Translate to ...... with one click.


Dec.2014 LauraHillenbrand FaceTheNation
ME+Unbroken Interview HERE -

Dec 2014 ~ "NIH"P2P4ME"

NIH="InsufficientResearch"=DUH !
Treatment= more"SELF Management"
DraftReport HERE
Nov.2014- "Plague"-Published !!
VOA-PodcastAudioInterview HERE
Amazon USA Link HERE

Friday, October 16, 2009

#20~ Tom Kindlon's PETITION & letter to CFSAC mtg

Please read it and Pass it on to those you feel
would support us and Please ask them to read
it and Sign the Petition.

We would like to get as MANY signature
Before Oct 28th as possible.. Thanks for
your help and please settle in and have a read.

Don't support the "Reeves empirical definition
criteria for CFS"?
Sign the petition at:
Mr Tom Kindlon  wrote the following
and has given permission for the 
(partial) reprint of his submission to the 
CFSAC upcoming meeting on Oct 29th.
He set up a petition on the issue on the 
15th of April, 2009.  This petition is 
summarized in 10 words as,
"CDC ~ CFS Research should not 
involve the empirical definition (2005)"

The petition:

We call on the Centers for Disease 
Control and Prevention (CDC) to stop
using the "empirical" definition
 [1] (also known as the Reeves 2005 definition) 
to define Chronic Fatigue Syndrome (CFS) 
patients in CFS research.
The definition: 

The CDC claim it is simply a way of 
operationalizing the Fukuda (1994)
definition[2]. However the prevalence 
rates suggest otherwise: the "empirical" 
definition gives a prevalence rate of 2.54% of 
the adult population[3] compared to 0.235% 
(95% confidence interval, 0.142%-0.327%)
and 0.422% 
(95% confidence interval, 0.29%-0.56%) 
when the Fukuda definition was used in 
previous population studies in the US[4,5].

The definition lacks specificity. 
For example, 
one research study[6] found that 38% 
of those with a diagnosis of a Major 
Depressive Disorder were misclassified 
as having CFS using the empirical
Reeves definition.


[1] Reeves WC, Wagner D, Nisenbaum R, 
Jones JF, Gurbaxani B, Solomon L,
Papanicolaou DA, Unger ER, Vernon SD, 
Heim C. Chronic fatigue syndrome--a
clinically empirical approach to its definition 
and study. BMC Med. 2005 Dec
15;3:19. Link:
[2] Fukuda K, Straus SE, Hickie I, Sharpe MC,
Dobbins JG, Komaroff A. The chronic fatigue 
syndrome; a comprehensive approach to its 
definition and study. Ann Int Med 1994, 
[3] Reeves WC, Jones JF, Maloney E, Heim C,
Hoaglin DC, Boneva RS, Morrissey M, Devlin R.
Prevalence of chronic fatigue syndrome in 
metropolitan, urban, and rural Georgia. 
Popul Health Metr. 2007 Jun 8;5:5.
[4] Reyes M, Nisenbaum R, Hoaglin DC, 
Unger ER, Emmons C, Randall B, Stewart JA,
Abbey S, Jones JF, Gantz N, Minden S, 
Reeves WC: Prevalence and incidence of 
chronic fatigue syndrome in Wichita, Kansas. 
Arch Int Med 2003, 163:1530-1536.
[5] Jason LA, Richman JA, Rademaker AW, 
Jordan KM, Plioplys AV, Taylor RR,
McCready W, Huang CF, Plioplys S. 
A community-based study of chronic fatigue
syndrome. Arch Intern Med. 1999 Oct 11;159
[6] Jason, LA, Najar N, Porter N, Reh C. 
Evaluating the Centers for Disease
Control's empirical chronic fatigue syndrome 
case definition. Journal of Disability Policy 
Studies 2008, doi:10.1177/1044207308325995.

Further reading: Leonard Jason, Ph.D., 
DePaul University. Problems with the New CDC 
CFS Prevalence Estimates i.e.

