Monday, October 11, 2010

Latest letter from Dr. Hooper

**MRC PACE Trial
Permission to Repost
http://www.meactionuk.org.uk/PACE-Hooper-071010.htm


This is the letter which was sent by Professor Malcolm Hooper,on the 7th
October, to The Rt Hon Dr Vince Cable MP, Secretary of State with
responsibility for the Medical Research Council(MRC), relating to the
failure of the MRC to respond to his formal complaint on the PACE Clinical
Trial, which he first lodged on the 11th February 2010. May be reposted.

.........................................................................................................


The Rt Hon Dr Vince Cable MP
Secretary of State
Department for Business, Innovation and Skills
1, Victoria Street
London
SW1H 0ET

7th October 2010

By Special Delivery

Dear Dr Cable,

re:Complaint about the MRC PACE Trial on "CFS/ME"

Mindful of your record of commitment to and concern about the serious plight
of people with the neuroimmune disorder myalgic encephalomyelitis/chronic
fatigue syndrome (ME/CFS), I ask that in your position as Secretary of State
responsible for the Medical Research Council (MRC), you will respond
promptly and fully to this letter.

Having received no response from the Medical Research Council to our
concerns about the PACE Trial that purports to be studying this disorder, on
11th February 2010 I lodged a detailed complaint with the Minister then
responsible for the MRC, The Rt Hon The Lord Drayson, enclosing a bound copy
of my 442 page fully referenced report "Magical Medicine: how to make a
disease disappear" setting out the evidence
that forms the basis of my
complaint.

He replied by letter dated 8th March 2010 (his reference being
2010/0013270POLD), advising that I should raise the matter formally with Dr
Morven Roberts of the MRC Clinical Trials Unit, which I duly did by letter
dated 30th March 2010, with which I enclosed a further bound copy of my
report.

I specifically asked Dr Roberts for an informed and considered response and
not the standard and dismissive pro forma MRC letter that has been sent to
numerous people who have already written to the MRC expressing their
concerns about the inappropriateness of the PACE Trial, the false beliefs of
the small but influential group of psychiatrists upon which it is
predicated, and its very real potential for iatrogenic harm.

My letter and the accompanying report were sent by Special Delivery and were
received by the MRC on 1st April 2010, for which the Royal Mail provided a
signed receipt.

I did not receive the courtesy of an acknowledgement, so six weeks later, on
18th June 2010, my research assistant telephoned the MRC and asked to speak
to Dr Morven Roberts. When my assistant explained that the enquiry related
to my formal complaint about the PACE Trial, she was informed that there was
no-one of the name of Dr Morven Roberts in the Clinical Trials Unit and was
met with a total refusal to discuss the matter, the MRC employee saying: "I
think I'm going to have to put the phone down", which she rudely did. The
episode was a quite extraordinary response to a simple and polite request to
speak to Dr Morven Roberts in relation to a complaint about an MRC trial.

The following day, Dr Morven Roberts sent me an email (incorrectly addressed
to Professor "Cooper") in which she wrote: "I understand you have recently
tried to contact me in regard to your complaint lodged with me as Clinical
Trials Manager about the PACE Trial. I can let you know that the MRC are
working through the large document you have sent and will respond in due
course. Morven".

Despite it being over six months since I lodged my complaint and four months
since Dr Morven Roberts assured me I would receive a response, I have heard
nothing from the MRC. I am sure you will agree that such a delay in such an
important matter is unacceptable.

On 5th October 2010, my research assistant telephoned your Department,
quoting the reference number on Lord Drayson's letter of 8th March 2010, to
seek your personal commitment to pursue this issue as a matter of urgency,
only to be informed that there is no record of my complaint as Lord
Drayson's reply to me has been lost and that I must start my complaint all
over again. She was informed that someone from your office would ring her
back that same day; you may not be surprised to know that no-one bothered to
do so.

Reasons why this complaint is now urgent

The MRC PACE Trial intentionally used the Principal Investigators' (PIs')
own entry criteria for "CFS" (the 1991 Oxford criteria), yet these criteria
lack diagnostic specificity, have been shown to have no predictive validity,
and select a widely heterogeneous patient population which may or may not
include people with true ME/CFS. It is virtually unheard of for studies to
use criteria that have been superseded; indeed, one of the PIs himself,
Professor Michael Sharpe – who was lead author of the Oxford criteria --
stated in 1997 that they "have been superseded by international consensus"
(Occup Med 1997:47:4:217-227).

Of equal concern is the fact that the PIs and other psychiatrists involved
with the PACE Trial continue to regard ME/CFS as a behavioural disorder and
refuse to engage with the extensive biomedical and scientific evidence that
identifies damage, deficits and dysfunction in major bodily systems of
patients with ME/CFS, particularly in the neurological, immune, endocrine
and cardiovascular systems. For over two decades they have asserted that ME does not exist (and that it is merely an "aberrant belief" that one has a disorder called ME); they equate it with chronic "fatigue", a completely different disorder classified by the WHO as a psychiatric disorder in ICD-10 at F48.0, whilst ME/CFS is classified as a neurological disorder at ICD-10 G93.3.

