My 20 years with Myalgic Encephalomyelitis

Originally posted May 12, 2014.

I have had Myalgic Encephalomyelitis, or M.E, for 20 years.  The CDC does not recognize this.  They insist that I have a condition called "Chronic Fatigue Syndrome," or CFS.  I have M.E.

At the age of 44 I led a charmed life.  I had been married to the love of my life for 20 years, and we had two lovely children.  We were both college professors - a deliberate choice that allowed us to do what we enjoyed - researching and teaching subjects that deeply interested us - while having the income to live comfortably (because we both worked) and plenty of time to spend with the children (because of the nature of academic life).  I had tenure at a good university, although my sights were set higher than that.  I had a working relationship as an associate fellow with a research institute at an Ivy League school, which enabled me the luxury of being around the best and the brightest in my field.  We traveled all around the country going to each other's conferences, often taking one of the kids along.  We also went to four Olympics, two final fours (NCAA basketball championships) and countless playoff games, several World Series, and, eventually, twenty years of baseball AllStar games.  We skied in the winter and went to the beach in the summer.  It was a charmed life.

On October 24, 1994, I went to my office to grade exams and suffered a blackout.  When I came to, I could not understand one word in the Bluebooks in my lap - they might as well have been written in Cyrillic alphabet.  It took time - and concentration - to be able to stand.  I had fallen down the rabbit hole; my life would never be the same.

Over the next four years I suffered from severe pain in the back of my neck and behind my eyes, 24/7.  My muscles ached, and I had migraine-level headaches.  I had ataxia, dyslexia, sensitivity to light and sound (to the point I had to wear sunglasses all the time), tinnitus, partial paralysis, memory loss, disorientation, expressive dysphasia, and massive confusion.  My family took care of me.  Obviously, I could not drive, and by 1996 I was using a wheelchair when I left the house (which someone else had to push).

I was lucky to have a family to take care of me, because I could not take care of myself.  I also soon discovered an Internet discussion list of fellow sufferers, and was referred to a very good specialist in Washington, Marsha Wallace (who unfortunately hasn't practiced since 2000).  Dr. Wallace taught me to live within my energy envelope and helped with sleep disruption and NMH/POTS, but I continued to deteriorate.

In the fall of 1998, Dr. Wallace introduced me to Dharam Ablashi, a researcher who had just retired from the National Cancer Institute at NIH.  Dr. Ablashi had been the co-discoverer of HHV-6 and it's two variants, A and B, while working with AIDS.  I had the version the AIDS patients did - Variant A - and my viral load was ten times the amount used to diagnose an active infection.

I would also test positive for active EBV or mono (which I had more than once - most notably in 1990, four years before my collapse, during an outbreak on my college campus), CMV (cytomegalovirus), HHV-7, and three strains of Coxsackie B.

My immune system was severely compromised: My natural killer cell function was less than 3%, I had the defective 37kDa Rnase-L, and I had an abnormal cytokine pattern.  But no one knows how all this happened.  All we know is that this disease can occur in cluster outbreaks, and it can pop up in individuals.  No one in my family got it from me, but I believe the outbreak of EBV in 1990 marked the beginning of my illness - the beginning of the cycle of immune defect-virus-damage that characterizes this disease for many of us.  I had to continue to teach through my infection with EBV, including an hour's commute and back, and while I recovered from mono at the end of the fall semester, my health began to deteriorate in seemingly disparate ways, until the ultimate collapse in 1994.

Years later I would have a spinal tap that revealed both HHV-6 and Cytomegalovirus were active in my spinal fluid.  No wonder I had the symptoms of encephalitis, and with the stiff neck, meningitis.  Along with the muscle pain, that meant literally that I had Myalgic Encephalomyelitis, or M.E., a disease that had been diagnosed in the UK since the mid-1950s.  In the United States, however, all I was given was a diagnosis of "chronic fatigue syndrome," a name chosen by committee and adopted by CDC in 1988 to replace the name given a number of cluster outbreaks occurring in the USA at the time, Chronic EBV.  They did not mention M.E. - though there were specialists at the meeting who insisted that was the correct diagnosis for these outbreaks.  They did not ask anyone in the disease community what they thought of this name.  They simply adopted it, and having done so, consigned the disease to the backwaters of medicine where neither research nor treatment could be found.

