Date:Wed, 1 Jul 2009 13:15:35 +0100
Reply-To:Tom Kindlon <[log in to unmask]>
Sender:ME/CFS and Fibromyalgia Information Exchange Forum
<[log in to unmask]>
From:Tom Kindlon <[log in to unmask]>
Subject:ACT: (Part 1 of 2) Tom Kindlon's submission on the CDC's draft
5-year plan for CFS
(Part 1 of 2) I sent the information about the 10 surveys out a few days ago
(I have altered the wording slightly as one person pointed out it is a
little unclear) - I am still interested in getting information on any other
survey results that might be out there on GET, CBT, etc. Also I'm
interested in more information on the Norwegian survey.
In my submission, I included what I sent to them at the end of April again
as I didn't have the time or inclination to spend the time, making the same
points again. I'm not including this now as the piece is long enough and I
have already posted something similar at: http://tinyurl.com/ko969a i.e.
http://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0904D&L=CO-CURE&P=R5317&I=-3&
m=20143 Tom]
~~~~~~~Submission starts here ~~~~
From Tom Kindlon ( [log in to unmask] or [log in to unmask] )
(*This appears longer than it should be because I have appended my April
submission below in green (Appendix 2) as well as 1440 signatures and
comments from the petition complaining against the CDC's use of the "empiric
definition" (Reeves, 2005). Most of the rest of the text is made up with
the results from 10 ME/CFS surveys. The rest of the text is not that long
(2881 words) *)
===========================================================
I would first like to thank you for the opportunity to make these comments.
Unfortunately I have not been able to allocate as much time as I would like
to the task. So in my main submission I am not going to repeat many of the
comments I made in my two oral statements to the April 27 meeting on the
CDC's draft research program which I wrote up and submitted in writing
before the April 30 deadline (appended below in green).
I should say that I have had two letters published in high impact journals
(the British Medical Journal and Brain) on the subject of Chronic Fatigue
Syndrome (CFS) in the last year. So although unfortunately because of
ill-health, I have not been able to reach my potential in terms of academic
qualifications [I scored 1460 in the SATs in 1991 (i.e. before they were
re-graded upwards, scoring the top percentile in both subjects); I became a
member of MENSA with an IQ in the top percentile in 1990 and in the last
exams I did in college before severe disability struck (2nd year,
Mathematical Science, Trinity College Dublin)) I got all (6) firsts, I have
shown I am able to make intelligent comment.
Given the CDC is now moving into the area of ME/CFS interventions and
particularly the area of treatment recommendations for others, I plan to
share some information, thoughts and analysis on the treatment/ management
modality of Graded Exercise Therapy (GET) and if time allows, also Cognitive
Behavioural Therapy (CBT) based on GET (given CBT is recommended for many
conditions in medicine, not all forms of CBT are the same).
I will also give some information on the petition I set up on April 15, "CDC
CFS research should not involve the empirical definition (2005)"
http://www.ipetitions.com/petition/empirical_defn_and_CFS_research .
I mentioned this before in my oral submission but the number of signatures
has now increased to 1440, with many people giving comments which can be
read at the site (more people have told me they gave comments but for some
reason to do with the software of the site (I believe) they did not appear).
The safety of treatments and interventions is one of the most important
issues, if not the most important issue in medicine. The ideas behind the
phrase "First do no harm" are something that are inculcated in medical
students around the world. As Wikipedia says (on the phrase), 'Another way
to state it is that "given an existing problem, it may be better to do
nothing than to do something that risks causing more harm than good."'.
With many interventions such as pharmaceutical drugs, there are mechanisms
in place so that if adverse reactions occur, even after a treatment has been
approved, this information is noted and attempts are made to collate the
information. For example, in the UK (and perhaps elsewhere in the world), a
yellow card scheme where either prescribing professionals or patients
themselves can report adverse reactions. Drugs can often be taken off the
market years after they were first "released" when it is discovered that
they can cause adverse reactions
Unfortunately, with non-pharmaceutical interventions, such options are not
there. So what is the next best thing? Using the information from patient
surveys is the obvious answer. Later I will give some information from
patient surveys about high rates of adverse reactions reported following the
use of (i) Graded Exercise Therapy (GET) and (ii) Cognitive Behavioural
Therapy (CBT) based on GET in the UK and indeed some other countries in
ME/CFS patients.
