Voices from the Shadows

“Voices from the Shadows” is a film about severe Myalgic Encephalomyelitis (ME). Natalie Boulton and her filmmaker son Josh Biggs made this film, which focuses on patients in the UK. This is an excellent, excellent film.

The name of Natalie Boulton might be familiar to some of you. Natalie made the book “Lost Voices”, also about severe ME, for InvestinME, the UK organization that sponsors the very best ME conference, annually in London. Richard and Pia Simpson, the guiding lights of InvestinME, do a great deal to further serious clinical and research work in the ME field.

“Voices from the Shadows” is an independently made video development of the book and focus on the consequences of psychiatric and psychosocial misunderstanding about the illness. Because of its sound, editing, pacing and interviews, it carries much more of a wallop.

“Voices from the Shadows” will be premiered at the Mill Valley Film Festival on Saturday, October 8th 2011 where it will followed by a panel discussion featuring Dr. Jose Montoya, the ME clinical researcher from Stanford University, and David Tuller, a medical journalist from the NY Times. Further screenings are being arranged. A trailer of the film can be found on the webpage of the film and is presented here.

I recently watched a finished version of “Voices from the Shadows” to preview it. I had seen several preliminary versions, and was struck by how the balance and pacing of the film was improved each time that I saw a new version.

The film follows various bedbound patients - from early home movies of happy children through the random strike of an “insult” (virus) to later illness severity. Caregivers and patients are interviewed. All interviews are set up and edited for maximum clarity and impact. The timing and fusing of many of the images is first rate. Care was taken in building and constructing every frame. The music is also carefully chosen and interwoven with the images for maximum effect. The music is subtle and persuasive, used with discretion and for visual and emotional emphasis. Particularly striking is the cello music, an instrument whose sound is so compatible with the “aching distress” of the subject. The bottom line is that every single square inch of this film is “considered” - to heighten the difficulties of ME and the obstacles that these patients face. Josh and Natalie have a close and abiding “attachment to the subject” – and it shows.

The film features three true heroes in the public ME world, Dr. Leonard Jason from DePaul University, Dr. Nigel Speight, Consultant pediatrician of Durham University Hospital, and Dr. Malcolm Hooper, the Dean of ME physicians in the UK. Each speaks with a clarity and conviction about the seriousness of ME - and of the longstanding disregard and mistreatment of ME patients. These three people are filmed and interviewed in such a way that their message is delivered with great emotional intensity and clarity.

It is my belief that this film will have a major impact on educating a wider audience about the true nature of ME. Natalie and Josh have made the absolutely correct decision to focus on the very severely ill, and on their medical treatment (or non-treatment). “Voices from the Shadows” depicts “the very bottom” of the illness, what I like to refer to as “the core of the illness”. This was an important choice - as this “bottom” is where the severity of the illness can be most clearly seen –and tested. More clinicians, more researchers should seek access to these patients to find out what really is happening in this illness. Even though the patients are sequestered in rooms, sophisticated, experimental tests can be run on them - involving, blood, urine, saliva and stool samples. The only physician that I know of who engages "the most ill" is Dr. Kenny de Meirleir, who goes into the homes in Norway and other places - and tries to determine what is happening through testing. Perhaps other clinicians do this? I would like to know who they are, as they are important witnesses. Too often clinicians see patients who are “half sick”, patients that can actually get out of their houses into a doctor’s office - so that they do not get an entirely clear or full view. But what about those who cannot move -or cannot be moved? Who sees them?

Josh and Natalie have made a number of exquisite decisions regarding this movie. In the first place it is the right length, a few minutes over an hour long. Within this span of time the story builds through a set of pictures and interviews of patients and physicians. The three principal medical personal reappear throughout the film giving it a great continuity. The pacing and image cutting/building is first rate, riveting the viewer along the path to a catastrophic ending. This film is not for everyone. I do not recommend that patients watch this film. But for others, clinicians and doctors, it is just the ticket to sober them up a bit about this illness.