I'm the first to admit that this isn't 
exactly the "catchiest" petition that
has ever been created.  One might think 
it would be lucky to get a few dozen

However already, in just over a month, 
1633 people have signed (at the time
of writing).  Many have left comments 
which can be read on the site:
Petition Signatures
[Aside: other people have also left comments
but for some reasons the comments have 
not gone up].

I believe this shows the depth of feeling 
there is on this issue.

As I said in my last submission, if one looks
at the CFSAC function, it is clear that the 
issues relating to the definition are 
fairly central.

I listed numerous problems regarding 
the definition in my submission to the
May 2009 CFSAC meeting
( ) so
I'm not going to repeat them now.

I do not believe that Dr Bill Reeves 
adequately dealt with the concerns 
about the Reeves 2005 criteria in the 
last meeting.  He said that the
difference between the prevalence rates they 
found in Georgia (2540 per 100,000) 
compared to previous estimates 
(235 and 422 per 100,000) were down
to two issues:

- the different methodology in the Georgia 
where they brought in people who did not 
complain of fatigue on the telephone screening.
He said that "20-30 percent of people who did
not complain about fatigue endorsed the 
Fukuda criteria."  However, the paper for
which he is the corresponding author actually 
gives a lower figure of 11.5% 
["In other words, 11.5% of subjects with
 CFS would not have been detected in 
previous studies that queried participants
only for fatigue"].  It should also be 
remembered that some of these people 
might not have satisfied the criteria for 
Fukuda as it is normally applied - 
the Reeves criteria make it easier to 
satisfy the criteria.  So the real figure
could well be less than 11.5%.  But even 
if one takes the figure of 11.5%, that 
would only bring the figures of 235 and
422 per 100,000 up to 266 and 479 per
100,000 which are still dwarfed by the
2540 per 100,000 prevalence rate from
 the Reeves criteria (2005).

- The other point he starts talking about
 in this section is criteria regarding major 
depressive disorder so he may have been 
trying to make a point with regard to this. 
Personally I agree with him and see this as an
important area also!  First a quick aside: 
there are various forms of depression 
e.g. dysthymia, atypical depression, etc. 
In the past, apart from bipolar, the main one
excluded was MDDm (melancholic Major 
Depressive Disorder), a severe type of 
depression.  Many people still had depression
but were included as they satisfied the criteria.

With the Reeves (2005) criteria, it says:
"Following recommendations of the
International CFS Study Group, only current 
MDDm was considered exclusionary
for CFS." However, part of the specific 
recommendations of the International
CFS Study Group [1] that 
(Reeves claims his definition is based on) 
was that MDDm had to have been resolved
for more than 5 years:
"The 1994 case definition stated that any
past or current diagnosis of major
depressive disorder with psychotic or 
melancholic features, anorexia nervosa, 
or bulimia permanently excluded a subject
from the classification of CFS ... we now 
recommend that if these conditions have been
resolved for more than 5 years before the
onset of the current chronically fatiguing
illness, they should not be considered 

It might not be important to point this out
for definitions for some illnesses: however 
if one looks at table 2 of the 2005 paper, 
6 of the 16 who are said to have CFS using 
the "current classification" of CFS, had been
diagnosed with MDDm at a previous 
assessment which suggests it is important
in this context.

Also Leonard Jason published a study which
found that 38% of those who have
Major Depressive Disorder but not CFS would
 satisfy the symptom, fatigue,
etc criteria in the Reeves definition.

Also the Nater et al. (2009) study found 
that 57% had current psychiatric
disorders and 89% had lifetime 
psychiatric disorders, suggesting the
definition is picking up a group with 
a lot of psychopathology.

