Saturday, January 1, 2011

Zombie Science and PACE

Dear All,

In spite of being furnished with a great deal of biomedical evidence
from registered stakeholders[1] that contraindicates their 'CFS/ME'
Clinical Guideline 53 (CG53), in their recent (and overdue) scheduled
Guideline review, The UK National Institute for Health and Clinical
Excellence (NICE) have stated that their Guideline Development Group
(GDG) sees no current reason to update or amend their guideline[2]. This
announcement quite rightly received protests from UK stakeholders and ME
charities.

It would appear however that NICE have given unfair favour to
stakeholders who effectively support/represent the psychosocial lobby:
stating that "a number of stakeholders advised that the results of the
PACE Trial are due to be published in 2011." And which, unlike the
extensive biomedical evidence provided, may warrant upgrading of CG53 in
the near future. NICE states: "As this significant trial [PACE] may
affect NICE's final decision regarding whether its existing guideline
warrants an update, NICE is deferring its announcement until further
information is available. This is so that the conclusions made by NICE
are as accurate and informed as possible. In the interests of high
quality patient care..."

A brief examination of some key points of concern of the PACE trial
would therefore be timely in my view as there is every indication that
NICE should NOT be viewing said trial as scientifically "significant"
and that basing a clinical guideline upon it will be very far from being
"In the interests of high quality patient care..."

Firstly, from the outset the psychosocial PACE Trial was viewed as
highly controversial, had significant difficulty recruiting patients and
was plagued with an extraordinary high drop-out rate: just some of the
reasons that the PACE results are overdue by years.

Secondly, The Designers and Principle Investigators of PACE have
long-standing links with the health insurance industry and have clear
conflicts of interest in that insurers stand to gain if patients are
viewed as suffering psychosocial illness that is treatable by CBT/GET.

Thirdly, One of the main financial sponsors of PACE is the UK
Government's Department of Work and Pensions (DWP). The DWP also has a
clear conflict of interest in potential welfare benefit savings if
patients are viewed as suffering psychosocial illness that is treatable
by CBT/GET.

Fourthly, PACE unscientifically conflates patients suffering from the
physical neuroendocrine disease known as Myalgic Encephalomyelitis
(categorised by the WHO in ICD-10 section G93.3) with those suffering
from psychiatric/idiopathic fatigue syndromes (categorised separately by
the WHO in ICD-10 section F.48). This is in defiance of good scientific
practice and contrary to World Health Organisation medical health
taxonomy which the NHS and NICE are legally obligated to adhere to.

Fifthly, The PACE "Oxford" patient selection criteria are unscientific
in that they rule out patients presenting with cardinal symptoms of ME
and broadly include those with psychiatric symptoms. These criteria are
far from widely accepted in the medical profession and were part funded
by PACE Principle Investigator Professor Peter White who also has a long
professional association with the medical insurance industry[3].

Sixthly, the internal PACE Trial Manuals obtained by the ME Community
under the freedom of information act clearly and unequivocally show that
PACE Trial recruiters and operators were inappropriately selecting and
filleting patients in a manner that is far from good practice expected
of genuine Randomised Control Trials (RCTs) - see extracts and links
below[4].

Such is the level of concern that PACE is not a genuine Randomised
Control Trial, is not genuine science in any recognisable way and is in
fact fraudulent, that many complaints have been made. Not least an
extensive formal complaint to the UK Medical Research Council (MRC) by
Professor Malcolm Hooper that presents truly alarming evidence of
alleged scientific malpractice.[5]

It is a sad reality of modern life that scientific fact and objectivity
do not quickley overcome bad science and vested interest. There is good
reason to be concerned in this respect with regard to both PACE and NICE
CG53. As professor Bruce Charlton states in his peer-reviewed paper
entitled 'Zombie Science – a sinister consequence of evaluating
scientific theories purely on the basis of enlightened self-interest':
"In terms of the classical theory of science; bogus theories should be readily demolished by sceptical competitor(s)… However, in practice, it seems that the even the most conclusive 'hatchet jobs' done on phoney theories will fail to kill, or even weaken, them when the phoney theories are backed-up with sufficient economic muscle in the form of funding."[6]

Unfortunately, in spite of many concerns that PACE is phoney science
based upon bogus psychosocial theory, there is every indication that the
economic and establishment muscle behind it is substantial and we are
about to have yet more questionable policy-based-evidence substituting
for genuine evidence-based-policy. If so, ME patients will not be the
only losers. It will be another nail in the coffin of public trust in
scientific and governmental integrity. However, even economic muscle
cannot hide the truth that ME is a physical illness for ever. I would
therefore urge the ME community to keep fighting and keep funding good
quality biomedical research. It always seems darkest just before a new dawn.