This film is not a “Professional” movie made by outsiders with a large budget and a large crew. This is a first rate documentary made on a low budget by two people who have access to the “core of the reactor”. There has never been a film like this, and there is apt not to be one again in the near future. This “core terrain” is a difficult place to access, as the illness itself being “stress-related” (“Picking up a glass of water is stress.”) disallows the spectator or helper getting close to the patient. Getting close requires great empathy with the patient’s particular situation, and one has to have great experience being around these ill patients. These two, Josh and Natalie, have a special key to get into the inner sanctum, and they do a marvelous job in a very trying situation.

One quibble that I have about the film is that it does not explain enough the condition of the patients that one sees in the images. For instance, several of these patients are wearing what appear to be headphones. In actuality, these are construction sound blockers. These patients have severe hyperacusis (noise sensitivity) along with photophobia (light sensitivity). Many wear masks twenty-four hours a day. Often they are afraid of sound, as it is incredibly painful to them. Certainly they wish they could listen to music, but it is impossible. Many patients live totally in isolation, in the dark, unable to see, hear or talk. Sometimes a patient has to have a sheet suspended above them, as the contact with the sheet is too painful.

Perhaps this film will do its part in hammering home the true nature of ME. Anyone who looks at this film is going to ask themselves a question. Is this the fatigue illness where patients lounge around or place their heads on the table in class, or drop dishes in the kitchen? Does this look like a “yawning” disease? Or does this depiction of ME indicate a virally (or retrovirally) induced sickness with serious autonomic and immune incapacities? ME is a serious neurological illness that include attacks on all senses – sight, sound, touch, smell, as well as the brain and every other organ in the body. Watch this film and see for yourself.

Too many doctors and too many researchers and too many friends and family do not want to go down the road to look at this illness. There are reasons why so many people turn away from the patients - and leave them abandoned and bereft. The illness is very Medieval and frightening. Most people, most doctors, most researchers, look away. This movie will help people take a good look. This movie will help wake people up.

And yet the film does focus on "those who do not back away" - the caregivers. These caregivers are trying valiantly to save their loved ones, but the stress is in their eyes, in their movements. It is a very difficult position to be in, to chose to move in close and support the very ill patient. Moments of interchange between the caregiver and patient are excruciatingly poignant and painful. This illness is terrible for the patients. It robs them of much of life's normal activities and interaction, and yet the caregiver, in his or her giving, suffers terribly also - and this film delivers that message. A properly balanced interaction between caregiver and patient - something that is extremely difficult to get right - is depicted with extraordinary sensitivity by these filmmakers.

“Voices from the Shadows” is being shown in a special sneak preview at the IACFS conference in Ottawa, It is scheduled for viewing between 5:30-7 on Thursday September 22^nd. The end of the day is the wrong time to show this film. This should be shown at the beginning of each day to get the conference participant's minds focused on their task. This is a breakfast film. The film will disabuse the viewer of any false notions that they might have had about this illness, and replace it with known facts and reality. "Voices from the Shadows” is a labor of love. It strikes from the heart – to the heart. Everyone who has an interest in this illness should see this film – from beginning to end.

Thiamine

For years I have read about thiamine, and thiamine deficiency, in ME. Thiamine deficiency is known to cause many symptoms that are similar to ME. There are a few stories of people improving with taking thiamine injections. Here is one story. There are others, enough to make me wonder more than once over the past few years of the need to check for thiamine deficiency.

In the search for information about hyperacusis I came across this fine article by Melody O'Beau, written, I presume, years ago. In it she relates her experience with a rare metabolic disorder that short-circuits thiamine being taken up and used by the body. It is not so much the amount of thiamine in the blood, but more the "functionality" of thiamine in the body. This functionality is low, presumably the result of a missing enzyme. Melody postulates, in her case, that this is a mitochondrial defect. Coincidentally, a few months ago, Dr. Joseph Brewer handed me a copy of this same article (of which I was aware) but this "reminder" stirred my interest enough to finally pursue the functional thiamine test (for my daughter) suggested in Melody's blog.

This test is call the transketolase test and can be done for $1oo at the King James Medical Laboratory in Westlake, OH (1-800- 437-1404). The lab needs two blood vials, one ambient, one frozen, both shipped overnight. They give two result - one, a baseline blood level of thiamine, and two, a level of the functionality of thiamine under TP provocation. Results over 17% indicate poor functionally of thiamine - and the need to raise thiamine levels, most likely through injections. Results of raising thiamine can be dramatic.

