Slightly Alive

Why won't CDC study MY disease?

2011-12-21T17:19:00.000-08:00

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?

Dear Dr. Wessely

2011-08-10T12:20:00.000-07:00

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. 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 MRC, in which your wife is an active member? 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 it's 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.

"Science" and the rush to judgment

2011-06-01T09:58:00.000-07:00

Here we go again. We barely get a chance to think about a new finding in CFS, and the door is slammed shut. I see nothing wrong with Jay Levy writing an article stating that XMRV is a contaminant - but I think it is most unseemly for "Science" to call for a voluntary retraction by WPI (and, ahem, that should be WPI + the Cleveland Clinic + the National Cancer Institute) of the 2009 Lombardi et al study. It is amazing that anyone would call for a halt to work on the retroviruses before the NIH study being conducted by Ian Lipkin has a chance to show results.

Okay, so at least they gave us eighteen months. Usually we don't get that long.

There were problems. I tested positive in that original 2009 study - they found XMRV by serum and antibodies. But when Dr. Peterson sent a sample to VIP labs early in 2010, it came back negative. That happened to a bunch of patients. My own take was that I was positive - I learned having HHV-6, Variant A, that commercial labs can't go to all the trouble that a researcher does - Dr. Ablashi did all my early testing. That is one of the main problems we have - the methods used in studies are far too labor-intensive for labs. It took two years after HIV was discovered – with everybody and their uncle trying – to get a viable commercial test for HIV.

While I understand why they did it, it was naive of the Whittemores to buy a lab (Redlabs, which they turned into VIP labs) to do XMRV testing – and even more naive of all concerned to charge people for testing before they knew the testing was going to work! (They quit testing for a while, then started it up again, then quit again. I was not surprised for that, just frustrated that no one seemed to know how expensive this was for patients, or how bad it looked. It raised suspicions among those who could have been allies.

[Added after comments: I am sorry if I left the impression that, on the whole, there is anything wrong with either WPI or VIP labs. That was just an early mistake. I still use VIP labs for a lot of different testing, and WPI has been nothing but professional with me. In particular, I want to show my support for Dr. Judy Mikovits, who is a scholar of stature and is working hard to uncover the roots of this Disease, and has shown particular kindness to my family. At the same time, I have nothing but respect and affection for Dr. Peterson, who has been the rock for so many of us with this disease, and has himself been responsible for developing a program of diagnosing through biomarkers and treating with valid, published treatment programs, or in formal studies. I'm just asking that we keep this professional, for the sakes of those professionals who are doing so much for our community.]

What really impressed me was the Lo-Alter study. It wasn't a replication, but it was confirmation that the gamma retroviruses (of which XMRV is one) were involved. Then the Barcelona study – followed by the sudden withdrawal of funds to the Barcelona group, which is a great loss because they were working on other biomarkers. It was a message: find the retrovirus, lose your funding. Hmmmm.

While we're in the subject, I think we should keep mum publicly about any positive studies we know about that haven’t been published yet – for now.

And I’ll be honest about something: I don’t want a retrovirus – and I really don’t want my daughter, who hasn’t had children yet, to have a retrovirus.

Personally, I think HHV-6 Variant A is a scarier disease than XMRV. HHV-3 has a name – vericella zoster, or chicken pox and shingles. HHV-4 has a name – Epstein-Barr or mono. HHV-5 has a name – cytomegalovirus. But then there are no names. And when you tell a doctor you have HHV-6 variant A, which causes encephalitis and CNS damage and can cause myocarditis, they say, “what does HHV stand for?”. When you answer “human herpesvirus,” they say, “Oh! Herpes!” Oh great. They think we’re talking about cold sores (HHV-1) or STD herpes (HHV-2).

The press doesn’t know about HHV-6A and its role in our disease, thanks to the CDC and NIH. I’ve tried to get reporters who are hot on the trail of XMRV interested in the OTHER biomarkers and viruses we KNOW we get, but they are not interested. Yawn. I have both HHV-6 Variant A and cytomegalovirus in my spinal fluid for heaven’s sake. Yawn.

It seems in the press the choice is either XMRV or the PACE study – either we have a scary old retrovirus or we are nuts. It may be the editors, not the reporters, but the end result is the same. Either we have a scary retrovirus or we're nuts.

Is ANYBODY going to write about the severity of our disease just based on the severity of our disease? Guess not. Very dispiriting.

Shut down CDC's program on CFS and start over

2011-05-11T14:35:00.000-07:00

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.
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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.

Civil Rights

2011-02-13T00:30:00.000-08:00

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 Kuther King, 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.

Unity, disagreement, and respect

2011-02-12T15:42:00.001-08:00

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.

Myra McClure and NIH's SEP

2011-02-05T11:19:00.000-08:00

[Note: Dr. McClure has withdrawn from the CFS SEP since the publication of this post - and many others.]

In what can only be seen as a most unfortunate move, the NIH has added Dr. Myra McClure of the UK to the CFS SEP (Special Emphasis Panel) requested by Congress to evaluate proposals for grant money from NIH concerning CFS.

Thanks to the work of patient advocate Pat Fero, we have profiles of the members of this SEP - few of whom even claim expertise on CFS. These are mainly people who study pain, and more than one who studies psychological factors affecting the sensation of pain.

Then there is Jim Jones at CDC. Jones started out working with a cluster outbreak in the Denver area, writing a companion article to Straus's at the end of 1984 suggesting CEBV (chronic Epstein-Barr Virus) was the culprit. When Straus dropped CEBV and renamed it CFS, Jones quickly adopted a model of somaticizing. It was particularly cruel because he worked with a lot of children and adolescents. He has a kind of a CBT/GET/SSRI model at CDC, where he was hired to conduct physician education a few years ago. I suspect he is the driving force behind that "new and improved" web site that praises the UK's NICE Guidelines [which attribute The Disease to "inappropriate illness beliefs" and recommend 10 weeks of CBT (Cognitive Behavior Therapy) plus 10 weeks of GET (Graded Exercise Therapy), known colloquially as CBT/GET, as a cure].

Now we come to Mrya McClure - co-author on a British study in PLoS One published just three months after the WPI/NCI/Cleveland Clinic study came out in "Science". **

Someone must have said they needed a retroviral expert on the panel. Who better than someone who couldn't find a gamma retrovirus if they slapped her face with a cat suffering from feline leukemia? As an observer commented at the time, did she take the lens cap off the camera?

Worse (in my opinion) for a person charged with evaluating grant proposals for CFS, McClure found nothing in any way peculiar about deriving her entire data set from patients in a purely psychiatric practice - Simon Wessely's and Anthony Cleare's at KCL (King's College, London). Wessely once told me that because I had been diagnosed with Hashimoto's and NMH, I would have been sent to a different clinic at KCL and he would never have seen me. So the patients chosen by McClure had NOTHING that could be diagnosed using biomedical markers.

If you harbor any doubts, this is taken from the abstract of the McClure's article failing to find XMRV. How did they define their patient cohort?

"Patients in our CFS cohort had undergone medical screening to exclude detectable organic illness and met the CDC criteria for CFS." **

One might question what they mean by the "CDC criteria." If you start out with a group of patients who are mainly depressed (as Michael Sharpe enthusiastically described the cohort defined by the Oxford definition in answer to a question at the 1998 AACFS conference - he agreed to my suggestion that up to 90% of his patients mainly had minor depression ...) you can squeeze through the Fukuda (1994) definition - fatigue, sleep problems, difficulty concentrating, headaches, muscle aches ... The critical point being that anyone with an organic explanation for any of this would already have been excluded from the group.

It is a stretch to claim they meet Fukuda, but they would easily have met Reeves' definition (the questionnaires). Lenny Jason found that the Reeves adjustment to Fukuda (those questionnaires) fail to diagnose the sickest 30% who would previously have met Fukuda, and then fold in a lot of patients with primary depression or anxiety .... So a data set consisting of patients from a psychiatric clinic could easily meet the Reeves criteria.

And, what a coincidence, Reeves referenced Simon Wessely and Trudy Chalder (British expert on "factitious illnesses" and "factitious illness by proxy") in the article that described his questionnaires, and Reeves sudden announcement in 2006 that 4-7 million people in the U.S. have CFS, is exactly what you would have gotten at the time using the Oxford definition (Wessely's).

If you want to see a website that will make your hair stand on end, take a gander at the KCL website on CFS (and you thought CDC's website was bad ...) - the emphasis is on getting rid of "enablers," such as doctors who do not spout Wesselyite dogma, helpful friends and neighbors, and wheelchairs.

http://www.kcl.ac.uk/projects/cfs/health/

Or you could skip to my two favorite sections, on "fear" and "letting go of support."

http://www.kcl.ac.uk/projects/cfs/health/#Fear

These were the folks who provided patients for McClure's study of XMRV.

So they not only have added an "XMRV expert" who can't find XMRV ... But also someone who thought the KCL depiction of "CFS/ME" was accurate.

Slap in the face - but really more of a slap in the face to Lo and Alter and NIH's Natl. Cancer Institute (the latter had co-authors on the "Science" study) than WPI. Their own institution kicked them down the stairs.

** "Failure to Detect the Novel Retrovirus XMRV in Chronic Fatigue Syndrome"
Otto Erlwein, Steve Kaye, Myra O. McClure, Jonathan Weber, Gillian Wills, David Collier, Simon Wessely, and Anthony Cleare
PLoS One. 2010; 5(1): e8519. Published online 2010 January 6. doi: 10.1371/journal.pone.0008519.
PMCID: PMC2795199
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2795199/

Mary Schweitzer, Ph.D.

The relationship of XMRV to CFS and M.E.

2011-01-21T15:08:00.000-08:00

I know that the “hot” topic of the moment is whether XMRV or the gamma retroviruses in general can be transmitted by way of blood donation, but I would like to back off for a minute and survey the problem.

I happened to be watching “And the Band Played On” last night, and I noticed that they were looking at material from lymph nodes, not from blood draws, when they discovered HIV. That’s very interesting for those of us who suffer from M.E. (given the hopelessly dismissive name “chronic fatigue syndrome” by the U.S. CDC in 1988), because, at least for those of us in the U.S., tender lymph nodes are a major characteristic of the disease. Dr. David Bell once pointed out that patients with this disease can point to lymph nodes other people don’t even know they have.

Why are we not looking at lymph nodes instead of just blood serum?

It seems to me that the primary issue is whether or not up to a million Americans, sick with a disease that has been given a stupid name and garbage diagnosis by the CDC, actually are carrying a retrovirus or family of retroviruses. CDC has been “studying” this disease for 25 years, yet freely admits that 85% of patients – at least 850,000 people – have the disease but no diagnosis.

Research in France suggested that the disease pools in the lungs of patients – boy would THAT be bad news! Why are we not looking for it in sputum, then?

Understand that a retrovirus – ANY retrovirus – is going to be transmissible through blood and body tissue because it becomes part of your DNA, and eventually finds its way all over your body. A better question, perhaps, is whether the mechanisms that have been used to keep from transmitting HIV and HTLV will work with a different family of viruses, the gamma retroviruses, where XMRV fits.

We do not know much about how gamma retroviruses in humans. XMRV was the first one found, almost five years ago, in patients with a particularly virulent form of prostate cancer). However, there is a lot of research into gamma retrovirus behavior in the animal world. So that part of it should not be that difficult.

In contrast, finding consistent and homogeneous data sets of patients with M.E. among those diagnosed with CFS the way recommended by CDC (by first starting with people who are fatigued, and then eliminating any possible physical cause), cannot be done without acknowledge the failure of the CDC approach.

Now I come to Exhibit A – me, moi-meme, I.

I was in the Lombardi et al study in “Science” (October 9, 2009), and I was positive for XMRV. Hmm, I thought, that’s interesting.

Interesting but not, for me, earth-shattering, because I already had plenty of abnormal test results and viruses! I have been the patient of two excellent specialists on this disease – Dr. Marsha Wallace of Washington, DC (who no longer practices), and Dr. Dan Peterson of Incline Village, NV, who has been treating patients with this disease and participating in research studies about it, since a major cluster outbreak occurred in the Tahoe-Truckee area, or North Lake Tahoe, where Incline Village is situated, in 1984-85. They knew I had what the cluster outbreak patients had, and every biomarker, every chronically activated virus, was another step in understanding what has caused these outbreaks.

I personally believe I was caught up in an outbreak centered on Cherry Hill, NJ, an area that contributed a large share of the students at Villanova University outside Philadelphia, where there was an outbreak of Epstein-Barr in 1990 that swept up not only students, but faculty as well, including two other members of my department besides me. My full collapse did not occur until later; I have often wondered if the information that was censored or dismissed in the late 1980s and early 1990s might have spared my transition into the hellish state of progressive M.E. on October 24, 1994.

More to the point, however, is that if anybody has what the CDC calls CFS, I do. (For the record, I do not have what the British psychiatrists call "CFS.") Let’s go back over some of what I test positive for besides CFS, shall we? (This is testing done most recently in 2008 and 2009, when I was in relapse off the experimental immune modulator Ampligen. I have been back on Ampligen for ten months, and many of these tests have better results now.)

