Opportunity and Danger
It’s getting to crunch time. This is a time of both opportunity and a time of danger. The coronavirus situation – as tragic as it is – is nevertheless providing a unique opportunity for the chronic fatigue syndrome (ME/CFS) field. It presents the possibility of ME/CFS being aligned with the health issue of our times. A window of opportunity has opened and our ability to step through it and garner as many resources as possible could very well be a defining moment (or not) for this illness.
With the enormous debt the U.S. is piling on and the severe economic downturn, though, the federal budget is also going to be squeezed like it rarely has been before.
Some good studies are underway, but right now the feds are focused on getting through the immediate crisis. There’s no indication yet that the NIH is interested in the part of the crisis that pertains to ME/CFS – the “long haulers” who’ve been able to fight off the virus, yet have been unable to recover fully.
The NIH does not appear interested in producing a major grant opportunity (RFA) to study those people. While some grant applications to do so are making their way through the system, the NIH is currently more focused on the understanding of the effects of hospitalization and lung damage: once again, it seems quite possible that ME/CFS could get lost in the mix.
Despite the fact that Anthony Fauci could use the long hauler situation to get younger people to be more careful, it took a direct question from ME Action’s Terri Wilder to Anthony Fauci to get him, for the first time, to publicly address the fact that many people who have fought off the virus remain ill.
The fact that the NIH is being the NIH should come as no surprise. Our voice carries little weight there. We’re still an afterthought.
The possibility that something big, bad and scary would come along that would knock ME/CFS funding out has worried Emily Taylor, the Solve ME/CFS Initiative’s (SMCI) full-time advocate, since she first stepped in the doors of the SMCI offices four years ago.
Our NIH funding, she explained, is currently discretionary. Meaning, those dollars are spent entirely based on NIH leadership decisions and are not guaranteed by law. Yes, we need to expand funding – but we also need to find a way to protect our funding.
Protecting and expanding funding are two reasons why getting Congressionally mandated funding at the National Institutes of Health (NIH) has been Taylor’s big goal since the beginning.
The Ultimate Decider: Congress
Congress, it turns out, does a lot more than allocate funding to the NIH. It actually plays a quite creative role. Emily stunned me when she said that most of the major NIH initiatives – from the Brain Initiative to the Heal Initiative to the All of US project, and even the Shark Tank COVID-19 testing initiative – were created with funding specifically allocated by the Congress or the President to the NIH.
The NIH, then, doesn’t really “invest” in diseases – unless it does so by congressional mandate. It doesn’t really care if the money goes to one disease or another, and it’s certainly not interested in addressing funding inequities. It’s not a particularly creative or fast-moving institution.
Even when decades of ME/CFS research potentially holds the clue to understanding what may be happening to hundreds of thousands of formerly healthy and productive post-COVID patients, the NIH is still not interested in ME/CFS. Emily Taylor hit it on the head when she spoke about how improved funding for ME/CFS could help ME/CFS patients and COVID-19 survivors.
“By rapidly mobilizing this research at the NIH, we hope to find answers that will help millions of COVID-19 survivors, including those who are already showing post-viral fatiguing and neuroimmune symptoms. Hopefully, this research will also identify viable treatments for the estimated 2.5 million Americans already suffering with ME/CFS.”
The COVID-19 crisis, it should be noted, has stopped work on the strategic plan for ME/CFS.
A Line-Item for ME/CFS
The situation is different at the Centers for Disease Control (CDC). CDC funding for ME/CFS is a federally mandated line-item in the federal budget. The CDC has to spend that money on ME/CFS. (Years ago they decided not to – and got into big trouble.)
That line-item provision is priceless because it provides us the opportunity to enroll Congress into forcing the NIH to spend more money on ME/CFS. That line item also makes the program vulnerable to yearly political uncertainty. We were on the path to increase funding for the program last year until political crosswinds blew us off course.
