CFSAC Testimony from November 2011 

This is the real public testimony from the Chronic Fatigue Syndrome’s Advisory Committee. People like you and me told there stories. (source: CFSAC HHS website) There’s a lot of testimony….so keep scrolling down.

Testimony 

Anonymous #1  

Dear CFSAC panel.  

Thank you for your service. I hope that Secretary Sebelius truly listens to your directions and acts. Unfortunately I haven’t seen much action since I got ill in the fall of 2008.  

Over the past few months, we have witnessed some good scientific debates with exposure to other scientists, and great potential for research breakthrough and funding dollars. Still there is no promises and no grants have been promised, other than a 600 000$ to research behavior changes. 

Patients need more than a change of their behavior, in the same way that AIDS patients will not get better by eating less fat and more vegetables.  

The CDC promised they would remove offending parts from their website. 

We have discussed it for the last years. They have not done one change to their website. So my physicians are still being told that I should exercise more, that they should prescribe more anti-depressants and that my natural killer cells should not be tested. It is critical that the CDC gets on with the program, so to speak, and stops studying behaviors and psychology, association with painful periods and more gyne problems. Patients need to know if they have more chance to give birth to children that will have either autism or ME/CFS. Patients need to know if their disease is transmissible sexually or casually.  

The CDC needs to apologize to all patients with ME/CFS for the despicable joke they have made of our disease. They need to recognize that they have been wrong since visiting Incline Village and since NOT visiting Lyndonville and take responsibility for stalling research as well as what they didn’t do over the last decades, while other diseases like Rheumatoid Arthritis, HIV/AIDS, Cancer, and others benefited greatly from good research and funding.  CFSAC needs to recommend careful research on XMRV and human gamma retroviruses. Some patients are helped with the use of antiretrovirals, which has not been studied formally but prescribed to them compassionately. With the media outlets promoting contamination theory on both sides of the ocean, Dr Mikovits and her group’s theory has been torn apart. Research in HIV would have stopped in 1983 but patients were dying so the government was forced into putting money into research. Here we are a very stigmatized group of patients who literally disappeared from society, however somehow it is considered ok to forget us over and over, because we are not dying, and because we are literally subdued- we can’t even protest in the streets. It doesn’t make it ok to keep on abusing us or make fun of us as a bunch of tired people. It is not ok for the governments of any countries to keep on abusing their patients and denying them a chance at being productive and thriving. 

It is in my belief that the clinical trial to confirm the very positive effect of Rituximab needs to happen as soon as possible. With this new data comes many questions. Is ME/CFS an auto-immune illness? Which patients are more likely to respond to Rituximab? Willrheumatologists embrace our illness and give us patients the opportunity to get well like the dozen of Norwegians who benefited from Rituximab? How are the side effects and response rate comparing to Ampligen, which 15 years later is still not approved as an acceptable treatment for ME/CFS by the FDA?  

How can CFSAC and Secretary Sebelius facilitate the involvement of rheumatologists with our illness, giving patients the possibility to get treatment near their community? Could this be legislated?

The reluctance from the medical community to embrace ME/CFS as an illness is huge. There needs to be an intervention somehow, somewhere. Every single patient with our disease has at least one incident  where they feel they were disrespected, not believed, refused treatments and told to exercise and go to a psychiatrist. How many more suicide do we have to witness before our governments start to act?

Patients have had hope for two years, and promises for clinical trials and treatments. This has yet to happen. Do we have to wait another two years until Rituximab can be approved?  Where is the hope when patients cannot see it at their local level and when the CDC cannot be trusted to spread the right message around the world?  

Patients from around the world are looking up to you, CFSAC members and US government. The Norwegians have stepped up for their people. What will the USA  choose to do?  

Anonymous, sick for the last three years; disability insurance in dispute; inancially going into a dark, dark hole. Seen by a dozen specialists, 75% of whom lack respect for this disease. 15% more who have no clue as of what to do.

Testimony 

Andrew Bokelman 

Thank you to the CFSAC for allowing me to speak. My name is Andrew Bokelman. 

Before I became ill with chronic fatigue syndrome, I didn’t take it seriously. But now I can tell you just how serious it is. In late 2005 I was hit with chronic fatigue syndrome. In January 2008, I was diagnosed with prostate cancer. Three months later I was diagnosed with a squamous cell carcinoma in my tongue.  And now I also suffer collateral damage from cancer treatment.  And after all of this, I can honestly say that having chronic fatigue syndrome has been much worse than dealing with two cancers. Because it is not cancer that keeps me from working and visiting friends.  It is not cancer that makes me so, sick I need help with basic personal care. It is actually chronic fatigue syndrome that has destroyed my life, as I used to know it.

Some people dismiss CFS because many of us don’t look sick. But I also didn’t look sick when I was diagnosed with cancer. And nobody used this to dismiss cancer. Other people dismiss CFS because some of us can articulate with the same strength and focus as healthy people. But I also articulated okay with a cancer tumor in my tongue, and I still can despite stiff scar tissue from radiation treatment.  And nobody uses this to dismiss cancer. With most illnesses, people are seen as heroic for all they accomplish despite being sick. But with CFS, our accomplishments are used to dismiss us. They are used to discredit us. 

So what is causing this dismissive attitude?  I think one problem is the fatigue-centric model. The illness name is misleading. The description is misleading. Most doctors who know the full description still think in terms of fatigue.  They look only for energizing solutions.  They ignore inflammation, immunity, and neurocognitive issues.  In my opinion, part of this problem could be solved if the name and description were changed according to the International Consensus Criteria. 

But I also think the available information about CFS is a problem.  

Imagine, if you would, that someone did a study on subjects who have chronic coughing and gave them sugar lozenges, and found moderate improvement in some subjects.  And then I took this study and claimed sugar lozenges treat asthma, while ignoring that the subjects were not evaluated for asthma, only for chronic coughing. Sounds crazy doesn’t it.  Yet, this is the type of thing that is being done with CFS.  For example, on the Centers for Disease Control website there is treatment information that cites Oxford criteria studies.  These criteria define a different syndrome that only requires physical and mental fatigue. No sore throat, no tender lymph nodes, no post exertion malaise. So it is not chronic fatigue syndrome – as defined in the United States.  It only has the same name.  And using different syndromes as if they are interchangeable is bad science, no matter what you name them. 

