- The NIH’s Blindspot: The Real Reason ME/CFS and FM Funding Stinks – Conclusion
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 under performing so badly at the NIH? That’s the question of this blog. An overview of fibromyalgia’s 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 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 – to no less than 19 for ME/CFS. (That’s 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 1990’s chronic fatigue syndrome was the beneficiary of it’s 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 National Institute of Arthritis and Muscoskeletal 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
In 2000 the FM was believed to effect 3.7 million Americans and was believed caused by central nervous system issues, muscoskeletal problems and/or an infection. In that year NIAMS director, Dr. Stephen Katz did an interview with a fibromyalgia group.
The interviewer notes correctly that the “The lion’s share of the fibromyalgia (FM) research supported by the federal government is funded by the National Institutes of Health (NIH) — in particular, the NIH National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)”
The interviewer asks 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. Check your wallet when any NIH official starts talking about the importance of basic research.
“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 acknowledges 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.”
Katz appears to be on FM patients side. Note, however, that he never says what the NIH will do. He never makes a promise he might be accountable for. He 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. You’re left thinking that you have an ally but in reality your pocket of good feelings has simply been picked.
The interviewer asks Katz what NIAMS can do to educate providers and others about the disease.
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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. Katz is employing exhaustion by overwhelm and is providing almost all boilerplate. The interviewer, apparently glad to have 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 it’s highpoint at the NIH. Everything was downhill from there.
By 2005 NIAMS ‘commitment to FM has been cut in half. Instead of 20 studies it’s funding ten: six on pathophysiology and four on behavioral aspects. One interesting fact, though. In the past fifteen years NIAMS has funded at least three FM drug trials; one for gabapentin, one for amytriptyline and CBT, and one that escapes me at the moment.
- GABAPENTIN IN THE TREATMENT OF FIBROMYALGIA-264022264
- IMAGING THE COGNITIVE MODULATION OF PAIN IN FIBROMYALGIA
- ARE FIBROMYALGIA AND CHIARI I MALFORMATION RELATED?
- VAGUS NERVE STIMULATION IN FIBROMYALGIA
- ROLE OF SUBDIAPHRAGMATIC VAGUS IN FIBROMYALGIA SYNDROME
- CENTRAL CONTRIBUTIONS TO PATHOBIOLOGY OF FIBROMYALGIA
- BEHAVIORAL INSOMNIA THERAPY WITH FIBROMYALGIA
- RANDOMIZED CLINICAL TRIAL IN JUVENILE FIBROMYALGIA
- BEHAVIORAL PREPARATION FOR TREATING FIBROMYALGIA
- OPTIMIZING FIBROMYALGIA SELF-MANAGEMENT
Ten Years Later
By 2014 NIAMS has cut its FM funding in half again. Now it’s funding just five studies on FM, three of which have behavioral elements and another that involves cognition. 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 appear to have almost completely ceased.
- SUBGROUPS OF FMS–SYMPTOMS, BELIEFS & TAILORED TREATMENT
- FIBROMYALGIA INTEGRATIVE TRAINING PROGRAM FOR TEENS (FIT TEENS)
- RANDOMIZED CLINICAL TRIAL OF FIT TEENS FOR JUVENILE FIBROMYALGIA (JFM)
- BRAIN MECHANISMS UNDERLYING CBT-RELATED REDUCTIONS IN FIBROMYALGIA
Since the high of 2000 the NIH’s commitment to FM has dwindled considerably. The NIH was spending $10 million research in 2000. It says it’s spending 11 million today. That’s an actual decrease in funding given inflation and certainly doesn’t track with the research successes of the past fifteen years. Funding should be going up every year in FM – not down.
A review of the 2014 spending suggests it’s actually worse that. The NIH spent $10 million in 2000 on FM specific projects but in 2014 only about $4 1/2 million is going for FM specific projects. Plus the commitment to understanding FM has declined. The two biggest studies in 2014 are for a $683,000 Tai Chi study and a $612,000 placebo effect study.
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 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. Walter J. Koroshetz, M.D., the director of NINDS, is the odd man out. He became director in 2015. (One of his studies, encouragingly, focused on brain lactate in Huntington’s Disease patients. NINDS, however, just rejected Ron Davis’s two ME/CFS grants without seeming to give them serious consideration.) Notice that these are all men.
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’s officials met with NFCPA officials to discuss what NIAMS was doing about FM. (The power of having a group like the NFCPA means you get your foot in the door – a fact that should not be lost on the ME/CFS community).
Fifteen years later we know that FM is almost three times as prevalent as was believed back then 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 that was reassuring is not at all clear.
Why has NIAMS been allowed to do this? Why, fifteen years later has there never been another RFA? 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 it appears 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.
Lobbying, to be sure, can be an energy consuming, expensive and often long term process that’s probably not particularly well-supported by patients. I don’t see any ME/CFS and FM support groups out there that are loaded with cash.
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 placeuntil 2012. When pressed by patients why the NIH wasn’t doing more one NIH official, with some exasperation asked why don’t you do something about it? According to the “Not Tonight” book, the creation of 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, however, has declined. Effective advocacy appeared to the pave the way for the increased activity at the NIH in the late 1990’s. The same was true earlier for ME/CFS.
The lesson may be that nothing can be taken for granted in the federal government for these disorders. The natural tendency for funding for them at this point may be to decline over time not increase. Both disorders 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 has never have 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 if we want to really move forward. The same is probably true for FM
The NIH has repeatedly shown that it’s a world apart. While funding for the Institute doubled funding for ME/CFS declined precipitously. Disease prevalence and economic losses apparently mean little or nothing to it. FDA approved drugs entice the agency to increase spending not at all. 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. Whether it will help us reach our goals is uncertain – there are no guarantees in this field – but it’s likely a necessary element.