Kevin Short.
31 December 2010.
contact@angliameaction.org.uk
[Permission to repost]


ENDNOTES:


[1] See for example:
http://www.angliameaction.org.uk/docs/eame-nice-cg53-response-nov2010.pdf
http://www.angliameaction.org.uk/docs/25megroup-nice-cg53-response-nov2010.pdf
http://www.25megroup.org/Campaigning/NICE/25MEgroup%20NICE%20Stakeholder%20ProForma%20-%20Nov%202010.pdf


[2] http://guidance.nice.org.uk/CG53


[3] See 'Corporate Collusion' at:
http://www.meactionuk.org.uk/Corporate_Collusion_2.htm


[4] OFFICIAL UK 'CFS/ME' PACE TRIAL Manuals are NOW ONLINE:
http://tinyurl.com/3xj3uke
http://tinyurl.com/37h35ca
"Evidence from research trials has indicated that patients who are in
receipt of benefits or permanent health insurance do less well than
those who are not in receipt of them"
[Extract/quote from Official Pace trial Manual - See below]

INTRODUCTION:
Manuals for the PACE Trial have been placed on a file-sharing facility.

In my view the documents illustrate how psychological and emotional
pressures have been applied to individual insecurities and scientific
ignorance surrounding ME/CFS, providing insights into the nature and
agenda of previous CBT and GET trials, and a view of the disease along
with a seemingly acceptable way to treat and portray lay people with
ME/CFS. The PACE documents and Study are endorsed/sponsored in the UK by
the Medical Research Council (MRC), the Department of Health (DoH), the
Department of Work and Pensions (DWP) and the Scottish Chief Scientist
Office.

The files include the official/internal Manuals of the Principle
Investigators of the psychosocial UK 'CFS/ME' PACE TRIAL. No ME/CFS
activist can afford not to download these large documents, circulate
them widely and comprehensively examine them. In the manuals' author's
own words, they lay bare what British ME sufferers are about to be
exposed to, what underpins that which is likely to be used by NICE to
endorse its 'CFS/ME' Clinical Guideline 53 in its imminent internal
review, and gives insight into what may lay ahead for patients in other
countries that follow the UK model.

There are two separate large files, both of which contain the same set
of Official PACE Manuals along with additional and respectively
different sets of relevant bonus materials. They are available to be
downloaded using bit-torrent / peer-to-peer file-sharing.

Either Google "XMRV - THE UK PACE TRIAL..." or go to the short URLs
given below:

File-#1: XMRV - The UK PACE TRIAL [1]
http://tinyurl.com/3xj3uke
[IMPORTANT - Click on the small green link at this peer-sharing website
entitled "DOWNLOAD THIS TORRENT", don't, repeat don't click on the Large
green button with the word "Download" on it as this directs you away
from the site.]

File-#2: XMRV - UK PACE TRIAL [2]
http://tinyurl.com/37h35ca
[IMPORTANT - Click on the small green link at this peer-sharing website
entitled "DOWNLOAD THIS TORRENT", don't, repeat don't click on the Large
green button with the word "Download" on it as this directs you away
from the site.]

I am very grateful indeed to those making these files available to the
ME community.

EXTRACTS/QUOTES FROM THE PACE MANUALS:

Standardised Specialist Medical Care Page 33 -

"If participants are insistent that there is an ongoing "physical"
problem, it is rarely helpful to directly challenge them on this point.
It is important that you acknowledge that their illness is real but its
effects can be reduced by the way they manage it."

Adapted Pacing Therapy Therapists Manual Page 55 -

"A patient's typical day will often look like the record shown below.