Yet, the CDC and others have been doing this for years. 

Do you think the Department of Health and Human Services would be complacent if their divisions used generic coughing studies to evaluate treatments for asthma, pertussis, or lung cancer?  Would you like this approach used with the medical care of your family?  In my opinion, the 

DHHS should stop condoning this, and instead, they should explain to people how this corrupts the understanding of CFS.

Further, the clinical section of the CDC website is missing important information about medications.  Now, I realize that pharmaceutical research is very limited.  But it is more reliable than treatment models based on the wrong syndrome.  So why not include the better medications, but also explain the limitations. 

There is new leadership in key positions at the DHHS and CDC.  So finally, the possibility exists for ending the practice of misrepresentation and selective omission of CFS information.  I’ve seen some positive change already.  I hope this is a sign of more to come, and not just a brief flurry of activity. 

Thank you for letting me speak.

Testimony 

Mary Dimmock 

Thank you for this opportunity to talk to you today and for all that you do for this community as individuals and as a committee.  Your efforts are essential. I am the mother of a 24-year-old man who came down with ME/CFS in 2010. Since then, I have had to come face-to-face with the hard reality that he is sick with a disease that patients have suffered tremendously from for thirty years, many barely eeking out an existence and others dying prematurely.  

Thirty years during which our government has neglected this devastating illness by seriously underfunding research and diddling around with studies focused on psychiatric issues. Thirty years during which the devastating neurological disease from which patients are suffering has become hopelessly confounded with generalized fatigue and depression. Thirty years with doctors ignoring them or worse, giving them harmful advice.  

I wake up every morning, thinking that this can’t really be happening. What parallel universe have I entered? 

Others will speak to you of the desperate need for adequate funding to support biomedical research specifically into ME/CFS. I am here to ask you for two things that I think are also critical to getting us out of this mess - reclassification of CFS as a neurological disease in the ICD-10-CM and replacement of Fukuda with a case definition that truly reflects the specific and unique nature of ME/CFS as a disease with significant neurological pathologies.  

Regarding the reclassification of CFS in ICD-10-CM: 

First let me acknowledge that everyone wants the name CFS to be wiped out. But obviously, this will not happen overnight. Until that happens, it is critical that CFS, the name actually used in the U.S., be properly classified.  The reclassification proposal that I authored and that was submitted to NCHS by the coalition requested exactly what you recommended – reclassify CFS from its current position under ‘Chronic Fatigue’ in Signs and Symptoms to G93.3 in Diseases of the Nervous System. As you know, this is exactly how it is listed in ICD-10. However, NCHS is concerned that doing this will result in the loss of historical data that has been collected specifically for CFS and PVFS, which currently use separate codes. In the September 14, 2011 meeting materials, the NCHS stated that these separate codes allows ‘the differentiation of cases of fatigue syndrome where the physician has determined the cause as being due to a past viral infection from cases where the physician has not established a post viral link”.   To address this concern, the NCHS has put forth their own proposal, called Option 2, which creates one sub-code for ME/CFS cases that are virally triggered and another sub-code for cases that are not virally triggered.   

Option 2 is not acceptable because it does not comply with the Canadian, the ME International or even the Fukuda case definitions, which do not discriminate into two separate diseases based on the trigger. It also doesn’t agree with published studies or diagnostic practices which result in a CFS diagnosis for those with a viral trigger. Implementing this option will further confound an already tortured disease definition. If the NCHS mandate to track their historical data requires that PVFS and CFS have separate codes, then the NCHS must consider available alternative options before the ICD-10-CM is implemented in 2013.  

Given your role to advise HHS on the science and definition of ME/CFS, I ask that you actively work with NCHS to ensure that the final decision on reclassifying CFS reflects the best option for the ME/CFS community.  I also ask that you work with NCHS to ensure that this change is made before ICD-10-CM is implemented in 2013. Further details are in the written version of this testimony.  

Reclassifying CFS in ICD-10-CM is an important step, a declaration that we are not talking about generalized chronic fatigue or a psychiatric illness.  But alone, it is not sufficient, which brings me to my second request.  

Some patients have voiced a legitimate concern with reclassifying CFS as a neurological disease in ICD-10-CM as long as Fukuda is the case definition used by the CDC. The concern is that Fukuda does not describe a neurological illness, does not adequately describe other facets of the disease or even require the hallmark post-exertional malaise as a necessary condition.  

What do we get instead with Fukuda?  A “conceptual framework to study fatiguing illnesses” and a Chinese menu of optional symptoms. No wonder ME/CFS has become so confounded with depression and chronic fatigue. No wonder we have such paltry and potentially harmful information on diagnostics and treatment on the CDC website.   Will the latest CDC’s educational efforts discussed by Dr. Unger at the New Jersey CFS meeting in Oct 2011 use this same foundation?  God help the patients if that is the case.  

Given its age and its focus on fatigue, Fukuda is incapable of reflecting what is known about this disease today.  It has outlived its utility, especially in the arena of clinical care. But there are other established case definitions that do reflect what is known - the well respected and tested Canadian Consensus Criteria or the recently released ME International Consensus Criteria.  Case definitions shaped by ME/CFS experts through the last 30 years of working with real ME/CFS patients.  

Like others before me, I ask that you take your recommendation to reclassify CFS as a neurological disease to its logical conclusion. I ask you to work assertively with the CDC to get rid of Fukuda and replace it with a proper case definition that reflects the unique and specific range of neurological and other pathologies that mark ME/CFS.   

Until this happens, patients will continue to suffer and die in their parallel universe. 

Thank you.

Additional details on the ICD-10-CM proposal.  