1. Immune biomarkers: 37kDa Rnase-L, a natural killer cell function of 3%, and abnormal cytokine counts.

2. Active viruses (some even active in my spinal fluid): recurring EBV (comes and goes – the rest are active all the time off medication); HHV-6 Variant A; HHV-7; cytomegalovirus; and three strains of Coxsackie B.

3. Abnormal SPECT scan and very abnormal VO2 MAX scores.

4. Abnormal Holter Monitor test and abnormal 24-hour BP/pulse test; diagnosed NMH/POTS

5. Hashimoto’s thyroiditis; hypothyroidism apparently caused by an inability to convert T4 to T3 (I take supplemental thyroid medication to keep my T7 panel normal).

6. Major symptoms: Severe pain behind my eyes and in the back of my neck 24/7, plus frequently occurring severe headaches. Photophobia, sensitivity to loud noises, tinnitus, parathesias, severe muscle weakness (to the point of collapsing to the floor), ataxia, blackouts, expressive dysphasia, central auditory processing (CAP) difficulties, dyslexia, dysgraphia, loss of volition (what I would call "the pause," as if someone had punched the pause button on my control panel), and profound confusion.

7. Other diagnosed related symptoms: inexplicable difficulty falling and staying asleep, myofascial pain syndrome, dropped left foot (that clears up on medication – I have no idea why), inability to pass a Romberg test.

See? XMRV was, well, okay, something new. And I find the research on both XMRV and the gammaretroviruses convincing, but then, I am not a scientist (although I can read statistics – and know how to put together a data set and how to evaluate one put together by someone else).

It is extremely important that while the light is shining on retroviruses, we not forget these other problems represented in one case – me – and that I share these viruses and biomarkers with a large number of my fellow patients (those who have had the money to get the tests, because by and large you have to pay cash for them, as I also have to pay cash for the treatment – the CDC is doing a tremendous job for the insurance industry). I have friends with infections I don’t have as yet – parvovirus, Lyme, mycoplasma, clamydia pneumonae. That we know of. And I have some things my friends don’t have.

We also have lost people to myocarditis (infection of the heart muscle), rare cancers such as stem cell cancer, and sometimes, just too many things wrong at the same time.

By and large this is a disease of immune defects, multiple infectious assaults, and resulting damage to the neurological, endocrine, cardiac, and biomechanic mechanisms.

The disease bears a resemblance to MS not only in symptoms, but also in having different flavors. I know patients who were sick in late adolescence, recovered completely, then relapsed again in their late 30s or 40s. I know patients who thought they had recovered until they started training for a marathon (one was a navy SEAL), which then threw them into a total bedridden state. I know patients who got very sick, got a bit better, and plateaued – have remained at that level, not well but not as sick as they originally were.

And then there are the people that call themselves “25-percenters” in the UK, because the best guesstimate would be that 25% of patients with M.E. have this disease in a progressive form that just keeps getting worse, and worse, and worse, leading eventually to a premature death. I believe I was a 25-percenter myself, saved from a lifetime in a one-person horror show by access to Ampligen. (I do not mean this to be an advertisement for Ampligen; I happen to respond unusually well to the drug. However, that should say something about both the drug and the patient, should it not?)

I have gone off Ampligen twice – the first time, after being on it 20 months and paying roughly $40,000 for the privilege (my parents helped my husband out with other bills), I thought I was cured. I had a wonderful year, which some of us call the “Ampligen honeymoon.” And then, at Cal Ripken’s last baseball game, October 6, 2001, I blacked out. When I came to, I was back in M.E.-land again, full throttle. The next day I had forgotten, and when I sleepily tried to get out of bed, I crumpled to the ground. Oh. That again. I could not get tested for the Rnase-L defect, but HHV-6 was back in spades.

It took seven months to get back into an Ampligen program, this time at Hahnemann Hospital in Philadelphia, about an hour from my home and accessible by train if I did not feel like driving. Once back on it, I swore I would not go off. The costs (including co-pays and testing not covered by insurance) was now down to about $20,000 a year, precisely my after-tax disability income. Our children were grown. We lived on Bob’s income.

But in January 2008, the head of my practice in Philadelphia died. Though he was not my doctor, he was technically the principle investigator on my “study.” In February I was informed that I could no longer receive Ampligen at Hahnemann. To my knowledge, no other Phase III patients (most of whom were patients with severe cancers) were cut off. They reapplied twice, but were denied.

In September 2008, I relapsed. And in the ensuing months, we did the testing that I listed earlier in this (increasingly long!) missive.

So there you have it. I have been back on Ampligen now for ten months. I can read again, I can drive a car, I can walk along Lake Tahoe, and all the symptoms I associate with encephalitis and meningitis – that is, encephalomyelitis – are gone. But I still suffer from pain, and stamina is still a major problem. My VO2 MAX scores remain abysmal. Unfortunately, since this drug is delivered by twice-weekly infusions, I am forcibly separated from my husband of 35 years, which to me is a terrible hardship. But then I see so many others with my disease who have suffered more, and I think I should not say much about being so homesick, about missing my dearest husband so much. After all, Lake Tahoe is not such a bad place to be marooned.

I’m just one case. Okay. But I will close with something an economist once said:

Anecdote is the singular of data.

I’m just one case, among many. When will we study the other aspects of my disease, of our disease? What else do we already know about M.E. (or “CFS”)? How many desperately ill people are out there, undiagnosed, untreated and confused? When I walked to Hahnemann on cold days, I would pass homeless persons huddled over heating ducts, and I would wonder how many of them had my disease.

There are one million people with some aspect of my disease, and 850,000 have no diagnosis. Of those who are diagnosed, only a handful are getting treatment. Where are the rest?

Where are the rest?

Written testimony to CFSAC 10/13/10

2010-10-10T17:50:00.000-07:00

Testimony to the
Chronic Fatigue Syndrome Advisory Committee of the
Department of Health and Human Services
October 2010

Mary M. Schweitzer, Ph.D.

Thank you for allowing me time to speak.

I have XMRV.

I was one of the subjects who tested positive for the retrovirus in the Lombardi et al study published in Science October 9, 2009.

I first fell ill in 1990 while living in Delaware. I was a tenured professor at Villanova University outside Philadelphia. I had giardia followed by Epstein-Barr during an outbreak at my university. In the four years that followed, I had bronchitis eight months out of the year; I lost my sense of balance; the slightest bit of alcohol made me sick; I had increasing trouble falling asleep; and I could not do my usual Nautilus circuit and aerobic exercise without my pulse skyrocketing. Yet I had periods of health; I skied every winter.

Then, on October 24, 1994, I had a blackout in my office. When I came to, I could not understand a word of the essays in the bluebooks in my lap. It took fifteen minutes to be able to stand. I do not know how I made it home. My chair put me on short-term leave, which eventually became long-term disability. Although I was “resting,” I got worse instead of better. After a blackout while driving close to home left me and my car on top of a stone fence (and no memory of how I got there), I gave up my car keys. At first I could walk across a room; eventually I could only move about the house by leaning on walls, furniture, and my golden retriever. When outside my house, I was in a wheelchair. Increasingly, however, I could not go outside because I could not sit up that long. This is a very isolating disease.

I continued to have a social life on internet, because nobody could tell how long an email or website took to complete – and other brainfoggy patients didn’t mind misspellings or wrong words inserted into a sentence. By fall 1998, however, even internet was too hard.

About a year into my illness I developed Hashimoto’s thyroiditis. I also was found to have NMH/POTS. My Washington specialist, Dr. Marsha Wallace, treated the sleep problems, the thyroid problems, and the disautonomia, but I continued to deteriorate. Eventually I spent most of my time curled up in bed, in the dark, listening to a favorite movie (because it was too painful to look at the tv); severe pain behind my eyes, in the back of my neck; migraine-level headaches; and general muscle aches everywhere.

In 1996 I heard Dr. Robert Suhadolnik of Temple present on his new discovery, 37kDa Rnase-L, and I was fascinated. Two years later, Dr. Wallace arranged for Dr. Dharam Ablashi to have my blood spun down into a PMBC pellet to be sent to Redlabs in Belgium for testing; at the same time, Dr.Ablashi tested me for HHV-6, Variant A, which he had co-discovered at NCI. I was positive for both.

I had read that abnormal Rnase-L was a good predictor of success with an experimental immune modulator, Ampligen, an asymmetrical double-stranded synthetic RNA. I had also read a study by Dr. Ablashi and Dr. Paul Levine that had shown Ampligen inhibited the growth of HHV-6 in vitro. With that evidence to work with, I made the decision to go on the experimental drug. I was too sick for the double-blind study then being set up, but that was just as well – I wanted to know I was getting the drug.

I responded extraordinarily well. My brain began behaving normally within four months; soon I was driving and reading again. Eventually I would return to research, but I have never regained normal stamina. The slightest illness would set me back for weeks. Nevertheless, I could go places again with my husband; travel and see things; walk – walk on a beach, walk on a trail far enough that I did not hear the sound of automobiles anymore. If you have ever been confined to a wheelchair, you will know what that meant, to be able to walk again. I had dreamed of walking. And now I could stride.

Ampligen was expensive. After 20 months I quit taking it. I experienced what we Ampligen patients sometimes refer to as the “Ampligen Honeymoon” – I felt so normal and was so happy. I even negotiated with Villanova to return to teaching.

And then, on October 6, 2001, at Cal Ripken’s last baseball game, I had a blackout. The usher, who knew us, got me to First Aid and found Bob (who was visiting friends). Bob got the car while a nurse took me out in a wheelchair. The Disease was back.

The next morning I forgot what had happened and went to get out of bed as usual – but I fell to the floor. Six weeks later Dr. Ablashi confirmed that HHV-6, Variant A, was back. I could not send blood to Belgium, but the HHV-6 results were enough. I knew I had to get back on Ampligen.

The physician who had provided Ampligen in 1999 was no longer doing so, but I learned that I could receive Ampligen infusions at Hahnemann Hospital in Philadelphia, where they had permission for double-blinds because of Phase II’s on rare blood diseases. It took seven months, but I finally was on Ampligen again. I had deteriorated terribly, however. It was as if I had never been better at all.

So I had to climb back out again. After that, I was afraid to go off the drug. I remained on it from May 2002 to February 2008. Dr. Wallace had retired, so in 2005 I began seeing Dr. Dan Peterson at Incline Village (joking that the price of a ticket on Southwest Airlines was cheaper than Amtrak to NYC, my other choice).

The money is a problem – but it is roughly the same as my after-tax disability pay, so I live on the largesse of my husband, who is a chaired professor in a business school and does a lot of moonlighting – everything from teaching banking in executive ed programs to college lacrosse officiating and odd jobs for Major League Baseball. We manage.

But so few of my friends could afford the testing I’ve had, let alone the treatment. Every test for which I am positive is on the CDC’s hit list – that paragraph that states the test is inappropriate for CFS. Consequently, insurance won’t pay for those tests. At roughly $500 apiece, the expense adds up. Nobody can get tested, nobody can say they have what I have, and if they could, they couldn’t get treatment anyway. Pretty neat deal. For the insurance companies.

I continued to do well on Ampligen and made great progress on a book. Then my worst nightmare came true. In January 2008, dear Dr. Brodsky, now in his 80s, passed away. In February I received a phone call: FDA had taken away the drug. Hahnemann applied twice to get it reinstated, and I am not sure where the bottleneck was, but they were denied. Which means I was denied.

All the places where it used to be possible to get Ampligen on the East Coast were no longer in the program. Now I began to panic. I knew I was a ticking time bomb – I hoped perhaps I could stay relatively well for more than a year because I had been on it for so long, and I was so much better. I was wrong.

Seven months after losing Ampligen, in September 2008, I had my third episode of sudden onset. Once again I descended into hell. I lost the ability to walk normally and we had to bring the wheelchair back up from the basement. I dropped things, and when I tried to load the dishwasher I crashed one glass against another. The exertion of five minutes of testimony at the October 2008 CFSAC meeting sent me to the floor; my friends helped me lie down softly as I had once been able to help them. It made no difference that now I knew the names of the various symptoms – ataxia, expressive aphasia, short-term memory loss, central auditory processing dysfunction, etc. My brain had disappeared. And there was the exhaustion. And the pain. Pain, pain, pain.

I went to see Dr. Peterson at the end of September, and he put me through a series of tests. My MRI results were negative but I had an abnormal SPECT scan. My VO2 MAX stress test was below the level Social Security lists as an automatic disability for people far older than me. My Holter Monitor test was abnormal, and a 24-hour blood pressure and pulse test showed an NMH/POTS event when I was standing in line at the pharmacy – suddenly my systolic dropped 40 points while my pulse skyrocketed 40 points. (That was the first time I had ever seen a readout of it.)