Time Activity

9.00 am Get up, Take 1-2 hours to come round, Get washed, dressed. Have
breakfast. Feed dog, make packed lunches

10.00 - 12 noon Do various bits of housework

1.00 pm Prepare and eat lunch

2.00 pm · 5.00pm Rest, often sleep

5.00pm Walk dog (sometimes)

6.00 - 8.00 pm Feed children, talk to family, watch TV

9.0 pm Go to bed take 1-2 to sleep"

CBT Therapists Manual Page 20 -

"Perfectionism

Just as personality can be a factor in contributing to the development
of CFS/ME, it can also be a perpetuating factor. People who are
perfectionists are likely to have more difficulty in taking breaks or
rests in the day as they feel that they are "wasting" time and "should"
be doing something useful. This may lead them to adopt a "boom and bust"
approach to activity which makes it difficult to establish any sort of
routine."


Adapted Pacing Therapy Therapists Manual Page 42 -

"Is this a cure?

Be honest, the answer is no"


CBT Therapists Manual Page 125 -

"Many people have successfully overcome CFS/ME using cognitive behaviour
therapy, and have maintained and consolidated their improvement once
treatment has ended"


GET manual Page 55 -

"It should be explained that in order for the body to continue
strengthening, and for changes to be maintained, that exercise should
form a regular part of their lives from here onwards.

The long-term benefits of exercise for prevention of CFS/ME
specifically, and other diseases in general can be emphasised."


GET manual Page 59 -

"In contrast to CBT, it is important that you do not consciously provide
cognitive interventions or interpretations e.g. suggest that being able
to exercise more may mean that there cannot be a persistent viral
infection in their body."


Pace Trial Management Group Page 31 -

"Graded Exercise Therapy
Information for Participants

There is nothing to stop your body from gaining strength and fitness, as
long as it is done in
a carefully monitored way, relating directly with your own particular
circumstances started and progressed at the right rate for you. Good luck!"


Pace Trial Management Group Page 84 -

"Your improvements will continue as long as you maintain your level of
activity and exercise.
It is crucially important not to stop exercising after discharge, but
rather to continue
maintaining or building upon the changes you have made.

Establishing a routine of physical activity and exercise is essential to
keep your good health and to prevent symptoms in future."


GET manual Page 23 -

"The more severely disabled group of CFS/ME patients were excluded from
previous studies as the studies involved an exercise test that may have
been too challenging.

However due to greater levels of inactivity in the more severely
disabled group, the deconditioning model should apply equally if not
more to these patients."


GET manual Page 50 -

"A central concept of GET is to MAINTAIN exercise as much as possible
during a CFS/ME
setback."


CBT Therapists Manual Page 50 -

"Current situation (housing, living with, work, benefits, interests)

This section will draw together a lot of what you may already know. It
may help you determine areas that will need to be addressed in your
sessions. For example, it may draw your attention to problem areas such
as inadequate housing, financial difficulties
due to not working that may be factors that are contributing to the
maintenance of their CFS/ME. Although you will have asked about
employment and benefits, it would be
useful to find out, if they are not working, whether they want to return
to their previous
job.

There is some evidence to suggest that being on benefits and/or income
protection
(IP) are poor prognostic factors as they are contingent upon the patient
remaining
unwell. Knowing about their current interests/hobbies may be helpful
when you come to
discuss targets for treatment."


CBT Therapists Manual Page 97 -

"Discuss potential blocks to recovery

Participants may be following their agreed programme diligently, but may
be experiencing difficulties in making progress, If this is the case, it
is useful to identify and discuss possible reasons. There may be some
very obvious reasons for their lack of progress, e.g. a total lack of
support from a partner, ongoing stressful situations or having another
illness on top of their CFS/ME.

Sometimes the reasons are less obvious. For example, if a participant is
in receipt of benefits, or income protection (lP), this may
inadvertently lead them not to push themselves too hard. This may result
from a feeling of having to prove that they are "still ill" in order to
keep their benefits."


CBT Therapists Manual Page 99 -

"Being in receipt of benefits or income protection (IP)

If this is something that has not already been addressed, it is
important to address it at this stage. People with CFS/ME are sometimes
very keen to come off benefits and it does not cause them too many
problems, maybe because they have another source of income. However, it
can raise a lot of issues for other people and can be a source of great
anxiety.

