Wednesday, December 21, 2011

Why won't CDC study MY disease?

Testimony to the
Chronic Fatigue Syndrome Advisory Committee
U.S. Department of Health and Human Services
Washington, DC
November 8-9, 2011

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 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. Can we change all my records to say that? Do you think it has anything to do with being positive for EBV, CMV, HHV-6A, HHV-7 - with both CMV and HHV-6A positive in my spinal fluid? (I also have Cocksackie B.) Where do I fit in that paragraph now? Should I not have been tested for viruses? Is this evidence unimportant?

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?

[n.b. The specific paragraph was removed, but CDC continues to insist these tests are meaningless.]

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:

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.

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 high-functioning CFS patients – my score on the first day is abysmal – 15, where anything at that level or below is considered an automatic disability by Social Security).

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? Reseachers in the United States have produced much better answers – but they have been ignored in favor of psychiatrists in the United Kingdom who work for insurance companies.

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

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 the time, Dr. Bill Reeves (head of the program for two decades) said he didn’t believe that teenagers got CFS, so it would be a waste of time to study them. Is that still CDC’s position?

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?

Wednesday, August 10, 2011

Dear Dr. Wessely

An open letter to Dr. Simon Wessely,

My my, such a to-do this week. Over precisely what? If you have received actual death threats, for heaven's sake take them to the police, now. Or are you just exagerrating your lack of popularity in the patient community?

If you really have received threats (and if so, that's what the law is for), then here is my response to you:

1. There are an estimated 250,000 patients in the UK suffering from M.E. Statistically speaking, it's probable that some within that large community might be personally unbalanced. It's irresponsible to use those few as an excuse to mistreat the rest. How have you mistreated them? In this particular case, by trying to scare off researchers and clinicians who might seek to help these people, many of whom are invalids.  You also blow a smoke screen so the press doesn't notice there's professional and sober criticism of your pet theories and research.
     This is irresponsible for a medical professional, and irresponsible for all those media outlets to give you so much space with which to condemn 250,000 sick people. Shame on you, and shame on them.

2. The researchers who I know who have left the field did so because of threats from their bosses and ridicule from colleagues, not patients, plus a lack of funding for biomedical research. Your outcries might perform the same function. Now why would you want that?

3. Things got pretty hot in the breast cancr community when they were debating full mastectomy v. simple lump removal, but nobody suggested stopping research into breast cancer.

4. If email had been available in the mid-1980s, does anyone believe the desperately sick and ignored AIDS community would never have sent insulting emails? To someone who insisted they were somaticizing?

5. How convenient that the press plasters Simon's paranoia all over the place, but the stories printed about ME/CFS in the NY Times and Wall Street Journal in the past year never got a peep in the British press - now why is that? Do you believe Americans are more polite? Not likely, is it? Do you think it might have something to do with the SMC, which you helped found? Has the British press really sunk this low?

There were lots of stories involving M.E. and CFS that could have been covered by the British press this past week. A committee has come up with a new definition of M.E., based on biomarkers and biological evidence, soon to be published in the Journal of Internal Medicine. That's certainly worthy of coverage. New biomarkers have come out of the New Jersey School of Medicine and Dentistry. But the British press doesn't cover the evidence that M.E. and CFS (Fukuda 1994) or ME/CFS (Canada 2003) are not caused by somaticizing (the physical expression of emotion).

In 1999, Harvard University medical professor Anthony Komaroff declared in the Journal of American Medicine that with thousands of refereed journal articles into biomedical symptoms, correlations, tests, and possible causes of CFS (Fukuda 1994), it's time to put an end to the psychiatric explanation of the disorder. He has not changed his position (except to note there are now thousands more). How long will it take for that information to reach British shores? Twelve years of silence is a very long time.

When will responsible scientists, journalists, and representatives of the government finally put an end to the monopoly of information in the UK by psychiatrists, with regards to both CFS and M.E.? WHO has coded M.E. under neurology, not psychiatry, since 1969. Why is all the information on this disease printed in the UK tilted towards psychiatry? It certainly hasn't helped the patients, who remain sick (with an estimated 65,000 housebound or bedridden). People have died from this disease, and at some point in its course it is apparently contagious - why keep shoving it under the rug?

Gosh, do you think it has anything to do with the monetary inconvenience it would pose for insurance companies and penurious governments if this disease were taken seriously - if the biomedical research was portrayed honestly?

I fear George Orwell's dystopia has arrived - 27 years late.

Wednesday, May 11, 2011

Shut down CDC's program on CFS and start over

Testimony to the CFSAC of the
U.S. Department of Health and Human Services
May 10, 2011
Mary M. Schweitzer, Ph.D.

First, I want to thank Wanda Jones and this committee for giving us a chance to speak, and in particular, for livestreaming this meeting so that patients who cannot travel (which would be most of the ones I know) and patients who are housebound (which would encompass too many of those I know) can view the meeting from their homes, both in the United States and abroad.