[Aside: A lot of people have made
suggestions to me speculating why the
CDC broadened the criteria in the way
I have.  I do not know the answer. 
The most plausible theory to me is the 
following: The CDC followed patients in
the community in 1997, 1998, 1999 and 2000. 
Between December 2002 and July
2003, they were brought in for intensive testing.
In total, 227 people were invited in, 
including 70 who had previously been 
diagnosed with CFS.  These people went 
through very expensive testing - 
the whole exercise cost $2m.
However, unfortunately, only 6 out of 
the 70 cases of CFS satisfied the Fukuda
definition when they were brought in.
Also 4 more of the other individuals
also satisfied the definition. 
If one only excludes people who currently 
have Melancholic Major Depressive Disorder 
(MDDm) (which was not the recommendation 
of the International CFS Study group), one
can get the numbers who satisfy the Fukuda
definition up to 16.   
The CDC admit this in their paper 
(Reeves, 2005).  However 10 (or 16 if one 
allows all the MDDm cases) people with CFS
 would not be enough for the CDC to publish CFS
studies with a lot of the data they have. 
For some of the experiments, people would
not have been suitable for one reason or 
another e.g. they were on medication. 
Also, often data is not complete or tests 
become corrupted so a percentage is lost.
For some of the experiments, gender might 
make a difference and one may end up 
excluding the men as there might not be
enough patients.  So 10 or 16 CFS patients
is not enough to publish CFS papers
using this data.  But $2m of the CFS fund
had been spent on this experiment and it 
might look like a waste of taxpayers' money
if papers were not published.   
The CDC had already gotten into
trouble for misusing the CFS budget
in the past.  So the definition of CFS
was expanded so that CFS papers could
be published.  So that's one plausible
theory although one does not need to
accept that to believe that the
empirical definition is flawed].

Even if for some reason, the CFSAC 
do not want to recommend against the
definition, it would be good if you 
pressed the CDC to make clear in each
and every paper they write that they 
use the empirical criteria, that they
were used.  The reference for the 
empirical criteria is often not being put
in the list of references.  I know the 
patients were selected using the
empirical criteria because they are part
of the 2-day Wichita study cohort
or from the Georgia study but most
people reading the papers will not
know this.

2) I think the CDC CFS program should
 have to cut its ties with Peter White,
 according to its own rules regarding
 external reviewers:

At the May 2008 CFSAC meeting, the 
following information was given on the
CDC External Peer Review of CFS Program <-- pdf

"CDC plans to conduct an external 
peer-review of the CFS program in late
summer/early fall 2008. This review will be
 conducted by a panel composed of
national and international experts that is
 to include representatives from
the Coordinating Center for Infectious 
Diseases Board of Scientific
Counselors and CFSAC. CDC is requesting
 that CFSAC members recommend names
of experts with no conflict of interest
 (direct funding from CDC)"


Dr. Miller:
"The panel will be external experts in the
field who have no conflict of interest-they
are not receiving CDC funding and 
***would not have a direct impact on 
the program in its development in stages
other than the recommendations.***"

One of the external review panel 
(which was small - only 4 people wrote the
report), was Dr Peter White.  At the May 2008
 CFSAC meeting, Dr Bill Reeves
said: "We talk to Dr. White fairly regularly."

It is unclear who nominated Dr. White
 to the panel of external reviewers -
perhaps the CFSAC could ask this.
It was not the CFSAC as the minutes
show. Dr. Reeves talked as if they might
have been suggested Dr. White be
involved because he was an 
"expert on autonomic
 nervous system function." 
(which is a
curious statement to make given 
Dr White is a psychiatrist, whose
PubMed-listed articles do not suggest
 he is an expert in this field).

Anyway, the external review panel made the
 following recommendations:
"The panelists recommend that the CDC
program urgently consider intervention
studies to help to elucidate the direction
 of causality in the several
pathophysiologies identified by the CDC.
 This strategy was not articulated
clearly. For example, since both cognitive 
behavior therapy and graded exercise 
therapies are known to address some of the
abnormalities found, and since both these
therapies have been shown to be efficacious
for CFS, these behavioral interventions should
be seriously considered. Collaborations with
providers and medical schools practised in
randomised controlled trials
might provide the best means to achieve this."