1. The proposal submitted by the Coalition to the NCHS was to move CFS to G93.3 where 

PVFS and ME are. This recommendation is aligned with how CFS is represented in the ICD-

10 used across many countries and also with other IDC-10 clinical modifications. The proposal also requested that this change be expedited before 2013 when ICD-10-CM rolls out. This is needed to correct the current situation, which lists CFS under Chronic Fatigue.  

The NCHS has accepted this proposal for review and called it Option 1, listed below. 

2. NCHS is concerned with this proposal because they have historical data on CFS and PVFS that would be lost if the two terms were to be merged under one code. Currently, PVFS and CFS have different codes. This is not an issue for ME since ME is rarely used. As a result of this concern, NCHS countered with a proposal called Option 2, which creates two sub-codes 

- G93.31 for PVFS and ME and G93.32 for CFS.  

In the materials for the Sept 14, 2011 meeting, the NCHS has stated that the current version of ICD-10-CM, where CFS is at R53.82 and PVFS is at G93.3 allows ‘the differentiation of cases of fatigue syndrome where the physician has determined the cause as being due to a past viral infection from cases where the physician has not established a post viral link”. 

Splitting ME/CFS into two separate diseases in this way is not supported by case definition since the ME/CFS Canadian criteria, the ME International Consensus Criteria and even the Fukuda definition do not discriminate cases into two separate diseases based on the trigger. 

Further, as reported by patients, cases with viral triggers still get a diagnosis of CFS. Finally, the literature itself includes both viral and non-viral triggers in the various studies into CFS or ME/CFS.  

Selecting Option 2 will only further exacerbate a poorly understood disease. 

3. In response to Option 2, which was made public a few days before the meeting, Option 3 was presented at the Sept 14 meeting. This option avoids the concerns stated above.  

Unfortunately, Option 3 is not being considered at this time and would have had to be submitted with the original proposal before July 15, 2011 to be considered for review.  

As a result, of the two options that the NCHS has agreed to consider, Option 1 is the only acceptable option for the reasons stated above. However, If the NCHS needs to be able to maintain their historical data, it is imperative that they consider Option 3 or other similar options. Doing so will likely require the submission of another proposal under expedited review to ensure that the selected option best meets both the needs of the ME/CFS community and NCHS’ data tracking needs and is implemented before ICD-10-CM is rolled out in 2013. 

In addition to making a recommendation for the appropriate option, other specific issues that need to be addressed across options before NCHS makes a final decision include: 

1. The heading of the G93.3 category for Option 2:  

When the NCHS created Option 2 and moved PVFS to a sub-code, they needed to have a new heading for G93.3. The term that was selected was “Postviral and Other Chronic Fatigue Syndromes”. This is a terrible heading that extends the disastrous legacy of the name CFS. An alternative name of ‘Post-infectious Fatigue Syndrome’ was presented as part of Option 3. It is recommended that this or a similar name that is compliant with WHO standards be used instead of ‘Postviral and Other Chronic Fatigue Syndromes’ for any option that creates sub-codes under G93.3. 

2.   Exclusions

ICD-10 and ICD-10-CM contain exclusions to control how two diagnoses are given to the same patient. The NCHS has recommended an Excludes2 between Chronic Fatigue and Chronic Fatigue Syndrome meaning that a patient can be diagnosed with both conditions at once. As recommended by an attendee at the September 14, 2011 meeting, this should be an Excludes1, which effectively prevents a patient from being diagnosed with both Chronic Fatigue (CF - the general sign and symptom) and Chronic Fatigue Syndrome. This should be done regardless of the option selected and should probably be done for G93.3 as a category. 

The ICD-10 contains an exclusion between Neurasthenia and the G93.3 category, which appears to be missing in ICD-10-CM. An Excludes1 should also be added back in here as well.  

3. Use of the term Chronic Fatigue Syndrome NOS The draft ICD-10-CM uses the term CFS NOS under Chronic Fatigue. In the materials for the September 14, 2011 meeting, the NCHS stated that CFS NOS means “not specified as being due to a past viral infection”. This usage has been carried over into Option 2. For the reasons stated above, it is inappropriate to use the term CFS NOS and would likely be problematic in implementation since patients don’t always know what the trigger is. The word NOS should be dropped.  

Details on the three options

Option 1 (Proposed by the Coalition and included in the NCHS material for the Sept 14 meeting) 

G93 Other Disorders of the Brain 

G93.3  Postviral fatigue syndrome 

            Chronic Fatigue Syndrome 

           (Benign ME is already listed against G93.3) 

Option 2 (Proposed by NCHS and included in the NCHS material for the Sept 14 meeting)

G93 Other disorders of the Brain

G93.3 Postviral and other chronic fatigue syndromes

G93.31 Postviral fatigue syndrome 

 Benign myalgic encephalomyelitis 

G93.32 Chronic Fatigue Syndrome 

 Chronic Fatigue Syndrome NOS 

 Excludes2: chronic fatigue, unspecified 

Option 3 (Coalition counter-proposal)

G93 Other disorders of the Brain 

G93.3 Post-infectious Fatigue Syndrome 

G93.31 Postviral fatigue syndrome 

G93.32  Myalgic encephalomyelitis (benign) 

Chronic Fatigue Syndrome 

Excludes1: chronic fatigue, unspecified  

Excludes1: neurasthenia

Testimony 

Pat Fero 

Recorded in the Minutes of the fall 2008 CFSAC meeting is inquiry from Dr. Jason and Dr. Klimas about NIH funding allocations and success rates for CFS grants. Dr. Hanna (pg. 14) suggested that the inconsistencies in reporting grant awards year to year will be clarified once the Research Condition and Disease Categorization system is in place in 2009. 

Since that time, I delivered a report of a 10-year summary of NIH CFS funding patterns showing that awards for CFS specific funding are limited to one or two grants per year. In addition, I included, but did not highlight the fact that millions of dollars are shown as CFS research expenditures but are not spent on anything CFS related.  I watched the <Grants.Gov> July 2011 webcast on ethics, investigator reporting, and definition of misuse of funds. From FOIA requests, 2000 – 2010, I once again isolated those awards that concern me. Charlotte Von Sails and I began an intense search to track grant activity of those in question. 