I was active for Epstein-Barr (it goes dormant and reactivates over and over again if I am not on medication). I can now add a low natural killer cell count and a very low natural killer cell function (2%). More viruses had appeared – most seriously, HHV-7 and cytomegalovirus (CMV). I was also weakly positive for Coxsackie B2, B3, and B6. We did not find HHV-6 in my plasma, however.

During this period I went back to see Dr. Peterson every couple of months. I could do this only because of the kindness of the people who push wheelchairs for Southwest Airlines, the airport limo drivers and Tahoe taxi drivers, and the kind people who run a motel on the north shore of the lake, who have a family member with The Disease. When I was scheduled for a lot of testing, my daughter would fly up from Los Angeles to drive me around. Somehow we made it work. But I always came back home.

In the fall of 2008 Dr. Peterson tried Vistide, a drug that is approved for CMV. I had my first two doses a week apart while staying at Tahoe. He had then set up a dose at an infusion center connected to the only infectious disease practice in northern Delaware – but when I came for the infusion, they refused to give it to me. “I’m sorry,” the doctor said, “we can’t give you this. It’s a strong drug, and all you have is CFS.” But I have cytomegalovirus, and Vistide is approved for cytomegalovirus. “We know. And if you had something serious, like AIDS, or were on chemo from cancer, we would give it to you. But all you have is CFS.” But you told my specialist you would administer it to me. “Yes, but we hadn’t seen your files yet. We didn’t know you have CFS.”

I had to fly to Reno, spend the night, get my dose, and fly home.

But Vistide was not in the works for me. Ironically, while I seem to be the poster child for Ampligen, Vistide made my liver function tests go off the charts. My SGOT and SPGT counts were 500 times what they should ever be. They returned quickly to normal, so we tried a half dose of Vistide and then halved it again, but each time SGOT and SPGT spiked just as before. Vistide was out of the question.

In July 2009 I had a spinal tap - my daughter and her boyfriend came up from L.A. to help me again (Bob was just trying to earn money!). Aha – that’s where HHV-6 had been hiding out. So now I could say I ran the table – HHV-4, 5, 6 and 7.

At one point I remember saying to Dr. Peterson, it has to be my immune system. Something has to be really wrong with my immune system. Otherwise this does not make sense. He agreed, and then he said, “Oh, there are things I would like to tell you!”

Now, I will admit here that the very well-kept secret did not turn out to be what I was hoping for. I hoped desperately that Ampligen had by some miracle been approved. The finding that there was a retrovirus in 2/3 of a sample of 101 CFS patients completely bowled me over. That one I had not expected. And a few weeks later, by email, came the suggestion from a fellow patient that I ask WPI if I had been in the study. I assumed it was the Tahoe-Truckee cluster outbreak of 1984-85. Instead, they had deliberately picked zip codes from all over the place – so my Delaware zip code had bought me a free XMRV test. I was afraid to call and find out – not afraid to have it (I had plenty!) – afraid that I would not have it. Just as I had been afraid of the Rnase-L test 11 years earlier. The epithet of diagnosis-seeker only has meaning to someone who has never struggled to find treatment for a severe illness. XMRV means two things to me: an explanation for why I can’t go off Ampligen without getting sick, and the possibility of a substitute for Ampligen if FDA refuses to approve it. It means hope.

One more anecdote: During this period I fell, resulting in a slipped disk. (I fall a lot when sick.) I have a good neuro-spine surgeon at Penn, and he shaved a piece off quite neatly. But I was amazed at the response from the anesthesiologist, and later the nursing staff, to my warning that I had been diagnosed with a newly discovered retrovirus and they needed to take precautions. I was treated very differently than in the past – same symptoms, same litany of diseases and abnormalities, but now we had added a recognized disease (CMV) and a retrovirus (XMRV), and everything had changed. They were very happy to get me out of the hospital as fast as possible – so was I.

CMV and XMRV represent the first diagnoses I have ever had which turned heads among hospital staff. But as my daughter said when I told her about my new diagnoses, “you were sick long before anybody said what you had, Mom.” And she should know. She spent five years taking care of me.

Last year my husband, Dr. Peterson, and I decided that because I responded so well to Ampligen, I had to go back on it. That meant I was going to have to live in Incline Village, NV, until Ampligen became available at home again. It’s ironic – I live in the Northeast Corridor – 10 minutes from I-95, 5 minutes from a train station. I’m within driving and/or easy Amtrak distance from 40 percent of the nation’s population. But I had the choice of western North Carolina or a resort town on Lake Tahoe to be able to go back to the only medication that has ever worked for me. Since Dr. Peterson was my specialist, the choice was obvious. And I imagine I won’t get much sympathy for having to live at beautiful Lake Tahoe. But I have been married 35 years, and I miss my husband terribly. At our age, you feel like two heads of the same body. It’s awful. Thank heavens for unlimited long distance calling, MLB.com’s internet package, and Southwest Air.

I know that XMRV is “hot” right now, and dominates the discussion. But please remember that there are a number of immune biomarkers and viruses that we have that CDC also pretends don’t exist. They couldn’t find XMRV? I’m not surprised – they never could find HHV-6, natural killer cell dysfunction, mycoplasma, or NMH/POTS, either. It’s been the same thing for years: A quick study with a few patients chosen in a creative manner and then they can announce that X, Y, or Z is not “The Cause” of CFS. Why should it have been any different with XMRV?

But look at my history – and I am no different from many, many others with my disease who have also been able to get testing and treatment. I have some things others don’t have; others have things I don’t have. There’s a young man getting Ampligen with me who shares HHV-6 and the 37kDa Rnase-L (and XMRV) – but he also has parvo, which I don’t have, and myocarditis, which I hope I don’t have. There’s a pretty standard array of testing that works for us – that demonstrates a very serious set of biomedical abnormalities. What matters right now is not finding The Cause, but identifying patterns that can lead to treatment and improvement. That can turn around the downward spiral.

When you go to test whether XMRVs or PMRVs are related to the condition known as CFS (Fukuda 1994), please go back to everything else CDC has ruled out for the 25 years they have hidden this disease. This is important. Our lives are in your hands.

Thank you.

What do we have if we do not have CFS?

2010-08-08T15:35:00.000-07:00

I have always despised the concept and name “chronic fatigue syndrome,” created in 1988 to describe a group of patients who had previously been thought to have “Chronic Epstein-Barr Virus.” “CFS” is not scientific. It is a social construct, a shape-shifter, something that gets redefined as those in a position of power, or society at large, wish to redefine it. But it had one advantage. It helped researchers study a group of patients who have been sick for decades with a mysterious, apparently contagious, disease. It helped researchers define subgroups of patients who exhibited similar patterns of biomarkers and pathogens. If CDC defines CFS so that those patients are no longer considered to have the disease, then what can we say they have? And what is left that can be called “CFS”? Why would we study CFS at all?

Defining CFS so that it no longer fits “CFS” patients

In the late 1990s, it had become clear that “chronic fatigue syndrome” had been polluted as a research term because there were so many different – often conflicting – definitions in use. How could you compare a study conducted using patients from Simon Wessely’s psychiatric practice at King’s College, London – where patients with confirmable physical ailments were turned away – with a study conducted using patients from Dr. Dan Peterson’s practice at Incline Village, NV, one of the most-studied sites of a cluster outbreak in the 1980s? Over time Dr. Peterson and others had found tests that distinguished the cluster-outbreak patients from those with simple “chronic fatigue” – low natural killer cell function; the 37kDa Rnase-L defect; SPECT scan abnormalities; extremely low VO2 Max stress test scores; viruses such as EBV, HHV-6, and cytomegalovirus. Other researchers have found mycoplasma infections, mitochondrial dysfunction, abnormal immune cell ratios, NMH/POTS; myocarditis. The list goes on. Formally, they were all using the CDC’s 1994 Fukuda definition in their research, but practically speaking, the patients came from practices where clinicians had seen chronic fatigue syndrome in cluster outbreaks.

The result is research that defines subgroups of patients with patterns of biomarkers and pathogens. In fact, this was how Dr. Fukuda had imagined research would proceed with CFS. In the 1994 article that introduced what is called the “Fukuda definition” to the world, he wrote that “additional subgrouping or stratification of study cases into more homogeneous groups is necessary for comparative studies.” An entire section of the short (6-page) article was devoted to “Subgrouping and Stratification of Major Classification Categories”:

"In formal studies, cases of the chronic fatigue syndrome and unexplained chronic fatigue should be subgrouped before analysis or stratified during analysis by the presence or absence of essential variables, which should be routinely established in all studies. Further subgrouping by optional parameters can be performed according to specific research interests."

But CDC has steadfastly ignored that mandate. Instead of studying evidence of subgroups, CDC would take each new biomarker or virus, run a small study that sometimes even didn’t even test for the right laboratory finding, and then announce to the public that X or Y or Z was not “the cause” of “Chronic Fatigue Syndrome.” The Fukuda article is referenced only for the research definition – not for the imperative to subgroup into homogeneous classes. Most patients, clinicians, and researchers are probably unaware that the article even mentioned – let alone emphasized – the need to define homogeneous subgroups.

Twenty-five years after CDC was first asked to examine cluster outbreaks of the disease they would later name “chronic fatigue syndrome,” the website states as the first obstacle to diagnosis:

“There's no diagnostic laboratory test or biomarker for CFS.”

That simple statement shows the extent to which CDC missed the point of the Fukuda article. Fukuda assumed there would be no such tests that would hold for everyone. The tests would define subgroups.

Today on CDC’s website you will find an entire paragraph devoted to the testing that has identified the subgroups Fukuda envisioned – but CDC’s approach could not be further from what he had described. Some are listed as exclusions; others as experimental. In the latter case, one wonders how long after peer-reviewed publication does information continue to be viewed as “experimental.” Much of this information was first published 15 years ago. Perhaps more to the point, denying patients access to this testing also results in denying them access to treatment that has been found successful for patients who have such biomarkers or pathogens.

CDC’s emphasis on one test-one result also denies the reality that most patients with “CFS” (according to the original definitions) have more than one thing wrong with them. But there is no way to tell that from the CDC website (See

http://www.cdc.gov/cfs/general/diagnosis/testing.html)

"A number of tests, some of which are offered commercially, have no demonstrated value for the diagnosis of CFS. These tests should not be performed unless required for diagnosis of a suspected exclusionary condition (e.g., MRI to rule out suspected multiple sclerosis) or unless they are part of a scientific study. In the latter case, written informed consent of the patient is required. No diagnostic tests for infectious agents, such as Epstein-Barr virus, enteroviruses, retroviruses, human herpesvirus 6, Candida albicans, and Mycoplasma incognita, are diagnostic for CFS and as such should not be used (except to identify an illness that would exclude a CFS diagnosis, such as mononucleosis). In addition, no immunologic tests, including cell profiling tests such as measurements of natural killer cell (NK) number or function, cytokine tests (e.g., interleukin-1, interleukin-6, or interferon), or cell marker tests (e.g., CD25 or CD16), have ever been shown to have value for diagnosing CFS. Other tests that must be regarded as experimental for making the diagnosis of CFS include the tilt table test for NMH, and imaging techniques such as MRI, PET-scan, or SPECT-scan. Reports of a pathway marker for CFS as well as a urine marker for CFS are undergoing further study; however, neither is considered useful for diagnosis at this time."

While these tests might not be useful in “diagnosing” a single entity called "CFS", they are very useful in understanding and treating CFS. I have three of the four pathogens mentioned. I also have cytomegalovirus (CMV), which I imagine CDC considers exclusionary for CFS. I am abnormal in testing for three of the four immune markers mentioned plus the 37kDa Rnase-L which is listed there as a “pathway marker for CFS,” I have NMH; and I have abnormal SPECT scans.

More to the point, there is a subgroup of patients within the larger CFS-diagnosed community whose testing turns out almost identical to mine. So researchers identify a subgroup, but instead of using that to benefit patients, CDC insists it is either unrelated to CFS, or exclusionary for CFS.

Furthermore, the pattern of biomarkers and viruses - not a single test – is critical for understanding various subgroups that could now be defined empirically, if CDC permitted it. And by listing everything as if each was a single test, and each test represented a different disease, CDC effectively misleads anyone who comes to their website seeking an understanding of “CFS.”

I fit quite neatly into a subgroup of CFS patients who were caught up in a cluster outbreak in the north Tahoe area of Nevada in the winter of 1984-85. The Holmes definition of 1988 and the Fukuda definition of 1994 were both explicitly intended to describe those patients. When Congress voted for research funding and an advisory committee (today's CFSAC) for “CFS” in the Department of Health and Human Services, they did not mean for these resources to go to just any old thing CDC wanted to call “CFS” – they wanted to find answers for the people who got sick in the 1980s, and later, with a disease that appeared similar among oubreaks.

We have reached a point where CDC explicitly defines CFS to exclude the very patients they were charged with helping.

If the patient representatives on the CFSAC do not have “CFS” according to CDC’s restrictive parameters; if the researchers on CFSAC do not study “CFS” according to CDC’s website; if clinicians on CFSAC do not treat “CFS” as defined by CDC – precisely what is CFSAC supposed to do?

