Presentation to the CFSAC
(Chronic Fatigue Syndrome Advisory Committee)
U.S. Department of Health and Human Services
Mary M. Schweitzer, Ph.D.
Washington, DC - October 29, 2008
Thank you for allowing me time to speak.
As I mentioned in my testimony last spring, I lost the experimental drug that had been keeping my biomarkers at bay since 1999 Ampligen, an experimental asymmetrical synthetic double-stranded RNA, which I received by twice-weekly infusions at Hahnemann Hospital in Philadelphia, at a cost of roughly $20,000 cash (not paid by my private health insurance or Medicare) annually. I have not found anyone from New York to Washington, D.C. (all of which are accessible to me because of Amtrak) who can give me Ampligen. I have lost all hope that I will get it back.
Before I went on Ampligen, I was found positive for reactivated Epstein-Barr Virus, the 37kDa Rnase-L defect, and Human Herpesvirus 6 (HHV-6), Variant A. My Karnovsky Disablity Score was 30, where 0 is dead and 100 is perfectly healthy. After being on Ampligen for six months, the markers and my worst symptoms disappeared. I went off Ampligen in October 2000, with a Karnovsky score of 70. One year later I relapsed. I could not get tested for the 37kDa Rnase-L, but I tested positive for HHV-6, Variant A, again. I went back on Ampligen in May 2002, and remained on Ampligen until February, 2008, when I lost the drug (because the head of the practice died and the FDA rejected the application by the doctor who had been treating me.) I have tried all the doctors I knew who used to give Ampligen, and asked around, and there is no one between NYC and DC who can give me the drug. I cannot move somewhere to get it, as I would have to live there for an indeterminate period and I would have great difficulty living apart from my husband.
Since late September I have had unrelieved symptoms: sore throat, swollen glands, headache, malaise, weakness, and a low-grade fever that comes and goes (it has been as high as 99.8). I do not trust my faculties to drive an automobile any more. In September I saw my specialist and tested positive for CEBV and a low natural killer cell count; I do not yet know how my HHV-6 or 37kDa Rnase-L tests went. There were other things that were wrong. My doctor and I are now considering what to do next. [Newer results from September testing: positive for cytomegalovirus and SPECT scan that showed abnormal decreased activity - and I'm still not as sick as I can get.]
I also scored very poorly on the VO2 MAX stress test (16, where 20 would be normal for an 80-year-old woman). The antibody count to my thyroid (I have had Hashimotos thyroiditis since 1995) was by far the highest I have ever seen it. I also tested positive for systemic scleroderma, something I have never been tested for before. Testing and symptoms indicate low amino acid absorption from my digestive system, and two IVs of amino acids while at my doctors (some 2000 miles away from my home) made me feel much better for a few days.
Had I instead gone to a regular family doctor (or even an immunologist), and the only information he had on how to test someone with the symptoms (and prior diagnosis) of Chronic Fatigue Syndrome, every test would have come out normal. In particular, my white blood cell count. (which many doctors use as a quick way to tell whether you have a serious infection) .was normal.. The doctor would have probably told me I had the flu, and had I come back later without the fever, who knows how I would have been treated. Perhaps I would have been given a "CFS" diagnosis, but increasingly that means a person who cannot "handle" normal living because of current or early stress. It would be way off the mark for what I do have, and I would not have received appropriate treatment.
The Appendices I have handed to you contrast the information given to doctors by the CDC on how to test people like me, with the information my specialist and I gained from other testing (testing that has been demonstrated through published research).
Going by the paragraph quoted in Appendix 3, I consider it probable that .I do not have chronic fatigue syndrome by any definition which the CDC uses today..
My basic cluster of symptoms is common to patients who were in the Incline Village, NV, cluster outbreak of the mid-1980s. I found this out originally because I kept asking around on internet until I found people who were mostly like me (I also resemble patients in England who were diagnosed with Myalgic Encephalomyelitis, not those who were diagnosed with Chronic Fatigue Syndrome, but they have not been able to get the testing I have). Later I would find that I had the same biomarkers as the Incline Village group in particular, the low natural killer cell count, 37kDa Rnase-L Factor, CEBV, and HHV-6.
I do not and never have scored positive for T + B Lymphocyte Short Profile (see Appendix 3), although I know others with my condition who do test positive for this set of markers. It may turn out that we are from different subgroups - but just because I didn't test positive does not mean those markers have not been helpful to other patients and their specialists.
To repeat - what I find most intriguing is that.the majority of patients in the Incline Village, NV, cluster outbreak of the mid-1980s have the same set of biomarkers I do.. This is the group that engendered the most publicity, and finally drew a pair of CDC demographers out to look at the 150+ patients who had fallen severely ill in less than a year. The eventual conclusion of the CDCs investigation of Incline Village would be a meeting held in 1987 by CDC and NIH to define a new disease entirely, using a name created a a year early by NIH researcher Stephen Straus as his best guess at what CEBV would be without the EBV. Chronic Fatigue. The name and the symptoms became known as the Holmes definition of CFS when published in 1988. The symptoms are notable because they bear such a close relationship to CEBV.
We have better testing available now, and we know much more about the intricacies of the bodys immune system, plus the complex array of pathogens that assault our bodies. We are indebted to all of the research that has gone into studying AIDS, because we now know so much more than we did twenty years ago. However, as patients diagnosed with CFS have tested positive for immune problems and viruses, using tools unavailable in the 1980s, the CDC has drifted farther and farther into the land of depression, anxiety, and stress, particularly early childhood stress. To put the last to rest: surely if CFS was due to early childhood stress, the children of wars and holocausts would be the most susceptible, and there is no evidence that is true. More to the point the search for yet another definition of depression and sources of stress have led the CDC away from the mounting evidence through biomarkers and pathogen testing that, as Byron Hyde used to say, .Chronic Fatigue Syndrome is a misdiagnosis.. Or, as the Fukuda committee concluded, eventually we would be able to identify subgroups new tests, new disease names, new markers. But the identification of subgroups has not led to any changes in the way the CDC approaches the disease indeed, as can be seen in Appendix 3, CDC is positively hostile to the information that has been gained in studying subgroups.
I no longer fit the CDCs definitions for Chronic Fatigue Syndrome. There are too many things obviously wrong with me (such as the VO2 MAX test and Hashimotos thyroiditis). I fit the profile of the Incline Village patients: low natural killer cell count, 37kDa Rnase-L defect, CEBV, and HHV-6. And when treated with antivirals and immune drugs, we all get better.
The evidence of damage from adult HHV-6 is now sufficiently strong that we even have our own ICD-9-CM code: 049.8.
Here is my question for you today:If the very people for whom the name "CFS" was first created no longer fit the CDC's diagnostic criteria for "CFS", then who is studying our disease? If the CDC's own diagnostic criteria from their CFS handout for physicians would have said I was perfectly normal, when it's clear from my other testing that I am very, very ill - What happens to patients with my disease when they go to a clinic or a family doctor for diagnosis? Where is the money for research, and where is the information for our doctors? Finally, given that this condition is clearly contagious, what damage has the CDC done to the health of the American public at large by keeping them, their physicians and their caregivers, ignorant of the dangers of my disease a condition that bears little resemblance to the disease they call Chronic Fatigue Syndrome.
Mary M. Schweitzer
Go to the CFIDS/M.E. Information Page
Mary Schweitzer's Essays on CFIDS/M.E.
Mary Schweitzer's Testimony to CFSAC and CFSCC