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Silver Platter of Frustration

March 12th, 2014

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.

keep-calm-and-bang-your-head-against-the-wall

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.

  1. 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?
  2. 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.
  3. 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.
  4. Not a single question for CDC, despite an issue that demanded strong questioning. (see the next section)
  5. Not a single question about the CFSAC charter renewal process.
  6. Not a single question about the appointment of a new Chairman.
  7. Not a single question about the timeline for appointing new members.
  8. 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.
  9. Not a single questions about the status of the High Priority Recommendations, and whether any have been completed.
  10. 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

keep-calm-and-call-shenanigansDr. 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.

wordsmith1It 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.

WhitegloveSilverPlatterSizedHow 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.

 

  1. rivka
    March 12th, 2014 at 16:29 | #1

    Why am I the first to comment on this blog post? Likely because we are all so stunned by the display we say at yesterday’s CFSAC meeting.

    I think what we witnessed is obviously the next step of a downward slide before they shut down CFSAC all together. They are making it smaller, shorter and lesser all the time. Next, they end it. This is my prediction. And, honestly, given the lack of results from CFSAC, I’m not sure it makes much of a difference if it continues or not.

    Or course, they could do the reverse, and it would help a HUGE amount: They could make these CFSAC meetings efficient, productive and yielding of results. (In fact, if they did this, it would save lives. Literally.) Meetings happen all over the globe, every hour of every day, that are efficient, productive and bring concrete results.

    If there ever was an under-served patient population deserving of help and concrete results, it is us; many of us have been homebound and bedridden for decades now, living isolated, on-the-edge-of-survival lives. I know, because I get emails and calls each week from patients who have no family support, can’t work, can’t socialize and are desperate for some kind of medical intervention and patient care.

    Why can’t — why won’t — our government help us? What is the problem here?

    I can’t help but feel that the fiasco that is CFSAC is intentional.

  2. Colleen S.
    March 12th, 2014 at 17:49 | #2

    I listened to the meeting – and it was excruciating at times both in dealing with the quality of the technical aspects and listening to them fix the recommendations. I was VERY pleased the improvements to the recommendation focusing on the CCC, but agree that had this been handled more professionally some of the other matters could have been dealt with. Your article is spot on!

  3. Kati D
    March 12th, 2014 at 18:58 | #3

    Thank you so much for this blogpost Jennie.
    This CFSAC meeting was once again a zoo. i am appalled at the recommendation of including MECFS in integrative health efforts. i mean, does integrative people care for HIV patients? Until we have a clear picture of what is wrong with us physiologically, is it a pathogen, is it the immune system, it would be best to demand for research funding and epidemiology rather than having naturopath and alternative medicine people on the committee and puliing the “you are what you eat”strings.
    It is very disturbing that Dr Belay denies that the CDC website is wrong. The influence of this CDC website on physicians around the world is what has destroyed us and why physicians recommend anti-depressamts, CBT and GET in the first place, and this happens all around the world.

  4. Ess
    March 12th, 2014 at 23:15 | #4

    WHY would there be any reason to have expected anything other than ‘more of the same’?!!

  5. Andrew
    March 13th, 2014 at 10:47 | #5

    The problem is that there is no leadership and accountability within the government, either by elected or non-elected officials.

    This sort of incompetence continues throughout because no one in the government actually cares. It is just hand-wringing.

    Meanwhile it is costing the government tens of billions of dollars in lost taxes and welfare.

  6. Iquitos
    March 13th, 2014 at 12:27 | #6

    Spot on write up.

    That meeting was just one more imitation of an imitation of “trying” to make progress. It’s intentional.

  7. kathy d.
    March 13th, 2014 at 20:06 | #7

    I think a major reason why the government doesn’t want to help those of us with ME/CFS is financial. The officials do not want more people getting medical coverage from Medicare and Medicaid nor does it want more people to receive federal disability benefits. And the insurance companies do not want to pay for medical care related to this disease.

    This is a time when disability benefits are being questioned for many people, if not outright denied, and when it’s harder to obtain Medicare and Medicaid. In fact, Medicare payments to doctors and coverage is being cut back somewhat.

    The federal budget has been cut. Funding for agencies, which do medical research has been decreased overall for our disease and others. This isn’t a good time for medical research.

    When the government shutdown occurred, a lot of programs were cut back. It was revealed by the media that funds had been cut back for the CDC and FDA for programs which monitor Salmonella and other food-borne diseases and for inspections of meat/poultry plants.

    Our health is not a priority.

    We have to continue to be loud and present as much as we can. At least this campaign holding the IOM and HHS accountable, which has been publicized all over the Internet and through social media has been great. These agencies are feeling the heat and the pressure.