The CDC, amongst other things, plans to begin "providing the most current
evidence-based information concerning CFS to federal, state, and local
public health authorities, related government agencies, and HMOs and
building long-term relationships with government and non-government
agencies."
I am concerned that these plans may involve promoting potentially dangerous
treatments: (i) Graded Exercise Therapy (GET) and (ii) Cognitive Behavioural
Therapy (CBT) based on GET.
I also concerned that information will not be passed on about adverse
reactions, that have been reported by patients using these treatment
modalities. There are plausible scientific reasons why people can be
suffering adverse reactions to treatments which encourage increases in
activity: there are numerous studies that show that the response to exercise
in ME/CFS is unusual. The abnormal response to exercise is not restricted to
intense exercise. It has also been noted in a study which measured the
effect of the journey to the testing centre (White, JoCFS, 2005). An
exercise test is like a trial of a high dose of a drug.
It is important that professionals are told of the abnormal response to
exercise in ME/CFS.
It is also important that patients are given the risks associated with
treatments. This does not seem to be occurring routinely at the moment in
some places around the world where GET and CBT based on GET is "offered".
This means patients can not give informed consent to the treatments they are
trying. Patients trying pharmaceutical agents are given information, so why
not patients with ME/CFS when they are being prescribed treatments? This
suggests that people with ME/CFS are being treated like second class
citizens, not worthy of the protections that are offered to other patients.
This needs to change with anything the CDC recommends.
It also appears likely that the effectiveness of these treatments will be
hyped.
For example, Bill Reeves at the May 2009 CFSAC meeting said: "CBT/GET is not
the cure for everybody - nobody knows how many it is - it probably applies
to a subset."
But where is the evidence from the literature that GET is a cure for anybody
with CFS? I am unaware of any.
And where is evidence that CBT based on GET is a cure for anybody with CFS?
Few studies have made such claims. To the best of my knowledge these have
used unsatisfactory definitions of recovery such as a patient being
considered "recovered" or "fully recovered" if they didn't score in the low
percentiles for certain self-rated questionnaires [such as the 85th
percentiles for the definition of "full recovery" in Knoop (2007) (although
some of patients actually scored in a lower percentile on one of the
questionnaires and were still considered "fully recovered"]. These are very
unsatisfactory definitions of recovery but I fear that because of the
influence of people like Peter White and Gijs Bleijenberg who hype these
treatments' effectiveness, official CDC literature will be talking about
these treatments leading to recovery in some.
It is generally accepted that CFS is a heterogeneous condition. In
particular, few if any researchers would say that CFS as defined by the
"empiric definition" (Reeves, 2005) represents a homogeneous condition.
However for some reason Peter White despite recognising that CFS is a
heterogeneous condition, believes that with regard to treatment CFS should
be regarded as homogeneous (sample reference: RSM lecture, April 2008).
This is a potentially dangerous belief to promulgate especially given all
the adverse reactions that have been reported with regard to GET and CBT
based on GET. I hope that the CDC will not use such lazy constructs and
will make clear when discussing CFS with regards to treatments (and, in
particular, with regards to GET and CBT based on GET) that CFS should be
considered as heterogeneous with regards to the effectiveness of treatments.
Not everyone has shown the same results in clinical trials as well as
surveys so until more is known about CFS, heterogeneity should also be
mentioned in the context of treatments.
