Wednesday, April 29, 2009

Mary's CDC Testimony

Thank you for allowing me time to speak.

I have too little time to get across so much, so I'm going to cut to the chase:.

* A completely new group should be created to operate and run the CDC's program on CFS. In the 25 years since the CDC was first contacted about the mid-1980s cluster outbreaks, the agency has done absolutely nothing to help a single patient, and done much that has harmed patients.
At least one million American adults have this disease. CDC admits that at least 85% of patients do not have a diagnosis at all, and half of all patients cannot work because of the severity of the disease. That's a failing grade by anybody's scale.
This is a travesty. This is a disease that is as severe as multiple sclerosis. The CDC's behavior over the past quarter-century towards these patients is completely unacceptable.

* CDC should immediately adopt the Canadian consensus diagnosis for clinical work. It a bit outdated now, but it paints a much more accurate picture of this complex and baffling illness. U.S. Drs. Dan Peterson, Nancy Klimas, and Martin Lerner were on the committee. And it does not rest on the theories of the narrow "biopsychosocial" school of British psychiatry. A summary of the Canadian consensus document can be downloaded here:

* In 1994, The Annals of Internal Medicine published what has come to be called the Fukuda Definition for research into the disease Chronic Fatigue Syndrome. Almost all the useful research on CFS was done using this definition. [Fukuda et al, "The chronic fatigue syndrome: a comprehensive approach to its definition and study." Annals of Internal Medicine, (1994) 121:953-959.]
However, in 2005-2006 the CDC shifted to the Reeves "international empirical" definition. The main difference between the Reeves definition and the Fukuda definition is that the Fukuda definition did not admit patients who had a diagnosis of depression for research purposes. Dr. Reeves lifted that constraint, with the proviso that the bout of depression have resolved at least FIVE YEARS before the ONSET of fatigue. [Reeves et al. "Identification of ambiguities in the 1994 chronic fatigue syndrome research case definition and recommendations for resolution." BMC Health Services Research (2003) 3:25. <>]
The "empirical" part of the definition refers to a set of questionnaires. Unfortunately, the questionnaires do not achieve the goals of the international committee to revise the Fukuda definition. The questionnaires were verified during a two-day hospital stay in Wichita, Kansas, where unfortunately only 6 patients identified with CFS during the 3-year community study conducted earlier by CDC were diagnosed with CFS with the questionnaires. The questionnaires identified 43 patients as having CFS, and at most only 10 could have been categorized as "CFS" using the Fukuda definition. That is a slim basis for a new definition, and a very slim basis on which to market a set of questionnaires. [Reeves et al. "Chronic fatigue syndrome - a clinically empirical approach to its definition and study." BMC Medicine (2005) 3:19. <>]

DePaul psychologist Leonard Jason demonstrated recently that, when applied to a set of patients in Chicago diagnosed using Fukuda, the questionnaires missed the sickest of the CFS patients, and a third or more of the patients now included had a major depressive disorder. Setting aside the depression, they still would not have met the Fukuda definition. [Jason et al, "Evaluating the Centers for Disease Control's Empirical Chronic Fatigue Syndrome Case Definition," Journal of Disability Policy Statistics (online first 10/21/08).]
Clearly this new definition represents not improvement but regression. I wonder just who will be helped by it – because patients with depression who are misdiagnosed as CFS are not going to be helped either, just as the worst cases of CFS will be left behind.
Therefore, I join with other patients in calling for a GAO investigation into the inequitable treatment CFS patients have received from CDC regarding both the allocation of funds, and their creation of a definition that ignores the sickest of the patients (who had been included in the Fukuda definition), and brings in patients with a professional diagnosis of major melancholic depression.

* The Fukuda article does not just set a definition for "chronic fatigue syndrome." Fukuda assumed that the patients diagnosed using this definition would represent a heterogeneous set, and that the next order of business was to go about identifying subgroups making use of biomarkers and objective measures.
That the CDC has steadfastly refused to do – instead turning to the new Reeves definition that actually makes the population even more heterogeneous than it was.