A summary of strategic recommendations
5. Clinical guidelines on management
 should be developed for use in the USA,
 by the CDC team in collaboration with
 others, and disseminated for CFS.

6. The team needs to consider studies
 that test the direction of causality
 of pathophysiology, such as using

At the May 2009 meeting, 
Dr Reeves said:
"Peter White, the psychiatrist that
 we work with at Emory,"

"We are in the process of planning a
 cognitive behavioral therapy (CBT) and
graded exercise (GET) trial as part of the 
provider registry population in Macon. 
We're going to do that in collaboration
with the providers in Macon, with Mercer 
Medical School, *with the U.K. group*,
and with Mayo Clinic."

- "International Workshop - 
Research, Clinical, and Pediatric 
Definitions of CFS - I would like to try to
get together by the winter of 2009. 
I know the IACFS/ME is interested in this.
We want to include countries such as UK
that have CFS care completely integrated
into their healthcare system."

- "Dr. Reeves: An excellent comment.
 Our focus is obviously on the United
States. There are three important 
reasons for international collaboration.
One of them I alluded to. There are 
countries that have put CFS evaluation,
diagnosis, and management into their
national health systems. The UK is one
of those. An international meeting
provides the chance to learn from
another government that has embraced
this illness- perhaps not to the extent
that everybody would like-but is trying
to work with it as a national health

Given that the only representative from the
UK that the CDC has invited to its CFS 
meetings since around 2001/2002 is 
Peter White, it looks very likely that they have
him in mind for both of these workshops.
Also it looks like he is involved in their 
Emory research and may be involved 
in the CBT/GET.
Both for the CDC's reputation and 
Dr White's, it would be better if the CDC
cuts its ties with him given he took 
part in the external peer-review.

3) There is potential that who the 
individuals the CDC invites to its
upcoming workshops may not be 
representative of the spectrum of opinion
amongst experts in the field, based on 
the make up of, for example, some
International CFS Study Groups 

The CDC are planning to have three 
workshops on CFS (according to their
draft plans):

- International Workshop - 
Clinical Management of CFS

- International Workshop - 
CFS Case Definition

- Workshop International -
 CFS Study Group (Research priorities)

However, it should be remembered that,
for example, what is considered good
management of CFS is a highly disputed
area.  Many professionals believe
that Graded Exercise Therapy (GET) and
Cognitive Behavioural Therapy (CBT)
based on GET 
"are basically all that patients need."  
Symptoms are seen as
largely due to deconditioning and 
maladaptive beliefs and behaviours 
rather than an ongoing disease process. 
I will call these the people of the "CBT
School of Thought."

A few professionals go further and claim that 
GET and CBT based on GET can lead to full 
recovery.  This is a small group but it includes
Peter White (mentioned above) and the 
psychologist, Gijs Bleijenberg PhD from the
Netherlands.  Both of these professionals, 
who many would consider to have
extreme views, have been the sole 
representatives from their countries at
workshops the CDC have organised on the 
illness (see for example ).

The CDC was involved in a paper this 
year, "Are chronic fatigue and chronic
fatigue syndrome valid clinical entities
across countries and healthcare
settings?" by Hickie I, Davenport T, 
Vernon SD, Nisenbaum R, Reeves WC,
Hadzi-Pavlovic D, Lloyd A and International
Chronic Fatigue Syndrome Study
Group (28 collaborators).   
Of the 35 individuals involved, apart 
from the CDC team members, virtually all
could be said to be of the CBT School of
Thought with regard to CFS.