As I understand it, the CDC has largely been depending on information from
Peter White to gain information on the situation in the UK. A major problem
with this is that I do not recall hearing or reading Peter White informing
readers or audiences the percentages that have reported adverse reactions
with regards to GET and CBT based on GET in surveys and the like. As I have
said, with no formal method for reporting adverse reactions to
non-pharmaceutical modalities such as GET and CBT based on GET, the results
of surveys take on a larger importance so I will give some information on
these in a moment. I have read people suggest that Peter White hypes the
effectiveness of GET and CBT based on GET and downplays any risks because of
his connections with the insurance industry. I remain to be convinced by
arguments based solely on money, although I do think it is important that
the CDC reports these interests in the same way that it would be expected to
report individuals interests in pharmaceutical agents. I think Peter White
has taken an approach not suitable for clinical medicine and simply ignored
information and data (on the issue of adverse reactions) that does not fit
with his pre-existing theories.
Anyway, to move to some numerical data, here are the results of some
numerical data from surveys of patients.
=======================
Survey 1: (UK) Action for ME (2001)
In the UK, the Chief Medical Officer (CMO) (i.e. a government job somewhat
similar to the position of Surgeon General in the US) set up in 1999 a
working group to report on the area of "CFS/ME".
Amongst other things, when they reported in 2002, the report included the
following data from a survey.
Therapy*
Respondents
Helpful
No change
Made worse
Drug medication for pain
1394
61%
28%
11%
Drug medication for sleep
1300
67%
17%
16%
Pacing your activities
2180
89%
9%
1%
Graded exercise
1214
34%
15%
50%
Diet changes
1864
65%
32%
3%
Nutritional supplements
1953
61%
36%
3%
Rest, including bed rest
2162
91%
8%
1%
Cognitive Behavioural Therapy
285
7%
67%
26%
Other
878
76%
11%
14%
*Not all the respondents experienced each treatment approach
(Action for ME Membership Survey, 2001. 2338 respondents in total)
This data was then included in the Full NICE Guidance on CFS/ME (Page 95 of
317):
Helpful
No change
Made worse
Drug medication for pain
61%
28%
11%
Drug medication for sleep
67%
17%
16%
Pacing your activities
89%
9%
2%
Graded exercise
34%
16%
50%
Diet changes
65%
32%
3%
Nutritional supplements
62%
36%
3%
Rest, including bed-rest
91%
8%
1%
Cognitive behavioural therapy
7%
67%
26%
Other
75%
11%
14%
[Aside: there are three changes by 1% from the figures given in the CMO
Report - these are on "occasions" when the first numbers did not add to 100%
but with the changes, the numbers all added to 100%. Somebody presumably
thought they need to be changed. Due to rounding, the numbers do not need to
add to 100% to be accurate, so I believe the first set of figures should be
considered the most accurate data]
As one can see, Graded Exercise Therapy had a terrible safety profile in
this data - 50% of 1214 people reported being made worse - that's the
equivalent of 607 reports of adverse reactions! CBT had the second worst
safety profile with 26% reporting being made worse by it. But this was for
a smaller number of patients (285) than GET, so is equivalent to 74 reports
of adverse reactions.
Pacing and rest (including bed rest) had both the highest rates of people
reporting they were helpful (89% and 91%) and also the lowest rates of
adverse reactions - just 1% for each (note: as I say, the first set of data
appears to be the most accurate one with the second data having being
adjusted to add to 100%).
=================
Survey 2: (UK) ME Association (2009)
The UK's ME Association recently organised possibly the largest ever survey
of people with ME/CFS. In its Spring 2009 magazine, it included data on 25
therapies. Yet again, Graded Exercise Therapy (GET) had the highest rates
of adverse reactions with a whopping 56.5% of people reporting being made
worse by the intervention:
Graded Exercise Therapy
906 replies:
Made much worse: 33.1%
Slightly worse: 23.4%
No change: 21.4%
Improved: 18.7%
Greatly improved: 3.4%
The related treatment modality of physiotherapy (i.e. therapy provided by a
physical therapist) also had a high rate of adverse reactions (32.8% in
total):
Physiotherapy
862 replies:
Made much worse: 15.7%
Slightly worse: 17.1%
No change: 36.7%
Improved: 27.0%
Greatly improved: 3.5%
Cognitive Behaviour Therapy (CBT) had a lower but still significant rate of
adverse reactions 19.5% or 194 out of 997 cases:
Cognitive Behaviour Therapy (CBT)
Made much worse: 7.9%
Slightly worse: 11.6%
No change: 54.6%
Improved: 27.0%
Greatly improved: 3.4%
CBT also came very low (21st of 25) on the table of treatments based on the
percentage of people helped by them. The only treatments below them were
Imunovir (which had only being tried by 62 patients, the lowest number of
the 25 treatments) (25.8% reporting it helped them), NADH and Graded
Exercise Therapy.
