My 28 years with Myalgic Encephalomyelitis

I have had Myalgic Encephalomyelitis, or M.E, for 28 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).  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.

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).  My confusion was so bad I once poured a pot of coffee into a silverware drawer convinced it was a cup.  When my family took me somewhere, one of them would have to fasten my seatbelt because I couldn't remember what those two things were for.

Most of the time, however, my family went without me.  Increasingly I spent most of my time lying curled up in bed in the dark, listening to a favorite movie (because I could not bear to look at the screen).   I got around the house by balancing against furniture and my golden retriever, but increasingly I spent the entire day upstairs.  By the end of 1998, I couldn't even brush my own teeth.  All that time, just slipping by.

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.  My viral load was over five times the amount used to diagnose an active infection.  Dr. Ablashi called my home and told my daughter, then in high school, to make sure I stayed in bed, because I was seriously ill.  I was in bed already because I had little choice, but we appreciated his thoughtfulness.

I would later 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.

Thirty-four years 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.  34 years since CDC formally recognized this illness, only 15% have a diagnosis.  That is a mighty admission of failure.

And while the majority of diagnosed patients are white and relatively higher income, the disease is equal opportunity with regard to ethnicity and income.  It is more common in women than men, but the ratio is more 65:35 than the 95:5 that CDC and NIH used to claim.

Back in 1994, 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.

Although the progressive version of M.E. that I suffered from was unusually severe, I turned out to be lucky.  Through Drs. Wallace and Ablashi, I was given the opportunity to go on the experimental Phase III immune drug Ampligen, in what is called a cost-recovery (I pay cash), compassionate care (I am allowed to do this because I get  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 17 of the past 23 years.  Again, I am unusual in that my illness erupts again within a year of going off the drug (which I did once voluntarily, three times 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).  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, it's getting better.  Dr. Collins at NIH has at least assigned us a specialty - neurology - and although the disease is grossly underfunded, we are starting to get projects going with major universities.  (I am currently in a study through Columbia University.)

I wrote this while on Ampligen.  On Ampligen, I can drive, take care of myself (mostly), walk, drive a car, 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.

As the years passed, it became more and more difficult to get Ampligen, because FDA refused to approve it.  The last three years I spent in Delaware, I had to commute by train twice a week, 100 miles north, to Dr. Derek Enlander's office in New York City, the closest site where I could get Ampligen.  I usually got home around 7 pm.  It was grueling, but at least I was getting the drug that kept me from being a bedridden invalid.  To be honest, I enjoyed going back to the City after years of being away, even though I did little else besides get my infusion and go back home.  Dr. Enlander's office was on 5th Ave. and the bus ride from Penn Station brought back a lot of memories.

Then in July 2013, my husband of 38 years, my best friend, my soulmate, died of bladder cancer.  I just couldn't stay where we had lived for 35 of those years.   So I moved to Incline Village, NV, on Lake Tahoe, where one of the best clinician/researchers in the country practices, Dan Peterson.  (The most famous cluster outbreak of the disease in the US occurred here in 1984-85 - over 200 patients.)  My infusions were now just two miles away.  Dr. Lipkin at Columbia has called the version of ME/CFS that I have "the Peterson subset."  There are a lot of patients here who have the same biomarkers I do.

I was doing well at Tahoe, a good place for healing both body and soul ... and then we lost Ampligen again after January 2017.  Dr. Peterson has gotten it back for 12 of us in a study with biomarkers that will hopefully suggest why it works so well for those of us for whom it is successful.  It required coordination between a number of agencies, the company, and the site - lots of papers changed, signed, passed around, changed again.

Over the next 18 months, I deteriorated to the point that I could only drive in the Tahoe bowl where the speed limit is 25 mph.  I could not go over the mountain passes or drive 50 miles an hour.  When I traveled, I needed wheelchairs.  I have a very spiffy electric one that's taken me to more than one TCM classic film festival.  But I had gotten to the point where I could read no more than a paragraph or two without the page turning back to cyrillic alphabet.  Back to the 24/7 pain.  No longer allowed to cook on the stove because I would forget and leave things there.  For every minute of every day I felt as if I had the flu. The immune biomarkers were back; the viruses were back.  My CPET was down to 16; my natural killer cell function 3%.  Very frightening to stare down into the hole, knowing where I would end up - like Charley in Flowers for Algernon or Robert de Niro's role in Awakenings - this time, with no caregiver.

