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PACE trial re-analysis and the 2007 NICE guideline on ME/CFS

A.B.

A.B.

Senior Member
Messages
3,780
Jonathan Edwards said:
The real problem is that psychiatrists appear to accept a level of evidence that would not normally be considered adequate by physicians.
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The way forward then is to raise more awareness of PACE among the greater research community. They do not have these low standards or psychobabble bias that is required to defend PACE. In the UK, psychiatry seems to be deeply entrenched, and also in bed with the Lancet.
 
Daisymay

Daisymay

Senior Member
Messages
754
charles shepherd said:
Point taken

It's just that once you step into an office belong to a solicitor the clock starts ticking on the payment meter and you don't get this sort of expert legal advice for less than £250 per hour… !
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Yes but £1000, £2000 might be an excellent investment for legal advice to protect the safety of PWME.
 
R

rosieness

Messages
49
Charles, I do fully realise that you are only explaining the views of NICE and NHS England in your posts, and I’m sure you appreciate that those views are totally unacceptable to many of us and regarded as insufficient reason for them to leave the current NICE Guidelines on ME/CFS in place.

As I see it, Professor Hooper and many others questioned the scientific evidence base supporting the present NICE guidelines both during their promulgation and immediately after their Publication. And in the intervening years the mounting questions surrounding the scientific evidence base supporting the recommended treatments of GET and CBT have reached and exceeded hurricane proportions.

The IOM report unequivocally makes the case that ME/CFS is a primary biological disease and that its principle feature is an inability to tolerate exertion/exercise. A conclusion supported by objective scientific evidence.

The UK ME charities have published comprehensive reports on harms arising from GET as reported by patients and thank you very much for your invaluable work in this respect, it deserves to be listened to and acknowledged by both NICE and NHS England.

The proponents of CBT and GET have themselves published papers demonstrating the ineffectiveness of their own treatments.

All of the above led recently (6 Sept 2016) to this statement in an open letter to QMUL by a group of eminent scientists:

“The PACE trial has greatly impacted policies and attitudes toward ME/CFS, popularizing the notion that psychotherapy and exercise are effective treatments. Yet patients routinely experience serious relapses after even minimal activity. A report last year from the Institute of Medicine called this phenomenon “exertion intolerance” and identified it as the defining symptom of the disease. This key IOM finding strongly suggests that to increase activity levels, as the PACE interventions recommend, is contraindicated and potentially harmful.” (My bold)

The current NICE guidelines do not reflect or give any information whatsoever on this objectively evidenced scientific and medical view of their recommended treatments of CBT and GET. To not do so place patients at risk of potential harm from these contraindicated interventions in my view. And to withhold this information in National Guidance deprives patients of crucial information in deciding what happens to their own bodies.

It is one of the main tenets of medicine and a basic human right as reflected in the Department of Health Reference guide to consent for examination or treatment that patients have the right to determine what happens to their own bodies:

'It is a general legal and ethical principle that valid consent must be obtained before starting treatment or physical investigation, or providing personal care, for a person. This principle reflects the right of patients to determine what happens to their own bodies, and is a fundamental part of good practice.”

Thank you for all the work you do for the ME community and I really wish you well in your discussions with NICE and NHS England.

I think we must keep putting this in front of them in whatever way we can until they do listen.
 
Y

Yogi

Senior Member
Messages
1,132
charles shepherd said:
Point taken

It's just that once you step into an office belong to a solicitor the clock starts ticking on the payment meter and you don't get this sort of expert legal advice for less than £250 per hour… !
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Thanks for your responses here and explaining the situation.

Given the widespread harm that CBT and GET causes thousands and millions worldwide and the public interest in this such as petitions and all the Tuller investigation and the MEA harms report and Lancet still not retracting and therefore NICE not amending the guidelines and if all the charities asked surely some law firm may provide legal advice on a pro bono basis to charities???

Is this something that could be looked at?
 
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S

Sidereal

Senior Member
Messages
4,856
charles shepherd said:
Remember - the recommendations on CBT and GET in the 2007 NICE guideline are NOT based on the PACE trial findings. They are based on the York University systematic review of evidence from RCTs relating to CBT and GET at the time
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The York University systematic review was of low quality due to indiscriminate inclusion of studies that had a high risk of bias due to methodological problems. One would hope that NICE have been made aware of the NIH meta-analysis of CBT, GET and other treatments for ME/CFS published in the Annals of Internal Medicine in 2015 ( http://annals.org/article.aspx?articleid=2322801 ) which excluded most of those studies York included. Once you exclude methodologically unacceptable studies, as is customary in systematic reviews, you're left with a crumbling evidence base for CBT/GET, just PACE and a few small studies. And once you exclude Oxford criteria studies you're left with virtually nothing.
 