There could not have been a worse choice of a name for this disease if CDC had hired a focus group,  Chronic (as in chronic whiner) Fatigue (as in "yeah, I've been feeling tired lately myself") Syndrome (as in syndrome of the month) - applied to upper middle class white women "trying to have it all" (as the late Bill Reeves of CDC once phrased it) - how inconsequential, silly even.  A quarter of a century  later, 85% of patients - over one million Americans - have no idea what is wrong with them, because, according to both CDC and private demographic evidence, only 15% have a diagnosis.  26 years later only 15% have a diagnosis.  That is a mighty admission of failure.

The infectious disease specialists in northern Delaware dismissed my illness as minor.  "You'll be back to normal in two years," they assured me. Oh good, I responded - I won't have to miss more than two seasons before I can go back to skiing.  "Oh no," was the response.  "You'll never ski again."  How was that "normal?" I asked.  They got angry at that.  That's when I was referred to Dr. Wallace and, thankfully, only had to deal with these people once more, when I was on the antiviral Vistide for my cytomegalovirus infection.  Dan Peterson, my new specialist, had asked them to let me get the infusions at their center, and they had agreed.  But when I showed up at their office, one of the doctors took me aside and said that they could not let me have Vistide because my medical records showed I "only had CFS - nothing serious, like AIDS or cancer."  They said they could not justify using the drug on someone with a diagnosis of CFS - even though it was an FDA-approved drug for the virus CMV, which was active in both my blood serum and my spinal fluid.

Let me repeat that:  once given the label Chronic Fatigue Syndrome, I would meet disrespect from many doctors and people at NIH and CDC. None of my extensive testing mattered.

Although the progressive version of M.E. that I suffered from was unusually severe, I turned out to be lucky.  I was given the opportunity to go on the experimental Phase III drug Ampligen, in what is called a cost-recovery (I pay cash), compassionate care (I am allowed to do this because I was so very sick), open label (I know I am on the drug so FDA ignores me) study.  I have to get Ampligen at the study site by IV infusion twice a week.  And FDA can take the drug away from me whenever they want.

I have been on Ampligen for eleven of the past fifteen years.  Again, I am unusual in that my illness erupts again within a year of going off the drug (which I did once voluntarily, and once because FDA did take the drug away).  FDA has admitted, in writing, that the drug is not toxic.  But they are not "convinced" it is effective.  My experiences do not count because I was not in a placebo trial; I knew I was on the drug.  There is no other drug in the FDA pipeline for either CFS or M.E. (Although there are immune boosters and antivirals available for patients, and an anti-cancer drug called Rituximab is showing some promise).  This is the only one expressly targeted to M.E. or CFS.  Over one million Americans suffer from my disease.  FDA, CDC, NIH - none of them cares - though in fairness, there are individuals within those agencies who do.  It is those who make decisions who do not care.

[Side note about the obsession with placebo trials - If just knowing you are on a drug can make your immune markers return to normal, your active viruses return to a dormant stage, and change tests such as SPECT scans and CPET scores, we should all be cured of anything by happy thoughts.  Does FDA really believe this?]

So here I am today.  I would not have written this were I not on Ampligen.  On Ampligen, I can drive, take care of myself (mostly), read a book, work on my own writing, spend time with my children and grandchildren.  Off Ampligen I am an invalid in bed in severe pain, curled up in the dark because light is too painful, listening to a favorite movie over and over again.

So twice a week I leave my house at 8:15 and commute by train 100 miles north to Dr. Derek Enlander's office in New York City, the closest site where I can get Ampligen.  I usually get home around 7 pm.  It is grueling, but at least I am getting the drug that keeps me from being a bedridden invalid.

Myalgic Encephalomyelitis is a serious disease.

CDC betrayed us by giving it a silly-sounding name in 1988 - CFS.  NIH allocates $6 million per year to study this disease - a pathetic amount.  MS gets $122/year with half the patients; "Behavioral and Social Science" gets almost $5 billion/year from NIH.

We came back with private research initiatives, funded by cash-strapped patients and their families, and more good biomedical research is being published than ever before.  The whole concept of what "CFS" is, silly sounding name and all, is undergoing a transformation. And for the first time in my memory, clinicians and researchers have agreed on a definition - the Canadian Consensus Criteria, updated with current research.