 We agreed to look at all grantees via NIH Reporter, PubMed, their affiliated institution, and Google hoping to find any references to CFS. 

Our goal was to eliminate any researcher from the long list of researchers with apparent misspending.  What follows is a listing of grant number, grantees and their affiliation, project name and the total dollar amount spent and recorded as CFS expenditure from 2000 – 2010. 

These awards are unrelated to CFS. The total dollar amount is $18, 563, 463. That’s right. About 18.5 million dollars.   

A grant award is a legally binding contract. A material deviation from what the researchers propose in the grant and the work outcome gives cause for probable concern. It warrants investigation. Charlotte and I plan to follow through with the Office of Inspector General. I will highlight a few awards that are questionable. Lastly, this report is preliminary and when I testify on November 8 or 9, I may bring changes. 

CFSAC Testimony – Schweitzer  

Testimony  

Mary M. Schweitzer, Ph.D. 

My testimony today will be about the CDC’s program on CFS. 

I have been coming here since 1996.  I have a number of questions that have never been 

answered.  I will be asking my Congressional delegation to see if they can get answers if I cannot get straight answers this time. 

Topic I – That paragraph on CDC’s website listing everything I should not be tested for because I have a diagnosis of CFS. 

1.  What is the scientific and scholarly rationale for the list of tests that should not be given to patients with CFS or suspected of having that is on CDC’s website?  I testified about this as recently as last spring, and we were told it was to be removed.  It has not been removed. 

2.  The primary rationale given for this list is that none of these tests can prove that a patient has CFS.  That is accurate.  However, many of them diagnose conditions and abnormalities that published peer-reviewed research has shown correlate with a diagnosis of CFS (Fukuda 1994).  Is the only reason for testing to prove or disprove a condition?  

Do we do this with MS, cancer, AIDS?   

3.  Earlier this week NIH issued a major press release on the creation of a vaccine for Epstein-Barr Virus.  Presumably, then, EBV is a serious disorder.  That paragraph says not to test for EBV unless you are excluding a diagnosis of CFS.  I have tested positive for EBV at least seven documented times.  I just got over a recent bout of active EBV.  

Unlike the other viruses that are active when I am not on Ampligen (a Phase III immune modulator that I have been taking since 1999) EBV comes and goes.  The press release makes it sound as if that is important information.  I have three questions about that, then: 

     a)  There is evidence that many patients with CFS (Fukuda 1994) begin their experience with the disease with a case of EBV.  Do you think that might have been important information to include in the press release?   

     b)  The press release was very strong on the hypothesis that EBV leads to cancers.  If a person has numerous bouts of reactivated EBV, is he/she more likely to develop cancer?  Do you even know?  I’ll answer that:  you don’t keep statistics on it, but Dr. Peterson does.  The answer is a preliminary yes.  I happen to be one of them. 

     c)  If I have recurring bouts of EBV, does that mean I do not have CFS?  (At least 7 times documented in the past two decades.) What then would my diagnosis be, and could somebody communicate that to the infectious disease specialists in my home state of 

CFSAC Testimony – Schweitzer

                         page 2 

Delaware, the people who run Medicare, and the people who run Blue Cross/Blue Shield? 

     d)  According to my current doctor, Derek Enlander, I came to him with viral encephalitis (which he calls encephalitis).  Can we change all my records to say that?  Do you think it has anything to do with being positive for EBV, CMV, HHV-6A, HHV-7. with CMV and HHV-6A positive in my spinal fluid?  (I also have Cocksackie B.)  Where do I fit in that paragraph now?  Should I not have been tested for viruses?  Is this evidence Unimportant?   

4.  We can go through this exercise with everything for which I test positive, because everything for which I test positive is in that paragraph.  What does it mean that when off Ampligen, I have the 37kDa Rnase-L defect, a natural killer cell function barely off the floor (2% last time I checked), abnormal cytokine patterns, abnormal SPECT scans, abnormal VO2 MAX scores, diagnosed NMH/POTS, diagnosed Hashimoto’s thyroiditis and hypothyroidism.  Symptoms of viral encephalitis and significant Central Nervous 

System disruption.  Now what does it mean that I have recurring EBV, and chronically active HHV-6A, HHV-7, Cytomegalovirus, and Coxsackie B?  Is this UNimportant?   

Can you assure me that if these viruses are left untreated I will not develop cancer from them? 

Topic II – The CFS Toolkit for Professionals 

There is a new CFS Toolkit for Professionals on CDC’s website.  In fact, there are two new versions of the “CFS Toolkit for Professionals.”  Oh joy.  One is a very pretty trifold.  The other is the usual 8 ½ by 11.   

Both of these versions of the “CFS Toolkit for Professionals” lean very heavily on “Cognitive Behavior Therapy” and “Graded Exercise” as the only remedies that can be offered patients with the disease. 

When asked about it, in the past, CDC has always answered that counseling is often helpful to patients with a long-term illness.  This is true.  They have also always answered that deconditioning is unhealthy and therefore it is a good idea to get the patient moving.  This is not necessarily true. 

But the entire effort is deceptive.  In the context of this disease, a very rigid form of Cognitive Behavior Therapy and Graded Exercise (abbreviated CBT/GET) is the subject of hundreds of refereed journal articles, and it is controversial.  It is the only treatment offered to patients with diagnoses of “CFS” or “Myalgic Encephalomyelitis (M.E.)” (not the same thing) by Public Health Services in the United Kingdom. 

So I must ask:  

CFSAC Testimony – Schweitzer

What is the scholarly and scientific basis for emphasizing CBT/GET in the material that 

CDC sends out to the public on this disease?  

First we could ask – do they mean the rigid version that is in hundreds of referee journal articles?  Perhaps at CDC they just don’t do their homework on these things.  Perhaps they just take it at face value that these are no more nor less than offering counseling and physical therapy.   