The issue is about to come to a head.

CDC insists that XMRV is not “the cause” of CFS. According to a reporter from the New York Times a month after the Science study had revealed the discovery that 2/3 of a sample of CFS patients had tested positive for the new retrovirus:

"Among those expected to try to replicate the XMRV findings is the Centers for Disease Control and Prevention. But Dr. William C. Reeves, who directs the agency’s research on the syndrome, has said that he does not expect to find the virus in blood samples from patients. He said that no other studies had ever proved a virus to be the cause, and that stress and a history of sexual and emotional abuse were more likely to play a role in many cases."

True to his prediction, when Reeves did publish a study on XMRV, he did not find any of the virus at all (despite consistent findings in earlier prostate cancer studies that 2-4% of controls had the retrovirus).

It now appears clear that if the scientific community accepts XMRV as the third known human retrovirus, CDC will simply define CFS so that it is not related to XMRV – they will simply add XMRV to that paragraph that lists all of the testing that is “inappropriate” for CFS. Thus Reeves will always be right when he declares XMRV to be unrelated to CFS - because CDC will redefine CFS such that XMRV by definition will be unrelated to it.

I was in the Science study and I was positive for XMRV. So I’m out of the CFS club, it appears. But I was already kicked out by virtue of testing positive for so many viruses and biomarkers. More to the point – if CDC defines CFS in such a way that the very patients it was created to describe no longer fit the description, what is the point of having a disease category called CFS in the first place? What is the point of a division of CDC devoted to CFS studies? What is the point of an advisory committee at DHHS to coordinate agency activities regarding CFS?

From the beginning, “chronic fatigue syndrome” was a disastrous name chosen to replace “Chronic Epstein-Barr Virus” back in 1988. It could not have been more dismissive if it had been chosen by a focus group. “Chronic” as in “chronic complainer” and “chronic whiner;” “fatigue” as in “yeah, I’ve been tired lately myself;” and “syndrome” as in “syndrome of the month.” In the first decade of the name, comedians had a field day with it. As recently as this year, a popular comedy show in England mocked the name and the disease.

Researchers familiar with the disease known as Myalgic Encephalomyelitis (M.E.) in England and old Commonwealth nations, and Epidemic Neuromyesthenia in the U.S., expressed the opinion at the Holmes meeting in 1988 that the disease was most likely M.E. (Epidemic Neuromyesthenia was no longer being diagnosed). But that information was not even included in a footnote.

M.E. would not be linked to the mysterious illness of the late 1980s as a possible biomedical explanation except in reverse. British psychiatrists eagerly grabbed the name “chronic fatigue syndrome” to portray M.E. as a psychogenic illness, “neurasthenia” (formerly known as “the vapors”). According to the British psychiatrists (Simon Wessely, Peter White, Michael Sharpe, Trudy Chalder, among others), patients with CFS had allowed themselves to become deconditioned because of “inappropriate illness beliefs.” A course of “cognitive behaviour therapy” (CBT), to teach the patient she wasn’t really sick at all, followed by “graded exercise therapy” (GET), to get her back into shape and on the job, was all that was needed.

British psychiatrists used a definition that omitted the sickest patients, excluded anyone with a physically diagnosable condition, and included patients with depression and anxiety disorders. Nothing could be further from the Fukuda definition – yet even today, because they say it is “CFS,” the media and many medical experts assume it is the same thing.

For years CDC used the Fukuda definition. Today, however, they use what can only be called the “Reeves” definition, after William Reeves at CDC, who created a set of questionnaires that he claimed “operationalize” Fukuda, but do nothing of the sort. The questionnaires – explicitly modeled after those used by British psychiatrists – define a population that is not severely ill, and contains patients who suffer mainly from depression or anxiety disorders. In short, CDC has moved to join the British psychiatrists in portraying the disease as psychogenic in origin – CDC uses the term “stress” instead of “neurasthenia” (because neurasthenia is not an accepted diagnosis by U.S. psychiatrists – it was omitted from DSM-IV, along with “hysteria,” because of the strong gender bias associated with the diagnosis). As Reeves told the reporter, CDC expresses the view that “a history of sexual and emotional abuse were more likely to play a role [than viruses or biomarkers] in many cases.”

Cognitive Behavior Therapy and Graded Exercise Therapy (CBT/GET) are now prominently displayed on CDC’s website as treatment for the disease. For a patient such as myself, who had viruses and immune defects, CBT is not going to bring about a cure. And for those of us who score abysmally low on the VO2 MAX stress test, GET is downright dangerous. But we are supposed to have been weeded out. Who is left?

How convenient to have a moving target, the social construct “chronic fatigue syndrome,” so that as research reveals the biomedical roots of the disease, CDC can maintain that it’s really caused by stress – having portrayed all the results of biomedical research as either inappropriate or useless. What good are thousands of refereed journal articles into biomedical causation (according to Harvard professor Anthony Komaroff) if CDC redefines the disease each time to exclude the new discoveries?

What the future will bring

As CDC’s pattern (and Reeves’ confession) make clear, patients with XMRV are going to be defined out of the CFS population. Will they have their own division at CDC? Will they have their own advisory committee at DHHS?

As researchers begin to study patients with XMRV formerly diagnosed with CFS, they will discover the patterns that CDC has heretofore hidden from public view – patients such as myself, with multiple immune defects, opportunistic viruses, and the resulting damage to the central nervous system, the brain, and multiple systems of the body.

What about those who do not test positive for XMRV? Will they be left behind, defined as having psychogenic CFS?

Or will the medical community come to its senses and realize that the real disease is in the patterns? Will they finally understand that the subsets of this disease were diagnosable with biomedical markers a long time ago?

If we do not have chronic fatigue syndrome, what do we have?

Testimony to CFSAC May 2010

2010-04-26T15:54:00.000-07:00

Testimony to the CFSAC of the
U.S. Department of Health and Human Services
May 10, 2010
Mary M. Schweitzer, Ph.D.

Thank you for allowing me the opportunity to present testimony. My testimony today addresses four issues, but they are all tied to one that is most basic: Accountability.

1. Accountability.

There is a stunning disconnect between what we supposedly know from this committee, and what the public knows (including medical professionals).

I have attended all save one or two of the meetings of the CFSCC and the CFSAC. Everything I know about my disease has been presented to this committee at one time or another. Dr. Suhadolnik spoke about the Rnase-L defect. Dr. Ablashi spoke about HHV-6. Dr. Rowe spoke about NMH/POTS. In the course of fifteen years there have been many more scientific presentations – and the presentations were tied to peer-reviewed journal articles.

Yet these researchers could have been shouting into the wind for all the good it has done. At its worst, the CDC and NIH have produced quick little studies enabling them to say “there is no known relationship between CFS and [pick a virus or biomarker].”[1] At its best, the CDC has simply ignored the information.

When the Science study by researchers from the Whittemore-Peterson Institute, Cleveland Clinic, and National Cancer Institute first surfaced, Dr. Reeves of CDC responded as he always has: the CDC will end up invalidating the findings. Because that is what he has been doing for twenty years; it is what Stephen Straus did for fifteen years.

It does not matter what testimony scientists have presented to this body; it matters even less the testimony that patients have struggled to bring to the attention of the agencies. There has never been any mechanism by which any of the agencies had to do anything at all relative to the information that came out of these meetings.

Every time CDC addresses the public about this disease, they begin with some version of the following: “Chronic fatigue syndrome (CFS) is an important public health problem. The causes of CFS are unknown and effective prevention strategies remain elusive.” [From the CDC's information for patients and caregivers] [2]

The same can be found in the “Toolkit for Professionals”:

“Diagnosing chronic fatigue syndrome (CFS) can be complicated by a number of factors: 1) there's no diagnostic laboratory test or biomarker for CFS…”[3]

And also from CDC’s “Toolkit for professionals:”

"Theoretical and Experimental Tests: A number of tests, some of which are offered commercially, have no demonstrated value for the diagnosis of CFS. These tests should not be performed unless required for diagnosis of a suspected exclusionary condition (e.g., MRI to rule out suspected multiple sclerosis) or unless they are part of a scientific study. In the latter case, written informed consent of the patient is required. No diagnostic tests for infectious agents, such as Epstein-Barr virus, enteroviruses, retroviruses, human herpesvirus 6, Candida albicans, and Mycoplasma incognita, are diagnostic for CFS and as such should not be used (except to identify an illness that would exclude a CFS diagnosis, such as mononucleosis). In addition, no immunologic tests, including cell profiling tests such as measurements of natural killer cell (NK) number or function, cytokine tests (e.g., interleukin-1, interleukin-6, or interferon), or cell marker tests (e.g., CD25 or CD16), have ever been shown to have value for diagnosing CFS. Other tests that must be regarded as experimental for making the diagnosis of CFS include the tilt table test for NMH, and imaging techniques such as MRI, PET-scan, or SPECT-scan. Reports of a pathway marker for CFS as well as a urine marker for CFS are undergoing further study; however, neither is considered useful for diagnosis at this time."[4]

What is the purpose of having researchers present information to the CFSAC if the CDC is going to deny it has any relationship to CFS? Along with many other patients, I have been diagnosed using many of the tests that the CDC continues to label “experimental,” and I have been treated as successfully as possible on the basis of those tests. We are well past the point where these should be still considered “experimental.”

Let’s contrast the CDC’s current position with the article by Fukuda et al establishing the current working research definition for CFS: “In formal studies, cases of the chronic fatigue syndrome and idiopathic chronic fatigue should be subgrouped before analysis or stratified during analysis by the presence or absence of essential variables, which should be routinely established in all studies.”[5] An entire section of the Fukuda article was devoted to the importance of establishing subgroups. That was sixteen years ago. Where are the subgroups?

Despite Fukuda’s urging, CDC has continued with a “one size fits all” approach to the disease. Either everybody has it, or it doesn’t matter. The possibility that there might be patients out there who were positive for any of the above viruses and biomarkers – let alone that there might be patients who were positive for several of them – is not admitted by CDC. Fukuda’s mandate to find diagnosable subgroups was completely ignored by CDC – and remains so to this day.

That stands in stark contrast to the numerous presentations and discussions I have heard while attending the CFSCC and CFSAC.

It also stands in contrast to what I know from my own experience. I am one of a subset of CFS patients who has both immune markers and numerous active viruses. I have abnormal Rnase-L; my natural killer cell function is 2%; I have recurring EBV and active HHV-6, HHV-7, cytomegalovirus – and XMRV. We’ve known about most of this for twelve years, and as a consequence, I have benefitted from treatment with the experimental immune modulator Ampligen. During these 12 years, why has not the CDC investigated the subset to which I clearly belong? Why haven’t other patients had the opportunity to be tested and treated?

So this is my first and primary question:

Where is the accountability from the federal agencies that report to the CFSAC?

2. Next I need to point out that there is a serious issue that the CFSAC must address, and address soon. That is the creation of a new psychiatric category for DSM-5 called CSSD, or Chronic Somatic Symptom Disorder.[6] The head of the committee that created CSSD is Michael Sharpe, a psychiatrist who is part of the Wessely school – a small group of professionals who assert that what appears to be a physical illness in CFS is actually “deconditioning,” which has been caused by “inappropriate illness beliefs.” The “cure” is for the patient to undergo Cognitive Behavior Therapy (CBT), during which the patient learns she is not physically ill at all, in conjunction with “graded exercise therapy” (GET) to get her back in shape. On the King’s College, London, website, one of the examples they give of their success with CBT/GET is a patient who is brought to the clinic in a wheelchair. She must be separated from friends, family, and medics who confirm her “inappropriate illness beliefs.” Then, and only then, she can rise out of that chair and walk.

Make no mistake about it, CSSD is designed for Michael Sharpe’s own specialty: CBT for CFS.[7] The APA received numerous letters protesting the category during an open comment period that ended April 20. They sent the protests back to the same committee, with the same person presiding. There will be another opportunity for open comments this summer. The CFSAC must formally address this effort to create a psychiatric category for chronic fatigue syndrome. At the least, before diagnosing a patient with CSSD, a doctor should be required to check for the symptoms of CFS. If the patient has CFS, then the patient cannot have CSSD.

3. Dr. Reeves may have left the CDC’s section on CFS, but his questionnaires remain. The Reeves questionnaires have created a different definition for CFS. While the CDC insists that the “Fukuda definition” has been used in all recent research, that statement is simply untrue. The Reeves questionnaires do not create a data set that conforms with the Fukuda definition. Therefore CDC must either acknowledge that we have a new definition, the “Reeves definition,” or it needs to disavow those questionnaires entirely.

4. Direct changes to the charter

We have been asked to comment on changes to the charter for the CFSAC when it is renewed in the fall.

