tag:blogger.com,1999:blog-13455731459579249582024-03-13T09:08:57.417-07:00Slightly AliveIn the Princess Bride, Miracle Max says, "Your friend here is mostly dead....Mostly dead is slightly alive." And so we are. I have diagnoses of Myalgic Encephalomyelitis (M.E.) and CFS. I have immune dysfunctions and persistent viruses: HHV-6A, EBV, CMV, and Coxsackie. HHV-6 and CMV are in my spinal fluid. I've had abnormal SPECT scans and VO2 MAX scores. I am an Ampligen responder. One million Americans suffer in silence from my disease, undiagnosed, untreated, alone. Slightly Alive.Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.comBlogger38125tag:blogger.com,1999:blog-1345573145957924958.post-62876195453814645132016-08-08T14:45:00.006-07:002022-04-30T15:48:17.678-07:00My 28 years with Myalgic EncephalomyelitisI have had Myalgic Encephalomyelitis, or M.E, for 28 years. The CDC does not recognize this. They insist that I have a condition called "Chronic Fatigue Syndrome," or CFS. I have M.E.<br />
<br />
At the age of 44 I led a charmed life. I had been married to the love of my life for 20 years, and we had two lovely children. We were both college professors - a deliberate choice that allowed us to do what we enjoyed - researching and teaching subjects that deeply interested us - while having the income to live comfortably (because we both worked) and plenty of time to spend with the children (because of the nature of academic life). We traveled all around the country going to each other's conferences, often taking one of the kids along. We also went to four Olympics, two final fours (NCAA basketball championships) and countless playoff games, several World Series, and, eventually, twenty years of baseball AllStar games. We skied in the winter and went to the beach in the summer. <br />
<br />
On October 24, 1994, I went to my office to grade exams and suffered a blackout. When I came to, I could not understand one word in the Bluebooks in my lap - they might as well have been written in Cyrillic alphabet. It took time - and concentration - to be able to stand. I had fallen down the rabbit hole; my life would never be the same.<br />
<br />
Over the next four years I suffered from severe pain in the back of my neck and behind my eyes, 24/7. My muscles ached, and I had migraine-level headaches. I had ataxia, dyslexia, sensitivity to light and sound (to the point I had to wear sunglasses all the time), tinnitus, partial paralysis, memory loss, disorientation, expressive dysphasia, and massive confusion. My family took care of me. Obviously, I could not drive, and by 1996 I was using a wheelchair when I left the house (which someone else had to push). My confusion was so bad I once poured a pot of coffee into a silverware drawer convinced it was a cup. When my family took me somewhere, one of them would have to fasten my seatbelt because I couldn't remember what those two things were for.<br />
<br />
Most of the time, however, my family went without me. Increasingly I spent most of my time lying curled up in bed in the dark, listening to a favorite movie (because I could not bear to look at the screen). I got around the house by balancing against furniture and my golden retriever, but increasingly I spent the entire day upstairs. By the end of 1998, I couldn't even brush my own teeth. All that time, just slipping by. <br />
<br />
I was lucky to have a family to take care of me, because I could not take care of myself. I also soon discovered an Internet discussion list of fellow sufferers, and was referred to a very good specialist in Washington, Marsha Wallace (who unfortunately hasn't practiced since 2000). Dr. Wallace taught me to live within my energy envelope and helped with sleep disruption and NMH/POTS, but I continued to deteriorate.<br />
<br />
In the fall of 1998, Dr. Wallace introduced me to Dharam Ablashi, a researcher who had just retired from the National Cancer Institute at NIH. Dr. Ablashi had been the co-discoverer of HHV-6 and it's two variants, A and B, while working with AIDS. I had the version the AIDS patients did - Variant A. My viral load was over five times the amount used to diagnose an active infection. Dr. Ablashi called my home and told my daughter, then in high school, to make sure I stayed in bed, because I was seriously ill. I was in bed already because I had little choice, but we appreciated his thoughtfulness.<br />
<br />
I would later positive for active EBV or mono (which I had more than once - most notably in 1990, four years before my collapse, during an outbreak on my college campus), CMV (cytomegalovirus), HHV-7, and three strains of Coxsackie B.<br />
<br />
My immune system was severely compromised: My natural killer cell function was less than 3%, I had the defective 37kDa Rnase-L, and I had an abnormal cytokine pattern. But no one knows how all this happened. All we know is that this disease can occur in cluster outbreaks, and it can pop up in individuals. No one in my family got it from me, but I believe the outbreak of EBV in 1990 marked the beginning of my illness - the beginning of the cycle of immune defect-virus-damage that characterizes this disease for many of us. I had to continue to teach through my infection with EBV, including an hour's commute and back, and while I recovered from mono at the end of the fall semester, my health began to deteriorate in seemingly disparate ways, until the ultimate collapse in 1994.<br />
<br />
Years later I would have a spinal tap that revealed both HHV-6 and Cytomegalovirus were active in my spinal fluid. No wonder I had the symptoms of encephalitis, and with the stiff neck, meningitis. Along with the muscle pain, that meant literally that I had Myalgic Encephalomyelitis, or M.E., a disease that had been diagnosed in the UK since the mid-1950s. In the United States, however, all I was given was a diagnosis of "chronic fatigue syndrome," a name chosen by committee and adopted by CDC in 1988 to replace the name given a number of cluster outbreaks occurring in the USA at the time, Chronic EBV. They did not mention M.E. - though there were specialists at the meeting who insisted that was the correct diagnosis for these outbreaks. They did not ask anyone in the disease community what they thought of this name. They simply adopted it, and having done so, consigned the disease to the backwaters of medicine where neither research nor treatment could be found.<br />
<br />
There could not have been a worse choice of a name for this disease if CDC had hired a focus group, Chronic (as in chronic whiner) Fatigue (as in "yeah, I've been feeling tired lately myself") Syndrome (as in syndrome of the month) - applied to upper middle class white women "trying to have it all" (as the late Bill Reeves of CDC once phrased it) - how inconsequential, silly even. <br />
<br />
Thirty-four years later, 85% of patients - over one million Americans - have no idea what is wrong with them, because, according to both CDC and private demographic evidence, only 15% have a diagnosis. 34 years since CDC formally recognized this illness, only 15% have a diagnosis. That is a mighty admission of failure.<br />
<br />
And while the majority of diagnosed patients are white and relatively higher income, the disease is equal opportunity with regard to ethnicity and income. It is more common in women than men, but the ratio is more 65:35 than the 95:5 that CDC and NIH used to claim.<br />
<br />
Back in 1994, the infectious disease specialists in northern Delaware dismissed my illness as minor. "You'll be back to normal in two years," they assured me. Oh good, I responded - I won't have to miss more than two seasons before I can go back to skiing. "Oh no," was the response. "You'll never ski again." How was that "normal?" I asked. They got angry at that. That's when I was referred to Dr. Wallace.<br />
<br />
Although the progressive version of M.E. that I suffered from was unusually severe, I turned out to be lucky. Through Drs. Wallace and Ablashi, I was given the opportunity to go on the experimental Phase III immune drug Ampligen, in what is called a cost-recovery (I pay cash), compassionate care (I am allowed to do this because I get so very sick), open label (I know I am on the drug so FDA ignores me) study. I have to get Ampligen at the study site by IV infusion twice a week. And FDA can take the drug away from me whenever they want.<br />
<br />
I have been on Ampligen for 17 of the past 23 years. Again, I am unusual in that my illness erupts again within a year of going off the drug (which I did once voluntarily, three times because FDA did take the drug away). FDA has admitted, in writing, that the drug is not toxic. But they are not "convinced" it is effective. My experiences do not count because I was not in a placebo trial; I knew I was on the drug. <div><br /></div><div>There is no other drug in the FDA pipeline for either CFS or M.E. (Although there are immune boosters and antivirals available for patients). This is the only one expressly targeted to M.E. or CFS. Over one million Americans suffer from my disease. FDA, CDC, NIH - none of them cares - though in fairness, it's getting better. Dr. Collins at NIH has at least assigned us a specialty - neurology - and although the disease is grossly underfunded, we are starting to get projects going with major universities. (I am currently in a study through Columbia University.)<br />
<br />
I wrote this while on Ampligen. On Ampligen, I can drive, take care of myself (mostly), walk, drive a car, read a book, work on my own writing, spend time with my children and grandchildren. Off Ampligen I am an invalid in bed in severe pain, curled up in the dark because light is too painful, listening to a favorite movie over and over. Again.<br />
<br />
As the years passed, it became more and more difficult to get Ampligen, because FDA refused to approve it. The last three years I spent in Delaware, I had to commute by train twice a week, 100 miles north, to Dr. Derek Enlander's office in New York City, the closest site where I could get Ampligen. I usually got home around 7 pm. It was grueling, but at least I was getting the drug that kept me from being a bedridden invalid. To be honest, I enjoyed going back to the City after years of being away, even though I did little else besides get my infusion and go back home. Dr. Enlander's office was on 5th Ave. and the bus ride from Penn Station brought back a lot of memories.<br />
<br />
Then in July 2013, my husband of 38 years, my best friend, my soulmate, died of bladder cancer. I just couldn't stay where we had lived for 35 of those years. So I moved to Incline Village, NV, on Lake Tahoe, where one of the best clinician/researchers in the country practices, Dan Peterson. (The most famous cluster outbreak of the disease in the US occurred here in 1984-85 - over 200 patients.) My infusions were now just two miles away. Dr. Lipkin at Columbia has called the version of ME/CFS that I have "the Peterson subset." There are a lot of patients here who have the same biomarkers I do. <br />
<br />
I was doing well at Tahoe, a good place for healing both body and soul ... and then we lost Ampligen again after January 2017. Dr. Peterson has gotten it back for 12 of us in a study with biomarkers that will hopefully suggest why it works so well for those of us for whom it is successful. It required coordination between a number of agencies, the company, and the site - lots of papers changed, signed, passed around, changed again. <br />
<br />
Over the next 18 months, I deteriorated to the point that I could only drive in the Tahoe bowl where the speed limit is 25 mph. I could not go over the mountain passes or drive 50 miles an hour. When I traveled, I needed wheelchairs. I have a very spiffy electric one that's taken me to more than one TCM classic film festival. But I had gotten to the point where I could read no more than a paragraph or two without the page turning back to cyrillic alphabet. Back to the 24/7 pain. No longer allowed to cook on the stove because I would forget and leave things there. For every minute of every day I felt as if I had the flu. The immune biomarkers were back; the viruses were back. My CPET was down to 16; my natural killer cell function 3%. Very frightening to stare down into the hole, knowing where I would end up - like Charley in Flowers for Algernon or Robert de Niro's role in Awakenings - this time, with no caregiver. <br />
<br />
And then ... we got the call! I restarted Ampligen August 6, 2018. At first you feel worse because your immune system suddenly wakes up and wreaks havoc with symptoms, but then it's just improvement. Takes about six months for me to start getting normal, but the best part is I know I am not in danger now of deteriorating more.</div><div>
<br /><i>
Myalgic Encephalomyelitis is a serious disease.</i>
<br />
<br />
CDC betrayed us by giving it a silly-sounding name in 1988 - CFS. NIH allocates less than $6 per patient per year to study this disease - a pathetic amount. After a report they commissioned from the Institute of Medicine came, saying this was emphatically <i>not</i> a psychiatric disorder, and that NIH needed to spend much more money on it, we were promised more funding - but so far, haven't received anything above the usual $5-6 million. See <a href="http://www.ncbi.nlm.nih.gov/pubmed/25695122" target="_blank"><span style="color: blue;">"Beyond Myalgic Encephalomyelitis"</span></a>.<br />
<br />
We came back with private research initiatives, funded by cash-strapped patients and their families, and more good biomedical research is being published than ever before. The whole concept of what "CFS" is, silly sounding name and all, is undergoing a transformation. And for the first time in my memory, clinicians and researchers have agreed on a definition - the Canadian Consensus Criteria, updated with current research. There are excellent research studies going on at Stanford, Columbia, and Cornell right now - but they get little, if any, NIH funding. Even Ron Davis, the Stanford scientist essential to the human genome project, can't get funding out of NIH for <i>this</i> disease.</div><div><br /></div><div>We are getting new attention now because there is a subset of patients with long-haul COVID who have precisely the symptoms I get. Even more, the very existence of long-haul COVID has created more research on post-infectious neurological illnesses - like M.E.<br />
<br />
The main study behind the government's prescription of psychiatric counseling and graded exercise, the PACE trial, has been exposed as a giant boondoggle - but at the moment, the scientific journal that published it, <i>The Lancet</i>, the institutions behind it in the UK, and the UK government, are still pretending they don't know how deeply flawed it was. See <span style="color: blue;"><a href="http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/" target="_blank"><span style="color: blue;">PACE: The research that sparked a patient rebellion and changed medicine</span></a>.</span><br />
<br />
Perhaps more important, why don't people outside our community - people in the media, in government, our doctors, our neighbors, our employers - why don't they know that there is a growing epidemic of a severe, life-altering and in some cases life-taking disease that CDC and NIH are keeping under wraps? I have friends who were teenagers when they got sick, and are now in their 40s. They did not get to marry their soulmate like I did. They did not go to college or have a career. They did not have children or grandchildren (I have two grandchildren now). I was lucky compared to them.
<br />
<br />
There are patients who are even worse than I was - completely bedridden, on feeding tubes. See <a href="http://www.25megroup.org/home.html" target="_blank"><span style="color: blue;">The 25% ME Group</span></a> and <span style="color: blue;"><a href="https://www.washingtonpost.com/national/health-science/with-his-son-terribly-ill-a-top-scientist-takes-on-chronic-fatigue-syndrome/2015/10/05/c5d6189c-4041-11e5-8d45-d815146f81fa_story.html" target="_blank"><span style="color: blue;">the story of Whitney Dafoe in the Washington Post</span></a>.</span><br />
<br />
They can barely afford to live from day to day. Few can afford the testing I have had - if they can afford it, they can't get anyplace that does it. They go untreated, hidden, silenced.<br />
<br />
I have lost too many friends to this disease; we have lost young people to this disease. A close friend lost her 23-year-old son to a massive heart attack. He had the disease, but no doctor would believe it. The viruses seem to be mostly in my nervous system in my case, but they can get into your heart muscles; they can wreak havoc with your digestive system; they can get into your liver. And then there are the suicides. I have lost so many friends that I find it difficult to go on Facebook any more.<br />
<br />
There has been a new series of outbreaks in the past five years. Look at those you love, and if you care for them - whether or not you care about us - do something. Because they could be the next victims.
<br />
<br />
Thank you for reading.</div>Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com9tag:blogger.com,1999:blog-1345573145957924958.post-10725951361775804112016-08-08T14:00:00.000-07:002016-08-08T14:00:20.021-07:00May 12, 2015: 20 years with Myalgic EncephalomyelitisI have had Myalgic Encephalomyelitis, or M.E, for 20 years. The CDC does not recognize this. They insist that I have a condition called "Chronic Fatigue Syndrome," or CFS. I have M.E.<br />
<br />
At the age of 44 I led a charmed life. I had been married to the love of my life for 20 years, and we had two lovely children. We were both college professors - a deliberate choice that allowed us to do what we enjoyed - researching and teaching subjects that deeply interested us - while having the income to live comfortably (because we both worked) and plenty of time to spend with the children (because of the nature of academic life). I had tenure at a good university, although my sights were set higher than that. I had a working relationship as an associate fellow with a research institute at an Ivy League school, which enabled me the luxury of being around the best and the brightest in my field. We traveled all around the country going to each other's conferences, often taking one of the kids along. We also went to four Olympics, two final fours (NCAA basketball championships) and countless playoff games, several World Series, and, eventually, twenty years of baseball AllStar games. We skied in the winter and went to the beach in the summer. It was a charmed life.<br />
<br />
On October 24, 1994, I went to my office to grade exams and suffered a blackout. When I came to, I could not understand one word in the Bluebooks in my lap - they might as well have been written in Cyrillic alphabet. It took time - and concentration - to be able to stand. I had fallen down the rabbit hole; my life would never be the same.<br />
<br />
Over the next four years I suffered from severe pain in the back of my neck and behind my eyes, 24/7. My muscles ached, and I had migraine-level headaches. I had ataxia, dyslexia, sensitivity to light and sound (to the point I had to wear sunglasses all the time), tinnitus, partial paralysis, memory loss, disorientation, expressive dysphasia, and massive confusion. My family took care of me. Obviously, I could not drive, and by 1996 I was using a wheelchair when I left the house (which someone else had to push). My confusion was so bad I once poured a pot of coffee into a silverware drawer convinced it was a cup. When my family took me somewhere, one of them would have to fasten my seatbelt because I couldn't remember what those two things were for.<br />
<br />
Most of the time, however, my family went without me. Increasingly I spent most of my time lying curled up in bed in the dark, listening to a favorite movie (because I could not bear to look at the screen). I got around the house by balancing against furniture and my golden retriever, but increasingly I spent the entire day upstairs. By the end of 1998, I couldn't even brush my own teeth. All that time, just slipping by. <br />
<br />
I was lucky to have a family to take care of me, because I could not take care of myself. I also soon discovered an Internet discussion list of fellow sufferers, and was referred to a very good specialist in Washington, Marsha Wallace (who unfortunately hasn't practiced since 2000). Dr. Wallace taught me to live within my energy envelope and helped with sleep disruption and NMH/POTS, but I continued to deteriorate.<br />
<br />
In the fall of 1998, Dr. Wallace introduced me to Dharam Ablashi, a researcher who had just retired from the National Cancer Institute at NIH. Dr. Ablashi had been the co-discoverer of HHV-6 and it's two variants, A and B, while working with AIDS. I had the version the AIDS patients did - Variant A. My viral load was over five times the amount used to diagnose an active infection.<br />
<br />
I would later positive for active EBV or mono (which I had more than once - most notably in 1990, four years before my collapse, during an outbreak on my college campus), CMV (cytomegalovirus), HHV-7, and three strains of Coxsackie B.<br />
<br />
My immune system was severely compromised: My natural killer cell function was less than 3% (normal is about 50%), I had the defective 37kDa Rnase-L, and I had an abnormal cytokine pattern. But no one knows how all this happened. All we know is that this disease can occur in cluster outbreaks, and it can pop up in individuals. No one in my family got it from me, but I believe the outbreak of EBV in 1990 marked the beginning of my illness - the beginning of the cycle of immune defect-virus-damage that characterizes this disease for many of us. I had to continue to teach through my infection with EBV, including an hour's commute and back, and while I recovered from mono at the end of the fall semester, my health began to deteriorate in seemingly disparate ways, until the ultimate collapse in 1994.<br />
<br />
Years later I would have a spinal tap that revealed both HHV-6 and Cytomegalovirus were active in my spinal fluid. No wonder I had the symptoms of encephalitis, and with the stiff neck, meningitis. Along with the muscle pain, that meant literally that I had Myalgic Encephalomyelitis, or M.E., a disease that had been diagnosed in the UK since the mid-1950s. In the United States, however, all I was given was a diagnosis of "chronic fatigue syndrome," a name chosen by committee and adopted by CDC in 1988 to replace the name given a number of cluster outbreaks occurring in the USA at the time, Chronic EBV. They did not mention M.E. - though there were specialists at the meeting who insisted that was the correct diagnosis for these outbreaks. They did not ask anyone in the disease community what they thought of this name. They simply adopted it, and having done so, consigned the disease to the backwaters of medicine where neither research nor treatment could be found.<br />
<br />
There could not have been a worse choice of a name for this disease if CDC had hired a focus group, Chronic (as in chronic whiner) Fatigue (as in "yeah, I've been feeling tired lately myself") Syndrome (as in syndrome of the month) - applied to upper middle class white women "trying to have it all" (as the late Bill Reeves of CDC once phrased it) - how inconsequential, silly even. <br />
<br />
Twenty-five years later, 85% of patients - over one million Americans - have no idea what is wrong with them, because, according to both CDC and private demographic evidence, only 15% have a diagnosis. 25 years later only 15% have a diagnosis. That is a mighty admission of failure.<br />
<br />
The infectious disease specialists in northern Delaware dismissed my illness as minor. "You'll be back to normal in two years," they assured me. Oh good, I responded - I won't have to miss more than two seasons before I can go back to skiing. "Oh no," was the response. "You'll never ski again." How was that "normal?" I asked. They got angry at that. That's when I was referred to Dr. Wallace and, thankfully, only had to deal with these people once more, when I was on the antiviral Vistide for my cytomegalovirus infection. Dan Peterson, my new specialist, had asked them to let me get the infusions at their center, and they had agreed. But when I showed up at their office, one of the doctors took me aside and said that they could not let me have Vistide because my medical records showed I "only had CFS - nothing serious, like AIDS or cancer." They said they could not justify using the drug on someone with a diagnosis of CFS - even though it was an FDA-approved drug for the virus CMV, which was active in both my blood serum and my spinal fluid.<br />
<br />
Let me repeat that: once given the label Chronic Fatigue Syndrome, I would meet disrespect from many doctors and people at NIH and CDC. None of my extensive testing mattered. I was told twice by those in a position to know better, that none of my testing mattered because "you people test positive for viruses you don't have." I asked what evidence that was based on; that ended the conversation.<br />
<br />
Although the progressive version of M.E. that I suffered from was unusually severe, I turned out to be lucky. I was given the opportunity to go on the experimental Phase III drug Ampligen, in what is called a cost-recovery (I pay cash), compassionate care (I am allowed to do this because I was so very sick), open label (I know I am on the drug so FDA ignores me) study. I have to get Ampligen at the study site by IV infusion twice a week. And FDA can take the drug away from me whenever they want.
<br />
<br />
I have been on Ampligen for 13 of the past 17 years. Again, I am unusual in that my illness erupts again within a year of going off the drug (which I did once voluntarily, and once because FDA did take the drug away). FDA has admitted, in writing, that the drug is not toxic. But they are not "convinced" it is effective. My experiences do not count because I was not in a placebo trial; I knew I was on the drug. There is no other drug in the FDA pipeline for either CFS or M.E. (Although there are immune boosters and antivirals available for patients, and an anti-cancer drug called Rituximab is showing some promise). This is the only one expressly targeted to M.E. or CFS. Over one million Americans suffer from my disease. FDA, CDC, NIH - none of them cares - though in fairness, there are individuals within those agencies who do. It is those who make decisions who do not care.
<br />
<br />
[Side note about the obsession with placebo trials - If just knowing you are on a drug can make your immune markers return to normal, your active viruses return to a dormant stage, and change tests such as SPECT scans and CPET scores, we should all be cured of anything by happy thoughts. Does FDA really believe this?]
<br />
<br />
So here I am today. I would not have written this were I not on Ampligen. On Ampligen, I can drive, take care of myself (mostly), read a book, work on my own writing, spend time with my children and grandchildren. Off Ampligen I am an invalid in bed in severe pain, curled up in the dark because light is too painful, listening to a favorite movie over and over. Again.<br />
<br />
As the years past, it became more and more difficult to get Ampligen, because FDA refused to approve it. The last three years I spent in Delaware, I had to commute by train twice a week, 100 miles north, to Dr. Derek Enlander's office in New York City, the closest site where I could get Ampligen. I usually get home around 7 pm. It was grueling, but at least I am getting the drug that keeps me from being a bedridden invalid.<br />
<br />
And then my beloved husband, my best friend, my soulmate, died of bladder cancer in July 2013. I moved to Incline Village, NV, on Lake Tahoe, where one of the best clinician/researchers in the country practices, Dan Peterson. (The most famous cluster outbreak of the disease in the US occurred here in 1985 - over 200 patients.) My infusions are just two miles away now. I'd like to call the version I have of this disease Peterson's Disease, but he won't let me. There are a lot of patients here who have the same biomarkers I do. <br />
<br />
Myalgic Encephalomyelitis is a serious disease.
<br />
<br />
CDC betrayed us by giving it a silly-sounding name in 1988 - CFS. NIH allocates less than $5 per patient per year to study this disease - a pathetic amount. After a report they commissioned from the Institute of Medicine came back last year, saying this was emphatically <i>not</i> a psychiatric disorder, and that NIH needed to spend much more money on it, we were promised more funding - but so far, haven't received anything above the usual $5-6 million. See <a href="http://www.ncbi.nlm.nih.gov/pubmed/25695122" target="_blank"><span style="color: blue;">"Beyond Myalgic Encephalomyelitis"</span></a>.<br />
<br />
We came back with private research initiatives, funded by cash-strapped patients and their families, and more good biomedical research is being published than ever before. The whole concept of what "CFS" is, silly sounding name and all, is undergoing a transformation. And for the first time in my memory, clinicians and researchers have agreed on a definition - the Canadian Consensus Criteria, updated with current research. There are excellent research studies going on at Stanford, Columbia, and Cornell right now - but they get little, if any, NIH funding. Even Ron Davis, the Stanford scientist responsible for the human genome project, can't get funding out of NIH for <i>this</i> disease.<br />
<br />
The main study behind the government's prescription of psychiatric counseling and graded exercise, the PACE trial, has been exposed as a giant boondoggle - but at the moment, the scientific journal that published it, <i>The Lancet</i>, the institutions behind it in the UK, and the UK government, are still pretending they don't know how deeply flawed it was. See <span style="color: blue;"><a href="http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/" target="_blank"><span style="color: blue;">PACE: The research that sparked a patient rebellion and changed medicine</span></a>.</span><br />
<br />
Perhaps more important, why don't people outside our community - people in the media, in government, our doctors, our neighbors, our employers - why don't they know that there is a growing epidemic of a severe, life-altering and in some cases life-taking disease that CDC and NIH are keeping under wraps? I have friends who were teenagers when they got sick, and are now in their 40s. They did not get to marry their soulmate like I did. They did not go to college or have a career. They did not have children or grandchildren (I have two grandchildren now). I was lucky compared to them.
<br />
<br />
There are patients who are even worse than I was - completely bedridden, on feeding tubes. See <a href="http://www.25megroup.org/home.html" target="_blank"><span style="color: blue;">The 25% ME Group</span></a> and <span style="color: blue;"><a href="https://www.washingtonpost.com/national/health-science/with-his-son-terribly-ill-a-top-scientist-takes-on-chronic-fatigue-syndrome/2015/10/05/c5d6189c-4041-11e5-8d45-d815146f81fa_story.html" target="_blank"><span style="color: blue;">the story of Whitney Dafoe in the Washington Post</span></a>.</span><br />
<br />
They can barely afford to live from day to day. Few can afford the testing I have had - if they can afford it, they can't get anyplace that does it. They go untreated, hidden, silenced.<br />
<br />
I have lost too many friends to this disease; we have lost young people to this disease. The viruses can get into your heart muscle; they can get into your liver. Patients die of rare cancers as well. And then there are the suicides.<br />
<br />
There has been a new series of outbreaks in the past five years. Look at those you love, and if you care for them - whether or not you care about us - do something. Because they could be the next victims.
<br />
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Thank you for reading.Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com0tag:blogger.com,1999:blog-1345573145957924958.post-39967424157115849212016-06-23T18:12:00.000-07:002016-06-23T19:26:44.377-07:00Comments for NIH Research Program on ME/CFS<div class="" style="font-family: Helvetica; font-size: 12px; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; line-height: normal;">
<b class="">1. It is critical that we find a way to diagnose the 850,000 Americans with ME/CFS who have no diagnosis today.</b></div>
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<span style="font-family: "helvetica"; font-size: 12px; line-height: normal;">In 1988, after a series of cluster outbreaks across the nation, US experts attended a meeting put together by NIH and CDC to give a name to the disease that had been called CEBV. They chose “chronic fatigue syndrome,” or CFS. </span><br />
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That was nearly 30 years ago. In the intervening time, CDC has so misjudged the prevelence, severity, and urgency of the need to get a handle on this disease, that today, with a national prevalence of at least 1 million adult Americans, CDC admits that only 15% of patients even have a diagnosis. </div>
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That tells me that the decision to focus on “fatigue” was a disaster. And I wonder where the other 850,000 Americans are. Since this is an equal opportunity disease - but that’s not true of those who are diagnosed - the population of undiagnosed patients with this disease is going to be skewed towards people of color, and I also suspect people of lower income. They are suffering alone. </div>
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<b class="">2. We need to go back and investigate the phenomenon of cluster outbreaks.</b></div>
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Once EBV was dismissed as a possible cause of this disease (prematurely, as it turns out), all interest in the possibility of cluster outbreaks disappeared. Yet many patients experienced this disease in what appears to have been a cluster outbreak. CDC and NIH responded to the experience of patients by saying (to me, personally), these were not outbreaks of disease - they were outbreaks of diagnosis. It was the belief of Drs. Straus and Reeves that since this was obviously not a disease that was in any way contageous (decided in Washington, not after looking at statistics), then the evidence of outbreaks must be cases where patients found a friendly doctor willing to confirm their belief they had a “real" illness. </div>
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That goes against the evidence.</div>
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More important, where we are today, I believe there has been a new set of cluster outbreaks. Why? Because I have been contacted by patients for twenty years, and starting around 2010 I began to be contacted by young people in their 20s and 30s and the parents of teenagers. They had become sick SINCE 2010. If there is indeed a new set of cluster outbreaks, let me suggest that we start to get a handle on it by looking at cases of EBV and asking for evidence of the long-run health of patients. </div>
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<b class="">3. We need biomarkers now.</b></div>
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Both Items 1 and 2 are direct consequences of the absence of biomarkers. It is hard to find out how many people have this disease when you are reduced to questionnaires. It is hard to find out whether there are cluster outbreaks (or outbreaks of diagnosis) without biomarkers. </div>
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I have had specialists who have been using biomarkers for two decades. I see no reason to have to start from scratch. We will at least catch a significant subset of patients. NIH needs to look at natural killer cell function as both a marker showing THAT you have The Disease, and also a marker of the SEVERITY of The Disease. </div>
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The 37kDA Rnase-L was a useful biomarker for some specialists until we lost the ability to send blood to Belgium. A new lab was started in the US, but the group it was connected to had problems and it closed. The patent was owned by Temple University, but they have said they do not care if they are reimbursed - anyone may use it. </div>
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Dr. Robert Suhadolnik, now deceased, did a study in the 1990s of 100 patients from the Incline Village cluster outbreak, 100 patients with fibromyalgia but no symptoms of CFS (Fukuda 1994), 100 patients with major melancholic depression (at the urging of Dr. Straus), and 100 controls. 98 of the 100 patients from Incline Village had the defective protein. Only 2-3% in each of the other three groups did. That is profound, but it was ignored. </div>
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In the meantime, Drs. Catherine Bisbal and Luc Montaigner tested patients with PVFS in France and Belgium, and had similar results. This is even more fascinating given that Dr. Suhadolnik was using an electron microscope, but Drs. Bisbal and Montaigner weighed the protein (hence the name 37kDA Rnase-L). </div>
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So two different sets of researchers, on two different continents, using two different methods, found the same thing. The researchers switched blinded samples and got them all right. So I think the 37kDa RNase-l biomarker is also another important characteristic of at least a subset of patients.</div>
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So many different specialists have worked with cytokine profiles that I can’t even list them all here. But that is also an area for biomarkers.</div>
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As I write, biomarkers are being proposed by researchers from Griffith University in Australia to Stanford and Columbia universities, to the Simmaron Foundation, the NOVA clinic in David, FL - we need a systematic way to look at the existing evidence and start using biomarkers to find at least a subset of patients.</div>
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<b class="">4. We need treatments now,</b></div>
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Ampligen is already available and it has been shown to lead to dramatic improvements in 30-40% of patients. I am one of them. We ask that NIH help us get this drug provisionally approved. The company does not have the money to do another large double-blind study. I would contribute my own money towards such an effort. In the meantime, the drug needs to be made more available because of the severe geographic restrictions it puts on those patients (such as myself) who would be vegetables without it. </div>
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Rituxmab needs to be researched. It has shown promise in Norway.</div>
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Patients have improved on gamma globulin and on antivirals, specifically Valcyte and Vistide.</div>
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We need to find other drugs to repurpose. I believe there also needs to be a push to develop more antivirals, period, and more pharmaceuticals targeted to the immune system.</div>
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<b class="">5. We need to pay more attention to viruses.</b></div>
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From the first diagnosis of atypical polio (which became Myalgic Encephalomyelitis in the British commonwealth nations and Epidemic Neuromyesthenia in the US in the 1950s, CEBV in the 1980s, and then CFS in 1988), the evidence has strongly suggested that the disease is connected to a virus. Which virus? If you don’t test people, how do you know? Now that there are better methods for finding viruses, we need an all-out push to find the viruses behind cases of ME/CFS in the United States. [In my own case, both HHV-6A and CMV were in my spinal fluid in 2009, during a 2-year period when I could not get Ampligen.]</div>
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The earliest viruses suggested were those in the polio family, now called enteroviruses. Coxsackie B was considered a prime candidate for the culprit in the UK (before the psychiatrists got involved), and it has also been found in patients in the US. I also know patients whose illness began with an episode of adenovirus infection.</div>
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However, in the US, the viruses most commonly found are EBV (particularly at the start) [HHV-4], CMV [HHV-5}, HHV-6A, HHV-6B, and HHV-7. </div>
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<b>6. Pay attention to 12 years of CFSAC recommendations.</b></div>
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Every year, CFSAC creates a list of recommendations for the Secretary of HHS. I know that they go to a lot of trouble to do this. Most of these are very good recommendations. Please go back and compile them and take them into consideration. </div>
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<b class="">7. Don’t start from scratch. Use existing research.</b></div>
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Let me suggest the numerous websites that i referenced in my May 12 blog, “ME is not a mysterious disease.” It would take too much space to write it all down here now!</div>
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<a href="http://slightlyalive.blogspot.com/2016/05/for-may-12-2016-me-is-not-mysterious.html">http://slightlyalive.blogspot.com/2016/05/for-may-12-2016-me-is-not-mysterious.html</a></div>
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This spring I lost 3 good friends whom I had known for 20 years as fellow patients with this disease. One had been sick for 32 years; another died at 40 from breast cancer because her ME-battered body could not take the necessary chemotherapy regimen; one died in the hospital of pneumonia, again because his body was so weakened. I look at a new generation of patients who got this disease as teenagers and wonder - will they still have it in their 40s, as is true for many patients I know? Are they doomed? Please stop this rolling epidemic now, because more and more people have it every time there are a series of outbreaks. </div>
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I thank you for the opportunity to comment, and I am hopeful that with the will to do so, NIH can stop this unending tragedy. </div>
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Mary M. Schweitzer, Ph.D.</div>
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Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com5tag:blogger.com,1999:blog-1345573145957924958.post-42775202004391697632016-05-17T22:38:00.003-07:002016-05-17T22:58:50.153-07:00Pat Blankenship, 1949-2016, Rest, dear friend<div class="page" title="Page 25">
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<span style="font-family: "timesnewromanpsmt";">On Monday, May 16, we lost another friend to Myalgic Encephalomyelitis, Pat Blankenship. She was just 67.</span><br />
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<span style="font-family: "timesnewromanpsmt";">Here is an essay Pat wrote for the Obama-Biden Transition Project Health Care Report, December 2008. That was 8 years ago. We had hopes at the time it would make a difference at NIH (which continued to fund research into ME and CFS at $6 million/year, or $6 per person a year - less than they spend on male pattern baldness. The full report remains part of the federal records at HHS. </span><br />
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<span style="font-family: "arial"; font-size: 11pt; font-weight: 700;">Living With M.E.</span><br />
<span style="font-family: "arial"; font-size: 11pt; font-weight: 700;">Pat S. Blankenship</span><br />
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<span style="font-family: "arialmt"; font-size: 11.000000pt;">In the next few pages, there is a short summary of my experience with Myalgic
Encephalomyelitis. I became ill in 1989, and remain totally disabled now. I have been
disabled by M.E. longer than I worked as a productive member of society. I am an
astrophysicist, but spent the bulk of my short career working in computer
telecommunications. Before moving back to my family home in Alabama, I lived in the
Northeastern US, primarily the Washington area. That is where I sought treatment for
this new disease when I became ill, and found that there was no treatment that worked.
