Fibromyalgia gets about double the funding of chronic fatigue syndrome, but of all the female-dominated chronic illnesses found in the NIH’s bottom forty in funding, only endometriosis gets lower funding per person (about $1/year). In fact, per person affected ME/CFS receives five times the funding as FM does. Relative to the economic losses and sheer amount of suffering caused by these diseases fibromyalgia may be the worst-funded disease at the NIH.
That’s puzzling. FM appears to have a lot going for it. It’s got three FDA-approved drugs, it’s “supported” by an Institute, it’s got a good name and, thanks to all the drug commercials, it’s got great name recognition. (The CDC has found that few people know about chronic fatigue syndrome.) Plus FM researchers have a central locus – the brain, FM is far more common than ME/CFS, and it tends to be less disabling.
So why with all these pluses is FM underperforming so badly at the NIH? That’s the question of this blog. An overview of fibromyalgias history at the NIH may provide some clues.
Fibromyalgia has a much longer history than ME/CFS in medicine, but it actually started behind at the NIH. According to Wikipedia, the first fibromyalgia study was published in 1981 and the first treatment trial occurred in 1986. In 1990 the American College of Rheumatology wrote the first diagnostic guidelines for the disorder. By 1993, however, the NIH was funding only four FM studies – compared to 19 for ME/CFS. (That’s actually considerably more than the NIH is funding today!)
According to the Fibromyalgia Network FM advocates got to work. The Network sponsored a scientist to submit testimony to the House and Senate regarding the urgent need for more funding. Over the next four years, representatives of the Network made numerous trips to lobby congressional members. Each year language was passed to urge the NIH to spend more money. In 1997 the Network began to directly target NIH officials in its lobbying efforts.
By the end of the 1990s chronic fatigue syndrome had become the beneficiary of its own lobbying efforts and was in some ways appeared to be doing fairly well. It had its own special emphasis panel, a federal advisory committee, two federally funded research programs at the NIH and CDC, and three federally funded research centers.
The NIH appears to have responded to Fibromyalgia Network’s advocacy efforts. In 1996 it produced a Workshop on fibromyalgia. By 1998 NIAMS was funding eight FM studies; five on pathophysiology and three on behavioral aspects.
- INHIBITED FUNCTIONAL BRAIN ACTIVITY IN FIBROMYLAGIA
- FIBROMYALGIA–CENTRAL FACTORS IN ITS ETIOPATHOGENESIS
- REGULATION OF ADRENAL FUNCTION IN FIBROMYALGIA
- COGNITIVE AND NEUROCHEMICAL FUNCTION IN FIBROMYALGIA
- HPA AXIS DYSREGULATION IN FIBROMYALGIA
- SUBGROUPS OF FMS–SYMPTOMS, BELIEFS & TAILORED TREATMENT
- BEHAVIORAL TREATMENT OF FIBROMYALGIA
- SOCIAL SUPPORT/HEALTH CARE USE IN FIBROMYALGIA
In 1999, following a response that the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Director Katz called “overwhelming,” the NIH produced a $2.6 million RFA funding over a dozen new studies. Katz stated, “These new grants should help us make significant inroads into a disease that causes so much pain, suffering, and lost productivity in so many people.”
NIAMS lead the way. By 2000 the NIH was spending about $10 million on 36 FM studies and NIAMS was responsible for 20 of them. Fibromyalgia was being examined on a wide variety of topics most of which concerned pathophysiology.
The 2000 Katz Interview
By 2000 the FM was believed to affect 3.7 million Americans and was believed caused by central nervous system issues, musculoskeletal problems and/or an infection. In that year NIAMS director, Dr. Stephen Katz did an interview with a fibromyalgia group.
The interviewer noted – correctly – that the “The lion’s share of the fibromyalgia (FM) research supported by the federal government is funded by…. the NIH National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)”
The interviewer asked why we know so little about prevalence – why there are no FDA-approved drugs, and what can NIAMS do about that?
Katz simply cited a finding from a 1998 report and urged more “basic research” – a phrase that should strike fear into the hearts of any advocate. (When Institutes aren’t willing to fund your disease they’ll tell you all about the basic research they’re doing that will someday illuminate it.)
“We must continue to support basic research to uncover the fundamental mechanisms of disease as well as develop good animal models of disease”.
Katz then allied himself with FM patients and advocates by declaring he fully agrees with them on their needs. FM is a serious disorder, he acknowledged and we must do more. There is so much “we”, all of us, must do, he says.
“We must have clinical studies to improve our diagnostic and therapeutic approaches; we must support clinical trials to determine therapeutic efficacy; we must have epidemiologic studies to understand the way a disease affects the entire population; and ultimately, we must devise preventive strategies whenever possible.”
Note, however, that Katz never makes promises and never talks dollars and cents. If there’s a plan to move FM forward he doesn’t mention it – he simply asserts his commitment to helping out. .
The interviewer asks Katz what NIAMS can do to educate providers and others about the disease.
In a long answer, Katz cites a number of small programs (brochures, website) but is unable to say anything meaningful NIAMS will do to address the problem. A similar answer is given to a question about the need for more researchers and treatments. By then, Katz’s long boilerplate answers suggest that he was employing a bureaucratic technique of exhaustion by overwhelm. The interviewer, apparently glad to have any contact at all with the head of NIAMS, simply let it go by.
That was unfortunate. Little did the FM community know it had just hit its high point at the NIH. Everything was downhill from there.