(1) The first and most important of these must be some way to hold the agencies accountable for their speech and actions regarding CFS. It is as if the CDC had continued to refer to GRID long after everyone else had agreed to use AIDS. They seem stuck in the period before any biomedical research had been conducted on what was a mysterious illness in the mid-1980s, but is not such a mysterious illness today. I do not know what the answer is – but there must be some way to require that the agencies take seriously what goes on in these meetings – or why are we bothering at all? I suggest that the CFSAC not only report to Secretary Sebelius, but also to Senator Tom Harkin, Chair of the Senate Committee on Health, Education, Labor, and Pensions.

(2) Return to the format of the CFSCC in the 1990s, when the public was permitted a short question-and-answer period after each ex officio presentation. When the CFSAC first met in 2003, we were told that only the representatives of the public on the committee had any right to address the ex officio members. I had the unpleasant experience, while testifying, of having to ask Dr. Reeves for a clarification of some of his research (the question had actually been asked of me by a public member on the CFSAC.) Dr. Reeves responded, “I don’t have to answer to you” and turned his back to me! I do not know what language was in the CFSCC that gave me the right to ask a question and have it answered, but I think we deserve to have that right back again. There needs to be a microphone in the middle of the aisle, and at some point people in the audience who wish to ask questions should be allowed to line up at the microphone. It is a simple courtesy.

(3) Require that patients be permitted at least 5 minutes of oral testimony each.

(4) Make available the records of past CFSAC and CFSCC meetings. The minutes were edited heavily during both the Clinton and Bush administrations, but an unedited aural tape was made of all the meetings, and I was assured it was being preserved. The public should have access to both the printed minutes and the unedited aural tapes.

(5) Return to the format of meeting four times a year. There is already too much to be done to be able to accomplish what is needed in only two meetings a year.

(6) For over a decade, the Committee as a whole as known that at least 800,000 adult Americans have this condition and do not have a diagnosis. At what point are we going to do something about that?

(7) Research by Leonard Jason and others has suggested that teenagers fall ill with this disease at a rate about half that of adults. But the age range for adults is much longer than it is for teenagers. That would suggest that while the incidence in adolescence is half of what it is in adults, the prevalence may be much higher. The CDC has no program for children and adolescents. These are the most vulnerable of all patients. The IACFS/ME has a clinical definition for children and adolescents, but CDC has refused to admit its existence. Because of the enormous ignorance about the disease in the public arena – yet anther disconnect - schoolchildren who have a diagnosis have been taken from their parents and placed in foster care. And what happens to schoolchildren who are every bit as sick, but have no diagnosis? Again I ask, at what point are we going to do something about this? The charter must include language directing the agencies to address the needs of children and adolescents with this disease.

(8) The CFSAC should hold at least one state-of-the-science meeting a year. This would require funding, but since CDC apparently believes that we do not know anything about how to diagnose or treat a disease that impacts at least one million Americans, it’s about time we made a start.

(9) NIH spending on CFS must be comparable to the estimate of at least one million adults with the disease, and the agency must be accountable for where the funds are spent. It is a good sign that the NCI has been involved in research on XMRV, but in the meantime, the dollars spent on researching CFS and its subgroups have been miniscule. At most, NIH has spent $6 per patient per year – and most of that money has gone to projects (such as pain clinics) that have little or nothing to do with CFS at all. The Congressionally mandated CFS study group for allocating research funds at NIH is a sham; the majority of the members know nothing about the disease,[8] and therefore research projects directly addressing CFS are seldom approved.

I wish to thank the Committee again for the opportunity to offer testimony.

Mary M. Schweitzer, Ph.D.

--------------------------
Endnotes:

1. As a recent example, see the effort to discredit research on NMH/POTS in Jones JF, Nicholson A, Nisenbaum R, Papanicolaou DA, Solomon L, Boneva R, Heim C, Reeves WC. "Orthostatic instability in a population-based study of chronic fatigue syndrome." American Journal of Medicine 118:1415.e19-1415.e28, 2005.

2. This particular quote came from “Early adverse experience and risk for chronic fatigue syndrome: results from a population-based study,” Heim C, Wagner D, Maloney E, Papanicolaou DA, Solomon L, Jones JF, Unger ER, Reeves WC. Archives of General Psychiatry 63:1258-1266, 2006.

3. http://www.cdc.gov/cfs/cfsdiagnosis.htm- accessed 26 April 2010.

4. http://www.cdc.gov/cfs/cfsdiagnosisHCP.htm - accessed 26 April 2010.

5. Fukuda et al, “The Chronic Fatigue Syndrome: A Comprehensive Approach to its Definition and Study.” Annals of Internal Medicine, Vol. 121, December 15, 1994, pp. 953-959.

6. See my essay on CSSD on this blogsite: Slightly Alive: Letter to the APA on CSSD as well as the APA’s website on the proposed category: http://www.dsm5.org/ProposedRevisions/Pages/proposedrevision.aspx?rid=368

7. Psychiatrist Michael Sharpe was an early proponent (and continues to be) for cognitive behaviour therapy (CBT) and graded exercise therapy (GET) as cures for CFS. “Chronic fatigue syndromes are not new. Victorian physicians diagnosed them as neurasthenia … Cognitive behaviour therapy … emphasises consistency in activity management and the gradual attainment of behavioural targets. Taken together this evidence suggests that it is important to differentiate between the needs of the patient with acute fatigue and the patient with a chronic fatigue state; rest may be indicated for the former, but a gradual increase in activity should be at the heart of the treatment plans for the latter.” Michael Sharpe and Simon Wessely, “Editorial: Putting the rest cure to rest – again: Rest has no place in treating chronic fatigue.” British Medical Journal 316 (14 March 1998) 796-800. It would be disingenuous to suggest that Sharpe’s interest in creating the category of CSSD is unrelated to his professional commitment to the psycholization of CFS and its treatment. For other samples of Sharpe’s view of CFS, see M Sharpe, KE Hawton, S Simkin, C Surawy, A Hackmann, I Klimes, T Peto, D Warrell, V Seagroatt. “Cognitive behaviour therapy for the chronic fatigue syndrome: a randomised controlled trial.” British Medical Journal 312 (1996) 22–26. S Wessely, C Nimnuan, M Sharpe. “Functional somatic syndromes: one or many” Lancet 1999:354:936 939; P Davison, M Sharpe, D Wade, C Bass. “’Wheelchair’ Patients with Nonorganic Disease: A Psychological Inquiry.” Journal of Psychosomatic Research 47 (1999) 1:99-103.

8. According to the research subcommittee of the CFSAC, during the Bush administration only 17% of the members of the Congressionally mandated CFS study group that is supposed to examine potential research projects for NIH funding has ever published or presented a paper on CFS.

My letter to APA on CSSD

2010-04-12T15:36:00.000-07:00

Submission to the Work Group for Somatic Symptom Disorders

The new category of Complex Somatic Symptom Disorder, or CSSD, bears a disturbing resemblance to the CDC's Holmes (1988) and Fukuda (1994) definitions of the disease Chronic Fatigue Syndrome (CFS). The requirement that patients experience six months of debilitating fatigue is taken straight from CDC's definitions. This development is disturbing for three reasons:

1. For two decades, British psychiatrists Michael Sharpe, Peter White, and Simon Wessely - all proponents of the ideology-driven "biopsychosocial" school of medicine - have ignored the CDC's definition for one of their own, which omits the physical symptoms required of the CDC diagnoses, and includes concurrent major mood disorders (exclusionary in Holmes and Fukuda). They have long insisted that "CFS" is really a modern version of "neurasthenia", which was removed from DSM a generation ago but is still diagnosed in the UK.

2. Earlier efforts to portray CFS as a somatisizing illness were foiled by requirements in the definition of somatisizing, such as the length of the illness (decades) and the absence of any gain. It strikes one as somewhat disingenuous to deliberately replace that category with another that can then be used to portray as psychological, a disease described as biomedical by the Chronic Fatigue Syndrome Advisory Committee of DHHS.

3. The APA has stated elsewhere that many of the changes in DSM-5 are intended to avoid gender biases in existing medical categories. Isn't it strange that the proponents of the new category CSSD have often stated 90 percent of victims of CFS (and CSSD by distinction) are female?

At the end of the 1980s, when CDC adopted the name "chronic fatigue syndrome" for a series of outbreaks of a mysterious, debilitating illness, Simon Wessely resurrected the diagnosis of "neurasthenia" [aka "the vapors"] for CFS patients in England. Although it is a direct violation of ICD-10, British psychiatric manuals classify CFS under neurasthenia, but could not do so in the U.S. because the diagnosis "neurasthenia" was removed from DSM a generation ago for gender bias.

In choosing the term neurasthenia, Wessely referenced not Freud but a New York physician named Beard who coined the term "neurasthenia" in 1869. Beard's book, "American Nervousness", is well-known among women's studies professors for advancing the theory that girls who were allowed to study science and math in high school would end up with either a shriveled uterus (his version of "hysteria"), or struggle with a life-long "nervous condition" (neurasthenia). Beard openly wondered whether allowing girls to attend high school would result in the death of the "American race"; the "Celtic race" (Irish immigrants) did not permit their daughters a secondary education, and they enjoyed large families as opposed to the small number of children born to the middle class of the "American race".

I have to say I never thought I would see that book cited as a reputable source by a contemporary scholar, but both Wessely and the late Stephen Straus of NIH used it frequently.

Adoption of CSSD will allow this bizarre nineteenth century view of the way women's bodies work to return to DSM, albeit under a more modern name.

In England, the insistence that CFS is really neurasthenia has led to cruel results, with women thrown into mental hospitals against their will. CBT (to cure the patient of her "inappropriate illness beliefs") and GET (to get her back into shape after she has allowed herself to become deconditioned) are the only treatments recommended by British public
health.

The result is that patients with the most severe cases of this disease are forced into hiding, bereft of all medical care whatsoever.

Adults in the U.S. have, in general, not been subjected to that level of cruelty - although the vast majority of doctors in the U.S. are ignorant of the large body of literature on the biomedical symptoms and causes of CFS and when they don’t actually harm their patients, they can’t help them. Too often they assume the problem is stress; too often they write a prescription for Prozac and send the patient away.

However, more vulnerable victims of CFS - teenagers - have been subject to removal from their homes and sent to foster care for the sin of having a poorly understood illness. Laypersons in school boards or child protective services have felt competent to diagnose Munchausen’s Syndrome By Proxy (or its more recent incarnation, Factitious Illness by Proxy) after hearing a lecture or reading an article on the subject. The more the parents fight the diagnosis, the more its proponents can claim it is true.

The phenomenon is reminiscent of the belief that autism is caused by "cold mother syndrome", or multiple sclerosis really "hysterical paralysis".

It is particularly ironic to see such a push towards psychologizing a physical disorder at the very moment evidence points to a new, serious cause.

In October 2009, an article published in "Science" demonstrated that 2/3 of a sample of patients diagnosed with CFS are victims of the third known human retrovirus, XMRV.

I was in that study, and I have XMRV.

At this point I must admit that I have a personal interest in this issue. But I have been fortunate; my university connections have allowed me to participate in cutting edge studies. Let me share with you what scientists have learned about CFS, using myself as the case study.

As mentioned, I have been diagnosed with the newly discovered retrovirus XMRV, only the third known human retrovirus.

I also have the 37kDa Rnase-L defect, and my natural killer cell function is 2%.

Perhaps that is why I suffer from recurring bouts of EBV, and have chronically activated cytomegalovirus (CMV), HHV-6 (Variant A), HHV-7, among other viruses.

I have been sick since suffering a blackout in my office in 1994. I have ataxia, expressive aphasia, expressive dysphasia, short-term memory loss, and profound confusion (I once poured a cup of coffee into a silverware drawer convinced it was a cup). I suffer from constant severe pain behind my eyes, in the back of my neck, and in the large muscles of my thighs and upper arms. Even one flight of stairs is very difficult for me. When we go places, we have to use a wheelchair. And I used to be an avid skier.

I cannot pass a simple Romberg test. I have abnormal SPECT scans and my VO2 MAX score is 15.5, lower than would be expected of my 85-year-old mother.

I have been helped greatly by an experimental immune modulator, only to relapse when permission from FDA to have the drug was removed.

If you believe that a retrovirus, significantly abnormal immune biomarkers, and herpes viruses known to cause encephalitis, meningitis, myocarditis, and other serious diseases when active over a long period of time - if you believe all of this can be resolved using talking therapy and SSRIs, then proceed with your new category.

Neither could help me in the past - only pharmacological intervention directed at the viruses and immune defects has improved my condition.

How many biomarkers and viruses must a patient have to be taken seriously? If one is in constant pain, does it not make sense to worry about pain? If one suffers from a significantly debilitating illness, does it not make sense to be concerned about the state of your health?

This new category would place those sensible concerns in the realm of abnormal anxiety dysfunction. Patients would be denied access to the tests - and treatments - I have been fortunate to be able to have.

I can’t see how that would benefit patients – but it certainly would help out insurance companies.

According to the CDC, at most, 15% of the 1 million adult patients with CFS in the U.S. even have a diagnosis. Of those 150,000, only a handful have had access to the care, testing, and treatment I have.