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Chrisb

Senior Member
Messages
1,051
Of course the earlier available evidence would have supported the benefits of CBT/GET.

When that is reported I quote my experience. I used to have very good, very experienced doctors who took a pragmatic view of the illness. Suddenly in about 1992/93 my then consultant told me that his clinic was to be closed. Patients were to be transferred to a new CFS clinic under the control of psychotherapists. He said I could go if I wanted to but he did not recommend it.

I presume that this was a nationwide initiative. In such circumstances it is hardly surprising that the available evidence, at the time of the preparation of NICE guidelines, would have shown the benefits of CBT/GET. One also has to consider what evidence might have been made available but wasn't. Is this not why you have to try to refute hypotheses rather than confirm them?
 
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charles shepherd

Senior Member
Messages
2,239
Chrisb said:
Of course the earlier available evidence would have supported the benefits of CBT/GET.

When that is reported I quote my experience. I used to have very good, very experienced doctors who took a pragmatic view of the illness. Suddenly in about 1992/93 my then consultant told me that his clinic was to be closed. Patients were to be transferred to a new CFS clinic under the control of psychotherapists. He said I could go if I wanted to but he did not recommend it.

I presume that this was a nationwide initiative. In such circumstances it is hardly surprising that the available evidence, at the time of the preparation of NICE guidelines, would have shown the benefits of CBT/GET. One also has to consider what evidence might have been made available but wasn't. Is this not why you have to try to refute hypotheses rather than confirm them?
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A quick bit of background information as to how NICE produces their treatment recommendations:

If we go back to the period 2005 - 2007, when the NICE guideline development group (GDG) were in action, they were working to the usual NICE remit - which is basically to consider all the results from clinical trials that have been published in peer reviewed journals

NICE don't pay much attention to research into causation - because they are producing a clinical guideline that concentrates on clinical assessment, diagnosis and management

One way in which a GDG assesses the 'Gold Standard' evidence from clinical trials is to commission a systematic review of the literature - which is what they did from the University of York. The York systematic review did a pretty exhaustive search of all the results from trials at the time (so I don't think anything was missed out) and rated the quality of all the trials that they looked at

It wasn't therefore surprising, in view of what had been published at the time, that NICE then concluded that the only two safe and effective treatment options for ME/CFS were CBT and GET

Unfortunately, patient evidence (from surveys etc) and clinician evidence (as to what experienced docs believe works and does not work) is given very low priority by NICE - even when this evidence conflicts with results from RCTs, as is the case with ME/CFS……….
 
Cheesus

Cheesus

Senior Member
Messages
1,292
Location
UK
@charles shepherd

What would you think about the MEA starting a petition on something like Change.org to ask NICE to review the clinical guidelines? I have thought about starting something along those lines in the past but I do not have the knowledge to write a bulletproof petition outline.

When petitions take off on Change.org they can sometimes attract a lot of publicity which ultimately puts the boot up the backside of the organisation being petitioned.
 
Daisymay

Daisymay

Senior Member
Messages
754
In Julie's Stats article, Professor Sir Simon Wessely commented:

"In my country (UK) there was already sufficient evidence to recommend both therapies in our NICE guidelines before PACE was published. PACE will not be retracted because there is no reason to do so, it is fully CONSORT compliant and so on, but if it had not happened the guidelines would remain the same."

I posted this reply.

"No Professor Wessely there wasn't sufficient evidence for the NICE guidelines as you must know only too well.

In correspondence between Professor Hooper and Frances Rawle, Head of Corporate Governance and Policy at the MRC, Rawle unambiguously admitted that prior to PACE there was a lack of sufficiently strong evidence to inform the use of CBT/GET for ME/CFS:


http://margaretwilliams.me/2011/hooper-reply-to-mrc-rawle_26jan2011.pdf

Prof. Hooper said to Frances Rawle:

"You attempt to justify the MRC’s funding of the PACE Trial by stating:

"there was a lack of high quality evidence to inform treatment of CFS/ME and in particular on the need to evaluate treatments that were already in use and for which there was insufficiently strong evidence from random controlled trials of their effectiveness”.
That is a remarkable admission, since the NICE Clinical Guideline 53 of August 2007 relies upon the pre-PACE Trial “evidence -base” to recommend the use of CBT and GET nationally as the intervention of choice for ME/CFS, yet you state in your letter that there was insufficient evidence for the implementation of this nationwide programme of CBT and GET recommended by NICE in its Clinical Guideline 53.