During the years I lingered there trying to find medical help, I became involved with the
CFS Coordinating Committee, now called the CFSAC. I gave testimony at several of
those meetings. I worked with the NIH to help select the first slate of patient members
of the committee, and I was also involved with the meetings at the CDC when the first
accounting scandal was made public. Those latter activities are public knowledge and
my involvement was small and brought about no positive outcome. That's why my
statement here is a personal one about how hard it is to live with this disease.
</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;"><br /></span>
<span style="font-family: "arialmt"; font-size: 11.000000pt;">I was struck down at the age of 40, while working as a consultant for the federal
government on communication interoperability issues, in November, 1989. In my case, I
had an extreme viral onset that was like a severe case of influenza; it was like Texas flu
or Swine flu, both of which I had during the years in which they were pandemic. As
usual, there was supreme difficulty in obtaining a diagnosis. My knowledge of this
disease was nil at that time. For all I knew, I had Lyme disease, or hepatitis, or any of a
very large number of viruses I was tested for. I was finally diagnosed by an infectious
diseases specialist who used the CDC 1988 definition of CFS, through a process of
elimination. I've come to know a lot about what I now know is Myalgic Encephalomyelitis
due to brute force exposure to it.
</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;"><br /></span>
<span style="font-family: "arialmt"; font-size: 11.000000pt;">What is it like to have Myalgic Encephalomyelitis (M.E.)? There are physical,
cognitive, and social as well as emotional aspects that have happened in my case; we
are all different, for this disease has 'different results after inflicting the same insult' upon
us. That is a phrase I learned probably 15 years ago from a fellow activist in the
Washington, D.C. area. Here is a little glimpse of how my life crumbled from what was
once a promising career at the top of a group of enterprising people who were planning
for 'Battlefield 2005 telecommunications,' to what I am now, a broken woman who can
barely string sentences together.
</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;"><br /></span>
<span style="font-family: "arialmt"; font-size: 11.000000pt;">I have been totally unable to work since 1991, and have been disabled since that
time. I lost my job. My legs literally went out from under me and I had to undergo
lengthy physical therapy while using 2 canes to walk, haltingly and for only short
distances. I walk much better now, after several courses of therapy, including two at
facilities of the Warm Springs Institute in Georgia. There are times when I stand too
long, and I begin to black out. I can avoid fainting if I sit down, and I will sometimes sit
down in a public place on the floor rather than risk fainting. Other physical problems
include the onset of fibromyalgia, and several organ system diseases which may be
related to the autonomic nervous system aspect of M.E. Since I don't know if they are
cause-and-effect, I don't relate them here, but I have become more-or-less bed bound,
with only 2 to four hours of activity per day .
</span><br />
<br /></div>
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<span style="font-family: "arialmt"; font-size: 11.000000pt;">Early in the disease, for some months, I was unable to speak more than a few
words. I can usually carry on a conversation now; my self-retraining in what I call word
retrieval has been compared to what a stroke victim goes through. Still, I frequently
have to close my eyes to remember words though. Reading the printed word became a
thing of the past. I can now read a few sentences at a time, but my retention is very poor.
I listen to audio books now, and I like to joke that I can listen to the same mystery novel
over and over because I don't remember the end. In the past 6 years, I've also
developed permanent visual dysfunction too, called palinopsia, which makes it nearly
impossible to drive at night, and makes reading from a computer screen much more
difficult.
</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;"><br /></span>
<span style="font-family: "arialmt"; font-size: 11.000000pt;">Memory is a very tricky problem now. I have a sort of sliding window of time in
the recent past during which I can remember events. It may be 3 days ago up to 6
months ago, or the window may shut down at 3 weeks. I never know if I am going to
remember an event, an appointment, or a person. In fact, I have more or less given up
on people recognition; unless I see someone daily or maybe weekly, I do not recognize
the face. The only reason I know about this sliding memory window is that I have lived
with my sister for several years, and she has described it to me. I keep track of
appointments and such on my cell phone calendar, without which I would never be able
meet any of my obligations. This technology has helped me tremendously in the last few
years.
</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;"><br /></span>
<span style="font-family: "arialmt"; font-size: 11.000000pt;">I've written this memory description down and keep it for whenever I need to
explain it to people, like doctors. Or, as in for this description of my condition for our
input to the policy makers for President-elect Obama.
</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;"><br /></span>
<span style="font-family: "arialmt"; font-size: 11.000000pt;">Maybe it is not obvious, but in becoming this ill and unable to function at any sort
of professional level, I lost the friends that I had made throughout the years in my field. I
lost track of my friends that I had still kept up with in academia, because I was still living
in the same northeastern megalopolis where we had been friends. My extreme inability
to travel – energy deficits, the need for frequent stops to sit or lie down, and other
problems that are poorly understood by healthy people – also cut me off from many of
my dearest friends, including my most 'significant other.' I stopped making new friends,
unless they were sick like me and I got to know them through support group meetings, or
in attending government committee meetings. Even then, I usually lost track of them
(unless I made a photograph – I learned that was an important tool) due to memory
problems and lack of functional time during each day.
</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;"><br /></span>
<span style="font-family: "arialmt"; font-size: 11.000000pt;">Social isolation has become probably the most frightening aspect of living with
M.E. The physical symptoms can only make you sick or dead. But isolation makes you
miserable every hour of your day. It never ends. Of course this is true for all chronic
illnesses, but M.E. Is so poorly understood by everyone who does not have it, it's not
even possible to get a fair hearing from one's pastor or an organization that is intended
to insure against isolation. Socially speaking, I am living in a dead zone.
</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;"><br /></span>
<span style="font-family: "arialmt"; font-size: 11.000000pt;">My own family cannot find their way to an understanding of what has happened
to me. I live in my own home, a huge house that I cannot clean, and cannot afford to
hire people to clean or to take care of the lawn. So I am always attempting – and always
unsuccessfully – to do those chores myself. The result – a feeling of self loathing
because I can't do what I should be able to do. After being sick for almost 20 years, I still </span><span style="font-family: "arialmt"; font-size: 11pt;">try to do what is of course impossible and act like I'm not sick.</span><br />
<span style="font-family: "arialmt"; font-size: 11pt;"><br /></span>
<span style="font-family: "arialmt"; font-size: 11pt;">That's irrational. So finally, there is the emotional part of this disease. I don't say
that I never feel depressed, but I'm not clinically depressed. What I am is just what the
book title said: </span><span style="font-family: "arial"; font-size: 11pt; font-style: italic;">Sick and Tired of Being Sick and Tired. </span><span style="font-family: "arialmt"; font-size: 11pt;">Angry that the people I have
trusted to find out what is wrong with me and to find out how to treat it, took the money
and misused it; they stole my trust. They might as well have stolen my life. Afraid that I
will never feel well enough to accomplish any of the things I had set aside in my younger
years to do after I climbed my big career mountain. Afraid I will never again enjoy life
like I did 21 years ago.</span><br />
<span style="font-family: "arialmt"; font-size: 11pt;"><br /></span></div>
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<span style="font-family: "arialmt"; font-size: 11.000000pt;">It took me several days to pull these few pages together, from material that I
mostly already had written. Along with an “executive summary,” I hope it will give some
insight into what living with M.E. Is like, and why we who have the disease cannot rest
until our few short pleas are met by our elected officials.
</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;"><br /></span>
<span style="font-family: "arialmt"; font-size: 11.000000pt;">--------------------------</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;">Addendum 1: Some things I wrote about CFS/ME in the past
</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;"><br /></span>
<span style="font-family: "arialmt"; font-size: 11.000000pt;">In 1999, I published this information on my web site (since discontinued due to
progressive illness) about the first time the CDC misspent funding for CFS research. It
was informative then and still is now.
</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;"><br /></span>
</div>
</div>
<img alt="page27image13416" height="0.719922" src="file:///page27image13416" width="434.880000" />
<img alt="page27image13576" height="0.719922" src="file:///page27image13576" width="434.880000" />
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<span style="font-family: "arial"; font-size: 11.000000pt; font-style: italic;">+++ DOLLARS AND SENSE +++ DOLLARS AND SENSE +++ DOLLARS AND
SENSE +++
</span><br />
<span style="font-family: "arial"; font-size: 11.000000pt; font-style: italic;"><br /></span>
<span style="font-family: "arialmt"; font-size: 11.000000pt;">I am working on a way to put these numbers (research funds misspent by CDC)
into understandable context. How about this: For every </span><span style="font-family: "arial"; font-size: 11.000000pt; font-weight: 700;">$0.98 </span><span style="font-family: "arialmt"; font-size: 11.000000pt;">the CDC spent on CFS
related research from 1995-1998 inclusive, they stole another </span><span style="font-family: "arial"; font-size: 11.000000pt; font-weight: 700;">$0.88 </span><span style="font-family: "arialmt"; font-size: 11.000000pt;">from the pot and
spent it on other programs, and they stole </span><span style="font-family: "arial"; font-size: 11.000000pt; font-weight: 700;">$0.41 </span><span style="font-family: "arialmt"; font-size: 11.000000pt;">from that same pot and no one can tell
WHERE it was spent.</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;"><br /></span>
<span style="font-family: "arialmt"; font-size: 11.000000pt;">Another way to state it: For every </span><span style="font-family: "arial"; font-size: 11.000000pt; font-weight: 700;">$1.00 </span><span style="font-family: "arialmt"; font-size: 11.000000pt;">Congress authorized to be spent on CFS
research, CDC spent only </span><span style="font-family: "arial"; font-size: 11.000000pt; font-weight: 700;">$0.43 </span><span style="font-family: "arialmt"; font-size: 11.000000pt;">on research, stole another </span><span style="font-family: "arial"; font-size: 11.000000pt; font-weight: 700;">$0.39 </span><span style="font-family: "arialmt"; font-size: 11.000000pt;">and spent it on other
programs, and then lost track of the remaining </span><span style="font-family: "arial"; font-size: 11.000000pt; font-weight: 700;">$0.18 </span><span style="font-family: "arialmt"; font-size: 11.000000pt;">and can't account for that at all. In
other words, only </span><span style="font-family: "arial"; font-size: 11.000000pt; font-weight: 700;">43% </span><span style="font-family: "arialmt"; font-size: 11.000000pt;">of the authorized funds were actually spent on CFS research.
</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;"><br /></span>
<span style="font-family: "arialmt"; font-size: 11.000000pt;">If I still paid taxes, I'd be hopping mad. As it is, if I could hop, I would be also. I
want to see careers in tatters and ruin. I want to see </span><span style="font-family: "arial"; font-size: 11.000000pt; font-weight: 700;">ACCOUNTABILITY</span><span style="font-family: "arialmt"; font-size: 11.000000pt;">.
</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;"><br /></span>
<span style="font-family: "arial"; font-size: 11.000000pt; font-style: italic;">NIH ++ CDC +++ NIAID++NIH ++ CDC +++ NIAID++NIH ++ CDC +++ NIAID
</span><br />
<span style="font-family: "arial"; font-size: 11.000000pt; font-style: italic;"><br /></span>
<span style="font-family: "arialmt"; font-size: 11.000000pt;">Now I have a question for NIH: How clean are THEIR accounts?
</span></div>
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<span style="font-family: "timesnewromanpsmt";">------------------------------------</span></div>
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<span style="font-family: "arialmt"; font-size: 11.000000pt;">Addendum 2:
</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;"><br /></span>
<span style="font-family: "arialmt"; font-size: 11.000000pt;">This is another snippet of information I put on my web page back in 1998. This
is one of the meetings I attended and testified at.
</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;"><br /></span>
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<span style="font-family: "arialmt"; font-size: 11.000000pt;">April 1998 Meeting of CFSCC
</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;"><br /></span>
<span style="font-family: "arialmt"; font-size: 11.000000pt;">Before I started my presentation, I displayed a copy of the May, 1998, Reader's
Digest which has an article about the American's with Disabilities Act (ADA) in which
CFS is lumped with myopia and body odor as 'not a real disability.' After displaying the
article, I told the group that more people will see this article than everything that has
been produced by this Committee in its entire history. That is the reason I am asking for
support from the Committee as follows:
</span><br />
<span style="font-family: "arialmt"; font-size: 11.000000pt;"><br /></span>
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<span style="font-family: "arial"; font-size: 11.000000pt; font-weight: 700;">Proposal: CFSCC to reply to media coverage of CFS
</span><br />
<span style="font-family: "arial"; font-size: 11.000000pt; font-weight: 700;"><br /></span>
<span style="font-family: "arial"; font-size: 11.000000pt; font-weight: 700;">* After 4 years, the CFSCC has yet to produce a single release of corrective
information after negative press on CFS
</span><br />
<span style="font-family: "arial"; font-size: 11.000000pt; font-weight: 700;"><br /></span>
<span style="font-family: "arial"; font-size: 11.000000pt; font-weight: 700;">* Attacks of CFS and PWCs are never-ending and not improving over time
* Who speaks for PWCs?
</span><br />
<span style="font-family: "arial"; font-size: 11.000000pt; font-weight: 700;"><br /></span>
<span style="font-family: "arial"; font-size: 11.000000pt; font-weight: 700;">Sample of press coverage of CFS:</span><span style="font-family: "arial"; font-size: 11.000000pt; font-style: italic; font-weight: 700;">Washington Post July 1995<br />
</span><span style="font-family: "arial"; font-size: 11.000000pt; font-weight: 700;">"Chronic Fatigue Rare, HMO Study Concludes"<br />
</span><span style="font-family: "arial"; font-size: 11.000000pt; font-style: italic; font-weight: 700;">* Citing CDC demographic studies, CFS branded as a rare diagnosis not
</span><br />
<span style="font-family: "arial"; font-size: 11.000000pt; font-style: italic; font-weight: 700;">warranting study funding<br />
* Major media outlet that provides articles for other newspapers across the
</span><br />
<span style="font-family: "arial"; font-size: 11.000000pt; font-style: italic; font-weight: 700;">country
</span><br />
<span style="font-family: "arial"; font-size: 11.000000pt; font-style: italic; font-weight: 700;"><br /></span>
<span style="font-family: "arial"; font-size: 11.000000pt; font-style: italic; font-weight: 700;">------------------------------------------------</span><br />
<span style="font-family: "arial"; font-size: 11.000000pt; font-style: italic; font-weight: 700;"><br /></span>
<span style="font-family: "arial";"><span style="font-size: 15px;">Pat was a smart, funny, practical woman. Her intellect was lost to the nation 27 years ago. Then she simply got sicker and sicker. The stage of her illness is frozen in time in 2008 in this essay that she wrote.</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 15px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 15px;">Pat, I miss you now and I will always miss you. Thank you for everything you gave us.</span></span><br />
<span style="font-family: "arial";"><span style="font-size: 15px;"><br /></span></span>
<span style="font-family: "arial";"><span style="font-size: 15px;">Mary Schweitzer</span></span></div>
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Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com12tag:blogger.com,1999:blog-1345573145957924958.post-40442381187473968852016-05-12T01:42:00.000-07:002016-06-27T16:28:40.262-07:00For May 12, 2016: ME is not a "mysterious" disease.<div style="-webkit-text-stroke-color: rgb(41, 47, 51); -webkit-text-stroke-width: initial; color: #292f33; font-family: 'Times New Roman'; font-size: 12px;">
Today, May 12, is International ME Awareness Day.</div>
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<br /></div>
<div style="-webkit-text-stroke-color: rgb(41, 47, 51); -webkit-text-stroke-width: initial; color: #292f33; font-family: 'Times New Roman'; font-size: 12px;">
The whole point of this blog is that NIH and CDC behave as if we knew nothing about ME. That is not true. It is not so mysterious. You do not have to start from scratch as you slowly turn to investigate it again. Bethesda and Atlanta may have been asleep, but the research community was awake.</div>
<div style="-webkit-text-stroke-color: rgb(41, 47, 51); -webkit-text-stroke-width: initial; color: #292f33; font-family: 'Times New Roman'; font-size: 12px;">
<br /></div>
<div style="-webkit-text-stroke-color: rgb(41, 47, 51); -webkit-text-stroke-width: initial; color: #292f33; font-family: 'Times New Roman'; font-size: 12px;">
<b><u>What is ME?</u></b></div>
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<br /></div>
<div style="-webkit-text-stroke-color: rgb(41, 47, 51); -webkit-text-stroke-width: initial; color: #292f33; font-family: 'Times New Roman'; font-size: 12px;">
ME stands for Myalgic Encephalomyelitis - technically, encephalitis, meningitis, and muscle pain; more generally, a neurological disease characterized by significant immune abnormalities. The original name was atypical polio, coined in 1934 to explain an outbreak at Los Angeles County Hospital. In the 1950s, the UK and British Commonwealth nations switched to Myalgic Encephalomyelitis. At the same time, however, US researchers started using “epidemic neuromyesthenia,” a name that never caught on in the US. ME was coded by the World Health Organization under neurological disorders in 1969 and has remained there since; epidemic neuromyesthenia is also coded under neurology.</div>
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<br /></div>
<div style="-webkit-text-stroke-color: rgb(41, 47, 51); -webkit-text-stroke-width: initial; color: #292f33; font-family: 'Times New Roman'; font-size: 12px;">
It is a serious, multi-systemic disease. To see what this disease is like, try these two sites:</div>
<div style="font-family: 'times new roman'; font-size: 12px;">
<span style="color: blue; font-kerning: none; text-decoration: underline;"><a href="http://www.25megroup.org/home.html">http://www.25megroup.org/home.html</a></span></div>
<div style="-webkit-text-stroke-color: rgb(41, 47, 51); -webkit-text-stroke-width: initial; color: #292f33; font-family: 'Times New Roman'; font-size: 12px;">
and</div>
<div style="-webkit-text-stroke-color: rgb(41, 47, 51); -webkit-text-stroke-width: initial; color: #292f33; font-family: 'Times New Roman'; font-size: 12px;">
<span style="font-kerning: none; text-decoration: underline;"><a href="http://www.forgottenplague.com/">http://www.forgottenplague.com</a></span></div>
<div style="-webkit-text-stroke-color: rgb(41, 47, 51); -webkit-text-stroke-width: initial; color: #292f33; font-family: 'Times New Roman'; font-size: 12px; min-height: 15px;">
<br /></div>
<div style="-webkit-text-stroke-color: rgb(41, 47, 51); -webkit-text-stroke-width: initial; color: #292f33; font-family: 'Times New Roman'; font-size: 12px;">
For three decades, if you asked the US government what this disease was like, you would have received a very different answer.</div>
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<br /></div>
<div style="-webkit-text-stroke-color: rgb(41, 47, 51); -webkit-text-stroke-width: initial; color: #292f33; font-family: 'Times New Roman'; font-size: 12px;">
In the mid-1980s, a series of cluster outbreaks in the US brought the federal government’s attention to the disease. Many of these were linked to an outbreak of Epstein-Barr Virus (EBV), or mono (also called glandular fever), so at first NIH began calling it “Chronic Epstein-Barr Virus.” However, by 1986 the US government’s “expert” on CEBV, the late Stephen Straus at NIAID (National Institute for Allergies and Infectious Disease) had concluded it was not related to EBV (a decision that has since come into question). In 1986 Straus began using the name Chronic Fatigue Syndrome as a substitute for CEBV.</div>
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<br /></div>
<div style="-webkit-text-stroke-color: rgb(41, 47, 51); -webkit-text-stroke-width: initial; color: #292f33; font-family: 'Times New Roman'; font-size: 12px;">
In 1988, a committee convened by CDC accepted Straus’s choice, Chronic Fatigue Syndrome, or CFS -“chronic” as in chronic complainer, “fatigue” as in “Yeah, I’ve been feeling tired lately, too,” and “syndrome” as in syndrome of the month. They could not have come up with a more dismissive name if they had held a focus group. The name went with a vacuous definition that emphasized the single symptom “fatigue,” which is common among many serious diseases. In a society where everyone feels a bit overworked, the name sounded silly and so then did the disease. CDC portrayed it as a disease of upper middle class white women trying to have it all, who could not handle the stress of their ambitious lifestyles. For decades the only solutions offered were psychiatric therapy, exercise, SSRIs, and sleep aids. </div>
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<br /></div>
<div style="-webkit-text-stroke-color: rgb(41, 47, 51); -webkit-text-stroke-width: initial; color: #292f33; font-family: 'Times New Roman'; font-size: 12px;">
Had the US government paid attention to experts in Canada and the UK, they might have simply adopted the name in use, ME. If you go to the decision-tree, to the point where CDC broke off and adopted CFS instead, along with what is called a “garbage” diagnosis (the disease was diagnosed by what it was not), it is clear that the next thirty years were disastrous for the patient population. </div>
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<br /></div>
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What was the result of this detour into the concept “CFS”? Nearly 30 years later, even CDC admits that at most only 15% of patients have a diagnosis. That means 850,000 adult Americans - and untold teenagers and younger students - have this disease and have no idea what is wrong with them.</div>
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And of the 150,000 who are diagnosed, the vast majority are white, have a higher-than-average education and (before their illness), a higher-than-average income. The illness leads to impoverishment for most patients. And for most patients, it is a life-long sentence.</div>
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A recent study has confirmed the results of other studies in finding that one-fourth of patients are bedridden and/or housebound. Only one in five can work either part-time or full time, which is why this disease experience is also a descent into severe poverty for most patients. </div>
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WHERE ARE THE 850,000 AMERICANS WHO HAVE NO DIAGNOSIS? Hint: They are most likely to be people of color, and they are more likely not to have started out with much money in the first place. Where are they, and where are their children? Some are lucky: they have extended families who care for them. But many are alone and for those who started out in poverty, I do not want to think what has happened to them. This is a criminal dereliction of duty on the part of CDC!<br />
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So for three decades, hundreds of thousands of Americans have fallen ill with this invisible disease, a life sentence in most cases, rendered unable to earn a living, and if they do not live in a family that can care for them, are reduced to severe poverty - if they didn’t start out in poverty to begin with. </div>
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In the meantime, the name and vacuous concept of “chronic fatigue syndrome” was a gift to a small group of British psychiatrists who fall into the school of “biopsychosocial” medicine. They adopted a definition different from that in the US - their definition, called Oxford, required only six months of debilitating fatigue, and did not distinguish between CFS and major depression or anxiety. They pushed the view that the disease was caused by “false illness beliefs” (mainly in women or young people of both genders), and could be cured with cognitive behavior therapy (to teach the patient she wasn’t really sick) and graded exercise therapy to get them back into shape, and voilà, everything would be okay. </div>
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Patients forced into CBT/GET (as the combination was called) were made much worse, in a very dark period of British medicine. The leading lights of these theories, Simon Wessely, Peter White, Michael Sharpe, and Trudy Chalder continue to pump out articles reaffirming their own work, never referencing that of researchers who have found biomedical abnormalities in patients with this disease. The most disastrous study to come out of this school of thought is the PACE study, funded by $8 million from the British government, purporting to “prove” that CBT/GET was the best choice for treatment. </div>
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The PACE study has so many problems I cannot possibly explain them all here, except to say I would have flunked a first-year statistics student who defied so many rules of statistics to come up with the solution they wanted. There is currently an effort by scientists and some patients to have the anonymized data from the study released so the results can be either confirmed or dismissed, but so far the relevant institutions, headed by QMUL, have refused to release the data - insisting that nobody really wants it for scientific reasons, but that there is an “orchestrated campaign” to harass the principle investigators. For the story of the PACE trial, read this article by David Tuller, of the school of journalism and health policy at the University of California, Berkeley (in three installments):</div>
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<span style="font-kerning: none; text-decoration: underline;"><a href="http://www.virology.ws/2015/20/22/trial-by-error-i/">http://www.virology.ws/2015/20/22/trial-by-error-i/</a></span></div>
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<span style="font-kerning: none; text-decoration: underline;"><a href="http://www.virology.ws/2015/10/22/trial-by-error-i/">http://www.virology.ws/2015/10/22/trial-by-error-ii/</a></span></div>
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<span style="font-kerning: none; text-decoration: underline;"><a href="http://www.virology.ws/2015/10/22/trial-by-error-iii/">http://www.virology.ws/2015/10/22/trial-by-error-iii/</a></span></div>
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This is a good summary of the difficulty getting the PACE authors to share anonymized data, written by a scholar with no ties to the ME/CFS community:</div>
<a href="http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/"><span style="color: blue;">http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/</span></a><br />
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As a scholar, for me the most egregious error in the "biopsychosocial" studies like PACE is the absence of references to the growing body of literature on biomedical abnormalities in patients with the disease. For a recent bibliography, see:</div>
<a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4761639/"><span style="color: blue;">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4761639/</span></a><br />
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The proponents of this viewpoint have had a great influence on how CDC and NIH have shaped their views of the disease. Somewhat ironically, the disease has never been studied at NIMH (the National Institute for Mental Health at NIH). Rather, for the first 12 years it was within NIAID at NIH and in the division of viruses and exanthums at CDC. So we had the strange picture of researchers who were not trained in psychiatry insisting that this disease was primarily psychiatric in nature. </div>
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Let us return to that point in time, where the wrong choice was made to go off into studying the disease as if “fatigue” were the identifying factor (it is not). Let us return to that poor choice and fix it: use the name they should have used in the first place, Myalgic Encephalomyelitis, ME. What are we talking about?</div>
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(The US HHS and NIH use ME/CFS as a compromise; CDC continues to use CFS.)</div>
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ME is a very serious disease. Both the Institute of Medicine (commissioned by the Department of Health and Human Services, or HHS) and an initiative called “Pathways to Prevention” at NIH, produced reports last year stating strongly that the disease is in no way psychiatric.</div>
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According to the CFS Advisory Committee (CFSAC) to the Secretary of Health and Human Services, Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) as defined by the Institute of Medicine is "an acquired, chronic multi-systemic disease characterized by significant relapse after physical, cognitive, or emotional exertion of any sort. The disease includes immune, neurological and cognitive impairment, sleep abnormalities, and autonomic dysfunction, resulting in significant functional impairment accompanied by a pathological level of fatigue. The cause of the disease remains unknown, although in many cases symptoms may have been triggered by an infection or other prodromal event. There are no approved diagnostics tests or treatments.”</div>
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NIH is going to study 40 select patients “to begin to understand the clinical and biological characteristics of ME/CFS.”</div>
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While I am pleased to see both CDC and NIH improve their perspectives on the disease, the fact of the matter is while they were sleeping for 30 years, other research was being conducted into the etiology and the biomedical parameters of this disease.</div>
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NIH: THERE IS NO NEED TO REINVENT THE WHEEL. </div>
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Why not begin with research that has been under way the entire 30 years that researchers were funded by patients, because there was virtually no funding available from the federal government?</div>
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What we need is for the US (and UK) governments to start with the existing research in the field. Here is a quick list of how to get started:</div>
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Invest in ME, an organization in the UK devoted to research on ME that runs an amazing international conference every year - a cornucopia of international information:</div>
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<span style="font-kerning: none; text-decoration: underline;"><a href="http://investinme.org/">http://investinme.org</a></span></div>
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<span style="color: #292f33;">Simmaron Research Institute: </span><a href="https://t.co/XYKHsACspG"><span style="-webkit-text-stroke-color: rgb(0, 132, 180); color: blue;">http://simmaronresearch.com </span></a></div>
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<span style="color: #292f33;">The Open Medicine Foundation: </span><a href="http://www.openmedicinefoundation.org/"><span style="color: blue;">http://www.openmedicinefoundation.org/</span></a></div>
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Stanford ME/CFS Initiative: <a href="http://med.stanford.edu/chronicfatiguesyndrome.html">http://med.stanford.edu/chronicfatiguesyndrome.html</a><br />
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National Centre for Neuroimmunology and Emerging Diseases, Griffith University, Australia:<br />
<a href="https://www.griffith.edu.au/health/national-centre-neuroimmunology-emerging-diseases">https://www.griffith.edu.au/health/national-centre-neuroimmunology-emerging-diseases</a><br />
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The Alison Hunter Memorial Foundation (Australia): <a href="http://ahmf.org/">http://ahmf.org</a></div>
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ME Research UK: <a href="http://www.meresearch.org.uk/">http://www.meresearch.org.uk/</a></div>
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Cure-ME (Europe): <a href="http://me-cfs.se/">http://me-cfs.se</a></div>
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The HHV-6 Foundation: <a href="http://www.hhv-6foundation.org/">http://www.hhv-6foundation.org/</a></div>
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The Enterovirus Foundation: <a href="http://www.enterovirusfoundation.org/">http://www.enterovirusfoundation.org</a></div>
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This is just a start.</div>
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But it IS a start. No need to reinvent the wheel. NIH - start from the existing state of the research, not from where NIH/CDC has been for the past thirty years. And please, £6 million/year is not enough for these research institutes. We need parity in research funding comparable to other disease in severity and prevalence. $500 million is about the right number. And we are still waiting for the promised RFAs.</div>
Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com7tag:blogger.com,1999:blog-1345573145957924958.post-31636325732008893682016-03-17T13:06:00.002-07:002016-03-18T18:06:18.239-07:00Open Letter to Dr. Sanjay Gupta on In-House NIH Study of ME/CFS<div class="MsoNormal">
The following is a response to Dr. Sanjay Gupta's blog on the upcoming in-house NIH study on ME/CFS, which can be found at this site: <a href="http://www.medpagetoday.com/Neurology/GeneralNeurology/56772" target="_blank">Medpage Today</a></div>
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Thank you for highlighting the first in-house study on patients with ME/CFS in two decades.</div>
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Over one million American adults suffer from ME/CFS.<span style="mso-spacerun: yes;"> A quarter of a century (28 years)</span> after CDC adopted the dismissive name "chronic fatigue syndrome," 85%
of these - that's 850,000 people - have no diagnosis.<span style="mso-spacerun: yes;"> </span>CDC has long advocated treatments recommended
by British psychiatrists of the so-called "biopsychosocial school."<span style="mso-spacerun: yes;"> </span>The British psychiatrists argue that the
patients perhaps once had a disease, but they became afraid of acting
normal.<span style="mso-spacerun: yes;"> </span>They are left with deconditioned
bodies, which makes them look sick and contributes to what are called
"false illness beliefs."<span style="mso-spacerun: yes;"> </span>Thus
they recommend Cognitive Behavior Therapy (CBT) not as it would normally be
used - to help the patient adjust to having a chronic illness - but instead to
address "false illness beliefs" and teach the patient she does not need to stay inactive; that goes hand-in-hand with a reconditioning program
called Graded Exercise Therapy to return the patient to normal.<span style="mso-spacerun: yes;"> </span>The combination is generally called CBT/GET.<o:p></o:p></div>
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It is important to note that these psychiatrists are quick
to say that just because they call the disease "neurasthenia," they
do not mean to say it is wholly psychiatric. <span style="mso-spacerun: yes;"> </span>They say our criticism of their insistence that ME/CFS is a somatoform disease is due to prejudice against psychiatry, and a false adherence to "Cartesian mind-body dualism."<span style="mso-spacerun: yes;"> That is actually not true. The criticism of their theory rests on their assumption that the patient suffers from MUS's (Medically Unexplained Symptoms); the criticism of CBT/GET is even simpler - it is due to evidence that neither helps patients, and graded exercise actually makes them worse.</span></div>
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For years, however, these psychiatrists have successfully deflected criticism of their
work by instead criticizing their doubters.<span style="mso-spacerun: yes;">
</span>In 2007 they were awarded a £6 million ($8 million) grant
to prove, once and for all, whether the diagnosis and treatment they and NHS
has been using for 2 decades is the best available. The study was published in <i>Lancet</i> in 2011.<span style="mso-spacerun: yes;"> </span>There were numerous problems with
the study (for example, objective markers were dropped halfway through the
study, and the goals for patients were actually changed mid-study).<span style="mso-spacerun: yes;"> </span>Advocates have asked to see the anonymized raw data, but the principle investigators have refused, labeling these requests
"vexatious."<span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
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Recently Berkeley journalism and public health professor
David Tuller published a series of articles on the problems in the PACE trials, on the highly-regarded blog site of
Columbia University virologist Vince Racaniello.<span style="mso-spacerun: yes;"> </span>Tuller and a group of scientists have asked
to see the anonymized data. This time they weren't told their request was vexatious (Dr. James Coyne, an open-data advocate from outside the ME/CFS community, was). Instead, they were told they could not access the data because it would not be fair to the patients. That's an odd response - they've already shared the data with the Cochrane Review (although the Cochrane Review study authors included one of the PACE study PI's), so one would think it has already been anonymized. At any rate, one would think they know how to anonymize data sets - or no study involving clinical trials could ever be published! Requests are making their way through the appeals process. The Coyne request is more complicated - it is not a FOIA request; rather, Dr. Coyne is on the editorial board of PLOSOne, a series of e-journals that require authors to share data. It is in that context that Dr. Coyne has asked for anonymized data from the study - and in that context he was told his request was vexatious. Stay tuned - the PACE controversy is far from over. <br />
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<span style="mso-spacerun: yes;">The Tuller articles can be accessed online beginning here: <a href="http://www.virology.ws/2015/10/21/trial-by-error-i/" target="_blank">PACE: Trial by Error</a> - Coyne's blog critiquing the PACE study can be found here: <a href="http://blogs.plos.org/mindthebrain/2015/10/29/uninterpretable-fatal-flaws-in-pace-chronic-fatigue-syndrome-follow-up-study/" target="_blank">Uninterpretable: Fatal flaws in PACE</a> .</span><o:p></o:p></div>
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It is odd that NIH would not be aware of the controversies surrounding the PACE study, particularly given that both CDC and NIH have frequently taken the advice of psychiatrists involved in the study, such as Peter White, Michael Sharpe, and Simon Wessely (the latter is not an author but was a participant). for example, psychiatrist Peter White, who has been Chief Medical Officer of Scottish Provident Insurance Company and continues to advise Swiss RE, a multinational re-insurance company, led the 2009 evaluation of CDC's program on CFS. </div>
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This position - that the disease is really a form of
somatoform disorder - has<span style="mso-spacerun: yes;"> </span>haunted
patients with our disease for 3 decades.<span style="mso-spacerun: yes;">
</span>The authors do not recognize the large body of literature on physical
abnormalities in patients.<span style="mso-spacerun: yes;"> </span>Many of the studies on biomedical markers and evidence are small sample because it is next to impossible to get funding from
NIH for this disease - at most, NIH has allocated $6 million/year for one
million patients, roughly one percent of what they give to
Multiple Sclerosis, itself hardly an overfunded disease.<span style="mso-spacerun: yes;"> </span>So it becomes a tautology - no funding
because there is no large-sample evidence of biomedical abnormalities; no large
samples because there is no funding.<o:p></o:p></div>
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The choice of name - "chronic fatigue syndrome" - coupled with publicity about the disease being cured by "cognitive behavior therapy" and "graded exercise" and statements to the press that it is actually a somatoform disorder (what the public calls psychosomatic) - has led to mistreatment and lack of any treatment at all even for the minority of patients who have a diagnosis. Patients have also found themselves the butt of jokes because of the name - recently the cartoon strip Blondie took a pot-shot at patients for the latest name for the disease, SEID (Systemic Exertion Intolerance Disease)</div>
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<div class="MsoNormal">
I have gone through this rather lengthy detour because I
wanted to be sure that you understood the patients' concerns about Dr.
