of the 20yr+ gang and we call ourselves "Survivors"
so far..
but time is feeling shorter and shorter to all of us...
We PRAY that the CFSAC , Scientific Research and the HHS/NIH will HURRY and make up for the 40 years of Neglect and Deceit by the CDC, and that our last chance for a Miracle "WILL" come at Last ...
After the CFSAC meetings are Completed, PLEASE be Ready to Join us
for our New Patient Advocacy Campaign, OK? ....more NEWS to come.
And now H-E-R-E' s TOM+ ♥ Plus Version .....
Good Afternoon Chairman Snell, Dr. Wanda Jones, members of the CFSAC, Ladies and Germs,
Thank you all for your efforts to make this meeting available on the Internet, so that the millions of sick people with these conditions around the world can have some access to see our government in action, or in this case, the LACK of action regarding these brutal illnesses over the past 3 decades.
When I asked many of our fellow M.E. and CFS patients if they wanted me to make any specific comments to you at today’s meeting, the biggest response I got was “Why Bother?” They said, “We have been telling the truth to this committee and its forerunners for more than 20 years, and NOTHING has changed. So, Why Bother?” This was not the response of a few, but the vast majority of long term sick patients that I spoke with or exchanged emails with in the past two months. The vast majority of sick patients have NO confidence that the HHS Director will ever even READ, let alone implement the recommendations of the CFSAC panel or the patients, who further damaged their health by working for weeks to make a clear, concise and cogent speech to this committee.
For many of us, who are themselves SO sick and SO nauseous and in
SO much pain, that simply listening to TV or radio is a painful and disorienting experience. To take the time and energy to condense decades of misery into a 5 minute speech is a Herculean task. To go through all this additional misery and pain, and not even have the HHS Secretary even read or acknowledge their suffering is a very painful and humiliating experience. To go through it for decades while lying in agony in their beds is pure torture. The sheer amount of physical misery we go through on a daily basis is incomprehensible to anyone who hasn’t gone through it, let alone the mental misery we all experience every single day. If I could wave a magic wand and give our symptoms to every politician and businessman on this planet for ONE week, there would be Tens of billions of dollars approved for research, by the close of business the very next week. The sheer misery and torture of a severe case of what I refer to as Myalgic Encephalomyelitis is, and I repeat, incomprehensible to those who have not experienced it.
SO much pain, that simply listening to TV or radio is a painful and disorienting experience. To take the time and energy to condense decades of misery into a 5 minute speech is a Herculean task. To go through all this additional misery and pain, and not even have the HHS Secretary even read or acknowledge their suffering is a very painful and humiliating experience. To go through it for decades while lying in agony in their beds is pure torture. The sheer amount of physical misery we go through on a daily basis is incomprehensible to anyone who hasn’t gone through it, let alone the mental misery we all experience every single day. If I could wave a magic wand and give our symptoms to every politician and businessman on this planet for ONE week, there would be Tens of billions of dollars approved for research, by the close of business the very next week. The sheer misery and torture of a severe case of what I refer to as Myalgic Encephalomyelitis is, and I repeat, incomprehensible to those who have not experienced it.
Sad to say, the vast majority of people I heard from do NOT think that anything positive will happen from this meeting, based upon the 30 year or more track record of the NIH, the CDC, the HHS, the AMA, or any other agency charged with the task of trying to help some of the sickest people on the planet get some relief from their daily misery. I am asking you today, to prove them wrong!
I know what they are talking about, because for the past 26 years, I have been one of them.
On April 15, 1989, at the VERY first International CFS meeting, I was asked to describe in layman’s terms what it felt like to have this condition, and I said that "It feels like I have been beaten with pieces of rubber hose from head to toe, 24/7 for the past 2 years! if you 600 doctors in attendance today, do NOTHING else, then put together a correct definition and ‘change the God damn name’ then you will have accomplished a tremendous achievement. If you DO NOT get rid of the dreaded “F” word right now, here today, before this horrendous so called “Holmes Criteria” gets a foothold worldwide, then you will condemn untold millions of sick people all over the planet to decades of misery, pain, and premature death because of your Incompetence and cowardice!”
There was spontaneous and sustained applause. I was shocked. There were catcalls and whistles. The members of the Press smelled a story and they crowded around Ms. Melinda Paras and myself at the Q and A session to ask what the real symptoms were and how serious this condition really was. I said that I didn’t know what caused this disease, but that it had NOTHING in common with any kind of fatigue I have EVER experienced. I said there are more than 6.2 Billion “chronically fatigued” people on this planet today. And only a small fraction will experience the sheer misery of not even being able to walk ten feet from their bed to the toilet. Or to be in SO much pain, that it will take 6 Fentanyl patches, (which are 70 times stronger than Morphine) to be able to crawl out of bed and cook dinner for your father who is dying from Alzheimers and then cooking a separate meal for your mother who suffers from severe osteoporosis, a 35 year hiatal hernia, and cataracts.
For our government, to embrace the Long Term Insurance business tag line of “Delay, Deny and Hope you DIE!” is just criminal. The stunning incompetence of our medical establishment, and the truly heartless response for at least 3 decades that I know of is no longer just incompetence on a grand scale. I believe it is one of the major medical crimes of the past 40 years! It really is that bad.
Now, Today’s topic is disability. How sick and disabled are we? And how can that be evaluated and documented for Insurance purposes. And what if anything can help these patients return to work as productive members of our society. If the 22,000 or more letters, resumes, phone calls and emails that I have received over the past 25 years is any guide, this patient population is exactly the type of person that wants to return to work! I believe that the compassionate, ethical workaholic is more prone than other populations to come down with these terrible afflictions. We are actually the exact OPPOSITE of malingerers. As one psychiatrist said, “these are the very type of people that others call on a Friday night to come in to work, when others want to go out to a party”. (I believe that this was Peter White in the UK who made that statement. But, I have found it to be true).
However, there is SOME light at the end of this tunnel. I take the following quote from the opening page of the University of the Pacific’s description of their raison D’etre:
However, there is SOME light at the end of this tunnel. I take the following quote from the opening page of the University of the Pacific’s description of their raison D’etre:
“Despite growing scientific evidence, there has been a strong belief by many physicians, insurers and others that these disorders are psychological. The Pacific Fatigue Lab has developed unique testing protocols that help more accurately assess the physiological status of patients who may be afflicted with fatigue-related disorders. Our goal is to facilitate an understanding of the biological basis for fatigue and provide objectively determined functional evaluations and therapeutic interventions that will improve quality of life for this population”.