Dr. David Bell writes about this low thiamin functionality in his Lyndonville News.

"Full thiamine deficiency is rare because of generally good nutrition, but some persons have a defect in the enzyme system that uses thiamine and as a result have dysautonomic symptoms. This can be detected with an erythrocyte transketolase index, where thiamine pyrophosphate (TPP) stimulation test greater than 14% demonstrates thiamine deficiency. The illness, caused by an enzyme abnormality, can be effectively treated by giving very high doses of thiamine which bypass the defect."

People with this situation have a difficult time raising thiamine with oral supplements. In this case, they take thiamine injections on a daily or twice weekly schedule. The injections can range from .1 ml to 2ml depending on the patient's particular need, which is determined by trial and error.

Thiamine function deficiency has been postulated to cause fatigue, muscular and sensitivity issues. The following bit of information appears on various sites: "Vitamin B1 (thiamine) deficiency produces optic nerve dysfunction". A noted mitochondrial researcher wrote to me, "The functional thiamine deficiency is an important finding as vitamin B1 is needed to get magnesium into cells. In muscle ATP always works as a complex with magnesium so correcting intracellular magnesium and factors that affect it like thiamine status is important."

From another dysautonomia study can be found this: "In spite of its largely unknown action TTP deficiency may play an important part since it is synthesized in mitochondria, supporting the conclusion that thiamine is an important nutrient where there is mitochondrial disruption."

Thiamine deficiency falls into the realm of something that is clearly identifiable and "something that is treatable". These are categories that escape ME patients except in rare instances - like Hashimoto's thyroiditis.

The internet is quite an amazing place to gather information. In this case the "trip-switch" information was written up quite a number of years ago by a seriously involved Lyme patient. Years later others are able to benefit from her written testimony/experience. I have communicated my appreciation to Melody herself, and noted the usefulness of this article written long ago.

Mitochondria

Recent events have gotten me to focus again on mitochondria and its relation to ME. None of the following is presented as medical advice or guidance. I am not a doctor and I do not want to be one. On the other hand, it is worth noting that those with ME are "on their own" when it

comes to medical diagnosis and treatment. The situation for ME sufferers is worse than the 19th century, when physicians at least would ply their trade.

Dr. Sarah Myhill's website, perhaps the most extensive ME website on the internet, has ample information on the critical role that mitochondria play in ME. It is a great starting point. Another informative article is by Dr. David Bell, and can be found in his Lyndonville News here. Dr Bell, an excellent clinician trying to find answers, has had a long-standing interest in the role of mitochondria in ME.

Various clinicians - Dr Joseph Brewer, Dr Sarah Myhill, Dr Paul Cheney - believe that mitochondrial irregularities play a part - perhaps a very large part - in ME/CFS. You can read an article by Dr. Myhill here. In this article Dr. Myhill outlines how mitochondrial failure plays such a very big role in ME. (Incidentally not everyone has caught on to this idea.)

Dr. Myhill collaborated with Dr. John McLaren Howard and Dr. Norman Booth in an important study published in January 2009. This paper, which can be viewed here, was presented by Dr. Booth at the IACFS conference in Reno, NV in 2009. A short article on these three researchers is available here.

Dr. John McLaren Howard is a real unsung hero in ME research. Dr. Howard co-founded Biolab in London (with Dr. Stephen Davies). Prior to retiring from Biolab a few years ago, Dr. Howard pioneered some very important testing in the area of mitochondria and ME. He has continued to do these tests at Acumen lab in Cornwall. His son Mark continues to work as Manager of Biolab.

Dr Myhill's website gives a good explanation of what Acumen is looking for in their testing.