Walitt, who has been designated Lead Associate Investigator on this study. <i>This</i> is the quote from the
article cited on your blog that concerns us: </div>
<div class="MsoNormal">
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<div class="MsoNormal">
<i><b>"The discordance between the severity of subjective experience and
that of objective impairment is the hallmark of somatoform illnesses, such as
fibromyalgia and chronic fatigue syndrome."</b></i> </div>
<div class="MsoNormal">
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<div class="MsoNormal">
That article was published last year.<o:p></o:p></div>
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<div class="MsoNormal">
We know that the British psychiatrists who promote "CFS/ME" as a somatoform disorder will say exactly what Dr.
Walitt said - that the only reason we are disturbed by the diagnosis is that we
believe in the false Cartesian dichotomy of mind and body.<span style="mso-spacerun: yes;"> </span>Walitt's
defense for having so casually labelled CFS a "somatoform" illness
was an oblique remark about the head being connected to the body.<span style="mso-spacerun: yes;"> </span>Please forgive us if that sets off alarm
bells.<span style="mso-spacerun: yes;"> </span>And no, claiming to have found a
biological cause for somatoform disorders does not alleviate our concerns.<span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
<div class="MsoNormal">
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<div class="MsoNormal">
For three decades patients with this disease have endured
the stigma of the name - chronic fatigue syndrome (chronic as in chronic
complainer, fatigue as in "Yeah, I feel tired lately myself," and
syndrome as in syndrome of the month), and the presumption of the disease
being<span style="mso-spacerun: yes;"> </span>- in the vernacular -
psychosomatic.<span style="mso-spacerun: yes;"> </span>We are not prejudiced
against psychiatry.<span style="mso-spacerun: yes;"> </span>But we are no
happier being told our disease is psychiatric in nature than you would be if
told your hot appendix was due to faulty thinking.<span style="mso-spacerun: yes;"> T</span>he entire thesis of these psychiatrists rest on the belief that patients' symptoms fall in the category of MUS's (Medically Unexplained Symptoms), and therefore when patients insist their disease is biomedical in nature, they are exhibiting false illness beliefs. These psychiatrists have published articles claiming the disease is somatoform in nature without bothering to respond to the actual biomedical literature on this disease - indeed, if all you read was the psychiatric literature on this disease, you would not know that there is peer-reviewed published research on biomedical factors behind the symptoms. Let me suggest this recent article from
DePaul psychologist Leonard Jason summing up the current state of the
literature on various symptoms of the disease:<span style="mso-spacerun: yes;"> <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4761639/" target="_blank">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4761639/</a></span><o:p></o:p></div>
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<div class="MsoNormal">
Indeed, the Institute of Medicine of the National Academy of
the Sciences stated firmly that the evidence on biomedical abnormalities in
this disease is so strong that no one should look at it as psychiatric any
more.<span style="mso-spacerun: yes;"> </span>You can find their report (and
less lengthy material) here:<span style="mso-spacerun: yes;"> <a href="http://nationalacademies.org/hmd/Reports/2015/ME-CFS.aspx" target="_blank">http://nationalacademies.org/hmd/Reports/2015/ME-CFS.aspx</a></span><o:p></o:p></div>
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<div class="MsoNormal">
We are encouraged by Dr. Collins' interest in the disease,
and the plans Dr. Nath has for the study are exciting.<span style="mso-spacerun: yes;"> </span>However, given they are only going to look at
40 patients, we are very concerned about the possibility of bias in patient selection.<span style="mso-spacerun: yes;"> </span>Early on we were told (apparently by
accident) that the Reeves definition (2003) was going to be used. This definition - actually a set of questionnaires - is wholly unacceptable.<span style="mso-spacerun: yes;"> </span>It is modeled on the questionnaires used by
the British psychiatrists, and a study has already shown that a cohort chosen
using these questionnaires brings in patients with anxiety and depression
instead of ME or CFS at the same time it fails to identify the most severely
afflicted ME/CFS patients.<span style="mso-spacerun: yes;"> </span>It is very telling
that independent researchers have ignored the Reeves definition
completely.<span style="mso-spacerun: yes;"> </span>In that context, we find it
concerning that CDC has just published an article on the Georgia cohort
(diagnosed using the Reeves criteria) where they discuss the questionnaires <i><b>without once mentioning Reeves' name</b></i> - that is, without informing the reader
that these questionnaires are precisely the ones created by the late Bill
Reeves at CDC that have been called the "Reeves definition."<span style="mso-spacerun: yes;"> </span>The unexpected sleight of hand has us
concerned that the Reeves definition will be used by simply not calling it the
Reeves definition. It will help for them to then diagnose the patients using the Canadian Consensus Criteria, but having used the old Reeves definition as a filter risks deeply biasing the selection process. With only 40 patients in the study, we are baffled that they would even take a chance on inserting these biases (Reeves questionnaires and Walitt's belief that the disease is somatoform in nature) into the project.<o:p></o:p></div>
<div class="MsoNormal">
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<div class="MsoNormal">
Over the past 30 years there have been numerous breaches of
faith with patients. CDC was even chastised by Congress in 1999 for diverting
the paltry funds allocated to study CFS to a different disease entirely.<span style="mso-spacerun: yes;"> </span>In the meantime, more patients come down with
the disease every year, and very few fully recover.<span style="mso-spacerun: yes;">
</span><o:p></o:p></div>
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<div class="MsoNormal">
Despite the name, CFS is not characterized by
"fatigue."<span style="mso-spacerun: yes;"> (You might want to fix the headline to your article, which referred only to "chronic fatigue.") </span>The identifying
features of ME/CFS are post-exertional worsening of symptoms (as measured in
two consecutive days of CPET studies), and significant cognitive dysfunction.<o:p></o:p></div>
<div class="MsoNormal">
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<div class="MsoNormal">
Many patients have already been shown to have significant
immune defects - abnormally low natural killer cell function, abnormal cytokine
patterns, and the abnormal 37kDa Rnase-L defect.<span style="mso-spacerun: yes;"> </span>Many patients have been shown to be battling
chronic viral infections, particularly the beta herpesviruses (CMV, HHV-6A, and
HHV-7) and EBV (mono).<span style="mso-spacerun: yes;"> </span>Others have
Coxsackie B (an enterovirus) and/or adenoviruses.<span style="mso-spacerun: yes;"> </span>To drag the medical community back to square
one, when the disease was labeled a somatoform disorder, is extremely
distressing.<span style="mso-spacerun: yes;"> </span>Dr. Walitt may believe that
somatoform diseases have a physical explanation (abnormal cytokines in the
brain) - but he is still saying they are somatoform diseases.<span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
<div class="MsoNormal">
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<div class="MsoNormal">
This is the first NIH study in 20 years on a disease that
impacts one million adult Americans.<span style="mso-spacerun: yes;"> </span>The
first study on a disease that leaves 500,000 Americans completely unable to
earn a living.<span style="mso-spacerun: yes;"> </span>The first study on a
disease that can attack teenagers and leave them disabled in their 40s. There are patients who were never able to go to college, never able to date or marry,
never able to have children, never able to have a career, and they live in fear
of losing their parents as they age because they need a caregiver.<span style="mso-spacerun: yes;"> </span>The first study on a disease that has killed
patients from specific causes such as myocarditis (when the viruses get into
the heart muscle), cancer, and general system failure.<span style="mso-spacerun: yes;"> </span>The first study of a disease that has led to
far too many suicides, because no one in the medical profession has been there
for the patient, and the government has offered no hope of a better future.<o:p></o:p></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Given that NIH is only using 40 patients because, they say,
that is all they have the funds for, given the severity and prevalence of the
disease, and given everything patients have been put through, I do not think it
is too much to ask to dispense with the services of Dr. Walitt - someone who only last year breezily declared CFS a somatoform illness.<span style="mso-spacerun: yes;"> </span>I do not think it is too much to ask of CDC
that they not rebrand the Reeves questionnaires to sneak the Reeves definition
back into the study.<span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
I do not think it is asking too much to have just one
community-recognized ME/CFS specialist (perhaps Dr. Jason) on the ME/CFS
expert committee.<span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
<div class="MsoNormal">
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And I do not think patients are asking too much to be
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<span style="mso-spacerun: yes;">Thank you for your time and interest, Dr. Gupta. I hope that you take our concerns seriously. See also my open letter to Drs. Collins and Nath: <a href="http://slightlyalive.blogspot.com/2016/03/an-open-letter-to-dr-collins-and-dr.html" target="_blank">An Open Letter to Dr. Collins and Dr. Nath</a> </span></div>
Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com11tag:blogger.com,1999:blog-1345573145957924958.post-91496752620663854532016-03-04T12:41:00.000-08:002016-03-07T15:01:17.983-08:00An Open Letter to Dr. Collins and Dr. Nath on the NIH internal ME/CFS study<div style="box-sizing: border-box; color: #1d0907; font-family: 'Open Sans', arial, san-serif; font-size: 14px; line-height: 1.6; margin-bottom: 22px;">
Note: As of Sunday, March 6, NIH has dropped the somatoform comparison group. Thank heavens! But they are still looking for "the underlying physiology of fatigue." So I still wish they would spend as much time learning about M.E. as they have spent deciding on the [admittedly admirable] lineup of tests.<br />
<br />
Dear Dr. Collins and Dr. Nath:</div>
<div style="box-sizing: border-box; color: #1d0907; font-family: 'Open Sans', arial, san-serif; font-size: 14px; line-height: 1.6; margin-bottom: 22px;">
I echo the sentiments of many ME/CFS patients in expressing concerns about the way the in-house NIH study on ME/CFS is proceeding.</div>
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<span style="line-height: 1.6;">The </span><b style="line-height: 1.6;">stated hypothesis</b><span style="line-height: 1.6;"> of this new study is that: </span><span style="background-color: white; line-height: 1.6;">“<b>post-infectious ME/CFS is triggered by a viral illness that results in immune-mediated brain dysfunction</b>." Is that really all there is to the hypothesis? Dr. Wallit's participation raises troubling questions as to whether that is so. The comparison groups chosen for this study also suggest there is more to the hypothesis than we have been told. </span></div>
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I beg you, Drs. Collins and Nath, please rethink the hypothesis - and Dr. Walitt's role in this study. I also ask you to rethink the comparison groups. This disease has been a serious problem in the US for 30 years, and for 30 years both NIH and CDC have obstructed the creation of a strong biomedical research community – nevertheless, it has existed. </div>
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What has happened here? A hypothesis created by people who know next to nothing about this disease is being plonked on top of us. If I may say so, yet again. Why?</div>
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Make no mistake about it, fellow patients: Dr. Walitt is playing with somatoform diseases here – he just thinks there’s a biological cause for them. </div>
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He seems insulted that we might be unhappy about his inclusion. All I can say is that anybody who uses the words "chronic fatigue syndrome," "fibromyalgia," and "somatoform illnesses" in the same sentence is unacceptable in a preliminary study of my disease sponsored by NIH. </div>
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Last March Dr. Walitt published an article containing the following sentence: <b>"<span style="background-color: white; font-family: "times new roman" , "stixgeneral" , serif; font-size: 16px; line-height: 21px;">The discordance between the severity of subjective experience and that of objective impairment is the hallmark of somatoform illnesses, such as fibromyalgia and chronic fatigue syndrome.</span><span style="background-color: white; font-family: "times new roman" , "stixgeneral" , serif; font-size: 16px; line-height: 21px;"> </span></b><span style="line-height: 1.6;"><b>"</b> (</span><a href="http://www.ncbi.nlm.nih.gov/pubmed/25573802" style="line-height: 1.6;" target="_blank">Chemobrain: a critical review and causal hypothesis</a><span style="line-height: 1.6;"> )</span></div>
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I really do not care if Dr. Wallit is looking for a physiological cause for what are called "somatoform" illnesses. The problem is that he <i>thinks</i> ME/CFS <i>is</i> a somatoform illness.</div>
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<b>Then there are the comparison groups</b>. Where did <b><i>these</i></b> come from? Two comparison groups: <b>post-symptomatic Lyme Disease patients, and patients with physical somatic disorders</b>. The choices of comparison groups themselves suggest that the research hypothesis for this project has not been fully revealed to patients.</div>
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<span style="line-height: 1.6;">With only enough money to put 40 ME/CFS patients in the study, may I ask why we are bothering with comparison groups at all? Does it not make more sense to do this first study with ME/CFS patients v. controls - and then use more ME/CFS patients? </span></div>
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Since 1998 I have known that i had the defective 37kDa Rnase-L and a severe case of HHV-6A. Later testing showed natural killer cell dysfunction (in my case, a natural killer cell function of 2-3%) and abnormal cytokine patterns. In 2009, Dr. Dan Peterson found active HHV-6A and CMV in my spinal fluid. Do you think that my serious encephalitic and neurological symptoms could have had something to do with that evidence? The immune defects and viruses go away on Ampligen and come back 7-12 months off it. I am a sample of 1, but there are more like me. Many more. We have patients improving on the antiviral Vistide at Dr. Peterson's (I cannot take Vistide; my liver markers shoot up). The late Martin Lerner had patients on both Vistide and another antiviral, Valcyte; Dr. Jose Montoya at Stanford has had success with Valcyte as well. </div>
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Please pay attention to this evidence. Talk to clinician/researchers. </div>
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If not – then please run that hypothesis past some non-psychiatric specialists in our field before running with it in the first NIH internal study on our disease since Straus discovered (to his dismay) that we have abnormally LOW levels of adrenaline (patients with major mood disorders tend to have abnormally HIGH levels of adrenaline) 20 years ago. Dr. Straus had planned to be able to say we really had depression; hence his disappointment. (Psychiatists in the UK - and CDC's CFS group - finally found a use for Straus's adrenaline study in the unsupported hypothesis that patients had too many stressors earlier in life and had, in effect, run out of mechanisms to cope with them. If that were true, wouldn't one expect to find this disease much more common in Kosovo, parts of Africa, and in the embattled mid-east? Why hasn't it popped up in refugee communities internationally?)</div>
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Perhaps you could put this off until you can hold a workshop with recognized ME/CFS experts. I am confident we could pull one together quickly.</div>
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The well-respected British organization, <a href="http://www.investinme.org/" target="_blank">Invest in ME</a> , is holding a research conference May 3 in London. I am certain they would include you if asked. Another international research organization for this disease, <a href="http://iacfsme.org/" target="_blank">IACFS/ME</a> (International Association for CFS/ME) is meeting in Miami in October. Put this on a workshop there, or let them help you set up an earlier one. Or ask the public members of CFSAC to help you create a workshop. Ask any of us to help you create a workshop. <b>You need to discuss the hypothesis and comparison groups with the longstanding biomedical ME/CFS community before committing to them. </b></div>
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In the beginning of 2000, ignoring the existence of CFSCC, the late Stephen Straus of NIAID and CAM at NIH ran a "state of the science" meeting about "CFS" with the usual suspects (if you forgive my saying so) – the psychiatrists from the UK who have had an inordinate amount of influence on perceptions of this disease both abroad and within HHS<span style="line-height: 1.6;">. After pressure from Congress he relented to having ONE public member from CFSCC attend (Nancy Klimas). But Congress continued to ask for a more objective conference. Donna Dean had just been placed as head of CFSCC, and she ran a conference the next fall that was fantastic – full of science and discussions with researchers who had previously known nothing about the disease. Unfortunately, there was a presidential shift in 2001 and CFSCC was shut down (to emerge, weakened, as CFSAC almost three years later). Dr. Dean left, and nothing happened again until 2011, when Dennis Mangan ran another excellent State of the Knowledge conference at NIH, which then came to naught.</span><span style="line-height: 1.6;"> </span></div>
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When researchers do not know the very long history of this disease (technically going back to atypical polio in 1934, but practically speaking, back 60 years to the Royal College outbreak and creation of the terms myalgic encephalomyelitis in the UK and epidemic neuromyesthenia in the US), they make blunders. They can be perfectly well-meaning, but this topic is a mine field and requires someone who knows the history to navigate it. I am discouraged that once again NIH is going off on its own, as if we were never here at all.</div>
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<b>One last way to salvage this study. Simply ditch the hypothesis and comparison groups and run it as a study of potential biomarkers in ME/CFS, without prejudging their meaning.</b></div>
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This is a very raw hypothesis. I love the scientific evidence you want to bring to bear, but I wish you were working on <b><u>biomarkers for ME/CFS</u></b> – not the physiological basis for "somatoform" illnesses.<br />
<br />
Mary M. Schweitzer, Ph.D.</div>
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Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com25tag:blogger.com,1999:blog-1345573145957924958.post-4694801454793163102016-02-19T12:51:00.000-08:002016-02-19T13:50:52.943-08:00The PACE trials: a £6 million failure<div class="" id="yui_3_16_0_1_1455843416819_46095" style="font-family: HelveticaNeue, 'Helvetica Neue', Helvetica, Arial, 'Lucida Grande', sans-serif; font-size: 13px;">
<span class="" id="yui_3_16_0_1_1455843416819_46097">There is nothing complicated about the <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/abstract" target="_blank"><span style="color: #3d85c6;">PACE trials</span></a> – or at least, there should not have been. Patients were selected to participate in a trial of cognitive behaviour therapy targeted to their “inappropriate illness beliefs” and a course of “graded exercise therapy” to get them back in shape – together this is called CBT/GET and has been proclaimed as the “best” treatment for ME and CFS by the governments of the UK, the US, among others, for two decades now. [For an excellent critique of the PACE trial, see <a href="http://www.virology.ws/2015/10/21/trial-by-error-i/" target="_blank"><span style="color: #3d85c6;">David Tuller's "Trial by Error"</span></a> .]</span></div>
<div class="" id="yui_3_16_0_1_1455843416819_46095" style="font-family: HelveticaNeue, 'Helvetica Neue', Helvetica, Arial, 'Lucida Grande', sans-serif; font-size: 13px;">
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<span class="" id="yui_3_16_0_1_1455843416819_46101">These treatments are controversial, to say the least. The main reason is that the entire programme of “CBT/GET” with regards to ME and CFS is based on the assertion that the patients’ physical symptoms have no medical explanation – in insurance (and now medical) parlance, these patients all have “MUS”s (Medically Unexplained Symptoms).</span></div>
<div class="" id="yui_3_16_0_1_1455843416819_46099" style="font-family: HelveticaNeue, 'Helvetica Neue', Helvetica, Arial, 'Lucida Grande', sans-serif; font-size: 13px;">
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<span class="" id="yui_3_16_0_1_1455843416819_46105">But there are numerous studies that DO offer a medical, or physiological, explanation for the symptoms. Most specifically, research has shown that high-functioning patients who fit the <a href="http://sacfs.asn.au/download/consensus_overview_me_cfs.pdf" target="_blank"><span style="color: #3d85c6;">Canadian Consensus Criteria for ME/CFS (2003)</span></a> do perform roughly the same as deconditioned controls on <span style="color: #3d85c6;"><a href="http://www.investinme.org/ArticleJ51-610%20Using%20Cardiopulmonary%20Exercise%20Testing.htm" target="_blank"><span style="color: blue;"><span style="color: #3d85c6;">Cardio-Pulmonary Exercise Testing</span> </span><span style="color: #3d85c6;">(CPET)</span></a><span style="color: #3d85c6;"> </span></span> – but on a SECOND day of testing, while the deconditioned controls perform the same as they did the day before, the patients’ scores drop by as much as one-half. (See, for example, <a href="http://ptjournal.apta.org/content/early/2013/06/26/ptj.20110368.abstract" target="_blank"><span style="color: #3d85c6;">Discriminative Validity of Metabolic and Workload Measurements to Identify Individuals With Chronic Fatigue Syndrome</span></a>, </span><span class="highwire-citation-author first has-tooltip hasTooltip" data-delta="0" rel="#hw-article-author-popups-node18914--4 .author-tooltip-0" style="border: 0px; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 18.6200008392334px; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;" title=""><span class="nlm-given-names" style="border: 0px; font-family: inherit; font-size: inherit; font-style: inherit; font-variant: inherit; line-height: inherit; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Christopher R.</span> <span class="nlm-surname" style="border: 0px; font-family: inherit; font-size: inherit; font-style: inherit; font-variant: inherit; line-height: inherit; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Snell</span></span><span style="background-color: white; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 18.6200008392334px;">, </span><span class="highwire-citation-author" data-delta="1" style="border: 0px; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 18.6200008392334px; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;"><span class="nlm-given-names" style="border: 0px; font-family: inherit; font-size: inherit; font-style: inherit; font-variant: inherit; line-height: inherit; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Staci R.</span> <span class="nlm-surname" style="border: 0px; font-family: inherit; font-size: inherit; font-style: inherit; font-variant: inherit; line-height: inherit; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Stevens</span></span><span style="background-color: white; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 18.6200008392334px;">, </span><span class="highwire-citation-author has-tooltip hasTooltip" data-delta="2" rel="#hw-article-author-popups-node18914--4 .author-tooltip-2" style="border: 0px; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 18.6200008392334px; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;" title=""><span class="nlm-given-names" style="border: 0px; font-family: inherit; font-size: inherit; font-style: inherit; font-variant: inherit; line-height: inherit; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Todd E.</span> <span class="nlm-surname" style="border: 0px; font-family: inherit; font-size: inherit; font-style: inherit; font-variant: inherit; line-height: inherit; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Davenport</span></span><span style="background-color: white; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 18.6200008392334px;">, and </span><span class="highwire-citation-author has-tooltip hasTooltip" data-delta="3" rel="#hw-article-author-popups-node18914--4 .author-tooltip-3" style="border: 0px; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 18.6200008392334px; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;" title=""><span class="nlm-given-names" style="border: 0px; font-family: inherit; font-size: inherit; font-style: inherit; font-variant: inherit; line-height: inherit; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">J. Mark</span> <span class="nlm-surname" style="border: 0px; font-family: inherit; font-size: inherit; font-style: inherit; font-variant: inherit; line-height: inherit; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Van Ness, </span><span class="nlm-surname" style="border: 0px; font-family: inherit; font-size: inherit; font-variant: inherit; line-height: inherit; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;"><i>Physical Therapy</i> (June 2013).</span></span></div>
<div class="" id="yui_3_16_0_1_1455843416819_46103" style="font-family: HelveticaNeue, 'Helvetica Neue', Helvetica, Arial, 'Lucida Grande', sans-serif; font-size: 13px;">
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<span class="" id="yui_3_16_0_1_1455843416819_46109">The CPET has long been used in cardiology – and athletics – and is highly regarded as objective. It can’t be gamed. The tester puts a mask over the patients nose and mouth (or over the mouth and clamps the nose shut) so that the air going into and out of the patients’ lungs is measured by a machine while the patient rides a stationary bicycle or walks on a treadmill that gets progressively more difficult. When the patient reaches maximal cardiac effort [a pulse of (200-age) x .8], the machine records the amount of oxygen intake and carbon dioxide release – that is, it measures how much oxygen the patient inputs and how much carbon dioxide has been produced.</span></div>
<div class="" id="yui_3_16_0_1_1455843416819_46107" style="font-family: HelveticaNeue, 'Helvetica Neue', Helvetica, Arial, 'Lucida Grande', sans-serif; font-size: 13px;">
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<span class="" id="yui_3_16_0_1_1455843416819_46113">CPET testing of patients with ME or CFS – which has now been replicated on three continents by numerous researchers (and is into second-order studies where the patients’ blood is tested for other characteristics before, during, and after testing) has effectively demonstrated that what patients have been saying for years – and what has been recognized by the non-psychiatric school of thought regarding the disease – is both profound and measurable – patients suffer from what is called in the literature “post-exertional malaise” or post-exertional worsening of symptoms. </span></div>
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<span class="" id="yui_3_16_0_1_1455843416819_46117">This symptom is considered so profound, and so important, that the recent <a href="http://iom.nationalacademies.org/Reports/2015/ME-CFS.aspx" target="_blank"><span style="color: #3d85c6;">Report on ME/CFS from the Institute of Medicine</span></a> at the US National Academies of Sciences concluded it should be a <b><i>requirement</i></b> for the definition of the disease.</span></div>
<div class="" id="yui_3_16_0_1_1455843416819_46115" style="font-family: HelveticaNeue, 'Helvetica Neue', Helvetica, Arial, 'Lucida Grande', sans-serif; font-size: 13px;">
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<span class="" id="yui_3_16_0_1_1455843416819_46121">Now, imagine a patient for whom a defining symptom is the inability to maintain the <i>same</i> level of exercise two days in a row. Imagine a treatment where the patient is told to (1) increase exercise daily, and (2) ignore how it makes them feel. These patients end up operating in constant anaerobic metabolism, which is dangerous for trained athletes – certainly it is dangerous for patients.</span></div>
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<span class="" id="yui_3_16_0_1_1455843416819_46125">That brings us to my own principle frustration with this literature. The psychiatric literature on the disease known as ME and/or CFS does not reference the great body of literature on physical abnormalities found in the disease. Those who know nothing of these diseases who read this psychiatric literature won’t know about post-exertional “malaise” (or worsening of symptoms); won’t know about significant cognitive dysfunction and sleep abnormalities; ataxia, gait abnormalities, muscle pain; and – above all – won’t know that one-fourth of patients are either bedridden or housebound.</span></div>
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<span class="" id="yui_3_16_0_1_1455843416819_46092">Here, then, is the major source of the division between QMUL/KCL and the rest of the ME/CFS community. It has nothing to do with how patients feel about psychiatrists or psychiatric diagnosis. Rather, the QMUL/KCL world admits to <b><i>no</i></b> evidence of physical abnormalities in patients with this disease – an assertion I do not believe they are entitled to make. Certainly readers should have the opportunity to choose for themselves; a full and objective bibliography should be provided by the authors, not just a bibliography of work that agrees with their thesis.</span></div>
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<span class="" id="yui_3_16_0_1_1455843416819_46131">Under the circumstances, the authors of this £6 million study – which used taxpayers’ funds – are being suspiciously coy. Patients have insisted for years that the CBT/GET protocol is not just meaningless – it is <b><i>directly harmful</i></b>. Indeed, if CBT/GET were a pharmaceutical drug instead of a protocol, it would have been denied a long time ago on the basis of the number of adverse events.</span></div>
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<span class="" id="yui_3_16_0_1_1455843416819_46135">But both the UK and the US governments continue to recommend this treatment – and they base that recommendation on the PACE trials plus the body of literature written by the schools of psychiatry at QMUL and KCL.</span></div>
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<span class="" id="yui_3_16_0_1_1455843416819_46139">It is not just an academic discussion. <b><i>Policy choices</i></b> rest on the conclusion. <b><i>Treatment choices</i></b> rest on the conclusions.</span></div>
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<span class="" id="yui_3_16_0_1_1455843416819_46143"><b><i>It is imperative that we get this right.</i></b> If the authors are wrong, then this is actually harming patients, even as I write this sentence. They would probably consider that sentence harassment. But how else am I to say it? There is evidence that the adverse events from this treatment protocol are being swept under the rug.</span><br />
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<span class="" id="yui_3_16_0_1_1455843416819_46147">One million American adults suffer from this disease. 250,000 patients in the UK are also victims. This is too important not to make absolutely certain we are doing the right thing.</span></div>
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<span class="" id="yui_3_16_0_1_1455843416819_46151">What I do not understand is why the psychiatrists at QMUL and KCL don’t agree with that.</span></div>
Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com3tag:blogger.com,1999:blog-1345573145957924958.post-53382327398616274792015-12-13T16:12:00.000-08:002015-12-19T14:41:07.434-08:00A postmodernist theory of medicine: "CFS/ME" and the PACE trials<div style="-webkit-text-stroke-color: rgb(0, 0, 0); -webkit-text-stroke-width: initial; font-family: Helvetica; font-size: 11px;">
What happens when a concept developed to analyze the arts, including literary criticism, migrates to medical science? The concept is postmodernism, and it is a very strange philosophy for a science having to do with keeping human beings healthy. Postmodernism is defined a bit differently depending on whether you are discussing postmodernism in architecture, the visual arts, or literary criticism. However, there are a few basic elements:</div>
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<li style="-webkit-text-stroke-color: rgb(0, 0, 0); -webkit-text-stroke-width: initial; font-family: Helvetica; font-size: 11px; margin: 0px;"><span style="font-size: 12px;"></span><b>Rejection of the modernist concept of progressivism</b> - that knowledge improves over time</li>
<li style="-webkit-text-stroke-color: rgb(0, 0, 0); -webkit-text-stroke-width: initial; font-family: Helvetica; font-size: 11px; margin: 0px;"><span style="font-size: 12px;"></span><b>Emphasis upon perception over “reality”</b> - to some extent, a rejection of reality itself in the belief that we can only know perception</li>
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<span style="-webkit-text-stroke-width: initial;">I am sure there are other ways to characterize postmodernism, but I think these three precepts run through most theories based upon postmodernism.</span></div>
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In this essay, I am going to suggest that there is a school of British psychiatry called “biopsychosocial” which is effectively postmodernist - a most peculiar theory upon which to base the diagnosis and treatment of real human beings in real time. The patients who have born the brunt of this school of thought are those afflicted with the condition Myalgic Encephalomyelitis (ME), which (by way of a detour through “chronic Epstein-Barr virus”) became known as “chronic fatigue syndrome” in 1988. It’s not a minor or rare illness - millions of patients worldwide have the disease; over one million in the US and 250,000 in the UK. </div>
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ME, the disease, is based upon a set of symptoms having to do with muscle failure, cognitive dysfunction, “unrefreshing” sleep, and pain. Perhaps the most unique symptom of ME is a delayed response to exertion, what patients call a “crash,” which can last days or weeks or even become permanent. The most seriously ill patients with this disease are confined to wheelchairs, bedridden, even on feeding tubes. It would hardly seem the best choice for a medical theory of postmodernism.</div>
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In contrast, “chronic fatigue syndrome,” or CFS, fits the bill for postmodernism perfectly, because it is almost entirely based upon perception - the perception of fatigue. </div>
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ME was first diagnosed in the 1950s to characterize three large outbreaks of disease in the UK, the most famous occurring at the Royal Free Hospital in London as a new term for a condition that had been observed since 1934, “atypical polio.” With polio supposedly conquered by vaccine (which only contains the 3 strains of polio considered most severe), medical researcher and clinician Melvin Ramsay, along with several colleagues, sought to define a condition that appeared to occur in cluster outbreaks, like polio, but had somewhat different characteristics. ME was adopted by the World Health Organization in 1969, coded within the chapter on neurological conditions in WHO’s International Classification of Diseases (ICD). It remains there in ICD-10, the current version.</div>
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In 1970 and 1971, psychiatrists McAvedy and Beard published two articles claiming that ME was actually mass hysteria (interesting time - just as psychiatry lost the diagnosis of hysterical paralysis for Multiple Sclerosis, they found a substitute in ME). Psychiatrists jumped on the name change to CFS in 1988 - in particular, a group of British psychiatrists who declared themselves to be practitioners of something called “biopsychosocial” medicine: most notably Simon Wessely, Michael Sharpe, and Peter White. </div>
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The “biopsychosocial” school consisted mainly of the claim that its adherents practiced a holistic vision of medicine combining biological, psychological, and social factors - but in practice, very little was ever said about biology. When the biopsychosocial psychiatrists were asked about the absence of references to biomedical research in their work, they tended to snap back with the <i>non sequitur</i> that the suggestion showed an adherence to “Cartesian mind-body dualism,” and prejudice against psychiatry in general. </div>
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According to these psychiatrists, “CFS” and “CFS/ME” (their terms) was caused by “inappropriate illness beliefs.” The patient had actually had an illness such as a bad flu in the beginning, but instead of going back to their normal lives after the virus was over, they became afraid to do too much in fear that the symptoms would return. The result of their inactivity, deconditioning, became the evidence that they were still sick. The cure could thus be found in a specific form of psychiatric therapy, cognitive behavior therapy (CBT) - to teach the patient that she wasn’t really sick as she thought - and graded exercise therapy (GET) - to get the patient’s body reconditioned. The combination of positive thoughts about improvement and actual improvement caused by the exercise would therefore “cure” the patient.</div>