And then ... we got the call!  I restarted Ampligen August 6, 2018.  At first you feel worse because your immune system suddenly wakes up and wreaks havoc with symptoms, but then it's just improvement.  Takes about six months for me to start getting normal, but the best part is I know I am not in danger now of deteriorating more.

Myalgic Encephalomyelitis is a serious disease.

CDC betrayed us by giving it a silly-sounding name in 1988 - CFS.  NIH allocates less than $6 per patient per year to study this disease - a pathetic amount.  After a report they commissioned from the Institute of Medicine came, saying this was emphatically not a psychiatric disorder, and that NIH needed to spend much more money on it, we were promised more funding - but so far, haven't received anything above the usual $5-6 million.   See "Beyond Myalgic Encephalomyelitis".

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.  There are excellent research studies going on at Stanford, Columbia, and Cornell right now - but they get little, if any, NIH funding.  Even Ron Davis, the Stanford scientist essential to the human genome project, can't get funding out of NIH for this disease.

We are getting new attention now because there is a subset of patients with long-haul COVID who have precisely the symptoms I get.  Even more, the very existence of long-haul COVID has created more research on post-infectious neurological illnesses - like M.E.

The main study behind the government's prescription of psychiatric counseling and graded exercise, the PACE trial, has been exposed as a giant boondoggle - but at the moment, the scientific journal that published it, The Lancet, the institutions behind it in the UK, and the UK government, are still pretending they don't know how deeply flawed it was.  See PACE: The research that sparked a patient rebellion and changed medicine.

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.

There are patients who are even worse than I was - completely bedridden, on feeding tubes.  See The 25% ME Group and the story of Whitney Dafoe in the Washington Post.

They can barely afford to live from day to day.  Few can afford the testing I have had - if they can afford it, they can't get anyplace that does it.  They go untreated, hidden, silenced.

I have lost too many friends to this disease; we have lost young people to this disease.  A close friend lost her 23-year-old son to a massive heart attack.  He had the disease, but no doctor would believe it.  The viruses seem to be mostly in my nervous system in my case, but they can get into your heart muscles; they can wreak havoc with your digestive system; they can get into your liver.  And then there are the suicides.  I have lost so many friends that I find it difficult to go on Facebook any more.

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.

May 12, 2015: 20 years with Myalgic Encephalomyelitis

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).  My confusion was so bad I once poured a pot of coffee into a silverware drawer convinced it was a cup.  When my family took me somewhere, one of them would have to fasten my seatbelt because I couldn't remember what those two things were for.

Most of the time, however, my family went without me.  Increasingly I spent most of my time lying curled up in bed in the dark, listening to a favorite movie (because I could not bear to look at the screen).   I got around the house by balancing against furniture and my golden retriever, but increasingly I spent the entire day upstairs.  By the end of 1998, I couldn't even brush my own teeth.  All that time, just slipping by.

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.  My viral load was over five times the amount used to diagnose an active infection.

I would later 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% (normal is about 50%), 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.

Twenty-five years 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.  25 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.  I was told twice by those in a position to know better, that none of my testing mattered because "you people test positive for viruses you don't have."  I asked what evidence that was based on; that ended the conversation.

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 13 of the past 17 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.

As the years past, it became more and more difficult to get Ampligen, because FDA refused to approve it.  The last three years I spent in Delaware, I had to commute by train twice a week, 100 miles north, to Dr. Derek Enlander's office in New York City, the closest site where I could get Ampligen.  I usually get home around 7 pm.  It was grueling, but at least I am getting the drug that keeps me from being a bedridden invalid.

And then my beloved husband, my best friend, my soulmate, died of bladder cancer in July 2013.  I moved to Incline Village, NV, on Lake Tahoe, where one of the best clinician/researchers in the country practices, Dan Peterson.  (The most famous cluster outbreak of the disease in the US occurred here in 1985 - over 200 patients.)  My infusions are just two miles away now.  I'd like to call the version I have of this disease Peterson's Disease, but he won't let me.  There are a lot of patients here who have the same biomarkers I do.

Myalgic Encephalomyelitis is a serious disease.

CDC betrayed us by giving it a silly-sounding name in 1988 - CFS.  NIH allocates less than $5 per patient per year to study this disease - a pathetic amount.  After a report they commissioned from the Institute of Medicine came back last year, saying this was emphatically not a psychiatric disorder, and that NIH needed to spend much more money on it, we were promised more funding - but so far, haven't received anything above the usual $5-6 million.   See "Beyond Myalgic Encephalomyelitis".