*My own history with ME/CFS:

I have had CFS since 1994, when I suffered a blackout in my office. When I came to, I could not understand a single work of the bluebooks in front of me. I was a tenured professor – you could say I made my living reading, analyzing, and giving lectures. But now I could not read, could not think, and could not express myself.

I prefer to use the designation M.E. for myself because I fit the Ramsay 1988 description of Myalgic Encephalomyelitis (M.E.), the Hyde descriptions (1992, 2006), and the technical definition in Stedman's medical dictionary. I also meet the Canadian consensus document's criteria for ME/CFS. M.E. and CFS are classified together under neurology in WHO's ICD-10 at G93.3. However, since the CDC does not recognize M.E., I will use "CFS" for the purposes of this essay.

The next four years I went downhill very quickly. By the fall of 1998 I had severe cognitive dysfunction, including expressive dysphasia, poor short-term memory, dyslexia, ataxia, and severe confusion. I could not pass a simple Romberg test. As an example of the severity of the cognitive dysfunction, I once poured a pot of coffee into a silverware drawer absolutely convinced it was a cup. At night I would fall into dreams where I could walk again, and awake to realize I could not.

I had constant pain behind my eyes and in the back of my neck, headaches that sometimes reached the level of migraines, muscle aches, and sore, swollen glands. On a bad pain day all I could do was lie in the dark, listening to my favorite movies.

In the fall of 1998 I was diagnosed for the 37kDa Rnase-L defect, yet another bout of active Epstein-Barr Virus, and active Human Herpesvirus 6, Variant A.

In February 1999 I began treatment with the experimental drug Ampligen, an immune modulator that also works as an effective antiviral. Within six months my symptoms had improved dramatically, and the three biomarkers disappeared. I could drive, I could walk, I could read a newspaper. I danced with my son at his wedding.

I went off Ampligen for a year, and then relapsed severely. So when I went back on Ampligen I was determined to stay on it, even though it cost my family out-of-pocket $20,000 a year.

[Note: Most patients don't make enough to afford $20,000 for a single medication. Many of my friends live alone on less than $12,000 a year; many of them have no health insurance – public or private – at all.]

A year ago February I lost Ampligen. It is supposed to be reviewed by FDA in May, unfortunately before the new FDA head will be in place. I have not been able to get it back, even paying for it - and I fear I will lose it forever.

By September I was in relapse. I have suffered from a low-grade fever for months, the severe pain in the back of my neck and behind my eyes is back, with the headaches. I have returned to the wheelchair. I cannot drive.

We can now add cytomegalovirus to the list of diseases. I scored 16 on a VO2 MAX stress test, which by itself would categorize me as disabled according to social security. A SPECT scan showed "decreased activity in left lateral temporal lobe and occipital lobes," and we can add a low natural killer cell count and function to the list of immune problems. We tried Vistide for the cytomegalovirus, but my liver rejected it.

I do not have a single day without pain. I do not have a single day without confusion.

I have testified to the CFSAC for ten years about these biomarkers, symptoms, and treatment. Did the CDC respond with interest in a possible subgroup? No. With deeply flawed statistical analysis that must have Popper whirling in the grave, and a complete misrepresentation of Occam's Razor, they take each possible biomarker and test it on a sample of CFS patients, then report back that everybody didn't have it, so it's not worthy of further study.

Well, yes. Everyone didn't have it. That is what you would expect out of a subgroup, isn't it?

*We do not have a "fatiguing" illness.

We were assured when the Holmes committee came up with the name "chronic fatigue syndrome" in 1987 that it did NOT mean fatigue writ large, that clinicians, researchers, and the public would understand it was a discrete illness, different from "fatigue."

Now the CDC has even betrayed that promise, creating the category of "fatiguing illnesses" and plopping CFS down in it as the poster child. I don't see leukemia there, or congestive heart failure. Just other poorly understood illness that - frankly – impact women far more often than men.