Evidence from research trials has indicated that patients who are in
receipt of benefits
or permanent health insurance do less well than those who are not in
receipt of them.

In reality, benefits and IP can help patients financially in the
short—term, but prove to be
an obstacle to getting better in the long term. In order for benefits or
IP to continue,
patients have to have regular check-ups in order to prove that they are
still ill. This can
understandably be very distressing for patients and be an active factor
in maintaining
their condition. For some patients, returning to work can be very
frightening as it may
have been a major contributing factor to them becoming ill in the first
place. Obviously
for some patients, work is not an option due to the severity of their
symptoms.

For more information on work related issues, please see Appendix 20.
There is also a
section in the participants' manual on work, courses and resources that
you may ask
them to read"


CBT Therapists Manual Page 100 -

"Benefits

Participants may feel trapped by their benefits, i.e. some benefits will
stop being paid if
they earn more than £20.00 a week. Participants may find the prospect of
stopping
benefits and working the number of hours required to earn more than
their benefits
would pay quite daunting. They can also be very fearful that if they
come off benefits
and have a relapse, they will not be able to receive benefits again. It
is therefore useful
to spend time discussing their fears and discuss different options. If
they are keen to
come off their benefits, it is useful to discuss steps to be taken to
increase their ability
to work, e.g. by doing some voluntary work, or 'permitted work'. '

IP

For participants who are in receipt of IP, it can be worth discussing
the advantages and
disadvantages of being on it. For participants who feel clear that they
do not wish to
return to that job, it may be useful for them to discuss the possibility
of resettlement
options with their employer. For participants who wish to return to
their previous job, but
feel unable to work the hours that they used to do, you could suggest
that they discuss
a graded return to work, or part-time work. For participants considering
a return to work
it is helpful to suggest that they build up their stamina and confidence
in their ability to
work again, e.g. by doing some voluntary work., For participants who
want to leave their
job, it is worth discussing different options with them and getting them
to look at
different alternatives for homework.

It is helpful for you to offer to write to employers, insurance
companies, be
involved in meetings with their occupational health department or what
ever is
necessary to help participant to meet their work-related goals."


CBT Therapists Manual Page 67 -

"Feeling that a physical cause has been missed and wanting further
investigations

Some participants may not hold a specific belief about what is wrong
with them, but feel
that despite many investigations, something has been missed. They may
feel that they
want to continue having investigations or try a variety of treatments
until they are cured.
Again, it is important to empathise with their situation, but to
encourage them to hold off
having further investigations until after they have completed a course
of CBT.

Participant

I am feeling so exhausted, I really cannot believe that all my tests are
clean l feel sure
that something has been missed. I think I might go to my GP just one
more time to ask
him if there are any other tests that I could have.

Therapist

I can understand that with feeling the way you do, you feel something
has been missed. However what I am proposing to do is to help you to
understand why you feel as bad as you do and also to see if we can help
you to feel a bit better in the process.

Would that be o.k. ?

Participant

But what if something has been missed that could be easily rectified?

Therapist

From your notes I can see that you have had many tests, none of which
point to a simple explanation for your fatigue. It therefore seems
unlikely that someone would be able to detect an obvious cause of your
problems. Although I can see the temptation of seeking further
clarification of your problems, in reality what can happen is that you
end up feeling more confused. I believe that your fatigue is a symptom
of a bigger picture and I would like to spend some time discussing my
thoughts on this matter with you. I wonder how you would feel about that?

Participant

Well, I suppose it wouldn't do any harm!

Therapist

What I suggest that we do is to get a large piece of paper and write
down what we do know about your illness, including your symptoms, what
was happening at the time you became ill and ways that you have been
managing to deal with your illness to date. This information may help us
to look at factors that may have triggered it and factors that may be
involved in keeping it going. I hope this will help us to make some
sense of your illness together before we move on to discussing ways of
overcoming it. Would you give my suggestion a go?

Participant

Yes

Therapist

Great. Then maybe that would be a good place to start this session."