With its ability to insert a line-item into the federal budget, Congress is the key player for us, but we need both Republican and Democrat support for this to work out. Unfortunately, the Republican Party has traditionally been hands off with telling the NIH to spend more money on a disease. They prefer the NIH to make those decisions.
Last fall, though, four years of effort in educating and enrolling House and Senate members was paying off. Emily Taylor has been fully embedded in the political process on the Hill. She has her contacts, she knows the players, plus the Solve ME/CFS Initiative had hired a DC lobbying firm to provide their expertise and support. More legislators than ever before knew about and supported ME/CFS.
She was getting ready to roll. Emily had been passing around potential legislation to organizations for other poorly funded allied diseases (fibromyalgia, POTS, endometriosis). If we could sign them on, not only would our chances of legislation increase, but insights into one disease might spur insights into others. She expected that piece of legislation would be ready by December or early next year.
Then, came the coronavirus – and a new opportunity. Now was the time to strike.
Emily ripped up the old plan and created a new plan focusing on the potential link between COVID-19 and post-viral ME. This new strategy became the basis for Solve M.E.’s 2020 advocacy day campaign – and on advocacy day, the community came through. More advocates participated in more congressional meetings (251) with more representatives during Solve M.E.’s advocacy day than had ever done so before.
- Four years ago the Solve ME/CFS Initiative (SMCI) hired Emily Taylor, first full-time advocate for ME/CFS
- Taylor presented the SMCI Board with a five year plan to gain support in Congress – and then go for the big ask – the first ever bill to force the NIH to increase its funding for ME/CFS.
- Boosted by dozens of media stories on post COVID-19 recovery problems, as well as a strong turnout during the SMCI’s 2020 Lobby Day, the SMCI has begun a push to pass a bill to double funding for ME/CFS at the NIH.
- With coronavirus issues swamping Congressional offices past leaders were unavailable. Into the breach stepped Representative Jamie Raskin of Maryland who agreed to take leadership of the bill in the house.
- The bill would double NIH funding for ME/CFS for four, require the establishment of more ME/CFS research centers, require the NIH (finally) to support a funded grant opportunity for ME/CFS, require it come up with a strategic plan to combat ME/CFS, and others.
- Senator Markey’s effort to attach the bill to a COVID-19 spending bill in the Senate failed when the Democrats in the House presented the Senate with a $3 trillion bill which had no chance of passing.
- Now the goal is to get House legislators to support the Raskin Bill – and attach it to another COVID-19 spending bill in the Senate.
- The current SMCI effort is focused on getting House legislators to sign onto the bill
- Another effort to increase CDC funding for ME/CFS is getting the thumbs up from staffers.
- Plus the SMCI effort to include ME/CFS in the $350 million Congressionally Directed Medical Research Program (CDMRP) has paid off in spades with dozens of ME/CFS research grants – mostly from researchers associated with the Open Medicine Foundation’s ME/CFS research centers – submitted.
- This is the most progress on the advocacy front I’ve ever seen.
“We’ve Got You Now”
It was a timely effort, indeed. With media stories blasting out warnings that many people were having trouble recovering from the virus, Congress was more than ever in the mood to listen.
Emily said the COVID-19 crisis has produced a complete transition in how we are being treated on the Hill. The same staff which had been giving us lip service are saying “we got you now”.
The coronavirus proved to be double-edged sword, however. Just as it was opening up opportunities, it was snatching them away. Congress was being swamped by COVID-19 issues. Constituent requests to congressional offices soared and brought legislative work to a near standstill. For instance, Senator Feinstein’s office received 210,000 requests and calls in just one week in April, compared to 35,000 during the same week the previous year.
It was all COVID-19, all the time, on the Hill. With several of our leaders too overwhelmed to assist, ME/CFS was in danger of being left behind, again. We needed someone to step forward – and someone did.
Raskin Steps Forward and a Historic Attempt at Legislation Emerges
Into the breach stepped Rep. Jamie Raskin, who just happens to represent the Maryland district the NIH is found in.