Dr. Stacy Stevens has done 1,000’s of single cardiopulmonary exercise tests on chronic fatigue syndrome (ME/CFS) over the years and close to a hundred with the Stevens’ Protocol at the Pacific Fatigue Lab. Whether in Stockton, Ca, Stanford U, Incline Village or Ithaca, New York they see the same general pattern again and again, a unique metabolic dysfunction that characterizes and objectifies the most mystifying symptom in the disease, post exertional malaise. If Anyone looks at the most comprehensive definition of these terrible disorders, the Canadian Case Definition for ME/CFS by Carruthers et al, you will see that the degree of debility varies greatly, but that if you use Koch’s postulates that to define an illness or disorder 100% of patients must be afflicted by agent X, We all suffer from P.E.M. or Post exertional Malaise. This Steven’s test costs roughly $2,000, but it does not need cutting edge materials or knowledge. You just need to apply the “Steven’s Protocol” and you can verify that we suffer devastating, but reproducible and quantifiable dysfunction in our autonomic nervous system if we attempt a brief but rigorous exercise protocol for 2 or 3 days in a row. Even dying Cancer or AIDS patients can return to a baseline level 24 hours after exertion. We can not! 21 years ago, I asked the panel of some 627 doctors and researchers assembled in San Francisco at the Hilton Hotel to find “something, anything, that is quantifiable and reproducible by people who do NOT trust us, and who do not believe we are ill, or who think that we are malingerers”. Since 1995, I felt that the tilt table test done by Drs. Rowe and Calkins at Johns Hopkins in Baltimore, Maryland was the gold standard. In many ways, it still is. I believe, and I have repeated at more than a dozen medical conferences for people who study these conditions that Louis Pasteur was correct when he said, “The antigen is nothing, the terrain is everything!”. I believe that we have cases of “Different Insult, same result”. Now, the medical Director of the CAA in Charlotte is Ms. Suzanne Vernon, PhD, who used large computer databases at the CDC to prove my theory. I believe that any type of virus, bacteria, prion, mycoplasma, or more commonly, a group of such toxic ‘insults’ forces its way across the blood/brain barrier, usually, but not always during a time of great stress, resulting in a dysfunctional autonomic nervous system. I suggest that it is like “stripping the gears on a fine swiss watch”. We all have our own brains, and our own exposures to various toxic insults every day. Those of us who have many neurons and synapses firing in our brains are often more intelligent, more creative, and more questioning than the average person. Many of us push ourselves harder than most “thus the derogatory term “yuppie flu” which really had nothing to do with money, but the type of person who pushes themselves beyond their limits during times of high stress. But now we have both the excellent tilt table test, and the Steven’s Protocol that prove that we suffer from P.E.M. They can now prove it to Insurance companies and disability evaluators. The next big question is “How can we fix it?”
I don’t know. It will take large amounts of time and money to find that out. But lying to the public and denying the existence of such a brutal group of illnesses for decades will surely not fix the problem. Now, I do want to publicly thank Dr. Judy Mikovits and the team at WPI. Dr. Sheila Bastien and Dr. Dan Peterson were able to do the proper testing to prove my illness to the Social Security Judge some 2 decades ago. But, sadly, even though I have been to many of the top doctors in this country, I am still in excruciating nerve and muscle pain 24/7 and I am unable to even care for myself, let alone a family. As Dr. Nancy Klimas, of the University of Miami HIV and ME/CFS center said last year, “I have treated thousands of HIV and ME/CFS patients over the past 2 decades, and today, If I had to choose one or the other, I would rather contract HIV than ME/CFS. Most of my AIDS patients are hale and hearty, whereas most of my ME/CFS patients are very sick”. I would ask the audience for a brief applause to thank both Dr. Klimas and Professor Lenny Jason, both of whom have spent the vast majority of their professional careers devoted to easing the misery and pain of this patient population. They have fought against incredible odds, and at great personal and professional expense to serve their patients and to serve on this committee. Thank you Nancy and Lenny! Back to Bidness! It is 30 years on that I know of, and for many patients, things are worse than ever. The so called “Reeves empirical definition of 2005” has made a bad situation worse. It is worse than worthless. The Holmes and Fukuda criteria were a complete joke to most medical researchers, and they were a cruel hoax for us patients. Supposedly, they were designed for research purposes, not for clinicians. But, they were used as clinical definitions from day one! YOU people represent the US government and the top of the medical pyramid in this country. IF YOU don’t know what the heck you are talking about after at least 30 years in, then how do you expect overworked, front line GP’s to know what to do with this epidemic. When I first fell Ill, the expert at NIH was Dr. Stephen Strauss. He told me that what I suffered from wasn’t real. He said that it didn’t exist and if it did, it wasn’t serious, and it would be gone in six months. 24 years later, I still can barely get out of bed to use the toilet. Today’s topic at the CFSAC is about disability. Employers and LTD companies are only concerned about two things: Can you WORK and pay taxes, or attend school and pass your courses. They want to know two things: can we perform our usual job or profession. Or can we perform ANY job in the US economy. They want us OFF their books. Period! And because there are now so many of us, with various ailments and various disabilities under a similar umbrella, they want to get us off their books by ANY means necessary, legal or otherwise. Many of my friends and colleagues are like me. Unable to care for ourselves, let alone someone else. We are not just disabled. We are SICK! I am very ILL. I feel like I have the flu from Hell every day of the week for 2 and a ½ decades. I was a 7 day a week worker all my life. Very active. 10 or 12 hour work days. many outside activities. In one night, I ate some raw shellfish, and BOOM! my life was destroyed. OVERNIGHT. Now, I have not been able to work 1 full day in 24 years! Sadly, my case is not abnormal. due to early activism and media appearances, people wrote to me from all over the world. They kept saying “The doctor says all my tests are in the normal range!” so, I saw
“your doctor is doing the wrong tests!” Right, now, we are lucky to have the chairman of this committee, Professor Christopher Snell right here in our midst. He works with a Ms. Stacy Stevens out at the University of the Pacific who designed
the protocol I described to you earlier. They have a test that costs about $2,000. It can demonstrate beyond the shadow of a doubt that people who REALLY DO HAVE this condition (which I call Myalgic Encephalomyelitis) and who suffer from what we called PEM or Post Exertional Malaise! Most of us can not do any extensive exercise at any time. But ALL of us can not do strenuous exercise two or three days in a row!
If your meeting today is about disability and how do you define it and how do you document it? how can you verify the disability that these patients claim they have.
I say Give them the Stacy Stevens exercise tolerance test 3 days in a row. I will wager that IF these patients suffer from what I call M.E. This test will put them flat on their backs for at least a month. Other speakers will speak about other topics, but this is how you can document our disability. Where do we go from HERE? Smarter minds than mine will have to figure that out! I will finish with the same line that
I did 21 years ago. The late, great Sam Rayburn said, “Any jackass can kick a barn down, but it takes a damn fine carpenter to build one. We need YOU to be those damn fine carpenters to help rebuild what is left of our lives.
Thank you for your time!
Dr. Stacy Stevens has done 1,000’s of single cardiopulmonary exercise tests on chronic fatigue syndrome (ME/CFS) over the years and close to a hundred with the Stevens’ Protocol at the Pacific Fatigue Lab. Whether in Stockton, Ca, Stanford U, Incline Village or Ithaca, New York they see the same general pattern again and again, a unique metabolic dysfunction that characterizes and objectifies the most mystifying symptom in the disease, post exertional malaise. If Anyone looks at the most comprehensive definition of these terrible disorders, the Canadian Case Definition for ME/CFS by Carruthers et al, you will see that the degree of debility varies greatly, but that if you use Koch’s postulates that to define an illness or disorder 100% of patients must be afflicted by agent X, We all suffer from P.E.M. or Post exertional Malaise. This Steven’s test costs roughly $2,000, but it does not need cutting edge materials or knowledge. You just need to apply the “Steven’s Protocol” and you can verify that we suffer devastating, but reproducible and quantifiable dysfunction in our autonomic nervous system if we attempt a brief but rigorous exercise protocol for 2 or 3 days in a row. Even dying Cancer or AIDS patients can return to a baseline level 24 hours after exertion. We can not! 21 years ago, I asked the panel of some 627 doctors and researchers assembled in San Francisco at the Hilton Hotel to find “something, anything, that is quantifiable and reproducible by people who do NOT trust us, and who do not believe we are ill, or who think that we are malingerers”. Since 1995, I felt that the tilt table test done by Drs. Rowe and Calkins at Johns Hopkins in Baltimore, Maryland was the gold standard. In many ways, it still is. I believe, and I have repeated at more than a dozen medical conferences for people who study these conditions that Louis Pasteur was correct when he said, “The antigen is nothing, the terrain is everything!”. I believe that we have cases of “Different Insult, same result”. Now, the medical Director of the CAA in Charlotte is Ms. Suzanne Vernon, PhD, who used large computer databases at the CDC to prove my theory. I believe that any type of virus, bacteria, prion, mycoplasma, or more commonly, a group of such toxic ‘insults’ forces its way across the blood/brain barrier, usually, but not always during a time of great stress, resulting in a dysfunctional autonomic nervous system. I suggest that it is like “stripping the gears on a fine swiss watch”. We all have our own brains, and our own exposures to various toxic insults every day. Those of us who have many neurons and synapses firing in our brains are often more intelligent, more creative, and more questioning than the average person. Many of us push ourselves harder than most “thus the derogatory term “yuppie flu” which really had nothing to do with money, but the type of person who pushes themselves beyond their limits during times of high stress. But now we have both the excellent tilt table test, and the Steven’s Protocol that prove that we suffer from P.E.M. They can now prove it to Insurance companies and disability evaluators. The next big question is “How can we fix it?”
