An Open Letter to Dr. Collins and Dr. Nath on the NIH internal ME/CFS study

Note: As of Sunday, March 6, NIH has dropped the somatoform comparison group.  Thank heavens!  But they are still looking for "the underlying physiology of fatigue."  So I still wish they would spend as much time learning about M.E. as they have spent deciding on the [admittedly admirable] lineup of tests.

Dear Dr. Collins and Dr. Nath:

I echo the sentiments of many ME/CFS patients in expressing concerns about the way the in-house NIH study on ME/CFS is proceeding.

The stated hypothesis of this new study is that: “post-infectious ME/CFS is triggered by a viral illness that results in immune-mediated brain dysfunction."  Is that really all there is to the hypothesis?  Dr. Wallit's participation raises troubling questions as to whether that is so.  The comparison groups chosen for this study also suggest there is more to the hypothesis than we have been told.  

I beg you, Drs. Collins and Nath, please rethink the hypothesis - and Dr. Walitt's role in this study. I also ask you to rethink the comparison groups. This disease has been a serious problem in the US for 30 years, and for 30 years both NIH and CDC have obstructed the creation of a strong biomedical research community – nevertheless, it has existed. 

What has happened here?  A hypothesis created by people who know next to nothing about this disease is being plonked on top of us. If I may say so, yet again.  Why?

Make no mistake about it, fellow patients: Dr. Walitt is playing with somatoform diseases here – he just thinks there’s a biological cause for them. 

He seems insulted that we might be unhappy about his inclusion.  All I can say is that anybody who uses the words "chronic fatigue syndrome," "fibromyalgia," and "somatoform illnesses" in the same sentence is unacceptable in a preliminary study of my disease sponsored by NIH.  

Last March Dr. Walitt published an article containing the following sentence:  "The discordance between the severity of subjective experience and that of objective impairment is the hallmark of somatoform illnesses, such as fibromyalgia and chronic fatigue syndrome. " (Chemobrain: a critical review and causal hypothesis )

I really do not care if Dr. Wallit is looking for a physiological cause for what are called "somatoform" illnesses.  The problem is that he thinks ME/CFS is a somatoform illness.

Then there are the comparison groups.  Where did these come from?  Two comparison groups:  post-symptomatic Lyme Disease patients, and patients with physical somatic disorders.  The choices of comparison groups themselves suggest that the research hypothesis for this project has not been fully revealed to patients.

With only enough money to put 40 ME/CFS patients in the study, may I ask why we are bothering with comparison groups at all?  Does it not make more sense to do this first study with ME/CFS patients v. controls - and then use more ME/CFS patients?  

Since 1998 I have known that i had the defective 37kDa Rnase-L and a severe case of HHV-6A. Later testing showed natural killer cell dysfunction (in my case, a natural killer cell function of 2-3%) and abnormal cytokine patterns. In 2009, Dr. Dan Peterson found active HHV-6A and CMV in my spinal fluid. Do you think that my serious encephalitic and neurological symptoms could have had something to do with that evidence? The immune defects and viruses go away on Ampligen and come back 7-12 months off it. I am a sample of 1, but there are more like me. Many more. We have patients improving on the antiviral Vistide at Dr. Peterson's (I cannot take Vistide; my liver markers shoot up).  The late Martin Lerner had patients on both Vistide and another antiviral, Valcyte;  Dr. Jose Montoya at Stanford has had success with Valcyte as well.  

Please pay attention to this evidence.  Talk to clinician/researchers.  

If not – then please run that hypothesis past some non-psychiatric specialists in our field before running with it in the first NIH internal study on our disease since Straus discovered (to his dismay) that we have abnormally LOW levels of adrenaline (patients with major mood disorders tend to have abnormally HIGH levels of adrenaline) 20 years ago.  Dr. Straus had planned to be able to say we really had depression; hence his disappointment. (Psychiatists in the UK - and CDC's CFS group - finally found a use for Straus's adrenaline study in the unsupported hypothesis that patients had too many stressors earlier in life and had, in effect, run out of mechanisms to cope with them.  If that were true, wouldn't one expect to find this disease much more common in Kosovo, parts of Africa, and in the embattled mid-east?  Why hasn't it popped up in refugee communities internationally?)