A longtime supporter, Raskin’s helped us in every one of our appropriations actions, in the fight to retain the Chronic Fatigue Syndrome Advisory Committee (CFSAC), in the multi-year work to get ME/CFS back into the Congressionally Directed Medical Research Programs (CDMRP), etc. but this is the first time he’s taken the lead – and he’s done it in a big way.
Rep. Raskin met the moment and took the lead in the House on the first ever congressional legislation to attempt to specifically increase funding for ME/CFS at the NIH.
Emily and Solve M.E.’s DC lobbying firm modeled the potentially historic legislation on a similar piece of legislation created for Tourette’s Syndrome.
H.R. 7057 – The Understanding COVID–19 Subsets and ME/CFS Act provides $15 million annually / $60 million / 4 years in Congressionally mandated funding for ME/CFS research at the NIH. The bill again and again emphasizes the potential link between post COVID-19 recovery problems and ME/CFS.
The bill uses the COVID-19 crisis to remind legislators of how important it is to understand ME/CFS – a disease that for many people starts with a pathogen. It states that many people with COVID-19 may never recover, that ME/CFS often starts with a similar viral infection, and that a significant increase of ME/CFS cases as a result of the COVID-19 epidemic is expected.
The bill does not, so far as a I can tell, fund COVID-19 research. Instead it asks the NIH to double down on funding for ME/CFS research with the idea that understanding ME/CFS will help us understand what’s happening people who fail to recover from COVID-19 – and with the understanding that many more people are likely to meet the criteria for ME/CFS very soon.
- New ME/CFS funding announcements
- Establishing new research centers and expanding the existing research centers
- Mandates that the NIH develop a research agenda (aka strategy) in collaboration with interagency partners, stakeholders and disease experts
- Ways to get new and early career researchers to enter the field
- Supports for improved data collection including epidemiological information, natural history, risk factors, comorbid conditions, and the availability of medical services for individuals with ME/CFS and their families
- An initiative to reach consensus on the ME/CFS case definition
- Expanding initiatives focusing on early diagnosis and appropriate treatment recommendations
- Enabling the US Department of Health & Human Services (HHS) to add ME/CFS to existing public awareness and medical education programs.
The bill was designed to shore up existing funding and add a new wing to it. Plus, it was written to ensure that the NIH won’t use it as an excuse to dump the present funding for ME/CFS.
On the Senate side, Senator Markey sent a letter signed by 13 Democrats and Republicans to Chuck Schumer and Mitch McConnell, asking that the ME/CFS legislation be included in the next COVID-19 2.0 CARES package.
Everything seemed set – we appeared to have the support we needed – and then got blown off course again.
Political Crosswinds Temporarily Knock ME/CFS Funding Effort Off Course Again
As that was happening, over at the House, Nancy Pelosi passed the huge $3 trillion CARES 2.0 legislation in the House – and with that – our bill was dead. As the responses of President Trump (“DOA”) and Mitch McConnell (“Bill – what bill?”) indicated, the Bill didn’t have a chance to pass the Senate.
Instead of an attempt at legislation, the bill was a political statement which enraged the Republicans, and, after stating they would have supported our efforts, caused them to back off.
This is second time we’ve been on the precipice of increasing funding only to have political sidewinds derail us. Last year, Trump’s funding raid to pay for his Wall stopped what appeared to be a sure thing – an increase in ME/CFS funding at the CDC. Emily has warned unexpected things like this can and do happen with some regularity in D.C.
As COVID-19 case numbers rise again, though, Republicans are being forced back to the table to negotiate a new relief package.
The big CARES 2.0 package has been broken into a number of smaller bills. Our great hope is that Senator Markey will be able to persuade Senate leadership to include the increase in ME/CFS research funding the Raskin bill calls for in one of those bills.