I don’t know. It will take large amounts of time and money to find that out. But lying to the public and denying the existence of such a brutal group of illnesses for decades will surely not fix the problem. Now, I do want to publicly thank Dr. Judy Mikovits and the team at WPI. Dr. Sheila Bastien and Dr. Dan Peterson were able to do the proper testing to prove my illness to the Social Security Judge some 2 decades ago. But, sadly, even though I have been to many of the top doctors in this country, I am still in excruciating nerve and muscle pain 24/7 and I am unable to even care for myself, let alone a family. As Dr. Nancy Klimas, of the University of Miami HIV and ME/CFS center said last year, “I have treated thousands of HIV and ME/CFS patients over the past 2 decades, and today, If I had to choose one or the other, I would rather contract HIV than ME/CFS. Most of my AIDS patients are hale and hearty, whereas most of my ME/CFS patients are very sick”. I would ask the audience for a brief applause to thank both Dr. Klimas and Professor Lenny Jason, both of whom have spent the vast majority of their professional careers devoted to easing the misery and pain of this patient population. They have fought against incredible odds, and at great personal and professional expense to serve their patients and to serve on this committee. Thank you Nancy and Lenny! Back to Bidness! It is 30 years on that I know of, and for many patients, things are worse than ever. The so called “Reeves empirical definition of 2005” has made a bad situation worse. It is worse than worthless. The Holmes and Fukuda criteria were a complete joke to most medical researchers, and they were a cruel hoax for us patients. Supposedly, they were designed for research purposes, not for clinicians. But, they were used as clinical definitions from day one! YOU people represent the US government and the top of the medical pyramid in this country. IF YOU don’t know what the heck you are talking about after at least 30 years in, then how do you expect overworked, front line GP’s to know what to do with this epidemic. When I first fell Ill, the expert at NIH was Dr. Stephen Strauss. He told me that what I suffered from wasn’t real. He said that it didn’t exist and if it did, it wasn’t serious, and it would be gone in six months. 24 years later, I still can barely get out of bed to use the toilet. Today’s topic at the CFSAC is about disability. Employers and LTD companies are only concerned about two things: Can you WORK and pay taxes, or attend school and pass your courses. They want to know two things: can we perform our usual job or profession. Or can we perform ANY job in the US economy. They want us OFF their books. Period! And because there are now so many of us, with various ailments and various disabilities under a similar umbrella, they want to get us off their books by ANY means necessary, legal or otherwise. Many of my friends and colleagues are like me. Unable to care for ourselves, let alone someone else. We are not just disabled. We are SICK! I am very ILL. I feel like I have the flu from Hell every day of the week for 2 and a ½ decades. I was a 7 day a week worker all my life. Very active. 10 or 12 hour work days. many outside activities. In one night, I ate some raw shellfish, and BOOM! my life was destroyed. OVERNIGHT. Now, I have not been able to work 1 full day in 24 years! Sadly, my case is not abnormal. due to early activism and media appearances, people wrote to me from all over the world. They kept saying “The doctor says all my tests are in the normal range!” so, I saw
“your doctor is doing the wrong tests!” Right, now, we are lucky to have the chairman of this committee, Professor Christopher Snell right here in our midst. He works with a Ms. Stacy Stevens out at the University of the Pacific who designed
the protocol I described to you earlier. They have a test that costs about $2,000. It can demonstrate beyond the shadow of a doubt that people who REALLY DO HAVE this condition (which I call Myalgic Encephalomyelitis) and who suffer from what we called PEM or Post Exertional Malaise! Most of us can not do any extensive exercise at any time. But ALL of us can not do strenuous exercise two or three days in a row!
If your meeting today is about disability and how do you define it and how do you document it? how can you verify the disability that these patients claim they have.
I say Give them the Stacy Stevens exercise tolerance test 3 days in a row. I will wager that IF these patients suffer from what I call M.E. This test will put them flat on their backs for at least a month. Other speakers will speak about other topics, but this is how you can document our disability. Where do we go from HERE? Smarter minds than mine will have to figure that out! I will finish with the same line that
I did 21 years ago. The late, great Sam Rayburn said, “Any jackass can kick a barn down, but it takes a damn fine carpenter to build one. We need YOU to be those damn fine carpenters to help rebuild what is left of our lives.
Thank you for your time!
===============================================
Dear Sir/ Madam,
Thank you for attending this CFSAC meeting and for the opportunity to address you with my concerns.
I write to you as a physician, former medical researcher, and person who has been disabled by Chronic Fatigue Syndrome. I am encouraged that some progress has been made since last year and would like to thank Dr. Harvey Alter's group for their study; Dr. Thomas Frieden for looking for a new CDC leader experienced in CFS; Dr. Francis Collins for personally attending the recent NIH XMRV workshop; Dr. Michael Gottesman for meeting with people affected by CFS and their families; and the numerous behind-the-scenes officials/ staff for organizing the XMRV workshop and the CFSAC meetings.
However there remains much to be done.
1. Increase collaboration with experienced non-governmental CFS
researchers/ clinicians and patient groups. The recent discrepancies in XMRV findings between various research groups highlights not only the importance of laboratory techniques but also how subjects are selected. The studies with positive results used clinicians (Dr. Dan Peterson, Dr. Anthony Komaroff, Dr. David Bell, Dr. Paul Cheney) who had decades of experience diagnosing CFS to select their subjects. The negative studies generally did not. Since CFS is an ill-defined illness, it would make sense to involve experienced clinicians in subject selection, as is frequently done in studies of other medical conditions, rather than using community-based random digit dialing, as the CDC did, to select subjects. I understand the need for community-based studies but it needs to be supplemented by clinic-based studies.
Similarly, patient have the biggest stake in this research, their lives, and many are eager to volunteer for studies or help out in any way they can.
Although patients and their families may seem to be a nuisance at times, realize that their true goal is not to make your life difficult but to get well. It's easy to lose sight of this - I know, I've been on the opposite side of the stethoscope. Tell us how we can help you work faster/ better and we will do what we can.
2. Perform a thorough review of the CFS research literature and
incorporate past findings into current materials and future research. In a recent meeting with Dr. Michael Gottesman of the NIH, people asked Dr.
Gottesman why this medical condition had been ignored for the last 2 decades. Dr. Gottesman replied that it was due to a lack of concrete scientific, clinical and medical findings. [1] This is not true but I am not surprised by Dr. Gottesman's statement as it is representative of the mainstream medical and scientific community's ignorance. I might have said the same statement before I became ill.