If that is true, why then does the CDC’s website refer to St. Bartholemew’s Hospital in London to explain what GET is?   

The website at St. Bart’s (as it is familiarly known) is part of the clinic run by psychiatrist Peter White, who is also Chief Medical Officer of two insurance companies – Scottish Provident and Swiss RE.   

As it happens, Peter White was one of three professionals asked to review the CDC’s five-year plan for CFS in 2009.  His Conflict of Interest Form does not mention that he holds an executive position with two insurance companies.  It says, “Peter White was not paid for his services by CDC; as a consequence, there is no conflict of interest.”  Is that true?  It doesn’t matter that he’s an executive at two insurance companies? 

Well, for what it is worth, the program of CBT/GET that is recommended at St. Bart’s and British National Health Services – and by our own CDC – has been embedded in the policies of these insurance companies when it comes to reimbursing patients for medical care or granting them disability.  Dr. White insists that patients go through a ten-week course of CBT and GET before they are permitted any other treatment and before they are allowed disability.  If the patient cannot complete the course (i.e., physically collapsed), that is written down as having “quit” and therefore the patient is “noncompliant.”  Funds denied. 

Imagine my dismay to learn that my own Delaware Blue Cross/Blue Shield, which has been paying my doctor bills for over three decades, will not pay for my treatment for “CFS” at Dr. Enlander’s unless he first sends me to get ten weeks of Cognitive Behavior Therapy!  Now, my Congressman is working on this, but gosh, THANKS for that. 

Dr. White is also lead author on the very expensive PACE trials that were recently conducted by the UK to see if CBT/GET was effective.  Amazingly, despite using a definition that allowed in patients whose primary medical condition was psychiatric, the trials were an abject failure.  Improvement was slight and limited to a minority of patients, and even then, in order to state there had been improvement, the criteria for 

illness was changed at the end of the study such that patients who would have been considered sick at the beginning of the study were now considered well. 

I can’t say that it builds much confidence in the reasons CDC chose for privileging CBT and GET on their website and in the two new Toolkit publications.

CFSAC Testimony – Schweitzer                                     p4

Well, perhaps that was the best they could do – perhaps it was all that is out there.   

No, that’s not right either.  To the contrary, there is a larger body of literature on biomedical abnormalities in patients diagnosed with CFS (Fukuda 1994) or M.E.   

Right here on this committee are researchers and clinicians who work with biomarkers to characterize subgroups of patients with this diagnosis, and treat them accordingly.   

Probably the most interesting of the published research is the work that biophysics researchers have conducted on the symptom that is called “post-exertional malaise” or “post-exertional fatigue”.  (I prefer post-exertional relapse myself.) Dr. Christopher Snell, Staci Stephens, and other members of Pacific Labs in Stockton, California, have published numerous articles on exercise testing of CFS (Fukuda 1994) patients.  The most interesting was published a year ago.  The researchers put patients diagnosed with CFS (Fukuda 1994 and Canadian 2003) through a VO2 MAX stress test for two days in a row.  This test measures the ability of the body’s cells to utilize oxygen, and for the respiratory system to expel carbon dioxide, at peak performance.  You cannot “game” this test.  The controls were deconditioned, but otherwise healthy, adults. 

Both groups scored the same on the first day (and here I must note that these were highfunctioning CFS patients – my score on the first day is abysmal – 15, where anything at that level or below is considered an automatic disability by Social Security).   

But on the second day, the couch potato controls either scored the same or improved a little because they were more used to the test.  In contrast, the patients’ scores plummeted in half. Dangerously so. 

And that is what is meant by post-exertional malaise (or fatigue or relapse).   

Is it not clear how dangerous a prescription for “graded exercise” could be?  CDC plays a silly little game with that, suggesting that the patient start with finger exercises.  This is not silly.  This is serious.  Why not recommend the test itself? 

There is more research that is being done in Utah by the Lights that looks at cell metabolism itself after exercise stress testing.  There are ways that a patient might be able to function better – but anyone familiar with both research programs must conclude it is insane to just willy-nilly suggest to general practitioners around the United States that patients will be okay if they have Cognitive Behavior Therapy and Graded Exercise. 

So – again I ask – why does that figure so prominently in CDC’s recommendations for doctors?  Researchers in the United States have produced much better answers – but they have been ignored in favor of psychiatrists in the United Kingdom who work for insurance companies.   

I hate to say this, but … follow the money. 

CFSAC Testimony – Schweitzer                                page 5 

These “toolkits” are not just inappropriate – they are dangerous.   

And what about someone like me?  I was diagnosed with encephalitis when I relapsed off Ampligen.  Perhaps that has something to do with all the active and reactivated viruses in my blood stream and spinal fluid – as one researcher commented, “Wow, your blood is really a toxic stew.”  Shouldn’t you first deal with the infection and then try to recondition the patient?   

So in addition to the questions I asked at the beginning of this paper, I would like answers for the following: 

1.  What is the scientific and scholarly basis for privileging the work of British psychiatrists in recommending “Cognitive Behavior Therapy” and “Graded Exercise” to physicians as the main avenues of treatment for patients who meet the definition for chronic fatigue syndrome (Fukuda 1994)? 

2.  What is the scientific and scholarly basis for ignoring the work of researchers and clinicians on this very body – CFSAC – when putting together these brochures? 

3.  Why is nothing said about the worst patients – those of us who are mostly bedridden and/or housebound?  Research suggests that would be one/fourth of the total – 250,000 

American adults in a state of serious invalidism – abandoned.  Abandoned and impoverished.   

4.  Why is nothing said about school-age children and teenagers who get this disease?  

We have been asking for a demographic study since the late 1990s, when Congress mandated such a study at CDC, and CDC got caught spending the money elsewhere?  At he time, Dr. Bill Reeves (head of the program for two decades) said he didn’t believe that teenagers got CFS, so it would be a waste of time to study them.  Is that still CDC’s position?   

