Thursday, February 26, 2015

The IOM Report on ME/CFS (SEID)

This blog started out as comments on other people's blogs on the report of the Institute of Medicine (IOM)'s new definition for "ME/CFS" and the new name chosen by this committee - SEID (Systemic Exertion Intolerance Disease).  Specifically, this began as a comment to Erica Verillo's thoughtful essay, which can be read here:

The full IOM report itself is available here:
(You can download and save it in PDF form for free, but that may require registering as if you were going to buy it, then downloading it for free when given that option.  They are charging $50 for the report in hard copy.)

And a new physician's guideline written by the IOM is available and can be downloaded here:

I think the IOM Committee meant well, but I think they failed.

The CFSAC (CFS Advisory Committee) is a Congressionally mandated committee charged with advising the Secretary of Health and Human Services (HHS) on issues related to CFS.  In 2004, CFSAC asked that HHS adopt the new Canadian Consensus Criteria (2003), created by a committee of clinicians - many from the US.  They were ignored.  They kept asking.

A decade later, CFSAC asked HHS to sponsor an OPEN workshop of EXPERTS to UPDATE THE CCC.  Instead, HHS paid the IOM $1 million to put together a committee to update the name and definition - but say nothing about treatment.  The committee was about half specialist, half amateur.

Why did HHS fail to take the advice of the committee charged by Congress to give it advice - CFSAC?  The first failure of the IOM committee was in its very existence.  HHS should have listened to CFSAC.

The second great flaw is the failure to discuss treatments.  That was mandated in the instructions to the IOM.  I wonder why.

British psychiatrists have been recommending a combination of Cognitive Behavior Therapy (CBT) and Graded Exercise Therapy (GET) for two decades, and so does the US CDC.  It does not really matter what you call it - if it can be cured by CBT/GET, quite obviously it's not really a physiological disorder.

If the committee's conclusions are accurate, CBT is a waste of time as a "cure." In fact, there is a short discussion of the literature on CBT at the very end of the report, in Appendix C on disability, which concludes there is no research providing evidence that CBT can get patients back to work.  But that was not in the body of the report, nor the summary provided the media, nor in the physician's guide that the IOM just released.

If the committee's conclusions are accurate, Graded Exercise Therapy can be downright dangerous - especially if administered as a "cure" by those who do not understand the disease.  And especially if in tandem with psychotherapy urging the patient to ignore what the body is saying and adopt a "positive attitude."  Post-exertional worsening of symptoms is a hallmark of this disease - that's why they named it SEID (Systemic Exertion Intolerance Disease).

But the committee was FORBIDDEN to discuss treatments, and there is nothing to keep CDC and others from continuing to recommend it.  Acquiescing to this "remit" will haunt the committee
forever, and it is the most serious problem with the report.  But it will make insurance companies happy.

Now for more specific comments:

1.  The name SEID (Systemic Exertion Intolerance Disease) is a train wreck.  Yes, they gave us "disease" instead of "syndrome" - but I doubt it will make much difference.  "Exertion intolerance" will be viewed by most people - including most in the medical profession - as a fancy way to say CFS.  And if you had any doubts, in the flow chart to assist diagnosis that is in both the report and the physician's guideline, the top and defining symptom is ... "Fatigue." (P. 7 of the full IOM report)

If you had any more doubts, the report criticizes AND REJECTS numerous studies because the researchers used healthy people as controls instead of people with "other fatiguing" conditions, or diseases, or complexes, or syndromes, or ... Well, you get the idea.  Last time I looked, the correct methodology is to contrast the study group with a control approximating the normal population as best as possible.  Why add this new criteria - particularly when NOWHERE in this report is there a list of so-called "fatiguing conditions"?

Yes, for a first pass at a diagnosis, if your definition begins with "fatigue" you want to make sure you are distinguishing the fatigue from this disease from fatigue for other reasons.  But ... I thought the new definition didn't focus on fatigue as the prime symptom.  Guess I was wrong  about that.

And if there are studies that have shown statistically significant differences from a sample of the normal population, a scientific report should have included them, whether or not they also used a control group of patients with "other fatiguing conditions."  This is a major failing.

