The bi-annual federal advisory committee (CFSAC) meeting for chronic fatigue syndrome is upon us. It’s intriguing to note that ME/CFS is one of the few disorders to have a federal advisory panel all to itself.
CFSAC contains ex-officio officials who represent a variety of federal agencies (CDC, NIH, FDA, Social Security Administration and others), and ME/CFS professionals who provide recommendations to those agencies. The meetings on Oct 3rd and 4th will be videocast live from 9-5pm EST.
Assistant Secretary of Health Koh Talks
Assistant Secretary of Health Dr. Koh has made a point of kicking off the meeting. He’s not required to do that, and other Asst Secretaries of Health have not, but unfortunately his presentations have generally been more about promise than substance.
At the last meeting Dr. Koh noted that the DHHS had formed a ‘high-level’ inter-departmental CFS group to improve communication, integrate efforts and identify opportunities to move forward. Dr. Sibelius was reportedly present at the meeting and signed off on an April 2011 statement announcing the formation of the group. She said..
“I want to assure you that several agencies within the Department of Health and Human Services (HHS) are working together with the Chronic Fatigue Syndrome Advisory Committee and advocacy groups to develop interdisciplinary initiatives that will address important aspects of this illness, including improved diagnosis and treatments.”
Improved diagnosis…..Treatments….and from the head of the Department of Human and Health Services herself. Finally we were getting some movement! Seven months later in November 2011, Asst Secretary of Health Koh reported that further additions of high-level officials able to make decisions were expected but the effort seemed to have stumbled. In her illuminating ‘Free Turkey’s’ blog , Jennie Spotila pointed out the patient advocacy (ie stakeholder) part had disappeared and the entire process was going to include just three to five meetings – hardly enough to improve diagnosis and treatments – nothing was going to be published and seven months later little had been done.
Ad hoc: done for particular purpose: done or set up solely in response to a specific situation or problem, without considering wider or longer-term issues
The Ad hoc committee is a step forward – there’s no doubt about that – and it’s good news when someone steps up and puts chronic fatigue syndrome on the table. But the best the Committee will probably do at this point is to throw buckets of water on a raging fire, and some of the ideas at this point being kicked around early on – a patient registry and CFS webinar – reflected that. This has all the hallmarks of a committee that will address issues around the edges.
Almost parallel to this interdepartmental effort, ME/CFS advocates were engaging in long email streams about how to fix the tepid decades-long federal response to ME/CFS, and in June of this year some 19 patient support organizations and 25 patient advocates went straight to the heart of the matter and requested that the Feds create a strategic plan to fix the glaring problems present and….
“undertake a strategic, coordinated and fully-funded response to the challenge of ME/CFS. We ask you to schedule a meeting between a group of ME/CFS patient representatives and key representatives from across DHHS to discuss the concerns raised in this letter and begin to formulate a comprehensive plan”
Dr. Lee, the DHHS liason to the CFSAC committee, responded by essentially saying- ‘not to worry; it’s already being done – by the Ad Hoc Committee…”. We beg to differ.
The federal situation regarding CFS is not an ‘ad hoc’ situation that’s going to be solved or even significantly dented by a couple of committee meetings. We recognize that Dr. Koh is operating in a brutal and uncertain spending environment, but simply coordinating activities better is not going to impact many patients’ lives.
It’ll be interesting to see what, if anything, Dr. Koh can provide on the group’s activities.
For all its good intentions CFSAC is failing to make much of a difference. The compelling patient presentations at the meeting would seem to be enough to encourage the federal officials to push for action but they appear to have fallen on deaf ears. Last session, one bedbound patient delivered a curtain of empty saline IV bottles to the meeting to demonstrate her plight, and Mary Dimmock’s son’s story of his ‘fall’ – from backpacking solo across Asia to becoming mostly home bound – was startling in its trajectory.
In the last CFSAC meeting Jennie Spotila went back to Oct 2010 to chart how the DHHS was responding to CFSAC recommendations and she found that they weren’t. Over the past twenty months the DHHS has responded to only three recommendations and those responses were “no, no and ongoing”.
From Jennie’s blog:
“We always hear nice promises at these meetings. There is always the illusion that real progress is being made, that things are beginning to change. But to me, the lack of progress on your recommendations – and the lack of accountability at HHS for ignoring your recommendations – is the true barometer of where we are. Committee members, don’t mistake these updates for real progress. To borrow from Dr. Grobstein’s comments yesterday, “Keep track. Keep asking.”
Actions speak louder than words. In our case, inaction speaks louder still.
Fourteen months ago, Dr. Frances Collins announced that the Secretary had directed that CFS be given “special attention.” Is this what special attention looks like? Maybe it’s just me, but I am not seeing much difference between the special attention we are allegedly receiving now and the lack of special attention we had before.”