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.  There are excellent research studies going on at Stanford, Columbia, and Cornell right now - but they get little, if any, NIH funding.  Even Ron Davis, the Stanford scientist responsible for the human genome project, can't get funding out of NIH for this disease.

The main study behind the government's prescription of psychiatric counseling and graded exercise, the PACE trial, has been exposed as a giant boondoggle - but at the moment, the scientific  journal that published it, The Lancet, the institutions behind it in the UK, and the UK government, are still pretending they don't know how deeply flawed it was.  See PACE: The research that sparked a patient rebellion and changed medicine.

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.

There are patients who are even worse than I was - completely bedridden, on feeding tubes.  See The 25% ME Group and the story of Whitney Dafoe in the Washington Post.

They can barely afford to live from day to day.  Few can afford the testing I have had - if they can afford it, they can't get anyplace that does it.  They go untreated, hidden, silenced.

I have lost too many 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.

Comments for NIH Research Program on ME/CFS

1.  It is critical that we find a way to diagnose the 850,000 Americans with ME/CFS who have no diagnosis today.

In 1988, after a series of cluster outbreaks across the nation, US experts attended a meeting put together by NIH and CDC to give a name to the disease that had been called CEBV.  They chose “chronic fatigue syndrome,” or CFS.  

That was nearly 30 years ago.  In the intervening time, CDC has so misjudged the prevelence, severity, and urgency of the need to get a handle on this disease, that today, with a national prevalence of at least 1 million adult Americans, CDC admits that only 15% of patients even have a diagnosis.  

That tells me that the decision to focus on “fatigue” was a disaster.  And I wonder where the other 850,000 Americans are.  Since this is an equal opportunity disease - but that’s not true of those who are diagnosed - the population of undiagnosed patients with this disease is going to be skewed towards people of color, and I also suspect people of lower income.  They are suffering alone.  

2.  We need to go back and investigate the phenomenon of cluster outbreaks.

Once EBV was dismissed as a possible cause of this disease (prematurely, as it turns out), all interest in the possibility of cluster outbreaks disappeared.  Yet many patients experienced this disease in what appears to have been a cluster outbreak.  CDC and NIH responded to the experience of patients by saying (to me, personally), these were not outbreaks of disease - they were outbreaks of diagnosis.  It was the belief of Drs. Straus and Reeves that since this was obviously not a disease that was in any way contageous (decided in Washington, not after looking at statistics), then the evidence of outbreaks must be cases where patients found a friendly doctor willing to confirm their belief they had a “real" illness.  

That goes against the evidence.

More important, where we are today, I believe there has been a new set of cluster outbreaks.  Why?  Because I have been contacted by patients for twenty years, and starting around 2010 I began to be contacted by young people in their 20s and 30s and the parents of teenagers.  They had become sick SINCE 2010.  If there is indeed a new set of cluster outbreaks, let me suggest that we start to get a handle on it by looking at cases of EBV and asking for evidence of the long-run health of patients.  

3.  We need biomarkers now.

Both Items 1 and 2 are direct consequences of the absence of biomarkers.  It is hard to find out how many people have this disease when you are reduced to questionnaires.  It is hard to find out whether there are cluster outbreaks (or outbreaks of diagnosis) without biomarkers.  

I have had specialists who have been using biomarkers for two decades.  I see no reason to have to start from scratch.  We will at least catch a significant subset of patients.  NIH needs to look at natural killer cell function as both a marker showing THAT you have The Disease, and also a marker of the SEVERITY of The Disease.  

The 37kDA Rnase-L was a useful biomarker for some specialists until we lost the ability to send blood to Belgium.  A new lab was started in the US, but the group it was connected to had problems and it closed.  The patent was owned by Temple University, but they have said they do not care if they are reimbursed - anyone may use it.  

Dr. Robert Suhadolnik, now deceased, did a study in the 1990s of 100 patients from the Incline Village cluster outbreak, 100 patients with fibromyalgia but no symptoms of CFS (Fukuda 1994), 100 patients with major melancholic depression (at the urging of Dr. Straus), and 100 controls.  98 of the 100 patients from Incline Village had the defective protein.  Only 2-3% in each of the other three groups did.  That is profound, but it was ignored.  

In the meantime, Drs. Catherine Bisbal and Luc Montaigner tested patients with PVFS in France and Belgium, and had similar results.  This is even more fascinating given that Dr. Suhadolnik was using an electron microscope, but Drs. Bisbal and Montaigner weighed the protein (hence the name 37kDA Rnase-L).  

