Friday, December 24, 2010

NICE Timing, Coincidence and 'CFS/ME'.

NICE Timing, Coincidence and 'CFS/ME'.

Dear All,

I am a registered patient/activist stakeholder for the NICE 'CFS/ME'
Clinical Guideline 53 (CG53) that was published in the UK in August
2007. The scheduled 3-yearly review was somewhat delayed by NICE. I have
today however, 24 December 2010, at 0.30 am on Christmas Eve no less,
received notification of their review decision in the following direct
email from NICE. I should just add that, on the matter of the timing of
such publication, it is reassuring to know, is it not, that British
Taxpayers get such great value from our NICE civil servants - who are
apparently willing to work all hours and put the welfare of 'CFS/ME'
patients above their need to attend to personal pressing matters such
preparing one's family Christmas or even their own need for sleep?

NICE's said email to me:

"Subject: NICE: NICE Alerts
Date: 24 Dec 2010 00:30:01 +0000
From: webalert@website.nice.org.uk
To: contact@angliameaction.org.uk
NICE Alerts
Bringing you the latest news, features and guidance advice from NICE
24 December 2010
Guidance by topic
the following guidance topics matching your health area preferences have
been published or updated...
Chronic fatigue syndrome / Myalgic encephalomyelitis
[ http://guidance.nice.org.uk/CG53 ]."

A click on the jolly old link in the NICE email brings you to the
following information on their web page:

"Chronic fatigue syndrome / Myalgic encephalomyelitis (or
encephalopathy); diagnosis and management...
Guideline review
Consultation on review proposal with stakeholders: 01 November 2010 - 14
November 2010
Review decision date: December 2010
Review decision:
During the public consultation on NICE's review proposal for clinical
guideline 53 on the diagnosis and management of CFS/ME, a number of
stakeholders advised that the results of the PACE Trial are due to be
published in 2011. As this significant trial 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,
it is important that health professionals continue to adhere to the
existing recommendations as they represent best clinical practice for
the NHS [ http://guidance.nice.org.uk/CG53 ]."

Prior to this announcement, and surprisingly, even before they had
received submissions from stakeholders on the matter during a very
short-lived consultation period of 1st to 14th November 2010, NICE
Guideline Development Group (GDG) members had announced that in their
view there was no need to update CG53 at all. Now I know what all you
readers are thinking, obviously those diligent folk at NICE not only
serve patients and taxpayers exceptionally well through hard work at all
hours, they provide clairvoyancy services as well and had precognition
that stakeholders would not wish to have CG53 revised either...

Alas no. I can assure you, NICE's actions came as something of a shock
to myself and other patient/ charity stakeholders as not only did we
agree with leading interested parties that CG53 was "not fit for
purpose" in the first place, we most certainly did know that there was
good scientific evidence showing it was even more unfit for purpose now
than when it was published. This in fact supported the case for urgent
and very radical revision. Moreover, we provided evidence that the
previous GDG membership may not have been collectively professionally
competent to carry out their role in accordance with a) NICE's own
Guideline Development Manual, and b) the European Union's 'AGREE
Instrument' which, along with the WHO, attempts to maintain minimum
international standards for clinical guideline development. We
subsequently set about formally drawing NICE's attention to that very
evidence and reasoning. See for example the EAME / 25% ME Group
Stakeholder Responses to NICE at:

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

Well I know what you are thinking now, "there's nowt as queer as folk",
as they say in Yorkshire (England): one minute those NICE people say
nothing is wrong with Guideline 53 and the next they seem to be saying
they may need to tweak it because "a number of stakeholders advised that
the results of the (equally tweaked - see below) PACE Trial are due to
be published in 2011." Ooooooo, I would just love to meet those
stakeholders! They too must be blessed with some form of clairvoyancy
because that there PACE Trial publication is soooo long overdue (years)
I'm amazed that anyone can actually know when it is likely to be
published! Perhaps one thing's for sure, if said stakeholders'
clairvoyancy talents are a reality, then the fact that the PACE results
"are due to be published in 2011" will at least mean those poor
taxpayer-salaried PACE Principle Investigators will not be burning the
midnight-oil rushing the results out on the eve of another public
holiday - New Year's Eve?

It is interesting that NICE refer to PACE as "this significant trial".
It is indeed very significant, but I wager not quite for the reasons
they hold? PACE is funded by a UK government agencies that are
responsible for spending taxpayers' money wisely, for upholding
scientific standards and for caring for seriously ill people. The most
outstanding reason the PACE Trial is perhaps "significant" however is
because it has been alleged to be pregnant with "scientific fraud" and
is the subject of multiple complaints, including a major formal erudite
critique 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

Back to the question of timing more generally. It's a funny old thing
you know? There's far too much conspiracy theory in the ME community and
not nearly enough recognition of simple coincidence:

It is just coincidence that nearly all official/government 'CFS'
research funding and committees seem to support the interests of the
permanent health insurance industry.

