Yesterday’s CFS Advisory Committee meeting was insane. Wait, maybe the meeting just drove me insane. Or was the whole thing just insanely inane? I don’t even know anymore. Wait a second, hang on.
Ok, let me start again.
Yesterday’s CFS Advisory Committee meeting served up a generous helping of frustration on a silver platter. While some of the mistakes from the last meeting were corrected, many mistakes were repeated and new ones were made. I’m going to be as succinct as possible in summarizing another episode of Tech, Wreck and Waste.
Webinar 101
Let me make this very straightforward and very simple: Do not run a webinar if you cannot make a webinar run. Here’s a checklist:
Can you provide clear audio? Some speakers were unintelligible. Dr. Sue Levine’s audio kept cutting out during her presentation. And for seven minutes (I timed it), the audio cut out completely. The closed captioning was not an adequate substitute, but did provide comic relief with such gems as translating “criteria” as “cry tears.”
Do you know how to use the slides? I really expected this to be nailed down after the fiasco that was the slide portion of the December meeting. But I was wrong. There were nine minutes (I timed it) at the beginning of Dr. Dane Cook’s presentation during which we listened to dead air followed by a discussion of whether members could advance the slides themselves, which buttons to push, which slides they were seeing, and so on. From this point on, the slides periodically caromed out of control, moving backwards and forwards to the point where I got dizzy and had to look away from the screen. Several times, the slides disappeared completely.
Have you secured your dog in another room? I love dogs. I own a big lug of a dog, and I know that you cannot always control what your dogs do or when they will decide to bark their fool heads off. Which is why, if you are speaking on a webinar, you should arrange for your dog to be in another room. It was hard enough to follow the sometimes chaotic discussion without distractions like background noise.
Have you anticipated technical difficulties and rehearsed ways to fix them if they arise? Slide problems. Sound problems. Conferencing people in and out problems. This went a little better than December, but still, it really isn’t rocket science to practice solutions in advance.
If you answered “No” to one or more of these questions, you are not ready to run a webinar.
The tech problems have real consequences for the public trying to follow the meeting. We don’t know who is speaking (or even who is present), the slides do not always advance with the discussion, and sound problems mean we can’t hear some discussion at all. It was very clear that CFSAC members are equally frustrated by these difficulties. In my opinion, the webinar format should be abandoned until these technical issues are solved.
Stupid Questions
I believe there is really only one kind of stupid question: the question you do not ask. And there were some doozies.
- Not a single question for FDA about the Draft Guidance to Industry document. If I could read it and come up with a list of questions, why didn’t CFSAC members?
- Not a single question for AHRQ about the systematic evidence review. The evidence review is not only the cornerstone of the P2P Meeting, it is arguably just as significant (and long-term in its implications) as the IOM study. I have a looong list of questions about it. But maybe that’s just me.
- Little discussion about Dr. Cook’s presentation from the research and clinician-scientist recruitment working group. It seems like a lot of work went into that, and there were many potential topics for discussion. But from my notes, it looks like 15 to 20 minutes of discussion occurred.
- Not a single question for CDC, despite an issue that demanded strong questioning. (see the next section)
- Not a single question about the CFSAC charter renewal process.
- Not a single question about the appointment of a new Chairman.
- Not a single question about the timeline for appointing new members.
- Not a single question about what HHS is doing to ensure the coordination of the multisite study, P2P process, and IOM study – or even why these are all being pursued simultaneously to begin with.
- Not a single questions about the status of the High Priority Recommendations, and whether any have been completed.
- Not a single question about the status of adding links to ME/CFS organizations on the Office of Women’s Health website.
I Call Shenanigans
Dr. Sue Levine and the medical education working group were justifiably critical of CDC’s CFS website. Dr. Levine even suggested that someone investigate the potential for legal action against CDC to force some movement on the changes CFSAC has repeatedly recommended. At a minimum, she advocated that CFSAC identify who is responsible for the website in order to identify and deal with the roadblocks.
Dr. Belay (who had not responded during any of the roll calls so I’m not sure when he joined the meeting) jumped in to say that CDC has extensively revised the website based on committee input. The TookKit has also been revised, although he admitted that CDC had not taken down the old version as recommended by CFSAC. Dr. Levine asked what was causing the delay in making changes, and Dr. Belay responded that “we’ve made the changes a few months to a year ago.”
This is not true, as any CFSAC member could have established very quickly.
Denise Lopez-Majano checked the CDC website, as each page identifies when the content was last reviewed. The homepage? May 2012. General information page? May 2012. CDC CFS Publications? April 2012. Continuing education? July 2012. Case definition? May 2012. Symptoms and Causes and Diagnosis and Management? May 2012. The ToolKit? September 2011.
So was Dr. Belay simply mistaken, and the 2012 updates reflect the revisions made with CFSAC’s input? Or are the changes still trapped in CDC internal review? I have no idea. Someone should have asked.
