MRC PACE Trial complaint - update on the situation

Daisymay

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Update on Professor Hooper's MRC PACE trial complaint - response from Mr Willetts office, followed by Professor Hooper/Margaret Williams reply. Permission to repost.

From: Willetts MPST
Sent: Thursday, December 23, 2010 12:46 PM
To:
Cc: Malcolm Hooper ; Willetts MPST
Subject: RE: MRC PACE Trial

Dear Ms Williams,

Thank you for your e-mail of 9 December and follow-up e-mail of 19 December about Professor Malcolm Hooper's complaint about the Medical Research Council (MRC)-funded PACE trial.

I apologise that Professor Hooper has not yet received a response from the Medical Research Council. Officials within BIS have been working closely with the MRC on this issue but, due to unforeseen circumstances, the MRC has not been able to meet the month deadline to which they originally committed. However, the MRC have confirmed that it is investigating this issue thoroughly and it will send you a response as soon as it can.

In terms of going forward, please do not hesitate to contact me in David Willetts's office if you have any questions or if you consider that there has been further undue delay in responding to the issues raised in your correspondence.

Kind regards,

Matthew.

Matthew Wicks | Private Secretary to David Willetts, Minister for Universities and Science | Department for Business, Innovation and Skills | 1 Victoria Street, London, SW1H 0ET | 020 7215 5518 | www.bis.gov.uk
..................

From:
Sent: Thursday, December 23, 2010 4:18 PM
To: Willetts MPST
Cc: Malcolm Hooper
Subject: Re: MRC PACE Trial


Dear Matthew

Professor Hooper thanks you for your reply of 23rd December 2010 which he has read, but he asks me to convey his disappointment with the continued lack of progress on the part of the MRC.

Given that the MRC seems so reluctant to deal directly with him, Professor Hooper asks me to seek your confirmation that David Willetts - or alternatively you on his behalf -- will assume responsibility for ensuring that the promised comprehensive response from the MRC is received as quickly as possible and that there is no further undue delay, since by any standards the MRC's delay has been inordinate for a UK national body that is clearly closely associated with Government.

The urgency of the situation demands a rapid resolution because the longer the delay, the longer people with ME/CFS continue to suffer needlessly.

The officials within BIS who have been discussing Professor Hooper's complaint with the MRC cannot be unaware that the eyes of clinicians and medical scientists in academic departments around the world are focused on the PACE Trial results and that they are keenly awaiting the MRC's response to his detailed complaint.

Professor Hooper is convinced, for valid scientific reasons, that the PACE Trial has no credible clinical or scientific basis.

He is also aware that, despite the Chief Principal Investigator Professor Peter White's indication of positive results that "will provide the most definitive test so far of both the efficacy and safety of this treatment" (Bulletin of the IACFS/ME: 2010:18(3):91-92), international clinicians and researchers continue to wonder how it will be possible for the results of the PACE Trial to be so constructed that they can be applicable to those with ME/CFS, given that the correct application of the Trial entry criteria (the Oxford criteria compiled by the Trial Principal Investigators themselves) excludes those with any neurological disorder from the outset and that results which pertain to those with chronic "fatigue" cannot be safely extrapolated to those with a chronic inflammatory neuroendocrineimmune disorder such as ME/CFS who exhibit vascular spasm, neuro-degeneration, a disrupted immune system, cellular hypoxia, mitochondrial defects, methylation defects, oxidative stress, hormone depletion and receptor insensitivity, evidence for which is widely available?

In particular, Professor Hooper is aware that many medical scientists are unable to reconcile how cognitive restructuring and incremental aerobic exercise can be beneficial to those in whom there is evidence of significantly lower global CBF (cerebral blood flow) across nearly every brain region assessed (Biswal B, Natelson BH et al; J Neurol Sci 2010; Epub ahead of print) and in whom the weighted evidence points towards a reduced physiological exercise capacity (Nijs J et al; Disabil Rehab 2010: Epub ahead of print).

Professor Hooper asks that you ensure that the officials within BIS put these points to the MRC and obtain a credible answer.

We are grateful to you for your assurance that we may contact you in David Willett's office.

Kind regards, and best wishes for a happy festive season.

Margaret Williams
 

cigana

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Thanks for posting this Dasiymay.

I wonder if we will know anything different this time next year!
 

pictureofhealth

XMRV - L'Agent du Jour
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This is an extraordinarily good, eloquent and clear letter outlining the biomedical deficits in ME/CFS and the lack of scientific credibility of the PACE trial as a result.
Outstanding - thank you.
 

Cort

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This is may be the most important topic in the PACE trial; who was excluded? and how many were excluded. The Trial should list how how they found potential participants, how many people were interviewed for the trial, how many were excluded and for what reasons. The Trial always should have a had a list of exclusionary factors....did it not have that?

This has been maybe the key complaint about the PACE trials and CBT studies; that researchers are excluding certain types of patients from the studies....I'm amazed this wasn't dealt with from the beginning.
 

Enid

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Quite agree Cort. And of course all those bedbound too ill to go anywhere are automatically excluded so they will not have a true sample in any case.
 

Cort

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And from just about any other study as well....the Invest in ME/WPI XMRV study is the only one I can think of that tried to include these people. They don't show up in ....immune studies, HPA axis studies, CBT HHV6 studies....they are missing from CFS research as a whole.
 

Enid

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It's unbelieveable. Surely the most sick should be those to investigate - just seems common sense that should reveal more at the height of this illness. Mind you didn't much appreciate my few investigations at the time. But there is more knowledge and better tests now to identify pathologies.