There have been about 5,000 papers over the last 25 years documenting physiological abnormalities in multiple organ systems, including orthostatic intolerance, dysregulated immune functioning, aerobic metabolism issues, and abnormal SPECT/ fMRI scans. [2, 3, 4, 5] There are numerous past papers on the epidemiology of CFS. [6] However, little of this information, especially non-CDC study findings, has been discussed in CDC research papers or materials presented to the public within the last decade.
For example, materials directed towards health care professionals on the CDC website do not mention that outbreaks of CFS have been observed for many decades or that up to 80% of people who develop CFS start their illness with a flu-like illness. [7] Certainly, we do not what these observations mean yet but it might help clinicians diagnosis patients more accurately and as early as possible. Clinicians might even think to ask patients if they have family members/ contacts with CFS, thereby adding to the knowledge base
about the epidemiology of CFS. Healthcare professionals are no strangers
to medical controversies but rather than discussing these topics and letting professionals make up their own minds these topics are not mentioned at all on the website.
In October of 2009, CFSAC recommended that AHRQ complete a review of CFS for an NIH State of the Knowledge Workshop. [8] I hope this is still being considered, that AHRQ does a thorough job, and that the CDC re-evaluates what they present as they are an influential agency. I have found much useful information from reviewing studies published by Dr. Leonard Jason, the International Association for CFS/ME, and the Journal of Chronic Fatigue Syndrome. Articles from these three parties are frequently not catalogued on Pubmed. Federal agency representative should also consider participating in the annual international conferences sponsored by various CFS research groups. Let's not re-invent the wheel here: use every bit of information available to solve this illness.
3. Investigate the long-term effects of CFS. Early studies examined
whether CFS increased the risk of lymphoma [9]. Jason found, in a small study, that people with CFS died of cancer or heart failure at a younger age than people in the general population. [10] Young people, labeled as "crazy" and ill for years, have died with unexplained findings at autopsy including inflammation of the spinal dorsal root ganglions [11] and non-acute viral myocarditis [12].
The full recovery rate for CFS is less than 10% [13]; a 2009 survey by the CFIDS Association of America with 1,100 respondents showed that a large percentage of individuals had been sick for over 10 years. [14]. A few studies have reported on CFS outbreak subjects 10 years later but they have relied primarily on written questionnaires or subject interviews rather than medical record review or interview with the subjects' physicians.
[15, 16] Subjective methods without confirmation may lead to an overestimation of improvement/ recovery and denial / downplaying of ongoing/ new symptoms. [17] In addition, CFS sometimes has a relapsing-remitting course such that many who believe that they have fully recovered find their symptoms returning years later.
Even though many questions surround CFS, do not let it delay research into this important topic. People are living with and dying of complications as we wait.
If more were known about long-term effects, patients and clinicians might know what to watch out for and perhaps existing treatments could be used to prevent or ameliorate complications.
4. Establish 5 Centers of Excellence for CFS. This has been requested
as a top priority by CFSAC to DHHS since at least September 2004. [18] Centers of Excellence or a similar structure are needed to carry out coordinated multi-disciplinary research, clinical care, and education of health care professionals. There are already several institutions carrying out CFS research that would be superb candidates, including the Whittemore-Peterson Institute and former CFS Cooperative Research Centers like the University of Miami. Furthermore, if MLV-related viruses turn out to play a major role in this illness, already established HIV Centers of Excellence might be adapted to include CFS research as well.
Encouragement should also be given to young or new investigators interested in CFS. I have heard from research/ clinical colleagues that they are reluctant to invest their time/ energy due to lack of funding and the still-held view by more senior colleagues that CFS is a psychological illness not worthy of scientific investigation. Other than establishing Centers and waiting for investigator-initiated applications, NIH should consider issuing a new Request for Application (RFA) for CFS, especially in light of renewed interest by researchers with the recent XMRV findings.
5. Look into adverse effects of graded exercise therapy (GET).
Information about activity pacing and graded exercise therapy has been modified for the better on the CDC website over the last year. However, the CDC maintains a link to the United Kingdom's National Health Service program on GET. [19] Over the last decade, 34-82% of CFS sufferers surveyed in the UK have reported that GET has worsened their health, not improved it. [20] This is not unexpected given the physiological abnormalities that have been detected with exercise. [21] Furthermore, adverse effects of GET in studies have not been tracked or reported as rigorously as they should be. [22] While GET programs in the US may be different from those in other countries, this information should be taken into account when writing clinical guidelines.
6. Deliver CFSAC recommendations to Secretary Sibelius and ask for a
written response to the recommendations. I have seen CFSAC video casts where members have noted that there has been no response from DHHS on many of their recommendations. It is unclear even whether the recommendations have been read. This is an unacceptable situation. I do not expect DHHS to agree with all CFSAC recommendations but I do expect Secretary Sibelius or her representative (Dr. Howard Koh) to read through the recommendations and tell us yes, no, maybe, we need more information to make a decision, etc.
Patients understand that CFS is complex and that answers will not come easily but we want an honest effort and an appropriate response from our
government. Please do your best! I want to get well and return to my
work and my life. Thank you for your time and attention.
Sincerely, MD/ MPH/ person with CFS
****
REFERENCES:
1. Solomon R. Summary of Sept 7, 2010, meeting with NIH officials and CFS patients and families. http://www.forums.aboutmecfs.org/sho...n-Sept.-7-2010. (Accessed 9/15/2010.)
2. Carruthers BM, van de Sande MI. Myalgic encephalomyelitis/ chronic fatigue syndrome: a clinical case definition and guidelines for practitioners. An overview of the Canadian Consensus documents. 2005. http://www.cfids-cab.org/MESA/me_overview.pdf. (Accessed 9/15/10.)
3. Cook DB, O'Connor PJ, Lange G, et al. Functional neuroimaging correlates of mental fatigue induced by cognition among chronic fatigue syndrome patients and controls. Neuroimage. 2007 May 15;36(1):108-22.
4. Van Ness JM, Snell CR, Stevens SR. Diminished Cardiopulmonary Capacity
During Post-Exertional Malaise. Journal of Chronic Fatigue Syndrome. 2006; 14(2): 77-85.
5. Kennedy G, Khan F, Hill A, et al. Biochemical and vascular aspects of pediatric chronic fatigue syndrome. Arch Pediatr Adolesc Med. 2010;164(9):817-823.
6. Briggs NC, Levine PH. A comparative review of systemic and neurological
symptomatology in 12 outbreaks collectively described as chronic fatigue syndrome, epidemic neuromyasthenia, and myalgic encephalomyelitis. Clinical Infectious Diseases. 1994 18(1):, S32-S42.
7. A.D.A.M. Chronic fatigue syndrome. http://adam.about.com/reports/Chroni...#adamHeading_5. (Accessed 9/15/10)
8. CFSAC. Committee recommendations, October 29-30, 2009. http://www.hhs.gov/advcomcfs/recomme.../10302009.html. (Accessed 9/15/2010)
9. Levine PH, Fears TR, Cummings P, et al. Cancer and a fatiguing illness in Northern Nevada--a causal hypothesis. Ann Epidemiol. 1998 May;8(4):245-9.
10. Jason LA, Corradi K, Gress, et al. Causes of death among patients with chronic
fatigue syndrome. Health Care for Women International. 2006; 27:615–626.