The definition and the summary were failures also because you have to read the full report to see that
they recommend CPET scores to measure PEM, NK cell function to measure the severity of the condition, and a tilt-table test (TTT) or an in-office substitute to test for autonomic dysfunction.  Instead, there is a plethora of subjective questionnaires offered.

I do give the physician's guide credit for mentioning these, but in the end they suggest ... Subjective questionnaires for diagnosis.

It would make an enormous difference in both the perception, and the real world treatment, of patients with this disease if objective tests were emphasized.  But they waffled at the end.  I guess they didn't want to tangle with insurance companies.

2.  The committee should have included a list of diseases that need to be ruled out because it is important for them to be treated.  That includes Hep C, congestive heart failure, hypothyroidism, hypocortisolism, primary mood disorders, and numerous others.  However ...

3.  Once such a condition is recognized and treated, if the patient continues to meet the definition for the disease, they can still get a diagnosis.  Skipping that interim step will do the patients no favors, and possibly result in numerous misdiagnoses.

4.  Once treated, however, most conditions should not be exclusionary.  The committee is correct in this - just as a person can have both cancer and hypothyroidism, so too can a patient have both "ME/CFS (SEID)" and hypothyroidism.  This is a particularly pertinent example, because research that did not make it into the report provides evidence many patients with a diagnosis of ME or CFS have a chronic viral infection.  It is known that many herpesvirus infections (EBV, CMV, HHV-6A) can cause Hashimoto's hypothyroidism.  To exclude Hashimoto's (a condition where your own antibodies attack your thyroid) would lead to the exclusion of many patients with chronic viral infections.

5.  Instead of offering an unbiased survey of the evidence of chronic viral infections in ME and CFS, the committee stuck to the government line that there are no chronic viral infections except in AIDS.  But if you start out by excluding evidence to the contrary, you have created a tautology.  Surely they could have examined that evidence, which goes beyond EBV, but added their OPINION - which is what it is - that the disease is not caused by chronic viral infections.  Perhaps they should go back and read Popper again on falsifiability and the inability to use statistics to disprove a hypothesis for which it is acknowledged there is evidence, but it is insufficient evidence.

6.  Some have called for NMH/POTS and Ehlers-Danlos Syndrome (a hereditary connective tissue disorder) to be exclusionary.  But - as the committee correctly noted - there is significant evidence that NMH/POTS and CFS (Fukuda 1994), and NMH/POTS and CCC are correlated.  Again, you can treat the NMH/POTS but the patient will still have the disease.  The symptoms will be a bit better, however, and it is irresponsible not to try to do something about it.  The literature in the correlation goes back to Ramsay's definition of M.E., and a 1995 article in JAMA (the Journal of the American Medical Association).  Newer research shows Ehlers-Danlos correlates with NMH/POTS.

7.  A patient with depression or anxiety should be treated for depression or anxiety - but if they have the disease, they will still be sick.  Furthermore, the incidence of secondary depression is similar to that in MS patients.  Of course these patients should be treated!

However, major mood disorders and depression/anxiety are the elephant in the room for this disease.  While they are exclusionary for almost every other diagnostic criteria - they are NOT excluded for what is called the "Oxford definition," which consists of six months of debilitating fatigue not caused by a physiological disorder (and was curiously missing from the list of extant definitions.). The Oxford definition underlies a parallel universe of psychiatric papers as numerous as the research on physiological aspects of the disease.  These psychiatrists generally do not mention the physiological evidence in their work, and they frequently cite each other, so a novice who is only aware of that research will only know about ... The Oxford definition and the so-called "biopsychosocial" school of British psychiatry.

These psychiatrists peddle CBT/GET as THE cure for what they call "CFS/ME."  The CDC's website throws in SSRIs and sleeping pills, but basically echoes the British psychiatric version.  That is not a coincidence: leading lights of the British school have all advised the CDC frequently on "CFS" (and often on GWI as well):  Simon Wessely, Peter White, Michael Sharpe, Trudie Chalder.

Once again, the failure of the IOM report to directly address the parallel literature in psychiatry, and the problems with CBT and GET, can only be viewed as a great failure.  It was nice for them to say "ME/CFS SEID" is not neurasthenia (a diagnosis favored by the British psychiatrists) - but it's a day late and a dollar short.

