Archive

Archive for the ‘Commentary’ Category

Don’t Silence Yourself

April 8th, 2014 53 comments

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.

black-tape-mouth-shut-no-speaking-700x45_660There’s been another round of the “should we speak or stay silent” debate about this meeting, catalyzed by Eileen Holderman’s public refusal of an invitation to speak. Ultimately, everyone has to do what they believe is right. But as I have said before, I believe the risk of staying silent is simply too great.

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.

 

Changing Tactics

March 24th, 2014 33 comments

bigstock-Bear-Trap-38159869-e1370296224125For decades, ME/CFS research and clinical care has been plagued by disagreement over the basic classification of the illness. Is ME/CFS a physical disease, as many patients and researchers insist? Or is it a mental health disorder perpetuated by deconditioning, as argued by the psychosocial school? There is growing rejection of the psychogenic explanation for ME/CFS, but it is not disappearing. In my view, the psychosocial school is simply changing tactics, and this is a trap that we must avoid at all costs.

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:

It is likely that all CFS/ME case definitions capture conditions with different or multifactorial pathogenesis and varying prognosis. The futile dichotomy of ‘organic’ versus ‘psychic’ disorder should be abandoned. Most medical disorders have a complex aetiology. Psychological treatments are often helpful also for clear-cut somatic disorders. Unfortunately, patient groups and researchers with vested interests in the belief that ME is a distinct somatic disease seem unwilling to leave the position that ME is an organic disease only. This position has damaged the research and practice for patients suffering from CFS/ME.

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:

Like CMI and many other symptom-based illnesses, ME/CFS is not without controversy, particularly regarding whether they are mental disorders or physical health disorders [cite to IACFS/ME Primer]. The committee notes that this either-or approach is not useful, for several reasons. The distinction between mental and physical disorders is often arbitrary, and most patients’ experiences of any illness are influenced by biologic, psychologic, and social factors. Either-or thinking leads too often to a presumption that medically unexplained symptoms must be psychogenic. In addition, psychiatric [sic] symptoms may not be fully evaluated if a patient’s symptoms are psychogenic. Although physical and psychologic stress can exacerbate many chronic conditions – including chronic pain, headache, respiratory, and gastrointestinal symptoms – there is an inherent risk in assuming that medically unexplained symptoms assume a “stress-induced” etiology.

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.

 

Silver Platter of Frustration

March 12th, 2014 14 comments

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.

 

Guest Post: Wind Up Clock

February 24th, 2014 11 comments

The final post in this stretch of guest authors comes from Claudia Goodell. Claudia is among the most proactive ME/CFS patients I know, trying to make a new life for herself with this disease while also participating in advocacy.

wind-up-peopleI am one out of 1 million Americans waiting for decades in a medical “no man’s land” for solutions to a debilitating disease with no known cause, NO approved treatment and none in the pipeline. We have no designated specialists, and no cure in sight. We feel abandoned by our government who funds research on our disease at a rate less than that of male pattern baldness, we feel failed by the researchers and drug companies who can’t seem to make progress fast enough, and we feel ostracized by the medical profession who throws us around like hot potatoes hoping someone else will handle us. If we are fortunate we have a support system and receive disability, but many struggle alone with no finances and no one to help them, some of whom are completely bedbound. We are so determined to return to the healthy active lives we once knew that some of us will try whatever we can to get well.

When I was in graduate school my professor of Auditory Neuroscience and Psychoacoustics lectured us about sound pressure. In teaching us the mathematical equation for sound traveling through the acoustic system, he made sure we understood that if one looked at only the first part of the equation it would appear that an acoustic signal actually gained energy as it passed through the middle ear. However, this increase only compensates for the loss of energy that eventually occurs when the sound enters the fluid filled inner ear. The net amount is actually a slight loss in energy, and if you see the entire equation this is clear. In order to make this point he taught us, “There ain’t no such thing as a free lunch” (TANSTAAFL), meaning that even if something seems like it is free, there is always a cost, no matter how indirect or hidden.

While I didn’t retain much of my hearing science knowledge, I remembered TANSTAAFL, and ME/CFS reminds me of this every single day. It’s as though I am an old fashioned wind up clock ticking along and then running down. As I run out of energy my tick tock sound gets slower and slower.  I sit on the table for various intervals, until someone randomly walks by, sees me and decides to rewind my mechanism. I may be mid-way between fully wound and fully spent; sometimes they rewind me all the way, and other times just a few rotations. I never know how much energy I really have. I just keep tick-tock-ing at whatever level I am capable given the amount of energy at any one time.

I worry. I worry that if I stop ticking I’ll suffer a slow, progression of this awful disease that forces me to stop moving.  It’s not because I want to stop moving, or because I’d rather sit around than be active. Nothing could be farther from true. But every time I feel well enough to move, and I get out there and do the things I love, at a much reduced level than before the disease I am left feeling a relapse of symptoms for days, weeks or months. This is not motivational, but fortunately I was an athlete before becoming sick, and I am a determined person.

I do all the good things I can to stay in control of my symptoms as best I can. I avoid foods and drinks that my body doesn’t tolerate, and I take only the few medicines and supplements I really need. I insure ample good quality sleep, drink plenty of water, get regular massage, meditate, walk, do yoga, advocate, and I paint. Although this practice gets me close to maintaining some sort of balance between staying somewhat active and being too sick to move, unfortunately none of this is enough to create what could even loosely resemble a full life. I am unable to work, unable to travel without relapsing, unable to participate in sports at a level I would like, and socializing is minimized. So, to quote a famous movie, “I’m not dead yet”, but I’m not really living either. I’m occupying no man’s land with the rest of my fellow patients, and none of us wants to be here.

 

Guest Post: Homeless

February 10th, 2014 24 comments
Credit: Jacquelyn Martin

Credit: Jacquelyn Martin

I continue to struggle with the crash from hell, but Joe Landson has graciously stepped up to provide a guest post. His chance encounter on the streets of Washington, DC gave him a powerful insight into our own advocacy situation.

One Sunday in early January, I mustered the energy to take my mother to the National Gallery of Art in Washington, DC, just a few blocks from the Capitol Dome. We walked past a steam grate with the usual collection of homeless men gathering warmth from it. However, one man was different, and stood out. First, he was white. Second, he was very young. Third and most oddly, he made direct eye contact with me, following my movement as I walked past holding an umbrella over my mother. The moment stuck with me, but what could I do? My first duty was to my mom.

The next morning I saw this article about him. For those of you who don’t have time to read the article, an Associated Press journalist photographed the very same man for a story about the cold snap here in the mid-Atlantic. While scanning the news, a friend of friend recognized the young man’s published photo, and alerted his parents. They in turn brought him home to upstate New York. He had disappeared from their house on New Year’s Day.