11. Hooper R. First official UK death from chronic fatigue syndrome. June 2006.
http://www.newscientist.com/article/...syndrome-.html. (Accessed 9/15/10)
12. Schweitzer, M. Testimony before CFSAC September 2005.
http://www.hhs.gov/advcomcfs/meeting...50912_min.html. (Accessed 9/15/2010)
13. Cairns R, Hotopf M. A systematic review describing the prognosis of chronic fatigue syndrome. Occup Med (Lond). 2005; 55(1):20-31.
14. CFIDS Association of America patient survey April 2009.
15. Levine PH, Snow PG, Ranum BA, et al. Epidemic neuromyasthenia and chronic fatigue syndrome in west Otago, New Zealand. A 10-year follow-up. Arch Intern Med. 1997 Apr 14;157(7):750-4.
16. Strickland PS, Levine PH, Peterson DL, et al. Neuromyasthenia and chronic fatigue syndrome in Northern Nevada/ California: a ten-year follow-up of an outbreak.
Journal of Chronic Fatigue Syndrome. 2001; 9 (3/4): 3-14.
17. Bell D. Fatigue with and without orthostatic tolerance. Lyndonville News. May 2010. http://www.davidsbell.com/LynNewsV7N1.htm. (Accessed 9/15/2010.)
18. CFSAC. Committee recommendations. September 2004. http://www.hhs.gov/advcomcfs/recomme.../09272004.html. (Accessed 9/15/2010.)
19. Centers for Disease Control and Prevention. CFS Toolkit – graded exercise therapy.
July 2010. http://www.cdc.gov/cfs/toolkit/get.html. (Accessed 9/15/2010)
20. Kindlon T. Adverse reactions to graded exercise therapy. May 2009. http://sacfs.asn.au/news/2009/09/09_...ons_to_get.htm.
(Accessed 9/15/2010)
21. Twisk FN, Maes M. A review on cognitive behavorial therapy (CBT) and graded exercise therapy (GET) in myalgic encephalomyelitis (ME) / chronic fatigue syndrome (CFS): CBT/GET is not only ineffective and not evidence-based, but also potentially harmful for many patients with ME/CFS. Neuro Endocrinol Lett. 2009;30(3):284-99.
22. Larun L, McGuire H, Edmonds M, Odgaard-Jensen J, Price JR. Exercise therapy for chronic fatigue syndrome. Cochrane Database of Systematic Reviews 2009, Issue 1.
(Updated from 2003, Issue 4.)
***************************************
The Emerald City - CFSAC Meeting October 29-30, 2009 -
---> HAPPY ANNIVERSARY WPI- XMRV <---
by Carol Anna Geraci on Friday, October 8, 2010 at 2:30pm
This is my testimony I gave last year at the CFSAC Meeting by phone as I was too ill to attend. Someone mentioned that I should post it since it was not on video. I thank each of you for all the work you are doing. You are all a great inspiration to me. Thank you WPI!
Good afternoon to members of the CFSAC committee, to Dr. Peterson, Mrs. Whittemore, patient advocates, doctors, to everyone suffering from ME-CFS and their families.
The Emerald City
October 8th 2009 came the news that XMRV is a retrovirus, a member of the same family of viruses as the HIV virus has been found in patients with CFS. I feel like I am in the wizard of Oz and the house just landed on the CDC. Now the red ruby slippers are now worn by the Whittemore Peterson Institute. The CDC has been shown up as having been grievously wrong for the past 30 years. Finally, there is real hope, real news and real science. It is our time even though many lost the best years of their lives but for those who just became ill I am hopeful there maybe treatments for you in the future. WPI is our Emerald City. They are our hope where causes, treatments and cures will be found for this devastating disease.
I offer my sincere appreciation to the Whittemore Peterson Institute, to Annette Whittemore, Dr. Peterson, Dr. Mikovits, the Cleveland Clinic and The National Cancer Institute for spending the time and energy on investigating ME/CFS from a scientific perspective that was published in the Science. Also, I would like to thank The NY Times, LA Times, Reuters, US News and many other newspapers for reporting this very important news regarding ME/CFS patients. The study was published in the Science one of the most prestigious medical journals. I thank you for publishing this groundbreaking news. (October 8, 2009)
Last week Reuters reported that a Study “isolates virus in chronic fatigue sufferers. Dr. Mikovits said “the study offers hope that CFS sufferers might gain relief from a cocktail of drugs designed to fight AIDS, cancer and inflammation.”
Her co-authors (Dr. Mikovits from WPI ) include scientists from the National Cancer Institute and the Cleveland Clinic.
Dr. Mikovits talks about clinical studies and treatments that could be used now.
Serious Health Crisis
The U.S. and the world are facing a serious health crisis that millions have contracted a disabling AID’s like illness. The US is in great risk as this epidemic continues to take the lives of millions. The Tragedies and the suffering that befall ME/CFS victims are immense. ME/CFS robs people of their life and of their very being. It destroys a person on every level. Many patients are completely bed ridden and unable do to the simplest tasks healthy people take for granted. Little tasks are a monumental undertaking for someone with ME/CFS. .
Patients suffer from immune & neurological problems, infections, viral, retroviral infections, fevers and a continual flu like illness. Many have Subclass IgG 3 deficiency, Low T4 cells, HHV-6, CMV, EBV, mycoplasma, cognitive/memory problems, exercise intolerance and lethargy and so many other serious conditions and symptoms. Many are bed ridden and cannot care for themselves. The kind of fatigue we suffer is not fatigue it is the inability to exert energy that we do not have. We have lethargy which is not fatigue and is only part of our illness.
The CDC is so out of touch with this illness and I wonder if this is on purpose. Why do you ignore science? Why will did the CDC coin the term Chronic Fatigue Syndrome? It is like calling people with diabetes, chronic sugar syndrome, or MS, Chronic walking syndrome, or TB Chronic coughing syndrome? It is harmful to marginalize such a serious debilitating illness and be called something that sounds so trivial.
Why would 17 million people from around the world suddenly give up their careers, family, hobbies and activities they once loved?
Crimes, Lies and Cover Up
What the CDC has done I consider very serious crimes against people who are disabled. The CDC cover up must end. The CDC must be investigated for the crimes committed against severely disabled people. Who is responsible and why the cover up? Who is to blame? Is it just Reeves and Wessley and Stause or is this a larger cover up going on?
We will get lawsuits and senate hearings. Patients will be vindicated one day. I hope Reeves and Wessely are put in jail for the lies and cover up of what I do believe will go down in history as one of the most serious diseases of our times.
I still wonder WHY? To allow patients with ME/CFS to endure severe suffering and torture for over 25 years. No medical treatments and no clinical studies in over 25 years for such a severe debilitating illness. Someone with ME/CFS feels everyday like someone who is dying from late stage Aids (Dr. Loveless). Yet the CDC does nothing.
I do not know why this would happen unless the government is well aware of what is going on.
Millions around the world are sick. Many once were earning a good living but are now living in poverty. How many women who wanted to have children find themselves barren without hopes having a child? How many more will suffer in silence because the CDC does nothing? Broken lives, dreams, hopes. Why?
Why?
My best friend use to tell me that we were a human experiment in 1990. I did really understand what she meant. I was young and a bit naive. I lost her in 1998 to this illness. I then saw a true story about Tuskegee syphilis experiment. It was a 40 year study where black men were not given penicillin to treat syphilis. The United States government wanted to see how they would die. It was a human experiment that President Clinton after hearings were done had to pay families millions of dollars.