The treatment with the highest percentage of people saying it helped was
pacing of activities:
Pacing
2137 replies
Made much worse: 1.2%
Slightly worse: 3.5%
No change: 24.1%
Improved: 59.6%
Greatly improved: 11.6%
Pacing also had one of the lowest rates of people saying they were made
worse by the treatment.
=============================
Survey 3: (UK) 25% ME Group (2004)
In the UK, there is an ME charity specifically for severely affected
patients with ME, called the 25% ME Group.
It conducted a survey of its members which got a response rate of 66% or 437
replies.
This is a direct quote from their report where they quote the statistics
i.e. out of 170 patients who had tried Graded Exercise Therapy (GET), 139
had been made worse by it!
"By far the most unhelpful form of treatment was considered to be Graded
Exercise Therapy (GET). This is a finding that may surprise some readers,
given the current medical popularity of this approach. However, these
patients' perceptions are supported by data from previous experience: of
the 39% of our members who had actually used Graded Exercise Therapy, a
shocking 82% reported that their condition was made worse by this treatment.
On the basis of our members' experiences we question whether GET is an
appropriate approach for patients with ME. It is worth noting that some
patients were not severely affected before trying GET. Thus, it is not only
people with severe ME who may be adversely affected by this form of
treatment."
=============
Survey 4: "Scotland M.E./CFS Scoping Exercise Report" (October 2007)
With Section 16b Funding through The Scottish Government, Action for ME
produced a report: "Scotland M.E./CFS Scoping Exercise Report" (October
2007)
"In total 564 people with M.E. were sent a questionnaire (510 sent hard
copies, 54 electronic versions). 399 completed questionnaires were received
which represents a 71% return." (Page 8)
Table (Page 9)
Treatment Helpful no effect made me worse
didn't try
CBT 15.5% 17.5% 7%
60%
GET 5% 6% 32%
57%
Graded Activity18% 8% 30%
44%
Pacing 77% 8.5% 3.5% 11%
----------------------------------------------------
Translating these percentages into percentages solely based on people who
had actually tried a treatment (more interesting figures, I think most
people would agree), would give the following figures (the actual figures
may have been a tiny bit different because of rounding):
---
CBT
---
Numbers Tried: 160
Helpful: 38.75% (=15.5/40) (62)
No effect: 43.75% (=17.5/40) (70)
Made me worse: 17.5% (=7/40) (28)
----------------------------------
GET (i.e. Graded Exercise Therapy)
----------------------------------
Numbers Tried: 172
Helpful: 11.63% (=5/43) (20)
No effect: 13.95% (=6/43) (24)
Made me worse: 74.42% (=32/43) (128)
---------------
Graded Activity
---------------
Numbers Tried: 224
Helpful: 32.14% (=18/56) (72)
No effect: 14.29% (=8/56) (32)
Made me worse: 53.57% (=30/56) (120)
------
Pacing
------
Numbers Tried: 298
Helpful: 86.52% (=77/89) (258)
No effect: 9.55% (=8.5/89) (28)
Made me worse: 3.93% (=3.5/89) (12)
A few proponents of GET have tried to say that figures from surveys are
somehow not significant because we don't know whether the people did Graded
Exercise Therapy under a professional or not. Firstly surveys 5 and 6
(below) show that the evidence isn't there to show that doing these
treatments under a specialist is safer. Also the fact remains that GET is
like an "over-the-counter" drug. People will try it if information is put
out that it is an effective treatment either under a professional or by
themselves. Which means promoting it as a treatment for ME/CFS risks
damaging people's health.
