The thirty-five is now fifty…
Instead of being mollified by the DHHS working document, the effort by ME/CFS experts to rescind the IOM contract to produce a clinical case definition has actually gathered steam. The fifty ME/CFS experts signing the letter now include Dr. Lily Chu, Dr. Kenneth Friedman, Dr. Betsy Keller (exercise physiologist), and Dr. Van Ness and Snell (Workwell) in the U.S., and Dr’s Bested, Fluge, Mella and others from outside the U.S.
With the IOM contract, the DHHS has basically created a template for how not to deal with hot-button topic; first, you choose a particularly controversial subject, then you block a community that’s been burned repeatedly in the past from participating, then you pull back and, out of the blue, move forward again. Throughout the process you keep communication at an absolute minimum. 🙂
Then, perhaps legitimately, but then again, the timing is soooo suspect, you announce that the one upcoming public forum in which this subject could be aired, is now closed; the CFSAC meeting is now going to be a webinar for the first time in its history.
The working document has some good points; the contract includes some sort of ‘study’ (not defined well), a commitment to consensus building (who? how?), a promise to consider new terminology (other than ME/CFS apparently), and then a program to disseminate the information to clinicians. The approach is hopeful – the DHHS was moving in the right direction – but the devils is in the details, and there are precious few of those.
Under this contract you could have, depending on your viewpoint – absymal, adequate or fantastic ME/CFS participation – there’s no way to tell , but it’s clear that the working document does not bake in significant ME/CFS participation. Whether that happens is apparently up to the IOM. On the crucial question of ME/CFS representation in the fifteen panel members that create a new definition, there’s no help.
Pandora’s announcement that ex-DHHS liason Wanda Jones is going to help produce a statement brings in a much trusted figure. Given the intransigence on both sides (DHHS – we’re moving forward), ME/CFS community (cancel the contract!), any person that can bridge the two communities is potentially very helpful.
(Wanda has played this role in the past; when the FDA declined to approve Ampligen and Bob Miller was on a hunger strike, Wanda was brought in to mediate, and here she is again. (She’s probably feeling like Al Pacino in the Godfather Pt III – “Just when I think I’m out, they keep pulling me back in”.)
Trust – the Key Issue
Trust is the key issue; a good clinical definition backed by the federal government and then disseminated to the public would be a huge win. It’s getting there that’s the problem. Fifty ME/CFS experts have just said we believe a) we have a good definition, and b) we certainly don’t trust you to come up with a better one.
A community that’s had a horrible name and two poor definitions foisted upon them by the feds, that knows they’re getting shafted from the federal government on funding, and has been hearing federal officials for years say how very important this disorder is (while nothing significant changes), probably isn’t going to respond well to ‘just trust us’. There’s too much history here. They want details.
This is more than an DHHS trust issue. Asking patients, researchers and doctors to trust the objectivity of the ‘scientific process’; ie to allow outside individuals, most probably with no experience in chronic fatigue syndrome to objectively come up with a good clinical definition of ME/CFS, is a huge stretch given the past definitions produced. Those definitions, which were produced by select groups of ME/CFS experts, remember, prompted the broader community to take it upon itself to produce two definitions of its own. They ensured that the community would not accept processes that were not representative of the broad community.
If the Contract Is Not Repealed – A Middle Road
Ideally, the whole process should be begun again. According to people who know better than me, that’s not going to happen but time will tell. If the contract isn’t repealed, the DHHS surely has the option to redo the contract. ME/CFS experts in collaboration with DHHS officials and IOM representatives should get together and work out a contract that’s is responsive to both the ME/CFS community’s needs to have substantial ME/CFS expert input, and to the DHHS’s desire to have outside input.
The ME/CFS community may have to give up its desire for the CCC being the starting place, and the DHHS would have to give ME/CFS experts more of a say. (If enough ME/CFS experts were on the panel, the CCC would still be the defacto starting point. The DHHS, on the other hand, may be reluctant to begin any process that designates a winner at the outset.) This could produce a definition that’s representative and accepted by both the ME/CFS community and the larger research/doctor community.
If the DHHS does not reopen the contract, it would probably behoove the ME/CFS community to shift its efforts from trying to stop the process to ensuring that it works; i.e., turning those vague promises into significant opportunities for the ME/CFS community to get its views inserted.
One thing that may have been lost is that this is not a research definition, it’s a definition to help doctors know how to describe ME/CFS. Because describing does not suggest a cause or even a treatment pathway, it’s a fairly non-controversial process. With two clinical descriptions already produced by two ME/CFS professional efforts, several video’s by ME/CFS experts produced under the auspices of the CDC, and the FDA’s document describing ME/CFS patients, coming up with a description of what a person with ME/CFS looks like in the doctors office should not be difficult. The working document specifically directs the panel to refer to those descriptions.
However this turns out; a repealed contract, a redone contract or the same contract, the heat generated thus far is going to help. The now fifty experts backing the Canadian Consensus Definition, the CAA’s promise to hold the DHHS’s feet to the fire to ensure ME/CFS experts are involved, PANDORA’s detailed inputs, Jennie Spotila’s razor-like focus on this issue, and the firestorm in the patient community is all going to help.
There are some silver linings. The fact that the federal government is throwing money at ME/CFS is shocking giving the federal governments budgetary restrictions, and we should note that the DHHS did finally respond to an important CFSAC recommendation. If you can push aside how they went about it, these are real positives. If they had done this another way – we might all be cheering.
Dr. Bateman is right; there’s a real opportunity here; let’s not put aside the possibility that this could end up being a real win. The flip side of all this controversy is getting a good, widely disseminated and publicized definition for the first time.
This opens the door to validation, funding and future research based on clear identification of gaps in our knowledge, review of our current evidence base, and creative thinking about how to move forward.
No Blame Game
I don’t think for a minute that Nancy Lee or Dr. Maier or Dr. Koh is out to get ME/CFS. Without having any inside information, my guess is that the DHHS felt they were following CFSAC recommendations, and that they meant well but did poorly.
For the DHHS to flaunt such a large outpouring of expert opinion, however, isn’t workable. Many of these experts have spent their careers working in this disorder. Their experiences and voices need to be heard and responded to. If the DHHS and the experts make a commitment to bride the gaps and move forward, this process can still work and even forge new relationships and new opportunities.
Learn how a 67 year old retiree and his wife felt compelled to lace up his running shoes and get into action to support their son – and everyone else with this disease in A Run For His Son…and Everyone