Perhaps you could put this off until you can hold a workshop with recognized ME/CFS experts. I am confident we could pull one together quickly.

The well-respected British organization, Invest in ME , is holding a research conference May 3 in London.  I am certain they would include you if asked.  Another international research organization for this disease, IACFS/ME (International Association for CFS/ME) is meeting in Miami in October. Put this on a workshop there, or let them help you set up an earlier one. Or ask the public members of CFSAC to help you create a workshop. Ask any of us to help you create a workshop. You need to discuss the hypothesis and comparison groups with the longstanding biomedical ME/CFS community before committing to them. 

In the beginning of 2000, ignoring the existence of CFSCC, the late Stephen Straus of NIAID and CAM at NIH ran a "state of the science" meeting about "CFS" with the usual suspects (if you forgive my saying so) – the psychiatrists from the UK who have had an inordinate amount of influence on perceptions of this disease both abroad and within HHS. After pressure from Congress he relented to having ONE public member from CFSCC attend (Nancy Klimas). But Congress continued to ask for a more objective  conference. Donna Dean had just been placed as head of CFSCC, and she ran a conference the next fall that was fantastic – full of science and discussions with researchers who had previously known nothing about the disease. Unfortunately, there was a presidential shift in 2001 and CFSCC was shut down (to emerge, weakened, as CFSAC almost three years later). Dr. Dean left, and nothing happened again until 2011, when Dennis Mangan ran another excellent State of the Knowledge conference at NIH, which then came to naught. 

When researchers do not know the very long history of this disease (technically going back to atypical polio in 1934, but practically speaking, back 60 years to the Royal College outbreak and creation of the terms myalgic encephalomyelitis in the UK and epidemic neuromyesthenia in the US), they make blunders. They can be perfectly well-meaning, but this topic is a mine field and requires someone who knows the history to navigate it. I am discouraged that once again NIH is going off on its own, as if we were never here at all.

One last way to salvage this study.  Simply ditch the hypothesis and comparison groups and run it as a study of potential biomarkers in ME/CFS, without prejudging their meaning.

This is a very raw hypothesis. I love the scientific evidence you want to bring to bear, but I wish you were working on biomarkers for ME/CFS – not the physiological basis for "somatoform" illnesses.

Mary M. Schweitzer, Ph.D.

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. 

Justice for Karina Hansen

I am reposting this urgent message from fellow patient Wendy Boutilier.  We believe this is a human rights violation and need international help for this young woman, imprisoned in a mental hospital for 2 1/2 years for the sin of having Myalgic Encephalomyelitis.  She was 24 when taken from her family; she just turned 27.

On February 12, 2013, five policemen from Holesbro County, Denmark, came to ME patient Karina Hansen's house and forcibly removed her from her bed.  

There were also 2 doctors, a locksmith, and 2 social workers present.

Karina called for her mother's help, but her mother was blocked by the police from aiding her.

Karina used her mobile phone for the first time in years to call her mother, her father, her cousin and her sister, Janni.

Karina is so ill that she can usually only speak in one or two word sentences, but during her removal she managed to call her father and say:  

"Help Dad!  In my room!"  and to her sister:  "Help, Janni!  I don't know where they are taking me!"

Karina's mother could not answer her phone because she was surrounded by policemen.

Karina was then driven to a hospital in an ambulance.  Her parents were not told where Karina was being taken or what reason they had for taking her.  No paperwork was given to her parents.

Later that day, they got a phone call and were told that Karina was at Hammel Neurocenter and that someone would call them every day at 10 am to tell them how Karina was doing.

They were also told that no one could visit Karina for 14 days.

On the morning of February 13, Karina managed to call her mother from her mobile phone.  She said:

"How can I get out of here?  I can't take this."  [Hvordan kan jeg komme væk herfra?  Jeg kan ikke klare det.]  Then the connection was cut.