======================
Survey 5: (UK) Action for ME (2003)
Action for ME in 2003 wanted to follow up on its previous survey to see
whether changes were occurring with regards to members' experiences of
treatments. It restricted responses to treatments received over the
previous three years so that the results would not overlap with a previous
survey. 550 patients were sent a questionnaire, "your experiences", with
354 people responding (a response rate of 64%).
List of results for people who did GET broken down by the practitioner:
Under a Physio:
Negative 12 (67%) Neutral 0 (0%) Positive 6 (33%)
Under an OT:
Negative 6 (100%) Neutral 0 (0%) Positive 0 (0%)
Under a Doctor:
Negative 3 (27%) Neutral 1 (9%) Positive 7 (64%)
Under a Behavioural Therapist:
Negative 1 (25%) Neutral 1 (25%) Positive 2 (50%)
Gym:
Negative 3 (100%) Neutral 0 (0%) Positive 0 (0%)
No Professional:
Negative 1 (8.33%) Neutral 4 (33%) Positive 7 (58%)
With regard to this group the authors of the report say:
"Had NO professional input (had they therefore paced themselves ?) -
mostly with positive outcomes"
If one combines
Under a physio + Under an OT + Under a doctor + Under a behavioural
therapist, to get a figure for under a professional:
Negative 22 (56.41%) Neutral 2 (5.13%) Positive 15 (38.46%)
So those who did GET under a professional had much higher rates of adverse
reactions.
=================
Survey 6: (UK) Action for ME/Association for Youth with ME (2008):
This is another large survey, with 2763 patients with ME or CFS in the UK
responding to a questionnaire which asked about people's experiences of
treatments over the last three years (to avoid overlap with other surveys
Action for ME had undertaken).
It found that of 699 who said they'd tried Graded Exercise Therapy, 34% said
they'd been made worse by it compared to 45% who said they'd been helped and
21% who said it made no difference.
The contention that people would not have being made worse by a treatment if
they had done the treatment under specialist supervision, is not backed up
by the data from this study.
In this study patients were asked who provided the GET treatment. 567
answered this question (i.e. 132 did not). 181 (31.92%) of these said it had
made them worse compared to 276 (48.68%) who said it helped and 110 (19.40%)
who said it made no difference.
335 of these 567 patients said they had done the management strategy under
an "NHS specialist". 111 (31.27%) of this group said they'd been made worse
compared to 162 (45.63%) who said they'd been helped and 82 (23.10%) who
said it made no difference.
So you can see that a similar percentage of people were made worse by GET
who had done it under an NHS Specialist as those who had not, so doing it
under an NHS specialist did not reduce the rate of adverse reactions.
So a large proportion of patients in the UK have experienced adverse
reactions for trying Cognitive Behaviour Therapy (CBT) and in particularly
Graded Exercise Therapy (GET). However it is my experience from reading
Peter White's writings and hearing him talk that he does not inform people
of this information.
Given the seriousness of the issue, I feel it would irresponsible if the CDC
allows Peter White to be the only representative from the UK.
Suggestions for others on the ground who are not in denial of the issue of
adverse reactions from GET (like Peter White appears to be) include: Charles
Shepherd MD [log in to unmask] ; Ellen Goudsmit PhD
CPsychol AFBPsS (a Chartered Health Psychologist) [log in to unmask]
; Abhijit Chaudhuri DM MD PhD FACP FRCP (a consultant neurologist)
[log in to unmask] ; Neil Abbot MSc PhD (Operations Director, ME Research
UK) [log in to unmask] and William Weir MD (an infectious disease
consultant who ran an NHS clinic for ME for a number of years - I don't have
an E-mail address at the time of writing but he can be contacted through his
practice at: +44-207-467-8478 (i.e. from the US: 00-44-207-467-8478). All
of these five professionals have published in the area and been in the area
for over 10 years - I think Dr William Weir is in the area for approximately
20 years and Drs Shepherd and Goudsmit for over 20 years. Drs Chaudhuri and
Goudsmit did their PhDs in the area.
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