I also want to thank Dennis Mangan, the NIH committee that I was privileged to be a part of, and all the participants, for the outstanding State of the Knowledge workshop on such short notice.

I want to focus on the Centers for Disease Control and Prevention (CDC) today. CDC has been studying this disease for over a quarter of a century, and hasn’t gotten very far. It is time that they caught up with 2011.

First I want to make clear that when I refer to CFS, I mean the Fukuda definition (1994), and when I refer to ME/CFS, I mean the Canadian definition (2003). When I refer to M.E., I use the Ramsay and World Health Organization definitions.

1. CDC’s Portrayal of the Disease

Suppose you broke your leg really badly. You knew it, your family knew it, your friends who were with you knew it. Somebody called emergency, and the ER techs came out. They had already been told by your family that you had a broken leg, but they said they had to find out for themselves. They came up to you and said, “Why do you think you have a broken leg?” Startled by the question, you said, “because it is obviously broken!” (Self-reported, one says to the other.) How about you stand up and we can see what’s going on with that leg. “NO!” you respond! “That’s going to hurt!” (Catastrophizer, they murmur among themselves. People who catastrophize about pain are more likely to feel pain.) Then they write a prescription for Prozac, say “Take this until you feel more comfortable about the prospect of standing up,” and they leave.

Now, of course that was a silly story. But it is exactly how I was treated by the first specialist I saw for this disease. “Self-reported” is an insurance term that is used by British psychiatric “experts” on CFS; and there is a published paper out there about CFS and fibromyalgia that uses the correlation between these diseases and fear of pain to conclude that people who fear pain are “catastrophizers,” and “catastrophizing” causes pain. There is a large body of psychiatric research on this disease that is just plain silly.

So don’t be surprised if patients are a bit worried about what researchers say about them, or what the government does about them. If you had a badly broken leg and nobody in the medical profession would believe you, you’d be a little cranky too. Indeed, when scientists injected lab monkeys with HHV-6, Variant A, the poor things hid in the corners of their cages looking supremely miserable, and one would drag his left arm and leg when they made him walk. Poor baby. Been there. At any rate, the scientists working with the monkeys said that they got a little cranky toward the end. No kidding.

Ever since CFS was abandoned by NIH, CDC has been the central agent of promoting views that are diametrically opposed to our experiences. For 25 years they have insisted this disease as caused by some sort of “stress,” – at first the stress of yuppie women “trying to have it all.” Today they claim the stress is caused by having been abused as children – but they’re still saying the same story. It’s just caused by an inability to handle stress.

Something else I have faced when coming here or when at a conference on my disease, is the phrase “Oh, I don’t believe that.” I recently wanted to talk with a well-respected virologist about HHV-6, Variant A, which is a vicious disease, and which I have in both my blood serum and spinal fluid unless I am on Ampligen. The researcher stopped me as soon as the words came out of my mouth, “I have HHV-6, Variant A.” “Oh, no you don’t,” he said, cheerfully. “There’s probably just some artifact in your blood that makes it look as if you have HHV-6, Variant A.” That’s pretty much the same thing Stephen Straus said to me when I testified here twelve years ago about HHV-6, Variant A. And my response is the same now as it was then: I was part of a study of a handful of CFS patients conducted by Dharam Ablashi, the co-discoverer of HHV-6 and its two variants, while looking at samples from AIDS patients at NCI. Ablashi saw the virus in my lymphocytes. It was no artifact. But …”Oh, I just don’t believe that” is something I often hear. Hardly a scientific response, don’t you think?

In the meantime, we remain sick. So let me offer my first suggestion: if the approach hasn’t helped anybody with the disease in a quarter of a century, time to change the approach.

2. When is CDC going to begin to identify subgroups using biomarkers?

The Fukuda article from 1994 that gave us the most commonly used research definition also strongly urged CDC to begin identifying subgroups using objective biomarkers. That was 17 years ago. But if you look on CDC’s website, when they discuss biomarkers or microbes associated with The Disease, they always put them in the context of “The Cause” of CFS. No, that’s not the point, guys. A biomarker does not have to be “The Cause” to be useful. It just has to correlate. And when we are trying to identify subgroups, it doesn’t have to correlate with everybody who has ever had a diagnosis of CFS.

I belong to an identifiable subgroup. When in relapse off Ampligen, I have, among other things, immune biomarkers and activated opportunistic viruses. There is a subgroup of patients who have precisely what I have, though I have more viruses than many, and some have viruses I don’t.

My immune biomarkers would be the 37kDA Rnase-L defect, which always shows up when I am off Ampligen and disappears when I go back on it, and natural killer cell dysfunction. During my most recent relapse, from September 2008 to the summer of 2010 (after having been on Ampligen for several months), I had a natural killer cell function of 2%. I also have an abnormal cytokine profile.