It is a Dickensian world, where the victims of this disease are relegated to extreme poverty, no matter what their profession prior to the illness.

Who, then, would benefit from creating a psychological category for this very biophysical disease?

This is a question that the profession needs to answer before proceeding with plans for CSSD.

[Note to readers: To read about the proposed psychiatric category of CSSD for DSM-5, go to the following website: Complex Somatic Symptom Disorder (CSSD). Instructions for comments are on the bottom of the page. We have only until April 20 to leave a comment.]

Mary M. Schweitzer, Ph.D.

Who does the CFIDS Association of America represent? Not me.

2010-02-27T22:58:00.000-08:00

I was stunned to read the essay, "Playing a Weak Hand Well," by Suzanne Vernon, scientific director of the CFIDS Association of America, published by Co-Cure on 27 Feb 2010:
http://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1002d&L=co-cure&T=0&F=&S=&P=7879

Vernon writes,

"Use of the less-restrictive Oxford criteria may be objectionable by current standards, but samples were collected before publication of either the Fukuda research criteria (1994) or the Canadian clinical definition (2003)."

True, the Oxford definition predates the Fukuda definition. However, the Oxford definition was published as a counter-argument to the Holmes definition of 1988, that defined "chronic fatigue syndrome" in the first place. Unlike Holmes, the Oxford definition permitted no physical symptoms, unless they could be explained psychologically, and included depression.

The Fukuda (1994) definition was a revision of the Holmes definition, and bears much more in common with Holmes than it does Oxford.

Why choose Oxford over Holmes? Only if you accept the dogma of the British "biopsychosocial school" of medicine. Proponents of the Oxford definition believe that the symptoms of Chronic Fatigue Syndrome are actually due to deconditioning. They believe that patients with CFS possess "inappropriate illness beliefs." Something has caused them to think they are sick, when they are not - perhaps a bad experience with a virus that had long disappeared, or perhaps "coddling" (as White would put it) by family, friends, and physicians. The "cure" is ten weeks of Cognitive Behaviour Therapy (CBT), a particular type of psychotherapy, to convince the patient she is not really sick at all, followed by ten weeks of Graded Exercise Therapy (GET), to return the patient to work or school.

In the UK, the psychiatric version of "CFS" and M.E. has resulted in patients being "sectioned" - sent to psychiatric hospitals against their will. According to the 25% group, an organization of the sickest M.E. patients, many victims have been sent into those hospitals able to walk, but returned home in a wheelchair. Fear of being forced into a mental hospital has led to the sickest M.E. and "CFS" patients in the UK being unable to attend clinics at all - even for other reasons - for fear of being sent away. The outcome must be decried in the sharpest language, not supported.

Proponents of the Oxford definition: Simon Wessely, Peter White, Michael Sharpe, Trudie Chalder (among others) have served as paid consultants to the CDC's CFS program too often, and the CDC has been criticized sharply for this. Is it too much to ask that the organization considered the "main" national organization for Americans with M.E. or CFS at least recognize the existence of the CDC definitions over that of psychiatrists who favor, for example, the diagnosis of "factitious illnesss"?

The concepts of "factitious illness" and "factitious illness by proxy" (which has replaced the discredited "Munchausen's Syndrome by Proxy") are not currently used in the U.S. to put adults in mental hospitals - but they are being used in a frightening number of cases to separate school-aged victims from their families and place them in foster homes,where their doctors' instructions are ignored.

I was also shocked by the gratuitous negative reference to Elaine DeFreitas' work. Certainly the description is controversial. Vernon states:

"Back in 1991, Elaine DeFreitas, Ph.D. and colleagues published in the prestigious Proceedings of the National Academy of Sciences that they had detected retroviral sequences related to human T-lymphotropic virus type II (HTLV-II) in two-thirds of 31 CFS patients, compared with zero positive findings in 20 controls. This report was not confirmed by other investigators who found the same rate of these HTLV-like sequences in controls and CFS cases and the search for viral markers chilled for several years thereafter."

According to Hillary Johnson ("Osler's Web") and others, the CDC did the same thing with DeFreitas' work that the British psychiatrists are trying to do with the Whittemore-Peterson Institute/National Cancer Institute/Cleveland Clinic research (the "Science" study)- they claimed to conduct a study to see if the research could be replicated, but they did not duplicate the methodology. Similarly the CDC would claim to be unable to find HHV-6 (or its variants A and B)in a study where they used the wrong reagents.

From my perspective, there is a line in the sand. The research conducted by the proponents of the Oxford Definition is unethical and strongly lacking in vigor. Similarly, much of the behavior of the CDC with regard to "CFS" has been unethical and strongly lacking in vigor.

This is what the CFIDS Association of America supports? It is a sad day for patients, because we have no other truly national organization. Perhaps this will propel the state organizations (who maintain close ties with their bases and - unlike the so-called national organizations - accept criticism), to create an umbrella organization that can speak for all. Most state organizations fear that involvement in the political games of "CFS" advocacy on the national level would destroy the delicate relationships that keep their organizations sound. However, I see no other alternative if we are to create a national organization that connects, through regional and state organizations, to patients and conditions on the ground.

Finally, a replication study requires that both the data set and the methodology be the same. That has not been true of any of the three attempts to "duplicate" the "Science" study linking XMRV to CFS. Knowing that her audience consisted of laypersons who might not understand the difference between "duplication" and "replication," Dr. Vernon, as a scientist, should have made the difference clear in her essay. I remain perplexed as to why she did not.

Time will tell whether the "Science" study will be replicated - but there has yet to be a true replication study published. I can understand why European psychiatrists would want to squelch the suggestion that 2/3 of patients diagnosed with "CFS" actually harbor a retrovirus (which leads to immune defects and consequent chronic infections) - but why would the scientific director to the CFIDS Association of America?

Anyone who sides with the Oxford definition over Holmes; anyone who would reach back to denigrate the Elaine DeFreitas retroviral study, which died for lack of funds, and anyone who would fail to spot an obviously false replication study does not speak for me.

Mary M. Schweitzer, Ph.D.

PS - a very good essay on the detractors of the "Science" study can be found here:
http://www.meactionuk.org.uk/exposing-more-anti-xmrv-spin.htm

CDC Research on CFS: Open Deception

2010-02-11T21:10:00.000-08:00

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 -

http://www.cdc.gov/od/oc/media/transcripts/t060420.htm

Couldn't find the website using the URL given by CDC? Neither could I. I believe CDC has deleted it, which is a violation of the Sunshine Laws, but there's always the Internet Wayback Machine:

http://web.archive.org/web/20060512010531/http://www.cdc.gov/od/oc/media/transcripts/t060420.htm

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.

http://www.cdc.gov/media/pressrel/r060420.htm

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).

http://www.cdc.gov/cfs/publications/casedef_10.htm

The origional article can be found here:

http://www.biomedcentral.com/1741-7015/3/19

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:

http://www.cdc.gov/cfs/publications/casedef_10.htm

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:

http://www.biomedcentral.com/1472-6963/3/25

"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.

See
http://www.cdc.gov/cfs/publications/causes_30

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

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

2010-02-01T14:04:00.000-08:00

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.

Can we choose "all of the above"?

2010-01-17T13:09:00.000-08:00

The critiques are beginning to come in about the discovery of a new retrovirus in patients with an agressive form of prostate cancer - and in patients with the diagnosis "chronic fatigue syndrome." [Lombardi et al, "Detection of Infectious Retrovirus, XMRV, in the Blood Cells of CFS Patients,” Science (9 Oct 2009).]

Everyone familiar with what passes for government-approved "research" regarding "chronic fatigue syndrome" knew that it would not take long for there to be a response denying the validity of the article on the retrovirus XMRV that was published in Science in October. We also knew that there would be no respect shown for the professionalism of the team that produced that research: the Whittemore-Peterson Institute, the Cleveland Clinic, and the National Cancer Institute of NIH.

Those of us who are saddled with the pathetically inept diagnosis of CFS are particularly vulnerable to the public dismissal of any and all research because of the success of various interest groups in creating an inchoate, ever-shifting social concept, "Chronic Fatigue Syndrome," in the guise of a disease. CFS may have been created to refer to a speciifc group of patients - but a quarter-century later, it has so many multiple meanings as to be absolutely useless for purposes of sound research.

The winner in the "get rid of the evidence" sweepstakes was what is now called the "McClure article" because the first author listed is named McClure - but buried in the list of authors are the three who put together the data set: Simon Wessely and two other colleagues from King's College, London (KCL). [See
McClure et al, "CFS patients in UK show no signs of suspect virus."]

It beggars the imagination to suggest there is anything in common with the way Simon Wessely and Dan Peterson diagnose patients. KCL was very touchy on that subject, insisting that they followed the Fukuda definition precisely, but if you have any doubts about the views of KCL researchers on CFS, take a good look at the KCL website on CFS for professionals:

http://www.kcl.ac.uk/projects/cfs/health/

The authors even make the claim that talking therapy healed a "CFS" patient who had allowed well-meaning friends and physicians to confine her to a wheelchair. Imagine telling physicians that a patient confined to a wheelchair is just there because she thinks she shoul be - if the patient had Multiple Scerosis, or Muscular Dystrophy, or ALS. Imagine physicians looking at a CFS patient in a wheelchair and thinking all that has to be done is convince the patient she can walk. To me, it harkens back to the shysters of the old circus tent evangelicals in the U.S., who would claim to be able to heal people with a touch of the hand. There's something seriously wrong when a professional medical website reads more like Elmer Gantry than Gray's Anatomy [the textbook, not the show]. It gives new meaning to the old saying "the inmates are running the asylum."

Until scientists require as much rigor in the data selection process as they claim in modeling and statistics (and medical science leaves much to be desired on those points as well), opinion is elevated to the level of fact, and ideological dogma parroted by a lazy (or hamstrung) popular media.

For the last decade, CDC's program on CFS has been collaborating with Emory University's department of psychiatry, section on somaticizing. As a result, we have to be concerned that the CDC's work is now also dependent on data sets that conflate depression with chronic fatigue. The old promise that the name "Chronic Fatigue Syndrome" would be viewed as a discrete illness, and never be confused with "chronic fatigue," has been completely abandoned by CDC. With both CDC's and the UK's preoccupation with a female patient who thinks she's sick but is not, I am not only appalled by the absence of intelligent scholarship at both institutions, but also offended to find myself, as a female patient, the target of their biases.

There is, however, a greater problem:

Nobody asks the simple question: what might this new finding mean in and of itself?

Instead, the value of the finding is determined by its ability to fit old paradigms when, in fact, the discovery actually blows the paradigm apart.

It has been my unfortunate luck to be able to check "all of the above" on the lists of causation (except I had a great childhood). But the CDC wants no part of multivariate modeling, claiming Occam's Razor requires absurd reduction to the lowest common denominator - a perversion of that dictum in model-making just as destructive as their use of statistics in a manner that must make Popper whirl in his grave. [The laws of statistics prohibit claiming to "prove" that CFS is not associated with Factor A, B, or C, simply by noting you could not find a statistically significant difference between a sample of patients and a sample of healthy citizens, particularly when small sample sizes are used, as was the case in the Wichita two-day hospital stay.]

English professors and historians receive grants from the National Endowment for the Humanities [NEH]; physicists and chemists from the National Science Foundation [NSF]. Nobody at either institute has the right to claim a theory and deny funding to all who oppose it. I was astounded to find the opposite true of both NIH and CDC. How did the bureaucrats at those institutions become so all-powerful?

And if they are right, why are they still in charge of the disease?

If "CFS" is really a psychological disorder - a type of somaticizing [KCL] or a type of post-traumatic stress disorder [CDC] - why does it not fall under the purview of NIMH (National Institue for Mental Health)? If not, why are psychiatrists given such an important role as paid consultants by CDC with reference to "CFS" - and why are supposed specialists in viruses and infectious diseases allowed to play amateur psychiatrist?

How can you look at the McClure paper and not question the data set? For that matter, shouldn't at least 3-4% of the people in the data set, diagnosed with "CFS" or not, have tested positive for XMRV?

XMRV cannot be "CFS" - can't even be a marker for it - because CFS exists only in the eyes of the beholder.

CDC's response was predictable. According to the New York Times (12 Oct 2009), Dr. William Reeves, who has run the CDC's program on CFS for two decades, neatly dismissed the finding offhand. "'We and others are looking at our own specimens and trying to confirm it,' he said, adding, 'If we validate it, great. My expectation is that we will not.' He noted that there had been false starts before, including a study in the 1990s linking the syndrome to another retrovirus, which could not be confirmed by later research."

I am amused that in his insistence no role for XMRV will be found for "CFS," Reeves mentioned the previous "false starts" - not by name, but I assume that would include EBV, NMH/POTS, 37kDa Rnase-L, natural killer cell dysfunction, and HHV-6 (specifically Variant A, which CDC apparently chooses not to "believe" exists, either). I am amused because I have all of them. There are other markers for which I am not positive - no cancer yet, thank heavens.