In other words, on the one hand Professor Peter White was strongly promoting CBT/GET in his submissions to NICE because he asserted that there was sufficient evidence of their efficacy for their implementation across the nation, yet on the other hand he has received millions of pounds of tax payers’ money to carry out the PACE Trial because there was NOT sufficient evidence of the efficacy of the same interventions.

This can only mean that since August 2007 NICE has been promoting interventions and subjecting sick people throughout the nation to a regime for which insufficient evidence exists, a situation that raises yet more legal issues and ramifications, since the correct option for NICE pending the outcome of the PACE Trial was to have recommended the use of CBT and GET “only in research”, not to have issued recommendations for widespread clinical use when evidence of efficacy for those interventions was insufficient at the time the Guideline was published.

This raises the issue of exactly why the Guideline Development Group was so determined to implement nationwide CBT and GET on an insufficient evidence-base."


Also in the PACE Trial Protocol, March 2007, White et al used the lack of evidence for the efficacy of CBT/GET as a justification for the PACE trial:

http://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-7-6


"Chronic fatigue syndrome (CFS, also called myalgic encephalomyelitis/encephalopathy or ME) is a debilitating condition with no known cause or cure. Improvement may occur with medical care and additional therapies of pacing, cognitive behavioural therapy and graded exercise therapy. The latter two therapies have been found to be efficacious in small trials, but patient organisations' surveys have reported adverse effects."


"Two independent systematic reviews have found that rehabilitative cognitive behaviour therapy (CBT) and GET were the most promising treatments for CFS/ME in secondary care [5,10,11,12]. The published trials of these treatments were however also criticized for being too small, too selective, and for using different outcome measures. No other treatments for CFS/ME have so far been shown to be helpful in more than one RCT [5,12]."


And from the full PACE trial paper:


http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3065633/#bib4


"The UK National Institute for Health and Clinical Excellence (NICE) recommend cognitive behaviour therapy (CBT) and graded exercise therapy (GET).2 Although this recommendation was supported by systematic reviews,4–7 supporting evidence remains restricted to small trials.4–7 Surveys by patients' organisations in the UK have reported that CBT and GET are sometimes harmful, and have recommended pacing and specialist health care.8,9"



So we have both Frances Rawle, MRC and the PACE authors admitting that prior to PACE there was insufficient scientific evidence for the efficacy and safety of CBT/GET.


And here's Dr Neil Abbott's clear and concise article exposing the flaws and limitations of the NICE evidence base:


http://www.meresearch.org.uk/wp-content/uploads/2012/11/NICE_Evidence.pdf
 
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C

charles shepherd

Senior Member
Messages
2,239
Cheesus said:
@charles shepherd

What would you think about the MEA starting a petition on something like Change.org to ask NICE to review the clinical guidelines? I have thought about starting something along those lines in the past but I do not have the knowledge to write a bulletproof petition outline.

When petitions take off on Change.org they can sometimes attract a lot of publicity which ultimately puts the boot up the backside of the organisation being petitioned.
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Thanks - this is a very sensible suggestion which is already on the radar

We will be discussing this option at the MEA Board of Trustees meeting next Monday

I will also raise it when all the ME/CFS charities meet at the House of Lords on October 25th

But we need to get the timing right if this goes ahead

My instinct is to wait until we know what sort of official response is being made by The Lancet - I am aware of the exchange that David Tuller has just had with the Lancet!
 
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charles shepherd

Senior Member
Messages
2,239
BurnA said:
Thanks once again but what makes you think The Lancet will reply ?
Judging on prior episodes I think it's very much head in the sand time.
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You may well be right and The Lancet does not reply and carries on as usual

If this is the case then it will affect what happens next and how - if we go down the petition route - a petition is organised and worded

At the moment there are clearly a considerable number of uncertainties as to what the key players here - Lancet, those involved in the PACE trial, NICE, charities - are going to do and what happens next…..

At the moment the various ME/CFS charities clearly need to be listening to what their members are saying

Which is what we are doing……..
 
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