Wordsmithing
I asked my husband last night if it was reasonable for senior-level people to present rough draft recommendations for a full committee to wordsmith together. He said he would be fired on the spot if he did that in his field. But wordsmithing by committee is precisely what happened for roughly two hours of the CFSAC meeting.
It wasn’t clear from Dr. Levine’s presentation whether she drafted the recommendations on her own, or if the working group had collaborated on drafting them. Whatever the working group’s process, it was abundantly clear that the draft was not ready for prime time, thus leading to the two hours of refinement.
Lack of clarity was pervasive throughout the recommendation language. What disease are we trying to educate doctors about? How should we define integrative medicine? Do we mean physicians or medical professionals? And on and on and on. The committee spent two hours hammering out all this stuff that could have been done partially in advance. FACA requires that the recommendations be discussed and approved in public. It does not require that they be written by the full committee in real time during a public meeting. There is no reason why the working group could not have spent two hours working out the details and supporting evidence, and then present a more polished version to the full committee. Non-working group members would still have a chance to ask questions, offer changes, etc.
I’m not saying the refinement was poorly done. The final version approved by the committee was significantly improved by the group effort. It was essential to replace verbs like “suggest” and “support” with verbs like “recommend” and “fund.” It was also essential to identify what supporting documentation and evidence should be submitted to the Secretary with the recommendations. My point is that these things could and should have been done before presentation to the committee. Not only was it frustrating and inefficient, but the time spent on this process meant that there was NO time for discussion of future issues for working groups and recommendations. A very large item of business was left unfinished.
So what did the committee actually recommend? Basically, the committee recommended that HHS fund the development of curriculum at medical schools, fund teaching modules featuring complex cases, support integrative medicine programs featuring learning about ME/CFS, fund novel programs to bring expert care to under-served areas, gather requisite data for established organizations to incorporate ME/CFS in education, and support the CFSAC effort to amend the CDC website. All of these recommendations were explicitly worded to focus on ME/CFS as defined by the 2003 Canadian Consensus Criteria.
What was missing was a statement of the case. Yes, multiple supporting documents were identified, including the 2003 Canadian Consensus Criteria, the Primer, and the Expert Letter to the Secretary. But the Secretary is (or should be) already familiar with those documents. HHS has already declined to follow the Expert Letter or to remove the CDC Toolkit. Why should the Secretary listen now? In order to create a compelling argument for these recommendations, the working group should have prepared a one page statement of the case. That case could present the data on medical school education and the responses the working group got when they contacted the professional associations (which boiled down to “prove to us this is a public health problem”). They should be sending the Secretary a few paragraphs that convey not only the urgent need for better provider education, but also why the current efforts are inadequate. Instead, the committee is apparently deferring that to Dr. Marshall, who will write the cover letter accompanying the recommendations. Will everyone on the committee be satisfied with what he writes? I hope so, since they delegated the task to him and did not ask to see a draft version before it goes to the Secretary.
Widening Divide
The public comments raised an issue that is increasingly troubling to me. Dr. Jon Kaiser (founder of K-PAX Pharmaceuticals) closed his remarks with strong praise for all the federal agencies and their efforts on ME/CFS. Bob Miller cited four examples of how he sees the federal government “turning a corner” on ME/CFS, although he pointed out that results will be the ultimate measure of success. The rest of the public comments took HHS and CFSAC to task for lack of progress, or worse.
There has always been a divide in the ME/CFS advocacy community between advocates who thought the government was making progress (albeit slow and inconsistent) and those who thought the government was stalled or moving backwards (perhaps intentionally). But it seems to me that this divide has grown significantly wider in the last year. I’ll be writing more about this soon, so I’ll just put a pin in the topic to save it for later.
The Silver Platter
The disconnect between the accountability and progress that ME/CFS patients deserve and the decisionmaking put on display at CFSAC meetings remains large. These meetings are so frustrating, and increasingly so, that it is easy to see why some people believe HHS is doing this on purpose. Maybe they blame individuals, maybe they blame the Department, maybe they blame a highly placed policy maker, but many ME/CFS advocates believe that the sheer volume of problems can only be explained by intentionality.
How else can we explain a repetition of technical difficulties from the December meeting? How else can we explain the CDC’s failure to be forthcoming about their own website? How else can we explain the conduct we see in these meetings, and the way CFSAC’s recommendations are handled by the Department? How else do we explain the lack of urgency?
I have no explanations to offer. But somebody could, and should. FDA has consistently demonstrated over the last two years that it is listening to patients and advocates. FDA has held open teleconferences and given advocates the freedom to ask questions and make their points. FDA held the public meeting last year, and followed through on its commitments to produce summary reports and draft guidance to industry within a year. Advocates do not agree with all of FDA’s decisions by any stretch of the imagination (e.g. Ampligen), but we recognize that FDA is listening and moving forward.
