19th December 2010
Dear Mr Willetts
Further to my letter of 9th December about the MRC PACE Trial (reference 2010/0085082PODW, to which as yet no acknowledgment has been received), and whilst he is mindful of the Christmas recess, Professor Hooper has asked me to draw your attention to the marked difference in UK and US research into the same disorder (ME/CFS).
In the UK, a small but unduly influential group of doctors, mostly psychiatrists, who work for the insurance industry have been granted funding of over £5 million (for the MRC PACE Trial) specifically to disabuse ME/CFS sufferers of their correct belief that they suffer from a serious, chronic and complex organic disorder by means of cognitive restructuring that includes incremental aerobic exercise (known in common parlance as brain washing). The PACE Trial is predicated on the Investigators’ scientifically unsupportable assumptions of sufferers’ alleged deconditioning (an assumption that has been disproved by several studies), on their alleged “perception” of effort and on their alleged “aberrant illness beliefs”. The Trial Identifier says: “CBT (cognitive behavioural therapy) will be based on the illness model of fear avoidance. There are three essential elements: (a) Assessment of illness beliefs and coping strategies, (b) structuring of daily rest, sleep and activity, with a graduated return to normal activity, (c) challenging of unhelpful beliefs about symptoms and activity” and it says about GET (graded exercise therapy): “GET will be based on the illness model of both deconditioning and exercise avoidance. Therapy involves negotiation of an individually designed home aerobic exercise programme with set target heart rates and times” (Section 3.2). The “Invitation to join the PACE trial” leaflet says: “CBT is about examining how your thoughts, behaviour and CFS/ME symptoms relate to one another” and says “GET is about gradually increasing your physical activity to make you fitter and get your body used to exercise again”.
In the USA, research undertaken by world-class expert Professor Nancy Klimas of the University of Miami is addressing the real issue.
The real issue is described by Professor Klimas as: “the magnitude and scope of (ME)CFS as a growing public health concern (and) the inadequacy of current acute illness research models for resolving complex disorders affecting multiple regulatory systems in the body. This illness cuts across race, gender and socio-economic status to affect a wide segment of society….Moreover complications and co-morbidity can be severe, including cardiovascular illness and cancer….Research has shown that immune, endocrine and nervous systems are all affected….We hypothesise that (ME)CFS results not only from component failure but perhaps more importantly from a significant deterioration of regulatory function linking these components….Embedded (in this research) we will also have captured the dynamic response of the overarching homeostatic control to exercise stress” (http://projectreporter.nih.gov/project_info_description.cfm?aid=8051249&icde=6432550).
Professor Klimas notes that the cost to the US economy is estimated at $9 billion (£5.8 billion) in lost productivity and up to $24 billion (£15 billion) in healthcare expenditure annually, comparative UK costs being in the order of £1.45 billion in lost productivity and £3.75 billion in healthcare costs annually.
The MRC PACE Trial is the very antithesis of the US research. It is specifically directed at changing sufferers’ (correct) cognition that they are seriously physically incapacitated, a matter that, given the extensive international evidence of biomedical abnormalities, Professor Hooper believes amounts to serious professional misconduct.
Professor Hooper believes that for the MRC to be promoting interventions that may actively damage patients because of mischaracterisation of the disorder as a psychosocial disorder -- with the consequent continued denial of appropriate medical care and support -- is an abuse of defenceless sick people. The MRC is funded and entrusted to support research to reduce, not enhance, the suffering of human beings.
Since the MRC continues to reject any notion of its own accountability and declines to communicate directly with Professor Hooper, given that responsibility for the MRC falls within your Ministerial portfolio, he seeks your personal intervention because he believes it is unacceptable for sick people to be coerced, misinformed and effectively abused by those whose duty is to relieve their suffering.
Professor Hooper specifically asks you to consider the duty of the MRC not to condone, let alone actively support, the publication of flawed research.
The classified neurological disorder ME has now been irrefutably shown to be a chronic inflammatory neuroendocrineimmune disorder in which physiological exhaustion is contingent upon reduced cardiac output being insufficient to meet metabolic demand. ME, which bears no resemblance to chronic “fatigue” or “tiredness”, has been diluted by the PACE Trial Investigators to the extent that it effectively ceases to exist as a distinct disease.
The trial cohort includes people “whose main complaint is fatigue (or a synonym)” as confirmed by the Chief Principal Investigator himself, Professor Peter White, in his letter of 14th July 2006 to the West Midlands MREC, and given that, as confirmed on 12th May 2004 by the Parliamentary Under Secretary of State Dr Stephen Ladyman MP, doctors were offered financial inducements to persuade patients who do not suffer from ME/CFS to enter the PACE Trial, the results of the PACE Trial cannot be applicable to those with ME/CFS and therefore cannot be other than irretrievably flawed.
The 2009 Judicial Review of the NICE Clinical Guideline 53 on “CFS/ME” was predicated on exactly the same basis as the PACE Trial. The challenge was unsuccessful, following the threat to the Claimants’ lawyers at the 11th hour by NICE of a significant wasted costs order and the imposition of that order by Mr Justice Simon to the tune of £50,000. Statements from 19 national and international ME/CFS experts were obtained (but were not able to be set before the Court because of NICE’s threat), all of which expressed deep concern about the inappropriateness of the recommended interventions that are the basis of the MRC PACE Trial (http://www.meactionuk.org.uk/Statements-of-Concern-for-High-Court.htm).
Professor Hooper urges you prevent the PACE Trial resulting in iatrogenic harm by ensuring that the promised investigation of his complaint is considered with utmost expediency. Indeed, you yourself wrote in your letter of 8th November 2010: “the Council has assured me that it takes allegations of coercion within a trial very seriously and is investigating your complaint thoroughly”.
He re-iterates what he said in his letter of 7th October 2010 to the Secretary of State, the Rt Hon Dr Vince Cable MP: “To recommend behavioural strategies for those suffering from such devastating organic illness would be inhumane and inexcusable….I trust you will appreciate the gravity and urgency of the current situation”.
You will be aware that the Department of Health is currently conducting a consultation until 14th January 2011 (“Liberating the NHS: Greater Choice and Control”). This document is clear:
"We need to raise the quality of the patient experience so we will put patients at the heart of everything we do...giving people more choice and control...more say in making decisions about their care".
The Executive Summary indicates that the Department wants patients to have far more influence and the NHS to be more responsive, which the Department acknowledges would mean a cultural change in the NHS, but its vision “is of informed, empowered patients making choices over the things that matter to them….Choice encourages healthcare providers to tailor their services to what people want and to improve their quality and efficiency”.
In light of the importance of this consultation to those with ME/CFS and their equally desperate families, Professor Hooper asks that you be kind enough to copy this correspondence to the Secretary of State for Health, the Rt Hon Andrew Lansley MP.
Professor Hooper once again requests that you intervene to ensure that patients with ME/CFS no longer remain disenfranchised, that their concerns about the PACE Trial interventions are at last afforded due status and that the agenda of the PACE Trial Investigators does not take precedence over the health of patients.
Should the outcome of the PACE Trial result in the continued recommendation and imposition by the existing CFS clinics of behavioural interventions for those with ME/CFS, not only will the DH’s consultation be exposed as an expensive and hollow waste of taxpayers’ money, but this travesty of science and the abuse of patients with ME/CFS in the UK will continue unabated by the NHS and other agencies of State.
Professor Hooper anticipates that, following the recess, he will receive a prompt and effective response from you.