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."

Dr Joan Grobstein - CFSAC testimony May 2011

Hello. I’m Dr. Joan Grobstein. I’m a physician.

Here we are again.

At the beginning of the NIH State of the Knowledge Workshop, Dr. Mangan emphasized that the Workshop was “not designed to prioritize or establish an agenda for future initiatives.” But we need to do this. In the absence of leadership from the NIH, the CDC, this committee or any other agency in the Department of Health and Human Services, I’m going make suggestions that should be implemented within the next six months.

First, I'm going to present a case.

I have Pat Fero’s permission to talk about her and her son, Casey. Pat’s acute onset ME/CFS started in 1980 with a viral-like syndrome. Casey was born prematurely in 1982. He was first diagnosed with ME/CFS at age 9 and worsened at age 15. He died suddenly at age 23. An autopsy was done. The pathologist told Pat that Casey’s heart tissue was “loaded with viruses, inflammation and fibrosis”. The University of Wisconsin lost the heart tissue blocks. The viruses in Casey’s heart were never identified.

What does this case tell us about priorities and an agenda for future initiatives?

First, it tells us that it is very likely that ME/CFS is transmitted within families. Establishing the mode of transmission should be the highest priority. As far as I know, the CDC has never investigated family clusters. It also hasn’t investigated geographic clusters for more than a decade. ME/CFS should be a reportable disease, so that clusters can be identified. To make it possible for physicians to report the disease, they must have a precise case definition. The best definition available is the Canadian Consensus Definition. It should be adopted now and disseminated to all physicians. Until we know who has and doesn’t have the disease we cannot study it. Epidemiologic studies should start immediately. Special attention must be paid to identifying the sickest, housebound patients, many of whom aren’t receiving any medical care. This is a disgrace.

Second, Casey’s disease progressed over time and resulted in death. We don’t know the natural history of either untreated or treated ME/CFS, although many people with the disease are not only untreated but undiagnosed. The CDC should conduct observational, longitudinal studies of Canadian Consensus-defined ME/CFS.

Third, it’s very likely viruses are involved in ME/CFS, and myocardial infection is possible. Japanese researchers have identified “small heart syndrome” in ME/CFS patients, which may reflect cardiac infection. Of course, other organ systems, including the CNS and Gi tract, may be infected. Sites of infection may vary from person to person. It’s urgent that associated viruses be identified and treated, if possible. New antivirals may need to be developed. The NIH and the CDC should work together to identify viruses that are associated with or cause ME/CFS. This is a very high priority.

Fourth, medical schools don’t take ME/CFS seriously. The NIH should convene a meeting of medical school leaders to educate them about the seriousness of this disease.

Finally, Casey was not treated successfully. Treatments for ME/CFS exist. Expert ME/CFS clinicians are using antivirals, dietary supplements, sleep medications, and treatments for orthostasis among other therapies, and they are improving the lives of many patients. The NIH should convene a meeting of expert clinicians to formulate guidelines for diagnostic testing and treatment.

The CDC website is inaccurate and misleading. It needs updating immediately. For example, the CDC says that tilt-table testing for orthostatic hypotension is experimental. This is incorrect. The test has been used for 15 years at Johns Hopkins, and orthostasis is a frequent and treatable finding in ME/CFS patients. The website also says testing for viruses is not indicated, yet several clinicians are having success treating viral infections. The website should cite the Canadian Consensus Criteria as the correct definition for ME/CFS. Many people visit the CDC website for information about ME/CFS. It must be accurate.

Thank you.

Mindy Kitei testimony - CFSAC, May 2011

Here is the testimony of Mindy Kitei at the recent CFSAC meeting. Mindy has a strong and clear voice and this testimony is especially powerful.