5.  Do you have any idea the damage you are capable of doing by handing school administrators and child protective services a CDC-sanctioned publication suggesting that all these kids need is exercise and psychotherapy?  You should – there has been testimony to this effect at every single meeting of the original CFS-ICC, CFSCC, and CFSAC, going back two decades.  Is anybody listening? 

And that is my final question – is anybody listening?   

Thank you. 

Testimony 

Christine Williams 

Good morning.  Thank you for the opportunity to provide public testimony today.  My name is Christine Williams and I was privileged to have served as an Ex-Officio to the CFSAC for the Agency for Healthcare Research and Quality until my retirement from the federal government in June of this year, after 30 years of service. 

I spent my career in health policy and health services research - about half of the time on Capitol Hill as the senior health policy staff to the Senate Majority Leader, George J. Mitchell (D-ME), and the balance at the Agency for Healthcare Research and Quality (AHRQ). 

In August of 2008 I had a sudden onset of flu-like symptoms that never went away.  I spent 7 frustrating months having doctors telling me there was nothing wrong with me - or that I wasn’t  ‘tired enough” to have CFS/ME.  Through my own persistent on-line searching I found a practicing physician, with expertise in CFS/ME, who determined that I had 7 of the 8 symptoms established by the CDC. My illness significantly affected my personal and professional lives.  I was no longer able to travel for business, needed to work at home on a regular basis, and too often did not have the energy to attend meetings to develop partnerships for the Agency, which was my primary job. Because I was determined to complete the remaining 2 1/2 years of federal service so I could retire, I spent most of my limited energy working.  I had to decline most after work activities with my husband or friends. I spent evenings and weekends on the couch trying to rest so I would have the energy to go back to work. And so, I was very relieved when I was able to retire in June. I spent my career in government because I believe it can be a force for good and can make an important difference in people’s lives.

 I have witnessed that positive impact both on Capitol Hill and in the Executive Branch. The Department of Health and Human Services (HHS) has the opportunity and the ability to make an enormous difference in the lives of people with CFS/ME, but that opportunity has not been fully realized. I would like to make a few suggestions about how the Department might move toward maximizing that opportunity. 1) Leadership: The Department must provide public and active =leadership to move the debate forward.  The Secretary, Assistant Secretary for Health, Drs. Collins, Jones and Lee have all exhibited their commitment to this issue, but the commitment needs to extend to all levels in the Department and Agencies. And the leadership must be backed up with action. 2) Research:  The Department, through NIH, AHRQ and other research agencies and divisions needs to be a leader in CFS/ME research, making it a priority, building on new studies and partnering with academic institutions and others in the field.  “Reverse translational research” from clinical experience must be part of this effort. 3) International Consensus Criteria:  HHS needs to be part of the dialog around the recently developed International Consensus Criteria, which demonstrates progress toward sharpening the case definition for CFS/ ME.  A more refined case definition could be the basis of improvements in focused research, patient registries, etc.  The existing “babble” and broadness of case definitions is a barrier to meaningful research, and other critical efforts to find answers to this complex illness. 4) Convener:  HHS can convene key stakeholders.  The 2011 State of the Knowledge Conference at NIH was an important start - some of the researchers at the table had never connected before. HHS can create and facilitate an ongoing “Learning Network” with these researchers and clinicians to help them “connect the dots” across disciplines. 

5) Coordination across HHS:  The Department must beef up its efforts to coordinate activities and initiatives across the agencies, through this committee or another group.  Agencies should not duplicate efforts, need to know what others are doing, partner to maximize resources and initiatives, and must be a source of current scientific information on its websites. 

Finally, don’t let difficult fiscal times and bureaucratic red tape be a barrier to progress.  There are actions this Department can take now. 

Move forward on the CFS/ME name change and other existing recommendations from the CFSAC, which have been pending for some time. 

When the AIDS epidemic hit in the 80s HHS rose to the challenge to find treatments for people who were dying. 

Patients with CFS/ME have lives that have died.  They are in beds and on couches watching the world pass them by.  This Department needs to be a real leader in the search for effective treatments so that people can recover. I know this great “Department of the People” can rise to the challenge. 

Thank you

Testimony 

Toby Vokal 

WHEN?

When are the people with the authority to help people with M.E. (Myalgic Encephalomyelitis) going to do so? When is the CDC going to change their website to be accurate? When is the NIH going to give research dollars to M.E. as they do to comparative diseases ($150 million annually minimum immediately)? When is there going to be a branch of the NIH for just M.E.? When is the CFSAC going to become the MEAC? When are we going to realize that this affects men, women, and children?  When will people understand that estimates as high as 4 million Americans and 20 million worldwide and growing have M.E. ? 

When are doctors going to be educated? When is it going to be in every single medical school and books? When are researchers going to be drawn to this field? I can tell you there would be no shortage of interest if the funding was there. When is there going to be a national awareness campaign? Not one that makes the public put off by M.E., however respects it and its seriousness? 

These questions are not rhetorical, they are serious. Anyone can tell you that these are measures that should have been put into place years ago. It is unacceptable the way we have been and still are treated. In this day and age which is full of technology we should as a nation should be leaders. British Columbia, Canada just opened a Center of Excellence. 

When is the U.S.A.? I thought we were supposed to have 5 regional research and care center’s up and running by now.  Can someone please tell me the given dates in realistic time goals? Or better yet post them on a website for everyone to see and track progress.

Meanwhile people with M.E. wait. Their lives are altered in ways unimaginable to someone healthy. We try our best to help awareness,however we are limited by our condition. I do commend the committee on holding meetings twice a year and giving some time to the public. This is not enough. We need to step it up now! 

Testimony  

Kenneth J. Friedman, Ph.D. 

Restoring ME/CFS Research, Education, and Patient Care to New Jersey I wish to inform the CFSAC and other stakeholder in the ME/CFS Community that there is a brief window of opportunity to potentially restore ME/CFS research, education, and other, related, scholarly activities to one of this country’s most populated states:  New Jersey.  

