Wednesday, December 21, 2011

Why won't CDC study MY disease?

Testimony to the
Chronic Fatigue Syndrome Advisory Committee
U.S. Department of Health and Human Services
Washington, DC
November 8-9, 2011

Mary M. Schweitzer, Ph.D.

My testimony today will be about the CDC’s program on CFS.

I have been coming here since 1996. I have a number of questions that have never been answered. I will be asking my Congressional delegation to see if they can get answers if I cannot get straight answers this time.

Topic I – That paragraph on CDC’s website listing everything I should not be tested for because I have a diagnosis of CFS.

1. What is the scientific and scholarly rationale for the list of tests that should not be given to patients with CFS or suspected of having that is on CDC’s website? I testified about this as recently as last spring, and we were told it was to be removed. It has not been removed.

2. The primary rationale given for this list is that none of these tests can prove that a patient has CFS. That is accurate. However, many of them diagnose conditions and abnormalities that published peer-reviewed research has shown correlate with a diagnosis of CFS (Fukuda 1994). Is the only reason for testing to prove or disprove a condition? Do we do this with MS, cancer, AIDS?

3. Earlier this week NIH issued a major press release on the creation of a vaccine for Epstein-Barr Virus. Presumably, then, EBV is a serious disorder. That paragraph says not to test for EBV unless you are excluding a diagnosis of CFS. I have tested positive for EBV at least seven documented times. I just got over a recent bout of active EBV. Unlike the other viruses that are active when I am not on Ampligen (a Phase III immune modulator that I have been taking since 1999) EBV comes and goes. The press release makes it sound as if that is important information. I have three questions about that, then:

a) There is evidence that many patients with CFS (Fukuda 1994) begin their experience with the disease with a case of EBV. Do you think that might have been important information to include in the press release?

b) The press release was very strong on the hypothesis that EBV leads to cancers. If a person has numerous bouts of reactivated EBV, is he/she more likely to develop cancer? Do you even know? I’ll answer that: you don’t keep statistics on it, but Dr. Peterson does. The answer is a preliminary yes. I happen to be one of them.

c) If I have recurring bouts of EBV, does that mean I do not have CFS? (At least 7 times documented in the past two decades.) What then would my diagnosis be, and could somebody communicate that to the infectious disease specialists in my home state of Delaware, the people who run Medicare, and the people who run Blue Cross/Blue Shield?

d) According to my current doctor, Derek Enlander, I came to him with viral encephalitis. Can we change all my records to say that? Do you think it has anything to do with being positive for EBV, CMV, HHV-6A, HHV-7 - with both CMV and HHV-6A positive in my spinal fluid? (I also have Cocksackie B.) Where do I fit in that paragraph now? Should I not have been tested for viruses? Is this evidence unimportant?

4. We can go through this exercise with everything for which I test positive, because everything for which I test positive is in that paragraph. What does it mean that when off Ampligen, I have the 37kDa Rnase-L defect, a natural killer cell function barely off the floor (2% last time I checked), abnormal cytokine patterns, abnormal SPECT scans, abnormal VO2 MAX scores, diagnosed NMH/POTS, diagnosed Hashimoto’s thyroiditis and hypothyroidism. Symptoms of viral encephalitis and significant Central Nervous System disruption. Now what does it mean that I have recurring EBV, and chronically active HHV-6A, HHV-7, Cytomegalovirus, and Coxsackie B? Is this UNimportant?

Can you assure me that if these viruses are left untreated I will not develop cancer from them?

[n.b. The specific paragraph was removed, but CDC continues to insist these tests are meaningless.]


Topic II – The CFS Toolkit for Professionals

There is a new CFS Toolkit for Professionals on CDC’s website. In fact, there are two new versions of the “CFS Toolkit for Professionals.” Oh joy. One is a very pretty trifold. The other is the usual 8 ½ by 11.

Both of these versions of the “CFS Toolkit for Professionals” lean very heavily on “Cognitive Behavior Therapy” and “Graded Exercise” as the only remedies that can be offered patients with the disease.

When asked about it, in the past, CDC has always answered that counseling is often helpful to patients with a long-term illness. This is true. They have also always answered that deconditioning is unhealthy and therefore it is a good idea to get the patient moving. This is not necessarily true.

