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.

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.

The PACE trials: a £6 million failure

There is nothing complicated about the PACE trials – or at least, there should not have been. Patients were selected to participate in a trial of cognitive behaviour therapy targeted to their “inappropriate illness beliefs” and a course of “graded exercise therapy” to get them back in shape – together this is called CBT/GET and has been proclaimed as the “best” treatment for ME and CFS by the governments of the UK, the US, among others, for two decades now.  [For an excellent critique of the PACE trial, see  David Tuller's "Trial by Error" .]

These treatments are controversial, to say the least. The main reason is that the entire programme of “CBT/GET” with regards to ME and CFS is based on the assertion that the patients’ physical symptoms have no medical explanation – in insurance (and now medical) parlance, these patients all have “MUS”s (Medically Unexplained Symptoms).

But there are numerous studies that DO offer a medical, or physiological, explanation for the symptoms. Most specifically, research has shown that high-functioning patients who fit the Canadian Consensus Criteria for ME/CFS (2003) do perform roughly the same as deconditioned controls on Cardio-Pulmonary Exercise Testing (CPET)  – but on a  SECOND day of testing, while the deconditioned controls perform the same as they did the day before, the patients’ scores drop by as much as one-half. (See, for example, Discriminative Validity of Metabolic and Workload Measurements to Identify Individuals With Chronic Fatigue Syndrome, Christopher R. Snell, Staci R. Stevens, Todd E. Davenport, and J. Mark Van Ness, Physical Therapy (June 2013).

The CPET has long been used in cardiology – and athletics – and is highly regarded as objective. It can’t be gamed. The tester puts a mask over the patients nose and mouth (or over the mouth and clamps the nose shut) so that the air going into and out of the patients’ lungs is measured by a machine while the patient rides a stationary bicycle or walks on a treadmill that gets progressively more difficult. When the patient reaches maximal cardiac effort [a pulse of (200-age) x .8], the machine records the amount of oxygen intake and carbon dioxide release – that is, it measures how much oxygen the patient inputs and how much carbon dioxide has been produced.

CPET testing of patients with ME or CFS – which has now been replicated on three continents by numerous researchers (and is into second-order studies where the patients’ blood is tested for other characteristics before, during, and after testing) has effectively demonstrated that what patients have been saying for years – and what has been recognized by the non-psychiatric school of thought regarding the disease – is both profound and measurable – patients suffer from what is called in the literature “post-exertional malaise” or post-exertional worsening of symptoms.  

This symptom is considered so profound, and so important, that the recent Report on ME/CFS from the Institute of Medicine at the US National Academies of Sciences concluded it should be a requirement for the definition of the disease.

Now, imagine a patient for whom a defining symptom is the inability to maintain the same level of exercise two days in a row. Imagine a treatment where the patient is told to (1) increase exercise daily, and (2) ignore how it makes them feel. These patients end up operating in constant anaerobic metabolism, which is dangerous for trained athletes – certainly it is dangerous for patients.

That brings us to my own principle frustration with this literature. The psychiatric literature on the disease known as ME and/or CFS does not reference the great body of literature on physical abnormalities found in the disease. Those who know nothing of these diseases who read this psychiatric literature won’t know about post-exertional “malaise” (or worsening of symptoms); won’t know about significant cognitive dysfunction and sleep abnormalities; ataxia, gait abnormalities, muscle pain; and – above all – won’t know that one-fourth of patients are either bedridden or housebound.

Here, then, is the major source of the division between QMUL/KCL and the rest of the ME/CFS community.  It has nothing to do with how patients feel about psychiatrists or psychiatric diagnosis.  Rather, the QMUL/KCL world admits to no evidence of physical abnormalities in patients with this disease – an assertion I do not believe they are entitled to make. Certainly readers should have the opportunity to choose for themselves; a full and objective bibliography should be provided by the authors, not just a bibliography of work that agrees with their thesis.

Under the circumstances, the authors of this £6 million study – which used taxpayers’ funds – are being suspiciously coy. Patients have insisted for years that the CBT/GET protocol is not just meaningless – it is directly harmful. Indeed, if CBT/GET were a pharmaceutical drug instead of a protocol, it would have been denied a long time ago on the basis of the number of adverse events.

But both the UK and the US governments continue to recommend this treatment – and they base that recommendation on the PACE trials plus the body of literature written by the schools of psychiatry at QMUL and KCL.

It is not just an academic discussion. Policy choices rest on the conclusion. Treatment choices rest on the conclusions.

It is imperative that we get this right. If the authors are wrong, then this is actually harming patients, even as I write this sentence. They would probably consider that sentence harassment. But how else am I to say it? There is evidence that the adverse events from this treatment protocol are being swept under the rug.

One million American adults suffer from this disease. 250,000 patients in the UK are also victims. This is too important not to make absolutely certain we are doing the right thing.

