When I first developed myalgic encephalomyelitis in 1994, I had no idea that I would be just as sick 25 years later, or that there would still be limited scientific understanding of the disease and no effective treatments. Nor did I imagine that my career as a lawyer was over, and that I would instead become an advocate for myself and others with ME (sometimes misleadingly called chronic fatigue syndrome, and referred to as ME/CFS by U.S. federal agencies).

An estimated 1 million Americans with this condition have been living for decades in the crisis mode of disability and lack of treatment. We have repeatedly pressed the National Institutes of Health to address the problem by increasing research funding; one ME/CFS organization even met with NIH Director Francis Collins in December 2018 to make that point. The response from the NIH is always the same: Researchers should submit more high-quality grant applications.

On the surface, this sounds reasonable. From documents a colleague and I obtained through a Freedom of Information Act request, I calculated that between 2011 and 2016 the NIH funded 25 percent of ME/CFS grant applications, a higher acceptance rate than the average for all grants. It seems obvious, then, that more applications would yield more funding.

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But it’s not that simple: Despite growing interest in ME/CFS, NIH grant applications to study the disease have dwindled since 2015.

Why? The NIH has erected an obstacle course for those wanting to do research on this disease. I see at least five obstacles that scientists must navigate on the path to funding.

Obstacle 1. In order to have a grant even considered for funding, a researcher must demonstrate that the proposed research is significant, that she has the capability to carry it out, and that it is based on solid science. Good ideas and “what if” proposals are not enough, and the NIH generally doesn’t fund proposals that don’t include preliminary data, such as blood test or brain imaging results from pilot studies. Yet even well-established ME/CFS researchers have difficulty providing preliminary data because the field has been stunted for decades by stigma and the false narrative that the disease is caused by deconditioning and depression. ME/CFS researchers need funding to conduct exploratory studies and generate hypotheses for further research, but NIH won’t fund those kinds of projects.

Obstacle 2. NIH funding for ME/CFS research has traditionally been low. Between 2008 and 2016, its total investment in this area averaged $5.1 million per year. 2017 represented the high-water mark — in that year the NIH issued two Requests for Applications for three collaborative research centers and a data management center, in addition to regular grant funding. Unlike regular grant applications, Requests for Applications come with funding already set aside. Researchers responded eagerly: At least 10 groups submitted applications and the NIH distributed almost $14 million for ME/CFS research.

Funding in 2018, however, dropped 17 percent from the 2017 high, and the NIH has clearly indicated that it has no intention of issuing another Request for Applications for ME/CFS research any time soon.

The situation is made worse because the NIH has no current general invitation for ME/CFS research proposals, called Program Announcements, as it does for diseases like hepatitis B or Alzheimer’s disease. These invitations are important because they communicate to the scientific community that there is interest in these proposals, and therefore potential for funding, even though none is set aside. The NIH’s last Program Announcement for ME/CFS research was issued in 2012 and it expired in 2015.

Obstacle 3. The NIH is made up of 27 institutes that tend to take responsibility for specific diseases: heart disease and stroke by the National Heart, Lung and Blood Institute; Alzheimer’s disease by the National Institute on Aging; and the like. No single institute within the NIH is responsible for ME/CFS research. That opens very wide cracks for applications to fall through. None of the institutes include ME/CFS in their own strategic plans or make it a priority for funding. Researchers are left on their own to find NIH program officers among the different institutes with an interest in the disease.

Obstacle 4. The peer-review process presents unique hurdles for ME/CFS applications. The NIH convenes a new ME/CFS Special Emphasis Panel three times a year for which it must recruit reviewers based on the expertise needed for each meeting, determined by the topics of the applications. ME/CFS applications can encompass immunology, neurology, imaging, bioinformatics, epidemiology, and many other fields. The downside is that only some of the reviewers have expertise in ME/CFS. With data obtained through the Freedom of Information Act request, I examined the makeup of these panels since 2000. Between 2000 and 2010, only 15 percent of the panelists were ME/CFS experts. Although the situation improved between 2011 and 2017, with panels including an average of 63 percent ME/CFS experts, it dropped back to 37 percent in 2018.

Scientists from related fields can certainly apply their own areas of expertise to ME/CFS. Yet they lack knowledge that is essential for evaluating these grant applications. They’re unlikely to understand, for example, that multiple case definitions, involving different symptoms, have been used over the years. An independent panel even urged the NIH to abandon one of those case definitions, but that information has not circulated widely.

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The expectations of non-ME/CFS experts regarding study design and data quality may be inappropriate given the state of the field. A cancer or heart disease researcher, for example, may be used to seeing grant applications with data from large multicenter studies, but those kinds of studies have not been possible in ME/CFS.

Even worse, some non-ME/CFS expert reviewers have demonstrated outright bias against the disease. ME/CFS researcher Ian Lipkin said that happened with one of his grant applications in 2014: “[O]ne of the people who critiqued my work said, in fact, that this is a psychosomatic illness.” Lipkin, who directs the Center for Infection and Immunity at the Columbia University Mailman School of Public Health, receives millions of dollars from the NIH for his non-ME/CFS research. If a prejudicial reviewer can tank one of his applications, what hope do other researchers have of fair reviews?