Yes, it is the same man as the one I saw. I recognized him instantly in the article photo, and the Federal Trade Commission building is directly across from the National Gallery of Art, where my mother and I went.

At first, I couldn’t help but wonder at how unlikely and lucky this rescue had been. Then I wondered if his rescue would ‘take’, if whatever compelled him to leave would be resolved, or if he would be back out on the street again in a month or three. And then after that, I wondered if he was us.

We with ME/CFS are homeless patients with an orphan illness. No medical specialty has claimed us. We have no medical authority to trust. To casual observers, we are obviously lazy whiners; to those paying attention, we are an unsolved mystery. In any case, we are waiting on a steam grate for some random investigator to publicize an image of us that will produce a shock of recognition for the awful disease we know we have.

We are waiting for our image to be recognized, because it’s hard to believe that anything we say makes any difference. I certainly get that feeling from the many meetings I have attended. Certainly nothing the homeless man said in a news interview could have mattered to the journalist, even if she wanted to help him. He was, quite literally, background for a story. But publishing his photograph possibly helped more than anything else she could have done.

It has been said before: 80 percent of success is showing up. So I’m beginning to wonder if all we can do is show up and wait – in other words, the two things we are least able to do. We desperately need help now if we are to recover anything resembling lives for ourselves. We only survive the endless waiting by NOT showing up – by skipping out on work, family duties and events, and virtually every aspect of public life.

It is very, very hard for most of us to show up and be seen: By doctors who don’t get it. By disability adjudicators who don’t believe us. By government officials with no sympathy. We meet cynical contempt everywhere, over and over again. Yet I’m becoming convinced that being seen, like formerly homeless Mr. Simmons was seen online, is the only hope for us, the only effective thing we can do. We can speak all we wish, to demand attention and more research, and we have at least partly succeeded here. However our words are powerless to influence the medical ‘facts’, as the licensed fact-makers see them. To the doctors and researchers, we can only mutely present ourselves for observation.

 

There Is No Spoon

January 2nd, 2014 30 comments

After I read How To Wake Up last summer, Toni Bernhard was kind enough to answer some of my questions about the book and the Buddhist practices she suggests. You can read the full text of our conversation here. This post has been in the works for many months, and I have felt very guilty about the delay. But as it happens, the beginning of a new year is the perfect time for me to reflect and refocus. I’m happy to share Toni’s wisdom with you today.

buddha-with-flowersMost of the plans I had for my life were wiped away like marks on a dry erase board when I got sick in 1994. Career? Children? Even grocery shopping? Gone, all gone. But I don’t want to be a person who always complains about what I can’t do or how sick I feel. One of my greatest struggles is to find a way to be content, even in the face of this suffering. I have only succeeded in doing so because of my spiritual journey.

One of the things I love (and sometimes hate) about spirituality and personal growth is that there is always more to learn. I am a Baha’i, but I draw inspiration and strength from many religions and spiritual traditions. Toni Bernhard’s books, How to Be Sick and How to Wake Up, have taught me about a Buddhist perspective on coping with suffering. I consider Toni to be one of my Teachers, and her lessons on detachment and impermanence have really helped me.

Many days, I long for escape from my body, this illness, my disability, my confinement in my home, my isolation. In the early years of being sick, I watched a lot of television – A LOT. I was too sick to read or write much. It was all I could do to pay the bills once a week and cook a little bit. Ignorant about ME/CFS and post-exertional malaise (it was the mid to late 1990′s), I was in a permanent push-crash cycle. All I wanted was out. Even now, when my cognitive function is somewhat improved and aggressive pacing/activity management has evened out my functionality, I still want out.

Toni’s second book begins with the necessity of waking up, of engaging life fully as it is. But why would I want to do that? I asked Toni if it was easier to not wake up to the pain in life. Some days, I think ignorance is bliss and distraction is divine. But Toni told me, “It depends on what you mean by ‘not being awake.’ To me, not being awake is a source of pain in my life in the form of mental suffering. By that I mean that one aspect of waking up is waking up to the realities of the human condition, so that we’re not deluded about what to expect in life.”

This, I understand. When I pretend my illness isn’t happening, either by pushing through my symptoms or by distracting myself, it actually doesn’t reduce my suffering. I might feel better in the moment of denial, but it’s impossible to maintain indefinitely. Sooner or later, the truth smacks everyone upside the head. I can’t pretend that I’m not disabled. Toni is right: when reality pushes through the flimsy wall of denial, it hurts more. Not only because my denial has probably led to a crash or other negative consequence, but because I’ve been fooling myself. That causes more pain.

But facing life as it really is in the moment, whether it’s good or bad, is not enough. We not only have to be present with whatever is happening, we need to recognize that we can’t have everything we want. Being dissatisfied with the way things are only creates more suffering. And even if we get what we want, it will be impermanent and change will come again. I could regain my health tomorrow, but I would still face illness and death again in the future.

One of the things I’ve learned from Toni is “weather practice.” In her first book, Toni describes seeing pain (physical, emotional, spiritual) as impermanent like the weather. No matter what I am feeling, it will pass. It will change. Knowing that pain and suffering will give way to beauty and joy makes it easier to bear the pain. And knowing that joy will give way to pain helps me stay detached from the high, so that my heart doesn’t break when it ends. There is a quote from the Baha’i Writings that I love:

Grieve thou not over the troubles and hardships of this nether world, nor be thou glad in times of ease and comfort, for both shall pass away. This present life is even as a swelling wave, or a mirage, or drifting shadows. – Abdu’l-Baha

lotus flower buddhaOne aspect of understanding impermanence and detachment has really troubled me. If everything is impermanent, and if wishing things were different causes pain, should we even try to make positive change? Certainly ME/CFS advocates want something different, as in all social justice movements. Many types of change or advancement in our personal lives comes from a desire for something more, something better. Does detachment mean giving up on achieving change? But Toni explained it to me this way:

Good things do come out of wholesome desires, such as the desire to be a civil rights or health advocate. The type of desire that the Buddha was cautioning us against is tanha. It’s an intense self-focused desire that’s experienced as a need. It leads us to think that if only we could get what we want (or get rid of what we don’t want), we’ll find lasting happiness. But the universal law of impermanence dictates that nothing lasts forever  . . .

Second, the wholesome desires I mentioned—those based on good intentions, such as care and compassion for others—can also become a source of dissatisfaction and suffering if we become attached to the results of our actions. This mean, do your advocacy work—with all your heart—but know that you may or may not succeed in your efforts. That wholesome desire can turn into the painful desire of tanha when you begin to feel that you need to get the results you want.

