MED: (Part a) Tom Kindlon's submission on the CDC's draft 5-year plan for CFS
Tom Kindlon
From: ME/CFS and Fibromyalgia Information Exchange Forum
[mailto:CO-...@LISTSERV.NODAK.EDU] On Behalf Of Tom Kindlon
Sent: 01 July 2009 13:16
To: CO-...@LISTSERV.NODAK.EDU
Subject: [CO-CURE] 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 ( tomki...@oceanfree.net or tomki...@gmail.com )
(*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.