[5] Formal erudite critique/complaint re PACE by Professor Malcolm
Hooper - details of which can be
read by following the paper-trail at these web-links:
http://www.meactionuk.org.uk/magical-medicine.htm
http://www.meactionuk.org.uk/Further_Articles.htm


[6] Professor Bruce Charlton – Zombie Science – a sinister consequence
of evaluating scientific theories purely on the basis of enlightened
self-interest, Medical Hypotheses (2008) 71 327-329, DOI:
10.1016/j.mehy.2008.05.018: Available online at:
http://medicalhypotheses.blogspot.com/2008/07/zombie-science-dead-but-wont-lie-down.html  



- ENDS - PERMISSION TO REPOST -

Friday, December 31, 2010

Great advocacy reminders and tips

Thanks, Ann!
 
Just came across this article from The CFS Patient Advocate.  It's about a
presentation given at ILADS this year, by the tireless AIDS advocate Dr. Marcus
Conant. Great reminders and advice!


http://cfspatientadvocate.blogspot.com/2010/11/dr-marcus-conant-and-advocacy.html


Dr. Marcus Conant and Advocacy
 
In his quest to help his daughter get better, the Patient Advocate went to hear
Dr. Marcus Conant at the recent ILADS conference. Dr. Conant was one of the
courageous few that clinically engaged the AIDS epidemic in San Francisco in the
early 1980's. Dr Conant did not flinch in the face of this terrible burden
thrust upon him. Instead he treated these near dead and dying patients - and
became a great advocate for them. He knows the business of disease advocacy, and
when he speaks it makes sense to listen.

Recently Dr. Conant moved from S.F. to New York, where he is a consultant. Among
other things, he has an interest in this XMRV retrovirus. Dr. Conant sees many
parallels of the current situation with neuro-immune illness and the early years
with AIDS. An astute Dr. Burrascano invited Dr. Conant to lecture. Dr. Conant
gave his lecture without remuneration.

In his half-hour lecture entitled "Lessons learned from AIDS", Dr. Conant gave a
stirring talk enumerating a number of key points. The Patient Advocate has read
over his notes on this lecture and Dr. Conant's advice to us follows:

"What the AIDS patient learned to advocate for was not compassion from the
public, was not sympathy from the public - what they learned to advocate for was
research dollars, research funds."

"Focus energies on getting money for research. Find out the etiology of this
disease." (in this case he was speaking of Lyme)

"Focus on research, not suffering."

"Don't trust the press." "The press is not your friend." - they are corrupt and
have another agenda.

"Congress is your last resource, not your first." "The federal government is not
your friend." You first have to prove that something is there.

"Dont blame your adversaries" "Bring them (your adversaries) in, don't cut them
out." Otherwise you will have to wait until they are dead - and that could be a
long time. (Dr. Conant was not talking about deadly enemies here. He expressed
clearly that he would not waste any time on someone whose mind he could not
change. In this above quote, he was emphasizing the notion of inclusion - and of
not unnecessarily making enemies)

"Develop coordinated activism" How do we best get funds to study this disease?

A month later this presentation still reverberates in the mind and heart of the
Patient Advocate. This talk could not have come at a better time.

With ME/CFS, we stand at a crossroads. At this moment the government is sitting
on the HHS XMRV blood study group's phase II study. The government is worried
about the blood supply. The government has the data and it is pretty convincing.
What will they do and when?

Meanwhile NIH research money is not coming to the WPI. The WPI funding
applications have been turned down at least four times. They are having trouble
getting their current research published in legitimate journals. Why is this?
Whatever limited funding they have is drying up. Whether this all is by design
is anyone's guess.

Meanwhile other research into XMRV is going on around the country in both
expected and unexpected places, fueled by discretionary funding or siphoned off
from other projects. Researchers are drawn by natural interest to this new
retrovirus. Here is one recent study. And here is another (from MN, no less).
These ongoing research projects hold the key to the solution of this ME/CFS
XMRV-related illness. Science is the answer. The WPI and their affiliates
triggered this. They tripped the switch on all this research. This flashpoint
Institute needs funding in order to come up with more answers. Research is the
answer. We cannot wait any longer.

Thursday, December 30, 2010

Lessons Learned As 'Doctors Behaving Badly' Tour Ends

 
"Medical boards are slow to act" -- when I complained about my doctors, I was told the medical board doesn't have enough money to investigate every complaint, so they only investigate if you've lost life or limb.  The fact that my lifestyle was radically changed by medical incompetence was not enough; I had to either die or have the wrong leg amputated.
 