I read about the study many years ago. I than watched the movie about the Tuskegee experiment of men who lived and died a torturous disease- tears rolled down my eyes for I felt a connection to those that endured so much suffering and I had to then question is this what they are doing to us? Are they waiting to see how we will die? For that is what they did in the Tuskegee experiment they wanted to see how men with syphilis (untreated) would die. For over 25 years the CDC has been watching us suffer and die. How can they let millions of people suffer and die when there are scientists proving that we have an infectious disease one that may even be contagious?
With the news of XMRV why do you still doubt you will find XMRV in us before even conducting tests? We need clinical studies immediately.
The damage is done; history will now look back and ask what the CDC did all these years while millions were sick and many died. Patients will no longer be judged. The CDC and those who watched millions of sick and severely disabled people being mistreated, abused and neglected will one day be judged. The CDC and whoever is involved in this crime justice must be served. The world will know the truth.
Do you laugh at us behind closed doors? Is this a joke to you? It must be for you have done nothing in over 25 years but to call us names.
What exactly is going on at the CDC while there are thousands of scientific articles that we are suffering from infections, viral, immune system disorders and neurological problems do you ignore science?
I will spend every moment I can to let the media know what has happened and try to get Congress to conduct hearings on the travesty of what the CDC has done. This illness has been marginalized by the CDC and the crimes committed have been committed on their behalf. The damage inflicted on patients who have been told this was a psychological disorder is insurmountable.
This is discrimination of severely disabled people.
ME/CFS Patients
While the news of XMRV linked to ME/CFS is great news, for those who have lost 20 years of their life it is a bitter sweet moment. I had a wonderful life ahead of me. I wanted children and a family and I would have had a wonderful life. I have two degrees in Computer Science and Mathematics (cum laude). I had an active social life. I was a healthy. The CDC robbed me of any chance of a normal healthy life. I could have been treated years ago but instead my life was taken away from me. I was a vibrant, healthy and so full of life.
In my 20’s I was denied by every insurance company because I had a pre existing condition of EBV. So what do the insurance companies know about EBV that doctors and the CDC does not? I think this deserves some explanation? Certainly five insurance companies know who is an at risk client. I called to speak to these insurance companies for certainly I thought there must be a mistake that I was denied insurance for I was so young. They each told me I was denied insurance because I had a pre-existing condition of EBV. I did not understand for I thought EBV was a no big deal virus.
I now have severe muscle weakness that I can no longer drive, walk, or take care of myself. I was gravely ill this year. It’s not the first time I came close to dyeing. I have been hospitalized many times with serious infections. Why is my immune system not able to fight infections? I am tired of the lies. I am tired of the cover up. I am tired of being so ill. We would not allow pets to suffer like this.
ME/CFS Patients
To continue to do studies in that our child hood we must have been abused, if this is what you spend our tax dollars on why bother? Last month all I heard us being called was “chronic fatigue”. This is not what we have.
Many family members do not take their loved ones serious, they do not help them, many marriages fail and friends over time disappear for they do not understand why we are always in bed. We end up living within walls in a dark room and our bed becomes our home. The phone that once would ring off the hook stops ringing. We end up alone broken down feeling helpless. Knowing no one cares or understands. Knowing there are no treatments or help.
CFSAC FIVE YEAR PLAN
While you are working on your five year plan I did not hear one thing in regards to treatments or clinical trials. Patients have gone long enough without any treatments of any kind.
For those ME/CFS expert doctors who are treating patients with antivirals, retrovirals, immunoglobulin’s, and many other treatments we need to have doctors informed of these treatments that are available now, so those that are suffering can get help.
There treatments being given by Dr. Peterson, Dr. Chenny, Dr. Levine, Dr. Montoya, Dr. De Meirleir and others. Patients need treatments now.
We need clinical trials. I do not see this in your five year plan. What else could be more important?
Norway is doing a clinical study using Cancer drug on CFS patients that have cured or at least put patients in remission. Why are we not looking at this very promising treatment? Why are we not doing any clinical studies with these medications?
Why do patients have to travel across the country and wait a year to see specialists? Japan takes this illness very serious and treats it with a medicine they created for it. Why are we not looking into that treatment?
How did AIDs get treatments? Clinical trials. Many treatments were fast tracked for both MS and Aids. We need treatments now, not in five years. There are treatments that can help us now.
Why not look at what Norway and other countries are doing? Italy is using a drug for Hepatitis off label for CFS with success. Why not invite the scientists into this meeting so they can give you an overview of their treatments that they give to their patients?
We need treatments now not five years, while clinical trials are needed, patients who have been ill for 10, 15, 20 years need treatments now before they die. Why not see if you get some treatments recommendations from experts and expedite this so patients can at least get some kind of treatment? Retroviral, Antiviral, antibiotics, Immune modulators, Immunoglobulin’s, steroids and the cancer treatments from Norway.
Whatever these few doctors are doing why not allow these treatments and testing to be done by other doctors? Doctors need training. I just do not understand how for almost 30 years nothing has been done.
I would also like to know why Ampligen the only real treatment that has helped patients with ME/CFS recover or get better (many patients) why it is not available? Why is it considered a clinical study but patients have to pay 2k a month for it? Again the crimes against people with ME/CFS are insurmountable. No treatments and no doctors while people suffer and die.
Recommendations for your 5 year agenda:
Agenda
Have a meeting with the best ME/CFS doctors around the country and WPI to see what tests and treatments they give.
Immediate treatment is necessary. Whatever these doctors are using to treat patients make it known to doctors what they are doing.
Doctors need to be notified of these treatments immediately. There is a list of CFS doctors you can start with them. This would not be that difficult a task for immediate testing and treatment.
Immunoglobulin must be made available for those with ME/CFS.
Clinical trials need to begin immediately. Not in 5 years.
Public awareness must be made about ME/CFS is a serious illness and that we suffer from a Neuro-immune disease.
Must inform hospitals, doctors, colleges, and the media how severely ill people with CFS are. If WPI can do it so can the CDC.
Must make doctors in the US aware that the rest of the world calls CFS~ ME.
Clinical trials like Norway are doing and the drug Italy is using with great success.
Make Artunsunate available in the US. Zadaxin is used in Italy for CFS. Reach out to the pharmaceutical companies as I am sure if they know there are over 17 million who suffer from this disease they will sponsor clinical trials.
Norway Cancer treatments- let doctors try these treatments on patients now. We are adults let us sign waivers but let us try treatments that could give us out life back or save us from death.
Stop all studies not relevant to treatments.
Update your website to include that ME/CFS is a real disease.
Not a syndrome! Stop marginalize the severity of how patients suffer.
ME/CFS is Torture
To suffer with ME/CFS is torture. It is a tortuous disease.
I urge everyone with ME-CFS to write to Congress, lawyers and the press. The more they understand our story one day they will have to take the CDC and anyone who was involved in this cover up on charges. Write to the media- do not stop- we need to stand strong now. Now is the time to hold the CDC accountable for what they have done. Do not bother writing to the CDC- for that is like going to your abuser and asking why they are beating you. We need the media, lawyers and scientists on our side. Justice must be served.
Mrs. Whittmore gave a speech in where she read from a government document that those with ME/CFS die 25 years younger than normal. They die from heart disease, suicide and a certain form of cancer. If the CDC does nothing knowing this is true, you will now begin to see more and more die under your watch. I hope you can live with yourselves knowing those facts while you do nothing to help us.
This is a quote from Dr. Loveless an AIDS doctor who testified before congress on the severity of CFS in 1995.