The current group's insistence that CFS is primarily a "fatiguing illness" shows the absence of any real knowledge of – or interest in – the disease as it exists for us out here, as we have it. We can't find doctors. Nobody understands what this is. That Reeves himself would dally with the concept of "fatiguing illnesses," especially in concert with British psychiatrists, shows that he either does not understand the disease – although surely he knows everything I know about it- or he does not really care. If you look at the pamphlets that CDC sends out to medical personnel who request information on CFS, you will find that they state starkly "There are no tests and there are no treatments." That is simply not true. They devote an inordinate amount of print to "CBT" (Cognitive Behaviour Therapy) – a type of analysis developed by British psychiatrists, using a different definition entirely for CFS, who claim that they need to "learn better illness beliefs," "GET" (Graded Exercise Therapy), which claims to be able to return patients to work with graded exercise, no matter how sick they start out, and the omnipresent SSRIs.

Imagine telling a roomful of patients with MS they would be fine if they just forgot to "play the sick role" and began to exercise again. What must Dr. Reeves think of us?

The name chronic fatigue syndrome was created in response to requests for attention to a number of cluster outbreaks, perhaps the best known of which occurred in north Lake Tahoe, on both the Nevada and California sides.

After 25 years, many of those patients remain severely ill, and others are doing okay only because they are on medicines that are either targeted at viruses or the immune system.

NONE of them would fit in the new Reeves definition.

Shouldn't the definition at least fit the patients it was commissioned to describe?

As I descend into Hades for the third time in my life, I beg you to please start over with this disease, and this time take Dr. Fukuda's imperative seriously – cooperate with the independent research centers that are already creating subgroups with biomarkers that also relate to a proposed etiology.

As I sat on the phone waiting for the chance to testify, imagine how I felt to have you segue into swine flu, and away from us. If the patients with swine flu end up with chronic viral infections or immune disorders like the one we have, will they also be completely abandoned by CDC?

There are good private research centers already out there, often in concert with a clinic –as examples, Dr. Nancy Klimas' CFS study group in Miami, and the new Whittemore-Peterson Institute (WPI) in Reno, Nevada. The WPI does not even have a building, but they are already producing cutting edge research into the viruses and immune dysfunctions surrounding this disease, using new tools made available for the study of molecular medicine. So there is reason for patients to be hopeful.

*What should the CDC be doing?

I see the role of the CDC not as primary researcher, but rather as the center that can pull in information from top researchers, in this case coordinate with the international research organization IACFS/ME to establish clinical definitions and identify subgroups, and then use the strength of the federal government to require the reporting of cases nationwide.

Currently you will not find a single article on the CDC's website for CFS that has not been authored by a person who was a member of CDC at the time. Most of the CDC's "bibliography" has Dr. Reeves' name on it. The CDC should not be someone's personal resume. Compare the CDC's bibliography on CFS with the bibliography on the back page of the Canadian Consensus Document (see above). The second bibliography ranges over a number of specialties and many authors. It is not a platform for a single person, or single point of view. THAT should be what doctors see when we go to CDC's website.

Rather than trying to do everything themselves, the CDC needs to go off-campus and make use of what's already there. As one example, there has recently been a lot of research, ignored by CDC, into what happens when more than one virus is activated at the same time. It would have been nice if CDC had funded more of that research, then paid attention to the results, BEFORE this new epidemic, wouldn't it?

As was suggested by the CFSAC (Chronic Fatigue Syndrome Advisory Committee to DHHS) in 2003, CDC should adopt the ICD-10 classification of CFS under neurology, together with Myalgic Encephalomyelitis (M.E.). The Canadian Consensus Document, recommended above, was written in response to ICD-10.

Finally, there is evidence that at some point in its lifetime "CFS" is contagious. Again, the CDC has ignored that – but they never really considered it. Hopefully they will do so before another 25 years has passed.

Please be aware that many of us have serious immune defects and are therefore more endangered by the possibility of a swine flu epidemic than the average citizen. We are especially concerned that there will be patients left damaged by this new flu strain who will, like us, still be sick 20 years from now.

In December I joined with a group of online ME/CFS patients to "meet" to discuss health care reform for the Obama-Biden transition team. The team chose a report from each state to publish on their website; ours represents my home state of Delaware. While the report was intended for the DHHS, the CDC obviously plays a prominent role. You can read the report at:

Mary M. Schweitzer, Ph.D.


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