The Governor of New Jersey, Chris Christie, has formed a UMDNJ Advisory Committee the purpose of which is to advise him as to the future of the University of Medicine and Dentistry of New Jersey (UMDNJ).  The options range from keeping UMDNJ, the largest, freestanding, academic healthcare University in the United States, intact and as is, to completely dismantling the University and dividing its components and assets amongst other institutions within the state.  

The Committee is now willing to accept comments from the public.   

The impetus for the establishment of the UMDNJ Advisory Committee may reside in the corroded image of UMDNJ, forever charred into this nation’s psyche, by its purposeful, $35 million dollar, double-billing of Medicare.   However, of equal or perhaps greater concern to the ME/CFFS Community is the February, 2010 decision of the University to ban ME/CFS research, education and related scholarly activities from the University using the pretext that such activity is not “professional” but rather “personal.”  According to that policy, any and all scholarly activity related to ME/CFS can only be performed outside of regular, normal business hours.  Moreover, the University’s portal to the internet cannot be used for any ME/CFS-related research, nor can the University’s email client server be used to correspond with anyone about anything related to ME/CFS. 

The University’s policy to ban ME/CFS scholarly activity came after two, related New Jersey Medical School decisions::  (1) that the worldwide distributed and read Consensus Manual for the Primary Care and Treatment of Chronic Fatigue Syndrome, commented upon, and approved for publication by, the Senior Editor of Harvard University Medical Press, Dr. Anthony Kamoroff, was not a peer-reviewed publication, and (2) that five years of service by a faculty member on the CFSAC did not constitute professional, academic service at the national level. UMDNJ controls all three of the state’s medical schools, as well as the state’s only dental school, school of nursing, school or health related professions, school of public health, and graduate school of biomedical sciences.  The ban of scholarly activity in the University is, therefore, of significant impact to patients in New Jersey, as well as to the advancement of ME/CFS research, and healthcare provider education and training within the United States.  Equally important, however, is the precedent that this establishes for other medical schools and schools training healthcare professionals throughout the United States.   

UMDNJ’s actions are clearly an attack on academic freedom – the right of college and university faculty to pursue their academic interest wherever they may lead – and should be opposed on that basis if for no other reason.  It seems logical that if UMDNJ wishes to continue as a university, then it must afford its faculty the rights afforded to all University faculty, and comply with the principle of academic freedom.  

However, of greater concern to the ME/CFS community, is the stark contrast between UMDNJ’s actions and the CDC’s policy towards ME/CFS as articulated by its Director in 2006, Dr. Julie Gerberding, who stated, “We are committed to improving the awareness that this [ME/CFS] is a real illness and that people need real medical care and they deserve the best possible help that we can provide.” Why does the Department of Health and Human Services’ continue to provide funding to UMDNJ when UMDNJ announced in 2010 that ME/CFS activity is personal and not professional?  The Department of Health and Human Services continues to give money to a University which knowingly and deliberately violates one of its agency’s mandates.  Why? 

Governor Chris Christie’s UMDNJ Advisory Committee has already held hearings at which it has heard much comment from current University employees expressing the desire for UMDNJ to be retained in its current configuration.  Current employees who may have a vested interest in retaining UMDNJ in its current corpus.  The ME/CFS Community may wish to express a different point of view, and the CFSAC may wish to make a recommendation to the U.S. Secretary of Health based upon the facts conveyed here and, perhaps, after its own, further investigation.  According to what was published by UMDNJ, “your thoughts about medical education in New Jersey and the future of our University,” may be submitted via email to:  

publiccomment@gov.state.nj.us.” 

The window of opportunity for submitting comments is not specified. I would not wait long. 

Thank you for your attention.

Testimony 

Gabby Klein 

I am a 56 year old wife, mother of three, grandmother of seven and have been suffering from ME/CFS for the past nine years. I used to work full time as a vice president of administration in an insurance company. In addition, I raised my children and took care of the household. All this came to a halt in February 2002 when I came down with a stomach virus that lasted for weeks. My condition kept deteriorating. I felt constantly ill and weak. I could not keep working and had to quit my job. Now I am so handicapped that I am mostly forced to stay housebound and when I crash, I am left bed bound for weeks or even months. 

I suffer from insomnia, weakness, orthostatic intolerance. I am in constant pain. I feel pain in my joints, legs, sinuses and most severely, I suffer from headaches.  

When I crash, I have to lie still in a dark quiet room. Any noise or movement brings excruciating pain. I have had weeks at a time like that with relentless severe pain. 

Painkillers help a little but, certainly not enough.  

In addition, I suffer from cognitive problems that are very disturbing. I have memory loss and word retrieval difficulties. At times when I crash because I have done too much which might be just trying to cook a simple meal, all my symptoms worsen including the cognitive problems. At those times, I cannot speak in comprehensible sentences. At times, only grunts are able to escape my mouth.. This past summer, I wrote these words in my journal.  

There is something wrong when:

The one thing you look forward to is falling asleep. 

The one thing in your life that you dread the most is waking up. 

You stay in bed all day, every day. 

You skip some meals because even though you are hungry, it hurts too much to go downstairs to the kitchen to get something. You don’t answer any phone calls, even from family members because it takes too much energy to talk. 

You feel like pouring a bucket of water outside on the little children who are part of a backyard camp that your neighbor is running. The noise is just too much. 

You feel like you have a sledgehammer in your head from the minute you wake up and painkillers don’t help. 

You watch TV on mute because you are so sensitive to noise. 

You look forward for your husband to come home from work but, by the time he gets here, all you could do is mumble some words that don’t make sense. 

You don’t answer you children’s phone calls because you don’t want them to know how sick you are but, if they don’t call, you are upset at them for not caring. 

You try to do as much advocacy as you can from bed but, it leads to nothing. 

You read Toni Bernhard’s book “How to be Sick” and it makes you feel guilty because you can’t be as gracefully sick as her. 

