Wednesday, June 13, 2012

CFSAC testimony: CDC must end use of toolkit and the Reeves "empirical" definition

Testimony to the Chronic Fatigue Syndrome Advisory Committee of the
U.S. Dept. of Health and Human Services
Wednesday-Thursday June 13-14, 2012
Mary M. Schweitzer, Ph.D.

Thank you for allowing me time to speak.

I’d like to express my admiration for the young people who testified today – I know how hard it was for them, and they did a great service. Thank you.

When you talk about educating people – whether teachers or physicians or the public in general – it comes down to the CDC’s website on CFS. Despite the changes you have made, that website remains both wrong and dangerous to patients.

CDC’s website on CFS continues to promote one particular viewpoint on CFS – that the disease can somehow be managed with cognitive behavior therapy and graded exercise. I was glad to hear the toolkit and brochures are going to be retired – but they should be burnt. That should be shut down NOW. Continuing the effective promotion of what is in there is simply wrong, and it harms patients in the real world – now. Why on earth are they still around?

The reference to cognitive behavior therapy signals the reader that the disease is really a somaticizing disorder – psychiatric, to be solved with psychiatric methods. Cognitive behavior therapy, or CBT, is very different from the pacing, or “envelope theory”, that most of us are taught to prevent the dangerous push-crash cycles we suffer. Saying that CFS can be fixed with CBT implies what British psychiatrists say out in the open – we appear to be sick because we are deconditioned; we are deconditioned because we have inappropriate beliefs about illness and CBT is necessary to teach us we really aren’t sick any more. That’s when the second half of the equation comes in – Graded Exercise, with the combination often called CBT/GET.

While the emphasis on CBT is misleading and a nuisance, promoting graded exercise therapy is downright dangerous. Researchers in the past few years have shown that patients with this disease do not operate normally in aerobic metabolism. We do not utilize oxygen in our cells as normal people do, and we do not expel carbon dioxide as normal people do. Without an understanding of this mechanism, graded exercise is dangerous.

Other research articles suggest that there are significant cardiac abnormalities in groups of patients with “CFS” (Fukuda 1994). Again, without understanding how this works, or how badly the patient is affected by it, graded exercise is dangerous.

Finally, studies conducted by patient organizations in the UK have consistently demonstrated that Graded Exercise harms more patients than it helps. If it were a drug – with more patients suffering adverse events than experiencing improvement - it would never get past FDA.

But – the CDC recommends graded exercise – on its website, and in the published material that is sent to anyone asking for information. This is not okay. End it NOW.

And please, end your relationship with British psychiatrists who work for insurance companies.

In fact, the only hard link to an institution outside the CDC remains in the section recommending graded exercise. It links to Dr. Peter White’s psychiatric CFS clinic at St. Bartholomew’s Hospital in London. White is chief medical officer of two insurance companies: Scottish Provident and Swiss RE.

What does Dr. White think of CFS? This is from an article published last month in the British Medical journal: "The requirement that conditions should be classified … either mental or physical … causes particular difficulty in the context of the functional somatic syndromes or somatoform disorders, in which physical symptoms are often assumed to have a psychological explanation. […] For example, chronic fatigue syndrome may be classified as myalgic encephalomyelitis (ME) within the neurology chapter (G93.3) of ICD-10, or as neurasthenia, a psychiatric disorder (F 48.0)."

Really? Does CDC believe that? CFS is a somatoform disorder? It may be classified as neurasthenia?

While CDC helpfully links us to Dr. White’s website, there are no links to American researchers or clinicians. None, zero, zippo, zilch. Why?

The most obvious reason – and another major critique I have of CDC’s website – is that the only research on that website is their own, often in conjunction with Emory University. For years the research was about childhood traumas somehow causing CFS. I see they have branched out to include cytokines – but I see no references to the researchers who have worked on the relationships between cytokine abnormalities and CFS for twenty years. If you go to the website, it looks as if CDC discovered it all by themselves.

We need CDC to give a balanced perspective on information about this disease. We need professional summaries of research in different disciplines – not the tiny little slices of the research pie that CDC allows us to see. And they should make use of the researchers and clinicians who have represented us on CFSAC (and the CFSCC) for almost twenty years. Why not?

Dr. Unger replied that they didn’t have to have a balanced bibliography or depiction of the disease because that is not what their website is for. It was just for saying what they were doing, period.