Most recently, a committee including British "CFS/ME" expert Michael Sharpe succeeded in getting a new condition called "Somatic Symptom Disorder" placed in the new DSM-5, the diagnostic manual of American psychiatry.  The definition looks remarkably like a definition for CFS.  It starts with complaining about fatigue.  And one of the "symptoms" is complaining of four or more physical symptoms!   If you weren't careful, a cancer patient could get thrown in this bin.

Therefore, had the committee not been so naïve (I do hope that is the reason), they would have made a strong statement that this disease IS NOT SOMATIC SYMPTOM DISORDER, and IS NOT A SOMATICIZING DISORDER, period.  The failure to do so is enormous in the real world of misdiagnoses, mistreatments, patients thrown into mental hospitals against their will, and young people sent to foster care because their "overbearing" parents (and perhaps a "misguided specialist") diagnosed the child with ME or CFS.

8.  We ALL - myself included - would prefer for the time being they name the disease after a key researcher such as Melvin Ramsay, or a patient, such as the late, brilliant young Alison Hunter.  CDC insists that scientists don't do that any more.  So maybe we patients should.

9.  When it comes to the disease M.E., which is a distinct illness diagnosed outside the US since 1955 and recognized as neurological by WHO since 1969, the committee did not seem to know what it was.  They seemed to think it was a synonym for CFS, just another choice of a name.  It is not, and it is not the committee's business to dismiss it.  They were charged with examining ME/CFS, but as Leonard Jason eloquently explained in his latest article, that is also a different condition with its own name.  (The CCC uses ME/CFS throughout because Canada's version of ICD-10, called ICD-10-CA, placed CFS and M.E. together in the tabular version of ICD-10-CA, adopted by Canada in 2002.). At any rate, I am giving the committee the benefit of the doubt and hoping that these were just typos:

-  The committee stated that M.E. and CFS are coded separately in WHO's ICD-10 (p. 27 of the full IOM report).  That's not so.  That is true of the US version of ICD-10, called ICD-10-CM.  It is a major error - period - an error of FACT.  ICD-10 codes M.E. in G93.3 in the chapter on neurological disorders (as they have since 1969).  If you look at the index (unfortunately unavailable online, but I have a xerox of the appropriate page in the printed index), CFS is also coded to G93.3.  Furthermore, André l'Hours of WHO frequently responded in writing to queries from British Parliament as to the proper coding of CFS, stating it belonged in G93.3.  (This was during a period when the British psychiatrists were insisting "CFS" was actually neurasthenia and should be coded under psychiatry.).  So the committee was FACTUALLY WRONG in stating that WHO's ICD-10 places M.E. and CFS in two different codes.

To be accurate, the US's ICD-10-CM, a clinical modification of ICD-10 due to go into effect in fall 2015, as well as ICD-9-CM, still in effect in the US, both place M.E. under neurology and CFS under "vague signs and symptoms."  But that is ONLY in the U.S.  It is not the world.
 The rest of the world has been using ICD-10 for the past 1-2 decades while the US was still stuck on ICD-9-CM.  CFS was never coded in WHO's ICD-9 because shortly after it was adopted on the US, WHO completed their conversion to ICD-10.

-   The committee also stated that the Holmes (1988) article introducing CFS and its first definition acknowledged the existence of M.E. (P. 29 of the full IOM report).  It did not.  You will not find M.E. in the body or the footnotes of the Holmes article.

These were important because if the option of diagnosing M.E. - a separate diagnosis in the US - if the option of diagnosing M.E. had been available and known to the physicians working with cluster outbreaks, they might have chosen THAT diagnosis as more appropriate.  The definition of M.E. in Melvin Ramsay's 1986 textbook can be found here (formatted as we are used to seeing definitions, but otherwise unaltered):

10.  It bears repeating here that another major failing of the report was the frequent criticism of existing studies because they used healthy patients as controls.  That is the usual thing to do in medicine.  Isn't it?  But as much as they said they wanted to downplay fatigue, they insisted that studies of the disease should have compared patients to those with "other fatiguing disorders".  They said this about a dozen times, but never listed what they had in mind by "other fatiguing disorders."  So once again, methinks they do protest too much.