Obstacle 5. If an ME/CFS grant application manages to survive peer review, it must then compete against all the other applications submitted to the particular institute’s council for decision. These councils do not have ME/CFS experts on them, and ME/CFS is not a named priority for any institute. That means an infection-related ME/CFS study submitted to the National Institute of Allergy and Infectious Diseases might be fabulous compared to other ME/CFS applications scored by the Special Emphasis Panel, but it might come up short when compared to hepatitis or influenza proposals that have larger sample sizes or more preliminary data.

Given these hurdles, it’s hardly surprising that researchers hesitate to submit ME/CFS grant applications to the NIH, or perhaps even choose to move to entirely different fields. Those who do apply must navigate this unique set of hurdles, created in part by NIH’s past actions. Its pronouncements that the only solution is more grant applications is unrealistic and, given the immense suffering of patients over decades of their lives, cruel.

The NIH needs to clear these obstacles. While there is no single solution for its broken response to ME, there are many actions it can take that would lower these barriers and encourage more applications for funding ME/CFS research. Difficult problems require complicated solutions, not unrealistic pronouncements.

Jennifer Spotila is an independent advocate for ME/CFS. She writes about the disease at Occupy M.E., where a longer version of this article appeared. She once collaborated on a grant submitted to the NIH in response to one of the Requests for Applications mentioned in the article; the grant was not funded.

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  • I have had this for 60 years that I can remember. My sister died from heart stoppage at 58 and my other sister and Mother suffered from this. I was a world champion athlete for 4 decades and sick with this the whole time. I am now bedridden and fighting to be up to bathe and do laundry and cook meals daily. I thank God that my now husband knew me when I was a teen and sick and loves me through the denigration of what is left of my health. I am getting to the point where I cannot eat anymore and am going to Stanford this summer. I pray for my fellow suffers and hope they can help us in the long run. Every infection, every virus, has taken what I could do and narrowed it down to what I can’t do. My condition is advancing as is my age and I will fight to the end.

  • Thank you, Jennie and STAT, for this important article. I’m a former public interest lawyer, forced into endless hibernation by this complex and debilitating disease. Skills I have successfully brought to other “lost causes” would be spot-on for dealing with the medical and bureaucratic bias that is leaving us for dead. But I am isolated and struggling. If I can get just a little ahead of this daily battle for survival, I’d love to brainstorm advocacy, service delivery systems, and more. Decades of my life lost…..

    • Kathleen, I really identify with your comment. My own legal experience has been very helpful in my advocacy efforts. If and when you have the capacity/readiness to join us in advocacy, I suggest MEAction.org as a good place to start. And you can always reach me through my blog occupyme.net. Best wishes for your health!

  • My daughter suffers with ME, and as a mother I have to sit by and watch her struggle with this illness. I think it is bad that not a lot as been done for everyone who suffers at the hands of this complex condition.

  • Very well articulated, Jennie. Thanks for this clear and actionable article.
    I hope NIH is ready to help now.

    “Let’s not be sorry after the fact
    and let the past become our fate;
    There is no time…
    This is the time
    Because there is no time”
    Lou Reed

  • The NIH process is no longer scientific. They want fast, sexy research that can pay off in corporate profits. The NIH really went downhill, when they allowed Biased unsceintific Accupuncture “Studies” to be posted on their research site. Americans need to face facts, the NIH and other agencies we once trusted are now run by corporate industry insiders. No one noticed that the death rate in America is rising, due to the refusal of the NIH to apply scince, rather than profit, and ideology. One basic metric they could have used was the maximum benefit of the research. They could have looked at the research that would benefit more Americans, but now with only metric is attention getting, and profitablity. It is no wonder a lot of Americans will die from preventable diseases this year, due to the lack of research in those areas. Just think, they could have prevented flu deaths, by objectively researching why people refuse to innoculated. That kind of research would save lives, but would expose corporate profiteering, the impact of Marketing, and the failures of our system.

  • Thank you, Jennie Spotila & STAT for publishing this very powerful article detailing the obstacles ME research must go through.
    I’ve been ill for over 20 years. Due to lack of research, progress in the field practically stood still until the past few years when research mostly funded privately has begun to move knowledge about this disease forward with small studies. NIH needs to step up its funding to replicate promising findings in larger studies and find more investigative research.

  • Much appreciated Jennie and Julie for all the work you do for the Myalgic Encephalomyelitis community. Keep those words coming. They may some day be our salvation. I do not believe we will get help from the government after their trying to discredit Myalgic Encephalomyelitis for decades. They won’t fund for research, education, trials or treatments. I see this as a Medical Civil Rights issue. We should sue the pants off them for lack of medical care. When the patients have to educate and convince their doctors about ME, something is very wrong! And we all know how much doctors love being told what plan of action to try. Then try another plan after the first one doesn’t work. So on and so on!
    Onward and hope for healing, Kathryn

    • I agree. We need a large class action lawsuits. Hopefully we can find a good law firm to take this on.

  • Ms. Spotila and STAT editors: Thank you for publishing this important piece. NIH leadership should read it. They can change this situation, if they want.

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