Reprinted with the kind permission of Cort Johnson and Health Rising.
By Cort Johnson
The NIH should be releasing it’s increased funding for chronic fatigue syndrome (ME/CFS) soon. As we wait for that let’s take a look at several things that have happened in the last month and assess where we are, and what we have learned. The first thing is that advocacy does work.
Advocacy is Working
Millions Missing Protest Gets Noticed – MEAction’s first Millions Missing protest got advocates the attention of a high-level official: Dr. Karen DeSalvo, Assistant Secretary of Health at the Department of Health and Human Services. She met with ME/CFS advocates and promised to help move things forward.
Congressional Letter Gets the NIH’s Attention – Next, the ME/CFS advocates from the Bay Area (Shari Boxer Baker, Janet Dafoe, Gail Cooper, and Carol Broadbent) got two Congresswomen (Anna Eschoo and Zoe Lofgren) to sign a letter putting the NIH on notice that they were expecting it to keep its promise to increase funding. MEAction and The Solve ME/CFS Initiative SMCI) and many patients worked hard to get the letter signed by no less than 55 sponsors – by far the most ever achieved for ME/CFS.
Reports from advocates privy to what happened next indicate that the letter made a splash at the NIH and provided a boost to Vickie Whittemore’s efforts.
Response to the Letter – In an encouraging sign, the response from the NIH to the Congressional letter came back quickly. It indicated that substantial progress is being made and that significant problems remain.
NIH is Moving Forward (Slowly)
A couple of months ago the NIH added supplemental funding of about $100,000 each for chronic fatigue syndrome projects already underway. The good news is that major Institutes such as NINDS (nervous system) and NIAID (immune) supported it. The bad news is that major institutes such as NIAMS (rheumatology), NHLBI (heart/lung), NIDDK (diabetes) and others didn’t. Of the fifteen Institutes in the Working Group five participated.
The NIAMS drop out meant that money wasn’t available to add ME/CFS cohorts to some FM studies. If this small project was a litmus test for Institute support it didn’t go so well.
With seven studies receiving approximately an extra $100,000 in funds each, the supplemental funding program, however, appears to be something of a success. The funding will help:
Dr. Fletcher and Dr. Nathanson at NSU will determine if men with ME/CFS respond differently to exercise than women and will explore the interaction between genetics and exercise. (It appears that the extra money allowed Dr. Fletcher to add men to a formerly all female exercise study.)
Dr. Nacul in London will use the extra money to help him compare immune, viral and genetic markers over time in ME/CFS and MS.
Dr. Katz and Lenny Jason will try to determine why some college students with mononucleosis are prone to develop ME/CFS.
Drs. Campagne and Maureen Hanson of Cornell will look for changes in the gene expression of immune cells
Stanford’s big immune researchers, Dr. Mark Davis will use new technologies to take a closer look at T-cells than has ever been done before
Dr. Ian Lipkin of Columbia will determine what pathogens ME/CFS patients have been exposed to in the past
ME/CFS Research Centers Are on Tap
The letter stated that two RFA’s (funded grant applications) will to fund ME/CFS research centers and an independent data collection center will be produced. The funding levels and number of the centers are unknown.
The last and probably only RFA ever for ME/CFS was in 2006. The length of time that it’s taken to get the RFA’s approved has lead to speculation that Vicky Whittemore is encountering resistance. Whittemore recently said, though, that that’s not true, that the Institutes are largely on board: the delay is just the result of NIH’s famed bureaucracy in action.
The NIH Intramural Center is Getting Educated About ME/CFS
Dr. Nath appears to be going above and beyond his mandate. He has created the ME/CFS Special Interest Group to educate the NIH Intramural Center about ME/CFS. Past experience suggests that learning about ME/CFS tends to spark researchers interest. The group has begun a lecture series by ME/CFS experts. Four presentations have taken place so far. (I believe 12 are planned).
Getting Lenny Jason in there to speak about diagnostics early in the series was a great move. Ditto with getting Dr. Peterson to talk about his experiences over time, and having Staci Stevens and Mark Van Ness to talk about exercise testing. We have been wanting to get the exercise testing results in front of top exercise physiologists for years.
June 15th, 2016: Anthony Komaroff, M.D.: An Overview of Chronic Fatigue Syndrome (ME/CFS)
July 18th, 2016: Leonard Jason, Ph.D.: Diagnostic Challenges and Case Definitions for CFS and ME
August 24th, 2016: Daniel Peterson, M.D.: CFS/ME: Perspectives from a Local Epidemic 1984-2016
September 21st, 2016: Staci Stevens, M.A. and Mark Van Ness, Ph.D.:Cardiopulmonary Exercise Testing in ME/CFS
The Stevens/Van Ness presentation resulted in the Intramural group creating a focus group on post-exertional malaise. From Staci Steven’s email:
Dr. Mark Van Ness and I recently visited the National Institutes of Health (NIH) to present our findings on cardiopulmonary exercise testing (CPET) and the importance of the symptom of post-exertional malaise to the NIH ME/CFS Special Interest Group.
It was an encouraging trip that resulted in Dr. Brian Walitt, lead investigator of the ME/CFS Intramural Study, extending an invitation to Workwell Foundation to help recruit patients for a focus group on post-exertional malaise.
If you are a person diagnosed with ME/CFS and have post-exertional malaise, please consider enrolling in this study. Those of you who have undergone the 2 day CPET and have had an abnormal recovery response know how important it is to identify and characterize the symptom of post-exertional malaise.
