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.
Changing Tactics
Transforming the Argument
The hypothesis that ME/CFS is a mental health issue has been disproved by the data. For years, the psychosocial school has claimed that CFS patients had poor coping skills and were simply deconditioned. All we needed to do was increase our physical activity (GET) and ferret out our dysfunctional illness beliefs (CBT), and we would recover. While the PACE trial and other research has been based on this premise, we have ample data that cuts the theory off at the knees. The two-day CPET (cardiopulmonary exercise testing) results cannot be faked, and distinguish ME/CFS patients from sedentary controls. Gene expression studies have also shown a distinct pattern of response to exercise in ME/CFS patients compared with sedentary controls and patients with other illnesses. Evidence, including imaging, spinal fluid, and immunological testing, has mounted to the point where Dr. Anthony Komaroff declared that the debate over back in 2006.
But the psychosocial school has not relented and I now see a change in their tactics. Instead of insisting that the illness is psychological, they are waving their hands and saying that the psychological v. physical debate is irrelevant. I offer two recent examples:
First, there is the systematic review of ME/CFS case definitions by Brurberg, et al., which I reviewed in detail in my post Systematic Overreaching. The authors stated:
As I said in my comment on the article published on BMJ Open, “The authors presented no evidence to support their accusation that the organic disease -only position has damaged research and clinical practice. Furthermore, they completely ignored the very real and logical possibility that the reverse is true. In other words, it is equally possible that the people with vested interests in the belief that ME/CFS has psychosocial causes are unwilling to leave that position, and have damaged the research and practice for patients suffering from the disease.”
Second, the recent report on the case definition for Gulf War Illness included the following discussion of the mental v. physical debate:
As in Brurberg, et al., there is no rejection of the psychogenic theory of ME/CFS. Instead, we’re told to abandon the debate. It’s not either-or, it’s both. Let’s stop arguing about the evidence, and go with a holistic view (that still includes the psychogenic theory).
It’s A Trap
Do you see what’s happening here? The ME/CFS psychogenic school is wrong – as shown by all the data that indicates biological abnormalities that are not seen in sedentary controls or people with depression or anxiety. But instead of admitting the error, they are simply changing tactics. Now they are saying that it’s psychological AND physical, and the distinction does not matter anyway.
Contrary to this new angle on psychosocial explanations, I believe it matters a great deal whether ME/CFS (or GWI) is a mental or physical disorder. The distinction between mental and physical is not “arbitrary,” but can be drawn based on signs and symptoms. I readily admit that my emotional state and coping skills have had an impact on my experience of this disease, but I completely reject the premise that therefore the distinction between mental and physical does not matter. It does.
People with mental health issues are primarily treated by psychologists, and in ME/CFS that usually means CBT and GET. We know that GET can have serious and long-lasting negative effects on ME/CFS patients. For decades, ME/CFS patients have endured dismissal and worse because of the psychogenic view of the disease. To say the distinction does not matter is foolish, at best. The practice of medicine is structured around that duology. There are medical diseases treated by physicians, and there are psychological diseases diagnosed with the DSM-IV (soon to be DSM-V) by psychologists. In the middle are psychiatric diseases like schizophrenia which are known to be biological, but are treated in the mental health setting because the symptoms of disease are behavioral. Mental health diagnoses are treated differently by health and disability insurance. There is a difference between the physical and psychological attributions of illness: in health care, in benefits, and in social views.
If the mental-physical duology no longer applies, shouldn’t that be true of all diseases? If “patients’ experiences of any illness are influenced by biologic, psychologic, and social factors,” then I suppose we are abandoning the dichotomy in cancer, heart disease, and multiple sclerosis too? I don’t know about anyone else, but I don’t hear anyone suggesting that those diseases are psychogenic in any way. I have family members who have endured MS, cancer and heart disease. Stress can make those diseases harder to manage, and even exacerbate the underlying disease process. But no one would ever say “let’s abandon the either-or thinking and agree it’s biologic and psychologic.” No way. Those diseases are accepted as physical in origin, with implications for behavior and coping. I believe that I deserve the same respect.
Bias and Decision Making
I’ve described the psychosocial school as changing their tactics, but I don’t necessarily believe there is a smoke-filled room where a cabal of psychologists sat down and said, “We’re losing the argument so let’s use these talking points instead.” I think the shift may be the result of cognitive bias and the difficulty humans have with admitting they’re wrong.
If I am a psychologist and I’ve invested 10 or 15 years in the theory that CFS is the result of poor coping skills and deconditioning, it’s going to be hard to change my mind. Despite mounting evidence that my theory is wrong, it will be hard to let it go. An easier step is to say that I’m not completely right but also not completely wrong. It’s not either/or, it’s both.
ME/CFS patients have gone through this process themselves. When the XMRV paper was published in 2009, many patients seized on the results. We had very good reasons to do so, and at first, the science and scientists seemed to support that position. But as contrary data emerged, and hard questions were asked, some scientists and patients found it very difficult to follow that data. They continued to insist that it was XMRV, and when that was disproved they claimed it was HGRVs. And when that was disproved, they claimed the science hadn’t been done right or there was a conspiracy or there were unidentified retroviruses at work. And it was three years before Dr. Mikovits finally took the courageous step of publicly admitting her conclusions had been wrong.
Nobody likes to admit a mistake, and the more you have invested in that mistake the harder it is to admit it. The psychogenic explanation of ME/CFS is wrong, but instead of admitting the mistake, some scientists are shifting gears and saying that it’s not completely wrong because the physical-psychological divide doesn’t actually matter. They are not following the data, and they are attempting to twist the dialogue so they don’t have to admit they are wrong.
Drawing the Line
The divide matters, and I will not be drawn into a compromise view. ME/CFS is a physical disease with physical causes. My emotions are relevant to my ability to cope with this physical disease, just as emotions are relevant to coping with cancer or AIDS. But I reject any hypothesis that leaves the psychogenic view on the table. Not because I don’t want to face up to having a mental illness. Not because I want my disease to be physical. Not because I am personally prejudiced against mental illness and not because I don’t see the relevance of emotions in physical health. I reject the psychogenic hypothesis because the data is not there.
I had a happy childhood. I had a satisfying career and personal life. I enjoyed being physically active. Then I got sick. And despite my strong desire to continue in that career, that personal life, and that physical activity, I have not been able to do so for almost twenty years.
The reasons why my life was destroyed matter. The cause of that destruction matters. To say that the distinction between physical and psychological causes is arbitrary and irrelevant is to dismiss my experiences. It may save face for the psychogenic school, but it is a slap in mine. I challenge the researchers and decision makers to admit their errors, and get on with the business of finding the answers that will repair my body and my life.
This post was translated into Dutch, with my permission.