ALERT: FRAUDULENT ME/CFS STUDY

European Society for ME:

ALERT: FRAUDULENT 'CFS/ME' STUDY - DIRE INTERNATIONAL CONSEQUENCES.

Collective International Professional Response to PACE Required? Feel free to REPOST this to proffesionals and campainers.


Dear All,

I write in response to the just-published results of the UK MRC/DWP-backed PACE Trial on 'CFS/ME' in The Lancet[1]. Which, amidst controversy and formal complaints to UK Government Ministers and the Medical Research Council claims that: "CBT and GET can safely be added to SMC [Standard Medical Care] to moderately improve outcomes for chronic fatigue syndrome, but APT [Adaptive Pacing Therapy] is not an effective addition." The full pdf version of the published Lancet PACE Trial paper is attached herewith.

Apart from rightly raised concerns about methodology, patient selection criteria and conflicts of interest, in my view, essentially what Professor Peter White et al have done with the PACE Trial is conflated two diseases that the WHO rightly categorises separately - neurological 'ME/PVFS' (ICD-10-G93.3) and psychiatric 'Fatigue Syndrome' (ICD-10-F.48.0) - and misrepresented the latter as the former.

The PACE Trial is thereby an effective response to Professor Simon Wessely's call for such an approach in his article in the British Medical Journal back in 2003 - where he misrepresented WHO ME/PVFS taxonomy as merely the patients' own "lay label" and then advocated tactics of what he called "constructive relabelling" to humour and mislead patients whilst advancing a questionable psychiatric agenda:

"Our challenge arises when patients have named their condition in a way that leaves doctors uncomfortable, as occurred with chronic fatigue syndrome. It may seem that adopting the lay label endorses the implicit causal theory and reinforces perceived disability. For better or worse, the medical profession has lost the monopoly on naming conditions, and rejecting lay terms can needlessly alienate patients. A compromise strategy is "constructive labelling," expanding on the lay name. It would mean treating chronic fatigue syndrome as a legitimate illness, acknowledging that it may have a viral trigger (as many patients report), while gradually expanding the understanding of the condition to incorporate the psychological and social dimensions." ['Managing patients with inexplicable health problems.' Simon Wessely, Baruch Fischhoff. BMJ 2003;326-595-7. doi:10.1136/bmj.326.7389.595]:
http://www.bmj.com/cgi/content/full/326/7389/595
http://www.bmj.com/cgi/reprint/326/7389/595

Read the PACE Trial manuals in the light of Wessely's BMJ words and ask yourself if the inherent misleading and manipulation of research subjects described therein should have passed genuine scientific ethics standards:
http://www.pacetrial.org/trialinfo.html
http://tinyurl.com/3xj3uke
http://tinyurl.com/37h35ca

At the request of many beleaguered ME patients, Professor Malcolm Hooper has bravely laboured to expose what he identifies as serious scientific flaws in the PACE Trial and the MRC approach. His brief and erudite response to the PACE/Lancet press-release is attached herewith and available online at:
http://www.meactionuk.org.uk/Hooper-response-to-PACE-Trial-Press-Release.htm
Professor Hooper's more detailed critique of PACE/MRC and formal complaint is available at:
http://www.meactionuk.org.uk/magical-medicine.htm

The UK National Institute for Health and Clinical Excellence (NICE) have already said that they will review their 'CFS/ME' Guideline 53 when the PACE Trial is published: having previously refused to do so on the basis of biomedical research evidence presented to them - even though the Guideline was due for a scheduled three-yearly review last August. With the published PACE Trial results under their belt, NICE are widely expected to firm-up their behavioural guideline and make it harder for doctors to treat 'CFS/ME' patients in any way other than with CBT/GET in spite of growing international evidence contraindicating such an approach.

Their is also concern of serious conflicts of interest at the UK Department of Work and Pensions (DWP) who part-funded the PACE Trial. Like the permanent health insurance industry, the DWP has a potential financial vested interest if patients' disability can be portrayed as caused by or largely exacerbated by behavioural factors. Thus the UK parliamentarian Gibson Group on the Scientific Research into ME rightly warned in its 2006 report:

“There have been numerous cases where advisers to the DWP have also had consultancy roles in medical insurance companies. Particularly the Company UNUM Provident. Given the vested interest private medical insurance companies have in ensuring CFS/ME remain classified as a psychosocial illness there is blatant conflict of interest here. The Group find this to be an area for serious concern and recommends a full investigation of this possibility by the appropriate standards body. It may even be that assessment by a medical ‘expert’ in a field of high controversy requires a different methodology of benefit assessment.” [2].

Such is the broad establishment head of steam supporting insurance-industry-linked psychological approaches to misrepresented patients with the neuro-immune disease classified by the WHO at ICD-10-G93.3 (ME/PVFS), that the PACE Trial results are likely to have a major adverse effect upon such patients around the world as well as in the UK. I believe therefore that a considered collective professional response to the PACE Trial from biomedical ME specialists and interested professionals/academics around the world is urgently needed: a joint statement or joint academic paper condemning what amounts to an abuse of both scientific process and international medical taxonomy. I hope that the ME community, together with responsible professionals, can work to produce such a response.

Anglia ME Action (UK).
contact@angliameaction.org.uk
19 February 2011.

ENDNOTES:

[1] Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial
Professor PD White et al. The Lancet, Early Online Publication, 18 February 2011
doi:10.1016/S0140-6736(11)60096-2
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2811%2960096-2/abstract
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2811%2960096-2/fulltext#
http://download.thelancet.com/pdfs/journals/lancet/PIIS0140673611600962.pdf?id=5bbe37e152166496:-237c741a:12e382b6f7d:-d641298025501163

[2] Page 30 - The Report of the UK Group on the Scientific Research into ME (GSRME), entitled: Inquiry into the Status of CFS/ME and Research into Causes and Treatment. November 2006.] At the GSRME House of Commons Website:
www.erythos.com/gibsonenquiry/index.html