With the Internal Working Group, the bio-repository, the CASA project and possibilities of national webinars and patient registries being floated, the Department of Health and Human Services is more engaged, but the NIH funding for CFS research is abysmal and the federal government is still not responding to the Committee’s recommendations.
NIH funding for ME/CFS is now, adjusted for inflation, at 1992 levels, and with a big chunk of studies ending this year and no initiative to attract more research, the possibility of a rapid decline in funding is very real. Until the DHHS can squeeze more than a couple of million dollars out a 45 billion dollar budget for ME/CFS, the small improvements to the program are more like Nero fiddling while Rome is burning. Nothing significant will be done without more research funding, and more research funding is exactly what the DHHS is not willing to provide.
There’s often a science section at CFSAC and this meeting Dr. Fletcher and Dr. Dimitrakoff will be talking about biomarkers. Dr. Demitrakoff has mostly been concerned with chronic pelvic pain syndrome, which overlaps with chronic fatigue syndrome. He recently found an enzyme (Ca(2+)/calmodulin-dependent protein kinase II) triggered by infection, which appears to cause an inflammatory cascade in the dorsal spinal cord which results in chronic pelvic pain in mice. Several other researchers are sniffing around the dorsal spinal cord for evidence that pain and fatigue signals get altered there in disorders like fibromyalgia.
Dr. Fletcher, of the Fletcher/Klimas team, has been studying natural killer cells and immune factors in ME/CFS for about 20 years. This team is in the thick of the hunt for biomarkers and we’ve heard some exciting anecdotal reports suggesting they’re getting close. Dr. Peterson uses the Fletcher/Klimas lab frequently because of their accurate cytokine results. Dr. Unger of the CDC reportedly visited the team’s labs earlier this year to get a full run down on their work in progress.
It should be an interesting hour.
Centers For Disease Control (CDC)
Few people thought the CDC Toolkit was any good before the IACFS/ME Treatment Primer came out, but its deficiencies became all the more glaring once the Primer was published. The Primer raised the issue, once again, of why the lead federal agency on ME/CFS treatment is still presenting ME/CFS as some sort of puff ball disorder that can be managed by anti-depressants and behavioral therapy.
The first recommendation from the last CFSAC meeting was that the CDC should remove the Toolkit from its website. (Since then I was told that CFSAC actually added a link to the CDC’s Toolkit on its website). The second recommendation was that the DHHS should work to make the IACFS/ME primer widely available to doctors.
At the last meeting, Eileen Holderman, the patient rep on the committee, said the CDC listened closely to the panel’s concerns regarding the CDC Toolkit and several changes have already been made, but the toolkit, which is so lackluster in treatment options that it almost constitutes an assault on the notion of ME/CFS as a serious disorder, needs more of a redo than a fix-up.
Ironically, at the recent Overlapping Pain Disorders Conference, Dr. Unger stated that the Toolkit was something of a stop gap measure that was intended to give uninformed physicians the idea that ME/CFS was a serious disorder, and it was never intended to be a complete treatment guide. It appears, though, that WebMD, Mayo Clinic and other prominent medical websites believe it is a good treatment guide as they basically follow its recommendations. In the last session the CDC stated they would add a Pediatric section to the website – not an exciting proposition given the state of the Toolkit.
The CDC has improved under Dr. Unger; they have talked to many patient groups, they’re working with ME/CFS physicians to clarify diagnostic protocols and to create CME courses, but the Toolkit is a big thorn in the ME/CFS Community’s side. Expect some questions to the CDC rep on the panel about the Toolkit’s status and the possibility of merging the Primer and the Toolkit together.
Food and Drug Administration (FDA)
The FDA is speaking! With only one drug for ME/CFS under review, FDA officials have rarely had reason to say anything at CFSAC, but with the Stakeholders meeting planned for Spring 2013 they’re going to have a full hour to talk about that and drug development.
The FDA has come a long way quickly. Ampligen was brought back to life by their decision not to require more expensive testing and we can expect a decision on that drug within a couple of months. At the last Conference call Dr. Kweder not only acknowledged that ME/CFS was a ‘serious and life-threatening disorder’ but she put it on par with cancer, epilepsy and other major disorders – a big step up for a disorder which the NIH spends less money on than it does on hay fever (allergic rhinitus).
Various agencies will report, we’ll get more patient testimony and there will be a session on the ME/CFS Definition – A Path Forward...which suggests that a ‘path forward’ may be forming in perhaps the knottiest issue in all of ME/CFS. Just the idea that there is a path forward is somewhat surprising given the four or five definitions being used (Canadian Criteria, Fukuda, ME criteria, Empirical Definition). Fukuda is overwhelmingly used in scientific papers but the Canadian Criteria is starting to show up and the CDC shows no signs of abandoning the Empirical Definition.