So two different sets of researchers, on two different continents, using two different methods, found the same thing.  The researchers switched blinded samples and got them all right.  So I think the 37kDa RNase-l biomarker is also another important characteristic of at least a subset of patients.

So many different specialists have worked with cytokine profiles that I can’t even list them all here.  But that is also an area for biomarkers.

As I write, biomarkers are being proposed by researchers from Griffith University in Australia to Stanford and Columbia universities, to the Simmaron Foundation, the NOVA clinic in David, FL - we need a systematic way to look at the existing evidence and start using biomarkers to find at least a subset of patients.

4.  We need treatments now,

Ampligen is already available and it has been shown to lead to dramatic improvements in 30-40% of patients.  I am one of them.  We ask that NIH help us get this drug provisionally approved.  The company does not have the money to do another large double-blind study.  I would contribute my own money towards such an effort.  In the meantime, the drug needs to be made more available because of the severe geographic restrictions it puts on those patients (such as myself) who would be vegetables without it.  

Rituxmab needs to be researched.  It has shown promise in Norway.

Patients have improved on gamma globulin and on antivirals, specifically Valcyte and Vistide.

We need to find other drugs to repurpose.  I believe there also needs to be a push to develop more antivirals, period, and more pharmaceuticals targeted to the immune system.

5.  We need to pay more attention to viruses.

From the first diagnosis of atypical polio (which became Myalgic Encephalomyelitis in the British commonwealth nations and Epidemic Neuromyesthenia in the US in the 1950s, CEBV in the 1980s, and then CFS in 1988), the evidence has strongly suggested that the disease is connected to a virus.  Which virus?  If you don’t test people, how do you know?  Now that there are better methods for finding viruses, we need an all-out push to find the viruses behind cases of ME/CFS in the United States.  [In my own case, both HHV-6A and CMV were in my spinal fluid in 2009, during a 2-year period when I could not get Ampligen.]

The earliest viruses suggested were those in the polio family, now called enteroviruses.  Coxsackie B was considered a prime candidate for the culprit in the UK (before the psychiatrists got involved), and it has also been found in patients in the US.  I also know patients whose illness began with an episode of adenovirus infection.

However, in the US, the viruses most commonly found are EBV (particularly at the start) [HHV-4], CMV [HHV-5}, HHV-6A, HHV-6B, and HHV-7.  

6.  Pay attention to 12 years of CFSAC recommendations.

Every year, CFSAC creates a list of recommendations for the Secretary of HHS.  I know that they go to a lot of trouble to do this.  Most of these are very good recommendations.  Please go back and compile them and take them into consideration. 

7.  Don’t start from scratch.  Use existing research.

Let me suggest the numerous websites that i referenced in my May 12 blog, “ME is not a mysterious disease.”  It would take too much space to write it all down here now!

http://slightlyalive.blogspot.com/2016/05/for-may-12-2016-me-is-not-mysterious.html

————————————

This spring I lost 3 good friends whom I had known for 20 years as fellow patients with this disease.  One had been sick for 32 years; another died at 40 from breast cancer because her ME-battered body could not take the necessary chemotherapy regimen; one died in the hospital of pneumonia, again because his body was so weakened.  I look at a new generation of patients who got this disease as teenagers and wonder - will they still have it in their 40s, as is true for many patients I know?  Are they doomed?  Please stop this rolling epidemic now, because more and more people have it every time there are a series of outbreaks.  

I thank you for the opportunity to comment, and I am hopeful that with the will to do so, NIH can stop this unending tragedy.  

Mary M. Schweitzer, Ph.D.

Pat Blankenship, 1949-2016, Rest, dear friend

On Monday, May 16, we lost another friend to Myalgic Encephalomyelitis, Pat Blankenship.  She was just 67.

Here is an essay Pat wrote for the Obama-Biden Transition Project Health Care Report, December 2008.  That was 8 years ago.  We had hopes at the time it would make a difference at NIH (which continued to fund research into ME and CFS at $6 million/year, or $6 per person a year - less than they spend on male pattern baldness.  The full report remains part of the federal records at HHS.   

Living With M.E.
Pat S. Blankenship

In the next few pages, there is a short summary of my experience with Myalgic Encephalomyelitis. I became ill in 1989, and remain totally disabled now. I have been disabled by M.E. longer than I worked as a productive member of society. I am an astrophysicist, but spent the bulk of my short career working in computer telecommunications. Before moving back to my family home in Alabama, I lived in the Northeastern US, primarily the Washington area. That is where I sought treatment for this new disease when I became ill, and found that there was no treatment that worked. During the years I lingered there trying to find medical help, I became involved with the CFS Coordinating Committee, now called the CFSAC. I gave testimony at several of those meetings. I worked with the NIH to help select the first slate of patient members of the committee, and I was also involved with the meetings at the CDC when the first accounting scandal was made public. Those latter activities are public knowledge and my involvement was small and brought about no positive outcome. That's why my statement here is a personal one about how hard it is to live with this disease.