"I have treated more than 2,000 AIDS and CFS patients in my career. And the CFS patients are MORE sick and MORE disabled every single day than my AIDS patients are, except for the last two months of life!" Dr. Marc Loveless
(infectious disease specialist and head of the CFS and AIDS Clinic at Oregon Health Sciences University, in Congressional Testimony, CFS Awareness Day, May 12, 1995)
What the CDC has done is a crime against humanity.
ME-CFS, is one of the most serious illnesses of our times
The CDC has lied to patients, doctors and their country.
Patients have been mistreated and abused by the CDC.
CFS is the third lowest funded illness at the US.
The CDC should be held criminally liable for deliberately making a faulty definition of people who are gravely ill. They should be held criminal liable to allowing people to suffer and die, ignore science and research scientists who have been warning the CDC that patients are suffering severe immune and neurological problems. This is medical malpractice and is criminal on every level. The CDC is responsible for diseases that maybe contagious. The CDC has been systematically been covering the worst disease of our time. For the CDC not care that XMRV a retrovirus like HIV could be the cause of ME/CFS is criminal. This is also discrimination of disabled people who cannot defend themselves. People are dying a slow torturous death. This is how history will see it.
My heart goes out to all affected by this illness and their families.
Thank you.
Carol Geraci
**MRC PACE Trial
Permission to Repost
This is the letter which was sent by Professor Malcolm Hooper,on the 7th
October, to The Rt Hon Dr Vince Cable MP, Secretary of State with
responsibility for the Medical Research Council(MRC), relating to the
failure of the MRC to respond to his formal complaint on the PACE Clinical
Trial, which he first lodged on the 11th February 2010. May be reposted.
*****************************************************The Rt Hon Dr Vince Cable MP
Secretary of State
Department for Business, Innovation and Skills
1, Victoria Street
London
SW1H 0ET
7th October 2010
By Special Delivery
Dear Dr Cable,
re:Complaint about the MRC PACE Trial on "CFS/ME"
Mindful of your record of commitment to and concern about the serious plight
of people with the neuroimmune disorder myalgic encephalomyelitis/chronic
fatigue syndrome (ME/CFS), I ask that in your position as Secretary of State
responsible for the Medical Research Council (MRC), you will respond
promptly and fully to this letter.
Having received no response from the Medical Research Council to our
concerns about the PACE Trial that purports to be studying this disorder, on
11th February 2010 I lodged a detailed complaint with the Minister then
responsible for the MRC, The Rt Hon The Lord Drayson, enclosing a bound copy
of my 442 page fully referenced report "Magical Medicine: how to make a
disease disappear" setting out the evidence that forms the basis of my
complaint.
He replied by letter dated 8th March 2010 (his reference being
2010/0013270POLD), advising that I should raise the matter formally with Dr
Morven Roberts of the MRC Clinical Trials Unit, which I duly did by letter
dated 30th March 2010, with which I enclosed a further bound copy of my
report.
I specifically asked Dr Roberts for an informed and considered response and
not the standard and dismissive pro forma MRC letter that has been sent to
numerous people who have already written to the MRC expressing their
concerns about the inappropriateness of the PACE Trial, the false beliefs of
the small but influential group of psychiatrists upon which it is
predicated, and its very real potential for iatrogenic harm.
My letter and the accompanying report were sent by Special Delivery and were
received by the MRC on 1st April 2010, for which the Royal Mail provided a
signed receipt.
I did not receive the courtesy of an acknowledgement, so six weeks later, on
18th June 2010, my research assistant telephoned the MRC and asked to speak
to Dr Morven Roberts. When my assistant explained that the enquiry related
to my formal complaint about the PACE Trial, she was informed that there was
no-one of the name of Dr Morven Roberts in the Clinical Trials Unit and was
met with a total refusal to discuss the matter, the MRC employee saying: "I
think I'm going to have to put the phone down", which she rudely did. The
episode was a quite extraordinary response to a simple and polite request to
speak to Dr Morven Roberts in relation to a complaint about an MRC trial.
The following day, Dr Morven Roberts sent me an email (incorrectly addressed
to Professor "Cooper") in which she wrote: "I understand you have recently
tried to contact me in regard to your complaint lodged with me as Clinical
Trials Manager about the PACE Trial. I can let you know that the MRC are
working through the large document you have sent and will respond in due
course. Morven".
Despite it being over six months since I lodged my complaint and four months
since Dr Morven Roberts assured me I would receive a response, I have heard
nothing from the MRC. I am sure you will agree that such a delay in such an
important matter is unacceptable.
On 5th October 2010, my research assistant telephoned your Department,
quoting the reference number on Lord Drayson's letter of 8th March 2010, to
seek your personal commitment to pursue this issue as a matter of urgency,
only to be informed that there is no record of my complaint as Lord
Drayson's reply to me has been lost and that I must start my complaint all
over again. She was informed that someone from your office would ring her
back that same day; you may not be surprised to know that no-one bothered to
do so.
Reasons why this complaint is now urgent
The MRC PACE Trial intentionally used the Principal Investigators' (PIs')
own entry criteria for "CFS" (the 1991 Oxford criteria), yet these criteria
lack diagnostic specificity, have been shown to have no predictive validity,
and select a widely heterogeneous patient population which may or may not
include people with true ME/CFS. It is virtually unheard of for studies to
use criteria that have been superseded; indeed, one of the PIs himself,
Professor Michael Sharpe – who was lead author of the Oxford criteria --
stated in 1997 that they "have been superseded by international consensus"
(Occup Med 1997:47:4:217-227).
Of equal concern is the fact that the PIs and other psychiatrists involved
with the PACE Trial continue to regard ME/CFS as a behavioural disorder and
refuse to engage with the extensive biomedical and scientific evidence that
identifies damage, deficits and dysfunction in major bodily systems of
patients with ME/CFS, particularly in the neurological, immune, endocrine
and cardiovascular systems. For over two decades they have asserted that ME
does not exist (and that it is merely an "aberrant belief" that one has a
disorder called ME); they equate it with chronic "fatigue", a completely
different disorder classified by the WHO as a psychiatric disorder in ICD-10
at F48.0, whilst ME/CFS is classified as a neurological disorder at ICD-10
G93.3.
The potentially harmful results of the PACE Trial for those with ME/CFS are
particularly important in the light of the findings of the strong
association between ME/CFS and a retrovirus (XMRV) of the same family as
HIV/AIDS. The findings of that paper, published one year ago in the journal
with the highest impact factor of any scientific journal worldwide (Science
2009:326:585), have been confirmed and strengthened by further research
published in August 2010 in the Proceedings of the National Academy of
Sciences (PNAS 10.1073/pnas.1006901107) showing polytropic murine leukaemia
virus-related viral sequences (MLV) to be present in the blood of 86.5% of
patients studied.
The over-riding international concern is that when the PACE Trial results
are eventually published, they will deliver what has long been known to be
the PIs' intention and primary objective, ie. the results will confirm the
PIs' favoured intervention of "cognitive restructuring" (which incorporates
graded aerobic exercise) as the intervention of choice. This is an
intervention that is specifically designed to disabuse ME/CFS sufferers of
their (correct) perception that they suffer from a serious, multi-system
neuroimmune disease.
The cognitive modification is directive, not supportive, ie. it is not
offered as adjunctive psychological support for those dealing with a
life-wrecking illness because the PACE Trial Manuals claim that it is
curative: the chief PI, Professor Peter White, claims that "a full recovery
is possible" (Psychother Psychosom 2007:76(3):171-176); the participants'
CBT Manual informs people that the PACE Trial therapies are curative, and it
is asserted that "many people have successfully overcome their CFS/ME" with
such behavioural interventions ("Information for relatives, partners and
friends", page 123).