During relapse, I had active viruses in both my blood serum and my spinal fluid. I hold a flush in herpes viruses – Human herpesviruses 4-7. My relapses usually start with Epstein-Barr, which comes and goes while I am really sick. I test positive for active HHV6, Variant A, cytomegalovirus, and HHV-7. I also have Coxsackie B. I have friends who have parvo or an adenovirus, and I have friends who do not have HHV-6 or cytomegalovirus. As for the immune biomarkers, there’s a pretty strong correlation between those who were in cluster outbreaks and natural killer cell dysfunction.

I think we’re a subgroup, and I’d be very grateful if that could be recognized. The researchers who work with HHV-6 have been asking for years that Variant A and Variant B be recognized as different viruses, with one renamed HHV-9. CDC has turned a deaf ear to their research and requests. Intriguingly, Variant A is found in AIDS, CFS, and in the lesions of MS patients. Variant B, which causes roseola in children, is the virus that reactivates when patients are put on immunosuppressant drugs. While Variant B is endemic (it is the childhood disease roseola), in 90 percent of the adult population, Variant A is found in only 7 percent of the population. These are different diseases, but we need CDC to recognize that.

Finally, outside scientists at the NIH State of the Knowledge workshop strongly urged researchers to adopt the VO2 MAX score as an objective marker of the disease. Mine were significantly abnormal during the relapse – 14.5 – and even now, at 16, not a whole lot better. I have a lot of recuperating to do.

3. NCHS, within CDC, is overseeing the development of ICD-10-CM. We need to keep CFS in the same code as in ICD-10 – under neurology, at G93.3. That’s where it is in WHO’s index to ICD-10 – adopted by over one hundred nations. It’s also under G93.3 in the tabular versions of the clinical modifications produced by Canada, Germany, and Australia. It should not be placed in R53.82, under “vague signs and symptoms.” We would be the only nation to have CFS in R53.82. Why?

4. CDC needs to stop using British psychiatrists as consultants and guides to the definition and treatment of CFS. I am speaking specifically of Simon Wessely, Michael Sharpe, Peter White, and nurse Trudie Chalder. The latter is a specialist in “factitious illness” and “factitious illness by proxy.” Is THAT what CDC thinks of us and our disease?

It should be noted from the outset that the British psychiatrists do not use the Fukuda (1994) definition. They use the Oxford definition to diagnose CFS. The Oxford definition requires six months of debilitating fatigue and NO physical conditions that could explain that fatigue. Conversely, psychiatric conditions are NOT excluded from Oxford. I had an email exchange with Simon Wessely in 1996 when he told me that I did not have CFS because I have NMH and Hashimoto’s thyroiditis. They also consider a failed Romberg test as exclusionary because it is a sign of neurologic abnormalities – in contrast to my original specialist, Dr. Marsha Wallace, who used my inability to pass a Romberg test as diagnostic for The Disease (as is also true for the Canadian Consensus Definition of ME/CFS.)

The British psychiatric view of CFS is that it is an “inappropriate illness belief.” That is why they prescribe Cognitive Behavior Therapy – not to help patients adjust to the disease, but – in their own words – to “reverse” the disease, to cure the disease. Graded exercise is recommended to get these poor women who have been deconditioned by their inappropriate illness beliefs back into shape and able to return to work and household.

Is THIS what CDC thinks of our disease? If not, why does CDC’s website suggest cognitive behavior therapy and graded exercise, perhaps with an SSRI added and something to help patients sleep, as the appropriate treatments for this disease? Why is there a direct link to the website for Peter White’s psychiatric practice at St. Bart’s hospital in England?

There is another reason that CDC needs to stop using Peter White, Michael Sharpe, and Simon Wessely. All three have close ties with insurance companies. I’m not talking about doing IME’s – I’m talking about serious ties. Wessely has been on the Board of Directors of UNUM. Michael Sharpe has written position papers on the disease for UNUM as well. Peter White has been Chief Medical Officer of Scottish Provident the whole time he has been advising CDC. That company was eaten by a British company that was eaten by Swiss RE, and now he is Chief Medical Officer of THAT company. Most recently, White was part of the three-person committee that evaluated the CDC’s 5-year-plan for CFS. I looked at his disclosure statement. It said he consulted for insurance companies – but did not say he held an executive office with one. Peter White was also the chief investigator in the multi-million pound disaster called the PACE studies – there isn’t enough time for me to explain everything that was wrong with those studies, but I have a copy of a good critique that I’d be happy to give to anyone who wants to read it. The Lancet has refused to publish critical letters about PACE, even from the oldest M.E. association in the U.K., the MEA.

What are insurance companies doing with CDC? Could there possibly be a connection between the need for insurance companies to make us disappear – who wants to pay out for a million people needing disability? – and their close ties with the British psychiatrists who have captured the disease in the UK and advise the CDC?