I was struck down at the age of 40, while working as a consultant for the federal government on communication interoperability issues, in November, 1989. In my case, I had an extreme viral onset that was like a severe case of influenza; it was like Texas flu or Swine flu, both of which I had during the years in which they were pandemic. As usual, there was supreme difficulty in obtaining a diagnosis. My knowledge of this disease was nil at that time. For all I knew, I had Lyme disease, or hepatitis, or any of a very large number of viruses I was tested for. I was finally diagnosed by an infectious diseases specialist who used the CDC 1988 definition of CFS, through a process of elimination. I've come to know a lot about what I now know is Myalgic Encephalomyelitis due to brute force exposure to it.

What is it like to have Myalgic Encephalomyelitis (M.E.)? There are physical, cognitive, and social as well as emotional aspects that have happened in my case; we are all different, for this disease has 'different results after inflicting the same insult' upon us. That is a phrase I learned probably 15 years ago from a fellow activist in the Washington, D.C. area. Here is a little glimpse of how my life crumbled from what was once a promising career at the top of a group of enterprising people who were planning for 'Battlefield 2005 telecommunications,' to what I am now, a broken woman who can barely string sentences together.

I have been totally unable to work since 1991, and have been disabled since that time. I lost my job. My legs literally went out from under me and I had to undergo lengthy physical therapy while using 2 canes to walk, haltingly and for only short distances. I walk much better now, after several courses of therapy, including two at facilities of the Warm Springs Institute in Georgia. There are times when I stand too long, and I begin to black out. I can avoid fainting if I sit down, and I will sometimes sit down in a public place on the floor rather than risk fainting. Other physical problems include the onset of fibromyalgia, and several organ system diseases which may be related to the autonomic nervous system aspect of M.E. Since I don't know if they are cause-and-effect, I don't relate them here, but I have become more-or-less bed bound, with only 2 to four hours of activity per day .

Early in the disease, for some months, I was unable to speak more than a few words. I can usually carry on a conversation now; my self-retraining in what I call word retrieval has been compared to what a stroke victim goes through. Still, I frequently have to close my eyes to remember words though. Reading the printed word became a thing of the past. I can now read a few sentences at a time, but my retention is very poor. I listen to audio books now, and I like to joke that I can listen to the same mystery novel over and over because I don't remember the end. In the past 6 years, I've also developed permanent visual dysfunction too, called palinopsia, which makes it nearly impossible to drive at night, and makes reading from a computer screen much more difficult.

Memory is a very tricky problem now. I have a sort of sliding window of time in the recent past during which I can remember events. It may be 3 days ago up to 6 months ago, or the window may shut down at 3 weeks. I never know if I am going to remember an event, an appointment, or a person. In fact, I have more or less given up on people recognition; unless I see someone daily or maybe weekly, I do not recognize the face. The only reason I know about this sliding memory window is that I have lived with my sister for several years, and she has described it to me. I keep track of appointments and such on my cell phone calendar, without which I would never be able meet any of my obligations. This technology has helped me tremendously in the last few years.

I've written this memory description down and keep it for whenever I need to explain it to people, like doctors. Or, as in for this description of my condition for our input to the policy makers for President-elect Obama.

Maybe it is not obvious, but in becoming this ill and unable to function at any sort of professional level, I lost the friends that I had made throughout the years in my field. I lost track of my friends that I had still kept up with in academia, because I was still living in the same northeastern megalopolis where we had been friends. My extreme inability to travel – energy deficits, the need for frequent stops to sit or lie down, and other problems that are poorly understood by healthy people – also cut me off from many of my dearest friends, including my most 'significant other.' I stopped making new friends, unless they were sick like me and I got to know them through support group meetings, or in attending government committee meetings. Even then, I usually lost track of them (unless I made a photograph – I learned that was an important tool) due to memory problems and lack of functional time during each day.

Social isolation has become probably the most frightening aspect of living with M.E. The physical symptoms can only make you sick or dead. But isolation makes you miserable every hour of your day. It never ends. Of course this is true for all chronic illnesses, but M.E. Is so poorly understood by everyone who does not have it, it's not even possible to get a fair hearing from one's pastor or an organization that is intended to insure against isolation. Socially speaking, I am living in a dead zone.

