Invest in ME Conference 12: First Class in Every Way
OverTheHills wraps up our series of articles on this year's 12th Invest in ME International Conference (IIMEC12) in London with some reflections on her experience as a patient attending the conference for the first time.
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MRC PACE Trial

Discussion in 'Action Alerts and Advocacy' started by Daisymay, Oct 9, 2010.

  1. Daisymay

    Daisymay Senior Member

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    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 Im 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 Draysons 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 Draysons 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 worlds 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 systemsthe patients become terribly ill. The immune system is really cranked up; its a tremendous amount of inflammation. I think that if doctors could get this in their heads that its sort of like lupus or one of these really inflammatory disordersit is that level of inflammation. Theres a tremendous amount of inflammatory stuff going on, and theres 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 neurologicalThats why I think it makes senseto call it Myalgic Encephalomyelitisbecause 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
     
  2. Sasha

    Sasha Fine, thank you

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    Excellent letter by Prof Hooper - what an extraordinary situation! The whole thing just sounds bizarre.

    I had a visit from an NHS physio this week who told me that their treatment to ME was "evidence based". When I said I'd question whether the evidence actually related to ME at all rather than broadly defined CFS she said they were the same thing and when I pointed out that the evidence didn't indicate benefit to severe cases she said that wasn't true. So much for "evidence based". She sounded as though she had been trained to give those responses when challenged.

    It is just so awful that a well-meaning NHS person and a vulnerable patient (and we're all vulnerable in the UK - we can't afford to annoy anyone in the NHS network) - always have to start off on a footing of mutual distrust. I now don't trust her because I think she has uncritically swallowed a line she has been taught and I think she has the impression of me as an obstructive patient for questioning her expertise and refusing being set "targets".

    I'm just so desperate for this situation to change and for us all to get some proper medical treatment. Good luck to Prof Hooper!
     
  3. justy

    justy Senior Member

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    What an astoundingly fantastic letter!

    i think i will copy out bits of this and make my own document to show family and riends who have been made to believe that i suffer from a primarily psychological disorder.
     
  4. Daisymay

    Daisymay Senior Member

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    Sasha and Rusty, agreed excellent letter, let's just wait and see what, if, the MRC finally responds properly to Professor Hooper's official complaint, it is eight months now since he sent it off, really appalling, or whether we get more of the same......

    Anyway, in case of interest, someone has started up a page on FB called "Fans of Professor Malcolm Hooper and Margaret Williams", sounds a bit naff but it is a good idea as it is a way for people to say thanks to them for all their years of work, because they don't really get feedback to know how much we appreciate all their work, and I know they have been really touched by people's comments.

    http://www.facebook.com/group.php?gid=155929401088458&v=wall&ref=mf
     
  5. Marco

    Marco Grrrrrrr!

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    Perhaps we should all write, or e-mail, Vince Cable's department - as individual ME patients - in support of Dr Hooper's demand for a response to his complaints to the MRC.

    Something along the lines of - Can the Secretary of State confirm that the MRC will repond in full to the complaints set out in Professor Hooper's document 'Magical Medicine'.
     
  6. justy

    justy Senior Member

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    Yes Marco, an excellent idea. Im going to do that tomorrow
     
  7. Marco

    Marco Grrrrrrr!

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    It's taken me a while to get around to this and I should have made it shorter. On the other hand I could have said a hell of a lot more.

    Professor Hooper deserves our support :





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

    Dear Dr Cable


    COMPLAINT ABOUT THE MRC PACE TRIAL ON ME/CFS - CORRESPONDENCE FROM PROFESSOR MALCOLM HOOPER

    I am writing to you, in your capacity as Minister with responsibility for the Medical Research Council, as one of the estimated 250,000 UK citizens afflicted with the neuro-immune disease originally known as Myalgic Encephalitis (ME), now variously referred to as ME, Chronic Fatigue Syndrome (CFS) or the compound abbreviation ME/CFS.

    I contracted this illness around 1985/86 and, despite the often debilitating symptoms, managed to successfully complete honours and masters degrees and build a moderately successful career. Throughout this period my various general practitioners tried to provide symptomatic relief but despite these interventions my illness has progressed and I eventually collapsed in early 2005 and was subsequently medically retired. I am currently unable to work and in light of the progression of my illness over the last 25 years there is no reason to expect any remission in the absence of effective treatment.

    I consider myself one of the fortunate ones in comparison with the estimated 25% of sufferers who are severely afflicted to the point of being bed-bound for years if not decades.

    The reason I am writing to you is that I believe something has gone very wrong in the treatment of ME/CFS patients in the United Kingdom. I understand that Professor Malcolm Hooper has written to you regarding the failure of the Medical Research Council to respond to a series of complaints about the MRC PACE trials, complaints detailed in his publicly available document Magical Medicine : How to make a disease disappear.