I have experienced the difference between wholesome desire for positive change and the painful desire of tanha in the last few months. I am passionate about doing whatever I can to contribute to a positive outcome in the IOM case definition study. I want such an outcome for all ME/CFS patients, not just myself. But I have sometimes fallen into the trap of believing that I will never be happy if the IOM process fails us. I think about what a bad result would do to us, and it feels like an abyss that I cannot see past. These thoughts cause me deep despair, and then the advocacy work becomes a source of true suffering. I have to act with all my heart, as Toni says, but also be personally prepared for (and a bit detached from) failure. That is the only way I have found to prevent this controversy from completely crushing me.

But I don’t control my mind all that well. My thoughts run all over the place, and it is far from orderly or sedate. There is a fantastic quote in How To Wake Up that captures this brilliantly. Toni quotes Bhante Gunaratana as saying, “Somewhere in this process, you will come face to face with the sudden and shocking realization that you are completely crazy. Your mind is a shrieking, gibbering madhouse on wheels barreling pell-mell down the hill, utterly out of control and hopeless. No problem.”

I laughed out loud when I read this the first time, because this is EXACTLY what my brain feels like. And as Toni explains, there is tremendous peace and relief in that realization:

He’s pointing to the fact that we can’t control what thoughts and emotions pop into our minds. Knowing this is tremendously helpful to me because it means that the key to peace and well-being is not controlling what thoughts and emotions arise, but learning to respond skillfully to them. . . .

The last step in that process is to “let it be” which, for me, is the best way to handle this crazy mind. We let it be by acknowledging whatever we’re feeling, without judgment or aversion. Then we patiently wait for the stressful thoughts and emotions to yield to the universal law of impermanence and pass out of our minds, while evoking compassion for ourselves over any suffering they’re giving rise to.

let goToni has helped me realize “we control a lot less than we think we do in life. When we can see this and accept it, then we’re better able to ride life’s ups and downs without being tossed around so much.” That sense of calm, peace and well-being is what I yearn for. Toni, in her kind and gentle way, has taught me that this is a possibility in each moment, and then the next, and the next.

I cannot force my life to conform to what I want. In reality, I have never been able to do that. All those plans I had that were wiped away by ME/CFS? There is no certainty that I would have ever achieved them anyway. In fact, the nature of existence is that at least some of them would not have come to pass. What I never grasped before reading Toni’s books is that, to quote the movies, there is no spoon. I cannot bend life to my whims, therefore it is I who must bend. Bend, and never break. Toni says:

Understanding that my dissatisfaction with my life can be traced to not getting what I want has helped me tremendously. I realized that I’m left with a choice—spend my days in frustration and dissatisfaction (dukkha) because I can’t get what I want (my health restored) or accept that I’m sick and that, although I’m doing my best to recover, I might not. In fact, I may be sick the rest of my life. I feel much better mentally when I’m able to give up the constant desire to get well. One reason that I feel much better is that it frees me to look around and see what life has to offer to me, even with this illness.

2013 was a brutal year for me. Our family dealt with multiple illnesses and surgeries, and my closest friends faced a number of difficulties. We joked that no one should want to be near us because we seemed to carry such a cloud of bad luck. But instead of seeing the year as the worst of my life, I’ve tried to reframe it as a year of miracles. We had many close calls, but my family is intact and on the mend. I have so much to be grateful for, even today when I am confined to bed for the third straight day this week.

Toni has taught me to accept the reality of whatever is happening, to detach from unhealthy desire, and to recognize that even the worst year of my life was not permanent. Being able to separate myself from my burning wants and do-not-wants, even for a moment, brings relief. It helps me be compassionate towards my body, working so hard to keep me going. It buffers the pain of disappointment and fear, and reminds me to focus on what matters most. And like every spiritual practice, it takes practice. I must detach, then detach again, then remind myself to detach again. Trying to govern my completely crazy mind is frustrating, but also an opportunity for hope. If I cannot detach in this moment, I can try again in the next.

 

My Feedback to the Institute of Medicine

December 19th, 2013 34 comments

Today, I submitted the following letter to the Institute of Medicine with my feedback on the panel for the Diagnostic Criteria for ME/CFS. Seven other advocates signed the letter: Chris Heppner, Claudia Goodell, Joe Landson, Denise Lopez-Majano, Matina Nicholson, Darlene Prestwich, and Tamara Staples.

Thank you for this opportunity to provide feedback on the Institute of Medicine’s provisional committee appointments for the Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. In order to understand the significance of my concerns, I believe you must first understand the damaging legacy of the psychogenic view of ME/CFS. Then I will share my specific feedback about the panel’s composition.

Legacy of Psychogenic Explanations for ME/CFS

For more than thirty years, the psychogenic model dominated the medical mainstream view of ME/CFS. Patients were labeled malingerers with “yuppie flu.” Allegedly, they could not cope with stress, indulged their psychosomatic symptoms, received secondary gain from disability, and simply needed to get therapy and more exercise. I have never met an ME/CFS patient who did not receive this message from at least one doctor.

Through the 1990’s, science seemed to confirm this model. Every investigation for a causative infectious agent failed. Contradictory results prevented the validation of diagnostic biomarkers. And psychologists published data showing that cognitive behavioral therapy and graded exercise therapy produced positive outcomes.

But ME/CFS patients, expert clinicians, and some researchers knew that the data were flawed. Mixed patient cohorts likely contributed to many of the contradictory results. Many of us followed the advice of well-meaning healthcare providers and tried to exercise ourselves out of disease. This therapy was not a treatment, and adverse side effects included relapse, exacerbation of the disease, and increased disability.

Science soon emerged to confirm what we knew empirically. Studies showed that ME/CFS patients have different physiological responses to activity as compared to multiple control groups.(1) Many body systems are implicated in the causation and perpetuation of ME/CFS. Field-testing of multiple case definitions measured what we already knew to be true: that some case definitions incorporated people with primary psychological conditions like depression, along with missed cases of multiple sclerosis, lupus, thyroid disease and primary sleep disorders. (2) Given the ample data showing physiological differences between ME/CFS patients and patients with depression and other illnesses, the inclusion of subjects with primary depression in CBT and GET trials is a fatal flaw in study design.

The psychogenic model of ME/CFS should have faded into obscurity by now. But it persists in open supporters of the hypothesis, and in less overtly expressed attitudes among scientists, doctors, and policy makers. Our long experience with the destructive effects of psychogenic pronouncements has taught us to be wary of these unseen and unvoiced assumptions.