My own family cannot find their way to an understanding of what has happened to me. I live in my own home, a huge house that I cannot clean, and cannot afford to hire people to clean or to take care of the lawn. So I am always attempting – and always unsuccessfully – to do those chores myself. The result – a feeling of self loathing because I can't do what I should be able to do. After being sick for almost 20 years, I still try to do what is of course impossible and act like I'm not sick.

That's irrational. So finally, there is the emotional part of this disease. I don't say that I never feel depressed, but I'm not clinically depressed. What I am is just what the book title said: Sick and Tired of Being Sick and Tired. Angry that the people I have trusted to find out what is wrong with me and to find out how to treat it, took the money and misused it; they stole my trust. They might as well have stolen my life. Afraid that I will never feel well enough to accomplish any of the things I had set aside in my younger years to do after I climbed my big career mountain. Afraid I will never again enjoy life like I did 21 years ago.

It took me several days to pull these few pages together, from material that I mostly already had written. Along with an “executive summary,” I hope it will give some insight into what living with M.E. Is like, and why we who have the disease cannot rest until our few short pleas are met by our elected officials.

--------------------------
Addendum 1: Some things I wrote about CFS/ME in the past

In 1999, I published this information on my web site (since discontinued due to progressive illness) about the first time the CDC misspent funding for CFS research. It was informative then and still is now.

+++ DOLLARS AND SENSE +++ DOLLARS AND SENSE +++ DOLLARS AND SENSE +++

I am working on a way to put these numbers (research funds misspent by CDC) into understandable context. How about this: For every $0.98 the CDC spent on CFS related research from 1995-1998 inclusive, they stole another $0.88 from the pot and spent it on other programs, and they stole $0.41 from that same pot and no one can tell WHERE it was spent.

Another way to state it: For every $1.00 Congress authorized to be spent on CFS research, CDC spent only $0.43 on research, stole another $0.39 and spent it on other programs, and then lost track of the remaining $0.18 and can't account for that at all. In other words, only 43% of the authorized funds were actually spent on CFS research.

If I still paid taxes, I'd be hopping mad. As it is, if I could hop, I would be also. I want to see careers in tatters and ruin. I want to see ACCOUNTABILITY.

NIH ++ CDC +++ NIAID++NIH ++ CDC +++ NIAID++NIH ++ CDC +++ NIAID

Now I have a question for NIH: How clean are THEIR accounts?

------------------------------------

Addendum 2:

This is another snippet of information I put on my web page back in 1998. This is one of the meetings I attended and testified at.

April 1998 Meeting of CFSCC

Before I started my presentation, I displayed a copy of the May, 1998, Reader's Digest which has an article about the American's with Disabilities Act (ADA) in which CFS is lumped with myopia and body odor as 'not a real disability.' After displaying the article, I told the group that more people will see this article than everything that has been produced by this Committee in its entire history. That is the reason I am asking for support from the Committee as follows:

Proposal: CFSCC to reply to media coverage of CFS

* After 4 years, the CFSCC has yet to produce a single release of corrective information after negative press on CFS

* Attacks of CFS and PWCs are never-ending and not improving over time * Who speaks for PWCs?

Sample of press coverage of CFS:Washington Post July 1995
"Chronic Fatigue Rare, HMO Study Concludes"
* Citing CDC demographic studies, CFS branded as a rare diagnosis not
warranting study funding
* Major media outlet that provides articles for other newspapers across the
country

------------------------------------------------

Pat was a smart, funny, practical woman.  Her intellect was lost to the nation 27 years ago.  Then she simply got sicker and sicker.  The stage of her illness is frozen in time in 2008 in this essay that she wrote.

Pat, I miss you now and I will always miss you.  Thank you for everything you gave us.

Mary Schweitzer

For May 12, 2016: ME is not a "mysterious" disease.

Today, May 12,  is International ME Awareness Day.

The whole point of this blog is that NIH and CDC behave as if we knew nothing about ME.  That is not true.  It is not so mysterious.  You do not have to start from scratch as you slowly turn to investigate it again.  Bethesda and Atlanta may have been asleep, but the research community was awake.

What is ME?