Most of us with one "CFS" biomarker have others. Shouldn't that mean something?

For years I testified to the CFSCC, and then the CFSAC, about the evidence of immune and viral damage connected to this disease, only to have Reeves mutter something into the microphone after my testimony, when I was not allowed to respond. Sometimes he would say, "it can't be replicated [Rnase-L defect];" sometimes he said "it's ubiquitous [HHV-6]"). Each time, the biomarker or microbe was presented to the public as either The Cause for CFS, or a worthless finding altogether.

Setting aside the question of just what "CFS:" could possibly be that, after 25 years of so many multiple meanings, could be defined by anything scientific,

Is there a case to be made for "all of the above"?

Is there a case to be made for simply studying the patients who test positive for XMRV and describing their health characteristics? What else do they have (besides, in some cases, prostate cancer)?

In the 12 years since I first brought up the subject of a biomarker in my testimony at CFSCC, only to have it summarily shot down by Reeves or, in the case of HHV-6, Straus (who had been sitting in the back of the room), surely we could have learned something. The skimpy articles defining CFS by Holmes (1988) and Fukuda (1994) were so modernistically sterile as to be misleading about the true nature of The Disease.

Yes, some very good research has been conducted by those of serious intent, using only Holmes or Fukuda.

But let's face it - the best research was not conducted by looking at the Holmes or Fukuda definition through naive eyes, but in collaboration with a clinician who knew how to diagnose what I call The Disease for lack of a better name.

Researchers who have come into the field searching for "Fatigue" writ large have in general produced such brilliant correlations as "the experience of pain correlates with fear of pain" - and then concluded "catastrophizing causes pain." I wouldn't have passed an undergraduate who tried that line of reasoning in a term paper - yet that article was eventually published.

Both Holmes and Fukuda pass the test of modernist simplicity - but how useless compared to the old-fashioned type of epidemiology observable in Gilliam's brilliant, 100-page description in public health's 1938 bulletin on the 1934 outbreak of "atypical polio" at L.A. County General Hospital, or Ramsay's description of M.E. in his 1988 textbook. [The Canadian definition made an effort at complexity, but it, too, is denigrated as a "clinical" definition.]

What we need first out of science is thick description of what it is we are looking at. But in a professional culture where modeling is supreme and basic description denigrated as "applied," even medicine, the most applied of applied sciences, only gains respect when pretending to be "pure." Even if that "purity" is outright fabrication [such as the references to Beard, American Nervousness, 1869, as a way to claim a scientific basis for "neurasthenia"].

Had we followed Gilliam's lead, we would now know so much more - had anyone in government shown concern for the long-run outcome of these conditions for the nation's health, instead of the short-run goal of keeping health care costs down, we would have made much greater progress in understanding The Disease, and whatever else gets dragged into that wastebasket diagnosis.

I actually do believe there is A Disease, and then a lot of misdiagnoses. To repeat: Those of us who test positive for one of the biomarkers tend to test positive for others. There is an identifiable complex disorder out there, and a lot of us have it.

We came to an understanding of AIDS symptom-first because we had to - the patients died off quickly, in the prime of life, from diseases they should not have had, before anybody had a clue as to a model or ultimate cause. The ramifications of HIV were shoved in everyone's faces. That those of us with this Disease die off two decades too soon isn't urgent enough to attract that kind of attention. So no one is interested in simply compiling a list of what goes together with what. Who would publish it? Who would care? That would be (shudder) clinical.

In addition to living a diminished life for years, unable to earn a living or enjoy the activities we used to, we do die early. We die an average of two decades too soon, of heart disease or rare cancers (leukemias and lymphomas). Ironically, after years and years of wishing CFS was not in our diagnosis, they finally take it out at the moment it should be there - when we die. There is no record of patients who have died of heart disease because of CFS, or leukemia because of CFS, or stem cell cancer because of CFS. The records say they died of heart failure, leukemia, or stem cell cancer. Period. We just know about it because they were our friends.

The XMRV discovery is a new opportunity for learning something, if we want to - and if we ask our governments on both sides of the Atlantic to show just a modicum of responsibility. And if we demand responsibility in the media and our professional publications.

Will we use this opportunity to actually study something before drawing vast conclusions?

This is the question I want answered:

*What do the patients diagnosed with XMRV have in common?"

Not "Is XMRV the answer to CFS?"

I want to see the CDC actually consider a multivariate model. I want the psychiatrists either out of the game, or an open admission that they're in - and if they are in, an explanation as to why research on The Disease isn't being managed by NIMH.

Otherwise, the discourse will dissolve again into competition for The One True Cause before we even know what it is we are studying. And, once again, the patients will be the losers.

Mary M. Schweitzer, Ph.D.

A Primer for XMRV and XAND

2009-11-21T13:29:00.000-08:00

On October 9, 2009, an article was published by Judy Mikovits et al in the highly prestigious research journal Science announcing the findings that a newly discovered retrovirus, called XMRV, had been found in 67 percent of a sample of patients diagnosed with CFS over a period of 25 years. There are only 3 known human retroviruses: HTLV, HIV (which leads to AIDS), and now XMRV. The importance of this finding cannot be overstated. The Cleveland Clinic had already found XMRV in roughly 10 percent of prostate cancer patients, but the more startling news had been that it was present in 3.4 percent of controls. That was too high. So they began to look for other possible roles this virus played.

The new Whittemore-Peterson Institute, or WPI, combined resources with the Cleveland Clinic and the National Cancer Institute (one of the National Institutes of Health, or NIH) to arrive at this startling conclusion. Mikovits is Research Director of the WPI, a private research institute created four years ago in association with the University of Nevada at Reno.

Here is a quick primer for those who have been diagnosed with CFS or M.E., and the many who have XMRV but have yet to be diagnosed. I am a social scientist, not a hard scientist, so keep in mind my viewpoint is that of the lay public. I will add more information and sources over time, but right now this basic primer should be of help.

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XMRV is not CFS

XMRV cannot be CFS because CFS means too many different things in the realms of medicine, research, and popular culture. Formally, CFS is what we call a "socially constructed concept."

For example:
According to British psychiatrist Peter White, CFS is a condition of unexplained symptoms that results from "inappropriate illness beliefs." It is best treated with Cognitive Behaviour Therapy (CBT) and Graded Exercise Therapy (GET). And this is pretty much the version of CFS that has been adopted by Britain’s National Health Services and their "NICE" medical guidelines.

Patients diagnosed by White and other British psychiatrists as having CFS cannot have any physical explanations for their symptoms. Therefore they cannot have XMRV.

Another way of putting that is: the moment a patient diagnosed in the UK with “CFS” is diagnosed with XMRV, he or she is suddenly free of the interim diagnosis of CFS. By the British medical establishment’s own rules. That means that any statement by “CFS” experts in Britain such as Peter White, Trudy Chalder, Michael Sharpe, or Simon Wessely, with regard to XMRV, is out of their field of expertise – they are all psychiatrists.

The U.S. CDC has several definitions for CFS, but the one in current use in their current study of a group of patients in Georgia does not permit any significant physical symptoms. If those patients have XMRV, then it’s a pretty vapid retrovirus!

It is no wonder that the head of the CDC’s program on CFS for the past twenty years, Dr. William Reeves, immediately responded that none of the CFS patients in his big, new Atlanta-area study would have the virus. "Dr. William C. Reeves, who directs the agency’s research on the syndrome, has said that he does not expect to find the virus in blood samples from patients. He said that no other studies had ever proved a virus to be the cause, and that stress and a history of sexual and emotional abuse were more likely to play a role in many cases." (See ”A Big Splash from an Upstart Medical Center,” New York Times, 11 November 2009).

I agree. Few of Dr. Reeves' patients will turn out to have XMRV. That is because for twenty years he has been studying “fatiguing illnesses” – not anything to do with the immune defects and viruses that caused cluster outbreaks of disease all over the United States. The patients he studies are not the ones from the cluster outbreaks, and if he tripped over one, he wouldn’t know what diagnosis to give them.

When Dr. Mikovits found that 95% of CFS patients from a large selection of practices in the U.S. had XMRV, it was a result that will not be replicated by the U.S. CDC using its own data sets of “CFS” patients. Because all over the world, CFS has been redefined as a disease of “fatigue,” and patients so diagnosed have nothing to do with the original cluster outbreak patients for which the name was created. We patients and our doctors have known this for a long time.

At the first CDC-sponsored conference to come up with a name for the new disease, several experts present suggested that these were outbreaks of Myalgic Encephalomyelitis, a neurological disease that has been diagnosed for over half a century in the UK, and has been coded under neurology by the World Health Organization for forty years. The disease is characterized by significant central nervous system (CNS) dysfunction, brain dysfunction, and muscle pain (myalgia). But the CDC rejected that name, too, because there was no evidence of inflammation, they said. They did not include a reference – not even a footnote – to the possibility that “CFS” was actually “M.E.” in the 1988 Holmes article. The link was not made until British psychiatrists, acting in concert with Dr. Straus of NIH, used it backwards: M.E. was really CFS, and CFS was really neurasthenia – a neurosis.

For years the CDC and NIH have brushed off all evidence that subgroups of the total set of people with a “CFS” diagnosis have very specific immune defects and active viruses, because it wasn’t true for all of them. Well, now that doesn’t matter, does it?

Finally, XMRV cannot be the same thing as CFS because it was first discovered among victims of prostate cancer – apparently at least 10 percent have XMRV. Unless prostate cancer is considered a form of CFS (to my knowledge it is not), then XMRV cannot be CFS.

XMRV is not CFS.

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XMRV is a Retrovirus

Viruses fall into classifications. Polio is an enterovirus. Epstein-Barr is a herpes virus. XMRV is a retrovirus. And there are categories within categories. Human Herpesvirus 1 (HHV-1), or herpes simplex virus, causes cold sores. And that’s about it. But HHV-8 causes Karposi’s sarcoma in AIDS patients – and kills them. None of the viruses just mentioned have anything to do with what we know as “the cold.”

What makes this discovery so profound is there are only three retroviruses known to be active in humans: HTLV, HIV – and now XMRV.

Unlike other viruses, XMRV attaches itself to you DNA - becomes part of your DNA. It is with you forever, in a very different way than other viruses.

Retroviruses cause problems by creating an environment for other viruses to flourish and even transform themselves into something new. Above all, they cause immune dysfunction.

Let’s look at HIV, then.

HIV is important because it either causes, or is so close to the cause as to be indistinguishable for practical purposes, AIDS. In fact, the name was chosen to refer to AIDS – Human Immunodeficiency Virus – HIV.

AIDS itself means Acquired Immune Dysfunction Syndrome. Ironically, when the CFS outbreak first occurred – in the middle of the AIDS outbreak – many patients on both Coasts called the disease HIV-negative AIDS. Quite a comedown in how you perceive the disease from HIV-negative AIDS to “chronic fatigue syndrome,” isn’t it? Many patients still refer to the disease as CFIDS – Chronic Fatigue and Immune Dysfunction Syndrome. But from the first article and definition (Holmes, 1988) from CDC, the agency has insisted that they were studying Epstein-Barr negative mononucleosis – best described as being tired all the time for no good reason. Chronic Fatigue Syndrome. As they’ve branched out into the study of all Fatiguing Illnesses, it’s no wonder that Dr. Reeves does not think any of his patients will have XMRV. Many – perhaps most - won’t. But they were the wrong patients to be studying in the first place, weren’t they?

Patients diagnosed with HIV aren’t sick yet. They are quite normal (which has made it easier for them to advocate for action to be taken against the disease – we don’t’ know we’re sick until we’re really sick).

The CDC and WHO both consider a patient to have AIDS when he has both HIV and an enumerated AIDS illness such as Karposi’s sarcoma (a type of skin cancer that was relatively benign and limited to elderly Mediterannean men) or pneumocystic pnsumonia, once an extremely rare opportunistic disease.

HIV alone does not equal AIDS.
HIV + Karposi’s Sarcoma = AIDS
HIV + pneumocystic pneumonia = AIDS

Just as there are perfectly healthy people walking around with HIV, there are perfectly healthy people walking around with XMRV. My husband could be one of them. (Yet another set of people due for early testing - healthy family members of patients who are sick and have XMRV.) Bob has been perfectly healthy the entire time I have had the disease, and this is true of a lot of ME/CFS spouses. Perhaps he is a carrier.

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XAND is to XMRV as AIDS is to HIV

XAND means XMRV Associated Neuroimmune Disorder, and XAND is to XMRV as AIDS is to HIV. We may not end up with the name XAND. It could end up being called AIDS II (since it now appears AIDS, or Acquired Immune Dysfunction Syndrome, is a category, not a single disease). It could end up with a different name altogether. But for the same of this essay, we will go with XAND, which is to my knowledge the only name that has been formally used for the disease that XMRV causes.