Insufficient Representation of Subject Matter Experts

I acknowledge the selection of seven well-known and well-regarded ME/CFS experts to the panel. I am confident in their individual and collective abilities to examine the data and share their experience with the full group. However, given the nature of the panel’s task, I believe that more ME/CFS experts should be added to the panel.

In creating “evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians,” the panel needs both fresh examination of the data by outsiders and consideration of the collective experiential knowledge of those who know this disease. Research and clinical care in ME/CFS has typically been small-scale and distributed widely among the people doing this work. Only when a critical mass of experts combines their knowledge, such as at the NIH ME/CFS State of the Knowledge Workshop in 2011, do the disparate themes come together in a cohesive picture.

My concern is not a numbers game with the goal of reaching a certain percentage of representation. The panel is missing key expertise:

  • First, the absence of a cardiologist is notable. While Drs. Keller, Lerner and Rowe have relevant experience, dysautonomia is too prevalent in ME/CFS for it to be only marginally addressed. Adding a panelist with expertise in postural orthostatic tachycardia syndrome, vasovagal syncope, and/or neurally mediated hypotension is appropriate. I suggest Julian M. Stewart, M.D., Ph.D. or Marvin S. Medow, Ph.D., both at the Center for Hypotension, New York Medical College.
  • Second, there is only one infectious disease specialist on the panel. This is a significant gap in expertise, given the unsuccessful hunt for a causal pathogen in a disease that has all the hallmarks of an infectious trigger. Dr. Martin Lerner is capable, but I suggest adding at least one more infectious disease specialist. Ian Lipkin, M.D., is Director of the Center for Infection and Immunity at Columbia University. An epidemiologist by training, Dr. Lipkin is known for detection of new pathogens and the role of infection in neurologic diseases. He also has experience in ME/CFS-related research. Another candidate to consider is Jose G. Montoya, M.D., Director of the Stanford ME/CFS Initiative and Professor of Medicine in Infectious Disease at Stanford University Medical Center. Dr. Montoya is a clinician-researcher in ME/CFS and also studies the role of infection in chronic disease.
  • Third, as the FDA recognized in their Voice of the Patient report, cognitive problems are a prominent part of ME/CFS. Gudrun Lange, Ph.D. of Beth Israel Medical Center is an expert in cognitive dysfunction in ME/CFS, and would be a strong addition to the panel.

Finally, the absence of psychologist Leonard Jason, Ph.D. from the panel is very troubling. As I am certain you are aware, Dr. Jason has done more work on field-testing ME/CFS case definitions than any other individual. His publications have demonstrated the inadequacies of the Fukuda and Oxford definitions, the correlation between more symptoms and psychopathology in the ME-ICC definition, and have shown that measuring frequency and severity of symptoms distinguishes patients with ME/CFS from those with fatigue alone. (3)

I recognize that one or more of the individuals I am recommending may be unwilling or unable to serve on the IOM panel. I urge you to harness their expertise in other ways. This is particularly true for Dr. Jason. If he cannot serve on the panel, I believe it is essential that he be invited to present to the committee and that his work be a significant part of the panel’s deliberations.

Investigating Bias in Three Panel Members

I believe that three members of the provisional panel may have bias that would preclude their service on the committee. I understand that the IOM’s Conflict of Interest policy bars individuals with bias from panels only when “unwilling, or reasonably perceived to be unwilling, to consider other perspectives or relevant evidence to the contrary.” (IOM Conflict of Interest Policy, p. 4). I also acknowledge the difficulty of assessing bias at a distance. Therefore, I request that IOM discuss and thoroughly consider the potential biases of these three panelists.

First, Dr. Margarita Alegria co-authored a paper on the prevalence and comorbidity of neurasthenia.(4) While this paper did not directly examine the potential overlap between ME/CFS and neurasthenia, I am troubled by the statements on page 1742 that CFS is “a controversial illness which has been argued to be a variant of neurasthenia,” and that individuals “may present with symptoms of neurasthenia, but may otherwise be misdiagnosed as having depression, anxiety, or CFS.” If Dr. Alegria believes that ME/CFS is actually a psychological condition such as neurasthenia, then her presence on the panel is unacceptable. I urge IOM to establish whether Dr. Alegria has such a bias, and remove her from the panel if she does.

Second, Dr. Theodore Ganiats has close ties to the American Academy of Family Practitioners. The AAFP has published inaccurate and incomplete material about ME/CFS as recently as 2012. (5) In fact, the AAFP’s material on CFS illustrates the outdated and incorrect view of ME/CFS that I discussed above, including the claim that childhood trauma raises the risk of the disease and that CBT and GET are effective treatments. (6) Furthermore, one of Dr. Ganiats’s close colleagues, Dr. William Sieber, has given presentations in which he has stated that CFS is caused by psychological problems. (7) IOM should establish whether Dr. Ganiats shares this psychogenic bias and whether he can truly consider the evidence to the contrary.

Third, Dr. Cynthia Mulrow led the last systematic evidence review on chronic fatigue syndrome conducted by the Agency for Healthcare Research and Quality in 2001. Her report stated, “The validity of any definition is difficult to establish because there are no clear biologic markers for CFS, and no effective treatments specific only to CFS have been identified.” (8) If Dr. Mulrow still believes that this is the test for establishing the validity of a definition, then she is not appropriate for this panel. The lack of “clear” biomarkers and specific effective treatment is due to the paucity of research funding. Many promising biomarkers and treatments need only sufficient investment to establish their validity. Furthermore, Dr. Mulrow’s 2001 article on the treatments for CFS states that there was no significant association between case definition used and treatment study outcome. (9) We now know that some case definitions select patients with psychological problems at a higher rate than others, and this must be accounted for in the panel’s analysis. Absence of evidence is not evidence of absence, and everyone on the panel must realize this. Given Dr. Mulrow’s 2001 publications in support of CBT and GET, and the risk of her inability to fairly consider all the evidence, IOM should establish whether she has an entrenched bias.

Conclusion

I acknowledge that I was among the ME/CFS advocates who vigorously opposed the contract with IOM when it became public in September 2013. I remain skeptical of whether the committee’s report will lead to better diagnosis and treatment for all the people suffering from this debilitating disease.

I urge IOM to add more ME/CFS experts to the panel, such as Dr. Stewart, Dr. Medow, Dr. Lipkin, Dr. Montoya, Dr. Lange, and Dr. Jason. All of these scientists will contribute knowledge that is essential to the panel’s task. I further urge IOM to thoroughly investigate and establish whether Dr. Alegria, Dr. Ganiats, and Dr. Mulrow have biases that should disqualify them from service.