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The biopsychosocial school, in practice, is postmodernism as medicine:</div>
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<li style="-webkit-text-stroke-color: rgb(0, 0, 0); -webkit-text-stroke-width: initial; font-family: Helvetica; font-size: 11px; margin: 0px;"><span style="font-size: 12px;"></span><b>Rejection of a metanarrative</b> - in this case, the authors claim to be rejecting outdated beliefs in “Cartesian dualism” that would differentiate between “biomedical” research and “psychiatric” research.</li>
<li style="-webkit-text-stroke-color: rgb(0, 0, 0); -webkit-text-stroke-width: initial; font-family: Helvetica; font-size: 11px; margin: 0px;"><span style="font-size: 12px;"></span><b>Rejection of modern concepts of progressivism</b> - the authors reached back to the nineteenth century diagnosis “neurasthenia,” citing books written in the mid-1800s about “nervous disorders.” Their research, they insisted, was not driven by pure theory but “evidence-based.” “Evidence-based” obviously sounds like a good idea, except that in this case it was based upon “evidence” from clinics where patients had already been diagnosed using their theories - it was, in effect, a tautology. But they could then insist they did not have to reference research driven by path-dependent theories linked by time, or answer to critiques of neurasthenia over the past 150 years. They were only studying the present. </li>
<li style="-webkit-text-stroke-color: rgb(0, 0, 0); -webkit-text-stroke-width: initial; font-family: Helvetica; font-size: 11px; margin: 0px;"><span style="font-size: 12px;"></span><b>Emphasis of perception over reality</b> - the patient only THINKS he or she cannot behave like healthy adults. It is the perception, these “inappropriate illness beliefs,” that need to be changed. The cure, then, is to be found in treatments that change that perception both literally, through CBT, and changing the experience itself, through GET. </li>
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It is in this context that I think we can best understand the £5,000,000 study commissioned by the UK government called the “PACE trials.” The PACE trials were supposed to prove once and for all whether the prescription of CBT/GET could cure the disease the authors called “CFS/ME.” Since the authors made their living - to a large extent - on the basis of this thesis, one would think the results would be evaluated using a fine tooth comb. But no sooner had they been published than critiques arose from the community of patients afflicted with the disease, and those who either treated or studied it. </div>
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Patients with backgrounds in medicine, science, and/or research were unable to break through to the public with their critiques. Many of them asked to see the data behind the study to understand how the conclusions reached could possibly have arisen from the study. Their requests did not exactly fall on deaf ears - to the contrary, the researchers complained both privately and publicly (in the press) that they were being harassed, the requests for data “vexatious.” No data was released. </div>
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Four years passed.</div>
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This fall, (2015), David Tuller, a Berkley journalism professor who had followed the disease for the New York Times and other outlets, wrote a detailed critique of the study, which was published on the blog site of noted Columbia virologist Vince Racaniello. There it drew the attention of James Coyne, a clinical health psychologist who has spent several years focusing on deception in research.</div>
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In fast succession, a new request for data was filed - and refused. Queen Mary’s University London (QMUL) and King’s College London (KCL) both insisted that the request was without basis, that it was intended only to harass the authors - that is, that it was “vexatious” - and they refused to comply.</div>
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For an excellent rundown of where we were in the story as I wrote this essay (12 December 2015), see:</div>
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<a href="https://autodidactauthor.wordpress.com/2015/12/13/pace-trials-forbidden-fruit/" target="_blank">PACE Trials - Forbidden Fruit</a></div>
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Elsewhere on this blog, Slightly Alive, you will find testimony to CFSAC and FDA on my condition, testing, and the experimental immune medicine which enables me to be able to write this essay. </div>
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Here, however, I wanted to add something new to the debate. What happens when theories inspired by postmodernism encounter a discipline that requires the belief that there <i>is</i> a there, there - there is a real patient, the real patient has a real body, and real things go wrong with that very real body. The result <i>sounds</i> like scholarship. It sounds <i>erudite</i>. But in the end, you cannot separate perception from reality in this manner. You cannot simply assume that the only problem with a patient is his or her perception of their health, on the basis that (in insurance industry language), the patients’ problem boils down to “<b>medically unexplained symptoms</b>” (which has even earned an acronym, <b>MUS</b>). </div>
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Aside from the costs to the patients who actually <i>have</i> the disease in question, ME, these theories are very dangerous to the larger discipline of medicine. Just because symptoms have no “medical explanation” does not mean they are based solely upon perception. No physician can possibly explain every medical symptom - and there are conditions that have yet to be explained. The absence of an explanation is not proof of the absence of a medical condition.</div>
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But in the world of “biopsychosocial” medicine, the absence of an explanation is precisely that: proof of the absence of a medical condition - of a <i>purely</i> medical condition, they would probably say.</div>
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Medical science needs to understand that this theory does not just apply to ME/CFS, and does not just apply to “MUS” conditions. Simon Wessely, for example, has already applied it to Gulf War Syndrome. </div>
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This is an enormously useful <i>political</i> concept in the current atmosphere of austerity. Applying CBT and GET is a lot less expensive than testing for immune defects and pathogens, looking at SPECT scans and CPETs, treating with immune modulators and antivirals. </div>
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The British government, which has much to gain from this theory that “CFS/ME” is perception rather than reality, and these researchers, who directly profit from that theory, were hardly disinterested parties to join together in conducting the PACE trials. The same goes for the institutions SMUL and KCL.</div>
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As such, they are not really in a position to reject mounting requests for an independent review of the study. <i>They should not be permitted the final say. </i></div>
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The ramifications of their intransigence are great. There are many conditions to which this new postmodernist view of medicine could be applied, greatly cutting costs without benefitting people in need of care. The risk is greatest with chronic illness. It is hardly a secret that both insurance companies and penurious governments are concerned about the mounting costs of chronic illness. What a convenient theory for such an austere time. </div>
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The authors of the PACE trials (and those who funded the study) must not be permitted to slip away without a thorough examination, because too much is at stake. Postmodernism and medicine are not a happy coupling. The effort to join them must undergo even <i>more</i> scrutiny than usual, because what is being tried here is most unusual. </div>
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It is highly unlikely that the authors of the study willingly would allow that data to see the light of day, because so far the evidence suggests the data cannot support the conclusions - and too much is riding on those conclusions. </div>
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If the most basic rules of scholarship are permitted to be broken here, where then will they be enforced? CFS/ME is merely perception. Global warming is just biased statistics. “Fracking” has no effect on the environment. That may be your <i>“view”</i>, but my <i>“view”</i> is just as important. </div>
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After all, it’s only perception. </div>
Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com25tag:blogger.com,1999:blog-1345573145957924958.post-27438964747570237842015-11-15T19:52:00.000-08:002015-11-18T18:27:14.568-08:00My 20 years with Myalgic EncephalomyelitisOriginally posted May 12, 2014.<br />
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I have had Myalgic Encephalomyelitis, or M.E, for 20 years. The CDC does not recognize this. They insist that I have a condition called "Chronic Fatigue Syndrome," or CFS. I have M.E.<br />
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At the age of 44 I led a charmed life. I had been married to the love of my life for 20 years, and we had two lovely children. We were both college professors - a deliberate choice that allowed us to do what we enjoyed - researching and teaching subjects that deeply interested us - while having the income to live comfortably (because we both worked) and plenty of time to spend with the children (because of the nature of academic life). I had tenure at a good university, although my sights were set higher than that. I had a working relationship as an associate fellow with a research institute at an Ivy League school, which enabled me the luxury of being around the best and the brightest in my field. We traveled all around the country going to each other's conferences, often taking one of the kids along. We also went to four Olympics, two final fours (NCAA basketball championships) and countless playoff games, several World Series, and, eventually, twenty years of baseball AllStar games. We skied in the winter and went to the beach in the summer. It was a charmed life.<br />
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On October 24, 1994, I went to my office to grade exams and suffered a blackout. When I came to, I could not understand one word in the Bluebooks in my lap - they might as well have been written in Cyrillic alphabet. It took time - and concentration - to be able to stand. I had fallen down the rabbit hole; my life would never be the same.<br />
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Over the next four years I suffered from severe pain in the back of my neck and behind my eyes, 24/7. My muscles ached, and I had migraine-level headaches. I had ataxia, dyslexia, sensitivity to light and sound (to the point I had to wear sunglasses all the time), tinnitus, partial paralysis, memory loss, disorientation, expressive dysphasia, and massive confusion. My family took care of me. Obviously, I could not drive, and by 1996 I was using a wheelchair when I left the house (which someone else had to push).<br />
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I was lucky to have a family to take care of me, because I could not take care of myself. I also soon discovered an Internet discussion list of fellow sufferers, and was referred to a very good specialist in Washington, Marsha Wallace (who unfortunately hasn't practiced since 2000). Dr. Wallace taught me to live within my energy envelope and helped with sleep disruption and NMH/POTS, but I continued to deteriorate.<br />
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In the fall of 1998, Dr. Wallace introduced me to Dharam Ablashi, a researcher who had just retired from the National Cancer Institute at NIH. Dr. Ablashi had been the co-discoverer of HHV-6 and it's two variants, A and B, while working with AIDS. I had the version the AIDS patients did - Variant A - and my viral load was ten times the amount used to diagnose an active infection.<br />
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I would also test positive for active EBV or mono (which I had more than once - most notably in 1990, four years before my collapse, during an outbreak on my college campus), CMV (cytomegalovirus), HHV-7, and three strains of Coxsackie B.<br />
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My immune system was severely compromised: My natural killer cell function was less than 3%, I had the defective 37kDa Rnase-L, and I had an abnormal cytokine pattern. But no one knows how all this happened. All we know is that this disease can occur in cluster outbreaks, and it can pop up in individuals. No one in my family got it from me, but I believe the outbreak of EBV in 1990 marked the beginning of my illness - the beginning of the cycle of immune defect-virus-damage that characterizes this disease for many of us. I had to continue to teach through my infection with EBV, including an hour's commute and back, and while I recovered from mono at the end of the fall semester, my health began to deteriorate in seemingly disparate ways, until the ultimate collapse in 1994.<br />
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Years later I would have a spinal tap that revealed both HHV-6 and Cytomegalovirus were active in my spinal fluid. No wonder I had the symptoms of encephalitis, and with the stiff neck, meningitis. Along with the muscle pain, that meant literally that I had Myalgic Encephalomyelitis, or M.E., a disease that had been diagnosed in the UK since the mid-1950s. In the United States, however, all I was given was a diagnosis of "chronic fatigue syndrome," a name chosen by committee and adopted by CDC in 1988 to replace the name given a number of cluster outbreaks occurring in the USA at the time, Chronic EBV. They did not mention M.E. - though there were specialists at the meeting who insisted that was the correct diagnosis for these outbreaks. They did not ask anyone in the disease community what they thought of this name. They simply adopted it, and having done so, consigned the disease to the backwaters of medicine where neither research nor treatment could be found.<br />
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There could not have been a worse choice of a name for this disease if CDC had hired a focus group, Chronic (as in chronic whiner) Fatigue (as in "yeah, I've been feeling tired lately myself") Syndrome (as in syndrome of the month) - applied to upper middle class white women "trying to have it all" (as the late Bill Reeves of CDC once phrased it) - how inconsequential, silly even. A quarter of a century later, 85% of patients - over one million Americans - have no idea what is wrong with them, because, according to both CDC and private demographic evidence, only 15% have a diagnosis. 26 years later only 15% have a diagnosis. That is a mighty admission of failure.<br />
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The infectious disease specialists in northern Delaware dismissed my illness as minor. "You'll be back to normal in two years," they assured me. Oh good, I responded - I won't have to miss more than two seasons before I can go back to skiing. "Oh no," was the response. "You'll never ski again." How was that "normal?" I asked. They got angry at that. That's when I was referred to Dr. Wallace and, thankfully, only had to deal with these people once more, when I was on the antiviral Vistide for my cytomegalovirus infection. Dan Peterson, my new specialist, had asked them to let me get the infusions at their center, and they had agreed. But when I showed up at their office, one of the doctors took me aside and said that they could not let me have Vistide because my medical records showed I "only had CFS - nothing serious, like AIDS or cancer." They said they could not justify using the drug on someone with a diagnosis of CFS - even though it was an FDA-approved drug for the virus CMV, which was active in both my blood serum and my spinal fluid.<br />
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Let me repeat that: once given the label Chronic Fatigue Syndrome, I would meet disrespect from many doctors and people at NIH and CDC. None of my extensive testing mattered.<br />
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Although the progressive version of M.E. that I suffered from was unusually severe, I turned out to be lucky. I was given the opportunity to go on the experimental Phase III drug Ampligen, in what is called a cost-recovery (I pay cash), compassionate care (I am allowed to do this because I was so very sick), open label (I know I am on the drug so FDA ignores me) study. I have to get Ampligen at the study site by IV infusion twice a week. And FDA can take the drug away from me whenever they want.<br />
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I have been on Ampligen for eleven of the past fifteen years. Again, I am unusual in that my illness erupts again within a year of going off the drug (which I did once voluntarily, and once because FDA did take the drug away). FDA has admitted, in writing, that the drug is not toxic. But they are not "convinced" it is effective. My experiences do not count because I was not in a placebo trial; I knew I was on the drug. There is no other drug in the FDA pipeline for either CFS or M.E. (Although there are immune boosters and antivirals available for patients, and an anti-cancer drug called Rituximab is showing some promise). This is the only one expressly targeted to M.E. or CFS. Over one million Americans suffer from my disease. FDA, CDC, NIH - none of them cares - though in fairness, there are individuals within those agencies who do. It is those who make decisions who do not care.<br />
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[Side note about the obsession with placebo trials - If just knowing you are on a drug can make your immune markers return to normal, your active viruses return to a dormant stage, and change tests such as SPECT scans and CPET scores, we should all be cured of anything by happy thoughts. Does FDA really believe this?]<br />
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So here I am today. I would not have written this were I not on Ampligen. On Ampligen, I can drive, take care of myself (mostly), read a book, work on my own writing, spend time with my children and grandchildren. Off Ampligen I am an invalid in bed in severe pain, curled up in the dark because light is too painful, listening to a favorite movie over and over again.<br />
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So twice a week I leave my house at 8:15 and commute by train 100 miles north to Dr. Derek Enlander's office in New York City, the closest site where I can get Ampligen. I usually get home around 7 pm. It is grueling, but at least I am getting the drug that keeps me from being a bedridden invalid.<br />
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Myalgic Encephalomyelitis is a serious disease.<br />
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CDC betrayed us by giving it a silly-sounding name in 1988 - CFS. NIH allocates $6 million per year to study this disease - a pathetic amount. MS gets $122/year with half the patients; "Behavioral and Social Science" gets almost $5 billion/year from NIH. <br />
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We came back with private research initiatives, funded by cash-strapped patients and their families, and more good biomedical research is being published than ever before. The whole concept of what "CFS" is, silly sounding name and all, is undergoing a transformation. And for the first time in my memory, clinicians and researchers have agreed on a definition - the Canadian Consensus Criteria, updated with current research.<br />
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So how is our government responding? Suddenly there are three different initiatives within the U.S. department of Health and Human Services (HHS) to redefine the disease and rename it - done behind closed doors. At CDC there is the Multi-site clinical assessment - which brought in respected clinics, but is now being polluted with research from a poorly conceived and run study by CDC in Georgia that used a different definition entirely. HHS has turned to the IOM - Institute of Open Medicine - with a committee of whom the majority are not experts in either CFS or M.E. NIH as a whole has given the "problem" of the name and definition to their "pathways to prevention" program, or P2P. In this case a committee was explicitly created consisting of individuals with NO experience -either medical of personal - with the disease, "like the jury system," a spokesman explained cheerfully. "Stakeholders" with different viewpoints testify to the committee, and then this committee of amateurs will recess and vote on the choice of what to do next. Precisely when did the jury system replace scientific method in determining medical policy?<br />
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[The IOM and P2P reports turned out better than expected, particularly the IOM report, because it has helped bring attention to the plight of over one million Americans suffering from a severe neuro-immune disease.]<br />
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They are going against the expressed wishes of 60 specialists who signed a letter asking that the U.S. adopt the Canadian Consensus Criteria (CCC), and the public members of the CFS Advisory Committee to HHS asking that the government adopt the CCC, and hold an open workshop of specialists to update it (it is ten years old) with current research results. Why are those of us within the world of M.E. ignored? Why is 60 years of biomedical research into M.E. ignored internationally?<br />
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Perhaps more important, why don't people outside our community - people in the media, in government, our doctors, our neighbors, our employers - why don't they know that there is a growing epidemic of a severe, life-altering and in some cases life-taking disease that CDC and NIH are keeping under wraps? I have friends who were teenagers when they got sick, and are now in their 40s. They did not get to marry their soulmate like I did. They did not go to college or have a career. They did not have children or grandchildren (I have two grandchildren now). I was lucky compared to them.<br />
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They can barely afford to live from day to day. They cannot afford the testing I have had, and they most certainly cannot afford the treatment I am on.<br />
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I have lost friends to this disease; we have lost young people to this disease. The viruses can get into your heart muscle; they can get into your liver. Patients die of rare cancers as well. And then there are the suicides.<br />
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There has been a new series of outbreaks in the past five years. Look at those you love, and if you care for them - whether or not you care about us - do something. Because they could be the next victims.<br />
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Thank you for reading.<br />
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Coda, 15 November 2015. The above was written for May 12, 2014 (ME Awareness Day).<br />
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I lost the love of my life, my soulmate, my husband of 40 years, to cancer on July 7, 2013. We had lived in Delaware for 35 years. To stay on Ampligen - and also because both my soul and my body need healing - I have moved to Incline Village, NV, at Lake Tahoe. It is beautiful here. My family (including 2 children and 2 grandchildren) are all back East, but Reno Airport is nearby and I put the cost of Ampligen on a Southwest credit card ... I am able to get my twice-weekly infusions from Dr. Dan Peterson just 2 miles away. And this is a good house for writing, so I hope to be able to finish my book manuscript, "Slightly Alive," this winter. I still live in fear of losing Ampligen. But I'm okay.<br />
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It has been 27 years since CDC adopted the silly name "chronic fatigue syndrome," and even they admit that one million Americans have my disease but no diagnosis. Where are they? The question continues to haunt me. <br />
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But there are optimistic new developments, from the IOM report (tho flawed, it is getting publicity) to newly locating our disease at NIH in NINDS. Stanford and Columbia Universities are taking the disease seriously. The most intriguing new developments are happening as I write, with healthy professionals finally asking that the PACE trial (whose authors claim cognitive behavior therapy and graded exercise cured "CFS/ME") be investigated by impartial scientists - thank you Dave Tuller, James Coyne, Vince Racaniello, Ron Davis, Jonathan Edwards, Leonard Jason, Bruce Levin, and Arthur Reingold. It would be nice to report that although we don't know the answer, we are finally getting the funds to find it. Even better to be able to say patients are finally being diagnosed, taken care of, and treated. The first step is getting the severity and prevalence of Myalgic Encephalomyelitis recognized. Let us hope that won't take another 27 years.Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com6tag:blogger.com,1999:blog-1345573145957924958.post-10759697862926235432015-10-18T15:23:00.000-07:002015-10-27T12:14:30.461-07:00Justice for Karina HansenI am reposting this urgent message from fellow patient Wendy Boutilier. <b>We believe this is a human rights violation and need international help for this young woman</b>, imprisoned in a mental hospital for 2 1/2 years for the sin of having Myalgic Encephalomyelitis. She was 24 when taken from her family; she just turned 27.<br />
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On February 12, 2013, five policemen from Holesbro County, Denmark, came to ME patient Karina Hansen's house and forcibly removed her from her bed. </div>
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There were also 2 doctors, a locksmith, and 2 social workers present.</div>
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Karina called for her mother's help, but her mother was blocked by the police from aiding her.</div>
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Karina used her mobile phone for the first time in years to call her mother, her father, her cousin and her sister, Janni.</div>
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Karina is so ill that she can usually only speak in one or two word sentences, but during her removal she managed to call her father and say: </div>
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"Help Dad! In my room!" and to her sister: "Help, Janni! I don't know where they are taking me!"</div>
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Karina's mother could not answer her phone because she was surrounded by policemen.</div>
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Karina was then driven to a hospital in an ambulance. Her parents were not told where Karina was being taken or what reason they had for taking her. No paperwork was given to her parents.</div>
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Later that day, they got a phone call and were told that Karina was at Hammel Neurocenter and that someone would call them every day at 10 am to tell them how Karina was doing.</div>
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They were also told that no one could visit Karina for 14 days.</div>
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On the morning of February 13, Karina managed to call her mother from her mobile phone. She said:</div>
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"How can I get out of here? I can't take this." [Hvordan kan jeg komme væk herfra? Jeg kan ikke klare det.] Then the connection was cut.</div>
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A few days later, Karina's parents got a letter from a psychiatrist Nils Balle Christensen, which said he would be in charge of Karina's treatment at Hammel Neurocenter. He also wrote that because of her condition, Karina was not allowed visitors for 14 days.</div>
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That ban on visitors was later extended to three weeks because Dr. Christensen was on vacation. Nils Balle Christensen works at the Research Clinic for Functional Disorders and Psychosomatics. He and his superior, psychiatrist Per Fink, believe that Myalgic Encephalomyelitis (ME) is a functional disorder. [Note from MS: The sister was finally allowed a visit, but burst into tears at the condition in which she found Karina, and after that NO family visitors have been permitted. For over two years.]<br />
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"Functional disorder" has replaced the term "psychosomatic illness" in psychiatry-speak. In this case, they had expanded it to what was called "Münchausen Syndrome by Proxy (MSBP)," or it's modern incarnation, "factitious illness by proxy," where the parents are accused of making their child appear sick. The treatments the clinic recommends are: exercise (GET), cognitive behavioral therapy (CBT), and antidepressants. <br />
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[Note from MS: If you have seen "Sixth Sense," you have seen a fictional case of MSBP. But it has been shown time and time again that while this may actually happen in a few very rare cases, there's no need for a special diagnostic category - the diagnosis "psychopath" already exists and fits the situation. But then it would be the <b><i>parents</i></b> who should be put in a mental hospital, not the <b><i>child</i></b>. As for the treatment, psychotherapy may help a patient accept the condition (as in MS), but cannot cure the disease. Indeed, the insistence by European psychiatrists that psychotherapy will cure this disease is reminiscent of the days when MS was called "hysterical paralysis" - except the European psychiatrists prefer the old term for the vapors, "neurasthenia." A new category was created recently, "Somatic Symptoms Disorder," and Per Fink, one of the psychiatrists involved in this case, is active in WHO and trying to get this accepted as a category in ICD-11. Karina's case thus has political overtones, unfortunately, which has made the psychiatrists involved unwilling to compromise.<br />
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Note continued: There has been significant research published showing that graded exercise is actually dangerous for even high-functioning patients, and this young woman is extremely disabled.]<br />
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The psychiatrists at this clinic have no experience with severely ill ME patients and we fear that Karina is being treated incorrectly, and that their mistreatment of her will lead to a severe and permanent worsening of her condition. <br />
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[Note from MS: This has occurred in the UK where it is not uncommon for young ME patients to be "sectioned" - forcibly committed to a mental hospital against their will - and they have come out of the hospital in much worse condition than when they entered. In one tragic case, Sophia Mirza died from irreversible damage to her condition that occurred in a mental hospital. Her autopsy showed significant damage to the basal root ganglia, and a formal inquiry concluded she died of ME.]<br />
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Various petitions have been set up and signed, letters have been sent to MPs in the UK, European Union Danish Ministry of Health, Danish Government of Power and the Danish Royal Family, all to no avail.<br />
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There is no contact permitted between Karina and her family, and there has only been limited contact permitted between Karina and her lawyer, as well as the Myalgic Encephalomyelitis Association of Denmark. Some updates on her condition is published from time to time, but it is basically censored.<br />
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Inside information tells a different story. Karina believes they are trying to kill her with this line of treatment. Her condition is worse now than before she was hospitalized. Unfortunately, that is what could be predicted given the severity of her disease when she entered the mental hospital and the rigid beliefs of this branch of the psychiatric profession in Denmark. <br />
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All of Karina's human rights have been severed. We have not been provided with the name of her lawyer and/or representative with the United Nations Human Rights Council, and we have no uncensored contact with Karina or any of her representatives.<br />
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There are a number of petitions being circulated, but this one has the most names, so if you can add your name to it we would be grateful. If you belong to any human rights organizations, tell them about Karina's case. And RETWEET!! <br />
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<span style="font-family: Helvetica; font-size: 12px;">JUSTICE FOR KARINA</span><br />
<span style="font-family: Helvetica; font-size: 12px;">Share Widely</span><br />
<span style="font-family: Helvetica; font-size: 12px;">TWITTER:</span><a href="http://www.avaaz.org/en/petition/Justice_for_Karina/?twi" style="font-family: Helvetica; font-size: 12px;">http://www.avaaz.org/en/petition/Justice_for_Karina/?twi</a><br />
<span style="font-family: Helvetica; font-size: 12px;">Avaaz:</span><a href="http://www.avaaz.org/en/petition/Justice_for_Karina/?email" style="font-family: Helvetica; font-size: 12px;">http://www.avaaz.org/en/petition/Justice_for_Karina/?email</a><br />
<span style="font-family: Helvetica; font-size: 12px;">PLEASE SIGN, EVEN IF YOU HAVE </span><span style="font-family: Helvetica; font-size: 12px;">SIGNED OTHERS</span><br />
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<span style="font-family: Helvetica; font-size: 12px;">URGENT - you can sign a letter to the new Prime Minister of Denmark by going to this website:</span><br />
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<span style="font-family: Helvetica; font-size: 12px;"><a href="http://sallyjustme.blogspot.com/2015/10/karina-hansen-please-sign.html?showComment=1445973024177#c3514633445715952724" target="_blank">Letter about Karina to Danish PM</a></span> </div>
Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com1tag:blogger.com,1999:blog-1345573145957924958.post-41139987976293630532015-10-03T17:39:00.002-07:002016-04-28T13:26:05.660-07:00Welcome to ICD-10-CMOn October 1, the entire medical establishment in the US had to change the medical codes they use for reimbursement for medical expenditures from insurance companies and the government. You can imagine the mess - if you're real lucky, you can experience the mess in person. But here I just want to explain what this means for patients in the U.S. with a diagnosis of CFS (chronic fatigue syndrome) or ME (myalgic encephalomyelitis).<br />
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That is because we have finally updated from ICD-9-CM to ICD-10-CM. More on that later.<br />
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All you really need to know is that ME remains in the chapter on neurology at the classification G93.3, along with postviral fatigue syndrome (which is a British name that has not been used much, if at all, in the United States). CFS "remains" (from CDC's perspective) in a different chapter for vaguely defined symptoms at R53.82. However, the rest of the world (which has been using ICD-10 for 1-2 decades now) has CFS coded to G93.3 with M.E. So what appears not to be a change actually IS a change, and a significant one. How did we end up to be the only nation in the world who codes "CFS" under "General symptoms and signs: Malaise and fatigue"? <br />
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Let's start with some history.<br />
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The World Health Organization (WHO) puts out an International Classification of Diseases, and has done so since World War II. For more information, go to: <a href="http://www.who.int/classifications/icd/en/" target="_blank">WHO: International Classification of Diseases (ICD)</a>.<br />
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WHO's ICD's have gone through 10 revisions and they are now working on ICD-11.<br />
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In the 1980s, there were a series of cluster outbreaks throughout the United States of a disease that was probably Myalgic Encephalomyelitis (ME) - except that the name and diagnosis was not used in the US. First the outbreaks were labeled Chronic Epstein-Barr Virus (CEBV), because a lot of cases seemed to start with mono, but that theory was soon discarded by NIH's point man on EBV, Stephen Straus. He then began using the phrase "the chronic fatigue syndrome" to identify the outbreaks in internal memos in 1986.<br />
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CDC convened a committee in 1988 to rename and define CEBV. There were specialists at the meeting who insisted the outbreaks were really cases of ME, but neither Gary Holmes from CDC, nor Straus from NIH, paid any attention to that. ME is not mentioned in either the body or footnotes of the resulting article, which became known because it gave the first definition for CFS: Holmes (1988).<br />
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The name and concept CFS was thus thrown out to the world in 1988. At the time, WHO was on ICD-9 (the 9th revision), but was no longer making changes to ICD-9 because they were getting ready to roll out ICD-10. And ICD-10 was released to the world in 1992.<br />
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Since CFS was not in ICD-9, as long as the US continued to use it, they were free to place CFS wherever they wanted. The US uses a modification of ICD-9 called ICD-9-CM (for "clinical modification"). In 1997, the US placed CFS in 780.71, under "Symptoms, Signs, and Ill-Defined Syndromes" in ICD-9-CM. And there it has remained for almost 20 years.<br />
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In the meantime, the rest of the world was adopting ICD-10. By 2000, most were using it, including the UK. <br />