The potentially harmful results of the PACE Trial for those with ME/CFS are
particularly important in the light of the findings of the strong
association between ME/CFS and a retrovirus (XMRV) of the same family as
HIV/AIDS. The findings of that paper, published one year ago in the journal
with the highest impact factor of any scientific journal worldwide (Science
2009:326:585), have been confirmed and strengthened by further research
published in August 2010 in the Proceedings of the National Academy of
Sciences (PNAS 10.1073/pnas.1006901107) showing polytropic murine leukaemia
virus-related viral sequences (MLV) to be present in the blood of 86.5% of
patients studied.

The over-riding international concern is that when the PACE Trial results
are eventually published, they will deliver what has long been known to be
the PIs' intention and primary objective, ie. the results will confirm the
PIs' favoured intervention of "cognitive restructuring" (which incorporates
graded aerobic exercise) as the intervention of choice. This is an
intervention that is specifically designed to disabuse ME/CFS sufferers of
their (correct) perception that they suffer from a serious, multi-system
neuroimmune disease.

The cognitive modification is directive, not supportive, ie. it is not
offered as adjunctive psychological support for those dealing with a
life-wrecking illness because the PACE Trial Manuals claim that it is
curative: the chief PI, Professor Peter White, claims that "a full recovery
is possible" (Psychother Psychosom 2007:76(3):171-176); the participants'
CBT Manual informs people that the PACE Trial therapies are curative, and it
is asserted that "many people have successfully overcome their CFS/ME" with
such behavioural interventions ("Information for relatives, partners and
friends", page 123).

To recommend behavioural modification strategies for those suffering from such devastating organic illness would be inhumane and inexcusable: if such an intervention were to be imposed on those with other neurological diseases (such as motor neurone disease or multiple sclerosis) to force them to change their correct perception that they suffer from a serious organic disorder, it would be roundly condemned as unethical.

You may already be aware that a world expert on both HIV/AIDS and ME/CFS is
on record as stating:

"I hope you are not saying that (ME)CFS patients are not as ill as HIV
patients. I split my clinical time between the two illnesses, and I can tell
you that if I had to choose between the two illnesses I would rather have
HIV" (Nancy Klimas, one of the world's foremost AIDS and ME/CFS physicians;
Professor of Medicine and Immunology, University of Miami
; New York Times,
15th October 2009). In addition, in a radio interview on 19th September
2010, she stated: "…there is a chronic inflammation, neuro-inflammation, and
it upsets the whole balance of your systems…the patients become terribly
ill…. The immune system is really cranked up; it's a tremendous amount of
inflammation. I think that if doctors could get this in their heads that
it's sort of like lupus or one of these really inflammatory disorders…it is
that level of inflammation. There's a tremendous amount of inflammatory
stuff going on, and there's a lot of inflammation in the brain itself
"
(http://www.litemiami.com/spotlite/index.aspx ).

This is important, because the incremental aerobic exercise recommended by
the PACE Trial Principal Investigators is contra-indicated in cases of
inflamed and damaged tissues and inevitably results in post-exertional
relapse with malaise, which is the cardinal symptom of ME/CFS.

Furthermore, in a lecture on 24th April 2010, Anthony Komaroff, Professor of
Medicine at Harvard and another world expert on ME/CFS, said on record in
answer to the question whether or not he would consider ME/CFS a
neurological illness: "…there is now abundant evidence of measurable
abnormalities in the central nervous system and the autonomic nervous system
in people with this illness. That makes it neurological
…That's why I think
it makes sense…to call it Myalgic Encephalomyelitis…because I think those
two words adequately classify or describe an underlying biology that tests
have shown to be the case" (http://www.masscfids.org/news-a-events/2/221 ).

As the evidence for retroviral involvement in ME/CFS becomes impossible to
dismiss, it becomes paramount to prevent the potentially damaging PACE Trial
results from being applied nationally to anyone with the label "CFS/ME" who,
given the indisputable heterogeneity of the PACE Trial cohort, may have
either chronic tiredness for which psychological interventions may be
appropriate or a multi-system neuroimmune disorder for which behavioural
modification is contra-indicated.

I trust you will appreciate the gravity and urgency of the current situation
that adversely affects an estimated 240,000 people in the UK (for
comparison, the Multiple Sclerosis Society estimates that there are 83,000
sufferers in the UK) and that your own involvement will be both prompt and
efficacious. The situation is particularly pressing now that people with
ME/CFS are embroiled with new legislation that many fear – and some have
already found – is threatening to remove state benefits they currently
receive that are vital to support their severely sick and damaged lives.

It is completely unacceptable that Dr Roberts and the MRC can be permitted
simply to ignore this complaint (which has received worldwide academic
attention, comment and support) in order to protect the unsustainable
beliefs of a handful of psychiatrists who work for the medical and permanent
health insurance industry and the scandalous waste of over £5 million,
especially given that the effects of the interventions on over 3,000
patients were already known to be at best ineffective and at worst to be
actively harmful in 50% of cases (for references, see "Magical Medicine" --
the copy that was sent to Lord Drayson should still be in your Department
but I will provide a further copy if necessary).

I ask that you give this matter your urgent attention; that you will
intervene to expedite the promised response from Dr Morven Roberts and that
you personally will supervise and approve her response.

Yours sincerely,

Malcolm Hooper

cc. Dr Morven Roberts, Clinical Trials Unit, MRC, 20 Park Crescent, London
W1B 1AL

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