No reliable diagnostic criteria, no validated treatments, controversial, lots of people affected … paltry funding. It sounds like chronic fatigue syndrome (ME/CFS) but it’s actually post-treatment or chronic Lyme disease. The numbers are similar (about 1,000,000 people in the U.S.), the suffering is similar, even the funding has been similar.
Despite the National Institute of Allergy and Infectious Diseases (NIAID) touting its “long-standing commitment to conduct research on Lyme borreliosis, or Lyme disease” dating back 35 years (which, come to think of it, brings us to 1985 – about when ME/CFS went public), from 2015-2019 the NIH spent about $25 million a year on Lyme disease. (Proving they can tout anything …)
As with ME/CFS, the NIH lists many impressive goals regarding Lyme disease (understanding microbial physiology, molecular, genetic, and cellular mechanisms of pathogenesis, etc.), and evinces such commitment and concern … and yet has produced so little work. The only major breakthrough NIAID touts on its Lyme webpage is the identification of the microbe – back in 1981.
Things have been changing, though. In 2016, the NIH funded the Novel Approaches to Understanding, Preventing and Treating Lyme Disease and Tick-borne Coinfections (R01) (nih.gov) grant opportunity and another smaller grant. Those grants didn’t go nearly far enough, but they did boost NIH funding by about 20%. (A similar grant opportunity more than doubled ME/CFS funding from 2015 to 2017).
Then something astonishing happened. After getting boosted by about 20%, Lyme disease funding jumped from $34 million in 2020 to $53 million on 2021 – a 64% increase in one year.
If you think the NIH finally got it big time about the seriousness of Lyme disease, think again. As Emily Taylor of Solve M.E. has noted, many NIH initiatives have begun in Congress – the only outside agency that has the ability to make the NIH move. It was Congressional action that prompted the big uptick in NIH funding.
The December, 2016 21st Century Cures Act required the Department of Health and Human Services (which the NIH is a part of) to create the Tick-borne Disease Working Group and produce a strategic plan.
Note that the bill didn’t even mention extra funding. Getting more Lyme funding has been a step-by-step process – the early steps of which did not include asking for more funding.
Even then, Lyme organizations reported that it took “two days of intense negotiations with Congressional offices” to get their language inserted into the bill. The seemingly small steps found in the 21st Century Cures Act, in retrospect, turned out to be large, though.
Report – Every two years, the Working Group provides a Report to Congress (hhs.gov) so that Congress can precisely track the NIH’s actions on Lyme Disease. (The 2020 Report ran to 180 pages.)
Strategic Plan – In late 2019, the NIH issued its NIH Strategic Plan for Tickborne Disease Research. Part of the process of producing the strategic document involved asking for stakeholder input, which included patients and advocacy groups, as well as researchers and doctors. Ninety-two people provided input.
It was a small document – just 26 pages – but it was NIH-produced (i.e. it had internal validity) – and it laid out five strategic priorities and numerous sub-objectives in precise detail. It was a true strategic plan.
Funding for Lyme disease remained stagnant in 2020, but in 2021, the National Institute of Allergy and Infectious Diseases requested a 64% increase in funding for Lyme disease ($54 million/year). Then Congress (the 180-page report from the Tick Borne Disease Working Group in hand) mandated that an extra $10 million be added on top of that.
Suddenly, Lyme disease funding at the NIH was up to $64 million dollar a year – about double what it had been a few years earlier.
Congressional Bill – Meanwhile, the 2019 Kay-Hagan Tick Act (named after a Senator who died of another tick-borne illness) provided an extra $21 million for the CDC’s efforts on on Lyme disease which included increased surveillance of tickborne diseases. The backers actually didn’t get nearly the money they wanted – but they got their end goal – a line-item in the budget which could be negotiated up the next year.
Congressionally Directed Medical Research Programs at the Dept. of Defense (CDMRP) – Lyme disease had already gotten pretty well ensconced within the CDMRP, where it was receiving about $7 million in funding a year.
With funding for the Tick Borne Research Group remaining stable, the federal government is due to spend $91 million on tickborne research next year – that’s a 65% increase from the $55 million the year before and three times what it had been just a few years earlier. Things are booming in tick research.
Big Donors Show Up – Plus, some big donors have been showing up lately. Late last year, a San Francisco family (four of whom have PTLDS) made a $2.14 million gift to the MIT School of Engineering to fund a two-year Lyme disease research project in an attempt to understand how the Lyme bacteria reprograms human immune systems. That came on the heels of an earlier $5 million dollar grant to Harvard. That’s $7 million in one year from one family – about half of what the NIH is spending yearly on ME/CFS.
Well, good for people with Lyme disease, you might say. But what does that have to do with ME/CFS? Potentially plenty.
Chronic Fatigue Syndrome (ME/CFS)
While Lyme disease funding at the federal level suddenly and dramatically boomed, ME/CFS funding has, if anything, been trending down a bit. Don’t let that fool you It’s possible that we’re at the early stages of the same trajectory. Over the past couple years, we’ve been treading a similar path to what Lyme disease used to dramatically increase its funding.
The NANDSC ME/CFS Working Group – From 2018 to 2019, an NIH-sponsored ME/CFS Working Group produced a document of its own. Instead of Congress, it was Walter Koroshetz, the head of the National Institute of Neurological Diseases (NINDS), who took it upon himself to create an internal working group called the NANDSC Working Group for ME/CFS Research to “provide scientific guidance on how best to advance research in ME/CFS at NIH.”