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Myalgic Encephalomyelitis (ME) has been in WHO's ICD codes since 1969, when it was first placed under neurology. The British had been using the name and diagnosis ME for almost 15 years by then. It had briefly begun as "benign" Myalgic Encephalomyelitis in the mid-1950s, when there were three major cluster outbreaks in the UK (replacing the name atypical polio that had been in use, along with a few other terms, since 1934). "Benign" had been stuck on the name because people were not dying in the streets from it, but the word was quickly discarded: As Melvin Ramsay, who went on to write two textbooks on ME, commented, there was nothing "benign" about ME! For some reason, when WHO first coded ME, they included "benign" in the name, and it's still there, although nobody else uses it. <br />
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ME is coded in ICD-9 and ICD-9-CM at 323.9 under neurology. It remained there in ICD-10, at G93.3, but it took second place in that category to post-viral fatigue syndrome, or PVFS (briefly fashionable as a diagnosis). CFS was never placed in the tabular, or more formal version of ICD-10 - however, it was placed in the index, and there it is coded to G93.3. <br />
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Canada, like the US, uses its own version of ICD-10, called ICD-10-CA. Since there were physicians in Canada who diagnosed ME, and physicians who diagnosed CFS, for what appeared to be the same disease, the Canadians placed CFS in the tabular version with ME at G93.3 when they adopted ICD-10-CA in 2001. The <a href="http://sacfs.asn.au/download/consensus_overview_me_cfs.pdf" target="_blank">Canadian Consensus Criteria</a>, which has been very popular in the ME and CFS community, was created by a committee convened by the National ME/FMS Action Network of Canada in 2003 in response to the blending of M.E. and CFS in G93.3 - and that is why the document uses ME/CFS throughout. <br />
<br />
But while the rest of the world had long converted to ICD-10, the US remained on ICD-9-CM. One explanation is that hospitals and medical clinics protested the planned adoption of ICD-10-CM in the early 00's because it would be expensive. (Why they thought it would be easier later is a mystery to me.) The US has remained on ICD-9-CM 23 years after WHO adopted ICD-10 - and today, as we have just shifted to ICD-10-CM, WHO is within a couple of years of adopting ICD-11. <br />
<br />
The agency responsible for the ICD-(whichever)-CD's in the US is the National Center for Health Statistics (NCHS) within CDC. (And that is where you will find the <a href="http://www.cdc.gov/nchs/icd/icd10cm.htm" target="_blank">Official Version of ICD-10-CM</a>.)<br />
<br />
Advocates in the US had expected CFS to be moved to G93.3 in ICD-10-CM - indeed, when Donna Pickett of NCHS first presented the proposed changes to ICD-10-CM to CFSAC, that is where she said it would go. However, the late William Reeves, who ran CDC's program on CFS, was visibly distressed by this. According to Reeves, the <i>only</i> way he knew to diagnose CFS was to start with chronic fatigue and then distill it further into chronic fatigue syndrome. He could not do that if it was classified at G93.3 - and, furthermore, he did not believe the condition was neurological in nature.<br />
<br />
So Pickett returned to CFSAC, and <i>this</i> time she suggested two classifications for CFS - CFS (postviral) would be placed in G93.3, and CFS (NOS) at R53.82 - <span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 19px;">in the chapter "General symptoms and signs," further characterized as "Malaise and fatigue." NOS stands for "not otherwise specified," in reference to CFS (postviral) in G93.3. The R53.82 was roughly equivalent to 780.71 in ICD-9-CM, so Reeves was satisfied. </span><br />
<span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 19px;"><br /></span>
<span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 19px;">However, soon word came out (and I don't know from whom) that CFS (postviral) was really the same thing as post-viral fatigue syndrome (PVFS), so CFS (postviral) was dumped from the draft of ICD-10-CM. That meant there was only ONE code for CFS - R53.82, CFS (NOS). It was peculiar that they retained "NOS" after deleting the only other code ever specified for CFS in ICD-10-CM. But there it is. </span><br />
<span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 19px;"><br /></span>
<span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 19px;">CDC, NCHS, Reeves, and his replacement Elizabeth Unger, all insisted that placing CFS in R53.82 meant they were not "making a change" to the code for CFS. Well, that was certainly the perspective from the US.</span><br />
<span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 19px;"><br /></span>
<span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 19px;">But the ICD codes do not originate in the US. They originate at the multinational organization WHO. And R53.82 represents a significant change from the coding used by WHO's ICD-10, G93.3 - a code accepted by more than one hundred nations. To say it hasn't changed is both disingenuous and self-centered. </span><br />
<span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 19px;"><br /></span>
<span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 19px;">In the meantime, in the late 1990s, the UK was having its own problems with the G93.3 code for CFS. British psychiatrists who had made their careers portraying CFS as a somaticizing (psychosomatic) disorder, specifically Simon Wessely and Peter White, wrote in textbooks that CFS was really "neurasthenia" (a "nervous disorder," once known as "the vapors" ...), and should be coded in F48.0 with neurasthenia under the chapter on psychiatry.</span><br />
<span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 19px;"><br /></span>
<span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif;"><span style="font-size: 14px; line-height: 19px;">The Countess of Mar in Parliament protested the equation of CFS (and by extension, ME) with neurasthenia. Andre L'Hours of WHO responded with a letter to Parliament stating that it was against WHO's regulations for signatory nations to move a disease into a different chapter (after all, the purpose of the ICD codes was to be able to coordinate information on diseases internationally). Parliament told the British psychiatrists to issue an errata slip, which they did ... but the next year the same dance was repeated.</span></span><br />
<span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif;"><span style="font-size: 14px; line-height: 19px;"><br /></span></span>
<span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif;"><span style="font-size: 14px; line-height: 19px;">Earlier this year, when the Institute of Medicine at the National Academies of Sciences in Washington issued an NIH-commissioned report on the name and definition for CFS, they explicitly rejected codes that placed CFS in the "R" chapter, and codes that placed CFS with neurasthenia. That presumably left G93.3, but they did not make that explicit. CFSAC (the Chronic Fatigue Syndrome Advisory Committee at HHS) did make it explicit, and stated that the name M.E. should be used and the disease placed in G93.3 until we knew more about it. CFSAC has been making that suggestion since 2004, when they advised HHS to adopt 323.9 in ICD-9-CM (the equivalent of G93.3 in ICD-10) and also adopt the Canadian Consensus Criteria. HHS has not responded.</span></span><br />
<span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif;"><span style="font-size: 14px; line-height: 19px;"><br /></span></span>
<span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif;"><span style="font-size: 14px; line-height: 19px;">Well, there we are. The US has apparently violated WHO's rules about placing a disease in a different chapter by using R53.82 - more to the point, it is simply cruel to the one million patients suffering from this serious disease - as debilitating as MS, end-stage renal disease, cancer, and AIDS - as merely afflicted by something vaguely termed "malaise and fatigue." Furthermore, the R category is what is known as garbage diagnoses - conditions that are characterized by what they are not, not what they are. CFS (Fukuda 1994), M.E. (Canada 2011), and the latest incarnation, SEID (IOM 2015) can all be positively diagnosed by what they ARE. In fact, there is substantial evidence of immunological, neurological, and cardiological damage. There is evidence of chronic viral assaults. There are biomarkers being used by specialists today. (For the biomarkers that my own specialists have used, see my blog post from May 12, 2014: <a href="http://slightlyalive.blogspot.com/2014/05/may-12-my-20-years-with-myalgic.html" target="_blank">My 20 years with Myalgic Encephalomyelitis</a>.)</span></span><br />
<span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 19px;"><br /></span>
<span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 19px;">But this is really nothing new. It is the same old same old. It is CDC being CDC. It has been 27 years since CDC adopted "chronic fatigue syndrome" for the name of this disease - and even CDC admits there are at least 850,000 adult Americans who have the disease but have no diagnosis. Many of these are people of lower income and people of color. I think it is a damning admission of failure. </span><br />
<span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 19px;"><br /></span>
<span style="color: #141823; font-family: "helvetica" , "arial" , sans-serif; font-size: 14px; line-height: 19px;">So is the code R53.82.</span><br />
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Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com14tag:blogger.com,1999:blog-1345573145957924958.post-17283936146484893742015-05-15T21:00:00.000-07:002016-08-08T13:40:01.838-07:00May 12, 2015: 20 years with Myalgic EncephalomyelitisI have had Myalgic Encephalomyelitis, or M.E, for 20 years. The CDC does not recognize this. They insist that I have a condition called "Chronic Fatigue Syndrome," or CFS. I have M.E.<br />
<br />
At the age of 44 I led a charmed life. I had been married to the love of my life for 20 years, and we had two lovely children. We were both college professors - a deliberate choice that allowed us to do what we enjoyed - researching and teaching subjects that deeply interested us - while having the income to live comfortably (because we both worked) and plenty of time to spend with the children (because of the nature of academic life). I had tenure at a good university, although my sights were set higher than that. I had a working relationship as an associate fellow with a research institute at an Ivy League school, which enabled me the luxury of being around the best and the brightest in my field. We traveled all around the country going to each other's conferences, often taking one of the kids along. We also went to four Olympics, two final fours (NCAA basketball championships) and countless playoff games, several World Series, and, eventually, twenty years of baseball AllStar games. We skied in the winter and went to the beach in the summer. It was a charmed life.<br />
<br />
On October 24, 1994, I went to my office to grade exams and suffered a blackout. When I came to, I could not understand one word in the Bluebooks in my lap - they might as well have been written in Cyrillic alphabet. It took time - and concentration - to be able to stand. I had fallen down the rabbit hole; my life would never be the same.<br />
<br />
Over the next four years I suffered from severe pain in the back of my neck and behind my eyes, 24/7. My muscles ached, and I had migraine-level headaches. I had ataxia, dyslexia, sensitivity to light and sound (to the point I had to wear sunglasses all the time), tinnitus, partial paralysis, memory loss, disorientation, expressive dysphasia, and massive confusion. My family took care of me. Obviously, I could not drive, and by 1996 I was using a wheelchair when I left the house (which someone else had to push). My confusion was so bad I once poured a pot of coffee into a silverware drawer convinced it was a cup. When my family took me somewhere, one of them would have to fasten my seatbelt because I couldn't remember what those two things were for.<br />
<br />
Most of the time, however, my family went without me. Increasingly I spent most of my time lying curled up in bed in the dark, listening to a favorite movie (because I could not bear to look at the screen). I got around the house by balancing against furniture and my golden retriever, but increasingly I spent the entire day upstairs. By the end of 1998, I couldn't even brush my own teeth. All that time, just slipping by. <br />
<br />
I was lucky to have a family to take care of me, because I could not take care of myself. I also soon discovered an Internet discussion list of fellow sufferers, and was referred to a very good specialist in Washington, Marsha Wallace (who unfortunately hasn't practiced since 2000). Dr. Wallace taught me to live within my energy envelope and helped with sleep disruption and NMH/POTS, but I continued to deteriorate.<br />
<br />
In the fall of 1998, Dr. Wallace introduced me to Dharam Ablashi, a researcher who had just retired from the National Cancer Institute at NIH. Dr. Ablashi had been the co-discoverer of HHV-6 and it's two variants, A and B, while working with AIDS. I had the version the AIDS patients did - Variant A. My viral load was over five times the amount used to diagnose an active infection.<br />
<br />
I would later positive for active EBV or mono (which I had more than once - most notably in 1990, four years before my collapse, during an outbreak on my college campus), CMV (cytomegalovirus), HHV-7, and three strains of Coxsackie B.<br />
<br />
My immune system was severely compromised: My natural killer cell function was less than 3% (normal is about 50%), I had the defective 37kDa Rnase-L, and I had an abnormal cytokine pattern. But no one knows how all this happened. All we know is that this disease can occur in cluster outbreaks, and it can pop up in individuals. No one in my family got it from me, but I believe the outbreak of EBV in 1990 marked the beginning of my illness - the beginning of the cycle of immune defect-virus-damage that characterizes this disease for many of us. I had to continue to teach through my infection with EBV, including an hour's commute and back, and while I recovered from mono at the end of the fall semester, my health began to deteriorate in seemingly disparate ways, until the ultimate collapse in 1994.<br />
<br />
Years later I would have a spinal tap that revealed both HHV-6 and Cytomegalovirus were active in my spinal fluid. No wonder I had the symptoms of encephalitis, and with the stiff neck, meningitis. Along with the muscle pain, that meant literally that I had Myalgic Encephalomyelitis, or M.E., a disease that had been diagnosed in the UK since the mid-1950s. In the United States, however, all I was given was a diagnosis of "chronic fatigue syndrome," a name chosen by committee and adopted by CDC in 1988 to replace the name given a number of cluster outbreaks occurring in the USA at the time, Chronic EBV. They did not mention M.E. - though there were specialists at the meeting who insisted that was the correct diagnosis for these outbreaks. They did not ask anyone in the disease community what they thought of this name. They simply adopted it, and having done so, consigned the disease to the backwaters of medicine where neither research nor treatment could be found.<br />
<br />
There could not have been a worse choice of a name for this disease if CDC had hired a focus group, Chronic (as in chronic whiner) Fatigue (as in "yeah, I've been feeling tired lately myself") Syndrome (as in syndrome of the month) - applied to upper middle class white women "trying to have it all" (as the late Bill Reeves of CDC once phrased it) - how inconsequential, silly even. <br />
<br />
Twenty-five years later, 85% of patients - over one million Americans - have no idea what is wrong with them, because, according to both CDC and private demographic evidence, only 15% have a diagnosis. 25 years later only 15% have a diagnosis. That is a mighty admission of failure.<br />
<br />
The infectious disease specialists in northern Delaware dismissed my illness as minor. "You'll be back to normal in two years," they assured me. Oh good, I responded - I won't have to miss more than two seasons before I can go back to skiing. "Oh no," was the response. "You'll never ski again." How was that "normal?" I asked. They got angry at that. That's when I was referred to Dr. Wallace and, thankfully, only had to deal with these people once more, when I was on the antiviral Vistide for my cytomegalovirus infection. Dan Peterson, my new specialist, had asked them to let me get the infusions at their center, and they had agreed. But when I showed up at their office, one of the doctors took me aside and said that they could not let me have Vistide because my medical records showed I "only had CFS - nothing serious, like AIDS or cancer." They said they could not justify using the drug on someone with a diagnosis of CFS - even though it was an FDA-approved drug for the virus CMV, which was active in both my blood serum and my spinal fluid.<br />
<br />
Let me repeat that: once given the label Chronic Fatigue Syndrome, I would meet disrespect from many doctors and people at NIH and CDC. None of my extensive testing mattered. I was told twice by those in a position to know better, that none of my testing mattered because "you people test positive for viruses you don't have." I asked what evidence that was based on; that ended the conversation.<br />
<br />
Although the progressive version of M.E. that I suffered from was unusually severe, I turned out to be lucky. I was given the opportunity to go on the experimental Phase III drug Ampligen, in what is called a cost-recovery (I pay cash), compassionate care (I am allowed to do this because I was so very sick), open label (I know I am on the drug so FDA ignores me) study. I have to get Ampligen at the study site by IV infusion twice a week. And FDA can take the drug away from me whenever they want.
<br />
<br />
I have been on Ampligen for 13 of the past 17 years. Again, I am unusual in that my illness erupts again within a year of going off the drug (which I did once voluntarily, and once because FDA did take the drug away). FDA has admitted, in writing, that the drug is not toxic. But they are not "convinced" it is effective. My experiences do not count because I was not in a placebo trial; I knew I was on the drug. There is no other drug in the FDA pipeline for either CFS or M.E. (Although there are immune boosters and antivirals available for patients, and an anti-cancer drug called Rituximab is showing some promise). This is the only one expressly targeted to M.E. or CFS. Over one million Americans suffer from my disease. FDA, CDC, NIH - none of them cares - though in fairness, there are individuals within those agencies who do. It is those who make decisions who do not care.
<br />
<br />
[Side note about the obsession with placebo trials - If just knowing you are on a drug can make your immune markers return to normal, your active viruses return to a dormant stage, and change tests such as SPECT scans and CPET scores, we should all be cured of anything by happy thoughts. Does FDA really believe this?]
<br />
<br />
So here I am today. I would not have written this were I not on Ampligen. On Ampligen, I can drive, take care of myself (mostly), read a book, work on my own writing, spend time with my children and grandchildren. Off Ampligen I am an invalid in bed in severe pain, curled up in the dark because light is too painful, listening to a favorite movie over and over. Again.<br />
<br />
As the years past, it became more and more difficult to get Ampligen, because FDA refused to approve it. The last three years I spent in Delaware, I had to commute by train twice a week, 100 miles north, to Dr. Derek Enlander's office in New York City, the closest site where I could get Ampligen. I usually get home around 7 pm. It was grueling, but at least I am getting the drug that keeps me from being a bedridden invalid.<br />
<br />
And then my beloved husband, my best friend, my soulmate, died of bladder cancer in July 2013. I moved to Incline Village, NV, on Lake Tahoe, where one of the best clinician/researchers in the country practices, Dan Peterson. (The most famous cluster outbreak of the disease in the US occurred here in 1985 - over 200 patients.) My infusions are just two miles away now. I'd like to call the version I have of this disease Peterson's Disease, but he won't let me. There are a lot of patients here who have the same biomarkers I do. <br />
<br />
Myalgic Encephalomyelitis is a serious disease.
<br />
<br />
CDC betrayed us by giving it a silly-sounding name in 1988 - CFS. NIH allocates less than $5 per patient per year to study this disease - a pathetic amount. After a report they commissioned from the Institute of Medicine came back last year, saying this was emphatically <i>not</i> a psychiatric disorder, and that NIH needed to spend much more money on it, we were promised more funding - but so far, haven't received anything above the usual $5-6 million. See <a href="http://www.ncbi.nlm.nih.gov/pubmed/25695122" target="_blank"><span style="color: blue;">"Beyond Myalgic Encephalomyelitis"</span></a>.<br />
<br />
We came back with private research initiatives, funded by cash-strapped patients and their families, and more good biomedical research is being published than ever before. The whole concept of what "CFS" is, silly sounding name and all, is undergoing a transformation. And for the first time in my memory, clinicians and researchers have agreed on a definition - the Canadian Consensus Criteria, updated with current research. There are excellent research studies going on at Stanford, Columbia, and Cornell right now - but they get little, if any, NIH funding. Even Ron Davis, the Stanford scientist responsible for the human genome project, can't get funding out of NIH for <i>this</i> disease.<br />
<br />
The main study behind the government's prescription of psychiatric counseling and graded exercise, the PACE trial, has been exposed as a giant boondoggle - but at the moment, the scientific journal that published it, <i>The Lancet</i>, the institutions behind it in the UK, and the UK government, are still pretending they don't know how deeply flawed it was. See <span style="color: blue;"><a href="http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/" target="_blank"><span style="color: blue;">PACE: The research that sparked a patient rebellion and changed medicine</span></a>.</span><br />
<br />
Perhaps more important, why don't people outside our community - people in the media, in government, our doctors, our neighbors, our employers - why don't they know that there is a growing epidemic of a severe, life-altering and in some cases life-taking disease that CDC and NIH are keeping under wraps? I have friends who were teenagers when they got sick, and are now in their 40s. They did not get to marry their soulmate like I did. They did not go to college or have a career. They did not have children or grandchildren (I have two grandchildren now). I was lucky compared to them.
<br />
<br />
There are patients who are even worse than I was - completely bedridden, on feeding tubes. See <a href="http://www.25megroup.org/home.html" target="_blank"><span style="color: blue;">The 25% ME Group</span></a> and <span style="color: blue;"><a href="https://www.washingtonpost.com/national/health-science/with-his-son-terribly-ill-a-top-scientist-takes-on-chronic-fatigue-syndrome/2015/10/05/c5d6189c-4041-11e5-8d45-d815146f81fa_story.html" target="_blank"><span style="color: blue;">the story of Whitney Dafoe in the Washington Post</span></a>.</span><br />
<br />
They can barely afford to live from day to day. Few can afford the testing I have had - if they can afford it, they can't get anyplace that does it. They go untreated, hidden, silenced.<br />
<br />
I have lost too many friends to this disease; we have lost young people to this disease. The viruses can get into your heart muscle; they can get into your liver. Patients die of rare cancers as well. And then there are the suicides.<br />
<br />
There has been a new series of outbreaks in the past five years. Look at those you love, and if you care for them - whether or not you care about us - do something. Because they could be the next victims.
<br />
<br />
Thank you for reading.Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com1tag:blogger.com,1999:blog-1345573145957924958.post-21078938353664109342015-05-12T21:00:00.000-07:002016-08-08T14:41:06.834-07:00May 12, 2015: 20 years with Myalgic EncephalomyelitisI have had Myalgic Encephalomyelitis, or M.E, for 20 years. The CDC does not recognize this. They insist that I have a condition called "Chronic Fatigue Syndrome," or CFS. I have M.E.<br />
<br />
At the age of 44 I led a charmed life. I had been married to the love of my life for 20 years, and we had two lovely children. We were both college professors - a deliberate choice that allowed us to do what we enjoyed - researching and teaching subjects that deeply interested us - while having the income to live comfortably (because we both worked) and plenty of time to spend with the children (because of the nature of academic life). I had tenure at a good university, although my sights were set higher than that. I had a working relationship as an associate fellow with a research institute at an Ivy League school, which enabled me the luxury of being around the best and the brightest in my field. We traveled all around the country going to each other's conferences, often taking one of the kids along. We also went to four Olympics, two final fours (NCAA basketball championships) and countless playoff games, several World Series, and, eventually, twenty years of baseball AllStar games. We skied in the winter and went to the beach in the summer. It was a charmed life.<br />
<br />
On October 24, 1994, I went to my office to grade exams and suffered a blackout. When I came to, I could not understand one word in the Bluebooks in my lap - they might as well have been written in Cyrillic alphabet. It took time - and concentration - to be able to stand. I had fallen down the rabbit hole; my life would never be the same.<br />
<br />
Over the next four years I suffered from severe pain in the back of my neck and behind my eyes, 24/7. My muscles ached, and I had migraine-level headaches. I had ataxia, dyslexia, sensitivity to light and sound (to the point I had to wear sunglasses all the time), tinnitus, partial paralysis, memory loss, disorientation, expressive dysphasia, and massive confusion. My family took care of me. Obviously, I could not drive, and by 1996 I was using a wheelchair when I left the house (which someone else had to push). My confusion was so bad I once poured a pot of coffee into a silverware drawer convinced it was a cup. When my family took me somewhere, one of them would have to fasten my seatbelt because I couldn't remember what those two things were for.<br />
<br />
Most of the time, however, my family went without me. Increasingly I spent most of my time lying curled up in bed in the dark, listening to a favorite movie (because I could not bear to look at the screen). I got around the house by balancing against furniture and my golden retriever, but increasingly I spent the entire day upstairs. By the end of 1998, I couldn't even brush my own teeth. All that time, just slipping by. <br />
<br />
I was lucky to have a family to take care of me, because I could not take care of myself. I also soon discovered an Internet discussion list of fellow sufferers, and was referred to a very good specialist in Washington, Marsha Wallace (who unfortunately hasn't practiced since 2000). Dr. Wallace taught me to live within my energy envelope and helped with sleep disruption and NMH/POTS, but I continued to deteriorate.<br />
<br />
In the fall of 1998, Dr. Wallace introduced me to Dharam Ablashi, a researcher who had just retired from the National Cancer Institute at NIH. Dr. Ablashi had been the co-discoverer of HHV-6 and it's two variants, A and B, while working with AIDS. I had the version the AIDS patients did - Variant A. My viral load was over five times the amount used to diagnose an active infection.<br />
<br />
I would later positive for active EBV or mono (which I had more than once - most notably in 1990, four years before my collapse, during an outbreak on my college campus), CMV (cytomegalovirus), HHV-7, and three strains of Coxsackie B.<br />
<br />
My immune system was severely compromised: My natural killer cell function was less than 3% (normal is about 50%), I had the defective 37kDa Rnase-L, and I had an abnormal cytokine pattern. But no one knows how all this happened. All we know is that this disease can occur in cluster outbreaks, and it can pop up in individuals. No one in my family got it from me, but I believe the outbreak of EBV in 1990 marked the beginning of my illness - the beginning of the cycle of immune defect-virus-damage that characterizes this disease for many of us. I had to continue to teach through my infection with EBV, including an hour's commute and back, and while I recovered from mono at the end of the fall semester, my health began to deteriorate in seemingly disparate ways, until the ultimate collapse in 1994.<br />
<br />
Years later I would have a spinal tap that revealed both HHV-6 and Cytomegalovirus were active in my spinal fluid. No wonder I had the symptoms of encephalitis, and with the stiff neck, meningitis. Along with the muscle pain, that meant literally that I had Myalgic Encephalomyelitis, or M.E., a disease that had been diagnosed in the UK since the mid-1950s. In the United States, however, all I was given was a diagnosis of "chronic fatigue syndrome," a name chosen by committee and adopted by CDC in 1988 to replace the name given a number of cluster outbreaks occurring in the USA at the time, Chronic EBV. They did not mention M.E. - though there were specialists at the meeting who insisted that was the correct diagnosis for these outbreaks. They did not ask anyone in the disease community what they thought of this name. They simply adopted it, and having done so, consigned the disease to the backwaters of medicine where neither research nor treatment could be found.<br />
<br />
There could not have been a worse choice of a name for this disease if CDC had hired a focus group, Chronic (as in chronic whiner) Fatigue (as in "yeah, I've been feeling tired lately myself") Syndrome (as in syndrome of the month) - applied to upper middle class white women "trying to have it all" (as the late Bill Reeves of CDC once phrased it) - how inconsequential, silly even. <br />
<br />
Twenty-five years later, 85% of patients - over one million Americans - have no idea what is wrong with them, because, according to both CDC and private demographic evidence, only 15% have a diagnosis. 25 years later only 15% have a diagnosis. That is a mighty admission of failure.<br />
<br />
The infectious disease specialists in northern Delaware dismissed my illness as minor. "You'll be back to normal in two years," they assured me. Oh good, I responded - I won't have to miss more than two seasons before I can go back to skiing. "Oh no," was the response. "You'll never ski again." How was that "normal?" I asked. They got angry at that. That's when I was referred to Dr. Wallace and, thankfully, only had to deal with these people once more, when I was on the antiviral Vistide for my cytomegalovirus infection. Dan Peterson, my new specialist, had asked them to let me get the infusions at their center, and they had agreed. But when I showed up at their office, one of the doctors took me aside and said that they could not let me have Vistide because my medical records showed I "only had CFS - nothing serious, like AIDS or cancer." They said they could not justify using the drug on someone with a diagnosis of CFS - even though it was an FDA-approved drug for the virus CMV, which was active in both my blood serum and my spinal fluid.<br />
<br />
Let me repeat that: once given the label Chronic Fatigue Syndrome, I would meet disrespect from many doctors and people at NIH and CDC. None of my extensive testing mattered. I was told twice by those in a position to know better, that none of my testing mattered because "you people test positive for viruses you don't have." I asked what evidence that was based on; that ended the conversation.<br />
<br />
Although the progressive version of M.E. that I suffered from was unusually severe, I turned out to be lucky. I was given the opportunity to go on the experimental Phase III drug Ampligen, in what is called a cost-recovery (I pay cash), compassionate care (I am allowed to do this because I was so very sick), open label (I know I am on the drug so FDA ignores me) study. I have to get Ampligen at the study site by IV infusion twice a week. And FDA can take the drug away from me whenever they want.
<br />
<br />
I have been on Ampligen for 13 of the past 17 years. Again, I am unusual in that my illness erupts again within a year of going off the drug (which I did once voluntarily, and once because FDA did take the drug away). FDA has admitted, in writing, that the drug is not toxic. But they are not "convinced" it is effective. My experiences do not count because I was not in a placebo trial; I knew I was on the drug. There is no other drug in the FDA pipeline for either CFS or M.E. (Although there are immune boosters and antivirals available for patients, and an anti-cancer drug called Rituximab is showing some promise). This is the only one expressly targeted to M.E. or CFS. Over one million Americans suffer from my disease. FDA, CDC, NIH - none of them cares - though in fairness, there are individuals within those agencies who do. It is those who make decisions who do not care.
<br />
<br />
[Side note about the obsession with placebo trials - If just knowing you are on a drug can make your immune markers return to normal, your active viruses return to a dormant stage, and change tests such as SPECT scans and CPET scores, we should all be cured of anything by happy thoughts. Does FDA really believe this?]
<br />
<br />
So here I am today. I would not have written this were I not on Ampligen. On Ampligen, I can drive, take care of myself (mostly), read a book, work on my own writing, spend time with my children and grandchildren. Off Ampligen I am an invalid in bed in severe pain, curled up in the dark because light is too painful, listening to a favorite movie over and over. Again.<br />
<br />
As the years past, it became more and more difficult to get Ampligen, because FDA refused to approve it. The last three years I spent in Delaware, I had to commute by train twice a week, 100 miles north, to Dr. Derek Enlander's office in New York City, the closest site where I could get Ampligen. I usually get home around 7 pm. It was grueling, but at least I am getting the drug that keeps me from being a bedridden invalid.<br />
<br />
And then my beloved husband, my best friend, my soulmate, died of bladder cancer in July 2013. I moved to Incline Village, NV, on Lake Tahoe, where one of the best clinician/researchers in the country practices, Dan Peterson. (The most famous cluster outbreak of the disease in the US occurred here in 1985 - over 200 patients.) My infusions are just two miles away now. I'd like to call the version I have of this disease Peterson's Disease, but he won't let me. There are a lot of patients here who have the same biomarkers I do. <br />
<br />
Myalgic Encephalomyelitis is a serious disease.
<br />
<br />
CDC betrayed us by giving it a silly-sounding name in 1988 - CFS. NIH allocates less than $5 per patient per year to study this disease - a pathetic amount. After a report they commissioned from the Institute of Medicine came back last year, saying this was emphatically <i>not</i> a psychiatric disorder, and that NIH needed to spend much more money on it, we were promised more funding - but so far, haven't received anything above the usual $5-6 million. See <a href="http://www.ncbi.nlm.nih.gov/pubmed/25695122" target="_blank"><span style="color: blue;">"Beyond Myalgic Encephalomyelitis"</span></a>.<br />
<br />
We came back with private research initiatives, funded by cash-strapped patients and their families, and more good biomedical research is being published than ever before. The whole concept of what "CFS" is, silly sounding name and all, is undergoing a transformation. And for the first time in my memory, clinicians and researchers have agreed on a definition - the Canadian Consensus Criteria, updated with current research. There are excellent research studies going on at Stanford, Columbia, and Cornell right now - but they get little, if any, NIH funding. Even Ron Davis, the Stanford scientist responsible for the human genome project, can't get funding out of NIH for <i>this</i> disease.<br />
<br />
The main study behind the government's prescription of psychiatric counseling and graded exercise, the PACE trial, has been exposed as a giant boondoggle - but at the moment, the scientific journal that published it, <i>The Lancet</i>, the institutions behind it in the UK, and the UK government, are still pretending they don't know how deeply flawed it was. See <span style="color: blue;"><a href="http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/" target="_blank"><span style="color: blue;">PACE: The research that sparked a patient rebellion and changed medicine</span></a>.</span><br />
<br />
Perhaps more important, why don't people outside our community - people in the media, in government, our doctors, our neighbors, our employers - why don't they know that there is a growing epidemic of a severe, life-altering and in some cases life-taking disease that CDC and NIH are keeping under wraps? I have friends who were teenagers when they got sick, and are now in their 40s. They did not get to marry their soulmate like I did. They did not go to college or have a career. They did not have children or grandchildren (I have two grandchildren now). I was lucky compared to them.
<br />
<br />
There are patients who are even worse than I was - completely bedridden, on feeding tubes. See <a href="http://www.25megroup.org/home.html" target="_blank"><span style="color: blue;">The 25% ME Group</span></a> and <span style="color: blue;"><a href="https://www.washingtonpost.com/national/health-science/with-his-son-terribly-ill-a-top-scientist-takes-on-chronic-fatigue-syndrome/2015/10/05/c5d6189c-4041-11e5-8d45-d815146f81fa_story.html" target="_blank"><span style="color: blue;">the story of Whitney Dafoe in the Washington Post</span></a>.</span><br />
<br />
They can barely afford to live from day to day. Few can afford the testing I have had - if they can afford it, they can't get anyplace that does it. They go untreated, hidden, silenced.<br />
<br />
I have lost too many friends to this disease; we have lost young people to this disease. The viruses can get into your heart muscle; they can get into your liver. Patients die of rare cancers as well. And then there are the suicides.<br />
<br />
There has been a new series of outbreaks in the past five years. Look at those you love, and if you care for them - whether or not you care about us - do something. Because they could be the next victims.