ME stands for Myalgic Encephalomyelitis - technically, encephalitis, meningitis, and muscle pain; more generally, a neurological disease characterized by significant immune abnormalities.  The original name was atypical polio, coined in 1934 to explain an outbreak at Los Angeles County Hospital.  In the 1950s, the UK and British Commonwealth nations switched to Myalgic Encephalomyelitis.  At the same time, however, US researchers started using “epidemic neuromyesthenia,” a name that never caught on in the US.  ME was coded by the World Health Organization under neurological disorders in 1969 and has remained there since; epidemic neuromyesthenia is also coded under neurology.

It is a serious, multi-systemic disease.  To see what this disease is like, try these two sites:

http://www.25megroup.org/home.html

and

http://www.forgottenplague.com

For three decades, if you asked the US government what this disease was like, you would have received a very different answer.

In the mid-1980s, a series of cluster outbreaks in the US brought the federal government’s attention to the disease.  Many of these were linked to an outbreak of Epstein-Barr Virus (EBV), or mono (also called glandular fever), so at first NIH began calling it “Chronic Epstein-Barr Virus.”  However, by 1986 the US government’s “expert” on CEBV, the late Stephen Straus at NIAID (National Institute for Allergies and Infectious Disease) had concluded it was not related to EBV (a decision that has since come into question).  In 1986 Straus began using the name Chronic Fatigue Syndrome as a substitute for CEBV.

In 1988, a committee convened by CDC accepted Straus’s choice, Chronic Fatigue Syndrome, or CFS -“chronic” as in chronic complainer, “fatigue” as in “Yeah, I’ve been feeling tired lately, too,” and “syndrome” as in syndrome of the month.  They could not have come up with a more dismissive name if they had held a focus group.  The name went with a vacuous definition that emphasized the single symptom “fatigue,” which is common among many serious diseases.  In a society where everyone feels a bit overworked, the name sounded silly and so then did the disease.  CDC portrayed it as a disease of upper middle class white women trying to have it all, who could not handle the stress of their ambitious lifestyles.  For decades the only solutions offered were psychiatric therapy, exercise, SSRIs, and sleep aids.  

Had the US government paid attention to experts in Canada and the UK, they might have simply adopted the name in use, ME.  If you go to the decision-tree, to the point where CDC broke off and adopted CFS instead, along with what is called a “garbage” diagnosis (the disease was diagnosed by what it was not), it is clear that the next thirty years were disastrous for the patient population.  

What was the result of this detour into the concept “CFS”?  Nearly 30 years later, even CDC admits that at most only 15% of patients have a diagnosis.  That means 850,000 adult Americans - and untold teenagers and younger students - have this disease and have no idea what is wrong with them.

And of the 150,000 who are diagnosed, the vast majority are white, have a higher-than-average education and (before their illness), a higher-than-average income.  The illness leads to impoverishment for most patients.  And for most patients, it is a life-long sentence.

A recent study has confirmed the results of other studies in finding that one-fourth of patients are bedridden and/or housebound.  Only one in five can work either part-time or full time, which is why this disease experience is also a descent into severe poverty for most patients.  

WHERE ARE THE 850,000 AMERICANS WHO HAVE NO DIAGNOSIS?  Hint:  They are most likely to be people of color, and they are more likely not to have started out with much money in the first place.  Where are they, and where are their children?  Some are lucky:  they have extended families who care for them.  But many are alone and for those who started out in poverty, I do not want to think what has happened to them.  This is a criminal dereliction of duty on the part of CDC!

So for three decades, hundreds of thousands of Americans have fallen ill with this invisible disease, a life sentence in most cases, rendered unable to earn a living, and if they do not live in a family that can care for them, are reduced to severe poverty - if they didn’t start out in poverty to begin with.  

In the meantime, the name and vacuous concept of “chronic fatigue syndrome” was a gift to a small group of British psychiatrists who fall into the school of “biopsychosocial” medicine.  They adopted a definition different from that in the US - their definition, called Oxford, required only six months of debilitating fatigue, and did not distinguish between CFS and major depression or anxiety.  They pushed the view that the disease was caused by “false illness beliefs” (mainly in women or young people of both genders), and could be cured with cognitive behavior therapy (to teach the patient she wasn’t really sick) and graded exercise therapy to get them back into shape, and voilà, everything would be okay.  

Patients forced into CBT/GET (as the combination was called) were made much worse, in a very dark period of British medicine.  The leading lights of these theories, Simon Wessely, Peter White, Michael Sharpe, and Trudy Chalder continue to pump out articles reaffirming their own work, never referencing that of researchers who have found biomedical abnormalities in patients with this disease.  The most disastrous study to come out of this school of thought is the PACE study, funded by $8 million from the British government, purporting to “prove” that CBT/GET was the best choice for treatment.  