This illness is a very lonely, misunderstood and ill-treated disease. It does not follow the rules of other illnesses. It is invisible and people have a hard time grasping how ill you really are. It renders you completely restricted. You become so hyper sensitive to all kinds of senses, like noise, light, odors, foods and medications.  Because of this, you can’t attend events where there are many people 

around. You stop socializing and slowly but surely, your friends start disappering. I don’t really fully blame them. They have no clue as to what’s wrong with you. 

Yes, they hear the name “Chronic Fatigue Syndrome” but, in their mind, they are thinking “I’m also tired all the time. What woman today, working and raising children is not tired all the time”. 

Most GPs and Internists who are the first line of defense in the medical system are also clueless about this illness. 

When I first took ill with a stomach virus that didn’t go away and my health kept declining, I went to my GP and explained to him how I felt . I told him I feel like I have the constant flu and am exhausted all the time as if I had just hiked up a mountain for two days in a row without any sleep. He took blood work from me. 

When all the tests came back negative he whispered to me “you know sometimes, we can be depressed yet not know it.  I’m going to put you on some anti depressant, you will feel much better.” My body could not tolerate any of the anti depressants that he tried.. It took me two years to get out of the abyss created by these drugs.  Of course it didn’t help me. I was not depressed. 

After two years of this where my symptoms just kept getting worse. I could not function. I could not sleep. I had to quit my job. The doctor finally said, “You know, it could be that you suffer from Chronic Fatigue Syndrome but, it doesn’t matter because the treatment is the same as for depression.” 

I was finally referred to a CFS specialist who started to take my condition seriously. 

He put me on anti virals and supplements to strengthen my immune system. He also gave me medication for sleep since I had terrible insomnia. The ability to sleep helped my condition somewhat but, the anti virals didn’t help. By the time I got to him, I was too sick. My viral load in my body was too strong and my immune system too weak for it to work. 

Since that time, I have gone and tried so many treatments; conventional and alternative that I can write an entire book about it. In add that I can write an entire book about it. In addition, I could have bought a house with the money I spent since most of the treatments are not covered by medical insurance. Some worked for a little while but nothing sustained for more than a couple of months. 

Here I am nine years later sicker than ever. I had dreams of retiring and enjoying my grandchildren around me. I had dreams of enjoying my hobby of painting. I had dreams of socializing with my friends. I had dreams of going out to eat or to a movie with my husband. They are all simple dreams but, unattainable for me now.  My heart breaks that I can’t enjoy the company of my grandchildren because it puts so much stress on my nervous system. I think that this illness has been cursed because it  has been given the name of Chronic Fatigue Syndrome which is really a joke. A very cruel joke because no one takes it seriously. It is insulting to the minds of the patients. Whenever I tell someone that this is what I suffer from, I see their eyes roll and they come up with the most inappropriate comments. For example “but you look fine” or “yes, I’m so tired all the time too”; the worst of the lot “all you need is just to get out more and exercise”.  Doctor’s by the way who are not informed about what this illness really is about, are the worst culprits. Maybe, it’s not their fault. They have not been taught about it and especially not about the latest studies that have come out recently. There is a tremendous need to educate the GP and the Internists about what this illness is and how greatly it affects the patients. They need guidance as to which tests to take and how to try to treat it. 

There is also the issue of lack of funding for studies to come up with real biomarkers to help with the diagnosis of this illness and for possible treatments.  

This illness is estimated to affect 1.7 million people in the U.S., though the funding is a fraction of what the funding for MS is currently.  

The CDC website still has the same antiquated information up which has been there for the past 20 years even though there is so much more that we know today. The ICC that came out a few months ago is a good place for them to start and follow their recommendations. This International Criteria was authored by the experts in the field coming from many different countries and the experience of studying and seeing thousands of patients. They recommend dropping the name of CFS and adopting the name of Myalgic Encephalomyelitis because it better describes the nature of the illness which is neuro-immune related. 

There is also a great need to code this illness properly in the IC-10-CM coding system under “diseases of the nervous system” at G93.3, so that patients can get the medical care they need and deserve. In addition, they will be able to get proper disability coverage. 

I am sure that you will hear many more testimonies of people. Some who were struck at a young age, where they don’t even get a chance at a normal life like getting married and having children?  Others, who live alone and have no support system to rely on. Some are homeless and despondent with no help in sight. The only wish that I have is that you open your heart when you hear these stories. They are not just stories, it could be your daughter, wife, father or even yourself who God forbid could be struck by this illness. The numbers are growing at an alarming rate.  The thing that is most lacking with this disease is hope. On a forum I belong to with other patients who have this illness, someone posed a question as to when people thought there will be a treatment for us. I was struck by the fact that a majority of members answered; “not in my lifetime.” 

“Hope is like peace. It is not a gift from God. It is a gift only we can give another.” 

-Elie Wiesel 

I did my part to come and testify. I hope you will do whatever is in yI did my part to come and testify. I hope you will do whatever is in your power to reconcile these problems and give back hope to 1.7 million Americans. It is very hard to describe pain or suffering to anyone. It is an invisible feeling.

Testimony 

Alexander Lopez-Majano 

I’ve been asked about the biggest obstacles I face because of ME/CFS.  

We all know about the paucity of successful ME/CFS treatments.  We all know about endless problems finding knowledgeable medical professionals. 

Beyond that, some of the biggest obstacles are DAILY struggles for acceptance of the severity of ME/CFS that stems from the ERRONEOUS perception that this is a psychological condition.  ME/CFS is a HORRIBLY disabling PHYSICAL illness. 

I want more education.  I want a profession.  Since I can only leave the house two times a week.  Since I can only study for 20 minutes at a time, perhaps three times a week, it probably will take a long time for me to obtain my college education.  Unfortunately, it will probably take a long time to then find a job.  THIS SHOULDN’T BE THE CASE. 

There need to be successful treatments for ME/CFS.  There need to be many more medical professionals who know about ME/CFS, respect patients, and who treat ME/CFS.  We must move forward.  You must define patients uniformly.  You must disseminate accurate information WIDELY and often.  WORK HARD. ME/CFS needs to be solved SOON.  I want my life back and so does my brother.

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