But the entire effort is deceptive. In the context of this disease, a very rigid form of Cognitive Behavior Therapy and Graded Exercise (abbreviated CBT/GET) is the subject of hundreds of refereed journal articles, and it is controversial. It is the only treatment offered to patients with diagnoses of “CFS” or “Myalgic Encephalomyelitis (M.E.)” (not the same thing) by Public Health Services in the United Kingdom.

So I must ask:

What is the scholarly and scientific basis for emphasizing CBT/GET in the material that CDC sends out to the public on this disease?

First we could ask – do they mean the rigid version that is in hundreds of referee journal articles? Perhaps at CDC they just don’t do their homework on these things. Perhaps they just take it at face value that these are no more nor less than offering counseling and physical therapy.

If that is true, why then does the CDC’s website refer to St. Bartholemew’s Hospital in London to explain what GET is?

The website at St. Bart’s (as it is familiarly known) is part of the clinic run by psychiatrist Peter White, who is also Chief Medical Officer of two insurance companies – Scottish Provident and Swiss RE.

As it happens, Peter White was one of three professionals asked to review the CDC’s five-year plan for CFS in 2009. His Conflict of Interest Form does not mention that he holds an executive position with two insurance companies. It says, “Peter White was not paid for his services by CDC; as a consequence, there is no conflict of interest.” Is that true? It doesn’t matter that he’s an executive at two insurance companies?

Well, for what it is worth, the program of CBT/GET that is recommended at St. Bart’s and British National Health Services – and by our own CDC – has been embedded in the policies of these insurance companies when it comes to reimbursing patients for medical care or granting them disability. Dr. White insists that patients go through a ten-week course of CBT and GET before they are permitted any other treatment and before they are allowed disability. If the patient cannot complete the course (i.e., physically collapsed), that is written down as having “quit” and therefore the patient is “noncompliant.” Funds denied.

Imagine my dismay to learn that my own Delaware Blue Cross/Blue Shield, which has been paying my doctor bills for over three decades, will not pay for my treatment for “CFS” at Dr. Enlander’s unless he first sends me to get ten weeks of Cognitive Behavior Therapy! Now, my Congressman is working on this, but gosh, THANKS for that.

Dr. White is also lead author on the very expensive PACE trials that were recently conducted by the UK to see if CBT/GET was effective. Amazingly, despite using a definition that allowed in patients whose primary medical condition was psychiatric, the trials were an abject failure. Improvement was slight and limited to a minority of patients, and even then, in order to state there had been improvement, the criteria for illness was changed at the end of the study such that patients who would have been considered sick at the beginning of the study were now considered well.

I can’t say that it builds much confidence in the reasons CDC chose for privileging CBT and GET on their website and in the two new Toolkit publications.

Well, perhaps that was the best they could do – perhaps it was all that is out there.

No, that’s not right either. To the contrary, there is a larger body of literature on biomedical abnormalities in patients diagnosed with CFS (Fukuda 1994) or M.E.

Right here on this committee are researchers and clinicians who work with biomarkers to characterize subgroups of patients with this diagnosis, and treat them accordingly.

Probably the most interesting of the published research is the work that biophysics researchers have conducted on the symptom that is called “post-exertional malaise” or “post-exertional fatigue”. (I prefer post-exertional relapse myself.)

Dr. Christopher Snell, Staci Stephens, and other members of Pacific Labs in Stockton, California, have published numerous articles on exercise testing of CFS (Fukuda 1994) patients. The most interesting was published a year ago. The researchers put patients diagnosed with CFS (Fukuda 1994 and Canadian 2003) through a VO2 MAX stress test for two days in a row. This test measures the ability of the body’s cells to utilize oxygen, and for the respiratory system to expel carbon dioxide, at peak performance. You cannot “game” this test. The controls were deconditioned, but otherwise healthy, adults.

Both groups scored the same on the first day (and here I must note that these were high-functioning CFS patients – my score on the first day is abysmal – 15, where anything at that level or below is considered an automatic disability by Social Security).

But on the second day, the couch potato controls either scored the same or improved a little because they were more used to the test. In contrast, the patients’ scores plummeted in half. Dangerously so.

And that is what is meant by post-exertional malaise (or fatigue or relapse).

Is it not clear how dangerous a prescription for “graded exercise” could be? CDC plays a silly little game with that, suggesting that the patient start with finger exercises. This is not silly. This is serious. Why not recommend the test itself?