<br />
<br />
Thank you for reading.Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com6tag:blogger.com,1999:blog-1345573145957924958.post-23286540181569621292015-02-26T15:00:00.004-08:002015-02-27T16:10:30.293-08:00The IOM Report on ME/CFS (SEID)<div style="-webkit-text-size-adjust: auto; font-family: UICTFontTextStyleBody; font-size: 17px;">
This blog started out as comments on other people's blogs on the report of the Institute of Medicine (IOM)'s new definition for "ME/CFS" and the new name chosen by this committee - SEID (Systemic Exertion Intolerance Disease). Specifically, this began as a comment to Erica Verillo's thoughtful essay, which can be read here:<br />
<a href="http://cfstreatment.blogspot.nl/2015/02/the-iom-report-good-bad-and-absolutely.html">http://cfstreatment.blogspot.nl/2015/02/the-iom-report-good-bad-and-absolutely.html</a><br />
<br />
The full IOM report itself is available here:<br />
<a href="http://books.nap.edu/openbook.php?record_id=19012">http://books.nap.edu/openbook.php?record_id=19012</a><br />
(You can download and save it in PDF form for free, but that may require registering as if you were going to buy it, then downloading it for free when given that option. They are charging $50 for the report in hard copy.)<br />
<br />
And a new physician's guideline written by the IOM is available and can be downloaded here:<br />
<a href="http://www.iom.edu/~/media/Files/Report%20Files/2015/MECFS/MECFScliniciansguide.pdf">http://www.iom.edu/~/media/Files/Report%20Files/2015/MECFS/MECFScliniciansguide.pdf</a><br />
<br />
I think the IOM Committee meant well, but I think they failed. <br />
<br />
The CFSAC (CFS Advisory Committee) is a Congressionally mandated committee charged with advising the Secretary of Health and Human Services (HHS) on issues related to CFS. In 2004, CFSAC asked that HHS adopt the new Canadian Consensus Criteria (2003), created by a committee of clinicians - many from the US. They were ignored. They kept asking.<br />
<br />
A decade later, CFSAC asked HHS to sponsor an OPEN workshop of EXPERTS to UPDATE THE CCC. Instead, HHS paid the IOM $1 million to put together a committee to update the name and definition - but say nothing about treatment. The committee was about half specialist, half amateur.<br />
<br />
Why did HHS fail to take the advice of the committee charged by Congress to give it advice - CFSAC? The first failure of the IOM committee was in its very existence. HHS should have listened to CFSAC.<br />
<br />
The second great flaw is the failure to discuss treatments. That was mandated in the instructions to the IOM. I wonder why.<br />
<br />
British psychiatrists have been recommending a combination of Cognitive Behavior Therapy (CBT) and Graded Exercise Therapy (GET) for two decades, and so does the US CDC. It does not really matter what you call it - if it can be cured by CBT/GET, quite obviously it's not really a physiological disorder. <br />
<br />
If the committee's conclusions are accurate, CBT is a waste of time as a "cure." In fact, there is a short discussion of the literature on CBT at the very end of the report, in Appendix C on disability, which concludes there is no research providing evidence that CBT can get patients back to work. But that was not in the body of the report, nor the summary provided the media, nor in the physician's guide that the IOM just released.<br />
<br />
If the committee's conclusions are accurate, Graded Exercise Therapy can be downright dangerous - especially if administered as a "cure" by those who do not understand the disease. And especially if in tandem with psychotherapy urging the patient to ignore what the body is saying and adopt a "positive attitude." Post-exertional worsening of symptoms is a hallmark of this disease - that's why they named it SEID (Systemic Exertion Intolerance Disease). <br />
<br />
But the committee was FORBIDDEN to discuss treatments, and there is nothing to keep CDC and others from continuing to recommend it. Acquiescing to this "remit" will haunt the committee<br />
forever, and it is the most serious problem with the report. But it will make insurance companies happy.<br />
<br />
Now for more specific comments:<br />
<br />
1. The name SEID (Systemic Exertion Intolerance Disease) is a train wreck. Yes, they gave us "disease" instead of "syndrome" - but I doubt it will make much difference. "Exertion intolerance" will be viewed by most people - including most in the medical profession - as a fancy way to say CFS. And if you had any doubts, in the flow chart to assist diagnosis that is in both the report and the physician's guideline, the top and defining symptom is ... "Fatigue." (P. 7 of the full IOM report)<br />
<br />
If you had any more doubts, the report criticizes AND REJECTS numerous studies because the researchers used healthy people as controls instead of people with "other fatiguing" conditions, or diseases, or complexes, or syndromes, or ... Well, you get the idea. Last time I looked, the correct methodology is to contrast the study group with a control approximating the normal population as best as possible. Why add this new criteria - particularly when NOWHERE in this report is there a list of so-called "fatiguing conditions"?<br />
<br />
Yes, for a first pass at a diagnosis, if your definition begins with "fatigue" you want to make sure you are distinguishing the fatigue from this disease from fatigue for other reasons. But ... I thought the new definition didn't focus on fatigue as the prime symptom. Guess I was wrong about that.<br />
<br />
And if there are studies that have shown statistically significant differences from a sample of the normal population, a scientific report should have included them, whether or not they also used a control group of patients with "other fatiguing conditions." This is a major failing.<br />
<br />
The definition and the summary were failures also because you have to read the full report to see that<br />
they recommend CPET scores to measure PEM, NK cell function to measure the severity of the condition, and a tilt-table test (TTT) or an in-office substitute to test for autonomic dysfunction. Instead, there is a plethora of subjective questionnaires offered.<br />
<br />
I do give the physician's guide credit for mentioning these, but in the end they suggest ... Subjective questionnaires for diagnosis.<br />
<br />
It would make an enormous difference in both the perception, and the real world treatment, of patients with this disease if objective tests were emphasized. But they waffled at the end. I guess they didn't want to tangle with insurance companies.<br />
<br />
2. The committee should have included a list of diseases that need to be ruled out because it is important for them to be treated. That includes Hep C, congestive heart failure, hypothyroidism, hypocortisolism, primary mood disorders, and numerous others. However ...<br />
<br />
3. Once such a condition is recognized and treated, if the patient continues to meet the definition for the disease, they can still get a diagnosis. Skipping that interim step will do the patients no favors, and possibly result in numerous misdiagnoses.<br />
<br />
4. Once treated, however, most conditions should not be exclusionary. The committee is correct in this - just as a person can have both cancer and hypothyroidism, so too can a patient have both "ME/CFS (SEID)" and hypothyroidism. This is a particularly pertinent example, because research that did not make it into the report provides evidence many patients with a diagnosis of ME or CFS have a chronic viral infection. It is known that many herpesvirus infections (EBV, CMV, HHV-6A) can cause Hashimoto's hypothyroidism. To exclude Hashimoto's (a condition where your own antibodies attack your thyroid) would lead to the exclusion of many patients with chronic viral infections.<br />
<br />
5. Instead of offering an unbiased survey of the evidence of chronic viral infections in ME and CFS, the committee stuck to the government line that there are no chronic viral infections except in AIDS. But if you start out by excluding evidence to the contrary, you have created a tautology. Surely they could have examined that evidence, which goes beyond EBV, but added their OPINION - which is what it is - that the disease is not caused by chronic viral infections. Perhaps they should go back and read Popper again on falsifiability and the inability to use statistics to disprove a hypothesis for which it is acknowledged there is evidence, but it is insufficient evidence.<br />
<br />
6. Some have called for NMH/POTS and Ehlers-Danlos Syndrome (a hereditary connective tissue disorder) to be exclusionary. But - as the committee correctly noted - there is significant evidence that NMH/POTS and CFS (Fukuda 1994), and NMH/POTS and CCC are correlated. Again, you can treat the NMH/POTS but the patient will still have the disease. The symptoms will be a bit better, however, and it is irresponsible not to try to do something about it. The literature in the correlation goes back to Ramsay's definition of M.E., and a 1995 article in JAMA (the Journal of the American Medical Association). Newer research shows Ehlers-Danlos correlates with NMH/POTS. <br />
<br />
7. A patient with depression or anxiety should be treated for depression or anxiety - but if they have the disease, they will still be sick. Furthermore, the incidence of secondary depression is similar to that in MS patients. Of course these patients should be treated!<br />
<br />
However, major mood disorders and depression/anxiety are the elephant in the room for this disease. While they are exclusionary for almost every other diagnostic criteria - they are NOT excluded for what is called the "Oxford definition," which consists of six months of debilitating fatigue not caused by a physiological disorder (and was curiously missing from the list of extant definitions.). The Oxford definition underlies a parallel universe of psychiatric papers as numerous as the research on physiological aspects of the disease. These psychiatrists generally do not mention the physiological evidence in their work, and they frequently cite each other, so a novice who is only aware of that research will only know about ... The Oxford definition and the so-called "biopsychosocial" school of British psychiatry.<br />
<br />
These psychiatrists peddle CBT/GET as THE cure for what they call "CFS/ME." The CDC's website throws in SSRIs and sleeping pills, but basically echoes the British psychiatric version. That is not a coincidence: leading lights of the British school have all advised the CDC frequently on "CFS" (and often on GWI as well): Simon Wessely, Peter White, Michael Sharpe, Trudie Chalder. <br />
<br />
Once again, the failure of the IOM report to directly address the parallel literature in psychiatry, and the problems with CBT and GET, can only be viewed as a great failure. It was nice for them to say "ME/CFS SEID" is not neurasthenia (a diagnosis favored by the British psychiatrists) - but it's a day late and a dollar short.<br />
<br />
Most recently, a committee including British "CFS/ME" expert Michael Sharpe succeeded in getting a new condition called "Somatic Symptom Disorder" placed in the new DSM-5, the diagnostic manual of American psychiatry. The definition looks remarkably like a definition for CFS. It starts with complaining about fatigue. And one of the "symptoms" is complaining of four or more physical symptoms! If you weren't careful, a cancer patient could get thrown in this bin. <br />
<br />
Therefore, had the committee not been so naïve (I do hope that is the reason), they would have made a strong statement that this disease IS NOT SOMATIC SYMPTOM DISORDER, and IS NOT A SOMATICIZING DISORDER, period. The failure to do so is enormous in the real world of misdiagnoses, mistreatments, patients thrown into mental hospitals against their will, and young people sent to foster care because their "overbearing" parents (and perhaps a "misguided specialist") diagnosed the child with ME or CFS.<br />
<br />
8. We ALL - myself included - would prefer for the time being they name the disease after a key researcher such as Melvin Ramsay, or a patient, such as the late, brilliant young Alison Hunter. CDC insists that scientists don't do that any more. So maybe we patients should. <br />
<br />
9. When it comes to the disease M.E., which is a distinct illness diagnosed outside the US since 1955 and recognized as neurological by WHO since 1969, the committee did not seem to know what it was. They seemed to think it was a synonym for CFS, just another choice of a name. It is not, and it is not the committee's business to dismiss it. They were charged with examining ME/CFS, but as Leonard Jason eloquently explained in his latest article, that is also a different condition with its own name. (The CCC uses ME/CFS throughout because Canada's version of ICD-10, called ICD-10-CA, placed CFS and M.E. together in the tabular version of ICD-10-CA, adopted by Canada in 2002.). At any rate, I am giving the committee the benefit of the doubt and hoping that these were just typos:<br />
<br />
- The committee stated that M.E. and CFS are coded separately in WHO's ICD-10 (p. 27 of the full IOM report). That's not so. That is true of the US version of ICD-10, called ICD-10-CM. It is a major error - period - an error of FACT. ICD-10 codes M.E. in G93.3 in the chapter on neurological disorders (as they have since 1969). If you look at the index (unfortunately unavailable online, but I have a xerox of the appropriate page in the printed index), CFS is also coded to G93.3. Furthermore, André l'Hours of WHO frequently responded in writing to queries from British Parliament as to the proper coding of CFS, stating it belonged in G93.3. (This was during a period when the British psychiatrists were insisting "CFS" was actually neurasthenia and should be coded under psychiatry.). So the committee was FACTUALLY WRONG in stating that WHO's ICD-10 places M.E. and CFS in two different codes.<br />
<br />
To be accurate, the US's ICD-10-CM, a clinical modification of ICD-10 due to go into effect in fall 2015, as well as ICD-9-CM, still in effect in the US, both place M.E. under neurology and CFS under "vague signs and symptoms." But that is ONLY in the U.S. It is not the world.<br />
The rest of the world has been using ICD-10 for the past 1-2 decades while the US was still stuck on ICD-9-CM. CFS was never coded in WHO's ICD-9 because shortly after it was adopted on the US, WHO completed their conversion to ICD-10.<br />
<br />
- The committee also stated that the Holmes (1988) article introducing CFS and its first definition acknowledged the existence of M.E. (P. 29 of the full IOM report). It did not. You will not find M.E. in the body or the footnotes of the Holmes article. <br />
<br />
These were important because if the option of diagnosing M.E. - a separate diagnosis in the US - if the option of diagnosing M.E. had been available and known to the physicians working with cluster outbreaks, they might have chosen THAT diagnosis as more appropriate. The definition of M.E. in Melvin Ramsay's 1986 textbook can be found here (formatted as we are used to seeing definitions, but otherwise unaltered):<br />
<a href="http://www.cfids-me.org/ramsay86.html">http://www.cfids-me.org/ramsay86.html</a><br />
<br />
10. It bears repeating here that another major failing of the report was the frequent criticism of existing studies because they used healthy patients as controls. That is the usual thing to do in medicine. Isn't it? But as much as they said they wanted to downplay fatigue, they insisted that studies of the disease should have compared patients to those with "other fatiguing disorders". They said this about a dozen times, but never listed what they had in mind by "other fatiguing disorders." So once again, methinks they do protest too much. <br />
<br />
11. In part because of (10), and in part because of a continuing prejudice in the medical profession against the possibility that a person can have a chronic viral infection (except for AIDS patients), all of the literature on pathogens (except EBV as a possible trigger) and most of the literature on immune system dysfunction was ignored. Did not appear in the report. This amounts to censorship - seriously so, because a finding that a patient has an active viral infection or a serious immune defect can lead to TREATMENT, and in the end, treatment is what these patients need most. Patients do not all test positive for the same conditions (mostly viruses), but there is a considerable body of evidence on chronic infection and this disease. After all, this disease was originally named atypical polio, and it first came to the attention of the public because of a series of cluster outbreaks around the US in the mid-1980s.<br />
The list of pathogens is long, and, to repeat, patients do not all have the same combination: enteroviruses in general, Coxsackie in specific; Human herpesviruses (HHVs): EBV (Epstein-Barr Virus, mono, HHV-4), CMV (HHV-5), HHV-6 Variant A, HHV-7; chlamydia pneumonae; parvovirus; adenovirus; and others. The evidence is there, but because there is so little funding, they tend to be small studies. That they are small, however, cannot be taken to mean they are inaccurate (get your Popper out again, guys). It just means we need more money for research. I think I said that before.<br />
<br />
12. There is so much else that is missing - the literature on mitochondria, toxic assaults including molds, and many others. I can't go into them all here - but THEY should have. If there was enough time, they should have said so and still listed the bibliography. <br />
<br />
------------------------------------<br />
<br />
Sadly, I don't think we can do much about this. It was suggested that we "act up" (a reference to AIDS activism). I think that suggestion was well-meaning, but again, naïve. Several specialists who treat both AIDS and CFS have said that CFS patients are, in general, as sick as AIDS patients are in the last two months of life. The people who were "acting up" were not THOSE patients - they were often the healthy friends and loved ones of dying AIDS patients.<br />
<br />
We can't occupy the Capitol building or the Stock Exchange because we can't take the chance of going to jail. For a person with this condition, that could be a medical disaster. So even those who want us to demonstrate are ignoring the nature of this disease as a disability.<br />
<br />
(I could also add that AIDS patients did not have to contend with the Patriot Act, or a nation hardened to demonstrations.)<br />
<br />
Nobody wanted to pay much attention to us advocates when we wanted to dump this whole exercise - for that matter, nobody paid attention to the Congressionally mandated CFSAC or a letter signed by nearly 50 specialists. I don't think they are going to pay much attention to us now.<br />
<br />
The US is in the process of switching over from ICD-9-CM to ICD-10-CM this fall. As a result, there is a coding freeze in place. Unless ordered from above within the government, SEID cannot get a code authorized until October 2016. <br />
<br />
So why go through the exercise? Well, it seems to have effectively stymied CFSAC's efforts to have the government sponsor a workshop of specialists to revise the CCC and then for the government to adopt it.<br />
<br />
We could always put together our OWN committee and have the results published in a peer-reviewed journal. Of course, the US government may ignore that - but perhaps clinicians and researchers won't. There is a precedent - the Reeves definition (2006) has been ignored by everybody except<br />
CDC, and even CDC uses the Jason prevalence rates on its website, not Reeves'.<br />
<br />
In fact, DePaul specialist Leonard Jason just published a new clinical definition that is (in my opinion) better than the IOM's:<br />
<a href="http://www.tandfonline.com/doi/abs/10.1080/21642850.2015.1014489">http://www.tandfonline.com/doi/abs/10.1080/21642850.2015.1014489</a><br />
<br />
But I think the next move will have to come from the US federal government.<br />
<br />
If CDC revamps its website and "toolkit" and gets rid of their recommendation of CBT, GET, antidepressants and sleep aids, I will eat my words and consider the IOM report a success.<br />
<br />
If NIH increases spending on our disease from $6 million a year (in the bottom five of all conditions funded by NIH) to something more commensurate with the severity and prevalence (one million adult Americans) of this disease - say, $100 million (still much lower than the spending for MS), I will eat my words and consider the IOM report a success.<br />
<br />
If, as I suspect, neither agency will amend their ways with regards to this disease, then all the good intentions in the world won't help. The IOM Report, $1million and the committee's time and effort, will all have been a terrible waste.<br />
<br />
The week before the rollout of the IOM report, a lovely young woman named Vanessa Li took her own life because she continued to suffer dramatically from the disease and she saw no hope for a change.<br />
<br />
Karina Hansen, only 25, has spent the past two years imprisoned in a Danish psychiatric asylum for the sin of having a diagnosis of M.E. and continues to languish there, unable to see her family.</div>
<div style="-webkit-text-size-adjust: auto; font-family: UICTFontTextStyleBody; font-size: 17px;">
<br />
By the report's own admission, a quarter of a million Americans are bedridden or housebound right now as a result of this disease.<br />
<br />
We don't need prevarication - we need URGENT ACTION.<br />
<br />
What will it take to get that?<br />
<br />
Mary Schweitzer, Ph.D.<br />
Incline Village, NV<br />
25 February 2015</div>
Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com49tag:blogger.com,1999:blog-1345573145957924958.post-21351370122662202582013-12-29T19:38:00.000-08:002015-02-13T18:18:56.225-08:00Guest post by Katharina VossKatharine Voss of Germany has graciously consented to my publishing her testimony to the P2P (NIH "Pathways to Prevention [P2P]" committee report on how NIH should fund future research on ME and CFS. Note: NIH has never funded more than $5 per patient in research on ME or CFS anyway - as compared to $350 per person for MS, a similar disorder. The P2P report was produced by a "jury" deliberately formed of completely uninformed members, who listened to "testimony" from "stakeholders" and then formed their conclusion. Their report can be found here:<br />
<a href="https://prevention.nih.gov/docs/programs/mecfs/ODP-MECFS-DraftReport.pdf" target="_blank">NIH's P2P program's MECFS-Draft Report</a><br />
<br />
Apparently NIH no longer believes in the scientific process, preferring, as one representative chirped happily, the "jury system! - it's the American way!"<br />
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Katharine Voss has two daughters with the disease. She presented testimony to the P2P because US government actions have international repercussions. I thought her testimony deserved a wider readership, so with her permission I have posted it here. I also wish to thank Jan Van Roijen for first widely posting Katharine's testimony on his private information list.<br />
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<br />
Katharine Voss<br />
December 27, 2014<br />
<br />
<span style="background-color: rgba(255, 255, 255, 0);">Public comment on the P2P Draft Statement by Katharina Voss, Dec 2014:</span><br />
<span style="background-color: rgba(255, 255, 255, 0);">(Corresponding line numbers of the report are shown here in parentheses, reference numbers are shown here in brackets)</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">What does the NIH leadership really think about our disease?</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">"They hate you!"</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">This was the answer of a retired NIH scientist to a patient at a medical conference in New York City, Dec 2013. [1] And his answer was the first and only honest answer patients with ME ever got from NIH. This NIH scientist frankly expressed what patients with ME undergo every single day: they face a wall of hatred and scorn.</span><br />
<br />
<span style="background-color: rgba(255, 255, 255, 0);">The NIH P2P Draft Statement clearly shows that he was right.</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">As many of ME activists predicted we got just the same bad recommendations given to Gulf war veterans (whose disease was “redefined” into the belittling “CMI”) and fibromyalgia patients. [2] NIH wants to put us off with ineffective harmful treatments like GET, CBT, antidepressants, and self-management. (Lines 113-116, 135-138, 344-350, 370-371).</span><br />
<br />
<span style="background-color: rgba(255, 255, 255, 0);">Self-management – have we read correctly? What else are we doing now for decades in the absence </span><span style="background-color: rgba(255, 255, 255, 0);">of proper medical care? Self-management! And the NIH spends millions of taxpayers` dollars to recommend self-management? Are you kidding us?</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">These treatments like GET, CBT, antidepressants, and self-management ("multimodal therapy“) couldn't possibly be effective for some psychological disorders, but they do harm to patients with organic diseases like ME, a fact that is proven by true science but which is rejected by the P2P "experts“! [3]</span><br />
<br />
<span style="background-color: rgba(255, 255, 255, 0);">Why does NIH neglect patients with ME?</span><br />
<br />
<span style="background-color: rgba(255, 255, 255, 0);">Although men are also affected, the majority of ME patients are women. Hence this neglect is clearly a case of misogyny! I want to compare the situation with the early AIDS epidemic when mainly gay men fell ill and were discriminated against as homosexuals and AIDS was called "gay plague", "Gay Related Immune Deficiency“ (GRID), "Gay People’s Immuno Deficiency Syndrome“ (GIDS), the CDC`s creation “the 4H disease” (Haitians, homosexuals, hemophiliacs, heroin users)]. [4] Racism, homophobia and misogyny impeded research much too long.</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">Today there is a big problem with the so-called "medically unexplained syndromes“, a term created by psychiatrists in order to cover and falsely include a lot of physical diseases. These psychiatrists - mostly the same psychiatrists who recommend CBT, GET and antidepressants for patients with "ME/CFS" - try to “prove” that exposure to childhood trauma is associated with significantly increased risk of “ME/CFS”. They try to “prove” that sexual abuse, emotional abuse and emotional neglect cause “ME/CFS”, and that these factors were most effective in distinguishing “ME/CFS” cases from healthy controls. [5] They try to “prove” this unscientific nonsense in spite of the very well-known results of biomedical research.</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">Their unscientific work results in falsely accusing mothers of children with ME of having a Munchausen by proxy syndrome. Parents, falsely accused of sexual abuse, emotional abuse and emotional neglect or of Munchausen by proxy syndrome lose custody and many children with ME have been separated from their families. They were mistreated with GET in psychiatric wards and their parents were wrongly criminalized. This is an ongoing praxis and this happens all due to the disregard of an organic disease. [6]</span><br />
<br />
<span style="background-color: rgba(255, 255, 255, 0);">All these so-called "medically unexplained syndromes“ which are in reality physical diseases affect more women than men. Women are probably genetically more susceptible for these diseases. Actually these diseases are not psychological disorders and many biomedical abnormalities can be measured for diseases like ME, fibromyalgia and so on, falsely labeled as "medically unexplained syndromes."</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">We must not assume that these psychiatrists who assert that all these diseases are medically unexplained and caused by sexual abuse, emotional abuse and emotional neglect are stupid. We have to assume that they are well familiar with the results of biomedical research. Therefore, it is a deliberate misrepresentation by these psychiatrists, driven by misogyny.</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">This intentional misrepresentation is a violation of the AMERICAN DECLARATION OF THE RIGHTS AND DUTIES OF MAN, a violation of article I (Right to life, liberty and personal security), article VII (Right to protection for mothers and children), article XI (Right to the preservation of health and to well-being).</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">NIH consistently denies the fact that ME is an infectious disease. The report encourages more "biopsychosocial" studies. (Lines 275-276) Is that really what we need? More of these "biopsychosocial" studies from Wessely School and their worldwide followers which will "prove" that ME is a mental illness perpetuated by our "false illness beliefs"? No, we don`t need any single further study of this kind!</span><br />
<br />
<span style="background-color: rgba(255, 255, 255, 0);">Why is NIH consistently denying the fact that ME is an infectious disease? There are so many clusters in families and among fellow workers and pupils proving that ME is indeed infectious. [7] Why is NIH hiding this very well-known fact? No actions have been taken to stop this epidemic. Why? A disease which was ""[not] numerically important on a national scale““ in the fifties has now evolved into the "most common chronic disease of young and middle-aged adults“ because NIH failed to recognize its epidemic character. [8]</span><br />
<br />
<span style="background-color: rgba(255, 255, 255, 0);">Everyone who is able to read can read that Mikovits and Ruscetti found uncontaminated retroviral variants other than XMRV. Those variants were not XMRV. [9]</span><br />
<br />
<span style="background-color: rgba(255, 255, 255, 0);">Only figure 1 of the Science paper was wrong. Figure 1 was the XMRV PCR sequencing/naming done by Silverman. Silverman was the one who sequenced XMRV in his lab, and these are the PCR data shown in figure 1 in the Science paper. [10]</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">GAll the other data on the Science paper still stand. [11] The serology information is well documented. The research also showed the dysfunctional immune profile, the cytokine signature, and microarray co-pathogens associated with those who were antibody positive in several studies. This data is all published. [12]</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">The prostate cancer paper by Silverman falsely claimed XMRV to be a human infection and was later retracted. However, no research came to a halt for prostate cancer because of Silverman`s error. Contrary to Dr. Judy Mikovits Silverman still has his career and the prostate cancer patients are still provided with research and treatment.</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">However, because of the original mistake made in XMRV prostate cancer research the ME patient population has been denied further research on Mikovits/Ruscettis original results and effective treatment. Silverman was wrong yet ME patients and Dr. Judy Mikovits are paying the price for his mistake.</span><br />
<br />
<span style="background-color: rgba(255, 255, 255, 0);">And by the way, what about Maureen Hansons findings, her detection of MLV-like gag sequences in blood samples from a patient cohort? [13]</span><br />
<br />
<span style="background-color: rgba(255, 255, 255, 0);">What about Sidney Grossberg`s isolation of the JHK retrovirus in ME patients? [14]</span><br />
<br />
<span style="background-color: rgba(255, 255, 255, 0);">And what about Elaine De Freitas` HTLV II-like retroviral sequences found in ME patients? [15]. </span><span style="background-color: rgba(255, 255, 255, 0);">Why had the CDC never tried to follow her protocol? [16]</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">Why did the NIH continue refusing unbiased and true science? Why did the NIH destroy future research for our disease because of the XMRV mistake made in prostate cancer? Why is NIH not pursuing the research for the variants and serology found in Ruscetti's lab? Why did the NIH destroy the hope of millions ME sufferers for effective antiretroviral, antiviral and anti-inflammatory treatments?</span><br />
<br />
<span style="background-color: rgba(255, 255, 255, 0);">Shall my beloved daughters never have a life? Both developed mild ME, at least at the age of three. The elder one lost 2 years of education due to her disease before she got completely bedbound, the younger one lost nearly a whole year of education before she got bedbound. In 2009 my elder daughter received a Boostrix shot (polio, tetanus, dyphtheria) followed by a very severe relapse which continues to date. (100% bedbound, spoonfed, unable to wash, to brush her teeth without help, touch-sensitive, sensitive to the slightest noise and often unable to bear the presence of their beloved family members even for only a few minutes) In January 2011 my younger daughter relapsed after a series of viral infections. Being 90% bedbound, suffering from severe neurological and neurocognitive problems she is too severely affected to participate in any form of education, even at home. (My daughters are just the most severely affected members of our family! Many have/had other neuroimmunological diseases or/and cancer.)</span><br />
<br />
<span style="background-color: rgba(255, 255, 255, 0);">My daughters clearly don`t suffer from a syndrome "characterized by extreme fatigue“ as "ME/CFS“ is described in the P2P draft. (Lines 2-4) My daughters suffer from a disease characterized by postexertional neuroimmune exhaustion (PENE). And PENE "is part of the body’s global protection response“ in a disease named Myalgic Encephalomyelitis in the fifties, recognized as a neurological disease from WHO in 1969. [17]</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">PENE, the cardinal symptom of ME, is an objectively measurable (i.e. Two-day Cardiopulmonal Exercise Test) abnormal biological response to exertion. [18] ME is not characterized by a subjective feeling of fatigue. Fatigue can be an accompanying symptom but many ME sufferers never experience fatigue. But every real ME sufferer experiences PENE. Without PENE – no ME!</span><br />
<br />
<span style="background-color: rgba(255, 255, 255, 0);">My elder daughter is now 21 years old and spent 5 ½ years in a darkened room with no hope to ever get out of there. When will NIH research release her from prison? The younger one is now 14 years old, being severely ill nearly one third of her young life!</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">Both girls lost half of their childhood due to mild ME and her whole youth due to very severe ME. But all the NIH has to offer is self-management? Will NIH not allow them to have a future?</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">Oh yes, all the tests, medications and medical care we really need (and some of us probably lifelong) would be costly if the NIH would actually recognize ME as an infectious and transmissible disease.</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">But what is the alternative? The alternative is that we will further spread this disease. And many of our beloved ones will contract this disease, our friends and carers and physicians. And this disease will not stop in front of the doors of NIH.</span><br />
<br />
<span style="background-color: rgba(255, 255, 255, 0);">Wake up, NIH! Break down the wall of hatred and scorn!</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">Wake up, America!</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">Thank you for your attention.</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">References: </span><br />
<br />
<span style="background-color: rgba(255, 255, 255, 0);">[1] Heckenlively, Kent, Mikovits, Judy. <i>Plague: One Scientist's Intrepid Search for the Truth about Human Retroviruses and Chronic Fatigue Syndrome, Autism, and Other Diseases</i>”. Foreword by Hillary Johnson, p. xxi, Skyhorse Publishing 2014.</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">[2]<i> Gulf War and Health </i>Volume 9: "Treatment for Chronic Multisymptom Illness”, Institute of Medicine.</span><br />
<span style="background-color: rgba(255, 255, 255, 0);"><br /></span>
<span style="background-color: rgba(255, 255, 255, 0);">[3] Snell, Christopher R., Stevens, Staci R., Davenport, Todd E., and Van Ness, J. Mark “Discriminative Validity of Metabolic and Workload Measurements to Identify Individuals With Chronic Fatigue Syndrome”, published online before print 27 June 2013 doi: 10.2522/ptj.20110368; </span><br />
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VanNess JM, Stevens SR, Bateman L, Stiles TL, Snell CR “Postexertional lmalaise in women with chronic fatigue syndrome.” <i>J Womens Health</i> (Larchmt). 2010;19:239-44; VanNess JM, Snell CR, Stevens S “Diminished Cardiopulmonary Capacity During Post- Exertional Malaise.” <i>J Chronic Fatigue Syndr.</i> 2008;14(2):77-85; Nijs J1, Almond F, De Becker P, Truijen S, Paul L “Can exercise limits prevent post-exertional malaise in chronic fatigue syndrome? An uncontrolled clinical trial.” <i>Clin Rehabil</i>. 2008 May; 22(5):426-35. doi: 10.1177/0269215507084410; LaManca JJ, Sisto SA, DeLuca J, Johnson SK, Lange G, Pareja J, Cook S,Natelson BH. “Influence of exhaustive treadmill exercise on cognitive functioning in chronic fatigue syndrome.” <i>Am J Med</i>. 1998 Sep </div>
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<span style="background-color: rgba(255, 255, 255, 0);">28;105(3A):59S-65S; </span><span style="background-color: rgba(255, 255, 255, 0);">VanNess JM, Snell CR, Stevens SR, Stiles TL “Metabolic and neurocognitive responses to an exercise challenge in chronic fatigue syndrome/(CFS)”, <i>Med Sci Sports Exerc</i>. 2007; </span></div>