To recommend behavioural modification strategies for those suffering from
such devastating organic illness would be inhumane and inexcusable: if such
an intervention were to be imposed on those with other neurological diseases
(such as motor neurone disease or multiple sclerosis) to force them to
change their correct perception that they suffer from a serious organic
disorder, it would be roundly condemned as unethical.
You may already be aware that a world expert on both HIV/AIDS and ME/CFS is
on record as stating:
"I hope you are not saying that (ME)CFS patients are not as ill as HIV
patients.I split my clinical time between the two illnesses, and I can tell
you that if I had to choose between the two illnesses I would rather have
HIV" (Nancy Klimas, one of the world's foremost AIDS and ME/CFS physicians;
Professor of Medicine and Immunology, University of Miami; New York Times,
15th October 2009). In addition, in a radio interview on 19th September
2010, she stated: "…there is a chronic inflammation, neuro-inflammation, and
it upsets the whole balance of your systems…the patients become terribly
ill…. The immune system is really cranked up; it's a tremendous amount of
inflammation. I think that if doctors could get this in their heads that
it's sort of like lupus or one of these really inflammatory disorders…it is
that level of inflammation. There's a tremendous amount of inflammatory
stuff going on, and there's a lot of inflammation in the brain itself"
This is important, because the incremental aerobic exercise recommended by
the PACE Trial Principal Investigators is contra-indicated in cases of
inflamed and damaged tissues and inevitably results in post-exertional
relapse with malaise, which is the cardinal symptom of ME/CFS.
Furthermore, in a lecture on 24th April 2010, Anthony Komaroff, Professor of
Medicine at Harvard and another world expert on ME/CFS, said on record in
answer to the question whether or not he would consider ME/CFS a
neurological illness: "…there is now abundant evidence of measurable
abnormalities in the central nervous system and the autonomic nervous system
in people with this illness. That makes it neurological…That's why I think
it makes sense…to call it Myalgic Encephalomyelitis…because I think those
two words adequately classify or describe an underlying biology that tests
have shown to be the case" (http://www.masscfids.org/news-a-events/2/221 ).
As the evidence for retroviral involvement in ME/CFS becomes impossible to
dismiss, it becomes paramount to prevent the potentially damaging PACE Trial
results from being applied nationally to anyone with the label "CFS/ME" who,
given the indisputable heterogeneity of the PACE Trial cohort, may have
either chronic tiredness for which psychological interventions may be
appropriate or a multi-system neuroimmune disorder for which behavioural
modification is contra-indicated.
I trust you will appreciate the gravity and urgency of the current situation
that adversely affects an estimated 240,000 people in the UK (for
comparison, the Multiple Sclerosis Society estimates that there are 83,000
sufferers in the UK) and that your own involvement will be both prompt and
efficacious. The situation is particularly pressing now that people with
ME/CFS are embroiled with new legislation that many fear – and some have
already found – is threatening to remove state benefits they currently
receive that are vital to support their severely sick and damaged lives.
It is completely unacceptable that Dr Roberts and the MRC can be permitted
simply to ignore this complaint (which has received worldwide academic
attention, comment and support) in order to protect the unsustainable
beliefs of a handful of psychiatrists who work for the medical and permanent
health insurance industry and the scandalous waste of over £5 million,
especially given that the effects of the interventions on over 3,000
patients were already known to be at best ineffective and at worst to be
actively harmful in 50% of cases (for references, see "Magical Medicine" --
the copy that was sent to Lord Drayson should still be in your Department
but I will provide a further copy if necessary).
I ask that you give this matter your urgent attention; that you will
intervene to expedite the promised response from Dr Morven Roberts and that
you personally will supervise and approve her response.
Yours sincerely,
Malcolm Hooper
cc. Dr Morven Roberts, Clinical Trials Unit, MRC, 20 Park Crescent, London
W1B 1AL
*********************************************************
I felt that a reason was in order as this meeting was not worth the
time and effort. The following was sent to CFSAC; HHS: Secretary
(HHS) Sebelius, Asst Secretary for Health Dr. Howard Koh, NIH Director
Francis Collins, NIAID Director Anthony Fauci, CDC Director Thomas
Frieden; my Senators and Congressional Representative.
Jill
----------------
I will not be attending the October, 2010 CFSAC meeting and
I am relinquishing my reserved spot to speak. This meeting does not
adequately cover the important issues or reflect even the
'state of the science' in the science portion.
Last years meeting was stunning, with standing room only
crowd. Dr. Dan Peterson received a standing ovation for
his presentation of the work being accomplished by the WPI,
who had just had their collaborative paper published in Science.
We were all expecting a continuation. This meeting is a huge step
backwards and right back to business as usual.
Since then, the work has progressed at an astonishing pace. XMRV
is known to be infectious and oncogenic, and associated with
neurologic and immune system abnormalities. This retrovirus is the
3rd human retrovirus in addition to HIV/AIDS and HTLV (leukemia).
Even very conservative doctors in the trenches have come out and
said that this is probably the cause.
This meeting does not reflect the seriousness and significance of this
research, and more importantly, the urgency of determining the effect
on public health.
The WPI has done more in a couple of years than HHS has done in over 20,
and it was their discovery. They were not invited. Why?
The WPI has not received any government funding for XMRV research.
Why is this? They have collaborated with well known researchers from other
federal agencies and published in prestigious journals.
Why has there been no intramural research on XMRV at NIH or NIAID.
Why have there been no expedited epidemiological studies to determine the
incidence, prevalence and mode of transmission of the virus and mechanisms
of pathogenesis?
Why have there been no RFA's (which should have been issued immediately) for
further studies?
Why have there been no clinical trials, when there are effective antiretrovirals
available? Patients have no access to any treatment.
In fact, with federal agencies involved in these findings, why has CDC been not
only ignoring them in terms of policy but going further in the opposite direction.
Why the change to the CDC website to include psychological interventions
as treatment, and GET, which may be very harmful. Why is the CDC's 5 year
research plan still in place, given the strength and seriousness of this
research, and when IACFS/ME (the international professional organization)
had strenuously voiced objections to this plan?
Where are discussions on children? There have been no studies and no
information, and CDC is prominently placing their adverse event studies
on children on the website.
Where is the discussion on funding, which is crucial, as it has been virtually
non-existent in relative terms to other illnesses and given the morbidity and
mortality.
Where are discussions about CFSAC recommendations, which
have gone mainly unnoticed, or discussions of how to rectify this?
Why is the Assistant Secretary not wanting to participate in or at least attend these
meetings, given the current situation and strength and significance of the
findings and serious implications to public health and safety of the blood supply.
Patients are suffering, bedridden and some are dying. From our experience,
the illness is progressive and people are going to continue to get worse
the longer they go without treatment. So literally spending more time on rehab
and vocational training and cognitive issues than XMRV? You cannot
rehabilitate someone who is seriously ill. Or to put another way, focus on
proper diagnosis, testing and treatment, which we now realistically have
the means to accomplish, the rest will somewhat take care of itself.
If this committee is not adequately fulfilling its mission and taking up the most
important issues (i.e., a retrovirus and the significance of the very likely role
it plays in this illness), then as a community we must address them elsewhere.
Sincerely,
Jill McLaughlin
************************************************
With those 5 pages of Testimony now submitted to the CFSAC
Permanent Records, we will have one more day of this year's
meeting and then PRAY Long and HARD... that
SomeHOW, someWAY, the Light Bulb Goes ON in the Heads
of those that hold our lives in their Hands...
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