Sincerely, and on behalf of the undersigned,

Jennifer M. Spotila, J.D.
Writer, occupycfs.com

Chris Heppner, Ph.D.
Vice President ME Victoria, BC

Claudia Goodell, MS
Patient Advocate- Race to Solve CFS

Joseph D. Landson
ME/CFS Patient and U.S. Navy veteran

Denise Lopez-Majano
Speak Up About ME
Parent, caregiver, advocate

Matina Nicholson
Patient Advocate

Darlene Prestwich
Patient Advocate

Tamara C. Staples
Patient, 15 Years
Patient Advocate, 5 Years

References:

(1) Light, AR, Bateman L, Jo D, Hughen RW, VanHaitsma TA, White AT, & Light KC. Gene expression alterations at baseline and following moderate exercise in patients with Chronic Fatigue Syndrome and Fibromyalgia Syndrome. Journal of Internal Medicine, (2011) 271(1), 64–81.

(2) Jason LA, Najar N, Porter N, & Reh C. Evaluating the Centers for Disease Control’s Empirical Chronic Fatigue Syndrome Case Definition. Journal of Disability Policy Studies, (2009) 20(2), 93–100.

(3) Jason LA, Sunnquist M, Brown A, Evans M, Vernon S, Furst J, Simonis V. Examining case definition criteria for chronic fatigue syndrome and myalgic encephalomyelitis. Fatigue: Biomedicine, Health & Behavior, Epub ahead of print, accessed Dec 11, 2013: http://www.tandfonline.com/doi/abs/10.1080/21641846.2013.862993?journalCode=rftg20&#.UrEQ0Y06Kw8

(4) Molina K, Chen C, Alegria M, Li H. Prevalence of neurasthenia, comorbidity, and association with impairment among a nationally representative sample of US adults. Soc Psychiatry Psychiatr Epidemiol (2012) 47:1733-1744.

(5) Yancey J & Thomas S. Chronic Fatigue Syndrome: Diagnosis and Treatment. Am Fam Physician. 2012 Oct 15: 86(8): 741-746.

(6) http://www.aafp.org/afp/2012/1015/p741-s1.html accessed December 16, 2013.

(7) Sieber, William. Calming the Anxious Brain, accessed December 16, 2013. http://www.innersolutionsforsuccess.com/PPT/CalmingAnxiousBrain_Oct_2013.pdf.

(8) Mulrow CD, Ramirez G, Cornell JE, et al. Defining and Managing Chronic Fatigue Syndrome. Evidence Report/Technology Assessment No. 42). AHRQ Publication No. 02-E001. Rockville (MD): Agency for Healthcare Research and Quality; October 2001.

(9) Whiting P, Bagnall AM, Sowden AJ, Cornell JE, Mulrow CD, Ramirez G. Interventions for the treatment and management of chronic fatigue syndrome: a systematic review. JAMA. 2001 Sep 19;286(11):1360-8.

 

IOM Panelists: TL; DR

December 18th, 2013 8 comments

I realize that the past two weeks have been a veritable blog-alanche here at Occupy CFS. There’s been more research and writing here on the IOM ME/CFS panel than any other place online of which I am aware. I know that it’s very hard to get through so much material, and several people have requested the Too Long, Didn’t Read version of all the posts in a single list. I’m happy to oblige!

  • The IOM panel was announced on December 3, 2013. (see official roster)
  •  

  • I worked with nine other advocates to research each panelist. (see our methods)
  •  

  • We all had different views of how/whether to participate in the IOM process, but we set our differences aside to collaborate on this project.
  •  

  • We found no conflicts of interest, as strictly defined in the IOM’s policies.
  •  

  • We had a difference of opinion on whether things like NIH funding or other interests constituted a conflict of interest. (see our summary on COI and overall balance)
  •  

  • We agreed that there are not enough ME/CFS experts on the panel.
  •  

  • We do not categorically reject the presence of any psychologist/psychiatrist on the panel. After all, we all want Dr. Leonard Jason on the panel and he is a psychologist.
  •  

  • Dr. Ellen Wright Clayton, chair of the panel, has a JD/MD and specializes in ethics of genetic screening and research. (see our writeup of the “unknown” panelists)
  •  

  • Dr. Margarita Alegria is a psychologist specializing in mental health research in multicultural populations. We have serious concerns that she may believe ME/CFS is a psychological condition. (see our writeup on her bias)
  •  

  • Dr. Lucinda Bateman is an ME/CFS expert clinician-researcher, with a large ME/CFS clinic. (see our writeup on the “known” panelists)
  •  

  • Dr. Lily Chu is a clinician-researcher whose career has been hijacked by ME/CFS.
  •  

  • Dr. Charles Cleeland is a psychologist specializing in cancer pain and qualitative measures.
  •  

  • Dr. Ronald Davis is a renowned geneticist, and has a close family member with ME/CFS.
  •  

  • Dr. Betty Diamond is a rheumatologist specializing in lupus.
  •  

  • Dr. Theodore Ganiats has expertise in family medicine and healthcare outcomes. We have serious concerns about his close ties to the AAFP and a colleague who has said that ME/CFS is a psychological condition. (see our writeup on his bias)
  •  

  • Dr. Betsy Keller is an exercise physiologist studying ME/CFS.
  •  

  • Dr. Nancy Klimas is an ME/CFS expert clinician-researcher, with expertise in immunology and a large clinical practice.
  •  

  • Dr. Martin Lerner is an ME/CFS expert clinician-researcher, specializing in infectious disease. He is also a recovered ME/CFS patient.
  •  

  • Dr. Cynthia Mulrow is an expert on systematic reviews. We have serious concerns about her bias based on two CFS publications in 2001. (see our writeup of her bias)
  •  

  • Dr. Benjamin Natelson is an ME/CFS expert clinician-researcher and neurologist.
  •  

  • Dr. Peter Rowe is an ME/CFS expert clinician-research, with one of the largest pediatric ME/CFS practices in the country.
  •  

  • Dr. Michael Shelanski is a cell biologist specializing in Alzheimer’s disease. We are puzzled about his presence on the panel.
  •  

  • You have until December 23rd to submit feedback to IOM about the panel. (see how to do that here)

 

Once again, I have to acknowledge the group effort that made this series of blog posts possible: Lori Chapo-Kroger, Claudia Goodell, Chris Heppner, Denise Lopez-Majano, Mike Munoz, Darlene Prestwich, Tamara Staples, WillowJ, and one advocate who wished to remain anonymous. My sincere thanks to them all.