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White AT, Light AR, Hughen RW, Bateman L, Martins TB, Hill HR, Light KC. “Severity of symptom flare after moderate exercise is linked to cytokine activity in chronic fatigue syndrome.” <i>Psychophysiology</i>. 2010 Jul 1;47(4):615-24. doi: 10.1111/j.1469-8986.2010.00978.x.; Twisk FNM, Maes M "A review on Cognitive Behavorial Therapy (CBT) and Graded Exercise Therapy (GET) in <i>Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS)</i>: CBT/GET is not only ineffective and not evidence-based, but also potentially harmful for many patients with ME/CFS.” <i>Neuro Endocrinol Lett</i>. 2009;30:284-299; Cooper DM, Radom-Aizik S, Schwindt CD, Zaldivar F. “Dangerous exercise: lessons learned from dysregulated inflammatory responses to physical activity.” <i>J Appl Physiol</i>. 2007;103:700–709; Vermeulen, Ruud CW and Vermeulen van Eck, Ineke WG “Decreased oxygen extraction during cardiopulmonary exercise test in patients with chronic fatigue syndrome“, <i>Journal of Translationa Medicine</i> 2014, 12:20 doi:10.1186/1479-5876-12-20; Light AR, White AT, Hughen RW, Light KC “Moderate exercise increases expression for sensory, adrenergic, and immune genes in chronic fatigue syndrome patients but not in normal subjects.” <i>J Pain</i>. 2009;10:1099-112; Kindlon, Tom ”Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome”, <i>Bulletin of the IACFS/ME</i>. 2011;19(2): 59-111. <a href="http://l.facebook.com/l.php?u=http%3A%2F%2Fwww.iacfsme.org%2FLinkClick.aspx%3Ffileticket%3DRd2tIJ0oHqk%253D&h=jAQFpk0_Z&enc=AZNBWv8zLMdlTAJTP8u2BF1W-YpJLURlrN7DYK6dqXBCH8MduuPvQbuAds4xI_eFqfCZDVHLjwwNUKCcM5lFe8V5k8hHzIXQhJ3NQWCrEFz_3vfxNDv8RKzHAx7pX4mgBThrRXjWEl-vjAVMj5Lf-Uku&s=1" rel="nofollow" style="cursor: pointer; text-decoration: none;" target="_blank">http://www.iacfsme.org/LinkClick.aspx…</a>& (12/25/2014); Bringsli, Gunn J., Gilje, Anette and Getz Wold, Bjørn K. “The Norwegian ME Association National Survey: Abridged English Version." </div>
<a href="http://l.facebook.com/l.php?u=http%3A%2F%2Fme-foreningen.com%2Fmeforeningen%2Finnhold%2Fdiv%2F2014%2F05%2FME-Nat-Norwegian-Survey-Abr-Eng-Ver.pdf&h=fAQFMgh2m&enc=AZNC0WYF0T78d4yN0EmZHSlcv46N9k26T4SNP7jh-1ft5K17HnXG1K6t5tweyb0xWelKtKePQNa1fHMykulM5_w_RyVBRXn4wKOi-4J0MZcY30bbKZvJ8TQZIpWKvAZFL_fBHIDpjajiuj57eEksz4M4&s=1" rel="nofollow" style="cursor: pointer; text-decoration: none;" target="_blank">http://me-foreningen.com/…/ME-Nat-Norwegian-Survey-Abr-Eng-…</a><span style="background-color: rgba(255, 255, 255, 0);">(12/25/2014).</span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">[4] "AIDS“,</span><span style="background-color: rgba(255, 255, 255, 0);"> </span><a href="http://l.facebook.com/l.php?u=http%3A%2F%2Fen.wikipedia.org%2Fwiki%2FHIV%2FAIDS%23Discovery&h=nAQG-_8AC&enc=AZNmWuKnz3EE7kOwizJRgtCiDJ_T7dR4jIPlIjTGsFjK96UcbniahMEe46Otb7YxEG5-zb68T90xYMkx0HWuSmjR8HcS48zgtUzw6d7PPB7VL9K7z7xFMKQqBAskL_ONmJNu_hMrYfVbgGQojCY9nw-w&s=1" rel="nofollow" style="cursor: pointer; text-decoration: none;" target="_blank">http://en.wikipedia.org/wiki/HIV/AIDS#Discovery</a><span style="background-color: rgba(255, 255, 255, 0);"> </span><span style="background-color: rgba(255, 255, 255, 0);">(12/25/2014); </span><span style="background-color: rgba(255, 255, 255, 0);">"Making Headway Under Hellacious Circumstances" </span><a href="http://l.facebook.com/l.php?u=http%3A%2F%2Fwww.sciencemag.org%2Fcontent%2F313%2F5786%2F470.2.full.pdf&h=BAQETpSfE&enc=AZPoNRVFu6Z7r-Zdbeznl4dxZS8qOSIpdgPriT52-T205HhVeki1edKumflMPqD1qFzPXJfUMg5H50CYeEOVtzg2eL72aI_a_TqS_ISy4Of9EGMjSo_kt70TxGmE5k2CUZeFHo-vJGh8N0tu14kiRp8r&s=1" rel="nofollow" style="cursor: pointer; text-decoration: none;" target="_blank">http://www.sciencemag.org/content/313/5786/470.2.full.pdf</a><span style="background-color: rgba(255, 255, 255, 0);"> </span><span style="background-color: rgba(255, 255, 255, 0);">(12/25/2014); </span><span style="background-color: rgba(255, 255, 255, 0);">"Ronald Reagan Remembered: First Public Discussion of HIV/AIDS" </span><a href="http://l.facebook.com/l.php?u=http%3A%2F%2Fwww.thebody.com%2Fcontent%2Fart31696.html&h=4AQFVEKgT&enc=AZMxObyl3iJiJryECxgL_WgYv9w9YjMPVe_mK2w2dtzRwFdc8lKs9D7j2Ta7g9JC0VHbxKPB_TR_7yIm-4Hp38X0MrXNIAkvDF-kiEsRPAR9VF1vvSdmbvXW_UxUFBrZNuYiNARQPIkHjiqqHcjIGDMS&s=1" rel="nofollow" style="cursor: pointer; text-decoration: none;" target="_blank">http://www.thebody.com/content/art31696.html</a><span style="background-color: rgba(255, 255, 255, 0);"> </span><span style="background-color: rgba(255, 255, 255, 0);">(12/25/2014).</span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">[5] Heim, Christine PhD; Nater, Urs M. PhD;. Reeves, William C. MD, MSc, et al. “Childhood Trauma and Risk for Chronic Fatigue Syndrome - Association with neuroendocrine dysfunction," <i>Arch Gen Psychiatry</i>. 2009;66(1):72-80. doi:10.1001/archgenpsychiatry.2008.508.</span></div>
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[6] Colby, Jane “False Allegations of Child Abuse in Cases of Childhood Myalgic Encephalomyelitis (ME)”. <a href="http://l.facebook.com/l.php?u=http%3A%2F%2Fwww.argumentcritique.com%2Fuploads%2F1%2F0%2F3%2F1%2F10317653%2Fcolby_j.pdf&h=PAQEQ69vC&enc=AZO4Fb9SAbT8eA2y7NZ-XrjBMiQcFu2ZX35rNRYqPWE0AWNjjCnFj6eSETid1wTvbhVagmzOfasU8LIGCg3f7r3l_uE0_WvrzLKkpBy5nMpJX79dw2V3JR5Efev-ZdM06N-RmNtfaWZqiqrJaw3kTjUq&s=1" rel="nofollow" style="cursor: pointer; text-decoration: none;" target="_blank">http://www.argumentcritique.com/…/0/3/1/10317653/colby_j.pdf</a> (12/25/2014).</div>
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[7] Dowsett EG, Colby, J. "Longterm sickness absence due to ME/CFS in UK schools: an epidemiological study with medical and educational implications." <i>JCFS</i> 3(2):2942, 1997, http://www.tymestrust.org/PDFs/dowsettcolby.pdf. (12/25/2014); Underhill, Rosemary A., O'gorman, Ruth. "Prevalence of Chronic Fatigue Syndrome and Chronic Fatigue Within Families of CFS Patients,"<i> Journal of Chronic Fatigue Syndrome</i> 2006, Vol. 13, No. 1, Pp 3-13, http://informahealthcare.com/doi/abs/10.1300/J092v13n01_02 (12/25/2014).</div>
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<span style="background-color: rgba(255, 255, 255, 0);">[8] Henderson, Donald A., and Shelokov, Alexis “Epidemic Neuromyasthenia — Clinical Syndrome?” <i>N Engl J Med</i> 1959; 260:757-764 April 9, 1959 DOI: 10.1056/NEJM195904092601506; </span><span style="background-color: rgba(255, 255, 255, 0);">Johnson, Hillary, <i>Osler's Web:</i> <i>Inside the Labyrinth of the Chronic Fatigue Syndrome Epidemic</i>, Penguin Books 1997, p. 203.</span></div>
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<span style="background-color: rgba(255, 255, 255, 0);">[9] Lombardi VC, Ruscetti FW, Das Gupta J, Pfost MA, Hagen KS, Peterson DL, Ruscetti SK, Bagni RK, Petrow-Sadowski C, Gold B, Dean M, Silverman RH, Mikovits JA. "Detection of an infectious retrovirus, XMRV, in blood cells of patients with chronic fatigue syndrome," <i>Science</i>. 2009 Oct 23;326(5952):585-9. doi: 10.1126/science.1179052; </span><span style="background-color: rgba(255, 255, 255, 0);">Goetz, Deborah L. S., Mikovits, Judy A., Deckoff-Jones, Jamie and Ruscetti, Francis W. "Innate Immune Changes in the Peripheral Blood of Chronic Fatigue Syndrome Patients: Risk Factors for Disease Progression and Management," Chapter VI (pp. 91-130) i</span>n <i>Chronic Fatigue Syndrome</i>, Nova Science Publishers, Inc. 2014, ISBN: 978-1-63321-961-8; Mikovits, Judy "The Exotic Biology of Xenotropic Murine Leukemia Related Virus XMRVs – Pitfalls and New Concepts”, Presentation from the Mount Sinai Conference Nov. 2013 <a href="https://www.facebook.com/media/set/?set=a.244564049033185.1073741854.101589063330685&type=1" style="cursor: pointer; text-decoration: none;">https://www.facebook.com/media/set/…</a> ; Heckenlively, Kent, Mikovits, Judy. <i>Plague: One Scientist's Intrepid Search for the Truth about Human Retroviruses and Chronic Fatigue Syndrome, Autism, and Other Diseases</i>, Skyhorse Publishing 2014, p. 336.<br />
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[10] Heckenlively, Kent, Mikovits, Judy, <i>Plague, op.cit., </i>pp. 337, 342. <br />
<br />
<span style="background-color: rgba(255, 255, 255, 0);">[11] Heckenlively, Kent, Mikovits, Judy, <i>Plague, op.cit.</i>, pp. 341 ff.</span><br />
<br />
[12] Goetz, Mikovits, Deckoff-Jones, Ruscetti, "Innate Immune Changes in the Peripheral Blood of CFS Patients,"<i> op.cit</i>.<br />
<br />
[13] Hanson, Maureen R, Bell, David S et al. "Detection of MLV-like gag sequences in blood samples from a New York state CFS cohort“, <i>Retrovirology</i>. 2011; 8(Suppl 1): A234. Published online 2011 June 6. doi: 10.1186/1742-4690-8-S1-A234<br />
<br />
[14] Halligan, Brian D, Sun, Hai-Yuan, Kushnaryov, Vladimir M & Grossberg, Sidney E “Partial molecular cloning of the JHK retrovirus using gammaretrovirus consensus PCR primers”, <i>Future Virology</i>, May 2013, Vol. 8, No. 5, Pages 507-520 , DOI 10.2217/fvl.13.25<br />
<br />
[15] DeFreitas, Elaine, Hilliard, Brendan, Cheney, Paul R., Bell, David S., Kiggundu, Edward, Sankey, Diene, Wroblewska, Zofia, Palladino, Maria, Woodward, John P., and Koprowski, Hilary. "Retroviral sequences related to human T-lymphotropic virus type II in patients with chronic fatigue immune dysfunction syndrome (Epstein-Barr virus syndrome/infectious mononucleosis/myalgic encephalomyelitis/polymerase chain reaction/in situ hybridization)“, <i>Proc. Natl. Acad. Sci. USA</i> Vol. 88, pp. 2922-2926, April 1991, Medical Sciences <a href="http://l.facebook.com/l.php?u=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC51352%2F&h=FAQG90fQM&enc=AZPbLl1zPMvmYgrVRM_t2fUqEKvqRQTbpkqFw5pfTxklygTR2VRnTFrPyGHHAO_W4essg0HKlOYdOzr1ANDAUyvXcEisIejZJYRlBTovoBuNmpIOzaoEKGMuYRU_Vp6trdozfzVojPb1A8xLG1B77b26&s=1" rel="nofollow" style="cursor: pointer; text-decoration: none;" target="_blank">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC51352/</a><br />
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[16] Heckenlively, Kent, Mikovits, Judy. <i>Plague, op.cit.</i>, p. xvii, ff.; Hooper, Malcolm, "ME/CFS (WHO ICD-10 G93.3) Biomedical Evidence Summaries." February 2010. <a href="http://l.facebook.com/l.php?u=http%3A%2F%2Fwww.stonebird.co.uk%2Fhooper.html&h=4AQFVEKgT&enc=AZO5mJKTnRpDkXKoYzwC9sSbvrvSABLq4VdEQJay1ngalGPZYYAl3rUyn2eBEkNbPhiW-ZhTnHt8Jhrey0mPufuEw6V4-ZyPOiBmN3vxxtxKjtCWrOI9Ln_3-VqvXGAWbzt6058Y68RwtyjTBf81G8ue&s=1" rel="nofollow" style="cursor: pointer; text-decoration: none;" target="_blank">http://www.stonebird.co.uk/hooper.html</a>(12/25/2014)<br />
<br />
[17] Carruthers, B M, van de Sande, M I [...], and Stevens, S "Myalgic Encephalomyelitis: International Consensus Criteria“, p. 331, <i>Journal of Internal Medicine</i>, Oct 2011, Review. <a href="http://l.facebook.com/l.php?u=http%3A%2F%2Fonlinelibrary.wiley.com%2Fdoi%2F10.1111%2Fj.1365-2796.2011.02428.x%2Fpdf&h=nAQG-_8AC&enc=AZNzsdFJ3yrDtMxYVQYePWh4lbirJ9IUF97Ap1tYr1_crQ252GNC6F-d-bwuil2vQfED7P1CP_IrHMHFiOvZTGHS0e1ga3l0B1Y3mvx2S4QjcD5O83RhosluarZUm7ofTSuwKRVxA65nKpvkU_rDULSJ&s=1" rel="nofollow" style="cursor: pointer; text-decoration: none;" target="_blank">http://onlinelibrary.wiley.com/…/j.1365-2796.2011.02428…/pdf</a><br />
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[18] Snell, Christopher R., Stevens, Staci R., Davenport, Todd E., and Van Ness, J. Mark “Discriminative Validity of Metabolic and Workload Measurements to Identify Individuals With Chronic Fatigue Syndrome”, published online before print 27 June 2013 doi: 10.2522/ptj.20110368<br />
White AT, Light AR, Hughen RW, Vanhaitsma TA, Light KC. “Differences in metabolite-detecting, adrenergic, and immune gene expression after moderate exercise in patients with chronic fatigue syndrome, patients with multiple sclerosis, and healthy controls.” <i>Psychosom Med. </i>2012 Jan;74(1):46-54. doi: 10.1097/PSY.0b013e31824152ed<br />
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Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com4tag:blogger.com,1999:blog-1345573145957924958.post-63580807619924402092013-09-16T13:41:00.001-07:002013-09-18T13:39:13.707-07:00Why CDC must use two-day CPET testing - and specialists must define the disease, not bureaucrats<br />
So Dr. Elizabeth Unger and the CDC have decided against a two-day exercise test in their supposedly all-encompassing, supposedly cooperative, upcoming CFS study.<br />
<br />
Why am I not surprised?<br />
<br />
When normal people go walking or bicycling or jogging, it is called "aerobic exercise" because while their body is exercising, it's using normal amounts of oxygen from air with carbon dioxide being expelled through their lungs. If you do aerobic exercise regularly, it is good for you. You get stronger and can go longer times or distances. For a normal person, aerobic metabolism can be measured with heart rate: (220 - your age) times 60% for the lower bound, (220 - your age) times 80% for the upper bound. <br />
<br />
If your heart rate exceeds the upper bound, you're no longer operating in aerobic metabolism - your body will shift into what is called anaerobic exercise.<br />
<br />
Weightlifting is an example of anaerobic exercise - you go past the point where the muscles can get enough oxygen from the lungs, and they start breaking down muscle to get it. That's okay - the muscle rebuilds stronger. But if you have to give the muscles a two-day rest, so in training, you either alternate working on upper body one day and lower body the next, or do weightlifting every other day.<br />
<br />
If you push harder than that - even as an athlete - if you go too far with the supposedly aerobic exercise that your body switches into anaerobic, or do anaerobic exercises (like weightlifting) too frequently, the body starts living in anaerobic metabolism, and that is bad, because breaking down too many proteins this way poisons the body. If you don't have the good sense to stop, your body does - eventually it will MAKE you rest.<br />
<br />
A gung-ho young athlete who is improperly trained can screw himself up with too much anaerobic exercise, and then his/her body will just refuse to keep going - for up to 3 weeks. That is called "over-training syndrome."<br />
<br />
Professional and collegiate trainers keep close tabs on their athletes because of this. <br />
<br />
For some reason our bodies shift into anaerobic metabolism (generally anything that sends our heart rates over 100) too soon. In my case, just walking does it when I'm sick. So you could say that our bodies are responding to "normal" activities as if we were athletes pushing too hard, that is, to a certain degree we are perpetually in the midst of "overtraining syndrome."<br />
<br />
They use the VO2 MAX test (or CPET - Cardio-Pulmonary Exercise Testing) to measure this.<br />
<br />
People with a bad heart have the same problem, and again they turn to the VO2 MAX stress test to measure it. <br />
<br />
A recent set of studies* have found that those of us who are REALLY sick score badly on just one day of exercise - which then makes you wonder about the over-prevalence of heart attacks among us. So a score in the danger range (that would be me off Ampligen) should be taken seriously.<br />
<br />
Most patients in this study are not going to score THAT low - they will score low-normal. The problem is, so do couch potatoes.<br />
<br />
The amazing thing Staci Stevens and Chris Snell found was that high-functioning patients may score the same as deconditioned controls (the afore-mentioned couch potatoes) in one day of exercise - but on the SECOND day, the controls' scores don't change, whereas the patients' scores plummet IN HALF.<br />
<br />
Which makes sense if you have a good understanding of this disease. But is really quite an astonishing finding for outsiders.<br />
<br />
AND it is the best argument we have with which to make the case that graded exercise programs can hurt patients. Can make them worse. In some cases, can leave them paralyzed (something no one in government wants to talk about).<br />
<br />
So if you want to measure that cardinal symptom of our disease that is often called post-exertional malaise (PEM), or post-exertional worsening of symptoms, you need a TWO-DAY test. Otherwise, we don't come off any different than someone who is not in shape.<br />
<br />
Which means that by refusing to do the two-day test, CDC's results will make it look as if graded exercise was a good idea.<br />
<br />
And that is bad. Bad enough that I think we are being set up. You can't say CDC doesn't KNOW that the two-day test has a different meaning - Chris Snell used to be president of CFSAC. And I've attended FDA meetings where Dr. Unger and Dr. Snell sat on the same dais. She knows. She is CHOOSING not to do the two-day test, knowing full well that it is the TWO-day test that demonstrates PEM.<br />
<br />
Now, you're CDC. Supposedly the best in the world. You'd want to use the best methods, wouldn't you? <br />
<br />
CDC's explanation for not dong the two-day test is that it would be an imposition for patients. But both Staci and Chris found that while the deconditioned controls could get whiney about having to do the test, patients with ME/CFS (Canadian) would walk on hot coals if it would move the science of this disease further along. So the supposition that the patients wouldn't want to have to come two days in a row does not fit what we already know.<br />
<br />
The only time I ever saw Dr. Unger get angry in a CFSAC meeting was when we were all calling for a change in the CDC's recommendation of graded exercise. We asked not only that they quit recommending it, but also that they openly WARN physicians about the dangers. She was furious. She said that the emphasis on graded exercise was supported by scientists and was not negotiable. Those very words. Not negotiable.<br />
<br />
Thus, by constructing this new study in such a way that patients will look like couch potatoes, Dr. Unger and CDC preserve their nonnegotiable stance of promoting graded exercise.<br />
<br />
Why do I feel like I am being set up?<br />
<br />
I think I'll ask Dr. Unger about that at the next CFSAC meeting. Oops! No can do - I'm not invited. The public is being excluded from the next CFSAC meeting, except for our pathetic little five-minute phone-in testimony.<br />
<br />
I also noticed in the latest CFSAC announcement that CDC has returned to the IOM, where nobody knows anything about this disease except what CDC tells them, for the "new definition." The community of ME/CFIDS patients and clinicians had strenuously protested this through appropriate channels; CDC responded that they they heard us and were backing off - but not two weeks later, they have already gone back on their word.<br />
<br />
Our position remains that it is currently active ME and CFIDS specialists and clinicians who should be drawing up that new definition. Like the ones on CFSAC. Not, well, strangers. They should put together a committee with John Chia (USC), Jose Montoya (Stanford), Dan Peterson (Simarron Institute), Lucinda Bateman (U of Utah), Alan and Kathleen Light (U of Utah), Nancy Klimas (Nova University), Mary Ann Fletcher (Miami), Martin Lerner, Paul Cheney, Maureen Hanson (Cornell), Gordon Broderick (U of Alberta), Charles Lapp (Duke), Anthony Komaroff (Harvard), Ben Natelson (NJ College of Medicine), Susan Levine, Ian Lipkin (Columbia), Derek Enlander (Mt. Sinai NYC) - and Chris Snell or Stavi Stevens. As a start. Not hired strangers.<br />
<br />
These are VERY VERY BAD developments that roll things backwards to the early 1990s.<br />
<br />
At least the insurance companies will be happy.<br />
<br />
-------------------------<br />
<br />
*For the most recent, see Christopher R. Snell, Staci R. Stevens, Todd E. Davenport, and J. Mark Van Ness. "Discriminative Validity of Metabolic and Workload Measurements to Identify Individuals With Chronic Fatigue Syndrome." Physical Therapy (2013). Click here for the abstract: <br />
<a href="http://ptjournal.apta.org/content/early/2013/06/26/ptj.20110368.short" target="_blank">http://ptjournal.apta.org/content/early/2013/06/26/ptj.20110368.short</a><br />
<br />
My apologies to those I missed, and those whose affiliations I missed. The larger point is that these are clinician-scholars working at top-level institutions. They should not be ignored.<br />
<br />
<br />Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com11tag:blogger.com,1999:blog-1345573145957924958.post-45490976896895217952013-05-24T12:02:00.000-07:002015-02-13T18:00:21.895-08:00Testimony to CFSAC - May 2013Testimony to the Chronic Fatigue Syndrome Advisory Committee<br />
Department of Health and Human Services<br />
United States Federal Government<br />
Washington, DC - 22 May 2013<br />
<br />
<span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);">Today I want to talk about two facts and one symptom. The facts are these:</span><br />
<br />
1. Of the more than one million Americans who have CFS, up to 850,000 remain undiagnosed. <b>Where are they? </b> What happens to those people? <b>Why is this not an urgent concern of CDC?</b><br />
<br />
2. <span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);">Of the more than one million Americans who have CFS, <b>at least one-fourth are homebound, and one-tenth bedridden. One half cannot work at all. WHERE ARE THEY? </b> Who takes care of them? What happens to them if there is no one to take care of them? What happens when there is no money because they cannot work and few make it through the social welfare maze? I can tell you. They end up on the street. You think that's an exaggeration? I personally know people who have ended up on the street because of this disease. I know others who ended up living in cars. What happens to a single mother when she is too sick to work and no one can care for her? She loses her children, and then she ends up on the street. <b>Why is this not an urgent concern of CDC?</b> City of Hope in Los Angeles was founded to get patients with tuberculosis off the streets. Where is the City of Hope for patients with ME or CFS?</span><br />
<br />
-------------------------<br />
Now I want to talk about one symptom: the symptom referred to on CDC's CFS website as "Post-exertional malaise lasting more than 24 hours." In the Fukuda (1994) definition, currently the official definition used by the federal government, PEM is one of eight symptoms, four of which have to be present for a diagnosis of CFS. Obviously it's not considered important.<br />
<br />
But if you ask patients, and you ask their doctors, they will tell you it is important. Post-exertional malaise (PEM) is a defining symptom of this disease. Maes and Twisk have even suggested it be used to differentiate CFS from M.E.<br />
<br />
In three minutes I do not have enough time to explain to you what this is. The word “malaise” is just as unrepresentative of the symptom as “fatigue” is unrepresentative of the disease. "Malaise" sounds vaguely ... unwell. My daughter, who had to take care of me from the age of 13, suggested <b>Post-exertional dysfunction</b>, because I would suddenly become completely dysfunctional. I could not talk intelligibly, could not understand much of what was said to me, had t o be helped to bed. I had a sudden increase in symptoms: light hurt; my head hurt. The pain behind my eyes and in the back of my neck, which never left me for a moment, got much worse. My glands ached. Most important, though, she said, <b>“Mom, you just could not function.”</b><br />
<br />
It does not take much to bring about what we patients all call a crash, depending on the condition of the patient. Just the activities of daily living - getting up, taking a shower, getting dressed - can do it. Mental exertion like reading or a long phone call can do it. But it is sudden, and it is unmerciful, and you are never quite sure how long it will last.<br />
<br />
I want to differentiate PEM from <b>post-exertional relapse</b>. In post-exertional relapse, exercise makes you ratchet down to a worse level of the disease than before, and you stay there. In roughly 24 hours I had over 50 patients respond to a query about this symptom. One wrote that she was asked by her doctor to take a half-hour swim several times a week. She ended up bedridden for two years. Others told of being asked to take walks, or in one case, to run for 9 minutes a day. They all ended up bedridden.<br />
<br />
Surely we already know this. Christopher Snell made an excellent presentation to the NIH State of the Knowledge Conference on CFS in 2011, describing the drop in performance by ME/CFS patients on the second day of CPET testing, in contrast to deconditioned controls and patients with other debilitating conditions. Alan and Kathleen Light et al at the University of Utah recently published research showing significant and unusual physiological abnormalities brought about by exercise in ME/CFS. As my own physician, Dr. Derek Enlander, recently wrote, “The notion that ME/CFS is caused by poor conditioning is no longer widely accepted.”<br />
<br />
Most doctors believe that a patient who is “fatigued” is going to be made better by exercising. Make it an overweight female and they are even more convinced that exercise is just what is needed. <i>But that is not true for this disease.</i><br />
<br />
CDC's website on CFS gives the following advice for offering graded exercise to a bedridden patient:<br />
<br />
A subset of patients with CFS are so severely ill that they're<br />
<span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);">largely </span><span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);">housebound or bedridden.<span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);"> They require special </span></span><br />
<span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);"><span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);"> attention, including </span></span><span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);"><span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);">a modified approach to exercise. Hand </span></span><br />
<span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.292969);"><span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);"> stretches and </span><span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);">picking up and </span></span><span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);">grasping objects may be all </span><br />
<span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);"> that can be managed at first. Gradually </span><span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);"><span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);">increasing </span><span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);">activity </span></span><br />
<span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);"><span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);"> to the point patients can handle activities of daily </span></span><span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);"><span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);">living – </span></span><br />
<span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);"><span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);"> getting up, personal hygiene, </span><span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);">and dressing – is the next step.</span></span><br />
<span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);"><span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);">[From the <a href="http://www.cdc.gov/cfs/toolkit/get.html" target="_blank">CDC's CFS Toolkit for Professionals</a> ]</span></span><br />
<span class="Apple-style-span" style="-webkit-composition-fill-color: rgba(175, 192, 227, 0.230469); -webkit-composition-frame-color: rgba(77, 128, 180, 0.230469); -webkit-tap-highlight-color: rgba(26, 26, 26, 0.296875);"><br /></span>
<b>Listen to yourselves!! You see a bedridden teenager with a feeding tube, and all you can think of is how to get her to exercise? Shouldn't you try to find out why she is bedridden in the first place? </b><br />
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Until you have found the 85% of patients you have lost, until you find the patients who are lost because they cannot care for themselves and there is no one to care for them, you have no business talking about telling patients to practice grasping objects. As long as there are doctors casually telling patients to “just get some exercise and you'll be fine,” you have no business telling bedridden patients what exercise they should do. <br />
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If doctors need to know anything about our disease, it is this: exercise can make us very sick. It can make us bedridden. <i><u>A bedridden patient is a very, very sick patient</u>. </i> Simple exercise that you think is easy can in fact be dangerous for us. It could very well be that what is happening with bedridden patients is that every activity sends them into over-exertion, into crash mode. They are that sick. <b>Quit trying to figure out what exercise to give them and find out what's wrong with them.</b><br />
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As Irish patient and advocate Tom Kindlon puts it, “If graded exercise therapy were a drug instead of a treatment protocol, it would have long ago been banned by FDA.” There are too many adverse responses, and (frankly) not much evidence of success.<br />
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<b>Post-exertional collapse, post-exertional dysfunction, post-exertional crash, post-exertional relapse – whatever you call it, is there really any debate any more over whether it exists? </b><br />
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<b>Shouldn't that be the first thing you tell doctors? </b><br />
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I can tell you that it's the first thing we wish they knew.<br />
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And then, let's figure out why you can't find 850,000 missing patients.<br />
<br />Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com19tag:blogger.com,1999:blog-1345573145957924958.post-38775139493603555802013-04-27T12:46:00.000-07:002013-04-27T12:54:49.243-07:00Thoughts on FDA Workshop April 2013Some thoughts on the FDA Workshop on M.E and CFS<br />
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As often happens when I attend a government meeting on our disease, I am left with more questions than answers.<br />
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The purpose was to facilitate drug development for our disease, and I don't think we made very much progress there. There's always someone to say "no," to put down an idea. It gets frustrating.<br />
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So here are some random impressions that could be productive:<br />
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1. We were informed there is money at NIH to develop and validate tests, questionnaires, and endpoints for drug testing. If you could get something verified, the drug company can just go ahead and use it. Otherwise, they don't have much to go on. Perhaps patient groups should think about tests that should be verified and getting this accomplished. <br />
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2. In the absence of validated tests, particularly biomarkers, we're left with questionnaires. Questionnaires pose a LOT of problems, but more so with our disease because cognitive dysfunction is a primary symptom. I think FDA was beginning to "get" this. We should use that to emphasize the need for objective testing.<br />
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3. Sometimes we can be our own worst enemies. We need whatever biomarkers we can get. There were patients complaining that VO2 MAX testing is unethical. Well, just how are you going to show the significance of our disability without walking on the edge? Off Ampligen, my VO2 MAX score is 14-15 - which is in the seriously disabled, dangerous range. (More on that later.). But I'd do it tomorrow if it meant someone would take our symptoms seriously, or I could get a drug passed.<br />
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4. I don't know how to get around this one, but those of us who have been really sick for a very long time may require a long period of treatment before we show much improvement. That's expensive. But it needs to be taken into account nevertheless.<br />
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Now, those were thoughts on testing for drug approval. Here are a few things that occurred to me just listening to what was said.<br />
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1. IT'S ALL ABOUT THE DEFINITION. I think that's self-evident to anyone reading this, but it about drove me crazy on the second day. I do not want to be in a "cooperative" data sharing effort with someone (e.g., the CDC) who uses the Reeves or "empiric Fukuda (2003)" definition. I want to be in studies that use the M.E. (2011) international research definition or the M.E./CFS (2003) Canadian consensus definition. For those of you in the UK, that means beware of a research program being set up that cooperates with those who use the Oxford definition. It will really skew the results because the ill-defined Oxford cohort will outnumber and swallow up any group defined by a more biomedical definition. When it comes to drug approval, we need to convince drug companies to go for a definition that gives you the most homogeneity. <br />
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2. What is the REAL meaning of those VO2 MAX (CPET) scores? Everyone talks about using the VO2 MAX stress test to prove disability, or using the 2-day version to demonstrate the biological nature of post-exertional collapse. But I want to take this a step further. I knew I was really sick, but I was honestly shocked at how low I scored on that test. WHAT DOES IT MEAN TO SCORE 15 OR BELOW ON A VO2 MAX STRESS TEST? It means THERE IS SOMETHING SERIOUSLY WRONG WITH YOUR CARDIOPULMONARY FUNCTION. <br />
To push this further, when I scored so badly I had a mess of active viruses in my blood serum (EBV, HHV-6A, CMV, HHV-7, and Coxsackie B). I had active CMV and HHV-6A in my spinal fluid and classic symptoms of encephalitis, so I think it's a good bet that I had viral encephalitis.<br />
But did I also have viral myocarditis? Lenny Jason has suggested we are more likely to die of a heart attack prematurely than die of suicide. IS THERE MORE CARDIAC DAMAGE IN THS DISEASE THAN RESEARCHERS HAVE REALIZED? How do we get someone to pay attention to this information?<br />
[For the record, most of the encephalitic symptoms clear up for me within six months on Ampligen. But my CPET scores don't budge for at least a year. Then they do start getting better, and after 4 years on Ampligen my CPET score was actually normal. Perhaps that helps explain why it seems to take much longer to get my stamina back.]<br />
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3. Where is the rest of the iceberg? How many years have we been told that only 15-20% of patients with this disorder have a diagnosis? Where is the 80-85%?<br />
Someone asked a panel about the distribution of this disease by ethnicity. Beth Unger of CDC responded (and I agree with her response) that evidence shows this disease is at the equal opportunity - and that African-Americans and Latin Americans may actually have a slightly higher prevalence rate.<br />
THERE WERE NO PEOPLE OF COLOR AT THIS CONFERENCE (AFAIK) except for one person who was not a patient. People of color are grossly under-represented in the diagnosed population; I don't want to think how badly they are represented in the practices of the handful of specialists who actually know what they are doing.<br />
Could we find out? Could we get an accounting from the clinician experts as to what percent of their patient population with this disease are white? How about income? I think we already know the answer to this. <br />
WHO WOULD BE INTERESTED IN THIS PROBLEM? Are there political groups who might be interested in the neglect of patients of color? <br />
And WHERE ARE THE 80-85%? I was an invalid. Someone would have had to take care of me, and someone did. What happens to a single mother of two when she gets a serous case of this disease and remains untreated? <br />
What has happened to patients I knew well online in the 1990s who have just disappeared?<br />
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The larger question, of course - the elephant in the room - has yet to be addressed by anyone in the government:<br />
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WHERE IS THE SENSE OF URGENCY? What is it going to take to hear that word spoken by someone in a position to actually change things?Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com10tag:blogger.com,1999:blog-1345573145957924958.post-38736105940488224262013-03-23T12:30:00.000-07:002016-05-04T17:44:12.246-07:00Ampligen and biomarkers: my testimony to FDA Dec 2012To: The Advisory Committee Reviewing Ampligen<br />
FDA, Washington, DC<br />
From: Mary M. Schweitzer, Ph.D.<br />
Date: December 5, 2012<br />
Subject: My experiences with ME/CFS and 14 years on Ampligen
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My name is Mary M. Schweitzer. I was a 44-year-old tenured professor of history at Villanova University when I suffered a blackout in my office on October 24, 1994. When I came to, at first I could not move at all. Once I could move, I was unable to understand a word in the papers on my lap that I had been grading. From that point on I was very sick, and my condition would continue to worsen for the next four years. I had no difficulty getting approved for private long-term disability and Social Security Disability Insurance because no one doubted how sick I was. I suffered from blackouts, ataxia, absence seizures, expressive dysphasia, disorientation, short-term memory loss, dyslexia, tinnitus, sensitivity to light and sound, and massive confusion to the extent that once I poured an entire pot of coffee into a silverware drawer, convinced it was a cup. I could not even pass a simple Romberg Test (I fell over as soon as I closed my eyes). I had intense pain behind my eyes and in the back of my neck 24/7, suffered intense headaches, and had constant muscle pain. Some times the pain was so bad all I could do was lie in a darkened room listening to a favorite movie.