What I do not understand is why the psychiatrists at QMUL and KCL don’t agree with that.

A postmodernist theory of medicine: "CFS/ME" and the PACE trials

What happens when a concept developed to analyze the arts, including literary criticism, migrates to medical science?  The concept is postmodernism, and it is a very strange philosophy for a science having to do with keeping human beings healthy.  Postmodernism is defined a bit differently depending on whether you are discussing postmodernism in architecture, the visual arts, or literary criticism.  However, there are a few basic elements:

• Rejection of a metanarrative
• Rejection of the modernist concept of progressivism - that knowledge improves over time
• Emphasis upon perception over “reality” - to some extent, a rejection of reality itself in the belief that we can only know perception

I am sure there are other ways to characterize postmodernism, but I think these three precepts run through most theories based upon postmodernism.

In this essay, I am going to suggest that there is a school of British psychiatry called “biopsychosocial” which is effectively postmodernist - a most peculiar theory upon which to base the diagnosis and treatment of real human beings in real time.  The patients who have born the brunt of this school of thought are those afflicted with the condition Myalgic Encephalomyelitis (ME), which (by way of a detour through “chronic Epstein-Barr virus”) became known as “chronic fatigue syndrome” in 1988.  It’s not a minor or rare illness - millions of patients worldwide have the disease; over one million in the US and 250,000 in the UK. 

ME, the disease, is based upon a set of symptoms having to do with muscle failure, cognitive dysfunction, “unrefreshing” sleep, and pain.  Perhaps the most unique symptom of ME is a delayed response to exertion, what patients call a “crash,” which can last days or weeks or even become permanent.  The most seriously ill patients with this disease are confined to wheelchairs, bedridden, even on feeding tubes.  It would hardly seem the best choice for a medical theory of postmodernism.

In contrast, “chronic fatigue syndrome,” or CFS, fits the bill for postmodernism perfectly, because it is almost entirely based upon perception - the perception of fatigue.  

ME was first diagnosed in the 1950s to characterize three large outbreaks of disease in the UK, the most famous occurring at the Royal Free Hospital in London as a new term for a condition that had been observed since 1934, “atypical polio.”  With polio supposedly conquered by vaccine (which only contains the 3 strains of polio considered most severe), medical researcher and clinician Melvin Ramsay, along with several colleagues, sought to define a condition that appeared to occur in cluster outbreaks, like polio, but had somewhat different characteristics.  ME was adopted by the World Health Organization in 1969, coded within the chapter on neurological conditions in WHO’s International Classification of Diseases (ICD).  It remains there in ICD-10, the current version.

In 1970 and 1971, psychiatrists McAvedy and Beard published two articles claiming that ME was actually mass hysteria (interesting time - just as psychiatry lost the diagnosis of hysterical paralysis for Multiple Sclerosis, they found a substitute in ME).  Psychiatrists jumped on the name change to CFS in 1988 - in particular, a group of British psychiatrists who declared themselves to be practitioners of something called “biopsychosocial” medicine:  most notably Simon Wessely, Michael Sharpe, and Peter White.  

The “biopsychosocial” school consisted mainly of the claim that its adherents practiced a holistic vision of medicine combining biological, psychological, and social factors - but in practice, very little was ever said about biology.  When the biopsychosocial psychiatrists were asked about the absence of references to biomedical research in their work, they tended to snap back with the non sequitur that the suggestion showed an adherence to “Cartesian mind-body dualism,” and prejudice against psychiatry in general.  

According to these psychiatrists, “CFS” and “CFS/ME” (their terms) was caused by “inappropriate illness beliefs.”  The patient had actually had an illness such as a bad flu in the beginning, but instead of going back to their normal lives after the virus was over, they became afraid to do too much in fear that the symptoms would return.  The result of their inactivity, deconditioning, became the evidence that they were still sick.  The cure could thus be found in a specific form of psychiatric therapy, cognitive behavior therapy (CBT) - to teach the patient that she wasn’t really sick as she thought - and graded exercise therapy (GET) - to get the patient’s body reconditioned.  The combination of positive thoughts about improvement and actual improvement caused by the exercise would therefore “cure” the patient.

The biopsychosocial school, in practice, is postmodernism as medicine:

• Rejection of a metanarrative - in this case, the authors claim to be rejecting outdated beliefs in “Cartesian dualism” that would differentiate between “biomedical” research and “psychiatric” research.
• Rejection of modern concepts of progressivism - the authors reached back to the nineteenth century diagnosis “neurasthenia,” citing books written in the mid-1800s about “nervous disorders.”  Their research, they insisted, was not driven by pure theory but “evidence-based.”  “Evidence-based” obviously sounds like a good idea, except that in this case it was based upon “evidence” from clinics where patients had already been diagnosed using their theories - it was, in effect, a tautology.  But they could then insist they did not have to reference research driven by path-dependent theories linked by time, or answer to critiques of neurasthenia over the past 150 years.  They were only studying the present.  
• Emphasis of perception over reality - the patient only THINKS he or she cannot behave like healthy adults.  It is the perception, these “inappropriate illness beliefs,” that need to be changed.  The cure, then, is to be found in treatments that change that perception both literally, through CBT, and changing the experience itself, through GET.  