 

IOM Panelists: Balance = Experts + Information – Bias

December 16th, 2013 15 comments

The issue on everyone’s mind is whether the Institute of Medicine panel is the right group to come up with a new ME/CFS clinical case definition. Our team has been debating this for nearly two weeks now, and we have not reached a unanimous conclusion. But our research and discussions illuminate some key issues, particularly on the inclusion of psychologists and the possibility of bias in three panelists.
 

Enough Experts?

 
The overall panel balance is 53% known and 47% unknown to the ME/CFS community. None of us think this is sufficient, but we do not agree on what the right split would be. Some of us think the panel should be 100% ME/CFS experts; others think the addition of at least one or two more experts would be appropriate.

Mary Dimmock has raised a very important point: in order to judge whether this panel is adequate, we have to think about the task. If this panel is going to create a case definition for the broader set of conditions that meet the various CFS criteria, then some might make the argument that this panel is appropriate. But if the panel is focused on the disease we described to the FDA in April, then Mary concludes that the panel needs more, and a broader cross-section, of ME/CFS experts and fewer psychologists. As Mary has reported, HHS and IOM have been vague in detailing which disease group is the focus of the panel.

We’re faced with a chicken-egg dilemma: identifying the disease focus should happen prior to the panel selection, but instead we have a panel with a seemingly vague task focus. This panel composition seems to hold a middle ground: there are not an overwhelming number of ME/CFS experts, but neither are there an overwhelming number of experts in unexplained chronic fatigue, psychogenic models, or “other multi-symptom, complex disorders” as described in the Statement of Work. To our team, the key issue is bias.
 

Psyched Out

 
There are two psychologists on the panel: Dr. Margarita Alegria and Dr. Charles Cleeland. None of us are particularly troubled by Dr. Cleeland, as the focus of his career has been chronic pain (a significant problem for many ME/CFS patients) and outcomes measures. Dr. Alegria is another story, as discussed in the next section.

In a comment on an earlier blog post, AJ asked if panels on other diseases have included psychologists or psychiatrists. We did some research into the question, and found mixed results:

  • Psychologists/psychiatrists were included in panels on treatment for Gulf War Illness (5 of 15), epilepsy (3 of 17), living with chronic illness (3 of 17), chronic pain (5 of 19), and breast cancer and the environment (1 of 15).
  • No psychologists/psychiatrists were included in panels on Gulf War and infectious disease, veterans and Agent Orange, cardiovascular and chronic lung disease, hypertension, hepatitis and liver cancer, and ALS in veterans.
  • The only other IOM panel creating a case definition, the case definition for chronic multisymptom illness (aka GWI), includes 3 psychologists/psychiatrists out of 16 total members.

The ME/CFS panel includes 2 psychologists out of 15 total members.  Creating a case definition for ME/CFS will involve confronting the psychosocial literature and assessing its validity. For this reason, we do not categorically reject the presence of psychologists on the panel. However, we have serious concerns about psychologists who are ignorant of the methodological flaws in much of that literature. We are also concerned about the bias Dr. Alegria may bring to the task, and explore that in more detail below.
 

Bad Bias vs. Good Bias

 
The IOM Conflict of Interest Policy does not bar individuals from serving just because they have adopted positions on the issues facing the panel. In fact, the policy admits that members with potential biases might be necessary to ensure a competent and balanced panel. Bias will preclude committee service when “one is totally committed to a particular point of view and unwilling, or reasonably perceived to be unwilling, to consider other perspectives or relevant evidence to the contrary.” (p. 4)

There are multiple panelists with potential bias. For example, Drs. Bateman, Chu, Keller, Klimas, Lerner and Natelson have all taken public positions on ME/CFS case definitions. At least one team member personally knows each of these individuals, so we believe we can say that none of them are unwilling to consider other perspectives or relevant evidence.

Of greater concern to our team are three unknown panelists who may have biases that could be very harmful to the interests of the ME/CFS community. It can be challenging to assess bias at a distance based on publications, but we have legitimate concerns about three panelists: Dr. Alegria, Dr. Theodore Ganiats, and Dr. Cynthia Mulrow.

Dr. Alegria

As we mentioned in our profile of Dr. Alegria, she has co-authored three publications potentially relevant to her views on ME/CFS. The first two (here and here) address the relationship between somatic symptoms and psychiatric disorders like depression. Only 14 symptoms were assessed in these papers, and fatigue was not one of them. The papers found that having 3 or more of the 14 symptoms was associated with depression/anxiety and mental health service use. However, one of the papers correctly noted that the data are ill suited to infer causality between the physical symptoms and mental health issues.

After examining the third paper in its entirety, we came to mixed conclusions about whether it represents unreasonable bias on Dr. Alegria’s part. The paper builds on previous research showing that neurasthenia has the highest rate of comorbidity among ICD-10 disorders, and examines whether prevalence and comorbidity rates hold up across racial/ethnic groups. Comorbidity was examined only in depressive, anxiety and substance abuse disorders. Space does not permit a full parsing of the data here, including significant methodological limitations. Although the paper itself does not directly examine the relationship between neurasthenia and CFS, statements about CFS included in the paper have caused serious concerns among advocates. We carefully considered the statements and whether these are indications of unreasonable bias.

Likewise, as Lee [51] argued, the ‘‘disappearance’’ of culture-bound syndromes is related to changing sociocultural conditions, including economic and political factors and changes in managed care and pharmaceutical forces, to name a few. Indeed, chronic fatigue syndrome (CFS), also a controversial illness which has been argued to be a variant of neurasthenia [4, 21] has become increasingly diagnosed in the US [52, 53], whereas neurasthenia is virtually no longer diagnosed in the US context [51].

Many advocates are correctly concerned about the statement above that CFS is “a controversial illness which has been argued to be a variant of neurasthenia.” The first reference is to a thoroughly offensive article from 1991 that argued that CFS is a culturally sanctioned form of illness behavior.  The second reference is from 2007, but examined the concordance of CFS and three neurasthenia criteria in four medical practices in Pune, India. Neither reference can legitimately be used to support the statement that CFS should be seen as a variant of neurasthenia today.

After noting again that neurasthenia has almost disappeared from US clinical practice, the paper states:

This has implications for diagnosis and treatment of individuals who may present with symptoms of neurasthenia, but may otherwise be misdiagnosed as having depression, anxiety, or CFS.