However, recently I heard from two different friends that there are new PSAs on the radio for “CFS”. Now, normally I would have been pleased with this. But at the end of the PSA, the listener is referred to … the CDC– to its website and/or the old toolkit for professionals and/or the new brochure, all of which remain woefully inaccurate.

It matters that CDC has deep biases in what it places on its website, and in its publications. Outsiders go to the CDC website and learn that we need cognitive behavior therapy and graded exercise – which does not in any way reflect the approach of American experts on the subject.

When I heard CDC’s testimony today, I had to wonder – where do I fit? Where do people like me fit? I have a diagnosis of Myalgic Encephalomyelitis and fit both the Ramsay and WHO definitions, as well as the 2011 International Definition (Carruthers et al, Journal of Internal Medicine). I have immune defects and am beset by viruses, some of which are in my spinal fluid. If you could not find anybody with viruses, then your subset was not patients like me. Why? Where do I belong then? What was wrong with your collection process that people like me were missing? Or if we were not missing, what was wrong with the way you did the research that we didn’t show up? Why are you hiding us? Why do you say this disease is such a mystery when it is not; that there are no treatments when there are?

Why isn’t there an MEAC - Myalgic Encephalomyelitis Advisory Committee?

There are at least one million Americans, of every class and ethnicity, with this disease. There have been cluster outbreaks in the past and there will be cluster outbreaks in the future.

This disease ruins whole lives. Children get it. Teenagers get it. It ruins families. Yet both CDC and NIH continue to spend virtually nothing on this disease. This has been going on thirty years – more than a generation. When will it end? How long do you think you can keep it a secret?

Postscript on definitios:

The Fukuda definition (1994) was only intended to be temporary until subsets of patients had been identified using biomarkers. If you actually READ the article itself, you will see that. CDC has done nothing in this regard. 18 years. Nothing.

The Reeves definition, sometimes misleading called “empirical,” is without any basis at all. In the lone article where he used his questionnaires on a set of 58 Kansas patients who had been diagnosed with CFS using Fukuda, he could only come up with SIX who met his definition. I would hardly call that a ringing endorsement. It should be dumped.

The Canadian definition of 2003 was created by a committee of seasoned clinicians after Canada adopted its own version of ICD-10 and placed both CFS and M.E. in the same category. It is intended for clinical use, but it has already been useful in research. If nothing else, use this definition.

Dr. Reeves always said there would be no references to different names or definitions until the community of scientists came up with one. Well – they have. Last summer a group of researchers and clinicians led by Bruce Carruthers published an article in the Journal of Internal Medicine, defining Myalgic Encepalomyelitis and offering a way to diagnose it. (I should note that Melvin Ramsay had a textbook describing M.E. in the 1980s – this has been ignored by CDC.) The new M.E. definition makes post-exertional exacerbation of symptoms – which can be measured objectively – the center of the disorder – not chronic fatigue.

This is what we need = acceptance of the diagnosis of Myalgic Encephalomyelitis with a scientific definition. For those diagnosed with chronic fatigue syndrome who do not meet the criteria for Myalgic Encephalomyelitis, I would recommend the Canadian definition – and if they don’t meet that, find out what they really have. And treat them.

CFS was a misstep. When the cluster outbreaks occurred around the United States in the 1980s, American clinicians did not know about M.E. because it was not used in the United States – epidemic neuromyesthenia had been used to mean the same thing, but there had been little about it after the 1970s.

Had those cluster outbreaks occurred in Surray, England, instead of lake Tahoe, or Lyndonville NY, or Rockville Maryland, or Hollywood, or Cherry Hill NJ – the patients would have been diagnosed with M.E. We would be much further along (I would hope) on diagnosing and treating patients.

Instead, CDC and NIH (represented by the late Stephen Straus) went its own way, adopting a made-up name for a disease that already had a name, a definition, and research. We have been set back 30 years by this misstep.

Time to go back to the name in place before that misstep – M.E. – time to accept that there already exist formal definitions for the disease, and time to quit saying its so mysterious, because it is not. Thank you.

10 comments:

  1. Bravo, Mary. Right on the mark, as usual. Thank you for representing us so well.

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  2. Thanks for representing us so well, Mary. Hope this trip didn't set you back too badly.

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  3. Thank you Sick in the South ... I didn't go this time because there was little notice and too much going on with my family's and my health care - I testified over the phone.