The test itself is relatively easy to do. I believe my daughter was the first person from the US to do this test, back in 2007. In crude terms the test measures ATP function (the rate at which it is recycled into cells) and the efficiency with which ATP is made from ADP. Further testing looks at various blockages to the transport of ATP and ADP. Here is an example of an ATP results page:

The blood test requires one heparanised and one EDTA tube, shipped ambient via Fedex to Acumen lab in the UK. USA Fedex shipments have to be sent to Acumen labs, c/o Cameras Plus, 17A Gold Street, Tiverton, Devon UK EX16 6QB. The samples have to be shipped "international priority" which will get them to Dr. Howard in 48 hours. They need to be shipped in an insulated pack with the proper paperwork. Fedex will help with the international shipping label. They will not help with the packaging in any way. A triplicate copy of an international waybill needs to be filled out in a specific way, the process of which can also be learned through the Fedex site. If the blood is drawn into the correct tubes, if the shipment is packed according to international Fedex procedures, if the paperwork is filled out properly, the sample will breeze through customs to Acumen labs in a timely fashion. Some care has to be taken in these matters.

The test can be done through Dr. Myhill. She will write a particularized summary that is very useful. She has seen hundreds of these tests and works closely with Dr. Howard.

Rich van Konynenburg's thoughts (always welcome) on mitochondria and ME can be seen on the Phoenix Rising forum. This ME/CFS information site was founded by Cort Johnson. This website provides us all with much needed information and connections - and is an ongoing, necessary resource. Not a day goes by that I do not read it.

The big question is, once the specific mitochondria problems are identified, can these deficiencies be rectified? As with all matters with ME, the proof is in the pudding. It is trial and error - but at least the patient has a target, and a means of measurement and tracking. Many people have been helped by this test and its targeted treatment.

Is it possible that such sharp and diverse minds as Myhill, Cheney, Howard, Booth, Bell, and Brewer can be gathered around a subject - mitochondrial failure - and that there be nothing there? No, I do not think so.

The interesting thing about mitochondria dysfunction or illness in general is that it is viewed as a disease - as opposed to ME, which is viewed as nothing. At the moment there is broad attention being paid to mitochondrial diseases and mitochondrial dysfunction, and this reality opens up an entire area on to which ME might be able to piggyback. One of the greatest hopes for ME patients is that something will slop over from another research area - HIV, cancer, mitochondria, MS, stem cell - and inadvertantly land in the lap of ME.

Several national mitochondrial disease websites can be viewed here and here.

The proposed intervention, tailored by the physician to the particular needs of the patient, revolve around what is know as the "mitochondria cocktail". Dr. Myhill stumbled upon mitochondria support through the research of Dr. Stephen Sinatra, the American metabolic cardiologist. The mitochondrial cocktail consists of various supplements. These include NAD, Co-Q10, d-ribose, carnitine, Idebenone, b2 (riboflavin), b1 (thiamine), creatine, and magnesium and b12 injections. A good webpage that covers some of these supplements is this Medscape article. Each patient's cocktail is particularized - either by a physician or by trial and error. The experienced patient, whether with lyme or ME or both, will be able to tell what works for them, and what doesn't, thus devising their own balanced protocol.

Dr. Denise Faustman

I know nothing about science and its practitioners. Personal circumstances have led me to read and learn about type 1 diabetes research for almost 25 years now. The cure or solution to diabetes type 1 was always presented as being around the corner, five or ten years away. Diabetes, especially type 2, is a huge industry with great pressure against a "breakthrough". There have been several promising avenues towards a cure for type 1 that have been pursued over the years. One has been islet cell transplants - and a small company - LCT - in Australia leads the way in this field, struggling mightily for financial support. More recently promising trials have begun in the US using stem cells. There are many fine researchers working in the field. Of special note is Bernhard Hering here at the University of Minnesota.

One of the most astonishing researchers in the field is Dr. Denise Faustman. Dr. Faustman has developed her own ideas about how to deal with this nasty illness. She is a revolutionary thinker. For many years now, Dr. Faustman has met stiff resistance - in spite of being connected to a first class laboratory at Mass General. Most of her research financing has come from private sources - Lee Iacocca in particular. The main- stream diabetes research organizations have been strangely reluctant to get behind her. Others have spent some time trying to sidetrack or "borrow" her research ideas, at the same time discounting them. It is an ugly story. Dr. Faustman has remained unfazed through all this, and continued at her work. She is a remarkable woman and you can see an interview with her here.