By 2005 NIAMS ‘commitment to FM has been cut in half. Instead of 20 studies, it was funding ten: six on pathophysiology and four on behavioral aspects. One interesting fact, though, for people with chronic fatigue syndrome (ME/CFS) who can’t get the NIH to fund any clinical trials. In the past fifteen years, NIAMS has funded at least three FM drug trials.
Ten Years Later
By 2014 NIAMS had cut its FM funding in half again. Now just $4 1/2 million is going to FM-specific projects. Plus the commitment to understanding FM has declined. Now it’s funding just five studies on FM, three on behavioral aspects, and another that involves cognition. The two biggest studies in 2014 are for a $683,000 Tai Chi study and a $612,000 placebo effect study. Note that none attempt to get at the biological roots of the disorder.
By 2015 NIAM’s FM portfolio is entirely behavioral. Even as more and more studies show central nervous system problems in FM, attempts to understand the pathophysiology of the disease at NIAMS have completely ceased.
Despite studies that have more than doubled FM’s prevalence (@$10 million) and show the disorder causes high economic losses (@20 billion dollars/year), NIAM’s commitment to FM has clearly declined considerably. It also appears to have decided that FM is either a behavioral disorder or is a disorder that can be treated sufficiently with behavioral techniques.
And Katz? Fifteen years later Katz is still there. He’s been director of NIAMS for 20 years. Fauci, the man who kicked ME/CFS out of NAIDS over fifteen years ago, is still there after 29 years.
Among NIH Institute Directors, Walter J. Koroshetz, M.D., the director of NINDS, is the odd man out. An public supporter of chronic fatigue syndrome, Koroshetz has kept the research going but has failed to provide the funds appropriate for the disease’s scope and prevalence.
Katz on Fibromyalgia Again
Fifteen years after NIAMS Director Katz did his 2000 interview with the FM group, he, the Deputy Director, and four other NIAM officials met with NFCPA officials to discuss what NIAMS was doing about FM. (Having a group like the NFCPA means you can at leat get your foot in the door from time to time.).
Fifteen years later we know that FM is almost three times as prevalent as was believed in 2000 and accounts for much high economic losses than suspected. What did Katz have to say about NIAMS and its dwindling FM research effort? The NFCPA reps reported that “Dr. Katz assured Jan and Rae that the NIH is funding fibromyalgia-specific scientific studies including one on cognitive behavior therapy and another on TENS therapy”.
How they were reassured by that is beyond me.
Why has NIAMS been allowed to do this? Why has there been no federal funding opportunity for FM in the last 15 years? Why has funding declined and why has the focus shifted so significantly to behavioral studies? Is anybody holding the NIAM’s feet to the fire?
I’m not up on FM advocacy, and I apologize if I’m missing something. In some important ways, FM advocacy in the United States is far ahead of ME/CFS advocacy. The National Fibromyalgia & Chronic Pain Association (NFCPA) reports it’s trained 175 advocates in their 1-3 day Leaders Against Pain intensive training programs since 2005. Nothing like that exists in the ME/CFS community.
I had a hard time, though, finding evidence of action on the federal front, The ME/CFS community may not have a full-time advocacy group but it regularly engages in short-term advocacy actions and Jen Brea and Beth Mazur’s #MEAction advocacy portal for the community suggests a new seriousness may be present in the ME/CFS community.
Some diseases have professional advocacy groups and others don’t. Whether a disease has one or not appears to be partly due to chance and the commitment of usually small numbers of people.
Migraine, for all its decades-long work to legitimize itself, for instance, did not have an advocacy group in place until 2012. When pressed by patients why the NIH wasn’t doing more on migraine one NIH official, with some exasperation asked why don’t you do something about it? According to the “Not Tonight” book, the creation of an advocacy migraine organization was primarily due to the work of one powerful person in the community.
There are some bright spots. Pain research, for instance, prompted by a devastating 2011 IOM report on the gaps in pain research and management, has gotten a new emphasis at the NIH.
A Pain Consortium at the NIH was formed to support interagency pain research and the NIH began tracking pain research funding for the first time in 2011. In 2000 the NIH was reportedly spending about $75 million on pain research, this year they report they’re spending about $500 million dollars on it plus they’re spending about $400 million dollars on “chronic pain conditions”.
Eleven medical schools were designated Centers of Excellence in Pain Education (CoEPEs) in 2012. These schools are intended to act as “hubs for the development, evaluation, and distribution of pain management curriculum resources … to enhance and improve how health care professionals are taught about pain and its treatment.” Doctors associated with these Centers may be up on better ways to treat pain.
In 2015 the Interagency Research Pain Coordinating Committee produced a National Pain Strategy.
Effective Advocacy – The Missing Key?
As funding for pain research increased, funding for FM research, ironically, has declined. Advocacy appeared to pave the way for increased NIH activity in the late 1990s. The same was true earlier for ME/CFS.
The lesson may be that nothing can be taken for granted. The natural tendency may be funding for them to decline over time not increase. Both FM and ME/CFS have suffered significant declines in funding over time.
ME/CFS and FM advocates may need to hold the NIH’s feet to the fire in a way that hasn’t happened before. For ME/CFS a national group – committed entirely to advocacy – that follows trends closely, produces grades, and advocates relentless for this community is probably a necessity. The same is probably true for FM
The NIH has repeatedly shown that it’s a world apart. While overall funding for the NIH doubled, funding for ME/CFS declined precipitously. Disease prevalence, economic losses, and unmet needs apparently mean little or nothing to the NIH. Even positive research findings appear to have little effect when ME/CFS and FM are concerned.
History suggests that consistent pressure from advocates and patients is required.