Finally, it was insurance companies who first came up with the name “medically unexplained diseases” (MUS) which has been used by British psychiatrists to label this disease. British psychiatrists regularly use the diagnosis “neurasthenia” (based on an 1869 book called “American Nervousness” that is typical of its day – sexist, racist, and nativist), but you won’t find either neurasthenia or its flip side, hysteria, in DSM-IV because it was deemed heavily gender biased. So Michael Sharpe is chairing a committee that is trying to place a new concept, “CSSD”, or “Complex Somatic Symptom Disorder,” in ICD-11 and DSM-5. Broken leg time again. I do NOT have a complex somatic symptom disorder. Forgive me if I am displeased with this development. As my husband says, if you can cure her, you can call it anything you want. But a closer look at the PACE trials shows that the combination of CBT and GET has cured NO ONE, even when the Oxford Definition was used to choose most of the subjects in the study.

5. CDC is going to have to abandon the Reeves questionnaires, which do not diagnose Fukuda 1994 but something else entirely. They are copies of questionnaires developed by Simon Wessely and Trudy Chalder (says so in the article where Reeves describes them in the first place). It should not be a surprise that they operationalize the Oxford definition, not the Fukuda definition.

CDC has been headed in the wrong direction for a long time. While they have rephrased some of their website so it is not so obviously inappropriate, they still refuse to identify subgroups and they still portray the disease as resulting from stress. Of everything I have said here, the most important is to change the direction at CDC. Recognize subgroups, because then you can start diagnosing and treating people.

A million adults have this disease, and untold numbers of teenagers and children. Back in the 1980s, CDC came out to Incline Village, NV, where there was a cluster outbreak, and decided the disease originally thought to be chronic EBV (closer than they knew, actually), SHOULD BE mainly characterized by fatigue. They made this decision in WASHINGTON, not on the site. Then when a group of researchers met to rename the disease, they chose the one coined by Stephen Straus in 1986: chronic fatigue syndrome.

Congress did not charge CDC with defining and identifying a name! They were supposed to be looking at a DISEASE. But patients with the disease, at Incline Village, Lyndonville, Rockland, Atlanta, Miami, Boston, Cherry Hill, and many other places, were left behind while CDC wandered off. Time to return to the patients and what they actually have – not what British psychiatrists and multi-national insurance companies want to SAY we have.

A broken leg is a broken leg. You treat it. There are clinicians in the United States, such as my own specialist Dan Peterson – Nancy Klimas, Lucinda Bateman, Jose Montoya, John Chia, Derek Enlander, Sue Levine, Paul Cheney, Charles Lapp, and very few others – who diagnose and treat the subset of patients who have immune defects and active pathogens, but only those of us who make enough money can afford them. I think that is criminal. It is well past time for CDC to admit to give up on the psychiatric depiction of the disease produced by insurance company hacks, and identify existing subgroups of patients, so that nation can start diagnosing and treating the disease. We lose billions of dollars a year in productivity, billions of dollars a year in income tax revenues, because so many people are too sick to work. Surely we can afford some money to begin to fix it.

Sunday, February 13, 2011

Civil Rights

Why did I write yesterday's post? Because we are allowing ourselves to be distracted, energies wasted, by small things. We are in a battle for something much larger - basic human rights.

That is what we are REALLY fighting for. The right to be free of the propaganda and censorship that has stood between our illness, and treatment, since 1988.

Our governments - but most energetically, the governments of the United States and the United Kingdom, have deliberately sought to deny us respect, care, and treatment. Why? The insurance lobby. The cost of treating us. Making a name for themselves. Pathetic, pitiful reasons to ruin the lives of so many.

NIH allocates (at most) $4 a person a year - one percent of what NIH spends on Multiple Sclerosis, hardly an overfunded disease. The UK has just issued special research funding - but who will get that funding? Does anyone really doubt where it will go? More "studies" that portray The Disease as the product of "inappropriate illness beliefs". Imitation research, that blames the victims for their own suffering. More censorship of biomedical information, and propaganda dressed up as psychiatry.

The CDC says we are sick because of some vague childhood abuse. They have joined Peter White in "discovering" that a large number of us actually have major psychiatric illnesses. And CDC's website praises the UK's NICE Guidelines, even including a link - those guidelines that condemned so many sick people to going without any medical care at all out of fear of being forced into Cognitive Behavior Therapy and Graded Exercise. Now the UK is changing the rules for those who are too sick to work, who need government assistance. Shirkers all. How long before the US follows suit?

We deserve more. We deserve an honest appraisal of the peer-reviewed research. We deserve doctors, and treatment centers, and real research. Some have been waiting three decades for this. Some have been living their whole lives, stricken as children, imprisoned in this disease - and all government has to offer them is insinuations that they are sick because they were abused, or because they somehow secretly want to be sick. All government has to offer them is the threat of being removed from their homes. They deserve better. Their parents deserve better.