Note that in contrast to the 92 people who provided comments to the Lyme Working Group, 281 provided comments to the ME/CFS working group. NIH officials were reportedly very pleased with that result which showed strong community support.
The group’s report did not directly call for more funding. Its top recommendation, though, was to ask the NIH to prepare “an overarching research strategy to address the complex nature of ME/CFS” – the same kind of document which appears to have propelled NIAID’s request for substantially more Lyme funding.
The Report also put the NIH on notice that NINDS agreed that:
- A lack of knowledge exists regarding the underlying biological mechanisms of ME/CFS
- Insufficient information exists about clinical aspects of the disease
- That the numbers of investigators and grant applications are too low
- That this disease needs many more “early career” investigators
- That the stigma that is still hampering ME/CFS at the NIH needs to be addressed
- That the field is lacking and that a strategic research approach to ME/CFS at the NIH (and elsewhere) is needed.
While the NANDSC report probably doesn’t have the cachet of an Congressionally mandated report, it was an internal document developed by NINDS and passed by its “grand council” (NANDSC), and therefore potentially has real clout.
So far as I can tell, the NIH moves in response to only two things: Congressional action and internal reports.
ME/CFS Strategic Document – The ME/CFS strategic document would likely have been done by now, but it was delayed by the pandemic. The document will presumably distinguish precise research pathways to follow, potentially laying the groundwork for more funding.
NINDS (and each of the other Institutes) have an Office (“The NINDS Office of Science Policy & Planning”) that’s devoted entirely to science policy and planning and developing strategic plans. Vickie Whittmore reported that the passage of the NANCSC reported provided the ME/CFS supporters at the NIH with resources they’d never had access to before.
Note that we already have a Working Group in the NIH – the Trans-NIH ME/CFS Working Group. It may not have the clout of the Tick-Borne Disease Working Group, but it is a stable group whose clout could rise over time.
The NIH ME/CFS Congressional Report – The Tick-Borne Disease Working Group provides a report to Congress every two years. After the last report, Congress bumped up funding for Lyme an extra $10 million, on top of a considerable increase in funding from the NIH.
When the attempt to increase CDC funding for ME/CFS failed, language was inserted into the funding bill requiring the NIH to provide a report to Congress on the ways it was increasing research on ME/CFS. When the pandemic struck, the report was put on the back burner – but it will come due.
The fact that Congress asked for the report indicates it’s concerned about the NIH’s support for ME/CFS. That report will give our Congressional supporters a foundation to ask for more funding.
ME/CFS – Increased CDC Funding – Lyme advocates were able to get a bill passed to get a line-item for CDC funding. ME/CFS already has a line-item in the budget for CDC funding. Emily Taylor of Solve M.E. reported that ME/CFS advocates had increased funding for CDC surveillance wrapped up in a box, with a bow tie on it, until the federal government used the projected funding for the Wall. That suggests that that extra funding is still in play.
CDMRP – Lyme disease benefits from about $7 million in CDMRP funding every year. The Solve ME/CFS Initiative worked to get us into the CDMRP program last year. While the actual grant rewards for ME/CFS were relatively small this year, the program shows real promise.
ME/CFS Congressional Bill – H.R. 7057 – Lyme’s big jump was, in part, triggered by its insertion into the 21st Century Cures Act in late 2016. Our attempt to give Congress say over NIH funding with H.R. 7057 ultimately failed, but it did garner over 50 House co-sponsors and was defeated, in part, because COVID became such a political football. Our support on the Hill has clearly grown substantially.
Big Donors – One thing we don’t seem to have are big donors. We could use some really big donors. Linda Tannenbaum of the Open Medicine Foundation told me the problem used to be getting researchers interested in ME/CFS, but that’s really not a problem anymore – many researchers are interested in ME/CFS now – they just need the funding.
ME/CFS’s Great Win – the Long COVID Funding Bill – ME/CFS’s great win was to play a “critical role” in educating Congress about long COVID and ME/CFS. That directly translated into $100 million in funding for long-COVID diagnostics, and helped bring in over a billon dollars in funding for long-COVID research at the NIH.
Two Diseases – Two Parallel Paths (and Futures?)
With their attempts to pass Congressional bills, produce strategic reports, utilize Working Groups, and use line-items to increase CDC funding, Lyme disease and ME/CFS have been treading down similar paths. With nearly $100 million in federal funding, Lyme funding is looking really strong right now. With extraordinary funding for long COVID coming due shortly, both post-infectious diseases (as well as fibromyalgia) should dramatically benefit.
Even absent the long-COVID funding, the Solve ME/CFS Initiative’s work in the federal legislative arena appears to be putting this disease on a similar path as Lyme Disease.
That future is brighter now than ever before, but it didn’t just land on us. Remember 2016 – the year we didn’t get embedded in the 21st Century Cures Act like Lyme Disease did. If we had, we might have had a Congressionally Mandated Working Group, a Strategic Plan, and a big uptick in funding by now.
We tried to get into the Act, but we didn’t make it; we weren’t there yet. Four years of consistent work – building political support, finding allies, and developing coalitions – has left us in a different place now. We have a seat at more tables now. That’s why hundreds of ME/CFS advocates were able to pave the way during Lobby Day, and in the battle for H.R. 7057, for the humongous long-COVID funding bill.
The question is, what’s next?
The next step on road is clear – the Solve ME/CFS Initiative’s Lobby Day will help further our progress. With two new disease organizations (the Long COVID Alliance and the EveryLife Foundation for Rare Diseases) joining the effort, the opportunity is there to take Lobby Day to an entirely new level.
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