The PACE study has so many problems I cannot possibly explain them all here, except to say I would have flunked a first-year statistics student who defied so many rules of statistics to come up with the solution they wanted.  There is currently an effort by scientists and some patients to have the anonymized data from the study released so the results can be either confirmed or dismissed, but so far the relevant institutions, headed by QMUL, have refused to release the data - insisting that nobody really wants it for scientific reasons, but that there is an “orchestrated campaign” to harass the principle investigators.  For the story of the PACE trial, read this article by David Tuller, of the school of journalism and health policy at the University of California, Berkeley (in three installments):

http://www.virology.ws/2015/20/22/trial-by-error-i/

http://www.virology.ws/2015/10/22/trial-by-error-ii/

http://www.virology.ws/2015/10/22/trial-by-error-iii/

This is a good summary of the difficulty getting the PACE authors to share anonymized data, written by a scholar with no ties to the ME/CFS community:

http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/

As a scholar, for me the most egregious error in the "biopsychosocial" studies like PACE is the absence of references to the growing body of literature on biomedical abnormalities in patients with the disease.  For a recent bibliography, see:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4761639/

The proponents of this viewpoint have had a great influence on how CDC and NIH have shaped their views of the disease.  Somewhat ironically, the disease has never been studied at NIMH (the National Institute for Mental Health at NIH).  Rather, for the first 12 years it was within NIAID at NIH and in the division of viruses and exanthums at CDC.  So we had the strange picture of researchers who were not trained in psychiatry insisting that this disease was primarily psychiatric in nature.  

Let us return to that point in time, where the wrong choice was made to go off into studying the disease as if “fatigue” were the identifying factor (it is not).  Let us return to that poor choice and fix it:  use the name they should have used in the first place, Myalgic Encephalomyelitis, ME.  What are we talking about?

(The US HHS and NIH use ME/CFS as a compromise; CDC continues to use CFS.)

ME is a very serious disease.  Both the Institute of Medicine (commissioned by the Department of Health and Human Services, or HHS) and an initiative called “Pathways to Prevention” at NIH, produced reports last year stating strongly that the disease is in no way psychiatric.

According to the CFS Advisory Committee (CFSAC) to the Secretary of Health and Human Services, Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) as defined by the Institute of Medicine is "an acquired, chronic multi-systemic disease characterized by significant relapse after physical, cognitive, or emotional exertion of any sort. The disease includes immune, neurological and cognitive impairment, sleep abnormalities, and autonomic dysfunction, resulting in significant functional impairment accompanied by a pathological level of fatigue. The cause of the disease remains unknown, although in many cases symptoms may have been triggered by an infection or other prodromal event.  There are no approved diagnostics tests or treatments.”

NIH is going to study 40 select patients “to begin to understand the clinical and biological characteristics of ME/CFS.”

While I am pleased to see both CDC and NIH improve their perspectives on the disease, the fact of the matter is while they were sleeping for 30 years, other research was being conducted into the etiology and the biomedical parameters of this disease.

NIH:  THERE IS NO NEED TO REINVENT THE WHEEL.  

Why not begin with research that has been under way the entire 30 years that researchers were funded by patients, because there was virtually no funding available from the federal government?

What we need is for the US (and UK) governments to start with the existing research in the field.  Here is a quick list of how to get started:

Invest in ME, an organization in the UK devoted to research on ME that runs an amazing international conference every year - a cornucopia of international information:

http://investinme.org

Simmaron Research Institute:  http://simmaronresearch.com 

The Open Medicine Foundation:  http://www.openmedicinefoundation.org/

Stanford ME/CFS Initiative:  http://med.stanford.edu/chronicfatiguesyndrome.html

National Centre for Neuroimmunology and Emerging Diseases, Griffith University, Australia:
       https://www.griffith.edu.au/health/national-centre-neuroimmunology-emerging-diseases

The Alison Hunter Memorial Foundation (Australia): http://ahmf.org

ME Research UK:  http://www.meresearch.org.uk/

Cure-ME (Europe): http://me-cfs.se

The HHV-6 Foundation:  http://www.hhv-6foundation.org/

The Enterovirus Foundation: http://www.enterovirusfoundation.org

This is just a start.

But it IS a start.  No need to reinvent the wheel.  NIH - start from the existing state of the research, not from where NIH/CDC has been for the past thirty years.   And please, £6 million/year is not enough for these research institutes.  We need parity in research funding comparable to other disease in severity and prevalence.  $500 million is about the right number.  And we are still waiting for the promised RFAs.