It is in this context that I think we can best understand the £5,000,000 study commissioned by the UK government called the “PACE trials.”  The PACE trials were supposed to prove once and for all whether the prescription of CBT/GET could cure the disease the authors called “CFS/ME.”  Since the authors made their living - to a large extent - on the basis of this thesis, one would think the results would be evaluated using a fine tooth comb.  But no sooner had they been published than critiques arose from the community of patients afflicted with the disease, and those who either treated or studied it.  

Patients with backgrounds in medicine, science, and/or research were unable to break through to the public with their critiques.  Many of them asked to see the data behind the study to understand how the conclusions reached could possibly have arisen from the study.  Their requests did not exactly fall on deaf ears - to the contrary, the researchers complained both privately and publicly (in the press) that they were being harassed, the requests for data “vexatious.”  No data was released.  

Four years passed.

This fall, (2015), David Tuller, a Berkley journalism professor who had followed the disease for the New York Times and other outlets, wrote a detailed critique of the study, which was published on the blog site of noted Columbia virologist Vince Racaniello.  There it drew the attention of James Coyne, a clinical health psychologist who has spent several years focusing on deception in research.

In fast succession, a new request for data was filed - and refused. Queen Mary’s University London (QMUL) and King’s College London (KCL) both insisted that the request was without basis, that it was intended only to harass the authors - that is, that it was “vexatious” - and they refused to comply.

For an excellent rundown of where we were in the story as I wrote this essay (12 December 2015), see:

PACE Trials - Forbidden Fruit

Elsewhere on this blog, Slightly Alive, you will find testimony to CFSAC and FDA on my condition, testing, and the experimental immune medicine which enables me to be able to write this essay. 

Here, however, I wanted to add something new to the debate.   What happens when theories inspired by postmodernism encounter a discipline that requires the belief that there is a there, there - there is a real patient, the real patient has a real body, and real things go wrong with that very real body.  The result sounds like scholarship.  It sounds erudite.  But in the end, you cannot separate perception from reality in this manner.  You cannot simply assume that the only problem with a patient is his or her perception of their health, on the basis that (in insurance industry language), the patients’ problem boils down to “medically unexplained symptoms” (which has even earned an acronym, MUS).  

Aside from the costs to the patients who actually have the disease in question, ME, these theories are very dangerous to the larger discipline of medicine.  Just because symptoms have no “medical explanation” does not mean they are based solely upon perception.  No physician can possibly explain every medical symptom - and there are conditions that have yet to be explained.  The absence of an explanation is not proof of the absence of a medical condition.

But in the world of “biopsychosocial” medicine, the absence of an explanation is precisely that:  proof of the absence of a medical condition - of a purely medical condition, they would probably say.

Medical science needs to understand that this theory does not just apply to ME/CFS, and does not just apply to “MUS” conditions.  Simon Wessely, for example, has already applied it to Gulf War Syndrome. 

This is an enormously useful political concept in the current atmosphere of austerity.  Applying CBT and GET is a lot less expensive than testing for immune defects and pathogens, looking at SPECT scans and CPETs, treating with immune modulators and antivirals.  

The British government, which has much to gain from this theory that “CFS/ME” is perception rather than reality, and these researchers, who directly profit from that theory, were hardly disinterested parties to join together in conducting the PACE trials.  The same goes for the institutions SMUL and KCL.

As such, they are not really in a position to reject mounting requests for an independent review of the study.  They should not be permitted the final say.  

The ramifications of their intransigence are great.  There are many conditions to which this new postmodernist view of medicine could be applied, greatly cutting costs without benefitting people in need of care.  The risk is greatest with chronic illness.  It is hardly a secret that both insurance companies and penurious governments are concerned about the mounting costs of chronic illness.  What a convenient theory for such an austere time.  

The authors of the PACE trials (and those who funded the study) must not be permitted to slip away without a thorough examination, because too much is at stake.  Postmodernism and medicine are not a happy coupling.  The effort to join them must undergo even more scrutiny than usual, because what is being tried here is most unusual.  

It is highly unlikely that the authors of the study willingly would allow that data to see the light of day, because so far the evidence suggests the data cannot support the conclusions - and too much is riding on those conclusions.  

If the most basic rules of scholarship are permitted to be broken here, where then will they be enforced?  CFS/ME is merely perception.  Global warming is just biased statistics.  “Fracking” has no effect on the environment.  That may be your “view”, but my “view” is just as important. 

After all, it’s only perception.