A few days later, Karina's parents got a letter from a psychiatrist Nils Balle Christensen, which said he would be in charge of Karina's treatment at Hammel Neurocenter.  He also wrote that because of her condition, Karina was not allowed visitors for 14 days.

That ban on visitors was later extended to three weeks because Dr. Christensen was on vacation.  Nils Balle Christensen works at the Research Clinic for Functional Disorders and Psychosomatics.  He and his superior, psychiatrist Per Fink, believe that Myalgic Encephalomyelitis (ME) is a functional disorder.  [Note from MS:  The sister was finally allowed a visit, but burst into tears at the condition in which she found Karina, and after that NO family visitors have been permitted.  For over two years.]

"Functional disorder" has replaced the term "psychosomatic illness" in psychiatry-speak.  In this case, they had expanded it to what was called "Münchausen Syndrome by Proxy (MSBP)," or it's modern incarnation, "factitious illness by proxy," where the parents are accused of making their child appear sick.  The treatments the clinic recommends are:  exercise (GET), cognitive behavioral therapy (CBT), and antidepressants.

[Note from MS:  If you have seen "Sixth Sense," you have seen a fictional case of MSBP.  But it has been shown time and time again that while this may actually happen in a few very rare cases, there's no need for a special diagnostic category - the diagnosis "psychopath" already exists and fits the situation.  But then it would be the parents who should be put in a mental hospital, not the child.  As for the treatment, psychotherapy may help a patient accept the condition (as in MS), but cannot cure the disease.  Indeed, the insistence by European psychiatrists that psychotherapy will cure this disease is reminiscent of the days when MS was called "hysterical paralysis" - except the European psychiatrists prefer the old term for the vapors, "neurasthenia."  A new category was created recently, "Somatic Symptoms Disorder," and Per Fink, one of the psychiatrists involved in this case, is active in WHO and trying to get this accepted as a category in ICD-11.  Karina's case thus has political overtones, unfortunately, which has made the psychiatrists involved unwilling to compromise.

Note continued:  There has been significant research published showing that graded exercise is actually dangerous for even high-functioning patients, and this young woman is extremely disabled.]

The psychiatrists at this clinic have no experience with severely ill ME patients and we fear that Karina is being treated incorrectly, and that their mistreatment of her will lead to a severe and permanent worsening of her condition.

[Note from MS:  This has occurred in the UK where it is not uncommon for young ME patients to be "sectioned" - forcibly committed to a mental hospital against their will - and they have come out of the hospital in much worse condition than when they entered.  In one tragic case, Sophia Mirza died from irreversible damage to her condition that occurred in a mental hospital.  Her autopsy showed significant damage to the basal root ganglia, and a formal  inquiry concluded she died of ME.]

Various petitions have been set up and signed, letters have been sent to MPs in the UK, European Union Danish Ministry of Health, Danish Government of Power and the Danish Royal Family, all to no avail.

There is no contact permitted between Karina and her family, and there has only been limited contact permitted between Karina and her lawyer, as well as the Myalgic Encephalomyelitis Association of Denmark.  Some updates on her condition is published from time to time, but it is basically censored.

Inside information tells a different story.  Karina believes they are trying to kill her with this line of treatment.  Her condition is worse now than before she was hospitalized.  Unfortunately, that is what could be predicted given the severity of her disease when she entered the mental hospital and the rigid beliefs of this branch of the psychiatric profession in Denmark.

All of Karina's human rights have been severed.  We have not been provided with the name of her lawyer and/or representative with the United Nations Human Rights Council, and we have no uncensored contact with Karina or any of her representatives.

There are a number of petitions being circulated, but this one has the most names, so if you can add your name to it we would be grateful.  If you belong to any human rights organizations, tell them about Karina's case.  And RETWEET!!

JUSTICE FOR KARINA
Share Widely
TWITTER:http://www.avaaz.org/en/petition/Justice_for_Karina/?twi
Avaaz:http://www.avaaz.org/en/petition/Justice_for_Karina/?email
PLEASE SIGN, EVEN IF YOU HAVE SIGNED OTHERS

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

URGENT - you can sign a letter to the new Prime Minister of Denmark by going to this website:

Letter about Karina to Danish PM