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  4. This together with Rik Carlson's VT CFIDS speech is dead on. Insurance is but one undue influence slowing the train. I'll believe CDC retires its crap when I can no longer read it. If Dr. Unger is the "concerned" "pathologist" Dr. Vernon would portray her as, she is more than compromised as a game player, and that compromises Dr. Vernon a lot of others.

    cdc.gov is for physicians and the public. In our case, CDC has chosen to misdirect both by hiding 25+ years of evidence and counting, to control the pace of the game and make it appear they're pulling lead, as Dr. Reeves made such efforts to show in his last public testimony. There is simply no need for another CDC primer telling current or future doctors what diagnoses to exclude.

    P.J. Langhoff has written her concern in regards to Lyme (Baker's Dozen), that science officially ignored today will be the future's newly discovered truth, either once the disease is simply too costly to gloss over, and/or certain parties are safe and set to profit as planned. One can sense the same happening with "CFS."

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  6. IMO "mysterious" accurately identifies one of the most important ways some of the denialists achieve their goals.

    Making a known disease seem mysterious is an act of extreme denigration in their hands.

    ===

    It is designed, as with everything else they do concerning these diseases, to delay all progress.

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  7. Thankyou..great stuff Mary :)

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  8. Mary,
    You consistently Lean In, as Sheryl Sandberg says in an entirely different context. You lean in and take on the challenging work, and we appreciate you so for it. Thank you.
    Pam Laird

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  9. I was just listening in on the YouTube advisory meeting held this summer. I am sick 12 + years and basically sitting quiet while docs mismanage this illness/disease and the government agencies add another year of nothing to my life (and that of so many others). As there is not other place to contact you Mary, can you tell me how you got a doc to measure your insufficiencies and viral content in your blood/tissue? My docs have done NONE of this testing...other than the normal blood panels and other heart related testing, brain imaging, etc. Nothing. I am sick at LEAST 12 years and as long as 30 and no real "proof" of this disease in testing other than low level of certain white blood cells and some cardiac arhythmias (sp?), and some thyroid issues as well. I live in Wisconsin and just wondered in all your testing, are there ME/CFS specialists to see that will do more? I have been left to my own device for all these years, as I know many others have. I am ashamed of my country's blatant disregard for other's lives...especially the young ones who acquire this disease and if they do nothing soon, have no chance at seeing "normal' living.

    Thank you so much to all of you who have testified or given credence to our plea for help.

    Eileen

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  10. I was lucky. Within weeks of my diagnosis, I was referred to a really good specialist in Washington, Marsha Wallace. Unfortunately, she no longer practices. But she knew Dharam Ablashi personally, and knew he was looking for patients to test for HHV-6, Variant A, which he had discovered in AIDS patients while working at NIH. So he tested me and would continue to until he retired. There are commercial labs that test for it - the HHV-6 Foundation has the addresses of some at it's website,
    http://www.hhv-6foundation.org

    I heard Dr. Robert Suhadionik give a presentation on the abnormal Rnase-L among patients in the Tahoe CFS cluster outbreak, and it made so much sense I wanted to be tested too. I had to wait for a commercial lab, and when that appeared in 1998 (Redlabs in Belgium), Dr. Wallace and Dr. Ablashi helped me get tested there. After 9/11 we were forbidden to send blood overseas (don't ask me why), so we had to wait for the establishment of Redlabs USA in Reno to get the test again. And pay cash. But I paid cash and got the tests. Unfortunately, I don't think you can get the test in the US right now.

    It made sense to do this because both HHV-6 and the 37kDa Rnase-L were predictive of improvement on Ampligen. If I was going to spend so much money on Ampligen, I wanted a biomarker. Even if I had to pay for it. And I got two, and both worked.

    Later I became a patient of Dr. Dan Peterson, going out to Tahoe once a year. When I lost Ampligen in Feb 2008 because the head of my practice died, I relapsed in Sept. 2008. Dr. Peterson did a lot of testing on me, some of it covered by insurance or medicare, but some had to be paid by cash. That's how I got the rest of the information, including the knowledge that I had both HHV-6A and CMV in my spinal fluid.

    For years CDC has ignored - or even derided - the information Dan Peterson has learned from patients in his practice over three decades - but it appears that perhaps the knowledge of long-term clinicians like Peterson, Klimas, Enlander, Bateman, Komaroff, Levine, Montoya - will get used. I sure hope so.

    BTW, the Wisconsin ME and CFS Association is really good - they may be able to help you find a local GP willing to work with a doctor from a distance. If they can't, I know they will help you with emotional and social support. Their website is:
    http://www.wicfs-me.org

    Mary

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