for his study of exertional exhaustion. Dr. Maureen Hanson received $197,943 to study the cellular metabolism of lymphocytes in ME/CFS patients. Dr. Dorothy Hudig received $176,693 to examine the risk of CFS due to the action of certain IgG receptor genes. Finally, Dr. Marshall Williams received $568,411 for that odd study of studying sickness behavior in an animal model of Epstein-Barr virus. As I said in last year’s analysis, it’s not clear what changed with this grant for NIH to count it under ME/CFS.
• NIH funded five new projects in 2016, all reviewed by the CFS Special Emphasis Panel. Dr. Armin Alaedini received $200,000 to investigate ME/CFS patients’ immune response to gluten. Dr. Lubov Nathanson received $182,520 for a new grant looking for male-specific biomarkers and therapeutic targets. Dr. Eleanor Riley received $132,224 to examine associations between human herpesviruses and ME/CFS. Dr. Marvin Medow received $246,000 for a trial comparing intravenous saline to Trioral hydration in the treatment of orthostatic intolerance in ME/CFS patients. Finally, Dr. Derya Unutmaz received $652,055 to look for immunological biomarkers.
• Also included in the total spending are two intramural studies at NIH. Dr. Leorey Saligan received $82,060 for his ongoing study on the correlates of fatigue in cancer and other diseases. Dr. Avindra Nath received $127,208 for the kick off of his study on ME/CFS.

Additional funding was awarded through the administrative supplement mechanism announced in April. Dr. Vicky Whittemore provided me with the specific figures for the awards made by the NIH. Drs. Katz, Campagne and Fletcher each received supplements as part of the awards discussed above ($182,267, $177,395 and $100,000 respectively). Dr. Nathanson received $99,086 to supplement his genomic study of biomarkers from last year. Dr. Luis Nacul received $233,158 to supplement his longitudinal study.* Finally, Dr. Mark Davis and Dr. Ian Lipkin each received supplements to very large grants not focused on ME/CFS. Dr. Davis will examine T cell receptor structure and function with $237,000, and Dr. Lipkin will screen samples against a protein library to identify viral exposures for $212,578.** These supplemental awards total more than $1.2 million dollars, or 16.3% of the total for 2016.

Trend Spotting

Looking at a year in isolation does not tell us much about how ME/CFS research is faring over time. Year to year comparisons, though, show whether research categories are trending in the right direction. I’ve added Dr. Friedberg’s two grants together under the psychological category for 2016.

(To see the analysis going back to 2008, click here.)

Total spending has gone up, with neuroendocrine immune research receiving the lion’s share. However, the return of psychological research is disappointing.

In 2016, new awards came to $2,283,877, just under 30% of the total funding. This is the same as the percentage of new money in 2015.

Computing grant proposal success rate is a bit more challenging, since a FOIA request is necessary and the titles of unfunded grant proposals are withheld. Also, grants may be reviewed in one fiscal year but not awarded and counted until the following year. The last complete annual data I have is for FY2015. A total of 18 ME/CFS applications were reviewed that year, and three were eventually funded, a success rate of 16.6%. This lags behind the success rates for the Institutes that award the most funding to ME/CFS: NIAID had an overall success rate of 21.4% and NINDS had an overall success rate of 20.5%. I’ll be able to update the numbers for FY2016 after another FOIA request.

To me, it is the year to year comparison where the rubber meets the road. Is NIH spending more on ME/CFS research each year?

The answer appears to be yes, at first glance. With the exception of 2012, ME/CFS research funding has increased each year since 2008.

For purposes of this chart, I exclude grants that are unrelated to ME/CFS. In the past, NIH has included unrelated grants in its own categorical spending analysis, but I examine each grant and strip out those that do not include ME/CFS patients or are otherwise unrelated. The dramatic 20% decrease in 2012 was partially attributable to the high percentage of XMRV and other spending that NIH was counting towards ME/CFS the previous year. It wasn’t until 2014 that NIH finally stopped including unrelated grants (although there is still the problem of Dr. Williams’ grant on sickness behavior in mice, but I’ve left that in).

So far, so good. Funding has increased each year, except for the outlier of 2012. But in 2016, we have a new problem.

The administrative supplements introduced this year were a welcome way to extend research funding by allowing investigators to do a bit more work on existing grants. In the case of Dr. Davis and Dr. Lipkin’s awards, the supplement added ME/CFS to what would otherwise have been non-ME/CFS work. Yet the supplements mask a potential problem, as well.  The 2016 supplements total $1,241,484 or 16.3% of the total. Look what happens when I remove the supplements from the funding total.

Without those supplement awards, NIH spent less money in 2016 than in 2015.

What Does It Mean?

Fiscal year 2016 was the year of The Promise. In October 2015, at the beginning of the fiscal year, Dr. Francis Collins said, “Give us a chance to prove we’re serious, because we are.” In March 2016, Dr. Collins personally attended a telebriefing with the ME/CFS community and asked us to, “please take our commitment with great seriousness. Please also stay the course with us.”

We are still waiting for the expected Requests for Applications. It has been suggested that advocates be less “antagonistic,” even as at least one key member of the new Clinical Care Center study has demonstrable bias towards the psychogenic theory of ME/CFS. Dr. Collins recently gave fifty-five members of Congress an update, but it did not include the requested information about NIH funding plans beyond FY2016.

NIH, and Dr. Collins personally, created high expectations with The Promise. Many advocates clapped their hands and expected imminent change. NIH’s failure to meet these expectations is disappointing, to say the least. And old-timers like me can point to a string of previous promises and claims that went unfulfilled. Viewed through this lens, even a 12% increase in funding is not worthy of much celebration. The administrative supplements were not offered until April 2016, and without them we would have seen a 5.6% DECREASE in funding.

But it is also true that NIH is a big, lumbering bureaucracy. No cruise ship can turn on a dime. Those administrative supplements might be a band-aid approach, but there is no doubt we need the band-aid. The RFAs have now been scheduled, in theory, for launch in December 2016 (funding will not begin until September 2017). And Dr. Whittemore recently said at the IACFS/ME conference that she expects FY2017 funding to be substantially higher than 2016. It remains to be seen whether this is another promise that will create expectations that NIH won’t meet, or if Dr. Whittemore is signaling a sea change.

I believe there are some signs of positive change. If the administrative supplements were a creative way to ensure funding increased while the RFAs were hammered out, then so be it. But I stand by what I have said before: until there is actually money on the table, there’s no money on the table.

Promises are great, if they are fulfilled.

*Dr. Luis Nacul was funded by NIH to conduct a longitudinal study of people with ME/CFS or MS, and healthy controls. The study looked at immunological and virological markers. Funding began in 2013, but NIH did not include the study in its categorical spending. I have gone back and corrected my funding analyses for previous years to include for this study.

**Funding Institutes put caps on direct costs of between $100,000 and $150,000 in those supplements. This is why some of those supplements were above $200,000 – that includes both direct and indirect costs.

Additional resources: Read my analysis of NIH spending in 2015, 2014, 2013, 2012, and 2011.