Our countries can do better.

The campaign of constant psychobabble is just that - a campaign. It is designed to portray us as "the other" - as "different." As not deserving of the medical choices a person with MS is entitled to. As not deserving of the medical choices a person who blew out his knee skiing, is entitled to. As not deserving of the choices a chain smoker gets when lung cancer sets in.

That is the recipe for denying human rights: portraying a person as "the other", not "one of us.". Not human, therefore without rights. In Anglo-American parlance, without the rights of free citizens.

But we are human. We are citizens. We deserve our rights as civilians, as members of the larger community. Our civil rights.

We have the right to be treated as human beings, not "weaklings," as Wessely loves to portray us when not in front of scientists.

All we are asking for is the truth. Disagree over it, come up with alternative theses - but start telling the truth.

Our enemies are the people in power who have portrayed us as "undeserving." Who censor the truth and issue propaganda in its place.

That's a big fight, and it's not easy. It calls for strength. We have that strength. It has been honed in the fires of our pain, suffering, confusion, and despair. Our isolation. Our loneliness. Our dashed hopes. And our cares for each other. We have somehow kept on, in spite of all they have thrown at us.

We cannot win this battle unless we stand together against our real enemies. We can squabble like any family does. But we must stop hurting each other. That also means the strength to allow disagreement - as long as disagreement does not turn into harassment.

We have to stand up to CDC. Stand up to NHS. Stand up to NICE. Even if standing up has to be done from a gurney.

Stand up as young people have in Tunesia and Egypt.

But stand together. With one common goal: we refuse to be invisible any more.

I have a quote from Martin Luther King, Jr., from a speech he gave at the end of the march from Selma to Montgomery, Alabama. In four years, his courage in speaking out for his rights would end in his death. He knew that was likely, but he still spoke up.

Keep this in your heart so that you remember what we are really fighting for. We are fighting for our rights as human beings. We are fighting for our freedom from invisibility. And we are fighting for the truth.

King said:

"I know you are asking today, ‘How long will it take?’ ...

“I come to say to you this afternoon, however difficult the moment, however frustrating the hour, it will not be long, because truth crushed to earth will rise again.

"How long? Not long, because no lie can live forever.

"How long? Not long, because you shall reap what you sow.

"How long? Not long, because the arc of the moral universe is long, but it bends toward justice."

Not long. We will not be invisible forever.

Saturday, February 12, 2011

Unity, disagreement, and respect

There has been a lot of talk about unity lately. I'm not sure unity is what we need. What we need is to understand we are all in this together. What we need is to treat each other with respect.

There is nothing wrong with criticizing research. Researchers do it all the time. Just keep it professional - that means, criticize the research choice or the evidence or the model or the conclusions. Offer alternatives that might have been included. Conversely, as a researcher I know all too well that your research sometimes feels like your baby. But no one should take offense at a desire to discuss the nature, or quality, or results of the research.

Personal attacks are different. Again, you can criticize what someone says, in a constructive discussion. To do so, you have to be willing to accept disagreement. Without demonizing the person you disagree with.

So that is what it comes down to. Allow disagreement, but keep disagreement civil. Show respect for each other.

There are a lot of raw feelings out there right now. For the first time in 25 years, patients have hope. Hope is a wonderful thing, but it is also scary. With so much at stake - the tyranny of the psychobabblers v. recognition that we have a real disease, which would mean treatment, which would mean freedom - it is no wonder that many are on edge.

I know all too well what it means, because on Ampligen I am a real person (who has problems with stamina and shaking off illnesses). I am no longer in a cloudy fog, in pain and confusion 24/7. I can walk, can drive a car, read a book, write. Visit my grown children and grandchildren. Go places with my husband. Walk barefoot on a beach.

And I know the fear. I have lost Ampligen, an immune modulator that has worked for me since 1999, and spent seven months in 2008 terrified of the inevitable crash when my immune system folded and I would be attacked by multiple viruses. Knowing that at some point within a year, the anvil over my head would fall. And it did, in September 2008.

But at least I have an excellent specialist, Dan Peterson. I have had access to testing and treatment that cost much more than most of my friends have to live on. I have been very, very lucky. I have been back on Ampligen for almost a year and am much better. But it has come, for me, at a terrible price. I have to live in Tahoe (that part is okay!), while my husband of 36 years remains 2500 miles away, at home. I get to see him about once a month. I miss him dreadfully. But there is no choice.

Since collapsing in my office on October 24, 1994, I have known hope, I have known hopelessness, and I have known fear. I have known despair, but also peace. However, thanks to sound biomedical research and treatment, I have also known the excitement of being able to walk outside without a cane. I have danced at my son's wedding, and held both grandchildren on the dates of their birth. I had thought none of that would be possible again.

I understand all the emotions of having a disease that is not supposed to exist. I know why we strike out in frustration and anger, and sometimes confusion.

