Guest guest Posted April 21, 2011 Report Share Posted April 21, 2011 Below you will find the first part of a complaint by Prof. Malcolm Hooper to the editor of The Lancet about the PACE Trial (White at al) and an article by Bleijenberg & Knoop; who practice the same anti-science activities and misleading information about ME/CFS as their UK partners. For private members the full text of this complaint is attached in Word format, but can also be found at: http://www.meactionuk.org.uk/COMPLAINT-to-Lancet-re-PACE.doc http://www.meactionuk.org.uk/COMPLAINT-to-Lancet-re-PACE.htm ~jan van roijen ```` REPORT: COMPLAINT TO THE RELEVANT EXECUTIVE EDITOR OF THE LANCET ABOUT THE PACE TRIAL ARTICLES PUBLISHED BY THE LANCET Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial PD White et al published online February 18, 2011 DOI:10.1016/S0140-6736(11)60096-2 (FAST TRACKED) and Chronic fatigue Syndrome: where to PACE from here? G Bleijenberg and H Knoop published online February 18, 2011 DOI:10.1016/S0140-6736(11)60172-4 Submitted by Malcolm Hooper, Emeritus Professor of Medicinal Chemistry (with grateful acknowledgment to members of the ME/CFS community) March 2011 PREAMBLE In 1996 when psychiatrists Drs. White and Simon Wessely co-authored a review of " Chronic Fatigue Syndrome " (Joint Royal Colleges Report, CR54, October 1996), a Lancet editorial roundly condemned the publication ( " Frustrating survey of chronic fatigue " , Volume 348, Issue 9033, Page 971, 12 October 1996): " Psychiatry has won the day for now …. The sixteen-strong committee was top-heavy with psychiatric experts, so the emphasis on psychological causes and management is no surprise …. We believe that the report was haphazardly set-up, biased, and inconclusive, and is of little help to patients or their physicians " . In 2011, when Professors White and Wessely collaborated in a multi-centre trial of cognitive behaviour therapy and graded exercise for " CFS " , peer review at The Lancet failed to identify the same faults. " Psychiatry has won the day " again - but only because once again the same people have not been subjected to sufficiently rigorous scientific scrutiny. INTRODUCTION This report deals with the results of the PACE Trial published in The Lancet in the following sections: 1. Terminology and Classification 2. Fast track publication 3. The competing interests of the PACE Trial team 4. The Principal Investigators were not studying classic ME/CFS 5. Failure to comply with professional ethical guidance and codes of practice 6. Failure to " control " the PACE Trial 7. Adverse events/reactions and serious deterioration 8. Changes to the entry criteria 9. Consideration of the data on outcomes 10. Data not reported/measures dropped 11. Overview of reporting results 12. Announcement of results to press at the Science Media Centre 13. Summary/Conclusion. Having served as an examiner in UK and other universities at graduate and postgraduate level, acted as referee for a number of scientific journals and served on an editorial Board, and having served on the Committee of the Council for National Academic Awards and also of the World Health Organisation, it is my professional opinion, based on the extensive published biomedical evidence about myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and supported by over 2,000 pages of evidence obtained under the Freedom of Information Act (FOIA), that the PACE Trial itself was unethical and unscientific: the Investigators had already formed their opinion about the intended outcome; entry criteria were used that have no credibility; definitions and outcome measures were changed repeatedly; data appears to have been manipulated, obfuscated, or not presented at all (so it cannot be checked), and the authors' interpretation of their published data as " moderate " success is unsustainable. Significant problems with the PACE Trial were identified from the outset and were brought to the attention of the Medical Research Council (a co-funder), who for over eleven months failed to respond. The concerns thus became the subject of at least two separate formal complaints at Ministerial level. A formal complaint about the West Midlands Multicentre Research Ethics Committee (MREC) that approved the PACE Trial Protocol was also served on the National Research Ethics Service (NRES) at the National Patient Safety Agency. The Lancet has published a report of a study about which legitimate and serious concerns were raised that are centred on apparent coercion and exploitation of patients; on the contempt in which patients are seen to be held; on manipulation; on pretension and misrepresentation; on reliance on flawed studies yielding meaningless results; on the remarkable lack of scientific rigour throughout the trial; on the unusual personal financial