That is what progress looks like. And the contrast with CFSAC could not be more stark or more troubling.
May 12th – ME/CFS Awareness Day – is just over a month away. Plans for a demonstration are underway, via Erica Verillo.
Don’t Silence Yourself
On May 5th, the IOM panel creating new diagnostic criteria for ME/CFS will hold its second public meeting. The only way you can provide input is by submitting written comments, unless you are an invited speaker. I’m here to plead with you to send your comments to the panel.
Some advocates are in favor of boycotting the IOM meeting and refusing to answer the questions they have posed to the patient community. Their argument is that patient input makes absolutely no difference, and will only be used to legitimize the process of creating a definition to destroy us. They believe in opting out of the process and continuing to seek cancellation of the contract.
That is a huge gamble.
Right now, there are at least eight members of the IOM panel who are trying to create the right case definition. These eight people know the devastation of this disease, and they are working hard to ensure that the case definition serves our interests. They need our help to do it.
HHS blatantly refused to seek our input into the decision to give this contract to IOM. Now IOM is offering us an opportunity to provide input into their decisions. How can we complain about being left out of one decision, and then refuse to provide input into the actual case definition decision? What conclusion will IOM draw from the silence of our community? Will they be impressed with our stance on the moral high ground? Or will they conclude that we must not care that much after all?
Have you seen the agenda for the May 5th meeting? One name stands out: Dr. Megan Arroll, Director of Research for The Optimum Health Clinic in London. The Clinic uses a number of alternative medicine treatments, including techniques derived from the Lightning Process and Mickel Therapy. Their approach is based on the chronic stress model of the disease. So part of the choice we have to make is whether we will cede the floor to this perspective. Should we allow that perspective to go unchallenged and unanswered? Should we leave it to the ME/CFS experts on the panel to make that argument for us?
You have valuable things to say to IOM. I know you do. You have your own experiences with seeking diagnosis and healthcare. I know you have strong opinions about the name. By opting out, you silence yourself. You deny IOM the benefit of your experiences. The IOM panel NEEDS to know what you have been through, and NEEDS to know what you think about the disease name. Chances are, you have something unique to say, something that the rest of us – while we will try to speak for you – might miss. Are you willing to take that risk?
Even if we say everything you would say, there is no substitute for volume. If ten of us say we want the name ME, that’s nice. But if 100 of us, or 1,000 of us say it, it is much harder to ignore. Part of our power comes from numbers. Why should we sacrifice that power? Don’t you think the IOM panel will notice if the meeting room is filled or half empty? Don’t you think someone will count the number of messages they get for this meeting? And if there is anyone on that committee looking for weak spots on our side, don’t you think they will point to lack of participation and use it against us?
If this is war, should we simply abandon one of the battlefields and turn our backs on the fight?
Not me. Time and again, ME/CFS advocates draw parallels to the HIV/AIDS movement. But remember one of the main slogans of that movement: Silence = Death. I will not be silent. I will not be shamed for speaking out to IOM. I say press on all fronts. I say cover all our bases. I say SPEAK NOW! Don’t let this opportunity pass by.
The IOM panel asks “what are the most important issues that healthcare providers should be educated about when it comes to diagnosis of ME/CFS?” So tell them. Tell the panel how long it took you to be diagnosed. Tell them what other diagnoses were considered and why, especially if you were told it was all in your head. Did your doctor tell you to exercise? Did your doctor understand anything about PEM? Has a healthcare provider ever talked to you about cognitive dysfunction? Were you given the information you needed to protect your health and cope with the disease? Do you think your gender, race, or socioeconomic status had any effect on your experience of getting diagnosed? Have you even found a healthcare provider who knows anything about the disease? Have you been harmed by the kind of information put out by organizations like CDC or the American Academy of Family Practitioners?
The IOM panel asks “What are your thoughts on the current terminology used to describe this disease: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome? If you could suggest new terminology, what would you suggest and why?” So tell them. Tell them you hate the name CFS, and why. Do you like ME/CFS? Prefer ME? Want them to come up with something new? Why? Tell them what you think, or allow them to make these choices in the face of your silence.
If you can, submit your comments before April 23rd to mecfsopensession@nas.edu. But you can submit input any time to mecfs@nas.edu, so don’t give up if you can’t send something in by the 23rd.
You are not limited to these questions, of course. If you want to tell them why you oppose the contract altogether, you are free to do so. If you want to talk about the danger of GET, go ahead. Tell them that you believe there are biomarkers, or that they should adopt the Canadian Consensus Criteria in its entirety, or that this is an autoimmune disorder, or that we need a specialty home. You should tell them whatever you want. I can’t guarantee they will listen. But I CAN guarantee that if you do not speak, they won’t hear you.