So how is our government responding?  Suddenly there are three different initiatives within the U.S. department of Health and Human Services (HHS) to redefine the disease and rename it - done behind closed doors.  At CDC there is the Multi-site clinical assessment - which brought in respected clinics, but is now being polluted with research from a poorly conceived and run study by CDC in Georgia that used a different definition entirely.  HHS has turned to the IOM - Institute of Open Medicine - with a committee of whom the majority are not experts in either CFS or M.E.  NIH as a whole has given the "problem" of the name and definition to their  "pathways to prevention" program, or P2P.  In this case a committee was explicitly created consisting of individuals with NO experience -either medical of personal - with the disease, "like the jury system," a spokesman explained cheerfully.  "Stakeholders" with different viewpoints testify to the committee, and then this committee of amateurs will recess and vote on the choice of what to do next.  Precisely when did the jury system replace scientific method in determining medical policy?

[The IOM and P2P reports turned out better than expected, particularly the IOM report, because it has helped bring attention to the plight of over one million Americans suffering from a severe neuro-immune disease.]

They are going against the expressed wishes of 60 specialists who signed a letter asking that the U.S. adopt the Canadian Consensus Criteria (CCC), and the public members of the CFS Advisory Committee to HHS asking that the government adopt the CCC, and hold an open workshop of specialists to update it (it is ten years old) with current research results.  Why are those of us within the world of M.E. ignored?  Why is 60 years of biomedical research into M.E. ignored internationally?

Perhaps more important, why don't people outside our community - people in the media, in government, our doctors, our neighbors, our employers - why don't they know that there is a growing epidemic of a severe, life-altering and in some cases life-taking disease that CDC and NIH are keeping under wraps?  I have friends who were teenagers when they got sick, and are now in their 40s. They did not get to marry their soulmate like I did.  They did not go to college or have a career.  They did not have children or grandchildren (I have two grandchildren now).  I was lucky compared to them.

They can barely afford to live from day to day.  They cannot afford the testing I have had, and they most certainly cannot afford the treatment I am on.

I have lost friends to this disease; we have lost young people to this disease.  The viruses can get into your heart muscle; they can get into your liver.  Patients die of rare cancers as well.  And then there are the suicides.

There has been a new series of outbreaks in the past five years.  Look at those you love, and if you care for them - whether or not you care about us - do something.  Because they could be the next victims.

Thank you for reading.

Coda, 15 November 2015.  The above was written for May 12, 2014 (ME Awareness Day).

I lost the love of my life, my soulmate, my husband of 40 years, to cancer on July 7, 2013.  We had lived in Delaware for 35 years.  To stay on Ampligen - and also because both my soul and my body need healing - I have moved to Incline Village, NV, at Lake Tahoe.  It is beautiful here.  My family (including 2 children and 2 grandchildren) are all back East, but Reno Airport is nearby and I put the cost of Ampligen on a Southwest credit card ...  I am able to get my twice-weekly infusions from Dr. Dan Peterson just 2 miles away.  And this is a good house for writing, so I hope to be able to finish my book manuscript, "Slightly Alive," this winter.  I still live in fear of losing Ampligen.  But I'm okay.

It has been 27 years since CDC adopted the silly name "chronic fatigue syndrome," and even they admit that one million Americans have my disease but no diagnosis.  Where are they?  The question continues to haunt me.

But there are optimistic new developments, from the IOM report (tho flawed, it is getting publicity) to newly locating our disease at NIH in NINDS.  Stanford and Columbia Universities are taking the disease seriously.  The most intriguing new developments are happening as I write, with healthy professionals finally asking that the PACE trial (whose authors claim cognitive behavior therapy and graded exercise cured "CFS/ME") be investigated by impartial scientists - thank you Dave Tuller, James Coyne, Vince Racaniello, Ron Davis, Jonathan Edwards, Leonard Jason, Bruce Levin, and Arthur Reingold.  It would be nice to report that although we don't know the answer, we are finally getting the funds to find it.  Even better to be able to say patients are finally being diagnosed, taken care of, and treated.   The first step is getting the severity and prevalence of Myalgic Encephalomyelitis recognized.  Let us hope that won't take another 27 years.

Dear Dr. Wessely

An open letter to Dr. Simon Wessely,

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

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

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

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

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

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

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

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

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

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

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

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

A Primer for XMRV and XAND

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.