But we cannot go after each other - we can disagree, but we should not get angry because one of ours disagrees with us. We should not go after individuals like a pack of wolves. I've seen that, too, lately - and though I know it comes from the hope and the fear, it is still wrong.

So I am going to ask for something that would sound strange to an outsider, but we know better.

This is the time to be strong. Yes, strong. Strong in character. We know it takes strength to live with this disease. I know you have it. Now is the time for strength.

Resist the impulse to panic at the sign of a setback. Assume the best of those in our community. Allow competition and disagreement.

We must be strong and united in our quest for the truth.

Because that is what we are fighting for - the truth. We are in a battle for the most basic of human rights - understanding, treatment, and care. Our foes are those who have portrayed us as less than human, undeserving of attention. Their tools are censorship and propaganda.

We must stand together. We can disagree among ourselves - indeed, we must - but no one should be attacked for disagreeing, and in disagreeing, never personally attack one of our own.

We must be above petty infighting.

Because we are in a battle for our fundamental civil rights. God willing, we will succeed.

Friday, February 11, 2011

CDC Research on CFS: Open Deception

This post contains evidence of deliberate deception by the CDC - in refereed journal articles and when speaking to the press.

I'm tired of sending this information to the CFSAC, to politicians, to reporters,and to scientists. Nothing ever happens. Maybe one of you reading this can find a way to do something about it.

Bill Reeves' name is on all of it - but he is not the only one, and I ask every co-author, every collaborator, to disavow this research, and the resulting questionnaires.

In the following documents, CDC describes a two-day hospital stay in Wichita. According to the CDC, there was only one such two-day hospital stay having to do with CFS.

We are told there were 227 patients with CFS, 58 patients with CFS, 43 patients with CFS, and 6 patients with CFS - same hospital stay, same group of patients. What happened here?

We are owed a public apology and a retraction, and we should not rest until we get one.

This is important, not because it was Reeves, but because the CDC still uses a set of diagnostic questionnaires that Reeves claimed "operationalize the Fukuda definition" - but the only formal effort to verify that claim was in this two-day Wichita hospital stay.

This must be aired publicly, because it is just plain wrong. There remains an article claiming to disprove NMH's relationship to CFS, the questionnaires continue to be used by CDC to diagnose "CFS", and co-authors continue to be decision-makers regarding our disease.

Here goes:

1. In April 2006 there was a conference call and press release about the genome study, where Reeves stated 227 patients with CFS from a population study brought into a hospital for two days were included in the data set - and also stated there was only one such study, so it's the same as in items 2, 3, and 4 -

You have to scroll down past Dr. Gerberding's long introduction to get to Dr. Reeves, and it's about ten paragraphs into his presentation to the reporters.

Just in case it looks like Reeves misspoke, there was also a written press release, also currently inaccessible (though it looks like there's a link) - but again, that's why we love caches and Google - in this one he says 227 patients with CFS in the second paragraph.

Why was this open deception okay? Where's the apology?

2. In December 2005, BioMed Central published an article describing the 2-day Wichit hospital stay, in which it was stated that 227 people from the Wichita surveillance study were brought into the hospital for a two-day stay: 58 who had been diagnosed with CFS during the study, and 169 people from 3 other categories: (1) "insufficient Symptoms of Fatigue" (ISF) to be classified using the Fukuda definition; (2) CFS and ISF with major melancholic depression, which was exclusionary; and (3) a set of matched controls.

So of the 227 people who were brought into the hospital, only 58 had been diagnosed with CFS. And of these 58, only 6 remained after various exclusionary criteria were applied.

To repeat, only six of those remaining in the study had been diagnosed with CFS using the methods of the surveillance study (telephone interview with physician follow-up, using the Fukuda criteria).

The origional article can be found here:

The information is mainly in the tables; if you are reading it online, click on table 2 and table 5.

3. The same article found 43 patients currently afflicted with CFS using the new questionnaires - including only those 6 patients who had been previously diagnosed with CFS during the surveillance study, plus another 4 who were newly diagnosed from the ISF group, plus 6 who would previously have been excluded for major melancholic depression for a total of 16 claimed to meet both the surveillance criteria and the new questionnaires -

Note: this is the only published trial performed by CDC to substantiate their claims that the questionnaires "operationalize" the Fukuda definition:

4. The depression exclusion was changed after a meeting of the so-called "CFS International Working Group" - but - the new criteria only said you could add in patients with major melancholic depression if and only if the bout of depression had resolved and not returned for at least five years before the onset of fatigue. You will not find the 5-year requirement in the abstract of the International Working Group's article on CDC's website - you have to pull up the article in BioMed Central:

"The 1994 case definition stated that any past or current diagnosis of major depressive disorder with psychotic or melancholic features, anorexia nervosa, or bulimia permanently excluded a subject from the classification of CFS. Because these illnesses may resolve with little or no likelihood of recurrence and only active disease or diseases requiring prophylactic medication would contribute to confusion with evaluation of CFS symptoms, we now recommend that if these conditions have been resolved for more than 5 years before the onset of the current chronically fatiguing illness [my emphasis] they should not be considered exclusionary.