interest of the Chief Principal Investigator (whose own money funded the PACE Trial entry criteria); on the vested interests of all the Principal Investigators, of the Director of the PACE Clinical Trial Unit and of the centre statistician; on the intentional inclusion of patients who do not suffer from the disorder supposedly being studied; on the lack of individual equipoise, and the failure to adhere to CONSORT (Consolidated Standards of Reporting Trials), to the Department of Health Research Governance Framework for Health and Social Care, Second Edition, 2005; 2:3:1; to the General Medical Council " Good Practice in Research " and " Consent to Research " , and to the Declaration of Helsinki (which is clear: " Authors, editors and publishers all have ethical obligations with regard to the publication of the results of research….Reports of research not in accordance with the principles of this Declaration should not be accepted for publication " ). On the basis of evidence seen, the underlying non-clinical purpose of the trial had the primary aim of removing patients from benefits (ie. the use of motivational behaviour therapy to achieve the intended result of the cessation of State/insurance benefits for patients with ME/CFS), as those involved with the trial continue to maintain that for people with ME/CFS, " medical intervention is no longer appropriate " and that the aim of therapy is to " reduce healthcare usage " (http://www.meactionuk.org.uk/Problems_and_Solutions.htm). In one of the MRC secret files about ME/CFS held at the National Archives in Kew (files that are closed for an unusually lengthy period of 73 years instead of the customary 30 years, some of which have been legally obtained), one of the Principal Investigators (PIs) of the PACE Trial (Professor Sharpe), admitted that CBT and GET were: " a purely pragmatic approach and without theoretical foundation " (CIBA Foundation Symposium, 12th-14th May 1992, reference S 1528/1). Particularly notable is that the same document states about ME/CFS patients: " The first duty of the doctor is to…avoid the legitimisation of symptoms and reinforcement of disability " . Avoiding the legitimisation of the symptoms of ME/CFS was considered by many to be the purpose of the PACE Trial. The Manuals used in the PACE Trial show that the authors either ignored medical science or that they do not understand medical science. The Manuals describe behaviours and techniques that should not -- and I believe cannot -- be considered ethical by any independent and reasonable observer, particularly the intense pressure on both therapists and participants to obtain the " right " results for the PIs and their funders (pressures that are supported by participants' published comments). Much of the written information and instruction to therapists and doctors is contradictory and internally inconsistent and appears highly exploitative, as well as revealing an ignorance of ME/CFS. One of the substantive complaints to the Minister about the PACE Trial can be accessed at http://www.meactionuk.org.uk/magical-medicine.htm and it addresses in detail the numerous ethical and scientific failures of the study. As Chief Principal Investigator, Professor White was aware of these complaints and in the interests of transparency and under the requirement for disclosure had a duty to bring them to the attention of The Lancet editorial staff before publication of the PACE Trial results, which he failed to do. For The Lancet to have published an article reporting a study that completely ignored the existing biomedical evidence-base of over 4,000 published papers about the disorder allegedly studied, including documented physiological contra- indications regarding aerobic exercise, is a matter of concern to the international scientific community, as it is in defiance of basic principles of scientific research. It also contravenes the Elsevier Editorial System (Ethics in Publishing: Instructions to Authors) which, under " Ethics and Procedures (General) " , sets out its " fundamental principles " that " the paper should….be appropriately placed in the context of prior and existing research " . Indeed, the UK Department of Health, a co-funder of the PACE Trial, stipulates that: " All existing sources of evidence…must be considered carefully before undertaking research " (Research Governance Framework for Health and Social Care, Second Edition, 2005; 2:3:1). Not only did White et al ignore the international biomedical evidence-base pertaining to ME/CFS, whilst in their article they make reference to the FINE Trial (Fatigue Intervention by Nurses Evaluation, a sibling of the PACE Trial), they do not point out that it failed (BMJ 2010:340:c1777), and they also failed to take due cognisance of the mixed evidence-base about the