Today there is the following article in the Wall Street Journal. The story is also in many other newspapers. The reader will notice that there are several interesting angles to this story.

Dr. Denise Faustman has long been a great hero to me, and this news comes as no surprise to me. She is one great gal. Many of the readers of this blog will not miss the parallels to another great researcher - Dr. Judy Mikovits.

Anonymous #3 - CFSAC testimony

May 10, 2011 To the Members of the Chronic Fatigue Syndrome Advisory Committee:

In 1994, I was a healthy 20-year-old college student who led an active, happy life. One afternoon in June, I was struck down by ME/CFS. Over the years I got gradually worse until I became essentially bedbound in 1999 and again in 2005.

My plans for graduate school, a career, marriage, and children have been on hold for 17 years..

I think there is a common misconception, even among doctors and researchers well-versed in ME/CFS, that this illness is not especially disabling. Even if they are unable to work, the thinking goes, most patients are able to take care of their basic needs and engage in activities of daily living.

That’s not the case for me and many people I know. Due to my extreme post- exertional fatigue, muscle weakness, and orthostatic intolerance, I’m forced to spend 95% of my time lying on my back on this mattress in my small bedroom with one window. I haven’t been able to take a shower since 2005—not even with the help of a shower chair. I bathe and clean my teeth in my bed. Once a month my elderly mother washes my hair for me in the bathtub.

My parents bring all of my meals to my room on a tray. If I want to go to another upstairs bedroom I have to be pushed in my wheelchair. I haven’t been able to go downstairs or outside since November. I’ve gone years at a time unable to leave my home, even to see a doctor. I’ve had periods of being incapable of feeding myself. I spend my worst days immobilized and unable to think, watching my bedroom get light, then dark, then light again. Outside my window, the seasons change, over and over.

My incapacity is not unique. One of my friends with ME/CFS hasn’t been able to leave her home in seven years and can’t walk; she uses an electric wheelchair to get to the bathroom. Another needed a catheter in her bladder because she couldn’t get up at all. Other friends are so weak that they can’t lift a cell phone or speak above a whisper. I’m lucky that my parents are supportive; some of the worst off have no financial or physical help from their families.

This intersection of severity and poverty turns their lives into a hellish struggle for food, shelter, and other basics of survival.

As severely ill as my friends and I are, many people are considerably worse off. At least I can type a little bit, lying down, and talk on the phone a couple times per week. But some patients have virtually no contact with other human beings or the outside world; their minds are too weak to hold a thought or to interact. They spend their years in an abyss of isolation and suffering.

How many patients are like me or worse? No one knows, because our government and advocacy groups have never studied us. Most doctors don’t know we exist because we have extreme difficulty going to their offices. We are excluded from virtually every research study, meeting and conversation about this disease.

Despite the realities imposed by severe ME/CFS, our government and even our largest advocacy group continue to portray this illness as a relatively benign condition that might slow people down for a few years, but otherwise isn’t a big deal. Average patients, according to them, should be able to undergo the CDC’s recommended treatments--exercise and psychotherapy—in addition to caring for themselves and maybe even working part-time.

For me, exercise is changing my nightgown. And the exertion of leaving my home for psychotherapy sessions—transported lying down—would set me back so far that I might not be able to lift a glass of water for a year.

Our government so devalues this illness that it spends 100 times more per capita on MS research than it does on ME/CFS research. As I struggle to brush my teeth and walk a few steps to the bathroom or bedside commode, I remember that our government considers my life only 1% as valuable as the life of someone with MS.

The government claims that ME/CFS is a poorly-defined condition, but surely I have as many abnormal test results as an MS patient: an abnormal SPECT scan; a LMW protein in RNase-L; undetectable IgA and low IgG3; POTS/NMH; and evidence for numerous infections (Lyme, Bartonella, Babesia, Erlichia, Mycoplasma, C. pneumoniae, EBV, and HHV6-B). I am also XMRV-positive.