And, finally,

5. The two-day hospital stay data was used in an article claiming to have disproved any connection between NMH and CFS (as described in a 1995 JAMA article by Johns Hopkins researchers)> The Reeves article states that 58 patients with CFS were brought into the hospital for a two-day stay and were given tilt table tests, and did not have NMH/POTS.


But we know that only 6 of the 58 supposedly still had CFS by the time they entered the hospital for that two-day study. Even if they had turned to the questionnaires to put together the sample, it was only 43. So where were the supposed 58 patients with CFS in a two-day hospital stay?

How many patients with CFS (Fukuda) participated in the two-day Wichita hospital stay?

6? 10? 16? 43? 58? 227?

Reeves (as representative of CDC) openly lied:

1. To the press corps (and probably the researchers in the genome study) when he said there were 227 patients with CFS in the two-day Wichita hospital study.

2. About the depression exclusion as defined by the Inernational Working Group on CFS - when he omitted the requirement that five years pass after the last incidence of depression and the beginning of current symptoms of fatigue.

3. About how many patients in the two-day hospital stay could be diagnosed with CFS - using the old or the new method - in an important refereed journal article used to "disprove" a theory about ANS dysfunction among CFS patients - when he said there were 58 patients with CFS who stayed in the hospital for two days;

4. And about having validated the questionnaires still used by CDC to diagnose CFS. Reeves has claimed that they "operationalize" the Fukuda definition. But his own published research show the questionnaires do not diagnose CFS (Fukuda) at all. He has quietly - and effectively - created a brand new definition, with far more in common with the Oxford definition used by British psychiatrists than the Fukuda definition he was supposed to use as director of the CFS program at CDC.

Ultimately, it is the questionnaires that perpetuate the biggest lie of all. If the CDC truly believes the Fukuda definition, amended by the Inernational Study Group, is the correct one, the questionnaires must be jettisoned now, and the Georgia data set re-examined, if not also discarded entirely.

All of us are owed a formal retraction and repudiation of the publications resulting from the two-day Wichita hospital stay.

The U.S. has allocated so little to the study of CFS, a disease that we know impacts a million Americans. How tragic that the money was wasted, apparently to promote an individual agenda.

I tried for four years to do something about this, and I failed.

I am now handing it to the community - and the co-authors, who share responsibility even if they worked on a different task in the study - to get something done.

Public apology and public retraction - nothing less.

Mary M. Schweitzer, Ph.D., Delaware, USA

Tuesday, February 1, 2011

Institutionalized Abuse and the Treatment of Patients with M.E. and CFS

Recently, as I read back through the psychiatric studies used to back the therapies of CBT and GET, I found myself thinking about the steps that an abusive spouse or parent takes to perpetrate the crime. People often ask victims of abuse, "Why didn't you report this the first time it happened?" The victim generally has no good answer, because he or she has been the unwitting subject of a psychological campaign by the abuser to prevent any disclosure of what is going on.

The British have been the worst abusers for years, in part because British psychiatry already has categories that fit a definition of CFS. In particular, the British have used "neurasthenia," harking back to an 1869 textbook that coined the term. The textbook is fascinating - the author makes the claim that girls who study science in high school risk either "neurasthenia" (a chronic nervous condition; the vapors; nervous breakdowns) or "hysteria" (defined here as a shrunken womb) because the body cannot develop both the mind and the reproductive organs at the same time.

How this ended up being accepted as a reputable source is beyond me, but then reviewers seldom actually look at the footnotes in a scientific journal - particularly footnotes that fall in the category of "survey of the literature." I believe that Simon Wessely and Stephen Straus, who both referenced Beard's "American Nervousness," slipped one past the profession there.

Neither neurasthenia nor hysteria are in the American Psychiatry Association's bible of diagnoses, DSM-IV. Thus far, adult Americans have been spared the worst abuses that have faced patients with M.E. or CFS in the UK.

However, a new category is being prepared for DSM-5. It is called Complex Somatic Symptom Disorder, or CSSD. The description reads just like the CDC's Fukuda (1994) definition for CFS, plus they've added in a pain version for fibromyalgia patients. So we all need to pay attention to what happens when psychiatrists believe that "CFS" symptoms are the physical manifestation of a psychological problem. The result is a classic abuse pattern.

Here are the main means by which abusers are able to continue their cruelty for years.

1. Isolate the victim
2. Tell the victim nobody will believe his/her story.
3. Threaten the victim with harm if he/she tries to tell the story anyway.