If you are willing to share your experience with post-exertional malaise, please contact Ms. Barbara Stussman at:firstname.lastname@example.org call (301) 496-1788. More information is available in the Focus Group Recruitment letter. Together, let’s reach out to NIH and help them understand post-exertional malaise.
Major Needs Remain
It’s also become increasingly clear that we’re not going to get a good deal of what we hoped for. We haven’t heard anything about ways to bring new, young investigators into the field. Nothing has been said about clinical trials. (We are one successful clinical trial away from Ampligen being approved.) Research centers are great but most of the ME/CFS investigators will inevitably work outside those centers. Nothing that we know of is being done to support this critical work in ME/CFS.
So far as we know grant applications to the CFS Special Emphasis Panel – where these investigator’s grants will go – remain at the same very low levels that they’ve been at for decades. (Researchers take note: the CFS SEP is now composed almost completely of ME/CFS experts.)
It’s clearly a mixed bag but we should note that for once the bag is actually mixed. Except for one brief period, we went a good decade without virtually any good news from the NIH. Research funding steadily went down. RFA’s weren’t even in the discussion. We were advised not to mention Centers of Excellence. At one point our “Working Group” apparently didn’t even meet for over a year.
We’re not tearing up the NIH but we are making progress.
We’re not tearing up the NIH but we are finally getting RFA’s. We will have (hopefully) at least some well-funded research centers. A very large intramural study is (finally) about to start. The NIH is getting educated by ME/CFS experts.The supplemental funding program is small but it has apparently added about $700,000 in research funding. The Working Group is actually working again – it’s meeting monthly – and we have a strong advocate in Vicky Whittemore. We’re supplementing that activity with some excellent advocacy.
We are making inroads with Congress and in the NIH. We’re building a constituency on both the political and scientific levels.
Dr. Collins pledged to produce a long-term effort on ME/CFS. What we seeing is the beginnings, but only the beginnings, of one. Does the Working Group have a long-term plan that goes above and beyond the formation of research centers? Too much remains to be done without a long-term plan to address the many needs of this disease.
We’ll hear more from Vicky Whittemore at the IACFS/ME Conference this month. The Trans-NIH ME/CFS Working Group will also be giving its first briefing probably ever on Wednesday, November 2, 2016, from 3:00-4:00pm EDT. The community will be able to ask questions.
Getting More Money Out of the NIH
The NIH received about a $2 billion dollar increase in funding this last year. Looking at recent funding levels across the 200 plus diseases and conditions the NIH keeps track of, we can both see where the money has gone, and get an idea of what we are up against.
Most programs probably received small 3-10 percent increases. Autism’s $8 million dollar increase constituted a 4% bump. Ditto with similar figures with arthritis ($8 million increase/$221 million budget), asthma ($8 million increase/$289 million budget) and brain cancer ($12 million increase/$310 million budget). (Arthritis funding has actually dropped $35 million in the past five years.)
A significant number of diseases (liver disease, COPD, Crohn’s disease, emphysema, Cooley’s disease, fibromyalgia, influenza, lupus, depression, Lyme) got little or no increase in funding. Fibromyalgia is up from $8 to 9 million/year but is still down from $12 million five years ago. (ME/CFS is slated on this table to get no increase but that’s clearly wrong.)
I only found two diseases that got major increases in funding.
Alzheimer’s got a huge boost – a 65% increase in funding in one year (from $598 million to $910 million). That surely reflects two things. One, Alzheimer’s has a strong and effective advocacy movement that has been working for years to get to this moment. Two, it’s become clear that Alzheimer’s poses a major threat to our medical system as the population ages.
With antimicrobial resistance finally being recognized as a huge threat it wasn’t surprising to see it bumped up 30% to $413 million.
The pattern from this quickie survey, though, seems pretty clear. Most diseases and conditions appear to have gotten a 4-10% increase in funding. A large number have gotten less than that and a considerable received no funding increase at all.
It’s clear that the NIH prefers to increase funding incrementally except in cases where some sort of widely recognized, more or less urgent need pops up. Alzheimer’s and antimicrobial resistance have needed more funds for years but, for some reason, the NIH acted on them now. (It would be good to find out how that happened.) In any case, there was probably broad support for their funding increase: their time had come at the NIH.
ME/CFS’s time has come but it’s in a different category. We have some support but we don’t have the widespread support that diseases like Alzheimer’s do. I want our programs budget to at least get above $15 million/year. That, however, would require more than doubling the current budget – something that no disease came close to doing So far as I can tell, only two programs in the NIH’s list of 200 plus conditions received more than a 30% increase in funding.
Plus, poorly funded diseases appear to have gotten less of a lift from the increased NIH funding than better-funded diseases. Only about a third of the 26 (n=9) diseases and conditions receiving less than $10 million/year received an increase. The most any of these diseases received was an extra $1 million.
On the plus side, it would only take a small increase in NIH funding – $7 million – to double ME/CFS’s budget, and there is a recent precedent for something like that occurring. From 2014 to 2015, Valley Fever’s funding jumped 300%, from $3 to $11 million dollars. We’ll see what happens.
One other cautionary note. Ron Davis – who we all know has ample reason to want research to proceed as fast as possible – has said several times that he believes that throwing too much money at this disease at once would be a mistake. That could result in money being wasted and a possible backlash. We need enough money to build a strong core of good researchers and research, but not soo much money that it gets distributed to poorly conceived projects.
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About the Author: Cort Johnson has had ME/CFS for over 30 years. The founder of Phoenix Rising and Health Rising, Cort has contributed hundreds of blogs on myalgic encephalomyelitis, chronic fatigue syndrome, fibromyalgia and their allied disorders over the past 10 years. Find more of Cort's and other bloggers' work at Health Rising.