11.  In part because of (10), and in part because of a continuing prejudice in the medical profession against the possibility that a person can have a chronic viral infection (except for AIDS patients), all of the literature on pathogens (except EBV as a possible trigger) and most of the literature on immune system dysfunction was ignored.  Did not appear in the report.  This amounts to censorship - seriously so, because a finding that a patient has an active viral infection or a serious immune defect can lead to TREATMENT, and in the end, treatment is what these patients need most.  Patients do not all test positive for the same conditions (mostly viruses), but there is a considerable body of evidence on chronic infection and this disease.  After all, this disease was originally named atypical polio, and it first came to the attention of the public because of a series of cluster outbreaks around the US in the mid-1980s.
The list of pathogens is long, and, to repeat, patients do not all have the same combination:  enteroviruses in general, Coxsackie in specific; Human herpesviruses (HHVs):  EBV (Epstein-Barr Virus, mono, HHV-4), CMV (HHV-5), HHV-6 Variant A, HHV-7; chlamydia pneumonae; parvovirus; adenovirus; and others.  The evidence is there, but because there is so little funding, they tend to be small studies.  That they are small, however, cannot be taken to mean they are inaccurate (get your Popper out again, guys).  It just means we need more money for research.  I think I said that before.

12.  There is so much else that is missing - the literature on mitochondria, toxic assaults including molds, and many others.  I can't go into them all here - but THEY should have.  If there was enough time, they should have said so and still listed the bibliography.


Sadly, I don't think we can do much about this.  It was suggested that we "act up" (a reference to AIDS activism).  I think that suggestion was well-meaning, but again, naïve.  Several specialists who treat both AIDS and CFS have said that CFS patients are, in general, as sick as AIDS patients are in the last two months of life.  The people who were "acting up" were not THOSE patients - they were often the healthy friends and loved ones of dying AIDS patients.

We can't occupy the Capitol building or the Stock Exchange because we can't take the chance of going to jail.  For a person with this condition, that could be a medical disaster.  So even those who want us to demonstrate are ignoring the nature of this disease as a disability.

(I could also add that AIDS patients did not have to contend with the Patriot Act, or a nation hardened to demonstrations.)

Nobody wanted to pay much attention to us advocates when we wanted to dump this whole exercise - for that matter, nobody paid attention to the Congressionally mandated CFSAC or a letter signed by nearly 50 specialists.  I don't think they are going to pay much attention to us now.

The US is in the process of switching over from ICD-9-CM to ICD-10-CM this fall.  As a result, there is a coding freeze in place.  Unless ordered from above within the government, SEID cannot get a code authorized until October 2016.

So why go through the exercise?  Well, it seems to have effectively stymied CFSAC's efforts to have the government sponsor a workshop of specialists to revise the CCC and then for the government to adopt it.

We could always put together our OWN committee and have the results published in a peer-reviewed journal.  Of course, the US government may ignore that - but perhaps clinicians and researchers won't.  There is a precedent - the Reeves definition (2006) has been ignored by everybody except
CDC, and even CDC uses the Jason prevalence rates on its website, not Reeves'.

In fact, DePaul specialist Leonard Jason just published a new clinical definition that is (in my opinion) better than the IOM's:

But I think the next move will have to come from the US federal government.

If CDC revamps its website and "toolkit" and gets rid of their recommendation of CBT, GET, antidepressants and sleep aids, I will eat my words and consider the IOM report a success.

If NIH increases spending on our disease from $6 million a year (in the bottom five of all conditions funded by NIH) to something more commensurate with the severity and prevalence (one million adult Americans) of this disease - say, $100 million (still much lower than the spending for MS), I will eat my words and consider the IOM report a success.

If, as I suspect, neither agency will amend their ways with regards to this disease, then all the good intentions in the world won't help.  The IOM Report, $1million and the committee's time and effort, will all have been a terrible waste.

The week before the rollout of the IOM report, a lovely young woman named Vanessa Li took her own life because she continued to suffer dramatically from the disease and she saw no hope for a change.

Karina Hansen, only 25, has spent the past two years imprisoned in a Danish psychiatric asylum for the sin of having a diagnosis of M.E. and continues to languish there, unable to see her family.

By the report's own admission, a quarter of a million Americans are bedridden or housebound right now as a result of this disease.

We don't need prevarication - we need URGENT ACTION.

What will it take to get that?

Mary Schweitzer, Ph.D.
Incline Village, NV
25 February 2015