On behalf of all the severely ill patients who can’t represent themselves at CFSAC or anywhere else, I ask you to pass vigorous resolutions on the following issues:

1. The International Classification of Diseases must accurately categorize CFS. This is an extremely urgent matter because the draft proposal is due to become final within months. The International Classification of Diseases 9 Clinical Modification (ICD-9-CM), currently used in the United States, will become the ICD-10-CM in 2013 and remain our country’s medical bible for years or decades. Unfortunately, the draft proposal for the new edition continues to place CFS in a wastebasket section of the ICD for “ill-defined conditions”. Another problem is that CFS will be renamed to CFS NOS (Not Otherwise Specified) . Excluding CFS from classification as a neurological disease under G 93.3, and renaming it CFS NOS, perpetuate the myth that CFS is a vague, poorly-defined non-disease. These actions may cause us to be labeled as hypochondriacs or malingerers, may adversely affect our insurance and disability payments, and will undermine research efforts into biomedical causes of CFS.

You must strongly advise that the CDC reclassify CFS as a neurological disease under G 93.3, the code used for CFS by the rest of the world in their versions of the ICD.

Secretary Sebelius must be made aware that this is a serious issue with a looming deadline. Furthermore, please discuss additional means of pressuring the CDC to recode CFS under G 93.3.

2. In the name of equal rights for equal disability , you must pass a resolution seeking parity in funding for ME/CFS research. ME/CFS should receive funds from Congress commensurate to the serious nature of the disease, and equivalent to what is received by similarly disabling illnesses, like MS. Asking for $100 million in funds would be a step toward righting the current gross disparity in research dollars.

3. The NIH has rejected every grant proposal from the Whittemore Peterson Institute since the publication of its landmark paper in Science linking ME/CFS to the retrovirus XMRV.

Please pass a resolution stating that this is unacceptable, and investigate why this has occurred. Is it because the Special Emphasis Panel responsible for reviewing ME/CFS grants is composed of so many dentists, psychiatrists and psychologists? If so, the review process for ME/CFS grants needs to be changed, perhaps by moving ME/CFS research out of the ORWH to NIAID.

4. Please resolve that the use of the Empirical Definition (Reeves Criteria) in research is absolutely unacceptable and should not be funded by the United States government. The Empirical Definition does not correspond to any disease entity but to a hodgepodge of psychiatric conditions, simple tiredness and unwellness.

Research based on this definition, which grossly inflates the number of Americans with CFS, is virtually meaningless. Furthermore, please advise the CDC and NIH to adopt the Canadian Consensus Criteria, or the equivalent, as the its official ME/CFS definition.

Thank you. It will take me a week to recover from writing this letter, which was the only activity I could manage for several days.

Sincerely, Anonymous

A voice for the most severe ME patients

It is always of interest to read about the ineptitudes of the functionaries who work for the United States Government. We must thank Dr. Joan Grobstein for her letter to Wanda Jones, outlining the abuse dished out to those ME patients who can actually move and attend a CFSAC. With these recent incongruities we are entering a zone of total absurdity and contempt. Something needs to change at the highest levels of the federal government in relation to this ME disease. They have gotten a free pass for too long and they take advantage of it with continued abuse toward these patients.

Consider for a moment the reality of this illness and of those who suffer at the very bottom. This is where the nuts and bolts of this illness presents itself and where research needs to be directed. Natalie Bouton has done a great service for the rest of us and for the uninitiated by giving us the InvestinME sponsored book "Lost Voices" which documents the most seriously ill ME patients. Soon we will be able to see an astonishingly powerful video produced by Natalie and her son Josh. It packs a wallop and presents this illness at its ground zero moment.

Another powerful articulate and sustained voice of the desperately ill has emerged recently and can be viewed here.

Dr Joan Grobstein - CFSAC videos

Dr. Joan Grobstein has testified four times at the CSFAC meetings in the last two years. What she has to say is very important and the government knows this. They are afraid of her and for good reason.

May 2011



October 2010

http://hhs.granicus.com/MediaPlayer.php?view_id=5&clip_id=99

Dr. Grobstein's testimony is Day 2 public speaker number two.

May 2010

Dr. Grobstein testified a fourth time and it is available here:

http://www.hhs.gov/advcomcfs/meetings/index.html Look under CFSAC Oct 29-30 Day 1. I think you need Real Player. Dr. Grobstein is the 5th speaker at 3h 35 min.