This sentence can be read two ways. In one interpretation, neurasthenia patients are misdiagnosed with depression, anxiety or CFS because “neurasthenia” is not used in the US, and this does not imply that CFS as an entity is actually neurasthenia. In the second interpretation, people are diagnosed with CFS incorrectly because CFS is actually neurasthenia. Depending on which interpretation you choose, Dr. Alegria’s presence on the panel can be quite alarming, as she may have a simplistic, outdated view of ME/CFS or worse. But other team members see these few sentences in the paper within the context of Dr. Alegria’s research focus, which does not appear to reflect a tendency to classify patients with diagnosable physical conditions as having mental disorders.

Regardless of our personal interpretations of the meaning of these three papers, we all share a strong concern about her presence on the panel. She seems to have little experience relevant to an ME/CFS case definition at best, and potentially disastrous views if she does in fact believe that the physical symptoms of ME/CFS are equivalent to neurasthenia. Given the damaging legacy of psychogenic approaches to ME/CFS, we believe that her potential bias must be thoroughly investigated before the panel is finalized.

Dr. Ganiats

In our profile of Dr. Ganiats, we noted that Dr. Ganiats himself has not published anything directly indicating a bias on ME/CFS. However, he has been very closely associated with the American Academy of Family Practitioners. The AAFP has published problematic material about ME/CFS as recently as 2012. The AAFP’s consumer health information site presents a simplistic view of CFS, including the statement that “Most symptoms improve with time,” which is patently untrue, as many of us can personally attest.

We also noted Dr. Ganiats’ close association with colleague Dr. William Sieber. Dr. Sieber is a psychologist who has given presentations claiming that CFS symptoms are due to psychological problems. Dr. Ganiats has also published a number of papers on “quality of well-being” with Dr. Robert Kaplan, the Director of NIH’s Office of Behavioral and Social Sciences Research. We are wary of assuming bias by association, but Dr. Ganiats’s connections raise the possibility that he may have an outdated view of ME/CFS as merely fatigue of potentially psychogenic origin.

One team member suggested that Dr. Ganiats adds little to the panel as a general practitioner, especially since Dr. Bateman was a general practitioner for many years prior to opening her Fatigue Consultation Clinic. On the other hand, Dr. Ganiats brings his close relationship with AAFP and his experience in doctor-patient decision making to the table. But if Dr. Ganiats shares the views of AAFP or Dr. Sieber on ME/CFS, then he may have a strong bias towards the psychogenic view, or may at least be predisposed to broader views of the illness. This bias is unacceptable, and should be thoroughly considered by IOM before the panel is finalized.

Dr. Mulrow

Some readers took issue with our statement that Dr. Mulrow’s experience on IOM and in systematic reviews made her “very qualified to tackle the massive systematic evidence review that will be part of the IOM ME/CFS study.” And if her experience with IOM and reviews were the only question, that statement would be accurate on its own. However, as noted in our original profile, she has publications on ME/CFS that give us great pause.

Specifically, Dr. Mulrow led an evidence review on CFS in 2001 that concluded, in part, “The superiority of one case definition over another is not well established. The validity of any definition is difficult to establish because there are no clear biologic markers for CFS, and no effective treatments specific only to CFS have been identified.” It’s arguable whether this was true in 2001, but we certainly hope her view is different now.

Dr. Mulrow also co-authored a paper on treatment interventions in CFS in 2001 and based in part on that AHRQ review. Based on 2001 evidence, CBT and GET were considered promising treatments, despite some high drop out rates and lack of concrete outcome measures.

While the paper does say that effectiveness must be considered in light of those methodological issues, the analysis of these studies seems rather forgiving. The presence of multiple methodological problems did not preclude the studies being treated as highly valid. This points to potential risks in evidence-based medicine and meta-analysis approaches. The protocol for the review is established in advance, but if it is overly simplistic or has low inclusion criteria, the results of the review will reflect that lack of rigor.

Several team members feel very strongly that Dr. Mulrow is a potential problem on the panel precisely because of her systematic review expertise. They are willing to accept that she may bring an open perspective to ME/CFS itself, but fear that her process approach is ill-suited for an area that has been consistently underfunded for decades leading to an overemphasis on cheap (possibly less rigorous) science. Other team members feel that systematic review experience is necessary to help un-bias the view of the literature by setting evaluation criteria in advance. But again, if she is unwilling to approach the field as it is today then this is a problem.
 

Hiding in Plain Sight

 
There is one panelist who continues to stump us: Dr. Michael Shelanski. As we described in the original profile, he is a a pathologist focused on cell biology and animal models in Alzheimer’s disease. We don’t doubt his credentials in that field, but we fail to see how relevant that experience will be to creating a case definition for ME/CFS

Several big names in ME/CFS are missing from the IOM panel. The biggest head scratcher is Dr. Leonard Jason, who received at least seven nominations from the ME/CFS community. Dr. Jason is the authority on ME/CFS definition assessment and comparison. If he cannot serve on the panel for any reason, then his expertise must be harnessed by the panel another way.

The absence of infectious disease experts besides Dr. Lerner is another disappointment. Dr. Ian Lipkin and Dr. Jose Montoya each received at least five nominations. Dr. Lipkin is currently researching evidence for pathogens in ME/CFS, while Dr. Montoya is a clinician-scientist at Stanford University who spoke on a panel at the April FDA meeting. Either would be a strong addition to the panel to build on Dr. Lerner’s experience.

Dr. Christopher Snell received at least seven nominations, and is the leading expert on exercising testing in ME/CFS. But Dr. Keller is an adequate replacement, given her familiarity with Dr. Snell’s techniques and her own growing expertise in working with ME/CFS patients.

The IOM did not appoint a cardiologist or endocrinologist to the panel, and this is a disappointment. Cardiac and endocrine abnormalities have been part of the ME/CFS picture for decades, and both were listed in the Statement of Work (although not as requirements). While Dr. Natelson is a neurologist, inclusion of a researcher specializing in cognitive impairments in ME/CFS would also be advisable.
 

A Final Step

 
Feedback on the provisional panel is due December 23rd. Our next post will include the feedback we intend to submit, and we hope that other advocates will also participate in whatever way they believe is appropriate.

 

Acknowledgements: This post was a group effort, and would not have been possible without the assistance and participation of Lori Chapo-Kroger, Claudia Goodell, Chris Heppner, Denise Lopez-Majano, Mike Munoz, Darlene Prestwich, Tamara Staples, WillowJ, and one advocate who wished to remain anonymous.

 

IOM Panelists: Balancing Act

December 13th, 2013 43 comments

753625-seesaw_square_largeThere is a good deal more to discuss about the Institute of Medicine ME/CFS case definition panelists beyond their individual backgrounds (see the known and unknown panelists’ profiles). Our team has been grappling with those issues, not always achieving consensus. We hold a spectrum of opinions, and it forms an important context for providing feedback to IOM on the panel.