    For most of the period of my illness, I was too preoccupied with trying to stay in full time employment to keep track of research into ME/CFS beyond that which was occasionally reported by the media. However, when I first became ill, the general assumption appeared to be that the illness was caused by a yet to be identified virus and in fact the illness was alternatively referred to as Post Viral Fatigue Syndrome. In the absence of an identified virus the consensus opinion appeared to be that the cause of the disease remained unknown and the attitude of my general practitioners reflected this as they were generally supportive and open minded but unable to offer more than palliative care. My last GP however stated that he intended to challenge me - a comment that confused me at the time.

    As I'm sure you are aware, ME/CFS patients in the UK are soon to be banned from donating blood, ostensibly to protect the health of patients but, more likely, as highlighted by the ME Association, because of the recent research strongly associating ME/CFS with a newly identified human gamma-retrovirus, XMRV, and thus the potential for contamination of the UK blood supply.

    The association of XMRV with ME/CFS (and various cancers) does not of course, as yet, prove causation however the precautionary principle would suggest that this potential should be taken seriously.

    Unfortunately, it now appears that, rather than keeping and open mind about the possible aetiology of ME/CFS, the current default position (some would say dogma propagated by a small cadre of psychiatrists) is that the illness is of psychological origin an assumption that was also at one time applied to Multiple Sclerosis. UK patients are now routinely referred to psychiatrist led 'specialist' clinics where the only, and universally applied, 'treatments' offered are Cognitive Behavioural Therapy (CBT) aimed at changing 'aberrant illness beliefs' and a programme of graded exercise (GET) designed to counteract assumed physical deconditioning. This is despite a growing body of scientific evidence showing serious organic pathology and the fact that a key, if not THE cardinal symptom of ME/CFS is post exertional malaise a severe worsening of symptoms following physical or mental exertion.

    The multi million pound PACE trials are designed to provide an 'evidence base' for the subsequent mainstreaming of this biopsychosocial model of ME/CFS and its associated treatments. Despite public protestations to the contrary, the CBT/GET approach claims to be fully curative, not just, as usually presented, a pragmatic attempt to provide symptomatic relief or partial rehabilitation. However, even the latter less ambitious aims are not supported by the evidence as shown by the recently published results of the related FINE trials that found that even those modest improvements for some patients in subjectively reported symptoms were transitory with no improvements in actual physical function. Patient surveys carried out on behalf of the major UK ME/CFS charities also show CBT and particularly GET as the therapies considered least acceptable to patients with a number of patients reporting being harmed by the exercise regime. I suspect that if such modest results coupled with this level of patient unacceptability were to be found in a pharmaceutical trial the drug would never be licensed.

    In truth, the underlying psychological theory is tenuous and the associated treatments don't appear to work, yet according to data put on the public record via Hansard, the MRC have devoted the bulk of the ME/CFS research budget to the PACE trials and appear to be reluctant to fund any meaningful research into a biological cause for the illness.

    US researchers in private and public laboratories are currently forging ahead investigating the association of XMRV with ME/CFS and prostate cancer with preliminary research also suggesting possible links to other neuro-immune diseases such as MS and autism. A federal multi-laboratory team is also currently assessing the risk to the US blood supply and developing reliable testing procedures. In contrast, to the outside observer, the MRC appear to have neither the inclination to fund research into XMRV nor any sense of urgency with respect to patients or the potential risk to the wider population. In short there is little evidence of open mindedness or the precautionary principle. Like many others, I applauded you and your coalition partners when you put aside party advantage in favour of the national interest. It would be frankly unacceptable if narrow sectional interests were to hinder research into this serious debilitating disease.

    On a purely utilitarian level, which as an economist I'm sure you will appreciate, ME/CFS is the biggest cause of school absence in the UK and in one US study Leonard Jason et al (http://www.dynamic-med.com/content/7/1/6) estimated the economic impact of ME/CFS on the US economy as lying between $18 to $23 Billion annually. This is is based on an estimate of 800,000 adult sufferers in the USA and is easily pro-rata'd for the estimated 250,000 UK patients. Apart from the continuing suffering of the patients I'm sure you will agree that this currently untreatable disease represents an enormous waste of human potential.

    In conclusion, Professor Hooper has made a number of legitimate complaints to the MRC regarding the PACE trials, trials that are viewed with deep suspicion by both ME Charities and patients. Leaving aside professional courtesy, the least that the MRC can do for ME patients is to dignify Professor Hooper's complaints with a full and considered response.

    Yours sincerely

    Name and address supplied.
     
  8. OverTheHills

    OverTheHills

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    What a great letter. Congratulations Marco.

    I had/have less contempt for Vince Cable than most politicians. He showed evidence of independent thinking before the global financial crisis, can I dare hope he will do so again?

    OTH
     
  9. Angela Kennedy

    Angela Kennedy

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    That's a very nice letter Marco.
     
  10. pictureofhealth

    pictureofhealth XMRV - L'Agent du Jour

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    Likewise - Marco - a v clear and well phrased letter. I do hope both Prof Hooper, & you, will receive a well considered response.
     
  11. Marco

    Marco Grrrrrrr!

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    Thanks folks.

    Difficult to know sometimes how to phrase these things but Vince seems a level headed bloke so I tried to steer clear of any unnecessary hyperbole.

    Plus it does feel good to do something for a change, no matter how little, rather than just sitting back being done to.
     

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