The Time is Now
Yesterday the SMCI launched its effort to get House legislators to support HR-7057 – the first legislation ever to force the NIH to double their funding for ME/CFS.
“While we are facing a monumentally dangerous public health crisis, we must take all necessary steps not only to stem the spread of COVID-19, but also to prevent and control its lasting repercussions. We cannot let the number of ME/CFS cases rise due to a lack of research and understanding. As we battle the coronavirus, this critical legislation will help us respond to this ME/CFS hidden health crisis. “Rep. Raskin.“
Use this link to ask your representative to tell the NIH to double its funding for ME/CFS.
(Note – you must add a prefix (Mr./Mrs., etc.) for the form to work)
Request for Increased CDC Funding Gets Thumbs Up
Back at the regular federal budget, Emily has reintroduced the request for increased funding at the CDC. She introduced the same request as last year – with an update regarding the need to follow people with long-term effects from COVID-19. A significant budget increase for the CDC program is getting the same “thumbs up” that it did last year.
If it goes through, next year’s budget for ME/CFS at the CDC will be $3 million larger – or somewhere around 60% larger.
Who Knew? ME/CFS Researchers Saturate the Congressionally Directed Medical Research Program with Applications
The CDMRP program was created in 1992 to fund novel approaches to “biomedical research in response to the needs … of the American public, the military, and Congress”. If the CDMRP actually follows its mandate – that it’s responsive to the needs of the American public – it might just be our ticket.
The U.S.’s main research funder, the NIH, after all, is mostly responsive to the needs of its researchers. The CDMRP might be a different story.
Emily Taylor and Solve M.E. have made getting back into the $350 million CDMRP a priority. The CFIDS Association of America got ME/CFS eligible for CDMRP funding in 2010/11, but it seemed to make little difference.
Taylor and Solve M.E. pushed for inclusion in the program in 2017. Then, Solve M.E. and ME Action pushed again for inclusion in 2018. Then, in December 2019, Solve M.E. brought it across the finish line: we now have a new $350 million dollar funding stream to aim our grant applications at.
With ME/CFS grant applications to the NIH at historic lows, how is a new funding stream going to make any difference? If we couldn’t get researchers (other than Ron Davis and company) to submit grants to the NIH, how were we doing to get them to embrace a different pot of money – one that had its own unique rules.
Emily concluded the first attempt at CDMRP missed a critical element – follow-up. Getting ME/CFS researchers into the CDMRP program didn’t mean they were actually going to utilize it. They needed support with a new and different program. This time they got it in spades – and this time they responded.
Emily and Allison Ramiller at Solve M.E. raised awareness and provided informational seminars and materials to help the research community apply for the grants. The COVID-19 / ME/CFS connection was consistently highlighted throughout the applications.
ME/CFS grant applications for the CDMRP program exploded in a way we’ve never seen before.
Crucially, this time we had group of researchers associated with the Open Medicine Foundation funded ME/CFS research centers who proved eager – very eager – to swamp the CDMRP with grant applications. Somehow, researchers associated with the OMF put in no less than 21 grant applications. All told, Emily said she knew of 25 ME/CFS grant applications for CDMRP funding. That is clearly a record for this field.
With three potential breakthroughs on the cusp, ME/CFS advocacy is humming like it’s never hummed before.
On the Hill, the ground has been prepared for this legislative effort for four years. The seeds were planted, the seedlings have been nurtured, and now hopefully – not in a year or two years from now, but in this legislative session – that work will go to flower – and NIH funding for ME/CFS will double.
At the same time, it’s possible that the CDC’s budget for ME/CFS will dramatically increase for the first time in decades as well. Plus, driven by Solve M.E.’s outreach program and an astounding effort from researchers associated with the Open Medicine Foundation’s ME/CFS research centers, the two dozen-plus ME/CFS CDMRP grant applications have the potential to provide a heady spike in funding as well.
(Note – you must add a prefix (Mr./Mrs,, etc.) for the form to work)