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My world grew smaller and smaller. I could not drive a car, but I could go places. In the summer of 1996 I started falling when we tried to walk to Camden Yards in Baltimore from the parking lot, and we had to start using a wheelchair whenever I left the house. I had a perfect score on my grad records in 1975, but now I could not understand a comic strip if I tried to read it in print. I found I could write on internet, although I had trouble reading much. In 1997 we added a riser to the toilet and a shower chair. I wrote several short essays and posted them; they all have a copyright date of 1997 because by 1998 even that was too difficult. Finally, in the fall of 1998 I was completely confined to bed, able only to make it on my own to the bathroom and back by holding on to furniture and walls and my golden retriever. By the end of 1998, I could not even brush my own teeth.
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I had a good physician in Washington, DC (Marsha Wallace, who has since retired). I was diagnosed with NMH/POTS in 1995 and began taking florinef, and I developed Hashimoto’s thyroiditis in 1996 and began thyroid supplements. She introduced me to Dr. Dharam Ablashi, the co-discoverer of HHV-6 and its two variants. He found me positive for HHV-6, Variant A, in the fall of 1998; he told us that my lymphocytes were riddled with the virus. [Variant A was the strain of HHV-6 he had found in AIDS patients.] He also sent a PBMC pellet from my blood to Redlabs in Belgium, where they found me positive for the 37kDA Rnase-L defect. We now had two serious biomarkers.
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I knew that Dr. Dan Peterson of Incline Village, NV, had found that patients with the 37kDa Rnase-L defect were more likely to respond to the experimental drug Ampligen, and I also knew that Drs. Ablashi and Paul Levine had run experiments with Ampligen and HHV-6A in vitro and found that Ampligen kept the virus from replicating. With those two biomarkers, I thought I stood a good chance of benefitting from the drug, so my family agreed to try it for one year. It would be a great strain to our finances but it would be worth it if it could stop the downward spiral I was in.
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I began Ampligen with the late Dr. Joseph Bellesorte in Chadds Ford, PA, on February 4, 1999. In two months I could walk without a cane. In five months I could drive again. But I think the most remarkable moment was when I realized that for the first time in four and a half years, I didn’t <i>FEEL SICK</i>. We retested me for HHV-6A and the 37kDa Rnase-L defect at six months, and both biomarkers were gone. Six months into treatment I read an entire book. In September I was able to dance with my son at his wedding, and I walked barefoot on a beach for the first time in five years. I continued to improve on Ampligen.
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After 20 months on Ampligen, we thought I had been cured and we ended treatment while I began negotiations to start teaching again. That was not to be, however. One year after I stopped taking Ampligen, on October 6, 2001, I had a blackout at Cal Ripken’s last baseball game and had to be taken out in a wheelchair. Dr. Ablashi tested me and HHV-6A was back.
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It took seven months to get back on Ampligen, but since I had experienced no adverse side effects, my family and I agreed that I should stay on it indefinitely. Now I received it at the I. Brodsky hematology-oncology practice at Hahnemann Hospital in Philadelphia. The cost had come down in half because the drug no longer needed to be prepared by a pharmacist before each use, and with co-pays, the entire cost (roughly $22,000/year) was covered by my after-tax disability pay. We lived on my husband’s salary as a chaired professor of finance at the University of Delaware.
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I remained on Ampligen this time for over five years. My health improved more slowly, but eventually substantially. I was able to publish 2 history essays and I wrote a 650-page draft for a book manuscript on this disease; my husband and I crossed the country five times by car because our daughter was now at USC; in the summer of 2007 I could even take short hikes with my brother in California.
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However, in January 2008, Dr. Brodsky died, and although he was not my doctor at the practice, permission to continue receiving Ampligen there was denied. They reapplied twice and were denied twice. Now there was no place on the East Coast where I could get Ampligen. You have to have it twice a week by IV – you cannot travel far to get it. We guessed that a two-hour radius from our home in Delaware was reasonable – and covered most of the mid-Atlantic, one of the most populous areas in the nation. There was no Ampligen available.
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I thought I would have a year or longer, but I only had seven months before the crash came in September, 2008. Thanks to Southwest Airlines, I was already seeing Dr. Peterson in Nevada once a year for my specialist, and I was scheduled to see him September 23. By the time I got there, I was running a fever and had active cases of Epstein-Barr (EBV) and cytomegalovirus (CMV). My natural killer cell function was 3%. I had an abnormal SPECT scan, Halter Monitor Test, and cytokine pattern, and my VO2 MAX score was so low that it fit social security’s definition for permanent disability.
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We tried Vistide, which Dr. Peterson had experienced success with in patients who had both HHV-6 and CMV, but after three doses my liver rejected it. He halved the dose, then halved it again, and both times my liver markers immediately spiked. I could not take Vistide. [During the period I was on Vistide, we asked a local (Delaware) infectious disease practice to give me the infusions every other week. They agreed, but when I came for my infusion, stopped me. “You have CFS, dear,” the doctor said. Uh, yes, but I have a recognized disease, CMV, and Vistide is an approved treatment for CMV (Cytomegalovirus, or HHV-5). “Vistide is too strong a drug for you because all you have is CFS. If you had AIDS or cancer, we could see giving it to you. But you aren’t sick enough to warrant taking such a strong drug.” I had to fly overnight to Reno to get that dose!]
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My condition continued to deteriorate. In July 2009 Dr. Peterson had me get a spinal tap in Reno; my daughter came up from L.A. to take care of me, because by this point I was no longer capable of taking care of myself. The spinal tap showed that in my spinal fluid, I had active HHV-6 and CMV as well as the 37kDa Rnase-L defect. After consulting with my husband, Dr. Peterson concluded that I had to get back on Ampligen, which would mean moving to Nevada. However, my ataxia was so great that I fell in a motel room and suffered a slipped disk; we had to have that fixed before he would start the Ampligen, so there were more delays and I got still worse.
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I moved out to Incline Village in March, 2010, and began Ampligen treatment again. My daughter and her boyfriend stayed with me the first two months to help take care of me. After they left, I leaned on the kind services of other clinic patients and their families, two generous taxi drivers who would get me fresh groceries, and my brother, who would drive from Santa Rosa once a month and make sure I had enough paper products, water, detergent, etc., for the next month. It helped that the apartment was only one floor.
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Once again I no longer needed my cane after two months. I began to recover, but it was slower than before. However, by the summer I was walking along the lake (starting at 6 minutes a day, then adding 2 minutes a day each week), and in August my husband shipped my car out to me because I was well enough to drive again. I began working on the book manuscript again. I was doing well, but<br />
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I missed my husband of 35 years – 3,000 miles east. I wanted to go home, but I knew I could not go off Ampligen. Then, in the spring of 2011, I learned that Dr. Derek Enlander would be starting Ampligen treatment in New York City. I drove home from Nevada at the end of April, 2011.
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It took longer to get back on Ampligen than we had thought, but I restarted it October 3, 2011, in New York City and have remained on it since. I have to commute the 100 miles north to New York twice a week, but I use local Philadelphia area and Amtrak trains, and there is a NY Metro bus that goes from Penn Station in Manhattan right to Dr. Enlander’s office, so although it is a long commute (3 hours one way), it’s not uncomfortable. And it has given me back a life.
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As long as I can remain on Ampligen, I can take care of myself (although I have very little stamina). Our daughter has moved back in with us, because my husband has an aggressive form of bladder cancer and now he needs to be cared for. Without Ampligen, my family would have to take care of me as well – instead, I can be of help.
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I have a great fear of losing Ampligen. It is difficult for a person who had been so successful in her life to be so dependent on a single drug, a single company, and a single decision by a government agency, but there I am.
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Please do not take the drug away from me again.
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Thank you.
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Mary M. Schweitzer, Ph.D.<br />
Newark, DE <br />
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Coda: My husband died of bladder cancer at the age of 63 in July 2013. In December, 2014, I moved back to Lake Tahoe at Incline Village, where I now live and continue to get Ampligen at Dr. Peterson's. It is a good place to heal both body and soul.<br />
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<br />Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com6tag:blogger.com,1999:blog-1345573145957924958.post-73685147740573364742013-02-02T13:06:00.000-08:002013-02-02T16:37:42.538-08:00The US Government and ME/CFSToday's blog started as a comment to an excellent essay in two parts by Jennifer Spotilla on her blogsite, "Occupy CFS"
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<a href="http://www.occupycfs.com/2013/01/28/highest-priority-part-one/">Highest Priority, Part I</a><br>
<a href="http://www.occupycfs.com/2013/01/30/highest-priority-part-two/">Highest Priority, Part II</a>
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CFSCC, or the Chronic Fatigue Syndrome Coordinating Committee, existed through from 1996-2001; CFSAC, the Chronic Fatigue Syndrome Advisory Committee, replaced CFSCC in 2003. The purpose of each was slightly different - one was supposed to coordinate activities; the other only to advise the Secretary of the Department of Health and Human Services, or HHS, on how to approach the disease. Since all CFSAC can do is advise, the committee sends recommendations to the Secretary of HHS. There has been little response. Consequently, and without involvement from the public, the committee has issued a new list of the recommendations they want to receive the highest priority. Jennifer's blog essay, "Highest Priority," discusses both the new list and the process by which it came about.
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The committee is the only interaction Washington has with patients with Myalgic Encephalomyelitis (M.E.), or those diagnosed with the insipidly named Chronic Fatigue Syndrome (CFS). Because I live 90 minutes north of Washington by Amtrak, I have attended all but a couple of meetings of both CFSCC and CFSAC. It can be an exercise in frustration.
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The biggest difference between the two isn't really that one coordinated and the other advises - the first never did much anyway. Rather, I find it very problematic that when it was CFSCC, back in the 1990s, there was a microphone at the head of the aisle and we were permitted to line up and ask questions – we, the public, the patients, parents, doctors. We could point out an obvious contradiction in a report by one of the ex officio members (representatives from the health agencies – CDC, NIH, FDA, HRSA …) and ask about information that was missing from their report, or simply wrong. Without that privilege – which is a standard right in all other public meetings, just not for us – the reports from the agencies since 2003 have been sawdust, bland comments with little meaning and sometimes blushingly misleading.
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For example, the essential problem with NIH is that they allocate less than $6 per year per patient to this disease (compared to $500 per patient per year for MS). So a meeting never passes without NIH blaming the absence of funding for our disease on the researchers – saying they don’t fill out funding requests effectively, but assuring us that they’ll hold seminars to fix that. The statement is not only insulting, it’s not really true, because most “CFS” researchers have had no trouble getting funding for something other than CFS. They suddenly become all thumbs when it comes to our disease? Sounds like the fault lies within NIH, not the researchers.
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But there's no one to say that.
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Without the ability to ask questions, we can’t verbalized a misstatement when we catch one, or ask a meaningful question and get it answered. I would really like to know why it is okay for CDC’s website to omit information about the large body of research into CFS regarding biomarkers (such as cytokine patterns); immune defects (particularly natural killer cell abnormalities and the 37kDa Rnase-L); viruses (particularly EBV, CMV, HHV-6A, and Coxsackie); cardiac abnormalities; hypothyroidism and hypocortisolism; the VO2 MAX stress test. The list goes on, but the bottom line is this: the first statement on CDC's website, that little is known about this disease, is simply not true. After 25 years of research NOT involving CBT or GET, you’d think some of it should find its way unto that website.
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Or the website should not exist.
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They tell us our moment for commenting is during the five minutes they give us to testify – which may occur before the ex officio testimony, in which case you cannot comment at all. But commenting is not the same as being able to communicate publicly with the ex officio members. I have testified innumerable times about CDC, and once we shifted to the CFSAC format, my comments were simply ignored by Dr. Reeves and Dr. Unger. Pat Fero has gone to a great deal of trouble to research the paltry funds given out by NIH and testifies to that – then the NIH representative will stand up and say the same thing as always, with no reference to Pat’s findings.
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It has become a comedy of the absurd – we exist in parallel universes, with a glass wall between the committee and the public. I used to pass notes to friendly members of the committee who would then ask my question for me, but now they are actually FORBIDDEN to do that!
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Saddest of all would be the seriously ill patient, earnestly testifying to the ravages of the disease, speaking slowly and haltingly because of neurological dysfunction, being cut off at precisely 5 minutes - so the committee can spend 25 minutes chatting about whether to go to lunch yet.
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And yet, CFSAC did pretty well, because public members of the committee such as Lenny Jason and David Bell worked hard to get serious recommendations up to the Secretary of HHS. It was frustrating that the only response we ever got from the Secretary, back in the last administration, was to have each ex officio member recite uncritically how their agency was responding to the public’s wishes – the same silly parade as before.
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Attending these meetings is not unlike the scene in “Animal House” where the undesirable at an open fraternity rush party keeps getting sent back to the same spot with the rest of the “undesirables”.
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Now we’ve lost the one thing we had in our favor at CFSAC – committee membership who actually wanted to change things. For that reason, it is disconcerting that they have gone back to re-prioritize the previous recommendations. The first recommendations in 2004 were just fine. Start there and demand answers, then move on to the next ones.
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My mother – then in her mid-70s and in much better health than I have been – took me in my wheelchair to the first CFSCC meeting. I remember my mother listening for a few minutes to Bill Reeves say that the one thing we DID know about CFS was that it was not caused by a viral infection. Mom looked down at the Table of Contents for the meeting. “Who is this guy?” she asked. “It says here someone is supposed to speak from the CDC’s department of viruses and exanthums [diseases with pussy sores].” That’s right, I answered. That’s who’s talking.
“But he is saying that this disease is basically psychological.” Yep. “Then why is he still in charge of it?”
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Mom had not listened to an ex officio report for five minutes before immediately gerting to the crux of the matter, the problem that haunts us everywhere in the US federal government. Here are a bunch of guys taking about psychiatric causation and feel-good solutions – and every one of them is an expert in something OTHER THAN PSYCHIATRY. (At NIH we were housed for years within NIAID, the National Institute for Allergies and Infectious Diseases, where virologist Steve Straus prided himself on being able to prove CFS was not related to viruses.)
What passes for “science” at HHS with regard to our disease is what I can only call psychobabble. It’s not even serious psychiatry. [I don't think a good psychiatrist would entertain the faux psychiatric theories put forward about our disease for an instant.] And when it comes to psychiatry, these heads of agencies are as unqualified as I would be – it is not and has never been their specialty. They are rank amateurs.
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We are hidden in plain sight. At least for a while, we had a committee willing to fight that injustice. But the best way would be to once again allow the public REAL access to the agencies.
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We need the right to ask questions ourselves of the agency representatives in public. We need the right to be able to point out discrepancies. We need the right to get ANSWERS.
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And the questioning can start with why the government ignores all the existing evidence into pathogens, biomarkers, and objectively defined abnormalities, substituting instead popular psychiatry.Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com2tag:blogger.com,1999:blog-1345573145957924958.post-76386011891434394952012-06-13T13:27:00.003-07:002012-06-13T13:53:19.548-07:00CFSAC testimony: CDC must end use of toolkit and the Reeves "empirical" definitionTestimony to the Chronic Fatigue Syndrome Advisory Committee of the<br>
U.S. Dept. of Health and Human Services<br>
Wednesday-Thursday June 13-14, 2012<br>
Mary M. Schweitzer, Ph.D.
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Thank you for allowing me time to speak.
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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.
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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 <i>wrong</i> and <i>dangerous</i> to patients.
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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 – <i>now</i>. Why on earth are they still around?
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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.
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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.
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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.
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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.
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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.
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And please, end your relationship with British psychiatrists who work for insurance companies.
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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.
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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)."
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Really? Does CDC believe that? CFS is a somatoform disorder? It may be classified as neurasthenia?
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While CDC helpfully links us to Dr. White’s website, there are no links to American researchers or clinicians. None, zero, zippo, zilch. Why?
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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.
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We <i>need</i> 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?
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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.
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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.
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It <i>matters</i> 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.
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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?
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Why isn’t there an MEAC - Myalgic Encephalomyelitis Advisory Committee?
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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.
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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?
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<u>Postscript on definitios:</u>
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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.
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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.
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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.
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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 <u>post-exertional exacerbation of symptoms</u> – which can be measured objectively – the center of the disorder – <i><u>not chronic fatigue.</u></i>
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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.
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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.
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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.
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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.
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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.Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com11tag:blogger.com,1999:blog-1345573145957924958.post-89689296274889506002012-05-05T16:42:00.000-07:002012-05-05T16:59:03.673-07:00My letter to APA on Somatic Symptom DisorderSubmission to the Work Group for Somatic Symptom Disorders<br />
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The new category of Somatic Symptom Disorder, or SSD, bears a remarkable resemblance to the CDC's Holmes (1988) and Fukuda (1994) definitions of the disease Chronic Fatigue Syndrome (CFS). The requirement that patients experience six months of debilitating fatigue is taken straight from CDC's definitions. This development is disturbing for three reasons:<br />
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1. For two decades, British psychiatrists Michael Sharpe, Peter White, and Simon Wessely - all proponents of the ideology-driven "biopsychosocial" school of medicine - have ignored the CDC's definition for one of their own (Oxford), which omits the physical symptoms required of the CDC diagnoses, and includes concurrent major mood disorders (exclusionary in Holmes and Fukuda). They have long insisted that "CFS" is really a modern version of "neurasthenia", which was removed from DSM a generation ago but is still diagnosed in the UK.<br />
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2. Earlier efforts to portray CFS as a somaticizing illness were foiled by requirements in the definition of somaticizing, such as the length of the illness (decades) and the absence of any gain. It strikes one as somewhat disingenuous to deliberately replace that category with another that can then be used to portray as psychological, a disease described as biomedical by the Chronic Fatigue Syndrome Advisory Committee of DHHS.<br />
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3. The APA has stated elsewhere that many of the changes in DSM-5 are intended to avoid gender biases in existing medical categories. Isn't it strange that the proponents of the new category SSD have often stated 90 percent of victims of CFS (and SSD by extension) are female? Or that the proponents of renaming the disease "neurasthenia" are also proponents of "SSD"?<br />
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At the end of the 1980s, when CDC adopted the name "chronic fatigue syndrome" for a series of outbreaks of a mysterious, debilitating illness, Simon Wessely resurrected the diagnosis of "neurasthenia" [aka "the vapors"] for CFS patients in England. Although it is a direct violation of ICD-10, British psychiatric manuals classify CFS under neurasthenia, but could not do so in the U.S. because the diagnosis "neurasthenia" was removed from DSM a generation ago for gender bias.<br />
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In choosing the term neurasthenia, Wessely referenced not Freud but a New York physician named Beard who coined the term "neurasthenia" in 1869. Beard's book, "American Nervousness", is well-known among women's studies professors for advancing the theory that girls who were allowed to study science and math in high school would end up with either a shriveled uterus (his version of "hysteria"), or struggle with a life-long "nervous condition" (neurasthenia). Beard openly wondered whether allowing girls to attend high school would result in the death of the "American race": The "Celtic race" (Irish immigrants) did not permit their daughters a secondary education, and they enjoyed large families as opposed to the smaller numbers of children born to the middle class of the "American race".<br />
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I have to say I never thought I would see that book cited as a reputable source by a contemporary scholar, but both Wessely and the late Stephen Straus of NIH used it frequently.<br />
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Adoption of SSD will allow this bizarre nineteenth century view of the way women's bodies work to return to DSM, albeit under a more modern name.<br />
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In England, the insistence that CFS is really neurasthenia has led to cruel results, with women thrown into mental hospitals against their will. CBT (to cure the patient of her "inappropriate illness beliefs") and GET (to get her back into shape after she has allowed herself to become deconditioned) are the only treatments recommended by British public health.<br />
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The result is that patients with the most severe cases of this disease are forced into hiding, bereft of all medical care whatsoever.<br />
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Adults in the U.S. have, in general, not been subjected to that level of cruelty - although the vast majority of doctors in the U.S. are ignorant of the large body of literature on the biomedical symptoms and causes of CFS and when they don’t actually harm their patients, they can’t help them. Too often they assume the problem is stress; too often they write a prescription for Prozac and send the patient away.<br />
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However, more vulnerable victims of CFS - teenagers - have been subject to removal from their homes and sent to foster care for the sin of having a poorly understood illness. Laypersons in school boards or child protective services have felt competent to diagnose Munchausen’s Syndrome By Proxy (or its more recent incarnation, Factitious Illness by Proxy) after hearing a lecture or reading an article on the subject. The more the parents fight the diagnosis, the more its proponents can claim it is true.<br />
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The phenomenon is reminiscent of the belief that autism is caused by "cold mother syndrome", or multiple sclerosis really "hysterical paralysis".<br />
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It is particularly ironic to see such a push towards psychologizing a physical disorder at the very moment evidence points to new, serious causes.<br />
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Several private research initiatives in the U.S. are using systems analysis to pull together evidence about immune defects and active viruses (both opportunistic and reactivated) found in the patient population.<br />
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At this point I must admit that I have a personal interest in this issue. I have been fortunate. My university connections have allowed me to participate in cutting edge studies. Let me share with you what scientists have learned about CFS, using myself as the case study.<br />
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I have the 37kDa Rnase-L defect, my natural killer cell function is 2%, and I have an abnormal cytokine pattern.<br />
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Perhaps that is why I suffer from recurring bouts of EBV, and have chronically activated cytomegalovirus (CMV), HHV-6 (Variant A), HHV-7, and three strains of Coxsackie B. HHV-6A and CMV (both known to cause encephalitis) were found to be active in my spinal fluid in a spinal tap in 2009, along with the presence there of the 37kDa Rnase-L. That doesn't sound very psychogenic to me.<br />
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I have been sick since suffering a blackout in my office in 1994. When in relapse, I have ataxia, expressive aphasia, expressive dysphasia, short-term memory loss, disorientation, and profound confusion (I once poured a cup of coffee into a silverware drawer convinced it was a cup). I suffer from constant severe pain behind my eyes, in the back of my neck, and in the large muscles of my thighs and upper arms. Even one flight of stairs is very difficult for me right now. At my worst, I could not walk ten paces, nor could I even brush my own teeth. I used to be an avid skier, but the disease put me in a wheelchair. I have a Ph.D. in history from Johns Hopkins, but I could not read. <br />
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I have abnormal SPECT scans and my VO2 MAX score (or CPET) is so low, I would be granted long term disability by that measure alone. I could not even pass a simple Romberg test.<br />
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I have been helped greatly by a Phase III immune modulator, only to relapse when permission from FDA to have the drug was removed. I am back on it now, and I am improving again, despite the 100-mile commute by rail from my home in Delaware to New York City. That is why some of the symptoms mentioned above are in the past tense. Without the immune drug, within months I relapse back into a severe state of invalidism.<br />
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If you believe that significantly abnormal immune biomarkers, Coxsackie B, and herpes viruses known to cause encephalitis, meningitis, myocarditis, and other serious diseases when active over a long period of time - if you believe all of this can be resolved using talking therapy and SSRIs, then proceed with your new category.<br />
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Neither could help me in the past - only pharmacological intervention directed at the viruses and immune defects has improved my condition. <br />
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How many biomarkers and viruses must a patient have to be taken seriously? If one is in constant pain, does it not make sense to worry about pain? If one suffers from a significantly debilitating illness, does it not make sense to be concerned about the state of your health?<br />
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This new category would place those sensible concerns in the realm of abnormal anxiety dysfunction. Patients would be denied access to the tests - and treatments - I have been fortunate to be able to have.<br />
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I can’t see how that would benefit patients – but it certainly would help out insurance companies.<br />
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According to the CDC, at most, 15% of the 1 million adult patients with CFS in the U.S. even have a diagnosis. Of those 150,000, only a handful have had access to the care, testing, and treatment I have.<br />
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It is a Dickensian world, where the victims of this disease are relegated to extreme poverty, no matter what their profession prior to the illness.<br />
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Who, then, would benefit from creating a psychological category for this very biophysical disease? Does psychiatry want to be the handmaiden for the insurance industry? Does psychiatry want to become the default option for "I just don't know"? <br />
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These are the questions that the profession needs to answer before proceeding with plans for SSD.<br />
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[Note to readers: To read about the proposed psychiatric category of SSD for DSM-5, go to the following website: <a href="http://www.dsm5.org/proposedrevision/pages/proposedrevision.aspx?rid=368">Somatic Symptom Disorder (SSD)</a>. Instructions for comments are on the bottom of the page. We have only until June 15, 2012, to leave a comment.]<br />
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Mary M. Schweitzer, Ph.D.Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com2296 E Main St, University of Delaware, Newark, DE 19711, USA39.6837226 -75.7496572-25.917448900000004 122.5315928 90 85.9690928tag:blogger.com,1999:blog-1345573145957924958.post-58733342199565076432011-12-21T17:19:00.000-08:002011-12-21T17:21:49.986-08:00Why won't CDC study MY disease?Testimony to the<br />Chronic Fatigue Syndrome Advisory Committee<br />U.S. Department of Health and Human Services<br />Washington, DC<br />November 8-9, 2011<br /><br />Mary M. Schweitzer, Ph.D.<br /><br />My testimony today will be about the CDC’s program on CFS.<br /><br />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.<br /><br />Topic I – That paragraph on CDC’s website listing everything I should not be tested for because I have a diagnosis of CFS.<br /><br />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.<br /><br />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? <br /><br />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:<br /><br /> 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? <br /><br /> 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.<br /><br /> 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?<br /><br /> 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? <br /><br />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? <br /><br />Can you assure me that if these viruses are left untreated I will not develop cancer from them? <br /><br />[n.b. The specific paragraph was removed, but CDC continues to insist these tests are meaningless.]<br /><br /><br />Topic II – The CFS Toolkit for Professionals<br /><br />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. <br /><br />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.<br /><br />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.<br /><br />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.<br /><br />So I must ask: <br /><br />What is the scholarly and scientific basis for emphasizing CBT/GET in the material that CDC sends out to the public on this disease? <br /><br />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. <br /><br />If that is true, why then does the CDC’s website refer to St. Bartholemew’s Hospital in London to explain what GET is? <br /><br />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. <br /><br />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?<br /><br />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.<br /><br />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.<br /><br />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.<br /><br />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.<br /><br />Well, perhaps that was the best they could do – perhaps it was all that is out there. <br /><br />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. <br /><br />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. <br /><br />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.)<br /><br />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.<br /><br />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). <br /><br />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.<br /><br />And that is what is meant by post-exertional malaise (or fatigue or relapse). <br /><br />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?<br /><br />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.<br /><br />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. <br /><br />I hate to say this, but … follow the money.<br /><br />These “toolkits” are not just inappropriate – they are dangerous. <br /><br />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? <br /><br />So in addition to the questions I asked at the beginning of this paper, I would like answers for the following:<br /><br />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)?<br /><br />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?<br /><br />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. <br /><br />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? <br /><br />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?<br /><br />And that is my final question – is anybody listening?Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com8tag:blogger.com,1999:blog-1345573145957924958.post-2094254984055437862011-08-10T12:20:00.000-07:002016-08-21T00:40:43.677-07:00Dear Dr. WesselyAn open letter to Dr. Simon Wessely,
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My my, such a to-do this week. Over precisely what? If you have received actual death threats, for heaven's sake take them to the police, now. Or are you just exagerrating your lack of popularity in the patient community?
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If you really have received threats (and if so, that's what the law is for), then here is my response to you:
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1. There are an estimated 250,000 patients in the UK suffering from M.E. Statistically speaking, it's probable that some within that large community might be personally unbalanced. It's irresponsible to use those few as an excuse to mistreat the rest. How have you mistreated them? In this particular case, by trying to scare off researchers and clinicians who might seek to help these people, many of whom are invalids. You also blow a smoke screen so the press doesn't notice there's professional and sober criticism of your pet theories and research. <br />
This is irresponsible for a medical professional, and irresponsible for all those media outlets to give you so much space with which to condemn 250,000 sick people. Shame on you, and shame on them.
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2. The researchers who I know who have left the field did so because of threats from their bosses and ridicule from colleagues, not patients, plus a lack of funding for biomedical research. Your outcries might perform the same function. Now why would you want that?
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3. Things got pretty hot in the breast cancr community when they were debating full mastectomy v. simple lump removal, but nobody suggested stopping research into breast cancer.
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4. If email had been available in the mid-1980s, does anyone believe the desperately sick and ignored AIDS community would never have sent insulting emails? To someone who insisted they were somaticizing?
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5. How convenient that the press plasters Simon's paranoia all over the place, but the stories printed about ME/CFS in the NY Times and Wall Street Journal in the past year never got a peep in the British press - now why is that? Do you believe Americans are more polite? Not likely, is it? Do you think it might have something to do with the SMC, which you helped found? Has the British press really sunk this low?
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There were lots of stories involving M.E. and CFS that could have been covered by the British press this past week. A committee has come up with a new definition of M.E., based on biomarkers and biological evidence, soon to be published in the Journal of Internal Medicine. That's certainly worthy of coverage. New biomarkers have come out of the New Jersey School of Medicine and Dentistry. But the British press doesn't cover the evidence that M.E. and CFS (Fukuda 1994) or ME/CFS (Canada 2003) are not caused by somaticizing (the physical expression of emotion).
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In 1999, Harvard University medical professor Anthony Komaroff declared in the Journal of American Medicine that with thousands of refereed journal articles into biomedical symptoms, correlations, tests, and possible causes of CFS (Fukuda 1994), it's time to put an end to the psychiatric explanation of the disorder. He has not changed his position (except to note there are now thousands more). How long will it take for that information to reach British shores? Twelve years of silence is a very long time.
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When will responsible scientists, journalists, and representatives of the government finally put an end to the monopoly of information in the UK by psychiatrists, with regards to both CFS and M.E.? WHO has coded M.E. under neurology, not psychiatry, since 1969. Why is all the information on this disease printed in the UK tilted towards psychiatry? It certainly hasn't helped the patients, who remain sick (with an estimated 65,000 housebound or bedridden). People have died from this disease, and at some point in its course it is apparently contagious - why keep shoving it under the rug?
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Gosh, do you think it has anything to do with the monetary inconvenience it would pose for insurance companies and penurious governments if this disease were taken seriously - if the biomedical research was portrayed honestly?
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I fear George Orwell's dystopia has arrived - 27 years late.Mary Schweitzerhttp://www.blogger.com/profile/11583106682242141031noreply@blogger.com8