1. Isolate the Victim

This is accomplished by a diagnosis that leaves the worst patients bereft of medical care and isolated at home. People in the "real world" do not see the worst cases. They do not see them when they come in to clinics - because they don't come in to clinics. They do not see them at the grocery store or outside because by leaving them untreated, they have rendered the worst victims unable to participate in any way in the outside world. And by laughing at our disease, they keep the walking wounded invisible too, because no one wants to confess to HAVING this disease. So the victim has been isolated. In the places where M.E. was a valid diagnosis, the abusive relatioship first required the premise that M.E.= CFS (it does not), followed by the premise that CFS = "maladaptive coping mechanisms to illness" or "inappropriate desire to play the sick role."

2. Tell the victim that nobody will believe his/her story

Now, this has a twist. The recommendations of the Wessely-White-Sharpe-Chalder-Deary school of professional abuse don't have to tell the victim he/she won't be believed - we already know that. The twist in this case is in the information they are giving health care providers. They say not to believe what we tell them. The concept of "false illness beliefs" is heavily emphasized in all of the literature, including the CFS website of King's College London. They recommend that the medical profesional offer sympathy and pretend to believe what the patient is saying, but they warn not to get drawn in. Doctors who do believe what the patient is saying are themselves isolated by being charged with supporting abnormal "illness behaviors."

The CDC's version of this was to say - There were no cluster outbreaks. There were just outbreaks of diagnosis. Patients would go from doctor to doctor, seeking a diagnosis to confirm the patient's own beliefs about his/her illness. it is, of course, an insult to the doctors who helped patients in the cluster outbreaks as well as an insult to patients - but the argument succeeded. Few people know about the cluster outbreaks of the 1980s, and nobody knows about those that have happened since. You will find evidence of this in Hillary Johnson's masterpiece, Osler's Web, and I was present to hear Dr. Reeves use this argument to explain away the "theory" of cluster outbreaks at the CFSAC.

3. Threaten the victim with harm if he/she tries to tell the story anyway.

This is the scariest one of the three - scary because we are not talking here about an individual, but about a society, about a government entity. About the very people who are supposed to help you (doctors). What is the threat? In the UK it's very clear: You will be sectioned. You will be sent to a psychiatric hospital. The threat can be the withdrawal of any medical care at all. That is, if you persist in peppering me with information about CFS, I will no longer be your doctor - so where will you go when you need medical treatment for something else? I'll treat you - but don't bring up that silly disease fantasy.

Sophia Mirza needed care, but no doctor would agree to her simple request that she just see somebody without the threat of being sent into a psychiatric hospital. Sophia had been mistreated badly in a mental hospital and did not want to go back. No doctor would promise not to send her back to the psychiatric hospital, so she saw no doctors. She had been threatened into isolation. Abuse by the medical profession that killed her.

The threat is greater in both nations when applied to young people who become severely ill with M.E., because it is the young who are the most vulnerable. The threat is that they will be taken from their parents, because their parents have gone to a lot of trouble to seek a diagnosis and find a way to make their child more comfortable - perhaps even find a cure.

This should be perceived as admirable behavior, but the diagnosis of "factitious illness" and "factitious illness by proxy" represent cruel violations of the normal doctor-patient relatioship. In the U.S., the threat of "coming out" - of trying to get treatment and accomodations for your child - is that your child will be sent off to the foster care system and never returned. The threat is to have happen to you what happened to the Baldwin family in North Carlina, whose son Ryan was removed from his parents' home apparently because his parents were successful in finding a diagnosis that could help relieve some of his discomfort, successful in getting him a wheelchair to help him be more independent, and successful in being accepted for disability payments in his behalf with which to make his life more comfortable, and fund his medical care.

In the rare instance that a parent might actually be deliberately making the child sick to get attention, it wouldn't be a fancy neurosis called "factitious illness by proxy." We would be dealing with a sadistic sociopath! Clearly this theory hasn't been thought out completely - but is that because once thought out, institutions would lose this threat over parents? Once a psychiatrist confirmed that parent was not a sadistic sociopath, that would be the end of it. Thus, the Institution created a category that they can control.

In England, the threat is to be "sectioned" - to be sent to a mental hospital. And in both nations, this threat is very, very real. So this is the final threat:

If you come out about what you have, we will make your life miserable. We may even kill you.

So says the abuser.

So say the advocates of the British psychiatric school of "CFS treatment."

So say the marketing wizards behind cognitive behavior therapy and graded exercise therapy.

So say those working in secret to create the category of Complex Somatic Symptom Disorder (CSSD) for the APA's new DSM-5.

What does history tell us about abuse? The victim needs help from the rest of society.

God willing, things will change.

Mary M. Schweitzer, Ph.D.

Note: For a fascinating read on how British psychiatrists believe patients with CFS should be treated, go to the website on CFS for professionals by King's College, London. For a new essay on the nightmare this has caused patients there, read The Mental Health Movement: Persecution of Patients? by Malcolm Hooper.