It is just coincidence that when Mikovits et al published XMRV findings
in Autumn 2009 that subsequent negative non-replicating studies were
published by others at break-neck speed.

It is just coincidence that two USA government studies on retroviruses
in 'CFS' patients in 2010 were pulled at the point of publishing and
that the CDC one with the negative result was reinstated days later
whilst the positive NIH one nearly didn't get published at all.

It is just coincidence that the British Government banned ME patients
from blood-donation for life at a time of international concern over
gamma retroviral infection of humans generally and 'CFS' patients in
particular.

It is just coincidence that four Retrovirology papers and one commentary
were published on the same day in December 2010 highlighting somewhat
shall we say incomplete coverage of "contamination" issues alleged in
'CFS' retrovirology research.

It is just coincidence that, at the same time, the UK Myalgic
EcephalOPATHY Association published articles highlighting such
"contamination" matters but without balancing comment from researchers
like Dr Mikovits and Dr De Meirleir.

It is just coincidence that the day after the Retrovirology
"contamination" publications most comment in the mainstream media went
even further than the authors in claiming the "new evidence" indicated
retroviruses were not a problem for 'CFS' patients.

It is just coincidence that the UK charity 'Action for ME' removed
patient input from its governance, appointed a former Royal Navy Vice
Admiral as its head, receives government money and does so much to
support psycho-social matters pertaining to 'CFS/ME' (see:
http://www.meactionuk.org.uk/Corporate_Collusion_2.htm ).

It is just coincidence that so many of those professionals promoting
psychosocial theories in 'CFS/ME' have links to the medical insurance
industry (see: http://www.meactionuk.org.uk/Corporate_Collusion_2.htm ).

It is just coincidence that Professor Simon Wessely, architect of so
much 'CFS/ME' psychosocial theory, was a founding director of PRISMA, a
company providing CBT-GET services to private and public agencies (see:
http://www.meactionuk.org.uk/Corporate_Collusion_2.htm ).

It is just a coincidence that Both Professor Wessely and Dr Charles
Shepherd of the Myalgic EncephalOPATHY Association have such a long
association with the big-pharma supported pressure-group known as
'Healthwatch' (see:
http://www.meactionuk.org.uk/Corporate_Collusion_2.htm ).

It is just coincidence that, in his self-confessed desire to shift ME
from being recognised as a physical illness to a mental one, Professor
Wessely called for step by step constructive relabelling to such ends
(see: Managing patients with inexplicable health problems. Baruch
Fischhoff & Simon Wessely, BMJ 2003; 326 : 595 doi:
10.1136/bmj.326.7389.595. Published 15 March 2003:
http://www.bmj.com/content/326/7389/595.full ).

It is just coincidence that, subsequent to Wessely's call for
relabelling, Dr Shepherd promoted substitution of the WHO-recognised
Myalgic Encephalomyelitis term with the completely uncategorised Myalgic
EncephalOPATHY one - and most medical dictionaries say the hallmark of
the latter is "disturbance of mental function".

It is just coincidence that the current round of WHO International
Classification of Diseases (ICD-11) has been missing its own published
deadlines, is not acting as transparently as it should and that patients
cannot find out the exact role and number of 'Wessely-School' supporters
having input on the question of WHO revision/ reclassification of ME/PVFS.

It is just coincidence that so many biomedical ME researchers /
clinicians have such difficult and fraught career paths.

I could go on and on persuading you of more mere coincidences that are
not worth joining together into some naive conspiracy theorist's
nightmare conclusion. Instead however, I digress: herewith, a plea for
personal advice concerning my own timing, sleep issues and indeed,
nightmares... As is the case for most ME patients, the timing and
quality of my sleep are often problematic. Recently though, matters have
been compounded with the same recurring and vivid nightmare - I dream I
am being mugged in a large oak-panelled committee room by a group of
prostitutes smoking Cuban cigars, then a fellow mugee in the dream keeps
endlessly repeating Pastor Martin Niemöller's famous words on the
Hitlerian regime:

"They came first for the Communists,
and I didn't speak up because I wasn't a Communist.

Then they came for the trade unionists,
and I didn't speak up because I wasn't a trade unionist.

Then they came for the Jews,
and I didn't speak up because I wasn't a Jew.

Then they came for me
and by that time no one was left to speak up."

Er, do you think I could use more melatonin at bed time? Advice
gratefully received.

I thank you for your time and wish a successful New Year to all those
genuinely working for science-based justice for ME patients. Here's
looking forward to genuine "best clinical practice for the NHS..."