    Last night an email came out from the CFIDS Association, which looked quite defensive and raised, in part, some of the objections to the IOM from the patient population and doctors.
    Public pressure is felt. The more, the better.

  8. Ess
    March 14th, 2014 at 02:47 | #8

    @kathy d.
    Finances are definitely a part in this–government/insurance companies and combined interests.

    Getting to the bio markers for ME\CFS has the potential of opening up that proverbial can of worms requiring insurance and disability payments AND proper treatment of a very physically sick large patient population group. AND, with that, the demand for answers from HHS, CFSAC, CDC and NIH and affiliations as to WHY ME/CFS has been largely ignored being LEFT to infect/affect/debilitate millions globally. AND, further questions–WHO has led and who continues to lead the movement AGAINST getting to the scientific answers to ME/CFS? WHY this discrimination? WHY the secrecy?

    Finances for ME/CFS are merely a surface excuse and only part of the whole problem in lack of transparency and accountability regarding ME/CFS. For example, there is a budget of $16M annually allocated for male pattern baldness . . . There is ‘reasonable’ research fundingMillions and billions of dollars are spent on space science, etc., etc.

    Good idea–let’s keep up our advocacy and the public pressure. We have to!

  9. Ess
    March 14th, 2014 at 03:04 | #9

    @Ess And Kathy D. Continued. Sorry I am not used to working with iPad while computer is crashed–and sometimes the iPad just takes off on me :(. Second last para, last sentence should read–There is reasonable research funding available and allocated to many diseases. In contrast, ME/CFS receives pitiful funding; and of that $1M plus is being needlessly and foolishly wasted on the IOM contract instead of going to much-needed biomedical research.

    More comparison and contrast–millions and billions of dollars are being spent on space science, etc., etc.

    Good idea to keep up our advocacy and public pressure. We have to! It is definitely our time for JUSTICE!

  10. kathy d.
    March 14th, 2014 at 21:15 | #10

    My view in all this is that funding should be made available for research and treatment for all diseases, including ME/CFS — and I’d suggest reparations should be paid, too, because of all of the lack of funding and misappropriation of funds for our disease.

    And I would say cut the military budget for research and development, including of more nuclear weapons, and everything else. Does the world really need better nuclear weapons, more drones and satellites? And cut the payments to banks and other financial institutions. Interest payments alone could fund research for all diseases.

    I do think the government does not want to recognize one more disease because of the funding and research. I believe there was resistance to funding AIDS research and treatment for quite ahilwe. I think that the AIDS activists, especially ACT-UP and others who were really public, pushed the government to do the research and fund it.

    I could also surmise that because this is primarily a woman’s disease (not all, I know), that
    there is even less interest in funding research.

    But I agree it isn’t only finances; it’s politics. It’s lack of interest in taking on a new challenge, in breaking with the status quo. The disease is an enigma. It would take a real concerted, unified research program to find the causes, biomarkers and treatments. Does the government want to do this? Not really.

    Here is Dr. Ian Lipkin, virologist, asking patients and relatives to donate for his research. This is crazy. The government could do it, and has tons more funds than our community has, obviously. It could easily give him $1 million, even $10 million.

  11. Billie Moore
    March 16th, 2014 at 11:00 | #11

    The NJCFSA is a non-voting member of CFSAC. The other non-voting members are the IACFSME and the CFIDS Association. I was a participant as the rep for the NJCFSA in Tuesday’s meeting and sent an audio clip of the meeting to the entire CFSAC on Friday, including Nancy Lee, Martha Bond, Joyce Grayson, the guy from Seamons who was the IT person in charge, and Howard Koh. I also included a link to this blog entry. I know the other members of the committee had no idea that the audio the public was hearing was so bad and thought they should know.

    Billie

    • Jennie Spotila
      March 16th, 2014 at 11:07 | #12

      Thank you for doing that, Billie. It’s critical that they understand the technical problems we’re experiencing, as well as the sources of our frustration.

  12. Justin Reilly
    March 25th, 2014 at 15:37 | #13

    @Iquitos
    Nice way of putting it.

    More broadly speaking, I can not understand at all how anyone could think that all of HHS’ malfeasance and nonfeasance isn’t intentional since the whole thing has been a bad impression of a parody of a poor imitation of trying to make progress, to riff on your words. Those like Robert Miller and Dr. Kaiser who pretend any differently give cover to those who are hurting us.

  13. Justin Reilly
    March 25th, 2014 at 15:41 | #14

    @Billie Moore
    Thank you so much, Billie! I strongly urge you to also follow Eileen Holderman’s, Dr. Fletcher’s, and now, happily, Dr. Levine’s (!) lead in “calling out” HHS on the record at the meetings any chance you get.

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