efficacy of CBT/GET which shows that those interventions are not effective in general and specifically that they may be harmful for people with ME/CFS. Feedback from almost 5,000 ME/CFS patients via several charities indicates that deterioration following exercise is reported in almost 50% of cases and indeed, in 2002 the Chief Medical Officer's Working Group Report highlighted the disparity between feedback from patients and the reported findings of the Wessely School (see below), stating: " …the data clearly indicate that the York review results (of controlled trials) do not reflect the full spectrum of patients' experience " . Nine years later, the £5 million PACE Trial (at a cost of £7,500 per participant) takes us no further forward, as safe guidance on management options must address the needs of all patients with ME/CFS. The PACE Trial excluded those more severely affected by ME/CFS (since including such patients would have greatly reduced any apparent benefit of the interventions), so it is not the case that the PACE Trial results are generalisable to all people with the disorder as claimed by the authors. It is essential that the findings of the PACE Trial are properly identified, interpreted and presented. The most pressing concern is that the findings published in The Lancet will be deemed appropriate for all people with ME/CFS, many of whom stand to suffer iatrogenic harm from incremental aerobic exercise because the findings of research conducted on the Oxford criteria (as used in the PACE Trial) cannot justifiably be applied to people with classic ME as recommended in The Lancet article, even with the authors' caveat " only if fatigue is their main symptom " . Thus a major factor motivating this complaint is that, as a result of The Lancet article, it is highly likely, perhaps even inevitable, that patients with classic ME/CFS will be forced to undertake exercise regimes as " rehabilitation " on pain of losing their State benefits, which are often their sole means of financial survival. Such regimes are guaranteed to exacerbate the symptoms of an already very difficult-to-bear illness. In such a situation, resort to suicide is not unimaginable and indeed already occurs with higher than normal regularity. The President of the International Association for ME/CFS, Professor Fred Friedberg from Stony Brook University, New York, emphasised his concern about the take-home message from the press conference held at the Science Media Centre (where Professor Wessely, Director of the PACE Clinical Trial Unit, is on the Science Advisory Panel) which rapidly led to the spread of false information around the world, that message being: " Exercise is good; Rest is bad " , because the evidence is that exercise regimes are " potentially harmful for patients with CFS/ME " . In his own press release, Professor Friedberg commented about the PACE Trial article in The Lancet: " The most fundamental concern we have is focused on the type of causal model that was linked to the CBT and GET conditions in this study. The model, based on the application of cognitive behavioural and physical deconditioning principles, predicts that properly designed behavioural or exercise interventions will 'reverse' the CFS illness. Not improve symptoms/functioning or provide better management, but 'reverse' the illness. This term implies that the illness can be cured (or something close to it) with behavioural techniques….If one assumes such a direct correspondence between behavioural treatment and curative outcomes, then the illness is by implication a psychiatric condition….Perhaps this is the most unfortunate aspect of the PACE trial: the omission of any reference to the medical complexity of this illness " http://www.iacfsme.org/PACETrial/tabid/450/Default.aspx In his closing remarks to an annual conference of about 300 civil servants on 3rd February 2011 held in London, the Government's Chief Scientific Advisor (Professor Sir Beddington CMG, FRS) said that pseudo-science ought to be considered in the same way as racism: " We are grossly intolerant, and properly so, of racism….We are not…grossly intolerant of pseudo-science, the building up of what purports to be science by the cherry-picking of the facts and the failure to use scientific evidence and the scientific method " (http://bit.ly/eUNIrB). To have published the contrived results of what can only be described as pseudo- science is not only damaging to patients but also to The Lancet, as well as raising legal implications for clinicians who may rely on the published conclusions of the study and who might thereby be in breach of GMC regulations and of advice from the medical defence unions. Quote Link to comment Share on other sites More sharing options...
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