Genuinely yours,

Kevin Short.
24 December 2010.
contact@angliameaction.org.uk
[Permission to repost anywhere in the world except on the UK LocalME
weblist]

Oh, and by the way, please do give as much money as you can spare to:

The Whittemore Peterson Institute:
http://www.wpinstitute.org/xmrv/

Invest in ME:
http://www.investinme.org/index.htm

ME Research UK:
http://www.meresearch.org.uk/

-MESSAGE-ENDS-

What the Yuck: How long is safe for a juice fast? – The Chart - CNN

Tuesday, December 21, 2010

CFS Chronicles: Retrocrapologists Allow Infectious Retrovirus to Run Rampant

 
"as Klimas said to Coffin during the meeting, "But you can't get an antibody response from a contaminant." Of course, Coffin might not know this about XMRV. If you can't find it in the first place, you aren't going to find an antibody to it either."
 
* * *
Or, you can't find what you're not looking for.
 
My quacks insisted "all blood tests are normal" but refused to run the tests recommended by CFIDS.org.  The tests they did were supposed to be normal in a CFS patient.
 
They weren't interested in doing x-rays to find the source of my pain, either.  They "knew" it was being caused by my being a middle-aged divorcee.  Amazing how a chiropractor managed to figure out that there were 3 fractured vertebrae when all these MDs who think chiros are quacks found nothing wrong ... oh, wait, because they weren't looking for a physical cause, and he was!
 
We've known for years that doctors hear what they want to hear and see what they want to see.  In 1987-88, my boss and co-workers could see I looked like death warmed over, and was frequently on the verge of passing out.  The doctor, however, saw nothing wrong because he didn't want to see anything other than a woman trying to manipulate her husband into letting her quit her job.  In 2000-2001, the doctor saw nothing wrong, because once he heard the word "divorced" he didn't see the need to listen to any symptoms to know that I was just depressed because my husband left me for a 20-something size 2.  (Except that I was the one who threw him out, and his new girlfriend was my age and outweighed me by a good 50-75 pounds.  But why let the facts stand in the way of a good stereotype.)
 
When put on the spot later, the doctor insisted "nothing you said made sense".  Of course not!  I was spoon-feeding him all the symptoms that prove it's CFS and not depression, which didn't make sense in the rubric that he was trying to sledgehammer them into.  Everything I said contradicted depression, therefore, the problem wasn't that he was misdiagnosing but that the patient was too stupid to know what symptoms she was describing.

Check out CFS Chronicles

CFS Patient Advocate: The Mouse that Roared*

Monday, December 20, 2010

XMRV Treatment Trials for CFS are Now Justified

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Special Edition







THE NICEGUIDELINES BLOG



Doctor Speedy and ME in search of medical honesty




Sunday, December 19, 2010





XMRV treatment
Trials for CFS are
now justified



Valerie Courgnauda, Jean-Luc Battinia,
Marc Sitbona,1, and Andrew L. Masonb,1


aInstitut de Génétique Moléculaire de Montpellier,
Centre National de la Recherche Scientifique, Unité
Mixte de Recherche 5535, Universite Montpellier 1
and 2, F-34293 Montpellier Cedex 5, France; and
bDepartment of Medicine, University of Alberta,
Edmonton, AB, Canada T6G 2E1




As we currently lack postulates to prove a causal
association with a prevalent agent and a chronic
disease with genetic predisposition, it would also be
appropriate to conduct interventional studies.


Indeed, the Helicobacter pylori hypothesis of peptic
ulcer disease was only accepted after Barry Marshall
showed that bacterial eradication with antibiotics
cured peptic ulcer disease


(21). Studies to gain proof of principle have been
performed with antivirals in other chronic, idiopathic
diseases linked to retroviral infection, such as
primary biliary cirrhosis associated with mouse
mammary tumor virus, another possible murine
zoonosis (22).


Trials using a combination of reverse transcriptase
inhibitors led to significant improvements in clinical,
histological, and biochemical outcomes in these
patients, albeit with some evidence of viral
resistance to therapy (23).


Such studies are now feasible for CFS, because
reverse-transcriptase inhibitors, such as tenofovir
and emtracitabine, and the integrase inhibitor
raltegravir can inhibit XMRV (24).


The caveats for conducting clinical trials in patients
with CFS and MLV infection are that the potential
benefits of treatment should outweigh the risks;
also, studies should be conducted as randomized
controlled trials with meaningful and feasible
endpoints using robust therapies.


At this juncture, studies to establish proof of
principle are justified to determine whether safe
antiviral regimens can impact on CFS and to
determine whether xenotropic or polytropic MLV is
causally associated with this debilitating disease.





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The full PDF file:

Mouse retroviruses and chronic fatigue syndrome:
Does X (or P) mark the spot?

is attached for private members, but can also be
found at: http://bit.ly/hHspa8