However, a meta-analysis 
(Malouff et al., 2008) found that the 
average Cohen's effect size for Cognitive 
Behavioural Interventions 
(include GET) for CFS was 0.48 
which does not reach the threshold of 0.5 for
something to have a moderate effect! 
Leonard Jason published a large NIH-funded study in
2007 which found that an intervention based 
around encouraging patients to pace activities 
did better than interventions that assessed CBT
or exercise programmes.  Prof. Jason 
subsequently published a paper which found
that within this trial, "Those who were able to
stay within their energy envelope had 
significant improvements in physical 
functioning and fatigue severity."

Is the CDC going to ensure that there
are a reasonable numbers of
individuals at these workshops who 
believe that pacing is a good management
strategy for CFS?  Some/many in the CBT 
School of Thought are against pacing and will 
not recommend it.  Are the CDC going to 
ensure there will be proponents of 
Energy Envelope Theory at these 
workshops?  Also I don't think one person is 
sufficient given group dynamics.

An even more important issue is the high
rate of adverse reactions reported by 
people with CFS who have done exercise
 programmes (and CBT based on
exercise programmes).  Unlike drugs, 
generally there is no easy way for
professionals or individual patients with 
CFS to report adverse reactions to
non-pharmacological interventions 
such as GET.  So formal data is not
systematically collected by statutory 
agencies in countries around the
world.  Surveys on the issue are the 
next best source of information it
would seem.  I sent information on 
10 such surveys to the CDC in my
submission on their draft plans - see

These are surveys from various countries 
(the UK, US, the Netherlands and Norway) 
and show the high rates of adverse reactions
that are reported.  The latest survey was from
the UK, by the ME Association: 
906 replies: 
Made much worse: 33.1% (300 individuals),
Slightly worse: 23.4%, No change: 21.4%.
Improved: 18.7% and Greatly improved: 3.4%.
These represent very high rates
of adverse reactions. 
If a drug made 33.1% "much worse", 
it would probably be taken off the 
market until they worked out if there 
were certain groups of patients for 
whom it was, and was not, appropriate. 
Dosages might be changed.

Some proponents of GET for CFS claim 
that it is simply because the GET was not
done under a suitable professional. 

However,  in the UK, where CFS clinics have
been set up around the country, this was
investigated in a survey by AYME/AfME
(May 2008).

They asked about experiences of GET in the
three previous years.  This was after the 
specialist services had been set up. 
There was no statistical difference between 
the rate of adverse reactions in those who did 
GET under an "NHS specialist" and the people
who did GET under other individuals or by

Even if it was the case that GET is only 
unsafe when not done under an
appropriate professional, GET is available
"over the counter" so if guidelines from
 the CDC and others recommend it, 
many patients will try this

Many proponents of GET and CBT based 
on GET do not impart information on the
high rates of adverse reactions to either
the patients themselves or even other 
professionals when they are educating 
them about the interventions. Some use 
the "catch phrase" that they are 
"safe and effective."  
The CFSAC should "insist" that any 
guidelines should give information on 
adverse reactions either with specific 
information or simply generally points 
about the high rates of adverse reactions
that have been reported.

Perhaps the CFSAC 
(and indeed other groups) could have 
a role in recommending names for these 
workshops to ensure these workshops 
are balanced e.g. the CFSAC get to 
recommend 25% of the groups, 
the IACFS/ME another 25%, 
a patient group such as the CAA 10% 
and the CDC 40%. 
(Groups could give alternates if some 
of their picks were already used).

Suggestions for professionals from the 
UK who I would think would give
balance to any workshops are: 
(i) Charles Shepherd MD ; (ii) Ellen Goudsmit
C.Psychol. PhD FBPsS (Health Psychologist 
and Visiting Research Fellow,
University of East London) ; 
(iii) Abhijit Chaudhuri DM MD PhD FACP FRCP 
(a consultant neurologist) ; 
(iv) Neil Abbot MSc PhD (Operations Director, 
ME Research UK)  and (v) William Weir MD 
(an infectious disease consultant who
ran an NHS clinic for ME for a 
number of years)

No comments:

Post a Comment