As the many of the diseases and immune defects that caused the AIDS epidemic had already become known by the time HIV was discovered, so too many diseases and immune defects associated with XMRV are already being studied in the context of original CFS patients – or CFIDS patients – or M.E./CFS patients (a compromise name recognizing the placement of CFS in the M.E. code under neurological diseases in WHO’s ICD-10 – but the U.S. is still on ICD-9 and does not recognize the connection). ME/CFS has the best diagnostic guidelines, the Canadian Consensus Document - and already some patients so diagnosed have already tested positive for XMRV.

So that is our AIDS. The disease that popped out in the 1980s that the CDC did not deign to actually study, choosing instead to create a "new" disease entity that they described as the result of upper middle class women trying to have it all. It is not the disease that, today, they define mainly as an inability to handle stress because of childhood emotional injuries.

Our AIDS is the disease behind an outbreak of geographic clusters of serious diseases throughout the United States in the 1980s, often (but not always) tied to Epstein-Barr Virus; often described as a bout of the flu that refused to go away. Our AIDS is the disease that the CDC refused to study at all. And our AIDS has been permitted to spread as a result.

There is one intriguing difference between HIV and XMRV. HIV apparently causes AIDS by permitting the AIDS abnormalities and diseases to flourish in an infected body. Dr. Mikovits has commented that XMRV appears to have the potential to cause neurological symptoms by itself.

For now, we could easily - immediately - begin to turn to our "AIDS" - to the cluster of conditions we already know are associated with CFS. Over the past 25 years, using homogeneous population groups that fit either the Holmes or Fukuda definition, or both, clinicians and researchers have come up with a number of immune defects and viruses associated with their “CFS” samples. (Again, not the CDC’s CFS samples. The CDC would be the first to tell you that.)

It begins with M.E., which has been associated with coxsackie B for years.

Patients from the cluster outbreaks in the U.S. are prone to immune defects such as T-cell inversions, natural killer cell dysfunction, and a defective form of Rnase-L. They were far more likely than the normal population to have HHV-6 (particularly Variant A), Cytomegalovirus (CMV), mycoplasma, a particular enterovirus that caused severe IBS symptoms, and parvovirus B19. Conditions such as parathesias, photophobia, chronic hypothyroidism, chronically low adrenal levels (never formalized into a disease name), and the autonomic nervous system dysfunction known as NMH/POTS (neurally mediated hypotension/postural orthostatic tachycardia syndrome) were brusquely dismissed with a sample of, say, 35 patients. The press release would say, for example, “HHV-6 has no statistical relationship to CFS.” And that would be the end of that.

Each time researchers discovered a biomarker or virus connected to a cluster of patients who fit the Holmes or Fukuda research definitions of CFS, the CDC or NIH brushed it aside because the finding was never a “perfect marker for CFS.”

But it is an ill wind that blows nobody good.

Because of all that research, we are starting out with a list of possible cofactors with which to connect the retrovirus XMRV to the disease XAND.

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What is XAND?

Note:XAND is a proposed name already in use, but it will take years for it to become official. Since XMRV is a newly discovered disease, we believe that the use of the new name XAND from the beginning will avoid confusion resulting from existing definitions for associated diseases.

XAND (I've never heard it pronounced, so I pronounce it ZAND) stands for XMRV Associated Neuroimmune Disorder.

To understand it, let’s go back to the AIDS model again.

HIV by itself is not AIDS. You have to have one of many defining diseases to be diagnosed with AIDS.

HIV + Karposi's sarcoma = AIDS
HIV + pneumocystic pneumonia = AIDS

So what is XAND?

XMRV + natural killer cell dysfunction = XAND
XMRV + active HHV-6 = XAND
XMRV + active CMV = XAND
XMRV + T-cell abnormalies = XAND
XMRV + coxsackie B = XAND

The disease that XMRV has now made it possible to diagnose is XAND.

And, depending on funding, this can happen very quickly. As I mentioned, we already have a lot of candidates for co-factors in terms of patterns of immune markers and viruses. All we need is to put the two together.

It would be nice if the CDC and NIH took over at this point. But patients, advocates, clinicians and researchers who have danced the dance with both agencies for a quarter of a century - while this retrovirus was permitted to spread unabated [Dr. Peterson has a patient sample from 1984 that contained the retrovirus] - they did everything in their power to hide it.

While there are obviously new scientists and researchers at NCI and DHHS who want to do the right thing, we are understandably nervous about all the bureaucratic officials still there who were part of the quarter-century cover-up.

For years, NIAID refused to fund any research into “CFS” unless it included a study of major melancholic depression. Since 2000, NIH has funded less than 5 million dollars of research into CFS (and not some other project disguised as CFS) - $5 per adult known to have the condition.

For obvious reasons, none of us are particularly thrilled at the idea of CDC controlling the research, either. As Dr. Nancy Klimas pointed out during the October 29 CFSAC meeting, it was the CDC that slammed the door on retrovirus research on CFS patients in 1991. We’d be just as happy to let Dr. Reeves pursue his fatiguing illnesses off into the sunset.

One suggestion has been that, in the beginning, due to the urgency, perhaps research funding on XMRV and the public face of XMRV should be placed directly in the head office of the Department of Health and Human Services. With the United States in the middle of the greatest potential health care overhaul in United States history, that is not very likely.

That is why we must support outside institutions such as the Whittemore-Peterson Institute and the British group InvestinME, until the government accepts the responsibilities of this very serious, contagious illness.

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Myalgic Encephalomyelitis

Where does XMRV fit in with M.E., or Myalgic Encephalomyelitis?
Perhaps M.E. is a cofactor: XMRV + M.E. = XAND.

Margaret Williams has suggested a natural relationship because of decades of evidence that M.E. is related to coxackie B. (See The Role of Viruses in M.E., 2009.)

Perhaps we can divide M.E. into ME-XMRV and ME-Ramsay (just as there are cases of prostate cancer that have nothing to do with XMRV).

Unlike CFS, M.E. is a disease, a disease that has been diagnosed for half a century and coded under neurological diseases in ICD-10, the World Health Organization's current International Classification of Diseases (G93.3) - and it has been there for FORTY YEARS.

The whole “CFS problem” might not have gotten away from us had the authorities followed the advice of specialists who strongly suggested, in 1987, that the 1980s outbreaks were due to M.E.

And M.E. would be a well-known disease today, as M.S. is, had it not been for a cult of British psychiatrists who claimed to follow the theories of "biopsychosocial" medicine (and whose answers fit well the needs of insurance companies and national health agencies to save money after the unexpected jolt of AIDS).

How silly it will look to have attributed the results of a retrovirus to "inappropriate illness beliefs."

Pay me now or pay me later. Every year the authorities refused to face this disease head-on, they saved money in the short run by leaving patients out in the cold. But they also increased costs in the long run by ensuring the disease would spread from the tens of thousands to millions - and now, without an end in sight.

Had everyone involved dealt with the “CFS” outbreaks as outbreaks of M.E. at the time, we would not have anywhere near so many people sick today. Perhaps they did not have M.E., but we would have learned a lot about what they did have. And patients with M.E. would not have been sacrificed to the effort to bury CFS.

The CDC and other agencies have suggested that the 3.5% estimate for the normal population effectively makes the retrovirus endemic. Really? If it is indeed too late to stop the spread, precisely whose fault would that have been? I don't think I want to take their recommendation that there is no need to continue to study the disease. Just how long do we want to play chicken with it?

Mr. President: Please appoint a private commission of retroviral, XMRV, and originalCFS and M.E. experts to organize the funding, testing, and treatment of patients with XMRV and XAND. Please do so as soon as possible because we have already lost 25 years, and this is a contagious disease.

The good news is that the answers are only a blood test away. It is a matter of organization, care, and funding. This time, let's get it done right.

Let's insist that the correct terminology for diseases in the context of a retrovirus be used. The CDC always said that when there was a scientific reason to drop CFS, we would drop CFS. WE MUST INSIST UPON IT THIS TIME.

XMRV is not CFS.
XMRV is to XAND as HIV is to AIDS.
After 25 years, time to study the right disease. Let's conquer XAND.

Mary M. Schweitzer, Ph.D.

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Postscript

There are, as usual, those who have rushed to "disprove" this study - but none has run a replication study - that is, they have not used the same process nor the same criteria for the data base. A very good essay on this subject can be found here:

http://www.meactionuk.org.uk/exposing-more-anti-xmrv-spin.htm

Hundreds of thousands of patients diagnosed with "CFS" are going to want to take the test, which is currently being offered at VIP labs in Reno.

It is probably a bit premature to get tested now. This research is in very early stages, so don't pin your hopes on a single test. It would be better to work through a physician, particularly one familiar with the comorbidities that turn XMRV into XAND, or a physician who would change your treatment protocol if it turned out you had XMRV. However, most ME/CFS patients in the United States have no one to work with who comes close to being a specialist on the disease they have, and I can understand the desire to find out if what you believe in your heart is true: there is a retrovirus underlying the whole problem. I just want to warn patients not to be discouraged if these early tests don't turn out to be positive. There is a lot that will come from this research.

Currently the NIH and WPI are working together to create a test that is quicker and easier, and can be performed by commercial laboratories with a high degree of both accuracy and specificity. That test could be available within a year. The NIH's main interest is in finding a way to ensure that XMRV does not get into the blood supply (and that current supplies can be tested for it).

This is a new experience for CFS patients. Usually tests that have been found to explain symptoms in patients have been noticed by the federal government just long enough to do a quick test dismissing the marker or virus as "the cause of CFS." It's been an enormous source of frustration for me, because I have been in more than one of these studies, and I test positive for quite a few immune markers and viruses that CDC ignores. Indeed, there's a paragraph on CDC's website for CFS that actually says not to give patients suspected of having CFS the testing that has shown a lot of what is wrong with me, and led the way towards treatment.

I'm not used to having a disease connected to CFS being taken seriously. And we're already getting quickly done studies that do not use the same methods, or the same type of data set, as the Whittemore-Peterson Institute and the National Cancer Institute - and claim, as in the old days, that they have "disproved" that XMRV can be a "cause" of CFS.

For the past twenty-five years, biomedical research into CFS has met with this type of dismissive response, and I'm certain the researchers who "can't find" XMRV think they're going to kill it as well. But that's not going to happen this time. It is not going to happen, because XMRV is a retrovirus, because XMRV also causes a virulent form of prostate cancer, and because too many scientists are already working on sophisticated research trying to decipher what XMRV actually does in the body.

There are still very important questions to be answered.

Personally, I'd like to know how I got it! The cluster outbreaks of the 1980s did not spread in a way one would associate with a retrovirus - how did those patients end up with it?

How is the virus transmitted or activated? Is XMRV by itself a symptom-causing disease, in addition to the peculiar role a retrovirus plays in conjunction with other diseases? What diseases are activated by XMRV? What treatments are already available, and how long will it take to get new treatments to patients? What does it mean that roughly 3.5% of apparently healthy people are positive for XMRV?

For a good summary of the issues involved, by a clinician in the center of the battlefield for 25 years, read Dr. David Bell's description of XMRV and XAND in the Lyndonville News. Another good written summary of the research and its meaning for patients with M.E. and CFS diagnoses can be found at the website for the British organization MERGE.

The taped presentations of Dr. Daniel Peterson and Dr. Coffin at the CFSAC on October 29, 2009 also make excellent introductions. Go to the main CFSAC website at http://www.hhs.gov/advcomcfs/. Click on "Day 1 videotape" in the box to the right of the page. You need to have RealPlayer to view it (it can easily be downloaded for free at RealPlayer if you do not already have it.) Dr. Peterson's presentation begins at roughly one hour and 23 minutes into the video for Day 1, and Dr. Coffin's presentation follows.

I have had the disease derisively called "CFS" for two decades; I have been unable to work for 15 years. My natural killer cell function is 2%; I have the abnormal Rnase-L. I suffer from recurring bouts of Epstein-Barr, and I have chronically active cytomegalovirus (CMV), HHV-6 (Variant A), and HHV-7. I responded well to the immune modulator Ampligen but the FDA has so restricted it that it has been two years since I have been able to get it anywhere within driving distance of my home - which means anywhere from New York City to Washington, DC. Right now I am very ill, and getting worse.

And I have XMRV. Having XMRV makes sense - it makes sense in light of what is wrong with me, and it makes sense in that Ampligen, an experimental immune modulator, has worked well for me while I am on it - but several months after I have had to go off it (twice - one year the first time, seven months the second), I have relapsed badly. That would be in keeping with the behavior of a retrovirus.

The private Whittemore-Peterson Institute needs your help to continue this work. It is a nonprofit institution founded by the parents of a patient who has had the disease for over 20 years - since she was 12. A donation as low as $5 will help speed up the time it takes to get people tested, identify cofactors, start treatment with existing remedies, and continue research on the nature of the disease and new treatments to offer.

Other similar nonprofit patient-run institutions created to support research include Invest in ME in the UK, and the HHV-6 Foundation.

Our world is about to change.

Mary M. Schweitzser, Ph.D.