The text of the original written testimony follows:

Here is Dr. Grobstein's written testimony, which she read at the 2009 CFSAC. It is different than the online version. It is a well known detail that those presenting patient testimony have to submit an sanitized version. At the presentation they then say whatever is on their minds.

CFSAC Oral Testimony October 2009

"Hello. I’m Dr. Joan Grobstein. I’ve been a physician since 1977, last working at Children’s Hospital of Philadelphia Division of Neonatology. I’ve had Myalgic Encephalomyelitis/Chronic Fatigue Syndrome since 1999. I’m a doctor and a patient. I‘m going to talk about science and ME/CFS.

To be blunt, scientific research on ME/CFS is a mess. Given how little time I have, I’ll focus mainly on the worst offender, the CDC. The CDC has underfunded and underinvestigated this disease since their initial involvement in the mid-‘80s. They’ve also failed to correctly define the disease. In 1994, they created the Fukuda definition, which is flawed but which has been used to define the CFS data set for fifteen years, resulting in a significant body of research.However, oddly, in 2005 the CDC redefined the data set. Perhaps they noticed research using the Fukuda definition seems to suggest physiologic explanations for ME/CFS symptoms. One wonders. In any case, using the new Reeves 2005 “empirical” definition, their estimate of the number of people with CFS in the United States suddenly jumped from one million to 4 million people. Basically, they created a new, unverified definition which defined a new, much larger data set, and they still used the name CFS for this very different data set. This is outrageous!This isn’t science--it’s a shell game.

Dr. Peter White was involved in a similar definitional misadventure in the ‘90s, also muddying the research waters. He helped develop the Oxford definition, which was actually a description of Idiopathic Chronic Fatigue, which is not CFS. Putting a prestigious name on a definition does not necessarily give it a useful meaning.

As Dr. Mikovits and her colleagues have shown so brilliantly in the past month, when researchers look at patients that meet the Fukuda & Canadian consensus criteria, they can quickly begin to discover potential mechanisms and possible treatments for this severe illness.

So how do we find our way out of this mess? We need to tidy up the literature, so we know when we’re talking about apples and when we’re talking about oranges. I suggest the following solution: Until we have a better name, call the cohort of patients who meet the Fukuda criteria:CFS-Fukuda; the Canadian Consensus cohort: CFS/ME; the Ramsey cohort: ME; the Oxford criteria cohort: Idiopathic Chronic Fatigue; and the Reeves definition cohort: Reeves’ disease.After removing CFS-Fukuda, CFS/ME and ME from the Reeves cohort, Reeves’ disease will probably consist of a group of people with Idiopathic Chronic Fatigue, various other undiagnosed conditions, and some, but not all, people with major depressive disorder. These people deserve study and treatment, but they do not have ME/CFS.

It is very important that any ME/CFS study published states in its abstract which group is being studied. A retrospective review of all previous CFS studies should be funded in order to determine what group of patients were actually studied. Research on Idiopathic Chronic Fatigue is not relevant to ME/CFS.

I suggest the following recommendations to Secretary Sebelius:

1. No taxpayer dollars should be wasted on ME/CFS research which uses the Reeves definition.All federally-funded research should use the Fukuda criteria & the Canadian Consensus Definition.

2. Abandon the CDC’s current proposed 5 year plan. Ensure that this Committee’s previous recommendation for a change in the CFS leadership at the CDC actually happens. The new leadership should propose a new 5 year plan which should then be reviewed by anunbiased panel. Meanwhile, make the taxpayer-funded data that the CDC has already collected available to all researchers to analyze.

3. If the XMRV connection to ME/CFS is confirmed, initiate a congressional inquiry into why Elaine DeFreitas’ research into retroviruses and ME/CFS was not pursued in the early ‘90s. Many people may have been harmed by this decision.

Finally,

4. Increase funding for ME/CFS research. Patients and doctors need more information.Designated funding for a collaborative trials network is imperative, as is the retrospective review previously discussed.

I could say much more, but my time is up. I have submitted written testimony. Thank you."