Remember, this doctor was handed a correct diagnosis on a silver platter -- diagnosed by a virologist in 1988, and re-diagnosed by a rheumatologist a few months before I saw this medical moron.  It was not an innocent "misdiagnosis", it was intentionally changing the right diagnosis to a wrong one, and then playing Blame The Patient when "nothing you said made sense" (because I know to feed a doctor all the symptoms that prove it's not depression) and when the wrong pills for the wrong condition simply made me sicker.
 
Read "How Doctors Think" by Jerome Groopman, MD, for proof that this attitude is endemic in the medical field.
 
The goal is not, to use Dr. Bell's word, Game Show Medicine, where the first person to ring in with an answer wins -- it's to get the RIGHT diagnosis.  Groopman's book says that doctors often reach a diagnosis in 18 seconds and then stop listening.  So if the first word out of your mouth is "fatigue", they're going to leap straight to depression and ignore anything you say after that that contradicts that diagnosis -- he stopped listening long before you got to things like fever and swollen glands and rashes that prove it's something else. 
 
In my case, the magic word was "divorced" -- I was a four-eyed middle-aged divorcee who was obviously depressed because my husband ran off with a 20-something hardbody and just needed to adjust to the idea that no man wants a woman my age.  He never bothered to ask questions, just assumed, or he would've found out that my ex was with a woman the same age as me, who outweighed me by a good 50 pounds, and he didn't leave me, I kicked him out.  I was very happy being rid of that expensive albatross. 
 
 

Wednesday, December 29, 2010

Plasma neuropeptide Y: a biomarker for symptom severity in chronic fatigue syndr

A provisional pdf of this study can be found here:
http://www.behavioralandbrainfunctions.com/content/6/1/76

Plasma neuropeptide Y: a biomarker for symptom severity in chronic
fatigue syndrome.

Chronic fatigue syndrome (CFS) is a complex, multi-symptom illness
with a multisystem pathogenesis involving alterations in the nervous,
endocrine and immune systems. Abnormalities in stress responses have
been identified as potential triggers or mediators of CFS symptoms.

This study focused on the stress mediator neuropeptide Y (NPY). We
hypothesized that NPY would be a useful biomarker for CFS.

Methods: The CFS patients (n = 93) were from the Chronic Fatigue and
Related Disorders Clinic at the University of Miami and met the 1994
case definition of Fukuda and colleagues.

Healthy sedentary controls (n = 100)) were from NIH or VA funded
studies. Another fatiguing, multi-symptom illness, Gulf War Illness
(GWI), was also compared to CFS.

We measured NPY in plasma using a radioimmunoassay (RIA). Psychometric
measures, available for a subset of CFS patients included: Perceived
Stress Scale, Profile of Mood States, ATQ Positive &Negative Self-Talk
Scores, the COPE, the Beck Depression Inventory, Fatigue Symptom
Inventory, Cognitive Capacity Screening Examination, Medical Outcomes
Survey Short Form-36, and the Quality of Life Scale.

Results: Plasma NPY was elevated in CFS subjects, compared to controls
(p=.000) and to GWI cases (p=.000).

Receiver operating characteristics (ROC) curve analyses indicated that
the predictive ability of plasma NPY to distinguish CFS patients from
healthy controls and from GWI was significantly better than chance
alone. In 42 patients with CFS, plasma NPY had significant
correlations (<0.05) with perceived stress, depression,
anger/hostility, confusion, negative thoughts, positive thoughts,
general health, and cognitive status.

In each case the correlation (+ or -) was in the anticipated direction.

Conclusions: This study is the first in the CFS literature to report
that plasma NPY is elevated compared to healthy controls and to a
fatigued comparison group, GWI patients. The significant correlations
of NPY with stress, negative mood, general health, depression and
cognitive function strongly suggest that this peptide be considered as
a biomarker to distinguish subsets of CFS.

Author: Mary Fletcher, Martin Rosenthal, Michael Antoni, Gail Ironson,
Xiao Zeng, Zachary Barnes, Jeanna Harvey, Barry Hurwitz, Silvina
Levis, Gordon Broderick, Nancy Klimas
Behavioral and Brain Functions 2010, 6:76