There is more research that is being done in Utah by the Lights that looks at cell metabolism itself after exercise stress testing. There are ways that a patient might be able to function better – but anyone familiar with both research programs must conclude it is insane to just willy-nilly suggest to general practitioners around the United States that patients will be okay if they have Cognitive Behavior Therapy and Graded Exercise.

So – again I ask – why does that figure so prominently in CDC’s recommendations for doctors? Reseachers in the United States have produced much better answers – but they have been ignored in favor of psychiatrists in the United Kingdom who work for insurance companies.

I hate to say this, but … follow the money.

These “toolkits” are not just inappropriate – they are dangerous.

And what about someone like me? I was diagnosed with encephalitis when I relapsed off Ampligen. Perhaps that has something to do with all the active and reactivated viruses in my blood stream and spinal fluid – as one researcher commented, “Wow, your blood is really a toxic stew.” Shouldn’t you first deal with the infection and then try to recondition the patient?

So in addition to the questions I asked at the beginning of this paper, I would like answers for the following:

1. What is the scientific and scholarly basis for privileging the work of British psychiatrists in recommending “Cognitive Behavior Therapy” and “Graded Exercise” to physicians as the main avenues of treatment for patients who meet the definition for chronic fatigue syndrome (Fukuda 1994)?

2. What is the scientific and scholarly basis for ignoring the work of researchers and clinicians on this very body – CFSAC – when putting together these brochures?

3. Why is nothing said about the worst patients – those of us who are mostly bedridden and/or housebound? Research suggests that would be one/fourth of the total – 250,000 American adults in a state of serious invalidism – abandoned. Abandoned and impoverished.

4. Why is nothing said about school-age children and teenagers who get this disease? We have been asking for a demographic study since the late 1990s, when Congress mandated such a study at CDC, and CDC got caught spending the money elsewhere? At the time, Dr. Bill Reeves (head of the program for two decades) said he didn’t believe that teenagers got CFS, so it would be a waste of time to study them. Is that still CDC’s position?

5. Do you have any idea the damage you are capable of doing by handing school administrators and child protective services a CDC-sanctioned publication suggesting that all these kids need is exercise and psychotherapy? You should – there has been testimony to this effect at every single meeting of the original CFS-ICC, CFSCC, and CFSAC, going back two decades. Is anybody listening?

And that is my final question – is anybody listening?

7 comments:

  1. Bravo! You have such knowledge, such poise, such patience, and such collectedness. I remain so infuriated by their b/s I am certain that I would not be able to maintain my composure, as you do! I guess that's why I stick with my letter writing campaign. Keep up the great work! Your efforts make me smile.

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  2. Thanks Mary for putting all this together and testifying. I have posted links on Twitter, Facebook, Google+ and some mailing links, highlighting this bit in particular:

    "Imagine my dismay to learn that my own Delaware Blue Cross/Blue Shield, which has been paying my doctor bills for over three decades, will not pay for my treatment for “CFS” at Dr. Enlander’s unless he first sends me to get ten weeks of Cognitive Behavior Therapy!"

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  3. Thanks, Mary. I am an argentine and was diagnosed CFS / ME in 1998, at 46, without being explained what it wasand lost my job. Since then, I've practically have had no treatment (in public hospitals not much is known about it) and am completely on my own making ends meet on a psychiatric pension. The expression you use, "slightly alive", is a perfect description of my condition. Thanks for all your hard work and all the best.

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  4. Mary you had done good job for the people as well as for you. I am also suffering from this disease and finding a good doctor for treatment. If you know any good doctor in NJ then let me know.
    ----------------------------------------
    - Chronic Fatigue Symptoms

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    Replies
    1. New Jersey has a very good patient advocacy group. You should get in touch with them - I am sure they must have a list of good doctors. Their website is here:
      http://www.njcfsa.org/

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  5. Thank you Mary. Reading this, even though I am unable to leave my home from severe disability, it makes me feel hopeful to read this testimony given knowing there are those fighting the fight I am too ill to do myself. After the death of my husband left me to cope alone with this severe disability in 03 I had no idea the true nightmare my life would become. It is TERRIFYING!!!

    ((hugs)) to all who are ill with CFIDS and are then severely harmed by the treatment we receive in our efforts to survive and live.
    Patricia

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  6. Did you get a response?

    A written record of what you told them is evidence.

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