The Moral Question

The reasons for the ME/CFS community’s opposition to the IOM study have been extensively explored over the last three months. Part of the struggle has been over what to do about it. Some advocates believe we should contribute to the process in a constructive way by providing feedback on the panelists and input on the substantive issues. Others believe that participation in the process is not only pointless, but will actually legitimize an illegitimate process. They advocate unconditional and complete resistance to the IOM study, and state that no advocate should provide feedback on the panel. There are other views as well, and everyone is entitled to act on their views as they see fit.

Our team has mixed views on this question of involvement in the process. Several members lead organizations that have publicly stated their support for participation. Others struggled with whether to be involved in our research project, let alone in providing feedback to IOM. Obviously, given the intense investment of time and energy we have made, the ten of us believe there is value in examining the panel. Information is powerful, and one must first have that information in order to make effective use of it.

Conflicts of Interest

As I explored in a previous blog post, the IOM takes issues of conflict of interest (COI) and bias very seriously. In fact, a large portion of the panel’s first meeting will be spent discussing potential conflicts. Our team struggled with how to define COI and apply that definition to this panel.

The IOM defines a COI as “any financial or other interest . . . [that] (1) could significantly impair the individual’s objectivity or (2) could create an unfair competitive advantage for any person or organization.” In researching the panelists’ background, we looked for clear financial interests that could affect a person’s judgment on the ME/CFS case definition. For example, if a panelist had received payments from a disability insurance company, we believed that would be a clear conflict. We didn’t find anything like that.

Our team also discussed other financial interests and the potential effect on panelists. For example, many panelists receive government funding (chiefly NIH and Department of Defense), and we also found that some have received significant research or consulting fees from pharmaceutical companies. Does this funding represent a conflict of interest? Some team members believe that it does, in that a panelist would be more likely to do what the government wants because he/she feared losing future funding. The IOM policy specifically limits COI to current – not future – financial interests, but that did not reassure these team members.

The counter-argument is that if receiving NIH funding is a conflict of interest then almost all of the panelists – including the ME/CFS experts – would be disqualified. Dr. Klimas and Dr. Natelson receive significant NIH and/or DoD funding for their work. One team member felt that in their cases, the interests of their patients would outweigh the government’s potential influence through funding, but others were concerned about creating these sorts of exemptions.

How far does this go? If having an ME/CFS clinical practice is such a strong influence, what of panelists like Dr. Bateman or Dr. Lerner? They do not receive NIH funding as principal investigators (although they may be co-investigators), but do they have a conflict of interest because they earn a living from ME/CFS patients? And what about the influence of CDC? Dr. Bateman, Dr. Klimas and Dr. Natelson are all participating in the CDC’s multisite study. Dr. Bateman, Dr. Natelson and Dr. Rowe have recently appeared in the CDC’s physician education programs. Furthermore, there are two panelists who will be personally and directly affected by the panel’s recommendations. Dr. Chu is a patient herself and Dr. Davis’s son is very ill. Any new case definition will have a direct impact on their lives. Does that mean they have a conflict of interest?

The challenge in assessing conflict of interest is to apply the definition evenly in all cases. If NIH funding is a COI, then everyone with such funding is out. If treating ME/CFS patients is a powerful influence on a panelist, then all those doctors are out. After much discussion, the majority of the team believed that things like NIH funding and clinical practice were not conflicts of interest. In addition, the IOM policy specifically allows panelists with COI to serve if they have unique and necessary qualifications. We believe that the points of view of patients are critical to this panel’s work, and therefore patient or family status should not be a bar to service.

Committee Balance

Selecting the IOM panel is not just a matter of individual expertise, but also the overall balance of viewpoints. Do the panelists’ views balance each other out, with no particular view dominating? Will they collectively be able to discuss and consider the full spectrum of issues?

The IOM Statement of Work listed the desired committee expertise. How well does this panel address that?

  • pathophysiology, spectrum of disease, and clinical care of ME/CFS (Bateman, Chu, Keller, Klimas, Lerner, Natelson, Rowe)
  • neurology (Natelson, and potentially Shelanski)
  • immunology (Diamond, Klimas, Natelson)
  • pain (Cleeland)
  • rheumatology (Diamond)
  • infectious disease (Lerner)
  • cardiology (no cardiologists, although Keller, Lerner, and Rowe have relevant experience)
  • endocrinology (none)
  • primary care, nursing, and other healthcare fields (Ganiats, Bateman, Alegria)
  • health education (Bateman, Ganiats, Klimas, Rowe)
  • and the patient/family perspective (Bateman, Chu, Davis, Lerner)

One member has experience in systematic reviews (Mulrow), and another has extensive experience in outcomes measures (Cleeland). Two or three may potentially take a behavioral view of ME/CFS (Alegria, Ganiats and Mulrow), but at least six can speak directly to pathophysiology (Bateman, Chu, Klimas, Lerner, Natelson and Rowe). Six panelists have co-authored previous ME/CFS definitions and/or adopted a public position in support of CCC (Bateman, Chu, Keller, Klimas, Lerner, and Natelson), and five currently treat ME/CFS patients (Bateman, Klimas, Lerner, Natelson and Rowe). At least two panelists appear to have no prior knowledge of ME/CFS (Clayton and Shelanski).

Some team members do not want any psychologists on the panel regardless of their backgrounds, and a few felt that the panel should be made up completely of ME/CFS experts. Others felt that bringing in non-ME/CFS experts has advantages. All of us are concerned about the views of Alegria, Ganiats, and Mulrow. The absence of a cardiologist and endocrinologist are unfortunate, but hopefully at least part of that angle can be covered by the ME/CFS experts.

Overall, the committee membership seems fairly balanced. There is diversity of professional experience and of ME/CFS specific experience. While all of us would have liked to have seen more ME/CFS specialists, it is important to note that we have confidence that the specialists on the panel are fully capable of conveying their points of view. We don’t expect that Drs. Bateman, Chu, Keller, Klimas, Lerner, Natelson or Rowe are likely to be bullied; indeed, many of us have personally witnessed their willingness to speak their minds.

Next Steps

The IOM is accepting feedback on the provisional panel until December 23rd. Many, if not all ten of us, hope to provide such feedback. We are looking more carefully into several of the panelists, and will share our assessment in a future post.

 

Acknowledgements: This post was a group effort, and would not have been possible without the assistance and participation of Lori Chapo-Kroger, Claudia Goodell, Chris Heppner, Denise Lopez-Majano, Mike Munoz, Darlene Prestwich, Tamara Staples, WillowJ, and one advocate who wished to remain anonymous.